Regulation of biocidal products was first introduced in 2000 to harmonise the data requirements and evaluation procedure for both active substances and biocidal products across the EU. The resulting Biocidal Products Regulation (EU) No 528/2012 (BPR) is now considered worldwide to be the most demanding piece of legislation applicable to biocidal products.
A major feature of the Regulation has been to make it more inclusive with more active substances and products falling within the scope of the Regulation than ever before. Whether you market an active substance, a biocidal product, a machine that can generate an active substance, a precursor that could be used to generate an active substance an article that has been treated with a biocidal product or simply make a claim that is considered biocidal, you could have obligations under the BPR. The burden of complying with the Regulation firmly rests with industry.
Arrow Regulatory's expert team can help you understand what your obligations are and provide cost effective solutions for compliance.
As of 1 January 2021, biocidal products in Great Britain (Scotland, Wales and England) are regulated under the GB regulatory framework for Biocidal Products Regulations and CLP; Statutory Instrument 2019, No 720. The GB Regulation mirrors that of the EU BPR with regard to the active substance approvals and product authorisation requirements. Deviation from the EU BPR lies in the authorising body for active substances, active substances supported in GB and whether co-formulants are supported under UK-REACH.
Arrow Regulatory's expert team can help you understand what your new GB obligations are and the implications for existing products already on the GB market.
World Wide Markets
There is no global harmonisation of biocidal product regulation with many countries recognising biocidal products as a distinct chemical category. Arrow Regulatory has a network of global contacts to help you negotiate the regulatory maze that exists outside the EU.
Preparation of active substance approvals and biocidal product authorisations (BPR and Transitional Arrangements)
Development of Biocidal Product Families
Development of Authorisation strategies
Planning of test programmes, including efficacy testing
Technical Equivalence Applications
Obtaining Article 95 status
Renewals of active substance approvals and biocidal product authorisations, including Comparative Assessment
Product Label Reviews
Advice on treated article status and labelling
Post-approval support and asset management
Global product compliance
The unique expertise of Arrow Regulatory's consultants includes over 18 years working on EU Regulation of biocides and involvement in the preparation of over 30 active substance inclusion dossiers, including in-situ generation systems and Annex I substances. We work with major producers to achieve Union authorisation or National authorisation with Mutual Recognition for their products. Our wide experience in supporting active substances and biocidal products is your guarantee of a quality expert service.
Contact us for information on how we can help you.