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Regulation (EC) No 648/2004 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (Text with EEA relevance)

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Article 1U.K.Objectives and scope

[F11.This Regulation establishes technical standards and requirements in relation to detergents and surfactants for detergents designed to achieve the free movement of those products throughout the United Kingdom while, at the same time, ensuring a high degree of protection for human health and the environment.]

2.[F2For those purposes, this Regulation establishes rules including those concerning the following aspects of placing detergents and surfactants for detergents on the Great Britain market:]

  • the biodegradability of surfactants in detergents;

  • restrictions or bans on surfactants on grounds of biodegradability;

  • [F3the additional labelling of detergents, including fragrance allergens;

  • the information that manufacturers must hold at the disposal of the [F4competent authority] and medical personnel;

  • limitations on the content of phosphates and other phosphorus compounds in consumer laundry detergents and consumer automatic dishwasher detergents.]

Textual Amendments

Article 2U.K.Definitions

For the purpose of this Regulation:

1.

‘Detergent’ means any substance or [F5mixture] 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 [F5mixture]’, 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 [F5mixture]’, 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 [F5mixtures]’, intended for any other washing and cleaning processes.

1a.

[F6‘Consumer laundry detergent’ means a detergent for laundry placed on the market for use by non-professionals, including in public laundrettes.

1b.

‘Consumer automatic dishwasher detergent’ means a detergent placed on the market for use in automatic dishwashers by non-professionals.]

2.

‘Washing’ means the cleaning of laundry, fabrics, dishes and other hard surfaces.

3.

[F3‘Cleaning’ means the process by which an undesirable deposit is dislodged from a substrate or from within a substrate and brought into a state of solution or dispersion.]

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.

‘[F5Mixture]’ means a mixture or solution composed of two or more substances.

6.

‘Surfactant’ means any organic substance and/or [F5mixture] 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.

8.

‘Ultimate aerobic biodegradation’ means the level of biodegradation achieved when the surfactant is totally used by micro-organisms in the presence of oxygen resulting in its breakdown to carbon dioxide, water and mineral salts of any other elements present (mineralisation), as measured by test methods listed in Annex III, and new microbial cellular constituents (biomass).

9.

[F3‘Placing on the market’ means the first making available on the [F7Great Britain] market. Import into [F8Great Britain] shall be deemed to be placing on the market.

9a.

‘Making available on the market’ means any supply for distribution, consumption or use on the [F9Great Britain] market in the course of a commercial activity, whether in return for payment or free of charge.]

10.

‘Manufacturer’ means the natural or legal person [F10, established in Great Britain or Northern Ireland,] responsible for placing a detergent or a surfactant for a detergent on the market; in particular, a producer, an importer, a packager working for his own account, or any person changing the characteristics of a detergent or of a surfactant for a detergent, or creating or changing the labelling thereof, shall be deemed to be a manufacturer. A distributor who does not change the characteristics, labelling or packaging of a detergent, or of a surfactant for a detergent, shall not be deemed to be a manufacturer, except where he acts as an importer.

11.

‘Medical personnel’ means a registered medical practitioner, or a person working under the direction of a registered medical practitioner, acting to provide patient care, make a diagnosis or administer treatment, and who is bound by professional confidentiality.

12.

‘Industrial and institutional detergent’ means a detergent for washing and cleaning outside the domestic sphere, carried out by specialised personnel using specific products.

13.

[F11‘Competent authority’ means the Secretary of State.

14.

‘Regulation (EU) 528/2012’ means Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.

15.

‘the REACH Regulation’ means Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency.

16.

‘qualifying Northern Ireland goods’ has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018. ]

Textual Amendments

Article 3U.K.The placing on the market

1.When placed on the market, detergents and surfactants for detergents referred to in Article 1 shall conform with the conditions, characteristics and limits laid down in this Regulation and its Annexes F12.... Surfactants that are also active substances within the meaning of [F13point (c) of Article 3(1) of Regulation (EU) 528/2012] and that are used as disinfectants are exempt from the provisions of Annexes II, III, IV and VIII of this Regulation provided:

[F14(a)they are included in:

  • — the GB list of approved active substances referred to in Article 8A of Regulation (EU) 528/2012, or

  • — the Simplified Active Substance List referred to in Article 24A of Regulation (EU) 528/2012 .]

