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

REGULATION (EC) No 648/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 31 March 2004

on detergents

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee ([^E0001]),

Acting in accordance with the procedure laid down in Article 251 of the Treaty ([^E0002]),

Whereas:

• (1) Council Directives 73/404/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to detergents ([^E0003]), 73/405/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactants ([^E0004]), 82/242/EEC of 31 March 1982 on the approximation of the laws of the Member States relating to methods of testing the biodegradability of non-ionic surfactants ([^E0005]), 82/243/EEC of 31 March 1982 amending Directive 73/405/EEC on the approximation of the laws of the Member States relating to methods of testing the biodegradability of anionic surfactants ([^E0006]) and 86/94/EEC of 10 March 1986 amending for the second time Directive 73/404/EEC on the approximation of the laws of the Member States relating to detergents ([^E0007]), have been significantly amended on several occasions. It is desirable, for reasons of clarity and rationalisation, that the provisions in question should be recast by bringing them all together in a single text. Commission Recommendation 89/542/EEC of 13 September 1989 ([^E0008]), as regards labelling provisions concerning detergents and cleaning products, should also be included in the single text.

• (2) Since the objective of this Regulation, to ensure the internal market in detergents, cannot be sufficiently achieved by the Member States, if there is no common technical criteria throughout the Community, and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of propotionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective. A Regulation is the appropriate legal instrument as it imposes directly on manufacturers precise requirements to be implemented at the same time and in the same manner throughout the Community; in the area of technical legislation, uniformity of application in the Member States is needed, and this can only be guaranteed by a Regulation.

• (3) A new definition for detergents is needed to cover equivalent uses and be in line with developments at Member State level.

• (4) It is necessary to introduce a surfactant definition, which was lacking in the existing legislation.

• (5) It is important to give a clear and precise description of the relevant types of biodegradability.

• (6) Measures concerning detergents should be adopted to ensure the functioning of the internal market and avoid restricting competition in the Community.

• (7) As confirmed by the Commission White Paper on the strategy for a future Chemical Policy, appropriate measures concerning detergents should ensure a high level of environmental protection, especially of the aquatic environment.

• (8) Detergents are already subject to certain Community provisions concerning their manufacture, proper handling, usage and labelling, in particular with reference to Commission Recommendation 89/542/EEC and Commission Recommendation 98/480/EC of 22 July 1998 concerning good environmental practice for household laundry detergents ([^E0009]); Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ([^E0010]) applies to detergents.

• (9) Ditallow-dimethyl-ammonium-chloride (DTDMAC) and nonylphenol (including ethoxylates derivatives-APEs) are priority substances undergoing at Community level risk assessment activities, in accordance with Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances ([^E0011]), and if necessary adequate strategies to limit the risks of exposure to these substances should therefore be recommended and implemented in the framework of other Community provisions.

• (10) The existing legislation on biodegradability of surfactants in detergents only covers primary biodegradability ([^E0012]) and it is only applicable to anionic ([^E0013]) and non-ionic ([^E0014]) surfactants; therefore it should be replaced by new legislation, which lays the main emphasis on ultimate biodegradability and meets the important concerns related to the potential toxicity of persistent metabolites.

• (11) This requires the introduction of a new set of tests based on EN ISO standards and OECD guidelines, which governs the granting of direct permission for placing detergents on the market.

• (12) To provide a high level of protection of the environment, detergents not fulfilling requirements laid down by this Regulation should not be placed on the market.

• (13) On 25 November 1999 the Scientific Committee on Toxicity, Ecotoxicity and the Environment issued an opinion on biodegradability of surfactants in detergents and relevance of test-methods for regulatory control in this area.

• (14) The existing requirements regarding primary biodegradability should be maintained on a second hierarchy level and supplemented by a complementary risk assessment, for those surfactants failing ultimate biodegradability tests; furthermore surfactants failing primary biodegradability tests should not obtain marketing authorisation by way of derogation

• (15) The primary biodegradability requirements should be extended to all surfactants, in particular cationic and amphoteric, whilst allowing the possibility of applying instrumental analyses in those cases in which semi-specific analytical methods are not suitable.

