COMMISSION IMPLEMENTING DECISION. of XXX

EUROPEAN COMMISSION Brussels, XXX SANTE/11961/2015 Rev. 1 (POOL/E4/2015/11961/11961R1- EN.doc) [ ](2016) XXX draft COMMISSION IMPLEMENTING DECISION of XXX pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on a horse rug impregnated with permethrin used for the purpose of controlling nuisance insects in the environment of the horse (Text with EEA relevance) EN EN

COMMISSION IMPLEMENTING DECISION of XXX pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on a horse rug impregnated with permethrin used for the purpose of controlling nuisance insects in the environment of the horse (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) On 21 September 2015, Ireland requested the Commission to decide, pursuant to Article 3(3) of Regulation (EU) No 528/2012, whether a horse rug placed on the market to be used for the protection of horses and their environment from insects (horse and stable flies) is a biocidal product or a treated article or neither. (2) According to the information provided by Ireland, the horse rug consists of two separate layers of fabric, of which the outer layer is impregnated with permethrin and separated from the horses' skin by a non-impregnated inner layer. The treatment with permethrin is claimed to further enhance the physical protection function of the rug against nuisance insects in the environment of the horse, as insects will be killed when landing on the outer layer of the rug. (3) The horse rug is intended to control insects, which meet the definition of harmful organism as provided under Article 3(1)(g) of Regulation (EU) No 528/2012 since they may have a detrimental effect on animals or humans. (4) In accordance with Article 3(1)(a) of that Regulation, destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism is a biocidal function. (5) The horse rug meets the definition of an article as provided under Article 3(2)(c) of Regulation (EU) No 528/2012, since it has a special shape, surface or design which determines its function to a greater degree than does its chemical composition. (6) The rug meets the definition of a treated article as provided under Article 3(1)(l) of Regulation (EU) No 528/2012, as permethrin is intentionally incorporated into it with the aim to control insects in the environment of the horse. (7) It is therefore essential to establish whether or not the horse rug has a primary biocidal function according to agreed Union guidance 2, in order to define whether it is a treated article or a biocidal product. 1 OJ L 167, 27.6.2012, p. 1. EN 2 EN

(8) Since (i) nuisance insects in the environment of the horse are not harmful to the rug itself; (ii) the concentration of permethrin in the rug is comparable to that in biocidal products and higher than the concentration used to control keratin feeding textile pests 3 ; (iii) the mode of action of permethrin in the rug is identical to that of a biocidal product; (iv) greater prominence and first importance is given in the product's information to the biocidal function of controlling insects than to other functions of the horse rug (in particular to mitigate cold weather conditions or UV-protection), the horse rug can be considered to have a primary biocidal function and to meet the definition of a biocidal product provided under Article 3(1)(a) of Regulation (EU) No 528/2012. (9) In accordance with Article 2(2) of Regulation (EU) No 528/2012 it is also important to consider whether the horse rug may fall within the scope of Directive 2001/82/EC of the European Parliament and of the Council 4 if it meets the definition of a veterinary medicinal product as provided under Article 1(2) of that Directive. (10) When the horse rug is not designed to be applied as a topical insecticide and is not used with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis in horses, and when the horse rug is not presented either as having properties for treating or preventing any horse diseases but to control insects that may be present in the environment of the horse and may disturb the animal, the horse rug does not meet the definition of a veterinary medicinal product as provided under Article 1(2) of Directive 2001/82/EC and therefore falls under the scope of Regulation (EU) No 528/2012. (11) Since product-type 18, as defined in Annex V to Regulation (EU) No 528/2012, covers products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction, the horse rug should be deemed to belong to product-type 18. Furthermore, as permethrin is not under assessment nor approved 5 for use in biocidal products of product-type 19, the horse rug should not be claimed to have any repellent function. (12) 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 A horse rug impregnated with permethrin for the purpose of controlling nuisance insects in the environment of the horse, by means other than repulsion or attraction, shall be considered 2 Note for guidance on Frequently asked questions on treated articles (Question 11), available at https://circabc.europa.eu/w/browse/d7363efd-d8fb-43e6-8036-5bcc5e87bf22 3 Assessment report of the evaluation of the active substance permethrin for product-type 18 (Section 2.1.2.1. Field of use envisaged / Function and organism(s) to be controlled), available at http://dissemination.echa.europa.eu/biocides/activesubstances/1342-18/1342-18_assessment_report.pdf 4 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). 5 Commission Implementing Regulation (EU) No 1090/2014 of 16 October 2014 approving permethrin as an existing active substance for use in biocidal products for product- types 8 and 18 (OJ L 299, 17.10.2014, p. 10). EN 3 EN

as a biocidal product in accordance with Article 3(1)(a) of Regulation (EU) No 528/2012 and shall fall within product-type 18 as defined in Annex V to that Regulation. 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, For the Commission The President Jean-Claude JUNCKER EN 4 EN

