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Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)

Type Regulation

Publication 2009-11-14

Last updated 2019-12-14

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 54

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Such documentation shall be kept available to the competent authority upon request.

In the case referred to in point (c) of paragraph 1, the consignments shall be accompanied by a health certificate corresponding to a model adopted in accordance with the regulatory procedure referred to in Article 52(3).

Article 38

Safe treatment

Safe treatment shall include application of a manufacturing process to the material used which reduces to an acceptable level risks to public and animal health arising from the material used or from other substances resulting from the manufacturing process.

It shall be ensured that the derived product poses no unacceptable risks to public and animal health, in particular by means of testing of the end product.

Article 39

Safe end uses

Safe end uses shall include the use of derived products:

(a) under conditions which pose no unacceptable risks to public and animal health; or

(b) which may pose a risk to public and animal health, for specific purposes provided that such use is justified by objectives set out in Community legislation, in particular for the protection of public and animal health.

Article 40

Implementing measures

Measures for the implementation of this Section may be laid down relating to the following:

(a) conditions for the placing on the market of imported pet food or of pet food produced from imported materials, from Category 1 material referred to in Article 8(c);

(b) conditions for the safe sourcing and movement of material to be used under conditions which exclude risks to public and animal health;

(d) parameters for the manufacturing process as referred to in the first paragraph of Article 38, in particular as regards the application of physical or chemical treatments to the material used;

(e) testing requirements applicable to the end product; and

(f) conditions for the safe use of derived products which pose a risk to public or animal health.

Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).

CHAPTER III Import, transit and export

Article 41

Import and transit

Animal by-products and derived products shall be imported into, or sent in transit through, the Community in accordance with:

(a) the relevant requirements of this Regulation and the implementing measures thereof for the particular animal by-product or derived product which are at least as stringent as those applicable to the production and marketing of such animal by-products or derived products within the Community;

(b) conditions recognised to be at least equivalent to the requirements applicable to the production and marketing of such animal by-products or derived products under Community legislation; or

(c) in the case of animal by-products and derived products referred to in Articles 33, 35 and 36, the requirements set out in those Articles.

The measures referred to in point (b) of the first subparagraph, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 52(4).

By way of derogation from paragraph 1, the import and transit of:

(a) specified risk material shall take place only in accordance with Regulation (EC) No 999/2001;

(b) animal by-products or derived products mixed or contaminated with any waste listed as hazardous in Decision 2000/532/EC shall take place only subject to the requirements of Regulation (EC) No 1013/2006;

(c) Category 1 material, Category 2 material and products derived therefrom which are not intended for the manufacture of derived products referred to in Articles 33, 35 and 36, shall only take place provided that rules for their import have been adopted in accordance with Article 42(2)(a);

(d) animal by-products and derived products destined for the purposes referred to in Article 17(1) shall take place in accordance with national measures which ensure the control of risks to public and animal health, pending the adoption of harmonised conditions referred to in Article 17(2).

In the case of import and transit of Category 3 material and products derived therefrom, the relevant requirements as referred to in point (a) of the first subparagraph of paragraph 1 shall be laid down.

Those requirements may specify that consignments:

(a) must come from a third country or part of a third country listed in accordance with paragraph 4;

(b) must come from establishments or plants approved or registered by the competent authority of the third country of origin and listed by that authority for that purpose; and

(c) must be accompanied at the point of entry into the Community where the veterinary checks take place by documentation such as a commercial document or a health certificate and where appropriate by a declaration, which corresponds to a model laid down pursuant to point (d) of the first subparagraph of Article 42(2).

Pending the adoption of the requirements referred to in points (a) and (c) of the second subparagraph, the Member States shall specify those requirements in national measures.

