1. The supplier of a substance or a [F1mixture] shall provide the recipient of the substance or [F1mixture] with a safety data sheet compiled in accordance with Annex II:
[F1(a) where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or]
(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or
(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).
2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment. If the safety data sheet is developed for a [F1mixture] and the actor in the supply chain has prepared a chemical safety assessment for that [F1mixture] , it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the [F1mixture] instead of with the chemical safety report for each substance in the [F1mixture] .
[F13. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:
(a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or
(b) in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or
(c) a substance for which there are Community workplace exposure limits.]
[F14. The safety data sheet need not be supplied where hazardous substances or mixtures offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.]
5. The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or [F1mixture] is placed on the market, unless the Member State(s) concerned provide otherwise.
6. The safety data sheet shall be dated and shall contain the following headings:
identification of the substance/ [F1mixture] 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.
7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI.
Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.
Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).
[F18. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied.]
9. Suppliers shall update the safety data sheet without delay on the following occasions:
(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
(b) once an authorisation has been granted or refused;
(c) once a restriction has been imposed.
The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or [F1mixture] within the preceding 12 months. Any updates following registration shall include the registration number.
[F210. Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 December 2010 , that classification may be added in the safety data sheet together with the classification in accordance with Directive 67/548/EEC.
From 1 December 2010 until 1 June 2015 , the safety data sheets for substances shall contain the classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008.
Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 June 2015 , that classification may be added in the safety data sheet, together with the classification in accordance with Directive 1999/45/EC. However, until 1 June 2015 , where substances or mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/2008 that classification shall be provided in the safety data sheet, together with the classification in accordance with Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.]
Textual Amendments
F1Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
F2 Inserted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
1. Any supplier of a substance on its own or in a [F1mixture] who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information:
(a) the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph;
(b) if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;
(c) details of any restriction imposed under Title VIII;
(d) any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.
2. The information referred to in paragraph 1 shall be communicated free of charge on paper or electronically at the latest at the time of the first delivery of a substance on its own or in a [F1mixture] after 1 June 2007 .
3. Suppliers shall update this information without delay on the following occasions:
(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
(b) once an authorisation has been granted or refused;
(c) once a restriction has been imposed.
In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or [F1mixture] within the preceding 12 months. Any updates following registration shall include the registration number.
Textual Amendments
F1Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
1. Any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
The relevant information shall be provided, free of charge, within 45 days of receipt of the request.
Any actor in the supply chain of a substance or a [F1mixture] shall communicate the following information to the next actor or distributor up the supply chain:
new information on hazardous properties, regardless of the uses concerned;
any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.
Distributors shall pass on that information to the next actor or distributor up the supply chain.
Textual Amendments
F1Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or [F1mixtures] that they use or may be exposed to in the course of their work.
Textual Amendments
F1Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
1. Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or [F1mixture] . That manufacturer, importer, downstream user or distributor shall submit this information or make it available without delay upon request to any competent authority of the Member State in which he is established or to the Agency, without prejudice to Titles II and VI.
2. In the event of a registrant, downstream user or distributor ceasing activity, or transferring part or all of his operations to a third party, the party responsible for liquidating the registrant, downstream user or distributor's undertaking or assuming responsibility for the placing on the market of the substance or [F1mixture] concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor.]
Textual Amendments
F1Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).