Companies that would like to keep their biocidal products on the UK market need to insure that the active substance/product type combination is:
• in the GB Review Programme AND,
• that their active substance supplier is compliant with the GB BPR Article 95 list.
1. GB Review Programme
HSE has published a list of active substances from the EU Review Programme, that are not being supported in GB. It has also invited companies that would like to take over the role of participant in the GB Review Programme for active substance/product type combinations listed on this list to submit a notification to the HSE. If a notification to take over the role of participant is not received (see list for deadline), these active substance/product type combinations will be subject to a GB non-approval decision. Biocidal products containing active substances with GB non-approval decisions for the relevant product types will have to be removed from the GB market.
2. GB BPR Article 95 list
Biocidal active substance and product suppliers included on the EU Article 95 List at the end of the EU exit transition period on 31 December 2020 were automatically added to the GB Article 95 List. However, in order to remain on the GB Article 95 List, suppliers must submit information to HSE by December 31 2022. Biocidal products containing active substances from suppliers not complaint with GB BPR Article 95 will have to be removed from the GB market.
URGENT ACTIONS FOR BIOCIDAL PRODUCT COMPANIES:
- Action 1: See if the substances in the
- Action 2: Communicate with your active substance supplier to ensure that they have taken the actions required to be listed on the GB BPR Article 95 list before the end of 2022.
Deadline approaching for active substance suppliers
Biocidal active substance and product suppliers included automatically in the GB Article 95 List until 31 December 2020, have until 31 December 2022 to resubmit data and confirm that their company is based in the UK, to remain on this List.
INFOTOX is organizing a Biocides Collaboration Group/Consortium, for the companies interested in doing an authorisation of biocidal products containing the following active substances:
• Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides (BKC), CAS 68424-85-1
• Didecyldimethylammonium chloride (DDAC), CAS 7173-51-5
The date of approval for these two active substances and deadline for BPR dossier submission will be on the 1st of November 2022, for products PT3 and PT4.
For products PT1 and PT2, the deadline for BPR dossier submissions will be in about 18 months. This last deadline will also include products with PT2 and PT4 in the same label.
If your company is interested in doing a BPR authorisation dossier for biocidal products that contain these two active substances, please contact INFOTOX.
Please contact us if you would like to have INFOTOX UK act as your UK only representative (OR).
Please contact INFOTOX if you need assistance
Since March 2020, ECHA and the European Commission have been informed about the increased number of non-compliant hand disinfectants. Non-compliance includes lack of the required authorization or permit, lack hazard labelling, disinfectants which had a formulation that cannot be sufficiently effective against viruses, etc.
National enforcement authorities continue to perform market inspections with regard human health protection, which can include fines and the withdrawal of the products from the market.
Please contact INFOTOX if you need assistance to ensure your disinfectants are fully compliant.
Given the current exceptional situation related to the COVID-19 Pandemic, the Portuguese biocidal product regulator (DGS) will accept dossier submissions for biocidal product transitional period notifications and authorisations via email.
This is only valid for transitional period product submissions, for which DGS is the national competent authority. Once this exceptional situation has passed, companies will need to send as soon as possible the paper version of the submitted dossier to DGS. This change is active from 18/03/2020 for an undetermined time period.
If you need assistance to develop and submit your notification/ authorisation to DGS, please contact INFOTOX via firstname.lastname@example.org.
Aims to help companies (specifically SMEs) meet BPR compliance. Joining this Group helps companies reduce costs related to BPR product authorisations, while maintaining full ownership of their product authorisations. Please click here to get more information.