Directive 2002/32/EC of the European Parliament and of the Council
of 7 May 2002
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 Commission1,
Having regard to the opinion of the Economic and Social Committee2,
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty3, in the light of the joint text approved by the Conciliation Committee on 26 March 2002,
Whereas:
Many amendments need to be made to Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition4. In the interests of clarity and efficiency the said Directive should be recast.
Livestock production occupies a very important place in farming in the Community and satisfactory results in terms of public and animal health, animal welfare, the environment and the livestock producers' finances depend to a large extent on the use of appropriate good quality feedingstuffs.
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. In addition, there is a need for comprehensive regulation on hygiene in order to guarantee good quality feedingstuffs on individual farms even when they are not commercially produced.
The same rules concerning the quality and safety of products intended for animal feed have to apply to the quality and safety of water consumed by the animals. Although the definition of feedingstuffs does not preclude water being considered as feedingstuff, it is not included in the non-exhaustive list of main feed materials, laid down by Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials5. The issue of water to be considered as feedingstuffs needs to be examined in the framework of that Directive.
It has been established that additives can contain undesirable substances. The scope of the Directive should therefore be extended to cover additives.
Products intended for animal feed may contain undesirable substances which can endanger animal health or, because of their presence in livestock products, human health or the environment.
It is impossible to eliminate fully 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 substances' 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.
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.
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.
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.
Products intended for animal feed must be sound, genuine and of merchantable quality and therefore when correctly used must not represent any danger to human health, animal health or to the environment or 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 must therefore be prohibited.
The presence of certain undesirable substances in complementary feedingstuffs must be limited by fixing appropriate maximum levels.
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 to the lowest possible levels in products intended for animal feed 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 and steps taken to reduce or eliminate such sources.
Where animal or human health or the environment is endangered, Member States should be allowed temporarily to reduce the fixed maximum permissible levels, to fix maximum levels for other substances or to prohibit the presence of such substances in products intended for animal feed. In order to ensure a uniform application, any amendments to Annex I to this Directive should be decided on by emergency Community procedure, on the basis of supporting documents and the precautionary principle.
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 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition6.
Member States must make appropriate monitoring arrangements pursuant to Directive 95/53/EC to ensure that the requirements regarding undesirable substances are met when products intended for animal feed are used or circulated.
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.
In order to facilitate implementation of the proposed measures, there should be a procedure for close cooperation between the Member States and the Commission within the Standing Committee for Feedingstuffs set up by Decision 70/372/EEC7.
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission8,
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 feedingstuffs9;
b
Council Directive 96/25/EC and Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs10;
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 vegetables11, Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals12, Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin13 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 vegetables14, 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 nutrition15;
f
Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes16.
Article 2
For the purposes of this Directive:
- (a)
‘feedingstuffs’ shall mean 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’ shall mean 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)
‘additives’ shall mean additives as defined in Article 2(a) of Council Directive 70/524/EEC;
- (d)
‘premixtures’ shall mean mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture of feedingstuffs;
- (e)
‘compound feedingstuffs’ shall mean mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;
- (f)
‘complementary feedingstuffs’ shall mean 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’ shall mean mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;
- (h)
‘products intended for animal feed’ shall mean feed materials, premixtures, additives, feedingstuffs and all other products intended for use or used in animal feed;
- (i)
‘daily ration’ shall mean 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’ shall mean 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)
‘putting into circulation’ or ‘circulation’ shall mean 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;
- (l)
‘undesirable substance’ shall mean any substance or product, with the exception of pathogenic agents, which is present in and/or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or could adversely affect livestock production.
Article 3
1
Products intended for animal feed may enter for use in the Community from third countries, be 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 adversely 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.
Article 4
1
Member States shall prescribe that the undesirable substances listed in Annex I may be tolerated in products intended for animal feed only subject to the conditions laid down therein.
2
In order to reduce or eliminate sources of undesirable substances of products intended for animal feed, Member States, in cooperation with economic 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 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.
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 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 shall 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 may not be mixed for dilution purposes with the same, or other, products intended for animal feed.
Article 6
In so far as 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 ration, contain levels of the undesirable substances listed in Annex I 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 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 immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.
F12
An immediate decision shall be taken as to whether Annexes I and II should be amended. The Commission is empowered to adopt delegated acts in accordance with Article 10a amending those Annexes.
Where, in the case of those amendments, imperative grounds of urgency so require, the procedure provided for in Article 10b shall apply to delegated acts adopted pursuant to this Article.
The Member State may maintain the measures it has implemented as long as the Commission has not taken any decision.
The Member State must ensure that the decision taken is made public.
