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11.1.2011 Official
Journal
of
the
European
Union
L
6/15
DECISIONS
COMMISSION DECISION
of 6 January 2011
concerning certain interim protection measures against foot-and-mouth disease in Bulgaria
(notified under document C(2011) 70)
(Text with EEA relevance)
(2011/8/EU)
THE EUROPEAN COMMISSION,
relating to classical swine fever in certain Member
States ( 4 ). However, being listed in Part II of Annex I to
that Decision allows Bulgaria to dispatch under certain
Having regard to the Treaty on the Functioning of the European
health conditions fresh pig meat and meat preparations
Union,
and products produced from such meat.
Having regard to Council Directive 89/662/EEC of
(5) The
disease
situation
in
Bulgaria
makes
it
necessary
to
11 December 1989 concerning veterinary checks in intra-
reinforce the control measures for FMD taken by the
Community trade with a view to the completion of the
competent authorities in Bulgaria.
internal market ( 1 ), and in particular Article 9(3) thereof,
Having regard to Council Directive 90/425/EEC of 26 June
(6) It
is
appropriate
to
define
as
a
permanent
measure
the
1990 concerning veterinary and zootechnical checks applicable
high and low risk areas in the affected Member State and
in intra-Community trade in certain live animals and products
to provide for a prohibition on the dispatch of
with a view to the completion of the internal market (
susceptible animals from the high and low risk areas

2 ), and in
particular Article 10(3) thereof,
and on the dispatch of products derived from susceptible
animals from the high risk area. The Decision should also
provide for the rules applicable to the dispatch from
Whereas:
those areas of safe products that either had been
produced before the restrictions, from raw material
sourced from outside the restricted areas or that had
(1) A
case
of
foot-and-mouth
disease
(‘FMD’)
has
been
undergone a treatment proven effective in inactivating
detected in a wild boar in Burgas region in the South-
possible foot-and-mouth disease virus.
East of Bulgaria within a zone of reinforced surveillance
along the border with Turkey.
(7) The
size
of
the
defined
risk
areas
is
a
direct
function
of
the outcome of tracing of possible contacts to the
(2) The
FMD
situation
in
Bulgaria
is
liable
to
endanger
the
infected holding and takes into account the possibility
herds of other Member States in view of trade in live
to implement sufficient controls on the movement of
biungulate animals and the placing on the market of
animals and products. At this point of time and based
certain of their products.
on information provided by Bulgaria, the whole of
Burgas region should currently remain a high risk area.
(3)
Bulgaria has taken measures in the framework of Council
Directive 2003/85/EC of 29 September 2003 on
Community measures for the control of foot-and-
(8) The
prohibition
of
dispatch
should
only
cover
products
mouth disease (
derived from animals of susceptible species coming from

3 ) (‘the Directive’), in particular the
measures provide for in Article 85(4) of that Directive
or obtained from animals originating in the high risk
and detailed in Annex XVIII thereto.
areas listed in Annex I and should not affect transit

through these areas of such products coming from or
obtained from animals originating in other areas.
(4) The
whole
territory
of
Bulgaria
is
subject
to
the
restrictions of Articles 2, 4, 5, 6, 8b and 11 of
Commission Decision 2008/855/EC of 3 November
(9) Council
Directive
64/432/EEC
( 5 ) concerns animal health
2008 concerning animal health control measures
problems affecting intra-Community trade in bovine
animals and swine.
( 1 ) OJ L 395, 30.12.1989, p. 13.
( 2 ) OJ L 224, 18.8.1990, p. 29.
( 4 ) OJ L 302, 13.11.2008, p. 19.
( 3 ) OJ L 306, 22.11.2003, p. 1.
( 5 ) OJ 121, 29.7.1964, p. 1977/64.

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L 6/16
EN
Official Journal of the European Union
11.1.2011
(10) Council
Directive
91/68/EEC
( 1 ) concerns animal health
(16) Council Directive 92/118/EEC
( 7 ) lays down animal
conditions governing intra-Community trade in ovine
health and public health requirements governing trade
and caprine animals.
in and imports into the Community of products not
subject to the said requirements laid down in specific
Community rules referred to in Annex A(I) to Directive
89/662/EEC and, as regards pathogens, to Directive
90/425/EEC.
(11) 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 and embryos not subject to animal health
requirements laid down in specific Community rules
(17) Regulation (EC) No 1774/2002 of the European
referred to in Annex A(I) to Directive 90/425/EEC ( 2 )
Parliament and of the Council of 3 October 2002
concerns, amongst others, trade in other biungulates
laying down health rules concerning animal by-
and in semen, ova and embryos of sheep and goats,
products not intended for human consumption
( 8 )
and in embryos of porcine animals.
provides for a range of treatments of animal by-
products suitable to inactivate the FMD virus.
(12) Regulation (EC) No 853/2004 of the European
Parliament and of the Council of 29 April 2004 laying
(18) Council
Directive
88/407/EEC
( 9 ) lays down the animal
down specific hygiene rules for food of animal origin ( 3 )
health requirements applicable to intra-Community trade
concerns, amongst others, the health conditions for the
in and imports of deep-frozen semen of domestic
production and marketing of fresh meat, minced meat,
animals of the bovine species.
mechanically separated meat, meat preparations, farmed
game meat, meat products, including treated stomachs,
bladders and intestines, and dairy products.
(19) Council
Directive
89/556/EEC
( 10 ) concerns the animal
health conditions governing intra-Community trade in
and imports from third countries of embryos of
(13) Regulation (EC) No 854/2004 of the European
domestic animals of the bovine species.
Parliament and of the Council of 29 April 2004 laying
down specific rules for the organisation of official
controls on products of animal origin intended for
human consumption ( 4 ) concerns, amongst others, the
(20) Council
Directive
90/429/EEC
( 11 ) lays down the animal
health marking of food of animal origin.
health requirements applicable to intra-Community trade
in and imports of semen of domestic animals of the
porcine species.
(14) Council
Directive
2002/99/EC
of
16
December
2002
laying down the animal health rules governing the
production, processing, distribution and introduction of
(21) The
model
health
certificates
for
trade
within
the
Union
products of animal origin for human consumption ( 5 )
in semen, ova and embryos of animals of the ovine and
provides for specific treatment of meat products that
caprine species and in ova and embryos of animals of the
ensure inactivation of the FMD virus in products of
porcine species are laid down in Commission Decision
animal origin.
2010/470/EU of 26 August 2010 laying down model
health certificates for trade within the Union in semen,
ova and embryos of animals of the equine, ovine and
caprine species and in ova and embryos of animals of the
(15) Commission
Decision
2001/304/EC
of
11
April
2001
porcine species ( 12 ).
on marking and use of certain animal products in
relation to Decision 2001/172/EC concerning certain
protection measures with regard to foot-and-mouth
disease in the United Kingdom ( 6 ) concerns a specific
(22) Council
Decision
2009/470/EC
of
25
May
2009
on
health mark to be applied to certain products of
expenditure in the veterinary field ( 13 ) provides for a
animal origin that shall be restricted to the national
mechanism to compensate affected holdings for losses
market. It is appropriate to lay down in a separate
incurred as a result of disease control measures.
Annex a similar marking in the case of FMD in Bulgaria.
( 7 ) OJ L 62, 15.3.1993, p. 49.
( 1 ) OJ L 46, 19.2.1991, p. 19.
( 8 ) OJ L 273, 10.10.2002, p. 1.
( 2 ) OJ L 268, 14.9.1992, p. 54.
( 9 ) OJ L 194, 22.7.1988, p. 10.
( 3 ) OJ L 139, 30.4.2004, p. 55.
( 10 ) OJ L 302, 19.10.1989, p. 1.
( 4 ) OJ L 139, 30.4.2004, p. 206.
( 11 ) OJ L 224, 18.8.1990, p. 62.
( 5 ) OJ L 18, 23.1.2003, p. 11.
( 12 ) OJ L 228, 31.8.2010, p. 15.
( 6 ) OJ L 104, 13.4.2001, p. 6.
( 13 ) OJ L 155, 18.6.2009, p. 30.

