Amended proposal for a directive of the European Parliament and the Council on undesirable substances and products in animal nutrition - Montesquieu Instituut

 

COUNCIL OF Brussels, 21 May 2001

THE EUROPEAN UNION

8843/01

Interinstitutional File:

99/0259 (COD) - LIMITE

AGRILEG 105

CODEC 415

REPORT

from: Working Party of Agricultural Attachés

dated:

to 7 May 2001 COREPER

No. Cion prop. : 14908/00 AGRILEG 221 CODEC 1075 Subject :

Amended proposal for a directive of the European Parliament and the Council on

undesirable substances and products in animal nutrition

I.

Previous proceedings

In December 1999, the Commission adopted a proposal for a Directive amending Council

Directive 1999/29/EC on undesirable substances and products in animal nutrition. The

Directive lays down the maximum levels of these substances and products with which

COREPER asked the Working Party to bring its work on the proposal to a speedy conclusion

on the basis of the solution reached with a view to establishing a common position of the

Council.

II. Outcome of the Working Party's proceedings

The text of the draft directive and of its Annexes I and II, established by the Agricultural Questions Working Party and finalised by the Group of Agriculture Attachés is to be found in Annex A to this report. This text takes on board most of the amendments of the European Parliament in first reading last October.

Annex B contains two declarations for the Council Minutes.

The outstanding questions are presented hereafter.

o

o o

1.

Main outstanding question: derogation for fodder produced and used on the same farm

(Article 4) 2

In proposing a ban on the dilution of products containing excessive levels of undesirable substances or products, the Commission considers it is no longer appropriate to maintain a derogation for particular local circumstances, which currently allows the maximum permitted levels to be exceeded in the case of fodder produced and used in the same state on the same agricultural holding.

Whereas the vast majority of delegations are agreed with the suppression of this derogation, the German delegation has requested to reinstate it.

2.

Other reservations

• - 

  Article 4: the German delegation requests that the language used for the fixing of

action thresholds requiring Member States to carry out investigations into sources

of contamination be strengthened. (see footnote 3 page 9)

• - 

  Article 6: the Italian delegation suggests using the expression "complete

feedingstuffs daily ration" in the provision requiring that complementary

feedingstuffs respect the same limits as those for complete feedingstuffs (see

footnote 5 page 10).

• - 

  Article 7: the German delegation considers it excessive, in cases where a danger

arises that is not foreseen by the Directive, to require Member States to inform all

interested parties (and not just other Member States and the Commission). (see

footnote 6 page 10)

-

Article 8: the German delegation suggests strengthening the proposed provision

on detoxification processes. (see footnote 7 page 11)

-

Article 9: the French delegation suggests qualifying the provision ensuring free

circulation of animal feed products, in order to cater for cases of unforeseen

dangers as covered by Article 7. (see footnote 8 page 11)

• - 

  Article 13: the French delegation has proposed alternative wording for this article,

covering cases where products intended for animal feed produced outside the

Community are returned to the exporting country because they do not fulfil the

requirements of the Directive. (see footnote 9 page 12)

-

ANNEX A

Draft Directive of European Parliament and of the Council on

undesirable substances in animal feed

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, Having regard to the opinion of the Economic and Social Committee, Having regard to the opinion of the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1)

Many amendments need to be made to Council Directive 1999/29/EC of 22 April 1999 on

the undesirable substances in animal feed. In the interests of clarity and efficiency the said

Directive should be recast.

(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, 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, animal welfare and the environment.

(6) It is impossible to fully eliminate the presence of undesirable substances but it is important

that their content in products intended for animal feed 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.

(6bis) 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 may be present in products intended for animal feed 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 feed. 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 products intended for animal feed as soon as they enter the

Community. It must therefore be stipulated that the maximum levels of undesirable

substances that are set apply in general from the date on which the products intended for

animal feed are put into circulation or used, at all stages, and in particular as soon as they are

imported.

(9) Products intended for animal feed must be sound, genuine and of merchantable quality and

therefore when correctly used do not represent any danger to human health, animal health or

to the environment or could adversely affect livestock production. Using or putting into

circulation products intended for animal feed which contain levels of undesirable substances

that exceed the maximum levels laid down in Annex I to this Directive must therefore be

prohibited.

(10) The presence of certain undesirable substances 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,

(13) Products intended for animal feed that satisfy the requirements of this Directive may not be

subject to restrictions on entry into circulation, as regards the level of undesirable substances

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 feed as last amended by Directive [XXX/XXX]

(14) Member States must make appropriate monitoring arrangements pursuant to Directive 95/53

to ensure that the requirements regarding undesirable substances are met when products

intended for animal feed are used or circulated.

(15) [deleted]

(16) An appropriate Community procedure is needed for adapting the technical provisions in the

Annexes 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.

