Making available on the market and use of biocidal products Text with EEA relevance - EU monitor

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Wednesday, May 22, 2019

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Current status

The regulation entered into force on July 17, 2012.


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
Original proposal COM(2009)267 EN
procedure number i 2009/0076(COD)
EURlex-code i 32012R0528
Legal instrument Regulation
Addressee Member States of the European Union
Date of decision 22-05-2012
Entry into force i 17-07-2012; Entry into force Date pub. +20 See Art 97
01-09-2013; Application See Art 97
Date of end of validity 31-12-9999


Legislative text

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)


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],


(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.

This text has been adopted from EUR-Lex.


Original proposal



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