Regulatory Affairs overview: June 2024
Dive into our team's expertise in this Linkedin newsletter on the Biocides and REACH markets.
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Biocides
1. The transition from the SPC editor to SPC in IUCLID is already in place.?
Several issues and problems have been identified so far when migrating, preparing or adapting the SPC files in IUCLID for the different types of submissions. ECHA has published a new document with recommendations on how to correctly use IUCLID for the preparation of your SPC documents in certain situations and reporting the main issues and how to sort them out. If you need assistance on the preparation of SPC files under the new .i6z format, our biocide regulatory managers can assist you.
2. Combined consultations of biocidal active substances candidates for substitution and the applicability of the derogation to the exclusion criteria (BPR Art. 5(2)) are open for the following Active Substance/PT combinations:
In addition, consultations on the Candidate for Substitution criteria for epsilon-Metofluthrin (EC -, CAS 240494-71-7, PT 18, 19) are also open.
Interested parties can submit their justifications for the applicability of the derogation conditions according to BPR Art 5(2) before the 23 July 2024.
3. Extension of Review Programme confirmed
The European Commission has published the delegated regulation extending the duration of the Review Programme from 31 December 2024 to 31 December 2030. It enters into force on 11 June 2024.
The Review Programme is the work programme for examining existing biocidal active substances contained in biocidal products.
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REACH
1. Draft 22nd ATP Published
The European Commission has published the draft 22nd Adaption to Technical Progress (ATP) of Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation). ATPs serve as amendments to the CLP Regulation. The ATP includes amendments to the classification and labelling of substances including:
The 22nd ATP will enter into force on the 20th day following its publication in the Official Journal of the European Union. Its exact publication date is not yet known. Its previous ATP or 21st ATP was published on the 5th of January 2024. It will come into force on the 25th of January 2024 and apply from 1st of September 2025.
2. Scope of Chromium (VI) Restriction Proposal Broadened
The European Commission has amended its original mandate to ECHA to prepare a REACH restriction proposal on chromium (VI) substances. The original request was made in September 2023, and has now been updated by broadening the scope of the restriction proposal to include at least 12 chromium VI substances. The original mandate focused on two entries currently listed on the REACH Authorisation List, namely chromium trioxide (entry 16) and chromic acids (entry 17). The updated mandate now includes the chromium (VI) substances specified in entries 16 to 22 and 28 to 31 of the REACH Authorisation List. ECHA will also consider adding other chromium (VI) substances not listed on the Authorisation List, in particular barium chromate (EC number 233-660-5). By extending the mandate, the Commission aims to reduce potential ‘regrettable substitution’. Important dates in the restriction process are illustrated below.
3. Potential Reform of Chemicals Regulations in the UK
The HSE (Health and Safety Executive) in the UK are exploring the potential reform of its chemicals supply regulations including:
These changes are in line with the government’s Smarter Regulation Programme, with one of the main pillars of the programme being to reform existing regulations to minimise regulatory burden and ensure regulations are both contemporary and forward looking. This reform of assimilated law is facilitated by the Retained EU Law (Revocation and Reform) Act 2023, which introduces powers to enact legislative reform. These powers expire in June 2026, so any changes need to be made by then.
4. Public Consultation on the Alternative Transitional Registrational model
The Department for Environment, Food and Rural Affairs (Defra) is currently consulting on proposals to introduce an ATRm (Alternative Transitional Registration Model) for UK REACH and also on proposals to improve the current UK REACH regime inherited from the EU. The ATRm was devised by Defra following an in-depth analysis of the current UK REACH requirements and aims to reduce costs to businesses transitioning from EU REACH to UK REACH i.e. costs associated with accessing EU hazard data. Some of the ATRm policy proposals to be consulted on are summarised below:
Separate proposals to improve UK REACH involve improving the restrictions process, increasing protections against animal testing, and improving the reporting process to reduce administrative burden. Comments can be submitted until the cessation of the consultation period on the 11th of July 2024.
In need for personalized regulatory advice to meet your specific needs? Whether you need assistance about compliance, product registration or any other regulatory issue, our experts are here to provide support. Contact us or visit our website for more information: