(Ikke-lovgivningsmæssige retsakter) FORORDNINGER

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1 DA Den Europæiske Unions Tidende L 139/1 II (Ikke-lovgivningsmæssige retsakter) FORORDNINGER KOMMISSIONENS DELEGEREDE FORORDNING (EU) Nr. 492/2014 af 7. marts 2014 om udbygning af Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 for så vidt angår regler for fornyelse af godkendelser af biocidholdige produkter, der er omfattet af gensidig anerkendelse (EØS-relevant tekst) EUROPA-KOMMISSIONEN HAR under henvisning til traktaten om Den Europæiske Unions funktionsmåde, under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter ( 1 ), særlig artikel 40, første afsnit, og ud fra følgende betragtninger: (1) Der bør fastsættes supplerende regler for fornyelse af nationale godkendelser, som er omfattet af gensidig anerkendelse i overensstemmelse med artikel 4 i Europa-Parlamentets og Rådets direktiv 98/8/EF ( 2 ) eller artikel 33 og 34 i forordning (EU) nr. 528/2012, både i de medlemsstater, der har meddelt den oprindelige godkendelse, og i de medlemsstater, som har udstedt godkendelser i kraft af gensidig anerkendelse af denne oprindelige godkendelse. (2) For at undgå unødvendigt dobbeltarbejde og for sikre sammenhæng bør fornyelse af godkendelser, der er omfattet af gensidig anerkendelse, i første omgang forvaltes af den kompetente myndighed i en enkelt referencemedlemsstat. Med henblik på at skabe fleksibilitet for ansøgere og kompetente myndigheder bør ansøgeren have mulighed for at vælge referencemedlemsstat med forbehold af sidstnævntes samtykke. (3) Med henblik på at lette proceduren og de opgaver, som de kompetente myndigheder skal udføre, bør denne forordnings anvendelsesområde begrænses til de godkendelser, bortset fra enkelte undtagelser, der har samme vilkår og betingelser i alle medlemsstaterne på tidspunktet for ansøgningen om fornyelse. For andre nationale godkendelser bør en ansøgning om fornyelse indgives til den pågældende medlemsstat i overensstemmelse med artikel 31 forordning (EU) nr. 528/2012. (4) Indholdet af en ansøgning om fornyelse af en national godkendelse er fastsat i artikel 31 forordning (EU) nr. 528/2012. For ansøgninger om fornyelse af nationale godkendelser, der er tildelt på grundlag af gensidig anerkendelse, bør ansøgningens indhold imidlertid specificeres yderligere bl.a. for at lette arbejdet for de medlemsstater, der er involveret i fornyelse af disse godkendelser. (5) Af hensyn til arbejdsbyrden i forbindelse med vurderingen bør den tid, der afsættes til at behandle en ansøgning, afhænge af, om der er behov for en fuldstændig vurdering. ( 1 ) EUT L 167 af , s. 1. ( 2 ) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af , s. 1).

2 L 139/2 DA Den Europæiske Unions Tidende (6) For at opnå samme grad af beskyttelse, når en godkendelse fornys, som ved den oprindelige meddelelse, bør den fornyede godkendelses maksimale gyldighedsperiode ikke overstige den oprindelige godkendelses gyldighedsperiode. Desuden bør der fastsættes udfasningsbestemmelser for de eksisterende produkter på medlemsstaternes markeder for de godkendelser, for hvilke en ansøgning om fornyelse ikke indgives eller afvises. (7) Enhver tvist om vurderingen af ansøgninger om fornyelse bør forelægges koordinationsgruppen, der er nedsat ved forordning (EU) nr. 528/2012, med henblik på at undersøge tvister vedrørende produkternes godkendelse og åbne mulighed for undtagelser fra princippet om gensidig anerkendelse på grundlag af den generelle begrundelse for sådanne undtagelser, der er fastsat i nævnte forordnings artikel 37. (8) For at opnå større forudsigelighed bør agenturet opstille retningslinjer for, hvordan fornyelser af ansøgninger håndteres, og retningslinjerne ajourføres regelmæssigt på grundlag af erfaringerne og den videnskabelige eller tekniske udvikling VEDTAGET DENNE FORORDNING: Artikel 1 Genstand og anvendelsesområde 1. Ved denne forordning fastsættes bestemmelser om fornyelse af en national godkendelse af et biocidholdigt produkt eller en familie af biocidholdige produkter, der har været omfattet af gensidig anerkendelse efter artikel 4 direktiv 98/8/EF eller artikel 33 og 34 i forordning (EU) nr. 528/2012, eller en national godkendelse, der er meddelt ved en sådan gensidig anerkendelse (i det følgende benævnt en»godkendelse«). 2. Denne forordning gælder for godkendelser, der har samme vilkår og betingelser på tidspunktet for ansøgningen om fornyelse i alle de medlemsstater, hvori der ansøges om fornyelse. 3. Denne forordning gælder også godkendelser på forskellige vilkår og betingelser med hensyn til et eller flere af følgende aspekter: a) De vedrører alene oplysninger, der kan være genstand for en administrativ ændring i overensstemmelse med Kommissionens gennemførelsesforordning (EU) nr. 354/2013 ( 1 ). b) De følger af en tilpasning af den oprindelige godkendelse på grundlag af artikel 4, stk. 1, andet og tredje afsnit, i direktiv 98/8/EF. c) De er fastsat ved en kommissionsafgørelse, der er vedtaget i henhold til enten artikel 4, stk. 4, i direktiv 98/8/EF eller artikel 37, stk. 2, litra b), i forordning (EU) nr. 528/2012. d) De følger af en aftale med ansøgeren i henhold til artikel 37, stk. 2, første afsnit, i forordning (EU) nr. 528/2012, eller fra tilsvarende aftaler, der er indgået ved gennemførelsen af bestemmelserne i artikel 4 i direktiv 98/8/EF. Artikel 2 Ansøgningens indhold 1. En ansøgning om fornyelse af en godkendelse skal foretages ved hjælp af det ansøgningsskema, der findes i registeret over biocidholdige produkter, og den skal indeholde følgende: a) navnet på den medlemsstat, der har vurderet den oprindelige ansøgning om godkendelse, eller i givet fald den medlemsstat, som ansøgeren har valgt, sammen med en skriftlig bekræftelse af, at medlemsstaten indvilger i at være ansvarlig for vurderingen af ansøgningen om fornyelse (i det følgende benævnt»referencemedlemsstaten«) b) en liste over alle andre medlemsstater, hvori der ansøges om fornyelse af en godkendelse (i det følgende benævnt de»berørte medlemsstater«), som også skal omfatte numrene på de godkendelser, der er udstedt af referencemedlemsstaten og de berørte medlemsstater ( 1 ) Kommissionens gennemførelsesforordning (EU) nr. 354/2013 af 18. april 2013 om ændringer af biocidholdige produkter, der er godkendt i henhold til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 (EUT L 109 af , s. 4).

3 L 139/3 Den Europæiske Unions Tidende DA c) bekræftelse fra ansøgeren om, at disse godkendelser er omfattet af denne forordnings anvendelsesområde, jf. artikel 1, stk. 2 og 3 d) alle relevante data, som kræves i henhold til artikel 31, stk. 3, litra a), i forordning (EU) nr. 528/2012, og som ansøgeren har tilvejebragt siden den oprindelige godkendelse eller i givet fald den foregående fornyelse, medmindre disse oplysninger allerede er forelagt agenturet i det krævede format e) et udkast til resumé af det biocidholdige produkts egenskaber med de oplysninger, der kræves i henhold til artikel 22, stk. 2, i forordning (EU) nr. 528/2012, på referencemedlemsstatens og de berørte medlemsstaters officielle sprog, og som i relevante tilfælde kan afvige mellem medlemsstaterne i overensstemmelse med denne forordnings artikel 1, stk. 3 f) ansøgerens vurdering af, om konklusionerne af den første eller foregående vurdering af det biocidholdige produkt eller familien af biocidholdige produkter fortsat er gyldige, herunder en kritisk gennemgang af alle oplysninger, der meddeles efter artikel 47 i forordning (EU) nr. 528/2012, herunder eventuelle supplerende oplysninger af værdi for denne vurdering, medmindre de allerede findes i registret over biocidholdige produkter. 2. Ved anvendelsen af stk. 1, litra d), skal ansøgningen om fornyelse af en godkendelse i givet fald også indeholde: a) en liste over de foranstaltninger, som skal gennemføres af indehaveren af godkendelsen ifølge betingelserne for gyldigheden af godkendelsen i en hvilken som helst medlemsstat, og en bekræftelse af, at disse foranstaltninger er truffet b) en liste over afgørelser om ændringer, som en medlemsstat har godkendt før den 1. september 2013 c) en liste over de afgørelser om ændringer, som en medlemsstat har godkendt ifølge gennemførelsesforordning (EU) nr. 354/2013 d) en liste over meddelelser eller ansøgninger om ændringer, som er indgivet til en medlemsstat i henhold til gennemførelsesforordning (EU) nr. 354/2013, men som ikke er færdigbehandlet på tidspunktet for indgivelsen af ansøgningen om fornyelse. Referencemedlemsstatens kompetente myndighed kan ved vurderingen af ansøgningen anmode om at få forelagt en kopi af de afgørelser, der er nævnt i litra b) og c). Artikel 3 Indgivelse og validering af ansøgningen 1. Ansøgere, som ønsker at ansøge om en fornyelse af en godkendelse af eller på vegne af en godkendelsesindehaver (i det følgende benævnt»ansøgeren«), skal indgive en ansøgning til referencemedlemsstatens kompetente myndighed mindst 550 dage før godkendelsens udløbsdato. 2. Ansøgeren skal samtidig med indgivelsen af ansøgningen til referencemedlemsstaten forelægge de kompetente myndigheder i de berørte medlemsstater en ansøgning om fornyelse af de godkendelser, der er meddelt i de berørte medlemsstater. 3. De kompetente myndigheder i referencemedlemsstaten og i de berørte medlemsstater oplyser ansøgeren om de gebyrer, der skal erlægges i henhold til artikel 80 i forordning (EU) nr. 528/2012, og afviser ansøgningen, hvis ansøgeren ikke har betalt gebyrerne inden for 30 dage. De giver ansøgeren og de øvrige kompetente myndigheder meddelelse herom. 4. Ved modtagelsen af disse gebyrer accepterer de kompetente myndigheder i referencemedlemsstaten og i de berørte medlemsstater ansøgningen og giver ansøgeren meddelelse herom med angivelse af datoer for accept. 5. Inden 30 dage efter referencemedlemsstatens accept skal denne medlemsstat validere ansøgningen, hvis den indeholder alle de relevante oplysninger, der er omhandlet i artikel 2. Referencemedlemsstaten underretter ansøgeren og de andre berørte medlemsstater herom. Ved valideringen af ansøgningen vurderer referencemedlemsstaten ikke de fremlagte datas eller begrundelsers kvalitet, eller om de er fyldestgørende.

4 L 139/4 DA Den Europæiske Unions Tidende Senest 30 dage efter en berørt medlemsstats accept skal den pågældende medlemsstat verificere, om godkendelsen er omfattet af denne forordnings anvendelsesområde, jf. artikel 1, stk. 2, og 3. Hvis godkendelsen ikke er omfattet af denne forordnings anvendelsesområde, skal den kompetente myndighed i den berørte medlemsstat behandle ansøgningen som en ansøgning, der er indgivet i henhold til artikel 31, stk. 1, i forordning (EU) nr. 528/2012, og den skal underrette ansøgeren og de kompetente myndigheder i andre medlemsstater herom. 7. Hvis referencemedlemsstatens kompetente myndighed finder, at ansøgningen er ufuldstændig, anmoder den ansøgeren om supplerende oplysninger med henblik på at validere ansøgningen, og den fastsætter en rimelig frist for indgivelse af disse oplysninger. Fristen må normalt ikke overstige 90 dage. Referencemedlemsstatens kompetente myndighed validerer ansøgningen senest 30 dage efter modtagelsen af de supplerende oplysninger, hvis disse oplysninger er tilstrækkelige til, at ansøgningen opfylder kravene i artikel 2. Referencemedlemsstatens kompetente myndighed afviser en ansøgning, hvis ansøgeren ikke inden for tidsfristen fremlægger de oplysninger, der kræves, og underretter ansøgeren og de øvrige berørte medlemsstater herom. Artikel 4 Vurdering af ansøgningen 1. På grundlag af de foreliggende oplysninger og i lyset af den aktuelle videnskabelige viden skal referencemedlemsstatens kompetente myndighed senest 90 dage efter valideringen af ansøgningen afgøre, om en fuldstændig vurdering af ansøgningen om fornyelse er nødvendig. 2. Såfremt en fuldstændig vurdering er nødvendig, skal referencemedlemsstatens kompetente myndighed udarbejde en vurderingsrapport efter den procedure og de tidsfrister, der er fastsat i artikel 30 forordning (EU) nr. 528/2012. I vurderingsrapporten skal det konkluderes, om betingelserne for at meddele godkendelsen, jf. forordningens artikel 19, fortsat er opfyldt, og der tages hensyn til resultaterne af den sammenlignende vurdering, som er foretaget i overensstemmelse med nævnte forordnings artikel 23, hvor dette er relevant. Uden at dette berører artikel 30, stk. 2, første afsnit, i forordning (EU) nr. 528/2012, skal vurderingsrapporten og et udkast til resumé af det biocidholdige produkts egenskaber sendes til de berørte medlemsstater og til ansøgeren senest 365 dage efter, at ansøgningen er valideret. 3. Såfremt en fuldstændig vurdering ikke er nødvendig, udarbejder referencemedlemsstaten en vurderingsrapport efter proceduren i litra a), b) og c) i artikel 30, stk. 3, i forordning (EU) nr. 528/2012. I denne rapport skal det konkluderes, om betingelserne for at meddele godkendelsen, jf. forordningens artikel 19, er opfyldt, og der tages hensyn til resultaterne af den sammenlignende vurdering, som er foretaget i overensstemmelse med nævnte forordnings artikel 23, hvor dette er relevant. Vurderingsrapporten og udkastet til resumé af det biocidholdige produkts egenskaber skal sendes til de berørte medlemsstater og til ansøgeren senest 180 dage efter, at ansøgningen er valideret. Artikel 5 Afgørelse om fornyelse 1. Senest 90 dage efter modtagelsen af vurderingsrapporten og udkastet til resumé af det biocidholdige produkts egenskaber, og med forbehold af artikel 6, skal de berørte medlemsstater nå til enighed om resuméet af det biocidholdige produkts egenskaber undtagen, i givet fald, de forskelle, der er nævnt i artikel 1, stk. 3, litra a), og de skal registrere deres godkendelse i registret over biocidholdige produkter. Referencemedlemsstaten indfører det godkendte resumé af det biocidholdige produkts egenskaber og den endelige vurderingsrapport i registret over biocidholdige produkter sammen med godkendte vilkår og betingelser, som pålægges i forbindelse med tilgængeliggørelsen på markedet eller anvendelsen af det biocidholdige produkt eller familien af biocidholdige produkter.

5 L 139/5 Den Europæiske Unions Tidende DA 2. Senest 30 dage efter, at der er opnået enighed, fornyer referencemedlemsstaten og hver berørt medlemsstat godkendelserne i overensstemmelse med det godkendte resumé af det biocidholdige produkts egenskaber. Uden at dette berører bestemmelserne i artikel 23, stk. 6, i forordning (EU) nr. 528/2012, skal godkendelsen fornys i en periode på højst 10 år. 3. Uden at dette berører artikel 7, gælder det, at når der ikke er opnået enighed inden 90 dage, kan hver medlemsstat, der godkender resuméet af det biocidholdige produkts egenskaber, jf. stk. 1, forny godkendelsen i overensstemmelse hermed. 4. Såfremt der på grund af forhold, der ikke kan tilskrives indehaveren af en godkendelse, ikke er truffet afgørelse om fornyelsen af denne godkendelse, inden den udløber, fornyer den pågældende kompetente myndighed godkendelsen i en periode, der er tilstrækkelig til, at vurderingen kan afsluttes. Artikel 6 Overgangsperiode Artikel 52 i forordning (EU) nr. 528/2012 finder anvendelse på eksisterende beholdninger af biocidholdige produkter, som tilgængeliggøres på følgende markeder: a) på en medlemsstats marked, hvor der ikke er indgivet ansøgning om fornyelse, eller hvor en ansøgning afvises i henhold til artikel 3, stk. 3, i denne forordning b) på referencemedlemsstatens og de berørte medlemsstaters marked, hvis referencemedlemsstaten afviser ansøgningen om fornyelse i henhold til artikel 3, stk. 3, eller artikel 3, stk. 7, tredje afsnit, i denne forordning. Artikel 7 Koordinationsgruppe, voldgift og undtagelse fra gensidig anerkendelse 1. En berørt medlemsstat kan foreslå at afvise at forny en godkendelse eller at ændre vilkår og betingelser i en godkendelse, jf. artikel 37 i forordning (EU) nr. 528/ I andre tilfælde end dem, som er nævnt i stk. 1, hvor de berørte medlemsstater ikke når til enighed om vurderingsrapportens konklusioner, eller, hvis det er relevant, resuméet af det biocidholdige produkts egenskaber som foreslået af referencemedlemsstaten i henhold til artikel 5, stk. 1, forelægger referencemedlemsstaten spørgsmålet for den koordinationsgruppe, som er nedsat ved artikel 35 i forordning (EU) nr. 528/2012. Hvis en berørt medlemsstat er uenig med referencemedlemsstaten, giver førstnævnte medlemsstat en detaljeret begrundelse for sine synspunkter til de øvrige berørte medlemsstater og ansøgeren. 3. Artikel 35 og 36 i forordning (EU) nr. 528/2012 er gældende for de uenigheder, der er nævnt i stk. 2. Artikel 8 Retningslinjer for håndtering af fornyelser i procedurerne for gensidig anerkendelse 1. Efter høring af medlemsstaterne, Kommissionen og interesseparterne opstiller agenturet retningslinjer for håndteringen af fornyelser af godkendelser, som er omfattet af denne forordning. 2. Disse retningslinjer ajourføres regelmæssigt, idet der tages højde for bidragene fra medlemsstater og interesseparter om gennemførelsen heraf såvel som den videnskabelige og tekniske udvikling.

6 L 139/6 DA Den Europæiske Unions Tidende Artikel 9 Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende. Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver medlemsstat. Udfærdiget i Bruxelles, den 7. marts På Kommissionens vegne José Manuel BARROSO Formand

7 EN Official Journal of the European Union L 139/1 II (Non-legislative acts) REGULATIONS COMMISSION DELEGATED REGULATION (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) No 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular the first paragraph of Article 40 thereof, Whereas: (1) It is appropriate to lay down supplementary rules for the renewal of national authorisations having been subject to mutual recognition in accordance with Article 4 of Directive 98/8/EC of the European Parliament and of the Council ( 2 ) or with Articles 33 and 34 of Regulation (EU) No 528/2012, both in the Member States where the first authorisations were granted and in those Member States having granted authorisations through mutual recognition of the first authorisations. (2) In order to avoid unnecessary duplication of work and to ensure consistency, renewal of authorisations having been subject to mutual recognition should in the first place be managed by the competent authority of one single reference Member State. In order to provide flexibility to applicants and competent authorities, the applicant should have the opportunity to choose the reference Member State subject to the latter's agreement. (3) In order to facilitate the smooth running of the procedure and the tasks to be carried out by the competent authorities, the scope of this Regulation should be limited to those authorisations having, apart from limited exceptions, the same terms and conditions in all the Member States at the time of the application for renewal. For other national authorisations, an application for renewal should be submitted to the Member State in question in accordance with Article 31 of Regulation (EU) No 528/2012. (4) The content of an application for renewal of a national authorisation is specified under Article 31 of Regulation (EU) No 528/2012. However, for applications for renewal of national authorisations granted on the basis of mutual recognition, the content of the application should be further specified, in particular to facilitate the work of the Member States involved in the renewal of these authorisations. (5) To take into account the workload associated with the evaluation, the time allowed for processing an application should depend on whether or not a full evaluation needs to be performed. ( 1 ) OJ L 167, , p. 1. ( 2 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1).

8 L 139/2 EN Official Journal of the European Union (6) In order to provide the same level of protection when an authorisation is renewed as when it is first granted, the maximum validity of the renewed authorisations should not exceed that of the initial authorisations. In addition, phasing-out provisions for the existing products on the market of Member States should be set for those authorisations for which an application for renewal is not submitted or is rejected. (7) It is appropriate to refer any disagreement in the evaluation of renewal applications to the coordination group established under Regulation (EU) No 528/2012 for the purpose of examining disagreements relating to product authorisation, and to allow derogations from mutual recognition based on the general grounds for such derogations laid down in Article 37 of that Regulation. (8) In order to bring further predictability, guidelines on the details related to the handling of renewals should be developed by the Agency and regularly updated on the basis of experience and scientific or technical progress, HAS ADOPTED THIS REGULATION: Article 1 Subject matter and scope 1. This Regulation lays down rules for the renewal of a national authorisation of a biocidal product or a biocidal product family that has been subject to mutual recognition in accordance with Article 4 of Directive 98/8/EC or with Articles 33 and 34 of Regulation (EU) No 528/2012, or of a national authorisation granted through such mutual recognition (hereinafter referred to as an authorisation ). 2. This Regulation shall apply to authorisations having the same terms and conditions at the time of the application for renewal in all the Member States where the renewal is sought. 3. This Regulation shall also apply to authorisations having different terms and conditions on one or more of the following aspects: (a) concerning merely information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 ( 1 ); (b) derived from an adjustment of the initial authorisation based on the second and third subparagraphs of Article 4(1) of Directive 98/8/EC; (c) established by a Commission Decision adopted either in accordance with Article 4(4) of Directive 98/8/EC or in accordance with Article 37(2)(b) of Regulation (EU) No 528/2012; (d) derived from an agreement with the applicant under the first subparagraph of Article 37(2) of Regulation (EU) No 528/2012, or from equivalent agreements reached when implementing the provisions of Article 4 of Directive 98/8/EC. Article 2 Content of the application 1. An application for renewal of an authorisation shall be made by using the application form available from the Register for Biocidal Products and shall contain the following: (a) the name of the Member State which evaluated the initial application for authorisation or, where relevant, the Member State having been chosen by the applicant together with written confirmation that the Member State agrees to be responsible for the evaluation of the application for renewal (hereinafter referred to as the reference Member State ); (b) a list of all other Member States where the renewal of an authorisation is sought (hereinafter the Member States concerned ), which shall also include the numbers of the authorisations granted by the reference Member State and the Member States concerned; ( 1 ) Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, , p. 4).

9 L 139/3 Official Journal of the European Union EN (c) confirmation from the applicant that those authorisations fall within the scope of this Regulation as provided for by Article 1(2) and (3); (d) all relevant data required under Article 31(3)(a) of Regulation (EU) No 528/2012 that the applicant has generated since the initial authorisation or, as appropriate, previous renewal, unless those data have already been submitted to the Agency in the required format; (e) a draft summary of the biocidal product characteristics containing the information required under Article 22(2) of Regulation (EU) No 528/2012, in the official languages of the reference Member State and of the Member States concerned which, where relevant, may differ between Member States in accordance with Article 1(3) of this Regulation; (f) the applicant's assessment of whether the conclusions of the initial or previous assessment of the biocidal product or biocidal product family remain valid, including a critical review of any information notified in accordance with Article 47 of Regulation (EU) No 528/2012, including any supporting information to that assessment where it is not already available on the Register for Biocidal Products. 2. For the purposes of paragraph 1(d), where applicable, the application for renewal of an authorisation shall also contain: (a) a list of the actions to be completed by the authorisation holder according to the conditions for the validity of the authorisation in any Member State and confirmation that these actions have been completed; (b) a list of the decisions on changes agreed by any Member State before 1 September 2013; (c) a list of the decisions on changes agreed by any Member State in accordance with Implementing Regulation (EU) No 354/2013; (d) a list of the notifications or applications for changes submitted to any Member State in accordance with Implementing Regulation (EU) No 354/2013, which are pending at the time of the submission of the application for renewal. The competent authority of the reference Member State may, for the purposes of the evaluation of the application, request the submission of a copy of the decisions referred to in points (b) and (c). Article 3 Submission and validation of the application 1. An applicant wishing to seek the renewal of an authorisation by or on behalf of an authorisation holder (hereinafter the applicant ) shall submit an application to the competent authority of the reference Member State at least 550 days before the expiry date of the authorisation. 2. The applicant shall, at the same time when submitting the application to the reference Member State, submit to the competent authorities of the Member States concerned an application for renewal of the authorisations granted in those Member States. 3. The competent authorities of the reference Member State and of the Member States concerned shall inform the applicant of the fees payable under Article 80 of Regulation (EU) No 528/2012 and shall reject the application if the applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities accordingly. 4. Upon receipt of those fees, the competent authorities of the reference Member State and of the Member States concerned shall accept the application and inform the applicant indicating the dates of acceptance. 5. Within 30 days of the acceptance in the reference Member State, that Member State shall validate the application if it contains all the relevant information referred to in Article 2. The reference Member State shall inform the applicant and the Member States concerned accordingly. When validating the application, the reference Member State shall not make an assessment of the quality or adequacy of the data or justifications submitted.

10 L 139/4 EN Official Journal of the European Union Within 30 days of acceptance by a Member State concerned, that Member State shall verify whether the authorisation falls within the scope of this Regulation as provided for by Article 1(2) and (3). Where the authorisation does not fall within the scope of this Regulation, the competent authority in the Member State concerned shall process the application as an application submitted in accordance with Article 31(1) of Regulation (EU) No 528/2012 and it shall inform the applicant and the competent authorities in other Member States accordingly. 7. Where the competent authority of the reference Member State considers that the application is incomplete, it shall require additional information for the validation of the application from the applicant and shall set a reasonable time limit for the submission of that information. The time limit shall not normally exceed 90 days. The competent authority of the reference Member State shall, within 30 days of receipt of the additional information, validate the application if the additional information is sufficient for the application to comply with the requirements laid down in Article 2. The competent authority of the reference Member State shall reject the application if the applicant fails to submit the required information within the deadline and shall inform the applicant and the Member States concerned accordingly. Article 4 Evaluation of the application 1. On the basis of an assessment of the available information and in the light of current scientific knowledge, the competent authority of the reference Member State shall, within 90 days of validating the application, decide whether a full evaluation of the application for renewal is necessary. 2. Where a full evaluation is necessary, the competent authority of the reference Member State shall draft an assessment report, following the procedure and timelines set out in Article 30 of Regulation (EU) No 528/2012. The assessment report shall conclude on whether the conditions for granting the authorisation set out in Article 19 of that Regulation are still satisfied, and take into account the results of the comparative assessment carried out in accordance with Article 23 of that Regulation, where appropriate. Without prejudice to the first subparagraph of Article 30(2) of Regulation (EU) No 528/2012, the assessment report and the draft summary of biocidal product characteristics shall be sent to the Member States concerned and to the applicant within 365 days of validating the application. 3. Where a full evaluation is not necessary, the reference Member State shall draft an assessment report, following the procedure laid down in points (a), (b) and (c) of Article 30(3) of Regulation (EU) No 528/2012. This report shall conclude on whether the conditions for granting the authorisation set out in Article 19 of that Regulation are met, and take into account the results of the comparative assessment carried out in accordance with Article 23 of that Regulation, where appropriate. The assessment report and the draft summary of biocidal product characteristics shall be sent to the Member States concerned and to the applicant within 180 days of validating the application. Article 5 Decision on renewal 1. Within 90 days of receipt of the assessment report and the draft summary of biocidal product characteristics, and subject to Article 6, the Member States concerned shall agree on the summary of biocidal product characteristics, with the exception, where relevant, of the differences referred to in Article 1(3)(a), and shall record their agreement in the Register for Biocidal Products. The reference Member State shall enter the agreed summary of biocidal product characteristics and the final assessment report in the Register for Biocidal Products, together with any agreed terms or conditions imposed on the making available on the market or use of the biocidal product or biocidal product family.

