Regulation on selling and using biocidal products

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:

In particular, it says that a biocidal product cannot be placed on the market or used unless it:

  1. only contains approved active substances and
  2. has been authorised.

The Regulation also include provisions to reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing.

How are products authorised, and by whom?

To obtain the authorisation needed to make available and use these products, companies must demonstrate that the product is effective and does not present unacceptable risks to:

  • human health
  • animal health and
  • the environment.

EU countries are responsible for authorising biocidal products that will be made available in their territory. Some types of products can be authorised by the Commission at EU level. This allows companies to place these products on the entire EU market.

What does the European Chemicals Agency do?

The European Chemicals Agency  provides scientific and technical support for the Commission and EU countries in implementing the Regulation.

Details of the Regulation