Medical Devices:
Consultation Open: EU seeks to simplify MDR and IVDR Frameworks
The European Commission has launched a public consultation to explore how to simplify the regulatory frameworks for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), while maintaining high levels of safety and performance.
The consultation focuses on key areas for improvement:
- Reducing bureaucratic burden
- Allowing for more proportionate assessments of low- and medium-risk devices
- Shortening certification timelines
- Aligning EU rules with international standards
Stakeholders are invited to contribute via the call for evidence, which remains open until 6 October 2025.
Cosmetics:
Broader Ban in Cosmetics substances: Adaptation of Regulation (EU) 2025/877
The European Commission has adopted Regulation (EU) 2025/877, which adds 21 new substances to the Annex II of the Cosmetic Products Regulation (EC 1223/2009), the list of prohibited substances in cosmetic products.
Among the newly banned chemicals, TPO might be the (Trimethylbenzoyl diphenylphosphine oxide), widely used as a photoinitiator in UV/LED nail gels. TPO has now been officially classified as a CMR substance (Carcinogenic, Mutagenic or Reprotoxic), and its use in cosmetic formulations is no longer permitted.
The regulation came into effect on 1 September 2025.
Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500877#ntr2-L_202500877EN.000101-E0002
Biocides:
Biocides decisions on union authorizations
The Commission has granted a Union authorization for:
- the single biocidal product CLARMARIN® 350 LD
- the biocidal product family BPF Propan-2-ol Dr Deppe
The Commission has amended a Union authorisation due to administrative changes for:
- the biocidal product family C(M)IT/MIT formulations
For the full list: https://eur-lex.europa.eu/EN/display-feed.rss?myRssId=yePn6pov%2BkgwdPmg2nZXP4dT84n0S2yERVYbeR%2BlQwc%3D#msdynmkt_trackingcontext=7a6736d8-b5b9-40d6-9741-cfc8c5350300
ECHA:
ECHA Committees Advance PFAS Restricion and OEL Discussions
On September 24 2025, ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) progressed their evaluation of the proposed EU-wide restriction on PFAS. RAC also adopted an opinion on the occupational exposure limits of N-(hydroxymethyl)acrylamide (NMA) and eight opinions on harmonized classification and labelling.
RAC and SEAC continued assessing the restriction proposal for per- and polyfluoroalkyl substances (PFAS).
The two committees reached provisional conclusions on specific uses:
- SEAC: Energy and lubricants
- RAC: Electronics and semiconductors
Both committees discussed PFAS manufacturing and addressed horizontal issues, such as:
- Concentration limits
- Hazard assessments
- Environmental risk management
Upcoming PFAS Timeline:
- December 2025:
- SEAC: Electronics and semiconductors
- RAC & SEAC: PFAS manufacturing + horizontal issues
- March 2026:
- RAC: Final discussion and adoption of opinion
- SEAC: Agreement on draft opinion
Occupational Exposure Limit: NMA
RAC adopted its scientific opinion on the occupational exposure limit (OEL) for N-(hydroxymethyl)acrylamide (NMA). Key recommendations include:
- Exposure-risk relationship (ERR) for cancer risk
- 8-hour TWA limit to protect against neurotoxic and reproductive effects
Lastly, RAC adopted eight opinions on harmonised classification and labelling, available in the annex to the meeting summary.
New Restriction Proposal: Octocrilene
Context
On September 24, RAC and SEAC also confirmed that France’s restriction proposal on Octocrilene meets the Annex XV requirements under REACH. The development of opinion has now started, with the launch of a public consultation open until 24 March 2026.
Proposed Restriction
- Scope: Finished cosmetic products as defined by Regulation (EC) No 1223/2009.
- Limit: Products must not contain octocrilene at ≥0.001% w/w.
- Timeline: Entry into force 24 months after adoption.
Consultation Details
The consultation runs until 24 March 2026, with stakeholders encouraged to submit their comments preferably by 23 January 2026, so the RAC and SEAC committees can consider them early during opinion development.
Submissions can include both general and confidential comments and may be submitted more than once during the consultation period. ECHA’s Committees will publish their final joint opinion by autumn 2026, after which the European Commission will decide whether to include the restriction in REACH Annex XVII.
Call for Evidence
ECHA requests stakeholder input on various technical and socio-economic aspects, including:
- Analytical methods for detecting octocrilene in products.
- Hazard data, such as bioaccumulation and toxicity.
- Environmental monitoring
- Market data, including volumes of octocrilene-containing products produced, imported, or exported.
- Reformulation frequency and cost for different types of products.
- Availability and safety of alternatives.
- Enforcement feasibility, such as lab testing capabilities across the EEA.
CLP:
Nel CLP Harmonised Classification Intentions Submitted
Brussels, September 2025
Two new intentions have been submitted under the CLP Regulation for harmonised classification and labelling (CLH):
- Penoxsulam (ISO)
Full chemical name: 2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]pyrimidin-2-yl)-6-(trifluoromethyl)benzene-1-sulfonamide (CAS 219714-96-2)
This substance is an herbicide, and the classification intention could impact its regulatory use in the EU. - Formaldehyde released from the reaction products of paraformaldehyde and benzyl alcohol
(No EC/CAS number assigned yet)
The intention covers formaldehyde-releasing substances, which are often used as preservatives or biocides, raising concerns due to formaldehyde’s known toxicological properties.
These entries mark the start of the formal harmonisation process under the CLP Regulation. Once dossiers are submitted, they will undergo public consultation and evaluation by ECHA’s Risk Assessment Committee (RAC).
