SDS: what are my obligations?
What is an SDS?
The Safety Data Sheet, or SDS, is a 16-section document that provides:
- Explanations of the health risks related to the exposure or use of hazardous products,
- All information on the handling, use or storage of the products.
Nota Bene: the SDS must be provided in the language of the country of use of the product.
EcoMundo provides you with step-by-step instructions on how to comply with your REACH obligations related to SDSs.
SDS obligations for suppliers
Article 31 of the REACH Regulation specifies that "a safety data sheet shall be provided free of charge in paper or electronic form no later than the date on which the substance or mixture is first supplied".
As a supplier (formulators, manufacturers, importers), you are required to provide a Safety Data Sheet:
- When substances meeting the criteria of dangerous substances classification according to CLP or mixtures meeting the criteria for classification of dangerous mixtures according to Directive 1999/45/EC are included in the product you supply.
- When the product you supply contains PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative) substances - Annex XII.
- When the product you supply contains substances included in the candidate list for authorisation - Article 59 §1 REACH.
The supplier must carry out these steps spontaneously. However, the recipient may request an SDS when the preparation does not meet the criteria for classification as a dangerous preparation (Articles 5,6,7 Directive 1999/45/EC), but nevertheless contains certain substances in specific concentrations (threshold defined in Article 31§3 REACH).
Finally, the Safety Data Sheet must be updated without delay by the supplier:
- As soon as new information that may affect risk management measures or new information on hazards becomes available.
- Once an authorisation has been granted or refused.
- Once a restriction has been imposed.
The specific obligations of downstream users and distributors
Stakeholders must carry out a chemical safety assessment of the substance. During the assessment, you must also ensure that the information in the Safety Data Sheet is consistent with the assessment.
At your request, the supplier must provide you with an SDS for dangerous substances or preparations intended for sale to the public. Nonetheless, if the product information enables users to take all safety, health and environmental measures, you are not obliged to request it.
The supply chain actors concerned must attach a Safety Data Sheet with exposure scenarios as an annex (Annex XI, section 3 of REACH).
The downstream user or distributor who prepares an SDS for specific uses must use the SDS initially provided and the exposure scenarios (Article 37(2)).
SDS Factory is a software solution that allows you to simplify and automate the creation, translation, updating management and distribution of your SDSs.
Formal obligations
The drafting of a Safety Data Sheet is highly regulated. It comprises 16 mandatory headings.
1. Identification of the substance/mixture and company/undertaking
- In the case of a substance, you must indicate the chemical name as well as the identification number (EC No. or CAS No. or INDEX No...) or the REACH registration number.
- In the case of a mixture, you must mention the name or commercial designation.
- In section 1.2, you should mention the relevant identified uses of the substance or mixture and the uses advised against.
- In section 1.3 you must state the identity of the manufacturer, importer, exclusive representative or distributor, attaching their full contact details as well as their telephone number and e-mail address.
- In section 1.4 you must enter the emergency call numbers.
In concrete terms, you must check that the information complies with the label and that the registration number is complete (ask your supplier for it).
Points of attention:
- In the case of registered substances, do not hesitate to look in the appendix if there is an exposure scenario. You will then have to comply within 12 months (operational and risk management mentioned).
- In section 1.2, remember to check that your use is listed in the field of use and in special cases (inconsistent exposure scenario, intermediate substances under strictly controlled conditions), contact your supplier.
- For sections 1.3 and 1.4, you must ensure that the information is present, in accordance with the label, and that the emergency call numbers are up to date.
2. Hazard identification
- In section 2.1 the classification of the substance or mixture must be defined according to the CLP Regulation.
- Section 2.2 should indicate the labelling elements of the substance/mixture that will also appear on the product label:
- Danger pictogram
- Disclaimer
- Danger statement
- Cautionary advice
- Additional labelling elements
- Section 2.3 indicates the information applicable to substances / mixtures that do not lead to a classification such as: very strong sense of smell and taste sensitisation, photochemical ozone creation potential, etc. The SVHC list (substances of very high concern), PBT (persistent, bioaccumulative, toxic), vPvB substances must also be specified.
3. Composition and information on ingredients
- In section 3.1 relating to substances, you must indicate the chemical name of the main component of the substance as well as its other constituents and, finally, the identification information (EC n°, CAS n°...).
- Mixtures are listed in section 3.2 and information on the hazardous components of the mixture must be given.
4. First Aid
You must indicate the measures to be followed in the event of inhalation, skin contact, eye contact, ingestion etc., and specify whether the intervention of a doctor is desirable or indispensable.
5. Fire-fighting measures
You must specify the means of extinguishing the fire by specifying the procedure to be followed and the dangers of using an inappropriate means.
6. Measures in case of accidental release
You must inform about the methods of cleaning and the precautions to be taken.
7. Handling and storage
In sections 7.1 to 7.3 complete the technical preventive measures (health protection, safety management, environmental protection) established according to the properties of the product and the exposures.
8. Personal exposure controls
- In section 8.1 is related to control parameters, so you should mention the National Occupational Exposure Limit Values (OELVs), Derived No-Effect Levels (DNELs), Derived Minimum Effect Levels (DNELs) and Predictable No-Effect Concentrations (PNECs) indicated if they exist.
- Section 8.2 contains all measures relating to collective, individual and environmental protection as well as technical measures for the prevention of exposure for man and the environment.
9. Physical and chemical properties
In this section, you must indicate additional physical and/or chemical properties..
10. Stability and reactivity
This section should show the conditions and materials to be avoided and the hazardous decomposition products.
11. Toxicological information
You must list the toxicological indications of the product. Specifically, you must indicate the adverse health effects according to the different routes of exposure (inhalation, ingestion, projection, etc.).
12. Ecological information
Here, you must specify the ecotoxicity of the product as well as its mobility, persistence and degradability.
13. Disposal considerations
In section 13, you must determine the methods for safe disposal of the contaminated product or packaging.
14. Transport information
The UN number, class, marine pollutant, shipping name, etc. must appear here.
15. Regulatory information
- This section should contain European and national regulations. You must indicate the table of occupational diseases, reinforced medical surveillance, etc., for products placed on the market in France.
- In addition, if the chemical safety assessment has been made this must be indicated in this Section 15.2.
In concrete terms, you must check whether the substance or mixture is subject to specific provisions and comply with the regulatory provisions. If there is a chemical safety assessment, you must look for an exposure scenario.
16. Other information
Information to be completed: in this section you must mention information on any changes compared to previous versions as well as the CLP classification for classified mixtures. If this is not mentioned in the previous headings you must define the meaning of the abbreviations and acronyms used. Finally, you can add the list of exposure scenarios that you attach in the appendix and give advice for the protection of human health and the environment.