11 L 139/5 Official Journal of the European Union EN 2. Within 30 days of reaching agreement, the reference Member State and each of the Member States concerned shall renew the authorisations in conformity with the agreed summary of biocidal product characteristics. Without prejudice to the provisions of Article 23(6) of Regulation (EU) No 528/2012, the authorisation shall be renewed for a maximum period of 10 years. 3. Without prejudice to Article 7, where no agreement is reached within 90 days, each Member State that agrees to the summary of biocidal product characteristics referred to in paragraph 1 may renew the authorisation accordingly. 4. Where, for reasons beyond the control of the holder of an authorisation, no decision is taken on the renewal of that authorisation before its expiry, the respective competent authority shall grant a renewal for the period necessary to complete the evaluation. Article 6 Period of grace Article 52 of Regulation (EU) No 528/2012 shall apply to existing stocks of the biocidal product made available on the following markets: (a) on the market of a Member State to which no application for renewal has been submitted or which has rejected an application pursuant to Article 3(3) of this Regulation; (b) on the market of the reference Member State and of the Member States concerned, where the reference Member State rejects the application for renewal in accordance with Article 3(3) or the third subparagraph of Article 3(7) of this Regulation. Article 7 Coordination group, arbitration and derogation from mutual recognition 1. A Member State concerned may propose to refuse to renew an authorisation or to adjust the terms and conditions of the authorisation in accordance with Article 37 of Regulation (EU) No 528/ Where, regarding matters other than those referred to in paragraph 1, the Member States concerned do not reach an agreement on the conclusions of the assessment report or, where relevant, on the summary of the biocidal product characteristics proposed by the reference Member State in accordance with Article 5(1), the reference Member State shall refer the matter to the coordination group established under Article 35 of Regulation (EU) No 528/2012. Where a Member State concerned is in disagreement with the reference Member State, the former shall give a detailed statement of the reasons for its position to all Member States concerned and to the applicant. 3. Articles 35 and 36 of Regulation (EU) No 528/2012 shall apply to matters of disagreement referred to in paragraph 2. Article 8 Guidance on handling renewals in the mutual recognition procedures 1. The Agency shall, after consulting the Member States, the Commission and interested parties, draw up guidelines on the details related to the handling of renewals of authorisations covered by this Regulation. 2. Those guidelines shall be regularly updated, taking into account the contributions from Member States and stakeholders on its implementation as well as scientific and technical progress.

12 L 139/6 EN Official Journal of the European Union Article 9 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 7 March For the Commission The President José Manuel BARROSO

13 DA Den Europæiske Unions Tidende L 294/1 II (Ikke-lovgivningsmæssige retsakter) FORORDNINGER KOMMISSIONENS DELEGEREDE FORORDNING (EU) Nr. 1062/2014 af 4. august 2014 om det arbejdsprogram for systematisk undersøgelse af alle eksisterende aktivstoffer i biocidholdige produkter, der er omhandlet i Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 (EØS-relevant tekst) EUROPA-KOMMISSIONEN HAR under henvisning til traktaten om Den Europæiske Unions funktionsmåde, under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter ( 1 ), særlig artikel 89, stk. 1, første afsnit, og ud fra følgende betragtninger: (1) I Kommissionens forordning (EF) nr. 1451/2007 ( 2 ) fastsættes der detaljerede regler for undersøgelsesprogrammet for eksisterende aktivstoffer i biocidholdige produkter (»undersøgelsesprogrammet«), som blev indledt i overensstemmelse med artikel 16, stk. 2, i Europa-Parlamentets og Rådets direktiv 98/8/EF ( 3 ). Da direktivet er blevet ophævet og erstattet af forordning (EU) nr. 528/2012, bør de detaljerede regler for videreførelse af undersøgelsesprogrammet tilpasses den forordnings bestemmelser. (2) Det er vigtigt at udpege, hvilke kombinationer af aktivstof og produkttype der, medmindre andet fremgår af de nationale bestemmelser, kan markedsføres og anvendes i henhold til de overgangsbestemmelser, der er fastlagt i artikel 89 i forordning (EU) nr. 528/2012. Dette bør være tilfældet med kombinationer af aktivstof og produkttype, der vurderes under undersøgelsesprogrammet. (3) Når et produkt er omfattet af undtagelsen for fødevarer og foderstoffer i artikel 6 i forordning (EF) nr. 1451/2007, men ikke af undtagelsen for fødevarer og foderstoffer i artikel 2, stk. 5, litra a), i forordning (EU) nr. 528/2012, bør de aktivstoffer, det indeholder, vurderes i undersøgelsesprogrammet for den relevante produkttype. Medmindre andet er fastlagt i de nationale bestemmelser, bør produktet kunne markedsføres og anvendes, indtil vurderingen er afsluttet. En ordning med forhåndsgodkendelse bør definere, hvilke produkter der er omfattet af denne bestemmelse. Det samme gælder, når den manglende anmeldelse af en kombination af aktivstof og produkttype skyldes den nye definition af produkttyper i forordning (EU) nr. 528/2012 sammenholdt med ( 1 ) EUT L 167 af , s. 1. ( 2 ) Kommissionens forordning (EF) nr. 1451/2007 af 4. december 2007 om den anden fase af det tiårs arbejdsprogram, der er omhandlet i artikel 16, stk. 2, i Europa-Parlamentets og Rådets direktiv 98/8/EF om markedsføring af biocidholdige produkter (EUT L 325 af , s. 3). ( 3 ) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af , s. 1).

14 L 294/2 DA Den Europæiske Unions Tidende direktiv 98/8/EF eller er begrundet i en afgørelse truffet af Kommissionen i henhold til artikel 3, stk. 3, i forordning (EU) nr. 528/2012, i retspraksis som f.eks. sag C-420/10 ( 1 ) eller i en bindende vejledning fra Kommissionen eller medlemsstaternes kompetente myndigheder, som efterfølgende undersøges. (4) Hvis et biocidholdigt produkt indeholder, består af eller genererer et aktivstof, som ikke længere indgår i undersøgelsesprogrammet, men anvendelsen af dette biocidholdige produkt er nødvendigt i en medlemsstat, bør denne anvendelse og tilgængeliggørelsen på markedet med henblik på denne anvendelse tillades i den pågældende medlemsstat på medlemsstatens ansvar, på visse betingelser og i et begrænset tidsrum. (5) For at sikre konsekvens og forenkling bør proceduren for vurdering af aktivstoffer i undersøgelsesprogrammet i alle de relevante dele være identisk med proceduren i forbindelse med ansøgninger, der indsendes i henhold til artikel 7 i forordning (EU) nr. 528/2012 eller i henhold til Kommissionens gennemførelsesforordning (EU) nr. 88/2014 ( 2 ). (6) I forbindelse med stoffer, der opfylder udelukkelses- og substitutionskriterierne, bør den kompetente vurderingsmyndighed fremsende et forslag til agenturet om en harmoniseret klassificering og mærkning i henhold til artikel 37, stk. 1, i Europa-Parlamentets og Rådets forordning (EF) nr. 1272/2008 ( 3 ) for så vidt angår de effektparametre, der giver anledning til bekymring, men bevarer samtidig retten til at fremsende et forslag vedrørende andre eller alle effektparametre. Den kompetente myndighed, der foretager vurderingen, bør også høre agenturet om stoffer, som opfylder kriterierne for at være persistente, bioakkumulerende eller toksiske, og om stoffer, der kan anses for at være hormonforstyrrende. (7) For at sikre, at undersøgelsesprogrammet afsluttes på datoen i artikel 89, stk. 1, i forordning (EU) nr. 528/2012, bør vurderingerne begrænses til de kombinationer af aktivstof og produkttype, for hvilke de relevante data er indsendt inden for tidsfristerne i forordning (EF) nr. 1451/2007 eller denne forordning. Endvidere bør der fastsættes passende tidsfrister for afslutning af vurderingerne under hensyntagen til den mulighed, at ansøgningerne bliver valideret mindre end et år før disse tidsfrister. (8) Der er endnu ikke fastsat nogen datakrav for optagelse i kategori 7 i bilag I til forordning (EU) nr. 528/2012. Derfor bør ansøgningerne om optagelse i dette bilag til kategori 1, 2, 3, 4, 5 eller 6 på nuværende tidspunkt begrænses. (9) Uanset artikel 90, stk. 2, i forordning (EU) nr. 528/2012 følger det af samme forordnings artikel 91, at kriterierne i forordningens artikel 10 bør være relevante for den efterfølgende godkendelse af biocidholdige produkter i alle tilfælde. Derfor bør de stoffer, der opfylder disse kriterier, udpeges i alle vurderinger af aktivstoffer. (10) En potentiel deltager i undersøgelsesprogrammet bør kunne slutte sig til eller indtræde i stedet for en eksisterende deltager efter fælles overenskomst, forudsat at vurderingen ikke derved forsinkes af begrænset dataadgang, idet den potentielle ansøger ellers ville være nødt til at fremlægge dataene igen. (11) Eftersom deltagelse i undersøgelsesprogrammet er frivillig, bør en deltager kunne udtræde af programmet. Sker det, bør potentielle deltagere kunne overtage støtten, medmindre den mulighed allerede har været benyttet én gang, således at undersøgelsesprogrammet allerede er blevet forsinket, og hvis agenturet ikke allerede er begyndt at arbejde på sin udtalelse. (12) Når det under vurderingen af et aktivstof viser sig, at den identitet, der formelt indgår i undersøgelsesprogrammet, ikke svarer nøjagtigt til det stof, der rent faktisk vurderes, og vurderingen ikke gør det muligt at drage konklusioner vedrørende den formelt optagne stofidentitet, bør det være muligt at omdefinere stoffet under vurderingen og tillade andre at overtage støtten til det formelt optagne stof. ( 1 ) Sag C-420/10:Domstolens dom (Tredje Afdeling) af 1. marts 2012 Söll GmbH mod Tetra GmbH (anmodning om præjudiciel afgørelse fra Landgericht Hamburg Tyskland) (Markedsføring af biocidholdige produkter direktiv 98/8/EF artikel 2, stk. 1, litra a) begrebet»biocidholdige produkter«et produkt, der bevirker flokkulation af skadegørere, uden at disse ødelægges, hindres eller uskadeliggøres). ( 2 ) Kommissionens gennemførelsesforordning (EU) nr. 88/2014 af 31. januar 2014 om fastlæggelse af en procedure for ændring af bilag I til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter (EUT L 32 af , s. 3). ( 3 ) Europa-Parlamentets og Rådets forordning (EF) nr. 1272/2008 af 16. december 2008 om klassificering, mærkning og emballering af stoffer og blandinger og om ændring og ophævelse af direktiv 67/548/EØF og 1999/45/EF og om ændring af forordning (EF) nr. 1907/2006 (EUT L 353 af , s. 1).

15 L 294/3 Den Europæiske Unions Tidende DA (13) Visse stoffer, der indgår i undersøgelsesprogrammet, støttes ikke af nogen deltagere på tidspunktet for vedtagelsen af denne forordning. Det samme gælder visse nanomaterialer, selv om sådanne materialer i henhold til artikel 4, stk. 4, i forordning (EU) nr. 528/2012 kun godkendes, hvor dette specifikt er nævnt. Deltagelsen for disse stoffer og nanomaterialer bør kunne overtages af andre personer, og ellers bør disse stoffer og nanomaterialer udelukkes fra undersøgelsesprogrammet. (14) For at sikre, at ingen stoffer uberettiget forbliver i eller medtages i undersøgelsesprogrammet uden efterfølgende at blive vurderet, bør et stof, der endnu ikke er under vurdering, kun forblive eller medtages i programmet, hvis der indsendes væsentlige data om stoffet VEDTAGET DENNE FORORDNING: KAPITEL 1 GENSTAND OG DEFINITIONER Artikel 1 Genstand I denne forordning fastsættes reglerne for gennemførelse af det arbejdsprogram for systematisk undersøgelse af alle eksisterende aktivstoffer i biocidholdige produkter, der er omhandlet i artikel 89 i forordning (EU) nr. 528/2012. Artikel 2 Definitioner I denne forordning forstås ved: a)»afgørelse om afvisning af godkendelse«: en afgørelse om ikke at godkende en kombination af stof og produkttype i medfør af artikel 9, stk. 1, litra b), eller artikel 89, stk. 1, tredje afsnit, i forordning (EU) nr. 528/2012, eller om ikke at optage det i bilag I eller IA til direktiv 98/8/EF b)»kombination af stof og produkttype, der indgår i undersøgelsesprogrammet«: en kombination af stof og produkttype på listen i bilag II, som opfylder følgende krav: i) det er ikke omfattet af nogen af følgende: et direktiv om optagelse i bilag I eller IA til direktiv 98/8/EF en forordning om, at det er godkendt i medfør af artikel 89, stk. 1, tredje afsnit, i forordning (EU) nr. 528/2012 ii) det er ikke omfattet af en afgørelse om afvisning af godkendelse, eller den seneste afgørelse om afvisning af godkendelse er trukket tilbage c)»deltager«: en person, som har indsendt en ansøgning vedrørende en kombination af stof og produkttype, der indgår i undersøgelsesprogrammet, eller som har indsendt en anmeldelse, der er i overensstemmelse med artikel 17, stk. 5, eller på hvis vegne en sådan ansøgning eller anmeldelse er blevet indsendt d)»kompetent vurderingsmyndighed«: den kompetente myndighed, som den medlemsstat, der er anført i bilag II, har udpeget i henhold til artikel 81 i forordning (EU) nr. 528/2012.

16 L 294/4 DA Den Europæiske Unions Tidende KAPITEL 2 PROCEDURE FOR VURDERING AF DOSSIERER Artikel 3 Ansøgning om godkendelse eller optagelse i bilag I til forordning (EU) nr. 528/ En ansøgning om godkendelse eller optagelse i bilag I til forordning (EU) nr. 528/2012 kan kun fremsendes af en deltager, hvis anmeldelse agenturet mener, opfylder kravene i henhold til denne forordnings artikel 17, stk. 5. Når ansøgningen vedrører optagelse i bilag I til forordning (EU) nr. 528/2012, kan den kun vedrøre kategori 1, 2, 3, 4, 5 eller 6 i dette bilag. 2. De i stk. 1 nævnte ansøgninger skal indsendes til agenturet senest to år efter udstedelsen af den i artikel 17, stk. 5, omhandlede overensstemmelseserklæring. Artikel 4 Accept af ansøgninger 1. Agenturet oplyser deltageren om de gebyrer, der skal erlægges i henhold til Kommissionens gennemførelsesforordning (EU) nr. 564/2013 ( 1 ), og afviser ansøgningen, hvis deltageren ikke har betalt gebyrerne inden for 30 dage. Det giver deltageren og den kompetente vurderingsmyndighed meddelelse herom. 2. Ved modtagelsen af de gebyrer, der skal erlægges i henhold til gennemførelsesforordning (EU) nr. 564/2013, accepterer agenturet ansøgningen og giver deltageren og den kompetente vurderingsmyndighed meddelelse herom med angivelse af datoen for accept af ansøgningen og dens entydige identifikationskode. 3. De afgørelser, som agenturet træffer i henhold til artikel 77, stk. 1, i forordning (EU) nr. 528/2012, kan påklages i overensstemmelse med denne artikel. 4. Den kompetente vurderingsmyndighed informerer deltageren om de gebyrer, der skal erlægges i henhold til artikel 80, stk. 2, i forordning (EU) nr. 528/2012 inden for 30 dage fra agenturets accept af ansøgningen, og afviser ansøgningen, hvis deltageren ikke betaler gebyrerne inden for 30 dage. Den giver deltageren og agenturet meddelelse herom. Artikel 5 Validering af ansøgninger om godkendelse eller optagelse i kategori 6 i bilag I til forordning (EU) nr. 528/ Når agenturet i medfør af artikel 4, stk. 2, har accepteret en ansøgning om godkendelse eller optagelse i kategori 6 i bilag I til forordning (EU) nr. 528/2012 indeholdende de data, der kræves i henhold til artikel 6, stk. 1 og 2, og gebyret er betalt i overensstemmelse med artikel 4, stk. 4, validerer den kompetente vurderingsmyndighed ansøgningen inden for 30 dage fra betalingen af gebyrerne. 2. Når den kompetente vurderingsmyndighed har modtaget dossieret fra deltageren i henhold til forordning (EF) nr. 1451/2007, men endnu ikke har accepteret dossieret som fuldstændigt i henhold til denne forordnings artikel 13, validerer den kompetente vurderingsmyndighed ansøgningen senest den 3. januar Den kompetente vurderingsmyndighed foretager ikke i de i stk. 1 og 2 omhandlede tilfælde en vurdering af kvaliteten eller tilstrækkeligheden af de fremlagte data eller begrundelser. 4. Finder den kompetente vurderingsmyndighed, at ansøgningen er ufuldstændig, informerer den deltageren om, hvilke supplerende oplysninger der er nødvendige for, at ansøgningen kan valideres, og den fastsætter en rimelig frist for fremsendelse af disse oplysninger. Denne frist må normalt ikke overstige 90 dage. ( 1 ) Kommissionens gennemførelsesforordning (EU) nr. 564/2013 af 18. juni 2013 om gebyrer og afgifter til Det Europæiske Kemikalieagentur i henhold til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter (EUT L 167 af , s. 17).

17 DA Den Europæiske Unions Tidende L 294/5 Den kompetente vurderingsmyndighed validerer ansøgningen senest 30 dage efter modtagelsen af de supplerende oplysninger, hvis den vurderer, at disse oplysninger er tilstrækkelige til, at ansøgningen opfylder kravet i stk. 2. Den kompetente vurderingsmyndighed afviser ansøgningen, hvis deltageren ikke inden for tidsfristen fremlægger de krævede oplysninger, og underretter deltageren og agenturet herom. I så fald tilbagebetales en del af det gebyr, der er indbetalt i henhold til artikel 80, stk. 1 og 2, i forordning (EU) nr. 528/2012. Når den kompetente vurderingsmyndighed har valideret en ansøgning, giver den straks deltageren, agenturet og andre kompetente myndigheder meddelelse herom med angivelse af datoen for valideringen. Artikel 6 Vurdering af ansøgninger 1. Denne artikel finder anvendelse, når en af følgende betingelser gør sig gældende: a) en ansøgning er blevet valideret i henhold til artikel 5 b) den kompetente vurderingsmyndighed har accepteret dossieret som fuldstændigt i henhold til artikel 13 i forordning (EF) nr. 1451/2007, men har endnu ikke sendt rapporten fra den kompetente myndighed til Kommissionen i henhold til samme forordnings artikel 14, stk. 4 c) agenturet har accepteret en ansøgning om optagelse i kategori 1, 2, 3, 4 eller 5 i bilag I til forordning (EU) nr. 528/2012 i overensstemmelse med artikel 4, stk. 2, og gebyret er blevet betalt i henhold til artikel 4, stk Den kompetente vurderingsmyndighed vurderer en ansøgning i overensstemmelse med artikel 4 og 5 i forordning (EU) nr. 528/2012, herunder i givet fald ethvert forslag om at tilpasse datakravene, som fremlægges i henhold til samme forordnings artikel 6, stk. 3, og fremsender en vurderingsrapport og konklusionerne af sin vurdering til agenturet. 3. Når flere deltagere støtter den samme kombination af stof og produkttype, udarbejder den kompetente vurderingsmyndighed kun en enkelt vurderingsrapport. Vurderingsrapporten og konklusionerne fremsendes inden for en af følgende tidsfrister, afhængigt af hvilken der er senest: a) 365 dage efter den seneste validering nævnt i stk. 1, litra a), accept af fuldstændighed som omhandlet i stk. 1, litra b), eller betaling af det i stk. 1, litra c), omhandlede gebyr for den pågældende kombination af stof og produkttype b) de i bilag III fastsatte tidsfrister. 4. Inden den kompetente vurderingsmyndighed fremlægger sine konklusioner for agenturet, giver den deltageren mulighed for inden for 30 dage at indgive skriftlige bemærkninger til vurderingsrapporten og konklusionerne af vurderingen. Den kompetente vurderingsmyndighed tager behørigt hensyn til disse bemærkninger i forbindelse med udarbejdelsen af den endelige vurdering. 5. Viser det sig, at der, for at vurderingen kan gennemføres, er behov for supplerende oplysninger, anmoder den kompetente vurderingsmyndighed deltageren om at fremsende sådanne oplysninger inden for en nærmere fastsat tidsfrist, og underretter agenturet herom. Den i stk. 3 omhandlede frist på 365 dage stilles i bero fra den dato, hvor der anmodes om supplerende oplysninger, og den genoptages først på den dato, hvor oplysningerne modtages. Berostillelsen må ikke overstige følgende tidsfrister, medmindre det er begrundet i arten af de ønskede oplysninger eller særlige omstændigheder: a) 365 dage, når de supplerende oplysninger vedrører spørgsmål, der ikke er omhandlet i direktiv 98/8/EF eller i den praksis, der er indført i forbindelse med gennemførelse af dette direktiv b) 180 dage i alle andre tilfælde. 6. Finder den kompetente vurderingsmyndighed, at den kumulative virkning af anvendelsen af biocidholdige produkter indeholdende de samme eller andre aktivstoffer giver anledning til bekymring for menneskers sundhed, dyrs sundhed eller miljøet, skal den dokumentere dette i overensstemmelse med de i de relevante bestemmelser i afsnit II.3 i bilag XV til Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 ( 1 ) omhandlede krav og tilføje dette som en del af sine konklusioner. ( 1 ) Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 af 18. december 2006 om registrering, vurdering og godkendelse af samt begrænsninger for kemikalier (REACH), om oprettelse af et europæisk kemikalieagentur og om ændring af direktiv 1999/45/EF og ophævelse af Rådets forordning (EØF) nr. 793/93 og Kommissionens forordning (EF) nr. 1488/94 samt Rådets direktiv 76/769/EØF og Kommissionens direktiv 91/155/EØF, 93/67/EØF, 93/105/EF og 2000/21/EF (EUT L 396 af , s. 1).

18 L 294/6 DA Den Europæiske Unions Tidende Når den kompetente vurderingsmyndighed har afsluttet sin risikovurdering, skal den straks og senest ved fremsendelsen af vurderingsrapporten i henhold til stk. 3, alt efter omstændighederne: a) fremsende et forslag til agenturet i henhold til artikel 37, stk. 1, i forordning (EF) nr. 1272/2008, når den mener, at et af de i denne forordnings artikel 36, stk. 1, opstillede kriterier er opfyldt og ikke er behandlet korrekt i del 3 i bilag VI til denne forordning b) konsultere agenturet, når den mener, at et af kriterierne i artikel 5, stk. 1, litra d) eller e), i forordning (EU) nr. 528/2012 eller betingelsen i artikel 10, stk. 1, litra d), i denne forordning er opfyldt og ikke er behandlet korrekt i bilag XIV til forordning (EF) nr. 1907/2006 eller i den i denne forordnings artikel 59, stk. 1, omhandlede kandidatliste. Artikel 7 Agenturets udtalelse 1. Denne artikel finder anvendelse, når en af følgende betingelser gør sig gældende: a) den kompetente vurderingsmyndighed har fremsendt en vurderingsrapport i henhold til artikel 6, stk. 2, og, hvor det er relevant, et forslag eller en konsultation i henhold til artikel 6, stk. 7 b) den kompetente myndigheds rapport er blevet fremsendt til Kommissionen i henhold til artikel 14, stk. 4, i forordning (EF) nr. 1451/2007, men Det Stående Udvalg for Biocidholdige Produkter har endnu ikke gennemgået vurderingsrapporten i henhold til den pågældende forordnings artikel 15, stk Når rapporten er accepteret, udarbejder og fremlægger agenturet en udtalelse for Kommissionen om godkendelse af kombinationen af stof og produkttype eller dens optagelse i kategori 1, 2, 3, 4, 5 eller 6 i bilag I til forordning (EU) nr. 528/2012 eller begge dele afhængigt af den kompetente vurderingsmyndigheds konklusioner. Agenturet påbegynder udarbejdelsen af udtalelsen inden for en af følgende tidsfrister, afhængigt af hvilken der er senest: a) tre måneder fra accept af rapporten b) de i bilag III fastsatte tidsfrister. Agenturet fremlægger udtalelsen for Kommissionen senest 270 dage efter, at det har påbegyndt udarbejdelsen af den. Artikel 8 Aktivstoffer, som er kandidater til substitution 1. Agenturet undersøger ved udarbejdelsen af sin udtalelse i henhold til artikel 7, stk. 2, om aktivstoffet opfylder et eller flere af kriterierne i artikel 10, stk. 1, i forordning (EU) nr. 528/2012, og nævner dette i sin udtalelse. 2. Inden agenturet fremsender sin udtalelse til Kommissionen, offentliggør det oplysninger om potentielle kandidater til substitution i en periode på højst 60 dage, hvor andre interesserede parter kan indgive relevante oplysninger, herunder oplysninger om tilgængelige erstatningsstoffer, jf. artikel 66 og 67 i forordning (EU) nr. 528/2012. Agenturet tager i forbindelse med udarbejdelsen af den endelige udtalelse behørigt hensyn til de oplysninger, der modtages. 3. Når aktivstoffet er godkendt og opfylder et af kriterierne i artikel 10, stk. 1, i forordning (EU) nr. 528/2012, skal det anføres som kandidat til substitution i den forordning, der vedtages i henhold til den pågældende forordnings artikel 89, stk. 1, første afsnit. Artikel 9 Kommissionens afgørelse Når Kommissionen har modtaget agenturets udtalelse i henhold til artikel 7, stk. 2, udarbejder den straks et udkast til afgørelse, som skal vedtages i henhold til artikel 89, stk. 1, eller alt efter omstændighederne artikel 28, stk. 1, i forordning (EU) nr. 528/2012.

19 L 294/7 Den Europæiske Unions Tidende DA KAPITEL 3 ÆNDRINGER AF ELEMENTER I UNDERSØGELSESPROGRAMMET Artikel 10 Tilslutning og udskiftning af deltagere efter fælles overenskomst 1. Hvervet som deltager kan efter fælles overenskomst overtages eller deles mellem en eksisterende deltager og en potentiel deltager, såfremt den potentielle deltager har ret til at henvise til alle de oplysninger, som den eksisterende deltager har fremsendt eller henvist til. 2. Den potentielle og den eksisterende deltager fremsender i fællesskab via det i artikel 71 i forordning (EU) nr. 528/2012 omhandlede register over biocidholdige produkter (i det følgende benævnt»registeret«) en meddelelse herom til agenturet, som skal omfatte alle relevante adgangstilladelser. 3. Når agenturet har modtaget en meddelelse i henhold til stk. 2, opdaterer det oplysningerne i registeret vedrørende deltagerens identitet. 4. En person, som er etableret i Unionen, og som har overtaget eller tilsluttet sig hvervet som deltager i henhold til denne artikel, anses for at have fremsendt et dossier eller en dataadgangstilladelse til et dossier i henhold til artikel 95 i forordning (EU) nr. 528/2012. Artikel 11 Deltageres udtræden 1. En deltager anses for at have trukket sin støtte til en kombination af stof og produkttype i undersøgelsesprogrammet tilbage i følgende tilfælde: a) når deltageren via registeret har underrettet agenturet eller den kompetente vurderingsmyndighed om, at denne agter at udtræde b) når deltageren ikke har fremsendt en ansøgning inden for de i artikel 3, stk. 2, fastsatte tidsfrister c) når deltagerens ansøgning er blevet afvist i henhold til artikel 4, stk. 1, artikel 4, stk. 4 eller artikel 5, stk. 4 d) når deltageren ikke har fremsendt supplerende oplysninger inden for de i artikel 6, stk. 5, fastsatte tidsfrister e) når deltageren på har undladt at erlægge de gebyrer, der skal betales til den kompetente vurderingsmyndighed eller agenturet. 2. En udtræden anses for at være sket rettidigt, medmindre den indtræder efter den dato, hvor den kompetente vurderingsmyndighed fremsender rapporten fra den kompetente myndighed til ansøgeren i henhold til artikel 6, stk. 4. Artikel 12 Konsekvenser af en rettidig udtræden 1. Når den kompetente vurderingsmyndighed, men ikke agenturet bliver bekendt med en rettidig udtræden, underretter den straks agenturet herom via registeret. 2. Når agenturet bliver bekendt med en rettidig udtræden, opdaterer det oplysningerne i registeret om deltagerens identitet. 3. Når alle de deltagere, der støtter den samme kombination af stof og produkttype, er udtrådt rettidigt af undersøgelsesprogrammet, og når hvervet som deltager i forbindelse med denne kombination tidligere er blevet overtaget, underretter agenturet Kommissionen herom via registeret.

20 L 294/8 DA Den Europæiske Unions Tidende Artikel 13 Omdefinering af aktivstoffer 1. Når vurderingen af et eksisterende aktivstof ikke gør det muligt at drage konklusioner om stoffet som identificeret i bilag II, skal den kompetente vurderingsmyndighed efter høring af den pågældende deltager, fastsætte en ny stofidentitet. Den underretter agenturet herom. 2. Agenturet ajourfører oplysningerne i registeret vedrørende stoffets identitet. Artikel 14 Overtagelse af hvervet som deltager 1. Agenturet offentliggør en åben invitation til at overtage hvervet som deltager for kombinationen af stof og produkttype, når et af følgende krav er opfyldt: a) alle de deltagere, der støtter den samme kombination af stof og produkttype er udtrådt rettidigt i henhold til artikel 11, og hvervet som deltager for denne kombination er ikke tidligere blevet overtaget b) efter en omdefinering i henhold til artikel 13, hvor invitationen kun vedrører et stof, der er omfattet af den eksisterende identitet i bilag II, men ikke af den nye stofidentitet. 2. Inden for 12 måneder fra den i stk. 1 nævnte offentliggørelsesdato kan alle fremsende en anmeldelse vedrørende kombinationen i henhold til artikel Inden for 12 måneder fra datoen for denne forordnings ikrafttræden, kan alle anmelde en kombination af et stof og en produkttype, som indgår i del 2 i bilag II i henhold til artikel 17. Artikel 15 Kombinationer af stof og produkttype, der kan indgå i undersøgelsesprogrammet Når et biocidholdigt produkt, der er omfattet af anvendelsesområdet for forordning (EU) nr. 528/2012, og som gøres tilgængeligt på markedet, indeholder eller genererer et eksisterende aktivstof, som hverken er godkendt eller indgår i undersøgelsesprogrammet for produkttypen og ikke er opført i bilag I til den pågældende forordning, kan dette stof indgå i undersøgelsesprogrammet for den pågældende produkttype med en af følgende begrundelser: a) den person, der gør produktet tilgængeligt på markedet, har baseret sig på vejledning offentliggjort af eller skriftlig rådgivning fra Kommissionen eller en kompetent myndighed udpeget i henhold til artikel 26 i direktiv 98/8/EF eller artikel 81 i forordning (EU) nr. 528/2012, når denne vejledning eller rådgivning indeholdt objektive begrundelser for at mene, at produktet var udelukket fra anvendelsesområdet for direktiv 98/8/EF eller forordning (EU) nr. 528/2012, eller at den pågældende produkttype var en produkttype, for hvilken aktivstoffet var blevet meddelt, og når denne vejledning eller rådgivning efterfølgende vurderes i en afgørelse vedtaget i henhold til artikel 3, stk. 3, i forordning (EU) nr. 528/2012 eller i en ny offentlig vejledning udgivet af Kommissionen b) stoffet er omfattet af undtagelsen for fødevarer og foderstoffer i artikel 6 i forordning (EF) nr. 1451/2007 c) det biocidholdige produkt henhører i forordning (EU) nr. 528/2012 under en anden produkttype end den, det tilhørte i direktiv 98/8/EF, som følge af en ændring af anvendelsesområdet for disse produkttyper, og indeholder et stof, der indgik i undersøgelsesprogrammet for den oprindelige produkttype, men ikke for den nye produkttype.

