2002R1774 — EN — 01.05.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B REGULATION (EC) No 1774/2002 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL
of3October2002
layingdownhealthrulesconcerninganimalby-productsnotintendedforhumanconsumption
(OJ L 273, 10.10.2002, p. 1)
Amended by:
Official Journal
No page date
►M1Commission Regulation (EC) No 808/2003 of 12 May 2003 L 117 1 13.5.2003
▼B
REGULATION (EC) No 1774/2002 OF THE EUROPEAN
PARLIAMENTANDOFTHECOUNCIL
of3October2002
laying down health rules concerning animal by-products not
intendedforhumanconsumption
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 152(4)(b) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of
the Treaty (3), in the light of the joint text approved by the Conciliation
Committee on 12 September 2002.
Whereas:
(1)Council Directive 90/667/EEC of 27 November 1990 laying
down the veterinary rules for the disposal and processing ofanimal waste, for its placing on the market and for the preven-tion of pathogens in feedingstuffs of animal or fish origin and
amending Directive 90/425/EEC (
4) established the principle
that all animal waste, regardless of its source, may be used forthe production of feed material following appropriate treatment.
(2)The Scientific Steering Committee hasadopted a number ofopinionss ince the adoption of that Directive. Their main conclu-
sion is that animal by-products derived from animals not fit for
human consumption following health inspection should not enterthe feed chain.
(3)In the light of those scientific opinions, a distinction should bedrawn between the measures to be implemented, depending on
the nature of animal by-products used. The possible uses of
certain animal materials should be limited. Rules should be laiddown for the use of animal by-products other than in feed andfor their disposal.
(4)In the light of the experience gained in recent years, it is appro-
priate to clarify the relationship between Directive 90/667/EEC
and Community environmental legislation. This Regulationshould not affect the application of existing environmental legis-lation or hinder the development of new ruleson environmentalprotection, particularly asregardsbiodegradable was te. In this
regard, the Commission has given a commitment that by the
end of the year 2004 a Directive on biowaste, including cateringwaste, will be prepared with the aim of establishing rules on safeuse, recovery, recycling and disposal of this waste and ofcontrolling potential contamination.
(5)The International Scientific Conference on Meat-and-Bone Mealorganised by the Commission and the European Parliament, heldin Brussels on 1 and 2 July 1997, initiated a debate concerning2002R1774 — EN — 01.05.2003 — 001.001 — 2
(1) OJ C 96 E, 27.3.2001, p. 40.
(2) OJ C 193, 10.7.2001, p. 32.
(3) Opinion of the European Parliament of 12 June 2001 (OJ C 53 E of
28.2.2002, p. 84), Council Common Position of 20 November 2001 (OJ C
45 E of 19.2.2002, p. 70) and Decision of the European Parliament of 13March 2002 (not yet published in the Official Journal). Decision of the
European Parliament of 24 September 2002 and Council Decision of 23
September 2002.
(
4) OJ L 363, 27.12.1990, p. 51. Directive aslas t amended by the 1994 Act of
Accession.
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the production and feeding of meat-and-bone meal. The Confer-
ence called for further reflection on the future policy in thisarea.In November 1997, to launch the widest possible public debate
about the future of the Community'sfeed legis lation, the
Commission finalised a consultation paper on meat-and-bonemeal. Following that consultation, it appears that there is ageneral recognition of the need to amend Directive 90/667/EECto bring it in line with the new scientific information.
(6)The European Parliament, in itsres olution of 16 November 2000on BSE and safety of animal feed (
1), called for a ban on the use
of animal protein in feed until the present Regulation enters into
force.
(7)Scientific advice suggests that the practice of feeding an animal
species with proteins derived from the bodies, or parts of bodies,
of the same species presents a risk of spreading disease. As aprecautionary measure, this practice should therefore be prohib-ited. Implementing rules should be adopted to ensure thenecessary separation of animal by-products destined for use in
feed at every stage of processing, storage and transport.
However, there should be scope to establish derogations fromthisgeneral prohibition in relation to fis h and fur animalsifjustified by scientific advice.
(8)Catering waste containing products of animal origin can also bea vector for the spread of disease. All catering waste generatedfrom means of transport operating internationally should bedisposed of safely. Catering waste produced within the Commu-
nity should not be used for the feeding of farmed animals other
than fur animals.
(9)From October 1996, the Food and Veterinary Office of theCommission (FVO) carried out a number of rounds of inspec-tions in Member States, to assess the presence and managementof main risk factors and surveillance procedures with regard toBSE. Part of the assessment covered the systems of commercialrendering and other methods of animal waste disposal. General
conclusions and a number of recommendations were drawn up
following those inspections, with particular reference to thetraceability of animal by-products.
(10)To avoid any risk of dispersal of pathogens and/or residues,animal by-products should be processed, stored and kept sepa-rated in an approved and supervised plant designated by theMember State concerned or be disposed of in a suitable manner.
In certain circumstances, especially when it is justified by
distance, time of transport, or capacity problems, the designatedprocessing, incineration or co-incineration plant could be locatedin another Member State.
(11)Directive 2000/76/EC of the European Parliament and of theCouncil of 4 December 2000 on the incineration of waste (
2)
does not apply to incineration plants if the waste treated consistssolely of animal carcases. It is necessary to lay down minimum
requirementsfor s uch incineration plantsto protect animal and
public health. Pending the adoption of Community requirements,Member States may adopt environmental legislation for suchplants. Less strict requirements should apply to low-capacityincineration plants, such as those located on farms and at petcrematoria, to reflect the lower risk posed by the material treated
and to avoid unnecessary transport of animal by-products.
(12)Specific rules should be laid down on controls for processingplants, with particular reference to detailed procedures for the
validation of processing methods and for self-supervision ofproduction.2002R1774 — EN — 01.05.2003 — 001.001 — 3
(1) OJ C 223, 8.8.2001, p. 281.
(2) OJ L 332, 28.12.2000, p. 91.
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(13)Derogationsfrom the ruleson the us e of animal by-products
may be appropriate to facilitate the feeding of animalsnot
destined for human consumption. The competent authoritiesshould control such uses.
(14)Derogations may also be appropriate to permit the disposal ofanimal by-products on site in controlled circumstances. TheCommission should receive the information necessary to enableit to monitor the situation and to lay down implementing rules if
appropriate.
(15)Community inspections should be carried out in the MemberStatesto ens ure uniform implementation of the health require-
ments. Such inspections should also include audit procedures.
(16)The basis for Community legislation on health issues is soundscience. To this end, the relevant scientific committees set upby Commission Decisions 97/404/EC (
1) and 97/579/EC (2)
should be consulted wherever necessary. In particular, furtherscientific advice is required on the use of products of animal
origin in organic fertilisers and soil improvers. Pending the
adoption of Community rulesin the light of thisadvice, MemberStatesmay maintain or adopt national rulesthat are s tricter thanthose envisaged in this Regulation, provided that such rulescomply with other applicable Community legislation.
(17)A wide variety of approachesexis tsin Member Statesasregardsthe financial support for processing, collection, storage and
disposal of animal by-products. To ensure that the conditions of
competition between agricultural productsare not affected, it isnecessary to carry out an analysis and, if necessary, to takeappropriate measures at Community level.
(18)In the light of the above, a fundamental revision of the Commu-nity rulesapplicable to animal by-productsappearsto benecessary.
(19)Animal by-products not destined for human consumption (in
particular processed animal protein, rendered fats, petfood, hides
and skins and wool) are included in the list of products in AnnexI to the Treaty. The placing on the market of such productsconstitutes an important source of income for part of the farmingpopulation. To ensure rational development in this sector andincrease productivity, animal health and public health rules for
the products in question should be laid down at Community
level. Given the significant risks of the spread of diseases towhich animals are exposed, particular requirements should applyto the placing on the market of certain animal by-products, parti-cularly in regions with a high health status.
(20)To ensure that products imported from non-member countriesare of a hygiene standard which is at least equal or equivalent
to the hygiene standard applied by the Community, a system of
approval should be introduced for non-member countries andtheir establishments, together with a Community inspectionprocedure to ensure that the conditions for such approval areobserved. The importation from third countries of petfood and
raw material for petfood can take place subject to conditions
different from those applicable to such material produced in theCommunity, in particular asregardsthe guaranteesrequiredconcerning the residues of substances prohibited in accordancewith Council Directive 96/22/EC of 29 April 1996 concerningthe prohibition on the use in stock farming of certain substances
having a hormonal or thyrostatic action and of beta-agonists, and
repealing Directives81/602/EEC, 88/146/EEC and 88/299/EEC (
3). To ensure that such petfood and raw material are used2002R1774 — EN — 01.05.2003 — 001.001 — 4
(1) OJ L 169, 27.6.1997, p. 85. Decision as amended by Decision 2000/443/EC
(OJ L 179, 18.7.2000, p. 13).
(2) OJ L 237, 28.8.1997, p. 18. Decision as amended by Decision 2000/443/EC.
(3) OJ L 125, 23.5.1996, p. 3.
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only for their intended purpose, it is necessary to lay down
appropriate control measures on importation of material coveredby such derogations.
(21)Animal by-products that pass through the Community in transit,
and those originating in the Community and destined for export,
can create a risk for animal and public health within theCommunity. Certain requirementslaid down by thisRegulationshould therefore apply to such movements.
(22)The accompanying document for productsof animal origin isthebest way of satisfying the competent authority of the place ofdestination that a consignment complies with the provisions ofthisRegulation. The health certificate s hould be maintained for
the purposes of verifying the destination of certain imported
products.
(23)Council Directive 92/118/EEC of 17 December 1992 layingdown animal health and public health requirementsgoverningtrade and importsinto the Community of productsnot s ubjectto the said requirements laid down in specific Community rulesreferred to in Annex A(I) to Directive 89/662/EEC and, as
regardspathogens , to Directive 90/425/EEC (
1) pursues the
abovementioned objectives.
(24)The Council and the Commission have adopted several Deci-sions implementing Directives 90/667/EEC and 92/118/EEC.Furthermore, Directive 92/118/EEC has been substantiallyamended and further amendmentsare to be made. Cons equently,a great number of Community actscurrently regulate the animal
by-products sector and there is a need for simplification.
(25)Such simplification will lead to more transparency with regard tospecific health rules for products of animal origin not destined
for human consumption. Simplification of the specific healthlegislation must not lead to deregulation. It is therefore necessaryto maintain and, to ensure public and animal health protection, totighten the detailed health rulesfor productsof animal origin notdestined for human consumption.
(26)The products concerned should be subject to the rules for veter-
inary checks, including checks by experts from the Commission,
and any protective measures laid down by Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootech-nical checksapplicable in intra-Community trade in certain liveanimalsand productswith a view to the completion of theinternal market (
2).
(27)Effective checkss hould be carried out on productsimported intothe Community. Thiscan be achieved by implementing the
controlslaid down in Council Directive 97/78/EC of
18 December 1997 laying down the principlesgoverning theorganisation of veterinary checks on products entering theCommunity from non-member countries(
3).
(28)Directive 90/667/EEC, Council Decision 95/348/EC of 22 June1995 laying down the veterinary and animal health rulesapplic-able in the United Kingdom and Ireland to the treatment of
certain typesof was te intended to be marketed locally asfeed-
stuffs for certain animal categories (
4) and Council Decision
1999/534/EC of 19 July 1999 on measures applying to theprocessing of certain animal waste to protect against transmis-sible spongiform encephalopathies and amending CommissionDecision 97/735/EC (
5) should therefore be repealed.2002R1774 — EN — 01.05.2003 — 001.001 — 5
(1) OJ L 62, 15.3.1993, p. 49. Directive as last amended by Commission Deci-
sion 2001/7/EC (OJ L 2, 5.1.2001, p. 27).
(2) OJ L 224, 18.8.1990, p. 29. Directive aslas t amended by Directive 92/118/
EEC.
(3) OJ L 24, 30.1.1998, p. 9.
(4) OJ L 202, 26.8.1995, p. 8.
(5) OJ L 204, 4.8.1999, p. 37.
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(29)To take account of technical and scientific progress, close and
effective cooperation should be ensured between the Commis-
sion and the Member States within the Standing Committee onthe Food Chain and Animal Health set up by Regulation (EC)No 178/2002 of the European Parliament and of the Council of28 January 2002 laying down the general principlesand require-ments of food law, establishing the European Food Safety
Authority and laying down proceduresin mattersof food
safety (
1).
(30)The measures necessary for the implementation of this Regula-tion should be adopted in accordance with Council Decision1999/468/EC of 28 June 1999 laying down the proceduresforthe exercise of implementing powers conferred on the Commis-
sion (
2),
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERALPROVISIONS
Article 1
Scope
1. ThisRegulation laysdown animal and public health rulesfor:
(a) the collection, transport, storage, handling, processing and use or
disposal of animal by-products, to prevent these products frompresenting a risk to animal or public health;
(b) the placing on the market and, in certain specific cases, the export
and transit of animal by-products and those products derived there-
from referred to in AnnexesVII and VIII.
2. ThisRegulation s hall not apply to:
(a) raw petfood originating from retail shops or in premises adjacent to
sale points, where the cutting and storage are performed solely forthe purpose of supplying the consumer directly on the spot;
(b) liquid milk and colostrum disposed of or used on the farm of
origin;
(c) entire bodies or parts of wild animals not suspected of being
infected with diseases communicable to humans or animals, except
for fish landed for commercial purposes and bodies or parts of wildanimals used to produce game trophies;
(d) raw petfood for use on site derived from animals slaughtered on the
farm of origin for use as foodstuffs by the farmer and his familyonly, in accordance with national legislation;
(e) catering waste, unless:
(i) from meansof trans port operating internationally,
(ii) destined for animal consumption, or
(iii) destined for use in a biogas plant or for composting;
(f) ova, embryos and semen intended for breeding purposes; and
(g) transit by sea or by air.
3. This Regulation shall not affect veterinary legislation having as
its objective the eradication and control of certain diseases.2002R1774 — EN — 01.05.2003 — 001.001 — 6
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.
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Article 2
Definitions
1. For the purpose of this Regulation, the following definitions shall
apply:
(a) animal by-products: entire bodies or parts of animals or products
of animal origin referred to in Articles4, 5 and 6 not intended forhuman consumption, including ova, embryos and semen;
(b) Category 1 material: animal by-productsreferred to in Article 4;(c) Category 2 material: animal by-productsreferred to in Article 5;(d) Category 3 material: animal by-productsreferred to in Article 6;(e) animal: any vertebrate or invertebrate animal (including fish,
reptilesand amphibians );
(f) farmed animal: any animal that iskept, fattened or bred by
humansand us ed for the production of food (including meat,milk and eggs), wool, fur, feathers, skins or any other product ofanimal origin;
(g) wild animal: any animal not kept by humans;(h) pet animal: any animal belonging to species normally nourished
and kept, but not consumed, by humans for purposes other thanfarming;
(i) competent authority: the central authority of a Member State
competent to ensure compliance with the requirements of this
Regulation or any authority to which that central authority hasdelegated that competence, in particular for the control offeedingstuffs; it shall also include, where appropriate, the corre-sponding authority of a non-member country;
(j) placing on the market: any operation the purpose of which is to
sell animal by-products, or products derived therefrom covered bythisRegulation, to a third party in the Community or any other
form of supply against payment or free of charge to such a third
party or storage with a view to supply to such a third party;
(k) trade: trade between Member Statesin goodswithin the meaning
of Article 23(2) of the Treaty;
(l) transit: a movement through the Community from one non-
member country to another;
(m) producer: any person whose activity produces animal by-
products;
(n) TSEs: all transmissible spongiform encephalopathies, except
those occurring in humans;
(o) specified risk material: material referred to in Annex V to Regu-
lation (EC) No 999/2001 of the European Parliament and of theCouncil of 22 May 2001 laying down rulesfor the prevention,
control and eradication of certain transmissible spongiform ence-
phalopathies(
1).
2. The specific definitions set out in Annex I shall also apply.
Article 3
General obligations
1. Animal by-products, and products derived therefrom, shall be
collected, transported, stored, handled, processed, disposed of, placedon the market, exported, carried in transit and used in accordance withthisRegulation.
2. However, Member Statesmay regulate under national law the
importation and placing on the market of productsnot referred to inAnnexesVII and VIII, pending the adoption of a decis ion in accor-2002R1774 — EN — 01.05.2003 — 001.001 — 7
(1) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission
Regulation (EC) No 1326/2001 (OJ L 177, 30.6.2001, p. 60).
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dance with the procedure referred to in Article 33(2). They shall imme-
diately inform the Commission of the use that they make of thispossibility.
3. Member States shall, either individually or cooperatively, ensure
that adequate arrangements are in place, and that a sufficient infrastruc-ture exists, to ensure compliance with the requirement of paragraph 1.
CHAPTER II
CATEGORISATION, COLLECTION, TRANSPORTATION,DISPOSAL, PROCESSING, USE AND INTERMEDIATE
STORAGEOFANIMALBY-PRODUCTS
Article 4
Category1material
1. Category 1 material shall comprise animal by-products of the
following description, or any material containing such by-products:
(a) all body parts, including hides and skins, of the following animals:
(i) animals suspected of being infected by a TSE in accordance
with Regulation (EC) No 999/2001 or in which the presence
of a TSE hasbeen officially confirmed,
(ii) animals killed in the context of TSE eradication measures,
(iii) animalsother than farmed animalsand wild animals , including
in particular pet animals, zoo animals and circus animals,
(iv) experimental animalsasdefined by Article 2 of Council
Directive 86/609/EEC of 24 November 1986 on the approxi-mation of laws, regulations and administrative provisions of
the Member Statesregarding the protection of animalsus ed
for experimental and other scientific purposes (
1), and
(v) wild animals, when suspected of being infected with diseases
communicable to humansor animals ;
(b) (i) specified risk material, and
(ii) where, at the time of disposal, specified risk material has not
been removed, entire bodiesof dead animalscontaining s peci-fied risk material;
(c) products derived from animals to which substances prohibited
under Directive 96/22/EC have been administered and products ofanimal origin containing residues of environmental contaminantsand other substances listed in Group B(3) of Annex I to Council
Directive 96/23/EC of 29 April 1996 on measures to monitor
certain substances and residues thereof in live animals and animalproductsand repealing Directives85/358/EEC and 86/469/EEC andDecisions 89/187/EEC and 91/664/EEC (
2), if such residues exceed
the permitted level laid down by Community legislation or, in theabsence thereof, by national legislation;
(d) all animal material collected when treating waste water from Cate-
gory 1 processing plants and other premises in which specified riskmaterial is removed, including screenings, materials from
desanding, grease and oil mixtures, sludge and materials removed
from drains from those premises, unless such material contains nospecified risk material or parts of such material;
(e) catering waste from means of transport operating internationally;
and
(f) mixturesof Category 1 material with either Category 2 material or
Category 3 material or both, including any material destined forprocessing in a Category 1 processing plant.2002R1774 — EN — 01.05.2003 — 001.001 — 8
(1) OJ L 358, 18.12.1986, p. 1.
(2) OJ L 125, 23.5.1996, p. 10.
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2. Category 1 material shall be collected, transported and identified
without undue delay in accordance with Article 7 and, except asother-wise provided in Articles 23 and 24, shall be:
(a) directly disposed of as waste by incineration in an incineration
plant approved in accordance with Article 12;
(b) processed in a processing plant approved under Article 13 using
any of processing methods 1 to 5 or, where the competent authorityso requires, processing method 1, in which case the resulting mate-rial shall be permanently marked, where technically possible withsmell, in accordance with Annex VI, Chapter I, and finallydisposed of as waste by incineration or by co-incineration in an
incineration or co-incineration plant approved in accordance with
Article 12;
(c) with the exclusion of material referred to in paragraph 1(a)(i) and
(ii), processed in a processing plant approved in accordance with
Article 13 using processing method 1, in which case the resultingmaterial shall be permanently marked, where technically possiblewith smell, in accordance with Annex VI, Chapter I, and finallydisposed of as waste by burial in a landfill approved under Council
Directive 1999/31/EC of 26 April 1999 on the landfill of waste (
1);
(d) in the case of catering waste referred to in paragraph 1(e), disposed
of aswas te by burial in a landfill approved under Directive 1999/
31/EC; or
(e) in the light of developments in scientific knowledge, disposed of by
other meansthat are approved in accordance with the procedurereferred to in Article 33(2), after consultation of the appropriate
scientific committee. These means may either supplement or
replace those provided for in subparagraphs (a) to (d).
3. Intermediate handling or storage of Category 1 material shall take
place only in Category 1 intermediate plantsapproved in accordancewith Article 10.
4. Category 1 material shall not be imported or exported except in
accordance with thisRegulation or with ruleslaid down under theprocedure referred to in Article 33(2). However, the import or exportof specified risk material shall take place only in accordance withArticle 8(1) of Regulation (EC) No 999/2001.
