Hazardous chemical substances and mixtures shall be classified and labelled. They also need to be packaged safely. This fact sheet describes the rules for classification, labelling and packaging according to the CLP Regulation, EC no. 1272/2008.
The purpose of the rules is to ensure that consumers and workers are informed about the hazard of chemicals, the nature of the hazard and how to handle these chemicals in a safe way. By use of standardized labelling information the hazard information is supplied in systematic and in a systematic and clear way. The rules cover chemicals sold to the general public as well as for professional use. Examples of hazardous chemicals used on a daily basis in households are e.g. detergents, drain cleaners, paint, impregnation spray, glue, car care products etc. Proper classification and labelling it is the responsibility of the companies placing the chemicals on the market.
Classification, labelling and packaging according to the CLP Regulation
The CLP Regulation is the european legislation for classification, labelling and packaging of chemical substances and mixtures. The CLP Regulation has replaced the previous rules for classification and labelling (Directive 67/548/EEC og Directive 99/45/EC) which were implemented in the Danish Statutory order on classification. (Note however, that the Danish national rules on sale and storage of toxic substances and mixtures (according to the Statutory Order no. 1565 of 19/12-2022 (in danish) still apply. Fact Sheet: Sale and Storage on toxic substances and mixtures).
Manufacturers and importers shall classify
Manufacturers and importers should have knowledge about and be able to asses the hazards of the substances and mixtures they place on the market in order to classify and label in accordance with the CLP Regulation. You are an importer if you import a substance or a mixtures to EU from a non-EU country.
A classification is the assessment of the hazardous properties of a substance or a mixture in relation to the impact on health, environment and assessment of the physical hazards such as flammable or explosive properties. The different hazards are divided into different hazard classes. A hazard class can be e.g. “acute toxicity” or “hazardous to the aquatic environment”. The hazard classes are used together with hazard- and precautionary statements to guide the users. Hazard- and precautionary statements are e.g. ”Toxic if swallowed” and “IF SWALLOWED: Rinse mouth”.
Those substances that have already been classified by the authorities are listed in Annex VI of the CLP Regulation (List of substances with a harmonised classification). If a substance is not on the list of harmonised classifications the manufacturer or importer shall assess if the substance shall be classified as hazardous. This is called self-classification. If a substance has a harmonized classification in one or more hazard classes, the manufacturer or importer has to assess if the substance shall be self-classified in those hazard classes not covered by the harmonized classification.
The manufacturer or the importer can establish specific concentration limits for self-classified substances instead of using the generic concentration limits in case data are available to support this. The concentration limits sets the limit for the concentration of a substance in a mixture, which will lead to the classification of the mixture as a whole in a given hazard class.
Notification of substance classifications to the European Chemicals Agency (ECHA)
The classification of substances placed on the market in EU shall be notified to the European Chemical Agency (ECHA) in Helsinki. This is the case for substances on their own as well as substances in mixtures. The classification shall be notified no later than one month after the substance or mixture is placed on the market. There is no lower limit for the notification of substance classifications.
Classification of mixtures – used of different types of data
In case test data are available for a mixture as a whole such data may be used for classifying a mixture (except for CMR properties). A mixture may also be classified by use of the “bridging principles”. These principles imply that if adequate information is available for similar tested mixtures, such information can be used to classify the mixture in question. If there are not test data for the mixture as a whole and if the bridging principles are not applicable then the classification shall be based on the classification and the concentration of the individual substances in the mixture (“the calculation method”).
Testing for hazardous properties
Substances and mixtures shall be tested to assess their potential physical hazards. There is no requirement of testing for other properties, and new animal studies may only be conducted for assessment of health- and environmental hazards for classification purposes if there are no alternatives. Any available data shall be used as the starting point for the assessment of health- and environmental hazard.
