Registration of Biocides
Registration of biocides is a key legislative mandate in the European Union, Canada, and in the United States.
Intertek offers comprehensive solutions for clients wishing to gain authorisation to place biocidal products (active ingredients and formulations) on the European Union, Canadian, and United States markets.
European Union (EU) / European Economic Area (EEA)
In 2012, to streamline and improve the biocidal products evaluation and authorisation process, the European Parliament adopted Regulation (EU) No 528/2012 (commonly referred to as the “BP Regulation” or “BPR”), which replaced the Biocidal Products Directive 98/8/EC (known as the “Biocides Directive” or BPD). This Biocidal Products Regulation covers a wide range of products types (i.e., rodenticides, disinfectants, embalming fluids etc.). The authorisation process for these products is very complex; therefore, a good registration strategy is fundamental to getting products on the market.
The BPR harmonises the marketing on an EU level and outlines criteria for:
- establishing a European list of approved active substances which may be used in biocidal products
- the authorisation process of biocidal products (i.e., mutual recognition of authorisation) to bring products to market
- the use of articles treated with, or intentionally incorporating, one or more biocidal products
- new simplified authorisation procedures (Annex I, parallel trade permit, product families and same products authorisation, etc.)
- comparative assessment and candidates for substitution
Intertek supports compliance with the EU Biocidal Products Regulation (BPR) 528/2012, as amended and Member State national requirements (during the ‘transitional’ period). Learn more about our European Union Biocides Regulation Services.
Pest Control Products intended for sale in Canada must go through pre-market approval with the Pest Management Regulatory Agency (PMRA), although registration exemptions do exist. Intertek can help companies navigate the regulatory requirements to bring their biocide product to market.
United States (US)
Intertek provides regulatory support for biocide registration in the United States. We will act as liaison with the authorities in order that submission for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration can be accomplished - based on U.S. 40 CFR part 152 (Code of Federal Regulations, Title 40: Protection of Environment, Part 152 – Pesticide Registration and Classification Procedures).