Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1529590660380&uri=CELEX:02004R0648-20150601
Timestamp: 2019-11-22 07:07:56
Document Index: 601471049

Matched Legal Cases: ['art 2', 'art 2', 'art 1', 'art 1', 'art 1', 'art 1']

2004R0648 — EN — 01.06.2015 — 007.001
(OJ L 104 8.4.2004, p. 1)
COMMISSION REGULATION (EC) No 907/2006 of 20 June 2006
REGULATION (EC) No 1336/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
COMMISSION REGULATION (EC) No 551/2009 of 25 June 2009
REGULATION (EU) No 259/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 March 2012
Council Directives 73/404/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to detergents ( 3 ), 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 ( 4 ), 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 ( 5 ), 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 ( 6 ) 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 ( 7 ), 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 ( 8 ), as regards labelling provisions concerning detergents and cleaning products, should also be included in the single text.
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.
A new definition for detergents is needed to cover equivalent uses and be in line with developments at Member State level.
It is necessary to introduce a surfactant definition, which was lacking in the existing legislation.
It is important to give a clear and precise description of the relevant types of biodegradability.
Measures concerning detergents should be adopted to ensure the functioning of the internal market and avoid restricting competition in the Community.
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.
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 ( 9 ); 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 ( 10 ) applies to detergents.
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 ( 11 ), 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.
The existing legislation on biodegradability of surfactants in detergents only covers primary biodegradability ( 12 ) and it is only applicable to anionic ( 13 ) and non-ionic ( 14 ) 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.
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.
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.
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.
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
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.
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.
Test-methods should produce data that give sufficient assurance of aerobic biodegradability of surfactants in detergents.
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.
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.
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 ( 16 ) 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 ( 17 ), 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 ( 18 ), 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 ( 19 ); 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 ( 20 ); 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) ( 21 ); 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) ( 22 ); 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 ( 23 ).
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 ►M2 mixtures ◄ covered by this Regulation; this should also apply to surfactants that have failed to pass the tests mentioned in Annex III.
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).
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.
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.
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.
Detergents complying with this Regulation should be allowed to be placed on the market without prejudice to other relevant Community provisions.
In order to ensure the protection of man and the environment from unforeseen risks of detergents, a safeguard clause is needed.
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.
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.
The five Directives and the Commission Recommendation mentioned in recital (1) which are replaced by this Regulation should be repealed,
— 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.
1. ‘Detergent’ means any substance or ►M2 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.
— ‘Auxiliary washing ►M2 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 ►M2 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 ►M2 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. ‘ ►M2 Mixture ◄ ’ means a mixture or solution composed of two or more substances.
6. ‘Surfactant’ means any organic substance and/or ►M2 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.
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.
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 ►M2 mixture ◄ , it shall, within three months of receiving the application, ask for further information, verification and/or confirmatory tests concerning these substances and/or ►M2 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.
— 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.
4. The Commission shall make publicly available the lists of competent authorities, mentioned in paragraph 1, and of approved laboratories, mentioned in paragraph 2.
1. ►M2 Without 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 ( 24 ), 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;
— 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:
2. Whenever substances and/or ►M2 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 ►M2 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.
1. 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.
4. Additionally, the packaging of consumer laundry detergents and consumer automatic dishwasher detergents shall bear the information provided for in section B of Annex VII.
1. The Commission shall be empowered to adopt delegated acts in accordance with Article 13a in order to introduce amendments necessary for adapting Annexes I to IV, VII and VIII to scientific and technical progress. The Commission shall, wherever possible, use European standards.
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 13a in order to introduce amendments to the Annexes of this Regulation regarding solvent-based detergents.
3. Where individual risk-based concentration limits for the fragrance allergens are established by the Scientific Committee on Consumer Safety, the Commission shall adopt delegated acts in accordance with Article 13a in order to adapt the limit of 0,01 % set out in section A of Annex VII accordingly.
2. The power to adopt delegated acts referred to in Article 13 shall be conferred on the Commission for a period of 5 years from 19 April 2012. By 19 July 2016, the Commission shall draw up a report in respect of the delegation of power. The delegation of power shall be tacitly extended for further periods of 5 years, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each such period.
3. The delegation of power referred to in Article 13 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
1. Member States shall not prohibit, restrict or impede the making available on the market of detergents, and/or of surfactants for detergents, which comply with the requirements of this Regulation, on grounds that are dealt with in this Regulation.