Article 5
Category2material
1. Category 2 material shall comprise animal by-products of the
following description, or any material containing such by-products:
(a) manure and digestive tract content;
(b) all animal materialscollected when treating was te water from
slaughterhouses other than slaughterhouses covered by Article4(1)(d) or from Category 2 processing plants, including screenings,
materials from desanding, grease and oil mixtures, sludge and
materials removed from drains from those premises;
(c) productsof animal origin containing res iduesof veterinary drugs
and contaminantslis ted in Group B(1) and (2) of Annex I to Direc-
tive 96/23/EC, if such residues exceed the permitted level laiddown by Community legislation;
(d) productsof animal origin, other than Category 1 material, that are
imported from non-member countriesand, in the cours e of theinspections provided for in Community legislation, fail to complywith the veterinary requirementsfor their importation into theCommunity, unless they are returned or their importation isaccepted under restrictions laid down under Community legislation;2002R1774 — EN — 01.05.2003 — 001.001 — 9
(1) OJ L 182, 16.7.1999, p. 1.
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(e) animals and parts of animals, other than those referred to in Article
4, that die other than by being slaughtered for human consumption,including animals killed to eradicate an epizootic disease;
(f) mixturesof Category 2 material with Category 3 material,
including any material destined for processing in a Category 2
processing plant; and
(g) animal by-productsother than Category 1 material or Category 3
material.
2. Category 2 material shall be collected, transported and identified
without undue delay in accordance with Article 7 and, except asother-wise provided in Articles 23 and 24, shall be:
(a) directly disposed of as waste by incineration in an incineration
plant approved in accordance with Article 12;
(b) processed in a processing plant approved in accordance with
Article 13 using any of processing methods 1 to 5 or, where thecompetent authority so requires, processing method 1, in whichcase the resulting material shall be permanently marked, wheretechnically possible with smell, in accordance with Annex VI,Chapter I, and:
(i) disposed of as waste either by incineration or by coincineration
in an incineration or co-incineration plant approved in accor-
dance with Article 12, or
(ii) in the case of rendered fats, further processed into fat deriva-
tives for use in organic fertilizers or soil improvers or forother technical uses, other than in cosmetics, pharmaceuticalsand medical devices, in a Category 2 oleochemical plantapproved in accordance with Article 14;
(c) processed in a processing plant approved in accordance with
Article 13 using processing method 1, in which case the resultingmaterial shall be permanently marked, where technically possible
with smell, in accordance with Annex VI, Chapter I, and:
(i) in the case of resulting proteinaceous material, used as an
organic fertilizer or soil improver in compliance with require-
ments, if any, laid down in accordance with the procedurereferred to in Article 33(2), after consultation of the appro-priate scientific committee,
(ii) transformed in a biogas plant or in a composting plant
approved in accordance with Article 15, or
(iii) disposed of as waste by burial in a landfill approved under
Directive 1999/31/EC;
(d) in the case of material of fish origin, ensiled or composted in
compliance with rulesadopted in accordance with the procedure
referred to in Article 33(2);
(e) in the case of manure, digestive tract content separated from the
digestive tract, milk and colostrum, if the competent authoritydoes not consider them to present a risk of spreading any serioustransmissible disease:
(i) used without processing as raw material in a biogas plant or in
a composting plant approved in accordance with Article 15 ortreated in a technical plant approved for thispurpos e in accor-dance with Article 18,
(ii) applied to land in accordance with thisRegulation, or
(iii) transformed in a biogas plant or composted in accordance with
ruleslaid down under the procedure referred to in Article33(2);
(f) in the case of entire bodies or parts of wild animals not suspected
of being infected with diseases communicable to humans oranimals, used to produce game trophies in a technical plantapproved for thispurpos e in accordance with Article 18; or
(g) disposed of by other means, or used in other ways, in accordance
with ruleslaid down under the procedure referred to in Article33(2), after consultation of the appropriate scientific committee.2002R1774 — EN — 01.05.2003 — 001.001 — 10
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These means or ways may either supplement or replace those
provided for in subparagraphs (a) to (f).
3. Intermediate handling or storage of Category 2 material, other
than manure, shall take place only in Category 2 intermediate plantsapproved in accordance with Article 10.
4. Category 2 material shall not be placed on the market or exported
except in accordance with thisRegulation or with ruleslaid downunder the procedure referred to in Article 33(2).
Article 6
Category3material
1. Category 3 material shall comprise animal by-products of the
following description, or any material containing such by-products:
(a) parts of slaughtered animals, which are fit for human consumption
in accordance with Community legislation, but are not intended forhuman consumption for commercial reasons;
(b) parts of slaughtered animals, which are rejected as unfit for human
consumption but are not affected by any signs of diseases commu-nicable to humansor animalsand derive from carcas esthat are fit
for human consumption in accordance with Community legislation;
(c) hides and skins, hooves and horns, pig bristles and feathers origi-
nating from animals that are slaughtered in a slaughterhouse, after
undergoing ante-mortem inspection, and were fit, as a result ofsuch inspection, for slaughter for human consumption in accor-dance with Community legislation;
(d) blood obtained from animalsother than ruminantsthat are s laugh-
tered in a slaughterhouse, after undergoing ante-mortem inspection,
and were fit, as a result of such inspection, for slaughter for human
consumption in accordance with Community legislation;
(e) animal by-productsderived from the production of products
intended for human consumption, including degreased bones andgreaves;
(f) former foodstuffs of animal origin, or former foodstuffs containing
productsof animal origin, other than catering was te, which are nolonger intended for human consumption for commercial reasons or
due to problemsof manufacturing or packaging defectsor other
defects which do not present any risk to humans or animals;
(g) raw milk originating from animals that do not show clinical signs
of any disease communicable through that product to humans oranimals;
(h) fish or other sea animals, except sea mammals, caught in the open
sea for the purposes of fishmeal production;
(i) fresh by-products from fish from plants manufacturing fish
productsfor human cons umption;
(j) shells, hatchery by-products and cracked egg by-products origi-
nating from animals which did not show clinical signs of any
disease communicable through that product to humans or animals;
(k) blood, hides and skins, hooves, feathers, wool, horns, hair and fur
originating from animals that did not show clinical signs of anydisease communicable through that product to humans or animals;and
(l) catering waste other than as referred to in Article 4(1)(e).
2. Category 3 material shall be collected, transported and identified
without undue delay in accordance with Article 7 and, except asother-wise provided in Articles 23 and 24, shall be:
(a) directly disposed of as waste by incineration in an incineration
plant approved in accordance with Article 12;
(b) processed in a processing plant approved in accordance with
Article 13 using any of processing methods 1 to 5, in which casethe resulting material shall be permanently marked, where techni-2002R1774 — EN — 01.05.2003 — 001.001 — 11
▼B
cally possible with smell, in accordance with Annex VI, Chapter I,
and disposed of as waste either by incineration or by co-incinera-tion in an incineration or co-incineration plant approved in
accordance with Article 12 or in a landfill approved under Direc-
tive 1999/31/EC;
(c) processed in a processing plant approved in accordance with
Article 17;
(d) transformed in a technical plant approved in accordance with
Article 18;
(e) used as raw material in a petfood plant approved in accordance
with Article 18;
(f) transformed in a biogas plant or in a composting plant approved in
accordance with Article 15;
(g) in the case of catering waste referred to in paragraph 1(l), trans-
formed in a biogasplant or compos ted in accordance with ruleslaid down under the procedure referred to in Article 33(2) or,pending the adoption of such rules, in accordance with national
law;
(h) in the case of material of fish origin, ensiled or composted in
accordance with ruleslaid down under the procedure referred to
in Article 33(2); or
(i) disposed of by other means, or used in other ways, in accordance
with ruleslaid down under the procedure referred to in Article
33(2), after consultation of the appropriate scientific committee.
These means or ways may either supplement or replace thoseprovided for in subparagraphs (a) to (h).
3. Intermediate handling or storage of Category 3 material shall take
place only in Category 3 intermediate plantsapproved in accordance
with Article 10.
Article 7
Collection, transportationandstorage
1. Animal by-products and processed products, with the exception of
Category 3 catering waste shall be collected, transported and identified
in accordance with Annex II.
2. During transportation, a commercial document or, when required
by thisRegulation, a health certificate, s hall accompany animal by-products and processed products. Commercial documents and health
certificates shall satisfy the requirements, and be kept for the period,
specified in Annex II. They shall, in particular, include informationconcerning the quantity and a description of the material and itsmarking.
3. Member States shall ensure that adequate arrangements exist to
guarantee the collection and transportation of Category 1 and Category
2 material in accordance with Annex II.
4. In accordance with Article 4 of Council Directive 75/442/EEC of
15 July 1975 on waste (
1), Member States shall take the necessary
measures to ensure that Category 3 catering waste is collected, trans-ported and disposed of without endangering human health and without
harming the environment.
5. The storage of processed products shall take place only in storage
plantsapproved in accordance with Article 11.
6. However, Member Statesmay decide not to apply the provis ions
of thisArticle to manure trans ported between two pointslocated on the
same farm or between farms and users located in the same MemberState.2002R1774 — EN — 01.05.2003 — 001.001 — 12
(1) OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Deci-
sion 96/350/EC (OJ L 135, 6.6.1996, p. 32).
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Article 8
Dispatch of animal by-products and processed products to other
MemberStates
1. Animal by-products and processed products shall be sent to other
Member Statesonly s ubject to the conditionslaid down in paragraphs2to 6.
2. The Member State of destination must have authorised the receipt
of Category 1 material, Category 2 material, processed products
derived from Category 1 or Category 2 material and processed animal
protein. Member States may make the application of processing method1 prior to dispatch a condition of authorisation.
3. Animal by-products, and processed products referred to in para-
graph 2, shall be:
(a) accompanied by a commercial document or, when required by this
Regulation, a health certificate, and
(b) conveyed directly to the plant of destination, which must have been
approved in accordance with thisRegulation.
4. When Member Statess end Category 1 material, Category 2 mate-
rial, processed products derived from Category 1 or Category 2material and processed animal protein to other Member States, thecompetent authority of the place of origin shall inform the competentauthority of the place of destination of each consignment by means of
the ANIMO system, or by another method by mutual agreement. The
message shall contain the information specified in Annex II, ChapterI, paragraph 2.
5. When informed of itsdis patch in accordance with paragraph 4,
the competent authority of the place of destination shall inform the
competent authority of the place of origin of the arrival of each
consignment by means of the ANIMO system, or by another methodby mutual agreement.
6. Member States of destination shall ensure, through regular
checks, that the designated plants on their territory use consignments
only for authorised purposes and keep full records demonstrating
compliance with thisRegulation.
Article 9
Records
1. Any person consigning, transporting or receiving animal by-
products shall keep a record of consignments. Records shall contain
the information, and be kept for the period, specified in Annex II.
2. However, this Article shall not apply to manure transported
between two pointslocated on the s ame farm or locally between farmsand users located in the same Member State.
CHAPTER III
APPROVAL OF INTERMEDIATE,STORAGE, INCINERATIONAND CO-INCINCERATION, CATEGORY 1 AND 2 PROCES-SING, CATEGORY 2 AND CATEGORY 3 OLEOCHEMICAL,
BIOGASANDCOMPOSTINGPLANTS
Article 10
Approvalofintermediate plants
1. Category 1, 2 and 3 intermediate plants shall be subject to
approval by the competent authority.
2. To be approved, Category 1 or Category 2 intermediate plants
must:
(a) meet the requirementsof Annex III, Chapter I;2002R1774 — EN — 01.05.2003 — 001.001 — 13
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(b) handle and store Category 1 or Category 2 material in accordance
with Annex III, Chapter II, Part B;
(c) undergo the plant'sown checksprovided for in Article 25; and
(d) be checked by the competent authority in accordance with Article
26.
3. To be approved, Category 3 intermediate plantsmus t:
(a) meet the requirementsof Annex III, Chapter I;
(b) handle and store Category 3 material in accordance with Annex III,
Chapter II, Part A;
(c) undergo the plant'sown checksprovided for in Article 25; and
(d) be checked by the competent authority in accordance with Article
26.
Article 11
Approvalofstorageplants
1. Storage plants shall be subject to approval by the competent
authority.
2. To be approved, storage plants must:
(a) meet the requirementsof Annex III, Chapter III; and
(b) be checked by the competent authority in accordance with Article
26.
Article 12
Approvalofincinerationandco-incineration plants
1. The incineration and co-incineration of processed products shall
take place in accordance with the provisions of Directive 2000/76/EC.The incineration and co-incineration of animal by-productss hall take
place either in accordance with the provisions of Directive 2000/76/
EC or, when that Directive doesnot apply, in accordance with theprovisions of this Regulation. Incineration and co-incineration plantsshall be approved under that Directive or in accordance with paragraph2o r3 .
2. To be approved by the competent authority for the purpose of
disposing of animal by-products, a high-capacity incineration or co-incineration plant to which Directive 2000/76/EC doesnot apply mus tfulfil:
(a) the general conditionslaid down in Annex IV, Chapter I;
(b) the operating conditionslaid down in Annex IV, Chapter II;
(c) the requirementslaid down in Annex IV, Chapter III, concerning
water discharges;
(d) the requirementslaid down in Annex IV, Chapter IV, concerning
residues;
(e) the temperature measurement requirements laid down in Annex IV,
Chapter V; and
(f) the conditionsconcerning abnormal operating laid down in Annex
IV, Chapter VI.
3. To be approved by the competent authority for the purpose of
disposing of animal by-products, a low-capacity incineration or co-incineration plant to which Directive 2000/76/EC doesnot apply mus t:
(a) be used only for the disposal of dead pet animals, animal by-
productsasreferred to in Articles4(1) (b), 5(1) and 6(1) to whichDirective 2000/76/EC doesnot apply;
(b) when located on a holding, be used only for the disposal of mate-
rial from that particular holding;2002R1774 — EN — 01.05.2003 — 001.001 — 14
▼M1
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(c) fulfil the general conditionslaid down in Annex IV, Chapter I;
(d) fulfil the applicable operating conditionslaid down in Annex IV,
Chapter II;
(e) fulfil the requirementslaid down in Annex IV, Chapter IV,
concerning residues;
(f) fulfil the applicable temperature measurement requirements laid
down in Annex IV, Chapter V;
(g) fulfil the conditionsconcerning abnormal operating laid down in
Annex IV, Chapter VI; and
(h) fulfil the conditionsin Annex IV, Chapter VII when us ed for the
disposal of animal by-products referred to in Article 4(1)(b).
4. Approval shall be suspended immediately if the conditions under
which it wasgranted are no longer fulfilled.
5. The requirementsof paragraphs2 and 3 may be modified in the
light of developmentsin s cientific knowledge in accordance with theprocedure referred to in Article 33(2), after consultation of the appro-priate scientific committee.
Article 13
ApprovalofCategory1andCategory2processingplants
1. Category 1 and Category 2 processing plants shall be subject to
approval by the competent authority.
2. To be approved, Category 1 and Category 2 processing plants
must:
(a) meet the requirementsof Annex V, Chapter I;
(b) handle, process and store Category 1 or Category 2 material in
accordance with Annex V, Chapter II and Annex VI, Chapter I;
(c) be validated by the competent authority in accordance with Annex
V, Chapter V;
(d) undergo the plant'sown checksprovided for in Article 25;
(e) be checked by the competent authority in accordance with Article
26; and
(f) ensure that, after processing, the products satisfy the requirements
of Annex VI, Chapter I.
3. Approval shall be suspended immediately if the conditions under
which it wasgranted are no longer fulfilled.
Article 14
ApprovalofCategory2andCategory3oleochemical plants
1. Oleochemical plants shall be subject to approval by the competent
authority.
2. To be approved, Category 2 oleochemical plantsmus t:
(a) process rendered fats derived from Category 2 material in accor-
dance with the standards laid down in Annex VI, Chapter III;
(b) establish and implement methods of monitoring and checking the
critical control points on the basis of the process used;
(c) keep a record of the information obtained pursuant to point (b) for
presentation to the competent authority; and
(d) be checked by the competent authority in accordance with Article
26.
3. To be approved, Category 3 oleochemical plants must process
rendered fatsderived only from Category 3 material and meet the rele-vant requirementsreferred to in paragraph 2.2002R1774 — EN — 01.05.2003 — 001.001 — 15
▼M1
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▼B
4. Approval shall be suspended immediately if the conditions under
which it wasgranted are no longer fulfilled.
Article 15
Approvalofbiogasplantsandcompostingplants
1. Biogas plants and composting plants shall be subject to approval
by the competent authority.
2. To be approved, biogasplantsand compos ting plantsmus t:
(a) meet the requirementsof Annex VI, Chapter II, Part A;
(b) handle and transform animal by-products in accordance with Annex
VI, Chapter II, PartsB and C;
(c) be checked by the competent authority in accordance with Article
26;
(d) establish and implement methods of monitoring and checking the
critical control points; and
(e) ensure that digestion residues and compost, as appropriate, comply
with the microbiological standards laid down in Annex VI, ChapterII, Part D.
3. Approval shall be suspended immediately if the conditions under
which it wasgranted are no longer fulfilled.
CHAPTER IV
PLACING ON THE MARKET AND USE OF PROCESSEDANIMAL PROTEINS AND OTHER PROCESSED PRODUCTSTHAT COULD BE USED AS FEED MATERIAL, PETFOOD,
DOGCHEWS AND TECHNICAL PRODUCTS AND APPROVAL
OFRELATEDPLANTS
Article 16
General animalhealthprovisions
1. Member States shall take all necessary measures to guarantee that
animal by-products, and products derived therefrom referred to inAnnexes VII and VIII, are not dispatched from any holding situated ina zone subject to restrictions because of the occurrence of a disease towhich the species from which the product is derived is susceptible, or
from any plant or zone from which movementsor trade would cons ti-
tute a risk to the animal health status of the Member States or areas ofMember States, except where products are treated in accordance withthisRegulation.
2. The measures referred to in paragraph 1 shall guarantee that the
productsare obtained from animalsthat:
(a) come from a holding, territory or part of a territory or, in the case
of aquaculture products, from a farm, zone or part of a zone, notsubject to animal health restrictions applicable to the animals andproducts concerned, and in particular restrictions under disease
control measures imposed by Community legislation or by virtue
of a serious transmissible disease listed in Council Directive 92/119/EEC of 17 December 1992 introducing general Communitymeasures for the control of certain animal diseases and specificmeasures relating to swine vesicular disease (
1);
(b) were not slaughtered in a plant in which animals infected, or
suspected of being infected, with one of the diseases covered by
the rules referred to in (a) were present at the time of slaughter.
3. Subject to compliance with the disease control measures referred
to in paragraph 2(a), the placing on the market of animal by-products,and productsderived therefrom referred to in AnnexesVII and VIII,2002R1774 — EN — 01.05.2003 — 001.001 — 16
(1) OJ L 62, 15.3.1993, p. 69. Directive aslas t amended by the 1994 Act of
Accession.
▼B
that come from a territory or part of a territory subject to animal health
restrictions but are not infected or suspected of being infected shall bepermitted provided that, asappropriate, the products :
(a) are obtained, handled, transported and stored separately from or at
different timesfrom productsfulfilling all animal health conditions ;
(b) have undergone a treatment sufficient to eliminate the animal
health problem concerned in accordance with thisRegulation at a
plant approved for that purpose by the Member State where the
animal health problem occurred;
(c) are properly identified;
(d) comply with the requirementslaid down in AnnexesVII and VIII,
or with detailed rulesto be laid down in accordance with the proce-dure referred to in Article 33(2).
Conditions alternative to those set out in the first subparagraph may be
laid down in specific situations by decisions adopted in accordancewith the procedure referred to in Article 33(2). Such decisions shall
take account of any measures concerning the animals or tests to be
carried out on them and the specific characteristics of the disease inthe species concerned and shall specify any measures needed to ensurethe protection of animal health in the Community.
Article 17
ApprovalofCategory3processingplants
1. Category 3 processing plants shall be subject to approval by the
competent authority.
2. To be approved, Category 3 processing plants must:
(a) meet the requirementsof Annex V, Chapter I, and Annex VII,
Chapter I;
(b) handle, process and store only Category 3 material in accordance
with Annex V, Chapter II, and Annex VII;
(c) be validated by the competent authority in accordance with Annex
V, Chapter V;
(d) undergo the plant'sown checksprovided for in Article 25;
(e) be checked by the competent authority in accordance with Article
26; and
(f) ensure that, after processing, the products satisfy the requirements
of Annex VII, Chapter I.
3. Approval shall be suspended immediately if the conditions under
which it wasgranted are no longer fulfilled.
Article 18
Approvalofpetfoodplantsandtechnicalplants
1. Petfood plants and technical plants shall be subject to approval by
the competent authority.
2. To be approved, the petfood plant or the technical plant must:
(a) undertake, in the light of the specific requirements laid down in
Annex VIII for the productsthe plant produces :
(i) to comply with the specific production requirements set out in
thisRegulation;
(ii) to establish and implement methods of monitoring and
checking the critical control points on the basis of the processused;
(iii) depending on the products, to take samples for analyses in a
laboratory recognised by the competent authority for thepurposes of checking compliance with the standards estab-lished by this Regulation;
(iv) to keep a record of the information obtained pursuant to points
(ii) and (iii) for presentation to the competent authority. The2002R1774 — EN — 01.05.2003 — 001.001 — 17
▼B
results of the checks and tests shall be kept for at least two
years;
(v) to inform the competent authority, should the result of the
laboratory examination referred to in point (iii) or any otherinformation available to them reveal the existence of a serious
animal health or public health hazard; and
(b) to be checked by the competent authority in accordance with
Article 26.
3. Approval shall be suspended immediately if the conditions under
which it wasgranted are no longer fulfilled.
