Chemical compliance… what’s happening?

What’s happening with regard to chemical regulations internationally? Here are some updates we’ve prepared for you for May 2022.

Don’t miss deadline for Safety Data Sheet updates

5 May 2022

The requirements for Safety Data Sheets (SDS) are changing for the EU market. The European Commission has amended Annex II of REACH, which describes what information should be included in each of the 16 sections of the SDS (Regulation (EU) 2020/878). The new regulation also adopted changes resulting from the 6^th and 7^th revisions of the Globally Harmonised System (GHS).

To supply chemicals in the EU, you should make sure that your SDS conforms with the new standard by the end of 2022.

The changes, which have both major and minor impact on SDS content, include expanded information required on:

nanoforms (section 1)
endocrine disrupting properties (sections 2, 3, 11 and 12)
physical and chemical properties (section 9), and
transportation (section 14)

Specific concentration limit, acute toxicity estimate (ATE) and M-factor should now be included (section 3), as well as lower concentration limits for certain substances, for example those classified as respiratory sensitisers and skin sensitisers.

ECHA has updated its Guidance document to reflect these changes.

Only about eight months of the transition period remain, so now is the time to review and decide on your SDS updates. Meet our HazCom team and get in contact for help.

Five more substances subject to REACH authorisation

The European Commission has added five substances to the REACH Authorisation List (Regulation (EU) 2022/586).

These are substances of very high concern due to their reprotoxic, carcinogenic or endocrine disrupting properties and are used, for example, as fuel additives, in the formulation of inks, in lubricants, and as a stabiliser in the production of polymers. The five substances are:

Tetraethyllead (EC 201-075-4, CAS 78-00-2);
4,4′-bis(dimethylamino)-4″-(methylamino)trityl alcohol (with ≥ 0,1 % of Michler’s ketone (EC No 202-027-5) or Michler’s base (EC No 202-959-2)) (EC 209-218-2; CAS 561-41-1)
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) (with ≥ 0,1 % w/w 4-heptylphenol, branched and linear) (EC -, CAS -)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC 239-622-4, CAS 15571-58-1); and
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) (EC -, CAS -).

Companies that wish to continue using any of these substances after their ‘sunset date’ of 1 May 2025 need to apply for authorisation before 1 November 2023 and get a positive authorisation decision by the European Commission.

Major pharmaceutical companies provide unpublished data on chemical substances

Previously unpublished data on chemicals tested as part of developing medicines is now publicly available. So far, four companies – Roche, Johnson & Johnson, Merck and Boehringer Ingelheim – have provided data in IUCLID format, the global format for collecting, storing and sharing information on chemicals.

The dataset contains information on the hazard properties of 19 substances from 153 studies which can contribute, among other purposes, to the development of predictive computational testing models. The data is downloadable from the IUCLID-ECHA website.

The Industry Data Contribution project is led by the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the biopharmaceutical industry operating in Europe.