2. Member States may maintain or lay down national rules concerning restrictions on the content of phosphates and of other phosphorus compounds in detergents for which no restrictions on the content are set out in Annex VIa where justified, in particular, on grounds such as the protection of public health or the environment and where technically and economically feasible alternatives are available.
3. Member States may maintain national rules that were in force on 19 March 2012 concerning restrictions on the content of phosphates and of other phosphorus compounds in detergents for which restrictions set out in Annex VIa have not yet become applicable. Such existing national measures shall be reported to the Commission by 30 September 2012 and may remain in force until the date when the restrictions set out in Annex VIa apply.
4. From 19 March 2012 until 31 December 2016 Member States may adopt national rules that implement the restriction on the content of phosphates and of other phosphorus compounds laid down in the point 2 of Annex VIa, where justified, in particular, on grounds such as the protection of public health or the environment and where technically and economically feasible alternatives are available. Member States shall notify such measures to the Commission in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services ( 25 ).
5. The Commission shall make publicly available the list of national measures referred to in paragraphs 3 and 4.
1. Where a Member State 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.
The Member State shall immediately inform the other Member States and the Commission thereof, giving the reasons for its decision.
1. By 31 December 2014, the Commission shall, taking into account information from Member States on the content of phosphorus in consumer automatic dishwasher detergents placed on the market in their territories and in the light of any existing or new scientific information available to it regarding substances employed in phosphates-containing and alternative formulations, evaluate by way of a thorough assessment whether the restriction set out in point 2 of Annex VIa should be modified. That assessment shall include an analysis of the impact on the environment, industry and consumers of consumer automatic dishwasher detergents with phosphorus levels above and below the limit value set out in Annex VIa, taking into account matters including cost, availability, cleaning efficiency and the impact on waste water treatment. The Commission shall submit that thorough assessment to the European Parliament and to the Council.
2. In addition, if the Commission, on the basis of the thorough assessment referred to in paragraph 1, considers that the restriction of phosphates and other phosphorus compounds used in consumer automatic dishwasher detergents requires revision, it shall, by 1 July 2015, present an appropriate legislative proposal. Any such proposal must be aimed at minimising the negative impact from all consumer automatic dishwasher detergent products on the wider environment, whilst considering any economic costs as identified in that thorough assessment. Unless the European Parliament and the Council, on the basis of such a proposal, decide otherwise by 31 December 2016, the limit value set out in point 2 of Annex VIa shall become the limitation for phosphorus content in consumer automatic dishwasher detergents from the date set out in that point.
— Directive 73/404/EEC;
— Directive 73/405/EEC;
— Directive 82/242/EEC;
— Directive 82/243/EEC and
— Directive 86/94/EEC.
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.
(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.
The method in use in the Federal Republic of Germany, (1989) DIN 38 409 — Ausgabe: 1989-07.
Surfactants in detergents shall be considered as biodegradable if the level of biodegradability (mineralisation) measured according to one of the following tests ( 26 ) 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 ( 27 ). 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.
Names in the IUPAC nomenclature
CAS number and CAS name (if available)
Einecs ( 28 ) or Elincs ( 29 ) numbers (if available)
Quantities of the surfactant used in detergents
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.
— 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).
— method of the Directive 67/548/EEC, Annex V.C.10 (including possible changes in operating conditions as proposed in EN ISO 11733).
— 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.).
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.
— 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 ( 30 ).
‘ELINCS’ means the European List of Notified Chemical Substances. The ELINCS number can be obtained from the European List of Notified Substances, as amended ( 31 ).
‘NLP’ means No-Longer Polymer. The term polymer is defined in Article 3(5) of Regulation (EC) No 1907/2006 ( 32 ) of the European Parliament and of the Council. The NLP number can be obtained from the list of ‘No-Longer Polymers’, as amended ( 33 ).
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,
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
LABELLING AND INGREDIENT DATA SHEET
A. Labelling of contents
— less than 5 %,
— 5 % or over but less than 15 %,
— 15 % or over but less than 30 %,
— 30 % and more,
— 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.
— enzymes,
— optical brighteners,
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 ( 34 ).
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 ( 35 ) 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.
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 ( 36 ). 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.
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.
— 10 % or more,
— 1 % or over, but less than 10 %,
— 0,1 % or over, but less than 1 %,
— less than 0,1 %.
‘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 ( 37 ) name and, where available, the INCI ( 38 ) 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.