9.6.2016 DA Den Europæiske Unions Tidende L 152/43 KOMMISSIONENS GENNEMFØRELSESAFGØRELSE (EU) 2016/903 af 8. juni 2016 om et hestedækken, der er imprægneret med permethrin med det formål at bekæmpe generende insekter omkring hesten, jf. artikel 3, stk. 3, 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 3, stk. 3, og ud fra følgende betragtninger: (1) Den 21. september 2015 anmodede Irland Kommissionen om i henhold til artikel 3, stk. 3, i forordning (EU) nr. 528/2012 at træffe afgørelse om, hvorvidt et hestedækken, der markedsføres til beskyttelse af heste og og deres omgivelser mod insekter (klæger og stikfluer), er et biocidholdigt produkt eller en behandlet artikel eller ingen af delene. (2) Ifølge oplysningerne fra Irland består hestedækkenet af to adskilte lag stof, hvoraf det ydre lag er imprægneret med permethrin, der ikke kommer i kontakt med hesten på grund af det indre ikke-imprægnerede lag. Det hævdes, at behandlingen med permethrin yderligere forbedrer dækkenets fysiske beskyttelsesfunktion mod generende insekter omkring hesten, idet insekter dør, når de kommer i kontakt med dækkenets ydre lag. (3) Formålet med hestedækkenet er at bekæmpe insekter, som er omfattet af definitionen»skadegørere«i artikel 3, stk. 1, litra g), i forordning (EU) nr. 528/2012, fordi de er skadelige for dyr eller for mennesker. (4) Ifølge artikel 3, stk. 1, litra a), i nævnte forordning er det en biocidfunktion at ødelægge, afskrække, uskadeliggøre, hindre virkningen af eller bekæmpe virkningen af skadegørere. (5) Hestedækkenet opfylder definitionen af en»genstand«i artikel 3, stk. 2, litra c), i forordning (EU) nr. 528/2012, fordi det har en særlig form, overflade eller design, der i højere grad er bestemmende for dets funktion end den kemiske sammensætning. (6) Dækkenet opfylder definitionen af en»behandlet artikel«i artikel 3, stk. 1, litra l), i forordning (EU) nr. 528/2012, fordi det med forsæt indeholder permethrin med det formål at bekæmpe insekter omkring hesten. (7) Det er derfor afgørende at fastslå, hvorvidt hestedækkenet har en primær biocidfunktion i henhold til den aftalte EU-vejledning ( 2 ), for at definere, hvorvidt det er en behandlet artikel eller et biocidholdigt produkt. (8) Idet i) generende insekter omkring hesten ikke er skadelige for selve dækkenet, ii) koncentrationen af permethrin i dækkenet kan sammenlignes med biocidholdige produkter og er højere end den koncentration, der anvendes til at bekæmpe keratinædende skadedyr i tekstiler ( 3 ), iii) virkningen af permethrinen i dækkenet er identisk med virkningen af et biocidholdigt produkt, og iv) der i produktinformationen lægges størst vægt på biocidfunktionen i forbindelse med at bekæmpe insekter end på andre af hestedækkenets funktioner (særligt hvad angår at modvirke kolde vejrforhold eller beskytte mod UV-stråling), kan hestedækkenet anses for at have en primær biocidfunktion og at opfylde definitionen af et biocidholdigt produkt som fastsat i artikel 3, stk. 1, litra a), i forordning (EU) nr. 528/2012. ( 1 ) EUT L 167 af 27.6.2012, s. 1. ( 2 ) Vejledning omkring ofte stillede spørgsmål vedrørende behandlede artikler (spørgsmål 11) kan findes på https://circabc.europa.eu/w/ browse/d7363efd-d8fb-43e6-8036-5bcc5e87bf22. ( 3 ) Vurderingsrapport fra evalueringen af aktivstoffet permethrin til produkttype 18 (sektion 2.1.2.1. Påtænkt anvendelsesområde/funktion og organisme(r), som skal bekæmpes) kan findes på http://dissemination.echa.europa.eu/biocides/activesubstances/1342-18/1342-18_ Assessment_Report.pdf.

