Explanatory Memorandum to COM(2002)485 - Detergents - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2002)485 - Detergents. |
|---|---|
| source | COM(2002)485  |
| date | 04-09-2002 |
The fundamental objective of this Regulation is the free movement of detergents in the Internal Market. In particular it modernises the existing detergent directives, regarding the biodegradability of surfactants and the protection of the environment in relation to this fundamental issue. The proposed new biodegradability tests ensure a higher level of environmental protection and at the same time are applicable to all types of surfactants in detergents. Furthermore, the requirements specified in Commission Recommendation 89/542, on labelling of detergents and cleaning products, and specific information to the consumers related to the presence in detergents of fragrance substances are made binding for the products covered by this Regulation.
Contents
- Article 2 and Annex I. - Definitions
- Articles 3 to 7. - Limitations to placing on the market
- Article 8. - Duties of the Member States
- Article 9. - Duties of Manufacturers
- Article 10. - Control measures
- Article 11 and Annex VIII. - Labelling and ingredient datasheet
- Article 12. - Committee procedure
- Article 13. - Adaptation of the annexes
- Article 14. - Free movement clause
- Article 15. - Safeguard clause
- Article 16. - Legislation to be replaced
- Article 17. - Sanctions for non-compliance
- Annex I. - Products covered within the meaning of detergent
- Annex II. - Primary biodegradability test methods
- Annex IV. - Complementary Risk Assessment
- Annex V. - List of derogations
- Annex VI. - List of banned or restricted surfactants under this Regulation
- Annex VII. - List of banned surfactants in implementation of other Community legislation
- Annex VIII. - Labelling and ingredient datasheet
- Annex IX. - List of test methods and analytical methods
The definition proposed for 'detergent' enlarges the scope of the existing legislation to cover other similar uses, which come within the objectives of this legislation in line with relevant experiences in implementation in Member States.
It introduces a definition for surfactants, which was lacking in existing legislation.
Definitions are provided for the biodegradation concepts involved in the Regulation, as these are useful for a correct implementation of its provisions.
Finally, other definitions (i.e.: 'cleaning', 'washing', 'substance', 'preparation', 'placing on the market', etc.) that may be useful for the application of this Regulation are also considered.
These articles refer explicitly to the requirements for the prohibition of substances on the market and to the conditions for the granting of derogations.
It is considered appropriate to establish a transition period of two years, counting from the date of implementation of the Regulation, to allow manufacturers (a term which in this text extends to include importers) of those substances concerned to apply for derogations.
The hierarchy of tests is based on environmental concerns and at the same time tries to minimise the expenses of economic operators as only a fraction of the substances concerned will have to be submitted to the whole array of relevant tests. This would be needed just for those substances.
The granting of derogations for those substances failing the 'ultimate biodegradability' type tests as established in Annex III, are to be allowed following explicit application by manufacturers and case by case Commission Decisions adopted by Committee procedure.
The granting of derogations needs as a pre-requisite the compliance with the primary biodegradability requirements in Annex II, and depends on the assessment of the additional information to be provided under Annex IV.
It has been considered appropriate to refer in this article to other legislation, in particular Directive 76/769/EEC, by which substances covered in this Regulation might be the object of marketing restrictions, as for example those in connection with Parcom Decisions or Recommendations.
It is intended that there should be a shift of emphasis of responsibility towards manufacturers who would have to ensure that all pertinent tests are carried out, instead of the present situation that depends much on Member States initiatives.
It is considered fundamental for the objectives of the Regulation to establish with precision the main actions involving direct responsibility of the appointed competent authorities in Member States in addition to those stipulated in Article 3 concerning the limitations to the placing on the market.
As in the preceding legislation, Member States should notify the list of Laboratories authorised to carry out the reference tests as established in Annexes II and III.
Manufacturers of detergents, and/or of surfactants for detergents, should have at the disposal of the national authorities the corresponding technical files for all substances concerned. Member states should take all appropriate measures including active actions in order to ensure this provision is complied with.
Manufacturers of detergents remain responsible for not marketing detergent preparations containing non-complying surfactants and for ensuring that all the required technical documentation is available.
The competent authorities of Member States should have the possibility of applying control measures to ensure that manufacturers comply with this Regulation.
This article together with the corresponding Annex keep the existing provisions on labelling as they are to be continued. At the same time and in order to take account of the development introduced by Commission Recommendation 89/542/EEC for the labelling of detergents and cleaning products, its provisions as established in Articles 2 and 3 are made binding.
The Recommendation has worked well in the sense that there has been a high level of compliance in most Member States. However, the present proposal is a useful opportunity to combine the labelling rules with other rules on the marketing of detergents.
This transition should be considered as a success of the Recommendation and it is by no means to be interpreted as an approach against voluntary agreements. The Commission Recommendation 98/480/EC, concerning good environmental practice for household laundry detergents, will remain separate as it concerns areas not covered by this Regulation.
In the light of the increasing importance of fragrances and preservation agents, they are included as a new element in relation to Recommendation 89/542/EEC.
A new provision is added obliging manufacturers of detergents to have at the disposal of health care professionals a full listing of the ingredients of the detergents to assist clinicians in investigating whether a causal link exists between the development of an allergic response and exposure to a particular chemical substance.
The Committee procedure proposed is a regulatory one, as established under the new Decision 1999/468/EC.
It is proposed that the revision of Annexes I to IX should follow the Committee procedure, as these relate to scientific and technical matters and do not touch the fundamental hierarchy established in the body of the Regulation.
The Committee procedure should also apply to Articles 4, 5, 7, 8 and 13 which are linked to the placing on the market of substances and preparations.
This is the explicit complement to the clauses on limitations to marketing and covers those substances and preparations that are complying with the provisions of the Regulation.