— 160 mg peptone;
— 110 mg meat extract;
— 30 mg urea, CO(NH2)2;
— 7 mg sodium chloride, NaCl;
— 4 mg calcium chloride, CaCl2.2H2O;
— 2 mg magnesium sulphate, MgSO4.7H2O;
— 28 mg of di-potassium hydrogen phosphate, K2HPO4;
— and 10 ± 1 mg of the surfactant.
Dissolve 24 g sodium bicarbonate, NaHCO3 AR, and 27 g anhydrous sodium carbonate (Na2CO3) AR in deionised water and dilute to 1 000 ml.
Dissolve 0,35 g methylene blue AR in deionised water and dilute to 1 000 ml. Prepare the solution at least twenty-four hours before use. The absorbency of the blank chloroform phase, measured against chloroform must not exceed 0,015 per 1 cm of layer thickness at 650 nm.
Dissolve 0,35 g methylene blue AR in 500 ml deionised water and mix with 6,5 ml H2SO4 (d = 1,84 g/ml). Dilute to 1 000 ml with deionised water. Prepare the solution at least twenty-four hours before use. The absorbency of the blank chloroform phase, measured against chloroform must not exceed 0,015 per 1 cm of layer thickness at 650 nm.
Chloroform (trichloromethane) AR freshly distilled
Ethanol pure, C2H5OH
sulphuric acid, H2SO4 0,5 M
Methanolic hydrochloric acid: 250 ml hydrochloric acid AR and 750 ml methanol
Graduated flask, 50 ml
Graduated flask, 500 ml
Graduated flask, 1 000 ml
Round-bottomed flask with ground glass stopper and reflux condenser, 250 ml; boiling granules
Photometer for measurements at 650 nm, with 1 to 5 cm cells
Qualitative grade filter paper
From a weighing pipette, weigh 400 to 450 mg of dodecyl-benzene-sulphonic-acid-methyl-ester (2.2.5) to the nearest 0,1 mg in a round-bottomed flask and add 50 ml of ethanolic potassium hydroxide solution (2.2.6) and some boiling granules. After mounting the reflux condenser, boil for one hour. After cooling, wash the condenser and ground glass joint with about 30 ml of ethanol, and add these washings to the contents of the flask. Titrate the solution with sulphuric acid against phenolphthalein until it becomes colourless. Transfer this solution to a 1 000 ml graduated flask (2.2.14), dilute to the mark with deionised water and mix.
Pure ethyl acetate, freshly distilled.
Sodium bicarbonate, NaHCO3 AR.
Dilute hydrochloric acid [20 ml concentrated acid (HCl) diluted to 1 000 ml with water]
Methanol AR, freshly distilled, stored in a glass bottle.
Bromocresol purple, 0,1 g in 100 ml methanol.
Precipitating agent: the precipitating agent is a mixture of two volumes of solution A and one volume of solution B. The mixture is stored in a brown bottle and can be used for up to one week after mixing.
Dissolve 1,7 g bismuth nitrate, BiONO3.H2O AR, in 20 ml glacial acetic acid, and make up to 100 ml with water. Then dissolve 65 g potassium iodide AR in 200 ml water. Mix these two solutions in a 1 000 ml measuring flask, add 200 ml glacial acetic acid (3.2.7) and make up to 1 000 ml with water.
Dissolve 290 g barium chloride, BaCl2.2H2O AR, in 1 000 ml of water.
Glacial acetic acid 99-100 % (lower concentrations are unsuitable).
Ammonium tartrate solution: mix 12,4 g tartaric acid AR and 12,4 ml of ammonia solution AR (d = 0,910 g/ml) and make up to 1 000 ml with water (or use the equivalent amount of ammonium tartrate AR).
Dilute ammonia solution: 40 ml ammonia solution AR (d = 0,910 g/ml) diluted to 1 000 ml with water.
Standard acetate buffer: dissolve 40 g solid sodium hydroxide AR, in 500 ml water in a beaker and allow to cool. Add 120 ml glacial acetic acid (3.2.7). Mix thoroughly, cool and transfer to a 1 000 ml volumetric flask. Make up to the mark with water.
Pyrrolidinedithiocarbamate solution (known as ‘carbate solution’): dissolve 103 mg sodium pyrrolidinedithiocarbamate, C5H8NNaS2.2H2O, in about 500 ml water, add 10 ml of n-amyl alcohol AR and 0,5 g NaHCO3 AR, and make up to 1 000 ml with water.
