The European Chemicals Agency (ECHA) Issues Practical Guidance on the Biocidal Products Regulation
The European Chemcials Agency (ECHA), a European Union (EU) regulatory agency charged with the implementation of the EU's chemicals legislation and based in Helsinki, Finland, has started the publication of a Practical Guide on Regulation No. 528/2012 (the "Biocidal Product Regulation" or "BPR"). The ECHA is also charged with the implementation of the REACH Regulation (No. 1907/2006), of Regulation No. 1272/2008 on the classification, labelling and packaging of substances and mixtures, and of the Prior Informed Consent Regulation (Regulation No. 649/2012).
The BPR establishes a set of common EU rules concerning the marketing of biocidal products. According to Article 3 of the BPR, a biocidal product is any substance containing active substances capable of destroying, deterring, or rendering harmless organisms like pests or bacteria, which have detrimental effect on humans, animals, the environment, or manufactured products. For the purpose of the BPR, biocidal products are categorized into four categories: 1) disinfectants (e.g., water disinfectants); 2) products used for the preservation of manufactured products (e.g. products used for the preservation of wood); 3) pest control products (e.g. products used for the control of rats and other invasive animals); and 4) other biocidal products.
The main provisions of the BPR concern:
- the authorization by ECHA of active substances that may be used for biocidal products and the creation of a common EU list of such substances;
- the authorization for the placing on the market of biocidal products granted by EU Member States;
- the mutual recognition process to extend the marketing authorizations granted in one EU Member State to other Member States; and
- the issuance of 'Union Authorizations,' through which the Commission authorizes the placing on the market of a biocidal product in all the territory of the EU.
To assist companies involved in the manufacturing, importation and marketing of active substances and biocidal products, the ECHA published a first version of a Practical Guide on the BPR. This first version provides user-friendly advice on how to interpret and comply with the BPR rules on the approval of active substances, technical equivalence, national authorizations, mutual recognition, renewal of authorizations and changes in biocidal products. Moreover, it provides useful information on the sharing of data concerning tests of biocidal products on vertebrate animals, as well as on the specific modalities to present appeal against ECHA decisions.
ECHA was expected to publish the last three sections of the Guide, focusing on the renewal and review of approval of active substances and on research and development, in December 2014. It is not clear when these three sections will be published.
Crowell & Moring will continue monitoring and reporting on any other action undertaken by ECHA with respect to the implementation of the BPR.
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