According to Article 31 (1) of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation) and
Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation),
the Safety Data Sheet ("SDS") provides a mechanism for transmitting appropriate safety information
on substances and mixtures where:
- A substance or a mixture meets the criteria for classification as hazardous according to CLP; or
- A substance is persistent, bioaccumulative and toxic ("PBT") or very persistent and very bioaccumulative ("vPvB"), according to the criteria given in Annex XIII or REACH; or
- A substance is included in the candidate list for eventual authorisation according to Article 59 (1) of REACH Regulation for any other reasons.
Commission Regulation (EU) 2020/878, amended
Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals ("REACH").
The Annex II of REACH regulation sets the content of the format requirements for chemical SDS in the EU.
The new regulation means that there will be revised requirements for SDSs for the EU market.
The Guidance of compilation of Safety Data Sheets ECHA-20-H-25-EN version 4.0 (December 2020) includes advices, among others, on the provisions regarding:
- Endocrine disrupting properties (various sections)
- The specific concentration limit, the M-factor and the acute toxicity estimate (SDS sections 3.1 and 3.2)
You can check Tox by Design methodology for Safety Data Sheet development, signed by an European Registered Toxicologist expert here.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Tox by Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using this email link to receive a quotation for Safety Data Sheet for chemicals used in your manufacturing lines.