TITLE IV
INFORMATION
IN THE SUPPLY CHAIN

 

Article 31
Requirements for safety data sheets

 

1.                       The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II:

(a)             where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC; 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 preparation and the actor in the supply chain has prepared a chemical safety assessment for that preparation, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance in the preparation.

3.                       The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a preparation does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains:

(a)             in an individual concentration of 1 % by weight for non-gaseous preparations and 0,2 % by volume for gaseous preparations at least one substance posing human health or environmental hazards; or

(b)             in an individual concentration of 0,1 % by weight for non-gaseous preparations at least one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative 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.

4.                       The safety data sheet need not be supplied where dangerous substances or preparations 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 preparation 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:

1.      identification of the substance/preparation 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.

7.                       Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37shall place the relevant exposure scenarios (including use and exposurecategories 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).

 

8.                       A safety data sheet shall be provided free of charge on paper or electronically.

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 preparation within the preceding 12 months. Any updates following registration shall include the registration number.

 

 

 

Article 32
Duty to communicate information down the supply chain
f or substances on their own or in preparations
for which a safety data sheet is not required

 

1.                       Any supplier of a substance on its own or in a preparation 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 preparation 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 preparation within the preceding 12 months. Any updates following registration shall include the registration number.

 

 

Article 33

Duty to communicate information on substances in articles

 

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.

 

 

Article 34
Duty to communicate information on
substances and preparations up the supply chain

 

Any actor in the supply chain of a substance or a preparation shall communicate the following information to the next actor or distributor up the supply chain:

(a)         new information on hazardous properties, regardless of the uses concerned;

(b)                    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.

 

 

Article 35
Access to information for workers

 

Workers and their representatives shall be granted acces s by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or preparations that they use or may be exposed to in the course of their work.

 

 

Article 36
Obligation to keep information

 

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 preparation. 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 preparation concerned shall be bound by the obligation in paragraph 1 in place of the registrant, downstream user or distributor.