Copper sulphate solution (for standardisation of 3.2.11).
Mix 1,249 g copper sulphate, CuSO4.5H2O AR, with 50 ml 0,5 M sulphuric acid and make up to 1 000 ml with water.
Mix 50 ml stock solution with 10 ml 0,5 M H2SO4 and make up to 1 000 ml with water.
Gas-stripping apparatus (see Figure 5).
Magnetic stirrer with magnet 25-30 mm.
Gooch crucible, diameter of the perforated base = 25 mm, Type G4.
Circular glass-fibre filter papers, 27 mm diameter with fibre diameter 0,3-1,5 m.
Two filter flasks with adapters and rubber collars, 500 and 250 ml respectively.
Recording potentiometer fitted with a bright platinum indicator electrode and a calomel or silver/silver chloride reference electrode with a 250 mV range, with automatic burette of 20-25 ml capacity, or alternative manual equipment.
Run off the organic phase into a separating funnel. Return any water in the separating funnel from the aqueous phase — it should only be a few ml — to the stripping apparatus. Filter the ethyl acetate phase through a dry qualitative filter paper into a 250 ml beaker.
Then add 10 ml standard acetate buffer (3.2.10), immerse the electrodes in the solution, and titrate potentiometrically with standard ‘carbate solution’ (3.2.11), the burette tip being immersed in the solution.
3.3.6. Control of the factor of the ‘carbate solution’
Determine the factor for the carbate solution on the day of use. To do this, titrate 10 ml of the copper sulphate solution (3.2.12) with ‘carbate solution’ after the addition of 100 ml water and 10 ml standard acetate buffer (3.2.10). If the amount used is a ml, the factor f is:
Every non-ionic surfactant has its own factor, depending on its composition, particularly on the length of the alkene oxide chain. The concentration of non-ionic surfactant is expressed in relation to a standard substance — a nonyl phenol with ten ethylene oxide units (NP 10) — for which the conversion factor is 0,054.
(b — c) xfx 0,054 = mg non-ionic surfactant as NP 10
volume of ‘carbate solution’ used by the sample (ml),
volume of ‘carbate solution’ used by the blank (ml),
factor of the ‘carbate solution’.
Alcoholic extraction followed by separation of the anionic surfactants by ion exchange
— 50 parts by volume isopropanol, CH3CHOH.CH3, and
— 50 parts by volume water (4.3.1)
4.3.5. Ammonium bicarbonate solution (60/40 v/v): 0,3 mol NH4HCO3 in 1 000 ml of an isopropanol/water mixture consisting of 60 parts by volume isopropanol and 40 parts by volume water (4.3.1)
4.3.9. 2 000 ml round-bottomed flask with ground glass stopper and reflux condenser
4.3.11. 2 000 ml filter flask
Normally, the quantity of product to be extracted will not exceed 1 000 g, but it may be necessary to extract further quantities of sample. For practical reasons, the quantity of product used should in most cases be limited to 5 000 g in preparing extracts for the biodegradation test.
Add 250 g of the synthetic detergent to be analysed to 1 250 ml ethanol, heat the mixture to boiling point and reflux for one hour with stirring. Pass the hot alcoholic solution through a coarse-pored suction filter heated to 50 ° C and filter rapidly. Wash the flask and suction filter with approximately 200 ml hot ethanol. Collect the filtrate and filter washings in a filter flask.
In the case of pastes or liquid products to be analysed, make sure that not more than 55 g anionic surfactants and 35 g soap are contained in the sample. Evaporate this weighed sample to dryness. Dissolve the residue in 2 000 ml ethanol and proceed as described above. In the case of powders of low apparent density (< 300 g/l) it is recommended to increase the ethanol ratio in the relation 20:1. Evaporate the ethanolic filtrate to dryness, preferably by means of a rotary evaporator. Repeat the operation if a greater quantity of extract is required. Dissolve the residue in 5 000 ml isopropanol/water mixture.
Place 600 ml cation-exchange resin (4.3.6) in a 3 000 ml beaker and cover by adding 2 000 ml hydrochloric acid (4.3.8). Allow to stand for at least two hours, with occasional stirring.
Displace the water with 2 000 ml isopropanol/water mixture (4.3.3) at a rate of 10-30 ml/min. The exchange column is now ready for operation.