(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, they should be adopted by use of the regulatory procedure provided for

in Article 5 of that Decision.

(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 in products intended for animal feed.
• 2. 

  This Directive shall apply without prejudice to the provisions in:

(a) Council Directive 70/524/EEC of 23 November 1970 concerning additives in

feedingstuffs;

(b) Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials and

Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound

feedingstuffs;

(c) Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of

maximum levels for pesticide residues in and on fruit and vegetables, Council

Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide

residues in and or on cereals, Council Directive 86/363/EEC of 24 July 1986 on the

fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin

and Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum

levels for pesticide residues in and on certain products of plant origin, including fruit

and vegetables, where these residues are not listed in Annex I to this Directive;

(d) Community legislation concerning veterinary matters relating to public health and

animal health;

(e) Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in

animal nutrition;

(f) Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for

particular nutritional purposes.

(c) `additives' means additives as defined in Article 2 of Council Directive 70/524/EEE of

23 November 1970 on additives in feedingstuffs;

(d) ´premixtures´ means mixtures of additives or mixtures of one or more additives with

substances used as carriers, intended for the manufacture of 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) `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;

(g) `complete feedingstuffs' means mixtures of feedingstuffs which, by reason of their

composition, are sufficient for a daily ration;

(h) ´products intended for animal feed´ means feed materials, premixtures, feed additives,

feedingstuffs and all other products intended for use or used in animal feed;

(i) `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;

(j) `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;

(k) [deleted]

(l) ´putting into circulation' or `circulation': means the holding of products intended for

animal feed for the purposes of sale, including offering for sale, or any other form of

transfer, whether free or not, to third parties, and the sale or other forms of transfer

themselves;

Article 3

• 1. 

  Products intended for animal feed may enter for use in the European Community from

third countries, put into circulation and/or used in the Community only if they are sound,

genuine and of merchantable quality and therefore when correctly used do not represent

any danger to human health, animal health or to the environment or could negatively affect

livestock production.

• 2. 

  In particular, products intended for animal feed shall be deemed not to be in conformity

with paragraph 1 if the level of undesirable substances they contain does not comply with

the maximum levels laid down in Annex I hereto.

Article 4

• 1. 

  Member States shall prescribe that the undesirable substances listed in Annex I hereto can

be tolerated in products intended for animal feed only subject to the conditions laid down

therein2.

• 2. 

  In order to reduce or eliminate sources of undesirable substances of products intended for

animal feed, the Member States, in co-operation with operators, shall carry out

investigations to identify the sources of undesirable substances, in cases where the

maximum levels are exceeded and in cases where increased levels of such substances and

products are detected, taking into account background levels. For a uniform approach in

cases of increased levels it may be necessary to set action thresholds to trigger such

investigations. These may be laid down in Annex II hereto3.

Member States shall transmit to the Commission and the other Member States all relevant

information and findings of the source and the measures taken to reduce the level or

elimination of the undesirable substances. This information shall be transmitted in the

frame of the annual report to be transmitted to the Commission according to the provisions

of Article 22 of Council Directive 95/53/EC except in those cases where the information is

of immediate relevance for the other Member States. In this latter case the information

should be transmitted immediately.

Article 5

Member States shall prescribe that products intended for animal feed containing levels of an

undesirable substance that exceed the maximum level fixed in Annex I hereto may not be mixed for

dilution purposes with the same or other products intended for animal feed.

Article 6 4

Insofar there are no special provisions for complementary feedingstuffs, Member States shall

prescribe that complementary feedingstuffs may not, taking into account the proportion prescribed

for their use in a daily ration5, contain levels of the undesirable substances 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 an undesirable substance not listed therein

present a danger to animal or human health or to the environment, that Member State may

provisionally reduce the existing maximum level, fix a maximum level or prohibit the

presence of that undesirable substance in products intended for animal feed. It shall

Article 8

In accordance with the procedure laid down in Article 11, the Commission, in the light of

developments in scientific and technical knowledge, shall adapt Annexes I and II.

Furthermore, in accordance with the procedure laid down in Article 11, the Commission shall

periodically adopt consolidated versions of Annexes I and II incorporating such amendments.

In accordance with the procedure laid down in Article 11, the Commission may define criteria for

the acceptability of detoxification processes in addition to products intended for animal feed which

have undergone such processes7.

Member States shall ensure that measures are taken to guarantee the correct application of such

acceptable processes and the conformity of the detoxified products intended for animal feed with

the provisions of Annex I.

Article 9

Member States shall ensure that products intended for animal feed which comply with this Directive

are not subject to any other restrictions on circulation as regards the presence of undesirable

substances other than those provided for in this Directive and Directive 95/53/EC8.