Article 19
Placing onthe market andexport ofprocessedanimal protein and
otherprocessedproductsthatcouldbeusedasfeedmaterial
Member States shall ensure that processed animal protein and other
processed products that could be used as feed material are placed on
the market or exported only if they:
(a) have been prepared in a Category 3 processing plant approved and
supervised in accordance with Article 17;
(b) have been prepared exclusively with Category 3 material, as speci-
fied in Annex VII;
(c) have been handled, processed, stored and transported in accordance
with Annex VII and in such a manner as to ensure compliance withArticle 22; and
(d) meet the specific requirements laid down in Annex VII.
Article 20
Placing on the market and export of petfood, dogchews and tech-
nicalproducts
1. Member States shall ensure that petfood, dogchews, technical
products, other than those referred to in paragraphs 2 and 3, and thoseanimal by-productsreferred to in Annex VIII are placed on the marketor exported only if they:
(a) meet either:
(i) the specific requirements laid down in Annex VIII, or
(ii) when a product could be used both as a technical product and
asfeed material, and Annex VIII containsno s pecific require-
ments, the specific requirements laid down by the relevant
Chapter of Annex VII; and
(b) come from plants approved and supervised in accordance with
Article 18 or, in the case of animal by-products referred to inAnnex VIII, from other plantsapproved in accordance with
Community veterinary legislation.
2. Member States shall ensure that organic fertilizers and soil impro-
vers produced from processed products, other than those produced frommanure and digestive tract content, are placed on the market orexported only if they meet requirements, if any, laid down in accor-dance with the procedure referred to in Article 33(2), after
consultation of the appropriate scientific committee.
3. Member States shall ensure that fat derivatives produced from
Category 2 material are placed on the market or exported only if they:
(a) have been prepared in a Category 2 oleochemical plant approved in
accordance with Article 14 from rendered fatsres ulting from theprocessing of Category 2 material in a Category 2 processing plantapproved in accordance with Article 13 following the applicationof any of processing methods 1 to 5;
(b) have been handled, processed, stored and transported in accordance
with Annex VI; and
(c) meet any specific requirements laid down in Annex VIII.2002R1774 — EN — 01.05.2003 — 001.001 — 18
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Article 21
Safeguardmeasures
Article 10 of Directive 90/425/EEC shall apply to the products covered
by AnnexesVII and VIII to thisRegulation.
Article 22
Restrictionsonuse
1. The following uses of animal by-products and processed products
are prohibited:
(a) the feeding of a species with processed animal protein derived from
the bodies or parts of bodies of animals of the same species;
(b) the feeding of farmed animalsother than fur animalswith catering
waste or feed material containing or derived from catering waste;and
(c) the application to pasture land of organic fertilizers and soil impro-
vers, other than manure.
2. Rulesfor the implementation of thisArticle, including rules
concerning control measures, shall be adopted in accordance with theprocedure referred to in Article 33(2). Derogationsfrom paragraph1(a) may be granted in relation to fish and fur animals by the sameprocedure, after consultation of the appropriate scientific committee.
CHAPTER V
DEROGATIONS
Article 23
Derogationsregardingtheuseofanimalby-products
1. Member States may authorise, under the supervision of the
competent authorities:
(a) the use of animal by-products for diagnostic, educational and
research purposes; and
(b) the use of animal by-products for taxidermy purposes in technical
plantsapproved for thispurpos e in accordance with Article 18.
2. (a) Member States may also authorise the use of the animal by-
products specified in subparagraph (b) for the feeding of theanimals specified in subparagraph (c), under the supervision of
the competent authoritiesand in accordance with the ruleslaid
down in Annex IX.
(b) The animal by-productsreferred to in s ubparagraph (a) are:
(i) Category 2 material, provided that it comesfrom animals
which were not killed or did not die asa res ult of thepresence or suspected presence of a disease communicableto humansor animals , and
(ii) Category 3 material referred to in Article 6(1)(a) to (j) and,
subject to Article 22, in Article 6(1)(l);
(c) The animalsreferred to in s ubparagraph (a) are:
(i) zoo animals,
(ii) circusanimals ,
(iii) reptilesand birdsof prey other than zoo or circusanimals ,
(iv) fur animals,
(v) wild animalsthe meat of which isnot des tined for human
consumption,
(vi) dogs from recognised kennels or packs of hounds, and
(vii) maggotsfor fis hing bait.
(d) In addition, Member States may authorise the use, under the
supervision of the competent authorities, of Category 1 materialreferred to in Article 4(1)(b)(ii) for the feeding of endangered or2002R1774 — EN — 01.05.2003 — 001.001 — 19
▼B
protected species of necrophagous birds in accordance with rules
laid down under the procedure referred to in Article 33(2) afterconsultation of the European Food Safety Authority.
3. Member States shall inform the Commission of:
(a) the use made of the derogations referred to in paragraph 2; and
(b) the verification arrangementsintroduced to ens ure that the animal
by-products concerned are used only for authorised purposes.
4. Each Member State shall draw up a list of users and collection
centres authorised and registered pursuant to paragraph 2(c)(iv), (vi)and (vii) within its territory. Each user and collection centre shall be
assigned an official number for inspection purposes and to be able to
trace the origin of the productsconcerned.
The competent authority shall supervise the premises of users and
collection centresreferred to in the previouss ubparagraph and have
free access at all times to all parts of such premises, to ensure compli-
ance with the requirementsreferred to in paragraph 2.
If such inspections reveal that those requirements are not being
complied with, the competent authority shall take appropriate action.
5. Detailed rulesconcerning verification meas uresmay be adopted
in accordance with the procedure referred to in Article 33(2).
Article 24
Derogationsregardingthedisposalofanimalby-products
1. The competent authority may, where necessary, decide that:
(a) dead pet animals may be directly disposed of as waste by burial;
(b) the following animal by-productsoriginating in remote areasmay
be disposed of as waste by burning or burial on site:
(i) Category 1 material referred to in Article 4(1)(b)(ii),
(ii) Category 2 material, and
(iii) Category 3 material; and
(c) animal by-products may be disposed of as waste by burning or
burial on site in the event of an outbreak of a disease mentioned
in List A of the International Office of Epizootic Diseases (OIE),if the competent authority rejects transport to the nearest incinera-tion or processing plant because of the danger of propagation ofhealth risks or because a widespread outbreak of an epizooticdisease leads to a lack of capacity at such plants.
2. No derogation may be granted in respect of Category 1 material
referred to in Article 4(1)(a)(i).
3. In the case of Category 1 material referred to in Article
4(1)(b)(ii), burning or burial may take place in accordance with para-graph 1(b) or (c) only if the competent authority authorises andsupervises the method used and is satisfied that it precludes all risk oftransmission of TSEs.
4. Member States shall inform the Commission of:
(a) the use they make of the possibilities provided for in paragraph
1(b) in respect of Category 1 and Category 2 material; and
(b) the areasthat they categoris e asremote areasfor the purpos e of
applying paragraph 1(b) and the reasons for that categorisation.
5. The competent authority shall take the measures necessary:
(a) to ensure that the burning or burial of animal by-products does not
endanger animal or human health; and
(b) to prevent the abandonment, dumping or uncontrolled disposal of
animal by-products.
6. Detailed arrangementsfor implementing thisArticle may be laid
down under the procedure referred to in Article 33(2).2002R1774 — EN — 01.05.2003 — 001.001 — 20
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CHAPTER VI
CONTROLSANDINSPECTIONS
Article 25
Plants'own-checks
1. Operators and owners of intermediate and processing plants or
their representatives shall adopt all measures necessary to complywith the requirementsof thisRegulation. They s hall put in place,implement and maintain a permanent procedure developed in accor-dance with the principles of the system of hazard analysis and critical
control points(HACCP). They s hall in particular:
(a) identify and control the critical control pointsin the plants ;
(b) establish and implement methods for monitoring and checking such
critical control points;
(c) in the case of processing plants, take representative samples to
check compliance:
(i) of each processed batch with the standards for the products
established by this Regulation, and
(ii) with the maximum permitted levels of physicochemical resi-
dueslaid down in Community legis lation;
(d) record the results of the checks and tests referred to in points (b)
and (c) and keep them for a period of at least two years for presen-tation to the competent authorities;
(e) introduce a system ensuring the traceablility of each batch
dispatched.
2. Where the results of a test on samples taken pursuant to para-
graph 1(c) do not comply with the provisions of this Regulation, theoperator of the processing plant must:
(a) notify the competent authority immediately of the full detailsof the
nature of the sample and the batch from which it was derived;
(b) establish the causes of failures of compliance;
(c) reprocess or dispose of the contaminated batch under the supervi-
sion of the competent authority;
(d) ensure that no material suspected or known to be contaminated is
moved from the plant before being reprocessed under the supervi-
sion of the competent authority and re-sampled officially in orderto comply with the standards laid down in this Regulation, unlessdestined for disposal;
(e) increase the frequency of sampling and testing of production;
(f) investigate animal by-products records appropriate to the finished
sample; and
(g) instigate appropriate decontamination and cleaning procedures
within the plant.
3. Detailed arrangementsfor implementing thisArticle, including
rulesconcerning the frequency of checksand reference methodsfor
microbiological analyses, may be laid down under the procedurereferred to in Article 33(2).
Article 26
Official controlsandlistsofapprovedplants
1. The competent authority shall at regular intervals carry out
inspections and supervision at plants approved in accordance with thisRegulation. Inspections and supervision of processing plants shall takeplace in accordance with Annex V, Chapter IV.
2. The frequency of inspections and supervision shall depend on the
size of the plant, the type of products manufactured, risk assessmentand guarantees offered in accordance with the principles of the systemof hazard analysis and critical control points (HACCP).2002R1774 — EN — 01.05.2003 — 001.001 — 21
▼B
3. If the inspection carried out by the competent authority reveals
that one or more of the requirementsof thisRegulation are not beingmet, the competent authority shall take appropriate action.
4. Each Member State shall draw up a list of plants approved in
accordance with this Regulation within its territory. It shall assign anofficial number to each plant, which identifiesthe plant with res pectto the nature of its activities. Member States shall send copies of the
list and updated versions to the Commission and other Member States.
5. Detailed arrangementsfor implementing thisArticle, including
rulesconcerning the frequency of checksand reference methodsformicrobiological analyses, may be laid down under the procedurereferred to in Article 33(2).
CHAPTER VII
COMMUNITYCONTROLS
Article 27
CommunitycontrolsinMember States
1. Experts from the Commission may make on-the-spot checks, in
cooperation with the competent authorities of Member States, in sofar as is necessary for the uniform application of this Regulation. TheMember State on whose territory checks are made shall provide theexperts with all the assistance necessary for carrying out their duties.
The Commission shall inform the competent authority of the results of
the checksmade.
2. Rulesfor the implementation of thisArticle, in particular thos e
governing the procedure for cooperation with national competentauthorities, shall be laid down under the procedure referred to in
Article 33(2).
CHAPTER VIII
PROVISIONS APPLICABLE TO THE IMPORTATION ANDTRANSIT OF CERTAIN ANIMAL BY-PRODUCTS AND
PRODUCTSDERIVEDTHEREFROM
Article 28
General provisions
The provisions applicable to the importation of products referred to in
AnnexesVII and VIII from non-member countriess hall be no more
favourable or less favourable that those applicable to the productionand marketing of those products in the Community.
However, the importation from third countriesof petfood and raw
material for petfood production, derived from animalswhich have
been treated with certain substances prohibited in accordance with
Directive 96/22/EC, shall be permitted provided that such raw materialispermanently marked and under s pecific conditionslaid down underthe procedure referred to in Article 33(2).
Article 29
ProhibitionsandcompliancewithCommunityrules
1. The importation and transit of animal by-products and processed
productss hall be prohibited, except in accordance with thisRegulation.
2. The importation into, and the transit through, the Community of
the productsreferred to in AnnexesVII and VIII may take place only
if such products satisfy the requirements set out in paragraphs 3 to 6.
3. Products referred to in Annexes VII and VIII shall, save as other-
wise specified in those Annexes, come from a third country or parts ofthird countrieson a lis t to be drawn up and updated in accordance withthe procedure referred to in Article 33(2).2002R1774 — EN — 01.05.2003 — 001.001 — 22
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The list may be combined with other lists drawn up for public and
animal health purposes.
When the list is drawn up, particular account shall be taken of:
(a) the legislation of the third country;
(b) the organisation of the competent authority and its inspection
services in the third country, the powers of those services, the
supervision to which they are subject, and their authority tomonitor effectively the application of their legislation;
(c) the actual health conditionsapplied to the production, manufacture,
handling, storage and dispatch of products of animal originintended for the Community;
(d) the assurances the third country can give regarding compliance
with the relevant health conditions;
(e) experience of marketing the product from the third country and the
results of import checks carried out;
(f) the result of any Community inspections in the third country;
(g) the health status of the livestock, other domestic animals and wild-
life in the third country, having particular regard to exotic animaldiseases and any aspects of the general health situation in the
country which might pose a risk to public or animal health in the
Community;
(h) the regularity and speed with which the third country supplies
information about the existence of infectious or contagious animal
diseases in its territory, in particular the diseases mentioned in ListsA and B of the OIE or, in the case of diseases of aquacultureanimals, the notifiable diseases as listed in the Aquatic AnimalHealth Code of the OIE;
(i) the regulationson the prevention and control of infectiousor conta-
gious animal diseases in force in the third country and theirimplementation, including ruleson importsfrom other countries .
4. Productsreferred to in AnnexesVII and VIII, except for technical
products, must come from plants on a Community list drawn up underthe procedure referred to in Article 33(2) on the basis of a communica-tion from the competent authoritiesof the third country to theCommission declaring that the plant complies with the Communityrequirements and is subject to supervision by an official inspection
service in the third country.
Approved lists shall be amended as follows:
(a) the Commission shall inform the Member States of the modifica-
tions proposed by the third country concerned to the lists of plantswithin five working daysof the receipt of the propos ed modifica-
tions;
(b) the Member States shall have seven working days, from receipt of
the modifications to the lists of plants referred to in (a), to send any
written comments to the Commission;
(c) when at least one Member State makes written comments, the
Commission shall inform the Member States within five working
daysand include the point on the agenda of the next meeting ofthe Standing Committee on the Food Chain and Animal Healthfor decision under the procedure referred to in Article 33(2);
(d) when the Commission receives no comments from the Member
Stateswithin the time limit referred to in s ubparagraph (b),Member States shall be considered to have accepted the modifica-tions to the list. The Commission shall inform the Member Stateswithin five working days, and imports shall be authorised from
such plants five working days after receipt of this information by
the Member States.
5. Technical productsreferred to in Annex VIII mus t come from
plantsthat the competent authoritiesof the third countrieshaveapproved and registered.2002R1774 — EN — 01.05.2003 — 001.001 — 23
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6. Save as otherwise specified in Annexes VII and VIII, a health
certificate corresponding to the model laid down in Annex X, certi-fying that the productsmeet the conditionsreferred to in thos e
Annexes and come from plants offering such conditions, must accom-
pany consignments of products referred to in those Annexes.
7. Pending the compilation of the list provided for in paragraph 4
and the adoption of model certificatesasreferred to in paragraph 6,Member Statesmay maintain the controlsprovided for in Directive97/78/EC and certificates provided for under existing national rules.
Article 30
Equivalence
1. In accordance with the procedure referred to in Article 33(2), a
decision may be taken recognising that the health measures applied bya third country, a group of third countriesor a region of a third countryto the production, manufacture, handling, storage and transport of oneor more categoriesof productsreferred to in AnnexesVII and VIII
offer guaranteesequivalent to thos e applied in the Community, if the
third country supplies objective proof in this respect.
The decision shall set out the conditions governing the importation and/
or transit of animal by-products from that region, country or group ofcountries.
2. The conditionsreferred to in paragraph 1 s hall include:
(a) the nature and content of the health certificate that must accom-
pany the product;
(b) specific health requirements applicable to importation into, and/or
transit through, the Community; and
(c) where necessary, procedures for drawing up and amending lists of
regionsor plantsfrom which importsand/or trans it are permitted.
3. Detailed rulesfor the application of thisArticle s hall be laid
down under the procedure referred to in Article 33(2).
Article 31
Communityinspectionsandaudits
1. Experts from the Commission, where appropriate accompanied by
experts from the Member States, may carry out on-the-spot checks with
a view to:
(a) drawing up the list of third countries or parts thereof and deter-
mining conditionsfor importation and/or trans it;
(b) verifying compliance with:
(i) the conditions for inclusion in a Community list of third coun-
tries,
(ii) import and/or transit conditions,
(iii) the conditions for recognising equivalence of measures,
(iv) any emergency measures applied under Community legisla-
tion.
The Commission shall appoint experts from the Member States respon-
sible for these checks.
2. The checksreferred to in paragraph 1 s hall be carried out on
behalf of the Community, which shall meet the costs incurred.
3. The frequency of and the procedure for the checksreferred to in
paragraph 1 may be specified in accordance with the procedure referredto in Article 33(2).
4. If a check referred to in paragraph 1 revealsa s eriousinfringe-
ment of the health rules, the Commission shall immediately ask thethird country to take appropriate measures or shall suspend consign-mentsof productsand immediately inform the Member States .2002R1774 — EN — 01.05.2003 — 001.001 — 24
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CHAPTER IX
FINALPROVISIONS
Article 32
AmendmentstoAnnexesandtransitionalmeasures
1. After consultation of the appropriate scientific committee on any
question that could have an impact on animal or public health, the
Annexes may be amended or supplemented and any appropriate transi-tional measures may be adopted in accordance with the procedurereferred to in Article 33(2).
2. With regard to the ban on the feeding of catering waste referred
to in Article 22, where appropriate control systems are in place inMember Statesprior to the application of thisRegulation, trans itionalmeasures shall be adopted, in accordance with paragraph 1, to permitthe continued use in feed of certain types of catering waste under
strictly controlled circumstances for a period of not more than four
years as from 1 November 2002. These measures shall ensure thatthere is no undue risk to animal or public health during the transitionalperiod.
Article 33
Regulatoryprocedure
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health, hereinafter referred to as‘theCommittee’.
2. Where reference ismade to thisparagraph, Articles5 and 7 of
Decision 1999/468/EC shall apply, having regard to the provisions ofArticle 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at 15 days.
3. The Committee shall adopt its rules of procedure.
Article 34
Consultationofscientific committees
The appropriate scientific committees shall be consulted on any matter
within the scope of this Regulation that could have an effect on animalor public health.
Article 35
Nationalprovisions
1. Member States shall communicate to the Commission the text of
the provisions of any national law that they adopt in the field coveredby thisRegulation.
2. In particular, Member States shall inform the Commission of the
measures taken to ensure compliance with this Regulation within oneyear of itsentry into force. On the bas isof the information received,the Commission shall submit a report to the European Parliament and
the Council accompanied, if appropriate, by legislative proposals.
3. Member Statesmay adopt or maintain national rulesres tricting
the use of organic fertilizers and soil improvers further than envisagedin thisRegulation pending the adoption of Community rulesfor their
use in accordance with Article 20(2). Member States may adopt or
maintain national rules restricting the use of fat derivatives producedfrom Category 2 material further than envisaged in this Regulationpending the addition to Annex VIII of Community rulesfor their us ein accordance with Article 32.2002R1774 — EN — 01.05.2003 — 001.001 — 25
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Article 36
Financialarrangements
The Commission shall prepare a report on the financial arrangements in
Member States for the processing, collection, storage and disposal of
animal by-products accompanied by appropriate proposals.
Article 37
Repeal
Directive 90/667/EEC and Decisions 95/348/EC and 1999/534/EC shall
be repealed with effect from six months after the entry into force of
thisRegulation.
References to Directive 90/667/EEC shall be construed from that date
asreferencesto thisRegulation.
Article 38
Entryintoforce
ThisRegulation s hall enter into force on the 20th day following its
publication in the Official Journal of the European Communities .
This Regulation shall apply six months after the date of its entry into
force. However, Article 12(2) shall apply as specified in Article 20 ofDirective 2000/76/EC and Articles22(1)(b) and 32 s hall apply from 1
November 2002.
