Legal background in the field of biocidal products
The assessment, approval, labelling and use of biocidal products is governed by a number of laws and regulations. European regulations play an important role in this connection.
On European level, the approval of active substances is governed by Regulation (EU) No. 528/2012. The active substances that are considered suitable for use in biocidal products are included in a Union list of approved active substances (EU-wide positive list).
In addition, EU Regulation No. 1272/2008 is also applied in the assessment of toxicological properties for classification and labelling.
As of 1 September 2013, Regulation (EU) No. 528/2012 also applies on national level as the legal basis for the approval of biocidal products. The authorities responsible for the implementation of this regulation in Germany and the remit of these authorities are governed by the German Chemicals Act (ChemG). Other national regulations are laid out in other ordinances such as the German Biocidal Product Approval Ordinance (ChemBiozidZulV) and the German Ordinance on the Registration of Biocidal Products (ChemBiozidMeldeV). According to Article 16e of the German Chemicals Act, the producers or importers and distributors of biocidal products must notify BfR of the composition of each product complete with instructions for use and recommendations for precautionary measures during use as well as emergency measures in the event of accidents (notification forms) so that this confidential information is available to doctors or poison information centres in the case of emergency.