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Labelling vs Safety Data Sheet
Once the hazardous properties of a substance or mixture have been identified, they need to be classified accordingly.
Manufacturers, importers, downstream users and distributors, as well as producers and importers of certain specific articles, must communicate the identified hazards to the other actors in the supply chain, including to consumers.
This is done by labelling the substance or mixture in accordance with CLP before placing it on the market, when:
- The substance or mixture is classified as hazardous.
- The mixture contains one or more substances classified as hazardous above a certain threshold.
- The article has explosive properties.
CLP defines the content of the label and the organisation of the various label elements. The label should be firmly attached to one or more of the packaging’s surfaces and has to include the following:
- The name, address and telephone number of the supplier
- The nominal quantity of a substance or mixture in packages made available to the general public (unless this quantity is specified elsewhere on the package)
- Product identifiers
- Where applicable, hazard pictograms, signal words, hazard statements, precautionary statements and supplemental information required by other legislation.
Evaluating Hazard Classification
You need to decide
If your evaluation of the mixture shows that the hazards associated with it meet the criteria for classification in one or more hazard classes, categories, or differentiations, you will need to decide on the appropriate physical, health, or environmental hazard class, category, or differentiation.
Corresponding Labelling Elements
After making this decision, you must check which labelling elements correspond to the hazard classifications. The tables in Parts 2 to 5 in Annex I to CLP relate the criteria of each hazard class and category/division with the appropriate classification and labelling elements. Remember to check if a statement, signal word, or a pictogram overrules another one. Chapters 3 to 6 of the Guidance on labeling and packaging explain the precedence rules for these label elements.
Hazard Information for Labeling
When you have decided on the classification, you will need to consider what hazard information to give on the label. The label needs to include the following information:
- Supplier details
- Product identifier
- Nominal quantity
- Hazardous components
- Hazard pictograms
- The signal word
- Hazard statements
- Precautionary statements (usually not more than six unless they are necessary to reflect the nature and the severity of the hazards)
- Supplemental information where relevant.
Regulatory Obligations
Article 13 of the CLP Regulation outlines the responsibility to classify and designate fitting hazard statements.
Hazard statements
In principle, the label of a product must include all the relevant hazard statements. However, if a substance or mixture is classified within several hazard classes or differentiations of a hazard class, all hazard statements resulting from the classification must appear on the label, unless there is evident duplication or redundancy. This is illustrated in an example in Section 4.1.6 of the Guidance on the application of CLP criteria.
Annex III to CLP provides the proper wordings for hazard statements on the label in all languages. You can search for each statement in all EU languages in the Multilingual Chemical Terminology database (ECHA-term).
In addition, there are special rules that concern the labelling of certain mixtures with particular properties. The specific hazards addressed by these rules are indicated on the label using the supplemental EUH-statements. These properties and rules are outlined in Annex II to the CLP Regulation. For example, the presence of lead in a mixture triggers labelling with EUH201 and the possibility that toxic gas might be liberated in contact with water triggers labelling with EUH029. Be careful to identify all relevant EUH-statements, as these are obligatory supplemental information. Even if a mixture is not classified as hazardous, the product may still need to be labelled in accordance with Annex II to CLP, as in the case of sensitising substances (EUH208) or a safety data sheet being available on request (EUH210).
Precautionary statements
Product labels must bear the relevant precautionary statements giving advice on how to prevent or minimise the adverse effects to human health or the environment arising from the hazards of a substance or mixture. Choose precautionary statements by considering the employed hazard statements. Avoid duplications and redundancies when specifying product uses and basic instructions in tables 6.1 to 6.5 of Annex IV to the CLP Regulation.
When providing a substance to the public, include disposal instructions for both the product and packaging. Labels need clarity, containing six precautions; if hazards require, add more precautions for comprehensiveness.
Information and advice on the selection of the most appropriate precautionary statements is provided in Chapter 7 of the Guidance on labelling and packaging.
The correct wordings of the precautionary statements as they must appear on the label are listed in all languages in Annex III to CLP. You can search for each statement in all EU languages in the Multilingual Chemical Terminology database (ECHA-term).
Correct SDS Labelling
For additional guidance, refer to examples in the labelling and packaging instructions provided for proper labeling. For information on the size of the label and the label elements, see Chapter 5.2 of the Guidance.
Safety data sheet
A safety data sheet (SDS) must be provided with mixtures classified as hazardous and also at the recipient’s request when the mixture contains hazardous substances above certain concentration levels.
When reclassifying a mixture, you need to update the safety data sheet to reflect the new CLP-compliant classification and labelling of your mixture. Is there a substantial change? You must provide the new version of the SDS to your customers. The changes must be outlined in the SDS, maintaining clarity and conciseness.
The Guidance for creating SDS provides detailed advice for preparing a quality safety data sheet.
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