ThisRegulation s hall be binding in itsentirety and directly applicable
in all Member States.2002R1774 — EN — 01.05.2003 — 001.001 — 26
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ANNEX I
SPECIFICDEFINITIONS
For the purpose of this Regulation:
1. ‘apiculture products’ means honey, beeswax, royal jelly, propolis or pollen
used in bee-keeping;
2. ‘batch’ means a unit of production produced in a single plant using uniform
production parameters — or a number of such units, when stored together
— and that can be identified for the purposes of recall and re-treatment or
disposal should tests show that to be necessary;
3. ‘biogasplant’ meansa plant in which biological degradation of productsof
animal origin isundertaken under anaerobic conditionsfor the production
and collection of biogas;
4. ‘blood products’ means products derived from blood or fractions of blood,
excluding blood meal; they include dried/frozen/liquid plasma, dried whole
blood, dried/frozen/liquid red cellsor fractionsthereof and mixtures ;
5. ‘blood’ meansfres h whole blood;
6. ‘bloodmeal’ meansproductsderived from the heat-treatment of blood in
accordance with Annex VII, Chapter II, and intended for animal consump-
tion or organic fertilizers;
7. ‘canned petfood’ means heat-processed petfood contained within a hermeti-
cally sealed container;
8. ‘Category 1 or Category 2 intermediate plant’ meansa plant in which
unprocessed Category 1 or Category 2 material is handled and/or tempora-
rily stored for the purpose of further transportation to its final destination
and where certain preliminary activities, such as removal of hides and skins
and performing post-mortem examinations, may take place;
9. ‘Category 1 processing plant’ means a plant in which Category 1 material is
processed before its final disposal;
10. ‘Category 2 oleochemical plant’ means a plant processing rendered fats
derived from Category 2 material under conditionss et out in Annex VI,
Chapter III;
11. ‘Category 2 processing plant’ means a plant in which Category 2 material is
processed before its final disposal, further transformation or use;
12. ‘Category 3 intermediate plant’ means a plant in which unprocessed Cate-
gory 3 material iss orted and/or cut and/or chilled or deep-frozen into
blocks and/or temporarily stored for the purpose of further transporting to
itsfinal des tination;
13. ‘Category 3 oleochemical plant’ means a plant processing rendered fats
derived from Category 3 material;
14. ‘Category 3 processing plant’ means a plant in which Category 3 material is
processed into processed animal protein and other processed products that
could be used as feed material;
15. ‘catering waste’ means all waste food including used cooking oil originating
in restaurants, catering facilities and kitchens, including central kitchens and
household kitchens;
16. ‘co-incineration plant’ means a disposal site as defined in Article 3(5) of
Directive 2000/76/EC;
17. ‘co-incineration’ means the disposal of animal by-products or products
derived therefrom in a co-incineration plant;
18. ‘collection centres’ means premises collecting and treating certain animal
by-products intended to be used for the feeding of the animals specified in
Article 23(2)(c);
19. ‘composting plant’ means a plant in which biological degradation of
productsof animal origin isundertaken under aerobic conditions ;
20. ‘digestion residues’ means residues resulting from the transformation of
animal by-productsin a biogasplant;2002R1774 — EN — 01.05.2003 — 001.001 — 27
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21. ‘digestive tract content’ means the content of the digestive tract of
mammals and ratites, whether or not separated from the digestive tract;
22. ‘dogchews’ means untanned products for pet animals to chew, produced
from hidesand s kinsof ungulatesor other animal material;
23. ‘feed material’ means those feed materials, as defined in Directive 96/25/
EC (1), that are of animal origin including processed animal proteins, blood
products, rendered fats, fish oil, fat derivatives, gelatin and hydrolysed
proteins, dicalcium phosphate, milk, milk-based products and colostrum;
24. ‘fishmeal’ means processed animal protein derived from sea animals, except
sea mammals;
25. ‘fur animals’ means animals kept or reared for the production of fur and not
used for human consumption;
26. ‘gelatin’ meansnatural, s oluble protein, gelling or non-gelling, obtained by
the partial hydrolysis of collagen produced from bones, hides and skins,
tendons and sinews of animals (including fish and poultry);
27. ‘greaves’ means the protein-containing residue of rendering, after partial
separation of fat and water;
28. ‘hermetically sealed container’ means a container that is designed and
intended to be secure against the entry of micro-organisms;
29. ‘hides and skins’ means all cutaneous and subcutaneous tissues;
30. ‘high-capacity incineration plant’ meansan incineration plant other than a
low-capacity incineration plant;
31. ‘hydrolysed proteins’ means polypeptides, peptides and aminoacids, and
mixtures thereof, obtained by the hydrolysis of animal by-products;
32. ‘incineration plant’ means a disposal site as defined in Article 3(4) of Direc-
tive 2000/76/EC;
33. ‘incineration’ means the disposal of animal by-products or products derived
therefrom in an incineration plant;
34. ‘laboratory reagent’ meansa packaged product, ready for us e by the end
user, containing a blood product, and intended for laboratory use as reagent
or reagent product, whether used alone or in combination;
35. ‘landfill’ means a disposal site as defined by Directive 1999/31/EC;
36. ‘low-capacity incineration plant’ meansan incineration plant with a
throughput of les sthan 50 kg of animal by-productsper hour;
37. ‘manure’ meansany excrement and/or urine of farmed animals , with or
without litter, or guano, that may be either unprocessed or processed in
accordance with Chapter III of Annex VIII or otherwise transformed in
biogas or composting plants;
38. ‘organic fertilizers’ and ‘soil improvers’ mean materials of animal origin
used to maintain or improve plant nutrition and the physical and chemical
properties and biological activity of soils, either separately or together; they
may include manure, digestive tract content, compost and digestion resi-
dues;
39. ‘pasture land’ means land covered with grass or other herbage and grazed
by farmed animals;
40. ‘petfood plant’ meansa plant producing petfood or dogchewsand in which
certain animal by-products are used in the preparation of such petfood or
dogchews;
41. ‘petfood’ meansfood for pet animalscontaining Category 3 material;
42. ‘processed animal protein’ means animal proteins derived entirely from
Category 3 material, which have been treated in accordance with Chapter
II of Annex V so as to render them suitable for direct use as feed material
or other use in feedingstuffs, including petfood, or use in organic fertilisers
or soil improvers; however, it does not include blood products, milk, milk-
based products, colostrum, gelatine, hydrolysed proteins and dicalcium
phosphate, eggs and egg-products, tricalcium phosphate and collagen;2002R1774 — EN — 01.05.2003 — 001.001 — 28
(1) Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials,
amending Directives70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC andrepealing Directive 77/101/EEC (OJ L 125, 23.5.1996, p. 35). Directive aslas t
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43. ‘processed petfood’ means petfood, other than raw petfood, that has under-
gone treatment in accordance with the requirementsof Annex VIII;
44. ‘processed products’ means animal by-products that have undergone one of
the processing methods or another treatment required by Annex VII or VIII;
45. ‘processing methods’ means the methods listed in Annex V, Chapter III;
46. ‘processing plant’ means an animal by-products processing plant;
47. ‘product used for in vitro diagnosis’ means a packaged product, ready for
use by the end user, containing a blood product, and used as a reagent,
reagent product, calibrator, kit or any other system, whether used alone or
in combination, intended to be used in vitro for the examination of samples
of human or animal origin, with the exception of donated organsor blood,
solely or principally with a view to the diagnosis of a physiological state,
state of health, disease or genetic abnormality or to determine safety and
compatibility with reagents;
48. ‘raw petfood’ meanspetfood which hasnot undergone any pres erving
process other than chilling, freezing or quick freezing to ensure preserva-
tion;
49. ‘remote areas’ means areas where the animal population is so small, and
where facilities are so far away, that the arrangements necessary for collec-
tion and transport would be unacceptably onerous compared to local
disposal;
50. ‘rendered fats’ means fats derived from processing of Category 2 material
or Category 3 material;
51. ‘storage plant’ means a plant, other than establishments and intermediaries
covered by Directive 95/69/EC (1), in which processed products are
temporarily stored before their final use or disposal;
52. ‘tanning’ means the hardening of hides, using vegetable tanning agents,
chromium salts or other substances such as aluminium salts, ferric salts,
silicic salts, aldehydes and quinones, or other synthetic hardening agents;
53. ‘technical plant’ meansa plant in which animal by-productsare us ed to
produce technical products;
54. ‘technical products’ means products directly derived from certain animal
by-products, intended for purposes other than human or animal consump-
tion, including tanned and treated hides and skins, game trophies,
processed wool, hair, bristles, feathers and parts of feathers, serum of
equidae, blood products, pharmaceuticals, medical devices, cosmetics, bone
products for china, gelatin and glue, organic fertilizers, soil improvers,
rendered fats, fat derivatives, processed manure and milk and milk-based
products;
55. ‘unprocessed feathers and parts of feathers’ means feathers and parts of
feathers that have not been treated with a steam current or by some other
method that ensures that no pathogens remain;
56. ‘unprocessed wool’ means sheep's wool that has not undergone factory
washing, been obtained from tanning, or been treated by some other method
that ensures that no pathogens remain;
57. ‘unprocessed hair’ means ruminant hair that has not undergone factory
washing, been obtained from tanning, or been treated by some other method
that ensures that no pathogens remain;
58. ‘unprocessed pig bristles’ means pig bristles that have not undergone
factory washing, been obtained from tanning, or been treated by some other
method that ensures that no pathogens remain;
59. ‘collagen’ means protein-based products derived from hides, skins and
tendons of animals, including bones in the case of pigs, poultry and fish;
60. ‘screenings’ means visible solid animal materials retained in the waste
water screen where a pre-treatment process as referred to in Annex II,
Chapter IX, isrequired;
61. ‘grease and oil mixture’ means floating animal materials collected at the
surface of waste water grease remover systems where a pre-treatment
process as referred to in Annex II, Chapter IX, is required;2002R1774 — EN — 01.05.2003 — 001.001 — 29
(1) Council Directive 95/69/EC of 22 December 1995 laying down the conditionsand
arrangements for approving and registering certain establishments and intermediariesoperating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC,79/373/EEC and 82/471/EEC (OJ L 332, 30.12.1995, p. 15). Directive aslas t amended
by Directive 1999/29/EC (OJ L 115, 4.5.1999, p. 32).▼M1
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62. ‘sludge’ means visible solid animal materials or sediments retained in the
waste water drains where a pre-treatment process as referred to in Annex
II, Chapter IX, isrequired;
63. ‘material from desanding’ means visible solid animal materials or sediments
retained in desanding systems where these constitute a pre-treatment process
referred to in Annex II, Chapter IX.2002R1774 — EN — 01.05.2003 — 001.001 — 30
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ANNEX II
HYGIENE REQUIREMENTS FOR THE COLLECTION AND TRANS-
PORTOFANIMALBY-PRODUCTSANDPROCESSEDPRODUCTS
CHAPTER I
Identification
1. All necessary measures must be taken to ensure that:
(a) Category 1, Category 2 and Category 3 materialsare identifiable and
kept separate and identifiable during collection and transportation; and
(b) processed products are identifiable and kept separate and identifiable
during transportation.
2. During transport, a label attached to the vehicle, container, carton or other
packaging material must clearly indicate:
(a) the category of the animal by-products or, in the case of processed
products, the category of animal by-products from which the processed
productswere derived; and
(b) (i) in the case of Category 3 material, the words ‘not for human
consumption’;
(ii) in the case of Category 2 material (other than manure and digestive
tract content) and processed products derived therefrom, the words
‘not for animal consumption’; however, when Category 2 material
isintended for the feeding of animalsreferred to in point (c) of
Article 23(2) under the conditionsprovided for in that Article, the
label shall instead indicate‘ for feeding to …’ completed with the
name of the specific species of those animal(s) for the feeding of
which the material isintended;
(iii) in the case of Category 1 material and processed products derived
therefrom, the words ‘for disposal only’;
(iv) in the case of manure and digestive tract content, the word
‘manure’.
CHAPTER II
Vehiclesandcontainers
1. Animal by-products and processed products must be collected and trans-
ported in sealed new packaging or covered leak-proof containers or vehicles.
2. Vehicles and reusable containers, and all reusable items of equipment or
appliances that come into contact with animal by-products or processed
products, must be:
(a) cleaned, washed and disinfected after each use;
(b) maintained in a clean condition; and
(c) clean and dry before use.
3. Reusable containers must be dedicated to the carriage of a particular product
to the extent necessary to avoid cross-contamination.
4. Packaging material must be incinerated or disposed of by some other means
in accordance with instructions from the competent authority.
CHAPTER III
Commercialdocumentsandhealthcertificates
1. During transportation, a commercial document or, when required by this
Regulation, a health certificate must accompany animal by-products and
processed products except in the case of processed products originating
from Category 3 material which are supplied within the same Member State
by retailers to final users other than business operators.
2. Commercial documents must specify:
(a) the date on which the material was taken from the premises;2002R1774 — EN — 01.05.2003 — 001.001 — 31
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(b) the description of the material, including the information referred to in
Chapter I, the animal species for Category 3 material and processed
products derived therefrom destined for use as feed material and, if
applicable, the ear-tag number;
(c) the quantity of the material;
(d) the place of origin of the material;
(e) the name and the address of the carrier;
(f) the name and the addres sof the receiver and, if applicable, itsapproval
number; and
(g) if appropriate:
(i) the approval number of the plant of origin, and
(ii) the nature and the methodsof the treatment.
3. The commercial document must be produced at least in triplicate (one
original and two copies). The original must accompany the consignment to
its final destination. The receiver must retain it. The producer must retain
one of the copiesand the carrier the other.
4. A model for the commercial document may be laid down under the proce-
dure referred to in Article 33(2).
5. Health certificates must be issued and signed by the competent authority.
CHAPTER IV
Records
The recordsreferred to in Article 9 mus t contain the information referred to in
Chapter III, paragraph 2, as follows. They must contain:
(a) the information referred to in subparagraphs (b) and (c); and
(b) in the case of records kept by any person consigning animal by-products,
the information referred to in subparagraphs (a), (e) and, if known, (f); or
(c) in the case of records kept by any person transporting animal by-products,
the information referred to in subparagraphs (a), (d) and (f); or
(d) in the case of records kept by any person receiving animal by-products, the
date of reception and the information referred to in subparagraphs (d) and
(e).
CHAPTER V
Retentionofdocuments
The commercial document and the health certificate referred to in Chapter III,
and the records referred to in Chapter IV, must be kept for a period of at least
two yearsfor pres entation to the competent authority.
CHAPTER VI
Temperatureconditions
1. The transport of animal by-products must take place at an appropriate
temperature, to avoid any risk to animal or public health.
2. Unprocessed Category 3 material destined for the production of feed material
or pet food must be transported chilled or frozen, unless processed within 24
hoursof departure.
3. The design of vehicles used for refrigerated transport must ensure the main-
tenance of an appropriate temperature throughout transport.
CHAPTER VII
Specificrulesfortransit
The carriage of animal by-products and processed products in transit must meet
the requirementsof ChaptersI, II, III and VI.
CHAPTER VIII
Controlmeasures
The competent authority must take the necessary measures to control the collec-
tion, transport, use and disposal of animal by-products and processed products,
including by checking the keeping of required recordsand documentsand, when
this Regulation requires it or the competent authority considers it necessary, by
sealing.2002R1774 — EN — 01.05.2003 — 001.001 — 32
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When the competent authority applies a seal to a consignment of animal by-
products or processed products, it must inform the competent authority of the
place of destination.
CHAPTER IX
Collectionofanimalmaterial whentreatingwastewater
1. Category 1 processing plants and other premises where specified risk mate-
rial is removed, slaughterhouses and Category 2 processing plants shall have
a pre-treatment process for the retention and collection of animal material as
an initial step in the treatment of waste water. The equipment used in the
pre-treatment process shall consist of drain traps or screen with apertures or
a mesh size of no more than 6 mm in the downstream end of the process or
equivalent systems that ensures that the solid particles in the waste water
passing through them are no more than 6 mm.
2. Waste water from the premises as referred to in paragraph 1 must enter a
pre-treatment process which shall ensure that all waste water has been
filtered through the process before being drained off the premises. No
grinding or maceration shall take place which could facilitate the passage of
animal material through the pre-treatment process.
3. All animal material retained in the pre-treatment process in premises as
referred to in paragraph 1 shall be collected and transported as Category 1
or Category 2 material, as appropriate, and disposed of in accordance with
thisRegulation.
4. Waste water having passed the pre-treatment process in premises referred to
in paragraph 1 and waste water from premises only receiving Category 3
material shall be treated in accordance with other relevant Community legis-
lation.2002R1774 — EN — 01.05.2003 — 001.001 — 33
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ANNEX III
HYGIENE REQUIREMENTS FOR INTERMEDIATE AND STORAGE
PLANTS
CHAPTER I
Requirementsfortheapprovalofintermediate plants
1. Premises and facilities must meet at least the following requirements.
(a) The premises must be adequately separated from the public highway and
other premises such as slaughterhouses. The layout of plants must ensure
the total separation of Category 1 and Category 2 material from Category
3 material from reception until dispatch.
(b) The plant must have a covered space to receive animal by-products.
(c) The plant must be constructed in such a way that it is easy to clean and
disinfect. Floors must be laid down in such a way as to facilitate the
draining of liquids.
(d) The plant must have adequate lavatories, changing rooms and washbasins
for staff.
(e) The plant must have appropriate arrangements for protection against
pests, such as insects, rodents and birds.
(f) The plant must have a waste-water disposal system which meets hygiene
requirements.
(g) Where it is necessary for the purpose of achieving the objectives of this
Regulation, plants must have suitable temperature-controlled storage
facilitiesof s ufficient capacity for maintaining animal by-productsat
appropriate temperaturesand des igned to allow the monitoring and
recording of those temperatures.
2. The plant must have adequate facilities for cleaning and disinfecting the
containersor receptaclesin which animal by-productsare received and the
vehicles, other than ships, in which they are transported. Adequate facilities
must be provided for the disinfecting of vehicle wheels.
CHAPTER II
Generalhygienerequirements
A.Category 3 intermediate plants
1. The plant must not engage in activities other than the importation, collection,
sorting, cutting, chilling, freezing into blocks, temporary storage and
dispatching of Category 3 material.
2. The sorting of Category 3 material must be carried out in such a way as to
avoid any risk of the propagation of animal diseases.
3. All the time during sorting or storage, Category 3 material must be handled
and stored separately from goods other than other Category 3 material and in
such a way as to prevent any propagation of pathogens and to ensure compli-
ance with Article 22.
4. Category 3 material must be stored properly, and, where appropriate, chilled
or frozen, until re-dispatched.
B.Category 1 or Category 2 intermediate plants
6. The plant must not engage in activities other than the collection, handling,
temporary storage and dispatching of Category 1 or Category 2 material.
7. The sorting of the Category 1 or Category 2 material must be carried out in
such a way as to avoid any risk of the propagation of animal diseases.
8. All the time during storage, the Category 1 or Category 2 material must be
handled and stored separately from other goods and in such a way as to
prevent any propagation of pathogens.
9. Category 1 or Category 2 material must be stored properly, including under
appropriate temperature conditions, until re-dispatched.2002R1774 — EN — 01.05.2003 — 001.001 — 34
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11. Waste water must be treated to ensure, as far as is reasonably practicable,
that no pathogensremain. Specific requirementsfor the treatment of was te
water from Category 1 and Category 2 intermediate plantsmay be laid
down in accordance with the procedure referred to in Article 33(2).
CHAPTER III
Requirementsfortheapprovalofstorageplants
Premises and facilities must meet at least the following requirements.
1. Premises storing processed products derived from Category 3 material must
not be at the same site as premises storing processed products derived from
Category 1 or Category 2 material, unless in a completely separate building.
2. The plant must:
(a) have a covered space to receive the products;
(b) be constructed in such a way that it is easy to clean and disinfect. Floors
must be laid down in such a way as to facilitate the draining of liquids;
(c) have adequate lavatories, changing rooms and washbasins for staff; and
(d) have appropriate arrangements for protection against pests, such as
insects, rodents and birds.
3. The plant must have adequate facilities for cleaning and disinfecting the
containersor receptaclesin which the productsare received and the vehicles ,
other than ships, in which they are transported. Adequate facilities must be
provided for the disinfecting of vehicle wheels.
4. Products must be stored properly until re-dispatched.2002R1774 — EN — 01.05.2003 — 001.001 — 35
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ANNEX IV
REQUIREMENTS FOR INCINERATION AND CO-INCINERATION
PLANTSTOWHICHDIRECTIVE2000/76/ECDOESNOTAPPLY
CHAPTER I
Generalconditions
1. Incineration or co-incineration plants must be designed, equipped and oper-
ated in such a manner as to fulfil the requirements of this Regulation. The
following hygiene conditionsmus t be met:
(a) Animal by-products must be disposed of as soon as possible after arrival.
They must be stored properly until disposal.
(b) Containers, receptacles and vehicles used for transporting unprocessed
material must be cleaned in a designated area, thereby ensuring that
waste water is treated during the storage referred to in Chapter III.
(c) Preventive measures against birds, rodents, insects or other vermin must
be taken systematically. A documented pest control programme must be
used for that purpose.
(d) Cleaning procedures must be established and documented for all parts of
the premises. Suitable equipment and cleaning agents must be provided
for cleaning.
(e) Hygiene control must include regular inspections of the environment and
equipment. Inspection schedules and results must be documented and
maintained for at least two years.
2. The operator of an incineration or co-incineration plant must take all neces-
sary precautions concerning the reception of animal by-products to prevent,
or limit asfar aspracticable, direct ris ksto human or animal health.
CHAPTER II
Operatingconditions
3. Incineration or co-incineration plants must be designed, equipped, built and
operated in such a way that the gas resulting from the process is raised in a
controlled and homogeneous fashion, even under the most unfavourable
conditions, to a temperature of 850 ºC, as measured near the inner wall or
at another representative point of the combustion chamber as authorised by
the competent authority, for two seconds.
4. Each line of high-capacity incineration plants must be equipped with at least
one auxiliary burner. This burner must be switched on automatically when
the temperature of the combustion gases after the last injection of combustion
air falls below 850 ºC. It must also be used during plant start-up and shut-
down operationsto ens ure that the temperature of 850 ºC ismaintained at
all timesduring thes e operationsand aslong asunburned material isin the
combustion chamber.
5. High-capacity incineration or co-incineration plantsmus t have and operate an
automatic system to prevent feed with animal by-products:
(a) at start-up, until the temperature of 850 ºC has been reached; and
(b) whenever the temperature of 850 ºC isnot maintained.
