I
(Acts whose publication is obligatory)
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)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty establishing the European Commu-
nity,andinparticularArticle37(2)andArticle152(4)(b)thereof,
Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and
Social Committee (
1),
After consulting the Committee of the Regions,
ActinginaccordancewiththeprocedurelaiddowninArticle251
of the Treaty (2),
Whereas:
(1)Livestock production plays a very important part in the
agricultural sector of the Community. Satisfactory resultsof this activity depend to a large extent on the use of safeand good quality feed.
(2)Thepursuitofahighlevelofprotectionofhumanandani-
mal health is one of the fundamental objectives of foodlaw, as laid down in Regulation (EC) No 178/2002 of theEuropean Parliament and of the Council of 28 January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthor-ity and laying down procedures in matters of foodsafety (
3). That Regulation also lays down other common
principles and definitions for national and Communityfoodlaw,includingtheaimofachievingfreemovementoffeed within the Community.(3)Council Directive 95/69/EC (4) established the conditions
andarrangementsapplicabletocertaincategoriesofestab-lishments and intermediaries in the animal feed sector, toenable them to exercise their activities. Experience hasshown that these conditions and arrangements constitutea sound basis for ensuring feed safety. That Directive alsoestablished conditions for the approval of establishmentsproducing certain substances listed in CouncilDirective82/471/EECof30June1982concerningcertainproducts used in animal nutrition (
5).
(4)Commission Directive 98/51/EC of 9 July 1998 laying
down certain measures for implementing CouncilDirective 95/69/EC laying down the conditions andarrangements for approving and registering certain estab-lishments and intermediaries operating in the animal feedsector (
6), established certain measures that included
arrangements for imports from third countries.
(5)Experience has also shown that it is necessary to ensure
that all feed businesses, including aquaculture, operate inconformity with harmonised safety requirements and thatit is necessary to conduct a general review in order to takeinto account the need to ensure a higher level of protec-tionofhumanandanimalhealth,andoftheenvironment.
(6)The principal objective of the new hygiene rules set out in
this Regulation is to ensure a high level of consumer pro-tectionwithregardtofoodandfeedsafety,takingparticu-lar account of the following principles:
(a) that primary responsibility for feed safety rests with
the feed business operator;
(1) OJ C 32, 5.2.2004, p. 97.
(2) Opinion of the European Parliament of 31 March 2004 (not yet pub-
lished in the Official Journal) and Council Decision of 21 December
2004.
(3) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)
No 1642/2003 (OJ L 245, 29.9.2003, p. 4).(4) OJL332,30.12.1995,p.15.DirectiveaslastamendedbyRegulation
(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).
(5) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council(OJ L 284, 31.10.2003, p. 1).
(
6) OJ L 208, 24.7.1998, p. 43.8.2.2005 EN Official Journal of the European Union L 35/1(b) the need to ensure feed safety throughout the food
chain,startingwithprimaryproductionoffeed,upto
andincluding,thefeedingoffood-producinganimals;
(c) the general implementation of procedures based on
the principles of hazard analysis and critical controlpoints (HACCP), which, together with the applicationof good hygiene practice, should reinforce feed busi-ness operators’ responsibility;
(d) thatguidestogoodpracticeareavaluableinstrument
tohelpfeedbusinessoperatorsatalllevelsofthefeedchain comply with feed hygiene rules and with theapplication of HACCP principles;
(e) theestablishmentofmicrobiologicalcriteriabasedon
scientific risk criteria;
(f) the need to ensure that imported feed attains a stan-
dardthatisatleastequivalenttothatoffeedproducedin the Community.
(7)Inordertoensurethecompleteapplicationoftheregistra-
tionandapprovalsystemtoallthefeedbusinessoperatorsand,consequently,toguaranteefulltraceability,itisappro-priate to ensure that they only source and use feed fromestablishments which are registered and/or approved inaccordance with this Regulation.
(8)An integrated approach is necessary to ensure feed safety
from,andincluding,primaryproductionoffeedupto,andincluding,itsplacingonthemarketorexport.Theprimaryproduction of feed includes products which only undergosimple physical treatment such as cleaning, packaging,storage, natural drying or ensiling.
(9)In accordance with the principles of proportionality and
subsidiarity, Community rules should not apply to certaincasesofprivatedomesticproductionoffeedandfeedingofcertain animals, nor to the direct supply of small quanti-tiesofprimaryproductionoffeedatlocallevel,nortotheretailing of pet food.
(10)Feed hazards present at the level of primary production of
feed should be identified and adequately controlled, toensure that the objectives of this Regulation are met. ThefundamentalprinciplesofthisRegulationshouldthereforeapply to farms which manufacture feed solely for therequirements of their own production, as well as to farmswhich place feed on the market. It should be taken intoconsiderationthattheriskislessiffeedisproducedandusedforfeeding
animals only used for domestic consumption, or for ani-malswhicharenotusedforfoodproduction.Thetradeofsmall quantities of feed products at local level and theretailing of pet food shall have particular treatment in theframework of this Regulation.
(11)The application of HACCP principles to primary produc-
tion of feed is the medium-term objective of Europeanhygiene legislation. But guides to good practice shouldalready be encouraging the use of appropriate hygienerequirements.
(12)Feed safety depends on a number of factors. Legislation
should lay down minimum hygiene requirements. Officialcontrols should be in place to check feed business opera-tors’ compliance. In addition, feed business operatorsshould take measures or adopt procedures to achieve ahigh level of feed safety.
(13)HACCP principles can help feed business operators attain
a higher standard of feed safety. HACCP principles shouldnot be regarded as a method of self-regulation and do notreplace official controls.
(14)The implementation of the HACCP principles requires the
full cooperation and commitment of feed businesses’employees.
