COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Regulation on Detergents

2002/0216 (COD)

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Regulation on Detergents

1- BACKGROUND

Date of transmission of the proposal to the EP and the Council (document COM(2002)485 final - 2002/0216 COD): // 04.09.2002

Date of the opinion of the European economic and Social Committee: // 26.02.2003

Date of the opinion of the European Parliament, first reading: // 10.04.2003

Date of transmission of the amended proposal: // 06.06.2003

Date of adoption of the political agreement (by qualified majority): // 19.05.2003

Date of adoption of the common position: // 6.11.2003

2- OBJECTIVE OF THE COMMISSION PROPOSAL

The objective of the proposal is to ensure the free movement of detergents in the internal market while at the same time providing a high level of protection to human health and the environment. The proposal seeks to achieve these objectives by modernising the directives that lay down rules for the biodegradability of surfactants used in detergents and by incorporating and expanding labelling rules contained in Commission recommendation 89/542/EEC. Modernisation is provided by new biodegradability tests which will provide an enhanced level of protection to the aquatic compartment. In addition, the scope of the tests is extended to all classes of surfactant thereby including the 10% of surfactants that escape current legislation. Labelling rules are extended to include fragrance ingredients that could cause allergies, and manufacturers are obliged to disclose a full list of ingredients to medical practitioners treating patients suffering from allergies. A Regulation is proposed to ensure that the new rules, and subsequent adaptations of them to technical progress, will apply simultaneously in all Member States without the need for transposition of lengthy technical annexes into 25 separate national legislations.

3- COMMENTS ON THE COMMON POSITION

3.1 General

The Common Position follows the general lines of the Commission's amended proposal.

3.2 The fate of the amendments

3.2.1 Amendments accepted in the amended proposal and in the common position

Amendments 2, 4, 8, 17, and 53 were accepted as presented by the Parliament.

Amendments 3, 18, 27, 34, 35, 36, 37, 45, 46, 52, 55 and 57 were accepted in part or in principle. They were subject to reformulation or additions as indicated in detail below.

3.2.1.1 Amendment 3 (Recital 14)

The mention of complementary risk assessment in the Parliament's amendment was accepted in principle. However, as the complementary risk assessment will be a new feature in the legislation, it is not appropriate to say that it will be "maintained". Instead, the Commission produced a reformulated text which was adopted by the Council.

3.2.1.2 Amendment 18 (Article 2)

The Commission supported in principle an additional definition in Article 2 for industrial and institutional detergents. Having introduced the definition, however, it is necessary to make use of it. This is done in Article 4, as described under amendment 55, in relation to derogations.

3.2.1.3 Amendment 27 (Article 9(3))

The Commission accepted in principle that part of the amendment concerning medical staff bound by professional secrecy as a useful additional requirement to preserve the confidentiality of ingredient data. To be consistent with amendment 8, which the Commission accepts, the term adopted in the Commission's reformulation is "medical personnel". Furthermore, it was considered useful to more fully define "medical personnel" in Article 2, including the necessity for confidentiality.

3.2.1.4 Amendments 34, 35, 36, 37 (Annex II, points A, B, C and D)

The Commission accepted the introduction of a reference to specific analytical methods. However, it would partially negate the benefit that could be obtained from these methods if they were to be restricted to only those surfactants that do not react with the reagents used in those methods i.e. MBAS etc. The Commission therefore reformulated the Parliament's amendment. The Council accepted the reformulation.

3.2.1.5 Amendment 45 (Annex VIII, point B, paragraph 1, indent 2)

The Commission and Council accepted the Parliament's amendment in principle because it will introduce useful additional information for the consumer for the two different categories of detergent. However, the terms normally used for the two categories are heavy-duty and low-duty detergents, as elsewhere in the text of the annex. The Parliament's amendment was therefore reformulated.

3.2.1.6 Amendment 46 (Article 2, point 6)

The Commission and Council accepted the Parliament's amendment in principle concerning the definition of a surfactant exclusively in terms of an extended list of properties instead of including the intention of the manufacturer. The list was reformatted to make clearer the cumulative nature of the list.

3.2.1.7 Amendment 52 (Recital 16)

The Commission and Council accepted in principle the Parliament's amendment because criteria for refusing derogations are given in Art 6 and not in the Annexes. The criteria for derogations will therefore remain subject to the co-decision procedure.