L 152/44 DA Den Europæiske Unions Tidende 9.6.2016 (9) I overensstemmelse med artikel 2, stk. 2, i forordning (EU) nr. 528/2012 er det også vigtigt at overveje, om hestedækkenet kan falde ind under anvendelsesområdet for Europa-Parlamentets og Rådets direktiv 2001/82/EF ( 1 ), hvis det opfylder definitionen af et veterinærlægemiddel i henhold til artikel 1, stk. 2, i nævnte direktiv. (10) Da hestedækkenet ikke er designet til at blive anvendt som insekticid og ikke anvendes med henblik på at genoprette, påvirke eller ændre fysiologiske funktioner ved at udøve en farmakologisk, immunologisk eller metabolisk virkning eller for at stille en medicinsk diagnose hos heste, og da hestedækkenet hverken fremhæves som værende i stand til at behandle eller forebygge sygdomme hos heste, men fremhæves som værende i stand til at bekæmpe eventuelle insekter omkring hesten, der måske generer den, opfylder hestedækkenet ikke definitionen for et veterinærlægemiddel i henhold til artikel 1, stk. 2, i direktiv 2001/82/EF og falder derfor ind under anvendelsesområdet for forordning (EU) nr. 528/2012. (11) Da produkttype 18, som defineret i bilag V til forordning (EU) nr. 528/2012 omfatter produkter til bekæmpelse af leddyr (f.eks. insekter, spindlere og krebsdyr) på anden vis end ved afskrækkelse eller tiltrækning, bør hestedækkenet anses for at høre til produkttype 18. Da permethrin desuden hverken er ved at blive vurderet eller godkendt ( 2 ) til anvendelse i biocidholdige produkter af produkttype 19, bør hestedækkenet ikke anprises som havende en afskrækkende funktion. (12) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter VEDTAGET DENNE AFGØRELSE: Artikel 1 Et hestedækken, der er imprægneret med permethrin med det formål at bekæmpe generende insekter omkring hesten på anden vis end ved afskrækkelse eller tiltrækning, betragtes som et biocidholdigt produkt i overensstemmelse med artikel 3, stk. 1, litra a), i forordning (EU) nr. 528/2012 og tilhører produkttype 18, jf. bilag V til nævnte forordning. Artikel 2 Denne afgørelse træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende. Udfærdiget i Bruxelles, den 8. juni 2016. På Kommissionens vegne Jean-Claude JUNCKER Formand ( 1 ) Europa-Parlamentets og Rådets direktiv 2001/82/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for veterinærlægemidler (EFT L 311 af 28.11.2001, s. 1). ( 2 ) Kommissionens gennemførelsesforordning (EU) nr. 1090/2014 af 16. oktober 2014 om godkendelse af permethrin som et eksisterende aktivstof til anvendelse i biocidholdige produkter af produkttype 8 og 18 (EUT L 299 af 17.10.2014, s. 10).

EUROPEAN COMMISSION Brussels, XXX SANTE/12397/2015 Rev. 1 (POOL/E4/2015/12397/12397R1- EN.doc) [ ](2016) XXX draft COMMISSION IMPLEMENTING DECISION of XXX pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on propan-2-ol containing products used for hand disinfection (Text with EEA relevance) EN EN

COMMISSION IMPLEMENTING DECISION of XXX pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on propan-2-ol containing products used for hand disinfection (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) In the context of an application under the Union authorisation procedure referred to in Article 41 of Regulation (EU) No 528/2012, on 3 December 2015 Germany requested the Commission to decide, pursuant to Article 3(3) of that Regulation, whether a group of ready to use propan-2-ol containing products ( the products ) placed on the market to be used for hand disinfection, including in this instance surgical hand disinfection, and to be authorised as a biocidal product family as defined in Article 3(1)(s) of that Regulation, are biocidal products. (2) Germany considered that the products are medicinal products in accordance with Directive 2001/83 2, arguing that the intended uses of the products show that they aim at preventing diseases in humans, as they can be used in areas and situations where disinfection is medically recommended. According to Germany, this is particularly the case when the products are used by health professionals as a preoperative treatment procedure to prevent the risk of transmission of microorganisms into the surgical wound. (3) The products are intended to control a number of bacteria, viruses and fungi, which meet the definition of harmful organism provided under Article 3(1)(g) of Regulation (EU) No 528/2012 since they may have a detrimental effect on humans. (4) Since destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism is a biocidal function, the products meet the definition of a biocidal product provided under Article 3(1)(a) of that Regulation. (5) In accordance with Article 2(2) of Regulation (EU) No 528/2012 it is important to consider whether the products may fall within the scope of Directive 2001/83/EC of the European Parliament and of the Council if they meet the definition of a medicinal product as provided under Article 1(2) of that Directive. 1 OJ L 167, 27.6.2012, p. 1. 2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67.). EN 2 EN

(6) Where the products are solely intended to reduce the micro-organism load on hands and the associated risk of transmitting micro-organisms from potentially contaminated hands and neither used to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, nor to make a medical diagnosis in humans, nor presented either as having properties to treat or to prevent any human diseases, the products do not meet the definition of a medicinal product as provided under Article 1(2) of Directive 2001/83/EC and therefore fall under the scope of Regulation (EU) No 528/2012. (7) Since product-type 1, as defined in Annex V to Regulation (EU) No 528/2012, covers products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp, the products belong to product-type 1. (8) 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 Propan-2-ol containing products to be used in hand disinfection, including in this instance surgical hand disinfection, for the purpose of reducing the risk of transmission of microorganisms shall be considered as biocidal products in accordance with Article 3(1)(a) of Regulation (EU) No 528/2012 and shall fall within product-type 1 as defined in Annex V to that Regulation. 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, For the Commission The President Jean-Claude JUNCKER EN 3 EN