6. Animal by-products should, where practicable, be placed straight in the
furnace without direct handling.
CHAPTER III
Waterdischarges
7. Incineration or co-incineration plant sites, including associated storage areas
for animal by-products, must be designed in such a way as to prevent
unauthorised and accidental release of any polluting substances into soil,
surface water and groundwater in accordance with the provisions provided
for in relevant Community legislation. Moreover, storage capacity must be
provided for contaminated rainwater run-off from the incineration plant site
or for contaminated water arising from spillage or fire-fighting operations.
8. The storage capacity must be adequate to ensure that such waters can be
tested and treated before discharge where necessary.2002R1774 — EN — 01.05.2003 — 001.001 — 36
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CHAPTER IV
Residues
9. For the purposes of this Chapter, ‘residues’ means any liquid or solid mate-
rial generated by the incineration or co-incineration process, the waste-water
treatment or other processes within the incineration or co-incineration plant.
They include bottom ash and slag, fly ash and boiler dust.
10. Residues resulting from the operation of the incineration or co-incineration
plant must be minimised in their amount and harmfulness. Residues must be
recycled, where appropriate, directly in the plant or outside in accordance
with relevant Community legislation.
11. Transport and intermediate storage of dry residues in the form of dust must
take place in such a way as to prevent dispersal in the environment (e.g., in
closed containers).
CHAPTER V
Temperaturemeasurement
12. Techniques must be used to monitor the parameters and conditions relevant
to the incineration or co-incineration process. High-capacity incineration
and co-incineration plants must have and use temperature measurement
equipment.
13. The approval issued by the competent authority, or conditions attached to it,
must lay down temperature measurement requirements.
14. The appropriate installation and the functioning of any automated moni-
toring equipment must be subject to control and to an annual surveillance
test. Calibration must be carried out by means of parallel measurements
with the reference methods at least every three years.
15. Temperature measurement results must be recorded and presented in an
appropriate fashion to enable the competent authority to verify compliance
with the permitted operating conditionslaid down in thisRegulation in
accordance with proceduresto be decided upon by that authority.
CHAPTER VI
Abnormaloperating
16. In the case of a breakdown, or abnormal operating conditions, the operator
must reduce or close down operations as soon as practicable until normal
operationscan be res umed.
CHAPTER VII
IncinerationofCategory1materialreferred toinArticle 4(1)(b)
1. The low-capacity incineration plant must be located on a well-drained hard
standing.
2. Livestock must not have access to the low-capacity incineration plant, animal
by-products that are awaiting incineration or ash resulting from the incinera-
tion of animal by-products. If the low-capacity incineration plant is located
on a livestock holding:
(a) there must be total physical separation between the incinerator and the
livestock and their feed and bedding, with fencing where necessary;
(b) equipment must be dedicated entirely to the operation of the incinerator
and not used elsewhere on the farm;
(c) the operatorsmus t change their outer clothing and footwear before hand-
ling livestock or livestock feed.
3. The storage of animal by-products and of ashes must be covered, labelled
and leak proof.
4. The operator must check that animal by-products are incinerated in such a
way that they are completely reduced to ash. Ash must be disposed of to a
landfill approved under Directive 1999/31/EC.
5. Incompletely incinerated animal by-products must not be disposed of to a
landfill, but must be re-incinerated or otherwise disposed of in accordance
with thisRegulation.
6. The low-capacity incineration plant must be equipped with an afterburner.2002R1774 — EN — 01.05.2003 — 001.001 — 37
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7. The operator must keep records of the quantities, category and species of
animal by-productsincinerated and the date of incineration.
8. The competent authority must inspect the low-capacity incineration plant
before approval, and at least once a year to monitor compliance with this
Regulation.2002R1774 — EN — 01.05.2003 — 001.001 — 38
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ANNEX V
GENERAL HYGIENE REQUIREMENTS FOR THE PROCESSING OF
CATEGORY1,2AND3MATERIAL
CHAPTER I
General requirements for the approval of Category 1, 2 and 3 processing
plants
1. Premises and facilities must meet at least the following requirements:
(a) premises for the processing of animal by-products must not be at the
same site as slaughterhouses, unless located in a completely separate
building. However, a conveyer system may link an individual processing
plant to a slaughterhouse on the same site provided the following condi-
tionsare met:
(i) there are separate entrances, reception bays, equipment, exits and
personnel for the processing plant and the slaughterhouse; and
(ii) the animal by-products to be processed originate on the same
premises.
Unauthorised persons and animals must not have access to the processing
plant;
(b) the processing plant must have a clean and unclean sector, adequately
separated. The unclean sector must have a covered place to receive
animal by-products and must be constructed in such a way that it is
easy to clean and disinfect. Floors must be laid in such a way as to facil-
itate the draining of liquids. The processing plant must have adequate
lavatories, changing rooms and washbasins for staff;
(c) the processing plant must have sufficient production capacity for hot
water and steam for the processing of animal by-products;
(d) the unclean sector must, if appropriate, contain equipment to reduce the
size of animal by-products and equipment for loading the crushed animal
by-products into the processing unit;
(e) all installations in which animal by-products are processed must operate
in accordance with the requirementsof Chapter II. Where heat treatment
is required, all installations must be equipped with:
(i) measuring equipment to monitor temperature against time and, if
necessary, pressure at critical points;
(ii) recording devices to record continuously the results of these
measurements; and
(iii) an adequate safety system to prevent insufficient heating;
(f) to prevent recontamination of the finished product by incoming animal
by-products, there must be a clear separation between the area of the
plant where incoming material for processing is unloaded and the areas
set aside for the processing of that product and the storage of the
processed product.
2. The processing plant must have adequate facilities for cleaning and disin-
fecting the containersor receptaclesin which animal by-productsare
received and the vehicles, other than ships, in which they are transported.
3. Adequate facilities must be provided for the disinfecting of vehicle wheels,
on leaving the unclean sector of the processing plant.
4. All processing plants must have a waste-water disposal system meeting the
competent authority'srequirements .
5. The processing plant must have its own laboratory or make use of the
services of an external laboratory. The laboratory must be equipped to carry
out necessary analyses and be approved by the competent authority.
CHAPTER II
Generalhygienerequirements
1. Animal by-products must be processed as soon as possible after arrival. They
must be stored properly until processed.
2. Containers, receptacles and vehicles used for transporting unprocessed mate-
rial must be cleaned in a designated area. That area must be situated or
designed to prevent the risk of contamination of processed products.2002R1774 — EN — 01.05.2003 — 001.001 — 39
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3. Persons working in the unclean sector must not enter the clean sector without
changing their working clothesand footwear or without dis infecting the
latter. Equipment and utensils must not be taken from the unclean sector
into the clean sector, unless first cleaned and disinfected. Personnel move-
ment procedures must be established to control the movement of personnel
between areas and to prescribe the proper use of foot baths and wheel baths.
4. Waste water originating in the unclean sector must be treated to ensure, as
far asisreas onably practicable, that no pathogensremain. Specific require-
ments for the treatment of waste water from processing plants may be laid
down under the procedure referred to in Article 33(2).
5. Preventive measures against birds, rodents, insects or other vermin must be
taken systematically. A documented pest control programme must be used
for that purpose.
6. Cleaning procedures must be established and documented for all parts of the
premises. Suitable equipment and cleaning agents must be provided for
cleaning.
7. Hygiene control must include regular inspections of the environment and
equipment. Inspection schedules and results must be documented and main-
tained for at least two years.
8. Installations and equipment must be kept in a good state of repair and
measuring equipment must be calibrated at regular intervals.
9. Processed products must be handled and stored at the processing plant in
such a way as to preclude recontamination.
CHAPTER III
Processingmethods
Method 1
Reduction
1. If the particle size of the animal by-products to be processed is more than 50
millimetres, the animal by-products must be reduced in size using appropriate
equipment, set so that the particle size after reduction is no greater than 50
millimetres. The effectiveness of the equipment must be checked daily and
its condition recorded. If checks disclose the existence of particles larger
than 50 millimetres, the process must be stopped and repairs made before
the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-productsmus t be heated to a core temperature
of more than 133 ºC for at least 20 minutes without interruption at a pressure
(absolute) of at least 3 bars produced by saturated steam (1); the heat treat-
ment may be applied as the sole process or as a pre- or post-process
sterilisation phase.
3. The processing may be carried out in batch or continuous systems.
Method 2
Reduction
1. If the particle size of the animal by-products to be processed is more than
150 millimetres, the animal by-products must be reduced in size using appro-
priate equipment, set so that the particle size after reduction is no greater
than 150 millimetres. The effectiveness of the equipment must be checked
daily and its condition recorded. If checks disclose the existence of particles
larger than 150 millimetres, the process must be stopped and repairs made
before the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-productsmus t be heated to a core temperature
greater than 100 ºC for at least 125 minutes, a core temperature greater than
110 ºC for at least 120 minutes and a core temperature greater that 120 ºC
for at least 50 minutes.2002R1774 — EN — 01.05.2003 — 001.001 — 40
(1) ‘Saturated steam’ means that all air is evacuated and replaced by steam in the whole
sterilisation chamber.
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3. The processing must be carried out in a batch system.
4. The animal by-productsmay be cooked in s uch a manner that the time-
temperature requirementsare achieved at the s ame time.
Method 3
Reduction
1. If the particle size of the animal by-products to be processed is more than 30
millimetres, the animal by-products must be reduced in size using appropriate
equipment, set so that the particle size after reduction is no greater than 30
millimetres. The effectiveness of the equipment must be checked daily and
its condition recorded. If checks disclose the existence of particles larger
than 30 millimetres, the process must be stopped and repairs made before
the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-productsmus t be heated to a core temperature
greater than 100 ºC for at least 95 minutes, a core temperature greater than
110 ºC for at least 55 minutes and a core temperature greater that 120 ºC for
at least 13 minutes.
3. The processing may be carried out in batch or continuous systems.4. The animal by-productsmay be cooked in s uch a manner that the time-
temperature requirementsare achieved at the s ame time.
Method 4
Reduction
1. If the particle size of the animal by-products to be processed is more than 30
millimetres, the animal by-products must be reduced in size using appropriate
equipment, set so that the particle size after reduction is no greater than 30
millimetres. The effectiveness of the equipment must be checked daily and
its condition recorded. If checks disclose the existence of particles larger
than 30 millimetres, the process must be stopped and repairs made before
the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-products must be placed in a vessel with added
fat and heated to a core temperature greater than 100 ºC for at least 16
minutes, a core temperature greater than 110 ºC for at least 13 minutes, a
core temperature greater that 120 ºC for at least eight minutes and a core
temperature greater that 130 ºC for at least three minutes.
3. The processing may be carried out in batch or continuous systems.4. The animal by-productsmay be cooked in s uch a manner that the time-
temperature requirementsare achieved at the s ame time.
Method 5
Reduction
1. If the particle size of the animal by-products to be processed is more than 20
millimetres, the animal by-products must be reduced in size using appropriate
equipment, set so that the particle size after reduction is no greater than 20
millimetres. The effectiveness of the equipment must be checked daily and
its condition recorded. If checks disclose the existence of particles larger
than 20 millimetres, the process must be stopped and repairs made before
the process is resumed.
Time, temperature and pressure
2. After reduction the animal by-productsmus t be heated until they coagulate
and then pressed so that fat and water are removed from the proteinaceous
material. The proteinaceousmaterial mus t then be heated to a core tempera-
ture greater than 80 ºC for at least 120 minutes and a core temperature
greater than 100 ºC for at least 60 minutes.
3. The processing may be carried out in batch or continuous systems.2002R1774 — EN — 01.05.2003 — 001.001 — 41
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4. The animal by-productsmay be cooked in s uch a manner that the time-
temperature requirementsare achieved at the s ame time.
Method 6
(for animal by-products of fishorigin only)
Reduction
1. The animal by-products must be reduced to … millimetres. They must then
be mixed with formic acid to reduce the pH to …. The mixture must be
stored for … hours pending further treatment.
2. The mixture must then be introduced into a heat converter and be heated to a
core temperature of … ºC for at least … minutes. The progression of the
product through the heat converter must be controlled by means of mechan-
ical commands limiting its displacement in such a way that at the end of the
heat treatment operation the product hasundergone a cycle which iss uffi-
cient in both time and temperature.
3. After heat treatment, the product must be separated into liquid, fat and
greaves by mechanical means. To obtain processed animal protein concen-
trate, the liquid phase must be pumped into two heat exchangers which are
steam-heated and equipped with vacuum chambers in order for its humidity
to be removed therein in the form of water vapour. The greavesmus t be rein-
corporated into the protein concentrate before storage.
Method 7
1. Any processing method approved by the competent authority where it has
been demonstrated to that authority that the final product has been sampled
on a daily basis over a period of one month in compliance with the following
microbiological standards:
(a) Samplesof material taken directly after heat treatment:
Clostridium perfringens absent in 1 g of the products
(b) Samplesof material taken during or upon withdrawal from s torage at the
processing plant:
Salmonella : absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae : n = 5, c = 2, m = 10, M = 300 in 1 g
where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered
satisfactory if the number of bacteria in all samples does not
exceed m;
M = maximum value for the number of bacteria; the result is consid-
ered unsatisfactory if the number of bacteria in one or more
samples is M or more; and
c = number of samples the bacterial count of which may be between
m and M, the sample still being considered acceptable if the
bacterial count of the other samples is m or less.
2. Details of the critical control points under which each processing plant satis-
factorily complies with the microbiological standards must be recorded and
maintained so that the owner, operator or their representative and the compe-
tent authority can monitor the operation of the processing plant. The
information to be recorded and monitored must include the particle size,
critical temperature and, as appropriate, the absolute time, pressure profile,
raw material feed-rate and fat recycling rate.
3. This information must be made available to the Commission on request.
CHAPTER IV
Supervisionofproduction
1. The competent authority must supervise processing plants to ensure compli-
ance with the requirementsof thisRegulation. It mus t in particular:
(a) check:
(i) the general conditions of hygiene of the premises, equipment and
staff;2002R1774 — EN — 01.05.2003 — 001.001 — 42
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(ii) the efficacy of the own checkscarried out by the plant, in accor-
dance with Article 25, particularly by examining the results and
taking samples;
(iii) the standards of the products after processing. The analyses and tests
must be carried out in accordance with scientifically-recognised
methods (in particular, those laid down in Community legislation
or, where none exist, recognised international standards or, in their
absence, national standards); and
(iv) the storage conditions;
(b) take any samples required for laboratory tests; and
(c) make any other checks it considers necessary to ensure compliance with
thisRegulation.
2. To allow it to carry out its responsibilities under paragraph 1, the competent
authority must have free access at all times to all parts of the processing
plant and to records, commercial documents and health certificates.
CHAPTER V
Validationprocedures
1. The competent authority must validate the processing plant in accordance
with the following proceduresand indicators :
(a) description of the process (by a process flow diagram);
(b) identification of critical control points(CCPs ) including the material
process rate for continuous systems;
(c) compliance with the specific process requirements laid down by this
Regulation; and
(d) achievement of the following requirements:
(i) particle size for batch-pressure and continuous processes — defined
by the mincer hole or the anvil gap size, and
(ii) temperature, pressure, processing time and material processing rate
(for continuous system only) as specified in paragraphs 2 and 3.
2. In the case of a batch pressure system:
(a) the temperature must be monitored with a permanent thermocouple and it
must be plotted against real time;
(b) the pressure stage must be monitored with a permanent pressure gauge.
Pressure must be plotted against real time;
(c) the processing time must be shown by time/temperature and time/pres-
sure diagrams.
At least once a year the thermocouple and the pressure gauge must be cali-
brated.
3. In the case of a continuous pressure system:
(a) the temperature and the pressure must be monitored with thermocouples,
or an infrared temperature gun, and pressure gauges used at defined posi-
tions throughout the process system in such a way that temperature and
pressure comply with the required conditions inside the whole continuous
system or in a section of it. The temperature and pressure must be plotted
against real time;
(b) measurement of the minimum transit time inside the whole relevant part
of the continuous system where the temperature and pressure comply
with the required conditions, must be provided to the competent authori-
ties, using insoluble markers (for example, manganese dioxide) or a
method which offers equivalent guarantees. Accurate measurement and
control of the material process rate is essential and must be measured
during the validation test in relation to a CCP that can be continuously
monitored such as:
(i) feed screw revolutions per minute (rev./min.),
(ii) electric power (ampsat given voltage),
(iii) evaporation/condensation rate, or
(iv) number of pump strokes per unit time.
All measuring and monitoring equipment must be calibrated at least once a
year.
4. The competent authority must repeat the validation procedures periodically,
when it considers it necessary, and in any case each time any significant
alterationsare made to the proces s(for example, modification of the
machinery or a change of raw materials).2002R1774 — EN — 01.05.2003 — 001.001 — 43
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5. Validation procedures based on testing methods may be laid down under the
procedure referred to in Article 33(2).2002R1774 — EN — 01.05.2003 — 001.001 — 44
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ANNEX VI
SPECIFIC REQUIREMENTSFOR THE PROCESSING OF CATEGORY
1AND2MATERIALANDFORBIOGASANDCOMPOSTINGPLANTS
CHAPTER I
Specific requirements for the processing of Category 1 and Category 2
material
The following requirementsapply in addition to the general requirementslaid
down in Annex V.
A.Premises
1. The layout of Category 1 and Category 2 processing plants must ensure the
total separation of Category 1 material from Category 2 material from recep-
tion of the raw material until dispatch of the resulting processed product.
2. However, the competent authority may authorise the temporary use of a
Category 2 processing plant for the processing of Category 1 material when
a widespread outbreak of an epizootic disease or other extraordinary and
unforeseeable circumstances leads to a lack of capacity at a Category 1
processing plant.
The competent authority must re-approve the Category 2 processing plant in
accordance with Article 13 before it processes Category 2 material again.
B.Processing standards
3. The critical control pointsthat determine the extent of the heat treatments
applied in processing must be identified for each processing method as speci-
fied in Annex V, Chapter III. The critical control pointsmay include:
(a) raw material particle size;
(b) temperature achieved in the heat treatment process;
(c) pressure applied to the raw material; and
(d) duration of the heat treatment process or feed rate to a continuous
system.
Minimum process standards must be specified for each applicable critical
control point.
4. Records must be maintained for at least two years to show that the minimum
process values for each critical control point are applied.
5. Accurately calibrated gauges/recorders must be used to monitor continuously
the processing conditions. Records must be kept to show the date of calibra-
tion of gauges/recorders.
6. Material that may not have received the specified heat treatment (e.g. mate-
rial discharged at start up, or leakage from cookers) must be recirculated
through the heat treatment or collected and reprocessed.
7. Animal by-products must be processed in accordance with the following
processing standards.
(a) Processing method 1 must be applied to:
(i) Category 2 material (other than manure, digestive tract content sepa-
rated from the digestive tract, milk and colostrum), destined for
biogas or composting plants or intended to be used as organic fertili-
sers or soil improvers, and
(ii) Category 1 and Category 2 material destined for landfill.
(b) Any of processing methods 1 to 5 must be applied to:
(i) Category 2 material from which the resulting protein is destined for
incineration or co-incineration,
(ii) Category 2 material from which the rendered fat isdes tined for a
Category 2 oleochemical plant, and
(iii) Category 1 or Category 2 material destined for incineration or co-
incineration.2002R1774 — EN — 01.05.2003 — 001.001 — 45
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C.Processed products
8. Processed products derived from Category 1 or 2 materials, with the excep-
tion of liquid products destined for biogas or composting plants, must be
permanently marked, where technically possible with smell, using a system
approved by the competent authority. Detailed rulesfor s uch marking may
be laid down under the procedure referred to in Article 33(2).
9. Samples of processed products destined for biogas or composting plants or
landfill, taken directly after heat treatment, must be free from heat-resistant
pathogenic bacteria spores ( Clostridium perfringens absent in 1 g of the
products).
CHAPTER II
Specificrequirements fortheapprovalofbiogasandcompostingplants
A.Premises
1. If the biogasplant islocated on premis eswhere farmed animalsare kept, the
plant shall be located at an adequate distance to the area where animals are
kept and there must be in any case total physical separation between that
plant and the animalsand their feed and bedding, with fencing where neces -
sary. The biogas plant must be equipped with:
(a) a pasteurisation/hygienisation unit, which cannot be by-passed, with:
(i) installations for monitoring temperature against time;
(ii) recording devices to record continuously the results of those
measurements; and
(iii) an adequate safety system to prevent insufficient heating; and
(b) adequate facilitiesfor the cleaning and dis infecting vehiclesand
containersupon leaving the biogasplant.
However, a pasteurisation/hygienisation unit is not mandatory for biogas
plantsthat trans form only animal by-productsthat have undergone
processing Method 1.
In addition, a pasteurisation/hygienisation unit is not mandatory for
biogasplantsthat trans form only Category 3 material that hasundergone
pasteurisation/hyginesation elsewhere.
2. If the composting plant is located on premises where farmed animals are
kept, the plant shall be located at an adequate distance to the area where
animals are kept and there must be in any case total physical separation
between that plant and the animalsand their feed and bedding, with fencing
where necessary. The composting plant must be equipped with:
(a) a closed composting reactor, which cannot be by-passed, with:
(i) installations for monitoring temperature against time;
(ii) recording devicesto record, where appropriate continuous ly, the
results of those measurements; and
(iii) an adequate safety system to prevent insufficient heating; and
(b) adequate facilitiesfor cleaning and dis infecting vehiclesand containers
transporting untreated animal by-products.