Article 8
F2F11
The Commission is empowered to adopt delegated acts in accordance with Article 10a amending Annexes I and II to adapt them to the scientific and technical developments.
Where, in the case of those amendments, imperative grounds of urgency so require, the procedure provided for in Article 10b shall apply to delegated acts adopted pursuant to this Article.
2
Furthermore the Commission:
shall periodically adopt consolidated versions of Annexes I and II incorporating any adaptations made pursuant to paragraph 1, in accordance with the regulatory procedure referred to in Article 11(2),
F1is empowered to adopt delegated acts in accordance with Article 10a in order to supplement this Directive by defining acceptability criteria for detoxification processes as a complement to the criteria provided for products intended for animal feed which have undergone such processes.
3
Member States shall ensure that measures are taken to guarantee the correct application of any acceptable processes pursuant to paragraph 2 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/EC.
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).
F3Article 10a
1
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2
The power to adopt delegated acts referred to in Article 7(2) and Article 8(1) and (2) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3
The delegation of power referred to in Article 7(2) and Article 8(1) and (2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making17.
5
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6
A delegated act adopted pursuant to Article 7(2) and Article 8(1) and (2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months from the notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 10b
1
Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2
Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 10a(6). In such case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
F2Article 11
1
The Commission shall be assisted by the Standing Committee for Feedingstuffs set up by Article 1 of Council Decision 70/372/EEC18.
2
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
F43
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F44
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F5Article 12
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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 authorise re-exportation under the conditions laid down in Article 12 of Regulation (EC) No 178/200219. The provisions of Article 20 thereof shall apply mutatis mutandis.
Article 14
1
Directive 1999/29/EC is hereby repealed as from 1 August 2003, 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 III.
Article 15
Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 1 May 2003. They shall forthwith inform the Commission thereof.
The measures adopted shall apply as from 1 August 2003.
When Member States adopt these measures, 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 day of its publication in the Official Journal of the European Communities.
Article 17
The Directive is addressed to the Member States.
F6ANNEX I
SECTION I:INORGANIC CONTAMINANTS AND NITROGENOUS COMPOUNDS | ||
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|---|---|
Feed materials | 2 | |
| 4 | |
| 421 | |
| 521 | |
| 10 | |
| 15 | |
| 20 | |
| 2521 | |
| 4021 | |
Iron particles used as tracer. | 50 | |
Feed additives belonging to the functional group of compounds of trace elements | 30 | |
| 50 | |
| 100 | |
Complementary feed | 4 | |
| 12 | |
| 1021 | |
| 30 | |
Complete feed | 2 | |
| 1021 | |
| 1021 | |
| Feed materials of vegetable origin | 1 |
Feed materials of animal origin | 2 | |
Feed materials of mineral origin | 2 | |
with the exception of: | ||
| 10 | |
Feed additives belonging to the functional group of compounds of trace elements | 10 | |
with the exception of: | ||
| 30 | |
Feed additives belonging to the functional groups of binders and anti-caking agents | 2 | |
Premixtures25 | 15 | |
Complementary feed | 0,5 | |
with the exception of: | ||
| ||
| 5 | |
| 0,75 per 1 % phosphorus27, with a maximum of 7,5 | |
| 2 | |
| 15 | |
Complete feed | 0,5 | |
with the exception of: | ||
| 1 | |
| 2 | |
Feed materials with the exception of: | 150 | |
| 500 | |
| 3 000 | |
| 2 000 | |
| 350 | |
| 600 | |
| F111 250 | |
Vermiculite (E 561). | 3 000 | |
Complementary feed: | ||
| 500 | |
| 125 per 1 % phosphorus27 | |
Complete feed with the exception of: | 150 | |
| 100 | |
| 350 | |
| 250 | |
| ||
| 30 | |
| 50 | |
Feed materials | 10 | |
| 30 | |
| 15 | |
| 20 | |
| 5 | |
Feed additives belonging to the functional group of compounds of trace elements | 100 | |
| 400 | |
| 200 | |
Feed additives belonging to the functional groups of binders and anti-caking agents | 30 | |
| 60 | |
Premixtures25 | 200 | |
Complementary feed | 10 | |
| 15 | |
| 60 | |
Complete feed. | 5 | |
Feed materials | 0,1 | |
| 0,5 | |
| 1,032 | |
| 0,3 | |
| 0,3 | |
Compound feed | 0,1 | |
| 0,2 | |
| 0,2 | |
| 0,3 | |
Feed materials | 15 | |
with the exception of: | ||
| 30 | |
| — | |
| — | |
Complete feed | 15 | |
with the exception of: | ||
| — | |
Feed with the exception of: | 2,5 | |
| 2,530 | |
| ||
| 20 | |
| — | |
| — | |
The maximum levels refer to total arsenic. | ||
Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of inorganic arsenic is lower than 2 ppm. This analysis is of particular importance for the seaweed species Hizikia fusiforme. | ||
Forage includes products intended for animal feed such as hay, silage, fresh grass, etc. | ||
The maximum levels refer to total mercury. | ||
The maximum levels are expressed as sodium nitrite. | ||
