Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on undesirable substances and products in animal nutrition (presented by the Commission pursuant to Article 250 (2) of the EC-Treaty)

EXPLANATORY MEMORANDUM

On 17 December 1999, the Commission presented to the Eureopean Parliament and the Council a proposal for a Directive of the European Parliament and the Council on undesirable substances and products (COM(1999) 654final - 1999/0259 COD)

On 4 October 2000, the European Parliament adopted a report on the proposal at first reading (Report A5-0257/2000). The report proposes 36 amendments to the text.

The Commission can accept amendments 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 21, 22, 23, 24, 25, 26, 28, 29, 31, 32 as these amendments constitute an improvement and clarification of the Commission's initial proposal. The Commission accepts these amendments for the following reasons:

-It is more appropriate to use the term "materials intended for animal nutrition" instead of repeating each time "feed materials, feedingstuffs and feed additives" to ensure that there can be no confusion and ambiguity that all materials intended for use in animal nutrition are covered. In addition, it is appropriate to define this term. This modification is proposed by amendments 4, 5, 7, 8, 9, 11, 12, 13, 14, 15, 17, 21, 22, 23, 24, 25, 26, 28, 29, 30, 31, 32.

-Amendments 8, 14, 21 widen the scope of the Directive in order to cover also the use of all materials intended for animal nutrition and not only the putting into circulation. The Commission agrees with this extension of the scope. Moreover, this is in line with the provisions of Directive 2000/16/EC of the European Parliament and the Council of 10 April 2000 amending Council Directive 79/373/EEC on the marketing of compound feedingstuffs and Council Directive 96/25/EC on the circulation of feed materials, whereby the scope of the Directive 96/25 has been widened in the same sense.

-Amendments 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 24, 26, 28, 29 consist of editorial improvements, clarifications and additional references to the provisions of Council Directive 1995/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition.

-Amendment 19 proposes to insert a definition for premixture, which is already foreseen in other relevant Community legislation.

The Commission can accept in principle the amendments 3, 4, 20, 30 and 34 with the understanding that the Commission is of the opinion that further changes might improve the text. The Commission accepts in principle these amendments for following reasons:

-Amendment 3 proposes to replace the term "be contaminated" in recital 4 by "contain" and amendment 4 proposes to replace the term "feed materials, feedingstuffs and feed additives" throughout the text by "products of any kind intended for animal nutrition". Both amendments can be accepted as such with the understanding that the term product is replaced by material. These amendments indicate also the need to define clearly the terms "undesirable substances and products" and that is the reason why the Commission propose in Article 2 to define these terms.

-Concerning amendment 20, the Commission can accept the principle of inserting a definition for 'consignment' in Article 2 but cannot agree on the proposed definition as proposed by amendment 20. The Commission is further of the opinion that it is appropriate to insert also a definition for 'undesirable substance and product' and 'product of any kind intended for use in animal nutrition' (see above).

-The proposed simplification and clarification in amendment 30 can be accepted by the Commission with exception of the deletion of 'serious'. Maintaining the qualification 'serious' in relation with risk is consistent with the general Community policy as laid down in the General Products Safety Directive.

-Amendment 34 proposes to determine the entry into force in function of the publication of the Directive in the Official Journal of the European Communities. The commission agrees that this is indeed more appropriate but is of the opinion that a longer period seems to be more appropriate, given the far-reaching nature of the proposed measures.

The Commission cannot accept amendments 18, 27, 33, 35, 36, 37 for following reasons

-Amendment 18, proposing to explicitly include water in the definition of feedingstuff, is not acceptable as it is clear from the Community legislation that water until now has not been considered as a feedingstuff. This can be derived from the fact that Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, containing a non-exhaustive list of the main feed materials, does not include water in that list. It is within the context of a future amendment to this Directive, that this issue should be discussed.

-Amendment 27 proposes to delete the provision to define criteria of acceptability of feed materials, which have undergone certain decontamination procedures. The Commission is of the opinion that it is necessary that for these decontamination procedures strict quality criteria can be laid down at Community level.

