Frequently Asked Questions
What is the format for the safety data sheet?
Safety data sheets must be provided in an official language of the Member State where the chemical is placed on the market. The information contained in the SDS should be understandable and concise and should be specific to the chemical and not generic. They must be prepared in accordance with Annex I of Regulation (EC) No. 453/2010 (revision of Annex II of the REACH Regulation) and must contain the following 16 headings:
- Identification of the substance/mixture and of the company/undertaking
- Hazards identification
- Composition/information on ingredients
- First-aid measures
- Fire-fighting measures
- Accidental release measures
- Handling and storage
- Exposure controls/personal protection
- Physical and chemical properties
- Stability and reactivity
- Toxicological information
- Ecological information
- Disposal considerations
- Transport information
- Regulatory information
- Other information
The date of issue/revision date must be given on the first page of the SDS. All pages should be numbered.
Any supplier who is required to prepare a Chemical Safety Report must attach the relevant Exposure Scenario, if required, in an Annex to the safety data sheet.
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Who should prepare a safety data sheet?
The safety data sheet must be prepared by a competent person with the necessary and relevant knowledge, experience and training. The e-mail address of this competent person must be given in section 1 of the safety data sheet.
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Who must provide a safety data sheet?
A supplier of a substance or mixture (preparation) must provide a SDS if the:
- Substance supplied is classified as hazardous according to Regulation (EC) No. 1272/2008 (CLP) or mixture supplied is classified as dangerous according to Directive 1999/45/EC (CPL)
- Substance is persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) to the environment in accordance with the criteria set out in Annex XIII to REACH
- Substance is on Candidate List of substances of very high concern (SVHC) for reasons other than those above
A supplier must provide a SDS at a recipient’s request where a mixture does not meet the criteria of dangerous according to Directive 1999/45/EC or hazardous according to CLP regulation but contains a substance which:
- Poses human health or environmental hazard (in an individual concentration of ≥1% w/w for non-gaseous mixtures and ≥0.2% w/v for gaseous mixtures) or
- Is a PBT or vPvB (in an individual concentration of ≥0.1% w/w for non-gaseous mixtures) or
- Is on Candidate List of SVHC (in an individual concentration of ≥0.1% w/w for non-gaseous mixtures) or
- Has been assigned a Community occupational exposure limit value (OELV)
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When should a safety data sheet be provided?
Safety data sheets must be provided free of charge on paper or electronically no later than at the time of the first delivery of the chemical in question. A SDS should not be received any later than the product itself. However, it may be sent separately, for example via post, fax or e-mail.
An updated or revised SDS must be provided by the supplier free of charge on paper or electronically to all former recipients supplied with the substance or mixture within the previous 12 months.
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Who should receive a safety data sheet?
A professional user or trades person should receive a SDS upon receipt of a substance or mixture which is classified as hazardous and also when an unclassified mixture contains a hazardous substance. If SDS's are not provided for such chemicals, then they should be requested.
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When should a safety data sheet be updated?
Suppliers must update SDS's without delay when:
- New information becomes available on the hazards of substance/mixture or on the risk management measures that need to be taken
- An authorisation has been granted or refused for a substance
- A restriction has been imposed
Any updates following registration must include the registration number(s) of the substance(s) concerned.
An updated or revised SDS must be provided by the supplier free of charge on paper or electronically to all former recipients supplied with the substance or mixture within the preceding 12 months.
All updated/revised SDS's must contain the revision date and the information which has been added, deleted or revised must be stated clearly (this information can be added in to section 16 “Other information” of the SDS).
With regards to updating SDS's to bring them into line with Reg. No. 453/2010, substances or mixtures placed on the market after the 1st Dec 2010 are required to have a SDS prepared according to Annex I of Reg. No. 453/2010.
