13 Sep August Regulatory Updates
Assessment of substance group published
A new report is now available for Acyl glycinates and sarcosinates.
ECHA submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) in firefighting foams in early 2022.
New proposals and intentions to harmonise classification and labelling.
New intentions have been received for:
- eugenol; 4-allyl-2-methoxyphenol (EC 202-589-1, CAS 97-53-0);
- 2,3-epoxypropyl o-tolyl ether(EC 218-645-3, CAS 2210-79-9); and
- Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene; Reaction products of diphenylamine with nonene, branched (EC -, CAS -).
Two proposals have been submitted for:
- methyl oct-2-ynoate(EC 203-836-6, CAS 111-12-6); and
- dinotefuran (ISO); 1-methyl-2-nitro-3-(tetrahydro-3-furylmethyl)guanidine (EC 605-399-0, CAS 165252-70-0).
Updates on toys regulation.
Two decrees transposing two Commission directives amending Directive 2009/48/EC on the safety of toys have been published in the Italian Official Journal. The amendments concern the ban on the use and labelling of allergenic fragrances in toys.
In particular, the decree transposing Directive 2020/2088/EU replaces the entry on citronellol and adds 61 new allergenic fragrances. In detail, the names of the allergenic fragrances shall be indicated on the toy, on the label, on the packaging and in the instructions attached to the toy, if present and added as such in the toy in concentrations greater than 100 mg/kg of the toy or its components.
Nine proposals to identify new substances of very high concern.
The substances and examples of their uses are:
- 4,4′-sulphonyldiphenol (bisphenol S; BPS) (EC 201-250-5, CAS 80-09-1). The substance is used for the manufacture of pulp, paper and paper products, textile, leather or fur, and chemicals.
- Perfluoroheptanoic acid and its salts (EC -, CAS -). The substances are not registered under REACH.
- Melamine (EC 203-615-4, CAS 108-78-1). The substance is used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
- Isobutyl 4-hydroxybenzoate (EC 224-208-8, CAS 4247-02-3). The substance is used in the manufacture of substances and in coating products, fillers, putties, plasters, modelling clay, and inks and toners.
- Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (EC -, CAS -). The substance is used as a flame retardant and as a plasticiser for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings and adhesives.
- Barium diboron tetraoxide (EC 237-222-4, CAS 13701-59-2). The substance is used in paints and coatings.
- Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine (FC-770) (EC 473-390-7, CAS -). The substance is used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.
- 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA) (EC 201-236-9, CAS 79-94-7). The substance is used as a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, paper and textiles.
- 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene] (EC 253-692-3, CAS 37853-59-1). The substance is not registered under REACH.
Modified recommendations to registrants on how to cover mutagenicity information requirements.
ECHA’s Member State Committee (MSC) agreed to modify the approach for investigating chromosomal aberration under REACH dossier evaluation during its June meeting.
The main changes include:
To fulfil REACH Annex VIII 8.4.2 requirements, an in vitro micronucleus study (OECD Test Guideline 487) is the default test as it allows the mode of action (clastogenicity and/or aneugenicity) to be identified.
If a concern for chromosomal aberration is identified in vitro, a follow-up study combining an in vivo comet assay (OECD Test Guideline 489) and an in vivo micronucleus test (OECD Test Guideline 474) will be needed in most cases.
Recommendations to registrants have been modified to reflect these changes, which have applied since 1 September 2022.
The European Commission has granted an authorisation for the use of sodium chromate (EC 231-889-5, CAS 7775-11-3) to Ariston Thermo SpA with a review period expiry date on 26 August 2033.
Have your say: EFSA and ECHA guidance on the impact of water treatment processes on active substance residues in drinking water.
ECHA has collaborated with the European Food Safety Authority (EFSA) to launch a consultation on a draft guidance on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water.
The deadline for comments is 27 October 2022.
New report on European arthropods and their role in pollination
A report has been published describing the biodiversity and the ecology of four insect orders: Diptera, Lepidoptera, Coleoptera and Hymenoptera, covering the majority of flower visiting insects. The report focuses on the sensitivity of these organisms to biocidal products.
Publication of the updated version of the Guideline “SAFETY DATA SHEETS” – Part 4.
How to evaluate the (e)SDS and decide the subsequent actions” and the “Tool to verify compliance with exhibition scenarios” in the light of the changes that REACH has made in recent years to the format and content of the Safety Data Sheets and following the changes introduced by the latest revision of the ECHA Guidelines on descriptors.