SAFETY DATA SHEETS COME UNDER SCRUTINY BY REACH ENFORCEMENT BODIES

The European Chemicals Agency has recently announced that the first coordinated enforcement project for REACH will focus on pre-registration, registration and safety data sheets for phase-in substances. The key target groups of the project will be manufacturers, importers and Only Representatives of non-European manufacturers.

For companies that import or manufacture chemical substances or preparations, this could mean that you may soon undergo inspection for the quality of your safety data sheets.

REACH and SDS

REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is the new statutory system for controlling chemicals in Europe. REACH adopts some of the older aspects of the chemicals system in Europe, including ‘Safety Data Sheet’ (SDS).

Manufacturers, importers, downstream users and distributors supplying substances or preparations meeting the criteria for classification as dangerous have previously, under the Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP) 2002, been required to compile and supply a Safety Data Sheet (SDS) at the first delivery of a substance or preparation. Since 1 June 2007, REACH has taken over this system, and introduced some changes.

When Do You Need an SDS?

In addition to previous requirements, a Safety Data Sheet is also required in the following circumstances after the inclusion of a substance on the new REACH Candidate List first published on 28 October 2008.

• EU and EEA suppliers of a substance have to provide a safety data sheet to their customers when the substance is on the Candidate List.

• EU and EEA suppliers of a preparation not classified as dangerous, according to Directive 1999/45/EC, have to provide the recipients, at their request, with a safety data sheet if the preparation contains at least one substance on the Candidate List and its individual concentration is at least 0.1% (w/w) for non-gaseous preparations and at least 0.2% by volume for gaseous preparations.

There is a similar requirement for a supplier of articles to pass on information relating to safe use of a product, at minimum, the name of a substance, if this substance also appears on the candidate list.

What are the Main Changes under REACH?

REACH has introduced a few changes to the information required in a Safety Data Sheet. The main ones are:

• Headings 2 and 3 swap around;

• 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. 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.

Want to learn more about Safety Data Sheet and how to make them compliant?

Read more about Safety Data Sheets.