• (16) The determination of biodegradability test-methods and the record-keeping of lists of derogations are technical matters and should be revised taking into account technical and scientific developments as well as regulatory developments.

• (17) Test-methods should produce data that give sufficient assurance of aerobic biodegradability of surfactants in detergents.

• (18) Methods to test biodegradability of surfactants in detergents may produce variable results. In such cases they should be complemented by additional assessments in order to determine the risks of continued use.

• (19) Provisions should also be laid down regarding the placing on the market in exceptional cases of surfactants in detergents failing ultimate biodegradability tests and this should take place on the basis of all relevant information to ensure environmental protection and on a case by case basis.

• (20) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ([^E0015]).

• (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 ([^E0016]) 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 ([^E0017]), 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 ([^E0018]), 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 ([^E0019]); 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 ([^E0020]); 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) ([^E0021]); 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) ([^E0022]); 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 ([^E0023]).

• (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).

• (24) Member States' competent authorities should be able to apply control measures to detergents on the market, but should avoid repeating tests made by the competent laboratories.

• (25) The existing labelling provisions for detergents should be continued, including those in Recommendation 89/542/EEC, which are included in this Regulation in order to fulfil the objective of modernising the rules on detergents. Specific labelling is introduced to inform consumers about fragrance substances and preservation agents that are present in detergents. Medical personnel should be able to obtain from the manufacturer upon request a full listing of all ingredients of a detergent to assist them investigate whether a causal link exists between the development of an allergic response and exposure to a particular chemical substance, and Member States should be able to require that such a listing is also made available to a specific public body designated to provide this information to medical personnel.

• (26) All the above points call for new legislation replacing the existing legislation; however, for a certain period, Member States can continue to apply their existing laws.

• (28) Detergents complying with this Regulation should be allowed to be placed on the market without prejudice to other relevant Community provisions.

• (29) In order to ensure the protection of man and the environment from unforeseen risks of detergents, a safeguard clause is needed.

• (30) The tests specified for the biodegradability of surfactants should be carried out in laboratories meeting an internationally recognised standard, namely EN/ISO/IEC/17025 or the principles of good laboratory practice; it would not be justified to ask for the application of this latter requirement to existing surfactants to the extent that the available tests on them had been performed before the entering into force of the above standard and still provide a comparable level of scientific quality.

• (31) The issues relating to anaerobic biodegradation, the biodegradation of the main non-surfactant organic detergent ingredients, and phosphate content, which are not dealt with in this Regulation should be examined by the Commission and, where this is justified, a proposal should be presented to the European Parliament and the Council. Pending further harmonisation, the Member States may maintain or lay down national rules concerning the above issues.

• (32) The five Directives and the Commission Recommendation mentioned in recital (1) which are replaced by this Regulation should be repealed,

HAVE ADOPTED THIS REGULATION:

Article 1

Objectives and scope

• —the biodegradability of surfactants in detergents;

• —restrictions or bans on surfactants on grounds of biodegradability;

• —the additional labelling of detergents, including fragrance allergens;

• —the information that manufacturers must hold at the disposal of the Member States’ competent authorities and medical personnel;

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

Article 2

Definitions

For the purpose of this Regulation:

• 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  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  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.

• 1a.‘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.‘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.‘ 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.

• 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.‘Placing on the market’ means the first making available on the Union market. Import into the Union customs territory 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 Union 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 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.

Article 3

The placing on the market

• (a)they are listed in Annex I or IA of Directive 98/8/EC, or

• (b)they are constituents of biocidal products authorised under Article 15(1) or 15(2) of Directive 98/8/EC, or

• (c)they are constituents of biocidal products allowed under the transitional measures or subject to the 10 year work programme provided for in Article 16 of Directive 98/8/EC.

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.

Article 4

Limitations based on the biodegradability of surfactants

Article 4a

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.

Article 5

Granting of derogation

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 a tiered approach. The tiered approach will be defined in a technical guidance document to be adopted in accordance with the procedure referred to in Article 12(2) by 8 April 2007. This guidance document will also specify, where appropriate, those tests for which the principles of good laboratory practice should be applied.