Article 10

Provisions that may have an effect upon public or animal health or on the environment shall be

adopted after consultation with the appropriate Scientific Committee(s).

Article 11

• 1. 

  The Commission shall be assisted by the Standing Committee for Feedingstuffs, instituted

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 products intended

for animal feed produced in the Community to be exported to third countries.

• 2. 

  Paragraph 1 shall not affect the right of Member States to authorize products intended for

animal feed produced outside the Community which do not fulfil the requirements of this

Directive to be returned back to the exporting third country. This return of products

intended for animal feed to the exporting third country can only take place after the

competent authority of the exporting third country has been fully informed of the reasons

for and circumstances under which the concerned products intended for animal feed could

not be put into circulation in the Community9.

Article 14

• 1. 

  Directive 1999/29/EC is repealed as from...*10, 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

Article 15

Member States shall bring into force and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than...

. They shall forthwith inform the

Commission thereof.

The measures adopted shall apply as from ......

.

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

Undesirable substances Products intended for animal feed Maximum content in

mg/kg (ppm) relative

to a feedingstuff with

a moisture content of

12%

(1) (2) (3)

• 1. 

  Arsenic Feed materials with the exception of: 2
• - 

  meal made from grass, from dried lucerne and from

dried clover, and dried sugar beet pulp and dried

molasses sugar beet pulp 4

• - 

  phosphates and feedingstuffs obtained from the

processing of fish or other marine animals 10

Complete feedingstuffs with the exception of: 2

• - 

  complete feedingstuffs for fish 4

Complementary feedingstuffs with the exception of: 4

• - 

  mineral feedingstuffs 12
• 2. 

  Lead Feed materials with the exception of: 10
• - 

  green fodder 40
• - 

  phosphates 30
• - 

  yeasts 5

Complete feedingstuffs 5

Complementary feedingstuffs with the exception of: 10

• - 

  mineral feedingstuffs 30
• 3. 

  Fluorine Feed materials with the exception of: 150
• - 

  feedingstuffs of animal origin 500
• - 

  phosphates 2 000

Complete feedingstuffs with the exception of: 150

• - 

  complete feedingstuffs for cattle, sheep and goats
• - 

  in milk 30
• - 

  other 50
• - 

  complete feedingstuffs for pigs 100

Undesirable substances Products intended for animal feed Maximum content in

mg/kg (ppm) relative

to a feedingstuff with

a moisture content of

12%

(1) (2) (3)

• 6. 

  Cadmium Feed materials of vegetable origin 1

Feed materials of animal origin, except: 2

• - 

  feedingstuffs for pets

Phosphates 10(3)

Complete feedingstuffs for cattle sheep and goats except: 1

• - 

  complete feedingstuffs for calves, lambs and kids

Other complete feedingstuffs except: 0,5

• - 

  feedingstuffs for pets

Mineral feedingstuffs 5(4)

Other complementary feedingstuffs for cattle, sheep and

goats 0,5

• 7. 

  Aflatoxin B

1 Feed materials with the exception of: 0,05

• - 

  groundnut, copra, palm-kernel, cotton seed, babassu,

maize and products derived from the processing

thereof 0,02

Complete feedingstuffs for cattle, sheep and goats with the

exception of: 0,05

• - 

  dairy cattle 0,005
• - 

  calves and lambs 0,01

Complete feedingstuffs for pigs and poultry (except young

animals 0,02

Other complete feedingstuffs 0,01

Undesirable substances Products intended for animal feed Maximum content in

mg/kg (ppm) relative

to a feedingstuff with

a moisture content of

12%

(1) (2) (3)

Complete feedingstuffs with the exception of: 20

• - 

  complete feedingstuffs for cattle, sheep and goats 500
• - 

  complete feedingstuffs for poultry (except laying hens)

and calves 100

• - 

  complete feedingstuffs for rabbits and pigs (except

piglets) 60

• 10. 

  Theobromine Complete feedingstuffs with the exception of: 300
• - 

  complete feedingstuffs for adult cattle 700

11 Volatile mustard oil Feed materials with the exception of: 100

• - 

  rapeseed cakes 4 000

(expressed as allyl

isothiocyanate)

Complete feedingstuffs with the exception of: 150

(expressed as allyl

isothiocyanate)

• - 

  complete feedingstuffs for cattle, sheep and goats 1 000

(except young animals) (expressed as allyl

isothiocyanate)

• - 

  complete feedingstuffs for pigs (except piglets) and 500

poultry (expressed as allyl

isothiocyanate)

• 12. 

  Vinyl thiooxazolidone Complete feedingstuffs for poultry with the exception of 1 000

(Vinyloxazolidine thione) - complete feedingstuffs for laying hens 500

• 13. 

