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Classification, packaging and labelling of dangerous preparations

The criteria related to the classification, packaging and labelling of dangerous substances and preparations have been harmonised in order to ensure the protection of health and the environment, as well as the free movement of products. These criteria were amended when the new Regulation (EC) No 1272/2008 entered into force and the European Chemicals Agency was created.

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 [See amending acts].

Summary

Scope

This Directive applies to dangerous preparations which contain at least one dangerous substance within the meaning of Article 2 or which are considered dangerous within the meaning of Articles 5, 6 or 7. The term “preparation” covers mixtures or solutions composed of two or more substances.

This Directive provides specific provisions for preparations which are not considered dangerous (within the meaning of Articles 5, 6 or 7), but which may nevertheless present a specific hazard.

This Directive shall not apply to the following preparations in the finished state, intended for the final user:

  • medicinal products for human or veterinary use;
  • cosmetic products;
  • mixtures of substances in the form of waste covered by Directive 2006/12/EC on waste disposal);
  • foodstuffs;
  • animal feedingstuffs;
  • preparations containing radioactive substances;
  • medical devices which are invasive or used in direct physical contact with the human body;
  • the carriage of dangerous preparations by rail, road, inland waterway, sea or air;
  • ,preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.

Classification

The classification of dangerous preparations shall be based on the definitions of categories of danger laid down in Article 2 of the Directive. These categories take into account the degree and specific nature of the hazards involved. They include preparations considered dangerous due to:

  • physico-chemical properties (for example, explosive, oxidising, or flammable); and/or
  • the health hazards it presents (for example, toxic, carcinogenic or harmful); and/or
  • the environmental hazards it presents.

The general principles of classification and labelling of dangerous substances applies to the methods specified in Regulation (EC) No 440/2008 and 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.

Packaging

The main requirements relating to packaging are as follows:

  • it shall be so designed and constructed that its contents cannot escape;
  • the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;
  • packaging 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;
  • the shape and/or graphic decoration of packaging shall not arouse the curiosity of children nor mislead consumers;
  • it shall be designed so that it cannot be confused with foodstuffs, animal feedingstuffs, medicinal products or cosmetics;
  • containers for preparations must be fitted with child-resistant fastenings and/or carrying a tactile warning of danger.

Labelling

Any package must be clearly and indelibly marked with certain specific information such as:

  • the trade name of the preparation;
  • the name and contact details of the person responsible for placing it on the market;
  • in general the chemical name of the substance or substances present in the preparation which have given rise to the classification of the preparation with regard to health hazards;
  • the danger symbols and indications of danger, the risk phrases and the safety advice. Specific provisions concerning the presentation, format and wording of this information are laid down in Annexes II and VI to the Directive 67/548/EEC.

Member States may require the labelling of a preparation to be produced in their official language(s).

Under certain very restricted conditions specified in Article 12 of the Directive, some dangerous preparations may be exempt from the general requirements on packaging and labelling. Henceforth, the labelling of these preparations may be optional or may differ from the requirements laid down if the quantities present are so low that they do not present any hazard to users.

Obligations and duties of the Member States

The Member States appoint a national authority who shall inform the Commission on the application of this Directive. Those responsible for placing dangerous preparations on the market must hold at the disposal of that authority all information relating to the classification of the preparation (safety data, etc.).

Member States are required to designate the bodies responsible for receiving information on the health effects of preparations. This information can be used only in response to requests of a medical nature.

Confidentiality

The person responsible for placing a dangerous preparation on the market may make a request for confidentiality. This request is addressed to the competent authority of the Member States in which the preparation is to be first placed on the market. This procedure prevents the disclosure of the chemical identity of a certain substance on the label and does not risk the confidential nature of intellectual property. When the authority has made its decision, it shall inform the person responsible for placing the preparation on the market.

Free movement clause

Member States may not prohibit, restrict or impede the placing on the market of dangerous preparations which satisfy the requirements of this Directive.

Safeguard clause

A Member State may provisionally prohibit the placing on the market of a dangerous preparation or subject it to special conditions in its territory, even if it complies with the provisions of this Directive.

The Member States shall inform the Commission and the other Member States immediately of the adoption of such a measure and the reasons for its decision. The Commission shall consult Member States as soon as possible before making its decision.

Procedure for adaptation to technical progress

The amendments required to adapt the nine annexes to technical progress are adopted by the Commission with the assistance of a regulatory committee made up of representatives of the Member States and chaired by a representative of the Commission.

Context

This Directive shall be repealed with effect on 1 June 2015 by Regulation (EC) No 1272/2008 on the classification, labelling and packaging of chemicals and their mixtures.

REFERENCES

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 1999/45/EC

30.7.1999

30.7.2002

O.J. L 200 of 30.7.1999

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1882/2003

20.11.2003

-

OJ L 284 of 31.10.2003

Regulation (EC) No 1907/2006

1.6.2007
Application:
1.6.2008
1.8.2008 (Art. 135)
1.6.2009 (Title VIII and Annex XVII)

-

OJ L 396 of 30.12.2006

Regulation (EC) No 1137/2008

11.12.2008

-

OJ L 311 of 21.11.2008

Regulation (EC) No 1272/2008

20.1.2009

-

OJ L 353 of 31.12.2008

The successive amendments and corrections to Directive 1999/45/EC have been incorporated in the original text. This consolidated version is of documentary value only.

Last updated: 09.09.2011
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