(b)they are constituents of biocidal products authorised under [F15Article 55(1) or (2) of Regulation (EU) 528/2012], or

(c)they are constituents of biocidal products allowed under the transitional measures [F16provided for in Article 89(2) of Regulation (EU) 528/2012].

Instead, such surfactants are deemed to be disinfectants and the detergents of which they are ingredients are subject to the labelling provisions for disinfectants of Annex VII A.

F172.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.Manufacturers shall be responsible for the conformity of detergents and/or of surfactants for detergents with the provisions of this Regulation and its Annexes.

Textual Amendments

[F18Article 3AU.K. Qualifying Northern Ireland goods

1Where paragraph (2) applies, detergents and surfactants for detergents are to be treated as being in conformity with Article 3(1).

2This paragraph applies where the detergent or surfactant for a detergent—

(a)is in conformity with Article 3(1) of Regulation (EC) No 648/2004 as it has effect in EU law; and

(b)is a qualifying Northern Ireland good.]

Textual Amendments

Article 4U.K.Limitations based on the biodegradability of surfactants

1.Under this Regulation, surfactants and detergents containing surfactants that meet the criteria for ultimate aerobic biodegradation as laid down in Annex III may be placed on the market without further limitations relating to biodegradability.

2.If a detergent contains surfactants for which the level of ultimate aerobic biodegradation is lower than that stipulated in Annex III, manufacturers of industrial or institutional detergents containing surfactants, and/or of surfactants for industrial or institutional detergents, may ask for derogation. Requests for derogation shall be made and decided in accordance with Articles 5, 6 and 9.

3.The level of primary biodegradability shall be measured for all surfactants in detergents failing ultimate aerobic biodegradation tests. Detergent surfactants, for which the level of primary biodegradability is lower than that stipulated in Annex II, shall not be granted derogation.

[F6Article 4a U.K. Limitations on the content of phosphates and of other phosphorus compounds

Detergents listed in Annex VIa that do not comply with the limitations on the content of phosphates and of other phosphorus compounds laid down in that Annex shall not be placed on the market from the dates set out therein.]

Textual Amendments

Article 5U.K.Granting of derogation

1.The request by a manufacturer for derogation shall be made by sending an application to the competent authority F19... providing evidence relating to the criteria mentioned under Article 6(1). [F20The competent authority] can make the request for derogation dependent upon the payment F21... of a fee. Such fees, if any, shall be levied in a non-discriminatory way and shall not exceed the cost of processing the application.

2.Applications shall include a technical file supplying all the information and justifications necessary for evaluating the safety aspects related to the specific use of surfactants in detergents failing to comply with the biodegradability limits, as set out in Annex III.

In addition to the results of tests stipulated in Annex III, the technical file shall include information and results of tests, as stipulated in Annexes II and IV.

The tests laid down in Annex IV, point 4 shall be carried out on the basis of [F22the tiered approach referred to in the Commission Recommendation of 23rd December 2005 on the tiered approach technical guidance document for the purpose of implementing Regulation (EC) No 648/2004 of the European Parliament and the Council]. F23...

3.The competent authority F24..., receiving applications for derogation in accordance with paragraphs 1 and 2, shall examine the requests [F25and] evaluate their compliance with the conditions for derogation F26... within six months of receiving the complete application.

If the competent authority F27... deems it necessary for the evaluation of the risk which may be caused by a substance and/or a [F5mixture], it shall, within three months of receiving the application, ask for further information, verification and/or confirmatory tests concerning these substances and/or [F5mixtures] 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 F27... 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. F28...

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.

4.On the basis of, in particular, the evaluation carried out [F29under paragraph 3, the competent authority] may grant a derogation F30.... F31... [F32The competent authority shall make its decision within 12 months of completing the evaluation carried out under paragraph 3.]

5.Such derogations may allow, limit or severely restrict the placing on the market and the use of surfactants as ingredients in detergents, depending on the results of the complementary risk assessment, as defined in Annex IV. They may include a phase-out period for placing on the market and the use of surfactants as ingredients in detergents. The [F33competent authority] may review a derogation as soon as information comes to light which would justify a significant revision of the technical file that was included in the application for derogation. For this purpose, the manufacturer shall, upon request, supply to the [F33competent authority] a technical file that has been updated regarding the items mentioned in Annex IV, point 2. On the basis of this updated information, the [F33competent authority] may decide to prolong, modify or terminate the derogation. Paragraphs 1 to 4 and 6 of this Article and Article 6 shall apply mutatis mutandis.

6.The [F34competent authority] shall publish the list of surfactants that have obtained derogation, with the corresponding conditions or limitations of use, as provided in Annex V.

Textual Amendments

Article 6U.K.Conditions for granting a derogation

1.Where the [F35competent authority] considers granting a derogation, it shall do so F36... on the basis of the following criteria:

  • use in low-dispersive applications, rather than in wide-dispersive applications;

  • use in specific industrial and/or institutional applications only;

  • the risk to the environment or to health posed by the volume of sales and the pattern of use throughout [F37Great Britain] is small compared to the socio-economic benefits, including food safety and hygiene standards.

F382.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F393.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.The [F40competent authority] shall publish [F41a] list of surfactants that have been identified as not complying with this Regulation.

Textual Amendments

Article 7U.K.Testing of surfactants

All tests referred to in Articles 3 and 4 and in Annexes II, III, IV and VIII shall be conducted in compliance with the standards mentioned in Annex I.1 and in accordance with testing requirements under [F42Article 13(4) of the REACH Regulation]. For this purpose, it is sufficient to apply either the EN ISO/IEC standard or the principles of good laboratory practice, except for those tests for which the principles of good laboratory practice have been made mandatory. In cases where surfactants are used in detergents which were placed on the market before the entry into force of the above standard, existing tests that were performed using the best scientific knowledge available, and that were performed to a standard comparable to those of the standards mentioned in Annex I may be accepted on a case-by-case basis. The manufacturer F43... may submit to the [F44Secretary of State] any case over which there is doubt or dispute. F45...

[F46For each case submitted, the Secretary of State must make a decision as to whether or not the relevant tests may be accepted. The Secretary of State must:

  • — make a decision within 90 days of receiving the manufacturer's submission;

  • — take appropriate expert advice and take that advice into account when coming to a decision;

  • — after taking a decision, promptly communicate it to the manufacturer concerned together with an explanation of the appeal process set out below.

If the Secretary of State decides that the relevant tests may not be accepted, the manufacturer may, within 14 days of having that decision communicated to it by the Secretary of State, appeal to the court against that decision.

On appeal, the court may—

  • — allow the appeal and rule that the tests may be accepted,

  • — allow the appeal but rule that the tests may only be accepted if conditions specified by the court are fulfilled, or

  • — dismiss the appeal.

(Article 18A makes further provision concerning appeals).]

Textual Amendments

Article 8U.K.[F47Approved laboratories]

F481.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F492.Tests required by this Regulation may be carried out by approved laboratories only.

‘Approved laboratories’ are laboratories that are:

  • — members of the UK GLP compliance programme referred to in the Good Laboratory Practice Regulations 1999 , or

  • — able to demonstrate compliance with standard EN ISO/IEC 17025: 2017 (general requirements for the competence of testing and calibration laboratories) to the satisfaction of the competent authority.]

F503.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F514.The competent authority shall publish a list of approved laboratories.]

Textual Amendments

Article 9U.K.Information to be provided by manufacturers

1.[F5Without prejudice to Article 45 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures(1), manufacturers placing on the market the substances and/or mixtures covered by this Regulation shall hold at the disposal of the competent [F52authority]:]

  • information on one or more results of the tests mentioned in Annex III;

  • for those surfactants failing to pass tests mentioned in Annex III, and for which a request for derogation was made as referred to in Article 5:

    (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 [F5mixtures] covered by this Regulation are placed on the market, the manufacturer shall be responsible for the correct performance of the relevant tests mentioned above. [F53The manufacturer] shall also have available documentation on the testing carried out to demonstrate compliance with this Regulation, and to show that [F54the manufacturer] 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 [F5mixtures] 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 [F55the relevant Ministers] to request that such a datasheet be made available to [F56the National Poisons Information Service (‘NPIS’) or such other body to which the relevant Ministers assign] the task of providing this information to medical personnel [F57within their respective territories].

[F58For the purposes of this Article, ‘the relevant Ministers’ means:

  • in England, the Secretary of State;

  • in Wales, the Welsh Ministers;

  • in Scotland, the Scottish Ministers;]

The information contained in the datasheet shall be kept confidential by the [F59the NPIS or other body assigned under the second subparagraph] and by the medical personnel, and shall be used only for medical purposes.

Textual Amendments

Article 10U.K.Control measures

1.[F60The competent authority] may apply, as appropriate, all necessary control measures to detergents placed on the market which ensure the compliance of the product with the provisions of this Regulation. The reference method shall be the test and analytical methods referred to in Annex VIII. These control measures shall not oblige manufacturers to repeat tests made by laboratories fulfilling the conditions indicated in Article 8(2), or to pay for any repeat or additional test, provided the initial test has shown compliance of detergents, or surfactants used as ingredients in detergents, with this Regulation.

2.In cases of concern that a test carried out in accordance with the methods listed in Annex II, III, IV or VIII has produced false positive results, [F61the competent authority must make a decision as to whether or not the test concerned produced a false positive result. The competent authority must:

  • — make a decision within 90 days of it becoming aware of a concern that the relevant test may have produced a false positive result;

  • — take appropriate expert advice and take that advice into account when coming to a decision;

  • — after taking a decision, promptly communicate it to the manufacturer concerned together with an explanation of the appeal process set out below.]

[F623.If the competent authority decides that a test produced false positive results:

  • — those results must be disregarded for the purpose of ensuring compliance with the provisions of this Regulation;

  • — the manufacturer may, within 14 days of having that decision communicated to it by the competent authority, appeal to the court against the decision.

4.On appeal, the court may:

  • — allow the appeal and rule that the tests did not produce false positive results, or

  • — dismiss the appeal.

  • (Article 18A makes further provision concerning appeals).]

Textual Amendments

Article 11U.K.Labelling

[F51.Paragraphs 2 to 6 are without prejudice to the provisions relating to the classification, labelling and packaging of substances and mixtures in Regulation (EC) No 1272/2008.]

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:

(a)the name and trade name of the product;

(b)the name or trade name or trademark and full address and telephone number of the party responsible for placing the product on the market;

(c)the address, email address, where available, and telephone number from which the datasheet referred to in Article 9(3) can be obtained.

The same information must appear on all documents accompanying detergents transported in bulk.

3.The packaging of detergents shall indicate the content, in accordance with the specifications provided for in Annex VII A. It shall also indicate instructions for use and special precautions, if required.

[F34.Additionally, the packaging of consumer laundry detergents and consumer automatic dishwasher detergents shall bear the information provided for in section B of Annex VII.]

[F635.The information specified in paragraphs 3 and 4 must be in English although this does not prevent the same information from also appearing in other languages.]

F646.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F65Article 12U.K. Committee procedure

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Textual Amendments

[F66Article 13U.K. Power to amend the Annexes

1.The Secretary of State may make regulations:

  • — amending Annexes 1 to 4, 7 and 8 to this Regulation for the purpose of adapting them to scientific and technical progress;

  • — amending the provisions of the Annexes to this Regulation that concern solvent-based detergents;

  • — amending the concentration levels of allergenic fragrances set out in section A of Annex 7 to this Regulation to reflect individual risk-based concentration limits for fragrance allergens established by the Scientific Committee on Consumer Safety referred to in Article 1 of Commission Decision 721/2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment.

2.Regulations made under the first indent in paragraph 1 shall, wherever possible, reflect international standards.