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EN
11.1.2011 Official
Journal
of
the
European
Union
L
6/17
(23) In
so
far
as
medicinal
products
defined
in
Directive
HAS ADOPTED THIS DECISION:
2001/82/EC of the European Parliament and of the
Council of 6 November 2001 on the Community code
relating to veterinary medicinal products ( 1 ), Directive
2001/83/EC of the European Parliament and of the
Article 1
Council of 6 November 2001 on the Community code
relating to medicinal products for human use ( 2 ), and
Live animals
Directive 2001/20/EC of the European Parliament and
1. Without
prejudice
to
the
measures
taken
by
Bulgaria
of the Council of 4 April 2001 on the approximation
within the framework of
of the laws, regulations and administrative provisions of
the Member States relating to the implementation of
good clinical practice in the conduct of clinical trials
on medicinal products for human use ( 3 ) no longer fall
under the scope of Regulation (EC) No 1774/2002 they
(a) Directive 2003/85/EC, and in particular those provided for
should be excluded from animal health related
in Article 85(4) of that Directive and detailed in Annex
restrictions set up by this Decision.
XVIII thereto; and
(b) Articles 2 and 4 of Decision 2008/855/EC;
(24) Article 6 of Commission Decision 2007/275/EC of
17 April 2007 concerning lists of animals and
products to be subject to controls at border inspection
posts under Council Directives 91/496/EEC and
Bulgaria shall ensure that the conditions set out in paragraphs 2
97/78/EC ( 4 ) provides for a derogation from the
to 7 of this Article are met.
veterinary checks for certain products containing
animal products. It is appropriate to allow dispatch
from the high risk areas of such products under a
simplified certification regime.
2. No
live
animals
of
the
bovine,
ovine,
caprine
and
porcine
species and other biungulates shall move between the areas
listed in Annex I and Annex II.
(25) Member
States
other
than
Bulgaria
should
support
the
disease control measures carried out in the affected areas
by ensuring that live susceptible animals are not
3. No
live
animals
of
the
bovine,
ovine,
caprine
and
porcine
consigned to those areas.
species and other biungulates shall be dispatched from or
moved through the areas listed in Annex I and Annex II.
(26) To
better
understand
the
epidemiological
situation
and
to
facilitate the detection of possible infection, it is
4. By way of derogation from paragraph 3, the competent
necessary to enforce a prolonged standstill for livestock
authorities of Bulgaria may authorise the direct and uninter
in the Member State concerned while granting the possi
rupted transit of biungulate animals through the areas listed
bility for slaughter and the transport of equidae under
in Annex I and Annex II on main roads and railway lines.
controlled conditions.
5. The
health
certificates,
as
provided
for
in
Directive
64/432/EEC for live bovine animals and, without prejudice to
(27) Pending the meeting of the Standing Committee on the
Articles 8b and 9 of Decision 2008/855/EC, for porcine
Food Chain and Animal Health and in collaboration with
animals and in Directive 91/68/EEC for live ovine and caprine
the Member State concerned the Commission should
animals, accompanying animals consigned from parts of the
take interim protection measures relating to FMD in
territory of Bulgaria not listed in Annex I and Annex II to
Bulgaria.
other Member States shall bear the following words:
(28) The
situation
shall
be
reviewed
at
the
meeting
of
the
‘Animals conforming to Commission Decision 2011/8/EU of
Standing Committee on the Food Chain and Animal
6 January 2011 concerning certain interim protection
Health scheduled for 11-12 January 2011, and the
measures against foot-and-mouth disease in Bulgaria (*).
measures adapted where necessary,
( 1 ) OJ L 311, 28.11.2001, p. 1.
( 2 ) OJ L 311, 28.11.2001, p. 67.
___________
( 3 ) OJ L 121, 1.5.2001, p. 34.
(*) OJ L 6, 11.1.2011, p. 15.’
( 4 ) OJ L 116, 4.5.2007, p. 9.

