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"B COMMISSION DECISION
of 29 December 2000
concerning control measures required for the implementation of Council Decision 2000/766/EC concerning
certain protection measures with regard to transmissible spongiform encephalopathies and the feeding of
animal protein
(notified under document number C(2000) 4412)
(Text with EEA relevance)
(2001/9/EC)
(OJ L 2, 5.1.2001, p. 32)
Amended by:
Official Journal
No page date
"M1 Commission Decision 2001/165/EC of 27 February 2001 L 58 43 28.2.20012001D0009 — EN — 01.03.2001 — 001.001 — 1
COMMISSION DECISION
of 29 December 2000
concerning control measures required for the implementation of Council
Decision 2000/766/EC concerning certain protection measures with
regard to transmissible spongiform encephalopathies and the feeding of
animal protein
(notified under document number C(2000) 4412)
(Text with EEA relevance)
(2001/9/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/662/EEC of 11 December 1989
concerning veterinary checks in intra-Community trade with a view to the
completion of the internal market (
1), as last amended by Directive
92/118/EEC (2), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning
veterinary and zootechnical checks applicable in intra-Community trade in
certain live animals and products with a view to the completion of the internal
market (3), as last amended by Directive 92/118/EEC, and in particular Article
10(4) thereof,
Having regard to 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 (4), and in particular
Article 22 thereof,
Whereas:(1) Council Decision 2000/766/EC of 4 December 2000 concerning
certain protection measures with regard to transmissible spongiform
encephalopathies and the feeding of animal protein (
5), prohibits the
feeding of processed animal proteins to certain farmed animals. Thisprohibition does not apply to certain processed animal proteins subjectto conditions to be established.
(2) On 26 June 1998, the Scientific Steering Committee (SSC) adopted an
opinion on the safety of dicalcium phosphate precipitated from
ruminant bones. That opinion was updated by the SSC on 26 and 27October 2000. In order to take account of that scientific opinion, it isnecessary to lay down requirements for the production of dicalcium
phosphate.
(3) On 22 and 23 October 1998, the Scientific Steering Committee (SSC)
adopted an opinion on the safety of hydrolysed proteins produced frombovine hides. This opinion was updated by the SSC on 25 and 26 May
2000. In order to take account of that scientific opinion, it is necessary
to lay down requirements for the production of hydrolysed proteins.The SSC stated that a maximum molecular weight of 10 000 Daltons,for the final product produced, may be used as an indicator of the
effectiveness of the production process.
(4) Decision 2000/766/EC establishes that placing on the market, trade,
importation and exportation of processed animal proteins for animalsnot kept, fattened or bred for the production of food may be allowed byMember States. It is necessary to set conditions to ensure that such
proteins cannot be used for non authorised purposes.
(5) The measures provided for in this Decision are in accordance with the
opinion of the Standing Veterinary Committee,!B
(1) OJ L 395, 30.12.1989, p. 13.
(2) OJ L 62, 15.3.1993, p. 49.
(3) OJ L 224, 18.8.1990, p. 29.
(4) OJ L 24, 30.1.1998, p. 9.
(5) OJ L 306, 7.12.2000, p. 32.2001D0009 — EN — 01.03.2001 — 001.001 — 2
HAS ADOPTED THIS DECISION:
Article 1
1. Member States shall authorise the feeding of fishmeal "M1to farmed
animals referred to in Article 2(1) of Decision 2000/766/EC 3other than
ruminants, only in accordance with the conditions laid down in Annex I.
2. Member States shall authorise the feeding of dicalcium phosphate
"M1to farmed animals referred to in Article 2(1) of Decision 2000/766/EC
3other than ruminants only in accordance with the conditions laid down in
Annex II.
3. Member States shall authorise the feeding of hydrolysed proteins
"M1to farmed animals referred to in Article 2(1) of Decision 2000/766/EC
3other than ruminants, only in accordance with the conditions laid down in
Annex III.
4. Member States shall ensure that, for the purpose of trade, dicalcium
phosphate and hydrolysed proteins are accompanied by an official certificateas laid down in Annex IV .
5. Member States shall forward to the other Member States and to the
Commission the list of approved processing plants producing fishmeal,dicalcium phosphate and hydrolysed proteins, which operate in accordance
with the conditions laid down by this Decision, within 15 days after the entry
into force of this Decision. Any modification to the list shall be notifiedimmediately to the other Member States and to the Commission.