Place 600 ml anion-exchange resin (4.3.7) in a 3 000 ml beaker and cover by adding 2 000 ml deionised water.
Wash the column with 0,3 M ammonium bicarbonate solution (4.3.5) until free of chloride. This requires about 5 000 ml solution. Wash again with 2 000 ml deionised water. Displace the water with 2 000 ml isopropanol/water mixture (4.3.3) at a rate of 10-30 ml/min. The exchange column is now in the OH-form and ready for operation.
Connect the exchange columns so that the cation-exchange column is placed on top of the anion-exchange column.
Heat 5 000 ml of the solution obtained in item 4.4.2 to 60 ° C and pass the solution through the exchanger combination at a rate of 20 ml/min. Wash the columns with 1 000 ml hot isopropanol/water mixture (4.3.3).
To obtain the anionic surface active agents (MBAS), disconnect the KAT column. Using 5 000 ml ethanol/CO2 solution at 50 ° C (4.3.4), elute the soap fatty acids out of the KAT column. Reject the eluate.
Then elute the MBAS out of the AAT column with 5 000 ml ammonium bicarbonate solution (4.3.5). Evaporate the eluate to dryness using a steam bath or in a rotary evaporator.
Then pass 2 000 ml isopropanol/water mixture (4.3.3) down the anion exchanger to wash. The anion exchanger is again ready for operation.
The treatment of non-ionic surface-active agents and formulated detergents prior to the determination of primary biodegradability in the confirmatory test is:
Alcoholic extraction followed by separation of the non-ionic surfactants by ion exchange
Isolation and separation of non-ionic surface active agents from soap, anionic and cationic surfactants are required for correct biodegradability tests.
After homogenising, the concentration of anionic and non-ionic surfactants in the detergent is determined according to the MBAS and BiAS analytical procedure. The soap content is determined by a suitable analytical method.
From a homogeneous sample (powders, dried paste and dried liquids) an ethanol extract is obtained which contains the surfactants, soap and other alcohol-soluble constituents of the detergent sample.
— 50 parts by volume water (5.3.1)
— Ammonium bicarbonate solution (60/40 v/v):
5.3.4. 0,3 mol NH4HCO3 in 1 000 ml of an isopropanol/water mixture consisting of 60 parts by volume isopropanol and 40 parts by volume water (5.3.1)
5.3.7. 2 000 ml round-bottomed flask with ground glass stopper and reflux condenser
5.3.9. 2 000 ml filter flask
The quantity of surfactant necessary for the degradation test is about 25 g BiAS.
In preparing extracts for the degradation tests, the quantity of product to be used should be limited to a maximum of 2 000 g. Therefore it may be necessary to carry out the operation two or more times in order to obtain sufficient quantity for the degradation tests.
Add 250 g of the synthetic detergent to be analysed to 1 250 ml ethanol and heat the mixture to boiling point and reflux for one hour with stirring. Pass the hot alcoholic solution through a coarse-pored suction filter heated to 50 ° C and filter rapidly. Wash the flask and suction filter with approximately 200 ml hot ethanol. Collect the filtrate and filter washings in a filter flask.
In the case of powders of low apparent density (< 300 g/l) it is recommended to increase the ethanol ratio in the relation 20:1.
Evaporate the ethanolic filtrate to complete dryness, preferably by means of rotary evaporator. Repeat the operation if a greater quantity of extract is required. Dissolve the residue in 5 000 ml isopropanol/water mixture.
Place 600 ml cation-exchange resin (5.3.5) in a 3 000 ml beaker and cover by adding 2 000 ml hydrochloric acid (5.3.7). Allow to stand for at least two hours, with occasional stirring.
Displace the water with 2 000 ml isopropanol/water mixture (5.3.3) at a rate of 10-30 ml/min. The exchange column is now ready for operation.
Place 600 ml anion-exchange resin (5.3.6) in a beaker and cover by adding 2 000 ml deionised water. Allow the resin to swell for at least two hours. Transfer the resin into the column by means of deionised water. The column should contain a glass-wool plug.
Wash the column with 0,3 M ammonium bicarbonate solution (5.3.4) until free of chloride. This requires about 5 000 ml solution. Wash again with 2 000 ml deionised water.
Displace the water with 2 000 ml isopropanol/water mixture (5.3.3) at a rate of 10-30 ml/min. The exchange column is now in the OH form and ready for operation.
