Article 1 Subject matter
This Regulation lays down: (a) general rules on feed hygiene; (b) conditions and arrangements ensuring traceability of feed; (c) conditions and arrangements for registration and approval of establishments.
Article 2 Scope
1. This Regulation shall apply to: (a) the activities of feed business operators at all stages, from and including primary production of feed, up to and including, the placing of feed on the market; (b) the feeding of food-producing animals; (c) imports and exports of feed from and to third countries. 2. This Regulation shall not apply to: (a) the private domestic production of feed: (i) for food-producing animals kept for private domestic consumption; and (ii) for animals not kept for food production; (a) the private domestic production of feed: (i) for food-producing animals kept for private domestic consumption; and (i) for food-producing animals kept for private domestic consumption; (ii) for animals not kept for food production; (b) the feeding of food-producing animals kept for private domestic consumption or for the activities mentioned in Article 1(2)(c) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( 9 ); (c) the feeding of animals not kept for food production; (d) the direct supply of small quantities of primary production of feed at local level by the producer to local farms for use on those farms; (e) the retailing of pet food. 3. Member States may establish rules and guidance governing the activities referred to in paragraph 2. Such national rules and guidance shall ensure the achievement of the objectives of this Regulation.
Article 3 Definitions
For the purposes of this Regulation, the definitions in Regulation (EC) No 178/2002 shall apply, subject to the following specific definitions: (a) ‘feed hygiene’ means the measures and conditions necessary to control hazards and to ensure fitness for animal consumption of a feed, taking into account its intended use; (b) ‘feed business operator’ means the natural or legal person responsible for ensuring that the requirements of the present Regulation are met within the feed business under their control; (c) ‘feed additives’ means substances or micro-organisms authorised under Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ( 10 ); (d) ‘establishment’ means any unit of a feed business; (e) ‘competent authority’ means the authority of a Member State or of a third country designated to carry out official controls; (f) ‘primary production of feed’ means the production of agricultural products, including in particular growing, harvesting, milking, rearing of animals (prior to their slaughter) or fishing resulting exclusively in products which do not undergo any other operation following their harvest, collection or capture, apart from simple physical treatment.
Article 4 General obligations
1. Feed business operators shall ensure that all stages of production, processing and distribution under their control are carried out in accordance with Community legislation, national law compatible therewith, and good practice. They shall ensure in particular that they satisfy the relevant hygiene requirements laid down in this Regulation. 2. When feeding food-producing animals, farmers shall take measures and adopt procedures to keep the risk of biological, chemical and physical contamination of feed, animals and animal products as low as reasonably achievable.
Article 5 Specific obligations
1. For operations at the level of primary production of feed and the following associated operations: (a) transport, storage and handling of primary products at the place of production; (b) transport operations to deliver primary products from the place of production to an establishment; (c) mixing of feed for the exclusive requirements of their own holdings without using additives or premixtures of additives with the exception of silage additives, feed business operators shall comply with the provisions in Annex I, where relevant for the operations carried out. 2. For operations other than those referred to in paragraph 1, including mixing of feed for the exclusive requirements of their own holdings when using additives or premixtures of additives with the exception of silage additives, feed business operators shall comply with the provisions in Annex II, where relevant for the operations carried out. 3. Feed business operators shall: (a) comply with specific microbiological criteria; (b) take measures or adopt procedures necessary to meet specific targets. The criteria and targets referred to in points (a) and (b) shall be defined by the Commission. 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 31(3). 4. Feed business operators may use the guides provided for in Chapter III to help them comply with their obligations under this Regulation. 5. Farmers shall comply with the provisions set out in Annex III when feeding food-producing animals. 6. Feed business operators and farmers shall only source and use feed from establishments which are registered and/or approved in accordance with this Regulation.
Article 6 Hazard analysis and critical control points (HACCP) system
1. Feed business operators carrying out operations other than those referred to in Article 5(1) shall put in place, implement and maintain, a permanent written procedure or procedures based on the HACCP principles. 2. The principles referred to in paragraph 1 are the following: (a) identify any hazards that must be prevented, eliminated or reduced to acceptable levels; (b) identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels; (c) establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards; (d) establish and implement effective monitoring procedures at critical control points; (e) establish corrective action when monitoring indicates that a critical control point is not under control; (f) establish procedures to verify that the measures outlined in points (a) to (e) are complete and working effectively. Verification procedures shall be carried out regularly; (g) establish documents and records commensurate with the nature and size of the feed businesses to demonstrate the effective application of the measures set out in points (a) to (f). 3. When any modification is made in a product, process or any stage of production, processing, storage and distribution, feed business operators shall review their procedure and make the necessary changes. 4. As part of the system of procedures referred to in paragraph 1, feed business operators may use guides to good practice in conjunction with guides on the application of HACCP, developed in accordance with Article 20. 5. Measures to facilitate the implementation of this Article, including for small businesses, may be adopted in accordance with the procedure referred to in Article 31(2).