The maximum level established for premixtures takes into account the additives with the highest level of lead and cadmium and not the sensitivity of the different animal species to lead and cadmium. As provided in Article 16 of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), in order to protect animal and public health, it is the responsibility of the producer of premixtures to ensure that, in addition to compliance with the maximum levels for premixtures, the instructions for use on the premixture are in accordance with the maximum levels for complementary and complete feed. | ||
Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency. | ||
The % of phosphorus is relative to a feed with a moisture content of 12 %. | ||
The maximum level refers to melamine only. The inclusion of the structurally related compounds cyanuric acid, ammeline and ammelide in the maximum level will be considered at a later stage. | ||
Calcium and magnesium carbonate refers to the natural mixture of calcium carbonate and magnesium carbonate as described in Commission Regulation (EU) No 575/2011 of 16 June 2011 on the Catalogue of feed materials (OJ L 159, 17.6.2011, p. 25). | ||
The maximum level is applicable to canned pet food as sold. | ||
For the determination of lead in kaolinitic clay and in feed containing kaolinitic clay, the maximum level refers to an analytical determination of lead, whereby extraction is performed in nitric acid (5 % w/w) for 30 minutes at boiling temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency. | ||
The maximum level is applicable on wet weight basis. |
SECTION II:MYCOTOXINS | ||
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|---|---|
| Feed materials | 0,02 |
Complementary and complete feed | 0,01 | |
with the exception of: | ||
| 0,005 | |
| 0,02 | |
| Feed materials and compound feed containing unground cereals. | 1 000 |
SECTION III:INHERENT PLANT TOXINS | ||
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|---|---|
| Feed materials | 20 |
with the exception of: | ||
| F116 000 | |
| 1 200 | |
Complete feed | 20 | |
with the exception of: | ||
| 500 | |
| 300 | |
| 100 | |
| 60 | |
| Feed materials | 50 |
with the exception of: | ||
| 250 | |
| 350 | |
| 100 | |
Complete feed | 50 | |
with the exception of: | ||
| 10 | |
| Complete feed | 300 |
with the exception of: | ||
| 200 | |
| 50 | |
| Complete feed for poultry | 1 000 |
with the exception of: | ||
| 500 | |
Feed materials | 100 | |
with the exception of: | ||
4 000 | ||
Complete feed | 150 | |
with the exception of: | ||
| 1 000 | |
| 500 | |
The maximum levels are expressed as allyl isothiocyanate. | ||
Upon request of the competent authorities, the responsible operator must perform an analysis to demonstrate that the content of total glucosinolates is lower than 30 mmol/kg. The method of analysis of reference is EN-ISO 9167-1:1995. |
SECTION IV:ORGANOCHLORINE COMPOUNDS (EXCEPT DIOXINS AND PCBs) | ||
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|---|---|
| Feed materials and compound feed | 0,0136 |
| with the exception of: | |
| 0,136 | |
| 0,0236 | |
| Fish, other aquatic animals and products derived thereof | 0,02 |
with the exception of | ||
| 0,2 | |
Complete feed for fish. | 0,05 | |
| Feed materials and compound feed | 0,02 |
with the exception of: | ||
| 0,05 | |
| Feed materials and compound feed | 0,05 |
with the exception of: | ||
| 0,5 | |
| Feed materials and compound feed with the exception of: | 0,1 |
| 0,3 | |
| 0,5 | |
| 1,0 | |
| 0,005 | |
| 0,05 | |
| Feed materials and compound feed | 0,01 |
with the exception of: | ||
| 0,05 | |
| Feed materials and compound feed | 0,01 |
with the exception of: | ||
| 0,2 | |
| Feed materials and compound feed | 0,01 |
with the exception of: | ||
| 0,2 | |
10.Hexachlorocyclohexane (HCH) | ||
| Feed materials and compound feed | 0,02 |
with the exception of: | ||
| 0,2 | |
| Feed materials | 0,01 |
with the exception of: | ||
| 0,1 | |
Compound feed | 0,01 | |
with the exception of: | ||
| 0,005 | |
| Feed materials and compound feed | 0,2 |
with the exception of: | ||
| 2,0 | |
Singly or combined expressed as dieldrin. | ||
Maximum level for aldrin and dieldrin, singly or combined, expressed as dieldrin. | ||
Numbering system according to Parlar, prefixed by either CHB or ‘Parlar’:
|
F14SECTION V:DIOXINS AND PCBs | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Undesirable substance | Products intended for animal feed | Maximum content in ng WHO-PCDD/F-TEQ/kg (ppt)38 relative to a feed with a moisture content of 12 % | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Feed materials of plant origin | 0,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
with the exception of: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of mineral origin | 0,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of animal origin: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 5,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
F11Feed additives belonging to the functional groups of binders and anti-caking agents43 | 0,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed additives belonging to the functional group of compounds of trace elements. | 1,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Premixtures | 1,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Compound feed | 0,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
