EUROPEAN COMMISSION Brussels, XXX SANTE/11949/2015 Rev. 2 (POOL/E3/2015/11949/11949R2- EN.doc) [ ](2015) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance) EN EN
COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with 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 17(7) thereof, Whereas: (1) In Commission Implementing Regulation (EU) No 414/2013 2 it is necessary to clarify that an individual product covered under a biocidal product family authorisation is also eligible as a related reference product with a view to obtain an authorisation for a same product. (2) References to applications for registration are now obsolete as this procedure is no longer applicable since the repeal of Directive 98/8/EC of the European Parliament and of the Council 3 and should therefore be deleted. (3) To respond to the needs of economic operators, in particular small and medium-sized enterprises, Article 3 of Implementing Regulation (EU) No 414/2013 should provide for the possibility to apply for national authorisation of same products in cases where the related reference product has been authorised by Union authorisation or is the subject of an application for such an authorisation. (4) It is necessary to clearly identify and to further specify the procedure for the submission of applications for authorisation of a same product and for acceptance of such applications where the related reference product has been authorised under the simplified authorisation procedure set out in Article 26 of Regulation (EU) No 528/2012 or is the subject of an application for such an authorisation. (5) In order to bring further predictability, guidelines on the details related to the handling of the applications covered by Implementing Regulation (EU) No 414/2013 should be developed by the European Chemicals Agency ( the Agency ) and regularly updated on the basis of experience and scientific or technical progress. 1 OJ L 167, 27.6.2012, p. 1. 2 Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4). 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
(6) To make the text clearer and unambiguous, the wording of Articles 5 and 6 should be amended. (7) Implementing Regulation (EU) No 414/2013 should therefore be amended accordingly. (8) 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 Implementing Regulation (EU) No 414/2013 is amended as follows: (1) Article 1 is replaced by the following: Article 1 Subject matter This Regulation lays down the procedure applicable where an authorisation is sought for a product (the same product ) which is identical to another single biocidal product, biocidal product family, or individual product of a biocidal product family which has been authorised or registered in accordance with Directive 98/8/EC of the European Parliament and of the Council* or Regulation (EU) No 528/2012, or for which an application for such authorisation has been submitted (the related reference product ), with regard to all the latest information submitted in relation to the authorisation or registration, except information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013**. * 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). ** 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, 9.4.2013, p. 4). (2) In Article 3, the following paragraph 1a is inserted. 1a. Where the related reference product has been authorised by Union authorisation or is the subject of an application for such an authorisation, applications for national authorisation of a same product shall be submitted in accordance with Article 29(1) of Regulation (EU) No 528/2012 to the competent authority of the Member State in which the national authorisation is sought.. (3) The following Article 4a is inserted: Article 4a Submission and acceptance of applications under the simplified procedure 1. Where the related reference product has been authorised in accordance with Article 26(3) of Regulation (EU) No 528/2012 or is the subject of an application for such an authorisation, applications for authorisation of a same EN 3 EN
product shall be submitted in accordance with Article 26(1) of Regulation (EU) No 528/2012 to the competent authority that has granted or is requested to grant the authorisation of the related reference product. 2. The competent authority shall accept the application in accordance with Article 26(2) of that Regulation.. (4) The following Article 4b is inserted: Article 4b Guidance on handling applications for authorisation of same products 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 applications covered by this Regulation. 