Regulation (EU) 528/2012 improves the functioning of the single market while ensuring a high level of protection for human health, animal health and the environment.
The Regulation sets out rules for:
- Approving active substances in biocidal products
- Authorising the supply and use of biocidal products
- The supply of articles treated with biocidal products.
In particular, it says that a biocidal product cannot be placed on the market or used unless it contains approved active substances, and has been authorised.
The Regulation also includes provisions to reduce animal testing by making data sharing on vertebrate studies compulsory, and encouraging a more flexible and intelligent approach to testing.
Report on the implementation of Regulation (EU) No 528/2012
According to Article 65(4), the European Commission is required to prepare every five years a report to the European Parliament and to the Council on the implementation of the Regulation. This report should be based on the reports provided by Member States. The first report was published in June 2021.
The regulation outlines the general principles and products which fall under the scope of the biocidal products regulation. This includes mixtures, articles and materials treated with biocidal products, including furniture and textiles, as well as a provision on dual use covering biocidal products that have a dual function.
This outlines the applicable definitions, making a distinction between those substances, mixtures and articles that should be regarded as biocidal products and those which should not, differentiating notably between articles that are biocidal products and those that are treated.
Although the Regulation does not ban animal testing completely, it attempts to minimise it as much as possible. Article 62 introduces an obligation to share data on vertebrate animal tests in exchange for fair compensation, and a prohibition to duplicate such tests, which is aimed at saving costs, as well as animal lives.
It also encourages data-sharing for non-animal tests, with a similar view to reducing the overall costs of the legislation to the industry and avoiding the duplication of efforts. Where necessary, ECHA is involved in the data sharing process.
In addition, all use of animals for scientific purposes must comply with the provisions set out in Directive 2010/63/EU, which entered into force on 1 January 2013. This Directive strengthens, and significantly improves on legislation in this area.
How are products authorised, and by whom?
To obtain the authorisation needed to supply and use these products, companies must demonstrate that the product is effective and does not present unacceptable risks to humans, animals or the environment.
Individual EU countries are responsible for authorising biocidal products that are made available on their own territory with mutual recognition processes possible between them. Some types of products can be authorised at the request of companies by the Commission at EU level enabling these companies to make these products available to the entire EU market.
Role of ECHA
The European Chemicals Agency (ECHA) is responsible for providing technical and scientific support in implementing Regulation (EU) 528/2012. Through its Biocidal Product Committee, it provides opinions to the European Commission on:
- Approving active substances
- Authorising biocidal products at EU level
- Various other scientific and technical matters.
On the basis of ECHA’s opinions, the Commission then decides whether to approve active substances and grant Union authorisations to biocidal products.
ECHA provides secretariat support to the Coordination Group, which plays an important role in the process of mutual recognition of product authorisations at national level between EU countries.
ECHA is also responsible for maintaining the Register for Biocidal Products (R4BP), an IT system used to:
- Submit applications under the Regulation
- Exchange information while applications are being assessed
- Disseminate information once active substances have been approved and products authorised.
ECHA also manages the list of suppliers of active substances established under Article 95 and related applications. ECHA further assesses technical equivalence and data sharing inquiries.
Expert group and Standing Committee
An expert group, made up of representatives of the competent authorities for the implementation of the Biocidal Products Regulation, assists the Commission with the preparation of policy initiatives, delegated acts, and implementation of the Biocidal Products Regulation, including the coordination of certain Member States’ activities. Representatives of NGOs and industry can also participate in meetings of the expert group as observers.
The Standing Committeeon Biocidal Products is made up of representatives of EU countries and is chaired by a representative of the European Commission. It delivers opinions on draft legislative measures that the Commission intends to adopt.
Minutes of the meetings of the expert group and Standing Committee can be found here.
The list of competent authorities, helpdesks and stakeholders for the implementation of the Regulation is available here.