Updates Required for EU SDSs and Labels

In the context of the CLP, a Safety Data Sheet may require an update when a substance or mixture has been classified, labeled and packaged according to CLP (which had previously been classified according to DSD/DPD), new knowledge on hazards becomes available, or substances or mixtures which were not classified under the DSD and DPD are now classified as hazardous or contain one or more component substances classified as hazardous for health or environmental effects above the specified threshold of greater than or equal to 1% by weight for non-gaseous mixtures and greater than or equal to 0.2% by volume for gaseous mixtures.

As for labels, suppliers must label and package their substances and mixtures in accordance with the provisions of the CLP Regulation before they are placed on the EU market. Earlier this month, ECHA issued a guidance document on the labeling and packaging requirements set out in the CLP Regulation, specifically on:

– What aspects to consider when estimating the label size needed,
– What types of supplemental information are possible, and where to place this information
on the label
– The conditions for small packaging exemptions
– The interaction between CLP and the transport labeling rules, and
– How to select the most appropriate set of precautionary statements for the label
Questions on your SDSs and labels? Contact SDSpro Regulatory Services today for assistance with your compliance requirements.

Louisa Mayers
(888) 673-7776


Borrowing a well-known saying from American author and professor of biochemistry Isaac Asimov, “the only constant is change, continuing change, inevitable change that is the dominant factor” in determining whether a manufacturer SDS is compliant with the chemical regulations for a given country. Through the SDScompliance Services program, all SDSs and labels authored by SDSpro Regulatory Services are reviewed annually at the SUBSTANCE level to ensure compliance with new regulations, new classifications and specific country requirements.

Labeling and Safety Data Sheets

Prior to shipping substances or mixtures to the European Union, a supplier/chemical manufacturer must label its products in accordance with CLP rules. The supplier must also provide Safety Data Sheets (SDSs) to its industrial customers whenever hazardous substances and mixtures are involved. SDSs are required for substances assessed to be PBTs (Persistent, Bioaccumulative and Toxic) or vPvBs (very Persistent and very Bioaccumulative), for substances included in the candidate list for potential inclusion in Annex XIV of the REACH Regulation, as well as for mixtures containing any of these substances.

According to CLP rules, a substance or mixture contained in packaging should be labeled
• When the substance is classified as hazardous, or
• When the mixture contains one or more substances classified as hazardous above a certain threshold.

The CLP Regulation defines the content of the label and the way the various labeling elements should be organized. LEARN MORE