2. Where necessary, those guidelines shall be updated taking into account the contributions from Member States and interested parties on its implementation as well as scientific and technical progress.. (5) Article 5 is replaced by the following: Article 5 Evaluation and decision on applications for national authorisation By way of derogation from Article 30 of Regulation (EU) No 528/2012, the receiving competent authority shall decide whether to grant or refuse authorisation of a same product in accordance with Article 19 of that Regulation within 60 days from the validation of the application in accordance with Article 3 of this Regulation, or, where applicable, from the subsequent date of adoption of the corresponding decision concerning the related reference product.. (6) In Article 6, paragraph 2 is replaced by the following: 2. If the Agency recommends the authorisation of the same product, the opinion shall contain at least both the following elements: (a) (b) a statement on whether the conditions laid down in Article 19 of Regulation (EU) No 528/2012 are fulfilled, and a draft summary of biocidal products characteristics, as referred to in Article 22(2) of that Regulation; where relevant, details of any terms and conditions which should be imposed on the making available on the market and use of the same product.. (7) The following Article 6a is inserted: Article 6a Evaluation and decision on applications under the simplified procedure 1. By way of derogation from Article 26(3) and (4) of Regulation (EU) No 528/2012, the receiving competent authority shall decide whether to grant or refuse authorisation of a same product in accordance with Article 25 of that Regulation within 60 days from the acceptance of the application in accordance with Article 4a(2), or, where applicable, from the subsequent date of adoption of the corresponding decision concerning the related reference product. 2. The evaluation shall include a check that the information indicated in Article 2 has been submitted and that the proposed differences between the same product EN 4 EN
and the related reference product concern merely information which can be the subject of an administrative change in accordance with Implementing Regulation (EU) No 354/2013. 3. Where the product authorised through this procedure is intended to be made available on the market of other Member States, Article 27 of Regulation (EU) No 528/2012 shall apply.. 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 EN 5 EN
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COMMISSION IMPLEMENTING DECISION (EU) / of XXX pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on a product consisting of dried lavender blossoms contained in a pad placed on the market to repel moths (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 28 May 2015, Germany requested the Commission to decide, pursuant to Article 3(3) of Regulation (EU) No 528/2012, whether a product consisting of dried lavender blossoms contained in a pad placed on the market to repel moths is a biocidal product or a treated article for the purposes of Article 3(1)(a) or (l) of that Regulation. (2) According to agreed Union guidance 2, whole living or unprocessed dead organisms (e.g. yeast, freeze-dried bacteria) or parts thereof (e.g. body parts, blood, branches, leaves, flowers, etc.) are not considered as substances, mixtures or articles within the meaning of Regulation (EC) No 1907/2006 of the European Parliament and of the Council 3. Dried lavender blossoms should therefore not be considered as a substance, mixture or article within the meaning of that Regulation and therefore they should not be considered either as a biocidal product or as a treated article in accordance with Regulation (EU) No 528/2012. (3) 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 product consisting of dried lavender blossoms in a pad is neither a biocidal product nor a treated article for the purposes of Article 3(1)(a) and (l) of Regulation (EU) No 528/2012. 1 OJ L 167, 27.6.2012, p. 1. 2 Guidance for Annex V Exemptions from the obligation to register (page 19), available at http://echa.europa.eu/documents/10162/13632/annex_v_en.pdf 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, 30.12.2006, p. 1). EN 2 EN
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
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COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX approving peracetic acid as an existing active substance for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6 (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 peracetic acid. (2) Peracetic 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 product-type 1, human hygiene biocidal products, product-type 2, private area and public health area disinfectants and other biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, product-type 5, drinking water disinfectants, and product-type 6, in-can preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 1, 2, 3, 4, 5 and 6 as defined in Annex V to Regulation (EU) No 528/2012. (3) Finland was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 16 January 2013. (4) In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 30 September 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. (5) According to those opinions, biocidal products used for product-types 1, 2, 3, 4, 5 and 6 and containing peracetic acid may be expected to satisfy the requirements of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain conditions concerning its use are complied 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