21 L 294/9 Den Europæiske Unions Tidende DA Artikel 16 Interessetilkendegivelse om anmeldelse 1. En interessetilkendegivelse om anmeldelse af et stof, der kan optages i undersøgelsesprogrammet i henhold til artikel 15, fremsendes via registeret af enhver, som har interesse i at anmelde en kombination af et stof og en produkttype, til en af følgende modtagere: a) til Kommissionen senest 12 måneder efter offentliggørelsen af den i artikel 15, litra a), nævnte afgørelse eller vejledning b) til agenturet senest den 30. oktober 2015 i de i artikel 15, litra b), nævnte tilfælde c) til Kommissionen senest den 30. oktober 2015 i de i artikel 15, litra c), nævnte tilfælde. 2. En erklæring skal angive den relevante kombination af stof og produkttype. I de i artikel 15, litra a), nævnte tilfælde skal erklæringen underbygges af en begrundelse, hvoraf fremgår, at alle de deri opstillede betingelser er opfyldt. 3. Når en erklæring er blevet fremsat i et af de i artikel 15, litra a) eller c), nævnte tilfælde, og finder Kommissionen efter høring af medlemsstaterne, at artikel 6 ikke finder anvendelse, og de i artikel 15, litra a), nævnte betingelser for anmeldelse er opfyldt, underretter den agenturet. 4. Når en erklæring er blevet fremsat i det i artikel 15, litra b), nævnte tilfælde, eller når Kommissionen har underrettet agenturet i henhold til stk. 3, offentliggør agenturet disse oplysninger elektronisk med angivelse af den relevante kombination af stof og produkttype. I denne forordning anses en offentliggørelse i henhold til artikel 3a, stk. 3, tredje afsnit, i forordning (EF) nr. 1451/2007 for at være en offentliggørelse i henhold til dette stykke. 5. Enhver person, der har interesse i at anmelde kombinationen af stof og produkttype, kan inden for seks måneder fra den i stk. 4 omhandlede offentliggørelsesdato gøre dette i henhold til artikel I de i artikel 15, litra a) og c), nævnte tilfælde anses en kombination af stof og produkttype for at være blevet anmeldt af en deltager og kan ikke gøres til genstand for en ny anmeldelse, når følgende betingelser er opfyldt: a) det relevante aktivstof er allerede medtaget i undersøgelsesprogrammet b) et af de dossierer, der er fremsendt til den vurderende medlemsstat for det pågældende aktivstof, indeholder allerede alle de oplysninger, der er nødvendige for vurderingen af produkttypen c) den deltager, som har fremsendt dossieret, udtrykker interesse for at støtte kombinationen af stof og produkttype. Artikel 17 Anmeldelsesprocedure 1. Anmeldelser i henhold til artikel 14, stk. 2 og 3, eller artikel 16, stk. 5, foretages til agenturet via registeret. 2. Anmeldelsen forelægges i Iuclid-format. Den indeholder de oplysninger, der er fastsat i bilag I. 3. Når ingen kompetent vurderingsmyndighed er anført i bilag II for det pågældende aktivstof, informerer anmelderen agenturet om navnet på den kompetente myndighed udpeget i henhold til artikel 81 i forordning (EU) nr. 528/2012, som anmelderen har valgt, og fremlægger en skriftlig bekræftelse på, at den pågældende kompetente myndighed har accepteret at vurdere dossieret. 4. Ved modtagelsen af en sådan anmeldelse informerer agenturet Kommissionen herom og informerer anmelderen om de gebyrer, der skal erlægges ifølge forordning (EU) nr. 564/2013. Undlader en anmelder at betale gebyret inden 30 dage fra modtagelsen af denne oplysning, afviser agenturet anmeldelsen og informerer anmelderen og Kommissionen herom.

22 L 294/10 DA Den Europæiske Unions Tidende Efter at betalingen af gebyrerne er modtaget, kontrollerer agenturet inden 30 dage, om anmeldelsen opfylder kravene i stk. 2. Opfylder anmeldelsen ikke disse krav, giver Kommissionen anmelderen en frist på 30 dage til at fuldstændiggøre eller rette anmeldelsen. Efter udløbet af fristen på 30 dage skal agenturet inden 30 dage enten erklære, at anmeldelsen opfylder kravene i stk. 2, eller afvise anmeldelsen og underrette anmelderen og Kommissionen herom. 6. De afgørelser, som agenturet træffer i henhold til denne artikels stk. 4 eller 5, kan påklages i henhold til artikel 77 i forordning (EU) nr. 528/ Når anmeldelsen anses for at være overensstemmende i henhold til stk. 5, skal agenturet straks: a) når anmeldelsen er fremsendt i henhold til artikel 14, stk. 2 eller 3, ajourføre oplysningerne i registeret om deltagerens og, hvor det er relevant, stoffets identitet b) når anmeldelsen er fremsendt i henhold til artikel 16, stk. 5, informere Kommissionen om overensstemmelsen. Artikel 18 Optagelse i undersøgelsesprogrammet Når kombinationen af stof og produkttype anses for at være anmeldt i henhold til artikel 16, stk. 6, eller når agenturet informerer Kommissionen om overensstemmelse i henhold til artikel 17, stk. 7, litra b), optager Kommissionen kombinationen af stof og produkttype i undersøgelsesprogrammet. Artikel 19 Information om stoffer, der ikke længere støttes under undersøgelsesprogrammet Når agenturet ikke har modtaget en anmeldelse inden for den i artikel 16, stk. 5, nævnte tidsfrist, eller når det har modtaget en anmeldelse omhandlet i denne artikel og efterfølgende afvist den i medfør af artikel 17, stk. 4 og 5, informerer agenturet medlemsstaterne herom via registeret og offentliggør denne information elektronisk. Artikel 20 Kommissionens afgørelser om stoffer, der ikke længere støttes under undersøgelsesprogrammet Kommissionen udarbejder et udkast til en afgørelse om afvisning af godkendelse i henhold til artikel 89, stk. 1, tredje afsnit, i forordning (EU) nr. 528/2012 i følgende tilfælde: a) når agenturet informerer Kommissionen om alle deltagernes rettidige udtræden i henhold til artikel 12, stk. 3, i denne forordning b) når ingen har indsendt en anmeldelse inden for de i denne forordnings artikel 14, stk. 2, eller artikel 13, stk. 3, fastsatte tidsfrister, eller når en sådan anmeldelse er blevet fremsendt og afvist i henhold til forordningens artikel 17, stk. 4, eller artikel 17, stk. 5 c) når en anmeldelse er fremsendt inden for de tidsfrister, der er fastsat i denne forordnings artikel 14, stk. 2, eller artikel 14, stk. 3, og er i overensstemmelse med forordningens artikel 17, stk. 5, men stofidentiteten i anmeldelsen kun omfatter en del af den eksisterende identitet i bilag II til denne forordning. I det i litra c) i første afsnit nævnte tilfælde, omfatter udkastet til afgørelse om afvisning af godkendelse alle stoffer omfattet af den eksisterende identitet i bilag II til denne forordning, men ikke af anmeldelsen eller af en godkendelsesafgørelse.

23 L 294/11 Den Europæiske Unions Tidende DA KAPITEL 4 OVERGANGSFORANSTALTNINGER Artikel 21 Overgangsforanstaltninger for de i artikel 15 nævnte stoffer 1. En medlemsstat kan fortsætte med at anvende sin aktuelle ordning eller praksis for markedsføring og anvendelse af biocidholdige produkter, som består af, indeholder eller genererer et eksisterende aktivstof omhandlet i artikel 15, litra b) og c). I sådanne tilfælde: a) markedsføres det biocidholdige produkt ikke længere med virkning fra 24 måneder efter datoen for denne forordnings ikrafttræden b) anvendelsen af eksisterende lagre af det biocidholdige produkt kan fortsætte indtil 30 måneder efter datoen for denne forordnings ikrafttræden. 2. En medlemsstat kan fortsætte med at anvende sin aktuelle ordning eller praksis for markedsføring og anvendelse af biocidholdige produkter, som består af, indeholder eller genererer et eksisterende aktivstof omhandlet i artikel 15, litra b) og c). I sådanne tilfælde: a) markedsføres det biocidholdige produkt ikke længere med virkning fra 24 måneder efter en af nedenstående datoer, afhængigt af hvilken der er senest: i) datoen for denne forordnings ikrafttræden ii) meddelelsen eller offentliggørelsen af den i artikel 15, litra a), nævnte afgørelse eller vejledning b) anvendelsen af eksisterende lagre af det biocidholdige produkt kan fortsætte indtil 30 måneder efter en af nedenstående datoer, afhængigt af hvilken der er senest: i) datoen for denne forordnings ikrafttræden ii) meddelelsen eller offentliggørelsen af den i artikel 15, litra a), nævnte afgørelse eller vejledning. 3. En medlemsstat kan fortsætte med at anvende sin aktuelle ordning eller praksis for markedsføring og anvendelse af biocidholdige produkter, som består af, indeholder eller genererer et eksisterende aktivstof omhandlet i artikel 16, stk. 4, for den relevante produkttype. I sådanne tilfælde: a) markedsføres det biocidholdige produkt ikke længere med virkning fra 12 måneder efter den dato, hvor agenturet har foretaget den i artikel 19 omhandlede elektroniske offentliggørelse b) kan anvendelsen af eksisterende lagre af det biocidholdige produkt fortsætte indtil 18 måneder efter datoen for denne offentliggørelse. Artikel 22 Nødvendig anvendelse 1. Uanset artikel 55, stk. 1, i forordning (EU) nr. 528/2012, kan en medlemsstat inden for 18 måneder fra datoen for en afgørelse om ikke at godkende et eksisterende aktivstof, når den mener, at dette eksisterende aktivstof er nødvendigt af en af de i første afsnit i artikel 5, stk. 2, litra b) eller c), nævnte årsager, fremsende en begrundet ansøgning til Kommissionen om en dispensation fra denne forordnings artikel 89, stk. 2, andet afsnit. 2. Den ansøgende medlemsstat fremsender den begrundede ansøgning til agenturet via registeret. Når ansøgningen indeholder fortrolige oplysninger, fremsender den ansøgende medlemsstat samtidig en udgave, der ikke er fortrolig. 3. Agenturet offentliggør ansøgningen, eller hvor det er relevant den udgave, der ikke er fortrolig, elektronisk. Medlemsstaterne eller en person kan fremsende kommentarer inden for 60 dage fra denne offentliggørelse.

24 L 294/12 DA Den Europæiske Unions Tidende Kommissionen kan under hensyntagen til de modtagne kommentarer indrømme en dispensation fra artikel 89, stk. 2, andet afsnit, i forordning (EU) nr. 528/2012, og tillade biocidholdige produkter, der består af, indeholder eller genererer det stof, der skal markedsføres i den ansøgende medlemsstat og anvendes i denne medlemsstat i henhold til nationale bestemmelser og på de i stk. 5 opstillede betingelse og eventuelle andre betingelser, Kommissionen måtte stille. 5. En medlemsstat, som indrømmes dispensation, skal: a) sikre, at den fortsatte anvendelse begrænses til tilfælde og perioder, hvor betingelserne i stk. 1 er opfyldt b) indføre passende risikobegrænsende foranstaltninger for at sikre, at eksponeringen af mennesker, dyr og miljø minimeres c) sikre, at der søges alternativer, eller at en ansøgning om godkendelse af aktivstoffet udarbejdes i henhold til artikel 7 i forordning (EU) nr. 528/2012 i god tid inden dispensationens udløb. KAPITEL 5 AFSLUTTENDE BESTEMMELSER Artikel 23 Ophævede retsakter Forordning (EF) nr. 1451/2007 ophæves. Henvisninger til den ophævede forordning læses som henvisninger til nærværende forordning. Artikel 24 Ikrafttræden Denne forordning træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende. Denne forordning er bindende i alle enkeltheder og gælder umiddelbart i hver medlemsstat. Udfærdiget i Bruxelles, den 4. august På Kommissionens vegne José Manuel BARROSO Formand

25 BILAG I Oplysninger, der kræves ved anmeldelse efter artikel 17 En anmeldelse efter artikel 17 skal indeholde følgende oplysninger: 1) dokumentation for, at stoffet er et eksisterende aktivstof som defineret i artikel 3, stk. 1, litra d), i forordning (EU) nr. 528/2012 2) angivelse af, hvilke produkttyper anmeldelsen vedrører 3) oplysning om, hvilke undersøgelser der er sat i gang med henblik på godkendelse eller optagelse i bilag I til forordning (EU) nr. 528/2012, herunder den dato, de forventes afsluttet 4) de oplysninger, der er omhandlet i: a) punkt 1, 2 og i tabellen i afsnit 1 i bilag II til forordning (EU) nr. 528/2012 for kemiske stoffer b) punkt 1, 2 og i tabellen i afsnit 2 i bilag II til forordning (EU) nr. 528/2012 for mikroorganismer 5) hvis anmeldelsen er forelagt i et tilfælde som omhandlet i artikel 15, litra a), dokumentation for, at stoffet var på markedet som et aktivstof i et biocidholdigt produkt af den pågældende produkttype på datoen for den anmeldelse eller offentliggørelse af den afgørelse eller vejledning, der er omhandlet i nævnte litra DA Den Europæiske Unions Tidende L 294/13

26 Nr. BILAG II KOMBINATIONER AF STOF OG PRODUKTTYPE, DER ER OMFATTET AF UNDERSØGELSESPROGRAMMET DEN 4. AUGUST 2014 DEL 1 Kombinationer af aktivstof og produkttype, der støttes den 4. august 2014, eksklusive alle nanomaterialer, der ikke udtrykkelig er nævnt i stof nr og Stof Rapporterende medlemsstat EF-nr. CAS-nr formaldehyd DE x x x 6 2-(2-butoxyethoxy)ethyl-6-propylpiperonylether (piperonylbutoxid/pbo) EL x 9 bronopol ES x x x x x x 29 chlorcresol FR x x x x x x 36 ethanol EL x x x 37 myresyre BE x x x x x x x 40 propan-2-ol DE x x x L 294/14 DA Den Europæiske Unions Tidende 43 salicylsyre NL x x x 45 propan-1-ol DE x x x 52 ethylenoxid N x 60 citronsyre BE x 69 glycolsyre LT x x x 70 pereddikesyre FI x x x x x x x x 71 L-(+)-mælkesyre DE x x x x

27 Nr. 79 Stof (2R,6aS,12aS)-1,2,6,6a,12,12a-hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-on (rotenon) Rapporterende medlemsstat EF-nr. CAS-nr UK x 85 symclosen UK x x x x x x 92 biphenyl-2-ol ES x x x x x x x x x 113 kanelaldehyd/3-phenylpropen-2-al UK x 117 geraniol FR x x 122 glyoxal FR x x x 133 hexa-2,4-diensyre (sorbinsyre) DE x 136 glutaral FI x x x x x x 154 chlorophen N x x phenoxyethanol UK x x x x x 172 cetylpyridiniumchlorid UK x 179 carbondioxid FR x 180 natriumdimethylarsinat PT x 185 tosylchloramidnatrium (chloramin T) ES x x x x 187 kaliumdimethyldithiocarbamat UK x x x 188 natriumdimethyldithiocarbamat UK x x x DA Den Europæiske Unions Tidende L 294/15

28 Nr. Stof Rapporterende medlemsstat EF-nr. CAS-nr natrium-2-biphenylat ES x x x x x x x x x 198 N-(trichlormethylthio)phthalimid (folpet) IT x x 206 thiram BE x 210 metamnatrium BE x x 227 ES x x x 235 diuron DK x x 239 cyanamid DE x x tetrahydro-3,5-dimethyl-1,3,5-thiadiazin- 2-thion (dazomet) dichlor-n-[(dimethylamino)sulfonyl]fluor- N-(p-tolyl)methansulfenamid (tolylfluanid) BE x x FI x x L 294/16 DA Den Europæiske Unions Tidende 283 terbutryn SK x x x 288 (thia 2-thiazol-4-yl-1H-benzoimidazol bendazol) N-(dichlorfluormethylthio)-N,N -dimethyl-n-phenylsulfamid (dichlofluanid) UK x x 289 kobberthiocyanat FR x 292 (1,3,4,5,6,7-hexahydro-1,3-dioxo-2Hisoindol-2-yl)methyl-(1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropancarboxylat (d-tetramethrin) DE x

29 Nr. 958 Stof calciumdihydroxid/calciumhydroxid/ læsket kalk/kalkhydrat Rapporterende medlemsstat EF-nr. CAS-nr UK x x 959 calciumoxid/brændt kalk/ulæsket kalk UK x x 306 dikobberoxid FR x butanon, peroxid HU x x 321 monolinuron UK x N-(3-aminopropyl)-N-dodecylpropan-1,3- diamin 2,2 -dithiobis[n-methylbenzamid] (DTBMA) PT x x x x x x x x PL x 339 1,2-benzisothiazol-3(2H)-on ES x x x x x x methyl-2H-isothiazol-3-on (MIT) SI x x x x 346 natriumdichlorisocyanuratdihydrat UK x x x x x x 345 troclosennatrium UK x x x x x x 348 mecetroniumethylsulfat (MES) PL x 354 triclosan DK x (ethylendioxy)dimethanol (reaktionsprodukter af ethylenglycol og paraformaldehyd (EGForm)) pyridin-2-thiol-1-oxid, (natriumpyrithion) natriumsalt PL x x x x x SE x x x x x x x DA Den Europæiske Unions Tidende L 294/17

30 Nr. Stof Rapporterende medlemsstat EF-nr. CAS-nr methenamin-3-chlorallylochlorid (CTAC) PL x x x ,2,2 -(hexahydro-1,3,5-triazin-1,3,5- triyl)triethanol (HHT) tetrahydro-1,3,4,6-tetrakis(hydroxyme thyl)imidazo[4,5-d]imidazol-2,5(1h,3h)- dion (TMAD) PL x x x x ES x x x x x 387 N,N -methylenbismorpholin (MBM) AT x x 392 methylendithiocyanat FR x ,3-bis(hydroxymethyl)-5,5-dimethylimidazolidin-2,4-dion (DMDMH) didecyldimethylammoniumchlorid (DDAC) PL x x IT x x x x x x x x x 401 sølv SE x x x x 403 kobber FR x L 294/18 DA Den Europæiske Unions Tidende 405 svovldioxid DE x 424 natriumbromid NL x x x 432 natriumhypochlorit IT x x x x x x x 434 tetramethrin DE x 439 hydrogenperoxid FI x x x x x x x x 444 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c] oxazol (EDHO) PL x x

31 Nr. Stof Rapporterende medlemsstat 450 sølvnitrat SE x 453 dinatriumperoxodisulfat/natriumpersulfat PT x EF-nr. CAS-nr calciumhypochlorit IT x x x x x 457 chlor IT x x x 458 ammoniumsulfat UK x x 473 pyrethriner og pyrethroider ES x x 491 chlordioxid PT x x x x x x 494 2,2-dibrom-2-cyanacetamid (DBNPA) DK x x x x x x 501 carbendazim DE x x x 515 ammoniumbromid SE x x 522 pyrithionzink SE x x x x x x 524 dodecylguanidinmonohydrochlorid ES x x 526 kalium-2-biphenylat ES x x x x 529 bromchlorid NL x 531 (benzyloxy)methanol UK x x 534 bis(1-hydroxy-1h-pyridin-2-thionato-o,s) kobber (kobberpyrithion) SE x 541 natrium-p-chlor-m-cresolat FR x x x x x x DA Den Europæiske Unions Tidende L 294/19

32 Nr. 550 Stof D-gluconsyre, forbindelse med N,N -bis (4-chlorphenyl)-3,12-diimino-2,4,11,13- tetraazatetradecandiamidin (2:1) (CHDG) Rapporterende medlemsstat EF-nr. CAS-nr PT x x x 554 p-[(diiodmethyl)sulfonyl]toluen UK x x x x (benzothiazol-2-ylthio)methylthiocyanat (TCMTB) 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent- 2-en-1-yl-2,2-dimethyl-3-(2-methylprop- 1-enyl)cyclopropancarboxylat (prallethrin) (kalium kalium-(e,e)-hexa-2,4-dienoat sorbat) α,α,α -trimethyl-1,3,5-triazin-1,3,5 (2H,4H,6H)-triethanol (HPT) N x x EL x DE x x AT x x x x octyl-2H-isothiazol-3-on (OIT) UK x x x x x x L 294/20 DA Den Europæiske Unions Tidende 577 dimethyloctadecyl[3-(trimethoxysilyl) propyl]ammoniumchlorid ES x x x 578 N -tert-butyl-n-cyclopropyl-6-(methylthio)-1,3,5-triazin-2,4-diamin (cybutryn) NL x 588 bromchlor-5,5-dimethylimidazolidin-2,4- dion (BCDMH/bromchlordimethylhydantoin) NL x x x (4-isopropylphenyl)-1,1-dimethylurinstof/isoproturon DE x x

33 Nr Stof 1-[2-(allyloxy)-2-(2,4-dichlorphenyl) ethyl]-1h-imidazol (imazalil) S-[(6-chlor-2-oxooxazolo[4,5-b]pyridin-3 (2H)-yl)methyl]-O,O-dimethylthiophosphat (azamethiphos) 2-brom-2-(brommethyl)pentandinitril (DBDCB) Rapporterende medlemsstat EF-nr. CAS-nr DE x UK x CZ x 961 calciummagnesiumoxid UK x x calciummagnesiumtetrahydroxid/calciummagnesiumhydroxid α-cyan-3-phenoxybenzyl-2,2-dimethyl-3- (2-methylprop-1-enyl)cyclopropancarboxylat (cyphenothrin) dimethyltetradecyl [3-(trimethoxysilyl) propyl]ammoniumchlorid blanding af cis- og trans-p-menthan-3,8- diol (citriodiol) (RS)-α-cyan-3-phenoxybenzyl-(1RS)-cis, trans-3-(2,2-dichlorvinyl)-2,2-dimethylcyclopropancarboxylat (cypermethrin) 3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3- (2,2-dichlorvinyl)-2,2-dimethylcyclopropancarboxylat (permethrin) UK x x EL x PL x UK x BE x IE x x DA Den Europæiske Unions Tidende L 294/21

34 Nr. 618 Stof 1-ethynyl-2-methylpent-2-enyl-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropancarboxylat (empenthrin) Rapporterende medlemsstat EF-nr. CAS-nr BE x iod-2-propynylbutylcarbamat (IPBC) DK x x x x tetrakis(hydroxymethyl)phosphoniumsulfat (2:1) (THPS) 1-[[2-(2,4-dichlorphenyl)-4-propyl-1,3- dioxolan-2-yl]methyl]-1h-1,2,4-triazol (propiconazol) kokosalkyltrimethylammoniumchlorid (ATMAC/TMAC) 4,5-dichlor-2-octylisothiazol-3(2H)-on (4,5-dichlor-2-octyl-2H-isothiazol-3-on (DCOIT)) MT x x x x FI x IT x N x x x x L 294/22 DA Den Europæiske Unions Tidende chlor-N-[[[4-(trifluormethoxy)phenyl] amino]carbonyl]benzamid (triflumuron) IT x 656 3,3 -methylenbis[5-methyloxazolidin] (oxazolidin/mbo) AT x x x x x 657 N-cyclopropyl-1,3,5-triazin-2,4,6-triamin EL x 666 α-cyan-4-fluor-3-phenoxybenzyl-3-(2,2- dichlorvinyl)-2,2-dimethylcyclopropancarboxylat (cyfluthrin) DE x

35 Nr Stof alkyl(c )dimethylbenzylammoniumchlorid (ADBAC (C )) alkyl(c )dimethylbenzylammoniumchlorid (ADBAC/BKC (C )) didecyldimethylammoniumchlorid (DDAC (C 8-10 )) kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, salte med 1,2-benzisothiazol-3(2H)-on-1,1-dioxid (ADBAS) Rapporterende medlemsstat EF-nr. CAS-nr IT x x x x x x x x IT x x x x x x x x IT x x x x x x x x MT x x 691 natrium-n-(hydroxymethyl)glycinat AT x 692 aminer, C alkyldimethyl, N-oxider PT x pentakalium-bis(peroxymonosulfat)-bis (sulfat) magnesiummonoperoxyphthalathexahydrat (MMPP) SI x x x x PL x 1015 margosaekstrakt DE x alkyl(c 12 -C 14 )dimethylbenzylammoniumchlorid (ADBAC (C 12 -C 14 )) alkyl(c 12 -C 14 )ethylbenzylammoniumchlorid (ADEBAC (C 12 -C 14 )) IT x x x x x x x x IT x x x x x x x x 731 Chrysanthemum cinerariaefolium, ekstrakt ES x 744 lavendel, Lavandula hybrida, ekstrakt PT x DA Den Europæiske Unions Tidende L 294/23

36 Nr Stof 1-(3,5-dichlor-4-(1,1,2,2-tetrafluorethoxy) phenyl)-3-(2,6-difluorbenzoyl)urinstof (hexaflumuron) Rapporterende medlemsstat EF-nr. CAS-nr PT x DE x x (phthalimido)peroxyhexansyre (PAP) IT x x x x butyl-benzo[d]isothiazol-3-on (BBIT) CZ x x x x x 792 tetrachlordecaoxidcomplex (TCDO) DE x x x 811 sølvnatriumhydrogenzirconiumphosphat SE x x x x x 794 sec-butyl-2-(2-hydroxyethyl)piperidin-1- carboxylat (icaridin) DK x L 294/24 DA Den Europæiske Unions Tidende 797 reaktionsprodukter af glutaminsyre og N- (C alkyl)propylendiamin (glucoprotamin) cis-1-(3-chlorallyl)-3,5,7-triaza-1-azoniaadamantanchlorid (cis-ctac) PL x x 800 [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3- yl]methyl-(1r)-cis-chrysanthemat; [2,4- dioxo-(2-propyn-1-yl)imidazolidin-3-yl] methyl-(1r)-trans-chrysanthemat (imiprothrin) UK x chlor-2-(4-chlorphenoxy)phenol (DCPP) AT x x x 807 (E)-1-(2-chlor-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidin (chlothianidin) DE x

37 Nr Stof Bacillus sphaericus 2362, stamme ABTS Bacillus thuringiensis subsp. israelensis, stamme SA3A Bacillus subtilis blanding af 5-chlor-2-methyl-2Hisothiazol-3-on (EINECS ) og 2-methyl-2H-isothiazol-3-on (EINECS ) (blanding af CMIT og MIT) aktiv chlor: fremstillet in situ ved reaktion mellem hypochlorsyrling og natriumhypochlorit peroxyoctansyre sølvzeolit ikke relevant 3-phenoxybenzyl-(1R)-cis,trans-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropancarboxylat (d-phenothrin) aminer, N-C 12-14(lige kulstofantal) -alkyltrimethylendi-, reaktionsprodukter med chloreddikesyre (ampholyt 20) reaktionsprodukter af 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin med brom og chlor (DCDMH) Rapporterende medlemsstat IT IT DE EF-nr. CAS-nr mikroorganisme mikroorganisme mikroorganisme x ikke relevant ikke relevant x FR blanding x x x x x x SK blanding ikke relevant x x x x FR SE IE IE NL ikke relevant ikke relevant ikke relevant foreligger ikke x x x ikke relevant x x x x x x x x x foreligger ikke x x DA Den Europæiske Unions Tidende L 294/25