(15)HACCP principles in feed production should take into
account the principles contained in the Codex Alimenta-
rius, but should allow sufficient flexibility in all situations.In certain feed business, it is not possible to identify criti-cal control points and, in some cases, good practices canreplacethemonitoringofcriticalcontrolpoints.Similarly,therequirementtoestablish‘criticallimits’,assetoutintheCodex Alimentarius, does not require a numerical limit tobe fixed in every case. The requirement to retain docu-ments as set out in the same Code needs to be flexible toavoidundueburdensforverysmallbusinesses.Itshouldbeensured that operations carried out by a feed business atthe level of primary production of feed, including associ-atedoperations,aswellasthemixingoffeedwithcomple-mentary feedingstuffs for the exclusive requirements of itsown holding, are not obliged to follow the HACCPprinciples.L 35/2
EN Official Journal of the European Union 8.2.2005(16)Flexibility is also necessary to accommodate the needs of
feed businesses situated in regions suffering from special
geographical constraints or related to structural require-ments. But such flexibility should not compromise feedhygiene objectives. Provision should be made for discus-sion within the Standing Committee on the Food Chainand Animal Health, where appropriate.
(17)A system of registration and approval by the competent
authority of the Member State of all feed businesses isappropriate to ensure traceability from manufacturer tofinal user and to facilitate the implementation of effectiveofficialcontrols.Theexistingsystemsforcollectionofdataconcerningfeedbusinessesmaybeusedbythecompetentauthority of the Member States to start up and implementthe system provided for in this Regulation.
(18)It is appropriate that an approval system for feed busi-
nesses be maintained for activities which can present ahigherriskinthemanufactureoffeed.Provisionshouldbemade for procedures to extend the current scope of theapproval system provided for in Directive 95/69/EC.
(19)In order to be approved or registered, feed businesses
shouldmeetseveralconditionsrelevanttotheiroperations,
concerning facilities, equipment, personnel, production,quality control, storage and documentation, in order toensurebothfeedsafetyandproducttraceability.Provisionshouldbemadefortheseconditionstobevaried,toensurethattheyareappropriatetothevarioustypesoffeedbusi-ness. Member States should be allowed to grant condi-tional approval of establishments, if it appears from theon-sitevisitthattheestablishmentmeetsalltheinfrastruc-ture and equipment requirements. However, it is alsoappropriatetosetamaximumlengthoftimeforsuchcon-ditional approval.
(20)Provision should be made for temporarily suspending,
amending or revoking the registration or approval, whereestablishmentschangeorceasetheiractivitiesornolongerfulfil the conditions applicable to their activity.
(21)The traceability of feed and feed ingredients throughout
the feed chain is an essential element in ensuring feedsafety. Regulation (EC) No 178/2002 contains rules toensurethetraceabilityoffeedandfeedingredientsandpro-vides a procedure for the adoption of implementing rulesapplicable to specific sectors.(22)Successivefeedcriseshaveshownthatfailuresatanystage
in the feed chain can have important economic conse-
quences. The characteristics of feed production and thecomplexity of the feed distribution chain mean that it isdifficult to withdraw feed from the market. The costs ofrectifying the economic damage along the feed and foodchainisoftenbornebypublicfunds.Theremedyingofthiseconomic consequence at a low cost to society could beimproved if the operator whose activity causes economicdamage in the feed sector is held financially responsible.However, establishing a general mandatory system offinancial liability and financial guarantees, for examplethrough insurance, which applies to all feed businessoperators may not be feasible or appropriate. The Com-mission should therefore consider this issue in greaterdepth,takingintoaccountprovisionsinexistinglegislationwith regard to liability in other spheres, as well as existingsystemsandpracticesamongsttheMemberStates.Tothisend, the Commission should present a report, accompa-nied where appropriate by legislative proposals.
(23)FeedimportedintotheCommunitymustsatisfythegeneral
requirements laid down in Regulation (EC) No 178/2002
and the import conditions laid down in Regulation (EC)No882/2004oftheEuropeanParliamentandoftheCoun-cil of 29 April 2004 on official controls performed toensure the verification of compliance with feed and foodlaw,animalhealthandanimalwelfarerules (
1).Inorderto
avoid trade disruptions it is appropriate that, pending thecompletion of the implementing measures, imports con-tinue to be authorised under the conditions laid down inDirective 98/51/EC.
(24)Community products exported to third countries have to
satisfy the general requirements laid down in Regulation(EC) No 178/2002.
(25)Itisappropriatetobroadenthescopeoftherapidalertsys-
tem for food and feed laid down by Regulation (EC)No178/2002toincluderiskstoanimalhealthortheenvi-ronment from feed used for animals not kept for foodproduction.
(26)Community legislation on feed hygiene has to be under-
pinnedbyscientificadvice.Tothisend,theEuropeanFoodSafetyAuthorityshouldbeconsultedwhenevernecessary.
(27)To take account of technical and scientific progress, there
should be close and effective cooperation between theCommission and the Member States within the StandingCommittee on the Food Chain and Animal Health.
(1) OJ L 165, 30.4.2004, p. 1 (Corrigendum: OJ L 191, 28.5.2004, p. 1).8.2.2005 EN Official Journal of the European Union L 35/3(28)This Regulation takes account of international obligations
laid down in the WTO Sanitary and Phytosanitary Agree-
mentandtheinternationalfoodsafetystandardscontainedin the Codex Alimentarius.
(29)The Member States should lay down rules on penalties
applicabletoinfringementsoftheprovisionsofthisRegu-lationandensurethattheyareimplemented.Thosepenal-ties have to be effective, proportionate and dissuasive.
(30)The measures necessary for the implementation of this
Regulation should be adopted in accordance with CouncilDecision 1999/468/EC of 28 June 1999 laying down theprocedures for the exercise of implementing powers con-ferred on the Commission (
1).
(31)It is appropriate to provide for a deferred date of applica-
tionoftheRegulation,inordertoallowthefeedbusinessesaffected by it time to adapt.
(32)For the above reasons, Directives 95/69/EC and 98/51/EC
should be repealed,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down:
(a) general rules on feed hygiene;(b) conditions and arrangements ensuring traceability of feed;(c) conditionsandarrangementsforregistrationandapprovalof
establishments.
