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ZeroPM Regulatory Watch Update April 2025

Commission outlines upcoming revision of REACH at CARACAL meeting

At the meeting of the competent authorities for REACH and CLP (CARACAL) on 3 April, the Commission presented the main elements of the upcoming revision of REACH. The revision will include a legislative proposal modifying the Regulation, and delegated acts modifying the Annexes to the Regulation, to be adopted as part of the Chemicals industry package in October / November 2025. The Chemicals industry package is also expected to provide clarity on policy intentions regarding PFAS.

The Commission presentation indicated that the Chemical Safety Assessment will include PMT/vPvM and endocrine disruptors and that Annexes to REACH will be amended to adapt to the updates to the CLP Regulation. All presentations with further details on the upcoming revision are available on CIRCABC.

Member States back non-renewal of approval of flufenacet

At the meeting of the standing committee of plants, animals, food and feed (SCoPAFF) on 11-12 March 2025, Member States voted in favour of the draft Regulation concerning the non-renewal of the approval of the active substance flufenacet. The draft Regulation highlights the ‘potential for the flufenacet metabolite trifluoroacetic acid (‘TFA’) to contaminate groundwater at levels that significantly exceed the statutory limit of 0.1 μg/l, provided for in the Groundwater Directive’.

During the same meeting, Member States discussed but did not vote on the draft Regulation concerning the non-renewal of the approval of the active substance flutolanil. The Draft Renewal report discussed at the meeting indicates that ‘the lack of knowledge on the level of TFA residues in rotational crops represents a significant uncertainty in the consumer risk assessment and a potential risk for groundwater’ and concludes that the approval of flutolanil should not be renewed.

2025-2027 CoRAP update includes five new suspected PMT/vPvM

The Community rolling action plan (CoRAP) update for the years 2025-2027, published on 25 March, lists 28 substances for evaluation by 8 Member State Competent Authorities, including 13 new substances compared to the previous CoRAP. Among the new substances, five are suspected PMT/vPvM, to be evaluated by Spanish authorities in 2026:

  • A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5- (1,1-dimethylethyl)-4- hydroxyphenyl]propionates
  • A mixture of: a-3-(3-(2Hbenzotriazol-2-yl)-5-tertbutyl-4-hydroxyphenyl)propionyl-?-hydroxypoly(oxyethylene); a-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-?-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4- hydroxyphenyl)propionyloxypoly(oxyethylene)
  • Methyl 3-[3-(2H- benzotriazol-2-yl)-4- hydroxy-5-(2-methyl-2- propanyl)phenyl]propanoate
  • Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert- butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate
  • Di-substituted tert-alkyl 3-[3-(2H-benzotriazol-2-yl)-5-tert-butyl-4- hydroxyphenyl]propanoate

Norway submits classification and labelling (CLH) intentions for two PMT/vPvM

On 25 March, Norway submitted classification and labelling (CLH) intentions for the classification of Dimethylsilanediol (CAS No. 1066-42-8) and 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonic acid (CAS No. 375-73-5) as PMT and vPvM.

Parliament adopts position on the One substance, one assessment package

The European Parliament has adopted in plenary session on 1 April 2025 its amendments on the proposal for a regulation establishing a common data platform on chemicals and other texts of the one substance, one assessment package – which replicate the ENVI Committee reports adopted in February. Following this vote, interinstitutional negotiations will likely start in the coming weeks and may be concluded during the Polish Presidency of the Council.

Cosmetic and pharmaceutical industries challenge UWWTD’s EPR system before CJEU

The Urban Wastewater Treatment Directive, adopted in October 2024, establishes an extended producer responsibility scheme in which producers of pharmaceuticals and cosmetics would contribute a minimum of 80% of the costs of quaternary treatment. Cosmetics Europe and the European Federation of Pharmaceutical Industries and Associations have announced in March 2025 having filed legal actions with the EU General Court to seek clarity on the rationale to include only two sectors in the EPR system bearing alone the costs of quaternary treatment while other sectors contribute to wastewater pollution. Both organisations ask for costs to be fairly distributed across sectors according to the share of pollution they represent.

Upcoming consultation deadlines:

Upcoming consultation deadlines:

  • Deadline to provide feedback to the call for evidence on the European Water Resilience Strategy: 4 March 2025.
  • Deadline to provide feedback to the call for evidence on the evaluation of the Cosmetic Products Regulation: 21 March 2025