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.

Article 6

Conditions for granting a derogation

• —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 the Community is small compared to the socio-economic benefits, including food safety and hygiene standards.

Article 7

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 Article 10(5) of Regulation (EEC) No 793/93. 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 or the Member State may submit to the Commission any case over which there is doubt or dispute. A decision shall then be taken in accordance with the procedure laid down in Article 12(2).

Article 8

Duties of the Member States

Article 9

Information to be provided by manufacturers

• —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.

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.

The information contained in the datasheet shall be kept confidential by the specific public body and by the medical personnel, and shall be used only for medical purposes.

Article 10

Control measures

Article 11

Labelling

• (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.

Article 12

Committee procedure

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Article 13

Adaptation of Annexes

Article 13a

Exercise of the delegation

Article 14

Free movement clause

Article 15

Safeguard clause

The Member State shall immediately inform the other Member States and the Commission thereof, giving the reasons for its decision.

Article 16

Report

Article 17

Legislation to be repealed

• —Directive 73/404/EEC;

• —Directive 73/405/EEC;

• —Directive 82/242/EEC;

• —Directive 82/243/EEC and

• —Directive 86/94/EEC.

Article 18

Penalties

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. This may also include appropriate measures allowing the competent authorities of the Member States to prevent the making available on the market of detergents or surfactants for detergents that fail to comply with this Regulation. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions and any subsequent amendment affecting those provisions to the Commission without delay.

Those rules shall include measures allowing the competent authorities of Member States to detain consignments of detergents that fail to comply with this Regulation.

Article 19

Entry into force

This Regulation shall enter into force 8 October 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Standards of accreditation, good laboratory practice and animal protection concerning the laboratories that are competent and authorised to provide the necessary service for checking compliance of detergents with the requirements of this Regulation and its Annexes

1. Standards applicable at the level of the laboratories:

EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories;

Directive 2004/10/EC;

Council Directive 86/609/EEC.

2. Standards applicable at the level of the accreditation bodies and good laboratory practice monitoring authorities:

EN 45003, Calibration and testing laboratory accreditation system, general requirements for operation and recognition;

Directive 2004/9/EC.

ANNEX II

PRIMARY BIODEGRADABILITY TEST METHODS FOR SURFACTANTS IN DETERGENTS

Primary biodegradability is measured by the determination in biodegraded liquors of the remaining level of parent surfactants. This Annex begins with a list of the test-methods common to all classes of surfactants, and then lists under headings A to D the analytical test procedures specific to each class of surfactant.

The pass criterion for primary biodegradability shall be a level of at least 80 %, as measured according to the test methods below.

The reference method for the laboratory testing of surfactants in this Regulation is based on the Confirmatory test procedure in the OECD method, described in Annex VIII.1. Changes to the Confirmatory test procedure are permissible provided that they comply with EN ISO 11733.

Test methods

• (1)The OECD method published in the OECD's technical report of 11 June 1976 on the ‘Proposed Method for the Determination of the Biodegradability of Surfactants in Synthetic Detergents’.

• (2)The method in use in France, approved by the ‘arrêté du 24 décembre 1987’ published in the Journal officiel de la République française of 30 December 1987, p. 15385, and by the standard NF 73-260 of June 1981, published by the Association française de normalisation (AFNOR).

• (3)The method in use in Germany, established by the ‘Verordnung über die Abbaubarkeit anionischer und nichtionischer grenzflächenaktiver Stoffe in Wasch- und Reinigungsmitteln’ of 30 January 1977, published in the Bundesgesetzblatt of 1977, Part I, p. 244, as set out in the Regulation amending that Regulation of 4 June 1986, published in the Bundesgesetzblatt of 1986, Part I, p. 851.

• (4)The method in use in the United Kingdom called the ‘Porous Pot Test’ and described in Technical Report No 70 (1978) of the Water Research Centre.

• (5)The ‘Confirmatory test procedure’ in the OECD method, described in Annex VIII.1 (including possible changes in operating conditions as proposed in EN ISO 11733). This is also the reference method used for the settlement of litigation.