9.6.2016 DA Den Europæiske Unions Tidende L 152/45 KOMMISSIONENS GENNEMFØRELSESAFGØRELSE (EU) 2016/904 af 8. juni 2016 om propan-2-ol-holdige produkter til hånddesinfektion, jf. artikel 3, stk. 3, 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 3, stk. 3, og ud fra følgende betragtninger: (1) I forbindelse med en ansøgning under en EU-godkendelsesprocedure omhandlet i artikel 41 i forordning (EU) nr. 528/2012 anmodede Tyskland den 3. december 2015 Kommissionen om i henhold til artikel 3, stk. 3, i forordning (EU) nr. 528/2012 at træffe afgørelse om, hvorvidt en gruppe af brugsklare propan-2-ol-holdige produkter (»produkterne«), der markedsføres til hånddesinfektion, i dette tilfælde også kirurgisk hånddesinfektion, og som er godkendt som en familie af biocidholdige produkter som defineret i artikel 3, stk. 1, litra s), i nævnte forordning, er biocidholdige produkter. (2) Tyskland finder, at produkterne er lægemidler i henhold til Europa-Parlamentets og Rådets direktiv 2001/83/EF ( 2 ), og hævder, at den påtænkte anvendelse af produkterne viser, at de sigter mod at forhindre sygdomme hos mennesker, da de kan anvendes i områder og i situationer, hvor desinfektion anbefales lægefagligt. Efter Tysklands opfattelse er dette navnlig tilfældet, når produkterne anvendes af fagfolk inden for sundhedssektoren som en præoperativ procedure for at forebygge risikoen for overførsel af mikroorganismer til sår efter kirurgiske indgreb. (3) Produkterne er beregnet til at bekæmpe et antal bakterier, vira og svampe, der lever op til definitionen af»skadegørere«i artikel 3, stk. 1, litra g), i forordning (EU) nr. 528/2012, da de kan være skadelige for mennesker. (4) Da det at ødelægge, afskrække, uskadeliggøre, hindre virkningen af eller bekæmpe virkningen af skadegørere på anden vis er en biocidfunktion, lever produkterne op til definitionen af et biocidholdigt produkt i ovennævnte forordnings artikel 3, stk. 1, litra a). (5) I henhold til artikel 2, stk. 2, i forordning (EU) nr. 528/2012 er det vigtigt at vurdere, om produkterne falder ind under direktiv 2001/83/EF, hvis de lever op til definitionen af et lægemiddel, jf. artikel 1, stk. 2, i direktivet. (6) Når produkterne kun anvendes med henblik på at reducere antallet af mikroorganismer på hænder og dermed risikoen for at overføre mikroorganismer fra potentielt kontaminerede hænder og hverken anvendes med henblik på at genoprette, ændre eller påvirke fysiologiske funktioner ved at udøve en farmakologisk, immunologisk eller metabolisk virkning eller for at stille en medicinsk diagnose på mennesker, og når produkterne enten ikke præsenteres som egnet middel til behandling eller forebyggelse af sygdom hos mennesker, lever produkterne ikke op til definitionen af et lægemiddel, jf. artikel 1, stk. 2, i direktiv 2001/83/EF, og falder derfor ind under rammerne af forordning (EU) nr. 528/2012. (7) Da produkttype 1, jf. bilag V til forordning (EU) nr. 528/2012, dækker hygiejne for mennesker, som anvendes på eller i berøring med hud eller hovedbund med det primære formål at desinficere huden eller hovedbunden, hører produkterne til produkttype 1. ( 1 ) EUT L 167 af 27.6.2012, s. 1. ( 2 ) Europa-Parlamentets og Rådets direktiv 2001/83/EF af 6. november 2001 om oprettelse af en fællesskabskodeks for humanmedicinske lægemidler (EFT L 311 af 28.11.2001, s. 67).