Article 7 Documents concerning the HACCP system
1. Feed business operators shall: (a) provide the competent authority with evidence of their compliance with Article 6 in the form requested by the competent authority; (b) ensure that any documents describing the procedures developed in accordance with Article 6 are up-to-date at all times; 2. The competent authority shall take into account the nature and size of the feed business when fixing requirements as to the form referred to in paragraph 1(a). 3. Detailed arrangements for the implementation of this Article may be adopted in accordance with the procedure referred to in Article 31(2). Such arrangements may facilitate certain feed business operators’ implementation of HACCP principles developed in accordance with Chapter III, with a view to complying with the requirements of Article 6(1).
Article 8 Financial guarantees
1. To prepare for an effective system of financial guarantees for feed business operators, the Commission shall submit to the European Parliament and to the Council by 8 February 2006 a report on financial guarantees in the feed sector. In addition to examining the existing national legal provisions, systems and practices relating to liability in the feed sector and related sectors, the report shall be accompanied, where appropriate, by legislative proposals for such a feasible and practicable guarantee system at Community level. Those guarantees should provide cover for the total costs for which operators could be held liable as a direct consequence of the withdrawal from the market, treatment and/or destruction of any feed, animals and food produced therefrom. 2. Feed business operators shall be liable for any infringements of the relevant legislation on feed safety and operators within the meaning of Article 5(2) shall submit proof that they are covered by the financial guarantees required by the Community legislative measures referred to in paragraph 1.
Article 9 Official controls, notification and registration
1. Feed business operators shall cooperate with the competent authorities, in accordance with the relevant Community legislation and national law compatible therewith. 2. Feed business operators shall: (a) notify the appropriate competent authority of any establishments under their control, active in any of the stages of production, processing, storage, transport or distribution of feed, in the form required by the competent authority with a view to registration; (b) provide the competent authority with up-to-date information on any establishments under their control as referred to in point (a), including notifying the competent authority of any significant change in activities and any closure of an existing establishment. 3. The competent authority shall maintain a register or registers of establishments.
Article 10 Approval of feed business establishments
Feed business operators shall ensure that establishments under their control and covered by this Regulation are approved by the competent authority, where: (1) such establishments carry out one of the following activities: (a) manufacturing and/or placing on the market of feed additives covered by Regulation (EC) No 1831/2003 or products covered by Directive 82/471/EEC and referred to in Chapter 1 of Annex IV to this Regulation; (b) manufacturing and/or placing on the market of premixtures prepared using feed additives referred to in Chapter 2 of Annex IV to this Regulation; (c) manufacturing for placing on the market, or producing for the exclusive requirements of their holdings, compound feedingstuffs using feed additives or premixtures containing feed additives and referred to in Chapter 3 of Annex IV to this Regulation; (1) such establishments carry out one of the following activities: (a) manufacturing and/or placing on the market of feed additives covered by Regulation (EC) No 1831/2003 or products covered by Directive 82/471/EEC and referred to in Chapter 1 of Annex IV to this Regulation; (b) manufacturing and/or placing on the market of premixtures prepared using feed additives referred to in Chapter 2 of Annex IV to this Regulation; (c) manufacturing for placing on the market, or producing for the exclusive requirements of their holdings, compound feedingstuffs using feed additives or premixtures containing feed additives and referred to in Chapter 3 of Annex IV to this Regulation; (2) approval is required under the national law of the Member State where the establishment is located; or (2) approval is required under the national law of the Member State where the establishment is located; (3) approval is required by a Regulation adopted by the Commission. This measure, 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 31(3).
Article 11 Requirements
Feed business operators shall not operate without: (a) registration as provided for in Article 9; or (a) registration as provided for in Article 9; (b) approval, when required in accordance with Article 10.
Article 12 Information on national rules on approval
Any Member State requiring the approval under Article 10(2) of certain establishments located on its territory shall inform the Commission and the other Member States of the relevant national rules.
Article 13 Approval of establishments
1. The competent authority shall approve establishments only where an on-site visit, prior to start-up of any activity, has demonstrated that they meet the relevant requirements of this Regulation. 2. The competent authority may grant conditional approval if it appears, from the on-site visit, that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears, from a new on-site visit carried out within three months of granting conditional approval, that the establishment meets the other requirements referred to in paragraph 1. If clear progress has been made, but the establishment still does not meet all of these requirements, the competent authority may prolong conditional approval. However, conditional approval shall not exceed a total of six months.
Article 14 Suspension of registration or approval
The competent authority shall temporarily suspend the registration or the approval of an establishment for one, more or all of its activities, where it is shown that the establishment no longer fulfils the conditions applicable to those activities. Such suspension shall last until the establishment again meets those conditions. Where such conditions are not met within one year, Article 15 shall apply.
