According to Article 31 (1) of the REACh regulation, a ‘supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II’.
The Safety Data Sheet (SDS) provides a mechanism for transmitting appropriate safety information on substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). Annex II of the REACh regulation provide clear guidelines to compilation of an SDS. Where a Chemical Safety Report (CSR) has been produced, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet.
An SDS is required, in accordance with Articles 31 (1) & (3) when:
- A substance or preparation is classified as dangerous in accordance with 67/548/EEC or 1999/45/EC;
- A substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to the criteria in Annex XIII;
- A substance is included in Annex XIV (the List of Substances Subject to Authorisation) for reasons other than that is classified as dangerous or as PBT or vPvB as above;
- A preparation which is not classified as dangerous but contains ≥1% by weight for non-gaseous preparations and ≥0.2% by volume for gaseous preparations of at least one substance posing human health or environmental hazards;
- A preparation which is not classified as dangerous but contains ≥0.1% of a substance classified as PBT or vPvB;
- A preparation which is not classified as dangerous but contains ≥0.1% of a substance included in Annex 14 (the List of Substances Subject to Authorisation) for reasons other than that is classified as dangerous or as PBT or vPvB;
- A preparation which is not classified as dangerous but includes a substance for which there is a Community Workplace Exposure Limit.
In accordance with Article 31 (6) the SDS should contain:
1. Identification of the substance/preparation and of the company/undertaking
2. Hazards identification
3. Composition/information on ingredients
4. First aid measures
5. fire-fighting measures
6. Accidental release measures
7. Handling and storage
8. Exposure controls/personal protection
9. Physical and chemical properties
10. Stability and reactivity
11. Toxicological information
12. Ecological information
13. Disposal considerations
14. Transport information
15. Regulatory information
16. Other information
What are the differences between a SDS under REACh and a MSDS?
- Headings 2 and 3 swap around;
- Emergency telephone number is required;
- An email contact address in section 1, for competent person(s) able to respond with appropriate advice should be included;
- A SDS should be supplied in an official language of the Member State(s) where the substance or preparation is placed on the market, (unless the Member State(s) concerned indicates otherwise).
In addition, SDSs for substances that have been fully registered under REACh will require:
- Inclusion of registration numbers when available (see also section on confidentiality provisions).
- Exposure scenarios including any risk management measures, where required, to be included in an Annex to the SDS, as an eSDS (extended SDS). The information in the SDS should be consistent with the information in any chemical safety assessment (CSA) for that substance, or a preparation if a CSA for the preparation is available.
When should a SDS be updated?
According to Article 31 (9):
1. As soon as new hazard information or information that may affect the risk management measures becomes available; or
2. Once an authorisation is granted or refused; or
3. Once a restriction has been imposed.
The new dated version of the information, identified as "Revision: date" shall be supplied to all customers (of the substance/preparation in question) of the preceding 12 months.
Who can compile an SDS?
According to Annex II of the REACh Regulation, an SDS can be compiled by a competent person who shall take into account the specific needs of the user audience, as far as it is known’.
The REACH24H Consulting Group can provide the following services:
- Screening of existing SDS
- Preparation of new SDS
- In all languages (English, German, French, other European languages available)
- Preparation of extended SDS (eSDS) after registration (Exposure Scenarios (ES) included in SDS Annex)
- Updating of existing SDS
Note: From 1 December 2010, COMMISSION REGULATION (EU) No 453/2010 amended Regulation (EC) No 1907/2006 (REACh) with regards to SDS compilation. Annex II of Regulation (EC) No 1907/2006 is now replaced with Annex I of COMMISSION REGULATION (EU) No 453/2010.