(6) It is therefore appropriate to approve peracetic acid for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6 subject to compliance with certain specifications and conditions. (7) For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing peracetic acid 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 4. Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of that Regulation. 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. (8) Peracetic acid is in an aqueous solution containing acetic acid and hydrogen peroxide. Due to the presence of hydrogen peroxide, which can be used in the production of explosive precursors, Regulation (EU) No 98/2013 of the European Parliament and of the Council 5 should continue to apply to hydrogen peroxide. (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 Peracetic acid is approved as an active substance for use in biocidal products for producttypes 1, 2, 3, 4, 5 and 6, 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). 5 Regulation (EU) No 98/2013 of the European Parliament and of the Council of 15 January 2013 on the marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1). EN 3 EN
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ANNEX Common Name IUPAC Name Identification Numbers Minimum degree of purity of the active substance 1 The specification is based on the starting materials hydrogen peroxide and acetic acid which are used to manufacture peracetic acid. Date of approval Expiry date of approval 30 September 2027 Product type Specific conditions Peracetic acid IUPAC Name: Peroxyethanoic acid EC No: 201-186-8 CAS No: 79-21-0 Peracetic acid in an aqueous solution containing acetic acid and hydrogen peroxide. 1st October 2017 1 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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. 2 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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. 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
(3) In view of the risks identified for the surface water, products for waste water disinfection shall not be authorised, unless it can be demonstrated that risks can be reduced to an acceptable level. 3 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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. 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 substance. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (3) Products shall not be incorporated in materials and articles intended to come into contact with food within EN 3 EN
the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of peracetic acid into food or it has been established pursuant to that Regulation that such limits are not necessary. 5 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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. 6 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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal EN 4 EN
protective equipment where exposure cannot be reduced to an acceptable level by other means. EN 5 EN
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KOMMISSIONENS GENNEMFØRELSESAFGØRELSE (EU) / af XXX om et produkt, der består af tørrede lavendelblomster i poser, og som markedsføres som middel mod møl, 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 28. maj 2015 anmodede Tyskland Kommissionen om i henhold til artikel 3, stk. 3, i forordning (EU) nr. 528/2012 at træffe afgørelse om, hvorvidt et produkt, der består af tørrede lavendelblomster i poser, og som markedsføres som middel mod myg, er et biocidholdigt produkt eller en behandlet artikel efter betydningen i samme forordnings artikel 3, stk. 1, litra a) eller l). (2) I henhold til aftalt EU-vejledning 2 betragtes hele levende eller uforarbejdede døde organismer (f.eks. gær, frysetørrede bakterier) eller dele deraf (f.eks. legemsdele, blod, grene, blade, blomster osv.) ikke som stoffer, blandinger eller artikler i henhold til Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 3. Tørrede lavendelblomster bør derfor ikke betragtes som et stof, en blanding eller en artikel som omhandlet i nævnte forordning, og de bør derfor ikke betragtes som et biocidholdigt produkt eller en behandlet artikel i overensstemmelse med forordning (EU) nr. 528/2012. (3) Foranstaltningerne i denne afgørelse er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter 1 EUT L 167 af 27.6.2012, s. 1. 2 Vejledning om bilag V Undtagelser fra registreringspligten (side 19), findes på http://echa.europa.eu/documents/10162/13632/annex_v_en.pdf 3 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 30.12.2006, s. 1). DA 2 DA
VEDTAGET DENNE AFGØRELSE: Artikel 1 Et produkt, der består af tørrede lavendelblomster i poser, er hverken et biocidholdigt produkt eller en behandlet artikel efter betydningen i artikel 3, stk. 1, litra a) og l), i forordning (EU) nr. 528/2012. Artikel 2 Denne afgørelse træder i kraft på tyvendedagen efter offentliggørelsen i Den Europæiske Unions Tidende. Udfærdiget i Bruxelles, den [ ]. På Kommissionens vegne Jean-Claude JUNCKER Formand DA 3 DA
