2001D0009 — EN — 01.04.2002 — 002.001 — 1
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►B COMMISSIONDECISION
of29December 2000
concerning control measures required for the implementation of Council Decision 2000/766/EC
concerningcertainprotectionmeasureswithregardtotransmissiblespongiformencephalopathies
andthefeedingofanimalprotein
(notified under document number C(2000) 4412)
(TextwithEEArelevance)
(2001/9/EC)
(OJ L 2, 5.1.2001, p. 32)
Amended by:
Official Journal
No page date
►M1Commission Decision 2001/165/EC of 27 February 2001 L 58 43 28.2.2001
►M2Commission Decision 2002/248/EC of 27 March 2002 L 84 71 28.3.2002
▼B
COMMISSIONDECISION
of29December 2000
concerning control measures required for the implementation of
Council Decision 2000/766/EC concerning certain protectionmeasureswithregardtotransmissiblespongiformencephalopathies
andthefeedingofanimalprotein
(notified under document number C(2000) 4412)
(TextwithEEArelevance)
(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 tothe 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 tothe 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 veterinarychecks 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 spongi-form encephalopathies and the feeding of animal protein(
5),
prohibits the feeding of processed animal proteins to certainfarmed animals. This prohibition does not apply to certain
processed animal proteins subject to conditions to be established.
(2)On 26 June 1998, the Scientific Steering Committee (SSC)adopted an opinion on the safety of dicalcium phosphate precipi-
tated from ruminant bones. That opinion was updated by theSSC on 26 and 27 October 2000. In order to take account ofthat scientific opinion, it is necessary to lay down requirementsfor 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 from bovine hides. This opinion was updated by the
SSC on 25 and 26 May 2000. In order to take account of thatscientific opinion, it is necessary to lay down requirements forthe production of hydrolysed proteins. The SSC stated that amaximum molecular weight of 10 000 Daltons, for the finalproduct produced, may be used as an indicator of the effective-
ness of the production process.
(4)Decision 2000/766/EC establishes that placing on the market,
trade, importation and exportation of processed animal proteinsfor animals not kept, fattened or bred for the production of foodmay be allowed by Member States. It is necessary to set condi-tions to ensure that such proteins cannot be used for nonauthorised purposes.2001D0009 — EN — 01.04.2002 — 002.001 — 2
(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.
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(5)The measures provided for in this Decision are in accordance
with the opinion of the Standing Veterinary Committee,
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◄other 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◄other than ruminants only in accordance with the condi-
tions 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◄other than ruminants, only in accordance with the condi-
tions laid down in Annex III.
4. Member States shall ensure that, for the purpose of trade, dical-
cium phosphate and hydrolysed proteins are accompanied by anofficial certificate as 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 fish-
meal, dicalcium phosphate and hydrolysed proteins, which operate inaccordance with the conditions laid down by this Decision, within 15days after the entry into force of this Decision. Any modification tothe list shall be notified immediately to the other Member States andto the Commission.
Article 2
Member States shall ensure that feedingstuffs, including pet food,
destined to animals other than farmed animals referred to in Article2(1) of Decision 2000/766/EC, which contain processed animalproteins as defined by that Decision are not manufactured in plantswhich prepare feed for farmed animals.
However, where those feedingstuffs are produced with no other
processed animal proteins than fishmeal, dicalcium phosphate andhydrolysed proteins, they may be manufactured in plants which preparefeed for farmed animals other than ruminants in accordance with
Annex I point 6, Annex II point 3 and Annex III point 2, as appro-
priate.
Article 3
1. Member States may send to other Member States processed
animal proteins, as defined in Decision 2000/766/EC, provided theyare destined for uses not prohibited by Article 3(1)(a) of that Decision,
and only if the following 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 lossand 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)2001D0009 — EN — 01.04.2002 — 002.001 — 3
(1) Commission Decision 91/398/EEC (OJ L 221, 9.8.1991, p. 30).▼M1
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the competent authority of the place of destination of each consign-
ment sent. The words ‘not for feed destined to animals which arekept, fattened or bred for the production 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 authorisedpurposes.
2. Member States may export to third countries 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,only if the following conditions are 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 notprohibited by Article 3(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 Commis-
sion 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 notprohibited by Article 3(1)(a) of that Decision, shall be dealt with in
accordance with the conditions laid 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 becarried 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 Commis-sion Decision 97/735/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 certifi-cate referred to in Article 3(1)(b) of the present Decision.2001D0009 — EN — 01.04.2002 — 002.001 — 4
(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.
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Article 5
This Decision shall apply from 1 January 2001.