Article 15 Revocation of registration or approval
The competent authority shall revoke the registration or the approval of an establishment, for one or more of its activities, where: (a) the establishment ceases one or more of its activities; (b) it is shown that the establishment has not fulfilled the conditions applicable to its activities, for a period of one year; (c) it identifies serious deficiencies or has had to stop production at an establishment repeatedly and the feed business operator is still not able to provide adequate guarantees regarding future production.
Article 16 Amendments to registration or approval of an establishment
Upon request, the competent authority shall amend the registration or approval of an establishment, where it has demonstrated its capacity to develop activities which are additional to those for which it was first registered or approved, or which replace them.
Article 17 Exemption from on-site visits
1. Member States are exempted from the obligation to carry out on-site visits, as provided for in Article 13, of feed businesses which act solely as traders, without holding the products on their premises. 2. Such feed businesses shall submit to the competent authority a declaration, in a form decided upon by the competent authority, to the effect that the feeds placed on the market by them comply with the conditions of this Regulation.
Article 18 Transitional measures
1. Establishments and intermediaries approved and/or registered in accordance with Directive 95/69/EC may continue their activities, on condition that they submit, by 1 January 2006, a notification to this effect to the relevant competent authority in whose area their facilities are located. 2. Establishments and intermediaries requiring neither registration nor approval in accordance with Directive 95/69/EC, but requiring registration in accordance with this Regulation may continue their activities, on condition that they submit, by 1 January 2006, an application for registration to the relevant competent authority in whose area their facilities are located. 3. By 1 January 2008 the applicant must declare, in a form decided upon by the competent authority, that the conditions laid down in this Regulation are being met. 4. The competent authorities shall take account of the systems already existing for the collection of data and request the notifier or the applicant to provide only additional information which guarantees compliance with the conditions of this Regulation. In particular, the competent authorities may consider as an application under paragraph 2 a notification pursuant to Article 6 of Regulation (EC) No 852/2004.
Article 19 List of registered and approved establishments
1. For each activity, the competent authority shall record in a national list or lists the establishments it has registered in accordance with Article 9. 2. Establishments approved by the competent authority in accordance with Article 13 shall be recorded in a national list, under an individual identifying number. 3. Member States shall keep updated the records of establishments in the lists referred to in paragraphs 1 and 2 in accordance with the decisions referred to in Articles 14, 15 and 16 to suspend, revoke or amend registration or approval. 4. The list referred to in paragraph 2 must be drawn up in accordance with the model set out in Annex V, Chapter I. 5. The identifying number referred to in paragraph 2 shall be in the form set out in Annex V, Chapter II. 6. The Commission shall compile and make available to the public the part of the Member States’ lists which includes the establishments referred to in paragraph 2 for the first time in November 2007, and thereafter each year, by 30 November at the latest. The compiled list shall take into account the amendments made during the year. 7. The Member States shall make available to the public the lists of establishments referred to in paragraph 1.
Article 20 Development, dissemination and use of guides
1. The Commission shall encourage the development of Community guides to good practice in the feed sector and for the application of HACCP principles in accordance with Article 22. Where necessary, Member States shall encourage the development of national guides in accordance with Article 21. 2. The dissemination and use of both national and Community guides shall be encouraged by the competent authorities. 3. Nevertheless, feed business operators may use these guides voluntarily.
Article 21 National guides
1. When national guides to good practice are developed, they shall be developed and disseminated by feed business sectors: (a) in consultation with representatives of parties whose interests may be substantially affected, such as competent authorities and user groups; (b) having regard to relevant codes of practice of the Codex Alimentarius; and (b) having regard to relevant codes of practice of the Codex Alimentarius; (c) when they concern primary production of feed, having regard to the requirements set out in Annex I. 2. Member States shall assess national guides to ensure that: (a) they have been developed in accordance with paragraph 1; (b) their contents are practicable for the sectors to which they refer; and (b) their contents are practicable for the sectors to which they refer; (c) they are suitable as guides for compliance with Articles 4, 5 and 6, in the sectors and/or for the feeds concerned. 3. Member States shall transmit national guides to the Commission. 4. The Commission shall set up and run a registration system for such guides and make it available to the Member States.