with the exception of: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,75 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Undesirable substance | Products intended for animal feed | Maximum content in ng WHO-PCDD/F-PCB-TEQ/kg (ppt)38 relative to a feed with a moisture content of 12 % | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Feed materials of plant origin with the exception of: | 1,25 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of mineral origin | 1,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of animal origin: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,25 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 20,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 4,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 9,0 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
F11Feed additives belonging to the functional groups of binders and anti-caking agents43 | 1,5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed additives belonging to the functional group of compounds of trace elements | 1,5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Premixtures | 1,5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Compound feed with the exception of: | 1,5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 5,5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Undesirable substance | Products intended for animal feed | Maximum content in μg/kg (ppb) relative to a feed with a moisture content of 12 %38 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Feed materials of plant origin | 10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of mineral origin | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of animal origin: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 175 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 30 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 50 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
F11Feed additives belonging to the functional groups of binders and anti-caking agents43 | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed additives belonging to the functional group of compounds of trace elements | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Premixtures | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Compound feed with the exception of: | 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 40 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 3,5 ng WHO-PCDD/F-TEQ/kg product and 6,5 ng WHO-PCDD/F-PCB-TEQ/kg product are applicable to fresh fish and 20,0 ng WHO-PCDD/F-PCB-TEQ/kg product is applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fresh fish and other aquatic animals directly delivered and used without intermediate processing for the production of feed for fur animals are not subject to the maximum levels, while maximum levels of 75 μg/kg product are applicable to fresh fish and 200 μg/kg product are applicable to fish liver used for the direct feeding of pet animals, zoo and circus animals or used as feed material for the production of pet food. The products or processed animal proteins produced from these animals (fur animals, pet animals, zoo and circus animals) cannot enter the food chain and cannot be fed to farmed animals which are kept, fattened or bred for the production of food. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The maximum level is also applicable to the feed additives belonging to the functional groups of substances for the control of radionuclide contamination and substances for reduction of the contamination of feed by mycotoxins which are also belonging to the functional groups of binders and anti-caking agents. |
F13SECTION VI:HARMFUL BOTANICAL IMPURITIES | ||
Undesirable substance | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|---|---|
| Feed materials and compound feed | 3 000 |
| 1 000 | |
| Feed materials and compound feed | 100 |
| Feed materials and compound feed | 1045 |
| Feed materials and compound feed | Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable |
| Feed materials and compound feed | Seeds and fruit as well as their processed derivatives may only be present in feed in trace amounts not quantitatively determinable |
| Feed materials46 with the exception of | 50 |
| 200 | |
Compound feed containing unground grains and seeds | 50 | |
| Feed materials and compound feed | Seeds may only be present in feed in trace amounts not quantitatively determinable |
In so far determinable by analytical microscopy. | ||
Includes also seed husk fragments. | ||
In case unequivocal evidence is provided that the grains and seeds are intended for milling or crushing, there is no need to perform a cleaning of the grains and seeds containing con-compliant levels of seeds of Ambrosia spp. before milling or crushing on the condition that:
In case these conditions are not fulfilled, the consignment must be cleaned before any transport into the EU and the screenings must be appropriately destroyed. |
SECTION VII:AUTHORISED FEED ADDITIVES IN NON-TARGET FEED FOLLOWING UNAVOIDABLE CARRY-OVER | ||
Coccidiostat | Products intended for animal feed47 | Maximum content in mg/kg (ppm) relative to a feed with a moisture content of 12 % |
---|---|---|
| Feed materials | 0,4 |
Compound feed for | ||
| 0,4 | |
| 1,2 | |
Premixtures for use in feed in which the use of decoquinate is not authorised. | ||
| Feed materials | 0,01 |
Compound feed for | ||
| 0,01 | |
| 0,01 | |
| 0,03 | |
Premixtures for use in feed in which the use of diclazuril is not authorised. | ||
| Feed materials | 0,03 |
Compound feed for | ||
| 0,03 | |
| 0,03 | |
| 0,09 | |
Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised. | ||
| Feed materials | 1,25 |
Compound feed for | ||
| 1,25 | |
| 1,25 | |
| 1,25 | |
| 3,75 | |
Premixtures for use in feed in which the use of lasalocid A sodium is not authorised. | ||
| Feed materials | 0,05 |
Compound feed for | ||
| 0,05 | |
| 0,05 | |
| 0,15 | |
Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised. | ||