38 Nr Stof reaktionsmasse af titandioxid og sølvchlorid reaktionsprodukter af 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin med chlor (DCEMH) sølvphosphatglas sølvzinkzeolit sølvkobberzeolit sølv adsorberet på siliciumdioxid (som nanomateriale i form af et stabilt aggregat af primærpartikler i nanoskala) Rapporterende medlemsstat SE NL SE SE SE SE EF-nr. CAS-nr foreligger ikke foreligger ikke foreligger ikke foreligger ikke foreligger ikke foreligger ikke foreligger ikke foreligger ikke x x x x x x x x x x x x x x x x x x x x foreligger ikke x x L 294/26 DA Den Europæiske Unions Tidende 1019 siliciumdioxid (som nanomateriale bestående af aggregater og agglomerater) FR foreligger ikke x 831 siliciumdioxid (kiselgur) FR plantebeskyttelsesmiddel x 854 (RS)-3-allyl-2-methyl-4-oxocyclopent-2- enyl-(1r,3r;1r,3s)-2,2-dimethyl-3-(2- methylprop-1-enyl)-cyclopropancarboxylat (blanding af 4 isomerer: 1R-trans, 1R:1R-trans, 1S:1R-cis, 1R:1R-cis, 1S, 4:4:1:1) (d-allethrin) DE plantebeskyttelsesmiddel x

39 Nr Stof (RS)-3-allyl-2-methyl-4-oxocyclopent-2- enyl-(1r,3r)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropancarboxylat (blanding af kun 2 isomerer: 1R-trans:1R/ S, 1:3) (esbiothrin) N-((6-chlor-3-pyridinyl)methyl)-N -cyan- N-methylethanimidamid (acetamiprid) esfenvalerat/(s)-α-cyan-3-phenoxybenzyl- (S)-2-(4-chlorphenyl)-3-methylbutyrat (esfenvalerat) [1α(S*),3α]-(α)-cyan-(3-phenoxyphenyl) methyl-3-(2,2-dichlorethenyl)-2,2-dichlorvinyl)-2,2-dimethylcyclopropancarboxylat (alpha-cypermethrin) plantebeskyttelsesmiddel 4-brom-2-(4-chlorphenyl)-1-ethoxymethyl-5-trifluormethylpyrrol-3-carbonitril (chlorfenapyr) polymer af N-methylmethanamin (EINECS ) og (chlormethyl) oxiran (EINECS )/polymer kvaternær ammoniumchlorid (PQpolymer) monohydrochlorid af polymer af N,N -1,6-hexandiylbis[N -cyanguanidin] (EINECS ) og hexamethylendiamin (EINECS )/polyhexamethylenbiguanid (monomer: 1,5-bis(trimethylen)guanylguanidiniummonohydrochlorid) (PHMB) Rapporterende medlemsstat DE BE PT BE PT EF-nr. CAS-nr plantebeskyttelsesmiddel plantebeskyttelsesmiddel plantebeskyttelsesmiddel plantebeskyttelsesmiddel x x x x x HU polymer x x FR polymer / x x x x x x x x DA Den Europæiske Unions Tidende L 294/27

40 Nr. Stof Rapporterende medlemsstat EF-nr. CAS-nr poly(hexamethylenbiguanid) FR polymer x x x x x x poly(oxy-1,2-ethandiyl), α-[2-(didecylmethylammonio)ethyl]-, ω-hydroxy-, propanoat (salt) (bardap 26) N-didecyl-N-dipolyethoxyammoniumborat/didecylpolyoxethylammoniumborat (polymer betain) Denne del af bilaget omfatter IT polymer x x x x EL polymer x DEL 2 Kombinationer af aktivstof og produkttype, der ikke støttes den 4. august 2014 den kombination af stof og produkttype, der er anført i tabellen nedenfor, også i nanomaterialeform alle nanomaterialeformer af alle kombinationer af stof og produkttype, som er opregnet på listen i del 1, undtagen dem, der er anført i nævnte tabel alle nanomaterialeformer af alle kombinationer af aktivstof og produkttype, som er godkendt den 4. august 2014, undtagen dem, der er udtrykkelig godkendt. L 294/28 DA Den Europæiske Unions Tidende For de kombinationer af stof og produkttype og de nanomaterialer, der er omfattet af denne del, bliver der efter artikel 20 vedtaget en afgørelse om afvisning af godkendelse, hvis ingen inden 12 måneder efter denne forordnings ikrafttræden har indsendt en anmeldelse efter artikel 14, stk. 3, eller hvis en sådan anmeldelse er afvist efter artikel 17, stk. 4 eller 5. Nr. Stof Rapporterende medlemsstat EF-nr. CAS-nr ,3-dichlor-5,5-dimethylhydantoin (omdefineret, jf. stof nr. 152) NL x 166 cetalkoniumchlorid (se nr. 948) benzyldimethyl(octadecyl)ammoniumchlorid (se nr. 948)

41 Nr. Stof Rapporterende medlemsstat 213 benzododeciniumchlorid (se nr. 948) miristalkoniumchlorid (se nr. 948) (thia 2-thiazol-4-yl-1H-benzoimidazol bendazol) didecyldimethylammoniumbromid nr. 949) dimethyldioctylammoniumchlorid nr. 949) (se (se benzyldodecyldimethylammoniumbromid (se nr. 948) EF-nr. CAS-nr ES x sølv SE x 418 siliciumdioxid amorft FR x 449 kobbersulfat FR x 1016 sølvklorid SE x x x x x x x 554 p-[(diiodmethyl)sulfonyl]toluen UK x decyldimethyloctylammoniumchlorid nr. 949) (se benzyldimethyloleylammoniumchlorid (se nr. 948) 3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3- (2,2-dichlorvinyl)-2,2-dimethylcyclopropancarboxylat (permethrin) IE x DA Den Europæiske Unions Tidende L 294/29

42 Nr Stof kvaternære ammoniumforbindelser, benzylkokosalkyldimethyl, chlorider (se nr. 948) kvaternære ammoniumforbindelser, dikokosalkyldimethyl, chlorider (se nr. 949) kvaternære ammoniumforbindelser, bis (hydrogeneret talgalkyl)dimethyl, chlorider (se nr. 949) kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, chlorider (se nr. 948) kvaternære ammoniumforbindelser, di-c alkyldimethyl, chlorider (se nr. 949) kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, chlorider (se nr. 948) Rapporterende medlemsstat EF-nr. CAS-nr L 294/30 DA Den Europæiske Unions Tidende 689 kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, chlorider (se nr. 948) aminer, C alkyldimethyl, N-oxider PT x 697 kvaternære ammoniumforbindelser, di-c alkyldimethyl, chlorider (se nr. 949) dihydrogenbis[monoperoxyphthalato(2-)- O1,OO1]magnesat(2-)hexahydrat PL x

43 Nr Stof anden margosaekstrakt end fra kerner af Azadirachta indica, der er ekstraheret med vand og yderligere behandlet med organiske opløsningsmidler kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, bromider (se nr. 948) 1,3-dichlor-5-ethyl-5-methylimidazolidin- 2,4-dion (omdefineret, jf. stof nr. 777) 1-(4-chlorphenyl)-4,4-dimethyl-3-(1,2,4- triazol-1-ylmethyl)pentan-3-ol (tebuconazol) reaktionsprodukt af dimethyladipat, dimethylglutarat, dimethylsuccinat og hydrogenperoxid (perestan) alkylbenzyldimethylammoniumchlorid/ benzalkoniumchlorid (se nr. 948) kvaternære ammoniumforbindelser (dialkyldimethyl (alkyl fra C 6 -C 18, mættede og umættede, samt talgalkyl, kokosalkyl og sojaalkyl) chlorider, bromider eller methylsulfater) (DDAC) kvaternære ammoniumforbindelser (alkyltrimethyl (alkyl fra C 8 -C 18, mættede og umættede, samt talgalkyl, kokosalkyl og sojaalkyl) chlorider, bromider eller methylsulfater) (TMAC) Rapporterende medlemsstat EF-nr. CAS-nr DE x NL x DK x HU ikke relevant x IT IT blanding blanding af stoffer, der er optaget i EINECS blanding af stoffer, der er optaget i EINECS ikke relevant x x x x x x x x ikke relevant x DA Den Europæiske Unions Tidende L 294/31

44 Nr Stof kvaternære ammoniumforbindelser (benzylalkyldimethyl (alkyl fra C 8 -C 22, mættede og umættede, samt talgalkyl, kokosalkyl og sojaalkyl) chlorider, bromider eller hydroxider) (BKC) 3-phenoxybenzyl-(1R)-cis,trans-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropancarboxylat (d-phenothrin) kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, chlorider (der ikke er omfattet af nr. 671) kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, chlorider (der ikke er omfattet af nr. 667) kvaternære ammoniumforbindelser, C alkyl[(ethylphenyl)methyl]dimethyl, chlorider (der ikke er omfattet af nr. 725) Rapporterende medlemsstat IT IE IT IT IT EF-nr. CAS-nr blanding af stoffer, der er optaget i EINECS ikke relevant ikke relevant ikke relevant ikke relevant ikke relevant x x x x x x x x x ikke relevant x x x x x x x x x ikke relevant x x x x x x x x ikke relevant x x x x x x x x L 294/32 DA Den Europæiske Unions Tidende 1005 kvaternære ammoniumforbindelser, benzyl-c alkyldimethyl, chlorider (der ikke er omfattet af nr. 724) IT ikke relevant ikke relevant x x x x x x x x 1006 sølv-zink-aluminium-bor-phosphatglas/ glasoxid, med sølv- og zinkindhold SE ikke relevant x x x 1009 kvaternære ammoniumforbindelser, di-c alkyldimethyl, chlorider (der ikke er omfattet af nr. 673) IT ikke relevant ikke relevant x x x x x x x x x

45 Nr Stof kvaternære ammoniumforbindelser, kokosalkyltrimethyl, chlorider (der ikke er omfattet af nr. 635) aluminiumnatriumsilicat-sølv-zinkcomplex/sølv-zink-zeolit (±)-1-(β-allyloxy-2,4-dichlorphenylethyl) imizadol (teknisk imazalil) Rapporterende medlemsstat IT SE DE EF-nr. CAS-nr ikke relevant ikke relevant plantebeskyttelsesmiddel ikke relevant x x x x x DA Den Europæiske Unions Tidende L 294/33

46 L 294/34 DA Den Europæiske Unions Tidende BILAG III Tidsfrister Produkttype Tidsfrist for indsendelse af vurderingsrapporten, jf. artikel 6, stk. 3, litra b) Tidsfrist for påbegyndelse af udarbejdelse af udtalelsen, jf. artikel 7, stk. 2, litra b) 8, 14, 16, 18, 19 og , 4 og og og , 9 og , 12, 15, 17, 20 og

47 EN Official Journal of the European Union L 294/1 II (Non-legislative acts) REGULATIONS COMMISSION DELEGATED REGULATION (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular the first subparagraph of Article 89(1) thereof, Whereas: (1) Commission Regulation (EC) No 1451/2007 ( 2 ) lays down the detailed rules for the programme of review of existing biocidal active substances (the review programme ) commenced in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council ( 3 ). Since that Directive has been repealed and replaced by Regulation (EU) No 528/2012, the detailed rules for the continuation of the review programme should be adapted to the provisions of that Regulation. (2) It is important to identify the active substance/product-type combinations that may be made available on the market and used, subject to national rules, by virtue of the transitional provisions laid down in Article 89 of Regulation (EU) No 528/2012. Such should be the case for active substance/product-type combinations that are under evaluation in the review programme. (3) Where a product has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007, but is not covered by the exemption for food and feed laid down in Article 2(5)(a) of Regulation (EU) No 528/2012, the active substances it contains should be evaluated in the review programme for the relevant product-type. Subject to national rules, it should be allowed to be made available on the market and used until the end of that evaluation. A system of prior declaration should define which products benefit from this provision. The same should apply where the failure to notify an active substance/product-type combination is due to the new definition of product-types in Regulation (EU) No 528/2012 compared with that in Directive 98/8/EC, or is well justified based on a Commission decision taken in accordance with Article 3(3) of ( 1 ) OJ L 167, , p. 1. ( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, , p. 3). ( 3 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1).

48 L 294/2 EN Official Journal of the European Union Regulation (EU) No 528/2012, on the case law, such as case C-420/10 ( 1 ), or on authoritative guidance from the Commission or Member States' competent authorities, which is subsequently reviewed. (4) Where a biocidal product contains, consists of or generates an active substance which is no longer included in the review programme but the use of that biocidal product is essential in a Member State, that use and the making available on the market for that use should be allowed in that Member State, under the responsibility of the Member State, subject to certain conditions and for a limited period of time. (5) With a view to ensure consistency and simplification, the procedure for evaluation of active substances in the review programme should, in all relevant parts, be identical with that for applications submitted pursuant to Article 7 of Regulation (EU) No 528/2012 or pursuant to Commission Implementing Regulation (EU) No 88/2014 ( 2 ). (6) For substances meeting the exclusion or substitution criteria, the evaluating Competent Authority should submit to the Agency a proposal for harmonised classification and labelling pursuant to Article 37(1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council ( 3 ) for the endpoints of concern, while preserving the right of the Member State to submit a proposal on other or all endpoints. The evaluating Competent Authority should also consult the Agency on substances which would meet the criteria for being persistent, bioaccumulative or toxic, or on substances that would be considered as having endocrine disrupting properties. (7) In order to ensure that the review programme is finalised by the target date indicated in Article 89(1) of Regulation (EU) No 528/2012, the evaluations should be limited to active substance/product-type combinations for which the relevant data has been submitted within the deadlines laid down in Regulation (EC) No 1451/2007 or this Regulation. Furthermore, appropriate time limits should be established for finalising the evaluations, taking into account the possibility that applications could be validated less than a year before those deadlines. (8) No data requirements have yet been established for inclusion in category 7 of Annex I to Regulation (EU) No 528/2012. It is therefore appropriate at this time to limit applications for inclusion in that Annex to category 1, 2, 3, 4, 5 or 6. (9) Notwithstanding Article 90(2) of Regulation (EU) No 528/2012, it follows from Article 91 of that Regulation that the criteria listed in Article 10 of that Regulation should be relevant for the subsequent authorisation of biocidal products in all cases. It is therefore appropriate to identify substances fulfilling those criteria in all active substance evaluations. (10) A prospective participant in the review programme should be allowed to join or replace an existing participant by mutual agreement, provided that the evaluation is not thereby delayed by limited data access, as the prospective applicant would otherwise have to generate data again. (11) Since participation in the review programme is voluntary, a participant should be allowed to withdraw from that programme. Where that occurs, prospective participants should be allowed to take over the support, unless that opportunity has already been granted once, thereby already causing delay to the review programme, and unless the Agency has already begun working on its opinion. (12) Where the evaluation of an active substance demonstrates that the identity formally included in the review programme does not exactly match that of the substance actually being evaluated, and the evaluation does not allow conclusions to be drawn regarding the formally included substance identity, it should be possible to redefine the substance in the course of the evaluation and allow other persons to take over the support of the formally included substance. ( 1 ) Case C-420/10: Judgment of the Court (Third Chamber) of 1 March 2012 (reference for a preliminary ruling from the Landgericht Hamburg Germany) Söll GmbH v Tetra GmbH (Placing on the market of biocidal products Directive 98/8/EC Article 2(1)(a) Concept of biocidal products Product causing flocculation of harmful organisms without destroying or deterring them or rendering them harmless). ( 2 ) Commission Implementing Regulation (EU) No 88/2014 of 31 January 2014 specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 32, , p. 3). ( 3 ) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, , p. 1).

49 L 294/3 Official Journal of the European Union EN (13) Certain substances included in the review programme are not supported by any participant at the time of adoption of this Regulation. The same applies to certain nanomaterials, although, pursuant to Article 4(4) of Regulation (EU) No 528/2012, such materials cannot be approved unless explicitly mentioned. Persons should be allowed to take over the participation for those substances and those nanomaterials, failing which those substances and nanomaterials should be excluded from the review programme. (14) In order to ensure that no substance is unduly maintained or included in the review programme without subsequently being evaluated, maintenance or inclusion of a substance not yet under evaluation should be subject to a notification of essential data regarding the substance, HAS ADOPTED THIS REGULATION: CHAPTER 1 SUBJECT MATTER AND DEFINITIONS Article 1 Subject matter This Regulation lays down rules for the carrying out of the work programme for the systematic examination of all existing active substances referred to in Article 89 of Regulation (EU) No 528/2012. Article 2 Definitions For the purposes of this Regulation, the following definitions shall apply: (a) non-approval decision means a decision not to approve a substance/product-type combination pursuant to Article 9(1)(b) of Regulation (EU) No 528/2012 or to the third subparagraph of Article 89(1) of that Regulation, or not to include it in Annex I or IA to Directive 98/8/EC; (b) substance/product-type combination included in the review programme means a substance/product-type combination listed in Annex II which complies with the following conditions: (i) it has not been the subject of either of the following: a Directive on inclusion in Annex I or IA to Directive 98/8/EC, a Regulation providing that it is approved pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012; (ii) it has not been the subject of any non-approval decision or the latest non-approval decision concerning it has been repealed; (c) participant means a person who has submitted an application for a substance/product-type combination included in the review programme, or has submitted a notification found compliant pursuant to Article 17(5) of this Regulation, or on whose behalf such application or notification has been submitted. (d) evaluating competent authority means the competent authority designated pursuant to Article 81 of Regulation (EU) No 528/2012 of the Member State indicated in Annex II to this Regulation.

50 L 294/4 EN Official Journal of the European Union CHAPTER 2 PROCESS FOR EVALUATION OF DOSSIERS Article 3 Application for approval or inclusion in Annex I to Regulation (EU) No 528/ An application for approval or inclusion in Annex I to Regulation (EU) No 528/2012 may be submitted only by a participant whose notification has been found compliant by the Agency pursuant to Article 17(5) of this Regulation. Where the application concerns inclusion in Annex I to Regulation (EU) No 528/2012, it may only concern category 1, 2, 3, 4, 5 or 6 of that Annex. 2. Applications referred to in paragraph 1 shall be submitted to the Agency within two years of the declaration of compliance pursuant to Article 17(5). Article 4 Acceptance of applications 1. The Agency shall inform the participant of the fees payable under Commission Implementing Regulation (EU) No 564/2013 ( 1 ) and shall reject the application if the participant fails to pay the fees within 30 days. It shall inform the participant and the evaluating competent authority accordingly. 2. Upon receipt of the fees payable under Implementing Regulation (EU) No 564/2013, the Agency shall accept the application and inform the participant and the evaluating competent authority accordingly, indicating the date of the acceptance of the application and its unique identification code. 3. An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of the Agency taken pursuant to paragraph 1 of this Article. 4. The evaluating competent authority shall inform the participant of the fees payable under Article 80(2) of Regulation (EU) No 528/2012 within 30 days after the Agency has accepted the application, and shall reject the application if the participant fails to pay the fees within 30 days. It shall inform the participant and the Agency accordingly. Article 5 Validation of applications for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/ Where an application for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012 containing the data required in accordance with Article 6(1) and (2) thereof has been accepted by the Agency pursuant to Article 4(2) and the fee has been paid pursuant to Article 4(4) the evaluating competent authority shall validate the application within 30 days of the payment of the fees. 2. Where the evaluating competent authority has received from the participant the dossier pursuant to Regulation (EC) No 1451/2007 but not yet accepted the dossier as complete pursuant to Article 13 thereof, the evaluating competent authority shall validate the application at the latest 3 January In the cases referred to in paragraphs 1 and 2, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted. 4. Where the evaluating competent authority considers that the application is incomplete, it shall inform the participant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days. ( 1 ) Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and chargespayable to the European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, , p. 17).

51 EN Official Journal of the European Union L 294/5 The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 2. The evaluating competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant and the Agency accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) of Regulation (EU) No 528/2012 shall be reimbursed. On validating an application, the evaluating competent authority shall without delay inform the participant, the Agency and other competent authorities accordingly, indicating the date of the validation. Article 6 Evaluation of applications 1. This Article shall apply where any of the following conditions applies: (a) where an application has been validated pursuant to Article 5; (b) where the evaluating competent authority has accepted the dossier as complete pursuant to Article 13 of Regulation (EC) No 1451/2007 but not yet submitted the competent authority report to the Commission pursuant to Article 14(4) of that Regulation; (c) where an application for inclusion in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012 has been accepted by the Agency pursuant to Article 4(2) and the fee has been paid pursuant to Article 4(4). 2. The evaluating competent authority shall evaluate the application in accordance with Articles 4 and 5 of Regulation (EU) No 528/2012, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3) of that Regulation, and send an assessment report and the conclusions of its evaluation to the Agency. 3. Where several participants support the same substance/product-type combination, the evaluating competent authority shall draft only one assessment report. The assessment report and the conclusions shall be sent within either of the following time-limits, whichever is the later: (a) 365 days of the last validation referred to in paragraph 1(a), acceptance of completeness referred to in paragraph 1(b) or payment of the fee referred to in paragraph 1(c), for the substance/product-type combination in question; (b) the time limits provided for by Annex III. 4. Prior to submitting its conclusions to the Agency, the evaluating competent authority shall give the participant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation. 5. Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the participant to submit such information within a specified time limit, and shall inform the Agency accordingly. The 365-day period referred to in paragraph 3 shall be suspended from the date of issue of the request until the date the information is received. Unless it is justified by the nature of the data requested or by exceptional circumstances, the suspension shall not exceed the following time-limits: (a) 365 days in cases where the additional information relates to concerns which were not addressed under Directive 98/8/EC or under the practice established for application of that Directive; (b) 180 days in other cases. 6. Where the evaluating competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council ( 1 ) and include this as part of its conclusions. ( 1 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, , p. 1).

52 L 294/6 EN Official Journal of the European Union Upon finalisation of its hazard evaluation, the evaluating competent authority shall without undue delay and no later than at the time of submission of the assessment report pursuant to paragraph 3, as appropriate: (a) submit a proposal to the Agency pursuant to Article 37(1) of Regulation (EC) No 1272/2008, where it considers that one of the criteria referred to in Article 36(1) thereof is fulfilled and not properly addressed in part 3 of Annex VI to that Regulation; (b) consult the Agency where it considers that one of the criteria of Article 5(1)(d) or (e) of Regulation (EU) No 528/2012, or the condition of Article 10(1)(d) of that Regulation, is fulfilled and not properly addressed in Annex XIV to Regulation (EC) No 1907/2006 or in the candidate list referred to in Article 59(1) of that Regulation. Article 7 Opinion of the Agency 1. This Article shall apply where either of the following conditions applies: (a) where the evaluating competent authority has submitted an assessment report pursuant to Article 6(2) and, where relevant, a proposal or a consultation pursuant to Article 6(7); (b) where a competent authority report has been submitted to the Commission pursuant to Article 14(4) of Regulation (EC) No 1451/2007, but the assessment report has not yet been reviewed within the Standing Committee on Biocidal Products pursuant to Article 15(4) of that Regulation. 2. Upon acceptance of the report, the Agency shall prepare and submit to the Commission an opinion on the approval of the substance/product-type combination or its inclusion in category 1, 2, 3, 4, 5 or 6 of Annex I to Regulation (EU) No 528/2012, or both, having regard to the conclusions of the evaluating competent authority. The Agency shall start the preparation of the opinion within either of the following deadlines, whichever is the later: (a) three months of the acceptance of the report; (b) the time limits provided for by Annex III. The Agency shall submit the opinion to the Commission within 270 days of the start of the preparation. Article 8 Active substances which are candidates for substitution 1. When preparing its opinion pursuant to Article 7(2), the Agency shall examine whether the active substance fulfils any of the criteria listed in Article 10(1) of Regulation (EU) No 528/2012 and address the matter in its opinion. 2. Prior to submitting its opinion to the Commission, the Agency shall make publicly available, without prejudice to Articles 66 and 67 of Regulation (EU) No 528/2012, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. The Agency shall take due account of the information received when finalising its opinion. 3. Where the active substance is approved and fulfils one of the criteria laid down in Article 10(1) of Regulation (EU) No 528/2012, it shall be identified as a candidate for substitution in the Regulation adopted pursuant to the first subparagraph of Article 89(1) of that Regulation. Article 9 Commission decision Upon receipt of the opinion of the Agency pursuant to Article 7(2), the Commission shall without undue delay prepare a draft decision for adoption pursuant to Article 89(1) or, as appropriate, Article 28(1) of Regulation (EU) No 528/2012.

53 L 294/7 Official Journal of the European Union EN CHAPTER 3 CHANGES OF ELEMENTS OF THE REVIEW PROGRAMME Article 10 Joining or replacing participants by mutual agreement 1. The role of participant may be taken over or shared by mutual agreement between an existing participant and a prospective participant, provided that the prospective participant has the right to refer to all the data submitted or referred to by the existing participant. 2. A notification for the purpose of this Article shall be submitted jointly to the Agency by the prospective and the existing participant through the Register for Biocidal Products referred to in Article 71 of Regulation (EU) No 528/2012 (hereinafter the Register ), and shall include all relevant letters of access. 3. Upon receipt of a notification complying with paragraph 2, the Agency shall update the information in the Register with respect to the identity of the participant. 4. A person established in the Union having taken over or joined the role of participant pursuant to this Article shall be considered as having submitted a dossier or a letter of access to a dossier for the purpose of Article 95 of Regulation (EU) No 528/2012. Article 11 Participants' withdrawal 1. A participant shall be considered to have withdrawn its support for a substance/product-type combination in the review programme in the following cases: (a) where it has informed the Agency or the evaluating competent authority through the Register of its intention to withdraw; (b) where it has failed to submit an application within the time limits specified in Article 3(2); (c) where its application has been rejected pursuant to Article 4(1), Article 4(4) or Article 5(4); (d) where it has failed to provide the additional information within the time limits provided for by Article 6(5); (e) where it has otherwise failed to pay the fees payable to the evaluating competent authority or the Agency. 2. A withdrawal shall be considered as timely unless it occurs after the date when the evaluating competent authority submits its competent authority report to the applicant pursuant to Article 6(4) of this Regulation. Article 12 Consequences of a timely withdrawal 1. Where a timely withdrawal is known to the evaluating competent authority but not to the Agency, the evaluating competent authority shall without undue delay inform the Agency thereof through the Register. 2. Where a timely withdrawal is known to the Agency, it shall update the information in the Register with respect to the identity of the participant. 3. Where all participants supporting the same substance/product-type combination have made a timely withdrawal from the review programme, and where the role of participant for that combination has previously been taken over, the Agency shall inform the Commission thereof through the Register.

54 L 294/8 EN Official Journal of the European Union Article 13 Redefinition of active substances 1. Where the evaluation of an existing active substance does not allow for conclusions to be drawn relating to the substance as identified in Annex II, the evaluating competent authority shall, after consultation with the participant concerned, establish a new substance identity. The evaluating competent authority shall inform the Agency thereof. 2. The Agency shall update the information in the Register with respect to the identity of the substance. Article 14 Taking over the role of participant 1. The Agency shall publish an open invitation to take over the role of participant for a substance/product-type combination where one of the following cases applies: (a) where all participants supporting the same substance/product-type combination have made a timely withdrawal pursuant to Article 11, and the role of participant for that combination has not previously been taken over; (b) following a redefinition pursuant to Article 13, in which case, the invitation shall only concern any substance covered by the existing identity in Annex II, but not by the new substance identity. 2. Within 12 months from the date of the publication referred to in paragraph 1, any person may submit a notification for the combination pursuant to Article Within 12 months from the date of entry into force of this Regulation, any person may notify a substance/ product-type combination included in part 2 of Annex II pursuant to Article 17. Article 15 Substance/product-type combinations eligible for inclusion in the review programme Where a biocidal product covered by the scope of Regulation (EU) No 528/2012 and being placed on the market consists of, contains or generates an existing active substance which is neither approved, nor included in the review programme, for the product-type, and is not included in Annex I to that Regulation, that substance shall be eligible for inclusion in the review programme for the relevant product-type on any of the following grounds: (a) the person placing the product on the market has relied on guidance published by, or written advice received from, the Commission or a competent authority designated in accordance with Article 26 of Directive 98/8/EC or Article 81 of Regulation (EU) No 528/2012, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Commission; (b) the substance has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007; (c) the biocidal product belongs under Regulation (EU) No 528/2012 to a different product-type than the one it belonged to under Directive 98/8/EC, as a result of a modification of scope of those product-types, and contains a substance included in the review programme for the original product-type but not for the new one.

