A BRIEF HISTORY OF THE REGULATORY FRAMEWORK FOR CHEMICALS

ACT
Council Directive 1967/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances .
Definitions

For the purposes of the Directive, "substances" means chemical elements and their compounds as they occur in the natural state or as produced by industry. "Preparations" means mixtures or solutions composed of two or more substances.

Classification
The classification of dangerous substances is based on categories clearly defined in the Directive according to the greatest degree of hazard and the specific nature of the risks. These categories include explosive substances, inflammable substances, toxic substances, harmful substances, etc. Annex I to the Directive lists the categories of dangerous substances.

Packaging
The packaging of substances must comply with the following provisions:
the packaging must prevent any loss of the contents, except where special safety devices are prescribed;
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;
packagings and fastenings must be strong and solid.

Labelling
The labelling must indicate:
the name of the substance;
the origin of the substance (name and address of the manufacturer, distributor or importer);
the danger symbol and indication of danger involved in the use of the substance;
a reference to the special risks arising from such dangers.
This information must be presented in accordance with the Annexes to the Directive (symbols, standard phrases, etc.). The same applies to any advice on safety precautions.
The labelling must, in addition, comply with provisions on the size of the labelling. In particular, the dimensions of the label must not be less than those of a standard A8 sheet (52 x 74 mm), and each symbol must cover at least one tenth of the surface area of the label.
Member States may require their national language or languages to be used in the labelling of dangerous substances.
Where the packaging is too small, the labelling may be affixed in some other manner. In addition, the packaging of dangerous substances which are neither explosive nor toxic may be unlabelled, or labelled in some other way, if they contain such small quantities that there is no danger to users.
The criteria which define a substance as dangerous are harmonised at European level, as are the packaging and labelling criteria designed to ensure that these substances are easily identifiable.

ACT
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.

Scope
The general principles of the classification and labelling of preparations are applied in accordance with the criteria laid down in Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances, save where alternative criteria in the Directive are applied.
A preparation is classed as dangerous and therefore subject to the provisions of Directive 1999/45/EC if it:
contains at least one dangerous substance within the meaning of Article 2 (definitions of dangerous substances);
is considered to be dangerous, after evaluation, because of its physico-chemical properties, or the dangers that it poses to health or to the environment. The methods of evaluation for these three criteria are set out in the annexes;
is not considered dangerous within the strict meaning of the Directive but may nevertheless present a specific danger. These preparations are specified in the annex.

Packaging
The main requirements relating to packaging are as follows:
the form of packaging and materials used must be strong and solid;
containers which contain dangerous preparations offered or sold to the general public must not have either a shape and/or graphic decoration likely to attract children or mislead consumers nor a presentation similar to that used for foodstuffs or animal feeding stuffs or medicinal or cosmetic products;
preparations offered or sold to the general public must be supplied in a container fitted with child-resistant fastenings and/or carrying a tactile warning of danger.

Labelling
As regards labelling, any package must be clearly and indelibly marked with certain specific information such as:
the trade name of the preparation and the name and address of the person responsible for placing it on the market;
the chemical name of the substance or substances in the preparation. Although this list does not have to be exhaustive, the names of the substances which have given rise to the classification "dangerous preparation" must be indicated;
the danger symbols and phrases indicating a risk, in accordance with the wording in the annexes to Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances. Provisions are also laid down for preparations containing several dangerous substances which require several symbols and phrases indicating a risk.