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Safety data sheet

The safety data sheet is governed by Regulation (EC) 1907/2006 of the European Parliament and of the Council (REACH). The sections governing the safety data sheet can be found in Article 31 and Annex II of this regulation. The safety data sheet must be made available free of charge in paper or electronic form no later than the date upon which the substance or mixture is first supplied.

A safety data sheet has to be compiled, if

  • a substance or preparation is dangerous
  • a substance is persistent, bioaccumulative and toxic (PBT) 
    or very persistent and very bioaccumulative (vPvB)
  • a substance is subject to authorisation.

The supplier shall provide the recipient at his request with a safety data sheet, where a preparation does not meet the criteria for classification as dangerous, but contains:

  • at least one substance posing human health or environmental hazards
    ≥ 1 % by weight for nongaseous preparations
    ≥ 0,2 % by volume for gaseous preparations
  • at least one substance that is PBT or vPvB or subject to authorisation
    ≥ 0,1 % by weight for non-gaseous preparations
  • a substance for which there are Community workplace exposure limits.

Amendments to Annex II of the REACH Regulation

Commission Regulation (EU) 453/2010 amending Annex II of the REACH Regulation comes into force on 1 December 2010. Its purpose is to adapt the REACH Regulation to the GHS Regulation. It consists of an Annex I and an Annex II, and replaces the existing Annex II of the REACH Regulation on the following dates:

  • For substances:
    Annex I becomes mandatory on 1 December 2010
    Annex II becomes mandatory on 1 June 2015
  • For mixtures:
    Annex I becomes mandatory on 1 December 2010
    Annex II is permitted from 1 December 2010 onwards, and becomes mandatory on 1 June 2015

The following provisions also apply:

Safety data sheets (SDSs) made available to a recipient at least once prior to 1 December 2010 may continue to be used, and need not satisfy Annex I of Regulation 453/2010 until 30 November 2012.

Without prejudice to Article 31 (9) of the REACH Regulation (updating of SDSs), the following provisions apply:

  • For substances 
    marketed prior to 1 December 2010, … that the SDS need not be replaced by an SDS in compliance with Annex I of Regulation 453/2010 until 1 December 2012
  • For mixtures 
    marketed prior to 1 June 2015, … that the SDS need not be replaced by an SDS in accordance with Annex II of Regulation 453/2010 until 1 June 2017

Updating

Suppliers must update their safety data sheets immediately when:

  • New information becomes available which may affect the risk management measures, or new information on hazards becomes available
  • An authorization has been granted or refused
  • A restriction has been imposed

The new, dated version of the information must be identified as "Revision: (date)" and be provided free of charge in paper or electronic form to all former recipients whom the suppliers have supplied with the substance or mixture within the preceding 12 months. Any updates following registration must include the registration number.

The safety data sheet in accordance with Regulation (EU) 453/2010 must contain the following sections and sub-sections, with the exception of Section 3, of which only either Sub-section 3.1 or 3.2 must be included, according to the case concerned.

 

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Wording of

Original text of the REACH regulation and its amendments

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