Article 2
Scope
1. This Regulation shall apply to:(a) theactivitiesoffeedbusinessoperatorsatallstages,fromand
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 Euro-peanParliamentandoftheCouncilof29April2004onthehygiene of foodstuffs (
2);
(c) the feeding of animals not kept for food production;
(d) thedirectsupplyofsmallquantitiesofprimaryproductionof
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 andguidance shall ensure the achievement of the objectives of thisRegulation.
Article 3
Definitions
For the purposes of this Regulation, the definitions in Regulation(EC) No 178/2002 shall apply, subject to the following specificdefinitions:
(a) ‘feed hygiene’ means the measures and conditions necessary
tocontrolhazardsandtoensurefitnessforanimalconsump-
tion of a feed, taking into account its intended use;
(1) OJ L 184, 17.7.1999, p. 23. (2) OJL139,30.4.2004,p.1.(Corrigendum:OJL226,25.6.2004,p.3).L 35/4 EN Official Journal of the European Union 8.2.2005(b) ‘feed business operator’ means the natural or legal person
responsibleforensuringthattherequirementsofthepresent
Regulation are met within the feed business under theircontrol;
(c) ‘feedadditives’meanssubstancesormicro-organismsautho-
rised under Regulation (EC) No 1831/2003 of the EuropeanParliament and of the Council of 22 September 2003 onadditives for use in animal nutrition (
1);
(d) ‘establishment’ means any unit of a feed business;
(e) ‘competentauthority’meanstheauthorityofaMemberState
orofathirdcountrydesignatedtocarryoutofficialcontrols;
(f) ‘primary production of feed’ means the production of agri-
cultural products, including in particular growing, harvest-
ing, milking, rearing of animals (prior to their slaughter) orfishing resulting exclusively in products which do notundergo any other operation following their harvest, collec-tion or capture, apart from simple physical treatment.
CHAPTER II
OBLIGATIONS
Article 4
General obligations
1. Feed business operators shall ensure that all stages of pro-duction, processing and distribution under their control are car-ried out in accordance with Community legislation, national lawcompatibletherewith,andgoodpractice.Theyshallensureinpar-ticular that they satisfy the relevant hygiene requirements laiddown in this Regulation.
2. When feeding food-producing animals, farmers shall take
measures and adopt procedures to keep the risk of biological,chemicalandphysicalcontaminationoffeed,animalsandanimalproducts as low as reasonably achievable.Article 5
Specific obligations
1. For operations at the level of primary production of feedand 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 inAnnex 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 theirown holdings when using additives or premixtures of additiveswith the exception of silage additives, feed business operatorsshall comply with the provisions in Annex II, where relevant forthe operations carried out.
3. Feed business operators shall:(a) comply with specific microbiological criteria;(b) takemeasuresoradoptproceduresnecessarytomeetspecific
targets.
The criteria and targets referred to in points (a) and (b) shall be
adopted in accordance with the procedure referred to inArticle 31(2).
4. Feed business operators may use the guides provided for in
ChapterIIItohelpthemcomplywiththeirobligationsunderthisRegulation.
5. Farmers shall comply with the provisions set out in
Annex III when feeding food-producing animals.
(1) OJ L 268, 18.10.2003, p. 29.8.2.2005 EN Official Journal of the European Union L 35/56. Feed business operators and farmers shall only source and
use feed from establishments which are registered and/orapproved in accordance with this Regulation.
Article 6
Hazard analysis and critical control points (HACCP)
system
1. Feed business operators carrying out operations other thanthosereferredtoinArticle5(1)shallputinplace,implementandmaintain,apermanentwrittenprocedureorproceduresbasedonthe 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) identifythecriticalcontrolpointsatthesteporstepsatwhich
controlisessentialtopreventoreliminateahazardorreduce
it to acceptable levels;
(c) establish critical limits at critical control points which sepa-
rate 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. Verifi-cation procedures shall be carried out regularly;
(g) establish documents and records commensurate with the
nature and size of the feed businesses to demonstrate theeffective application of the measures set out in points (a)to (f).
3. When any modification is made in a product, process oranystageofproduction,processing,storageanddistribution,feedbusinessoperatorsshallreviewtheirprocedureandmakethenec-essary changes.4. As part of the system of procedures referred to in para-
graph1,feedbusinessoperatorsmayuseguidestogoodpracticein conjunction with guides on the application of HACCP, devel-oped in accordance with Article 20.
5. Measures to facilitate the implementation of this Article,
including for small businesses, may be adopted in accordancewith the procedure referred to in Article 31(2).
Article 7
Documents concerning the HACCP system
1. Feed business operators shall:
(a) providethecompetentauthoritywithevidenceoftheircom-
pliance with Article 6 in the form requested by the compe-
tent authority;
(b) ensure that any documents describing the procedures devel-
opedinaccordancewithArticle6areup-to-dateatalltimes;
2. The competent authority shall take into account the natureand size of the feed business when fixing requirements as to theform referred to in paragraph 1(a).
3. Detailed arrangements for the implementation of this
Articlemaybeadoptedinaccordancewiththeprocedurereferredto in Article 31(2). Such arrangements may facilitate certain feedbusiness operators’ implementation of HACCP principles devel-oped in accordance with Chapter III, with a view to complyingwith the requirements of Article 6(1).
Article 8
Financial guarantees
1. To prepare for an effective system of financial guaranteesfor feed business operators, the Commission shall submit to theEuropean Parliament and to the Council by 8 February 2006 areport on financial guarantees in the feed sector. In addition to
examining the existing national legal provisions, systems andpracticesrelatingtoliabilityinthefeedsectorandrelatedsectors,the report shall be accompanied, where appropriate, by legisla-tive proposals for such a feasible and practicable guarantee sys-tem at Community level. Those guarantees should provide coverfor the total costs for which operators could be held liable as adirectconsequenceofthewithdrawalfromthemarket,treatmentand/or destruction of any feed, animals and food producedtherefrom.L 35/6
EN Official Journal of the European Union 8.2.20052. Feedbusinessoperatorsshallbeliableforanyinfringements
oftherelevantlegislationonfeedsafetyandoperatorswithinthemeaning of Article 5(2) shall submit proof that they are coveredby the financial guarantees required by the Community legisla-tive measures referred to in paragraph 1.
