Dear Members, please see below update from MedTech Europe, let me know at regulatory@bivda.org.uk if any of these impact you. Items highlighted have previously been flagged as chemicals in use by the MD/IVD sector.
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 3 September.
Please note that the substances highlighted in yellow are the ones already present in the substance tracker
REACH
- Intention to restrict the manufacture, placing on the market and use of 1,4-dioxane in surfactants withdrawn.
- Call for evidence: screening report on RP-HP (open until 8 October 2025)
ECHA is looking for comments on a draft screening report, and for relevant information on reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) in products (articles).
- New substance evaluation conclusions published:
- Oxybenzone (EC 205-031-5, CAS 131-57-7), evaluated by Denmark.
- 4,4′-isopropylidenedi-2,6-xylol (EC 227-033-5, CAS 5613-46-7), evaluated by Denmark.
- Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate (EC 257-573-7, CAS 51981-21-6), evaluated by France.
CLP
- Consultations on harmonised classification and labelling (open until 24 October 2025)
- 3-aminopropyldiethylamine; N,N-diethyl-1,3-diaminopropane (EC 203-236-4, CAS 104-78-9)
- 3-aminopropyldimethylamine; N,N-dimethyl-1,3-diaminopropane (EC 203-680-9, CAS 109-55-7)
- Reaction products of boric acid with didecylamine and ethylene oxide (EC -, CAS -)
- New proposals to harmonise classification and labelling
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride (name to be confirmed) (EC -, CAS 1961312-55-9)
- Aqueous ethanol extract from wood of Vitis vinifera (Vitaceae) (name, EC and CAS to be confirmed)