A. ANALYTICAL METHODS FOR ANIONIC SURFACTANTS

The determination of anionic surfactants in the tests shall be done by the Methylene Blue Active Substance (MBAS) analysis according to the criteria established in Annex VIII.2. For those anionic surfactants not reacting to the abovementioned MBAS method, or if it seems more appropriate for reasons of efficiency or precision, appropriate specific instrumental analyses such as high performance liquid chromatography (HPLC) or gas chromatography (GC) are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent authorities of the Member States upon request.

B. ANALYTICAL METHODS FOR NON-IONIC SURFACTANTS

The determination of non-ionic surfactants in the tests shall be done by the Bismuth Active Substance (BiAS) method, according to the analytical procedure established in Annex VIII.3.

For those non-ionic surfactants not reacting to the abovementioned BiAS method, or if it seems more appropriate for reasons of efficiency or precision, appropriate specific instrumental analyses such as HPLC or GC are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent authorities of the Member States upon request.

C. ANALYTICAL METHODS FOR CATIONIC SURFACTANTS

The determination of cationic surfactants in the tests shall be done by the Disulfine Blue Active Substance (DBAS) analysis according to the following DBAS procedures:

The method in use in the Federal Republic of Germany, (1989) DIN 38 409 — Ausgabe: 1989-07.

For those cationic surfactants not reacting to the abovementioned test method, or if it seems more appropriate for reasons of efficiency or precision (this must be justified), appropriate specific instrumental analyses such as HPLC or GC are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent national authorities of the Member States upon request.

D. ANALYTICAL METHODS FOR AMPHOTERIC SURFACTANTS

The determination of amphoteric surfactants in the tests shall be done by analysis following the procedures listed below:

• 1.If cationics absent: The method in use in the Federal Republic of Germany, (1989) DIN 38 409-Teil 20.

• 2.Otherwise: Orange II method (Boiteux, 1984). For those amphoteric surfactants not reacting to the abovementioned tests, or if it seems more appropriate for reasons of efficiency or precision (this must be justified), appropriate specific instrumental analyses such as HPLC or GC are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent authorities of the Member States upon request.

ANNEX III

ULTIMATE BIODEGRADABILITY (MINERALISATION) TEST METHODS FOR SURFACTANTS IN DETERGENTS

• A.The reference method for laboratory testing of surfactant ultimate biodegradability in this Regulation is based on the EN ISO standard 14593: 1999 (CO2 headspace test). Surfactants in detergents shall be considered as biodegradable if the level of biodegradability (mineralisation) measured according to one of the following tests ([^E0026]) is at least 60 % within 28 days: 1.EN ISO Standard 14593: 1999 — Water quality — Evaluation of ultimate aerobic biodegradability of organic compounds in aqueous medium — Method by analysis of inorganic carbon in sealed vessels (CO2 headspace test). Pre-adaptation is not to be used. The 10-day window principle is not applied (reference method). 2.Directive 67/548/EEC method, Annex V.C.4-C (carbon dioxide (CO2) Eeolution modified Sturm test): pre-adaptation is not to be used. The 10-day window principle is not applied. 3.Directive 67/548/EEC method, Annex V.C.4-E (closed Bottle): pre-adaptation is not to be used. The 10-day window principle is not applied. 4.Directive 67/548/EEC method, Annex V.C.4-D (manometric respirometry): pre-adaptation is not to be used. The 10-day window principle is not applied. 5.Directive 67/548/EEC method, Annex V.C.4-F (MITI: Ministry of International Trade and Industry, Japan): pre-adaptation is not to be used. The 10-day window principle is not applied. 6.ISO 10708:1997 — Water quality — Evaluation in an aqueous medium of the ultimate aerobic biodegradability of organic compounds — Determination of biochemical oxygen demand in a two-phase closed bottle test. Pre-adaptation is not to be used. The 10-day window principle is not applied.