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L 6/18
EN
Official Journal of the European Union
11.1.2011
6. The
health
certificates
accompanying
biungulates
other (a) the meat is clearly identified, and has been transported and
than those covered by the certificates referred to in paragraph
stored since the date of production separately from meat
5, consigned from parts of the territory of Bulgaria not listed in
which is not eligible, in accordance with this Decision, for
Annex I and Annex II to other Member States shall bear the
dispatch outside the areas listed in Annex I;
following words:
(b) the meat complies with one of the following conditions:
‘Live biungulates conforming to Commission Decision
2011/8/EU of 6 January 2011 concerning certain interim
protection measures against foot-and-mouth disease in
Bulgaria (*).
(i) it was obtained before the date of application of this
Decision; or
___________
(ii) it is derived from animals that have been reared for at
(*) OJ L 6, 11.1.2011, p. 15.’
least 90 days, or since birth if less than 90 days of age,
prior to the date of slaughter and which have been
slaughtered, or in the case of meat obtained from
wild game of species susceptible to foot-and-mouth
7. Animals
accompanied
by
an
animal
health
certificate
as
disease (‘wild game’) killed, outside the areas listed in
referred to in paragraphs 5 and 6 may be moved to other
Annexes I and II; or
Member States only if the local veterinary authority in
Bulgaria has, three days before the move, notified the central
and local veterinary authorities in the Member State of
(iii) it complies with the conditions set out in points (c), (d)
destination.
and (e);
8. By
way
of
derogation
from
paragraph
2
the
competent (c) the meat was obtained from domestic ungulates or from
authorities of Bulgaria may authorise the transport of animals of
farmed game of species susceptible to foot-and-mouth
species susceptible to foot-and-mouth disease from holding
disease (‘farmed game’), as specified for the respective
situated in areas listed in Annex II to a slaughterhouse
category of meat in one of the appropriate columns 4 to
situated in the areas listed in Annex I.
7 in Annex III, and complies with the following conditions:
Article 2
(i) the animals have been reared for at least 90 days prior
Meats
to the date of slaughter, or since birth if less than 90
days of age, on holdings situated within the areas
1. For
the
purposes
of
this
Article,
‘meats’
means
‘fresh
meat’,
specified in columns 1, 2 and 3 of Annex III, where
‘minced meat’, ‘mechanically separated meat’ and ‘meat prep
there has been no outbreak of foot-and-mouth disease
arations’ as defined in points 1.10, 1.13, 1.14 and 1.15 of
during at least 90 days prior to the date of slaughter;
Annex I to Regulation (EC) No 853/2004.
(ii) during the 21 days prior to the date of transport to the
2. Bulgaria
shall
not
dispatch
meats
of
the
bovine,
ovine,
slaughterhouse, or in the case of farmed game prior to
caprine and porcine species and other biungulates coming
the date of on-farm slaughtering, the animals have
from or obtained from animals originating in the areas listed
remained under the supervision of the competent
in Annex I.
veterinary authorities on a single holding which is
situated in the centre of a circle around the holding
of at least 10 km radius, where there has been no
outbreak of foot-and-mouth disease during at least 30
3. Meats not eligible for dispatch from Bulgaria in
days prior to the date of loading;
accordance with this Decision shall be marked in accordance
with the second subparagraph of Article 4(1) of Directive
2002/99/EC or in accordance with Annex IV.
(iii) no animals of species susceptible to foot-and-mouth
disease have been introduced into the holding referred
to in point (ii) during the 21 days prior to the date of
4. Without
prejudice
to
Articles
6
and
8b
of
Decision
loading, or in the case of farmed game prior to the date
2008/855/EC, the prohibition set out in paragraph 2 shall
of on-farm slaughtering, except in the case of pigs
not apply to meats bearing the health mark in accordance
coming from a supplying holding which complies
with Chapter III of Section I of Annex I to Regulation
with the conditions laid down in point (ii), in which
(EC) No 854/2004, provided that:
case the period of 21 days may be reduced to 7 days;

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EN
11.1.2011 Official
Journal
of
the
European
Union
L
6/19
However, the competent authority may authorise the
— the animals referred to in point (c)(iv) have been
introduction into the holding referred to in point (ii)
transported to the establishment without contact
of animals of species susceptible to foot-and-mouth
to holdings situated in areas not specified in
disease which comply with the conditions set out in
columns 1, 2 and 3 of Annex III, and
points (i) and (ii) and which
— the establishment is not situated in a protection
— come from a holding where no animals of species
zone;
susceptible to foot-and-mouth disease have been
introduced during the 21 days prior to the date
of transport to the holding referred to in point
(ii),except in the case of pigs coming from a
(ii) the meat is at all times clearly identified, handled, stored
supplying holding in which case the period of 21
and transported separately from meat which is not
days may be reduced to 7 days, or
eligible for dispatch from the area listed in Annex I;
(iii) during post-mortem inspection by the official
— were subjected with negative results to a test for
veterinarian in the establishment of dispatch, or in
antibodies against the foot-and-mouth disease
the case of on-farm slaughtering of farmed game on
virus carried out on a blood sample taken within
the holding referred to in point (c)(ii), or in the case of
10 days prior to the date of transport to the
wild game at the game-handling establishment, no
holding referred to in point (ii), or
clinical signs or post-mortem evidence of foot-and-
mouth disease were established;
— come from a holding that was subjected with
negative results to a serological survey pursuant to
(iv) the meat has remained in the establishments or
a sampling protocol suitable to detect 5
%
holdings referred to in point (e)(iii) for at least 24
prevalence of foot-and-mouth disease with at least
hours following the post-mortem inspection of the
a 95 % level of confidence;
animals referred to in points (c) and (d);
(iv) the animals or, in the case of farmed game slaughtered
(v) any further preparation of meat for dispatch outside the
on the farm, the carcases have been transported under
area listed in Annex I shall be suspended:
official control in means of transport that have been
cleansed and disinfected before loading from the
holding referred to in point (ii) to the designated
slaughterhouse;
— in the case where foot-and-mouth disease has been
diagnosed in the establishments or holdings referred
to in point (e)(iii), until the slaughter of all animals
present and the removal of all meat and dead
(v) the animals have been slaughtered less than 24 hours
animals has been completed, and at least 24
following the time of arrival at the slaughterhouse and
hours have elapsed since the completion of the
separately from animals the meat of which is not
total cleansing and disinfection of those estab
eligible for dispatch from the area listed in Annex I;
lishments and holdings under the control of an
official veterinarian, and
(d) the meat, if positively marked in column 8 of Annex III,
— in the case of slaughter in the same establishment of
was obtained from wild game, that was killed in areas where
animals susceptible to foot-and-mouth disease
there has been no outbreak of foot-and-mouth disease for at
coming from holdings situated in areas listed in
least a period of 90 days before the date of killing and at a
Annex I that do not comply with the conditions
distance of at least 20 km from areas not specified in
set out in point 4(c) or (d), until the slaughter of
columns 1, 2 and 3 of Annex III;
all such animals and the cleansing and disinfection
of those establishments have been completed under
the control of an official veterinarian;
(e) Meat referred to in points (c) and (d) must in addition
comply with the following conditions:
(vi) the central veterinary authorities shall communicate to
the other Member States and the Commission a list of
those establishments and holdings which they have
(i) the dispatch of such meat is only to be authorised by
approved for the purposes of application of points
the competent veterinary authority of Bulgaria, if
(c), (d) and (e).