3.2.1.8 Amendment 55 (Article 4(1), now renumbered 4(2))

The part of the amendment that places the limits for the biodegradability test in Article 4 instead of in Annex III was not accepted because these limits refer specifically to the test method mentioned in that Annex. If the limits are placed in the annex, then they can be adapted in parallel, e.g. revised upwards, with any future change to the test method: the limit and the test method belong together.

For consistency with the introduction in amendment 18 of a definition of the term "industrial and institutional detergents", use is made of the term here to make clearer that derogations will be considered only for these low volume speciality products and not for laundry detergents. Without this addition, the definition would not be used anywhere in the proposal.

The addition, in the Parliament's amendment, of a mention of the action to follow from a request for derogation was accepted in principle. However, as Article 6 deals with refusal of derogation and not with granting of derogation, the Council reformulated it slightly.

3.2.1.9 Amendment 57 (Article 5(2) to 5(5))

The Commission accepted parts of the Parliament's amendment concerning paragraphs 2, 3 (except last sentence) and 4 as useful clarifications concerning the implementation of the provisions.

The parts of the amendment addressing Article 5(2) and 5(3) concerning Annex IV and testing strategies respectively were not accepted because Annex IV testing is designed to demonstrate that the surfactant is not toxic to the environment, despite failing the ultimate biodegradability test, and the range of tests specified in Annex IV was considered to be the minimum necessary to ensure this. However a tiered approach appears in the Common Position at the initiative of the Council - see section 3.3.12.

The part of the amendment to Article 5(3) concerning a timeframe was accepted in principle. Manufacturers should be prevented from marketing indefinitely products that require a derogation. For this reason, mention also needs to be made that Article 6(2) shall no longer apply if the information is not made available within the timeframe. The length of time manufacturers are to be allowed for providing information should be 12 months to allow sufficient time in case a manufacturer needs to contract a third party to carry out further testing on his behalf.

The part of the amendment concerning Article 5(4) which introduces the words "On the basis of the evaluation done by the Member States" was not accepted because the Commission needs to preserve the right to act in cases where Member States are slow to complete an evaluation. The part of the amendment concerning Article 5(4) which introduces the word "shall" can be accepted by the Commission as it is a logical complement to the qualification "if necessary" earlier in the sentence.

The part of the amendment concerning Article 5(5) was not accepted. Derogations are granted on the basis of risk assessments, evaluated by Member States, that demonstrate that there is no risk to the environment. Derogations will therefore not be granted for surfactants that pose such a risk. There is no justification for measures that would lead to the replacement of a surfactant that poses no risk to the environment. There is no safer alternative to a substance that poses no risk.

The Commission therefore reformulated the text for paragraphs 2 - 5 and the reformulation was accepted by the Council.

3.2.2 Amendments appearing in the amended proposal but not in the common position

3.2.2.1 Amendment 17 (Article 2(2), definition of "Washing")

Rather than extend the list in the definition of "Washing" with the specific items mentioned in the Parliament's amendment i.e. "floors, windows or sanitary facilities", the Council has chosen instead to use the words "and other hard surfaces". The Commission supports this change as it encompasses the Parliament's amendment and makes the definition more inclusive.

3.3 New provisions introduced by the Council

3.3.1 Recital 21 (references to other horizontal legislation)

The list of other horizontal legislation applicable to detergents has been extended to include the directives on biocides, good laboratory practice, and protection of animals.

The Commission and Council accepted these changes because they make clearer the relationship between the various pieces of legislation. The reference to Directive 86/609/EEC is in line with Parliament amendment 13.

3.3.2 Recital 25 (Ingredient data sheet)

Text has been added requiring that the ingredient data sheet should be made available to Member States bodies as well as to medical personnel. The Commission accepted this change which is in line with Parliament amendment 27 concerning Article 9(3).

3.3.3 Recital 30 (testing standards - good laboratory practice)

The good laboratory practice standards are introduced as an alternative to EN/ISO/IEC testing standards.

The Commission accepted this change as allowing a greater freedom of choice concerning testing standards without compromising on the quality of the test results.