Article 9
Official controls, notification and registration
1. Feedbusinessoperatorsshallcooperatewiththecompetentauthorities, in accordance with the relevant Community legisla-tion and national law compatible therewith.
2. Feed business operators shall:(a) notify the appropriate competent authority of any establish-
ments under their control, active in any of the stages of pro-
duction,processing,storage,transportordistributionoffeed,intheformrequiredbythecompetentauthoritywithaviewto registration;
(b) providethecompetentauthoritywithup-to-dateinformation
on any establishments under their control as referred to inpoint(a),includingnotifyingthecompetentauthorityofanysignificantchangeinactivitiesandanyclosureofanexistingestablishment.
3. The competent authority shall maintain a register or regis-ters of establishments.
Article 10
Approval of feed business establishments
Feed business operators shall ensure that establishments undertheir control and covered by this Regulation are approved by thecompetent authority, where:
(1) suchestablishmentscarryoutoneofthefollowingactivities:
(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 referredto in Chapter 1 of Annex IV to this Regulation;(b) manufacturingand/orplacingonthemarketofpremix-
tures prepared using feed additives referred to in Chap-ter 2 of Annex IV to this Regulation;
(c) manufacturing for placing on the market, or producing
for the exclusive requirements of their holdings, com-pound feedingstuffs using feed additives or premixturescontainingfeedadditivesandreferredtoinChapter3ofAnnex IV to this Regulation;
(2) approval is required under the national law of the Member
State where the establishment is located;
or
(3) approval is required by a Regulation adopted in accordance
with the procedure referred to in Article 31(2).
Article 11
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.
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 theCommissionandtheotherMemberStatesoftherelevantnationalrules.
Article 13
Approval of establishments
1. Thecompetentauthorityshallapproveestablishmentsonlywhere an on-site visit, prior to start-up of any activity, hasdemonstrated that they meet the relevant requirements of thisRegulation.8.2.2005
EN Official Journal of the European Union L 35/72. Thecompetentauthoritymaygrantconditionalapprovalif
it appears, from the on-site visit, that the establishment meets allthe infrastructure and equipment requirements. It shall grant fullapproval only if it appears, from a new on-site visit carried outwithin three months of granting conditional approval, that theestablishment meets the other requirements referred to in para-graph 1. If clear progress has been made, but the establishmentstill does not meet all of these requirements, the competentauthority may prolong conditional approval. However, condi-tional approval shall not exceed a total of six months.
Article 14
Suspension of registration or approval
The competent authority shall temporarily suspend the registra-tion or the approval of an establishment for one, more or all ofits activities, where it is shown that the establishment no longerfulfils the conditions applicable to those activities.
Such suspension shall last until the establishment again meets
those conditions. Where such conditions are not met within oneyear, Article 15 shall apply.
Article 15
Revocation of registration or approval
The competent authority shall revoke the registration or theapproval 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 con-
ditions applicable to its activities, for a period of one year;
(c) it identifies serious deficiencies or has had to stop produc-
tion at an establishment repeatedly and the feed business
operator is still not able to provide adequate guaranteesregarding future production.
Article 16
Amendments to registration or approval of an
establishment
Upon request, the competent authority shall amend the registra-tion or approval of an establishment, where it has demonstrateditscapacitytodevelopactivitieswhichareadditionaltothoseforwhich 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 carryouton-sitevisits,asprovidedforinArticle13,offeedbusinesseswhichactsolelyastraders,withoutholdingtheproductsontheirpremises.
2. Suchfeedbusinessesshallsubmittothecompetentauthor-
ity a declaration, in a form decided upon by the competentauthority, to the effect that the feeds placed on the market bythem comply with the conditions of this Regulation.
Article 18
Transitional measures
1. Establishments and intermediaries approved and/or regis-tered in accordance with Directive 95/69/EC may continue theiractivities, on condition that they submit, by 1 January 2006, anotification to this effect to the relevant competent authority inwhose area their facilities are located.
2. Establishments and intermediaries requiring neither regis-
tration nor approval in accordance with Directive 95/69/EC, butrequiring registration in accordance with this Regulation maycontinue their activities, on condition that they submit, by1 January 2006, an application for registration to the relevantcompetent authority in whose area their facilities are located.
3. By 1 January 2008 the applicant must declare, in a form
decideduponbythecompetentauthority,thattheconditionslaiddown in this Regulation are being met.
4. Thecompetentauthoritiesshalltakeaccountofthesystems
already existing for the collection of data and request the notifieror the applicant to provide only additional information whichguarantees compliance with the conditions of this Regulation. Inparticular, the competent authorities may consider as an applica-tion under paragrap h 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 anational list or lists the establishments it has registered in accor-dance with Article 9.L 35/8
EN Official Journal of the European Union 8.2.20052. 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 establish-
mentsinthelistsreferredtoinparagraphs1and2inaccordancewith the decisions referred to in Articles 14, 15 and 16 to sus-pend, 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 theestablishments referred to in paragraph 2 for the first time inNovember2007,andthereaftereachyear,by30Novemberatthelatest. The compiled list shall take into account the amendmentsmade during the year.
7. The Member States shall make available to the public the
lists of establishments referred to in paragraph 1.
CHAPTER III
GUIDES TO GOOD PRACTICE
Article 20
Development, dissemination and use of guides
1. TheCommissionshallencouragethedevelopmentofCom-munity guides to good practice in the feed sector and for theapplication of HACCP principles in accordance with Article 22.
Where necessary, Member States shall encourage the develop-
ment of national guides in accordance with Article 21.