55 L 294/9 Official Journal of the European Union EN Article 16 Declaration of interest to notify 1. A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to Article 15 shall be submitted through the Register by any person with an interest to notify a substance/product-type combination to one of the following recipients: (a) to the Commission at the latest 12 months after the publication of the decision or guidance referred to in point (a) of Article 15; (b) to the Agency at the latest 30 October 2015 in cases referred to in point (b) of Article 15; (c) to the Commission at the latest 30 October 2015 in cases referred to in point (c) of Article A declaration shall indicate the relevant substance/product-type combination. In cases referred to in point (a) of Article 15, the declaration shall provide a substantiated justification showing that all the conditions listed therein are fulfilled. 3. Where a declaration has been made in a case referred to in point (a) or (c) of Article 15, and the Commission finds, in consultation with the Member States, that paragraph 6 is not applicable, and, where relevant, that the conditions for notification listed in point (a) of Article 15 are fulfilled, it shall inform the Agency thereof. 4. Where a declaration has been made in the case referred to in point (b) of Article 15, or where the Commission has informed the Agency pursuant to paragraph 3, the Agency shall make that information publicly available by electronic means, mentioning the relevant substance/product-type combination. For the purposes of this Regulation, a publication made pursuant to the third subparagraph of Article 3a(3) of Regulation (EC) No 1451/2007 shall be considered as a publication made pursuant to this paragraph. 5. Within 6 months from the date of a publication referred to in paragraph 4, any person with an interest to notify the substance/product-type combination may do so pursuant to Article In cases referred to in points (a) and (c) of Article 15, a substance/product-type combination shall be considered as notified by a participant, and shall not be eligible for additional notification where the following conditions apply: (a) the relevant active substance is already included in the review programme; (b) one of the dossiers submitted to the evaluating Member State for the relevant active substance already contains all the data required for the evaluation of the product-type; (c) the participant which has submitted that dossier indicates an interest to support the substance/product-type combination. Article 17 Notification procedure 1. Notifications pursuant to Article 14(2) and (3) or Article 16(5) shall be made to the Agency through the Register. 2. The notification shall be submitted in IUCLID format. It shall contain the information referred to in Annex I. 3. Where no evaluating competent authority is indicated in Annex II for the active substance in question, the notifier shall inform the Agency of the name of its choice of competent authority designated in accordance with Article 81 of Regulation (EU) No 528/2012, and provide written confirmation that that competent authority agrees to evaluate the dossier. 4. Upon receipt of a notification, the Agency shall inform the Commission thereof, and inform the notifier of the fees payable under Regulation (EU) No 564/2013. If the notifier fails to pay the fee within 30 days from the receipt of that information, the Agency shall reject the notification and inform the notifier and the Commission thereof.

56 L 294/10 EN Official Journal of the European Union Upon receipt of payment of the fees, the Agency shall verify within 30 days whether the notification complies with the requirements of paragraph 2. If the notification does not comply with those requirements, the Agency shall grant the notifier a period of 30 days in which to complete or correct the notification. After the expiry of that 30-day period, the Agency shall, within 30 days, either declare that the notification complies with the requirements of paragraph 2 or reject the notification, and inform the notifier and the Commission thereof. 6. An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of the Agency taken pursuant to paragraph 4 or paragraph Where a notification has been found compliant pursuant to paragraph 5, the Agency shall without delay: (a) where the notification has been submitted pursuant to Article 14(2) or (3), update the information in the Register with respect to the identity of the participant and, where relevant, of the substance; (b) where the notification has been submitted pursuant to Article 16(5), inform the Commission of the compliance. Article 18 Inclusion in the review programme Where a substance/product-type combination is considered notified in accordance with Article 16(6), or where the Agency informs the Commission of compliance in accordance with Article 17(7)(b), the Commission shall include the substance/ product-type combination in the review programme. Article 19 Information on substances no longer supported under the review programme Where no notification has been received within the time limit referred to in Article 16(5), or where a notification referred to in that Article has been received and subsequently rejected by the Agency pursuant to Article 17(4) or (5), the Agency shall inform the Member States thereof through the Register and publish that information electronically. Article 20 Commission decisions on substances no longer supported under the review programme The Commission shall prepare a draft non-approval decision pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012 in the following cases: (a) where the Agency informs the Commission of all participants' timely withdrawal pursuant to Article 12(3) of this Regulation; (b) where no person has submitted a notification within the time limits provided for by Article 14(2) or 14(3) of this Regulation, or where such a notification has been submitted and rejected pursuant to Article 17(4) or 17(5) thereof; (c) where a notification has been submitted within the time limits provided for by Article 14(2) or 14(3) of this Regulation and has been found compliant pursuant to Article 17(5) thereof, but the substance identity in the notification only covers part of the existing identity in Annex II to this Regulation. In case referred to in point (c) of first paragraph, the draft non-approval decision shall cover any substance covered by the existing identity in Annex II to this Regulation, but not by the notification or any approval decision.

57 L 294/11 Official Journal of the European Union EN CHAPTER 4 TRANSITIONAL MEASURES Article 21 Transitional measures for substances referred to in Article A Member State may continue to apply its current system or practice of making available on the market and using a biocidal product consisting of, containing or generating an existing active substance referred to in points (b) and (c) of Article 15. In such cases: (a) the biocidal product shall no longer be made available on the market with effect from 24 months after the date of entry into force of this Regulation; (b) the use of existing stocks of the biocidal product may continue until 30 months after the date of entry into force of this Regulation. 2. A Member State may continue to apply its current system or practice of making available on the market and using a biocidal product consisting of, containing or generating an existing active substance referred to in point (a) of Article 15. In such cases: (a) The biocidal product shall no longer be made available on the market with effect from 24 months after of either of the following, whichever is the later: (i) the date of entry into force of this Regulation; (ii) the notification or publication of the decision or guidance referred to in point (a) of Article 15. (b) Use of existing stocks of the biocidal product may continue until 30 months after either of the following, whichever is the later: (i) the date of entry into force of this Regulation; (ii) the notification or publication of the decision or guidance referred to in point (a) of Article A Member State may continue to apply its current system or practice of making available on the market or using a biocidal product consisting of, containing or generating an existing active substance for which the Agency has made a publication pursuant to Article 16(4) for the relevant product-type. In such cases: (a) The biocidal product shall no longer be made available on the market with effect from 12 months after the date when the Agency has made the electronic publication referred to in Article 19; and (b) Use of existing stocks of the biocidal product may continue until 18 months after the date of that publication. Article 22 Essential use 1. Without prejudice to Article 55(1) of Regulation (EU) No 528/2012, within 18 months of the date of a decision not to approve an existing active substance, where a Member State considers this existing active substance essential for one of the reasons referred to in points (b) or (c) of the first subparagraph of Article 5(2) of Regulation (EU) No 528/2012, that Member State may submit a reasoned application to the Commission for a derogation from the second subparagraph of Article 89(2) of that Regulation. 2. The requesting Member State shall submit the reasoned application to the Agency through the Register. Where the application contains confidential information, the requesting Member State shall at the same time submit a non-confidential version. 3. The Agency shall make the application or, where relevant, the non-confidential version, publicly available by electronic means. Member States or any other person may submit comments within 60 days of the publication.

58 L 294/12 EN Official Journal of the European Union Taking account of the comments received, the Commission may grant a derogation from the second sub-paragraph of Article 89(2) of Regulation (EU) No 528/2012 allowing biocidal products consisting of, containing or generating the substance to be made available on the market of the requesting Member State and used in that Member State in accordance with national rules and subject to the conditions in paragraph 5 and any further conditions imposed by the Commission. 5. The Member State to which the derogation is granted shall: (a) ensure that continued use is limited to such cases where and such time during which the conditions of paragraph 1 are fulfilled; (b) impose appropriate risk mitigation measures to ensure that exposure of humans, animals and the environment is minimised; (c) ensure that alternatives are being sought, or that an application for approval of the active substance is being prepared for submission in accordance with Article 7 of Regulation (EU) No 528/2012 in due time before the expiry of the derogation. CHAPTER 5 FINAL PROVISIONS Article 23 Repeal Regulation (EC) No 1451/2007 is repealed. References to that Regulation shall be construed as references to this Regulation. Article 24 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 4 August For the Commission The President José Manuel BARROSO

59 ANNEX I Information requirements for notifications pursuant to Article 17 A notification pursuant to Article 17 shall contain the following information: (1) evidence that the substance is an existing active substance within the meaning of Article 3(1)(d) of Regulation (EU) No 528/2012; (2) an indication of the product-type(s) concerned by the notification; (3) information on any studies that have been commissioned for the purpose of application for approval or inclusion in Annex I to Regulation (EU) No 528/2012, as well as the expected date of completion; (4) the information referred to in Sections (a) 1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II to Regulation (EU) No 528/2012 for chemical substances; (b) 1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II to Regulation (EU) No 528/2012 for micro-organisms; (5) where the notification has been made in a case referred to in point (a) of Article 15, evidence that the substance was on the market as an active substance of a biocidal product falling under the relevant product-type on the date of notification or publication of the decision or guidance referred to in that point EN Official Journal of the European Union L 294/13

60 ANNEX II SUBSTANCE/PRODUCT-TYPE COMBINATIONS INCLUDED IN THE REVIEW PROGRAMME ON 4 AUGUST 2014 PART 1 Active substance/product-type combinations supported on 4 August 2014, excluding any other nanomaterial than those explicitly mentioned in entries 1017 and 1019 Entry number Substance name Rapporteur Member State EC number CAS number Formaldehyde DE x x x 6 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether (Piperonyl butoxide/pbo) EL x 9 Bronopol ES x x x x x x 29 Chlorocresol FR x x x x x x 36 Ethanol EL x x x 37 Formic acid BE x x x x x x x 40 Propan-2-ol DE x x x L 294/14 EN Official Journal of the European Union 43 Salicylic acid NL x x x 45 Propan-1-ol DE x x x 52 Ethylene oxide N x 60 Citric acid BE x 69 Glycolic acid LT x x x 70 Peracetic acid FI x x x x x x x x 71 L-(+)-lactic acid DE x x x x

61 Entry number 79 Substance name (2R,6aS,12aS)-1,2,6,6a,12,12a-hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one (Rotenone) Rapporteur Member State EC number CAS number UK x 85 Symclosene UK x x x x x x 92 Biphenyl-2-ol ES x x x x x x x x x 113 Cinnamaldehyde/3-phenyl-propen-2-al (Cinnamic aldehyde) UK x 117 Geraniol FR x x 122 Glyoxal FR x x x 133 Hexa-2,4-dienoic acid (Sorbic acid) DE x 136 Glutaral (Glutaraldehyde) FI x x x x x x 154 Clorophene (Chlorophene) N x x Phenoxyethanol UK x x x x x 172 Cetylpyridinium chloride UK x 179 Carbon dioxide FR x Sodium dimethylarsinate (Sodium Cacodylate) Tosylchloramide sodium (Tosylchloramide sodium Chloramin T) PT x ES x x x x 187 Potassium dimethyldithiocarbamate UK x x x 188 Sodium dimethyldithiocarbamate UK x x x EN Official Journal of the European Union L 294/15

62 Entry number Substance name Rapporteur Member State EC number CAS number Sodium 2-biphenylate ES x x x x x x x x x 198 N-(trichloromethylthio)phthalimide (Folpet) IT x x 206 Thiram BE x 210 Metam-sodium BE x x thiazol-4-yl-1H-benzoimidazole (Thiabendazole) ES x x x 235 Diuron DK x x 239 Cyanamide DE x x Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet) Dichloro-N-[(dimethylamino)sulphonyl] fluoro-n-(ptolyl)methanesulphenamide (Tolylfluanid) BE x x FI x x L 294/16 EN Official Journal of the European Union 283 Terbutryn SK x x x 288 N-(Dichlorofluoromethylthio)-N,N - dimethyl-n-phenylsulfamide (Dichlofluanid) UK x x 289 Copper thiocyanate FR x 292 (1,3,4,5,6,7-hexahydro-1,3-dioxo-2Hisoindol-2-yl)methyl (1R-trans)-2,2- dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-tetramethrin) DE x

63 Entry number 958 Substance name Calcium dihydroxide/calcium hydroxide/ caustic lime/hydrated lime/slaked lime Rapporteur Member State EC number CAS number UK x x 959 Calcium oxide/lime/burnt lime/quicklime UK x x 306 Dicopper oxide FR x Butanone, peroxide HU x x 321 Monolinuron UK x N-(3-aminopropyl)-N-dodecylpropane- 1,3-diamine (Diamine) 2,2 -dithiobis[n-methylbenzamide] (DTBMA) PT x x x x x x x x PL x 339 1,2-benzisothiazol-3(2H)-one (BIT) ES x x x x x x methyl-2H-isothiazol-3-one (MIT) SI x x x x 346 Sodium dichloroisocyanurate dihydrate UK x x x x x x 345 Troclosene sodium UK x x x x x x 348 Mecetronium ethyl sulphate (MES) PL x 354 Triclosan DK x (ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm)) Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione) PL x x x x x SE x x x x x x x EN Official Journal of the European Union L 294/17

64 Entry number Methenamine (CTAC) Substance name 3-chloroallylochloride 2,2,2 -(hexahydro-1,3,5-triazine-1,3,5- triyl)triethanol (HHT) Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5 (1H,3H)-dione (TMAD) Rapporteur Member State EC number CAS number PL x x x PL x x x x ES x x x x x 387 N,N -methylenebismorpholine (MBM) AT x x 392 Methylene dithiocyanate FR x ,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH) Didecyldimethylammonium chloride (DDAC) PL x x IT x x x x x x x x x 401 Silver SE x x x x 403 Copper FR x L 294/18 EN Official Journal of the European Union 405 Sulphur dioxide DE x 424 Sodium bromide NL x x x 432 Sodium hypochlorite IT x x x x x x x 434 Tetramethrin DE x 439 Hydrogen peroxide FI x x x x x x x x 444 7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c] oxazole (EDHO) PL x x

65 Entry number Substance name Rapporteur Member State 450 Silver nitrate SE x 453 Disodium persulphate peroxodisulphate/sodium EC number CAS number PT x 455 Calcium hypochlorite IT x x x x x 457 Chlorine IT x x x 458 Ammonium sulphate UK x x 473 Pyrethrins and Pyrethroids ES x x 491 Chlorine dioxide PT x x x x x x 494 2,2-dibromo-2-cyanoacetamide (DBNPA) DK x x x x x x 501 Carbendazim DE x x x 515 Ammonium bromide SE x x 522 Pyrithione zinc (Zinc pyrithione) SE x x x x x x 524 Dodecylguanidine monohydrochloride ES x x 526 Potassium 2-biphenylate ES x x x x 529 Bromine chloride NL x 531 (benzyloxy)methanol UK x x 534 Bis(1-hydroxy-1H-pyridine-2-thionato- O,S)copper (Copper pyrithione) SE x 541 Sodium p-chloro-m-cresolate FR x x x x x x EN Official Journal of the European Union L 294/19

66 Entry number 550 Substance name D-gluconic acid, compound with N,N -bis(4-chlorophenyl)-3,12-diimino- 2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG) Rapporteur Member State EC number CAS number PT x x x 554 p-[(diiodomethyl)sulphonyl]toluene UK x x x x (benzothiazol-2-ylthio)methyl thiocyanate (TCMTB) 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent- 2-en-1-yl 2,2-dimethyl-3-(2-methylprop- 1-enyl)cyclopropanecarboxylate (Prallethrin) Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate).alpha.,.alpha.,.alpha. -trimethyl-1,3,5- triazine-1,3,5(2h,4h,6h)-triethanol (HPT) N x x EL x DE x x AT x x x x octyl-2H-isothiazol-3-one (OIT) UK x x x x x x L 294/20 EN Official Journal of the European Union 577 Dimethyloctadecyl[3-(trimethoxysilyl) propyl]ammonium chloride ES x x x 578 N -tert-butyl-n-cyclopropyl-6- (methylthio)-1,3,5-triazine-2,4-diamine (Cybutryne) NL x 588 Bromochloro-5,5-dimethylimidazolidine- 2,4-dione (BCDMH/Bromochlorodimethylhydantoin) NL x x x (4-isopropylphenyl)-1,1-dimethylurea/ Isoproturon DE x x

67 Entry number Substance name 1-[2-(allyloxy)-2-(2,4-dichlorophenyl) ethyl]-1h-imidazole (Imazalil) S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin- 3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos) 2-bromo-2-(bromomethyl)pentanedinitrile (DBDCB) Rapporteur Member State EC number CAS number DE x UK x CZ x 961 Calcium magnesium oxide/dolomitic lime UK x x Calcium magnesium tetrahydroxide/ calcium magnesium hydroxide/hydrated dolomitic lime.alpha.-cyano-3-phenoxybenzyl 2,2-dimethyl-3-(2-methylprop-1-enyl) cyclopropanecarboxylate (Cyphenothrin) Dimethyltetradecyl[3-(trimethoxysilyl) propyl]ammonium chloride Mixture of cis- and trans-p-menthane-3,8 diol (Citriodiol) (RS)-α-cyano-3phenoxybenzyl-(1RS)- cis, trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Cypermethrin) 3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Permethrin) UK x x EL x PL x UK x BE x IE x x EN Official Journal of the European Union L 294/21

68 Entry number 618 Substance name 1-ethynyl-2-methylpent-2-enyl 2,2-dimethyl-3-(2-methylprop-1-enyl) cyclopropanecarboxylate (Empenthrin) Rapporteur Member State EC number CAS number BE x iodo-2-propynylbutylcarbamate (IPBC) DK x x x x Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS) 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl]-1h-1,2,4-triazole (Propiconazole) Coco alkyltrimethylammonium chloride (ATMAC/TMAC) 4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro- 2-octyl-2H- isothiazol-3- one (DCOIT)) 2-chloro-N-[[[4-(trifluoromethoxy) phenyl]amino]carbonyl]benzamide (Triflumuron) MT x x x x FI x IT x N x x x x IT x L 294/22 EN Official Journal of the European Union 656 3,3 -methylenebis[5-methyloxazolidine] (Oxazolidin/MBO) AT x x x x x 657 N-cyclopropyl-1,3,5-triazine-2,4,6-triamine (Cyromazine) EL x 666.alpha.-cyano-4-fluoro-3-phenoxybenzyl 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Cyfluthrin) DE x

69 Entry number Substance name Alkyl (C ) dimethylbenzyl ammonium chloride (ADBAC (C )) Alkyl (C ) dimethylbenzyl ammonium chloride (ADBAC/BKC (C 12 -C 16 )) Didecyldimethylammonium (DDAC (C 8-10 )) chloride Quaternary ammonium compounds, benzyl-c alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS) Rapporteur Member State EC number CAS number IT x x x x x x x x IT x x x x x x x x IT x x x x x x x x MT x x 691 Sodium N-(hydroxymethyl)glycinate AT x 692 Amines, C alkyldimethyl, N-oxides PT x Pentapotassium bis(peroxymonosulphate) bis(sulphate) Magnesium monoperoxyphthalate hexahydrate (MMPP) SI x x x x PL x 1015 Margosa extract DE x Alkyl (C 12 -C 14 ) dimethylbenzylammonium chloride (ADBAC (C 12 -C 14 )) Alkyl (C 12 -C 14 ) ethylbenzylammonium chloride (ADEBAC (C 12 -C 14 )) IT x x x x x x x x IT x x x x x x x x 731 Chrysanthemum cinerariaefolium, ext. ES x 744 Lavender, Lavandula hybrida, ext./lavandin oil PT x EN Official Journal of the European Union L 294/23

70 Entry number Substance name 1-(3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)phenyl)-3-(2,6-difluorobenzoyl) urea (Hexaflumuron) Reaction products of: glutamic acid and N-(C 12 -C 14 -alkyl)propylenediamine (Glucoprotamin) Rapporteur Member State EC number CAS number PT x DE x x (phthalimido)peroxyhexanoic acid (PAP) IT x x x x butyl-benzo[d]isothiazol-3-one (BBIT) CZ x x x x x 792 Tetrachlorodecaoxide complex (TCDO) DE x x x Silver sodium hydrogen zirconium phosphate sec-butyl 2-(2-hydroxyethyl)piperidine-1- carboxylate/icaridine (Icaridine) cis-1-(3-chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride (cis CTAC) SE x x x x x DK x PL x x L 294/24 EN Official Journal of the European Union 800 [2,4-Dioxo-(2-propyn-1-yl)imidazolidin- 3-yl]methyl(1R)-cis-chrysanthemate;[2,4- Dioxo-(2-propyn-1-yl)imidazolidin-3-yl] methyl(1r)-trans-chrysanthemate (Imiprothrin) UK x chloro-2-(4-chlorphenoxy)phenol (DCPP) AT x x x 807 (E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3- methyl-2-nitroguanidine (Clothianidin) DE x

71 Entry number Substance name Bacillus sphaericus 2362, strain ABTS-1743 Bacillus thuringiensis subsp. israelensis, strain SA3A Bacillus subtilis Mixture of 5-chloro-2-methyl-2Hisothiazol-3-one (EINECS ) and 2-methyl-2H-isothiazol-3-one (EINECS ) (Mixture of CMIT/MIT) Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ Peroxyoctanoic acid Silver zeolite Not applicable 3-phenoxybenzyl (1R)-cis,trans-2,2- dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-phenothrin) Amines, N-C 12 -C 14 (even-numbered)-alkyltrimethylenedi-, reaction products with chloroacetic acid (Ampholyt 20) Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH) Rapporteur Member State IT IT DE EC number CAS number Microorganism Microorganism Microorganism x Not applicable Not applicable x FR Mixture x x x x x x SK FR SE IE IE NL Mixture Not applicable Not applicable Not applicable Not applicable Not available Not applicable x x x x x x x x x x x x x x x x Not available x x EN Official Journal of the European Union L 294/25

72 Entry number Substance name Reaction mass of titanium dioxide and silver chloride Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH) Silver phosphate glass Silver zinc zeolite Silver copper zeolite Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale) Rapporteur Member State SE NL SE SE SE SE EC number CAS number Not available Not available Not available Not available Not available Not available Not available x x x x x x x Not available x x x x x x x x x x x x x Not available x x L 294/26 EN Official Journal of the European Union 1019 Silicon dioxide (as a nanomaterial formed by aggregates and agglomerates) FR Not available x 831 Silicium dioxide (Silicium dioxide/kieselguhr) FR Plant protection product x 854 (RS)-3-Allyl-2-methyl-4-oxocyclopent-2- enyl-(1r,3r;1r,3s)-2,2-dimethyl-3-(2- methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 4 isomers 1R trans, 1R: 1R trans, 1S: 1R cis, 1R: 1R cis, 1S 4:4:1:1) (d-allethrin) DE Plant protection product x

73 Entry number Substance name (RS)-3-Allyl-2-methyl-4-oxocyclopent-2- enyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 2 isomers 1R trans: 1R/S only 1:3) (Esbiothrin) N-((6-Chloro-3-pyridinyl)methyl)-N - cyano-n-methylethanimidamide (Acetamiprid) Esfenvalerate/(S)-.alpha.-Cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate (Esfenvalerate) [1.alpha.(S*),3.alpha.]-(.alpha.)-cyano-(3- phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (alpha-cypermethrin) 4-bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr) Polymer of N-Methylmethanamine (EINECS with (chloromethyl) oxirane (EINECS )/Polymeric quaternary ammonium chloride (PQ Polymer) Monohydro chloride of polymer of N,N -1,6-hexanediylbis[N -cyanoguanidine] (EINECS ) and hexamethylenediamine (EINECS )/ Polyhexamethylene biguanide (monomer: 1,5-bis(trimethylen)-guanylguanidinium monohydrochloride) (PHMB) Rapporteur Member State DE BE PT BE PT EC number CAS number Plant protection product Plant protection product Plant protection product Plant protection product Plant protection product x x x x x HU Polymer x x FR Polymer / x x x x x x x x EN Official Journal of the European Union L 294/27

74 Entry number Substance name Rapporteur Member State EC number CAS number Poly(hexamethylenebiguanide) FR Polymer x x x x x x Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.- hydroxy-, propanoate (salt) (Bardap 26) N-Didecyl-N-dipolyethoxyammonium borate/didecylpolyoxethylammonium borate (Polymeric betaine) This part of this Annex includes IT Polymer x x x x EL Polymer x PART 2 Active substance/product-type combinations not supported on 4 August 2014 the substance/product-type combinations listed in the table below, including any nanomaterial forms, any nanomaterial forms of all substance/product-type combinations listed in the table in part 1, except those listed in that table, and any nanomaterial forms of all active substance/product-type combinations approved by 4 August 2014, except those explicitly approved. L 294/28 EN Official Journal of the European Union The substance/product-type combinations and nanomaterials included in this part will be the subject of a non-approval decision pursuant to Article 20 if no person makes a notification within 12 months of the entry into force of this Regulation pursuant to Article 14(3), or if such a notification is rejected pursuant to Article 17(4) or 17(5). Entry number Substance name Rapporteur Member State EC number CAS number ,3-dichloro-5,5-dimethylhydantoin (redefined as per entry 152) NL x 166 Cetalkonium chloride (see entry 948) Benzyldimethyl(octadecyl)ammonium chloride (see entry 948)

75 Entry number 213 Substance name Benzododecinium chloride (see entry 948) Rapporteur Member State EC number CAS number Miristalkonium chloride (see entry 948) thiazol-4-yl-1H-benzoimidazole (Thiabendazole) Didecyldimethylammonium bromide (see entry 949) Dimethyldioctylammonium chloride (see entry 949) Benzyldodecyldimethylammonium bromide (see entry 948) ES x Silver SE x 418 Silicon dioxide amorphous FR x 449 Copper sulphate FR x 1016 Silver chloride SE x x x x x x x 554 p-[(diiodomethyl)sulphonyl]toluene UK x Decyldimethyloctylammonium (see entry 949) Benzyldimethyloleylammonium (see entry 948) chloride chloride 3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Permethrin) IE x EN Official Journal of the European Union L 294/29

76 Entry number Substance name Quaternary ammonium compounds, benzylcoco alkyldimethyl, chlorides (see entry 948) Quaternary ammonium compounds, dicocoalkyl dimethyl, chlorides (see entry 949) Quaternary ammonium compounds, bis (hydrogenated tallow alkyl)dimethyl, chlorides (see entry 949) Quaternary ammonium compounds, benzyl-c alkyldimethyl, chlorides (see entry 948) Quaternary ammonium compounds, di- C alkyldimethyl, chlorides (see entry 949) Quaternary ammonium compounds, benzyl-c alkyldimethyl, chlorides (see entry 948) Rapporteur Member State EC number CAS number L 294/30 EN Official Journal of the European Union 689 Quaternary ammonium compounds, benzyl-c alkyldimethyl, chlorides (see entry 948) Amines, C alkyldimethyl, N-oxides PT x 697 Quaternary ammonium compounds, di- C alkyldimethyl, chlorides (see entry 949) Dihydrogen bis[monoperoxyphthalato (2-)-O1,OO1]magnesate(2-) hexahydrate PL x

77 Entry number Substance name Margosa extract other than from the kernels of Azadirachta indica extracted with water and further processed with organic solvents. Quaternary ammonium compounds, benzyl-c alkyldimethyl, bromides (see entry 948) 1,3-dichloro-5-ethyl-5-methylimidazolidine-2,4-dione (redefined as per entry 777) 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4- triazol-1-ylmethyl)pentan-3-ol (Tebuconazole) Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide (Perestane) Alkyl-benzyl-dimethylammonium chloride/benzalkonium chloride (see entry 948) Quaternary ammonium compounds (dialkyldimethyl (alkyl from C 6 -C 18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (DDAC) Quaternary ammonium compounds (alkyltrimethyl (alkyl from C 8 -C 18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (TMAC) Rapporteur Member State EC number CAS number DE x NL x DK x HU IT IT Not applicable Mixture Mixture of EINECS listed substances Mixture of EINECS listed substances Not applicable Not applicable x x x x x x x x x x EN Official Journal of the European Union L 294/31

78 Entry number Substance name Quaternary ammonium compounds (benzylalkyldimethyl (alkyl from C 8 -C 22, saturated and unsaturated, tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or hydroxides) (BKC) Not applicable 3-phenoxybenzyl (1R)-cis,trans-2,2- dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-phenothrin) Quaternary ammonium compounds, benzyl-c alkyldimethyl, chlorides (other than the substance covered by entry 671) Quaternary ammonium compounds, benzyl-c alkyldimethyl, chlorides (other than the substance covered by entry 667) Quaternary ammonium compounds, C alkyl[(ethylphenyl)methyl]dimethyl, chlorides (other than the substance covered by entry 725) Rapporteur Member State IT IE IT IT IT EC number CAS number Mixture of EINECS listed substances Not applicable Not applicable Not applicable Not applicable x x x x x x x x x Not applicable Not applicable Not applicable x x x x x x x x x x x x x x x x x x x x x x x x x L 294/32 EN Official Journal of the European Union 1005 Quaternary ammonium compounds, benzyl-c alkyldimethyl, chlorides (other than the substance covered by entry 724) IT Not applicable Not applicable x x x x x x x x 1006 Silver-zinc-aluminium-boronphosphate glass/glass oxide, silver- and zinccontaining SE Not applicable x x x 1009 Quaternary ammonium compounds, di- C alkyldimethyl, chlorides (other than the substance covered by entry 673) IT Not applicable Not applicable x x x x x x x x x

79 Entry number Substance name Quaternary ammonium compounds, coco alkyltrimethyl, chlorides (other than the substance covered by entry 635) Aluminium sodium silicate-silver zinc complex/silver-zinc-zeolite Not applicable (±)-1-(.beta.-allyloxy-2,4-dichlorophenylethyl)imidazole (Technical grade imazalil) Rapporteur Member State IT SE DE EC number CAS number Not applicable Plant protection product Not applicable x x x x x EN Official Journal of the European Union L 294/33

80 L 294/34 EN Official Journal of the European Union ANNEX III Time limits Product-types Time limits for submitting the assessment report pursuant to Article 6(3)(b) Time limits for starting the preparation of the opinion pursuant to Article 7(2)(b) 8, 14, 16, 18, 19 and , 4 and and and , 9 and , 12, 15, 17, 20 and

81 DA Den Europæiske Unions Tidende L 186/111 KOMMISSIONENS GENNEMFØRELSESAFGØRELSE af 25. juni 2014 om forlængelse af godkendelsen af difethialon og difenacoum til anvendelse i biocidholdige produkter af produkttype 14 (EØS-relevant tekst) (2014/397/EU) EUROPA-KOMMISSIONEN HAR under henvisning til traktaten om Den Europæiske Unions funktionsmåde, under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter ( 1 ), særlig artikel 14, stk. 5, og ud fra følgende betragtninger: (1) Aktivstofferne difethialon og difenacoum er optaget i bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF ( 2 ) til anvendelse i biocidholdige produkter af produkttype 14 og anses ifølge artikel 86 i forordning (EU) nr. 528/2012 for godkendt i henhold til den forordning, så længe de specifikationer og betingelser, der er anført i bilag I til nævnte direktiv, overholdes. (2) Godkendelserne udløber henholdsvis den 31. oktober 2014 og den 31. marts Der er i overensstemmelse med artikel 13, stk. 1, i forordning (EU) nr. 528/2012 ansøgt om fornyelse af godkendelserne af disse aktivstoffer. (3) Som følge af de konstaterede risici og egenskaberne ved aktivstofferne difethialon og difenacoum, som betyder, at de er potentielt persistente, potentielt bioakkumulerende og toksiske, eller meget persistente og meget potentielt bioakkumulerende, forudsætter en fornyelse af godkendelserne, at et eller flere alternative aktivstoffer undersøges. De nævnte egenskaber betyder endvidere, at godkendelserne af aktivstofferne kun kan fornys, hvis det påvises, at mindst én af betingelserne i artikel 5, stk. 2, første afsnit, i forordning (EU) nr. 528/2012 er opfyldt. (4) For at kunne foreslå de foranstaltninger, der er bedst egnede til at begrænse de risici, som egenskaberne ved antikoagulansrodenticider indebærer, har Kommissionen iværksat en undersøgelse af, hvilke risikobegrænsende foranstaltninger der kan træffes for sådanne aktivstoffer. (5) Undersøgelsen er endnu ikke afsluttet, og de, der ansøger om fornyelse af godkendelserne af disse aktivstoffer, bør have mulighed for at henvise til undersøgelsens konklusioner i deres ansøgninger. Endvidere bør undersøgelsens resultater tages med i betragtning ved enhver afgørelse om fornyelse af godkendelser af antikoagulansrodenticider. (6) For at gøre det lettere at gennemgå og sammenligne fordele og risici ved alle antikoagulansrodenticider og de risikobegrænsende foranstaltninger, der gælder for sådanne aktivstoffer, bør vurderingen af difethialon og difenacoum udskydes, indtil den sidste ansøgning om fornyelse af det sidste antikoagulansrodenticid er indgivet. Ansøgninger om fornyelse af godkendelserne af de sidste antikoagulansrodenticider, dvs. brodifacoum, warfarin og warfarinnatrium, ventes at være indgivet inden den 31. juli (7) Under disse omstændigheder, som ansøgerne ikke har nogen indflydelse på, vil godkendelsen af difethialon og difenacoum formentlig udløbe, inden der er truffet afgørelse om en fornyelse. Derfor bør de gældende godkendelser af disse aktivstoffer forlænges i så lang tid, at ansøgningerne kan behandles. (8) Stofferne bør bortset fra godkendelsens udløbsdato fortsat være godkendt under forudsætning af, at specifikationerne og betingelserne i bilag I til direktiv 98/8/EF overholdes. (9) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter ( 1 ) EUT L 167 af , s. 1. ( 2 ) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af , s. 1).