However, other types of composting systems may be allowed provided
they:
(i) ensure that there is no access by vermin;
(ii) are managed in such a way that all the material in the system
achievesthe required time and temperature parameters , including,
where appropriate, continuousmonitoring of the parameters ;
(iii) comply with all other requirementsof thisRegulation.
3. Each biogas plant and composting plant must have its own laboratory or
make use of an external laboratory. The laboratory must be equipped to carry
out the necessary analyses and approved by the competent authority.2002R1774 — EN — 01.05.2003 — 001.001 — 46
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B.Hygiene requirements
4. Only the following animal by-productsmay be trans formed in a biogasor
composting plant:
(a) Category 2 material, when using processing method 1 in a Category 2
processing plant;
(b) manure and digestive tract content separated from the digestive tract,
milk and colostrum, and
(c) Category 3 material.
5. Animal by-products referred to in paragraph 4 must be transformed as soon
as possible after arrival. They must be stored properly until treated.
6. Containers, receptacles and vehicles used for transporting untreated material
must be cleaned in a designated area. This area must be situated or designed
to prevent risk of contamination of treated products.
7. Preventive measures against birds, rodents, insects or other vermin must be
taken systematically. A documented pest-control programme must be used
for that purpose.
8. Cleaning procedures must be documented and established for all parts of the
premises. Suitable equipment and cleaning agents must be provided for
cleaning.
9. Hygiene control must include regular inspections of the environment and
equipment. Inspection schedules and results must be documented.
10. Installations and equipment must be kept in a good state of repair and
measuring equipment must be calibrated at regular intervals.
11. Digestion residues must be handled and stored at the plant in such a way as
to preclude recontamination.
C.Processing standards
12. Category 3 material used as raw material in a biogas plant equipped with a
pasteurisation/hygienisation unit must be submitted to the following
minimum requirements:
(a) maximum particle size before entering the unit: 12 mm;
(b) minimum temperature in all material in the unit: 70 ºC; and
(c) minimum time in the unit without interruption: 60 minutes.
13. Category 3 material used as raw material in a composting plant must be
submitted to the following minimum requirements:
(a) maximum particle size before entering the composting reactor: 12 mm,
(b) minimum temperature in all material in the reactor: 70 ºC; and
(c) minimum time in the reactor at 70 ºC (all material): 60 minutes.
14. However, pending the adoption of rulesin accordance with Article 6(2)(g),
the competent authority may, when catering waste is the only animal by-
product used as raw material in a biogas or composting plant, authorise the
use of specific requirements other than those laid down in this Chapter
provided that they guarantee an equivalent effect regarding the reduction
of pathogens. Those specific requirements may also apply to catering waste
when it is mixed with manure, digestive tract content separated from the
digestive tract, milk and colostrum provided that the resulting material is
considered as if it were from catering waste.
Where manure, digestive tract content separated from the digestive tract,
milk and colostrum are the only material of animal origin being treated in
a biogas or composting plant, the competent authority may authorise the use
of specific requirements other than those specified in this Chapter provided
that it:
(a) does not consider that those material present a risk of spreading any
serious transmissible disease;
(b) considers that the residues or compost are untreated material.2002R1774 — EN — 01.05.2003 — 001.001 — 47
▼M1
▼B
▼M1
▼B
D.Digestion residues and compost
15. Samples of the digestion residues or compost taken during or on withdrawal
from storage at the biogas or composting plant must comply with the
following standards:
Salmonella : absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae : n = 5, c = 2, m = 10, M = 300 in 1 g
where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered
satisfactory if the number of bacteria in all samples does not exceed
m;
M = maximum value for the number of bacteria; the result is considered
unsatisfactory if the number of bacteria in one or more samples is M
or more; and
c = number of samples the bacterial count of which may be between m
and M, the sample still being considered acceptable if the bacterial
count of the other samples is m or less.
CHAPTER III
Treatmentstandardsforthefurtherprocessingofrenderedfats
The following processes may be used to produce fat derivatives from rendered
fatsderived from Category 2 material:
1. transesterification or hydrolysis at least 200 ºC, under corresponding appro-
priate pressure, for 20 minutes (glycerol, fatty acids and esters); or
2. saponification with NaOH 12M (glycerol and soap):
(a) in a batch process at 95 ºC for three hours; or
(b) in a continuous process at 140 ºC 2 bars (2 000 hPa) for eight minutes, or
under equivalent conditionslaid down in accordance with the procedure
referred to in Article 33(2).2002R1774 — EN — 01.05.2003 — 001.001 — 48
▼B
ANNEX VII
SPECIFIC HYGIENE REQUIREMENTS FOR THE PROCESSING AND
PLACING ON THE MARKET OF PROCESSED ANIMAL PROTEIN
AND OTHER PROCESSED PRODUCTS THAT COULD BE USED AS
FEEDMATERIAL
CHAPTER I
SpecificrequirementsfortheapprovalofCategory3processingplants
The following requirementsapply in addition to the general requirementslaid
down in Annex V.
A.Premises
1. Premises for the processing of Category 3 material must not be at the same
site as premises processing Category 1 or Category 2 material, unless in a
completely separate building.
2. However, the competent authority may authorise the temporary use of a
Category 3 processing plant for the processing of Category 1 or Category 2
material when a widespread outbreak of an epizootic disease or other extra-
ordinary and unforeseeable circumstances lead to a lack of capacity at a
Category 1 or Category 2 processing plant.
The competent authority must re-approve the Category 3 processing plant in
accordance with Article 17 before it processes Category 3 material again.
3. Category 3 processing plants must have:
(a) an installation to check the presence of extraneous matter, such as packa-
ging material, metallic pieces, etc. in the animal by-products; and
(b) if the volume of productstreated requiresregular or permanent pres ence
of the competent authority, an adequately equipped lockable room for the
exclusive use of the inspection service.
B.Raw material
4. Only Category 3 material listed in points (a) to (j) of Article 6(1) that has
been handled, stored and transported in accordance with Articles 7, 8 and 9
may be used for the production of processed animal proteins and other feed
material.
5. Before processing, animal by-products must be checked for the presence of
extraneous matter. When present, it must be removed immediately.
C.Processing standards
6. The critical control pointsthat determine the extent of the heat treatments
applied in processing must be identified for each processing method as speci-
fied in Annex V, Chapter III. The critical control points must at least include:
— raw material particle size,
— temperature achieved in the heat treatment process,— pressure applied to the raw material, if applicable, and
— duration of the heat treatment process or feed rate to a continuous system.
Minimum process standards must be specified for each applicable critical
control point.
7. Records must be maintained for at least two years to show that the minimum
process values for each critical control point are applied.
8. Accurately calibrated gauges/recorders must be used to monitor continuously
the processing conditions. Records must be kept for at least two years to
show the date of calibration of gauges/recorders.
9. Material that may not have received the specified heat treatment (for
example, material discharged at start up, or leakage from cookers) must be
recirculated through the heat treatment or collected and reprocessed.2002R1774 — EN — 01.05.2003 — 001.001 — 49
▼M1
▼B
▼B
D.Processed products
10. Samplesof the final productstaken during or on withdrawal from s torage at
the processing plant must comply with the following standards:
Salmonella : absence in 25 g: n = 5, c = 0, m = 0, M = 0
Enterobacteriaceae : n = 5, c = 2, m = 10, M = 300 in 1 g
where:
n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered
satisfactory if the number of bacteria in all samples does not exceed
m;
M = maximum value for the number of bacteria; the result is considered
unsatisfactory if the number of bacteria in one or more samples is M
or more; and
c = number of samples the bacterial count of which may be between m
and M, the sample still being considered acceptable if the bacterial
count of the other samples is m or less.
11. Unused or surplus processed products may after they have been perma-
nently marked:
(a) be disposed of as waste by incineration or co-incineration in an incin-
eration or co-incineration plant approved in accordance with Article 12;
(b) be disposed of in a landfill approved under Directive 1999/31/EC; or
(c) be transformed in a biogas plant or in a composting plant approved in
accordance with Article 15.
CHAPTER II
Specific requirementsforprocessedanimalprotein
The following conditionsapply in addition to the general conditionslaid down
in Chapter I.
A.Processing standards
1. Mammalian processed animal protein must have been submitted to proces-
sing Method 1.
However, while the feed ban provided for in Council Decision 2000/766/EC
remains in force, mammalian processed animal protein may have been
submitted to any of the processing Methods 1 to 5 or Method 7, and shall
be permanently marked with a stain or otherwise immediately after that
processing, before its disposal as waste in accordance with applicable
Community legislation.
In addition, while the feed ban provided for in Council Decision 2000/766/
EC remains in force, processed animal protein of mammalian origin exclu-
sively destined for use in petfood, which is transported in dedicated
containers that are not used for the transport of animal by-products or
feedingstuffs for farmed animals, and which is consigned directly from Cate-
gory 3 processing plant to the petfood plants, may have been submitted to
any of the processing Methods 1 to 5 or 7.
2. Non-mammalian processed animal protein, with the exclusion of fishmeal,
must have been submitted to any of processing methods 1 to 5 or 7.
3. Fishmeal must have been submitted:
(a) to any of the processing methods; or
(b) to a method and parameterswhich ens ure that the product complieswith
the microbiological standards set in Chapter I, paragraph 10.
B.Storage
4. Processed animal protein must be packed and stored in new or sterilised bags
or stored in properly constructed bulk bins.
5. Sufficient measures must be taken to minimise condensation inside bins,
conveyorsor elevators .2002R1774 — EN — 01.05.2003 — 001.001 — 50
▼M1
▼B
▼M1
▼B
▼B
6. Products in conveyors, elevators and bins must be protected from casual
contamination.
7. Processed animal protein handling equipment must be maintained in a clean
and dry condition and should have adequate inspection points so that equip-
ment can be examined for cleanliness. All storage facilities must be emptied
and cleaned regularly, asproduction requirementsrequire.
8. Processed animal protein must be kept dry. Leakages and condensation in the
storage area must be prevented.
C.Importation
9. Member States must authorise the importation of processed animal protein:
(a) if it comesfrom third countriesthat appear on the lis t in Part II of
Annex XI or, in the case of fishmeal, that appear on the list in Part III
of Annex XI;
(b) if it comes from a processing plant that appears on the list referred to in
Article 29(4);
(c) if it hasbeen produced in accordance with thisRegulation; and
(d) if it isaccompanied by a health certificate asprovided for in Article
29(6).
10. Before consignments are released for free circulation within the Commu-
nity, the competent authority must sample imports of processed animal
protein at the border inspection post to ensure compliance with the require-
mentsof Chapter I, paragraph 10. The competent authority mus t:
(a) sample each consignment of products carried in bulk; and
(b) carry out random sampling of consignments of products packaged in the
manufacturing plant of origin.
11. However, when six consecutive tests on bulk consignments originating in a
given third country prove negative, the competent authority may carry out
random sampling of subsequent bulk consignments from that third country.
If one of these random samples proves positive, the competent authority
carrying out the sampling must inform the competent authority of the
country of origin so that it can take appropriate measures to remedy the
situation. The competent authority of the country of origin must bring these
measures to the attention of the competent authority carrying out the
sampling. In the event of a further positive result from the same source,
the competent authority must sample each consignment from the same
source until six consecutive tests again prove negative.
12. Competent authorities must keep a record for at least two years of the
results of sampling carried out on all consignments that have undergone
sampling.
13. Where a consignment proves to be positive for salmonella , it must either:
(a) be dealt with in accordance with the procedure laid down by Article
17(2)(a) of Directive 97/78/EC (1); or
(b) reprocessed in a processing plant approved pursuant to this Regulation
or decontaminated by a treatment authorised by the competent
authority. A list of permitted treatments may be established in accor-
dance with the procedure referred to in Article 33(2). The consignment
must not be released until it has been treated, tested for salmonella by
the competent authority in accordance with Chapter I, paragraph 10, and
a negative result obtained.
CHAPTER III
Specificrequirements forbloodproducts
The following conditionsapply in addition to the general conditionslaid down
in Chapter I.
A.Raw material
1. Only blood coming under paragraph 1(a) and (b) of Article 6 may be used
for the production of blood products.2002R1774 — EN — 01.05.2003 — 001.001 — 51
(1) Council Directive 97/78/EC of 18 December 1997 laying down the principles
governing the organisation of veterinary checks on products entering the Community
from third countries(OJ L 24, 30.1.1998, p. 9).
▼B
B.Processing standards
2. Blood products must have been submitted:
(a) to any of processing methods 1 to 5 or 7; or
(b) to a method and parameterswhich ens ure that the product complieswith
the microbiological standards set in Chapter I, paragraph 10.
C.Importation
3. Member States must authorise the importation of blood products if they:
(a) come from third countriesthat appear on the lis t in Part V of Annex XI;
(b) come from a processing plant that appears on the list referred to in
Article 29(4);
(c) have been produced in accordance with thisRegulation; and
(d) are accompanied by a health certificate asprovided for in Article 29(6).
CHAPTER IV
Specific requirementsforrenderedfatsandfishoil
The following conditionsapply in addition to the general conditionslaid down
in Chapter I.
A.Processing standards
1. Unless the rendered fats have been produced in accordance with Chapter II
of Annex C to Council Directive 77/99/EEC (1), or Chapter 9 of Annex I to
Council Directive 92/118/EEC (2), rendered fats must be produced using
Methods 1 to 5 or Method 7, and fish oils may be produced using Method
6, asreferred to in Annex V, Chapter III.
Rendered fats derived from ruminant animals must be purified in such a way
that the maximum levelsof remaining total ins oluble impuritiesdoesnot
exceed 0,15 % in weight.
B.Importation of rendered fats
2. Member States must authorise the importation of rendered fats if they:
(a) come from third countriesappearing on the lis t in Part IV of Annex XI;
(b) come from a processing plant that appears on the list referred to in
Article 29(4);
(c) have been produced in accordance with thisRegulation;
(d) either:
(i) are entirely or partly derived from swine raw material and come
from a country or a part of the territory of a country free from
foot-and-mouth disease for the previous 24 months and free from
classical swine fever and African swine fever for the previous 12
months,
(ii) are entirely or partly derived from poultry raw material and come
from a country or a part of the territory of a country free from
Newcastle disease and avian influenza for the previous six months,
(iii) are entirely or partly derived from ruminant raw material and come
from a country or a part of the territory of a country free from foot-
and-mouth disease for the previous 24 months and free from Rinder-
pest for the previous 12 months, or
(iv) where there hasbeen an outbreak of one of the abovementioned
diseases during the relevant period mentioned above, have been
subjected to one of the following heat treatment processes:
— at least 70 ºC for at least 30 minutes, or
— at least 90 ºC for at least 15 minutes,
and detailsof the critical control pointsare recorded and maintained
so that the owner, operator or their representative and, as necessary,
the competent authority can monitor the operation of the plant. The
information must include the particle size, critical temperature and,2002R1774 — EN — 01.05.2003 — 001.001 — 52
(1) OJ L 26, 31.1.1977, p. 85.
(2) OJ L 62, 15.3.1993, p. 49.▼M1
▼B
▼B
as appropriate, the absolute time, pressure profile, raw material feed-
rate and fat recycling rate; and
(e) are accompanied by a health certificate asprovided for in Article 29(6).
C.Importation of fishoil
3. Member States must authorise the importation of fish oil if it:
(a) comesfrom third countriesappearing on the lis t in Part III of Annex XI;
(b) comes from a processing plant that appears on the list referred to in
Article 29(4);
(c) hasbeen produced in accordance with thisRegulation; and
(d) isaccompanied by a health certificate asprovided for in Article 29(6).
D.Hygiene requirements
4. Where rendered fat or fish oil is packaged, it must be packaged in new
containersor in containersthat have been cleaned, and all precautionsmus t
be taken to prevent itsrecontamination. Where bulk trans port of the products
isintended, the pipe, pumpsand bulk tanksand any other bulk container or
bulk road tanker used in the transportation of the products from the manufac-
turing plant either directly on to the ship or into shore tanks or direct to
plants must have been inspected and found to be clean before use.
CHAPTER V
Specificrequirementsformilk,milk-basedproductsandcolostrum
The following conditionsapply in addition to the general conditionslaid down
in Chapter I.
A.Processing standards
1. Raw milk and colostrum must be produced under conditions offering
adequate guaranteesasregardsanimal health. Such conditionsmay be es tab-
lished in accordance with the procedure referred to in Article 33(2).
2. Milk or treated or processed milk products must be subjected to a heat treat-
ment of at least 2 ºC for at least 15 seconds or any combination of
temperature and time having at least an equivalent heat effect and producing
a negative reaction to the phosphatase test, followed by:
(a) in the case of dried milk or dried milk products, a drying process; or
(b) in the case of an acidified milk product, a process by which the pH is
reduced and kept for at least one hour at a level below 6.
3. In addition to the requirementslaid down in paragraph 2, dried milk or dried-
milk products must meet the following requirements:
(a) after completion of the drying process, every precaution must be taken to
prevent contamination of the products; and
(b) the final product must be:
(i) packed in new containers, or
(ii) in the case of bulk transport, transported in vehicles or containers
that have been disinfected using a product approved by the compe-
tent authority before loading with the milk, milk-based product or
colostrum.
B.Importation
4. Member States must authorise imports of milk and milk-based products if:
(a) they come from third countriesappearing on the lis t in Part I of Annex
XI;
(b) in the case of milk and milk-based products from third countries or parts
of third countries listed in column B of the Annex to Decision 95/340/
EC (1), they have undergone a pasteurisation treatment sufficient to2002R1774 — EN — 01.05.2003 — 001.001 — 53
(1) Commission Decision 95/340/EC of 27 July 1995 drawing up a provisional list of third
countries from which Member States authorise imports of milk and milk-basedproducts and revoking Decision 94/70/EC (OJ L 200, 24.8.1995, p. 38). Decision as
last amended by Decision 96/584/EC (OJ L 255, 9.10.1996, p. 20).
▼B
produce a negative phosphatase test and a health certificate conforming
to the model laid down in Chapter 2(A) of Annex X accompaniesthem;
(c) in the case of milk-based products with a pH reduced to less than 6 from
third countriesor partsof third countrieslis ted in column C of the Annex
to Decision 95/340/EC, they have first undergone a pasteurisation treat-
ment sufficient to produce a negative phosphatase test and a health
certificate conforming to the model laid down in Chapter 2(B) of Annex
X accompaniesthem;
(d) in the case of milk and milk-based products from third countries or parts
of third countries listed in column C of the Annex to Decision 95/340/
EC, they have first undergone a sterilisation process or a double heat
treatment where each treatment wass ufficient to produce a negative
phosphatase test on its own and a health certificate conforming to the
model laid down in Chapter 2(C) of Annex X accompaniesthem; and
(e) they come from a processing plant which appears on the list referred to
in Article 29(4).
5. Milk and milk-based products from third countries or parts of third countries
listed in column C of the Annex to Decision 95/340/EC where there has been
an outbreak of foot-and-mouth disease in the last 12 months or where vacci-
nation against foot-and-mouth disease has been carried out in the last 12
monthsmus t, before introduction on to Community territory, have undergone
either:
(a) a sterilisation process whereby an Fc value equal to or greater than 3 is
achieved; or
(b) an initial heat treatment with a heating effect at least equal to that
achieved by a pasteurisation process of at least 72 ºC for at least 15
seconds and sufficient to produce a negative reaction to a phosphatase
test, followed by:
(i) a second heat treatment with a heating effect at least equal to that
achieved by the initial heat treatment, and which would be sufficient
to produce a negative reaction to a phosphatase test, followed, in the
case of dried milk, or dried milk-based products, by a drying
process, or
(ii) an acidification process such that the pH has been maintained at less
than 6 for at least one hour.
6. Where a risk of introduction of an exotic disease or any other risk to animal
health isidentified, additional conditionsfor the protection of animal health
may be established in accordance with the procedure referred to in Article
33(2).
CHAPTER VI
Specificrequirements forgelatinandhydrolysedprotein
The following conditionsapply in addition to the general conditionslaid down
in Chapter I.
A.Processing standards for gelatin
1. (a) Gelatin must be produced by a process that ensures that unprocessed
Category 3 material iss ubjected to a treatment with acid or alkali,
followed by one or more rinses. The pH must be adjusted subsequently.
Gelatin must be extracted by heating one or several times in succession,
followed by purification by means of filtration and sterilisation.
(b) After having been subjected to the processes referred to in subparagraph
(a), gelatin may undergo a drying process and, where appropriate, a
process of pulverisation or lamination.
(c) The use of preservatives, other than sulphur dioxide and hydrogen
peroxide, isprohibited.
2. Gelatin must be wrapped, packaged, stored and transported under satisfactory
hygiene conditions. In particular:
(a) a room must be provided for storing materials for wrapping and packa-
ging;
(b) wrapping and packaging must take place in a room or in a place intended
for that purpose;
and
(c) wrappingsand packagescontaining gelatin mus t carry the words‘gelatin
suitable for animal consumption’.2002R1774 — EN — 01.05.2003 — 001.001 — 54
▼B
B.Processing standards for hydrolysed protein
3. Hydrolysed protein must be produced using a production process involving
appropriate measures to minimise contamination of raw Category 3 material.
