This Fact sheet describes the rules according to the Statutory Order of classification (the old rules). A fact sheet is under preparation on classification according to the Classification Regulation (CLP - the new rules).
Classification and labelling may still be made for mixtures according to the old rules until 1 June 2015.
For mixtures on the market before 1 December 2010 labeling must be updated within 1 June 2017.
For chemical substances the CLP entered into force on 1 June 2010.
Dangerous chemical substances and products (chemicals) must be classified and labelled. They must also be packaged responsiblyThe regulations govern chemicals sold to private consumers as well as professional users.
Examples of chemicals covered by the regulations and used by private consumers include “pure” chemicals, such as benzene (dry-cleaning fluid), acetic acid and mineral turpentine, and household products such as dishwasher detergent, chlorine-based cleaners and sprays for impregnating leather and textiles.
Consumers must be informed when products and chemicals are dangerous The regulations shall ensure that consumers and other users are clearly and systematically informed as to which chemicals and products are dangerous, the dangers of these chemicals &.c., and how to manage them.
Warning labels shall not be approved.
Manufacturers and importers responsible for classificationProducers and importers must be aware of, able to assess the dangers associated with chemicals and products, and able to classify the chemicals and products according to danger level.
Classification involves the assessment of whether a substance is dangerous to people or the environment and a describtion of the risks, using categories such as “HARMFUL”. Risk categories shall be used in conjunction with risk and safety phrases, such as “Harmful if swallowed” and “Keep out of the reach of children”.
The substances which the authorities have already classified as dangerous can be found in the list of dangerous substances. If a substance is not on the list of dangerous substances, the producer or importer must assess whether it should be classified as dangerous. The Danish EPA has published four sets of guidelines dealing with classification. Please refer to the links at the bottom of the page.
Product labels If a chemical or product is classified as dangerous, the producer or importer must affix a warning label to the packaging. This label must contain the following information:
• The chemical name or product trading name • Contents (weight or volume) – only applies to products sold to private consumers • The name, company address and telephone number of the producer or importer • The name(s) of the dangerous ingredients that have resulted in a danger classification • Chemicals must include the EC number (e.g. the EINECS or ELINCS number). Chemicals listed as dangerous must also bear the “EC label” designation • Risk description and symbols, risks (Risk phrases) and safety advice (Safety phrases)
Follow this link for more information on labelling (in Danish).
If a chemical product is classified as harmful, the chemical or chemicals responsible for the classification must be listed on the label. The only exemption is chemicals with local irritant effects.
Some products require additional labelling irrespective of their harmfulness (see Annex 2 of the Classification Statutory Order). These include:
• aerosols, • substances and products which are carcinogenic, mutagenic or toxic to reproduction, • products containing new substances, active chlorine, lead, cadmium, cyanoacrylates, epoxy compounds, isocyanates, halogenated carbohydrates or sensitising substances.
Cement and cement products must also be labelled with additional information in some cases.
The text of warning labels must be in Danish and stand out clearly from any other information on the packaging. It must be easy to read and not erasable. The colour and appearance of the label must ensure that the risk symbol stands out clearly in black ink against an orange background. The label must be at least 52 x 74 millimetres, increasing with the size of the package.
The risk symbol must take up at least ten per cent and not less than one square centimetre of the warning label.
The warning label text must run horizontally with the packaging in its usual orientation.
Tactile warning Chemical substances or retail products classified as “Extremely flammable”, “Highly flammable”, “Very toxic”, “Toxic”, “Corrosive” or “Harmful”, must bear a tactile warning for the visually impaired. The tactile warning takes the form of a raised triangle.
Examples of products included are methylated spirits and acetic acid.
Risk or safety phrases may be omitted on labels for small packages containing no more than 125 ml of highly flammable, oxidizing or irritant substances. The same applies to small packages containing harmful substances which are not on sale to private consumers.
Risk and safety phrases are not required for products classified as dangerous for the environment and assigned the “N” danger symbol, highly flammable, oxidizing or irritants with R36, R37 and/or R38.
Safety phrases may be omitted on containers of 125 ml or less of chemical products classified as flammable or dangerous for the environment without the “N” danger symbol.
Packaging A package containing dangerous chemical substances or products must fulfil the following requirements:
The package and its opening must be constructed in a way that the contents cannot leak out unintentionally.
The packaging material must be impermeable to the contents and must not react with them to form dangerous compounds.
The packaging must be able to easily withstand the type of handling experience has shown it will be subjected to.
Some substances and products must be fitted with child-resistant closures. Fact sheet: Child-resistant closures
Exemptions Cosmetics and pesticides are not covered by this regulation. The regulations do not apply to medications, foodstuffs or feedstuffs (cf. section 2)Fact sheet No. 5: Labelling cosmeticsFact sheet No. 11: Labelling and packaging pesticides
Producers and importers are responsible Any person producing or importing dangerous chemical substances or products must comply with the regulations in the Statutory Order.
The EPA's chemical inspectors monitor compliance with the regulations and have powers to enforce compliance. This may involve withdrawing the product from the Danish market, or legalising the product in some other way. Any person breaching the regulations may additionally face a fine or prison sentence of up to two years.
More informationThe Classification Order can be found via this link (in Danish only).
The CLP list of dangerous substances has replaced the Danish list. The Danish statutory order supplementing this list may be found here (in Danish only).
The Danish EPA also published a number of guidelines in Danish to the classification of chemical substances and products:Classification, etc. for chemical substances and products. Guide No. 3/2004Classification of dangerous chemical substances – required information. Guide No. 10/1997.Classification of dangerous chemical substances – optional information. Guide No. 11/1997.Classification of substances carcinogenic, mutagenic or toxic to reproduction. Guide No. 12/1997.
LinksEINECS list of existing substances (ECB website)ELINCS list of new substances (ECB website)
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National REACH helpdesk is a service established in every Member State providing advice to companies and other stakeholders on the obligations they may have under REACH.
The Danish REACH helpdesk:www.reachhelpdesk.dk (in Danish) Ph: + 45 7012 0211
Read more about REACH and national helpdesks atThe European Chemicals Agency