Article 2
Member States shall ensure that feedingstuffs, including pet food, destined to
animals other than farmed animals referred to in Article 2(1) of Decision
2000/766/EC, which contain processed animal proteins as defined by thatDecision are not manufactured in plants which prepare feed for farmedanimals.
However, where those feedingstuffs are produced with no other processed
animal proteins than fishmeal, dicalcium phosphate and hydrolysed proteins,
they may be manufactured in plants which prepare feed for farmed animals
other than ruminants in accordance with Annex I point 6, Annex II point 3 andAnnex III point 2, as appropriate.
Article 3
1. Member States may send to other Member States processed animal
proteins, as defined in Decision 2000/766/EC, provided they are destined for
uses not prohibited by Article 3(1)(a) of that Decision, and only if thefollowing additional conditions are fulfilled:
(a) the Member State of destination must have authorised the receipt of the
processed animal proteins;
(b) the processed animal proteins shall be accompanied by an official
certificate as laid down in Annex V;
(c) the processed animal proteins must be transported in sealed, covered
containers or vehicles, in such a way as to prevent loss and conveyed
directly to the petfood or feed plants;
(d) Member States which send processed animal proteins to other Member
States must inform by means of the ANIMO system (
1) the competent
authority of the place of destination of each consignment sent. The words‘not for feed destined to animals which are kept, fattened or bred for theproduction of food’ must be contained in the ANIMO message;
(e) Member States of destination must inform the competent authority of the
place of origin, by means of the ANIMO system, of the arrival of each
consignment; if such information is not provided, Member States of
origin shall immediately take appropriate action;
(f) Member States of destination must ensure that the designated plants on
their territory use the consignment only for the authorised purposes.!B
(1) Commission Decision 91/398/EEC (OJ L 221, 9.8.1991, p. 30).!M1
!B2001D0009 — EN — 01.03.2001 — 001.001 — 3
2. Member States may export to third countries processed animal proteins,
as defined in Decision 2000/766/EC, provided they are destined for uses notprohibited by Article 3(1)(a) of that Decision, only if the following conditionsare fulfilled:
(a) a bilateral agreement with the third country shall be made prior to
exportation, which includes an undertaking from the third country to
respect the final use and not to export the processed animal protein unless
incorporated in a product destined for uses not prohibited by Article3(1)(a) of Decision 2000/766/EC;
(b) the processed animal proteins shall be accompanied by an official
certificate as laid down in Annex V .
Member States which allow such exportation shall inform the Commission
and the other Member States of all terms and conditions as agreed with the
third country concerned, for the effective implementation, of this Decision, in
the context of the Standing Veterinary Committee.
3. Member States shall ensure that imported processed animal proteins, as
defined in Decision 2000/766/EC, destined for uses not prohibited by Article3(1)(a) of that Decision, shall be dealt with in accordance with the conditionslaid down in Article 8 of Council Directive 97/78/EC (
1).
4. Member States shall carry out documentary checks and tests on feed
materials and compound feedingstuffs throughout the production and
distribution chain to ensure compliance with the provisions of this Decision
and Decision 2000/766/EC. These checks and tests shall be carried out, inter
alia, in farms in which ruminants are kept with other animal species.
Member States shall inform the Commission of the results of these checks by
31 May 2001.
5. The additional control measures set out in paragraphs 1, 2 and 3 shall not
apply:
— to pet food referred to by Chapter 4 of Annex I to Directive 92/118/EEC,
and
— to products exempted by Article 2(2) of Decision 2000/766/EC, from the
prohibition established by Article 2(1) of that Decision, provided they
fulfil, where applicable, the conditions set out in the Annexes I to III to
the present Decision.
6. The additional control measures set out in paragraph 1 shall not apply to
processed animal proteins referred to in Article 4 of Commission Decision97/735/EC (
2), as last amended by Decision 1999/534/EC (3).
Article 4
Article 2 of Decision 97/735/EC shall not apply to consignments of processed
animal proteins which are accompanied by the health certificate referred to in
Article 3(1)(b) of the present Decision.
Article 5
This Decision shall apply from 1 January 2001.
Article 6
This Decision is addressed to the Member States.!B
(1) OJ L 24, 30.1.1998, p. 9.
(2) OJ L 294, 28.10.1997, p. 7.