-Amendment 33 whereby the possibility is deleted to re-export non-complying consignments to the country of origin is not acceptable for the Commission as the re-export of non complying consignments to the country of origin should remain possible in order to avoid the sometimes heavy burden of the destruction for the country of import. However, the Commission accepts that it is appropriate to insert an additional provision that re-export to the country of origin is possible after having informed the competent authority of the country of origin and after having received guarantees for the safe disposal of the contaminated lot.

-Amendments 35, 36 and 37 proposing to modify the maximum limits for cadmium, lead, dioxin and PCBs in certain feedingstuffs cannot be accepted by the Commission as modifications to the annexes have to be based on a scientific risk assessment and are to be modified by the Commission following the Committee procedure. The Commission will review the current provisions concerning cadmium and mercury as a priority and will ask the Scientific Committee for Animal Nutrition to provide a scientific risk assessment for cadmium and mercury. This has already been done for dioxins and PCBs and this scientific risk assessment has become available in October 2000. On the basis of these scientific risk assessments the Commission will propose the appropriate measures to limit the presence of these respective substances in feedingstuffs and the European Parliament will be fully informed thereof

As the Commission has accepted a number of amendments, it is appropriate that the Commission modifies its proposal taking into account the above-mentioned positions.

The modifications to the initial proposal of the Commission are highlighted as follows: underlining of additions and/or modifications and strikethrough of the deletions.

Amended proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on undesirable substances and products in animal nutrition

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152 (4) (b) thereof,

Having regard to the proposal from the Commission [1],

[1] OJ C 89, 28.3.2000, p.70

Having regard to the opinion of the Economic and Social Committee [2],

[2] OJ C 140, 18.5.2000, p. 9

Having regard to the opinion of the Committee of the Regions [3],

[3] OJ C [...], [...], p. [...].

Acting in accordance with the procedure laid down in Article 251 of the Treaty [4],

[4] OJ C 340,10.11.1997, p. 73

Whereas:

(1) Many amendments need to be made to Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition [5]. In the interests of clarity and efficiency the said Directive should be recast.

[5] OJ L 115, 4.5.1999, p. 32.

(2) Livestock production occupies a very important place in farming in the Community and satisfactory results in terms of public health, animal health, animal welfare and the environment and the livestock producers' finances, depend to a large extent on the use of appropriate good-quality feedingstuffs.

(3) Rules on feedingstuffs are needed to ensure agricultural productivity and sustainability, and to make it possible to ensure public and animal health and animal welfare. In addition, there is a need for comprehensive regulation on food hygiene in order to guarantee good quality feedingstuffs on individual farms even when they are not commercially produced.

(4) It has been established that additives can contain undesirable substances and products. The scope of the Directive should therefore be extended to cover additives.

(5) Materials intended for animal nutrition may contain undesirable substances or products which can endanger animal health or, because of their presence in livestock products, human health.

(6) It is impossible to fully eliminate the presence of the substances and products in question but it is important that their content in materials intended for animal nutrition should be reduced, with due regard to the substance's acute toxicity, bio-accumulability and degradability, in order to prevent undesirable and harmful effects. It is at present inappropriate to fix this content below the levels detectable by methods of analysis to be defined for the Community.

(6a) The methods for determining residues of undesirable substances are becoming increasingly sophisticated, so that even quantities of residues which are negligible for animal and human health can be detected.

(7) Undesirable substances and products may be present in materials intended for animal nutrition only in accordance with the conditions laid down in this Directive and may not be used in any other way for the purposes of animal feeding. This Directive should therefore apply without affecting other Community provisions on feedingstuffs, and particularly the rules applicable to compound feedingstuffs.

(8) This Directive must apply to materials intended for animal nutrition as soon as they enter the Community. It must therefore be stipulated that the maximum levels of undesirable substances or products that are set apply in general from the date on which the materials intended for animal nutrition are put into circulation or used , at all stages , and in particular as soon as they are imported.

(9) Materials intended for animal must be sound, genuine and of merchantable quality. Using or putting into circulation materials intended for animal nutrition which contain levels of undesirable substances or products that exceed the maximum levels laid down in Annex I to this Directive must therefore be prohibited.