82 L 186/112 DA Den Europæiske Unions Tidende VEDTAGET DENNE AFGØRELSE: Artikel 1 Godkendelsen af difethialon og difenacoum til anvendelse i biocidholdige produkter af produkttype 14 forlænges til den 30. juni Artikel 2 Denne afgørelse træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende. Udfærdiget i Bruxelles, den 25. juni På Kommissionens vegne José Manuel BARROSO Formand

83 EN Official Journal of the European Union L 186/111 COMMISSION IMPLEMENTING DECISION of 25 June 2014 postponing the expiry date of approval of difethialone and difenacoum for use in biocidal products for product-type 14 (Text with EEA relevance) (2014/397/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular Article 14(5) thereof, Whereas: (1) The active substances difethialone and difenacoum were included into Annex I to Directive 98/8/EC of the European Parliament and of the Council ( 2 ) for use in biocidal products for product-type 14, and pursuant to Article 86 of Regulation (EU) No 528/2012 are considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive. (2) Their approval will expire on 31 October 2014 and 31 March 2015, respectively. In accordance with Article 13(1) of Regulation (EU) No 528/2012, applications have been submitted for the renewal of the approval of these active substances. (3) Because of the identified risks and the characteristics of the active substances difethialone and difenacoum, which render them potentially persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the renewal of their approval is subject to an assessment of an alternative active substance or substances. In addition, due to these characteristics, the approval of those active substances may be renewed only if it is shown that at least one of the conditions of the first subparagraph of Article 5(2) of Regulation (EU) No 528/2012 is fulfilled. (4) The Commission has launched a study on the risk-mitigation measures that may be applied to anticoagulant rodenticides with a view to proposing the measures that are most suitable for mitigating the risks associated to the properties of those active substances. (5) That study is currently on-going, and the possibility should be given to the applicants for the renewal of approval of those active substances to address the conclusions of the study in their application. Furthermore, the conclusions of that study should be taken into account when deciding on the renewal of the approval of all anticoagulant rodenticides. (6) In order to facilitate the review and comparison of the risks and benefits of all anticoagulant rodenticides as well as of the risk-mitigation measures applied to them, the assessment of difethialone and difenacoum should be postponed until the last application for the renewal of the last anticoagulant rodenticide is submitted. Applications for the renewal of the approval of the last anticoagulant rodenticides, namely brodifacoum, warfarin and warfarin sodium, are expected to be submitted by 31 July (7) Consequently, for reasons beyond the control of the applicants, the approval of difethialone and difenacoum is likely to expire before a decision has been taken on their renewal. It is therefore appropriate to postpone the expiry date of approval of those active substances for a period of time sufficient to enable the examination of the applications. (8) Except for the expiry date of the approval, those substances should remain approved subject to the specifications and conditions set out in Annex I to Directive 98/8/EC. (9) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, ( 1 ) OJ L 167, , p. 1. ( 2 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1).

84 L 186/112 EN Official Journal of the European Union HAS ADOPTED THIS DECISION: Article 1 The expiry date of approval of difethialone and difenacoum for use in biocidal products for product-type 14 shall be postponed to 30 June Article 2 This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Done at Brussels, 25 June For the Commission The President José Manuel BARROSO

85 DA Den Europæiske Unions Tidende L 188/85 KOMMISSIONENS GENNEMFØRELSESAFGØRELSE af 25. juni 2014 om begrænsninger af godkendelser af biocidholdige produkter, der indeholder IPBC, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF (meddelt under nummer C(2014) 4167) (EØS-relevant tekst) (2014/402/EU) EUROPA-KOMMISSIONEN HAR under henvisning til traktaten om Den Europæiske Unions funktionsmåde, under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter ( 1 ), særlig artikel 36, stk. 3, og ud fra følgende betragtninger: (1) Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF ( 2 ) indeholder en liste over aktive stoffer, der er godkendt på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/79/EF ( 3 ) blev det aktive stof IPBC til anvendelse i produkter tilhørende produkttype 8, træbeskyttelsesmidler, optaget på listen, jf. bilag V til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses IPBC således for at være et godkendt aktivstof, som er optaget på den liste, der er omhandlet i artikel 9, stk. 2, i samme forordning. (2) Det Forenede Kongerige har godkendt produkter, der indeholder IPBC, og som er beregnet til industriel brug og brug af fagfolk, til anvendelse på træ ved automatiseret neddypning i form af fuldstændig nedsænkning i en dyppetank, der indeholder træbeskyttelsesmidlet. Godkendelserne er efterfølgende blevet gensidigt anerkendt af andre medlemsstater. (3) Tysklands kompetente myndighed for biocidholdige produkter har modtaget ansøgninger om gensidig anerkendelse af godkendelser af nogle af disse produkter (i det følgende benævnt»de omtvistede produkter«) i medfør af artikel 4, stk. 1, i direktiv 98/8/EF. De omtvistede produkter er opført på listen i bilaget til denne afgørelse. (4) Tyskland meddelte den 4. oktober 2012 og den 6. november 2012 Kommissionen, de andre medlemsstater og ansøgerne sit forslag om at begrænse godkendelserne af de omtvistede produkter i overensstemmelse med artikel 4, stk. 4, i direktiv 98/8/EF. Tyskland foreslog at afslå godkendelse af produkterne til automatiseret neddypning, da produkterne under sådanne forhold ikke opfylder kravene i artikel 5, stk. 1, i direktiv 98/8/EF med hensyn til deres indvirkning på menneskers sundhed. Ifølge meddelelserne havde Tyskland identificeret en række problemer for så vidt angår professionelle operatører, hvis hud eksponeres for IPBC, når produktet anvendes til automatiseret neddypning. Disse problemer har særlig relevans for Tyskland, hvor en betydelig andel af de anlæg, der benytter denne metode, har et lavt automatiseringsniveau, og der derfor er en højere risiko for, at de pågældende operatørers hud kommer i kontakt med det behandlede træ eller med kontaminerede overflader. (5) Kommissionen opfordrede de øvrige medlemsstater og ansøgerne til skriftligt at fremsætte bemærkninger til hver enkelt af meddelelserne inden 90 dage, jf. artikel 27, stk. 1, i direktiv 98/8/EF. Flere medlemsstater og ansøgerne indsendte bemærkninger inden for fristen. Meddelelserne blev også drøftet mellem repræsentanter for Kommissionen og medlemsstaternes kompetente myndigheder vedrørende biocidholdige produkter, og i givet fald ansøgerne, på møder i gruppen for produktgodkendelse og lettere gensidig anerkendelse, jf. artikel 35 i forordning (EU) nr. 528/2012. ( 1 ) EUT L 167 af , s. 1. ( 2 ) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af , s. 1). ( 3 ) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af , s. 12).

86 L 188/86 DA Den Europæiske Unions Tidende (6) Af disse drøftelser og bemærkninger fremgår det, at de eksisterende modeller til vurdering af menneskers eksponering i forbindelse med neddypningsprocesser bør tilpasses. Ekspertgruppen om menneskelig eksponering udarbejdede tilpassede modeller til vurdering af eksponeringen af professionelle operatører, der udfører industriel behandling af træ i form af fuldautomatiseret neddypning, og gruppens udtalelse blev godkendt på det tekniske møde om biocider den september 2013 ( 1 ). De tilpassede modeller viser, at i tilfælde hvor de omtvistede produkter anvendes i fuldautomatiserede neddypningsprocesser, skønnes professionelle operatørers eksponering for IPBC ikke at have nogen uacceptabel indvirkning på menneskers sundhed, jf. artikel 5, stk. 1, i direktiv 98/8/EF. (7) Derfor bør de omtvistede produkter godkendes på betingelse af, at det af mærkningen fremgår, at produktet kun må anvendes i fuldautomatiserede neddypningsprocesser. (8) Forordning (EU) nr. 528/2012 finder anvendelse på de omtvistede produkter i overensstemmelse med bestemmelserne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for denne afgørelse er artikel 36, stk. 3, i nævnte forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. artikel 36, stk. 4, i forordning (EU) nr. 528/2012. (9) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter VEDTAGET DENNE AFGØRELSE: Artikel 1 Tysklands forslag om at afslå godkendelser af de biocidholdige produkter til anvendelse ved automatiseret neddypning, der er opført i bilaget, afvises. Artikel 2 Godkendelser af de biocidholdige produkter, der er opført i bilaget, omfatter et krav om, at følgende skal fremgå af mærkningen på produktet:»produktet (indsæt navnet på produktet) må kun anvendes i fuldautomatiserede neddypningsprocesser, hvor alle trin i behandlings- og tørringsprocessen er mekaniserede, og ikke omfatter manuelle handlinger, herunder når de behandlede artikler transporteres gennem dyppetanken til drænings-/tørringsområdet og lageret (hvis de ikke allerede er tørre på overfladen, inden de flyttes til lageret). Om nødvendigt skal de træartikler, der skal behandles, fastgøres helt (f.eks. med spændebånd eller fastspændingsanordninger) inden behandling og under neddypningsprocessen og må ikke håndteres manuelt, før overfladen på de behandlede artikler er tør.«denne afgørelse er rettet til medlemsstaterne. Artikel 3 Udfærdiget i Bruxelles, den 25. juni På Kommissionens vegne Janez POTOČNIK Medlem af Kommissionen ( 1 ) Tilgængelig på

87 L 188/87 Den Europæiske Unions Tidende DA BILAG De biocidholdige produkter, som er omhandlet i artikel 1 og 2, omfatter de biocidholdige produkter, der er opført i tabellen nedenfor under ansøgningens referencenummer i registret over biocidholdige produkter, samt produkter, der er berørt af en ansøgning om gensidig anerkendelse af godkendelserne af produkterne: 2010/7969/7206/UK/AA/ /7969/7232/UK/AA/ /8209/8150/UK/AA/ /7969/7206/UK/AA/ /7969/7226/UK/AA/ /7969/7226/UK/AA/ /7969/7227/UK/AA/ /7969/7227/UK/AA/ /7969/7228/UK/AA/ /7969/7228/UK/AA/ /7969/7229/UK/AA/ /7969/7229/UK/AA/ /7969/7230/UK/AA/ /7969/7230/UK/AA/ /7969/7231/UK/AA/ /7969/7231/UK/AA/ /7969/7232/UK/AA/ /7969/7233/UK/AA/ /7969/7233/UK/AA/ /7969/7234/UK/AA/ /7969/7234/UK/AA/ /7969/7759/UK/AA/ /7969/7786/UK/AA/ /7969/7786/UK/AA/ /7969/7787/UK/AA/ /7969/7787/UK/AA/ /7969/7788/UK/AA/ /7969/7788/UK/AA/ /1349/8153/UK/AA/10515

88 EN Official Journal of the European Union L 188/85 COMMISSION IMPLEMENTING DECISION of 25 June 2014 regarding restrictions of authorisations of biocidal products containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2014) 4167) (Text with EEA relevance) (2014/402/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular Article 36(3) thereof, Whereas: (1) Annex I to Directive 98/8/EC of the European Parliament and of the Council ( 2 ) contained the list of active substances approved at Union level for use in biocidal products. By Commission Directive 2008/79/EC ( 3 ), the active substance IPBC for use in products belonging to product-type 8, Wood preservatives, as defined in Annex V to Directive 98/8/EC, was added to the list. By virtue of Article 86 of Regulation (EU) No 528/2012, IPBC is therefore an approved active substance included in the list referred to in Article 9(2) of that Regulation. (2) The United Kingdom has authorised products containing IPBC for industrial and professional application on wood by automated dipping through immersion in a dip tank containing the wood preservative. The authorisations have subsequently been mutually recognised by other Member States. (3) The German competent authority for biocidal products received applications for mutual recognition of authorisations according to Article 4(1) of Directive 98/8/EC for some of those products ( the contested products ). The contested products are listed in the Annex to this Decision. (4) On 4 October 2012 and 6 November 2012, Germany notified the Commission, the other Member States and the applicants of its proposal to restrict the authorisations of the contested products in accordance with Article 4(4) of Directive 98/8/EC. Germany proposed not to authorise the products for automated dipping since it considered that the products would not meet the requirements of Article 5(1) of Directive 98/8/EC with regards to effects on the human health under such circumstances. According to the notifications, Germany identified some concerns with regard to the dermal exposure to IPBC of professional users when the products are applied by automated dipping. Those concerns were of particular relevance for Germany, where a significant share of premises using this application method are reported to have a low level of automation, and thus high likelihood of skin contact with treated wood or contaminated surfaces. (5) For each notification, the Commission invited the other Member States and the applicants to submit comments in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by several Member States and the applicants. The notifications were also discussed between the Commission and Member States' Competent Authorities for biocidal products and, where appropriate the applicants, in meetings of the Product Authorisation and Mutual Recognition Facilitation Group and of the Coordination Group referred to in Article 35 of Regulation (EU) No 528/2012. ( 1 ) OJ L 167, , p. 1. ( 2 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). ( 3 ) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto (OJ L 200, , p. 12).

89 L 188/86 EN Official Journal of the European Union (6) From those discussions and comments received, it followed that existing models for assessing human exposure for dipping processes should be adapted. Adapted models for exposure assessment for professional operators undertaking industrial treatment of wood by fully automated dipping were developed by the Human Exposure Expert Group, whose opinion was endorsed by the Biocides Technical Meeting of September 2013 ( 1 ). The adapted models show that, where the contested products are used in fully automated processes, exposure to IPBC of professional operators is not expected to have unacceptable effects for human health within the meaning of Article 5(1) of Directive 98/8/EC. (7) Consequently, the contested products should be authorised subject to instructions on the label restricting the use to fully automated dipping. (8) Regulation (EU) No 528/2012 applies to the contested products in accordance with the provisions of Article 92(2) of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this Decision should be addressed to all Member States in accordance with Article 36(4) of Regulation (EU) No 528/2012. (9) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS DECISION: Article 1 The proposal by Germany not to authorise the biocidal products listed in the Annex for automated dipping is rejected. Article 2 Authorisations of the biocidal products listed in the Annex shall include a condition that the label of the products contains the following instruction: Product (insert name of the product) must only be used in fully automated dipping processes where all steps in the treatment and drying process are mechanised and no manual handling takes place, including when the treated articles are transported through the dip tank to the draining/drying and storage (if not already surface dry before moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until after the treated articles are surface dry. This Decision is addressed to the Member States. Article 3 Done at Brussels, 25 June For the Commission Janez POTOČNIK Member of the Commission ( 1 ) Available at

90 L 188/87 Official Journal of the European Union EN ANNEX The biocidal products referred to in Article 1 and 2 of this Decision include the biocidal products listed in the table below, identified by their application reference number in the Register for Biocidal Products, as well as all products concerned by an application for mutual recognition of the authorisations of these products: 2010/7969/7206/UK/AA/ /7969/7232/UK/AA/ /8209/8150/UK/AA/ /7969/7206/UK/AA/ /7969/7226/UK/AA/ /7969/7226/UK/AA/ /7969/7227/UK/AA/ /7969/7227/UK/AA/ /7969/7228/UK/AA/ /7969/7228/UK/AA/ /7969/7229/UK/AA/ /7969/7229/UK/AA/ /7969/7230/UK/AA/ /7969/7230/UK/AA/ /7969/7231/UK/AA/ /7969/7231/UK/AA/ /7969/7232/UK/AA/ /7969/7233/UK/AA/ /7969/7233/UK/AA/ /7969/7234/UK/AA/ /7969/7234/UK/AA/ /7969/7759/UK/AA/ /7969/7786/UK/AA/ /7969/7786/UK/AA/ /7969/7787/UK/AA/ /7969/7787/UK/AA/ /7969/7788/UK/AA/ /7969/7788/UK/AA/ /1349/8153/UK/AA/10515

91 DA Den Europæiske Unions Tidende L 311/69 KOMMISSIONENS GENNEMFØRELSESAFGØRELSE af 29. oktober 2014 om begrænsninger af godkendelserne af biocidholdige produkter, der indeholder IPBC og propiconazol, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF (meddelt under nummer C(2014) 7909) (EØS-relevant tekst) (2014/756/EU) EUROPA-KOMMISSIONEN HAR under henvisning til traktaten om Den Europæiske Unions funktionsmåde, under henvisning til Europa-Parlamentets og Rådets forordning (EF) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter ( 1 ), særlig artikel 36, stk. 3, og ud fra følgende betragtninger: (1) Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF ( 2 ) indeholder en liste over aktivstoffer, der er godkendt på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/78/EF ( 3 ) og 2008/79/EF ( 4 ) tilføjedes aktivstofferne propiconazol og IPBC til anvendelse i produkttype 8, træbeskyttelsesmidler, jf. bilag V til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses disse aktivstoffer således for at være godkendte aktivstoffer, som er optaget på den liste, der er omhandlet i artikel 9, stk. 2, i samme forordning. (2) I overensstemmelse med artikel 8 i direktiv 98/8/EF indgav virksomheden Janssen PMP ansøgninger til Det Forenede Kongerige om godkendelse af tre træbeskyttelsesmidler i form af biocidholdige produkter, der indeholder IPBC og propiconazol (»de omtvistede produkter«). Det Forenede Kongeriges produktgodkendelser dækkede forskellige påføringsmetoder, herunder automatiseret neddypning til industriel brug og sprøjtning (indendørs og udendørs) til erhvervsmæssig og ikke-erhvervsmæssig brug. Flere medlemsstater har efterfølgende godkendt de omtvistede produkter ved gensidig anerkendelse. (3) Janssen PMP (»ansøgeren«) indgav fyldestgørende ansøgninger til Tyskland om gensidig anerkendelse af godkendelserne af de omtvistede produkter, der er meddelt af Det Forenede Kongerige. (4) Den 28. august 2013 meddelte Tyskland Kommissionen, de andre medlemsstater og ansøgeren sit forslag om at begrænse godkendelserne i overensstemmelse med artikel 4, stk. 4, i direktiv 98/8/EF. Tyskland finder, at de omtvistede produkter ikke opfylder kravene angående menneskers sundhed og miljøet, jf. artikel 5, stk. 1, i direktiv 98/8/EF. (5) Ifølge Tyskland var godkendelsen af påføringsmetoden ved sprøjtning udendørs ikke vurderet behørigt i Det Forenede Kongerige med hensyn til miljørisici. I Tysklands vurderinger af de tre produkter blev der konstateret uacceptable risici for dybereliggende jordbundslag. ( 1 ) EUT L 167 af , s. 1. ( 2 ) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af , s. 1). ( 3 ) Kommissionens direktiv 2008/78/EF af 25. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at optage propiconazol som et aktivt stof i bilag I hertil (EUT L 198 af , s. 44). ( 4 ) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af , s. 12).

92 L 311/70 DA Den Europæiske Unions Tidende (6) Tyskland er endvidere af den opfattelse, at for et af produkternes vedkommende bør påføring ved automatiseret neddypning begrænses til systemer med en tilstrækkelig høj grad af automatisering på grund af uacceptable sundhedsrisici for erhvervsmæssige brugere. (7) Kommissionen opfordrede de andre medlemsstater og ansøgeren til skriftligt at fremsætte bemærkninger til meddelelserne inden 90 dage i overensstemmelse med artikel 27, stk. 1, i direktiv 98/8/EF. Det Forenede Kongerige, Tyskland og ansøgeren fremsatte bemærkninger inden fristens udløb. Meddelelsen blev også drøftet mellem Kommissionen og medlemsstaternes kompetente myndigheder vedrørende biocidholdige produkter den 24. september 2013 på mødet i koordinationsgruppen, der er nedsat ved artikel 35 i forordning (EU) nr. 528/2012. (8) Med hensyn til risiciene for miljøet fremgår det af disse drøftelser og bemærkninger, at konklusionerne af Det Forenede Kongeriges miljømæssige vurdering var baseret på det relevante scenario i OECD's serie af emissionsscenariedokumenter ( 1 ), der stod til rådighed på vurderingstidspunktet. (9) Det følger ligeledes heraf, at Tysklands konklusioner bygger på et revideret scenarie i OECD's emissionsscenariedokumenter ( 2 ), der først stod til rådighed efter tidspunktet for Det Forenede Kongeriges godkendelser og Tysklands meddelelse. (10) Dertil kommer, at ifølge de aftalte retningslinjer fra det 47. møde blandt repræsentanter for medlemsstaternes kompetente myndigheder med henblik på gennemførelsen af direktiv 98/8/EF om markedsføring af biocidholdige produkter ( 3 ), kan nye retningslinjer kun tages i betragtning, hvis de stod til rådighed før datoen for indgivelsen af ansøgningen om produktgodkendelse, medmindre de videnskabelige fremskridt viser, at det at forlade sig på gamle retningslinjer giver anledning til alvorlige betænkeligheder. I disse retningslinjer fastslås det endvidere, at alvorlige betænkeligheder ville udløse en revision af eksisterende godkendelser. Imidlertid fandt hverken Det Forenede Kongerige eller de medlemsstater, der har godkendt produktet via gensidig anerkendelse, at betænkelighederne var så alvorlige, at dette kunne berettige til at revidere de eksisterende godkendelser. (11) I lyset af ovenstående bemærkninger støtter Kommissionen konklusionerne af Det Forenede Kongeriges vurdering og de andre medlemsstater, der har godkendt produkterne via gensidig anerkendelse, i betragtning af at de omtvistede produkter opfylder kravene i artikel 5, stk. 1, i direktiv 98/8/EF med hensyn til miljøet. Kommissionen finder derfor, at Tysklands anmodning om at begrænse godkendelserne ikke er berettiget med den anførte begrundelse. (12) Med hensyn til anvendelsen af automatiseret neddypning finder Kommissionen, at det omtvistede produkt bør være underlagt de bestemmelser, der er fastlagt i en tidligere kommissionsafgørelse ( 4 ) vedrørende beskyttelse af sundheden for erhvervsmæssige brugere, når denne påføringsmetode anvendes sammen med produkter, der indeholder IPBC. Derfor bør det omtvistede produkt godkendes på betingelse af, at det af mærkningen fremgår, at produktet kun må anvendes i fuldautomatiserede neddypningsprocesser, og produktgodkendelsen bør ændres tilsvarende. (13) Forordning (EU) nr. 528/2012 finder anvendelse på det omtvistede produkt i overensstemmelse med bestemmelserne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for nærværende afgørelse er artikel 36, stk. 3, i den nævnte forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. forordningens artikel 36, stk. 4. (14) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter ( 1 ) Se Emission scenarios for outdoor treatments i Part II i OECD's Emission Scenario Document (ESD) for Wood Preservatives (2003), der findes på webstedet ( 2 ) Se Outdoor spraying emission scenario i OECD's Revised Emission Scenario Document for Wood Preservatives (ENV/JM/MONO(2013) 21), der findes på webstedet 21&doclanguage=en. ( 3 ) Se dokumentet CA-July12-Doc.6.2d Final Relevance of new guidance becoming available during the process of authorisation and mutual recognition of authorisations of biocidal products, der findes på webstedet ( 4 ) Kommissionens gennemførelsesafgørelse 2014/402/EU af 25. juni 2014 om begrænsninger af godkendelser af biocidholdige produkter, der indeholder IPBC, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF (EUT L 188 af , s. 85).

93 L 311/71 Den Europæiske Unions Tidende DA VEDTAGET DENNE AFGØRELSE: Artikel 1 Denne afgørelse finder anvendelse på produkter, som er identificeret ved følgende referencenumre i referencemedlemsstaten som fastsat i registret over biocidholdige produkter: 2010/2709/7626/UK/AA/ /2709/8086/UK/AA/ /2709/7307/UK/AA/8801 Artikel 2 Tysklands forslag om at afslå godkendelser af de biocidholdige produkter, der er nævnt i artikel 1, til sprøjtning udendørs afvises. Artikel 3 Ved brug til automatiseret neddypning skal godkendelser af biocidholdige produkter med referencenummer 2010/2709/7626/UK/AA/8666 indeholde en betingelse om, at mærkningen af produktet skal indeholde følgende instruks:»produktet (indsæt navnet på produktet) må kun anvendes i fuldautomatiserede neddypningsprocesser, hvor alle trin i behandlings- og tørringsprocessen er mekaniserede og ikke omfatter manuel håndtering, herunder når de behandlede artikler transporteres gennem dyppetanken til drænings-/tørringsområdet og lageret (hvis de ikke allerede er tørre på overfladen, inden de flyttes til lageret). Om nødvendigt skal de træartikler, der skal behandles, fastgøres helt (f.eks. med spændebånd eller fastspændingsanordninger) inden behandling og under neddypningsprocessen og må ikke håndteres manuelt, før overfladen på de behandlede artikler er tør.«denne afgørelse er rettet til medlemsstaterne. Artikel 4 Udfærdiget i Bruxelles, den 29. oktober På Kommissionens vegne Janez POTOČNIK Medlem af Kommissionen

94 EN Official Journal of the European Union L 311/69 COMMISSION IMPLEMENTING DECISION of 29 October 2014 concerning restrictions of the authorisations of biocidal products containing IPBC and propiconazole notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2014) 7909) (Text with EEA relevance) (2014/756/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular Article 36(3) thereof, Whereas: (1) Annex I to Directive 98/8/EC of the European Parliament and of the Council ( 2 ) contained the list of active substances approved at Union level for inclusion in biocidal products. Commission Directives 2008/78/EC ( 3 ) and 2008/79/EC ( 4 ) added the active substances propiconazole and IPBC, respectively, for use in products belonging to product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC. By virtue of Article 86 of Regulation (EU) No 528/2012, those substances are therefore approved active substances included in the list referred to in Article 9(2) of that Regulation. (2) In accordance with Article 8 of Directive 98/8/EC, the company Janssen PMP submitted applications to the United Kingdom for authorisation of three wood preservative biocidal products containing IPBC and propiconazole ( the contested products ). The product authorisations granted by the United Kingdom covered different application methods, including automated dipping for industrial use and spraying (indoors and outdoors) for professional and non-professional use. A number of Member States have subsequently authorised the contested products through mutual recognition. (3) Janssen PMP ( the applicant ) submitted complete applications to Germany for mutual recognition of the authorisations of the contested products granted by the United Kingdom. (4) Germany notified the Commission, the other Member States and the applicant on 28 August 2013 of its proposal to restrict the authorisations in accordance with Article 4(4) of Directive 98/8/EC. Germany considers that the contested products do not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to human health and the environment. (5) According to Germany, the authorisation of the application method by spraying outdoors was not appropriately assessed by the United Kingdom in terms of environmental risks. The assessment performed by Germany for the three products concluded in unacceptable risks for the distant soil compartment. ( 1 ) OJ L 167, , p. 1. ( 2 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). ( 3 ) Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I thereto (OJ L 198, , p. 44). ( 4 ) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto (OJ L 200, , p. 12).

