This fact sheet informs you of the most important provisions of EU Regulation 648/2004/EC on detergents (the Detergent Regulation) on placing detergents on the market and the contents of non-ionic surfactants in detergents.
The Regulation also lays down a requirement as to which wash-active ingredients may be used and requirements as to the list of ingredients and the requirement for an information sheet on ingredients that must be available to the authorities and medical personnel.
Surfactants must be biodegradable
All surfactants must be completely aerobically biodegradable according to harmonised test-methods as laid down in the Regulation. This applies also to amphoteric and cationic tensides.
The packaging of detergents placed on the market for consumers must be labelled with the following information with legible, visible and indelible letters:
• The name of the product and the trade name;
• Name or trade name or brand and full address and telephone number of the person responsible for marketing activities;
• Address and telephone number and e-mail address where doctors can find relevant information about the ingredients of the product;
• The address of a website where there is access to the list of ingredients of the product;
• Dosage instructions as described.
Annex VII of the Regulation lays down the rules on listing ingredients in intervals by weight. In addition, preservation agents, enzymes and disinfectants, optical brighteners and perfume must be listed on the packaging irrespective of their concentration. Perfumes which by the Scientific Committee on Cosmetic Products (SCCP) have been assessed to be allergenic must be listed specifically by name if they occur in concentrations of more than 0.01 per cent by weight.
The enterprise responsible for the listing must be informed of all ingredients in the primary products that it receives from the supplier. E.g. a detergent manufacturer who uses essential oils in a product is responsible for making an assessment as to whether these oils have a natural content of fragrance allergens that must be put on the list of ingredients. This may be particularly relevant for the lemon in citrus oil.
Note that the rules on classification and labelling of chemical substances and products must also be complied with.
See fact sheet on classification, packaging and labelling.
Information for the authorities and medical personnel
Manufacturers and importers of detergents must on request, and immediately and free of charge, make an information sheet with all the ingredients available to medical personnel and national authorities.
Limited exemption clause
Manufacturers and importers of detergents for commercial use or use in institutions must apply for an exemption to use surfactants that do not meet the requirements for biodegradability. Exemption is only granted if the surfactants meet the requirement for primary biodegradability (at least 80 per cent corresponding to the previous rules), and if a supplementary risk assessment is carried out showing that there is no risk of serious environmental and health effects.
Any exemption is assessed based on the criteria
a) limited use instead of widespread use,
b) exclusively specific commercial and/or institutional use,
c) assessment of risks to environment and health in relation to the socio-economic benefits.
Applicants wishing to apply for exemptions must send applications to the national authority (in Denmark: The Danish Environmental Protection Agency).
Alternative to contents labelling of products for commercial use
If the detergents are only meant for commercial use and are not sold to ordinary consumers, the requirements for contents labelling do not need to be complied with if the corresponding information can be found in the form of technical information sheets, safety sheets or similar.
Amendment of the regulations
The first amendments of the Regulation entered into force on 11 July 2006. At this time an extra test-method was added in Annex III of the Regulation. A number of amendments to the regulations on labelling were also added as well as a data sheet for ingredients (Annex VII). These amendments took effect on 11 January 2007. Further amendments may be adapted to the legislation in the coming years. These will deal with new requirements on the contents of phosphates and the contents of wash-active ingredients that are non-degradable under oxygen-free conditions. In addition, the interpretation of the Regulation is regularly fine-tuned in special areas.
Manufacturers, importers and anyone who changes the products/the labelling are responsible
Manufacturers and importers are responsible for compliance with the provisions of the Regulation. Note that anyone who changes the properties of a detergent or a surfactant, or the labelling must also comply with the provisions of the Regulation.
The Environmental Protection Agency's chemical inspectors monitor compliance with the regulations and will ensure that illegal situations are brought into compliance. This may involve withdrawing the product from the Danish market, or making the product legal in some other way. Anyone who breaches the regulations may additionally face a fine or a prison sentence of up to two years.
The Statutory Order is available at the EUR-Lex website: Regulation (EC) No 648/2004 of 31 March 2004 of the European Parliament and of the Council on detergents. See also the website of the European Commission about detergents: http://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htm
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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