Implementing regulation 2013/354 - Changes of biocidal products authorised in accordance with Regulation 528/2012 - Main contents
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official title
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 Text with EEA relevance| Legal instrument | Implementing regulation |
|---|---|
| Number legal act | Implementing regulation 2013/354 |
| CELEX number i | 32013R0354 |
| Document | 18-04-2013 |
|---|---|
| Publication in Official Journal | 19-04-2013; Special edition in Croatian: Chapter 13 Volume 063,OJ L 109, 19.4.2013 |
| Effect | 09-05-2013; Entry into force Date pub. +20 See Art 18 01-09-2013; Application See Art 18 |
| End of validity | 31-12-9999 |
19.4.2013 |
EN |
Official Journal of the European Union |
L 109/4 |
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
(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 51 thereof,
Whereas:
(1) |
In order to ensure a harmonised approach, it is appropriate to adopt provisions for changes of biocidal products in respect of any of the information submitted in relation to the initial application for the authorisation or registration of biocidal products and biocidal product families authorised or registered in accordance with 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 (2) and Regulation (EU) No 528/2012. |
(2) |
Proposed changes of biocidal products should be classified in different categories, taking into account the extent to which they require a reassessment of the risk for human or animal health or the environment and of the efficacy of the biocidal product or biocidal product family. It is appropriate to establish the criteria to be used for classifying a change of a product in one of the categories referred to in Article 50(3) of Regulation (EU) No 528/2012. |
(3) |
In order to bring further predictability, the European Chemicals Agency (hereinafter ‘the Agency’) should issue opinions on the classification of changes of products. The Agency should also issue guidelines on the details of the various categories of changes. Those guidelines should be regularly updated in the light of scientific and technical progress. |
(4) |
It is necessary to clarify the procedure which will lead to a decision by the Commission in accordance with the first subparagraph of Article 50(2) of Regulation (EU) No 528/2012 and, where relevant, Article 44(5) thereof. |
(5) |
In order to reduce the overall number of possible applications and to enable Member States, the Agency and the Commission to focus on those changes that have a genuine impact on the properties of biocidal products, an annual reporting system should be introduced for certain changes of an administrative nature. Such changes should not require any prior agreement and should be notified within 12 months following implementation. However, other types of changes of an administrative nature, whose immediate reporting and prior examination is necessary for the continuous supervision of the biocidal product concerned should not be subject to the annual reporting system. |
(6) |
Each change should require a separate submission. Grouping of changes should nevertheless be allowed in certain cases, in order to facilitate the review of the changes and reduce the administrative burden. |
(7) |
Provisions should be introduced regarding the role of the coordination group established under Regulation (EU) No 528/2012 to increase cooperation between Member States and allow for the settlement of disagreements in the evaluation of certain changes. |
(8) |
This Regulation should clarify when the authorisation holder is allowed to implement a given change, as such clarification is essential for economic operators. |
(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:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
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