| Feed materials | 1,25 |
Compound feed for | ||
| 1,25 | |
| 1,25 | |
| 3,75 | |
Premixtures for use in feed in which the use of monensin sodium is not authorised. | ||
| Feed materials | 0,7 |
Compound feed for | ||
| 0,7 | |
| 2,1 | |
Premixtures for use in feed in which the use of narasin is not authorised. | ||
| Feed materials | 1,25 |
Compound feed for | ||
| 1,25 | |
| 3,75 | |
Premixtures for use in feed in which the use of nicarbazin (alone or in combination with narasin) is not authorised. | ||
| Feed materials | 0,7 |
Compound feed for | ||
| 0,7 | |
| 0,7 | |
| 2,1 | |
Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised. | ||
| Feed materials | 0,7 |
Compound feed for | ||
| 0,7 | |
| 0,7 | |
| 2,1 | |
Premixtures for use in feed in which the use of salinomycin sodium is not authorised | ||
| Feed materials | 0,25 |
Compound feed for | ||
| 0,25 | |
| 0,25 | |
| 0,75 | |
Premixtures for use in feed in which the use of semduramicin sodium is not authorised. | ||
Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 29). | ||
The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50 % of the maximum levels established in the feed when the instructions for use of the premixture are followed. |
F14ANNEX II
Undesirable substances | Products intended for animal feed | Action threshold in ng WHO-PCDD/F TEQ/kg (ppt)51 relative to a feedingstuff with a moisture content of 12 % | Comments and additional information (e.g. nature of investigations to be performed) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Feed materials of plant origin | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
with the exception of: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of mineral origin | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of animal origin: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,75 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 4,0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,75 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,25 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed additives belonging to the functional groups of binders and anti-caking agents | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed additives belonging to the functional group of compounds of trace elements | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Premixtures | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Compound feed with the exception of: | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 1,25 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Feed materials of plant origin with the exception of: | 0,35 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of mineral origin | 0,35 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed materials of animal origin: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,75 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 0,35 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 11,0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2,0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 5,0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed additives belonging to the functional groups of binders and anti-caking agents | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Feed additives belonging to the functional group of compounds of trace elements | 0,35 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Premixtures | 0,35 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Compound feed with the exception of: | 0,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 2,5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Table of TEF (= toxic equivalency factors) for dioxins, furans and dioxin-like PCBs: WHO-TEFs for human risk assessment based on the conclusions of the World Health Organisation (WHO) – International Programme on Chemical Safety (IPCS) expert meeting which was held in Geneva in June 2005 (Martin van den Berg et al., The 2005 World Health Organisation Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds. Toxicological Sciences 93(2), 223–241 (2006))
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Upper-bound concentrations; upper-bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Identification of source of contamination. Once source is identified, take appropriate measures, where possible, to reduce or eliminate source of contamination. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
In many cases it might not be necessary to perform an investigation into the source of contamination as the background level in some areas is close to or above the action level. However, in cases where the action level is exceeded, all information, such as sampling period, geographical origin, fish species etc., shall be recorded with a view to future measures to manage the presence of dioxins and dioxin-like compounds in these materials for animal nutrition. |
ANNEX III
Directive 1999/29/EC | This Directive |
---|---|
Article 1 | Article 1 |
Article 2(a) | Article 2(a) |
Article 2(b) | Article 2(b) |
Article 2(c) | Article 2(g) |
Article 2(d) | Article 2(f) |
Article 2(e) | Article 2(e) |
Article 2(f) | Article 2(i) |
Article 2(g) | Article 2(j) |
Article 2(h) | — |
— | Article 2(c) |
— | Article 2(d) |
— | Article 2(h) |
— | Article 2(k) |
— | Article 2(l) |
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 I |
Annex II | — |
Annex III | — |
Annex IV | Annex II |
Substituted by Commission Regulation (EU) No 574/2011 of 16 June 2011 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels for nitrite, melamine, Ambrosia spp. and carry-over of certain coccidiostats and histomonostats and consolidating Annexes I and II thereto (Text with EEA relevance).