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 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 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 .
Article 2
For the purposes of this Directive:
1. ‘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;
2. ‘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;
3. ‘additives’ shall mean additives as defined in Article 2(a) of Council Directive 70/524/EEC;
4. ‘premixtures’ shall mean mixtures of additives or mixtures of one or more additives with substances used as carriers, intended for the manufacture of feedingstuffs;
5. ‘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;
6. ‘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;
7. ‘complete feedingstuffs’ shall mean mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;
8. ‘products intended for animal feed’ shall mean feed materials, premixtures, additives, feedingstuffs and all other products intended for use or used in animal feed;
9. ‘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;
10. ‘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;
11. ‘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;
12. ‘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.
2
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
1
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),
- is 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).
Article 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-Making
.
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.
Article 11
1
The Commission shall be assisted by the Standing Committee for Feedingstuffs set up by Article 1 of Council Decision 70/372/EEC .
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.
3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Article 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 178/2002 . 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.
OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 2205/2001 (OJ L 297, 15.11.2001, p. 3).
OJ L 86, 6.4.1979, p. 30. Directive as last amended by the European Parliament and Council Directive 2002/2/EC (OJ L 63, 6.3.2002, p. 23).
OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2000/57/EC (OJ L 244, 29.9.2000, p. 76).
OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2002/23/EC (OJ L 64, 7.3.2002, p. 13).
OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive 2002/23/EC.
OJ L 350, 14.12.1990, p. 71. Directive as last amended by Directive 2002/23/EC.
OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).
OJ L 237, 22.9.1993, p. 23. Directive as last amended by Directive 1999/29/EC (OJ L 115, 4.5.1999, p. 32).
OJ L 123, 12.5.2016, p. 1 .
OJ L 170, 3.8.1970, p. 1 .
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
Substituted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).
Substituted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.
Inserted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).
Deleted by Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance).
Deleted by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part Two.