2. The dissemination and use of both national and Commu-
nity 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, theyshall be developed and disseminated by feed business sectors:
(a) in consultation with representatives of parties whose inter-
estsmaybesubstantiallyaffected,suchascompetentauthori-
ties and user groups;
(b) having regard to relevant codes of practice of the Codex
Alimentarius;
and
(c) whentheyconcernprimaryproductionoffeed,havingregard
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
(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 orfor the application of the HACCP principles are developed, theCommission shall consult the Committee referred to inArticle 31(1). The objective of this consultation shall be to con-sider the case for such guides, their scope and subject matter.8.2.2005
EN Official Journal of the European Union L 35/92. 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) incollaborationwithpartieswhoseinterestsmaybesubstan-
tially 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
(b) when they concern primary production of feed, the require-
ments set out in Annex I.
4. TheCommitteereferredtoinArticle31(1)shallassessdraft
Community guides to ensure that:
(a) they have been developed in accordance with paragraphs 2
and 3;
(b) theircontentsarepracticablethroughouttheCommunityfor
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/or for the feeds concerned.
5. The Commission shall invite the Committee referred to in
Article 31(1) periodically to review any Community guides pre-pared in accordance with this Article, in cooperation with theentities mentioned in paragraph 2 of this Article. The aim of thisreview shall be to ensure that the guides remain practicable andto 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 oftheOfficial Journal of the European Union .CHAPTER IV
IMPORTS AND EXPORTS
Article 23
Imports
1. Feedbusinessoperatorsimportingfeedfromthirdcountries
shallensurethatimportationtakesplaceonlyinaccordancewiththe following conditions:
(a) the third country of dispatch appears on a list, drawn up in
accordancewithArticle48ofRegulation(EC)No882/2004,
of third countries from which imports of feed are permitted;
(b) theestablishmentofdispatchappearsonalist,drawnupand
kept updated by the third country in accordance withArticle 48 of Regulation (EC) No 882/2004, of establish-ments from which imports of feed are permitted;
(c) thefeedwasproducedbytheestablishmentofdispatchorby
another establishment appearing on the list referred to inpoint (b) or in the Community;
and
(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) whereaspecificagreementbetweentheCommunityand
theexportingcountryexists,therequirementscontained
therein.
2. A model import certificate may be adopted in accordancewith the procedure referred to in Article 31(2).
Article 24
Interim measures
By way of derogation from Article 33 and pending the drawingup of the lists provided for in Article 23(1)(a) and (b), importsshallcontinuetobeauthorisedundertheconditionslaiddowninArticle 6 of Directive 98/51/EC.L 35/10
EN Official Journal of the European Union 8.2.2005Article 25
Exports
Feed, including feed for animals not kept for food production,
which is produced in the Community for placing on the marketin third countries, must satisfy the provisions of Article 12 ofRegulation (EC) No 178/2002.
CHAPTER V
FINAL PROVISIONS
Article 26
Implementing measures
Implementingmeasuresmaybelaiddowninaccordancewiththeprocedure referred to in Article 31(2).
Article 27
Amendments to Annexes I, II, and III
AnnexesI,IIandIIImaybeamendedinaccordancewiththepro-cedure referred to in Article 31(2), 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.
Article 28
Derogations from Annexes I, II and III
Derogations from Annexes I, II and III may be granted in accor-
dance with the procedure referred to in Article 31(2) for particu-lar reasons, provided that such derogations do not affect theachievement of the objectives of this Regulation.Article 29
Rapid Alert System
Should a specific feed, including feed for animals not kept forfoodproduction,presentaseriousrisktohumanoranimalhealthortotheenvironment,Article50ofRegulation(EC)No178/2002shall apply mutatis mutandis .
Article 30
Penalties
The Member States shall lay down the rules on penalties appli-cable to infringements of this Regulation and shall take the mea-sures necessary to ensure that they are implemented. The penal-ties provided for must be effective, proportionate and dissuasive.The Member States shall notify those provisions to the Commis-sion by 8 February 2007, and shall notify it without delay of anysubsequent amendment affecting them.
Article 31
Committee Procedure
1. TheCommissionshallbeassistedbytheStandingCommit-tee on the Food Chain and Animal Health set up by Regulation(EC) No 178/2002 (hereinafter referred to as the Committee).
2. Wherereferenceismadetothisparagraph,Articles5and7
of Decision 1999/468/EC shall apply, having regard to the pro-visions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Article 32
Consultation of the European Food Safety Authority
The Commission shall consult the European Food Authority on
anymatter,fallingwithinthescopeofthisRegulation,thatcouldhave a significant impact on public health and, in particular,before proposing criteria or targets in accordance withArticle 5(3).8.2.2005
EN Official Journal of the European Union L 35/11Article 33
Repeal
The following Directives are repealed, without prejudice to the
obligations of the Member States concerning the deadlines fortransposition, 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 publica-
tion 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 i n all Member States.
Done at Strasbourg, 12 January 2005.
For the European Parliament
The President
J. P. BORRELL FONTELLESFor the Council
The President
N. SCHMITL 35/12 EN Official Journal of the European Union 8.2.2005ANNEX I
PRIMARY PRODUCTION
PART A
Requirements for feed businesses at the level of primary production of fee d referred to in Article 5(1)
I. Hygiene provisions
1. Feed business operators responsible for primary production of feed sha ll ensure that operations are managed and car-
ried out in such a way as to prevent, eliminate or minimise hazards with the p otential to compromise feed safety.
2. Feed business operators shall ensure, as far as possible, that primary p roducts produced, prepared, cleaned, packed,
stored and transported under their responsibility are protected against contamination and spoilage.
3. Feedbusinessoperatorsshallmeettheobligationssetoutinpoints1an d2bycomplyingwithappropriateCommunity
and national legislative provisions relating to the control of hazards, i ncluding:
(i) measures to control hazardous contamination such as that arising from the air, soil, water, fertilisers, plant protec-
tion products, biocides, veterinary medicinal products and handling and disposal of waste,
and
(ii) measures relating to plant health, animal health and the environment that have implications for feed safety, includ-
ing programmes for the monitoring and control of zoonoses and zoonotic age nts.
