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,
Whereas:
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.
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 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 F1mixtures 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.
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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,
HAVE ADOPTED THIS REGULATION: