The requirement to be GHS compliant have all MSDS converted to SDS by June 1, 2015 is a regulation not just applicable to the U.S; it is a worldwide regulation. What many people don’t realize is that different countries and regulation agencies may have slightly different requirements or exceptions to regulations that still comply with GHS mandates.
When it comes to creating SDSs for the European Union (EU), the European Chemicals Agency (ECHA) has a “Guidance on the compilation of safety data sheets” document that details what is and what is not required. Thankfully, we’ve compiled some of the information for you so that you don’t have to read the whole document yourself.
In addition to the general exemptions to the regulations to supply SDSs that are listed in Article 2, the following mixtures in the final state intended for the final user also do not require SDSs (for the definitions of each of these mixtures, please refer to their associated regulatory directives):
- medicinal products for human or veterinary use
- cosmetic products
- medical devices that are invasive or used in direct physical contact with the human body
- food or feeding stuffs, such as food additives, flavorings, additives to animal feedstuffs, and animal nutrition
There are some mixtures that may not require an SDS, but if the recipient requests one the supplier must create and provide an SDS for said mixture. Until June 1, 2015, an SDS must be provided if requested for mixtures that do not meet the criteria for classification as dangerous but contains one of the following:
- at least one substance prosing human health or environmental hazards in an individual concentration of ≥ 1% by weight for non-gaseous mixtures and ≥ 0,2% by volume for gaseous mixtures
- at least one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative, in an individual concentration of ≥ 0,1% by weight for non-gaseous mixtures
- at least one substance for which there are community workplace exposure limits
Starting June 1, 2015, mixtures that do not meet the criteria for classification as hazardous but contains one of the following need to have an SDS upon request in the EU:
- At least one substance posing human health or environmental hazards in an individual concentration of ≥ 1% by weight for non-gaseous mixtures and ≥ 0,2% by volume for gaseous mixtures
- At least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), in an individual concentration of ≥ 0,1% by weight for non-gaseous mixtures
- At least a substance for which there are community workplace exposure limits
Additionally, ECHA specifically details how to display version information on SDSs when changes are made. In EU SDSs, the date of when the revision was made should be made on the first page and information on the changes must be listed in Section 16 of the SDS, unless they have been indicated elsewhere. In that case, the first page should also include the SDS version number, revision number, and what version has been replaced.
For more detailed information on the ECHA SDS requirements for the EU, please refer to their handy guidance document.