4. Where appropriate, feed business operators shall take adequate measur es, in particular:
(a) to keep clean and, where necessary after cleaning, to disinfect in an ap propriate manner, facilities, equipment, con-
tainers, crates and vehicles used for producing, preparing, grading, pac king, storing and transporting feed;
(b) to ensure, where necessary, hygienic production, transport and stora ge conditions for, and the cleanliness of, feed;
(c) to use clean water whenever necessary to prevent hazardous contaminat ion;
(d) to prevent, as far as possible, animals and pests from causing hazardou s contamination;
(e) to store and handle wastes and hazardous substances, separately and se curely, so as to prevent hazardous
contamination;
(f) to ensure that packaging materials are not a source of hazardous contam ination of feed;
(g) totakeaccountoftheresultsofanyrelevantanalysescarriedoutonsa mplestakenfromprimaryproductsorother
samples relevant to feed safety.
II. Record-keeping
1. Feed business operators shall keep records relating to measures put in p lace to control hazards, in an appropriate man-
nerandforanappropriateperiod,commensuratewiththenatureandsizeof thefeedbusiness.Feedbusinessoperators
must make relevant information contained in these records available to th e competent authority.
2. Feed business operators must, in particular, keep records on:
(a) any use of plant protection products and biocides;8.2.2005 EN Official Journal of the European Union L 35/13(b) use of genetically modified seeds;
(c) any occurrence of pests or diseases that may affect the safety of primar y products;
(d) the results of any analyses carried out on samples taken from primary pr oducts or other samples taken for diag-
nostic purposes that have importance for feed safety;
(e) the source and quantity of each input of feed and the destination and qua ntity for each output of feed.
3. Otherpersons,suchasveterinarians,agronomistsandfarmtechnician s,mayassistthefeedbusinessoperatorswiththe
keeping of records relevant to the activities they carry out on the farm.
PART B
Recommendations for guides to good practice
1. WherenationalandCommunityguidesreferredtoinChapterIIIofthisRe gulationaredrawnup,theyshallcontainguid-
ance on good practices for the control of hazards in primary production of f eed.
2. Guides to good practices shall include appropriate information on haza rds arising in primary production of feed and
actionstocontrolhazards,includingrelevantmeasuressetoutinCommun ityandnationallegislationorinCommunity
and national programmes, such as:(a) the control of contamination such as mycotoxins, heavy metals, radioa ctive material;
(b) the use of water, organic waste and fertilisers;(c) the correct and appropriate use of plant protection products and bioci des and their traceability;
(d) the correct and appropriate use of veterinary medicinal products and f eed additives and their traceability;
(e) the preparation, storage and traceability of feed materials;(f) the proper disposal of dead animals, waste and litter;(g) protective measures to prevent the introduction of contagious diseas es transmissible to animals through feed and
any obligation to notify the competent authority thereof;
(h) procedures,practicesandmethodstoensurethatfeedisproduced,pre pared,packed,storedandtransportedunder
appropriate hygienic conditions, including effective cleaning and pest -control;
(i) details relating to record-keeping.L 35/14 EN Official Journal of the European Union 8.2.2005ANNEX II
REQUIREMENTS FOR FEED BUSINESSES OTHER THAN AT THE LEVEL OF
PRIMARY PRODUCTION OF FEED REFERRED TO IN ARTICLE 5(1)
FACILITIES AND EQUIPMENT
1. Feed processing and storage facilities, equipment, containers, crate s, vehicles and their immediate surroundings shall be
kept clean, and effective pest control programmes shall be implemented.
2. The lay-out, design, construction and size of the facilities and equipm ent shall:
(a) permit adequate cleaning and/or disinfection;
(b) be such as to minimise the risk of error and to avoid contamination, cros s-contamination and any adverse effects
generallyonthesafetyandqualityoftheproducts.Machinerycominginto contactwithfeedshallbedriedfollow-
ing any wet cleaning process.
3. Facilities and equipment to be used for mixing and/or manufacturing ope rations shall undergo appropriate and regular
checks, in accordance with written procedures pre-established by the man ufacturer for the products.
(a) All scales and metering devices used in the manufacture of feeds shall b e appropriate for the range of weights or
volumes to be measured and shall be tested for accuracy regularly.
(b) All mixers used in the manufacture of feeds shall be appropriate for the range of weights or volumes being mixed,
andshallbecapableofmanufacturingsuitablehomogeneousmixturesandh omogeneousdilutions.Operatorsshall
demonstrate the effectiveness of mixers with regard to homogeneity.
4. Facilities must have adequate natural and/or artificial lighting.5. Drainage facilities must be adequate for the purpose intended; they mus t be designed and constructed to avoid the risk
of contamination of feedingstuffs.
6. Waterusedinfeedmanufactureshallbeofsuitablequalityforanimals; theconduitsforwatershallbeofaninertnature.
7. Sewage, waste and rainwater shall be disposed of in a manner which ensure s that equipment and the safety and quality
of feed is not affected. Spoilage and dust shall be controlled to prevent pe st invasion.
8. Windowsandotheropeningsmust,wherenecessary,beproofedagainstpe sts.Doorsmustbeclose-fittingandproofed
against pests when closed.
9. Where necessary, ceilings and overhead fixtures must be designed, cons tructed and finished to prevent the accumula-
tion of dirt and to reduce condensation, the growth of undesirable moulds a nd the shedding of particles that can affect
the safety and quality of feed.
PERSONNEL
Feedbusinessesmusthavesufficientstaffpossessingtheskillsandqual ificationsnecessaryforthemanufactureoftheprod-
ucts concerned. An organisation chart setting out the qualifications (e. g. diplomas, professional experience) and responsi-
bilities of the supervisory staff must be drawn up and made available to the competent authorities responsible for inspec-
tion.Allthestaffmustbeinformedclearlyinwritingoftheirduties,res ponsibilitiesandpowers,especiallywhenanychange
is made, in such a way as to obtain the desired product quality.8.2.2005 EN Official Journal of the European Union L 35/15PRODUCTION
1. A qualified person responsible for production must be designated.
2. Feed business operators must ensure that the different stages of produc tion are carried out according to pre-established
written procedures and instructions aimed at defining, checking and mast ering the critical points in the manufacturing
process.
