Dear members, please find below MedTech Europe Chemicals Working group update, if any of these topics impact you, please let me know at regulatory@bivda.org.uk
To: Chemicals Working Group (IVD & MD)
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 18 June.
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
- Intention to harmonise classification and labelling – link here:
- Silver chloride (provisional chemical name) (EC 232-033-3, CAS 7783-90-6).
- Proposals to harmonise classification and labelling – link here:
- diclofop-methyl (ISO); methyl 2-(4-(2,4-dichlorophenoxy)phenoxy)propionate; methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate (EC 257-141-8, CAS 51338-27-3);
- 2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (EC 260-829-0, CAS 57583-35-4);
- [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); and
- Sodium fluoride (EC 231-667-8, CAS 7681-49-4).
In addition:
- ECHA updated its report on Key Areas of Regulatory Challenge with new topics in line with the European Union’s Competitiveness Compass and the Clean Industrial Deal.
The report introduces new topics to reflect ECHA’s growing responsibilities. It also covers emerging topics in waste and recycling that aim to support circularity and enhance Europe’s industrial competitiveness.
For example, more specific research is needed on:
- chemical emissions and exposure from the waste stage of materials to help create more accurate emission estimates to avoid potentially over-conservative regulatory measures;
- recycled non-fossil fuel resources, to improve our understanding of their hazards and support EU policies that aim to reduce pollution and promote sustainable growth; and
- the valuing of environmental impacts to assess the effectiveness and proportionality of chemicals regulation and specific regulatory actions under, for example, REACH and the Batteries Regulation.
- In the context of Biocides, ECHA updated (1) the list of substance-product-type combinations that can be used in treated articles, (2) Article 95 list of active substance and product suppliers and (3) the list of substance and product-type combinations for which a compliant notification for inclusion in the Review Programme has been made.