European Chemicals Agency Releases Practical Guide on Biocidal Products Regulation

Not a moment too soon, the European Chemicals Agency (ECHA) released a useful and clearly written Practical Guide on Biocidal Products Regulation, ECHA-14-B-19-EN. ECHA is the European Union (EU) agency tasked with implementing the Biocidal Products Regulation (BPR), along with other EU chemical laws and regulations. Adopted in 2012, the BPR revised the Biocidal Products Directive and imposes requirements on producers of active substances and biocidal products. Starting on September 1, 2013, all legal entities producing active ingredients or biocidal products available in the EU are required to obtain an approval for each active substance in the biocidal product and an authorization for the biocidal product itself. The Guide provides a “how to” comply with the BPR to “help companies to better fulfill their obligations and tasks under the BPR.” The Guide is organized into sections and explains the obligations imposed on regulated entities, who is responsible for the obligations, what are the relevant timelines and the deadlines, which are the information requirements and procedures to follow, and the expected results of the process. The Guide also highlights the exceptions and cases for some of the processes, and lists the relevant fees for each obligation.

The Guide contains the following chapters:

■ Approval of active substance;
■ Article 95: list of active substances and suppliers;
■ Technical equivalence;
■ National authorizations;
■ Mutual recognition;
■ Renewal of national authorization and authorizations subject to mutual recognition;
■ Union authorization;
■ Simplified authorizations;
■ Changes of biocidal products;
■ Data sharing; and
■ Appeals (on ECHA decisions).

The following additional chapters are expected to be published at a later date:

■ Renewal of approval of active substance;
■ Review of an approval of active substance; and
■ Research and development.