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L 6/20
EN
Official Journal of the European Union
11.1.2011
5. Compliance with the conditions set out in paragraphs 3
meat obtained from cutting plants situated in the areas listed in
and 4 shall be checked by the competent veterinary authority
Annex I under the following conditions:
under the supervision of the central veterinary authorities.
(a) only fresh meat as described in paragraph 4(b) is processed
6. Without
prejudice
to
Articles
6
and
8b
of
Decision
in that cutting plant, on the same day. Cleaning and disin
2008/855/EC, the prohibition set out in paragraph 2 of this
fection shall be carried out after processing of any meat not
Article shall not apply to fresh meat obtained from animals
meeting this requirement;
reared outside the areas listed in Annex I and Annex II and
transported, by way of derogation from Article 1(2) and (3),
directly and under official control without contact to holdings
situated in areas listed in Annex I to a slaughterhouse situated
(b) all meat bears the health mark in accordance with Chapter
in the areas listed in Annex I outside the protection zone for
III of Section I of Annex I to Regulation (EC) No 854/2004;
immediate slaughter, provided that such fresh meat is only
placed on the market in the areas listed in Annex I and
Annex II and complies with the following conditions:
(c) the cutting plant is operated under strict veterinary control;
(a) all such fresh meat is marked in accordance with the second
subparagraph of Article 4(1) of Directive 2002/99/EC or in
(d) the fresh meat is clearly identified, and transported and
accordance with Annex IV to this Decision;
stored separately from meat which is not eligible for
dispatch outside the areas listed in Annex I.
(b) the slaughterhouse
Compliance with the conditions set out in the first
subparagraph shall be checked by the competent veterinary
authority under the supervision of the central veterinary
(i) is operated under strict veterinary control;
authorities.
(ii) suspends any further preparation of meat for dispatch
The central veterinary authorities shall communicate to the
outside the areas listed in Annex I in the case of
other Member States and the Commission a list of the estab
slaughter in the same slaughterhouse of animals
lishments which they have approved for the purpose of
susceptible to foot-and-mouth disease coming from
application of this paragraph.
holdings situated in areas listed in Annex I until the
slaughter of all such animals and the cleansing and
disinfection of the slaughterhouse have been
completed under the control of an official veterinarian;
8. Meat
dispatched
from
Bulgaria
to
other
Member
States
shall be accompanied by an official certificate, which shall
bear the following words:
(c) the fresh meat is clearly identified, and transported and
stored separately from meat which is eligible for dispatch
outside Bulgaria.
‘Meat conforming to Commission Decision 2011/8/EU of
6 January 2011 concerning certain interim protection
measures against foot-and-mouth disease in Bulgaria (*).
(d) Compliance with the conditions set out in the first
subparagraph shall be checked by the competent veterinary
___________
authority under the supervision of the central veterinary
authorities.
(*) OJ L 6, 11.1.2011, p. 15.’
(e) The central veterinary authorities shall communicate to the
Commission and to the other Member States a list of the
Article 3
establishments which they have approved for the purposes
Meat products
of
application of this paragraph.
1. Bulgaria shall not dispatch meat products, including
treated stomachs, bladders and intestines, of animals of the
bovine, ovine, caprine and porcine species and other biun
gulates (‘meat products’) coming from the areas listed in
7. Without
prejudice
to
Article
6
of
Decision
2008/855/EC, Annex I or prepared using meat obtained from animals
the prohibition set out in paragraph 2 shall not apply to fresh
originating in those areas.

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EN
11.1.2011 Official
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European
Union
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2. Without
prejudice
to
Articles
6
and
8b
of
Decision recorded, that compliance with the conditions required for the
2008/855/EC, the prohibition set out in paragraph 1 shall
treatment laid down in point (b)(ii) of the first subparagraph of
not apply to meat products, including treated stomachs,
paragraph 2 is stated in the commercial document accom
bladders and intestines, bearing the health mark in accordance
panying the consignment, endorsed in accordance with
with Chapter III of Section I of Annex I to Regulation (EC) No
Article 9(1).
854/2004, provided that the meat products:
5. By
way
of
derogation
from
paragraph
3
it
shall
be
(a) are clearly identified and have been transported and stored
sufficient, in the case of meat products heat treated in
since the date of production separately from meat products
accordance with point (b)(ii) of the first subparagraph of
not eligible, in accordance with this Decision, for dispatch
paragraph 2 in hermetically sealed containers so as to ensure
outside the areas listed in Annex I;
that they are shelf stable, to be accompanied by a commercial
document stating the heat treatment applied.
(b) comply with one of the following conditions:
Article 4
(i) they are made from meats described in Article 2(4)(b);
Colostrums and milk
or
1. Bulgaria
shall
not
dispatch
colostrums
and
milk
from
animals of species susceptible to foot-and-mouth disease
intended or not intended for human consumption from the
(ii) they have undergone at least one of the relevant
areas listed in Annex I.
treatments laid down for foot-and-mouth disease in
Part 1 of Annex III to Directive 2002/99/EC.
2. The prohibition set out in paragraph 1 shall not apply to
milk produced from bovine, ovine and caprine animals kept in
Compliance with the conditions set out in the first
areas listed in Annex I which has been subjected to a treatment
subparagraph shall be checked by the competent veterinary
in accordance with:
authority under the supervision of the central veterinary
authorities.
(a) Part A of Annex IX to Directive 2003/85/EC, if the milk is
intended for human consumption; or
The central veterinary authorities shall communicate to the
other Member States and the Commission a list of the estab
lishments which they have approved for the purpose of
application of this paragraph.
(b) Part B of Annex IX to Directive 2003/85/EC, if the milk is
not intended for human consumption or is intended for
feeding to animals of species susceptible to foot-and-
mouth disease.
3. Meat
products
dispatched
from
Bulgaria
to
other
Member
States shall be accompanied by an official certificate, which shall
bear the following words:
3. The prohibition set out in paragraph 1 shall not apply to
milk from bovine, ovine and caprine animals prepared in estab
‘Meat products, including treated stomachs, bladders and
lishments situated in the areas listed in Annex I under the
intestines, conforming to Commission Decision 2011/8/EU of
following conditions:
6 January 2011 concerning certain interim protection measures
against foot-and-mouth disease in Bulgaria (*).
(a) all milk used in the establishment must either conform
to the conditions set out in paragraph 2 or be obtained
___________
from animals reared and milked outside the areas listed in
(*) OJ L 6, 11.1.2011, p. 15.’
Annex I;
(b) the establishment is operated under strict veterinary control;
4. By
way
of
derogation
from
paragraph
3
it
shall
be
sufficient, in the case of meat products which comply with
the requirements of paragraph 2 and have been processed in
an establishment operating hazard analysis and critical control
(c) the milk must be clearly identified, and transported and
points (HACCP) and an auditable standard operating procedure
stored separately from milk and dairy products which are
which ensures that standards for treatment are met and
not eligible for dispatch outside the areas listed in Annex I;

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Official Journal of the European Union
11.1.2011
(d) transport of raw milk from holdings situated outside the
2. The prohibition set out in paragraph 1 shall not apply to
areas listed in Annex I to the establishments situated in
dairy products:
the areas listed in Annex I is carried out in vehicles which
were cleaned and disinfected prior to operation and had no
subsequent contact with holdings in the areas listed in
Annex I keeping animals of species susceptible to foot-
(a) produced before the date of application of this Decision; or
and-mouth disease.
(b) prepared from milk complying with the provisions in
Compliance with the conditions set out in the first
Article 4(2) or (3); or
subparagraph shall be checked by the competent veterinary
authority under the supervision of the central veterinary
authorities.
(c) for export to a third country where import conditions
permit such products to be subject to treatment other
The central veterinary authorities shall communicate to the
than those laid down in Article 4(2) which ensures the
other Member States and the Commission a list of the estab
inactivation of the foot-and-mouth disease virus.
lishments which they have approved for the purpose of
application of this paragraph.
3. Without prejudice to Chapter II of Section IX of Annex III
to Regulation (EC) No 853/2004, the prohibition set out in
4. Milk
dispatched
from
Bulgaria
to
other
Member
States paragraph 1 of this Article shall not apply to the following
shall be accompanied by an official certificate, which shall
dairy products intended for human consumption:
bear the following words:
(a) dairy products produced from milk of a controlled pH less
‘Milk conforming to Commission Decision 2011/8/EU of
than 7,0 and subject to a heat treatment at a temperature of
6 January 2011 concerning certain interim protection
at least 72 °C for at least 15 seconds, on the understanding
measures against foot-and-mouth disease in Bulgaria (*).
that such treatment was not necessary for finished products,
the ingredients of which comply with the respective animal
health conditions laid down in Articles 2, 3 and 4 of this
___________
Decision;
(*) OJ L 6, 11.1.2011, p. 15.’
(b) dairy products produced from raw milk of bovine, ovine or
caprine animals which have been resident for at least 30
5. By
way
of
derogation
from
paragraph
4
it
shall
be
days on a holding situated, within an area listed in Annex I,
sufficient, in the case of milk which complies with the
in the centre of a circle of at least 10 km radius in which no
requirements of paragraph 2 and has been processed in an
outbreak of foot-and-mouth disease has occurred during 30
establishment operating HACCP and an auditable standard
days prior to the date of production of the raw milk, and
operating procedure which ensures that standards for
subject to a maturation or ripening process of at least 90
treatment are met and recorded, that compliance with those
days during which the pH is lowered below 6,0 throughout
requirements is stated in the commercial document accom
the substance, and the rind of which has been treated with
panying the consignment, endorsed in accordance with
0,2 % citric acid immediately prior to wrapping or
Article 9(1).
packaging.
6. By
way
of
derogation
from
paragraph
4
it
shall
be
4. The prohibition set out in paragraph 1 shall not apply to
sufficient, in the case of milk which complies with the
dairy products prepared in establishments situated in the areas
requirements in paragraph 2(a) or (b) and which has been
listed in Annex I under the following conditions:
heat treated in hermetically sealed containers so as to ensure
that it is shelf stable, to be accompanied by a commercial
document stating the heat treatment applied.
(a) all milk used in the establishment either complies with the
conditions laid down in Article 4(2) or is obtained from
animals outside the areas listed in Annex I;
Article 5
Dairy products
1. Bulgaria shall not dispatch dairy products produced from
(b) all dairy products used in the final products either comply
colostrums and milk from animals of species susceptible to
with the conditions set out in paragraph 2(a) and (b) or
foot-and-mouth disease intended or not intended for human
paragraph 3 or are made from milk obtained from
consumption from the areas listed in Annex I.
animals outside the areas listed in Annex I;

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Union
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(c) the establishment is operated under strict veterinary control;
Article 6
Semen, ova and embryos
(d) the dairy products are clearly identified and transported and
1. Bulgaria
shall
not
dispatch
semen,
ova
and
embryos
of
the
stored separately from milk and dairy products which are
bovine, ovine, caprine and porcine species and other biun
not eligible for dispatch outside the areas listed in Annex I.
gulates (‘semen, ova and embryos’) from the areas listed in
Annex I and Annex II.
Compliance with the conditions set out in the first
subparagraph shall be checked by the competent authority
under the responsibility of the central veterinary authorities.
2. Without
prejudice
to
Article
5
of
Decision
2008/855/EC,
the prohibitions set out in paragraph 1 shall not apply to:
The central veterinary authorities shall communicate to the
other Member States and the Commission a list of the estab
lishments which they have approved for the purposes of
(a) semen, ova and embryos produced before the date of
application of this paragraph.
application of this Decision;
5. The
prohibition
set
out
in
paragraph
1
shall
not
apply
to
dairy products prepared in establishment situated outside the
areas listed in Annex I using milk obtained before the date of
(b) frozen bovine semen and embryos, frozen porcine semen,
application of this Decision, provided that the dairy products
and frozen ovine and caprine semen and embryos imported
are clearly identified and transported and stored separately from
into Bulgaria in accordance with the conditions laid down
dairy products which are not eligible for dispatch outside those
in Directives 88/407/EEC, 89/556/EEC, 90/429/EEC or
areas.
92/65/EEC respectively, and which since their introduction
into Bulgaria have been stored and transported separately
from semen, ova and embryos not eligible for dispatch in
accordance with paragraph 1;
6. Dairy
products
dispatched
from
Bulgaria
to
other
Member
States shall be accompanied by an official certificate, which shall
bear the following words:
(c) frozen semen and embryos obtained from bovine, porcine,
ovine and caprine animals kept for at least 90 days prior to
‘Dairy products conforming to Commission Decision
the date of and during collection outside the areas listed in
2011/8/EU of 6 January 2011 concerning certain interim
Annex I and Annex II and which:
protection measures against foot-and-mouth disease in
Bulgaria (*).
___________
(i) have been be stored in approved conditions for a
minimum period of 30 days prior to the date of
(*) OJ L 6, 11.1.2011, p. 15.’
dispatch; and
7. By
way
of
derogation
from
paragraph
6
it
shall
be
sufficient, in the case of dairy products which comply with
(ii) have been collected from donor animals standing in
the requirements of paragraph 2(a) and (b) and paragraphs 3
centres or on holdings which have been free from
and 4 and have been processed in an establishment operating
foot-and-mouth disease for at least three months prior
HACCP and an auditable standard operating procedure which
to the date of collection of the semen or embryos and
ensures that standards for treatment are met and recorded, that
30 days after the date of collection and which are
compliance with those requirements is stated in the commercial
situated in the centre of an area of 10 kilometres
document accompanying the consignment, endorsed in
radius in which there has been no case of foot-and-
accordance with Article 9(1).
mouth disease for at least 30 days prior to the date
of collection.
8. By
way
of
derogation
from
paragraph
6
it
shall
be
sufficient, in the case of dairy products which comply with
the requirements of paragraph 2(a) and (b) and paragraphs 3
(d) Before the dispatch of the semen or embryos referred to in
and 4 and which have been heat treated in hermetically sealed
points (a), (b) and (c) the central veterinary authorities shall
containers so as to ensure that they are shelf stable, to be
communicate to the other Member States and the
accompanied by a commercial document stating the heat
Commission a list of centres and teams approved for the
treatment applied.
purpose of application of this paragraph.

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Official Journal of the European Union
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3. The health certificate provided for in Directive 7. The
health
certificate
provided
for
in
Directive
92/65/EEC
88/407/EEC and accompanying frozen bovine semen
and accompanying frozen ovine or caprine embryos dispatched
dispatched from Bulgaria to other Member States shall bear
from Bulgaria to other Member States shall bear the following
the following words:
words:
‘Frozen bovine semen conforming to Commission Decision
2011/8/EU of 6 January 2011 concerning certain interim
‘Frozen ovine/caprine embryos conforming to Commission
protection measures against foot-and-mouth disease in
Decision 2011/8/EU of 6 January 2011 concerning certain
Bulgaria (*).
interim protection measures against foot-and-mouth disease in
Bulgaria (*).
___________
(*) OJ L 6, 11.1.2011, p. 15.’
___________
(*) OJ L 6, 11.1.2011, p. 15.’
4. Without prejudice to Article 9(b) of Decision
2008/855/EC, the health certificate provided for in Directive
90/429/EEC and accompanying frozen porcine semen
8. Without prejudice to Article 9(c) of Decision
dispatched from Bulgaria to other Member States shall bear
2008/855/EC, the health certificate provided for in Directive
the following words:
92/65/EEC and accompanying frozen porcine embryos
dispatched from Bulgaria to other Member States shall bear
the following words:
‘Frozen porcine semen conforming to Commission Decision
2011/8/EU of 6 January 2011 concerning certain interim
protection measures against foot-and-mouth disease in
Bulgaria (*).
‘Frozen porcine embryos conforming to Commission Decision
2011/8/EU of 6 January 2011 concerning certain interim
protection measures against foot-and-mouth disease in
___________
Bulgaria (*).
(*) OJ L 6, 11.1.2011, p. 15.’
___________
5. The health certificate provided for in Directive (*) OJ L 6, 11.1.2011, p. 15.’
89/556/EEC and accompanying bovine embryos dispatched
from Bulgaria to other Member States shall bear the following
words:
Article 7
‘Bovine embryos conforming to Commission Decision
Hides and skins
2011/8/EU of 6 January 2011 concerning certain interim
protection measures against foot-and-mouth disease in
1. Bulgaria shall not dispatch skins of animals of the porcine
Bulgaria (*).
species (‘skins’) from the areas listed in Annex I.
___________
2. The prohibition set out in paragraph 1 shall not apply to
(*) OJ L 6, 11.1.2011, p. 15.’
skins which:
6. The
health
certificate
provided
for
in
Directive
92/65/EEC
(a) were produced in Bulgaria before the date of application of
and accompanying frozen ovine or caprine semen dispatched
this Decision; or
from Bulgaria to other Member States shall bear the following
words:
(b) comply with the requirements provided for in point (2)(c)
‘Frozen ovine/caprine semen conforming to Commission
or (d) of Part A of Chapter VI of Annex VIII to Regulation
Decision 2011/8/EU of 6 January 2011 concerning certain
(EC) No 1774/2002; or
protection measures against foot-and-mouth disease in
Bulgaria (*).
(c) were produced outside the areas listed in Annex I in
accordance with the conditions laid down in Regulation
___________
(EC) No 1774/2002, and have since introduction into
(*) OJ L 6, 11.1.2011, p. 15.’
Bulgaria been stored and transported separately from skins
not eligible for dispatch in accordance with paragraph 1.