L 152/46 DA Den Europæiske Unions Tidende 9.6.2016 (8) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter VEDTAGET DENNE AFGØRELSE: Artikel 1 Propan-2-ol-holdige produkter til hånddesinfektion, herunder i dette tilfælde kirurgisk hånddesinfektion, med det formål at reducere risikoen for overførsel af mikroorganismer betragtes som biocidholdige produkter i henhold til artikel 3, stk. 1, litra a), i forordning (EU) nr. 528/2012 og tilhører produkttype 1, jf. bilag V til forordningen. Artikel 2 Denne afgørelse træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende. Udfærdiget i Bruxelles, den 8. juni 2016. På Kommissionens vegne Jean-Claude JUNCKER Formand

EUROPEAN COMMISSION Brussels, XXX SANTE/11959/2015 (POOL/E4/2015/11959/11959-EN.doc) [ ](2016) XXX draft COMMISSION IMPLEMENTING DECISION of XXX on the terms and conditions of the authorisation of a biocidal product containing difenacoum referred by Spain in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) EN EN

COMMISSION IMPLEMENTING DECISION of XXX on the terms and conditions of the authorisation of a biocidal product containing difenacoum referred by Spain in accordance with Article 36 of 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 Article 36(3) thereof, Whereas: (1) The company Will Kill S.A. ( the applicant ) submitted a complete application to France ( the Member State concerned ) on 20 December 2013 for the mutual recognition of an authorisation granted by Spain ( the reference Member State ) in respect of a rodenticide biocidal product containing the active substance difenacoum as a liquid formulation ( the contested product ). (2) The reference Member State authorised the contested product for use against mice and the rat species Rattus norvegicus ( rats ) for use indoors and in and around buildings by professional users, and outdoors by trained professional users only. The contested product is supplied in nonreusable bottles together with a roll-on dispenser and a bait station ( the device ) in order to avoid primary and secondary poisoning. After use, the whole device is to be disposed of in order to avoid exposure to the user. (3) Pursuant to Article 35(2) of Regulation (EU) No 528/2012, the Member State concerned referred a number of points of disagreement to the coordination group indicating that the contested product does not meet the conditions laid down in Article 19(1)(b)(i), (iii) and (iv) of that Regulation. (4) The coordination group secretariat invited the other Member States concerned and the applicant to submit written comments about the referral. Austria, France, Germany, Italy, the Netherlands, Norway, Portugal, Spain, Sweden, the United Kingdom and the applicant submitted comments. The identified points of disagreement were discussed by the Member States' competent authorities for biocidal products in the coordination group's meetings of 23 January and 17 March 2015. (5) Pursuant to Article 36(1) of Regulation (EU) No 528/2012, the reference Member State provided the Commission with a detailed statement of the matters on which Member States were unable to reach agreement and the reasons for their disagreement 1 OJ L 167, 27.6.2012, p. 1. EN 2 EN

on 30 June 2015. A copy of that statement was also forwarded to the Member States concerned and the applicant. (6) The unresolved objections referred to the Commission concerned the efficacy of the contested product against rats and mice, which was insufficiently demonstrated in well-documented field trials; the efficacy in Member States with wet climates, which might be reduced as a result of the target organisms having easier access to water; the efficiency of the device as a risk mitigation measure to avoid leaching; and an unacceptable risk to the health of users during the cleaning of bait stations. (7) Pursuant to paragraph 12 of Annex VI to Regulation (EU) No 528/2012, the reference Member State considered the contested product to be sufficiently effective on the basis of field data generated by using a prototype device and the judgment of its experts. That conclusion was conditional, however, on the submission of field data corroborating those findings. (8) The reference Member State concluded that the results of the field trials submitted by the applicant demonstrate an acceptable level of efficacy in accordance with the criteria established in the Union guidance on efficacy evaluation of rodenticides 2. (9) Concerning efficacy in wet climates, the indoor use of the product in areas where abundant food or feed is available to rodents shows no significant difference across Member States. Regarding use in and around buildings and outdoors, the product authorisation already includes a condition to restrict the use of the product to situations where it is difficult to access water. Given that the product was sufficiently effective in field trials in areas with full access to water, the product authorisation should not be subject to any restriction on the grounds of specific weather conditions. (10) The reference Member State considered the device to be a suitable risk mitigation measure to prevent spillage and avoid primary and secondary poisoning compared to the application of the contested product in open trays. This conclusion was confirmed in the field trials where spillage only occurred twice due to an accident with agriculture machinery or vandalism. In order to limit accidental spillage as much as possible, the product authorisation should include additional instructions for use such as fixing the bait station to the ground and a recommendation that in the event of an accidental spillage, the bait station is to be disposed of as hazardous waste. (11) The reference Member State assessed the health risk to users of the product by using a model developed for solid bait formulations and by using very conservative parameters under a worst case scenario. As an unacceptable risk to the user was identified, a risk mitigation measure was introduced stating that the device was to be disposed of after use in order to prevent any potential exposure during the cleaning of the bait stations. (12) The product authorisation has been subject to an agreed change based on a recalculation of the risk to human health as a result of exposure to the contested product based on a product-specific dermal absorption study and new parameters generated by the applicant based on the real use of the contested product (for example 2 See Technical Notes for Guidance on Product Evaluation. Appendices to Chapter 7. Product Type 14: Efficacy Evaluation of Rodenticidal Biocidal Products, available on the website http://echa.europa.eu/documents/10162/16960215/bpd_guid_revised_appendix_chapter_7_pt14_2009_ en.pdf EN 3 EN

