Commission Regulation (EC) No 523/2008 of 11 June 2008 amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the import of blood products for the manufacture of technical products (Text with EEA relevance)
Date: 2008-06-11
Institutions: European Commission
Subjects: agricultural by-product, animal product, bioprocess, health certificate, health control, import

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COMMISSION REGULATION (EC) No 523/2008

of 11 June 2008

amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and
of the Council as regards the import of blood products for the manufacture of technical products

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(4)

Having regard to the Treaty
Community,

establishing the European

Having regard to Regulation (EC) No 1774/2002 of
the
European Parliament and of the Council of 3 October 2002
laying down health rules concerning animal by-products not
intended for human consumption (1),
and in particular
Article 4(4), the second paragraph of Article 28, the first sub-
paragraph of Article 29(3) and Article 32(1),

Whereas:

(1)

(2)

(3)

Regulation (EC) No 1774/2002 lays down animal and
public health requirements for
into and
through the Community of blood products
transit
intended
including model
import health certificates and list of countries authorised
for imports.

technical purposes,

the import

for

Regulation (EC) No 1774/2002 provides that animal by-
products which have been derived from animals treated
with certain substances prohibited under Council
Directive 96/22/EC of 29 April 1996 concerning the
prohibition on the use in stock farming of certain
substances having a hormonal or thyrostatic action and
of ß-agonists, and repealing Directives 81/602/EEC,
88/146/EEC and 88/299/EEC (2) may only be imported
into the Community in accordance with Regulation (EC)
No 1774/2002 or with specific rules to be laid down.

The possibility to import such blood products is vital for
the biotechnology industry for
the manufacture of
various technical products used mainly by the pharma-
ceutical and research community. As those products are
not intended either for human or animal consumption
and during their processing and technical use they pose
no risk to animal and human health by reason of being
derived from animals treated with certain substances
prohibited under Directive 96/22/EC,
it is appropriate
to allow the imports into the Community of such
blood products.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 437/2008 (OJ L 132, 22.5.2008,
p. 7).

(2) OJ L 125, 23.5.1996, p. 3. Directive as amended by Directive
2003/74/EC of the European Parliament and of the Council
(OJ
L 262, 14.10.2003, p. 17).

Regulation (EC) No 1774/2002 provides that the blood
products used for the manufacture of technical products
must be specifically treated or the country or region of
origin of the products must be free from certain diseases
without vaccination. However,
countries or
several
certain regions are eligible to deliver
fresh meat of
ruminants to the Community by reason of being free
from foot-and-mouth disease with vaccination, provided
that
circulation is
mitigated. Similarly,
it is appropriate to allow imports
of untreated blood products of ruminants from such
countries or regions, provided that those products are
channelled to their place of destination under secure
conditions for further processing.

risk against possible virus

the

(5)

(6)

(7)

(8)

Regulation (EC) No 1774/2002 also provides, in case of
blood products of ruminant origin that the region of
origin must be eligible for the import of live animals
of the same species into the Community. According to
international standards, blood products are less likely to
transmit diseases of concern than live animals.
is
therefore appropriate to delete this condition from the
relevant requirements.

It

Part VI(A) of Annex XI
to Regulation (EC) No
1774/2002 sets out lists of third countries from which
Member States may authorise imports of blood products
intended for technical purposes. Those lists are currently
limited to countries from which the import of all cate-
gories of fresh meat of the respective species for human
consumption is authorised.

Since the applicable requirements allow for the treatment
of the blood products, those lists should be extended also
to countries which are not authorised to export fresh
meat of the respective species into the Community but
are able to comply with the treatment requirements.
However, for the sake of clarity, separate health certi-
ficates should be laid down for treated and untreated
blood products.

It is appropriate to update the requirements related to the
import of blood products from poultry and other avian
species by referring to the international standards laid
down in the Terrestrial Animal Health Code of
the
World Organisation for Animal Health (OIE).

(9)

Annexes VIII, X and XI
1774/2002 should therefore be amended accordingly.

to Regulation (EC) No

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(10) A transitional period should be provided for after the
date of entry into force of this Regulation, in order to
to
provide the necessary time for
the stakeholders
the
comply with the new rules and to allow for
the
continued importation into the Community of
blood products as currently covered by Regulation (EC)
No 1774/2002.

Article 2

Consignments of blood products accompanied by health certi-
ficates completed and signed in accordance with the provisions
of Regulation (EC) No 1774/2002 applicable before the date of
entry into force of this Regulation shall be accepted for import
into the Community until 12 December 2008 at the latest.

(11)

The measures provided for in this Regulation are in
Standing
accordance with
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Annexes VIII, X and XI to Regulation (EC) No 1774/2002 are
amended in accordance with the Annex to this Regulation.

Such consignments shall also be accepted until 12 February
2009 at the latest if the accompanying health certificates were
completed and signed by 12 December 2008 at the latest.

Article 3

This Regulation shall enter into force and apply on the third
day following that of its publication in the Official Journal of the
European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 11 June 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

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ANNEX

The Annexes to Regulation (EC) No 1774/2002 are amended as follows:

(1) In Annex VIII, Chapter IV is replaced by the following:

‘CHAPTER IV

Requirements for blood and blood products, excluding from equidae, for the manufacture of technical
products

A. Importation

1. Imports of blood are subject to the requirements laid down in Chapter XI.

2. Member States must authorise imports of blood products for the manufacture of technical products, including
material originating from animals to which substances prohibited pursuant to Directive 96/22/EC have been
administered, if they:

(a) come from third countries that appear on the list in Part VI (A) of Annex XI as applicable;

(b) come from a technical plant meeting the specific conditions laid down in this Regulation or from the

establishment of collection;

(c) are accompanied by a health certificate that conforms to the model set out in Chapter 4(C) or Chapter 4(D)

of Annex X as appropriate.