Article 22 Community guides
1. Before Community guides to good practice for hygiene or for the application of the HACCP principles are developed, the Commission shall consult the Committee referred to in Article 31(1). The objective of this consultation shall be to consider the case for such guides, their scope and subject matter. 2. Where Community guides are prepared, the Commission shall ensure that they are developed and disseminated: (a) by or in consultation with appropriate representatives of European feed business sectors and other interested parties, such as consumer groups; (b) in collaboration with parties whose interests may be substantially affected, including competent authorities. 3. Community guides shall be developed and disseminated taking into account: (a) relevant codes of practice of the Codex Alimentarius, and (a) relevant codes of practice of the Codex Alimentarius, (b) when they concern primary production of feed, the requirements set out in Annex I. 4. The Committee referred to in Article 31(1) shall assess draft Community guides to ensure that: (a) they have been developed in accordance with paragraphs 2 and 3; (b) their contents are practicable throughout the Community for the sectors to which they refer; and (b) their contents are practicable throughout the Community for the sectors to which they refer; (c) they are suitable as guides for compliance with Articles 4, 5 and 6, in the sectors and/or for the feeds concerned. 5. The Commission shall invite the Committee referred to in Article 31(1) periodically to review any Community guides prepared in accordance with this Article, in cooperation with the entities mentioned in paragraph 2 of this Article. The aim of this review shall be to ensure that the guides remain practicable and to take account of technological and scientific developments. 6. The titles and references of Community guides prepared in accordance with this Article shall be published in the C series of the Official Journal of the European Union .
Article 23 Imports
1. Feed business operators importing feed from third countries shall ensure that importation takes place only in accordance with the following conditions: (a) the third country of dispatch appears on a list, drawn up in accordance with Article 48 of Regulation (EC) No 882/2004, of third countries from which imports of feed are permitted; (b) the establishment of dispatch appears on a list, drawn up and kept updated by the third country in accordance with Article 48 of Regulation (EC) No 882/2004, of establishments from which imports of feed are permitted; (c) the feed was produced by the establishment of dispatch or by another establishment appearing on the list referred to in point (b) or in the Community; and (c) the feed was produced by the establishment of dispatch or by another establishment appearing on the list referred to in point (b) or in the Community; (d) the feed satisfies: (i) the requirements laid down in this Regulation, and in any other Community legislation laying down rules for feed; or (ii) those conditions recognised by the Community to be at least equivalent thereto; or (iii) where a specific agreement between the Community and the exporting country exists, the requirements contained therein. (d) the feed satisfies: (i) the requirements laid down in this Regulation, and in any other Community legislation laying down rules for feed; or (i) the requirements laid down in this Regulation, and in any other Community legislation laying down rules for feed; (ii) those conditions recognised by the Community to be at least equivalent thereto; or (ii) those conditions recognised by the Community to be at least equivalent thereto; (iii) where a specific agreement between the Community and the exporting country exists, the requirements contained therein. 2. A model import certificate may be adopted in accordance with the procedure referred to in Article 31(2).
Article 24 Interim measures
By way of derogation from Article 33 and pending the drawing up of the lists provided for in Article 23(1)(a) and (b), imports shall continue to be authorised under the conditions laid down in Article 6 of Directive 98/51/EC.
Article 25 Exports
Feed, including feed for animals not kept for food production, which is produced in the Community for placing on the market in third countries, must satisfy the provisions of Article 12 of Regulation (EC) No 178/2002.
Article 26 Implementing measures
Implementing measures may be laid down in accordance with the procedure referred to in Article 31(2).
Article 27 
Amendments to Annexes I, II and III Annexes I, II and III may be amended to take account of: (a) the development of codes of good practice; (b) the experience gained from the implementation of HACCP-based systems pursuant to Article 6; (c) technological developments; (d) scientific advice, particularly new risk assessments; (e) the setting of feed safety targets; and (e) the setting of feed safety targets; (f) the development of requirements relating to specific operations. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 31(3).
Article 28 
Derogations from Annexes I, II and III Derogations from Annexes I, II and III may be granted by the Commission for particular reasons, provided that such derogations do not affect the achievement of the objectives of this Regulation. 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 31(3).
Article 29 Rapid Alert System
Should a specific feed, including feed for animals not kept for food production, present a serious risk to human or animal health or to the environment, Article 50 of Regulation (EC) No 178/2002 shall apply mutatis mutandis .
Article 30 Penalties
The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take the 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 8 February 2007, and shall notify it without delay of any subsequent amendment affecting them.
Article 31 Committee Procedure
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up by Regulation (EC) No 178/2002 (hereinafter referred to as the Committee). 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. 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.
Article 32 Consultation of the European Food Safety Authority
The Commission shall consult the European Food Authority on any matter, falling within the scope of this Regulation, that could have a significant impact on public health and, in particular, before proposing criteria or targets in accordance with Article 5(3).
Article 33 Repeal
The following Directives are repealed, without prejudice to the obligations of the Member States concerning the deadlines for transposition, with effect from 1 January 2006: (a) Council Directive 95/69/EC; (b) Commission Directive 98/51/EC.
Article 34 Entry into force
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union . It shall apply as from 1 January 2006. This Regulation shall be binding in its entirety and directly applicable in all Member States.