3.3.4 Recital 31 (phosphates)

The text was modified to clarify that the scope of the Regulation excludes, inter-alia, phosphates.

Although the Commission accepted this change, it would have preferred to include issues such as phosphates within the scope of the present Regulation. Any future measures on these issues will now need to be dealt with in a separate piece of legislation.

3.3.5 Article 1(2) (scope of the regulation)

The scope of the legislation is made more explicit in order to restrict the scope to biodegradability and labelling.

The Commission can accept this change, but would have preferred the scope to be wider in order to permit all future detergent related issues to be tackled within the same single piece of legislation. The second indent is partly in line with Parliament amendment 15.

3.3.6 Article 2(1) (definition of "Detergent")

The items from Annex I.A which supplemented the definition of detergent in Article 2(1) have now been incorporated into Article 2(1). The reference to water-based cleaning processes has been deleted: detergents based on organic solvents are now included in the scope of this Regulation.

The Commission can accept these changes. The transfer of the text of Annex I.A to Article 1 is in line with Parliament's amendment 29 which sought to exclude Annex I.A from adaptations to technical progress. The extension of the scope to non-water based detergents, while in line with Parliament's amendment 16, is expected to make little difference in practice as disposal of these preparations into the aquatic environment will in any case be controlled under other legislation, i.e. Directive 2000/60/EC.

3.3.7 Article 2(10) (definition of "Manufacturer")

The definition has been expanded to make explicit the responsibilities of all economic operators in the supply chain.

The Commission accepts these changes. They clarify the responsibilities of all operators in the supply chain. For example, a supermarket that sells a detergent under its own label is now included in the definition of manufacturer, whereas a normal retailer is not.

3.3.8 Article 2(11) (definition of "Medical personnel")

The Commission accepts the new definition of "medical personnel". In conjunction with Article 9(3) it makes clear that the ingredient datasheet is provided for the purpose of patient care only.

3.3.9 Article 3(1) (conditions for placing on the market)

Additional text was added concerning the Biocides Directive.

The Commission accepts this change as it clarifies the treatment of detergents containing biocides or of detergents in which the surfactants have biocidal properties. The text aims to ensure that there are no loopholes and that double testing is avoided.

3.3.10 Article 4(1)new (Limitations to placing on the market)

The title is changed and a new paragraph 1 has been added to limit the scope to the biodegradability of surfactants.

The Commission can accept this change, as this formulation makes explicit the right of manufacturers to place their products on the market provided certain conditions are met.

3.3.11 Article 5(1) (Granting of derogation)

Member States will be able to charge fees.

The Commission accepts this change. Fees to cover the cost of processing applications should not add excessively to the cost of the derogation process.

3.3.12 Article 5(2) (Granting of derogation)

A tiered approach to testing will be introduced.

The Commission accepts this change, which is in line with Parliament's amendment 57.

3.3.13 Article 6(1) second bullet point (Refusal of derogation)

Mention of industrial and institutional (I&I) detergents has been removed.

The Commission accepts this change because Article 4(2) has been changed in parallel - see 3.2.1.8 - and now states that only I&I detergents may be considered for derogation, hence a repeated mention in Article 6 becomes superfluous.

3.3.14 Article 6(3)new and 6(4) new (Refusal of derogation)

The Commission accepts the change concerning 6(3). It is important to set a time limit for taking a decision to refuse a derogation, analogous to that set in Article 5 for the granting of a derogation.

The Commission accepts the change concerning 6(4). This new text replaces a similar text formerly in Article 7(2), which has now been deleted.

3.3.15 Article 7(1) (Testing of surfactants)

Additional testing standards are included.

The Commission accepts these changes because they allows more flexibility while maintaining the required standards.

3.3.16 Article 7(2) and 7(3) and Annex VII (listing of banned surfactants)

Article 7(2), 7(3) and Annex VII are deleted.

The Commission accepts the change to 7(2), the provisions of which now appear instead in Article 6(4). The deletion of 7(3) and Annex VII is also accepted because it is sufficient that surfactants banned under Directive 76/769/EEC will be listed under that directive and the information is already more conveniently available on the Commission's web site.

3.3.17 Article 8(2 and 3) (notification of laboratories)

Good laboratory practice laboratories may also be notified as an alternative.