3. The blood from which blood products for the manufacture of technical products are produced must have been

collected:

(a)

in slaughterhouses approved in accordance with Community legislation;

(b) in slaughterhouses approved and supervised by the competent authority of the third country; or

(c)

from live animals in facilities approved and supervised by the competent authority of the third country.

4. In the case of blood products for the manufacture of technical products which have been derived from animals
belonging to the taxa Artiodactyla, Perissodactyla and Proboscidea, including their crossbreeds, they must comply
with the conditions of either points (a) or (b):

(a)

the products have undergone one of the following treatments guaranteeing the absence of pathogens of the
diseases referred to in point (b):

(i) heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check,

(ii) irradiation at 25 kGy by gamma rays, followed by an effectiveness check,

(iii) heat treatment of at least 80 °C throughout their substance, followed by an effectiveness check,

(iv) in the case of animals other than Suidae and Tayassuidae only: change in pH to pH 5 for two hours,

followed by an effectiveness check;

(b) in case of blood products not treated in accordance with point (a) the products originate from a country or

region:

(i) where no case of rinderpest, peste des petits ruminants and Rift Valley fever has been recorded for 12
months and in which vaccination has not been carried out against those diseases for at least 12
months,

(ii) where no case of foot-and-mouth disease has been recorded for 12 months and in which vaccination

has not been carried out against this disease for at least 12 months, or

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where no case of foot-and-mouth disease has been recorded for 12 months and in which vaccination
programmes against foot-and-mouth disease are being officially carried out and controlled in domestic
ruminant animals for at least 12 months;
in this case, following the border check provided for in
Directive 97/78/EC, and in accordance with the conditions laid down in Article 8(4) of that Directive,
the products must be transported directly to the technical plant of destination and all precautions,
including safe disposal of waste, unused or surplus material, must be taken to avoid risks of spreading
diseases to animals or humans.

In addition to points (i) and (ii),
following conditions must be complied with:

in the case of animals other than Suidae and Tayassuidae, one of the

— in the country or region of origin no case of vesicular stomatitis and bluetongue (including the presence
of seropositive animals) has been recorded for 12 months and vaccination has not been carried out
against those diseases for at least 12 months in the susceptible species,

— following the border check provided for in Directive 97/78/EC, and in accordance with the conditions
laid down in Article 8(4) of that Directive, the products must be transported directly to the technical
plant of destination and all precautions, including safe disposal of waste, unused or surplus material,
must be taken to avoid risks of spreading diseases to animals or humans.

In addition to points (i) and (ii), in the case of Suidae and Tayassuidae, in the country or region of origin no
case of swine vesicular disease, classical swine fever and African swine fever has been recorded for at least
12 months, vaccination has not been carried out against those diseases for at least 12 months and one of
the following conditions are complied with:

— in the country or region of origin no case of vesicular stomatitis (including the presence of seropositive
animals) has been recorded for 12 months and vaccination has not been carried out against this disease
for at least 12 months in the susceptible species,

— following the border check provided for in Directive 97/78/EC, and in accordance with the conditions
laid down in Article 8(4) of that Directive, the products must be transported directly to the technical
plant of destination and all precautions, including safe disposal of waste, unused or surplus material,
must be taken to avoid risks of spreading diseases to animals or humans.

5. In the case of blood products for the manufacture of technical products which have been derived from poultry

and other avian species, they must comply with the conditions of either points (a) or (b):

(a)

the products have undergone one of the following treatments guaranteeing the absence of pathogens of the
diseases referred to in point (b):

(i) heat treatment at a temperature of 65 °C for at least three hours, followed by an effectiveness check,

(ii) irradiation at 25 kGy by gamma rays, followed by an effectiveness check,

(iii) heat treatment of at least 70 °C throughout their substance, followed by an effectiveness check;

(b) in case of blood products not treated in accordance with point (a) the products originate from a country or

region:

(i) which has been free from Newcastle disease and highly pathogenic avian influenza as defined in the

Terrestrial Animal Health Code of the OIE,

(ii) which during the last 12 months has not carried out vaccination against avian influenza,

(iii) where the poultry or other avian species from which the products derive have not been vaccinated
against Newcastle disease with vaccines prepared from a Newcastle disease master strain showing a
higher pathogenicity than lentogenic virus strains.’

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(2) Annex X is amended as follows:

(a) Chapter 4(C) is replaced by the following:

‘CHAPTER 4(C)

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(b) The following Chapter 4(D) is added:

‘CHAPTER 4(D)

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(3) In Annex XI, Part VI (A) is replaced by the following:

‘A. Blood products:

1. Untreated blood products of ungulates:

Third countries or parts of third countries listed in Part 1 of Annex II to Decision 79/542/EEC from which
imports of fresh meat of any domestic ungulate species is authorised and only for the period indicated in
columns 7 and 8 of that Part,

Japan.

2. Untreated blood products of poultry and other avian species:

Third countries or parts of third countries listed in Part 1 of Annex II to Decision 2006/696/EC,

Japan.

3. Untreated blood products of other animals:

Third countries listed either in Part 1 of Annex II to Decision 79/542/EEC,
Commission Decision 2006/696/EC or in Annex I to Commission Decision 2000/585/EC,

in Part 1 of Annex II to

Japan.

4. Treated blood products of any species:

Third countries listed in Part 1 to Annex II of Decision 79/542/EEC,
2006/696/EC or in Annex I to Decision 2000/585/EC,
Japan.’

in Part 1 of Annex II to Decision