3.Regulations under this Article may make:

  • — consequential, supplementary, incidental, transitional, transitory or saving provision;

  • — different provision for different purposes.

4.Regulations under this Article are to be made by statutory instrument.

5.A statutory instrument containing regulations under this Article is subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

F67Article 13aU.K. Exercise of the delegation

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Textual Amendments

F68Article 14U.K. Free movement clause

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Textual Amendments

Article 15U.K.Safeguard clause

[F31.Where [F69an appropriate authority with the necessary competence] has justifiable grounds for believing that a specific detergent, although complying with the requirements of this Regulation, constitutes a risk to the safety or health of humans or of animals or a risk to the environment, it may take all appropriate provisional measures, commensurate with the nature of the risk, in order to ensure that the detergent concerned no longer presents that risk, is withdrawn from the market or recalled within a reasonable period or its availability is otherwise restricted.

[F70Manufacturers and other natural or legal persons involved in the distribution, supply and sale of detergents must comply with provisional measures taken under this Article.]

[F71In any particular case, provisional measures may not be imposed for a period of more than ninety days.

After that ninety day period has ended, the General Product Safety Regulations 2005 are to apply to the specific detergents in respect of which provisional measures have been taken under this Article as if, in regulation 2 of those Regulations:

  • — in the definition of “product”, at the end, there were inserted “ “product” includes the specific detergents in respect of which provisional measures have been taken from time to time under Article 15 of Regulation (EC) No 648/2004 of the European Parliament and of the Council on detergents;”;

  • — in the definition of “safe product”, at the end of the first sentence, there were inserted “and for the environment”;]]

[F722.In this Article:

  • — ‘Appropriate authority’ means the Secretary of State or the devolved authority;

  • — ‘Devolved authority’ means:

    • in Scotland, the Scottish Ministers;

    • in Wales, the Welsh Ministers;]

[F733.The Secretary of State may impose provisional measures if and to the extent that the exercise of the function to impose those measures:

  • — relates to England;

  • — relates to Scotland and is not within devolved competence (within the meaning of section 54 of the Scotland Act 1998 );

  • — relates to Wales and is not within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006 );

4.The Scottish Ministers have competence to impose provisional measures if and to the extent that the exercise of the function to impose those measures is within devolved competence (within the meaning of section 54 of the Scotland Act 1998).

5.The Welsh Ministers have competence to impose provisional measures if and to the extent that the exercise of the function to impose those measures is within devolved competence (within the meaning of sections 58A(7) and (8) of the Government of Wales Act 2006).

8.When an appropriate authority takes provisional measures in accordance with paragraph 1:

  • — it must immediately inform the other appropriate authorities, giving reasons for its action and submitting the scientific or technical information on which it is based;

  • — the other appropriate authorities must decide whether or not to impose the same provisional measures within their respective areas of competence.]

Textual Amendments

F74Article 16U.K. Report

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Textual Amendments

Article 17U.K.Legislation to be repealed

1.The following Directives are hereby repealed with effect from 8 October 2005.

  • Directive 73/404/EEC;

  • Directive 73/405/EEC;

  • Directive 82/242/EEC;

  • Directive 82/243/EEC and

  • Directive 86/94/EEC.

2.Recommendation 89/542/EEC is hereby repealed with effect from 8 October 2005.

3.References made to the repealed Directives shall be construed as being references to this Regulation.

F754.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F76Article 18U.K. Penalties

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Textual Amendments

[F77Article 18AU.K.Appeals

1.In this Regulation, “court” means:

  • — in England and Wales, the county court;

  • — in Scotland, the sheriff;

2.Despite any rule of court to the contrary, an appeal under this Regulation:

  • — is to be a rehearing of the relevant decision;

  • — may be determined having regard to matters of which the competent authority or Secretary of State was unaware when making the decision.

3. In England and Wales, the county court may transfer appeal proceedings under this Regulation to the High Court.

4.In Scotland, the sheriff may transfer appeal proceedings under this Regulation to the Court of Session.]

Textual Amendments

Article 19U.K.Entry into force

This Regulation shall enter into force 8 October 2005.

F78...

Textual Amendments

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