Dear members, please see below MedTech Europe Update, another busy week with the items below highlighted as having previously been identified as potentially used by the MD/IVD sectors. Let me know at regulatory@bivda.org.uk if any of the highlighted items are in your products.
Dear members,
We hope you are all well.
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 2 July.
Please note that the substances highlighted in yellow are the ones already present in the substance tracker – the latter is linked at the bottom of this email.
CLP
- Consultation on harmonized classification and labelling (feedback by 22 August) – link here:
- propyl 4-hydroxybenzoate (EC 202-307-7, CAS 94-13-3).
- Intentions to harmonise classification and labelling – link here:
- vanadium tetrachloride [1] vanadium trichloride oxide [2] ammonium trioxovanadate [3] sodium metavanadate [4] potassium vanadium trioxide [5] Vanadate(1-), oxo[phosphato(3-)-kO]-, hydrogen, hydrate (2:1) [6] (EC -, CAS -);
- 5,5′-sulfonyldi(2-benzofuran-1,3-dione) (EC -, CAS 2540-99-0);
- benzophenone-3,3′,4,4′-tetracarboxylic dianhydride (EC 219-348-1, CAS 2421-28-5);
- 4,4′-biphthalic dianhydride; [5,5′-bi-2-benzofuran]-1,1′,3,3′-tetrone (EC 219-342-9, CAS 2420-87-3);
- 4,4′-oxydiphthalic anhydride (EC 412-830-4, CAS 1823-59-2);
- 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt [1] 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo-[d,g][1,3,2]dioxaphosphocin 6-oxide, lithium salt [2] hydroxy aluminium bis(2,4,8,10-tetra-tert-butyl-6-hydroxy-12H-dibenzo[d,g][1.3.2]dioxaphosphocin-6-oxide) [3] 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide [4] (EC -, CAS -); and
- Tetrabromophthalic anhydride (EC 211-185-4, CAS 632-79-1).
- Proposals to harmonise classification and labelling – link here:
- tris[2-chloro-1-(chloromethyl)ethyl] phosphate (provisional chemical name) (EC 237-159-2, CAS 13674-87-8); and
- reaction products of phosphoryl trichloride and methyloxirane [1] tris(2-chloro-1-methylethyl) phosphate [2] bis(2-chloro-1-methylethyl) 2-chloropropyl phosphate [3] bis(2-chloropropyl) 2-chloro-1-methylethyl phosphate [4] tris(2-chloropropyl) phosphate [5] any individual stereoisomer of the substances listed above and any combination thereof [6] (EC – [1]; 237-158-7 [2]; – [3]; – [4]; 228-150-4 [5]; – [6], CAS 1244733-77-4 [1]; 13674-84-5 [2]; 76025-08-6 [3]; 76649-15-5 [4]; 6145-73-9 [5]; – [6]).
In addition:
- Three new hazardous chemicals have been added to the Candidate List of substances of very high concern (SVHC):
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- 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane (EC 241-867-7; CAS 17928-28-8)
- Decamethyltetrasiloxane (EC 205-491-7; CAS 141-62-8)
- Tetra(sodium/potassium) 7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chloro-6-({2-[(4-fluoro-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazine-2-yl)amino]propyl}amino)-1,3,5-triazine-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalenetrisulfonate; Reactive Brown 51 (EC 466-490-7; CAS -)
- ECHA published the regulatory needs assessments for the following substance groups:
- ECHA’s Enforcement Forum has updated its compendium of analytical methods to help authorities to enforce and companies to comply with REACH restrictions. The compendium consists of a collection of methods that are used, for example, in official laboratories supporting EU enforcement authorities. In the future, it will be updated and expanded more frequently. The compendium contributes to harmonised enforcement of REACH throughout the EU.