(3) OJ L 204, 4.8.1999, p. 37.2001D0009 — EN — 01.03.2001 — 001.001 — 4
ANNEX I
CONDITIONS REFERRED TO IN ARTICLE 1(1)
1. Fishmeal shall be produced in processing plants dedicated only to fishmeal
production, which are approved for this purpose by the competent authority inaccordance with Article 5(2) of Directive 90/667/EEC.
2. Before release for free circulation in Community territory, each consignment of
imported fishmeal shall be analysed in accordance with Commission Directive98/88/EC (
1).
3. Fishmeal shall be transported directly from the processing plants to the
establishments manufacturing animal feed, by means of vehicles which at thesame time do not transport other feed materials. If the vehicle is subsequentlyused for the transport of other products, it shall be thoroughly cleaned andinspected before and after the transport of fishmeal.
4. Fishmeal shall be transported directly from the border inspection post to the
establishments manufacturing animal feed, in accordance with the conditionslaid down in Article 8 of Directive 97/78/EC, by means of vehicles which at thesame time do not transport other feed materials. If the vehicle is subsequently
used for the transport of other products, it shall be thoroughly cleaned and
inspected before and after the transport of fishmeal.
5. By way of derogation from points 3 and 4, intermediate storage of fishmeal may
be allowed only if it is carried out in dedicated storage plants which are
authorised for this purpose by the competent authority.
6. Feedingstuffs containing fishmeal can be produced only in establishments
manufacturing animal feed which do not prepare feedingstuffs for ruminant
animals and which are authorised for this purpose by the competent authority.
By way of derogation from this provision, the production of feedingstuffs for
ruminant animals in establishments which also produce feedingstuffs containingfishmeal for other animal species may be permitted by the competent authorityon condition that:
— the transport and storage of feed materials destined to ruminant animals is
completely separate from feed material prohibited for feeding to ruminantanimals, and
— the storage, transport, manufacturing and packaging facilities for the
compound feedingstuffs destined to ruminant animals are completelyseparate, and
— records detailing the purchases and uses of fishmeal and the sales of
feedingstuff containing fishmeal are made available to the competentauthority, and
— routine tests are carried out on feedingstuffs destined to ruminant animals
to ensure that prohibited processed animal proteins as defined by Article 1of Decision 2000/766/EC are not present.
7. The labelling of feedingstuffs containing fishmeal shall clearly indicate the
words ‘it contains fishmeal — cannot be fed to ruminant animals’.
8. Bulk feedingstuffs containing fishmeal shall be transported by means of
vehicles which at the same time do not transport feed for ruminant animals. Ifthe vehicle is subsequently used for the transport of other products, it shall bethoroughly cleaned and inspected before and after the transport of bulkfeedingstuffs containing fishmeal.
9. The use and storage of feedingstuffs, other than pet food referred to by Chapter
4 of Annex I to Directive 92/118/EEC, containing fishmeal shall be prohibitedin farms where ruminant animals are kept, fattened or bred for the production offood.
By way of derogation from this provision, the competent authority may permit
the use and storage of feedingstuffs containing fishmeal in farms whereruminant animals are kept, if they are satisfied that on-farm measures areimplemented to prevent that feedingstuffs containing fishmeal is fed toruminant animals.!
B
(1) OJ L 318, 27.11.1998, p. 45.2001D0009 — EN — 01.03.2001 — 001.001 — 5
ANNEX II
CONDITIONS REFERRED TO IN ARTICLE 1(2)
1. Dicalcium phosphate shall be produced in processing plants approved by the
competent authority in accordance with Article 5(2) of Directive 90/667/EEC.
2. Dicalcium phosphate from defatted bones shall:
— be derived from bones fit for human consumption following ante- and
post-mortem inspection,
— be produced by a process which ensures that all bone-material is finely
crushed and degreased with hot water and treated with dilute hydrochloricacid (at a minimum concentration of 4 % and pH 51,5) over a period of at
least two days followed by a treatment of the obtained phosphoric liquor
with lime, resulting in a precipitate of dicalcium phosphate at pH 4 to 7,which is finally air dried with inlet temperature of 65 °C to 325 °C and endtemperature between 30 °C to 65 °C or by an equivalent process approvedin accordance with the procedure of Article 17 of Directive 89/662/EEC.