  Rye ergot (Claviceps purpurea) All feedingstuffs containing unground cereals 1 000
• 14. 

  Weed seeds and unground and All feedingstuffs 3 000

uncrushed fruits containing

alkaloids, glucosides or other

toxic substances separately or in

Undesirable substances Products intended for animal feed Maximum content in

mg/kg (ppm) relative

to a feedingstuff with

a moisture content of

12%

(1) (2) (3)

• 21. 

  DDT (sum of DDT-, TDE- and All feedingstuffs with the exception of: 0,05

DDE-isomers, expressed as DDT) - fats 0,5

• 22. 

  Endosulfan (sum of alpha- and All feedingstuffs with the exception of: 0,1

beta-isomers and of - maize 0,2

endosulfansulphate expressed as - oilseeds 0,5

endosulfan) - complete feedingstuffs for fish 0,005

23 Endrin (sum of endrin and of All feedingstuffs with the exception of: 0,01

delta-ketoi-endrin, expressed as - fats 0,05

endrin)

24 Heptachlor (sum of heptachlor All feedingstuffs with the exception of: 0,01

and of heptachlorepoxide, - fats 0,2

expressed as heptachlor)

25 Hexachlorobenzene (HCB) All feedingstuffs with the exception of: 0,01

• - 

  fats 0,2
• 26. 

  Hexachlorocyclo-hexane (HCH)

26.1 alpha-isomers All feedingstufs with the exception of: 0,02

• - 

  fats 0,2

26.2 beta-isomers Compound feedingstuffs with the exception of: 0,01

• - 

  feedingstuffs for dairy cattle 0,005

Feed materials with the exception of: 0,01

• - 

  fats 0,1

26.3 gamma-isomers All feedingstuffs with the exception of: 0,2

• - 

  fats 2,0

Undesirable substances Products intended for animal feed Maximum content in

mg/kg (ppm) relative

to a feedingstuff with

a moisture content of

12%

(1) (2) (3)

• 28. 

  Apricots Prunus armeniaca L.
• 29. 

  Bitter almond Prunus dulcis

(Mill.) D.A. Webb var. amara

(DC.) Focke (= Prunus amygdalus

Batsch var. amara (DC.) Focke)

• 30. 

  Unhusked beech mast Fagus

silvatica L.

• 31. 

  Camelina Camelina sativa (L.)

Crantz

• 32. 

  Mowrah, Bassia, Madhuca

Madhuca longifolia (L.) Macbr.

(= Bassia longifolia L. = Illipe Seeds and fruit

malabrorum Engl.) Madhuca of the plant

indica Gmelin (= Bassia latifolia species listed

Roxb.) = Illipe latifolia (Roscb.) opposite as well

F. Mueller) as their

processed

• 33. 

  Purghera Jatropha curcas L. All feedingstuffs derivatives may

only be present

• 34. 

  Croton Croton tiglium L. in feedingstuffs

in trace amounts

• 35. 

  Indian mustard Brassica juncea not

(L.) Czern. And Coss. Ssp . quantitatively

integrifolia (West.) Thell. determinable

• 36. 

  Sareptian mustard Brassica

juncea (L.) Czern. And Coss. ssp

.juncea

37 Chinese mustard Brassica

juncea (L.) Czern. And Coss. ssp.

juncea var. lutea Batalin

ANNEX II

Undesirable Products Action threshold in mg/kg (ppm) Comments and additional

substances and intended relative to a product intended for animal information ( e.g. nature of

products for animal feed with a moisture content of 12% investigations to be performed)

feed

-

ANNEX B

Declarations for the Council Minutes

1.

Ad Article 3

"The Council notes that there are differing interpretations among the Member States as to the

concept of putting into circulation defined in Article 2 of this Directive. It should be

determined whether or not this concept, and consequently the rules referring to it, should be

applied to products intended for animal nutrition coming from third countries, which have not

yet been entered for free circulation within the meaning of Council Regulation No 2913/92 of

12 October 1992 establishing a Community Customs Code. This question arises, in particular,

with regard to products covered by specific economic arrangements such as inward or

outward processing. The Council considers that the autonomy of the regulations on animal

nutrition in relation to customs regulations is likely to give rise to uncertainty for the

competent authorities responsible for checks.

In view of the importance of this issue with regard to health safeguards for animal

feedingstuffs, the Council calls upon the Commission to provide the necessary clarification as

soon as possible, if need be in the form of legislative proposals, extending consideration of the

matter to cover all legislation relevant from the viewpoint of the health safety of foodstuffs

and animal health. It suggests that the Commission base itself on the provisions of Council

Directive 97/78/EC of 18 December 1997 laying down the principles governing the

organisation of veterinary checks on products entering the Community from third countries,

and in particular Article 12 thereof".

• 2. 

  Ad article 15