Lists of third countries or parts of third countries from which animal by-products or derived products may be imported or transit through the Community shall be drawn up in accordance with the regulatory procedure referred to in Article 52(3), taking into account in particular:

(a) the legislation of the third country;

(b) the organisation of the competent authority and its inspection services in the third country, the powers of those services, the supervision to which they are subject, and their authority to monitor effectively the application of their legislation;

(c) the actual health conditions applied to the production, manufacture, handling, storage and dispatch of products of animal origin intended for the Community;

(d) the assurances the third country can give regarding compliance with the relevant health conditions;

(e) experience of marketing the product from the third country and the results of import checks carried out;

(f) the result of any Community inspections in the third country;

(g) the health status of the livestock, other domestic animals and wildlife in the third country, having particular regard to exotic animal diseases and any aspects of the general health situation in the country which might pose a risk to public or animal health in the Community;

(h) the regularity and speed with which the third country supplies information about the existence of infectious animal diseases in its territory, in particular the diseases listed in the Terrestrial Animal Health Code and the Aquatic Animal Health Code of the World Organisation for Animal Health;

(i) the regulations on the prevention and control of infectious animal diseases in force in the third country and their implementation, including rules on imports from other third countries.

The lists of establishments or plants referred to in point (b) of the second subparagraph of paragraph 3 shall be kept up to date and communicated to the Commission and the Member States and made available to the public.

Article 42

Implementing measures

Measures for the implementation of Article 41 which may exclude animal by-products or derived products manufactured in certain establishments or plants from import or transit in order to protect public or animal health shall be adopted in accordance with the regulatory procedure referred to in Article 52(3).

Other measures for the implementation of Article 41 shall be laid down relating to the following:

(a) conditions for the import and transit of Category 1 and Category 2 materials and for products derived therefrom;

(b) restrictions regarding public or animal health applicable to imported Category 3 material or products derived therefrom which may be laid down by reference to Community lists of third countries or parts of third countries drawn up in accordance with Article 41(4) or for other public or animal health purposes;

(c) conditions for the manufacture of animal by-products or derived products in establishments or plants in third countries; such conditions may include the arrangements for controls of such establishments or plants by the competent authority concerned and may exempt certain types of establishments or plants handling animal by-products or derived products from approval or registration as referred to in point (b) of the second subparagraph of Article 41(3); and

(d) models for health certificates, commercial documents and declarations which are to accompany consignments, specifying the conditions under which it can be stated that the animal by-products or derived products concerned have been collected or manufactured in accordance with the requirements of this Regulation.

Article 43

Export

The export of animal by-products and derived products destined for incineration or landfill shall be prohibited.

The export of animal by-products and derived products to third countries which are not members of the OECD for use in a biogas or composting plant shall be prohibited.

Category 1 material, Category 2 material and products derived therefrom shall only be exported for purposes other than those referred to in paragraphs 1 and 2 provided that rules for their export have been laid down.

Article 12 of Regulation (EC) No 178/2002 concerning food and feed exported from the Community shall apply mutatis mutandis to the export of Category 3 material or products derived therefrom in compliance with this Regulation.

By way of derogation from paragraphs 3 and 4, the export of:

(a) specified risk material shall take place only in accordance with Regulation (EC) No 999/2001;

(b) animal by-products or derived products mixed or contaminated with any waste listed as hazardous in Decision 2000/532/EC shall take place only subject to the requirements of Regulation (EC) No 1013/2006.

TITLE III OFFICIAL CONTROLS AND FINAL PROVISIONS

CHAPTER I Official controls

Article 44

Procedure for approval

The competent authority shall approve establishments or plants only where an on site visit, prior to start-up of any activity, has demonstrated that they meet the relevant requirements laid down in accordance with Article 27.

The competent authority may grant conditional approval if it appears, from the on site visit, that the establishment or plant meets all the infrastructure and equipment requirements with a view to ensuring the application of the operational procedures in compliance with this Regulation. It shall grant full approval only if it appears, from another on site visit carried out within three months of granting conditional approval, that the establishment or plant meets the other requirements referred to in paragraph 1. If clear progress has been made, but the establishment or plant still does not meet all of these requirements, the competent authority may extend conditional approval. However, conditional approval shall not exceed a total of six months.

Operators shall ensure that an establishment or plant ceases to operate if the competent authority withdraws its approval or in the case of conditional approval fails to extend it or to grant full approval.

Article 46

Suspensions, withdrawals and prohibitions on operations

If the official controls and supervision carried out by the competent authority reveal that one or more of the requirements of this Regulation are not met, it shall take appropriate action.