95 L 311/70 EN Official Journal of the European Union (6) Germany also considers that for one of the products, the application by automated dipping should be limited to systems with a sufficiently high degree of automation due to unacceptable risks for the health of professional users. (7) The Commission invited the other Member States and the applicant to submit comments to the notifications in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by Germany, the United Kingdom and the applicant. The notification was also discussed between the Commission and Member States' Competent Authorities for biocidal products on 24 September 2013 in the meeting of the coordination group established under Article 35 of Regulation (EU) No 528/2012. (8) With regard to the risks for the environment, from those discussions and comments it follows that the conclusions of the environmental assessment carried out by the United Kingdom were based on the relevant scenario of the Series on Emission Scenario Documents of the Organisation for Economic Co-operation and Development (OECD) ( 1 ) available at the time of the evaluation. (9) It also follows that the conclusions from Germany are based on a revised scenario of the OECD Series on Emission Scenario Documents ( 2 ), available since the authorisations were granted by the United Kingdom and also since the notification made by Germany. (10) In addition, according to agreed guidance by the 47th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market ( 3 ), new guidance can only be taken into consideration if it was available before the date of submission of the application for product authorisation, unless scientific progress shows that the reliance on old guidance gives rise to serious concern. This guidance further establishes that a serious concern would trigger revision of existing authorisations. However, neither the United Kingdom nor the other Member States having approved the products through mutual recognition considered that the concern was such as to justify a revision of existing authorisations. (11) In the light of the above comments, the Commission supports the conclusions of the evaluation carried out by the United Kingdom and the other Member States having approved the products through mutual recognition, considering that the contested products fulfil the requirements set by Article 5(1) of Directive 98/8/EC with regard to the environment. The Commission therefore considers that the request by Germany to restrict the authorisations cannot be justified on the grounds put forward. (12) With regard to the application by automated dipping, the Commission considers that the contested product should be subject to the provisions established by a previous Commission Decision ( 4 ) addressing the protection of the health of professional users when applying IPBC containing products by this application method. Consequently, the contested product should be authorised subject to instructions on the label restricting the use to fully automated dipping processes and the product authorisation should be amended accordingly. (13) Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2) of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this Decision should be addressed to all Member States by virtue of Article 36(4) of that Regulation. (14) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, ( 1 ) See Emission scenarios for outdoor treatments from Part II of OECD Emission Scenario Document (ESD) for Wood Preservatives (2003), available on the website ( 2 ) See Outdoor spraying emission scenario from OECD Revised Emission Scenario Document for Wood Preservatives (ENV/JM/MONO (2013)21), available on the website 21&doclanguage=en ( 3 ) See document CA-July12-Doc.6.2d Final on Relevance of new guidance becoming available during the process of authorisation and mutual recognition of authorisations of biocidal products, available on the website ( 4 ) Commission Implementing Decision 2014/402/EU of 25 June 2014 regarding restrictions of authorisations of biocidal products containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (OJ L 188, , p. 85).

96 L 311/71 Official Journal of the European Union EN HAS ADOPTED THIS DECISION: Article 1 This Decision applies to products identified by the following application reference numbers in the Reference Member State, as provided for by the Register for Biocidal Products: 2010/2709/7626/UK/AA/ /2709/8086/UK/AA/ /2709/7307/UK/AA/8801 Article 2 The proposal by Germany not to authorise the biocidal products referred to in Article 1 for spraying outdoors, is rejected. Article 3 Where used for automated dipping, authorisations of biocidal products identified by the application reference number 2010/2709/7626/UK/AA/8666 shall include a condition that the label of the products contains the following instruction: Product (insert name of the product) must only be used in fully automated dipping processes where all steps in the treatment and drying process are mechanised and no manual handling takes place, including when the treated articles are transported through the dip tank to the draining/drying and storage (if not already surface dry before moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until after the treated articles are surface dry. This Decision is addressed to the Member States. Article 4 Done at Brussels, 29 October For the Commission Janez POTOČNIK Member of the Commission

97 L 311/72 DA Den Europæiske Unions Tidende KOMMISSIONENS GENNEMFØRELSESAFGØRELSE af 29. oktober 2014 om begrænsning af godkendelse af et biocidholdigt produkt, der indeholder IPBC, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF (meddelt under nummer C(2014) 7914) (EØS-relevant tekst) (2014/757/EU) EUROPA-KOMMISSIONEN HAR under henvisning til traktaten om Den Europæiske Unions funktionsmåde, under henvisning til Europa-Parlamentets og Rådets forordning (EU) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter ( 1 ), særlig artikel 36, stk. 3, og ud fra følgende betragtninger: (1) Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF ( 2 ) indeholder en liste over aktive stoffer, der er godkendt på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/79/EF ( 3 ) blev det aktive stof IPBC optaget til anvendelse i produkter tilhørende produkttype 8, træbeskyttelsesmidler, jf. bilag V til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses dette stof således for at være et godkendt aktivstof, som er optaget på den liste, der er omhandlet i artikel 9, stk. 2, i samme forordning. (2) I overensstemmelse med artikel 8 i direktiv 98/8/EF har virksomheden ISP Cologne Holding GmbH den 22. december 2010 indgivet en ansøgning til Danmark om godkendelse af et biocidholdigt træbeskyttelsesmiddel indeholdende IPBC (»det omtvistede produkt«). Danmark godkendte det omtvistede produkt den 19. december 2011 til brugsklasse 2 og 3 for behandlet træ som omhandlet i Technical Notes for Guidance on Product Evaluation ( 4 ). Produktgodkendelsen dækker forskellige påføringsmetoder, herunder automatiseret dypning i professionelt øjemed. To medlemsstater har efterfølgende godkendt det omtvistede produkt ved gensidig anerkendelse. (3) ISP Cologne Holding GmbH (»ansøgeren«) indsendte den 20. februar 2012 en fuldstændig ansøgning til Tyskland med henblik på at opnå gensidig anerkendelse af Danmarks godkendelse af det omtvistede produkt. (4) Den 30. august 2013 meddelte Tyskland Kommissionen, de øvrige medlemsstater og ansøgeren sit forslag om at begrænse godkendelsen i overensstemmelse med artikel 4, stk. 4, i direktiv 98/8/EF. Tyskland finder ikke, at det omtvistede produkt opfylder kravene i artikel 5, stk. 1, i direktiv 98/8/EF, hvad angår folkesundheden og miljøet. (5) Ifølge Tyskland tog den danske vurdering ikke i tilstrækkeligt omfang højde for de miljøproblemer, som det omtvistede produkt rejser. Tyskland konkluderede i sin miljørisikovurdering af brugslevetiden for behandlet træ under brugsklasse 3-vilkår, at risikoen for jordbunden på dag 30 (»tidspunkt 1«) er uacceptabel uanset påføringsmetoden. Tyskland foreslår derfor, at man ikke godkender anvendelse af træ, der er behandlet med det omtvistede produkt, under brugsklasse 3-vilkår. (6) Tyskland finder desuden, at påføring ved automatiseret dypning bør begrænses til systemer med en tilstrækkeligt høj automatiseringsgrad på grund af uacceptable risici for professionelle brugeres sundhed. (7) Kommissionen opfordrede de øvrige medlemsstater og ansøgeren til skriftligt at fremsætte bemærkninger til meddelelsen inden for en frist på 90 dage i overensstemmelse med artikel 27, stk. 1, i direktiv 98/8/EF. Der blev fremsat bemærkninger fra Tyskland, Danmark og ansøgeren inden for den pågældende frist. Meddelelsen blev også drøftet af Kommissionen og medlemsstaternes myndigheder med ansvar for biocidholdige produkter på mødet den 24. september 2013 i den koordineringsgruppe, der er nedsat ved artikel 35 i forordning (EU) nr. 528/2012. ( 1 ) EUT L 167 af , s. 1 ( 2 ) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af , s. 1). ( 3 ) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af , s. 12). ( 4 ) Tilgængelig på nedenstående adresse

98 DA Den Europæiske Unions Tidende L 311/73 (8) Hvad angår miljørisiciene, fremgår det af disse drøftelser og bemærkninger, at den evaluering, Danmark har gennemført, er i overensstemmelse med de gældende retningslinjer ( 1 ). Selv om der identificeres en risiko på tidspunkt 1 som resultat af et worst-case-scenarie, kan det antages, at anvendelsen af behandlet træ under brugsklasse 2- og 3-vilkår er sikker, når miljørisikoen ved udløbet af brugslevetiden anses for at være acceptabel. (9) Kommissionen bemærker også, at tilfælde, hvor der påvises en uacceptabel risiko på tidspunkt 1, er under drøftelse på EU-plan med henblik på fastlæggelse af en harmoniseret tilgang. Kommissionen finder på den baggrund, at indtil en sådan tilgang er vedtaget formelt, bør konklusionerne af den danske vurdering af det omtvistede produkt anses for at være gyldig, indtil produktgodkendelsen fornys. (10) I lyset af de fremsatte bemærkninger støtter Kommissionen konklusionerne af den evaluering, der er foretaget af Danmark og de øvrige medlemsstater, der har godkendt produktet ved gensidig anerkendelse, idet det vurderes, at det omtvistede produkt opfylder de miljøkrav, der er fastsat i artikel 5, stk. 1, i direktiv 98/8/EF. Kommissionen finder derfor ikke, at Tysklands anmodning om at begrænse godkendelsen er berettiget ud fra den fremførte begrundelse. (11) Hvad angår påføring ved automatiseret dypning, finder Kommissionen, at det omtvistede produkt bør være underlagt de bestemmelser, der er fastsat ved en tidligere kommissionsafgørelse ( 2 ), som omhandler beskyttelse af professionelle brugere ved påføring af produkter, der indeholder IPBC, med denne påføringsmetode. Det omtvistede produkt bør derfor godkendes på betingelse af, at det af mærkningen fremgår, at produktet kun må anvendes i fuldautomatiserede dyppeprocesser, og produktgodkendelsen bør ændres i overensstemmelse hermed. (12) Forordning (EU) nr. 528/2012 finder anvendelse på det omtvistede produkt i overensstemmelse med bestemmelserne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for nærværende afgørelse er artikel 36, stk. 3, i den nævnte forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. forordningens artikel 36, stk. 4. (13) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter VEDTAGET DENNE AFGØRELSE: Artikel 1 Denne afgørelse finder anvendelse på produkter, der er identificeret ved nedenstående ansøgningsreferencenummer i referencemedlemsstaten som fastsat i registeret for biocidholdige produkter: 2010/5411/6906/DK/AA/8325 Artikel 2 Tysklands forslag om at begrænse den godkendelse, der er indrømmet af Danmark den 19. december 2011, af de produkter, der er omhandlet i artikel 1, kan ikke imødekommes. Artikel 3 Godkendelser af biocidholdige produkter, der anvendes til automatiseret dypning, og som er identificeret ved ansøgningsreferencenummeret i artikel 1, skal omfatte et krav om, at følgende skal fremgå af mærkningen på produktet:»produktet (indsæt navnet på produktet) må kun anvendes i fuldautomatiserede neddypningsprocesser, hvor alle trin i behandlings- og tørringsprocessen er mekaniserede, og ikke omfatter manuel håndtering, herunder når de behandlede artikler transporteres gennem dyppetanken til drænings-/tørringsområdet og lageret (hvis de ikke allerede er tørre på overfladen, inden de flyttes til lageret). Om nødvendigt skal de træartikler, der skal behandles, fastgøres helt (f.eks. med spændebånd eller fastspændingsanordninger) inden behandling og under neddypningsprocessen og må ikke håndteres manuelt, før overfladen på de behandlede artikler er tør.«( 1 ) Report of leaching workshop (Arona, Italien, juni 2005), der er tilgængelig på nedenstående websted our_activities/public-health/risk_assessment_of_biocides/doc/esd/esd_pt/pt_08/pt_8_leaching_workshop_2005.pdf/at_download/ file ( 2 ) Kommissionens gennemførelsesafgørelse 2014/402/EU af 25. juni 2014 om begrænsninger af godkendelser af biocidholdige produkter, der indeholder IPBC, meddelt af Tyskland i overensstemmelse med Europa-Parlamentets og Rådets direktiv 98/8/EF (EUT L 188 af , s. 85).

99 L 311/74 DA Den Europæiske Unions Tidende Artikel 4 Denne beslutning er rettet til medlemsstaterne. Udfærdiget i Bruxelles, den 29. oktober På Kommissionens vegne Janez POTOČNIK Medlem af Kommissionen

100 L 311/72 EN Official Journal of the European Union COMMISSION IMPLEMENTING DECISION of 29 October 2014 concerning restrictions of the authorisation of a biocidal product containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2014) 7914) (Text with EEA relevance) (2014/757/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular Article 36(3) thereof, Whereas: (1) Annex I to Directive 98/8/EC of the European Parliament and of the Council ( 2 ) contained the list of active substances approved at Union level for inclusion in biocidal products. Commission Directive 2008/79/EC ( 3 ) added the active substance IPBC for use in products belonging to product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC. By virtue of Article 86 of Regulation (EU) No 528/2012, this substance is therefore an approved active substance included in the list referred to in Article 9(2) of that Regulation. (2) In accordance with Article 8 of Directive 98/8/EC, the company ISP Cologne Holding GmbH submitted on 22 December 2010 an application to Denmark for authorisation of a wood preservative biocidal product containing IPBC ( the contested product ). Denmark authorised the contested product on 19 December 2011 for Use classes 2 and 3 of the treated wood, as described in the Technical Notes for Guidance on Product Evaluation ( 4 ). The product authorisation covers different application methods, including automated dipping for professional use. Two Member States have subsequently authorised the contested product through mutual recognition. (3) ISP Cologne Holding GmbH ( the applicant ) submitted on 20 February 2012 a complete application to Germany for mutual recognition of the authorisation of the contested product granted by Denmark. (4) Germany has notified the Commission, the other Member States and the applicant on 30 August 2013 of its proposal to restrict the authorisation in accordance with Article 4(4) of Directive 98/8/EC. Germany considers that the contested product does not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to the human health and the environment. (5) According to Germany, the assessment performed by Denmark did not appropriately address the environmental concerns raised by the contested product. The environmental risk assessment performed by Germany of the service life of treated wood under Use Class 3 conditions concluded in an unacceptable risk for the soil compartment at day 30 ( time 1 ) regardless of the application method. As a result, Germany proposes not to authorise the use of wood treated with the contested product under Use class 3 conditions. (6) Germany also considers that the application by automated dipping should be limited to systems with a sufficiently high degree of automation due to unacceptable risks on the human health of professional users. (7) The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by Germany, Denmark and the applicant. The notification was also discussed between the Commission and Member States' Competent Authorities for biocidal products on 24 September 2013 in the meeting of the coordination group established under Article 35 of Regulation (EU) No 528/2012. ( 1 ) OJ L 167, , p. 1. ( 2 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). ( 3 ) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto (OJ L 200, , p. 12). ( 4 ) Available on the website

101 EN Official Journal of the European Union L 311/73 (8) With regard to the risks for the environment, from those discussions and comments it follows that the evaluation carried out by Denmark is compatible with current guidance ( 1 ). Where a risk is identified at time 1 as a result of a worst-case assumption, safe use of treated wood under Use classes 2 and 3 conditions can be assumed when the risk for the environment at the end of the service life is deemed acceptable. (9) The Commission also notes that cases where an unacceptable risk is identified at time 1 are currently under discussion at Union level in order to establish a harmonised approach. Against this background the Commission considers that, until such an approach is formally adopted, the conclusions of the assessment of the contested product by the Denmark should be considered as valid until the renewal of the product authorisation. (10) In the light of those comments, the Commission supports the conclusions of the evaluation carried out by Denmark and the other Member States having approved the product through mutual recognition, considering that the contested product fulfils the requirements set by Article 5(1) of Directive 98/8/EC with regard to the environment. The Commission therefore considers that the request by Germany to restrict the authorisation cannot be justified on the grounds put forward. (11) With regard to the application by automated dipping, the Commission considers that the contested product should be subject to the provisions established by a previous Commission Decision ( 2 ) addressing the protection of the health of professional users when applying IPBC containing products by this application method. Consequently, the contested product should be authorised subject to instructions on the label restricting the use to fully automated dipping processes and the product authorisation should be amended accordingly. (12) Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2) of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this decision should be addressed to all Member States by virtue of Article 36(4) of that Regulation. (13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS DECISION: Article 1 This Decision applies to products identified by the following application reference number in the Reference Member State, as provided for by the Register for Biocidal Products: 2010/5411/6906/DK/AA/8325 Article 2 The proposal by Germany to restrict the authorisation granted by Denmark on 19 December 2011 of the products referred to in the Article 1, is rejected. Article 3 Where used for automated dipping, authorisations of biocidal products identified by the application reference number listed in Article 1 shall include a condition that the label of the products contains the following instruction: Product (insert name of the product) must only be used in fully automated dipping processes where all steps in the treatment and drying process are mechanised and no manual handling takes place, including when the treated articles are transported through the dip tank to the draining/drying and storage (if not already surface dry before moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until after the treated articles are surface dry. ( 1 ) Report of leaching workshop (Arona, Italy, June 2005), available on the website ( 2 ) Commission Implementing Decision 2014/402/EU of 25 June 2014 regarding restrictions of authorisations of biocidal products containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (OJ L 188, , p. 85).

102 L 311/74 EN Official Journal of the European Union Article 4 This Decision is addressed to the Member States. Done at Brussels, 29 October For the Commission Janez POTOČNIK Member of the Commission

103 DA Den Europæiske Unions Tidende L 311/75 KOMMISSIONENS GENNEMFØRELSESAFGØRELSE af 29. oktober 2014 om afvisning af et afslag på godkendelse af biocidholdige produkter, der er meddelt af Tyskland i henhold til Europa-Parlamentets og Rådets direktiv 98/8/EF (meddelt under nummer C(2014) 7915) (EØS-relevant tekst) (2014/758/EU) EUROPA-KOMMISSIONEN HAR under henvisning til traktaten om Den Europæiske Unions funktionsmåde, under henvisning til Europa-Parlamentets og Rådets forordning (EF) nr. 528/2012 af 22. maj 2012 om tilgængeliggørelse på markedet og anvendelse af biocidholdige produkter ( 1 ), særlig artikel 36, stk. 3, og ud fra følgende betragtninger: (1) Bilag I til Europa-Parlamentets og Rådets direktiv 98/8/EF ( 2 ) indeholder en liste over aktivstoffer, der er godkendt på EU-plan til anvendelse i biocidholdige produkter. Ved Kommissionens direktiv 2008/78/EF ( 3 ), 2008/79/EF ( 4 ) og 2008/86/EF ( 5 ) tilføjedes aktivstofferne propiconazol, IPBC og tebuconazol til anvendelse i produkttype 8, træbeskyttelsesmidler, jf. bilag V til direktiv 98/8/EF. I henhold til artikel 86 i forordning (EU) nr. 528/2012 anses disse aktivstoffer således for at være godkendte aktivstoffer, som er optaget på den liste, der er omhandlet i artikel 9, stk. 2, i samme forordning. (2) I overensstemmelse med artikel 8 i direktiv 98/8/EF indgav virksomheden Arch Timber Protection Ltd. den 2. april 2010 en ansøgning til Det Forenede Kongerige om godkendelse af et træbeskyttelsesmiddel i form af et biocidholdigt produkt, der indeholder propiconazol, IPBC og tebuconazol (»det omtvistede produkt«). Den 7. juni 2012 godkendte Det Forenede Kongerige det omtvistede produkt udelukkende til industriel anvendelse og midlertidig beskyttelse af nysavet/nyfældet træ og råtømmer, idet det også blev angivet, at træ, der er behandlet med dette produkt, kan anvendes som træ til brugsklasse 2 og 3 som beskrevet i Technical Notes for Guidance on Product Evaluation ( 6 ). Produktet består af to pakninger, der blandes og fortyndes på industrianlæg og alt efter lokale produktionsforhold påføres ved nedsænkning eller i en sprøjtetunnel. Ti medlemsstater har efterfølgende godkendt det omtvistede produkt ved gensidig anerkendelse. (3) Arch Timber Protection Ltd. (»ansøgeren«) indgav den 16. juli 2012 en fyldestgørende ansøgning til Tyskland om gensidig anerkendelse af den godkendelse af det omtvistede produkt, der er meddelt af Det Forenede Kongerige. (4) Den 19. august 2013 meddelte Tyskland Kommissionen, de andre medlemsstater og ansøgeren sit forslag om at afvise godkendelsen i overensstemmelse med artikel 4, stk. 4, i direktiv 98/8/EF. Tyskland fandt, at det omtvistede produkt ikke opfylder miljøkravene i artikel 5, stk. 1, i direktiv 98/8/EF. (5) Ifølge Tyskland fremgik det ikke i tilstrækkeligt grad af godkendelsen, at produktet er bestemt til midlertidig træbeskyttelse, og produktet er ikke vurderet behørigt af Det Forenede Kongerige med hensyn til miljørisici. Tyskland konkluderede i sin vurdering, at der foreligger en uacceptabel risiko for miljøet på 30. dagen efter anvendelsen af produktet (»tidspunkt 1«), hvilket også giver anledning til betænkeligheder angående den potentielle anvendelse af træ, som er behandlet med det omtvistede produkt, som træ til brugsklasse 2 og 3. ( 1 ) EUT L 167 af , s. 1. ( 2 ) Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af , s. 1). ( 3 ) Kommissionens direktiv 2008/78/EF af 25. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at optage propiconazol som et aktivt stof i bilag I hertil (EUT L 198 af , s. 44). ( 4 ) Kommissionens direktiv 2008/79/EF af 28. juli 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at optage IPBC som et aktivt stof i bilag I hertil (EUT L 200 af , s. 12). ( 5 ) Kommissionens direktiv 2008/86/EF af 5. september 2008 om ændring af Europa-Parlamentets og Rådets direktiv 98/8/EF med henblik på at optage tebuconazol som et aktivt stof i bilag I hertil (EUT L 239 af , s. 9). ( 6 ) Findes på webstedet

104 L 311/76 DA Den Europæiske Unions Tidende (6) Tyskland fandt desuden, at eftersom forholdet mellem aktivstoffer og ikke-aktivstoffer i produktets brugsopløsning er variabel, opfylder produktet ikke definitionen af biocidholdige produkter i artikel 2, litra a), i direktiv 98/8/EF, og det burde have været godkendt som en rammeformulering, jf. definitionen i artikel 2, litra j), i direktiv 98/8/EF. (7) Kommissionen opfordrede de andre medlemsstater og ansøgeren til skriftligt at fremsætte bemærkninger til meddelelsen inden 90 dage i overensstemmelse med artikel 27, stk. 1, i direktiv 98/8/EF. Det Forenede Kongerige, Tyskland og ansøgeren fremsatte bemærkninger inden fristens udløb. Meddelelsen blev også drøftet den 24. september 2013 på et møde i koordinationsgruppen, der er nedsat ved artikel 35 i forordning (EU) nr. 528/2012. (8) Med hensyn til miljørisici fremgår det af disse drøftelser og bemærkninger, at Det Forenede Kongeriges vurdering i mangel af en fælles model for midlertidig beskyttelse af træ fulgte den på daværende tidspunkt bedste disponible vejledning ( 1 ), som bygger på modeller for behandlet træ, der skal markedsføres som træ til brugsklasse 2 og 3. Vurderingen byggede også på en antagelse om det værst tænkelige tilfælde, hvorved aktivstofferne frigives fuldstændigt på tidspunkt 1. (9) Det fremgår endvidere, at Det Forenede Kongeriges vurdering i henhold til disse modeller kan forenes med de aktuelle retningslinjer ( 2 ). Påpeges en risiko på tidspunkt 1 som følge af en antagelse om det værst tænkelige tilfælde, kan anvendelsen af behandlet træ som træ til brugsklasse 2 og 3 antages at være sikker, når risikoen for miljøet ved udløbet af brugslevetiden anses for acceptabel. (10) Kommissionen bemærker ligeledes, at tilfælde, hvor der påvises en uacceptabel risiko på tidspunkt 1, i øjeblikket drøftes på EU-plan med henblik på at fastlægge en harmoniseret fremgangsmåde. På den baggrund finder Kommissionen, at indtil en sådan metode er formelt godkendt, bør konklusionerne af Det Forenede Kongeriges vurdering af det omtvistede produkt anses for gyldig indtil fornyelsen af produktgodkendelsen. (11) Med hensyn til produktets identitet fremgår det af disse drøftelser og bemærkninger, at det omtvistede produkt i den form, hvori det leveres til industrielle brugere, har specifikt fastlagte koncentrationer af aktivstoffer og ikkeaktivstoffer. Det forhold, at industrielle brugere kan blande forskellige produktopløsninger på industrianlægget alt afhængig af produktionsprocessen, kan efter Kommissionens opfattelse ikke tolkes således, at godkendelsesindehaveren markedsfører en gruppe forskellige biocidholdige produkter som omhandlet i artikel 2, litra j), i direktiv 98/8/EF. (12) I lyset af disse argumenter støtter Kommissionen konklusionerne af Det Forenede Kongeriges vurdering og de andre medlemsstater, der har godkendt produktet via gensidig anerkendelse, i betragtning af, at det omtvistede produkt er omfattet af definitionen i artikel 2, litra a), i direktiv 98/8/EF og opfylder kravene i direktivets artikel 5, stk. 1, med hensyn til miljøet. Kommissionen finder derfor, at Tysklands anmodning om at afslå godkendelsen ikke er berettiget med den anførte begrundelse. (13) På baggrund af drøftelserne forekommer det endvidere nødvendigt udtrykkeligt at anføre i produktgodkendelsen, at produktet skal anvendes til midlertidig træbeskyttelse, og som betingelse for meddelelse af godkendelse at sikre, at industrielle brugere forsynes med specifikke instrukser i anvendelsen af produktet, idet der tages hensyn til særlige produktionsforhold på industrianlæg, hvor produktet skal anvendes. (14) Forordning (EU) nr. 528/2012 finder anvendelse på det omtvistede produkt i overensstemmelse med bestemmelserne i samme forordnings artikel 92, stk. 2. Da retsgrundlaget for nærværende afgørelse er artikel 36, stk. 3, i den nævnte forordning, bør afgørelsen rettes til samtlige medlemsstater, jf. forordningens artikel 36, stk. 4. (15) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter ( 1 ) Se OECD's emissionsscenariedokumenter (EDS) om træbeskyttelsesmidler: del 1-4 (2003), der kan findes på webstedet europa.eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents/ ( 2 ) Report of leaching workshop (Arona, Italien, juni 2005), der kan findes på webstedet public-health/risk_assessment_of_biocides/doc/esd/esd_pt/pt_08/pt_8_leaching_workshop_2005.pdf/at_download/file/

105 L 311/77 Den Europæiske Unions Tidende DA VEDTAGET DENNE AFGØRELSE: Artikel 1 Denne afgørelse finder anvendelse på produkter, som er identificeret ved følgende referencenummer i referencemedlemsstaten som fastsat i registret over biocidholdige produkter: 2010/2509/5687/UK/AA/6745 Artikel 2 Tysklands forslag om at afslå Det Forenede Kongeriges godkendelse af 7. juni 2012 af det i artikel 1 nævnte produkt afvises. Artikel 3 Den tiltænkte anvendelse, der er beskrevet i produktgodkendelsen, affattes således:»udelukkende til midlertidig beskyttelse af nysavet/nyfældet træ og råtømmer mod svampe og overfladeskimmel. Træ, der er behandlet med dette produkt, kan anvendes som træ til brugsklasse 2 og 3 (dvs. tømmer, som ikke er i kontakt med jord, og som enten er vedvarende udsat for vejrliget eller er beskyttet mod vejrliget, men udsat for lejlighedsvis fugt).«artikel 4 Følgende betingelse for godkendelse pålægges for de produkter, der er nævnt i artikel 1:»Som en betingelse for godkendelse skal godkendelsesindehaveren sikre, at udførlige instrukser for anvendelse af produktet hvori der tages hensyn til særlige produktionsforhold på det industrianlæg, hvor produktet skal anvendes stilles til rådighed for brugerne på påføringsstedet.«denne afgørelse er rettet til alle medlemsstater. Artikel 5 Udfærdiget i Bruxelles, den 29. oktober På Kommissionens vegne Janez POTOČNIK Medlem af Kommissionen