The Commission accepts these changes because they allow more flexibility while maintaining the required standards.

3.3.18 Article 9(3) (information datasheet)

The provisions clarify who is entitled to receive the datasheet and for what purpose.

The Commission accepts this change as it clarifies the purpose of making available the datasheet and is in line with Parliament's amendment 27.

3.3.19 Article 11(2) (labelling)

Additional labelling information is made mandatory.

The Commission accepts this change as being of benefit to the consumer.

3.3.20 Article 11(3) (labelling)

This provision now requires additional labelling for the intended use of the detergent.

The Commission accepts this change as being of benefit, especially to users of specialised detergent products.

3.3.21 Article 11(5) (labelling)

Member States no longer have to inform the Commission of national language requirements.

The Commission accepts this change which was intended solely to enable the Commission to provide a service to manufacturers wanting information on the various language requirements in the Member States.

3.3.22 Article 11(6) new (labelling)

The Commission accepts this change which enables Portugal to maintain its existing national legislation on this issue.

3.3.23 Article 13 (adaptation of the annexes)

All annexes may now be adapted by committee procedure.

The Commission accepts this change following the transfer of Annex I.A into the text of Article 1 and the extension of the scope of the Regulation to cover detergents based on organic solvents.

3.3.24 Article 14 (free movement clause)

The new formulation limits the harmonisation of the internal market to issues dealt with in this Regulation.

The Commission accepts this change, which is linked to the scope of the Regulation, but would have preferred to harmonise all aspects of the internal market in detergents via a wider scope in Article 1(2) - see 3.3.5.

3.3.25 Article 16(4) new (legislation to be replaced)

The new formulation provides that Member States must repeal their national legislation.

The Commission accepts this change which will avoid the possibility of old national legislation being in force at the same time as the new Regulation.

3.3.26 Annex I (standards of accreditation)

Annex I.A is deleted and its contents are moved to Article 1. Annex I.B becomes Annex I and is expanded to include standards on good laboratory practice and the treatment of animals in laboratory testing.

The Commission accepts this change as providing additional flexibility while maintaining the level of testing standards appropriate for this regulation. The mention of Directive 86/609/EEC is in line with Parliament's amendment 13.

3.3.27 Annex IV (complementary risk assessment)

The text in the fourth and fifth paragraphs is replaced by provisions concerning a tiered approach.

The Commission accepts this change, which is in line with one of the items in Parliament's amendment 57.

3.3.28 Annex IV 4.2.2 (effects on organisms)

Toxicity tests are to be carried out according to good laboratory practice standards.

The Commission accepts this change.

3.3.29 Annex VII (List of substances banned under other legislation)

This annex is deleted.

The Commission accepts this change. The annex would have no legal effect and would be difficult to keep up to date in printed form. Such information is already available on the Commission's website.

3.3.30 Annex VIII.A (Labelling for contents)

The limits for allergenic fragrances are aligned with those of the Cosmetics Directive for rinse-off products, until risk-based limits are established.

The Commission accepts this change because the use of risk-based limits will ensure that there is a sound scientific basis for these provisions. This is in line with Parliament's amendment 43.

4- CONCLUSION

The Commission supports the Council Common Position because it largely follows the lines of the amended proposal.

5- DECLARATIONS

I. Fragrance Allergens

The Commission recognises the importance of the incidence of allergy amongst consumers. It is therefore necessary to take all necessary measures to ensure that detergents are appropriately labelled so that consumers who know that they are allergic, can avoid specific ingredients.

Thus, the Commission will ask the Scientific Committee on Cosmetics and Non-Food Products to continue - and where possible accelerate - its work on establishing individual risk based limits for fragrance allergens, with special reference to detergents.

It is the aim of the Commission to have such limits established and adopted by Comitology closely after the entry into force of the Detergents Regulation.

II. Publication of Standards

The Commission recognises that some of the standardised test methods are rather old and in need of updating. In addition, some of them are national standards and are therefore only available in their original language.

It is desirable to remedy this situation by establishing European Standards that would replace the national ones and would be available in the languages of the CEN system.

The Commission will therefore ask CEN to review the existing national standards and to adopt, where possible, equivalent European Standards. As soon as these are available, the Commission will propose to integrate them into the Regulation by Comitology.