• B.Depending on the physical characteristics of the surfactant, one of the methods listed below may be used if appropriately justified ([^E0027]). It should be noted that the pass criterion of at least 70 % of these methods is to be considered as equivalent to the pass criterion of at least 60 % referred to in methods listed in point A. The adequacy of the choice of the methods listed below shall be decided on a case-by-case confirmation, in accordance with Article 5 of this Regulation. 1.Directive 67/548/EEC method, Annex V.C.4-A (dissolved organic carbon DOC die-away): pre-adaptation is not to be used. The 10-day window principle is not applied. The pass criteria for biodegradability measured according to the test shall be at least 70 % within 28 days. 2.Directive 67/548/EEC method, Annex V.C.4-B (modified OECD screening-DOC die-away): pre-adaptation is not to be used. The 10-day window principle is not applied. The pass criteria for biodegradability measured according to the test shall be at least 70 % within 28 days.

NB: Those of the abovementioned methods that are taken from Council Directive 67/548/EEC can also be found in the publication ‘Classification, Packaging and Labelling of Dangerous Substances in the European Union’, Part 2: ‘Testing Methods’. European Commission 1997, ISBN 92-828-0076-8.

ANNEX IV

COMPLEMENTARY RISK ASSESSMENT FOR SURFACTANTS IN DETERGENTS

For those surfactants for which an environmental risk assessment is available in the context of Directive 93/67/EEC, or Regulation (EEC) No 793/93 and Regulation (EC) No 1488/94, and Technical Guidance Documents, this risk assessment shall be considered together with the complementary risk assessment run in the scope of this Regulation.

The complementary risk assessment run in the scope of this Regulation, in case it is likely that recalcitrant metabolites are produced, shall be considered in the context of assessments made on the basis of Directive 93/67/EEC or Regulation (EEC) No 793/93. This is to be assessed case by case and in particular on the basis of the results of the tests referred to in part 3.

The study shall cover the aquatic environmental compartment. Additional information relating to specific risk assessment concerns might be required by the Committee referred to in Article 12(2) on a case by case basis. Additional information might include other environmental compartments such as sewage sludge and soil. A tiered approach shall be adopted concerning the information required for the technical file referred to in Articles 5 and 9. The file shall contain at least the information described under points 1, 2 and 3 below.

However, to minimise testing, and especially to avoid unnecessary animal testing, the additional studies listed under point 4.2.2 should be requested only where such information is necessary and proportionate. In case of dispute concerning the extent of additional information required, a Decision may be taken in accordance with the procedure laid down in Article 12(2).

As noted in Article 13, the guidelines included in this Annex for the Decisions on derogation may be adapted as appropriate on the basis of the accumulated experience.

1. Identity of the surfactant (in accordance with the provisions laid down by Annex VII.A of Directive 67/548/EEC).

1.1.   Name

• 1.1.1. Names in the IUPAC nomenclature

• 1.1.2. Other names

• 1.1.3. CAS number and CAS name (if available)

• 1.1.4. Einecs ([^E0028]) or Elincs ([^E0029]) numbers (if available)

1.2.   Molecular and structural formula

1.3.   Composition of the surfactant

2. Information on the surfactant

• 2.1. Quantities of the surfactant used in detergents

• 2.2. The information on use patterns given in this section shall be sufficient to allow an approximate but realistic estimate of function and environmental exposure to the surfactant as associated with its use in detergents. It shall include the following:

• —importance of the application (societal value),

• —use conditions (release scenario),

• —use volume,

• —availability and suitability of alternatives (performance and economic considerations),

• —assessment of relevant environmental information.

3. Information on the potential recalcitrant metabolites

Toxicity information on test liquors shall be provided. If no data are available on residue identity, the information referred to in point 4.2.1 may be requested, depending on the potential risk, the importance and the quantity of the surfactant used in detergents. In conflicting cases concerning this information, a Decision may be taken in accordance with the procedure laid down in Article 12(2).

4. Additional studies

4.1.   Biodegradability tests

4.1.1.   Pre-adapted inoculum

Any of the tests described in Annex III, may be run with pre adapted inoculum in order to provide evidence of the relevance of pre-adaptation for the surfactant.

4.1.2.   Inherent Biodegradability Tests

At least one of the tests referred to below shall be included:

• —method of the Directive 67/548/EEC, Annex V.C.12 (Modified SCAS test),

• —method of the Directive 67/548/EEC, Annex V.C.9 (Zahn-Wellens).

