SDS Safety Data Sheets Directive

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)