Commission Directive 2001/58/EC
of 27 July 2001
amending for the second time Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 14 of European Parliament and Council Directive 1999/45/EC and relating to dangerous substances in implementation of Article 27 of Council Directive 67/548/EEC (safety data sheets)
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(1), and in particular Article 14 thereof,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2), as last amended by Commission Directive 2000/33/EC(3), and in particular Article 27 thereof,
Whereas:
(1) Article 14 of Directive 1999/45/EC provides that the person responsible for placing on the market certain specified preparations must provide a safety data sheet.
(2) Article 27 of Directive 67/548/EEC provides that the person responsible for placing dangerous substances on the market must also provide a safety data sheet.
(3) Safety data sheet information is principally intended for use by professional users and must enable them to take the necessary measures as regards the protection of health, safety and the environment at the place of work.
(4) Safety data sheets for dangerous substances and certain preparations, and their supply must comply with the provisions of Commission Directive 91/155/EEC(4), as amended by Directive 93/112/EC(5).
(5) Article 14(2.1)(b) of Directive 1999/45/EC introduces a new requirement for persons responsible for placing preparations on the market to provide on the request of professional users a safety data sheet containing proportionate information for preparations not classified as dangerous within the meaning of Articles 5, 6 and 7 of Directive 1999/45/EC, but which contain in an individual concentration of &gt;= 1 % by weight for non-gaseous preparations and &gt;= 0,2 % by volume for gaseous preparations at least one substance posing health or environmental hazards, or one substance for which there are Community workplace exposure limits.
(6) Directive 1999/45/EC also introduces a requirement for preparations to be classified and labelled for their effects on the environment.
(7) It is therefore necessary to amend Directive 91/155/EEC accordingly, as specified in Article 14(2.3) of Directive 1999/45/EC, before 30 July 2002.
(8) Article 4 of Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risk related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(6) requires employers to determine whether any hazardous chemical agents are present at the workplace, and to assess any risk to the health and safety of workers arising from the presence of those chemical agents, taking into consideration the information provided by the supplier via safety data sheets; it is therefore opportune to amend the Annex to Directive 91/155/EEC accordingly.
(9) It is known from recent enforcement activities and studies in the Member States that many safety data sheets are of poor quality and do not provide adequate information for the user; one way of improving the quality of safety data sheets is to improve the guidance given to compilers of safety data sheets set out in the Annex to Directive 91/155/EEC; it is therefore opportune to amend the Annex to Directive 91/155/EEC accordingly; the Commission and the Member States will consider other means by which the quality of safety data sheets can be improved further in future.
(10) The measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations established under Article 20 of Directive 1999/45/EC,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 91/155/EEC is amended as follows:
1. Article 1(1) is replaced by the following: "1. (a) The person who is responsible for placing a chemical substance or preparation on the market, whether the manufacturer, importer or distributor, shall supply the recipient, who is a professional user of the substance or preparation, with a safety data sheet containing the information set out in Article 3 and the Annex to this Directive, if the substance or preparation is classified as dangerous according to Directive 67/548/EEC or European Parliament and Council Directive 1999/45/EC(7).
(b) Any person who is responsible for placing a preparation on the market, whether the manufacturer, importer or distributor, shall supply, on request of a professional user, a safety data sheet providing proportionate information as set out in Article 3 and the Annex to this Directive, if the preparation is not classified as dangerous according to Articles 5, 6 and 7 of Directive 1999/45/EC, but the preparation contains in an individual concentration of &gt;= 1 % by weight for non-gaseous preparations and &gt;= 0,2 % by volume for gaseous preparations at least one substance posing health or environmental hazards, or one substance for which there are Community workplace exposure limits."
2. The Annex referred to in Article 3 is replaced by the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 July 2002 at the latest. They shall forthwith inform the Commission thereof.
2. Member States shall apply the laws, regulations and administrative provisions referred to in paragraph 1:
(a) to preparations not within the scope of Council Directive 91/414/EEC(8) on the placing of plant protection products on the market, or Council Directive 98/8/EC(9) on the placing of biocidal products on the market as from 30 July 2002;
(b) and to preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2004.
3. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 27 July 2001.