Regulation 2012/528 - Making available on the market and use of biocidal products

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This page contains a limited version of this dossier in the EU Monitor.

Contents

  1. Current status
  2. Key information
  3. Key dates
  4. Legislative text
  5. Original proposal
  6. Sources and disclaimer
  7. Full version
  8. EU Monitor

1.

Current status

This regulation has been published on June 27, 2012 and entered into force on July 17, 2012.

2.

Key information

official title

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 Text with EEA relevance
 
Legal instrument Regulation
Number legal act Regulation 2012/528
Original proposal COM(2009)267 EN
CELEX number427 32012R0528

3.

Key dates

Document 22-05-2012
Publication in Official Journal 27-06-2012; Special edition in Croatian: Chapter 13 Volume 049,OJ L 167, 27.6.2012
Effect 17-07-2012; Entry into force Date pub. +20 See Art 97
01-09-2013; Application See Art 97
End of validity 31-12-9999

4.

Legislative text

27.6.2012   

EN

Official Journal of the European Union

L 167/1

 

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

(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,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

 

(1)

Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials. However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns.

 

(2)

Biocidal products should neither be made available on the market nor used unless authorised in accordance with this Regulation. Treated articles should not be placed on the market unless all active substances contained in the biocidal products with which they were treated or which they incorporate are approved in accordance with this Regulation.

 

(3)

The purpose of this Regulation is to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. Particular attention should be paid to the protection of vulnerable groups, such as pregnant women and children. This Regulation should be underpinned by the precautionary principle to ensure that the manufacturing and making available on the market of active substances and biocidal products do not result in harmful effects on human or animal health or unacceptable effects on the environment. With a view to removing, as far as possible, obstacles to trade in biocidal products, rules should be laid down for the approval of active substances and the making available on the market and use of biocidal products, including rules on the mutual recognition of authorisations and on parallel trade.

 

(4)

To ensure a high level of protection for human health, animal health and the environment, this Regulation should apply without prejudice to Union legislation on safety in the workplace and environmental and consumer protection.

 

(5)

Rules concerning the making available on the market of biocidal products within the Community were established by Directive 98/8/EC of the European Parliament and of the Council (3). It is necessary to adapt those rules in the light of experience and in particular the report on the first seven years of the implementation submitted by the Commission to the European Parliament and the Council, which analyses problems with and weaknesses of that Directive.

 

(6)

Taking into account the main changes that should be made to the existing rules, a regulation is the appropriate legal instrument to replace Directive 98/8/EC to lay down clear, detailed and directly applicable rules. Moreover, a regulation ensures that legal requirements are implemented at the same time and in a harmonised manner throughout the Union.

 

(7)

A distinction should be drawn between existing active substances which were on the market in biocidal products on the transposition date set in Directive 98/8/EC and new active substances which were not yet on the market in biocidal products on that date. During the ongoing review of existing active substances, Member States should continue to allow biocidal products containing such substances to be made available on the market according to their national rules until a decision is taken on approval of those active...


More

This text has been adopted from EUR-Lex.

5.

Original proposal

  • COM(2009)267 - Placing on the market and use of biocidal products
 

6.

Sources and disclaimer

For further information you may want to consult the following sources that have been used to compile this dossier:
  • dossier EUR-Lex decision428

This dossier is compiled each night drawing from aforementioned sources through automated processes. We have invested a great deal in optimising the programming underlying these processes. However, we cannot guarantee the sources we draw our information from nor the resulting dossier are without fault.

 

7.

Full version

This page is also available in a full version containing the summary of legislation, de geconsolideerde versie, the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand, the related cases of the European Court of Justice and finally consultations relevant to the dossier at hand.

The full version is available for registered users of the EU Monitor by ANP and PDC Informatie Architectuur.

8.

EU Monitor

The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals developments in your chosen topics of interest. Apologies to unregistered users, we can no longer add new users.This service will discontinue in the near future.


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  • 411. 
    Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.

     
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  • 418. 
    Regulation (EC) N° 1907/2006

     
  • 419. 
    Estimates of the commitment and payment appropriations are limited to the current financial programming running until 2013.

     
  • 420. 
    The current Directive 98/8/EC provides for the systematic evaluation of active substances, which were already on the market on 14 May 2000, when that Directive came into force. This evaluation is carried out by Member States, which have all been allocated a number of substances for which they have to produce assessment reports. These assessment reports are then peer reviewed by the other Member States and discussed at different meetings organised by the Commission JRC for the scientific and technical issues and then by DG Environment for the final discussions before the final steps of the decision-making process are taken (Comitology procedure). The scientific and technical discussions and the preparatory work they entail to read the reports and analyse the different issues require significant resources, which are currently provided by the Commission JRC and financed under the LIFE
     
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  • 424. 
    Cost of which is NOT covered by the reference amount

     
  • 425. 
    Cost of which is NOT covered by the reference amount

     
  • 426. 
    Cost of which is included within the reference amount

     
  • 427. 
    Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
     
  • 428. 
    EUR-lex provides an overview of the proposal, amendments, citations and legality.