Regulation 2014/334 - Amendment of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market - Main contents
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Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market Text with EEA relevance| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2014/334 |
| Original proposal | COM(2013)288  |
| CELEX number i | 32014R0334 |
| Document | 11-03-2014 |
|---|---|
| Publication in Official Journal | 05-04-2014; OJ L 103 p. 22-32 |
| Effect | 01-09-2013; Application Partial application See Art 2 25-04-2014; Entry into force Date pub. +20 See Art 2 |
| End of validity | 31-12-9999 |
5.4.2014 |
EN |
Official Journal of the European Union |
L 103/22 |
REGULATION (EU) No 334/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 March 2014
amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) |
Article 2 of Regulation (EU) No 528/2012 of the European Parliament and of the Council (3) sets out the scope of that Regulation, and, among other things, excludes from its application biocidal products when used as processing aids. Article 2(5) should be amended to clarify beyond doubt that ‘processing aids’ means those defined in Regulations (EC) No 1831/2003 (4) and (EC) No 1333/2008 (5) of the European Parliament and of the Council. |
(2) |
Point (s) of Article 3(1) and Article 19(6) of Regulation (EU) No 528/2012 should be amended to allow similar biocidal products to be part of a biocidal product family if they can be satisfactorily assessed based on identifiable maximum risks and minimum level of efficacy. |
(3) |
In point (e) of Article 19(1) and in Article 19(7) of Regulation (EU) No 528/2012, it should be clarified that the limits required to be established in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council (6) are specific migration limits or limits for the residual content in food contact materials. |
(4) |
To ensure consistency between Regulation (EU) No 528/2012 and Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7), point (b) of Article 19(4) of Regulation (EU) No 528/2012 should be amended to include specific target organ toxicity by single or repeated exposure category 1 as a classification criterion, in order to preclude authorisation for the making available on the market for use by the general public of a biocidal product meeting the criteria for this classification. Point (c) of Article 19(4) of Regulation (EU) No 528/2012 prohibits authorisation for making available on the market for use by the general public of biocidal products meeting the criteria for being persistent, bioaccumulative and toxic (‘PBT’), or very persistent and very bioaccumulative (‘vPvB’) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (8). However, whereas biocidal products are often mixtures and sometimes articles, those criteria apply only to substances. Point (c) of Article 19(4) of Regulation (EU) No 528/2012 should therefore refer to biocidal products consisting of, containing or generating, substances meeting those criteria. |
(5) |
As comparative assessment is not referred to in Annex VI to Regulation (EU) No 528/2012, the reference to that Annex in Article 23(3) of that Regulation should be deleted. |
(6) |
Article 34(4) of Regulation (EU) No 528/2012 should be amended to correct the cross reference to Article 30. |
(7) |
Pursuant to Article 35(3) of Regulation (EU) No 528/2012, where all Member States concerned have reached an agreement with the reference Member State on mutual recognition, a biocidal product is to be authorised in accordance with Article 33(4) or 34(6) thereof. However, the provisions referring to decisions by all Member States concerned to grant authorisations by mutual recognition are... |
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