HSE have published their latest bulletins:
REACH
- EU active substance non-approval decision
Non-approval of an active substance/product type combination not included in the review programme
Following the evaluation of the application for approval under the EU BPR, a decision has been taken not to approve the following active substance/product type combination. This will affect NI.
Impact on biocidal products and treated articles
This active substance was not part of the EU Review Programme which means that there should not be any biocidal products containing it on the NI market at this time.
Biocidal products containing this active substance in the relevant product type can only be supplied and used in NI once the active substance is approved and the specific biocidal product is authorised under EU BPR.
Phase-out periods for the removal of biocidal products from the NI market are not applicable in these circumstances.
Treated articles containing this active substance in the relevant product type cannot be placed on the market in NI at this time. Treated articles containing this active substance in the relevant product type can only be placed on the market in NI once the active substance is approved under the EU BPR.
If you are aware of any disproportionate negative impacts that are likely to arise from the non-approval of the active substance/product type combination listed above, please contact us.
- Changes to Annexes II and III of GB Biocidal Products Regulation
Regulations updating the data requirements for active substances and biocidal products have been laid in Parliament
The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024, which update the data requirements in Annexes II and III of GB BPR, were laid in Parliament on 13 March 2024.
These Regulations are due to come into force on 6 April 2024, subject to successful completion of Parliamentary processes.
An 8-week public consultation on the proposed changes was carried out between 17 January and 14 March 2023. A report on the outcome of the consultation is available on our website.
This legislation updates some of the data requirements to reflect developments in science and technology. These include the use of alternative testing approaches to determine some hazardous properties which previously relied on animal testing.
The new data requirements will apply to applications received 18 months after the legislation came into force (6 October 2025) and will not be applied to existing applications. Further guidance on these changes will be provided on the HSE website in due course. If you have any queries, please contact us.
CLP
- Publication of GB mandatory classification and labelling (GB MCL) technical reports
A GB MCL technical report is an independent scientific evaluation of the information submitted under the stand-alone GB MCL process or as part of the EU harmonised classification and labelling process.
It sets out whether there is adequate scientific evidence to support a new or revised GB MCL of a substance and what that GB MCL should be.
The next batch of GB MCL technical reports is now available for download at the end of the GB MCL publication table (.xlsx).
These GB MCL technical reports relate to substances for which the Committee for Risk Assessment (RAC) published a RAC Opinion under Article 37(4) of EU CLP during 2023, based on information submitted under the EU CLP Regulation. The scientific information supporting the RAC Opinion is evaluated under the GB MCL system.
At the time of publication, the classification and labelling proposed in these technical reports has not been agreed and/or adopted in Great Britain.
For information on the next steps in the process, please see our webpage on the GB MCL system.
We expect to publish our next batch of technical reports in late March 2024. CLP ebulletin alerts will be issued when technical reports are published on the HSE website. If you have any questions or feedback on the GB MCL technical reports, please contact us at: GBCLP.GBMCL@hse.gov.uk
Journalists should contact HSE’s press office for further information.
- ECHA public consultation: call for comments (Deadline: 10 May 2024)
The Great Britain Mandatory Classification and Labelling (GB MCL) process includes the consideration of information gathered from public consultations, conducted by HSE or international bodies such as the European Chemicals Agency (ECHA).
ECHA has announced a public consultation on the following proposal for harmonised classification and labelling (CLH):
- 2,2′-iminodiethanol; diethanolamine (EC: 203-868-0; CAS: 111-42-2). Chemical registered under REACH. Health hazard classes open for commenting.
View the consultation on the ECHA website.
UK-based businesses with an interest in the proposal are strongly encouraged to share any relevant information.
Scientific and technical information should be submitted directly to ECHA using their commenting webform by 10 May 2024. Comments will be published on ECHA’s website.
If your business is affected by the GB CLP Regulation, please also consider if you are likely to be affected by the classification and labelling proposal and let us know at an early stage if you anticipate any significant impacts or benefits. Information on wider policy and impact considerations can be submitted to HSE at GBCLP.GBMCL@hse.gov.uk. Under the GB CLP Regulation, HSE will consider all published opinions of the Committee of Risk Assessment of ECHA (RAC) before publishing its own Agency Technical Reports and Agency Opinions, so any information you provide will be important in any final GB MCL decision. More information on the new GB MCL system is available on the HSE website.
REACH
- Consultations on testing proposals under Article 40(2) of UK REACH (deadline: 2 May 2024)
HSE has received testing proposals to undertake testing in vertebrates to consider and evaluate.
Article 40(2) of the UK REACH Regulation requires HSE to invite third parties to submit scientifically valid information and studies that are relevant to the hazard endpoints for which vertebrate testing is proposed. These submissions will be considered and evaluated alongside the proposals submitted by the registrants.
Any interested third parties are invited to provide such information and studies that address the substances and hazard endpoints below. Information can be submitted by any member of the public or interested party.
Consultation details for the endpoints for which testing is proposed can be viewed by following the links below:
- Reaction product of propylidynetrimethanol, propoxylated, reaction products with ammonia and 2,2-Dimethyl-3-(4-morpholinyl)propanal
CAS: 1379822-00-0 and EC: 700-879-7
Repeated dose toxicity (sub-chronic 90 day)
Reproductive toxicity (pre-natal developmental toxicity)
- N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine
CAS: 1217271-02-7 and EC: 700-584-3
Repeated dose toxicity (sub-chronic 90 day)
Reproductive toxicity (pre-natal developmental toxicity)
Scientific and technical information relevant to the hazard endpoints should be submitted directly to HSE using the commenting webform and templates by 2 May 2024.
- Reaction product of propylidynetrimethanol, propoxylated, reaction products with ammonia and 2,2-Dimethyl-3-(4-morpholinyl)propanal
