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Regulation (EC) No 183/2005 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (Text with EEA relevance)

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CHAPTER IU.K.SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1U.K.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 2U.K.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;

(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(1);

(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.

F13.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 3U.K.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(2);

(d)

‘establishment’ means any unit of a feed business;

(e)

‘competent authority’ means the authority F2... 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.

(g)

[F3third country” means any country or territory other than the British Islands;

(h)

appropriate authority” means—

(i)

in relation to England, the Secretary of State;

(ii)

in relation to Wales, the Welsh Ministers;

(iiii)

in relation to Scotland, the Scottish Ministers;

(i)

Food Safety Authority” means—

(i)

as regards England and Wales, the Food Standards Agency;

(ii)

as regards Scotland, Food Standards Scotland;

(j)

prescribe” means prescribe by regulations]

CHAPTER IIU.K.OBLIGATIONS

Article 4U.K.General obligations

[F41.Feed business operators must ensure that all stages of production, processing and distribution under their control are carried out in accordance with relevant hygiene requirements laid down in retained EU law.]

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 5U.K.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.

[F53.Feed business operators must:

(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) may be prescribed by the appropriate authority.]

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 6U.K.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 F6...

[F75.Measures to facilitate the implementation of this Article, including for small businesses, may be prescribed by the appropriate authority.]

Article 7U.K.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).

[F83.Detailed arrangements for the implementation of this Article may be prescribed by the appropriate authority. Such arrangements may facilitate certain feed business operators' implementation of HACCP principles developed in accordance with Chapter 3, with a view to complying with the requirements of Article 6(1).]

F9Article 8U.K.Financial guarantees

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Article 9U.K.Official controls, notification and registration

[F101.Feed business operators must cooperate with the competent authorities as regards matters related to compliance with retained EU law.]

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 10U.K.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;

(2)

F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

or

(3)

[F12approval is required under measures prescribed by the appropriate authority, which measures must be designed to amend non-essential elements of this Regulation by supplementing it.]

Article 11U.K.Requirements

Feed business operators shall not operate without:

(a)

registration as provided for in Article 9;

or

(b)

approval, when required in accordance with Article 10.

F13Article 12U.K.Information on national rules on approval

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 13U.K.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 14U.K.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 15U.K.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 16U.K.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.

[F14Article 17U.K. Exemption from on-site visits

1.Competent authorities 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 must 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 18U.K.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 19U.K.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.[F15Competent authorities] 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.

F166.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7.The [F15competent authorities] shall make available to the public the lists of establishments referred to in paragraph 1.

CHAPTER IIIU.K.GUIDES TO GOOD PRACTICE

F17Article 20U.K.Development, dissemination and use of guides

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 21U.K.National guides

[F181.When guides to good practice are developed, they must 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

(c)when they concern primary production of feed, having regard to the requirements set out in Annex 1.

2.The Food Safety Authority must assess 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

(c)they are suitable as guides for compliance with Articles 4, 5 and 6, in the sectors and for the feeds concerned.]

F193.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F194.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F20Article 22U.K.Community guides

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER IVU.K.IMPORTS AND EXPORTS

[F21Article 23U.K.Imports

1.Feed business operators importing feed into Great Britain from a third country must ensure that importation takes place only in accordance with the following conditions—

(a)the country of dispatch appears on a list of countries from which imports of feed are permitted;

(b)the establishment of dispatch appears on a list 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 Great Britain; and

(d)the feed satisfies—

(i)the requirements laid down in this Regulation;

(ii)those conditions recognised by the appropriate authority to be at least equivalent to those requirements;

(iii)where a specific agreement between the United Kingdom and the exporting country exists, the requirements contained in that agreement.

2.A model import certificate may be prescribed by the appropriate authority.]

Article 24U.K.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 [F22(reading Article 6 of Directive 98/51/EC as if the requirement imposed on the Member States were a requirement imposed on the appropriate authority and as if references to the Community were references to Great Britain)].

Article 25U.K.Exports

Feed, including feed for animals not kept for food production, which is produced in [F23Great Britain] for placing on the market in third countries, must satisfy the provisions of Article 12 of Regulation (EC) No 178/2002.

CHAPTER VU.K.FINAL PROVISIONS

F24Article 26U.K.Implementing measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F25 Article 27 U.K. Amendments of Annexes 1, 2 and 3

The appropriate authority may prescribe amendments of Annexes 1, 2 and 3 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

(f)the development of requirements relating to specific operations.]

[F26 Article 28 U.K.Derogations from Annexes 1, 2 and 3

Derogations from Annexes 1, 2 and 3 may be prescribed by the appropriate authority for particular reasons, provided that such derogations do not affect the achievement of the objectives of this Regulation.]

F27Article 29U.K.Rapid Alert System

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F28Article 30U.K.Penalties

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Article 30a U.K. Exercise of the delegation

F29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F30Article 31U.K.Committee Procedure

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[F31Article 31AU.K. Regulations and devolved powers

1.Any power to make regulations under this Regulation—

(a)so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b)so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.

2.For regulations made under this Regulation by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).

3.Any power to make regulations under this Regulation includes power—

(a)to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and

(b)to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

4. Any statutory instrument or Scottish statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution—

(a)in the case of England, of either House of Parliament;

(b)in the case of Wales, of Senedd Cymru;

(c)in the case of Scotland, of the Scottish Parliament.

5.In this Regulation, any power—

(a)of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b)of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c)of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.]

[F33Article 32U.K.Consultation of the F32... Food Safety Authority

The appropriate authority must consult the Food Safety 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 33U.K.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 34U.K.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.

F34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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