the number of splashes to which the user may be exposed as well as the droplet size of the splash). (13) Given the risk of accidental splash, additional risk mitigation measures should be included in the authorisation. Those measures should include restricting use to trained professional users only and the specification that users wear protective gloves. Taking into account that trained professional users are expected to follow the instructions for use closely, the contested product is expected to be safe for this category of user under the proposed terms and conditions. (14) In order to avoid unnecessary plastic waste, the current condition of the authorisation to supply the product and the roll-on dispenser together with the bait station as a single device and to dispose of the whole device, including the bait station, after use should be removed from the authorisation. (15) 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 the product identified by the asset number ES-0000196-0000, as provided for by the Register for Biocidal Products. Article 2 1. The product meets the conditions laid down in Article 19(1)(b)(i) of Regulation (EU) No 528/2012. 2. The condition restricting the use of the product to situations where it is difficult to access water shall be removed from the product authorisation. Article 3 1. The user category in the authorised uses of the product shall be restricted to trained professional users only. 2. The product authorisation shall include the following risk mitigation measure: "Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)". 3. The condition to supply the product and the roll-on dispenser together with the bait station as a single device and to dispose of the bait station as part of the whole device after use of the product shall be removed from the product authorisation. 4. Under the terms and conditions set out in paragraphs 1, 2 and 3, the product meets the conditions laid down in Article 19(1)(b)(iii) of Regulation (EU) No 528/2012. Article 4 1. The following instructions for use shall be included in the product authorisation: "Fix the bait station to the ground". "In case of accidental spillage of the liquid, dispose of the bait station as hazardous waste". EN 4 EN

2. Under the terms and conditions set out in paragraph 1, the product meets the conditions laid down in Article 19(1)(b)(iv) of Regulation (EU) No 528/2012. Article 65 This Decision is addressed to the Member States. Done at Brussels, For the Commission Vytenis ANDRIUKAITIS Member of the Commission EN 5 EN

EUROPEAN COMMISSION Brussels, XXX SANTE/10159/2016 (POOL/E4/2016/10159/10159-EN.doc) [ ](2016) XXX draft COMMISSION IMPLEMENTING DECISION of XXX on the terms and conditions of the authorisation of a biocidal product containing spinosad referred by the United Kingdom in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) EN EN

COMMISSION IMPLEMENTING DECISION of XXX on the terms and conditions of the authorisation of a biocidal product containing spinosad referred by the United Kingdom in accordance with Article 36 of 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 Article 36(3) thereof, Whereas: (1) The company Scotts Celaflor GmbH ( the applicant ) submitted a complete application to Germany ( the Member State concerned ) on 29 June 2015 for the mutual recognition of an authorisation granted by the United Kingdom ( the reference Member State ) in respect of an insecticide biocidal product containing the active substance spinosad as a granular solid bait formulation to be applied directly or to be diluted and applied as liquid drench ( the contested product ). (2) The reference Member State authorised the contested product on 23 April 2015 for use by the general public against ants outdoors by means of direct application to ant nests. The authorisation has subsequently been mutually recognised by Ireland. (3) Pursuant to Article 35(2) of Regulation (EU) No 528/2012, the Member State concerned referred a point of disagreement to the coordination group on 26 October 2015 indicating that the contested product does not meet the conditions laid down in Article 19(1)(b)(iv) of that Regulation. (4) The Member State concerned considers that the contested product does not fulfil the requirement set out in paragraph 66 of Annex VI to Regulation (EU) No 528/2012 as the PEC/PNEC ratio for the soil compartment is greater than 1 and as a result the contested product poses an unacceptable risk to the environment, albeit in very small areas and for very short periods of time. (5) The coordination group secretariat invited the other Member States concerned and the applicant to submit written comments about the referral. Belgium, France, the Netherlands, the United Kingdom and the applicant submitted comments. The referral was also discussed by the Member States' competent authorities for biocidal products in the coordination group's meetings of 17 November 2015 and 20 January 2016. (6) As no agreement was reached by the coordination group, the reference Member State provided the Commission on 5 February 2016 with a detailed statement of the matters 1 OJ L 167, 27.6.2012, p. 1. EN 2 EN