However, as stated above, there are transitional arrangements in place as follows:
- For substances already placed on the shelves before 1st December 2010 and not required to be re-labelled and re-packaged until 1st December 2012, the SDS does not need to be replaced with a SDS according to Annex I of Reg. No. 453/2010 until 1st Dec 2012
- For mixtures already placed on the shelves before 1st June 2015 and not required to be re-labelled and re-packaged until 1st June 2017, the SDS does not need to be replaced with a SDS according to Annex II of Reg. No. 453/2010 until 1st June 2017.
- For suppliers of mixtures: SDS's for mixtures provided to any recipient at least once before 1st December 2010 may continue to be used and need not comply with Annex I to Reg. No. 453/2010 until 30th November 2012
These 3 derogations above apply without prejudice to Art 31(9) of REACH, therefore, the derogations don’t apply in the cases where:
- new knowledge on hazards or data which can affect the risk management measures become available.
- an authorisation is granted or refused, or
- a restriction is imposed.
And so the SDS's must be updated immediately according to Reg. No. 453/2010 if any of the above changes apply.
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Are there any exemptions?
There are some exemptions for certain products from providing information in the supply chain under REACH. These exemptions mean that the supplier of these substances/products are not required under REACH to provide safety data sheets nor comply with any of the other requirements of Title IV of the regulation in relation to communicating information up and down the supply chain.
The exemptions are as follows:
Where a substance is used in:
- Medicinal products for human or veterinary use within the scope of Directives 2001/83/EC and 2001/82/EC and Regulation (EC) NO. 726/2004
- Food or feeding stuffs in accordance with Regulation (EC) No 178/2002
There is also an exemption to comply with providing information in the supply chain for the following mixtures in the finished state intended for the final user:
- Medicinal products for human and veterinary use as defined in Directive 2001/83/EC
- Cosmetics products as defined in Directive 76/768/EEC
- Medical devices which are invasive or used in direct physical contact with the human body
- Food or feeding stuffs in accordance with Regulation (EC) No 178/2002 including use as a food additive in foodstuffs, as a flavouring in foodstuffs, as an additive in feeding stuffs and/or in animal nutrition
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When does a safety data sheet not need to be supplied?
The safety data sheet does not need to be supplied for hazardous substances or mixtures which are sold or offered to the general public with sufficient information, such as labelling, to enable the user to take the necessary measures to protect human health as well as the environment. A SDS will need to be provided, however, if a downstream user or a distributor requests it.
There is no obligation to provide safety data sheets to consumers. If a professional user buys products in consumer packaging, the retailer must provide a safety data sheet at the user´s request.
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What to do when a safety data sheet is not required:
When a safety data sheet is not required for a substance or mixture the supplier must provide the recipient with the following information:
- The registration number(s) of any substance(s) for which the following information is given
- Details of any authorisation granted or denied for a substance
- Details of any restriction imposed
- Any available and relevant information about a substance required to take appropriate risk management measures
This information must be supplied to the recipient free of charge on paper or electronically no later than at the time of the first delivery of the chemical in question.
This information must be updated without delay if:
- New information becomes available on the hazards of substance/mixture or on the risk management measures that need to be taken
- An authorisation has been granted or refused for a substance
- A restriction has been imposed
The updated information must be provided by the supplier free of charge on paper or electronically to all former recipients supplied with the substance or mixture within the preceding 12 months and any update following registration must include the registration number.
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How is a Registration Number communicated in the SDS?
Where a registration number is available for a substance, that number must be provided in section 1 of the SDS where the SDS deals with a pure substance. A distributor or downstream user only may omit the last four digits of the registration number, which refers to the individual registrant of a joint submission, provided that they provide the full registration number to the enforcement authorities upon request or forward the request on to their supplier within 7 days and inform the authority that he has passed the request onward.
Where the SDS deals with a mixture, the registration numbers, where available for substances contained in that mixture, should be provided in section 3. Again in this case, the supplier of the mixture (downstream user or distributor) may omit the last four digits of the registration number, which refers to the individual registrant of a joint submission, provided that they provide the full registration number to the enforcement authorities upon request or forward the request on to their supplier within 7 days and inform the authority that he has passed the request onward.
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