Tag Archives: Classification

Classification, packaging and labelling of dangerous preparations

Classification, packaging and labelling of dangerous preparations

Outline of the Community (European Union) legislation about Classification, packaging and labelling of dangerous preparations

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Chemical products

Classification, packaging and labelling of dangerous preparations

Document or Iniciative

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.

Classification, packaging and labeling of chemicals and their mixtures

Classification, packaging and labeling of chemicals and their mixtures

Outline of the Community (European Union) legislation about Classification, packaging and labeling of chemicals and their mixtures

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Single Market for Goods > Chemical products

Classification, packaging and labeling of chemicals and their mixtures

Document or Iniciative

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006 [See amending act(s)].

Summary

This Regulation harmonises requirements concerning the classification, labelling and packaging of chemical substances and mixtures in line with the international system approved by the United Nations. This harmonisation enhances protection of health and the environment, and improves the free circulation of chemical substances and mixtures.

Enterprises must classify, label and pack their substances and mixtures in line with the provisions of this Regulation before putting them on the market.

Scope

The Regulation covers chemical substances and mixtures which are composed of two chemical substances or more.

The Regulation does not apply to:

  • radioactive substances and mixtures covered by Directive 96/29/Euratom;
  • substances subject to customs supervision which are in temporary storage, in a free zone or free warehouse with a view to re-exportation or still in transit;
  • non-isolated intermediates (substances which are manufactured in order to be chemically transformed into another substance);
  • substances and mixtures for scientific research and development which are not placed on the market;
  • waste;
  • medicinal products;
  • cosmetic products;
  • some medical devices;
  • food;
  • the transport of dangerous goods.

Classification

The classification of chemical substances and mixtures is based on categories which take into account the degree of hazard and the specific nature of the hazardous properties. These include inflammable substances or mixtures, those which are highly toxic, those which are dangerous for the aquatic environment, etc. Annex I establishes the criteria for the classification and labelling of hazardous substances and mixtures.

The Annexes of the Regulation also include the list of hazard statements, the list of precautionary statements, pictograms for each hazard class and the lists of classifications and labelling harmonised at Community level.

Labelling

Labelling must mention:

  • the name of the substance or mixture and/or an identification number;
  • the name, address and telephone number of the supplier;
  • the nominal quantity of the substance or mixture.

If applicable, labelling must include:

  • hazard pictograms (see Annex V of the Regulation);
  • the signal words “Danger” or “Warning”;
  • hazard statements such as “Fire or projection hazard”, “Fatal if swallowed”, etc. (see Annex III of the Regulation);
  • precautionary statements such as “Keep only in original container”, “Protect from moisture”, “Keep out of reach of children”, etc. (see Annex IV of the Regulation);
  • supplemental information, for example on physical properties or health hazards (see Annex II of the Regulation).

Hazard pictograms shall be in the shape of a square set at a point. They shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible. Each hazard pictogram shall cover at least one fifteenth of the surface area of the harmonised label and the minimum area shall not be less than 1 cm2.

The dimensions of the label shall be as follows:

Capacity of the package Dimensions (in millimetres)
Not exceeding 3 litres If possible, at least 52 × 74
Greater than 3 litres but not exceeding 50 litres At least 74 × 105
Greater than 50 litres but not exceeding 500 litres At least 105 × 148
Greater than 500 litres At least 148 × 210

The label for the hazardous substance or mixture shall be written in the official language(s) of the Member State where it is placed on the market, unless the Member State concerned provides otherwise.

Hazard pictograms, signal words, hazard statements and precautionary statements shall be located together on the label in an order established by the supplier, provided that the statements are grouped by language.

Packaging

Packaging containing hazardous substances or mixtures shall comply with the following requirements:

  • packaging must prevent any of the contents escaping;
  • packaging must be made of materials which are resistant if they come into contact with the contents;
  • packaging must be strong and solid;
  • packaging must have sealable fastenings.

In some cases, child-resistant fastenings and tactile warnings are required.

Harmonisation procedure

In order to trigger the harmonisation procedure for the classification and labelling of substances, Member States, or even manufacturers, importers or downstream users, can submit a proposal for the harmonised classification and labelling of substances, containing the information set out in Annex VI, Part 1 of this Regulation to the European Chemicals Agency. Generally, only substances satisfying the classification criteria for Category 1 respiratory sensitisation, mutagenicity, carcinogenicity or reproductive toxicity, or active ingredients in pesticides or biocides will be subject to such harmonisation, but other substances may be subject thereto if a necessity for harmonisation is demonstrated.

Within eighteen months from receipt of the proposal, the risk assessment committee of the Agency shall give an opinion on the proposal.

The Agency shall send this opinion to the Commission which, if it considers that harmonisation is appropriate, will include the substance and its classification and labelling elements in Annex VI, Part 3 of this Regulation.

The classification and labelling inventory

At the latest one month after having placed a substance on the market, the manufacturer or importer shall notify the Agency of information concerning its identity, the identity of the substance, hazard classes, concentration limits, etc. All this information shall be included in an inventory of classification and labelling that the Agency shall update on a regular basis.

Context

This Regulation supplements the REACH system for registration, assessment, authorisation and restrictions concerning chemical substances.

This Regulation amends Directive 67/548/EEC on chemical substances and Directive 1999/45/EC on mixtures and repeals them with effect from 1June 2015.

References

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

Regulation (EC) No 1272/2008

20.1.2009
1.12.2010 (Titles II, III and IV for substances)
1.6.2015 (Titles II, III and IV for mixtures)

OJ L 353, 31.12.2008

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

Regulation (EC) No 286/2011

19.4.2011

OJ L 83, 30.3.2011

AMENDMENTS TO THE ANNEXES

Annex I – Classification and labelling requirements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex II – Special rules for labelling and packaging
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex III – List of hazard statements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex IV – List of precautionary statements
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex V – Hazard pictograms
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annex VI – List of harmonised classification and labelling of hazardous substances
Regulation (EC) No 790/2009 [Official Journal L 235 of 5.9.2009];
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].

Annexe VII – Translation table
Regulation (EU) No 286/2011 [Official Journal L 83 of 30.3.2011].