on which Member States were unable to reach agreement and the reasons for their disagreement on 5 February 2016, pursuant to Article 36(1) of Regulation (EU) No 528/2012. A copy of that statement was also forwarded to the Member States concerned and the applicant. (7) As regards the unresolved objection referred to the Commission, paragraph 66 of Annex VI to Regulation (EU) No 528/2012 sets out that where the PEC/PNEC ratio is greater than 1, the evaluating body is to judge, on a case-by-case basis, the elements or the risk mitigation measures to be considered in order to conclude whether the biocidal product complies with Article 19(1)(b)(iv). (8) From the discussions within the coordination group, it seems that there is a lack of agreed Union guidance to assist the evaluating body in making such a judgment. (9) From those discussions it also follows that the unacceptable risk identified is limited because of the use pattern of the product, which is only applied to small areas (for example on ant nests) and is expected to break down in a short period of time so that non-target species can recolonise the treated area after use. (10) In the absence of agreed Union guidance, the conclusion of the reference Member State was based on the available information and on the judgement of its experts, pursuant to paragraph 12 of Annex VI to Regulation (EU) No 528/2012. (11) Against this background and until such agreed guidance is formally adopted, the conclusion reached by the reference Member State on the point of disagreement is considered to be valid until the renewal of the product authorisation. (12) From the discussions within the coordination group it also follows that the current terms and conditions of the product authorisation should better describe the field of use of the contested product and should provide some information on its application. Those terms and conditions should therefore be amended accordingly. (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 the product identified by the asset number UK-0008829-0000, as provided for by the Register for Biocidal Products. Article 2 The product meets the conditions laid down in Article 19(1)(b)(iv) of Regulation (EU) No 528/2012. Article 3 1. The field of use in the product authorisation is amended as follows: "Outdoor use (only for direct application to ant nests around domestic premises)". 2. The sentence "Apply directly to the nest only" listed in the product authorisation as both an instruction for use and as a risk mitigation measure is replaced by the following: EN 3 EN

"Apply this biocidal product directly to ant nests only. Do not scatter dry granules or pour liquid onto hard surfaces or bare soil used as ant runways". Article 4 This Decision is addressed to the Member States. Done at Brussels, For the Commission Vytenis ANDRIUKAITIS Member of the Commission EN 4 EN

EUROPEAN COMMISSION Brussels, XXX SANTE/10094/2016 (POOL/E4/2016/10094/10094-EN.doc) [ ](2016) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX approving Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with chloroacetic acid as an existing active substance for use in biocidal products of producttypes 2, 3 and 4 (Text with EEA relevance) EN EN

COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX approving Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with chloroacetic acid as an existing active substance for use in biocidal products of producttypes 2, 3 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 1062/2014 2 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with chloroacetic acid. (2) Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with chloroacetic acid has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council 3 for use in products of product-type 2, private area and public health area disinfectants and other biocidal products, of producttype 3, veterinary hygiene biocidal products, and of product-type 4, food and feed area disinfectants, as described in Annex V to that Directive, which correspond respectively to product-types 2, 3 and 4 as described 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 on 30 August 2013. (4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 15 April 2015 for use in products of product-type 3 and on 8 December 2015 for use in products of product-types 2 and 4 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. (5) According to those opinions, biocidal products of product-types 2, 3 and 4 and containing Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with 1 OJ L 167, 27.6.2012, p. 1. 2 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, 10.10.2014, p. 1). 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, 24.4.1998, p. 1). EN 2 EN

chloroacetic acid may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with. (6) It is therefore appropriate to approve Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with chloroacetic acid for use in biocidal products of producttypes 2, 3 and 4, subject to compliance with certain specifications and conditions. (7) For use in products of product-type 4, the evaluation did not address the incorporation of biocidal products containing Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with chloroacetic acid in materials and articles intended to come into contact directly or indirectly with food referred to in Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council 4. The approval should therefore not cover such use, unless the Commission has established specific limits on the migration into food, as referred to in Article 5(1)(e) of that Regulation, or has established that such limits are not necessary. (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 Amines, N-C10 C16-alkyltrimethylenedi-, reaction products with chloroacetic acid is approved as an active substance for use in biocidal products of product-types 2, 3 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 Jean-Claude JUNCKER 4 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, 13.11.2004, p. 4). EN 3 EN

EUROPEAN COMMISSION Brussels, XXX SANTE/10094/2016 ANNEX (POOL/E4/2016/10094/10094-EN ANNEX.doc) [ ](2016) XXX draft ANNEX 1 ANNEX to the COMMISSION IMPLEMENTING REGULATION (EU) /... approving Amines, N-C10 16-alkyltrimethylenedi-, reaction products with chloroacetic acid as an existing active substance for use in biocidal products of product-types 2, 3 and 4 EN EN

ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 Date of approval Expiry date of approval Prod uct type Specific conditions EC No: N/A CAS No: 139734-65-9 The theoretical calculated dry weight specification: 1000 g/kg (100,0 %, by wt). Amines, N- C10 C16- alkyltrimethylen edi-, reaction products with chloroacetic acid IUPAC Name: Amines, N-C10 C16- alkyltrimethylenedi-, reaction products with chloroacetic acid The active substance as manufactured is an aqueous solution of 160-220 g/kg of Amines, N-C10 C16- alkyltrimethylenedi -, reaction products with chloroacetic acid (16-22 %, by wt). 1 January 2018 31 December 2027 2 The authorisations of biocidal products are subject to the following conditions: 1) The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 2) In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to: a) professional users; b) children for products used in institutional areas; c) surface water and sediment for products used in industrial or institutional areas; d) soil for products used in industrial areas. 3 The authorisations of biocidal products are subject to the following conditions: 1) The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 2) In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to: a) professional users; b) surface water and sediment for products used for : i) 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 89(1) 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. EN 2 EN

the disinfection of animal housing; ii) the disinfection of vehicles used for animal transport; iii) the disinfection of footwear and animals' hooves; c) soil for products used for the disinfection of vehicles used for animal transport; d) micro-organisms of the sewage treatment plant for products used for the disinfection of footwear and animals' hooves. 3) 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 2 or Regulation (EC) No 396/2005 of the European Parliament and of the Council 3 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 4 The authorisations of biocidal products are subject to the following conditions: 1) The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 2) In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to: a) professional users; b) surface water and sediment for products used in: i) food, drink and milk industry sites; ii) milking parlours; iii) slaughterhouses and butcheries and iv) 2 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, 16.6.2009, p. 11). 3 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, 16.3.2005, p. 1). EN 3 EN

large scale catering kitchens and canteens; c) soil for products used in i) food, drink and milk industry sites; ii) slaughterhouses and butcheries and iii) large scale catering kitchens and canteens. 3) 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 or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. 4) Products 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 Amines, N-C10 16- alkyltrimethylenedi-, reaction products with chloroacetic acid peracetic acid into food or it has been established pursuant to that Regulation that such limits are not necessary. EN 4 EN

EUROPA- KOMMISSIONEN Bruxelles, den XXX SANTE/10095/2016 ANNEX (POOL/E4/2016/10095/10095-EN ANNEX.doc) [ ](2016) XXX draft ANNEX 1 BILAG til KOMMISSIONENS GENNEMFØRELSESFORORDNING (EU) /... om godkendelse af biphenyl-2-ol som et eksisterende aktivstof til anvendelse i biocidholdige produkter af produkttype 3 DA DA

BILAG Almindeligt anvendt navn IUPAC-navn Identifikationsnr. Aktivstoffets minimumsrenheds grad 1 Godkend elsesdato Udløbsdato for godkendelse n Produ kttype Særlige betingelser Biphenyl-2-ol IUPAC-navn: Orthophenylphenol EF-nr.: 201-993-5 CAS-nr.: 90-43-7 995 g/kg 1. januar 2018 31. december 2027 3 Godkendelserne af biocidholdige produkter meddeles på følgende betingelser: 1) Ved vurderingen af produktet skal der lægges særlig vægt på den eksponering, de risici og den effektivitet, der er forbundet med enhver anvendelse, som er omfattet af ansøgningen om godkendelse, men som ikke har været behandlet i risikovurderingen af aktivstoffet på EU-plan. 2) I betragtning af de risici, der er konstateret for de anvendelser, der er vurderet ved vurderingen af produktet, skal der lægges særlig vægt på: a) Erhvervsmæssige brugere b) overfladevand, sedimenter og jordbund. 3) For produkter, som kan føre til restkoncentrationer i fødevarer eller foder, undersøges behovet for at fastsætte nye eller ændre eksisterende maksimalgrænseværdier i overensstemmelse med Europa-Parlamentets og Rådets forordning (EF) nr. 470/2009 2 eller Europa-Parlamentets og Rådets forordning (EF) nr. 396/2005 3, og der træffes alle hensigtsmæssige risikobegrænsende foranstaltninger til at sikre, at gældende maksimalgrænseværdier ikke overskrides. 1 Renheden som angivet i denne kolonne er det minimum af renheden af aktivstoffet, der er anvendt til vurderingen efter artikel 89, stk. 1, i forordning (EU) nr. 528/2012. Aktivstoffet i det produkt, der markedsføres, kan have samme eller en anden renhedsgrad, hvis der er påvist teknisk ækvivalens med det vurderede aktivstof. 2 Europa-Parlamentets og Rådets forordning (EF) nr. 470/2009 af 6. maj 2009 om fællesskabsprocedurer for fastsættelse af grænseværdier for restkoncentrationer af farmakologisk virksomme stoffer i animalske fødevarer, om ophævelse af Rådets forordning (EØF) nr. 2377/90 og om ændring af Europa-Parlamentets og Rådets direktiv 2001/82/EF og Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 (EUT L 152 af 16.6.2009, s. 11). 3 Europa-Parlamentets og Rådets forordning (EF) nr. 396/2005 af 23. februar 2005 om maksimalgrænseværdier for pesticidrester i eller på vegetabilske og animalske fødevarer og foderstoffer og om ændring af Rådets direktiv 91/414/EØF (EUT L 70 af 16.3.2005, s. 1). DA 2 DA