The competent authority shall in particular, as appropriate to the nature and to the gravity of the deficiencies and to the potential risks for public and animal health:

(a) suspend approvals of establishments or plants approved pursuant to this Regulation, if:
(i) the conditions for approving or operating the establishment or plant are no longer fulfilled;
(ii) the operator can be expected to remedy the deficiencies within a reasonable period of time; and
(iii) the potential risks to public and animal health do not require action in accordance with point (b);

(b) withdraw approvals of establishments or plants approved pursuant to this Regulation, if:
(i) the conditions for approving or operating the establishment or plant are no longer fulfilled; and
(ii) the operator cannot be expected to remedy the deficiencies within a reasonable period of time:
— for reasons relating to the infrastructure of the establishment or plant,
— for reasons relating to the personal capacity of the operator or the staff under his supervision, or
— because of serious risks to public and animal health requiring major adjustments to the operation of the establishment or plant before the operator may apply for re-approval;

The competent authority shall, as appropriate to the nature and to the gravity of the deficiencies and to the potential risks for public and animal health, temporarily or permanently prohibit operators referred to in Articles 23(1) and (3) and Article 24(1) from carrying out operations under this Regulation, as appropriate, following receipt of information indicating:

(a) that the requirements of Community legislation are not met; and

(b) potential risks to public or animal health arising from such operations.

Article 47

Lists

Each Member State shall draw up a list of establishments, plants and operators which have been approved or registered in accordance with this Regulation within its territory.

It shall assign an official number to each approved or registered establishment, plant or operator, which identifies the establishment, plant or operator with respect to the nature of its activities.

Member States shall indicate, if applicable, an official number which has been assigned to the establishment, plant or operator under other Community legislation.

Member States shall make the lists of approved or registered establishments, plants and operators available to the Commission and other Member States.

Member States shall keep up-to-date the lists of approved or registered establishments, plants and operators and make them available to other Member States and to the public.

Measures for the implementation of this Article may be laid down in accordance with the regulatory procedure referred to in Article 52(3), in particular on:

(a) the format for the lists referred to in paragraph 1; and

(b) the procedure for making the lists referred to in paragraph 1 available.

Article 48

Controls for dispatch to other Member States

Where an operator intends to dispatch Category 1 material, Category 2 material and meat-and-bone meal or animal fat derived from Category 1 and Category 2 materials to another Member State, it shall inform the competent authority of the Member State of origin and the competent authority of the Member State of destination.

The competent authority of the Member State of destination shall decide upon application by the operator, within a specified time period:

(a) to refuse receipt of the consignment;

(b) to accept the consignment unconditionally; or

(c) to make receipt of the consignment subject to the following conditions:
(i) if the derived products have not undergone pressure sterilisation, it must undergo such treatment; or
(ii) the animal by-products or derived products must comply with any conditions for the dispatch of the consignment which are justified for the protection of public and animal health in order to ensure that animal by-products and derived products are handled in accordance with this Regulation.

Formats for applications by operators referred to in paragraph 1 may be adopted in accordance with the regulatory procedure referred to in Article 52(3).

The competent authority of the Member State of origin shall inform the competent authority of the Member State of destination, by means of the Traces system in accordance with Decision 2004/292/EC, of the dispatch of each consignment sent to the Member State of destination, of

(a) animal by-products or derived products referred to in paragraph 1;

(b) processed animal protein derived from Category 3 material.

When informed of the dispatch, the competent authority of the Member State of destination shall inform the competent authority of the Member State of origin of the arrival of each consignment by means of the Traces system.

Category 1 and Category 2 materials, meat-and-bone meal and animal fat referred to in paragraph 1 shall be transported directly to the establishment or plant of destination, which must have been registered or approved in accordance with Articles 23, 24 and 44 or, in the case of manure, to the farm of destination.

When animal by-products or derived products are sent to other Member States via the territory of a third country, they shall be sent in consignments which have been sealed in the Member State of origin and shall be accompanied by a health certificate.

The sealed consignments shall re-enter the Community only via a border inspection post, in accordance with Article 6 of Directive 89/662/EEC.

By way of derogation from paragraphs 1 to 5, animal by-products or derived products referred to therein which have been mixed or contaminated with any waste listed as hazardous in Decision 2000/532/EC shall be sent to other Member States only subject to the requirements of Regulation (EC) No 1013/2006.