106 EN Official Journal of the European Union L 311/75 COMMISSION IMPLEMENTING DECISION of 29 October 2014 rejecting the refusal of the authorisation of a biocidal product notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (notified under document C(2014) 7915) (Text with EEA relevance) (2014/758/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular Article 36(3) thereof, Whereas: (1) Annex I to Directive 98/8/EC of the European Parliament and of the Council ( 2 ) contained the list of active substances approved at Union level for inclusion in biocidal products. Commission Directives 2008/78/EC ( 3 ), 2008/79/EC ( 4 ) and 2008/86/EC ( 5 ) added the active substances propiconazole, IPBC and tebuconazole, respectively, for use in products belonging to product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC. By virtue of Article 86 of Regulation (EU) No 528/2012, these substances are therefore approved active substances included in the list referred to in Article 9(2) of that Regulation. (2) In accordance with Article 8 of Directive 98/8/EC, the company Arch Timber Protection Ltd submitted on 2 April 2010 an application to The United Kingdom for authorisation of a wood preservative biocidal product containing propiconazole, IPBC and tebuconazole ( the contested product ). The United Kingdom authorised the contested product on 7 June 2012 for industrial use and temporary protection of freshly sawn/felled wood and unseasoned timber only, also indicating that wood treated with this product can be used for Use Classes 2 and 3 as described in the Technical Notes for Guidance on Product Evaluation ( 6 ). The product consists of two packs to be mixed and diluted at industrial premises depending on site-specific application conditions by dipping or enclosed deluge. Ten Member States have subsequently authorised the contested product through mutual recognition. (3) Arch Timber Protection Ltd ( the applicant ) submitted on 16 July 2012 a complete application to Germany for mutual recognition of the authorisation of the contested product granted by the United Kingdom. (4) Germany notified the Commission, the other Member States and the applicant on 19 August 2013 of its proposal to refuse the authorisation in accordance with Article 4(4) of Directive 98/8/EC. Germany considered that the contested product does not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to the environment. (5) According to Germany, the authorisation did not reflect well that the product was intended for temporary wood protection and the product was not appropriately assessed by the United Kingdom in terms of environmental risks. The assessment performed by Germany concluded in an unacceptable risk for the environment at day 30 following the application of the product ( time 1 ), which also raised concerns regarding the potential use of wood treated with the contested product under Use Classes 2 and 3 conditions. ( 1 ) OJ L 167, , p. 1. ( 2 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). ( 3 ) Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I thereto (OJ L 198, , p. 44). ( 4 ) Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto (OJ L 200, , p. 12). ( 5 ) Commission Directive 2008/86/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto (OJ L 239, , p. 9). ( 6 ) Available on the website

107 L 311/76 EN Official Journal of the European Union (6) Germany also considered that, since the ratio of the active substances and non-active substances in the working solutions of the product is variable, the product does not meet the definition of biocidal products in Article 2(a) of Directive 98/8/EC and should have been authorised as a frame formulation as defined by Article 2(j) of Directive 98/8/EC. (7) The Commission invited other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by Germany, The United Kingdom and the applicant. The notification was also discussed on 24 September 2013 in the meeting of the coordination group established under Article 35 of Regulation (EU) No 528/2012. (8) With regard to the risks for the environment, from those discussions and comments it follows that the evaluation carried out by the United Kingdom, in the absence of an agreed model for temporary wood protection, followed the best guidance available at the time ( 1 ), which is based on models for treated wood to be placed on the market under Use Classes 2 and 3 conditions. The assessment was also based on a worst-case assumption of a complete release of the active substances at time 1. (9) It also follows that the evaluation performed by the United Kingdom following those models is compatible with current guidance ( 2 ). Where a risk is identified at time 1 as a result of a worst-case assumption, safe use of treated wood under Use Classes 2 and 3 conditions can be assumed when the risk for the environment at the end of the service life is considered acceptable. (10) The Commission also notes that cases where an unacceptable risk is identified at time 1 are currently under discussion at Union level in order to establish a harmonised approach. Against this background the Commission considers that, until such an approach is formally adopted, the conclusions of the assessment of the contested product by the United Kingdom should be considered as valid until the renewal of the product authorisation. (11) With regard to the identity of the product, from those discussions and comments it follows that the contested product, in the form in which it is supplied to the industrial users, has specific fixed concentrations of the active and non-active substances. The Commission considers that the fact that industrial users can prepare different solutions of the product at the work place, which are process dependant, cannot be interpreted in a way as if the authorisation holder was placing on the market a group of different biocidal products as referred to in Article 2(j) of Directive 98/8/EC. (12) In the light of those arguments, the Commission supports the conclusions of the evaluation carried out by the United Kingdom and the other Member States having approved the product through mutual recognition, considering that the contested product meets the definition in Article 2(a) of Directive 98/8/EC and fulfils the requirements set by Article 5(1) of that Directive with regard to the environment. The Commission therefore considers that the request by Germany to refuse the authorisation cannot be justified on the grounds put forward. (13) Finally, on the basis of the discussions held, it appears necessary to explicitly mention in the product authorisation that the use of the product is for temporary wood protection and to ensure, as a condition for the authorisation, that specific instructions for use of the product are provided to industrial users taking into consideration the characteristics of the industrial sites where the product is to be used. (14) Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2) of that Regulation. Since the legal basis for this Decision is Article 36(3) of that Regulation, this decision should be addressed to all Member States by virtue of Article 36(4) of that Regulation. (15) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, ( 1 ) See OECD Emission Scenario Documents (EDS) for Wood Preservatives: Part 1 4 (2003), available on the website eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents ( 2 ) Report of leaching workshop (Arona, Italy, June 2005), available on the website

108 L 311/77 Official Journal of the European Union EN HAS ADOPTED THIS DECISION: Article 1 This Decision applies to products identified by the following application reference number in the Reference Member State, as provided for by the Register for Biocidal Products: 2010/2509/5687/UK/AA/6745 Article 2 The proposal by Germany to refuse the authorisation granted by the United Kingdom on 7 June 2012 of the products referred to in Article 1, is rejected. Article 3 The intended use described in the product authorisation shall be amended as follows: For temporary wood protection use against wood staining fungi and surface moulds on freshly sawn/felled wood and unseasoned timber only. Wood treated with this product can be used for Use Classes 2 and 3 (i.e. timbers not in ground contact, either continually exposed to the weather or protected from the weather but subject to frequent wetting).. Article 4 The following condition for authorisation is imposed to the products referred to in Article 1: As a condition of the authorisation, the authorisation holder must ensure that detailed instructions for use of the product, taking into account the characteristics of the industrial site where the product is to be used, are provided to users at the site of application.. This Decision is addressed to the Member States. Article 5 Done at Brussels, 29 October For the Commission Janez POTOČNIK Member of the Commission

109 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.11.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING DECISION of XXX pursuant to Article 3(3) of Regulation (EU) No 528/2012 on cationic polymeric binders with quaternary ammonium compounds incorporated in paints and coatings (Text with EEA relevance) EN EN

110 COMMISSION IMPLEMENTING DECISION of XXX pursuant to Article 3(3) of Regulation (EU) No 528/2012 on cationic polymeric binders with quaternary ammonium compounds incorporated in paints and coatings (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular Article 3(3) thereof, Whereas: (1) Pursuant to Article 3(3) of Regulation (EU) No 528/2012, on 30 October 2013, the Netherlands submitted a request to the Commission to decide whether a series of products (cationic polymeric binders with quaternary ammonium compounds) placed on the market with a view to be incorporated in paints and coatings (hereafter referred as 'paints') and confer to those paints the property to kill harmful and pathogenic microorganisms on the paints dried surface, were biocidal products as defined under Article 3(1)(a) first indent of that Regulation, or not, and whether the paints themselves should be considered as biocidal products or not. (2) According to the information provided by the company placing the products on the market (hereafter referred as 'the company'), those products consist of polymers modified with quaternary ammonium groups. The polymer used varies from one product to another depending on the request of paint manufacturers. The products themselves do not have an antimicrobial activity. The company sells those products to paint manufacturers, who then mix them with other polymers used for paint manufacturing and a hardener thereby cross-linking all polymers. The cross-linked polymers form a cationic surface in the dried paint, which exerts the antimicrobial effect. (3) After a first round of discussions with experts from the Member States, the Commission requested on 2 February 2014 an opinion from the European Chemicals Agency in accordance with Article 75(1)(g) of Regulation (EU) No 528/2012 as to whether the products of the company contribute to the antimicrobial properties of paints in which it may be incorporated, if those properties result from the action of an active substance, and if so, what is the identity of the active substance. (4) The opinion of the European Chemicals Agency was formulated on 9 April 2014 by the Biocidal Product Committee. (5) According to that opinion, the mode of action under consideration involves an active substance as it is based on a substance, within the meaning of Article 3 of Regulation 1 OJ L 167, , p. 1. EN 2 EN

111 (EC) No 1907/2006 of the European Parliament and of the Council 2, which has an action on harmful organisms. (6) The active substance is formed in the paint in which it is incorporated by a chemical reaction of three constituents: the cationic polymeric binder, with quaternary ammonium groups, of variable chain length and equipped with a functional group; a polymeric dispersion equipped with the same functional group as the cationic polymeric binder and a polymeric hardener for cross-linking the above mentioned polymeric constituents. (7) Furthermore, according to that opinion, the mode of action of the active substance relies on electrostatic attractions leading to modifications of physiological and biochemical mechanisms (e.g. bacterial signal transduction systems) and to the death of the target organisms. The mode of action can therefore not be considered to be merely physical or mechanical. (8) In accordance with Article 3(1)(a) of Regulation (EU) No 528/2012, destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism is a biocidal function. (9) The cationic polymeric binders are not intended to have a biocidal function in the form in which they are supplied by the company to paint manufacturers and therefore do not comply with the definition of a biocidal product. (10) Paints incorporating those products are mixtures, which, in the form they are supplied by paint manufacturers to their customers, generate an active substance and are intended to have a biocidal function other than by mere physical or mechanical action, and therefore comply with the definition of a biocidal product. (11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS DECISION: Article 1 The cationic polymeric binders with quaternary ammonium compounds placed on the market to be incorporated in paints and coatings (hereafter referred as 'paints') by paint manufacturers with a view to confer to those paints a biocidal function shall not be considered biocidal products. The paints, in which the cationic polymeric binders with quaternary ammonium compounds are incorporated by paint manufacturers with a view to confer to those paints a biocidal function, shall be considered biocidal products. Article 2 This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, , p ). EN 3 EN

112 Done at Brussels, For the Commission The President EN 4 EN

113 L 299/10 EN Official Journal of the European Union COMMISSION IMPLEMENTING REGULATION (EU) No 1090/2014 of 16 October 2014 approving permethrin as an existing active substance for use in biocidal products for producttypes 8 and 18 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular the third subparagraph of Article 89(1) thereof, Whereas: (1) Commission Regulation (EC) No 1451/2007 ( 2 ) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council ( 3 ). That list includes permethrin. (2) Permethrin has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 8, wood preservatives, and product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012. (3) Ireland was designated as evaluating Competent Authority and submitted the assessment reports, together with its recommendations, to the Commission on 7 December 2010 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007. (4) The opinion of the European Chemicals Agency was formulated on 8 April 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating Competent Authority. (5) According to those opinions, biocidal products used for product-types 8 and 18 and containing permethrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council provided that certain specifications and conditions relating to its use are satisfied. (6) It is therefore appropriate to approve permethrin for use in biocidal products for product-type 8 and 18 subject to compliance with certain specifications and conditions. (7) Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. (8) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements laid down. (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, ( 1 ) OJ L 167, , p. 1. ( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, , p. 3). ( 3 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1).

114 L 299/11 Official Journal of the European Union EN HAS ADOPTED THIS REGULATION: Article 1 Permethrin shall be approved as an active substance for use in biocidal products for product-types 8 and 18, subject to the specifications and conditions set out in the Annex. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 October For the Commission The President José Manuel BARROSO

115 Common Name Permethrin IUPAC Name Identification Numbers IUPAC Name: 3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2- dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate EC No: CAS No: The cis:trans ratio is 25:75. Minimum degree of purity of the active substance ( 1 ) ANNEX Date of approval Expiry date of approval Product type Specific conditions ( 2 ) 930 g/kg 1 May April The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. For biocidal products, authorisations are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. (2) Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular: labels and, where provided, safety data sheets of products authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hardstanding, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal. L 299/12 EN Official Journal of the European Union (3) Products shall not be authorised for wood that will be exposed to frequent weathering unless data is submitted to demonstrate that the product will meet the requirements of Article 19 and Annex VI of Regulation (EU) No 528/2012, if necessary by the application of appropriate risk mitigation measures

116 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance ( 1 ) Date of approval Expiry date of approval Product type Specific conditions ( 2 ) (4) Products shall not be authorized for treatment of outdoor constructions near or above water or for the treatment of wood that will be used for outdoor constructions near or above water, unless data are submitted to demonstrate that the product will not present unacceptable risks, if necessary by the application of appropriate mitigation measures. For treated articles, the following condition applies: Where a treated article has been treated with or intentionally incorporates permethrin, and where necessary due to the possibility of skin contact as well as the release of permethrin under normal conditions of use, the person responsible for placing the article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/ The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. For biocidal products, authorisations are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment EN Official Journal of the European Union L 299/13

117 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance ( 1 ) Date of approval Expiry date of approval Product type Specific conditions ( 2 ) (2) Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. Labels and, where provided, safety data sheets of products authorised shall indicate such measures required. In particular, products authorised for the application to textile fibres or other materials to control insect damage shall indicate that freshly treated fibres and other appropriate materials shall be stored to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal. For treated articles, the following condition applies: Where a treated article has been treated with or intentionally incorporates permethrin, and where necessary due to the possibility of skin contact as well as the release of permethrin under normal conditions of use, the person responsible for placing the article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. L 299/14 EN Official Journal of the European Union ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. ( 2 ) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: eu/environment/chemicals/biocides/index_en.htm

118 EN Official Journal of the European Union L 299/15 COMMISSION IMPLEMENTING REGULATION (EU) No 1091/2014 of 16 October 2014 approving tralopyril as a new active substance for use in biocidal products for product-type 21 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( 1 ), and in particular Article 90(2) thereof, Whereas: (1) The United Kingdom has received on 17 July 2007 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council ( 2 ), for the inclusion of the active substance tralopyril in its Annex I for use in product-type 21, antifouling products, as defined in Annex V to that Directive. (2) Tralopyril was not on the market on 14 May 2000 as an active substance of a biocidal product. (3) The United Kingdom submitted the assessment report, together with its recommendations, to the Commission on 1 September 2009 in accordance with Article 11(2) of Directive 98/8/EC. (4) The opinion of the European Chemicals Agency was formulated on 8 April 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. (5) It appears from that opinion that biocidal products used for product-type 21 and containing tralopyril may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain specifications and conditions relating to its use are satisfied. (6) It is therefore appropriate to approve tralopyril for use in biocidal products for product-type 21 subject to compliance with certain specifications and conditions. (7) Since the evaluations did not address nanomaterials, the approvals should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. (8) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements laid down. (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION: Article 1 Tralopyril shall be approved as an active substance for use in biocidal products for product-type 21, subject to the specifications and conditions set out in the Annex. ( 1 ) OJ L 167, , p. 1. ( 2 ) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1).

119 L 299/16 EN Official Journal of the European Union Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 October For the Commission The President José Manuel BARROSO

120 Common Name Tralopyril IUPAC Name Identification Numbers IUPAC Name: 4-bromo-2-(4-chlorophenyl)-5- (trifluoromethyl)-1h-pyrrole-3- carbonitrile EC No: N/A CAS No: Minimum degree of purity of the active substance ( 1 ) ANNEX Date of approval Expiry date of approval Product type Specific conditions ( 2 ) 975 g/kg 1 April March The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In the event that products containing tralopyril are subsequently authorised for use in non-professional antifouling products, persons making products containing tralopyril available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves. Authorisations are subject to the following conditions: (1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. (2) Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry. (3) Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimise emissions to the environment, and that any losses or waste containing tralopyril shall be collected for reuse or disposal EN Official Journal of the European Union L 299/17

121 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance ( 1 ) Date of approval Expiry date of approval Product type Specific conditions ( 2 ) (4) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council ( 3 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 4 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. ( 1 ) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. ( 2 ) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: eu/environment/chemicals/biocides/index_en.htm ( 3 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, , p. 11). ( 4 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, , p. 1). L 299/18 EN Official Journal of the European Union

122 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.2.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving propan-2-ol as an active substance for use in biocidal products for producttypes 1, 2 and 4 (Text with EEA relevance) EN EN

123 COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving propan-2-ol as an active substance for use in biocidal products for producttypes 1, 2 and 4 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular the third subparagraph of Article 89(1) thereof, Whereas: (1) Commission Delegated Regulation (EU) No 1062/ establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes propan-2-ol. (2) Propan-2-ol has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 1, human hygiene disinfectants, product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4, food and feed area disinfectants, as defined in Annex V to Regulation (EU) No 528/2012. (3) Germany was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 5 November 2012 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/ (4) The opinions of the European Chemicals Agency were formulated on 18 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. (5) According to those opinions, biocidal products used for product-types 1, 2 and 4 and containing propan-2-ol may be expected to satisfy the requirements laid down in 1 OJ L 167, , p Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, , p. 1). 3 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, , p. 3). EN 2 EN

124 Article 5 of Directive 98/8/EC of the European Parliament and of the Council 4 provided that certain specifications and conditions relating to its use are satisfied. (6) It is therefore appropriate to approve propan-2-ol for use in biocidal products for product-types 1, 2 and 4 subject to compliance with certain specifications and conditions. (7) Since the evaluations did not address nanomaterials, the approvals should not cover such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012. (8) For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing propan-2-ol in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council 5. Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary. (9) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. (10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION: Article 1 Propan-2-ol shall be approved as an active substance for use in biocidal products for producttypes 1, 2 and 4, subject to the specifications and conditions set out in the Annex. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President 4 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). 5 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, , p. 4). EN 3 EN

125 EN ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 Propan 2 ol IUPAC Name : 2 Propanol EC n : % w/w 1 July June The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. CAS n : The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 4 The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active 1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. 2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: 1

126 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 substance. For biocidal products, authorisations are subject to the following conditions: (1) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council 3 or Regulation (EC) No 396/2005 of the European Parliament and of the Council 4 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. (2) Biocidal products containing propan 2 ol shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of propan 2 ol into food or it has been established pursuant to that Regulation that such limits are not necessary. 3 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, , p. 11). 4 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, , p. 1). 2

127 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.5.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving carbon dioxide as an active substance for use in biocidal products for product-type 15 (Text with EEA relevance) EN EN

128 COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving carbon dioxide as an active substance for use in biocidal products for product-type 15 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular Article 90(2) thereof, Whereas: (1) The Netherlands received on 22 February 2012 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council 2, for the inclusion of the active substance carbon dioxide in its Annex I for use in producttype 15, avicides, as defined in Annex V to that Directive. (2) The Netherlands submitted an assessment report, together with its recommendations, to the Commission on 30 August 2013 in accordance with Article 11(2) of Directive 98/8/EC. (3) The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. (4) According to that opinion, biocidal products used for product-type 15 and containing carbon dioxide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain specifications and conditions relating to its use are satisfied. (5) It is therefore appropriate to approve carbon dioxide for use in biocidal products for product-type 15 subject to compliance with certain specifications and conditions. (6) Since the evaluations did not address nanomaterials, the approval should not cover such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012. (7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, 1 OJ L 167, , p Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). EN 2 EN

129 HAS ADOPTED THIS REGULATION: Article 1 Carbon dioxide shall be approved as an active substance for use in biocidal products for product-type 15, subject to the specifications and conditions set out in the Annex. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President EN 3 EN

130 EN ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 Carbon dioxide IUPAC Name : Carbon dioxide EC n : ml/l 1 June May The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. CAS n : For biocidal products, authorisations are subject to the following conditions: (1) Products shall only be supplied to and used by trained professionals. (2) Appropriate measures, including, if necessary, the availability of personal protective equipment (PPE), shall be taken to protect users. (3) Appropriate measures, such as exclusion from the treatment area, shall be taken to protect bystanders. 1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. 2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: 1

131 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 (4) Application doses and instructions for use shall ensure that birds are killed without unnecessary pain and suffering. (5) Conditions of use shall specify that carbon dioxide shall be used as a meaure of last resort, in the context of an integrated pest management strategy, whose aim shall be to limit to the minimum the recourse to such a product. 2

132 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.6.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving dinotefuran as an active substance for use in biocidal products for producttype 18 (Text with EEA relevance) EN EN

133 COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving dinotefuran as an active substance for use in biocidal products for producttype 18 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular Article 90(2) thereof, Whereas: (1) The United Kingdom received on 29 March 2012 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council 2, for the inclusion of the active substance dinotefuran in its Annex I for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. (2) Dinotefuran was not on the market on 14 May 2000 as an active substance of a biocidal product. (3) The United Kingdom submitted an assessment report, together with its recommendations, to the European Chemicals Agency on 15 October 2013 in accordance with Article 8(1) of Regulation (EU) No 528/2012. (4) The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. (5) According to that opinion, biocidal products used for product-type 18 and containing dinotefuran may be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions relating to its use are satisfied. (6) It also appears from that opinion that the characteristics of dinotefuran render it very persistent (vp) and toxic (T) in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 3. 1 OJ L 167, , p Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). 3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, , p. 1). EN 2 EN

134 Therefore, dinotefuran should be considered as a candidate for substitution pursuant to Article 10(1)(d) of Regulation (EU) No 528/2012 for the purpose of authorising products in accordance with Article 23 of that Regulation. (7) It is therefore appropriate to approve dinotefuran for use in biocidal products for product-type 18 subject to compliance with certain specifications and conditions. (8) Since the evaluations did not address nanomaterials, the approvals should not cover such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012. (9) Since the conditions of the first subparagraph of Article 90(2) of Regulation (EU) No 528/2012 are met, the provisions of that Regulation should apply. Dinotefuran should be approved for a period not exceeding 7 years in accordance with Article 10(4) of that Regulation. (10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION: Article 1 Dinotefuran shall be approved as an active substance for use in biocidal products for producttype 18, subject to the specifications and conditions set out in the Annex. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President EN 3 EN

135 EN ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 Dinotefuran IUPAC Name : (RS)-1-methyl-2-nitro-3-(tetrahydro-3- furylmethyl)guanidine EC n : Not available CAS n : g/kg 1 June May Dinotefuran is considered a candidate for substitution in accordance with Article 10(1)(d) of Regulation (EU) No 528/2012. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. For biocidal products, authorisations are subject to the following condition: For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. 1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. 2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: 1

136 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.7.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving alpha-cypermethrin as an active substance for use in biocidal products for product-type 18 (Text with EEA relevance) EN EN

137 COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving alpha-cypermethrin as an active substance for use in biocidal products for product-type 18 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular the third subparagraph of Article 89(1) thereof, Whereas: (1) Commission Delegated Regulation (EU) No 1062/ establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes alpha-cypermethrin. (2) Alpha-cypermethrin has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012. (3) Belgium was designated as evaluating competent authority and submitted an assessment report, together with its recommendations, to the Commission on 17 November 2011 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/ (4) The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. (5) According to that opinion, biocidal products used for product-type 18 and containing alpha-cypermethrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council 4 provided that certain specifications and conditions relating to its use are satisfied. 1 OJ L 167, , p Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, , p. 1). 3 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, , p. 3). 4 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). EN 2 EN

138 (6) It is therefore appropriate to approve alpha-cypermethrin for use in biocidal products for product-type 18 subject to compliance with certain specifications and conditions. (7) Since the evaluations did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. (8) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION: Article 1 Alpha-cypermethrin shall be approved as an active substance for use in biocidal products for product-type 18, subject to the specifications and conditions set out in the Annex. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President EN 3 EN

139 EN ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 Alphacypermethrin IUPAC Name : Reaction mass of (S)-α-cyano-3- phenoxybenzyl-(1r,3r)-3-(2,2 dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate and (R)- α-cyano-3-phenoxybenzyl-(1s,3s)-3-(2,2- dichlorovinyl)-2,2 imethylcyclopropanecarboxylate (1:1) EC n : Not available CAS n : g/kg Sum of the isomers in a 1:1 ratio 1 July June The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. For biocidal products, authorisations are subject to the following conditions: (1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. (2) To prevent risks for the aquatic compartment, for the treament of surfaces prone to frequent wet cleaning, products shall only be used to treat 1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. 2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: 1

140 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 crack and crevices, unless it can be demonstrated in the application for product authorisation that risks for the aquatic compartment can be reduced to an acceptable level. 2

141 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.9.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 as an active substance for use in biocidal products for product-type 18 (Text with EEA relevance) EN EN

142 COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 as an active substance for use in biocidal products for product-type 18 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular the third subparagraph of Article 89(1) thereof, Whereas: (1) Commission Delegated Regulation (EU) No 1062/ establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes Bacillus sphaericus. (2) Bacillus sphaericus has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012. (3) The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of Bacillus sphaericus, i.e. Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of Bacillus sphaericus in the abovementioned list of active substances in Regulation (EU) No XX/2014. Therefore, only Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 should be covered by this approval. (4) Italy was designated as evaluating competent authority and submitted an assessment report, together with its recommendations, to the Commission on 9 January 2009 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/ OJ L 167, , p Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, , p. 1). 3 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, , p. 3). EN 2 EN

143 (5) The opinion of the European Chemicals Agency was formulated on 19 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. (6) According to that opinion, biocidal products used for product-type 18 and containing Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council 4 provided that certain specifications and conditions relating to its use are satisfied. (7) It is therefore appropriate to approve Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 for use in biocidal products for product-type 18 subject to compliance with certain specifications and conditions. (8) Since the evaluations did not address nanomaterials, the approval should not cover such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012. (9) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. (10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION: Article 1 Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 shall be approved as an active substance for use in biocidal products for product-type 18, subject to the specifications and conditions set out in the Annex. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President 4 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). EN 3 EN

144 EN ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 Bacillus sphaericus 2362 serotype H5a5b, strain ABTS1743 Not applicable No relevant impurities 1 July June The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. For biocidal products, authorisations are subject to the following conditions: (1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. (2) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance 1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. 2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: 1

145 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 with Regulation (EC) No 470/2009 of the European Parliament and of the Council 3 or Regulation (EC) No 396/2005 of the European Parliament and of the Council 4 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 3 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, , p. 11). 4 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, , p. 1). 2

146 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.8.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A as an active substance for use in biocidal products for product-type 18 (Text with EEA relevance) EN EN

147 COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A as an active substance for use in biocidal products for product-type 18 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 1, and in particular the third subparagraph of Article 89(1) thereof, Whereas: (1) Commission Delegated Regulation (EU) No 1062/ establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes Bacillus thuringiensis subsp. israelensis serotype H14. (2) Bacillus thuringiensis subsp. israelensis serotype H14 has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012. (3) The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of Bacillus thuringiensis subsp. israelensis serotype H14, i.e. Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of Bacillus thuringiensis subsp. israelensis serotype H14 in the abovementioned list of active substances in Regulation (EU) No XX/2014. Therefore, only Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A should be covered by this approval. (4) Italy was designated as evaluating competent authority and submitted an assessment report, together with its recommendations, to the Commission on 12 June 2009 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/ OJ L 167, , p Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, , p. 1). 3 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, , p. 3). EN 2 EN

148 (5) The opinion of the European Chemicals Agency was formulated on 19 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. (6) According to that opinion, biocidal products used for product-type 18 and containing Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council 4 provided that certain specifications and conditions relating to its use are satisfied. (7) It is therefore appropriate to approve Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A for use in biocidal products for product-type 18 subject to compliance with certain specifications and conditions. (8) Since the evaluations did not address nanomaterials, the approval should not cover such materials in accordance with Article 4(4) of Regulation (EU) No 528/2012. (9) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. (10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, HAS ADOPTED THIS REGULATION: Article 1 Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A shall be approved as an active substance for use in biocidal products for product-type 18, subject to the specifications and conditions set out in the Annex. Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the Commission The President 4 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, , p. 1). EN 3 EN

149 EN ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A Not applicable No relevant impurities 1 July June The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. For biocidal products, authorisations are subject to the following conditions: (1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. (2) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance 1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance. 2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: 1

150 Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Product type Specific conditions 2 with Regulation (EC) No 470/2009 of the European Parliament and of the Council 3 or Regulation (EC) No 396/2005 of the European Parliament and of the Council 4 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 3 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, , p. 11). 4 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, , p. 1). 2

151 EUROPEAN COMMISSION Brussels, XXX SCBP41-Doc.10.1 [ ](2014) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) No /.. of XXX approving tolylfluanid as an active substance for use in biocidal products for producttype 21 (Text with EEA relevance) EN EN