Failure to pass the inherent biodegradability test would indicate potential for persistency which may be considered, in general terms, as sufficient to prohibit the placing on the market of such a surfactant except in cases where the criteria set out in Article 6 indicate that there is no justification for refusing a derogation.

4.1.3.   Activated Sludge Simulation Biodegradability Tests

The following tests referred below shall be included:

• —method of the Directive 67/548/EEC, Annex V.C.10 (including possible changes in operating conditions as proposed in EN ISO 11733).

Failure to pass the activated sludge simulation biodegradability test would indicate potential for the release of the metabolites by sewage treatment, which may be considered, in general terms, as evidence of need for a more complete risk assessment.

4.2.   Toxicity testing of biodegradation test liquors

Toxicity information on test liquors is to be provided on:

4.2.1.   Chemical and physical information, such as:

• —identity of the metabolite (and analytical means by which it was obtained);

• —key physical chemical properties (water solubility, Octanol: Water partition coefficient (Log Po/w, etc.).

4.2.2.   Effects on organisms. Tests to be conducted in compliance with the principles of good laboratory practice.

Fish: the test recommended is that in Annex V.C.1 of Directive 67/548/EEC

Daphnia: the test recommended is that in Annex V.C.2 of Directive 67/548/EEC

Algae: the test recommended is that in Annex V.C.3 of Directive 67/548/EEC

Bacteria: the test recommended is that in Annex V.C.11 of Directive 67/548/EEC

4.2.3.   Degradation

Biotic: the test recommended is that in Annex V.C.5 of Directive 67/548/EEC

Abiotic: the test recommended is that in Annex V.C.7 of Directive 67/548/EEC. The information to be provided will consider as well the potential of metabolites for bio-concentration and their partitioning to the sediment phase.

Moreover, if some metabolites are suspected for endocrine disrupting activity, it is recommended to determine if these have potential to result in adverse affects as soon as validated testing schemes to assess such adverse effects are available.

N.B.

All the abovementioned tests can also be consulted in the publication Classification, Packaging and Labelling of Dangerous Substances in the European Union; Part 2: ‘Testing Methods’. European Commission 1997. ISBN 92-828-0076-8.

ANNEX V

LIST OF SURFACTANTS THAT HAVE OBTAINED A DEROGATION

By way of derogation granted in accordance with Articles 4-6 and in accordance with the procedure laid down in Article 12(2), the following detergent surfactants, which pass the tests stipulated in Annex II, but which fail the tests stipulated in Annex III, may be placed on the market and used subject to the limitations mentioned below.

Name in the IUPAC nomenclature	EC Number	CAS number	Limitations
Alcohols, Guerbet, C16-20, ethoxylated, n-butyl ether (7-8EO)	None (polymer)	147993-59-7	May be used for the following industrial applications until 27 June 2019: — bottle washing, — cleaning-in-place, — metal cleaning,

The ‘EC number’ means the Einecs, ELINCS or NLP number and is the official number of the substance within the European Union.

‘Einecs’ means the European Inventory of Existing Commercial Chemical Substances. This inventory contains the definitive list of all substances deemed to be on the Community market on 18 September 1981. The Einecs number can be obtained from the European Inventory of Existing Commercial Chemical Substance ([^E0030]).

‘ELINCS’ means the European List of Notified Chemical Substances. The ELINCS number can be obtained from the European List of Notified Substances, as amended ([^E0031]).

‘NLP’ means No-Longer Polymer. The term polymer is defined in Article 3(5) of Regulation (EC) No 1907/2006 ([^E0032]) of the European Parliament and of the Council. The NLP number can be obtained from the list of ‘No-Longer Polymers’, as amended ([^E0033]).

ANNEX VI

LIST OF BANNED OR RESTRICTED DETERGENT SURFACTANTS

The following detergent surfactants have been identified as not complying with the provisions of this Regulation:

Name in the IUPAC nomenclature	EC Number	CAS number	Limitations

The ‘EC number’ means the Einecs, ELINCS or NLP number and is the official number of the substance within the European Union.

