COUNCIL DIRECTIVE of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (67/548/EEC)
THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;
Having regard to the proposal from the Commission;
Having regard to the Opinion of the European Parliament (1);
Having regard to the Opinion of the Economic and Social Committee (2);
Whereas any rules concerning the placing on the market of dangerous substances and preparations must aim at protecting the public, and in particular workers using such substances and preparations;
Whereas the differences between the national provisions of the six Member States on the classification, packaging and labelling of dangerous substances and preparations hinder trade in these substances and preparations within the Community and hence directly affect the establishment and functioning of the common market;
Whereas it is therefore necessary to remove such hindrances ; whereas this entails approximating the laws, regulations and administrative provisions on classification, packaging and labelling;
Whereas, in view of the preparatory work still to be carried out, the approximation of provisions relating to dangerous preparations will have to be dealt with in later directives ; whereas therefore the present Directive must be restricted to the approximation of provisions relating to dangerous substances;
Whereas in view of the extent of this field and the many detailed measures which will be required for the approximation of all the provisions relating to dangerous substances, it would appear advisable to deal first with the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances and to deal in later directives with the approximation of the provisions relating to the use of those dangerous substances and preparations if it is established that the differences between such provisions directly affect the establishment or functioning of the common market;
Whereas the approximation of national provisions which is laid down by this Directive does not prejudice application of the provisions of Articles 31 and 32 of the Treaty;
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States on: - classification,
- packaging, and
- labelling
of dangerous substances which are placed on the market in the Member States of the Community.
2. This Directive does not affect the provisions relating to: (a) medicinal products, narcotics and radioactive substances ; (1) OJ No 209,11.12.1965, p. 3133/65. (2) OJ No 11,20.1.1966, p. 143/66.
(b) the carriage of dangerous substances by rail, road, inland waterway, sea or air;
(c) munitions and objects containing explosive matter in the form of igniters or motor fuels.
3. This Directive does not apply to dangerous substances exported to third countries.
4. Articles 5 to 7 of this Directive do not apply to containers for gases which are compressed, liquefied or dissolved under pressure.
Article 2
1. For the purposes of this Directive: (a) "substances" means
chemical elements and their compounds as they occur in the natural state or as produced by industry;
(b) "preparations" means
mixtures or solutions composed of two or more substances.
2. The following substances and preparations are "dangerous" within the meaning of this Directive: (a) explosive:
substances and preparations which may explode under the effect of flame or which are more sensitive to shocks or friction than dinitrobenzene;
(b) oxidising:
substances and preparations which give rise to highly exothermic reaction when in contact with other substances, particularly flammable substances;
(c) easily flammable: - substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy, or
- solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition, or
- liquid substances and preparations having a flash point below 21º C, or
- gaseous substances and preparations which are flammable in air at normal pressure, or
- substances and preparations which, in contact with water or damp air, evolve highly flammable gases in dangerous quantities;
(d) flammable:
liquid substances and preparations having a flash point between 21º C and 55º C;
(e) toxic:
substances and preparations which, if they are inhaled or taken internally or if they penetrate the skin, may involve serious, acute or chronic health risks and even death;
(f) harmful:
substances and preparations which, if they are inhaled or taken internally or if they penetrate the skin, may involve limited health risks;
(g) corrosive:
substances and preparations which may, on contact with living tissues, destroy them;
(h) irritant:
non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, can cause inflammation.
Article 3
The classification of dangerous substances according to the greatest degree of hazard and specific nature of the risks shall be based on the categories laid down in Article 2.
Article 4
Annex I to this Directive gives the list of dangerous substances classified in accordance with the provisions of Article 3.
Article 5
Member States shall take all necessary measures to ensure that dangerous substances cannot be placed on the market unless the strength and impermeability of their packaging satisfies the following requirements, any packaging meeting these requirements being regarded as adequate: 1. The packagings must be so arranged and fastened as to preclude any loss of the contents ; this requirement does not apply where special safety devices are prescribed;
2. The materials constituting the packaging and fastenings must not be liable to attack by the contents, or liable to form harmful or dangerous compounds with the contents ;
3. The packagings and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling.
Article 6
1. Member States shall take all necessary measures to ensure that dangerous substances cannot be placed on the market unless the labelling on their packaging satisfies the following requirements.
2. All packagings must be labelled with: - the name of the substance,
- the origin of the substance,
- the danger symbol and indication of danger involved in the use of the substance,
- a reference to the special risks arising from such dangers;
(a) the name of the substance must be one of the terms listed in Annex I to this Directive;
(b) the indication of origin must include the name and address of the manufacturer, the distributor or the importer;
(c) the following symbols and indications of danger are to be used:
PIC FILE= "T
The symbols must conform to those in Annex II to this Directive ; they shall be printed in black on an orange-yellow background.
(d) The nature of the special risks involved in using the substances must be indicated by one or more of the standard phrases which, in conformity with the references contained in the list in Annex I, are set out in Annex III to this Directive.
3. If the packaging is accompanied by advice on safety precautions relating to the use of the substances, the wording of this shall, in conformity with the references contained in the list in Annex I, be taken from Annex IV to this Directive.
Article 7
1. Where the particulars required by Article 6 appear on a label, that label must be placed on one or more surfaces of the packaging so that it can be read horizontally when the package is set down normally. The dimensions of the label must not be less than those of a standard A 8 sheet (52 X 74 mm), but there is no obligation that it exceed those of a standard A 5 sheet (148 x 210 mm). Each symbol must cover et least one-tenth of the surface area of the label. The entire surface of the label must stick to the immediate packaging of the substance.
2. A label shall not be required where the particulars are clearly printed on the normal packaging as specified in paragraph 1.
3. The particulars on the packaging or on the label must be printed in clearly legible and indelible characters so as to ensure that the symbols and indications of danger and the reference to special risks are sufficiently prominent.
4. Member States may make the placing on the market of dangerous substances in their territories subject to the use of the national language or languages in the labelling of these substances.
5. The obligations of paragraphs 1 to 4 concerning labelling shall be regarded as being satisfied where a container is dispatched bearing a label complying with the dispatch requirements and where this label displays the appropriate symbol laid down in Article 6 (2) (c). This derogation shall not apply to containers which are inside other containers.
Article 8
Member States may (a) permit the labelling required by Article 6 to be affixed in some other appropriate manner on packaging too small to allow labelling in accordance with Article 7 (1) or (2);
(b) by way of derogation from Articles 6 and 7, permit the packaging of dangerous substances which are neither explosive nor toxic to be unlabelled, or to be labelled in some other way if they contain such small quantities that there is no danger to workers or others.
Article 9
Member States shall inform the Commission of all laws, regulations and administrative provisions which they adopt in the field covered by this Directive.
Article 10
Member States shall adopt the measures needed in order to comply with this Directive and shall apply them by 1 January 1970 at the latest.
They shall forthwith inform the Commission thereof.
Article 11
This Directive is addressed to the Member States.
Done at Brussels, 27 June 1967.