This fact sheet describes the rules concerning the classification, packaging and labelling of chemical substances and mixtures in accordance with the CLP Regulation, Regulation (EC) No 1272/2008.
Hazardous chemical substances and mixtures (chemicals) must be classified and labelled. They must also be packaged adequately. The rules cover both chemicals that are sold for private use and chemicals that are used professionally. The purposes of these rules are to ensure that the hazard of substances and products is communicated to consumers and others in a systematic and obvious way. The users are thus informed about which substances and products are hazardous, what hazards they pose and how they should be handled.
Examples of chemicals for private use are "pure" chemicals such as petrol, acetic acid and white spirit, as well as everyday goods such as dishwasher powder, chlorine and sprays for impregnating leather and textiles. All these products are covered by the regulation:
Stepwise transition to new regulations for classification and labelling
The CLP Regulation is the new European legislation concerning the classification, labelling and packaging of chemical substances and mixtures which entered into force in 2009. The CLP Regulation supersedes the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (99/45/EC) in a stepwise process. During a transitional period, all chemicals must thus be classified in accordance with the Classification Regulation (CLP). The regulation is abbreviated to "CLP" from "Classification, Labelling and Packaging". Substances are to be classified, packaged and labelled in accordance with this Regulation by 1 December 2010 at the latest, whilst the corresponding date for mixtures is 1 June 2015.
Substances and mixtures that have already been placed on the market before 1 December 2010 in the case of substances, or 1 June 2015 in the case of mixtures, must be provided with new labelling and packaging pursuant to the Regulation no later than 1 December 2012 in the case of substances, or 1 June 2017 in the case of mixtures.
Read more about the classification of mixtures in accordance with the old Classification Statutory Order (fact sheet)
Manufacturers and importers must classify
Manufacturers and importers must have knowledge of and be able to assess the hazard of substances and mixtures and classify the substances and products into hazard classes.
Classifying means assessing whether a substance is hazardous to people and the environment and describing the hazard by use of hazard classes. A hazard class could for example be "acute toxicity" or "hazardous to the aquatic environment". The hazard classes are used together with hazard and precautionary statements in order to guide users. Examples of hazard and precautionary statements are "Harmful if swallowed" and " IF SWALLOWED: Rinse the mouth".
Substances which have already been classified as hazardous by the authorities can be found in the list of harmonised classifications (Annex VI of the CLP Regulation). If a substance is not on the list of harmonised classifications, the manufacturer or importer must assess whether or not it should be classified as hazardous. The criteria for classification are set out in Annex I of the Regulation.
The classification must be notified to the classification and labelling inventory (C & L Inventory) of the European Chemicals Agency (ECHA) in Helsinki. For existing hazardous substances, the deadline was 3 January 2011, whilst substances marketed after 1 December 2010 must be notified no later than one month after they are marketed. There is no lower weight limit for the notification of classifications.
The manufacturer or importer may establish higher or lower concentration limits for self-classified substances, deviating from the general concentration limits. The concentration limit indicates the threshold for when a constituent of a substance or mixture will result in a hazard classification of the substance and/or mixture as a whole.
Signal words, hazard and precautionary statements
Chemical substances and mixtures must be labelled with "signal words". The signal words are "Danger" and "Warning". "Danger" is used for the most hazardous substances and mixtures. As before, the hazard statements (formerly "R statements") are linked to the classification of the substance/mixture. The precautionary statements (formerly "S statements") must be selected taking into account the hazard statements and the intended use of the chemical.
Classification of mixtures
In cases where test data are available for a mixture, these data can be used (except as regards CMR effects). The "bridging principle" has been introduced as an entirely new principle for the classification of mixtures. This principle means that if, for example, sufficient information is available for similar tested mixtures and hazardous individual substances in the mixture, this information can be used to classify the mixture concerned. If the bridging principle cannot be used, the classification must be performed through calculation based on the hazard of the constituent substances.
Trials and test methods
New animal testing may only be conducted in the absence of any alternatives. No tests involving humans and other primates may be carried out. As before, substances and mixtures must be tested for their physical/chemical properties. There is no requirement to test for other properties in order to comply with the regulation.
The products must be labelled
If a substance or product is classified as hazardous, the manufacturer or importer must apply a label to the packaging which states:
Product indicators for substances are the name of the substance and other information that identifies the substance. For example, this may be the substance's identification number on the list of harmonised classifications or, if the substance is not on this list, the substance's name and identification number in the C & L Inventory. If the substance is not on these lists, the CAS no. and IUPAC name (or other international chemical designation) must be stated. Product indicators for mixtures are the identity of the substances that give rise to classification for health hazards. Exempted from this are substances with irritating effects.
The hazard pictograms are as follows:
Some mixtures require additional labelling, regardless of whether or not they are classified as hazardous (see Article 25 of the CLP Regulation), including:
The text on the label must be in Danish. The information given on the label must be clear, easy to read and indelible. The colour and appearance of the label must ensure that the hazard symbol clearly stands out with its black printing on a white background surrounded by a red frame. The label must be at least 52 x 74 mm in size. The larger the packaging, the larger the label should be.
Each hazard symbol must take up at least one fifteenth – and at least one square centimetre – of the label.
It must be possible to read the text on the label horizontally when the packaging is applied normally and the label must be securely attached to the packaging.
As regards small packages containing up to and not more than 125 ml, special exemptions from the labelling obligation apply. These exemptions are described in Annex 1 to the Regulation.
In the interests of the blind and the visually impaired, flammable, corrosive and particularly harmful chemical substances or mixtures that are supplied to the general public must carry a tactile warning. This tactile warning has the form of a raised triangle or three raised dots. The tactile warning applies to the following hazard classifications:
Germ cell mutagenicity, Category 2
Carcinogenicity, Category 2
Reproductive toxicity, Category 2
Respiratory sensitisation or Specific Target Organ Toxicity (STOT), Categories 1 and 2
Flammable gases, liquids and solids in Categories 1 and 2
Packaging that contains hazardous chemical substances or products must fulfil the following requirements, amongst others:
• Both the packaging itself and its closure must be designed so that the contents cannot unintentionally escape.
• The packaging material shall be capable of withstanding the contents and must not be capable of forming hazardous compounds with it.
• The packaging must be able to tolerate with certainty the treatment that experience indicates it will be exposed to.
Some substances and products must be provided with child-proof closure.
Cosmetics, medicines, medical equipment and pesticides are not covered by this regulation. In addition, the regulation does not apply to foodstuffs or animal feed (cf. Article 1)
Fact Sheet: Labelling of cosmetics (in Danish)
Fact Sheet: Labelling and packaging of pesticides (in Danish)
Manufacturers, importers and "downstream users" are responsibleAnyone who manufactures or imports a hazardous chemical substance or mixture is responsible for ensuring compliance with the provisions set out in the Regulation. Downstream users who use a substance or mixture for industrial or professional purposes are similarly subject to the provisions in the Regulation.
The Danish Environmental Protection Agency's Chemicals Inspection Service carries out inspection to ensure compliance with the regulation and shall ensure that unlawful circumstances are legitimised. This may mean that the product must be withdrawn from the Danish market or that the product must be made lawful in some other way. Contraventions of the regulations may in addition be punished by a fine or imprisonment for up to two years.
The Regulation in its entirety can be found at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:da:PDF (in Danish)
More about classification and labelling:http://www.mst.dk/Virksomhed_og_myndighed/Kemikalier/klassificering_emballering_maerkning/ (In Danish)
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