3. Technical or organisational measures must be taken to avoid or minimise , as necessary, any cross-contamination and
errors. There must be sufficient and appropriate means of carrying out che cks in the course of manufacture.
4. The presence of prohibited feed undesirable substances and other conta minants in relation to human or animal health
shall be monitored, and appropriate control strategies to minimise the ri sk shall be put in place.
5. Wasteandmaterialsnotsuitableasfeedshouldbeisolatedandidentifi ed.Anysuchmaterialscontaininghazardouslev-
els of veterinary drugs, contaminants or other hazards shall be disposed o f in an appropriate way and not used as feed.
6. Feed business operators shall take adequate measures to ensure effecti ve tracing of the products.
QUALITY CONTROL
1. Where appropriate, a qualified person responsible for quality control must be designated.
2. Feedbusinessesmust,aspartofaqualitycontrolsystem,haveaccessto alaboratorywithadequatestaffandequipment.
3. A quality control plan must be drawn up in writing and implemented, to inc lude, in particular, checks on the critical
points in the manufacturing process, sampling procedures and frequencie s, methods of analysis and their frequency,
compliance with the specifications – and the destination in the event of no n-compliance – from processed materials to
final products.
4. Documentationrelatingtotherawmaterialsusedinfinalproductsmust bekeptbythemanufacturerinordertoensure
traceability. Such documentation must be available to the competent auth orities for a period appropriate for the use to
which the products are placed on the market. In addition, samples of ingred ients and of each batch of products manu-
facturedandplacedonthemarketorofeachspecificportionofproduction (inthecaseofcontinuousproduction)must
betakeninsufficientquantityusingaprocedurepre-establishedbythem anufacturerandberetained,inordertoensure
traceability(onaregularbasisinthecaseofmanufacturesolelyforthem anufacturer’sownneeds).Thesamplesmustbe
sealedandlabelledforeasyidentification;theymustbestoredundercon ditionswhichpreventanyabnormalchangein
the composition of the sample or any adulteration. They must be kept at the d isposal of the competent authorities for
a period appropriate to the use for which the feed is placed on the market. In the case of feedingstuffs for animals not
kept for food production, the manufacturer of the feedingstuff must only k eep samples of the finished product.
STORAGE AND TRANSPORT
1. Processed feeds shall be separated from unprocessed feed materials and additives, in order to avoid any cross-
contamination of the processed feed; proper packaging materials shall be used.
2. Feeds shall be stored and transported in suitable containers. They shal l be stored in places designed, adapted and main-
tainedinordertoensuregoodstorageconditions,towhichonlypersonsau thorisedbythefeedbusinessoperatorshave
access.L 35/16 EN Official Journal of the European Union 8.2.20053. Feedsshallbestoredandtransportedinsuchawayastobeeasilyidentif iable,inordertoavoidanyconfusionorcross-
contamination and to prevent deterioration.
4. Containersandequipmentusedforthetransport,storage,conveying,h andlingandweighingoffeedshallbekeptclean.
Cleaning programmes shall be introduced, and traces of detergents and dis infectants shall be minimised.
5. Any spoilage shall be minimised and kept under control to reduce pest inv asion.
6. Where appropriate, temperatures shall be kept as low as possible to avoi d condensation and spoilage.
RECORD-KEEPING
1. Allfeedbusinessoperators,includingthosewhoactsolelyastradersw ithouteverholdingtheproductintheirfacilities,
shall keep in a register relevant data, comprising details of purchase, pr oduction and sales for effective tracing from
receipt to delivery, including export to the final destination.
2. Feed business operators, except those who act solely as dealers without ever holding the product in their facilities, shall
keep in a register:
(a) Documentation relating to the manufacturing process and controls.
Feed businesses must have a system of documentation designed to define and ensure mastery of the critical points
inthemanufacturingprocessandtoestablishandimplementaqualitycont rolplan.Theymustkeeptheresultsof
the relevant controls. This set of documents must be kept so that it is possi ble to trace the manufacturing history
of each batch of products put into circulation and to establish responsibi lity, if complaints arise.
(b) Documentation relating to traceability, in particular:
(i) for feed additives:
— thenatureandquantityoftheadditivesproduced,therespectivedateso fmanufactureand,whereappro-
priate, the number of the batch or of the specific portion of production, in the case of continuous
manufacture,
— thenameandaddressoftheestablishmenttowhichtheadditivesweredeli vered,thenatureandquantity
of the additives delivered and, where appropriate, the number of the batch or of the specific portion of
production, in the case of continuous manufacture;
(ii) for products covered by Directive 82/471/EEC:
— the nature of the products and the quantity produced, the respective date s of manufacture and, where
appropriate, the number of the batch or of the specific portion of producti on, in the case of continuous
manufacture,
— thenameandaddressoftheestablishmentsorusers(establishmentsorfa rmers)towhomtheseproducts
havebeendelivered,togetherwithdetailsofthenatureandquantityofth eproductsdeliveredand,where
appropriate, the number of the batch or of the specific portion of producti on, in the case of continuous
manufacture;
(iii) for premixtures:
— thenameandaddressofthemanufacturersorsuppliersofadditives,then atureandquantityoftheaddi-
tives used and, where appropriate, the number of the batch or of the specifi c portion of production, in
the case of continuous manufacture,8.2.2005 EN Official Journal of the European Union L 35/17— the date of manufacture of the premixture and the batch number where appro priate,
— the name and address of the establishment to which the premixture is deliv ered, the delivery date, the
nature and quantity of the premixture delivered, and the batch number wher e appropriate.
(iv) for compound feedingstuffs/feed materials:
— the name and address of additive/premixture manufacturers or suppliers , the nature and quantity of the
premixture used, with the batch number where appropriate,
— the name and address of the suppliers of the feed materials and complement ary feeds and the delivery
date,
— the type, quantity and formulation of the compound feed,
— thenatureandquantityoffeedmaterialsorcompoundfeedingstuffsmanu factured,togetherwiththedate
of manufacture, and the name and address of the buyer (e.g. farmer, other fe ed business operators).