Poison Centre Notification
Annex VIII to the CLP regulation places obligations on importers and downstream users who place hazardous mixtures on the EU market to provide specific information on the mixtures to appointed bodies. The annex also specifies a harmonized format for notifications. Miljøstyrelsen is the appointed body in Denmark and uses the ECHA PCN portal for submission.
The usage of XML formats, UFI generator, EuPCS and ECHA Submission Portal provided by the Agency is free of charge.
However, it needs to be noted that a fee may be levied in each Member State for each submission. It is at the discretion of the competent authority of the Member State where the submission is to be made to decide whether fees are applicable for submission to the national appointed body/bodies.
In Denmark, however, no fee is applicable for submission.
Information on poison centre notification and Unique Formula Identifier can be found on ECHA’s Poison Centre website
Labelling – requirements for information on the label
Hazardous substances and mixtures shall be labelled with hazard pictograms indicating the worst hazards represented and with a signal word. The signal words are either “Danger” or “Warning”. “Danger” is used for the most hazardous substances and mixtures.
The hazard (H) statements are reflected by the classification of the substance or mixture. The precautionary (P) statements shall be chosen (among several possible statements), taking into account the hazards represented and the normal foreseen use of the substance/mixture.
If a substance or a mixture is classified as hazardous it shall be labelled by the supplier.
The label shall contain the following information (according to article 17 of the CLP Regulation):
- The name or designation of the substance or mixture and the relevant “product identifiers”
- Nominal quantity (weight or volume) of the substance/mixture in the package made available to the general public
- Name, address and telephone number of the supplier
- Labelling with signal word, hazard- and precautionary statements
- One or more hazard pictograms
- Any supplementary labelling information if relevant (CLP article 25). inklusiv UFI
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 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.
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.
Supplementary labelling
Some mixtures require additional labelling, regardless of whether or not they are classified as hazardous (see Article 25 of the CLP Regulation), including:
- Aerosols
- Paints containing lead
- Cement and cement mixtures (depending on the chromium content)
- Mixtures containing, for example, cyanoacrylates, isocyanates, certain epoxy compounds, sensitising substances, halogenated hydrocarbons (liquid mixtures), active chlorine (mixtures sold for private use only), cadmium (mixtures intended for soldering only
Requirements of the size of the hazard label and the hazard pictograms
There are minimum requirements as of the size of the part of the label containing the hazard information. For packaging with a volume ≤ 3 L the label shall e.g. at least be 52 x74 mm. The bigger the paciaging the larger the hazard label.
Each hazard pictogram must take up at least one fifteenth of the label. For packaging with a volume ≤ 3 L the hazard pictogram shall be at least one square centimeter.
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.
Packaging
Packaging that contains hazardous chemical substances or mixtures must fulfil certain 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.
Tactile warning
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:
- Acute toxicity
- Skin corrosion
- Carcinogenicity, Category 2
- Mutagenicity, Category 2
- Reproductive toxicity, Category 2
- Respiratory sensitisation or Specific Target Organ Toxicity (STOT), Categories 1 and 2
- Aspiration hazard
- Flammable gases, liquids and solids in Categories 1 and 2
Child proof closure
Some substances and mixtures must be provided with child-proof closure. Fact Sheet: Child proof closures
Exemptions – products not covered by the CLP Regulation
A range of products covered by specific regulations in the EU and are exempted from the CLP Regulation. This applies e.g. to cosmetics, medicines, medical equipment, waste, food and feeding stuffs. Biocides and pesticides are – in addition to the CLP Regulation –covered by specific regulations, i.e. including requirements of approval by the authorities and further labelling.
Fact Sheet: Labelling of cosmetics
Control
Supervision of the rules The Danish Environmental Protection Agency's Chemical Inspection ensures that the rules in the CLP regulation are complied with and ensures that illegal conditions are legalized. This may mean that the product has to be withdrawn from the Danish market, or that the product has to be made legal in another way. If you violate the rules, you can also risk a fine or imprisonment for up to two years.