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KOMMISSIONENS GENNEMFØRELSESFORORDNING (EU) / af XXX om godkendelse af pereddikesyre som et eksisterende aktivstof til anvendelse i biocidholdige produkter af produkttype 1, 2, 3, 4, 5 og 6 (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, tredje afsnit, og ud fra følgende betragtninger: (1) I Kommissionens delegerede forordning (EU) nr. 1062/2014 2 er der opstillet en liste over eksisterende aktivstoffer, som skal vurderes med henblik på eventuel godkendelse til brug i biocidholdige produkter. Listen omfatter pereddikesyre. (2) Pereddikesyre er i overensstemmelse med artikel 16, stk. 2, i Europa-Parlamentets og Rådets direktiv 98/8/EF 3 blevet vurderet til anvendelse i produkttype 1, biocidholdige produkter til hygiejne for mennesker, produkttype 2, desinfektionsmidler til privat brug og brug i det offentlige sundhedsvæsen og andre biocidholdige produkter, produkttype 3, biocidholdige produkter til veterinærhygiejne, produkttype 4, desinfektionsmidler til brug i forbindelse med levnedsmidler og fodringssteder, produkttype 5, desinfektionsmidler til drikkevand, og produkttype 6, konserveringsmidler til anvendelse i beholdere, som defineret i bilag V til nævnte direktiv, hvilket svarer til henholdsvis produkttype 1, 2, 3, 4, 5 og 6 i bilag V til forordning (EU) nr. 528/2012. (3) Finland blev udpeget som kompetent vurderingsmyndighed og fremsendte vurderingsrapporterne sammen med sine henstillinger den 16. januar 2013. (4) I overensstemmelse med artikel 7, stk. 1, litra b), i delegeret forordning (EU) nr. 1062/2014 fremsatte Udvalget for Biocidholdige Produkter den 30. september 2015 Det Europæiske Kemikalieagenturs udtalelser, hvori der var taget hensyn til den kompetente vurderingsmyndigheds konklusioner. (5) Det fremgår af disse udtalelser, at de biocidholdige produkter, der anvendes til produkttype 1, 2, 3, 4 og 6, og som indeholder pereddikesyre, kan forventes at opfylde kravene i artikel 19, stk. 1, litra b), i forordning (EU) nr. 528/2012, forudsat at visse betingelser vedrørende dets anvendelse er opfyldt. 1 EUT L 167 af 27.6.2012, s. 1. 2 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 (EUT L 294 af 10.10.2014, s. 1). 3 Europa-Parlamentets og Rådets direktiv 98/8/EF af 16. februar 1998 om markedsføring af biocidholdige produkter (EFT L 123 af 24.4.1998, s. 1). DA 2 DA
(6) Derfor bør pereddikesyre godkendes til anvendelse i biocidholdige produkter af produkttype 1, 2, 3, 4, 5 og 6, forudsat at visse specifikationer og betingelser er opfyldt. (7) Med hensyn til anvendelse i produkttype 4 blev der i vurderingen ikke taget højde for, at biocidholdige produkter, der indeholder pereddikesyre, kan indgå i materialer og genstande bestemt til direkte eller indirekte kontakt med fødevarer, jf. artikel 1, stk. 1, i Europa-Parlamentets og Rådets forordning (EF) nr. 1935/2004 4. For sådanne materialer kan det kræves, at der fastsættes specifikke grænser for migration over i fødevarer, jf. artikel 5, stk. 1, litra e), i nævnte forordning. Godkendelsen bør derfor ikke omfatte en sådan anvendelse, medmindre Kommissionen har vedtaget sådanne grænser, eller det ved ovennævnte forordning er blevet fastsat, at sådanne grænser ikke er nødvendige. (8) Pereddikesyre er i en vandig opløsning, der indeholder eddikesyre og hydrogenperoxid. På grund af tilstedeværelsen af hydrogenperoxid, som kan anvendes til produktion af udgangsstoffer til eksplosivstoffer, bør Europa-Parlamentets og Rådets forordning (EU) nr. 98/2013 5 stadig finde anvendelse på hydrogenperoxid. (9) Der bør gå en vis tid, inden et aktivstof godkendes, således at de berørte parter kan træffe de fornødne forberedelser til at opfylde de nye krav. (10) Foranstaltningerne i denne forordning er i overensstemmelse med udtalelse fra Det Stående Udvalg for Biocidholdige Produkter VEDTAGET DENNE FORORDNING: Artikel 1 Pereddikesyre godkendes som et aktivstof til anvendelse i biocidholdige produkter af produkttype 1, 2, 3, 4, 5 og 6 med forbehold af specifikationerne og betingelserne i bilaget. Artikel 2 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 [ ]. På Kommissionens vegne Jean-Claude JUNCKER Formand 4 Europa-Parlamentets og Rådets forordning (EF) nr. 1935/2004 af 27. oktober 2004 om materialer og genstande bestemt til kontakt med fødevarer og om ophævelse af direktiv 80/590/EØF og 89/109/EØF (EUT L 338 af 13.11.2004, s. 4). 5 Europa-Parlamentets og Rådets forordning (EU) nr. 98/2013 af 15. januar 2013 om markedsføring og brug af udgangsstoffer til eksplosivstoffer (EUT L 39 af 9.2.2013, s. 1). DA 3 DA
