Commission Regulation (EC) No 878/2004 of 29 April 2004 laying down transitional measures in accordance with Regulation (EC) No 1774/2002 for certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes (Text with EEA relevance)
Date: 2004-04-29
Institutions: European Commission
Subjects: animal product, by-product, export, health control, health legislation, import, marketing, transit

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Official Journal of the European Union

30.4.2004

COMMISSION REGULATION (EC) No 878/2004

of 29 April 2004

laying down transitional measures in accordance with Regulation (EC) No 1774/2002 for certain
animal by-products classified as Category 1 and 2 materials and intended for technical purposes

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

Pending such advice, it is appropriate to provide transi-
tional measures allowing the continued placing on the
market, export,
import and transit of certain products
classified as Category 1 and 2 materials under Regulation
(EC) No 1774/2002, intended exclusively for technical
uses.

Having regard to the Treaty establishing the European Com-
munity,

Having regard to Regulation (EC) No 1774/2002 of the Euro-
pean 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 Articles 4(4),
5(4), 16(3) and 32(1) thereof,

Whereas:

(1)

(2)

(3)

(4)

(5)

According to the Regulation (EC) No 999/2001 of the
European Parliament and of the Council of 22 May
2001 laying down rules for the prevention, control and
eradication of certain transmissible spongiform encepha-
lopathies (2), specified risk material
intended for food,
feed or fertilisers may not be imported into the Com-
munity.

However, Category 1 materials, which may contain
specified risk material, may be imported into or exported
from the Community in accordance with rules laid
down in Regulation (EC) No 1774/2002 or to be estab-
lished under the procedure referred to in its Article
33(2).

the European Parliament and of

Commission Regulation (EC) No 812/2003 of 12 May
2003 on transitional measures under Regulation (EC) No
1774/2002 of
the
Council as regards the importation and transit of certain
products from third countries (3) provides a temporary
derogation until 30 April 2004 from the importation
prohibition on certain animal by-products from third
countries as set out in Regulation (EC) No 1774/2002.

Certain operators and trading partners have expressed
concerns over a prohibition on animal by-products
intended for technical uses, outside the feed or food
chain.

The Commission has requested scientific advice on a
quantitative assessment of the residual risk of bovine
in a number of
spongiform encephalopathy (BSE)
bovine-derived products such as gelatine and tallow,
which is expected in the near future. It is also intended
to seek further specific advice.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 808/2003 (OJ L 117, 13.5.2003,
p. 1).

(2) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Regu-

lation 2245/2003 (OJ L 333, 20.12.2003, p. 28).

(3) OJ L 117, 13.5.2003, p. 19. Regulation as amended by Regulation

(EC) No 2268/2003 (OJ L 336, 23.12.2003, p. 24).

(7)

Accordingly, transitional measures should be adopted to
allow the technical use of certain, strictly defined, Cate-
gory 1 and 2 materials. The specific uses of such mate-
rials intended for technical purposes should be subject to
strict channelling and control measures, further reducing
the risk of diversion into the food and feed chains and
unintended use in other technical products such as ferti-
lisers and soil improvers, cosmetics, medicinal products
and medical devices.

(8) Where the use of Category 1 and 2 animal by-products
cannot be avoided for the production of medicinal
products, the competent authority may, on the basis of
an appropriate case-by-case risk assessment in accord-
ance with relevant Community legislation, derogate from
the provisions of the Regulation

a

intended for

(9) With regard to the placing on the market and export of
animal by-products
technical use
produced in the Community, the rules laid down in
Regulation (EC) No 1774/2002 should be generally suffi-
cient, subject to complementing the rules for collection
and transport to ensure the strict channelling, identifica-
tion, and control objectives being pursued; with regard
to consignments for imports or in transit, additional
certification and channelling requirements should be
implemented.

(10) Member States should implement additional verification
arrangements as necessary for the implementation of
this Regulation and in particular to avoid the risk of
diversion, and should cooperate to that effect;
they
should inform the Commission and other Member States
accordingly, and take all necessary measures in the
context of the relevant Community legislation in case of
non compliance.

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Official Journal of the European Union

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(11)

In order to avoid disruption of trade it is appropriate to
provide for a reasonable period of time for the conti-
nuing acceptance of
imported animal by-products
arriving at
the border inspection posts after 1 May
2004, and which may still be accompanied by old
models of health certificates.

(12)

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

HAS ADOPTED THIS REGULATION:

Article 1

Scope

This Regulation shall apply to the following animal by-
products, classified as Category 1 or Category 2 material under
Regulation (EC) No 1774/2002 and intended exclusively for
technical uses:

(a) hides and skins derived from animals which have been
treated with certain substances which are prohibited
pursuant to Directive 96/22/EC (1);

(b) rendered fats derived from Category 1 materials produced
using Method 1 as referred to in Annex V, Chapter III of
Regulation (EC) No 1774/2002, and in the case rendered
fats from ruminant animals have been purified so that the
maximum level of remaining total insoluble impurities does
not exceed 0,15 % in weight, and derived fat derivatives
meeting at least the standards referred to in Annex VI,
Chapter III of Regulation (EC) No 1774/2002;

(c) ruminant intestines (with or without content); and

(d) bone and bone products containing vertebral column and
skulls, and bovine horns which have been removed from
the cranial cavity
the skull using a method which left
intact.