(10) The presence of certain undesirable substances or products in complementary feedingstuffs must be limited by fixing appropriate maximum levels.

(11) While in certain cases a maximum level is fixed, taking account of background levels, continued effort is still needed to restrict the presence of some specific undesirable substances and products to the lowest possible levels in materials intended for animal nutrition so as to reduce their presence in the feed and food chain. It should therefore be permitted, under this Directive, to lay down action thresholds well below the maximum levels fixed. Where such action thresholds are exceeded, investigations must be carried out to identify the sources of the undesirable substances or products and steps taken to reduce or eliminate such sources.

(12) Where animal or human health is endangered, Member States should still be allowed temporarily to reduce the fixed maximum permissible levels, to fix maximum levels for other substances or products or to prohibit the presence of such substances or products in materials intended for animal nutrition . To ensure Member States do not abuse this power, any amendments to the Annex to this Directive should be decided on by emergency Community procedure, on the basis of supporting documents and the precautionary principle.

(13) Materials intended for animal nutrition that satisfy the requirements of this Directive may not be subject to restrictions on entry into circulation, as regards the level of undesirable substances and products they contain, other than those provided for in this Directive and in Council Directive 1995/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition [6] as last amended by Directive [XXX/XXX

[6] OJ L 265, 8.11.1995, p. 17.

(14) Member States must make appropriate monitoring arrangements pursuant to Directive 95/53 to ensure that the requirements regarding undesirable substances and products are met when materials intended for animal nutrition are used or circulated.

(15) As part of the information system introduced by this Directive within the official control departments, Member States should also be informed by operators of cases where this Directive is not being complied with. In such cases, Member States should be required to take all the necessary steps to ensure that undesirable substances and products cannot be used in materials intended for animal nutrition. Member States should be obliged, where applicable, to ensure that any such batches of materials intended for animal nutrition are actually destroyed, if this course of action has been decided by their owner.

(16) An appropriate Community procedure is needed for adapting the technical provisions in the Annex to this Directive in the light of developments in scientific and technical knowledge.

(17) In order to facilitate implementation of the proposed measures, there should be a procedure for close co-operation between the Member States and the Commission within the Standing Committee on Feedingstuffs set up by Decision 70/372/EEC [7].

[7] OJ L 170, 3.8.1970, p. 1.

(18) Since the measures necessary for the implementation of this Directive are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [8], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

[8] OJ L 184, 17.7.1999, p. 23.

(19) This Directive should not affect the Member States' obligation to comply with the deadlines set out in Part B of Annex III thereto for transposition of Directive 1999/29/EC,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

1. This Directive deals with undesirable substances and products in materials intended for animal nutrition.

2. This Directive shall apply without prejudice to the provisions on:

(a) additives in feedingstuffs;

(b) the putting into circulation of feedingstuffs;

(c) the fixing of maximum permitted levels for pesticide residues in and on products intended for animal feeding, where these residues are not listed in Section B of Annex I to this Directive;

(d) micro-organisms in feedingstuffs;

(e) certain products used in animal nutrition;

(f) feedingstuffs for particular nutritional purposes.

Article 2

For the purposes of this Directive:

(a) 'feedingstuffs' means products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding;

(b) 'feed materials' means various products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing additives, which are intended for use in oral animal feeding either directly as such or, after processing, in the preparation of compound feedingstuffs or as substrates for premixtures;

(c) 'complete feedingstuffs' means mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;

(d) 'complementary feedingstuffs' means mixtures of feedingstuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if used in combination with other feedingstuffs;

(e) 'compound feedingstuffs' means mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;

(f) 'daily ration' means the average total quantity of feedingstuffs, calculated on a moisture content of 12%, required daily by an animal of a given species, age class and yield, to satisfy all its needs;

(g) 'animals' means animals belonging to species normally fed and kept or consumed by man as well as animals living freely in the wild in cases where they are fed with feedingstuffs;

(h) 'pet animals' means animals belonging to species normally fed and kept but not consumed by man, except animals bred for fur production.

(i) 'additives' means additives as defined in Article 2 of Council Directive 70/524/EEE of 23 November 1970 on additives in feedingstuffs [9].