3. Feedingstuffs containing dicalcium phosphate from defatted bones can be
produced only in establishments manufacturing animal feed which do notprepare feedingstuffs for ruminant animals and which are authorised for thispurpose by the competent authority.
By way of derogation from this provision, the production of feedingstuffs for
ruminant animals in establishments which also produce feedingstuffs containing
dicalcium phosphate from deffatted bones for other animal species may bepermitted by the competent authority on condition that:
— the transport and storage of feed materials destined for ruminant animals is
completely separate from feed material prohibited for feeding to ruminantanimals, and
— the storage, transport, manufacturing and packaging facilities for the
compound feedingstuffs destined for ruminant animals are completely
separate, and
— records detailing the purchases and uses of dicalcium phosphate from
defatted bones and the sales of feedingstuff containing dicalcium
phosphate from defatted bones are made available to the competentauthority, and
— routine tests are carried out on feedingstuffs destined for ruminant animals
to ensure that prohibited processed animal proteins as defined by Article 1of Decision 2000/766/EC are not present.
4. The labelling of the feedingstuffs containing dicalcium phosphate from defatted
bones shall clearly indicate the words ‘it contains dicalcium phosphate fromdefatted bones — cannot be fed to ruminant animals’.
5. Bulk feedingstuffs containing dicalcium phosphate from defatted bones shall be
transported by mean of vehicles which at the same time do not transport feed forruminant animals. If the vehicle is subsequently used for the transport of otherproducts, it shall be thoroughly cleaned and inspected before and after thetransport of bulk feedingstuffs containing dicalcium phosphate from defattedbones,
6. The use and storage of feedingstuffs, other than pet food referred to by Chapter
4 of Annex I to Directive 92/118/EEC, containing dicalcium phosphate fromdefatted bones shall be prohibited in farms where ruminant animals are kept,fattened or bred for the production of food.
By way of derogation from this provision, the competent authority may permit
the use and storage of feedingstuffs containing dicalcium phosphate fromdefatted bones in farms where ruminant animals are kept, if they are satisfiedthat on-farm measures are implemented to prevent that feedingstuffs containingdicalcium phosphate from defatted bones is fed to ruminant animals.!
B2001D0009 — EN — 01.03.2001 — 001.001 — 6
ANNEX III
CONDITIONS REFERRED TO IN ARTICLE 1(3)
1. Hydrolysed proteins derived from fish, feather and hides and skins shall:
— be produced in a processing plant dedicated only to hydrolysed proteins
production, which are approved for this purpose by the competentauthority in accordance with Article 5(2) of Directive 90/667/EEC;
— be sampled after processing and found to have a molecular weight below
10 000 Dalton.
In addition, hydrolysed proteins from hides and skins shall:
— be derived from hides and skins obtained from animals which have been
slaughtered in a slaughterhouse and whose carcasses have been found fitfor human consumption following ante and post mortem inspection;
— be produced by a production process which involves appropriate measures
to minimise contamination of hides and skins, preparation of the rawmaterial by brining, liming and intensive washing followed by exposure ofthe material to a pH of 411 for more than three hours at a temperature of
more than 80 °C and followed by heat treatment at a temperature of more
than 140 °C for 30 minutes at more than 3,6 bar; or by an equivalentproduction process approved in accordance with the procedure of Article17 of Directive 89/662/EEC.
2. Feedingstuffs containing hydrolysed proteins can be produced only in plants
manufacturing animal feedingstuffs which do not prepare feedingstuffs for
ruminant animals and which are authorised for this purpose by the competentauthority,
By way of derogation from this provision, the production of feedingstuffs for
ruminant animals in establishments which also produce feedingstuffs containinghydrolysed proteins for other animal species may be permitted by the competent
authority on condition that:
— the transport and storage of feed materials destined to ruminant animals is
completely separate from feed material prohibited for feeding to ruminantanimals, and
— the storage, transport, manufacturing and packaging facilities for the
compound feedingstuffs destined to ruminant animals are completelyseparate, and
— records detailing the purchases and uses of hydrolysed proteins and the
sales of feedingstuff containing hydrolysed proteins are made available tothe competent authority, and
— routine tests are carried out on feedingstuffs destined to ruminant animals
to ensure that prohibited processed animal proteins as defined by Article 1of Decision 2000/766/EC are not present.
