Packaging & Labelling
Scope
The EU Directive on the classification, packaging, and labelling of dangerous substances and preparations harmonises laws throughout the EU to protect public health and the environment and ensure the free movement of products.
The Directive does not apply to:
- Medical products;
- Cosmetic products;
- Seed;
- Animal feed;
- Radioactive substances;
- Pesticides;
- Other substances for which notification or approval procedures exist;
- Carriage of dangerous substances;
- Unrefined substances in transit subject to customs inspection.
Classification
The classification of dangerous substances is based on categories defined in the Directive according to the degree of hazard and specific nature of the risks. The categories include explosive substances, flammable substances, toxic substances, and harmful substances.
The Annexes to the Directive contain a list of dangerous substances, including:
- Their classification and provisions for labelling;
- The symbol relating to each substance, standard phrases relating to the nature of the specific risks of each substance, and, if applicable, any phrases advising on safety precautions for the substance.
Packaging
The packaging of substances must comply with the following provisions:
- The packaging must prevent any loss of contents except where special safety devices are prescribed;
- The materials constituting the packaging and fastenings must not be susceptible to attack by the contents or liable to form harmful or dangerous compounds with the contents;
- Packaging and fastenings must be resistant and solid.
Labelling
The labelling must indicate the
- name of the substance,
- the origin of the substance, including
- the name and address of the manufacturer, distributor, or importer, as well as:
- danger symbols, an indication of the danger involved in the use of the substance, and
- a reference to the specific risks arising from such dangers.
The information must be presented in accordance with the Annexes to the Directive. Specified symbols and standard phrases are required, as is any advice on safety precautions.
The labelling must also comply with provisions on label size. The dimensions of the label must not be smaller than those of a standard A8 sheet. Each symbol must cover at least one-tenth of the surface area of the label.
States may require their national language or languages to be used in the labelling of dangerous substances. If the package is too small, the labelling may be affixed in another manner.
Member States may allow dangerous substances that are not toxic or explosive to deviate from the general labelling rules. The labelling of these substances may be optional or may differ from the established rules if they are present in such small quantities that there is no danger to users.
In the context of the international and/or national transport of dangerous substances, the labelling must comply with international and/or national rules. States must not restrict the free movement within the EU of dangerous substances that comply with the Directive unless they establish that the substance poses a hazard to health or the environment. In such cases, the Member State must inform the Commission, which must initiate a consultation procedure to assess the hazards and take any necessary action.
Chemicals
The Regulation on the classification, packaging, and labelling of chemicals and their mixtures harmonises requirements in accordance with an international system approved by the United Nations. The harmonisation aims to enhance the protection of health and the environment and improve the free circulation of chemical substances and mixtures.
Businesses must classify, label, and package substances and mixtures in accordance with the Regulation before placing them on the market. The Regulation does not apply to:
- Radioactive substances (covered otherwise);
- Substances subject to customs supervision which are in temporary storage;
- Non-isolated intermediaries, i.e., manufactured to be chemically transformed into another substance;
- Substances and mixtures for scientific research and development which are not placed on the market;
- Waste;
- Cosmetic products;
- Certain medical devices;
- Food;
- Transport of dangerous goods.
The classification of chemical substances and mixtures is based on categories, which consider the degree of hazard and nature of the hazardous property. They include flammable substances or mixtures, those that are highly toxic, and those that are dangerous to the aquatic environment. Annex I establishes criteria for the classification and labelling of hazardous substances and mixtures.
Labelling Chemicals
The Annexes to the Regulation include lists of hazard statements, precautionary statements, pictograms for each hazard class, and classifications and labelling harmonised at the EU level. 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, the labelling must include:
- Hazard pictograms in accordance with the Regulation Annex;
- Signal words, such as “Danger” or “Warning”;
- Hazard statements, such as “Fire or projection hazard,” “Fatal if swallowed,” etc.;
- Precautionary statements, such as “Keep only in original container” or “Keep out of reach of children”;
- Supplemental information, for example, on physical properties or health hazards.
Hazard pictograms must be in the shape of a square set at a point, with a black symbol on a white background and a red frame sufficiently wide to be clearly visible. Each hazard pictogram must cover at least one-fifteenth of the surface area of the harmonised label, with a minimum area of at least 1 cm².
