Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Detergents

(presented by the Commission)

2002/0216 (COD)

Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Detergents

(presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

(Text with EEA relevance)

1. State of procedure

The proposal - COM(2002)458 final - 2002/0216 (COD) was adopted by the Commission on 4th September 2002 and was transmitted to the European Parliament and to the Council on the same date.

The European Economic and Social Committee adopted its opinion on the Commission proposal on 26th February 2003.

The European Parliament adopted 53 amendments in the first reading on 10th April 2003.

2. Objective of the 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. Objective of the amended proposal

The amended proposal adapts the original proposal for a Regulation on Detergents in a number of respects concerning the clarity of the text and of the definitions, and also concerning a number of detailed improvements on matters of substance which are in line with the Commission's original proposal.

4. Comments on the amendments adopted by the Parliament

4.1. Amendments accepted by the Commission

Amendments 2, 4, 8, 17, and 53 can be accepted as they are presented by the Parliament as these amendments add clarity to the text and improve certain definitions.

4.2. Amendments accepted by the Commission in part or subject to reformulation

Amendments 3, 18, 27, 34, 35, 36, 37, 45, 46, 52, 55 and 57 can be accepted in part, or in principle subject to reformulation, because they introduce a number of improvements concerning either the clarity of the text or concerning certain matters of detail, or of additions that could be useful in the implementation of the proposal. These changes are in line with the Commission's original proposal.

4.2.1. Amendment 3 (Recital 14)

The mention of complementary risk assessment in the Parliament's amendment can be 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 proposes the following reformulation:

"the existing requirements regarding primary biodegradability [and the complementary risk assessment] are to be maintained on a second hierarchy level, and are to be supplemented by a complementary risk assessment, for those surfactants failing "ultimate biodegradability" tests; furthermore surfactants failing primary biodegradability tests cannot obtain marketing authorisation by way of derogation;"

4.2.2. Amendment 18 (Article 2)

The Commission can support 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.

""Industrial and institutional" detergent means a detergent for washing and cleaning outside the domestic sphere, carried out by specialised personnel using specific products."

4.2.3. Amendment 27 (Article 9(3))

The Commission can accept 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 would be useful to more fully define "medical personnel" in Article 2, including the necessity for confidentiality. The Commission's reformulation is as follows:

"3. Manufacturers placing on the market the preparations covered by this Regulation shall, upon request, make available without delay and free of charge to medical [staff] personnel a datasheet listing all ingredients as stipulated in Annex VIII.C

This is without prejudice to the right of a Member State to request that such a datasheet be made available to a specific public body to which the Member State has assigned the task of providing this information to medical personnel."

And, in Article 2, the following definition:

"Medical personnel" means a doctor of medicine acting to provide patient care, make a diagnosis, or administer treatment and who is bound by professional confidentiality.

4.2.4. Amendment 34 (Annex II, point A)

The Commission can accept 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 MBAS. The Commission therefore reformulates the Parliament's amendment as follows:

"For those anionic surfactants not reacting to the above-mentioned MBAS method, or if it seems more appropriate for reasons of efficiency or precision, appropriate specific instrumental analyses such as high performance liquid chromatography (HPLC) [and]or gas chromatography (GC) are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent national authorities of the Member States upon request."

4.2.5. Amendment 35 (Annex II, point B)

The Commission can accept 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 BiAS. The Commission therefore reformulates the Parliament's amendment as follows:

"For those non-ionic surfactants not reacting to the above-mentioned BiAS method, or if it seems more appropriate for reasons of efficiency or precision, appropriate specific instrumental analyses such as (high performance liquid chromatography (HPLC) [and]or gas chromatography (GC) are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent national authorities of the Member States upon request."

4.2.6. Amendment 36 (Annex II, point C)

The Commission can accept 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 DBAS. The Commission therefore reformulates the Parliament's amendment as follows:

"For those cationic surfactants not reacting to the above-mentioned test method, or if it seems more appropriate for reasons of efficiency or precision, appropriate specific instrumental analyses such as high performance liquid chromatography (HPLC) [and] or gas chromatography (GC) are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent national authorities of the Member States upon request."

4.2.7. Amendment 37 (Annex II, point A)

The Commission can accept 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 cannot be analysed with the two non-instrumental methods specified. The Commission therefore reformulates the Parliament's amendment as follows:

"For those amphoteric surfactants not reacting to the above-mentioned tests, or if it seems more appropriate for reasons of efficiency or precision, appropriate specific instrumental analyses such as high performance liquid chromatography (HPLC) [and]or gas chromatography (GC) are to be applied. Samples of the pure surfactant of interest shall be provided by the manufacturer to the competent national authorities of the Member States upon request."

