Prestige Compliance Regulatory Consultants in Nottingham use Knowledge, Expertise, and Experience, which enables us to offer Comprehensive Compliance Solutions that incorporate all your requirements. We provide Professional Regulatory Affairs Consultancy Services for Manufacturers, Suppliers, and Distributors.
What are Biocides?
A Biocide is a Chemical Substance, Mixture, or Microorganism intended to Protect People and Animals, Preserve Goods, stop Pests like Insects or Rodents and Control Viruses, Bacteria, and Fungi through a Chemical or Biological action. Biocidal Products are typically a mixture of Chemicals including the 'Active Substance' which has the controlling effect on the harmful organisms, although they can be comprised solely of an Active Substance. Biocidal Products include Articles which have been impregnated with the Active Substance and Products formed through 'In-Situ Generation' where the Active Substance is created when the Product is used. Markets on the International Regulatory Landscape have their own Rules and Regulations for the Registration and Authorisation of Biocides. These Regulations make sure that when Biocidal Products are used properly, they do not harm People, Pets, or the wider Environment.
Law in the European Union and Great Britain
Biocidal Products are controlled in the European Union under the Regulation (EU) No 528/2012 (commonly referred to as the Biocidal Products Regulation (BPR), which replaced the Biocidal Products Directive 98/8/EC known as the Biocides Directive (BPD). They are enforced by the European Chemicals Agency (ECHA). In Great Britain (England, Scotland, and Wales), Biocidal Products are controlled under the GB Biocidal Products Regulation (GB BPR) by the Medicines and Healthcare products Regulatory Agency (MHRA).
Law in the USA and Canada
In the United States of America, Biocidal Products are controlled under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registration must 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). Pest Control Products intended for sale in Canada are subject to The Pest Control Products Act and must go through Pre-Market approval with the Pest Management Regulatory Agency (PMRA).
What We Can Do
Prestige Compliance Regulatory Consultants in Nottingham provide Regulatory Support and Advice to assist with meeting all Regulatory Requirements, helping you navigate on the International Regulatory Landscape.
The Registration and Authorisation process for Biocidal Products is often very complex therefore we provide a thorough Regulatory Strategy which is fundamental to getting Products on the Market. We help you identify Regulations for some types of Biocidal Products which have more specific Legislation that applies to them, including Pesticides, Medicines, Medical Devices, and Cosmetics.
Prestige Compliance support your business needs from Product Innovation through to Market Authorisation.