Hydrolysed protein shall have a molecular weight below 10 000 Dalton.
In addition, hydrolysed proteins entirely or partly derived from ruminants
hides and skins shall be produced in a processing plant dedicated only to
hydrolysed protein production, using a process involving the preparation of
raw Category 3 material by brining, liming and intensive washing followed
by:
(a) exposure of the material to a pH of more than 11 for more than three
hours at a temperature of more than 80 ºC and subsequently by heat
treatment at more than 140 ºC for 30 minutesat more than 3,6 bar;
(b) exposure of the material to a pH of 1 to 2, followed by a pH of more
than 11, followed by heat treatment at 140 ºC for 30 minutesat 3 bar; or
(c) an equivalent production process approved in accordance with the proce-
dure referred to in Article 33(2).
C.Importation
4. Member States must authorise the importation of gelatine and hydrolysed
proteinsif they:
(a) come from third countriesthat appear on the lis t in Part XI of Annex XI;
(b) come from a processing plant that appears on the list referred to in
Article 29(4);
(c) have been produced in accordance with thisRegulation; and
(d) are accompanied by a health certificate asprovided for in Article 29(6).
CHAPTER VII
Specificrequirementsfordicalciumphosphate
The following conditionsapply in addition to the general conditionslaid down
in Chapter I.
A.Processing standards
1. Dicalcium phosphate must be produced by a process that:
(a) ensures that all Category 3 bone-material is finely crushed and degreased
with hot water and treated with dilute hydrochloric acid (at a minimum
concentration of 4 % and a pH of less than 1,5) over a period of at least
two days;
(b) following the procedure at (a), appliesa treatment of the obtained phos -
phoric liquor with lime, resulting in a precipitate of dicalcium phosphate
at pH 4 to 7; and
(c) finally, air driesthe precipitate of dicalcium phos phate with inlet
temperature of 65 ºC to 325 ºC and end temperature between 30 ºC and
65 ºC, or
by an equivalent process approved in accordance with the procedure referred
to in Article 33(2).
2. Where dicalcium phosphate is derived from defatted bones it shall be derived
from bones fit for human consumption following ante and post-mortem
inspection.
B.Importation
3. Member States must authorise the importation of dicalcium phosphate if it:
(a) comesfrom third countriesthat appear on the lis t in Part XI of Annex
XI;
(b) comes from a processing plant that appears on the list referred to in
Article 29(4);
(c) hasbeen produced in accordance with thisRegulation; and
(d) isaccompanied by a health certificate asprovided for in Article 29(6).2002R1774 — EN — 01.05.2003 — 001.001 — 55
▼M1
▼B
▼M1
▼M1
CHAPTER VIII
Specificrequirementsfortricalcium phosphate
The following conditionsapply in addition to the general conditionslaid down
in Chapter I.
A.Processing standards
1. Tricalcium phosphate must be produced by a process hat ensures:
(a) that all Category 3 bone-material is finely crushed and degreased in
counter-flow with hot water (bone chipsles sthan 14 mm);
(b) grinding of the chipsbelow 1 mm before cooking and continuous
cooking with steam at 145 ºC during 30 minutes at 4 bars;
(c) separation of the protein broth from the hydroxyapatite (tricalcium phos-
phate) by centrifugation; and
(d) granulation of the tricalcium phosphate after drying in a fluid bed with
air at 200 ºC; or
by an equivalent production process approved in accordance with the proce-
dure referred to in Article 33(2).
B.Importation
2. Member States must authorise the importation of tricalcium phosphate if it:
(a) comesfrom third countriesthat appear on the lis t in Part XI of Annex
XI;
(b) comes from a processing plant that appears on the list referred to in
Article 29(4);
(c) hasbeen produced in accordance with thisRegulation; and
(d) isaccompanied by a health certificate asprovided for in Article 29(6).2002R1774 — EN — 01.05.2003 — 001.001 — 56
▼B
ANNEX VIII
REQUIREMENTS FOR THE PLACING ON THE MARKET OF
PETFOOD,DOGCHEWSANDTECHNICALPRODUCTS
CHAPTER I
Requirementsfortheapprovalofpetfoodandtechnical plants
Plantsproducing petfood, dogchewsand technical products , other than organic
fertilizers, soil improvers and fat derivatives derived from Category 2 material,
must fulfil the following requirements:
1. they must have adequate facilities for storing and treating incoming material
in complete safety; and
2. they must have adequate facilities for disposing of unused animal by-
productsremaining after the production of the productsin accordance with
this Regulation, or this material must be sent to a processing plant or to an
incineration or co-incineration plant in accordance with thisRegulation.
CHAPTER II
Requirementsforpetfoodanddogchews
A.Raw material
1. The only animal by-productsthat may be us ed to produce petfood and
dogchewsare thos e referred to in Article 6(1)(a) to (j). However, raw petfood
may be manufactured only from animal by-productsreferred to in Article
6(1)(a).
B.Processing standards
2. Canned petfood must be subjected to heat treatment to a minimum Fc value
of 3.
3. Processed petfood other than canned petfood must be subjected to a heat
treatment of at least 90 ºC throughout its substance. After treatment, every
precaution must be taken to ensure that the product is not exposed to contam-
ination. The product must be packed in new packaging.
4. Dogchews must be subjected to a heat treatment during processing sufficient
to destroy pathogenic organisms (including salmonella ). After treatment,
every precaution must be taken to ensure that the product is not exposed to
contamination. The product must be packed in new packaging.
5. Raw petfood must be packed in new packaging preventing any leakage.
Effective steps must be taken to ensure that the product is not exposed to
contamination throughout the production chain and up to the point of sale.
The wording ‘petfood only’ must be visibly and legibly displayed on the
packaging.
6. Random samples must be taken during production and/or during storage
(before dispatch) to verify compliance with the following standards:
Salmonella : absence in 25 g, n = 5, c = 0, m = 0, M = 0.
Enterobacteriaceae : n = 5, c = 2, m = 10, M = 300 in 1 g
Where:n = number of samples to be tested;
m = threshold value for the number of bacteria; the result is considered
satisfactory if the number of bacteria in all samples does not exceed
m;
M = maximum value for the number of bacteria; the result is considered
unsatisfactory if the number of bacteria in one or more samples is M
or more; and
c = number of samples the bacterial count of which may be between m
and M, the sample still being considered acceptable if the bacterial
count of the other samples is m or less.2002R1774 — EN — 01.05.2003 — 001.001 — 57
▼M1
▼M1
However, for canned petfood that hasundergone the heat treatment
referred to in paragraph 2, sampling and testing for Salmonella and
Enterobacteriaceae may not be necessary.
C.Importation
7. Member States must authorise importation of petfood and dogchews if they:
(a) come from third countriesthat appear on the lis t in Part X of Annex XI;
(b) come from petfood plantsapproved by the competent authority of the
third country meeting the specific conditions laid down in this Regula-
tion;
(c) have been produced in accordance with thisRegulation;
(d) are accompanied:
(i) in the case of canned petfood, by a certificate that conforms to the
model laid down in Chapter 3(A) of Annex X,
(ii) in the case of processed petfood other than canned petfood, by a
certificate that conformsto the model laid down in Chapter 3(B) of
Annex X,
(iii) in the case of dogchews, by a certificate that conforms to the model
laid down in Chapter 3(C) of Annex X, or
(iv) in the case of raw petfood, by a certificate that conforms to the
model laid down in Chapter 3(D) of Annex X.
CHAPTER III
Requirements for manure, processed manure and processed manure
products
I.Unprocessed manure
A. Trade
1. (a) Trade in unprocessed manure of species other than poultry or equidae is
prohibited, except for manure:
(i) from an area which is not subject to restrictions by virtue of a
serious transmissible disease, and
(ii) intended for application, under the supervision of the competent
authorities, to land forming part of a single holding located on both
sides of the border of two Member States.
(b) However, the competent authority may grant specific approval for the
introduction on to itsterritory of:
(i) manure intended for processing in a technical plant or a biogas plant
or in a composting plant approved by the competent authority in
accordance with thisRegulation with a view to the manufacture of
the productsreferred to under Section II below. The competent
authority must take account of the origin of the manure when
approving such plants; or
(ii) manure intended for applying to land on a holding. Such trade can
only occur with the consent of the competent authorities of both the
Member States of origin and destination. When considering giving
consent, the competent authorities must have particular regard to
the origin of the manure, its destination and animal health and safety
considerations.
A health certificate conforming to a model laid down under the proce-
dure referred to in Article 33(2) must accompany the manure in such
cases.
2. Trade in unprocessed poultry manure is subject to the following conditions:
(a) the manure must originate in an area which is not subject to restrictions
by virtue of Newcastle disease or avian influenza;
(b) in addition, unprocessed manure from poultry flocks vaccinated against
Newcastle disease must not be dispatched to a region which has obtained2002R1774 — EN — 01.05.2003 — 001.001 — 58
▼B
▼B
Newcastle disease non-vaccinating status pursuant to Article 15(2) of
Directive 90/539/EEC (1); and
(c) a health certificate conforming to a model laid down under the procedure
referred to in Article 33(2) must accompany the manure.
3. Trade in unprocessed manure of equidae is not subject to any animal health
conditions.
B. Importation
4. Member States must authorise the importation of unprocessed manure if it:
(a) comesfrom third countriesthat appear on the lis t in Part IX of Annex
XI;
(b) satisfies, according to the species concerned, the requirements of para-
graph 1(a);
(c) isaccompanied by a health certificate asprovided for in Article 29(6).
II.Processed manure and processed manure products
A. Placing on the market
5. The placing on the market of processed manure and processed manure
products is subject to the following conditions:
(a) they must come from a technical plant, a biogas plant or a composting
plant approved by the competent authority in accordance with thisRegu-
lation;
(b) they must have been subjected to a heat treatment process of at least
70 ºC for at least 60 minutes or to an equivalent treatment in accordance
with ruleslaid down under the procedure referred to in Article 33(2);
(c) they must:
(i) be free from salmonella (nosalmonella in 25 g treated product),
(ii) be free from enterobacteriaceae (based on the aerobic bacteria
count: < 1 000 cfu per gram of treated products), and
(iii) have been subjected to reduction in spore-forming bacteria and toxic
formation; and
(d) they must be stored in such a way that, once processed, contamination or
secondary infection and dampness is impossible. They must therefore be
stored in:
(i) well-sealed and insulated silos, or
(ii) properly sealed packs (plastic bags or ‘big bags’).
B. Importation
6. Member States must authorise importation of processed manure and
processed manure products if they:
(a) come from third countriesthat appear on the lis t in Part IX of Annex XI;
(b) come from a plant approved by the competent authority of the third
country meeting the specific conditions laid down in this Regulation;
(c) satisfy the requirements of paragraph 5 above; and
(d) are accompanied by a health certificate asprovided for in Article 29(6).
III.Guano
7. The placing on the market of ‘guano’ isnot s ubject to any animal health
conditions.2002R1774 — EN — 01.05.2003 — 001.001 — 59
(1) Council Directive 90/539/EEC of 15 October 1990 on animal health conditions
governing intra-Community trade in, and importsfrom third countriesof poultry andhatching eggs (OJ L 303, 31.10.1990, p. 6). Directive as last amended by Commission
Decision 2000/505/EC (OJ L 201, 9.8.2000, p. 8).
▼B
CHAPTER IV
Requirements for blood and blood products used for technical purposes,
including pharmaceuticals, in vitrodiagnosis and laboratory agents, but
excludingserumofequidae
A.Placing on the market
1. The placing on the market of blood productscovered by thisChapter is
subject to the requirements laid down in Article 20.
B.Importation
2. Importsof blood are s ubject to the requirementslaid down in Chapter XI.
3. Member States must authorise importation of blood products if they:
(a) come from third countriesthat appear on the lis t in Part VI of Annex XI;
(b) come from a plant approved by the competent authority of the third
country meeting the specific conditions laid down in this Regulation; and
(c) are accompanied by a health certificate asprovided for in Article 29(6);
and either
(d) originate in a third country in which no case of foot-and-mouth disease
has been recorded within at least 24 months and no case of vesicular
stomatitis, swine vesicular disease, rinderpest, peste des petits ruminants ,
Rift Valley Fever, blue tongue, African horse sickness, classical swine
fever, African swine fever, Newcastle disease or avian influenza has
been recorded for 12 months in the susceptible species and in which
vaccination has not been carried out against those diseases for at least
12 months. The health certificate may be made out according to the
species of animal from which the blood products are derived; or
(e) in the case of blood products derived from bovine animals:
(i) originate in an area of a third country fulfilling the requirementsof
subparagraph (d) from which imports of bovine animals, their fresh
meat or their sperm are authorised pursuant to Community legisla-
tion. The blood from which such products are manufactured must
be from bovine animalsfrom that area of the third country and
must have been collected:
— in slaughterhouses approved in accordance with Community
legislation,
or
— in slaughterhouses approved and supervised by the competent
authority of the third country. The Commission and Member
States must be notified of the address and approval number of
such slaughterhouse or the certificate must indicated them; or
(ii) have undergone one of the following treatmentsguaranteeing the
absence of pathogens of the bovine diseases referred to in subpara-
graph (d):
— heat treatment at a temperature of 65 ºC for at least three hours,
followed by an effectiveness check,
— irradiation at 2,5 megaradsor by gamma rays , followed by an
effectiveness check,
— change in pH to pH 5 for two hours, followed by an effective-
ness check,
— heat treatment of at least 90 ºC throughout their substance,
followed by an effectiveness check, or
— any other treatment provided for in accordance with the proce-
dure referred to in Article 33(2); or
(iii) fulfil the requirementslaid down in Chapter X. In thiscas e, the
packaging may not be opened during storage and the technical plant
must carry out one of the treatments listed in point (ii).
4. The specific conditions relating to imports of products for use in in vitro
diagnosis and laboratory reagents may be laid down, where necessary, under
the procedure referred to in Article 33(2).2002R1774 — EN — 01.05.2003 — 001.001 — 60
▼M1
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▼B
CHAPTER V
Requirementsforserumofequidae
A.Raw material
1. Serum must:
(a) come from equidae which show no signs of the serious transmissible
diseases referred to in Directive 90/426/EEC (1) or of any other serious
transmissible disease to which equidae are susceptible; and
(b) have been obtained in bodies or centres not subject to health restrictions
pursuant to that Directive.
B.Importation
2. Member States must authorise the import of serum of equidae if:
(a) it comesfrom equidae born and rais ed in a third country from which the
importation of horses for slaughter is authorised;
(b) it was obtained, processed and dispatched in conformity with the
following conditions:
(i) it comes from a country where the following diseases are compulso-
rily notifiable: African horse sickness, dourine, glanders, equine
encephalomyelitis(all typesincluding VEE), equine infectious
anaemia, vesicular stomatitis, rabies, anthrax;
(ii) it was obtained, under the supervision of a veterinarian, from
equidae which, at the time of collection, were free from clinical
signs of infectious disease;
(iii) it wasobtained from equidae that have remained s ince birth in the
territory or, in case of official regionalisation according to Commu-
nity legislation, in parts of the territory of a third country in which:
— Venezuelan equine encephalomyelitishad not occurred during
the last two years,
— dourine had not occurred during the last six months, and— glanders had not occurred during the last six months;
(iv) it wasobtained from equidae that had never been pres ent on a
holding that had been subject to prohibition for animal health
reasons or where:
— in the case of equine encephalomyelitis, the date on which all
the equidae suffering from the disease were slaughtered was at
least six months before the date of collection,
— in the case of infectious anaemia, all the infected animals had
been slaughtered and the remaining animals showed a negative
reaction to two Cogginstes tscarried out three monthsapart,
— in the case of vesicular stomatitis, the prohibition was lifted at
least six months before the date of collection,
— in the case of rabies, the last recorded case was at least a month
before the date of collection,
— in the case of anthrax, the last recorded case was at least 15 days
before the date of collection, or
— all the animals of species susceptible to the disease located on
the holding were slaughtered and the premises disinfected, at
least 30 days before the date of collection (or, in the case ofanthrax, at least 15 days before);
(v) it hasundergone all precautionsto avoid contamination with patho-
genic agentsduring production, handling and packaging;
(vi) it waspacked in s ealed impermeable containersclearly labelled
‘serum from equidae’ and bearing the registration number of the
establishment of collection;
(c) it comesfrom a plant approved by the competent authority of the third
country meeting the specific conditions laid down in this Regulation; and
(d) a certificate conforming to the model laid down in Chapter 4 of Annex X
accompaniesit.2002R1774 — EN — 01.05.2003 — 001.001 — 61
(1) Council Directive 90/426/EEC of 26 June 1990 on animal health conditionsgoverning
the movement and import from third countriesof equidae (OJ L 224, 18.8.1990, p. 42).Directive as last amended by Commission Decision 2001/298/EC (OJ L 102, 12.4.2001,
p. 63).
▼B
CHAPTER VI
Requirementsforhidesandskinsofungulates
A.Scope
1. The provisions of this Chapter do not apply:
(a) to hidesand s kinsof ungulatesfulfilling the requirementsof Council
Directive 64/433/EEC of 26 June 1964 on health problemsaffecting
intra-Community trade in fresh meat (1);
(b) to hides and skins of ungulates having undergone the complete process of
tanning;
(c) to ‘wet blue’;
(d) to ‘pickled pelts’; and
(e) to limed hides(treated with lime and in brine at a pH of 12 to 13 for at
least eight hours).
2. Within the scope defined in paragraph 1, the provisions of this Chapter apply
to fresh, chilled and treated hides and skins. For the purpose of this Chapter,
‘treated hides and skins’ means hides and skins that have been:
(a) dried;
(b) dry-salted or wet-salted for at least 14 days prior to dispatch;
(c) salted for seven days in sea salt with the addition of 2 % of sodium
carbonate;
(d) dried for 42 daysat a temperature of at leas t 20 ºC; or
(e) preserved by a process other than tanning specified in accordance with
the procedure referred to in Article 33(2).
B.Trade
3. Trade in fresh or chilled hides and skins is subject to the same health condi-
tions as those applicable to fresh meat pursuant to Council Directive 72/461/
EEC of 12 December 1972 on health problemsaffecting intra-Community
trade in fresh meat (2).
4. Trade in treated hides and skins is authorised on condition that the commer-
cial document provided for in Annex II accompanieseach cons ignment and
attests that:
(a) the hidesand s kinshave been treated in accordance with paragraph 2;
and
(b) the consignment has not been in contact with other animal products or
live animals presenting a risk of spreading a serious transmissible
disease.
C.Importation
5. Member States must authorise the import of fresh or chilled hides and skins
if:
(a) they have been obtained from animalsreferred to in Article 6(1)(b) or
(c);
(b) they originate from a third country or, in the case of regionalisation in
accordance with Community legislation, from a part of a third country
from which imports of all categories of fresh meat of the corresponding
species are authorised and which:
(i) for at least 12 months before dispatch, has been free from the
following diseases:
— classical swine fever,
— African swine fever, and
— rinderpest, and
(ii) has been free for at least 24 months before dispatch from foot-and-
mouth disease and where, for 12 months before dispatch, no vaccina-
tion has been carried out against foot-and-mouth disease;2002R1774 — EN — 01.05.2003 — 001.001 — 62
(1) OJ 121, 29.7.1964, p. 2012. Directive aslas t amended by Directive 95/23/EC (OJ L
243, 11.10.1995, p. 7).
(2) OJ L 302, 31.12.1972, p. 24. Directive last amended by the 1994 Act of Accession.
▼B
(c) they have been obtained from:
(i) animalsthat have remained in the territory of the country of origin
for at least three months before being slaughtered or since birth in
the case of animals less that three months old,
(ii) in the case of hides and skins from bi-ungulates, animals that come
from holdingsin which there hasbeen no outbreak of foot-and-
mouth disease in the previous 30 days, and around which within a
radius of 10 km there has been no case of foot-and-mouth disease
for 30 days,
(iii) in the case of hides and skins from swine, animals that come from
holdings in which there has been no outbreak of swine vesicular
disease in the previous 30 days, or of classical or African swine
fever in the previous40 days , and around which within a radiusof
10 km there has been no case of these diseases for 30 days, or
(iv) animals that have passed the ante-mortem health inspection at the
slaughterhouse during the 24 hours before slaughter and have shown
no evidence of foot-and-mouth disease, rinderpest, classical swine
fever, African swine fever or swine vesicular disease;
(d) they have undergone all precautionsto avoid recontamination with patho-
genic agents; and
(e) a certificate conforming to the model laid down in Chapter 5(A) of
Annex X accompaniesthem.