[9] OJ L 270, 14.12.1970, p 1.

(j) 'premixtures' means mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture of feedingstuffs.

(k) 'materials intended for animal nutrition' means feed materials, premixtures, feed additives, feedingstuffs and all other products intended for use or used in animal nutrition

(l) 'undesirable substance or product' means any substance or product, with the exception of pathogenic micro-organisms, which is present in and/or on the product intended for animal feeding and which constitutes a potential danger to animal or human health or the environment or could negatively affect livestock production.

(m) 'consignment' means an identifiable quantity of product intended for animal feed delivered at one time and having common characteristics, such as origin, variety, type of packing, packer, consignor, production place and harvest time

Article 3

1. Materials intended for animal nutrition may be put into circulation and used in the Community only if they are sound, genuine and of merchantable quality.

2. In particular, materials intended for animal nutrition shall be deemed not to be sound, genuine and of merchantable quality if the level of undesirable substances or products they contain is so high that they cannot comply with the maximum levels fixed for materials intended for animal nutrition in Annex I hereto.

Article 4

1. Member States shall prescribe that the substances and products listed in Annex 1 hereto may be tolerated in materials intended for animal nutrition only subject to the conditions laid down therein.

2. In order to minimise the presence of certain substances and products inevitably found in materials intended for animal the Member States shall require investigations to be carried out to identify and reduce or eliminate sources of contamination, not only in cases where the maximum levels are exceeded, but also where increased levels of such inevitable substances and products are detected. If necessary, an action threshold may be laid down in Annex I hereto.

Article 5

Member States shall prescribe that consignments of materials intended for animal nutrition containing levels of an undesirable substance or product that exceed the maximum level fixed in column 3 in Annex I hereto may not be mixed with other consignments of such materials intended for animal nutrition .

Article 6

Insofar as there are no special provisions for complementary feedingstuffs, Member States shall prescribe that such feedingstuffs may not, allowing for the dilutions prescribed for their use, contain levels of the substances and products listed in Annex I hereto that exceed those fixed for complete feedingstuffs.

Article 7

1. Where a Member State has grounds, based on new information or a reassessment of existing information made since the provisions in question were adopted, demonstrating that a maximum level fixed in Annex I hereto or a substance or product not listed therein constitutes a danger to animal or human health or the environment, that Member State may provisionally reduce the existing maximum level, fix a maximum level or prohibit the presence of that substance or product in materials intended for animal nutrition . It shall immediately inform the other Member States and the Commission and, in an appropriate manner, the economic sectors concerned thereof, stating the grounds for its decision.

2. An immediate decision shall be taken, in accordance with the procedure laid down in Article 12, as to whether Annex I should be amended.

So long as neither the Council nor the Commission has taken a decision, the Member State may maintain the measures it has implemented.

Article 8

The procedure laid down in Article 11 shall be used, in the light of developments in scientific and technical knowledge:

(a) to adopt amendments to be made to Annex I;

(b) to draw up a consolidated version of Annex I periodically incorporating the successive amendments made under (a);

(c) to define criteria for the acceptability of feed materials which have undergone certain decontamination processes.

Article 9

Member States shall ensure that materials intended for animal nutrition which comply with this Directive are not subject to any other restrictions on circulation as regards the presence of undesirable substances and products other than those provided for in this Directive and Directive 95/53/EC.

Article 10

1. Member States shall take all necessary measures to ensure that materials intended for animal nutrition are officially monitored pursuant to Directive 95/53/EC, at least by random sampling, to verify whether the conditions laid down in this Directive are satisfied.

2. Member States shall inform the other Member States and the Commission of the names of the departments appointed to carry out this monitoring.

3. Member States shall prescribe that where operators (importers, producers, etc.) or persons who, by virtue of their professional activities, are or have been in possession of, or have had direct contact with a consignment of materials intended for animal nutrition become aware that a given consignment is unsuitable for any use in animal nutrition either because it contains an undesirable substance or product listed in Annex I and therefore does not comply with Article 3(1) and consequently constitutes a serious risk for animal or public health, or because it contains an undesirable substance or product not listed in Annex I but which potentially constitutes a serious risk for animal or public health,

such persons or operators shall immediately inform the official authorities, even if the destruction of the consignment is planned.