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BILAG Almindeligt anvendt navn IUPAC-navn Identifikationsnr. Aktivstoffets minimumsrenheds grad 1 Godkend elsesdato Udløbsdato for godkendels en Produk ttype Særlige betingelser Pereddikesyre IUPAC-navn: Peroxyeddikesyre EF-nr.: 201-186-8 CAS-nr.: 79-21-0 Specifikationen bygger på udgangsmaterialerne hydrogenperoxid og eddikesyre, som anvendes til at fremstille pereddikesyre. Pereddikesyre i en vandig opløsning, der indeholder eddikesyre og hydrogenperoxid. 1. oktober 2017 30. september 2027 1 Ved vurderingen af produktet skal der lægges særlig vægt på den eksponering, den risiko og den effektivitet, der er forbundet med alle anvendelser, der er omfattet af ansøgningen om godkendelse, men som ikke har været behandlet i risikovurderingen af aktivstoffet på EU-plan. Godkendelserne af biocidholdige produkter meddeles på følgende betingelser: 1) På grund af tilstedeværelsen af hydrogenperoxid berører godkendelser af biocidholdige produkter ikke forordning (EU) nr. 98/2013. 2) Til erhvervsmæssig brug skal der fastsættes sikre arbejdsprocedurer og passende administrative foranstaltninger. 2 Ved vurderingen af produktet skal der lægges særlig vægt på den eksponering, den risiko og den effektivitet, der er forbundet med alle anvendelser, der er omfattet af ansøgningen om godkendelse, men som ikke har været behandlet i risikovurderingen af aktivstoffet på EU-plan. Godkendelserne af biocidholdige produkter meddeles på følgende betingelser: 1) På grund af tilstedeværelsen af hydrogenperoxid berører godkendelser af biocidholdige produkter ikke forordning (EU) nr. 98/2013. 2) Til erhvervsmæssig brug skal der fastsættes sikre arbejdsprocedurer og passende administrative 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. DA 2 DA
foranstaltninger. Produkterne skal anvendes med de fornødne personlige værnemidler i tilfælde, hvor eksponeringen ikke kan nedbringes til et acceptabelt niveau ved andre midler. 3) I betragtning af de risici, der er konstateret for overfladevandet, må produkter til desinfektion af spildevand ikke godkendes, medmindre det kan godtgøres, at risikoen kan reduceres til et acceptabelt niveau. 3 Ved vurderingen af produktet skal der lægges særlig vægt på den eksponering, den risiko og den effektivitet, der er forbundet med alle anvendelser, der er omfattet af ansøgningen om godkendelse, men som ikke har været behandlet i risikovurderingen af aktivstoffet på EU-plan. Godkendelserne af biocidholdige produkter meddeles på følgende betingelser: 1) På grund af tilstedeværelsen af hydrogenperoxid berører godkendelser af biocidholdige produkter ikke forordning (EU) nr. 98/2013. 2) Til erhvervsmæssig brug skal der fastsættes sikre arbejdsprocedurer og passende administrative foranstaltninger. Produkterne skal anvendes med de fornødne personlige værnemidler i tilfælde, hvor eksponeringen ikke kan nedbringes til et acceptabelt niveau ved andre midler. 4 Ved vurderingen af produktet skal der lægges særlig vægt på den eksponering, den risiko og den effektivitet, der er forbundet med alle anvendelser, der er omfattet af ansøgningen om godkendelse, men som ikke har været behandlet i risikovurderingen af aktivstoffet på EU-plan. Godkendelserne af biocidholdige produkter meddeles på følgende betingelser: DA 3 DA
1) På grund af tilstedeværelsen af hydrogenperoxid berører godkendelser af biocidholdige produkter ikke forordning (EU) nr. 98/2013. 2) Til erhvervsmæssig brug skal der fastsættes sikre arbejdsprocedurer og passende administrative foranstaltninger. Produkterne skal anvendes med de fornødne personlige værnemidler i tilfælde, hvor eksponeringen ikke kan nedbringes til et acceptabelt niveau ved andre midler. 3) Produkter må ikke indgå i materialer og genstande bestemt til kontakt med fødevarer, jf. artikel 1, stk. 1, i forordning (EF) nr. 1935/2004, medmindre Kommissionen har fastsat specifikke grænser for migration af pereddikesyre over i fødevarer, eller det ved ovennævnte forordning er blevet fastsat, at sådanne grænser ikke er nødvendige. 5 Ved vurderingen af produktet skal der lægges særlig vægt på den eksponering, den risiko og den effektivitet, der er forbundet med alle anvendelser, der er omfattet af ansøgningen om godkendelse, men som ikke har været behandlet i risikovurderingen af aktivstoffet på EU-plan. Godkendelserne af biocidholdige produkter meddeles på følgende betingelser: 1) På grund af tilstedeværelsen af hydrogenperoxid berører godkendelser af biocidholdige produkter ikke forordning (EU) nr. 98/2013. 2) Til erhvervsmæssig brug skal der fastsættes sikre arbejdsprocedurer og passende administrative foranstaltninger. Produkterne skal anvendes med de fornødne personlige værnemidler i tilfælde, hvor eksponeringen ikke kan nedbringes til et acceptabelt niveau ved andre midler. 6 Ved vurderingen af produktet skal der lægges særlig vægt på den eksponering, den risiko og den effektivitet, der er forbundet med alle anvendelser, der er omfattet af ansøgningen om DA 4 DA
godkendelse, men som ikke har været behandlet i risikovurderingen af aktivstoffet på EU-plan. Godkendelserne af biocidholdige produkter meddeles på følgende betingelser: 1) På grund af tilstedeværelsen af hydrogenperoxid berører godkendelser af biocidholdige produkter ikke forordning (EU) nr. 98/2013. 2) Til erhvervsmæssig brug skal der fastsættes sikre arbejdsprocedurer og passende administrative foranstaltninger. Produkterne skal anvendes med de fornødne personlige værnemidler i tilfælde, hvor eksponeringen ikke kan nedbringes til et acceptabelt niveau ved andre midler. DA 5 DA