3. The labelling of feedingstuffs containing hydrolysed proteins shall clearly
indicate the words ‘it contains hydrolysed proteins — cannot be fed to ruminantanimals’.
4. Bulk feedingstuffs containing hydrolysed proteins shall be transported by means
of vehicles which at the same time do not transport feed for ruminant animals. Ifthe vehicle is subsequently used for the transport of other products, it shall bethoroughly cleaned and inspected before and after the transport of bulk
feedingstuffs containing hydrolysed proteins.
5. The use and storage of feedingstuffs, other than pet food referred to by Chapter
4 of Annex I to Directive 92/118/EEC, containing hydrolysed proteins shall be
prohibited in farms where ruminants are kept, fattened or bred for the
production of food.
By way of derogation for this provision, the competent authority may permit the
use and storage of feedingstuffs containing hydrolysed proteins in farms whereruminant animals are kept, if they are satisfied that on-farm measures areimplemented to prevent that feedingstuffs containing hydrolysed proteins is fed
to ruminant animals.!
B
!M1
!B2001D0009 — EN — 01.03.2001 — 001.001 — 7
ANNEX IV
!B2001D0009 — EN — 01.03.2001 — 001.001 — 8
IV.Health attestation
I the undersigned, official veterinarian, certify that the product described above:
— was produced in a plant approved in accordance with Directive 90/667/EEC,— was produced in accordance with the conditions laid down in Annex II/Annex III(
1) to Decision 2001/9/EC and
cannot be used for the feeding of ruminant animals,
— wassubjectedtoasamplingfromeachbatchandtheproductwasfoundtohaveamolecularweightbelow10000
Daltons(1).
Doneat.............................................................,
(place).....................................................................
(date)
/SS74Stamp(2)....................................................................................
(signature of the official veterinarian)(2)
....................................................................................
(name, qualification and title, in capital letters)
(1) Delete as appropriate
(2) The signature and the stamp must be in a different colour to that of the printing.!B2001D0009 — EN — 01.03.2001 — 001.001 — 9
ANNEX V
HEALTH CERTIFICATE
for processed animal proteins as defined by Decision 2000/766/EC, other than pet food referred to in Annex I,
Chapter4ofDirective92/118/EECandprocessedanimalproteinlistedinArticle2(2)ofthatDecision,destinedforuses not prohibited by Article 3(1)(a) of Decision 2000/766/EC and intended for intra-Community trade or for
export to third countries
ReferenceNoofthishealthcertificate: ....................................................................................................
Countryofdestination: .....................................................................................................................
MemberStateoforigin: ....................................................................................................................
Responsibleministry: ......................................................................................................................
Certifyingdepartment: .....................................................................................................................
I.Identification of the consignment
Natureoftheprocessedanimalproteinorproduct: ................................................................................
Processedanimalproteinof: ..........................................................................................................
(species)
Natureofpackaging: ............................................................................................................. .....
Numberofpackages: ..................................................................................................................
Netweight: ..................................................................................................................... ........
BatchproductionreferenceNo: ......................................................................................................
II.Origin of the consignment
AddressandapprovalNooftheprocessingplant: ..................................................................................
............................................................................................................................... ............
III.Destination of the consignment
The processed animal proteins will be sentfrom:.......................................................................................................................... ..........
(place of loading)
to: ............................................................................................................................ ...........
(country and place of destination)
by the following means of transport:
— type: ......................................................................................................................... .......
— platenumberornameofthevessel: .............................................................................................
Noofseal: ..............................................................................................................................
Nameandaddressofconsignor: .....................................................................................................
Nameandaddressofconsignee: ......................................................................................................!B2001D0009 — EN — 01.03.2001 — 001.001 — 10
IV.Health attestation
I the undersigned, official veterinarian, certify that the product described above:
— was produced in a plant approved in accordance with Directive 90/667/EEC,— containsprocessedanimalproteinsasdefinedbyDecision2000/766/ECandcannotbeusedforthefeedingoffarmed
animals which are kept, fattened or bred for the production of food.
Doneat.............................................................,
(place).......................................................................
(date)
/SS74Stamp(1)....................................................................................
(signature of the official veterinarian)(1)
....................................................................................
(name, qualification and title,
in capital letters)
(1) The signature and the stamp must be in a different colour to that of the printing.!B2001D0009 — EN — 01.03.2001 — 001.001 — 11