Article 6
This Decision is addressed to the Member States.2001D0009 — EN — 01.04.2002 — 002.001 — 5
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ANNEXI
CONDITIONSREFERREDTOINARTICLE1(1)
1. Fishmeal shall be produced in processing plants dedicated only to the
production of fish derived products, which shall be approved for this purpose
by the competent authority in accordance with Article 5(2) of Council Direc-
tive 90/667/EEC.
2. Before release for free circulation in Community territory, each consignment
of imported fishmeal shall be analysed in accordance with Commission
Directive 98/88/EC(1).
3. Fishmeal shall be transported directly from the processing plants to the estab-
lishments manufacturing animal feed, by means of vehicles which at the
same 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.
4. Fishmeal shall be transported directly from the border inspection post to the
establishments manufacturing animal feed, in accordance with the conditions
laid down in Article 8 of Directive 97/78/EC, by means of vehicles which at
the same time do not transport other feed materials. If the vehicle is subse-
quently 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
containing fishmeal for other animal species may be permitted by the compe-
tent 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 ruminant
animals, and
— the storage, transport, manufacturing and packaging facilities for the
compound feedingstuffs destined to ruminant animals are completely
separate, and
— records detailing the purchases and uses of fishmeal and the sales of
feedingstuff containing fishmeal are made available to the 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
1 of 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 vehi-
cles which at the same time do not transport feed for ruminant animals. 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 bulk
feedingstuffs 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
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 fishmeal in farms
where ruminant animals are kept, if they are satisfied that on-farm measures
are implemented to prevent that feedingstuffs containing fishmeal is fed to
ruminant animals.2001D0009 — EN — 01.04.2002 — 002.001 — 6
(1) OJ L 318, 27.11.1998, p. 45.▼M2
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▼B
ANNEXII
CONDITIONSREFERREDTOINARTICLE1(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 hydrochloric
acid (at a minimum concentration of 4 % and pH < 1,5) 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 ºC to 325 ºC
and end temperature between 30 ºC to 65 ºC or by an equivalent process
approved in 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 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
containing dicalcium phosphate from deffatted bones for other animal species
may be permitted 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 rumi-
nant animals, 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 phos-
phate from defatted bones are made available to the competent
authority, and
— routine tests are carried out on feedingstuffs destined for ruminant
animals to ensure that prohibited processed animal proteins as defined
by Article 1 of 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 phos-
phate from defatted 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 for ruminant animals. If the vehicle is subsequently used for the trans-
port of other products, it shall be thoroughly cleaned and inspected before
and after the transport of bulk feedingstuffs containing dicalcium phosphate
from defatted bones,
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 phos-
phate from defatted 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
from defatted bones in farms where ruminant animals are kept, if they are
satisfied that on-farm measures are implemented to prevent that feedingstuffscontaining dicalcium phosphate from defatted bones is fed to ruminant
animals.2001D0009 — EN — 01.04.2002 — 002.001 — 7
▼B
ANNEXIII
CONDITIONSREFERREDTOINARTICLE1(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 competent
authority in accordance with Article 5(2) of Directive 90/667/EEC;
— be sampled after processing and found to have a molecular weight below
10000 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 fit
for 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 raw material by brining, liming and intensive washing followed by
exposure of the material to a pH of > 11 for more than three hours at a
temperature of more than 80 ºC and followed by heat treatment at a
temperature of more than 140 ºC for 30 minutes at more than 3,6 bar;
or by an equivalent production process approved in accordance with the
procedure of Article 17 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 competent
authority,
By way of derogation from this provision, the production of feedingstuffs for
ruminant animals in establishments which also produce feedingstuffs
containing hydrolysed 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 ruminant
animals, and
— the storage, transport, manufacturing and packaging facilities for the
compound feedingstuffs destined to ruminant animals are completely
separate, and
— records detailing the purchases and uses of hydrolysed proteins and the
sales of feedingstuff containing hydrolysed proteins are made available
to the 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
1 of 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 rumi-
nant animals’.
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. 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 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
where ruminant animals are kept, if they are satisfied that on-farm measures
are implemented to prevent that feedingstuffs containing hydrolysed proteins
is fed to ruminant animals.2001D0009 — EN — 01.04.2002 — 002.001 — 8
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ANNEXIV
►(1)M12001D0009 — EN — 01.04.2002 — 002.001 — 9
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2001D0009 — EN — 01.04.2002 — 002.001 — 10
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ANNEXV
2001D0009 — EN — 01.04.2002 — 002.001 — 11
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2001D0009 — EN — 01.04.2002 — 002.001 — 12