The fact that a substance is found to be readily biodegradable does not preclude the possibility of concern for the degradation products and biodegradation rates in relation to certain types of uses, in particular, in cases of high influx into ecosystems.
This establishes which directives are to be superseded by the present Regulation that covers their relevant provisions.
This requires the Member States to establish sanctions for non-compliance with this Regulation.
This lists the products containing soap or other surfactants that are covered by the new definition of detergent as set out in Article 2 and gives also a definition of them.
This establishes the test systems and analytical methods for assessing the primary biodegradability of surfactants: anionic, non-ionic, cationic, and amphoteric.
The main changes in relation to the methods in the existing legislation are intended to cover for the first time cationic and amphoteric surfactants and also those anionic and non-ionics not reacting to the tests included in present legislation. The use of instrumental analysis for those surfactants not reacting to semi-specific methods is required so that all surfactants are covered.
These tests will be relevant in cases of non-compliance with those on 'ultimate' biodegradability in Annex III, and they will be examined by the Committee on a case by case basis. It has been considered better to keep the present choice of options on primary biodegradability tests, but the reference methods for the cases of conflicting results in different Member States are stipulated. These tests will also be necessary for calculating the predicted environmental concentrations of the parent substance for risk assessment.
Annex III. - 'Ultimate biodegradability' test methods
The approach presented is based on Annex V part C.4 (Determination of 'ready' biodegradability) of Directive 67/548/EEC.
However, account is taken of the need to adapt to scientific progress the test chosen for reference purposes as developed by ISO.
The use of some tests not considered well suited, in general, for surfactants is made dependent of specific authorisation by Committee procedure.
The study 'Surfactant Ring Test-I' of May 1999 (WRC) concluded that pre-exposing sludge to a surfactant for seven days in a SCAS unit before testing the surfactant in the headspace method did not have uniform effects on the biodegradation achieved or on its variability, although in general the degree of biodegradation was increased. Taking results from all laboratories it is not worthwhile using this rather mild pre-exposure since it involves a fair amount of effort for little advantage.
The proposed Annex III is also fully in line with the recommendations included in the opinion of the Cstee, which may be summarised as follows:
1. The proposed 'ultimate biodegradability' type tests are an improvement in relation to primary biodegradability;
2. The methods ISO headspace, OECD 301 B i and OECD 301 D i are suitable but the two OECD methods had some limitations of applicability;
3. The methods OECD 301 A i, OECD 301 C i, OECD 301 E i and OECD 301 F i were less suitable than the above mentioned;
4. Pre-adaptation is not deemed desirable;
5. The ten days window is not deemed desirable.
The test methods of Annex III are therefore the best of the available standardised test methods for ultimate biodegradability. They are also more demanding than those for primary biodegradability that are used in the current EU legislation. It is estimated that 3 % of the surfactants that are capable of passing the test for primary biodegradability under current EU legislation would not pass the test specified for the ultimate biodegradability in Annex III. Besides being stricter than the existing test, the new test also covers a significant market segment composed of cationic and amphoteric surfactants, representing about 10 % of all detergent surfactants, that were not previously covered by the existing tests.
This establishes the additional information needed for substances failing Annex III tests but passing Annex II tests and being submitted for derogation under Article 3 i.
Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances laid down detailed rules concerning the collection, circulation and accessibility of information on existing substances, as well as concerning the evaluation of the risks of existing substances to man and to the environment in order to ensure better management of those risks within the framework of Community provisions.
Evaluation of risks before the placing on the market of new substances according to agreed procedures is another type of programmed assessment. Such an evaluation and an appropriate notification to a competent authority before the placing on the market are required for chemicals by Directive 92/32/EEC amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances. Plant protection products and other biocides also have to pass thorough risk evaluation before they can receive an authorisation to be commercialised.
The approach envisaged here is to establish an ad-hoc complementary assessment not intended to be closely parallel to the risk assessment procedure in the two above mentioned pieces of legislation. Instead, the intention of the complementary assessment step is to assess the reasons for failing the first level stage and the opportunity to allow marketing (provided that primary biodegradability is complied with).
It is to be considered that in any event these would apply to the substances covered by the future detergent Regulation when so stipulated.
It is to be considered that detergents and their ingredients are also covered by all the horizontal legislation on substances and preparations and the corresponding risk assessments.
Following this line, the chosen approach is to concentrate on the elements helping to judge whether a negative result on 'ready biodegradability' type tests is a false negative and to provide also a number of other elements considered essential to judge the environmental impact of the surfactant in question and of its biodegradation products.
Account is taken of the Recommendations in the opinion of the CSTEE, so that the risk assessment should put emphasis on possible metabolites and that information on the toxicity of these metabolites is needed together with their bioconcentration potential, as well as their partition to the sediment phase. It is emphasised that if recalcitrant metabolites are produced, a risk assessment should be performed, according to the relevant EU legislation on dangerous substances and to the related Technical Guidance Documents. Moreover, if some metabolites are suspected for endocrine disrupting activity, it is recommended to have data on this particular hazard, as soon as validated protocols to assess this kind of effect will be available.
This lists all the surfactants obtaining derogations.
This lists all the surfactants identified as not complying with the provisions of this Regulation or restricted in use as a result of this Regulation.
This lists surfactants covered by this Regulation and banned or restricted by other Community legislation, in particular Directive 76/769/EEC.
This describes how detergent packaging shall be labelled for certain ingredients, for the recommended quantities of detergent appropriate for a standard washing machine load, and for the number of standard washing machine loads that can be washed with the contents of the package. It also prescribes the format to be used for the listing of ingredients on the datasheet intended for health care professionals.
This lists the test methods and analytical methods that apply to control procedures of detergents on the market by Member States, which were annexed to the existing detergent legislation.