After verifying the information received, Member States shall ensure that the necessary measures are taken to ensure that such consignment is not used in animal nutrition.

Member States shall ensure that the final destination of the consignment, including possible destruction, cannot have harmful effects on public or animal health or on the environment.

4. If a consignment of materials intended for animal nutrition is likely to be sent to a Member State after it has been judged in another Member State not to comply with this Directive because it contains excessive levels of undesirable substances or products, the latter Member State shall immediately notify the other Member States and the Commission of any useful information concerning that consignment.

Article 11

1. The Commission shall be assisted by the Standing Committee for Feedingstuffs, instituted by Article 1 of Council Decision 70/372/EEC of 20 July 1970 [10].

[10] OJ L 170, 3.8.1970, p. 1.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 paragraph 3 and Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 12

1. The Commission shall be assisted by the Standing Committee for Feedingstuffs, instituted by Article 1 of Council Decision 70/372/EEC.

2. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply in compliance with Article 7 paragraph 3 and Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be fifteen days.

Article 13

1. The Member States shall apply at least the provisions of this Directive to materials intended for animal nutrition intended for export to third countries.

2. Paragraph 1 shall not affect the right of Member States to allow consignments of materials intended for animal nutrition which do not fulfil the requirements of this Directive to be exported back to an exporting third country. This re-export of a consignment can only take place if the competent authority of the exporting third country expressly agreed, after having been fully informed of the reasons for and circumstances under which the concerned consignment could not be put into circulation in the Community.

Article 14

1. Directive 1999/29/EC is hereby repealed, without prejudice to the obligations of the Member States to comply with the deadlines set out in Part B of Annex III thereto for the transposition of the Directives listed in Part A of that Annex.

2. References to Directive 1999/29/EC shall be construed as references to this Directive and should be read in accordance with the correlation table in Annex II.

Article 15

Member States shall bring into force and publish the laws, regulations and administrative provisions necessary to comply with this Directive within twelve months of its publication in the Official Journal of the European Communities . They shall forthwith inform the Commission thereof.

The measures adopted shall apply as from twelve months of its publication in the Official Journal of the European Communities .

When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for making such reference shall be adopted by Member States.

Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive

Article 16

This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.

Article 17

The Directive is addressed to the Member States.

Done at ,

For the European Parliament For the Council

The President The President

ANNEX I

>TABLE POSITION>

(1) Member States may also prescribe a maximum fluorine content of 1,25% of the phosphate content.

(2) Fluorine content per 1% phosphorus.

(3) Member States may also prescribe a maximum cadmium content of 0,5 mg per 1% phosphorus.

(4) Member States may also prescribe a maximum cadmium content of 0,75 mg per 1% phosphorus.

(5) Upper bound concentrations are calculated assuming that all values of the different congeners less than the limit of detection are equal to the limit of detection.

ANNEX II

CORRELATION TABLE

Directive 1999/29 // This Directive

Article 1 // Article 1

Article 2(a) // Article 2(a)

Article 2(b) // Article 2(b)

Article 2(c) // Article 2(c)

Article 2(d) // Article 2(d)

Article 2(e) // Article 2(e)

Article 2(f) // Article 2(f)

Article 2(g) // Article 2(g)

Article 2(h) // Article 2(h)

--- // Article 2(i)

Article 3 // Article 3

Article 4(1) // Article 4(1)

Article 4(2) // ---

---- // Article 4(2)

Article 5 // ---

Article 6 // ---

Article 7 // Article 5

Article 8 // Article 6

Article 9 // Article 7

Article 10 // Article 8

Article 11 // Article 9

Article 12 // Article 10

Article 13 // Article 11

Article 14 // Article 12

Article 15 // Article 13

Article 16 // ---

--- // Article 14

--- // Article 15

Article 17 // Article 16

Article 18 // Article 17

Annex I // Annex 1

Annex II // ---

Annex III // ---

Annex IV // Annex II