ANNEX VIa

LIMITATIONS ON THE CONTENT OF PHOSPHATES AND OF OTHER PHOSPHORUS COMPOUNDS

Detergent	Limitations	Date as of which the limitation applies
1. Consumer laundry detergents	Shall not be placed on the market if the total content of phosphorus is equal to or greater than 0,5 grams in the recommended quantity of the detergent to be used in the main cycle of the washing process for a standard washing machine load as defined in section B of Annex VII for water of hard water hardness — for ‘normally soiled’ fabrics in the case of heavy-duty detergents, — for ‘lightly soiled’ fabrics in the case of detergents for delicate fabrics,	30 June 2013
2. Consumer automatic dishwasher detergents	Shall not be placed on the market if the total content of phosphorus is equal to or greater than 0,3 grams in the standard dosage as defined in section B of Annex VII	1 January 2017

ANNEX VII

LABELLING AND INGREDIENT DATA SHEET

A. Labelling of contents

The following provisions on labelling shall apply to the packaging of detergents sold to the general public.

The following weight percentage ranges:

• —less than 5 %,

• —5 % or over but less than 15 %,

• —15 % or over but less than 30 %,

• —30 % and more,

shall be used to indicate the content of the constituents listed below where they are added in a concentration above 0,2 % by weight:

• —phosphates,

• —phosphonates,

• —anionic surfactants,

• —cationic surfactants,

• —amphoteric surfactants,

• —non-ionic surfactants,

• —oxygen-based bleaching agents,

• —chlorine-based bleaching agents,

• —EDTA and salts thereof,

• —NTA (nitrilotriacetic acid) and salts thereof,

• —phenols and halogenated phenols,

• —paradichlorobenzene,

• —aromatic hydrocarbons,

• —aliphatic hydrocarbons,

• —halogenated hydrocarbons,

• —soap,

• —zeolites,

• —polycarboxylates.

The following classes of constituent, if added, shall be listed irrespective of their concentration:

• —enzymes,

• —disinfectants,

• —optical brighteners,

• —perfumes.

If added, preservation agents shall be listed, irrespective of their concentration, using where possible the common nomenclature established under Article 8 of Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products ([^E0034]).

If added at concentrations exceeding 0,01 % by weight, the allergenic fragrances that appear on the list of substances in Annex III, Part 1 to Directive 76/768/EEC, as a result of its amendment by Directive 2003/15/EC of the European Parliament and of the Council ([^E0035]) to include the allergenic perfume ingredients from the list first established by the Scientific Committee on Cosmetics and Non-food Products (SCCNFP) in its opinion SCCNFP/0017/98, shall be listed using the nomenclature of that Directive, as shall any other allergenic fragrances that are subsequently added to Annex III, Part 1 to Directive 76/768/EEC by adaptation of that Annex to technical progress.

The website address, from which the list of ingredients mentioned in section D of Annex VII can be obtained, shall be given on the packaging.

For detergents intended to be used in the industrial and institutional sector, and not made available to members of the general public, the abovementioned requirements do not have to be fulfilled if the equivalent information is provided by means of technical data sheets, safety data sheets, or in a similar appropriate manner.

B. Labelling of dosage information

As prescribed in Article 11(4), the following provisions on labelling shall apply to the packaging of detergents sold to the general public.

Consumer laundry detergents

The packaging of detergents sold to the general public intended to be used as laundry detergents shall bear the following information:

• —the recommended quantities and/or dosage instructions expressed in millilitres or grams appropriate to a standard washing machine load, for soft, medium and hard water hardness levels and making provision for one or two cycle washing processes,

• —for heavy-duty detergents, the number of standard washing machine loads of ‘normally soiled’ fabrics, and, for detergents for delicate fabrics, the number of standard washing machine loads of ‘lightly soiled’ fabrics, that can be washed with the contents of the package using water of medium hardness, corresponding to 2,5 millimoles CaCO3/l,

• —the capacity of any measuring cup, if provided, shall be indicated in millilitres or grams, and markings shall be provided to indicate the dose of detergent appropriate for a standard washing machine load for soft, medium and hard water hardness levels,

The standard washing machine loads are 4,5 kg dry fabric for heavy-duty detergents and 2,5 kg dry fabric for light-duty detergents, in line with the definitions of Commission Decision 1999/476/EC of 10 June 1999 establishing the Ecological Criteria for the award of the Community Eco-label to Laundry Detergents ([^E0036]). A detergent shall be considered to be a heavy-duty detergent unless the claims of the manufacturer predominantly promotes fabric care, i.e. low temperature wash, delicate fibres and colours.