Measures for the implementation of this Article may be adopted relating to the following:

(a) a specified time period for the decision of the competent authority as referred to in paragraph 1;

(b) supplementary conditions for the dispatch of animal by-products or derived products referred to in paragraph 4;

(d) conditions under which animal by-products or derived products intended to be used for exhibitions, artistic activities, for diagnostic, educational or research purposes may be sent to other Member States, by way of derogation from paragraph 1 to 5 of this Article.

Measures for the implementation of this Article may specify the conditions subject to which, by way of derogation from paragraphs 1 to 4, the competent authorities may allow:

(a) the dispatch of manure transported between two points located on the same farm or between farms located in the border regions of Member States sharing a common border;

(b) the dispatch of other animal by-products transported between establishments or plants located in the border regions of Member States sharing a common border; and

(c) the transport of a dead pet animal for incineration to an establishment or plant located in the border region of another Member State sharing a common border.

CHAPTER II Final provisions

Article 51

National provisions

Member States shall communicate to the Commission the text of the provisions of national law they adopt in areas under their competence which directly concern the proper implementation of this Regulation.

Article 51a

Exercise of the delegation

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

The power to adopt delegated acts referred to in Article 5(2) shall be conferred on the Commission for a period of five years from 15 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.

The delegation of power referred to in Article 5(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.

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 ([^E0003]).

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

A delegated act adopted pursuant to Article 5(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 of 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 52

Committee procedure

The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58(1) of Regulation (EC) No 178/2002.

Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

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.

Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The time limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be two months, one month and two months respectively.

Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 53

Penalties

The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 4 June 2011 and shall notify it without delay of any subsequent amendment affecting them.

Article 54

Repeal

Regulation (EC) No 1774/2002 shall be repealed with effect from 4 March 2011.

References to Regulation (EC) No 1774/2002 shall be construed as references to this Regulation and shall be read in accordance with the correlation table laid down in the Annex.

Article 55

Transitional measure

Establishments, plants and users approved or registered in accordance with Regulation (EC) No 1774/2002 before 4 March 2011 shall be deemed to be approved or registered, as required, in accordance with this Regulation.

Article 56

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 4 March 2011.

However, Article 4 shall apply to Mayotte, as an outermost region within the meaning of Article 349 of the Treaty on the Functioning of the European Union (hereinafter ‘Mayotte’), from 1 January 2021. Animal by-products and derived products generated in Mayotte before 1 January 2021 shall be disposed of in accordance with Article 19(1)(b) of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

CORRELATION TABLE

Regulation (EC) No 1774/2002	This Regulation
Article 1	Articles 1 and 2
Article 2	Article 3
Article 3(1)	Article 4(1) and(2)
Article 3(2)	Article 41(3), fourth subparagraph
Article 3(3)	Article 4(3), (4) and (5)
Article 4(1)	Article 8
Article 4(2)	Articles 12, 15 and 16
Article 4(3)	Article 24(h), (i) and (j)
Article 4(4)	Article 41(2)(c), Article 43(3) and (5)(a)
Article 5(1)	Article 9
Article 5(2)	Articles 13, 15 and 16
Article 5(3)	Article 24(h), (i) and (j)
Article 5(4)	Article 41(2)(c) and Article 43(3)
Article 6(1)	Article 10
Article 6(2)	Articles 14, 15 and 16
Article 6(3)	Article 24(h), (i) and (j)
Article 7	Article 21
Article 8	Article 48
Article 9	Article 22
Articles 10 to 15, 17 and 18	Articles 23, 24, 27 and 44
Article 16	Article 6
Article 19	Article 31
Article 20(1)	Articles 35 and 36
Article 20(2)	Article 32
Article 20(3)	Article 36
Article 21	—
Article 22	Article 11
Article 23	Articles 17 and 18
Article 24	Article 19
Article 25	Articles 28 and 29
Article 26	Articles 45, 46 and 47
Article 27	Article 49
Article 28	Article 35(a)(ii) and Article 41(1)
Article 29	Articles 41 and 42
Article 30	Article 41(1)(b)
Article 31	Article 50(1)
Article 32	—
Article 33	Article 52
Article 34	—
Article 35	Article 15(2) and Article 51
Article 36	—
Article 37	Article 54
Article 38	Article 56

[^E0001]: Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) ( OJ L 95, 7.4.2017, p. 1 ).

[^E0002]: OJ L 276, 20.10.2010, p. 33.

[^E0003]: OJ L 123, 12.5.2016, p. 1.

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