However, those animal by-products shall not be derived from
animals referred to in Article 4(1)(a)(i) and (ii) of Regulation
(EC) No 1774/2002

Article 2

Derogation regarding the placing on the market and
export of animal by-products

By way of derogation from Article 20(1) of Regulation (EC) No
1774/2002, the Member States may authorise the placing on
the market and export of the animal by-products referred to in
Article 1 of this Regulation (‘the animal by-products’).

However, the derogation provided for in the first sub-paragraph
shall not apply to the export of the animal by-products referred
to in points (c) and (d) of Article 1 of this Regulation.

(1) 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).

Article 3

Derogation regarding the importation and transit of
animal by-products

By way of derogation from Article 29(1) of Regulation (EC) No
1774/2002, the Member States may authorise the importation
and transit of the animal by-products.

A label similar to that referred to in point (a) of Article 5 of
this Regulation shall also be required for the imported animal
by-products.

Article 4

Conditions for the placing on the market, export and
import of the animal by-products

1.
The placing on the market or export of the animal by-
products shall be carried out in a way that does not present a
risk to animal and public health and the environment.

2.
Imports of the animal by-products shall be subjected to
sanitary certification requirements in accordance with national
legislation.

Imported consignments and consignments in transit shall be
channelled in accordance with the monitoring procedure
provided for in Article 8 (4) of Council Directive 97/78/EC.

Article 5

Collection and transport of the animal by-products

The collection and transport of the animal by-products shall
comply with the following additional requirements:

(a) in addition to the identification requirements provided for
in Chapter I of Annex II to Regulation (EC) No 1774/2002,
all packages shall bear a label indicating ‘PROHIBITED IN
FOOD, FEED, FERTILISERS, COSMETICS, MEDICINAL
PRODUCTS AND MEDICAL DEVICES’;

However, a different label may be used in the case the
animal by-products are intended for medicinal products in
accordance with Community legislation. Any such label
shall make
are
the
‘DESTINED FOR MEDICINAL PRODUCTS ONLY’;

animal by-products

clear

that

(b) the by-products shall be delivered to a dedicated technical
plant approved in accordance with Article 18 of Regulation
(EC) No 1774/2002, and shall be subjected to a treatment
which satisfies the competent authority in such a way that
the resulting technical product does not pose a risk to
animal and public health;

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(c) the technical plant referred to in point

(b) shall keeps
records in accordance with Article 9 of Regulation (EC) No
1774/2002, and shall uses the animal by-products exclu-
sively for technical purposes authorised by the competent
authority.

Article 6

Controls

1. With regard to consignments imported or in transit, the
competent authority shall carry out documentary checks at
regular intervals, and at least twice a year, on the channelling
chain from the border inspection posts of first entry to the
approved technical plant in case of import, and to the border
inspection post of exit in case of transit, for the purpose of
reconciliation of the quantities of animal by-products imported,
used and disposed of, ensuring compliance with this Regulation
and with Regulation (EC) No 1774/2002.

For consignments in transit, the competent authorities respon-
sible for the border inspection post of first entry and of exit
respectively shall cooperate as necessary to ensure effective
traceability and checks. The competent authorities shall also
cooperate in their surveillance to ensure reconciliation of quan-
tities imported in one Member State and used in another, of
quantities exported from one Member State but produced in
another, and of quantities in transit -in and out.

2. With regard to consignments for placing on the market
in the Community or for export, the competent authorities
shall carry out the checks provided for in Regulation (EC) No
1774/2002, in particular its Articles 7 and 8, with the same
objectives of checking the reconciliation of quantities and
compliance.

Article 7

Information to be provided by the Member States

Member States shall immediately inform the Commission and
other Member States
the Standing
Committee on the Food Chain and Animal Health of:

in the framework of

(a) the use made of the derogation provided in Articles 2 and

3; and

(b) the verification arrangements provided for in Article 6 to
the animal by-products concerned are used
ensure that
only for purposes authorised in accordance with Article
5(c).

Article 8

Measures to be taken in the event of non-compliance with
this Regulation

The competent authority shall take appropriate action immedi-
ately in the case of any non-compliance.

Article 9

Entry into force and applicability

This Regulation shall enter into force on the day of its

1.
publication in the Official Journal of the European Union.

2.

It shall apply from 1 May 2004.

3.
However, the certificates drawn up in the format under
Commission Regulation (EC) No 812/2003 may be used until
15 June 2004.

4. Member States shall authorise until 15 August 2004 the
the third country
import of consignments which have left
before 15 June 2004, and which may still be accompanied by
the certificates referred to in point 3 above.

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

Done at Brussels, 29 April 2004.

For the Commission

David BYRNE

Member of the Commission