Conditions under which a safety data sheet must be supplied

Safety data sheet knowledge base – Conditions under which a safety data sheet must be provided

 

Safety data sheet and the flow of information

Safety Data Sheets are an important communication tool in the supply chain, helping all the actors in the chain to meet their responsibilities in relation to the management of risks arising from the use of substances and mixtures.

Final exposure scenarios for identified uses should be provided by the registrant to his partners as an attachment to the safety data sheet. These exposure scenarios (eSDS) should be made as a part of the chemical safety assessment and they contain instructions for risk management measures to ensure adequate control of the risks.

 

A safety data sheet must be provided to the customer

  • If a substance or mixture is classified as hazardous
  • If a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII.
  • If a substance is included in the list established in accordance with paragraph (1) of Article 59,

 

We must provide a safety data sheet to the buyer on request – in case of non-hazardous mixtures if

  • It contains a hazardous substance in a concentration of ≥ 1 % by weight for non-gaseous mixtures.
  • It contains a hazardous substance in a concentration of ≥ 0,2 % by volume for gaseous mixtures.
  • It contains a substance in a concentration of ≥ 0,1 % by weight that is carcinogenic category 2 or toxic to reproduction category 1A, 1B or 2, skin sensitiser category 1, respiratory sensitiser category 1 or contains a substance that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) (Annex XIII)
  • If it contains a substance which is included in the list established in accordance with paragraph (1) of Article 59.
  • It contains a substance for which there are Community workplace exposure limits.

 

Supplying information required by Article 32 – in those cases when supplying an SDS is not compulsory

  • If the substance is subjected to authorization, the details of the authorization granted or, if the authorization is refused, the appropriate information on the details of the restriction.
  • Any relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied.
  • The registration number(s), if available, for any substances for which information is communicated under the points above.

 

No safety data sheet need to be compiled and made available for

1. products which are for consumer use and

  • sufficient information is provided to enable users to take the necessary measures to protect human health, safety and the environment.

2. the following finished products for end users:

  • Medicinal products for human or veterinary use
  • Cosmetic products
  • Medical devices which are invasive or used in direct physical contact with the human body
  • food or feedingstuffs (including: food additives in foodstuffs, flavouring in foodstuffs, additive in feedingstuffs)

 

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