6. Member States must authorise the import of treated hides and skins if:
(a) they have been obtained from animalsreferred to in Article 6(1)(b), (c)
or (k);
(b) a certificate conforming to the model laid down in Chapter 5(B) of
Annex X accompaniesthem;
(c) they come either:
(i) from animalsoriginating in a region of a third country or in a third
country not subject, pursuant to Community legislation, to restric-
tions as a result of an outbreak of a serious transmissible disease towhich the animals of the species concerned are susceptible and they
have been treated in accordance with paragraph 2, or
(ii) from animalsoriginating from other regionsof a third country or
other third countriesand they have been treated in accordance with
paragraph 2(c) or (d), or
(iii) from ruminant animalsand have been treated in accordance with
paragraph 2 and have been kept separate for 21 days or have under-
gone transport for 21 uninterrupted days. In this case, the certificate
referred to in subparagraph (b) is replaced by a declaration
conforming to the model laid down in Chapter 5(C) of Annex X,
to the effect that or proving that those requirements have been met;
(d) in the case of salted hides and skins transported by ship, the hides have
been salted before importation for the duration stated in the certificate
accompanying the consignment; and
(e) the consignment has not been in contact with other animal products or
with live animals presenting a risk of spreading a serious transmissible
disease.
7. Fresh, chilled or treated hides and skins of ungulates must be imported in
containers, road vehicles, railway wagons or bales sealed by the competent
authority of the third country of dispatch.
CHAPTER VII
Requirementsforgametrophies
A.Raw material
1. Without prejudice to the measures adopted pursuant to Council Regulation
(EC) No 338/97 of 9 December 1996 on the protection of species of wild
fauna and flora by regulating trade therein (
1), game trophies:
(a) of ungulatesand birdshaving undergone a complete taxidermy treatment
ensuring their preservation at ambient temperatures; and
(b) of species other than ungulates and birds,2002R1774 — EN — 01.05.2003 — 001.001 — 63
(1) OJ L 61, 3.3.1997, p. 1. Regulation as last amended by Commission Regulation No
1579/2001 (OJ L 209, 2.8.2001, p. 14).
▼B
are not subject to any ban or restriction for reasons of animal health.
2. Without prejudice to the measures adopted pursuant to Regulation (EC) No
338/97, game trophiesof ungulatesand birdsnot having undergone the treat-
ment mentioned in paragraph 1(a) are subject to the following conditions.
They must:
(a) come from animals originating in an area not subject to restrictions as a
result of the presence of serious transmissible diseases to which animals
of the species concerned are susceptible; or
(b) comply with the conditionslaid down in paragraphs3 or 4 if they come
from animals originating in an area subject to restrictions as a result of
the presence of serious transmissible diseases to which animals of the
species concerned are susceptible.
3. In respect of game trophies consisting solely of bone, horns, hooves, claws,
antlersor teeth, the trophiesmus t:
(a) have been immersed in boiling water for an appropriate time so as to
ensure that any matter other than bone, horns, hooves, claws, antlers or
teeth isremoved;
(b) have been disinfected with a product authorised by the competent
authority, in particular with hydrogen peroxide where parts consisting of
bone are concerned;
(c) be packaged, immediately after treatment, without being in contact with
other productsof animal origin likely to contaminate them, in individual,
transparent and closed packages so as to avoid any subsequent contami-
nation; and
(d) be accompanied by a document or certificate certifying that the above
conditionshave been met.
4. In respect of game trophies consisting solely of hides or skin, the trophies
must:
(a) have been either:
(i) dried, or
(ii) dry- or wet-salted for a minimum of 14 days before dispatch, or
(iii) preserved by a treatment other that tanning approved in accordance
with the procedure referred to in Article 33(2);
(b) be packaged, immediately after treatment, without being in contact with
other productsof animal origin likely to contaminate them, in individual,
transparent and closed packages so as to avoid any subsequent contami-
nation; and
(c) be accompanied by a document or certificate certifying that the above
conditionshave been met.
B.Importation
5. Member States must authorise the importation of treated game trophies from
birds and ungulates, being solely bones, horns, hooves, claws, antlers, teeth,
hides or skins, from third countries if:
(a) a certificate that conformsto the model laid down in Chapter 6(A) of
Annex X accompaniesthem; and
(b) they comply with the requirementsof paragraphs3 and 4. However, in
the case of dry-salted or wet-salted skins transported by ship, the skins
need not be salted 14 days before dispatch, provided that they are salted
for 14 daysbefore importation.
6. Member Statesmus t, in accordance with the requirementsof paragraph 7,
authorise the importation of game trophies from birds and ungulates
consisting of entire anatomical parts, not having been treated in any way,
from third countries:
(a) that appear in one of the lists in the Annex to Commission Decision 94/
86/EC of 16 February 1994 drawing up a provisional list of third coun-
triesfrom which Member Statesauthoris e importsof wild game meat (1);
and
(b) from which the importation of all categoriesof fres h meat of the corre-
sponding species is authorised.2002R1774 — EN — 01.05.2003 — 001.001 — 64
(1) OJ L 44, 17.2.1994, p. 33.
▼B
7. Member States must authorise importation of the game trophies referred to in
paragraph 6 if:
(a) they come from animals originating in an area not subject to restrictions
as a result of the presence of serious transmissible diseases to which
animals of the species concerned are susceptible;
(b) they were packaged, immediately after treatment, without being in
contact with other productsof animal origin likely to contaminate them,
in individual, transparent and closed packages so as to avoid any subse-
quent contamination; and
(c) a certificate conforming to the model laid down in Chapter 6(B) of
Annex X accompaniesthem.
CHAPTER VIII
Requirementsforwool,hair,pigbristles,feathersandpartsoffeathers
A.Raw material
1. (a) Unprocessed wool, unprocessed hair, unprocessed pig bristles and unpro-
cessed feathers and parts of feathers must have been obtained from
animals referred to in Article 6(1)(c) or (k). They must be securely
enclosed in packaging and dry. However, in the case of unprocessed
feather and part of feathers sent directly from the slaughterhouse to the
processing plant, the competent authority may allow derogation from
the dry requirement, provided that:
(i) all necessary measures are taken to avoid any possible spread of
disease;
(ii) the transport takes place in leak-proof containers and/or vehicles
which must be cleansed and disinfected immediately after each
use; and
(iii) the Member State notifies the Commission when such derogation is
given.
(b) Movements of pig bristles from regions in which African swine fever is
endemic are prohibited except for pig bristles that have:
(i) been boiled, dyed or bleached; or
(ii) undergone some other form of treatment which is certain to kill
pathogenic agents, provided that evidence to this effect is submitted
in the form of a certificate from the veterinarian responsible for the
place of origin. Factory washing may not be regarded as a form of
treatment for the purposes of this provision.
2. The provisions of paragraph 1 do not apply to decorative feathers or feathers:
(a) carried by travellersfor their private us e; or
(b) in the form of consignments sent to private individuals for non-industrial
purposes.
B.Importation
3. Member States must authorise the importation of pig bristles from third
countries or, in case of regionalisation according to Community legislation,
regionsthereof, if:
(a) the pig bristles were obtained from animals originating, and slaughtered
in a slaughterhouse, in the country of origin; and
(b) either:
(i) where no case of African swine fever has occurred during the
previous12 months , a certificate conforming to the model laid
down in Chapter 7(A) of Annex X accompaniesthe cons ignment; or
(ii) where one or more cases of African swine fever have occurred
during the previous12 months , a certificate conforming to the model
laid down in Chapter 7(B) of Annex X accompaniesthe cons ign-
ment.
4. Member States must authorise the importation of unprocessed wool, hair,
feathersand partsof feathersif they are:
(a) securely enclosed in packaging and dry; and2002R1774 — EN — 01.05.2003 — 001.001 — 65
▼M1
▼B
▼B
(b) sent directly to the technical plant or to an intermediate plant in condi-
tions such that any spread of pathogenic agents is avoided.
CHAPTER IX
Requirementsforapicultureproducts
A.Raw material
1. Apiculture products intended exclusively for use in apiculture must:
(a) not come from an area which is subject of a prohibition order associated
with an occurrence of:
(i) American foulbrood, except where the competent authority has
assessed the risk to be negligible, issued a specific authorisation for
use only in that Member State, and taken all other necessary
measures to ensure no spread of that disease; or
(ii) acariosis, except where the area of destination has obtained addi-
tional guaranteesin accordance with Article 14(2) of Directive 92/
65/EEC (1); and
(b) meet the requirementsprovided for in Article 8(a) of Directive 92/65/
EEC.
B.Importation
2. Member States must authorise the importation of apiculture products
intended for use in apiculture if:
(a) the commercial document accompanying the consignment includes the
following information:
(i) the country of origin,
(ii) the name of the establishment of production,
(iii) the registration number of the establishment of production,
(iv) the nature of the products, and
(v) the indication: ‘Apiculture products intended exclusively for use in
apiculture originating from a holding not subject to restrictions
because of occurrence of bee diseases and collected in the centre
of a region with a radiusof 3 kilometreswhich isnot s ubjected to
restrictions because of American foulbrood, which is a notifiable
disease, for at least 30 days.’; and
(b) the competent authority supervising the registered establishment of
production hass tamped the commercial document.
CHAPTER X
Requirements for bones and bone products (excluding bone meal), horns
and horn products (excluding horn meal) and hooves and hoof products
(excludinghoofmeal)intendedforuseother thanasfeedmaterial, organic
fertilizers orsoilimprovers
1. Member States must authorise the importation of bones and bone products
(excluding bone meal), hornsand horn products(excluding horn meal) and
hoovesand hoof products(excluding hoof meal) to produce technical
productsif:
(a) the productsare dried before export and not chilled or frozen;
(b) the productsare conveyed only by land and s ea from their country of
origin direct to a border inspection post in the Community and are not
transhipped at any port or place outside the Community;
(c) following the document checksprovided for in Directive 97/78/EC, the
productsare conveyed directly to the technical plant.2002R1774 — EN — 01.05.2003 — 001.001 — 66
(1) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements
governing trade in and imports into the Community of animals, semen, ova andembryos not subject to animal health requirements laid down in specific Communityrulesreferred to in Annex A(I) to Directive 90/425/EEC (OJ L 268, 14.9.1992, p. 54).Directive as last amended by Commission Decision 2001/298/EC (OJ L 102, 12.4.2001,
p. 63).▼M1
▼B
▼B
2. Each consignment must be accompanied by:
(a) a commercial document stamped by the competent authority supervising
the establishment of origin, including the following information:
(i) the country of origin,
(ii) the name of the establishment of production,
(iii) the nature of the product (dried bone/dried bone product/dried
horns/dried horn products/dried hooves/dried hoof products), and
(iv) the fact that the product was:
— derived from healthy animals slaughtered in a slaughterhouse, or
— dried for 42 daysat an average temperature of at leas t 20 ºC, or— heated for one hour to at least 80 ºC to the core before drying,
or
— ashed for one hour to at least 80 ºC to the core before drying, or— underwent an acidification process such that the pH was main-
tained at less than 6 to the core for at least one hour before
drying, and
is not intended at any stage to be diverted for any use in food, feed
material, organic fertilizers or soil improvers; and
(b) the following declaration of the importer which must be in at least one
official language of the Member State through which the consignment
first enters the Community and in at least one official language of the
Member State of destination:
3. On dispatch to the Community territory, the material must be enclosed in
sealed containers or vehicles or carried in bulk in a ship. If transported in
containers, the containers, and in all cases all the accompanying documents,
must bear the name and the address of the technical plant.
4. Following the border check provided for in Directive 97/78/EC, and in accor-
dance with the ruleslaid down in Article 9(4) of that Directive, the material
must be transported direct to the technical plant.2002R1774 — EN — 01.05.2003 — 001.001 — 67
▼B
5. Recordsmus t be kept of the quantity and nature of the material, during
manufacture, in such a way as to ensure that the material has actually been
used for the intended purposes.
CHAPTER XI
Animal by-products for the manufacture of petfood and pharmaceutical
andothertechnicalproducts
Member States must authorise the importation of animal by-products intended
for the manufacture of petfood, pharmaceutical productsand other technical
productsif:
1. they come from third countrieswhich appear on the lis t in Part VII of Annex
XI;
2. they consist only of animal by-products referred to in Article 6(1)(a);
3. they have been deep frozen at the plant of origin;
4. they have undergone all precautionsto avoid recontamination with patho-
genic agents;
5. they were packed in new packaging preventing any leakage;
6. a certificate conforming to the model laid down in Chapter 8 of Annex X
accompaniesthem; and
7. following the border check provided for in Directive 97/78/EC, and in accor-
dance with the ruleslaid down in Article 9(4) of that Directive, they are
transported either:
(a) directly to a petfood or technical plant, which hasgiven the guarantee
that the animal by-products will be used only for the permitted purpose
and will not leave the plant untreated; or
(b) to an intermediate plant.
CHAPTER XII
Renderedfatsforoleochemical purposes
Member States must authorise the importation of rendered fat intended to be
processed by a method that at least meets the standards of one of the processes
described in Annex VI, Chapter III, if:
1. the product isconveyed only by land and s ea from the country of origin
direct to a border inspection post in the Community;
2. following the document checksprovided for in Directive 97/78/EC, and in
accordance with the ruleslaid down in Article 9(4) of that Directive, the
productsare conveyed to the oleochemical plant where they will be
processed;
3. a declaration made by the importer accompanieseach cons ignment. This
declaration must state that products imported in accordance with this Chapter
will not be diverted for any use other than further processing by a method
which at least meets the standards of one of the processes described in Annex
VI, Chapter III. This declaration must be presented to, and annotated by, the
competent authority at the border inspection post at the first point of entry of
the goodsinto the Community, and thereafter accompany the cons ignment up
to the oleochemical plant.2002R1774 — EN — 01.05.2003 — 001.001 — 68
▼B
ANNEX IX
RULES APPLICABLE TO THE USE OF CERTAINCATEGORY 2 AND
CATEGORY 3 MATERIAL FOR THE FEEDING OF CERTAIN
ANIMALSINACCORDANCEWITHARTICLE23(2)
1. This Annex applies only to users and collection centres authorised and
registered pursuant to Article 23(2)(c)(iv), (vi) and (vii). For the purposes
of thisAnnex, ‘relevant material’ meansthe animal by-productss pecified
in Article 23(2)(b) and productsderived therefrom.
2. Relevant material must be transported to the users or to collection centres in
accordance with Annex II.
2a. Entire bodiesof dead animalss hall be handled asCategory 2 material
during collection and transportation, without prejudice to the requirement
to remove the specific risk material for subsequent disposal before the rest
of the body may be used for feeding as provided for in Article 23.
3. Collection centresmus t:
(a) comply at least with the following requirements of Annex V:
(i) Chapter I, paragraphs1(a), (b), (c), (d) and (f), 2, 3 and 4, and
(ii) Chapter II, paragraphs1, 2, 4, 5 and 9; and
(b) have adequate facilities for destroying unused unprocessed relevant
material, or send it to a processing plant or to an incineration or co-
incineration plant in accordance with thisRegulation.
Member States may authorise the use of a Category 2 processing plant as a
collection centre.
4. In addition to the recordsrequired in accordance with Annex II, the
following recordsmus t be kept in relation to relevant material:
(a) in the case of final users, the quantity used and the date of use; and
(b) in the case of collection centres:
(i) the quantity treated in accordance with paragraph 5;
(ii) the name and address of each final user buying the material;
(iii) the premises to which the material is taken for use;
(iv) the quantity dispatched; and
(v) the date on which the material wasdis patched.
5. Operators of collection centres supplying relevant material other than fish
offal to final users, must ensure that:
(a) it undergoesone of the following treatments(either in the collection
centre or in a slaughterhouse approved by the competent authority in
accordance with Community legislation):
(i) denaturing with a solution of a colouring agent approved by the
competent authority. The solution must be of such a strength that
the colouring on the stained material is clearly visible, and the
whole surface of all pieces of material have been covered with a
solution as aforesaid either by immersing the material in, or
spraying or otherwise applying the solution;
(ii) sterilisation, that is to say boiling or steaming under pressure until
every piece of material iscooked throughout; or
(iii) any other treatment approved by the competent authority; and
(b) it ispackaged after treatment and before dis tribution in packaging that
isclearly and legibly marked with the name and the addres sof the
collection centre and the indication ‘not for human consumption’.2002R1774 — EN — 01.05.2003 — 001.001 — 69
▼M1
▼B
▼B
ANNEX X
MODEL HEALTH CERTIFICATES FOR THE IMPORTATION FROM THIRD COUNTRIES OF
CERTAINANIMALBY-PRODUCTSANDPRODUCTSDERIVEDTHEREFROM
CHAPTER 1
2002R1774 — EN — 01.05.2003 — 001.001 — 70
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 71
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 72
▼B
CHAPTER 2(A)
2002R1774 — EN — 01.05.2003 — 001.001 — 73
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 74
▼B
CHAPTER 2(B)
2002R1774 — EN — 01.05.2003 — 001.001 — 75
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 76
▼B
CHAPTER 2(C)
2002R1774 — EN — 01.05.2003 — 001.001 — 77
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 78
▼B
CHAPTER 3(A)
2002R1774 — EN — 01.05.2003 — 001.001 — 79
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 80
▼B
CHAPTER 3(B)
2002R1774 — EN — 01.05.2003 — 001.001 — 81
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 82
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 83
▼B
CHAPTER 3(C)
2002R1774 — EN — 01.05.2003 — 001.001 — 84
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 85
▼B
CHAPTER 3(D)
2002R1774 — EN — 01.05.2003 — 001.001 — 86
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 87
▼B
CHAPTER 4
2002R1774 — EN — 01.05.2003 — 001.001 — 88
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 89
▼B
CHAPTER 5(A)
2002R1774 — EN — 01.05.2003 — 001.001 — 90
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 91
▼B
CHAPTER 5(B)
2002R1774 — EN — 01.05.2003 — 001.001 — 92
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 93
▼B
CHAPTER 5(C)
2002R1774 — EN — 01.05.2003 — 001.001 — 94
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 95
▼B
CHAPTER 6(A)
2002R1774 — EN — 01.05.2003 — 001.001 — 96
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 97
▼B
CHAPTER 6(B)
2002R1774 — EN — 01.05.2003 — 001.001 — 98
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 99
▼B
CHAPTER 7(A)
2002R1774 — EN — 01.05.2003 — 001.001 — 100
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 101
▼B
CHAPTER 7(B)
2002R1774 — EN — 01.05.2003 — 001.001 — 102
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 103
▼B
CHAPTER 8
2002R1774 — EN — 01.05.2003 — 001.001 — 104
▼B
2002R1774 — EN — 01.05.2003 — 001.001 — 105
▼B
ANNEX XI
LISTS OF THIRD COUNTRIES FROM WHICH MEMBER STATES
MAY AUTHORISE IMPORTS OF ANIMAL BY-PRODUCTS NOT
INTENDEDFORHUMANCONSUMPTION
The inclusion of a country on one of the following lists is a necessary, but not
sufficient, condition for the importation of relevant products from that country.
Imports must also fulfil the relevant animal health and public health require-
ments.
PART I
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
milkandmilk-basedproducts
Third countries listed in column B or column C of the Annex to Decision 95/
340/EC.
PART II
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
processedanimalproteins(excludingfishmeal)
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART III
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
fishmealandfishoil
Third countries listed in the Annex to Decision 97/296/EC.
PART IV
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
renderedfats(excludingfishoil)
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART V
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
bloodproductsforfeedmaterial
A. Blood productsfrom ungulates
Third countriesor partsof countrieslis ted in Part I of the Annex to Decis ion 79/
542/EEC from which imports of all categories of fresh meat of the respective
species are authorised.
B. Blood productsfrom other s pecies
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART VI
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
blood products (with the exception of equidae) intended for technical and
pharmaceuticaluses
A. Blood productsfrom ungulates
Third countriesor partsof countrieslis ted in Part I of the Annex to Decis ion 79/
542/EEC from which imports of all categories of fresh meat of the respective
species are authorised.
B. Blood productsfrom other s pecies
Third countries listed in Part I of the Annex to Decision 79/542/EEC.2002R1774 — EN — 01.05.2003 — 001.001 — 106
▼B
PART VII
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
unprocessedmaterialforthemanufactureofpetfoodandtechnicalproducts
A. Unprocessed material from bovine, ovine, caprine, porcine and equine
animals
Third countriesor partsof countrieslis ted in Part I of the Annex to Decis ion 79/
542/EEC from which imports of all categories of fresh meat of the respective
species are authorised.
B. Unprocessed material from poultry
Third countries from which Member States authorise imports of fresh poultry-
meat.
C. Unprocessed material from other species
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART VIII
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
untreatedpigbristles
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
PART IX
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
manurefortreatmentofthesoil
A. Processed manure products
Third countries listed in Part I of the Annex to Decision 79/542/EEC.
B. Processed manure from equidae
Third countries listed in Part I of the Annex to Decision 79/542/EEC for live
equidae.
C. Unprocessed manure from poultry
Third countries from which Member States authorise imports of fresh poultry-
meat.
PART X
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
petfoodanddogchews
Third countries listed in Part I of the Annex to Decision 79/542/EEC, and the
following countries:
(LK) Sri Lanka (1)
(JP) Japan (2)
(TW) Taiwan (2).
PART XI
ListofthirdcountriesfromwhichMemberStatesmayauthoriseimportsof
gelatin,hydrolysedproteinanddicalciumphosphate
Third countries listed in Part I of the Annex to Decision 79/542/EEC, and the
following countries:
(KR) The Republic of Korea (3)
(MY) Malaysia (3)
(PK) Pakistan (3)
(TW) Taiwan (3).2002R1774 — EN — 01.05.2003 — 001.001 — 107
(1) Dogchewsmade from hidesand s kinsof ungulatesonly.
(2) Processed petfood for ornamental fish only.
(3) Gelatin only.