Connect the exchange columns so that the cation-exchange column is placed on top of the anion-exchange column. Heat the exchange columns to 50 ° C using thermostatic control. Heat 5 000 ml of the solution obtained in item 5.4.2 to 60 ° C and pass the solution through the exchanger combination at a rate of 20 ml/min. Wash the columns with 1 000 ml hot isopropanol/water mixture (5.3.3).
Passing about 5 000 -6 000 ml of ammonium bicarbonate solution (5.3.4) down the column at a flow rate of approximately 10 ml/min until the eluate is free from anionic surfactants (methylene blue test) regenerates the anion-exchange resin. Then pass 2 000 ml isopropanol/water mixture (5.3.3) down the anion exchanger to wash. The anion exchanger is again ready for operation.
Figure 1 Activated sludge plant: overviews
Aeration chamber (three litres capacity)
Sintered aerator
Figure 2 Activated sludge plant: detail (dimensions in millimetres)
Glass or waterproof plastic (hard PVC)
Figure 3 Calculation of biodegradability — Confirmatory test
Period used for calculation (twenty-one days)
Readily biodegradable surfactant
Surfactant not readily biodegradable
Biodegradation ( %)
Figure 4 Heated exchange column (dimensions in millimetres)
Figure 5 Gas stripping apparatus (dimensions in millimetres)
( 1 ) OJ C 95, 23.4.2003, p. 24.
( 2 ) Opinion of the European Parliament of 10 April 2003 (not yet published in the Official Journal), Council Common Position of 4 November 2003 (OJ C 305 E, 16.12.2003, p. 11) and Position of the European Parliament of 14 January 2004 (not yet published in the Official Journal). Decision of the Council of 11 March 2004.
( 3 ) OJ L 347, 17.12.1973, p. 51. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122,16.5.2003, p. 36).
( 4 ) OJ L 347, 17.12.1973, p. 53. Directive as amended by Directive 82/243/EEC (OJ L 109, 22.4.1982, p. 11).
( 5 ) OJ L 109, 22.4.1982, p. 1.
( 6 ) OJ L 109, 22.4.1982, p. 18.
( 7 ) OJ L 80, 25.3.1986, p. 51.
( 8 ) OJ L 291, 10.10.1989, p. 55.
( 9 ) OJ L 215, 1.8.1998, p. 73.
( 10 ) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
( 11 ) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003.
( 12 ) Directives 73/404/EEC and 86/94/EEC.
( 13 ) Directives 73/405/EEC and 82/243/EEC.
( 14 ) Directive 82/242/EEC.
( 16 ) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commission Directive 2004/21/EC (OJ L 57, 25.2.2004, p. 4).
( 17 ) OJ L 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003.
( 18 ) OJ L 227, 8.9.1993, p. 9.
( 19 ) OJ L 161, 29.6.1994, p. 3.
( 20 ) OJ L 123, 24.4.1998, p. 1. Directive as amended by Regulation (EC) No 1882/2003.
( 21 ) OJ L 50, 20.2.2004, p. 44.
( 22 ) OJ L 50, 20.2.2004, p. 28.
( 23 ) OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230, 16.9.2003, p. 32).
( 24 ) OJ L 353, 31.12.2008, p. 1.
( 25 ) OJ L 204, 21.7.1998, p. 37.
( 26 ) These tests are identified as the most suitable for surfactants.
( 27 ) The DOC methods could give results on the removal and not on the ultimate biodegradation. The manometric respirometry and the MITI and two-phase BOD methods would not be appropriate in some cases because the high initial test concentration could be inhibitory.
( 28 ) European Inventory of Existing Commercial Substances.
( 29 ) European List of Notified Chemical Substances.
( 30 ) OJ C 146 A, 15.6.1990, p. 1.
( 31 ) Office for Official Publications of the European Communities, 2006, ISSN 1018-5593 EUR 22543 EN.
( 32 ) OJ L 396, 30.12.2006, p. 1, as corrected by OJ L 136, 29.5.2007, p. 3.
( 33 ) Office for Official Publications of the European Communities, 2007, ISSN 1018-5593 EUR 20853 EN/3.
( 34 ) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32).
( 35 ) OJ L 66, 11.3.2003, p. 26.
( 36 ) OJ L 187, 20.7.1999, p. 52. Decision as amended by Decision 2011/264/EU (OJ L 111, 30.4.2011, p. 34).
( 37 ) International Union of Pure and Applied Chemistry.
( 38 ) International Nomenclature Cosmetic Ingredient.