ChemRegs Newsletter – September 2024
Guidance on new EU CLP hazard classes
ECHA is holding a free webinar on 21 November 2024 at 11:00 (Helsinki time) to give an overview of the new ECHA guidance on the recently introduced hazard classes under the EU Classification, Labelling and Packaging (CLP) Regulation.
This session will introduce the new updated guidance developed by experts from ECHA, EU Member States, EU level non-governmental organisations and associations as well as other nominated experts. The guidance outlines the new hazard classes for endocrine disruptors, Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative (PBT/vPvB), and Persistent, Mobile, and Toxic or Very Persistent, Very Mobile (PMT/vPvM) properties. These additions aim to better protect human health and the environment by addressing emerging concerns in chemical safety.
During the webinar, participants will gain an overview of the new hazard classes under the CLP Regulation and practical guidance on the classification process. Participants will also learn about the regulatory timelines and how ECHA manages the related administrative process once proposals for harmonised classification and labelling are submitted.
Participants can watch live from the ECHA home page on 21 November at 11:00 EET, GMT +2. No registration is required.
A Q&A document with answers to all questions received will be available soon after the event.
Planned removal of approved biocidal substance suppliers from GB Article 95 List
The Biocidal Products Regulation (BPR) has as one of its objectives the establishment of a level playing field for parties dealing with active substances. This is achieved through Article 95 of the BPR, and the creation of a nominative list known as “the list of relevant substances and suppliers” (“Article 95 list”).
A biocidal product consisting of, containing, or generating a “relevant substance”, cannot be made available on the market if the “substance supplier” or “product supplier” is not included on the Article 95 list for the product types (“PT”) to which the product belongs. The legal definition of “relevant substance” and “product/substance supplier” is given in Article 95 (1) of the BPR.
Following the end of the EU exit transition period on 31 December 2020, the EU Article 95 list of biocidal active substance suppliers is no longer applicable in Great Britain. Under the GB Biocidal Products Regulation (GB BPR) Great Britain maintains its own, independent list of biocidal active substance suppliers, referred to as the GB Article 95 List. The GB Article 95 list gives details of suppliers for active substance/product type combinations that can be used in biocidal products in Great Britain under the GB BPR.
Biocidal active substance and product suppliers included on the EU Article 95 List on 31 December 2020 were automatically added to the GB Article 95 List. To remain on the GB Article 95 List suppliers were required to provide relevant information to HSE, including:
• confirmation of being established in the UK (GB & NI)
• resubmission of data dossier or Letter of Access to a relevant data dossier
Suppliers that have met these requirements remain on the Article 95 List and their status has been updated to confirm all transitional status requirements have been met.
Suppliers that have failed to submit the relevant information to HSE, will be removed from the GB Article 95 List on 3 March 2025.
The suppliers due to be removed from the GB Article 95 List can be found on this supplementary list and have over 2700 entries.
Action for GB Article 95 suppliers
GB Article 95 suppliers are advised to check the list of entries pending removal and to also check the GB Article 95 List. If your GB Article 95 entry is on the list pending removal and you do not think it should be, check that you have submitted the relevant information to HSE. If you have submitted the relevant information but have been included on this list, you should contact the HSE as soon as possible.
If you forgot to apply, there is an extended deadline to notify the HSE of intention to submit by 1 November 2024.
Action for GB biocidal product suppliers
Suppliers of biocidal products are advised to check the list of suppliers due for removal to see if your active substance supplier is going to be removed from the GB Article 95 list. If your active substance supplier is going to be removed from the GB Article 95 List:
• check with your supplier that actions are being taken for them to remain on the list
• regularly check the GB Article 95 List to see the status of all suppliers for the active substance you use
• take action to ensure you are using a supplier that will remain on the GB Article 95 list
If your active substance supplier is going to be removed from the list, you will need to change to a compliant active substance supplier or apply to get on the GB Article List yourself. You should do this as soon as possible in order to maintain access to the GB market.
In the event that your active substance supplier is removed from the GB Article 95 List and an alternative source cannot be found, a period of grace of 180 days may be granted for making the product available.
Changing your supplier
If you change your active substance supplier, you may need to inform HSE.
You must apply to HSE:
• to change to your GB BPR product authorisation where there is a change to the manufacturer’s identity or manufacturing location or process
• for an amendment to your COPR approval where there is any change
You do not need to notify HSE:
• under GB BPR, for a change in supplier where there is no change to the manufacturer’s identity or manufacturing location or process, no action is required
• if you supply biocidal products that do not currently require GB BPR authorisation or COPR approval, no further action is required. You should however be able to demonstrate your compliance with GB Article 95 if challenged by enforcement authorities.
If you are unable to access a compliant active substance supplier, or to prepare your own application for the Article 95 List before the 3 March 2025 deadline let the HSE know at gb.biocides@hse.gov.uk
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk