HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 53/56
EN
Official Journal of the European Union
26.2.2011
COMMISSION REGULATION (EU) No 189/2011
of 25 February 2011
amending Annexes VII and IX to Regulation (EC) No 999/2001 of the European Parliament and of
the Council laying down rules for the prevention, control and eradication of certain transmissible
spongiform encephalopathies
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
deferred period of 18 months. In the interests of
certainty of Union legislation, it is appropriate to
amend Annex VII to that Regulation so that the
deferral period begins from the date of confirmation of
Having regard to the Treaty on the Functioning of the European
the index case.
Union,
(4) In
addition,
in
July
2010,
the
preliminary
results
of
a
Having regard to Regulation (EC) No 999/2001 of the European
scientific study ( 2 ) conducted by the Cypriot authorities
Parliament and of the Council of 22 May 2001 laying down
under the supervision of the European Union Reference
rules for the prevention, control and eradication of certain
Laboratory (EURL) for TSEs showed that a genetic
transmissible spongiform encephalopathies ( 1 ), and in particular
resistance to scrapie in caprine animals could exist.
the first paragraph of Article 23 thereof,
However, the definitive results of that study are not
expected to be available before the second semester of
2012.
Whereas:
(5) If
that
study
confirms
the
existence
of
a
resistance
to
scrapie, it may be considered appropriate, from January
(1) Regulation
(EC)
No
999/2001
lays
down
rules
for
the
prevention, control and eradication of transmissible
2013, to amend Regulation (EC) No 999/2001, in order
spongiform encephalopathies (TSEs) in animals. It
to exempt scrapie resistant caprine animals from the
applies to the production and placing on the market of
requirements for killing and complete destruction laid
live animals and products of animal origin and, in certain
down in Chapter A of Annex VII to that Regulation. In
specific cases, to exports thereof.
order to avoid the unnecessary killing and complete

destruction of caprine animals that may be considered
as scrapie resistant in the near future, on holdings where
animals are kept for the production of milk with a view
(2) Chapter
A
of
Annex
VII
to
Regulation
(EC)
No
999/2001
to placing it on the market, it is appropriate to prolong
lays down the eradication measures to be carried out
the deferral period for the killing and complete
following the confirmation of TSE in ovine and caprine
destruction of those animals for a period ending on
animals. In the case of confirmation of TSE other than
31 December 2012, where the index case was
bovine spongiform encephalopathy (BSE) in an ovine or
confirmed before 1 July 2011.
caprine animal, the eradication measures consist in either
the killing and complete destruction of all animals on the
holding or the killing and complete destruction of ovine
animals genetically susceptible to scrapie on the holding
(6)
Annex IX to Regulation (EC) No 999/2001 sets out rules
and in the killing and the complete destruction of all
for the importation into the Union of live animals,
caprine animals on the holding insofar as no genetic
embryos, ova and products of animal origin. Chapter C
resistance to scrapie has been demonstrated in caprine
of that Annex sets out the rules for imports of products
animals.
of animal origin from bovine, ovine and caprine animals,
and in particular gelatine.
(3) Chapter
A
of
Annex
VII
to
Regulation
(EC)
No
999/2001
also provides that the Member States may decide to delay
(7) Article
16
of
Regulation
(EC)
No
999/2001
provides
that
the destruction of the animals by up to 5 breeding years
gelatine derived from hides and skins from healthy
subject to certain conditions. However, in the case of
ruminants is not to be subject to restrictions on
ovine or caprine animals kept for the production of
placing on the market pursuant to certain provisions of
milk with a view to placing it on the market, the
that Regulation. Therefore, imports into the Union of
killing and destruction of the animals may only be
gelatine derived from hides and skins from healthy
delayed for a maximum of 18 months. Regulation (EC)
ruminants should also not be subject to those
No 999/2001 does not define the starting date for that
restrictions.
( 1 ) OJ L 147, 31.5.2001, p. 1.
( 2 ) http://www.efsa.europa.eu/en/scdocs/scdoc/1371.htm

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EN
26.2.2011 Official
Journal
of
the
European
Union L
53/57
(8) Chapter
D
of
Annex
IX
to
Regulation
(EC)
No
999/2001
Union legislation, the amendments made to Chapter D
lays down the rules for imports of animal by-products
of Annex IX to Regulation (EC) No 999/2001 by this
and processed products derived therefrom from bovine,
Regulation should also apply from that date.
ovine and caprine animals.
(12) The
measures
provided
for
in
this
Regulation
are
in
(9) Certain
animal
by-products
and
derived
products,
as
accordance with the opinion of the Standing
defined in Regulation (EC) No 1069/2009 of the
Committee on the Food Chain and Animal Health,
European Parliament and of the Council of 21 October
2009 laying down health rules as regards animal by-
products and derived products not intended for human
HAS ADOPTED THIS REGULATION:
consumption and repealing Regulation (EC) No
1774/2002 (Animal by-products Regulation) ( 1 ), do not
present any risk of TSE transmission to humans or
Article 1
animals. Therefore, the health certification requirements
Annexes VII and IX to Regulation (EC) No 999/2001 are
laid down in Chapter D of Annex IX to Regulation (EC)
amended in accordance with the Annex to this Regulation.
No 999/2001 should not apply to imports of such
products.
Article 2
(10) Annexes VII and IX to Regulation (EC) No 999/2001
This Regulation shall enter into force on the 20th day following
should therefore be amended accordingly.
its publication in the Official Journal of the European Union.
(11) Regulation
(EC)
No
1069/2009
applies
from
4
March
Point 2(b) of the Annex to this Regulation shall apply from
2011. In the interests of clarity and coherency of
4 March 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 February 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 300, 14.11.2009, p. 1.

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L 53/58
EN
Official Journal of the European Union
26.2.2011
ANNEX
Annexes VII and IX to Regulation (EC) No 999/2001 are amended as follows:
(1) In Annex VII, Chapter A is amended as follows:
(a) point 2.3(f) is replaced by the following:
‘(f) where the frequency of the ARR allele within the breed or holding is low or absent, or where it is deemed
necessary in order to avoid inbreeding, a Member State may decide to delay the killing and complete
destruction of the animals referred to in point 2.3(b)(i) and (ii) for a period not exceeding 5 breeding
years from the date of confirmation of the index case provided that no breeding rams other than those of
the ARR/ARR genotype are present on the holding.
However, in the case of ovine and caprine animals kept for the production of milk with a view to placing it
on the market, the killing and complete destruction of the animals may only be delayed for a maximum
period of 18 months from the date of confirmation of the index case, except for caprine animals where the
killing and complete destruction may be delayed until 31 December 2012 if the index case is confirmed
before 1 July 2011.’
(b) the following point is inserted after point 2.4:
‘2.5 Pending the killing and complete destruction of the animals referred to in points 2.3(b) (i) and (ii), including
animals for which the killing and complete destruction has been delayed as provided for in point 2.3(f), the
measures set out in point 3.1(a) and (b), point 3.2 and point 3.3(a), (b) first indent and (d) shall apply on the
holding(s).’
(2) Annex IX is amended as follows:
(a) in Chapter C, Section A is replaced by the following:
‘SECTION A
Products
The following products of bovine, ovine and caprine origin, as defined by points 1.10, 1.13, 1.15, 7.1, 7.5, 7.6,
7.7 and 7.9 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council (*), shall
be subject to the conditions laid down in Sections B, C and D of this Chapter depending on the BSE risk category
of the country of origin:
— fresh meat,
— minced meat,
— meat preparations,
— meat products,
— rendered animal fat,
— greaves,
— gelatine other than gelatine derived from hides and skins,
— treated intestines.
___________
(*) OJ L 139, 30.4.2004, p. 55.’

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EN
26.2.2011 Official
Journal
of
the
European
Union L
53/59
(b) Chapter D is replaced by the following:
‘CHAPTER D
Imports of animal by-products and processed products derived therefrom from bovine, ovine and
caprine animal origin
SECTION A
Animal by-products
This Chapter shall apply to the following animal by-products and derived products, as defined in points (1) and
(2) of Article 3 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (*), provided
that those products are of bovine, ovine and caprine animal origin:
(a) rendered fats derived from Category 2 material, which are intended to be used as organic fertilisers or soil
improvers, as defined in point 22 of Article 3 of Regulation (EC) No 1069/2009, or their starting materials or
intermediate products;
(b) bones and bone products derived from Category 2 material;
(c) rendered fats derived from Category 3 material which are intended to be used as organic fertilisers or soil
improvers or as feed, as defined in points 22 and 25 of Article 3 of Regulation (EC) No 1069/2009, or their
starting materials or intermediate products;
(d) pet food including dog chews;
(e) blood products;
(f) processed animal protein;
(g) bones and bone products derived from Category 3 material;
(h) gelatine derived from materials other than hides and skins;
(i) category 3 material and derived products other than those referred to in points (c) to (h) excluding:
(i) fresh hides and skins, treated hides and skins;
(ii) gelatine derived from hides and skins;
(iii) fat derivatives;
(iv) collagen.
SECTION B
Health certificate requirements
Imports of the animal by-products and derived products of bovine, ovine and caprine animal origin referred to in
Section A shall be subject to the presentation of a health certificate which has been completed with the following
attestation:
(a) the animal by-product or derived product does not contain and is not derived from specified risk material or
mechanically separated meat obtained from bones of bovine, ovine or caprine animals and the animals from
which this animal by-product or derived product is derived, have not been slaughtered after stunning by
means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration of
central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity; or
(b) the animal by-product or derived product does not contain and is not derived from bovine, ovine and caprine
materials other than those derived from animals born, continuously reared and slaughtered in a country or
region classified as posing a negligible BSE risk by a decision in accordance with Article 5(2).
In addition to points (a) and (b), imports of the animal by-products and derived products referred to in Section A,
containing milk or milk products of ovine or caprine animal origin and intended for feeding ruminants, shall be
subject to the presentation of a health certificate which has been completed with the following attestation:

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L 53/60
EN
Official Journal of the European Union
26.2.2011
(c) the ovine and caprine animals from which those products are derived must have been kept continuously since
birth or for the last 3 years on a holding where no official movement restriction is imposed due to a
suspicion of TSE and which has satisfied the following requirements for the last 3 years:
(i) it has been subject to regular official veterinary checks;
(ii) no classical scrapie case has been diagnosed or, following the confirmation of a classical scrapie case:
— all animals in which classical scrapie was confirmed have been killed and destroyed, and
— all ovine and caprine animals on the holding have been killed and destroyed, except for breeding rams
of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele;
(iii) ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are
introduced into the holding only if they come from a holding which complies with the requirements set
out in points (i) and (ii);
or
(d) for animal by-products or derived products destined for a Member State listed in the Annex to Commission
Regulation (EC) No 546/2006 (**), the ovine and caprine animals from which these products are derived must
have been kept continuously since birth or for the last 7 years on a holding where no official movement
restriction is imposed due to a suspicion of TSE and which has satisfied the following requirements for the last
7 years:
(i) it has been subject to regular official veterinary checks;
(ii) no classical scrapie case has been diagnosed or, following the confirmation of a classical scrapie case:
— all animals in which classical scrapie was confirmed have been killed and destroyed, and
— all ovine and caprine animals on the holding have been killed and destroyed, except for breeding rams
of the ARR/ARR genotype and breeding ewes carrying at least one ARR allele and no VRQ allele;
(iii) ovine and caprine animals, with the exception of sheep of the ARR/ARR prion protein genotype, are
introduced into the holding only if they come from a holding which complies with the requirements set
out in points (i) and (ii).
___________
(*) OJ L 300, 14.11.2009, p. 1.
(**) OJ L 94, 1.4.2006, p. 28.’

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