Dear members,
MedTech Europe have provided an update below on the latest chemical developments at ECHA. Please note that Ethylene Oxide has been declined as an active substance under the Biocides regulation for PT 2, however use of Ethylene Oxide to sterilise medical devices within the scope of EU MDR means that the use of Ethylene Oxide can continue as a medical device.
Please also note the entries in the chemicals list below, these have previously been added to MedTech Europe’s watchlist as being present in medical devices or IVDs.
Please let Neil know at regulatory@bivda.org.uk if these substances are in your products. We need to follow these substances as there may be action taken in the UK as a result of the actions of the EU.
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To: Chemicals Working Group (IVD & MD)
With this email, we would like to inform you about the latest chemicals developments at ECHA and kindly ask you to indicate if any of the following impacts your company by 16 June.
Please note that the substances highlighted in yellow are the ones already present in the substance tracker (linked at the bottom of this email) – we kindly ask you to pay particular attention to these.
CLP
- Intentions to harmonise classification and labelling – link here:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline (EC 225-716-2, CAS 5026-74-4);
- dioctyltin oxide (EC 212-791-1, CAS 870-08-6);
- m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline (EC 275-662-9-1, CAS 71604-74-5); and
- dichloro(dimethyl)silane (200-901-0, CAS 75-78-5).
- Proposals to harmonise classification and labelling – link here:
- 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (Provisional chemical name) (EC 271-093-5, CAS 68515-50-4);
- dicyclohexyl phthalate (Provisional chemical name) (EC 201-545-9, CAS 84-61-7);
- benzyl butyl phthalate (Provisional chemical name) (EC 201-622-7, CAS 85-68-7);
- [1α(S*),3α]-(α)-cyano-(3-phenoxyphenyl)methyl3-(2,2-dichlor-oethenyl)-2,2-dichlorovinyl)-2,2-dimethyl-cyclopropanecarboxylate αCypermethrin) (Provisional chemical name) (EC -, CAS 67375-30-8);
- diisooctyl phthalate (Provisional chemical name) (EC 248-523-5, CAS 27554-26-3);
- dibutyl phthalate (Provisional chemical name) (EC 201-557-4, CAS 84-74-2);
- 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (Provisional chemical name) (EC 276-158-1, CAS 71888-89-6);
- bis(2-ethylhexyl) phthalate (Provisional chemical name) (EC 204-211-0, CAS 117-81-7);
- fenazaquin (ISO);4-[2-[4-(1,1-dimethylethyl)phenyl]-ethoxy]quinazoline (EC 410-580-0, 120928-09-8);
- Naphthenic acids, zinc salts, basic (EC 282-762-6, CAS 84418-50-8);
- dihexyl phthalate (Provisional chemical name) (EC 201-559-5, CAS 84-75-3);
- tetraconazole (ISO); (+/-) 2-(2,4-dichlorophenyl)-3-(1H-1,2,4-triazole-1-yl)propyl 1,1,2,2-tetrafluoroethyl ether (EC 407-760-6, CAS 112281-77-3);
- Methyl-1H-benzotriazole [1] and its inorganic salts, with the exception of those specified elsewhere in this Annex (Provisional chemical name) (EC -, CAS -);
- Chlormequat chloride (Provisional chemical name) (EC 213-666-4, CAS 999-81-5);
- sulphuryl difluoride (Provisional chemical name) (EC 220-281-5, CAS 2699-79-8); and
- diisohexyl phthalate (Provisional chemical name) (EC 276-090-2, CAS 71850-09-4).
In addition:
- ECHA published a new substance evaluation conclusion for O,O,O-triphenyl phosphorothioate (EC 209-909-9, CAS 597-82-0), evaluated by the Netherlands (link).
- ECHA will host the following events: (1) Workshop to discuss the roadmap to phase out animal testing on 16-17 June 2025. Onside participation is now closed but the workshop can be followed live online on the ECHA website. We will follow the workshop and will report back to members on the discussion/presentations (2) Webinar to learn about a new addition to the ECHA CHEM database: the first set of regulatory process and obligation lists on 23 September 2025 at 11h-13h (Helsinki time).
- ECHA’s scientific officers have compiled a reference list of neurotoxic substances to support the development of new approach methodologies. The list, based on available harmonised classifications, is published in NeuroToxicology and may be used for assay validation.
- The Commission published its decision not approving the active substance ethylene oxide for product-type 2.