COMPLAINTS AND PRODUCT RECALL
1. Feed business operators shall implement a system for registering and pr ocessing complaints.
2. They shall put in place, where this proves necessary, a system for the pro mpt recall of products in the distribution net-
work. They shall define by means of written procedures the destination of a ny recalled products, and before such prod-
ucts are put back into circulation they must undergo a quality-control rea ssessment.L 35/18 EN Official Journal of the European Union 8.2.2005ANNEX III
GOOD ANIMAL FEEDING PRACTICE
PASTURE GRAZING
The grazing of pastures and croplands shall be managed in a way that minimis es the contamination of foods of animal ori-
gin by physical, biological or chemical hazards.
Whereappropriate,anadequaterestperiodshallbeobservedbeforeallow inglivestocktograzeonpasture,cropsandcrop
residues and between grazing rotations to minimise biological cross-con tamination from manure, where such a potential
problem exists, and to ensure that the withholding periods for agricultur al chemical applications are observed.
REQUIREMENTS FOR STABLE AND FEEDING EQUIPMENT
The animal production unit shall be designed so that it can be adequately cl eaned. The animal production unit and feeding
equipment shall be cleaned thoroughly and regularly to prevent any build- up of hazards. Chemicals used for cleaning and
sanitising shall be used according to instructions and stored away from fe ed and feeding areas.
Apestcontrolsystemshallbeputinplacetocontroltheaccessofpeststot heanimalproductionunitwithaviewtomini-
mising the possibility of contamination of feed and bedding materials or a nimal units.
Buildingsandfeedingequipmentshallbekeptclean.Systemsshallbeputi nplacetoregularlyremovemanure,wastemate-
rial and other possible sources of contamination of feed.Feed and bedding material used in the animal production unit shall be frequ ently changed and not allowed to become
mouldy.
FEEDING
1. Storage
Feed shall be stored separately from chemicals and other products prohibi ted for animal feed. Storage areas and con-
tainers shall be kept clean and dry and appropriate pest-control measures implemented where necessary. Storage areas
and containers shall be cleaned regularly to avoid unnecessary cross-con tamination.
Seed shall be stored properly and in such a way that it is not accessible to an imals.
Medicatedfeedandnon-medicatedfeedintendedfordifferentcategories orspeciesofanimalsshallbestoredsuchasto
reduce the risk of feeding to non-target animals.
2. Distribution
Theon-farmfeeddistributionsystemshallensurethattherightfeedisse nttotherightdestination.Duringdistribution
and feeding, feed shall be handled in such a way as to ensure that contaminat ion does not occur from contaminated
storage areas and equipment. Non-medicated feeds shall be handled separa tely from medicated feeds to prevent
contamination.
On-farm feed transport vehicles and feeding equipment shall be cleaned pe riodically, in particular when used to deliver
and distribute medicated feed.8.2.2005 EN Official Journal of the European Union L 35/19FEED AND WATER
Waterfordrinkingorforacquacultureshallbeofappropriatequalityfor theanimalsbeingproduced.Wherethereiscause
for concern about contamination of animals or animal products from the wat er, measures shall be taken to evaluate and
minimise the hazards.
Feeding and watering equipment must be designed, constructed and placed i n such a way that contamination of feed and
water is minimised. Watering systems shall be cleaned and maintained regu larly, where possible.
PERSONNEL
Thepersonresponsibleforthefeedingandhandlingofanimalsshallposse sstherequisiteability,knowledgeandcompetence.L 35/20 EN Official Journal of the European Union 8.2.2005ANNEX IV
CHAPTER 1
Additives authorised pursuant to Regulation (EC) No 1831/2003:
— Nutritional additives: all additives in the group,— Zootechnical additives: all additives in the group,
— Technologicaladditives:additivescoveredbyAnnexI(1)(b)(‘antioxi dants’)ofRegulation(EC)No1831/2003:only
those with a fixed maximum content,
— Sensory additives: additives covered by Annex I(2)(a) (‘colorants’) of Regulation (EC) No 1831/2003: carotenoids and
xantophylls.
Products covered by Directive 82/471/EEC:— Proteins obtained from micro-organisms belonging to the group of bacter ia, yeasts, algae, lower fungi: all products in
the group (except for subgroup 1.2.1)
— Co-products of the manufacture of amino acids by fermentation: all produ cts in the group
CHAPTER 2
Additives authorised under Regulation (EC) No 1831/2003:— Zootechnical additives: additives covered by Annex I(4)(d) (‘other zoo technical additives’) of Regulation (EC)
No 1831/2003— Antibiotics: all additives,— Coccidiostats and histomonostats: all additives,— Growth promoters: all additives;
— Nutritional additives:
— additivescoveredbyAnnexI(3)(a)(Vitamins,provitaminsandchemical lywelldefinedsubstanceshavingasimilar
effect) of Regulation (EC) No 1831/2003: A and D,
— additivescoveredbyAnnexI(3)(b)(‘compoundsoftraceelements’)ofRe gulation(EC)No1831/2003:CuandSe.
CHAPTER 3
Additives authorised under Regulation (EC) No 1831/2003:Zootechnicaladditives:additivescoveredbyAnnexI(4)(d)(‘otherzoot echnicaladditives’)ofRegulation(EC)No1831/2003
— Antibiotics: all additives— Coccidiostats and histomonostats: all additives,— Growth promoters: all additives.8.2.2005 EN Official Journal of the European Union L 35/21ANNEX V
CHAPTER I
List of approved feed businesses
1 234 5
Identifying number Activity Name or business
name (1)Address (2) Remarks
(1) Name or business name of the feed businesses.
(2) Address of the feed businesses.
CHAPTER II
The identifying number must have the following structure:
1. the character ‘α’ if the feed business is approved;2. the ISO code of the Member State or of the third country where the feed busi ness is located;
3. the national reference number, to a maximum of eight alphanumerical cha racters.L 35/22 EN Official Journal of the European Union 8.2.2005