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Treated pig skins shall be separated from untreated hides and
— in a hermetically sealed container with a Fo value of
skins of animals of species susceptible to foot-and-mouth
3,00 or more, or
disease.
— in which the centre temperature is raised to at least
3. Bulgaria shall ensure that skins to be dispatched to other
70 °C; or
Member States shall be accompanied by an official certificate
which bears the following words:
(ii) were produced outside the areas listed in Annex I in
accordance with the conditions laid down in Regulation
‘Skins conforming to Commission Decision 2011/8/EU of
(EC) No 1774/2002, and which since introduction into
6 January 2011 concerning certain interim protection
Bulgaria have been stored and transported separately
measures against foot-and-mouth disease in Bulgaria (*).
from animal products not eligible for dispatch in
accordance with paragraph 1;
___________
(*) OJ L 6, 11.1.2011, p. 15.’
(b) blood and blood products as defined in points 4 and 5 of
Annex I to Regulation (EC) No 1774/2002 which have been
subjected to at least one of the treatments provided for in
point 4(a) of Part A of Chapter IV of Annex VIII to Regu
4. By
way
of
derogation
from
paragraph
3
it
shall
be
lation (EC) No 1774/2002, followed by an effectiveness
sufficient, in the case of skins which comply with the
check, or have been imported in accordance with Part A
requirements of points (1)(b) to (e) of Part A of Chapter VI
of Chapter IV of Annex VIII to Regulation (EC) No
of Annex VIII to Regulation (EC) No 1774/2002, to be accom
1774/2002;
panied by a commercial document stating compliance with
those requirements.
(c) lard and rendered fats which have been subject to the heat
treatment prescribed in point 2(d)(iv) of Part B of Chapter
5. By
way
of
derogation
from
paragraph
3
it
shall
be
IV of Annex VII to Regulation (EC) No 1774/2002;
sufficient, in the case of skins which comply with the
requirements of point (2)(c) or (d) of Part A of Chapter VI of
Annex VIII to Regulation (EC) No 1774/2002, that compliance
(d) animal casings complying with the conditions in Part A of
with those requirements is stated in the commercial document
Chapter 2 of Annex I to Directive 92/118/EEC and which
accompanying the consignment, endorsed in accordance with
have been cleaned, scraped and then either salted, bleached
Article 9(1).
or dried, followed by steps to prevent the recontamination
of the casings;
Article 8
Other animal products
(e) sheep wool, ruminant hair and pigs bristles which have
undergone factory washing or have been obtained from
1. Bulgaria shall not dispatch products of animals of the
tanning and unprocessed sheep wool, ruminant hair and
bovine, ovine, caprine and porcine species and other biun
pigs bristles which are securely enclosed in packaging and
gulates not mentioned in Articles 2 to 7 produced after the
dry;
date of application of this Decision and coming from the
areas listed in Annex I, or obtained from animals originating
in the areas listed in Annex I.
(f) petfood conforming to the requirements of points 2, 3 and
4 of Part B of Chapter II of Annex VIII to Regulation
(EC) No 1774/2002;
Bulgaria shall not dispatch dung and manure of the bovine,
ovine, caprine and porcine species and other biungulates from
the areas listed in Annex I.
(g) composite products which are not subject to further
treatment containing products of animal origin, on the
understanding that the treatment was not necessary for
2. The prohibition set out in the first subparagraph of
finished products, the ingredients of which comply with
paragraph 1 shall not apply to:
the respective animal health conditions laid down in this
Decision;
(a) animal products which:
(h) game trophies in accordance with points 1, 3 or 4 of Part A
of Chapter VII of Annex VIII to Regulation (EC) No
(i) have been subjected to a heat treatment
1774/2002;

