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Questions and Answers

 

What is the current legal requirement for a safety data sheet (SDS)?

Annex II of the REACH Regulation lays out the requirements for compiling a SDS. It has been revised by Regulation (EU) 2020/878 and applies from 1st January 2021. All SDSs must be updated to be in compliance with Annex II as amended by Regulation (EU) 2020/878.

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What is the format for the safety data sheet (SDS)?

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 II of the REACH Regulation as amended by Regulation (EU) 2020/878 and must contain the following 16 headings:

  1. Identification of the substance/mixture and of the company/undertaking
  2. Hazards identification
  3. Composition/information on ingredients
  4. First-aid measures
  5. Fire-fighting measures
  6. Accidental release measures
  7. Handling and storage
  8. Exposure controls/personal protection
  9. Physical and chemical properties
  10. Stability and reactivity
  11. Toxicological information
  12. Ecological information
  13. Disposal considerations
  14. Transport information
  15. Regulatory information
  16. 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 (SDS) must be prepared by a competent person. The e-mail address of this competent person must be given in section 1 of the safety data sheet. The supplier of the SDS can delegate this function to their own staff or to third parties.

No specific definition of the “competent person” is given in the Regulation. However the term may usefully be defined in this context as meaning a person (or combination of persons) – or a coordinator of a group of people - who has or have, as a result of their training, experience and continued education, sufficient knowledge for the compilation of the respective sections of the SDS or of the entire SDS.

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Who must provide a safety data sheet (SDS) and under what conditions?

A supplier of a substance or mixture must provide a SDS if the:

  • Substances and mixtures supplied are classified as hazardous according to Regulation (EC) No. 1272/2008 (CLP)
  • 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 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 (SDS) 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. If sending an SDS electronically a direct link to the specific SDS for the chemical product supplied should be provided and it is not acceptable to provide a link to the website were all SDSs are located. See further information in Section 2.13 of the ECHA SDS guidance 

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.

The duty to provide an SDS is triggered at the point of supply to the recipient within the EU and not at the point of entry (import) into the EU. The relevant transport documentation is normally sufficient in transit and should be applied by the exporter.  However, customs or other relevant enforcement authorities, can request an SDS at point of entry into the EU e.g. to validate the product hazard classification.

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Are there any exemptions regarding safety data sheet (SDS) provision?

There are some exemptions for certain products from providing information in the supply chain under REACH. These exemptions mean that the supplier of the following mixtures in the finished state intended for the final user 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:

  • 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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Who should receive a safety data sheet (SDS)?

A professional user or trade 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 (SDS) 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 must include the registration number(s) of the substance(s) concerned, where applicable. 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).

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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 safety data sheet (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 disclose 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 disclose 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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What emergency number must be provided in section 1.4 of the safety data sheet (SDS)?

In accordance with the provisions of Section 1.4 of Annex II of REACH, it is obligatory to include a national poison centre emergency number for any mixture classified as hazardous on the basis of its health or physical effects. Any chemical product that meets these provisions should be notified to the National Poisons Information Centre (NPIC) in Ireland and the associated safety data sheet for that chemical product should include the NPIC emergency contact number.

It is also permitted to include (in addition) an external emergency number, as appropriate.

The NPIC emergency number cannot be used in Section 1.4 of an SDS until the notification process, which includes payment of an annual fee, is complete. The notification process is explained on the

NPIC website www.poisons.ie/Manufacturers/Product-Registration

When placing chemical products on the market in other EU Member States, the respective national poison centre number, where established, is required to be included in Section 1.4 of the SDS. Further information is available on the ECHA website under the National Helpdesk contact details.

For substances as well as mixtures which are not classified as hazardous (but do require a SDS based on the presence of hazardous ingredients) and mixtures which are classified for environmental hazards only, reference to an emergency service belonging to the supplier himself or to a competent third party provider of such a service must be made.

Where the supplier provides his own emergency information service, be it alone or in combination with an official advisory body or other provider, the necessary competence should be available.

Any limitations on any the official advisory body, the supplier’s own, or any third party’s services (opening hours or types of information that can be provided) must be indicated.

Please also see Poison Centre Notification information sheet

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Should Employees have access to safety data sheets?

Workers must be granted access by their employer to safety data sheets for substances or mixtures that they use or may be exposed to in the course of their work. The employer has a responsibility to complete a chemical risk assessment to manage risks at the specific workplace.

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How long should a Safety Data Sheet be kept for?

Each manufacturer, importer, downstream user and distributor and downstream user must keep the safety data sheet for at least 10 years after they last manufactured, imported, supplied or used the chemical.

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Further Information:

 

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