GB biocides regulations
On 1 January 2021, Great Britain (GB) introduced a stand-alone regulatory regime governing the placing of biocidal products on the GB market (England, Scotland and Wales). Northern Ireland (NI) remains largely within the EU process.
TSG can help
Whether your company is looking to maintain access to the GB market, appoint a UK-based representative, make a new active substance application to HSE, or needs strategic guidance, TSG Consulting can help.
- Our multidisciplinary team of scientists and registration specialists has years of proven experience helping companies secure and maintain biocidal product authorisations in the EU and, more recently, supporting applications under GB BPR
- Through our in-depth knowledge of the regulations and processes, we can advise of the actions needed to ensure regulatory compliance with the GB and EU BPR. We can also help manage the impact on active substance evaluations, approvals and approved ‘GB Article 95’ suppliers
- TSG Consulting can act as representative of GB companies on the EU Article 95 list as well as EU companies on the GB Article 95 list
- We work with both major chemical companies and small suppliers, targeting services to each company’s specific needs
- We have wide-ranging expertise from working in industry, government organizations, and research facilities
- We believe that proactive project management is essential to ensure that our clients’ needs are identified and met in a timely manner
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG’s team of specialized consultants drawn from industry, regulatory authorities and contract research manage all aspects of biocidal active substance approval, biocidal product authorisation/registration and strategic planning. Led by Amy Burrows, Head of Biocides & Cosmetics, key professionals working in the sector include Samantha Walker, Philippa O’Donovan, Séverine Macke and Ian Nicholls.
Frequently asked questions
Northern Ireland-based businesses that hold a valid authorisation for their biocidal product under the EU BPR, must first notify HSE 90 days before the product is placed on the GB market. In addition, the authorisation holder must be established in NI, the active substance must be approved under GB BPR and the active substance must be sourced from a GB Article 95 supplier.
Yes. Exports from GB to NI must comply with the EU BPR. In addition, businesses may also be required to comply with other GB legislation such as GB Prior Informed Consent (GB PIC) or specific customs and export rules.
EU Article 95 listings of suppliers for active substances/product-type combinations were grandfathered into the UK for two years. After this time, data needs to be resubmitted to remain on the list. If data submission is supplied via a Letter of Access (LoA), it must be to a complete substance dossier and is dependent on the data owner having submitted the data to the UK. GB Article 95 legal entities must also be established in the UK (GB or NI) before the 31 December 2022 deadline. This may occur sooner if necessary to support other applications. The use of a UK representative is possible.
GB BPR requires authorisation holders to be established within the UK by the end of 2021 and GB Article 95 legal entities to be established within the UK (or represented by a UK established legal entity) by the end of 2022. An ‘establishment form’ is available to formally advise HSE.
TSG routinely represents non-UK based businesses. If your business is established outside of the UK and you would like TSG Consulting to represent you, please get in touch at firstname.lastname@example.org