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L 6/26
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Official Journal of the European Union
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(i) packed animal products intended for use as in-vitro
8. Derogating
from
the
provisions
in
paragraph
3,
it
shall
be
diagnostic, laboratory reagents;
sufficient, in the case of composite products that fulfil the
conditions set out in Article 6(1) of Decision 2007/275/EC
that they are accompanied by a commercial document, which
(j) medicinal products as defined in Directive 2001/83/EC,
bears the following words:
medical devices manufactured utilising animal tissue which
is rendered non-viable as referred to in Article 1(5)(g) of
Directive 93/42/EEC, veterinary medicinal products as
‘These composite products are shelf stable at ambient
defined in Directive 2001/82/EC, and investigational
temperature or have clearly undergone in their manufacture a
medicinal products as defined in Directive 2001/20/EC.
complete cooking or heat treatment process throughout their
substance, so that any raw material is de-natured’.
3. Bulgaria
shall
ensure
that
the
animal
products
referred
to
in paragraph 2 to be dispatched to other Member States shall be
accompanied by an official certificate which bears the following
Article 9
words:
Certification
1. Where reference is made to this paragraph, the competent
‘Animal products conforming to Commission Decision
authorities of Bulgaria shall ensure that the commercial
2011/8/EU of 6 January 2011 concerning certain interim
document required by Union legislation for trade between
protection measures against foot-and-mouth disease in
Member States is endorsed by the attachment of a copy of an
Bulgaria (*).
official certificate stating that:
___________
(a) the products concerned have been produced
(*) OJ L 6, 11.1.2011, p. 15.’
(i) in a production process that has been audited and found
in compliance with the appropriate requirements in
4. By
way
of
derogation
from
paragraph
3,
it
shall
be
Union animal health legislation and suitable to destroy
sufficient, in the case of the products referred to in paragraph
the foot-and-mouth disease virus; or
2(a) to (d) and (f) of this Article that compliance with the
conditions for the treatment stated in the commercial
document required in accordance with the respective Union
legislation is endorsed in accordance with Article 9(1).
(ii) from pre-processed materials which had been certified
accordingly; and
5. By
way
of
derogation
from
paragraph
3
it
shall
be
sufficient, in the case of products referred to in paragraph
2(e) to be accompanied by a commercial document stating
(b) provisions are in place to avoid possible re-contamination
either the factory washing or origin from tanning or compliance
with the foot-and-mouth disease virus after treatment.
with the conditions laid down in points 1 and 4 of Part A of
Chapter VIII of Annex VIII to Regulation (EC) No 1774/2002.
Such certification of the production process shall bear a
reference to this Decision, shall be valid for 30 days, shall
6. By
way
of
derogation
from
paragraph
3
it
shall
be state the expiry date and shall be renewable after inspection
sufficient, in the case of products referred to in paragraph
of the establishment.
2(g) which have been produced in an establishment operating
HACCP and an auditable standard operating procedure which
ensures that pre-processed ingredients comply with the
respective animal health conditions laid down in this
2. In
case
of
products
for
retail
sale
to
the
final
consumer,
Decision, that this is stated on the commercial document
the competent authorities of Bulgaria may authorise
accompanying the consignment, endorsed in accordance with
consolidated consignments of animal products other than
Article 9(1).
fresh meat, minced meat, mechanically separated meat and
meat preparations, each of which is eligible for dispatch in
accordance with this Decision, to be accompanied by a
commercial document endorsed by the attachment of a copy
7. By
way
of
derogation
from
paragraph
3,
it
shall
be of an official veterinary certificate confirming that:
sufficient, in the case of products referred to in paragraph 2(i)
and (j), to be accompanied by a commercial document stating
that the products are for use as in- vitro diagnostic, laboratory
reagents, medical products or medical devices, provided that the
(a) the premises of dispatch have in place a system to ensure
products are clearly labelled ‘for in-vitro diagnostic use only’ or
that goods can only be dispatched if they are traceable to
‘for laboratory use only’, as ‘medicinal products’ or as ‘medical
documentary evidence of compliance with this Decision;
devices’.
and

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(b) the system referred to in (a) has been audited and found
(i) have, since introduction into the territory of Bulgaria,
satisfactory.
been transported, stored and processed separately from
products which are not eligible for dispatch outside the
areas listed in Annex I;
Such certification of the traceability system shall bear a
reference to this Decision, shall be valid for 30 days, shall
state the expiry date and shall be renewable only after the
(ii) are accompanied by a commercial document or official
establishment had been audited with satisfactory results.
certificate as required by this Decision.
Article 12
The competent authorities of Bulgaria shall communicate to the
other Member States and the Commission the list of estab
Cooperation between Member States
lishments which they have approved for the purpose of appli
cation of this paragraph.
Member States shall cooperate in monitoring personal luggage
of passengers travelling from the areas listed in Annex I and in
information campaigns carried out to prevent introduction of
Article 10
products of animal origin into the territory of Member States
other than Bulgaria.
Cleansing and disinfection
Without prejudice to Article 11 of Decision 2008/855/EC,
Article 13
Bulgaria shall ensure that vehicles which have been used for
the transport of live animals in the areas listed in Annex I
Implementation
and Annex II are cleansed and disinfected after each operation,
Member States shall amend the measures which they apply to
and that such cleansing and disinfection is recorded in
trade so as to bring them into compliance with this Decision.
accordance with Article 12(2)(d) of Directive 64/432/EEC.
They shall immediately inform the Commission thereof.
Article 11
Article 14
Certain exempted products
This Decision shall apply until 28 February 2011.
The restrictions laid down in Articles 3, 4, 5 and 8 shall not
apply to the dispatch from the areas listed in Annex I of the
Article 15
animal products referred to in those Articles if such products
Addressees
were:
This Decision is addressed to the Member States.
(a) not produced in Bulgaria and remained in their original
packaging indicating the country of origin of the
Done at Brussels, 6 January 2011.
products; or
For the Commission
(b) produced in an approved establishment situated in the areas
listed in Annex I from pre-processed products not orig
John DALLI
inating from those areas, which:
Member of the Commission

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L 6/28
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ANNEX I
The following areas in Bulgaria:
Region of Burgas
ANNEX II
The following areas in Bulgaria:
Regions of Yambol, Sliven, Shumen and Varna
ANNEX III
The following areas in Bulgaria:
1
2
3
4
5
6
7
8
Group ADNS Administrative
unit
B S/G
P FG WG
Bulgaria 00002 Region
of
Burgas
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
ADNS = animal disease notification system code (Decision 2005/176/EC).
B =
bovine
meat.
S/G =
sheep
and
goat
meat.
P =
pigmeat.
FG =
farmed
game
of
species
susceptible
to
foot-and-mouth
disease.
WG =
wild
game
of
species
susceptible
to
foot-and-mouth
disease.

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ANNEX IV
The health mark referred to in Article 2(3):
Dimensions:
BG = 7 mm
Establishment No = 10 mm
Circle outer diameter = 50 mm
Line thickness of circle = 3 mm

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