The dimensions of the label are prescribed depending on the capacity of the package. The label of the hazardous substance or mixture must be written in the official language of the State where it is placed on the market, unless the Member State concerned provides otherwise:
Hazard pictograms, signal words, hazard statements, and precautionary statements must be located together on the label in an order established by the supplier, provided the statements are grouped by language.
Packaging Hazardous Substances
Packaging containing hazardous substances or mixtures must comply with the following requirements:
- Packaging must prevent any contents from escaping;
- Packaging must be made of materials that 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.
To initiate the harmonisation procedure for the classification and labelling of substances, States or even manufacturers, importers, or downstream users can submit a proposal for the harmonised classification and labelling of substances, including information set out in the Annex to the 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. Other substances may be subject to harmonisation if a necessity is demonstrated.
Within 18 months of receiving a proposal, the Risk Assessment Committee of the Agency must provide an opinion on the proposal.
The Agency shall send this opinion to the Commission. If the Commission deems harmonisation appropriate, it will include the substance and classification and labelling elements in the Annex to the Regulation.
At least one month after placing a substance on the market, the manufacturer or importer must notify the Agency of information concerning the identity of the substance, hazard classes, and concentration limits. All information must be included in an inventory of classification and labelling, which the Agency updates regularly.
Dangerous Preparations
The Directive on the classification, packaging, and labelling of dangerous preparations applies to dangerous preparations that contain at least one dangerous substance as defined in the Annex or are considered dangerous within the meaning of the Regulation.
Preparations include mixtures or solutions composed of two or more substances. The Directive provides provisions for preparations that are not considered dangerous but may still present a hazard.
The exclusions are similar to those applicable above.
The classification of dangerous preparations is based on the definition of categories of danger laid down in the Directive. These categories take account of the degree and specific nature of the hazards involved. They include preparations considered dangerous due to:
- Physicochemical properties (e.g., explosive, oxidising, flammable);
- Health hazards (e.g., toxic, carcinogenic, or harmful);
- Environmental hazards.
The general principles of classification and labelling of dangerous substances apply, along with the criteria for dangerous substances. The packaging must comply with the following:
- Be designed and constructed so that its contents cannot escape;
- The materials constituting the packaging and fastenings must not be susceptible to attack by the contents or liable to form dangerous compounds with them;
- Packaging and fastenings must be strong and solid to ensure they will not loosen and will withstand normal handling stresses;
- The shape and/or graphic decoration of the packaging must not arouse the curiosity of children or mislead consumers;
- Packaging must be designed so it cannot be confused with foodstuffs, animal feed, medicinal products, or cosmetics;
- Containers for preparations must have child-resistant fastenings.
A package must be clearly and indelibly marked with information including:
- The trade name of the preparation;
- The name and contact details of the person responsible for placing it on the market;
- The general chemical name of the substance(s) in the preparation that has led to its classification as a health hazard;
- Danger symbols and indications of danger, risk phrases, and safety advice, with specific format and wording as laid down in the Directive.
States may require that the labelling of a preparation is in their national language.
Under restricted conditions, some dangerous preparations may be exempt from the general requirements on packaging and labelling. In such cases, labelling may be optional or may differ from the requirements if the quantities present are so low that they do not pose a hazard to users.
States must appoint a national authority to inform the Commission on the application of this Directive. Those responsible for placing dangerous preparations on the market must keep information related to the classification of the preparation at the disposal of that authority.
States must designate bodies responsible for receiving information on the health effects of preparations, which can be used only in response to requests of a medical nature.
A person placing a dangerous preparation on the market may request confidentiality from the competent authority in the State where the preparation is first marketed. This procedure prevents the disclosure of the chemical identity of certain substances on the label while safeguarding intellectual property. Once the authority has made its decision, it will inform the person responsible for placing the preparation on the market.
States may not prohibit, restrict, or impede the placing of dangerous preparations on the market if they meet the requirements of this Directive.
However, States may provisionally prohibit the placing of a dangerous preparation on the market or subject it to special conditions even if it complies with the Directive. The State must immediately inform the Commission and other States of the measure adopted and the reasons for the decision.
The amendments required to adapt the Annexes to the Directive’s progress are adopted by the Commission with assistance from a regulatory committee made up of State representatives.