LegalizeReform history
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (Text with EEA relevance)
7 versions
· 2004-03-31
2015-06-01
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2012-04-19
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2009-06-27
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2009-04-20
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2009-01-20
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Changes on 2009-01-20
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(21) It is appropriate to recall that other horizontal legislation is applicable to detergent surfactants, in particular Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (<sup>16</sup>) by which the marketing and use of dangerous substances covered by this Regulation might be banned or restricted, Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (<sup>17</sup>), Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and the environment of substances notified in accordance with Council Directive 67/548/EEC (<sup>18</sup>), Regulation (EEC) No 793/93, and Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances (<sup>19</sup>); Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (<sup>20</sup>); Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances (codified version) (<sup>21</sup>); Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version) (<sup>22</sup>); and Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (<sup>23</sup>).
(22) It should be the responsibility of manufacturers to refrain from marketing detergents not complying with this Regulation and to have at the disposal of the national authorities the technical files for all substances and preparations covered by this Regulation; this should also apply to surfactants that have failed to pass the tests mentioned in Annex III.
(22) It should be the responsibility of manufacturers to refrain from marketing detergents not complying with this Regulation and to have at the disposal of the national authorities the technical files for all substances and mixtures covered by this Regulation; this should also apply to surfactants that have failed to pass the tests mentioned in Annex III.
(23) Manufacturers should be able to request a derogation from the Commission, which should have the possibility to grant such derogation in accordance with the procedure referred to in Article 12(2).
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For the purpose of this Regulation:
1.‘Detergent’ means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, moulded piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes.
1.‘Detergent’ means any substance or mixture containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, moulded piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes.
Other products to be considered as detergents are:
—‘Auxiliary washing preparation’, intended for soaking (pre-washing), rinsing or bleaching clothes, household linen, etc.;
—‘Auxiliary washing mixture’, intended for soaking (pre-washing), rinsing or bleaching clothes, household linen, etc.;
—‘Laundry fabric-softener’, intended to modify the feel of fabrics in processes which are to complement the washing of fabrics;
—‘Cleaning preparation’, intended for domestic all purposes cleaners and/or other cleaning of surfaces (e.g.: materials, products, machinery, mechanical appliances, means of transport and associated equipment, instruments, apparatus, etc.);
—‘Other cleaning and washing preparations’, intended for any other washing and cleaning processes.
—‘Cleaning mixture’, intended for domestic all purposes cleaners and/or other cleaning of surfaces (e.g.: materials, products, machinery, mechanical appliances, means of transport and associated equipment, instruments, apparatus, etc.);
—‘Other cleaning and washing mixtures’, intended for any other washing and cleaning processes.
2.‘Washing’ means the cleaning of laundry, fabrics, dishes and other hard surfaces.
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4.‘Substance’ means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
5.‘Preparation’ means a mixture or solution composed of two or more substances.
6.‘Surfactant’ means any organic substance and/or preparation used in detergents, which has surface-active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that it is capable of reducing the surface tension of water, and of forming spreading or adsorption monolayers at the water-air interface, and of forming emulsions and/or microemulsions and/or micelles, and of adsorption at water-solid interfaces.
5.‘ Mixture’ means a mixture or solution composed of two or more substances.
6.‘Surfactant’ means any organic substance and/or mixture used in detergents, which has surface-active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that it is capable of reducing the surface tension of water, and of forming spreading or adsorption monolayers at the water-air interface, and of forming emulsions and/or microemulsions and/or micelles, and of adsorption at water-solid interfaces.
7.‘Primary biodegradation’ means the structural change (transformation) of a surfactant by micro-organisms resulting in the loss of its surface-active properties due to the degradation of the parent substance and consequential loss of the surface-active property as measured by test methods listed in Annex II.
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3. The competent authority of the Member State, receiving applications for derogation in accordance with paragraphs 1 and 2, shall examine the requests, evaluate their compliance with the conditions for derogation and inform the Commission about the results within six months of receiving the complete application.
If the competent authority of the Member State deems it necessary for the evaluation of the risk which may be caused by a substance and/or a preparation, it shall, within three months of receiving the application, ask for further information, verification and/or confirmatory tests concerning these substances and/or preparations or their transformation products, of which they have been notified or have received information under this Regulation. The time period for the evaluation of the dossier by the competent authority of the Member State will start only after the dossier is completed with the additional information. If the requested information is not provided within 12 months, the application shall be considered incomplete and thus invalid. In such a case Article 6(2) shall not apply.
If the competent authority of the Member State deems it necessary for the evaluation of the risk which may be caused by a substance and/or a mixture, it shall, within three months of receiving the application, ask for further information, verification and/or confirmatory tests concerning these substances and/or mixtures or their transformation products, of which they have been notified or have received information under this Regulation. The time period for the evaluation of the dossier by the competent authority of the Member State will start only after the dossier is completed with the additional information. If the requested information is not provided within 12 months, the application shall be considered incomplete and thus invalid. In such a case Article 6(2) shall not apply.
If further information on metabolites is sought, stepwise testing strategies should be employed to ensure maximum use of in-vitro and other non-animal test methods.
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##### Information to be provided by manufacturers
1. Without prejudice to Article 17 of Directive 1999/45/EC, manufacturers placing on the market the substances and/or preparations covered by this Regulation shall hold at the disposal of the competent authorities of the Member States:
1. Without prejudice to Article 17 of Directive 1999/45/EC, manufacturers placing on the market the substances and/or mixtures covered by this Regulation shall hold at the disposal of the competent authorities of the Member States:
—information on one or more results of the tests mentioned in Annex III;
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(i)a technical file on results of the tests mentioned in Annex II,
(ii)a technical file on results of the tests and information mentioned in Annex IV.
2. Whenever substances and/or preparations covered by this Regulation are placed on the market, the manufacturer shall be responsible for the correct performance of the relevant tests mentioned above. He shall also have available documentation on the testing carried out to demonstrate compliance with this Regulation, and to show that he is allowed to benefit from the property rights concerning the test results, other than for those test results already in the public domain.
3. Manufacturers placing on the market the preparations covered by this Regulation shall, upon request, make available without delay and free of charge, to any medical personnel, an ingredient datasheet as stipulated in Annex VII C.
2. Whenever substances and/or mixtures covered by this Regulation are placed on the market, the manufacturer shall be responsible for the correct performance of the relevant tests mentioned above. He shall also have available documentation on the testing carried out to demonstrate compliance with this Regulation, and to show that he is allowed to benefit from the property rights concerning the test results, other than for those test results already in the public domain.
3. Manufacturers placing on the market the mixtures covered by this Regulation shall, upon request, make available without delay and free of charge, to any medical personnel, an ingredient datasheet as stipulated in Annex VII C.
This is without prejudice to the right of a Member State to request that such a datasheet be made available to a specific public body to which the Member State has assigned the task of providing this information to medical personnel.
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##### Labelling
1. The provisions of this Article are without prejudice to the provisions relating to the classification, packaging and labelling of dangerous substances and preparations in Directives 67/548/EEC and 1999/45/EC.
1. The provisions of this Article are without prejudice to the provisions relating to the classification, packaging and labelling of dangerous substances and mixtures in Directives 67/548/EEC and 1999/45/EC.
2. The following information must appear in legible, visible and indelible characters on the packaging in which the detergents are put up for sale to the consumer:
2007-01-12
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2006-07-11
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original version
Text at this date