Consumer automatic dishwasher detergents

The packaging of detergents sold to the general public intended to be used as automatic dishwasher detergents shall bear the following information:

• —the standard dosage expressed in grams or ml or number of tablets for the main washing cycle for normally soiled tableware in a fully loaded 12 place settings dishwasher, making provisions, where relevant, for soft, medium, and hard water hardness.

C. Ingredient data sheet

The following provisions shall apply to the listing of ingredients on the data sheet referred to in Article 9(3).

The data sheet shall list the name of the detergent and that of the manufacturer.

All ingredients shall be listed; in order of decreasing abundance by weight, and the list shall be sub-divided into the following weight percentage ranges:

• —10 % or more,

• —1 % or over, but less than 10 %,

• —0,1 % or over, but less than 1 %,

• —less than 0,1 %.

Impurities shall not be considered to be ingredients.

‘Ingredient’ means any chemical substance, of synthetic or natural origin, intentionally included in the composition of a detergent. For the purpose of this Annex, a perfume, an essential oil, or a colouring agent shall be considered to be a single ingredient and none of the substances that they contain shall be listed, with the exception of those allergenic fragrance substances that appear on the list of substances in Annex III, Part 1 to Directive 76/768/EEC if the total concentration of the allergenic fragrance substance in the detergent exceeds the limit mentioned in section A.

The common chemical name or IUPAC ([^E0037]) name and, where available, the INCI ([^E0038]) name, the CAS number, and the European Pharmacopoeia name, shall be given for each ingredient.

D. Publication of the list of ingredients

Manufacturers shall make available on a website the ingredient data sheet mentioned above except for the following:

• —information on weight percentage ranges is not required

• —CAS numbers are not required

• —the ingredient names shall be given in INCI nomenclature, or where this is not available, the European Pharmacopoeia name, shall be given. If neither name is available, the common chemical name or IUPAC name shall be used instead. For a perfume the word ‘parfum’ shall be used and for a colouring agent, the word ‘colorant’. A perfume, an essential oil, or a colouring agent shall be considered to be a single ingredient and none of the substances that they contain shall be listed, with the exception of those allergenic fragrance substances that appear on the list of substances in Annex III, Part 1 to Directive 76/768/EEC if the total concentration of the allergenic fragrance substance in the detergent exceeds the limit mentioned in section A.

Access to the website shall not be subject to any restriction or condition and the content of the website shall be kept up to date. The website shall include a link to the Commission Pharmacos website or to any other suitable website that provides a table of correspondence between INCI names, European Pharmacopoeia names, and CAS numbers.

This obligation shall not apply to industrial or institutional detergents, or to surfactants for industrial or institutional detergents, for which a technical data sheet or safety data sheet is available.

ANNEX VIII

TEST METHODS AND ANALYTICAL METHODS

The following test and analytical methods apply to control procedures for detergents on the market carried out by Member States:

1. Reference method (confirmatory test)

1.1.   Definition

This method describes a laboratory model of the activated sludge + secondary settler which is designed to simulate municipal sewage treatment. The conditions described are those from the Directives that preceded this Regulation. Improved state-of-the-art operating conditions can be applied to this test method as described in EN ISO 11733.

1.2.   Equipment needed for measurement

The method of measurement employs the small-activated sludge plant shown in Figure 1, and in greater detail in Figure 2. The equipment consists of a sewage vessel A for synthetic sewage, dosing pump B, aeration vessel C, settling vessel D, air-lift pump E to recycle the activated sludge, and vessel F for collecting the treated effluent.