On May 22, 2012, Biocides Regulation (EU) 528/2012 was adopted. It will repeal and replace Directive 98/8/EC, and will be applicable as of 1 September 2013.
The Directive established a two-step process of approval:
1) evaluation of the active substance at the Union level, and
2) product authorisation at Member State level.
The new Regulation will maintain this two-step approach while providing for the possibility that some biocidal products are authorised at the Union level giving them direct access to the entire Union market.
The objective of the new Regulation is to improve the functioning of the internal market in biocidal products whilst ensuring a high level of environmental and human health protection. The new Regulation will also remedy a number of weaknesses that were identified during the 11 years of implementation of the current Directive 98/8/EC.
This new measure simplifies and streamlines the requirements for approving active substances and authorizing products. The new provisions will also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A dedicated IT platform (the Register for Biocidal Products) will be used for submitting applications as well as recording decisions and disseminating information to the public. The new Regulation is also the first piece of legislation to build in the new Commission definition on nanomaterials.
It should be noted that the text is also a major breakthrough for the internal market with the creation of a Union authorisation of biocidal products, which will allow industry to directly place their products on the entire Union market.
The European Chemicals Agency (ECHA) will provide a strong scientific and technical back-up to the Commission and the Member States under this new Regulation. In particular, ECHA will be responsible for the assessment of applications for the Union authorisation of biocidal products.
In summary some key elements in a nutshell:
- Provide for the authorisation at the Union level of certain biocidal products;
- Improve the functioning of national authorisations and mutual recognition by introducing binding deadlines and strengthening the system of mutual recognition dispute settlement;
- Reduce the number of animal tests by obligatory data sharing with respect to vertebrate animal studies;
- Strengthen the rules on data waiving (i.e. not request data which is not necessary);
- Extend the scope to cover articles and materials treated with biocidal products (e.g. furniture treated with wood preservatives), which are imported from third countries;
- Harmonised fee structure which will harmonise the conditions and criteria for setting the fees in all Member States;
- The European Chemicals Agency (ECHA) will be involved in the scientific work on biocides;
- Persons placing biocidal products on the market will have to hold the data on active substances (before they are obliged to do so under the product authorisation application).
Source: EU Commission