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

The Commission can accept 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 term used for the two categories are heavy-duty and low-duty detergents in the subsequent text. The Parliament's amendment is therefore reformulated as:

"- For [normal] 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."

4.2.9. Amendment 46 (Article 2, point 6)

The Commission can accept 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 is reformatted to make clearer the cumulative nature of the list.

"6. "Surfactant" means any organic substance and/or preparation 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;"

4.2.10. Amendment 52 (Recital 16)

The Commission can accept 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 codecision procedure

"(16) the determination of biodegradability test-methods and the record-keeping of lists of derogations are technical matters[. The setting of criteria for derogations is a political matter. These matters] which need to be revised taking into account technical and scientific developments as well as regulatory [and political] developments;"

4.2.11. Amendment 55 (Article 4(1))

The part of the amendment that places the limits for the biodegradability test in Article 4 instead of in Annex III cannot be 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.

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 are intended only for these low volume speciality products and not for laundry detergents. Without this addition, the definition would not 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 is acceptable in principle to the Commission. However, as Article 6 deals with refusal of derogation and not with granting of derogation, the following reformulation has been made:

"1. If a detergent contains surfactants for which the level of "ultimate aerobic biodegradation" is less than that stipulated in Annex III [60% within 28 days, or for which the tests pursuant to Annex IV, point 3 have shown toxicity of the test liquor], manufacturers of industrial or institutional detergents containing surfactants, and/or of surfactants for industrial or institutional detergents may ask for derogation. Requests for derogation shall be made and [granted] decided in accordance with the provisions of Articles 5, 6 and 9."

4.2.12. Amendment 57 (Article 5)

The Commission can accept 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 in Article 4(2) and 4(3) concerning Annex IV and testing strategies respectively cannot be accepted because Annex IV testing is designed to demonstrate that the surfactant is not toxic to the environment, despite failing the ultimate biodegradability test. The range of tests specified in Annex IV is the minimum necessary to ensure this. A tiered approach, by requesting less than the minimum information for assessing the toxicity risk, might create loopholes for surfactants that are toxic, or that have toxic metabolites.

The part of the amendment to Article 4(3) concerning a timeframe can be 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 4(4) which introduces the words "On the basis of the evaluation done by the Member States" cannot be 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 4(4) which introduces the word "shall" can be accepted by the Commission as it is a logical compliment to the qualification "if necessary" earlier in the sentence.

This part of the amendment concerning Article 5(5) cannot be 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 has therefore reformulated the text as follows:

"2. Applications shall include a technical file supplying all the information and justifications necessary for evaluating the safety aspects related to the specific use of surfactants in detergents failing to comply with the biodegradability limits, as set out in [Article 4(1), or showing toxicity of the test liquor pursuant to Annex IV, point 3] Annex III.

In addition to the results of tests stipulated in Annex III, the technical file shall include results of tests, as stipulated in Annexes II and IV.

[2a. The tests laid down in Annex IV(4) shall be carried out on the basis of a graded risk assessment (tiered approach). Before ...*, the Commission shall lay down an appropriate technical guideline in accordance with the procedure referred to in Article 12(2).]

3. The competent authorities of the Member States, receiving applications for derogation according to paragraphs 1 and 2 above, shall examine the requests, evaluate their compliance with the conditions for derogation and inform the Commission about the results without delay.

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 preparation, it shall ask for further information, verification and/or confirmatory tests concerning these substances and/or preparations or their transformation products, of which they have been notified or have received information under this Regulation. If the [necessary] requested information is not provided within [a timeframe to be clearly specified,] twelve months, the application shall be considered incomplete and thus invalid. In such a case Article 6(2) shall not apply.

[If further information on metabolites is sought, stepwise testing strategies should be employed to ensure maximum use of in-vitro and other non-animal test methods.]

4. [On the basis of the evaluation done by the Member States, the] The Commission may grant derogation in accordance with the procedure set out in Article 12(2). If necessary before granting derogation the Commission shall evaluate further the matters indicated in paragraph 3 of this Article.

5. Such derogations may allow, limit or severely restrict the placing on the market and the use of surfactants in detergents, depending on the results of the complementary risk assessment, as defined in Annex IV of this Regulation. They may include a phase-out period for placing on the market and the use of surfactants in detergents. [A derogation must be reviewed after 5 years and the applicant must provide information that he is developing alternatives, which will fulfil the demands to the "ultimate aerobic biodegradation"]".

4.3. Amendments not accepted by the Commission

Amendments 1, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 20, 24, 25, 26, 28, 29, 30, 32, 33, 38, 39, 40, 41, 42, 43, 44, 47, 48, 49, 55, 56, 57, 59, 60, 61, 62 cannot be accepted by the Commission.

5. Amended proposal

Having regard to Article 250 (2) of the EC Treaty, the Commission amends its proposal as indicated above.