2003/721/EC: Commission Decision of 29 September 2003 amending Council Directive 92/118/EEC as regards requirements for collagen intended for human consumption and repealing Decision 2003/42/EC (Text with EEA relevance) (notified under document number C(2003) 3393)
Date: 2003-09-29
Institutions: European Commission
Subjects: agricultural trade, animal disease, animal product, health certificate, health control, veterinary legislation

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COMMISSION

COMMISSION DECISION

of 29 September 2003

amending Council Directive 92/118/EEC as regards requirements for collagen intended for human
consumption and repealing Decision 2003/42/EC

(notified under document number C(2003) 3393)

(Text with EEA relevance)

(2003/721/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 92/118/EEC of 17
December 1992 laying down animal health and public health
requirements governing trade in and imports into the Commu-
nity of products not subject to the said requirements laid down
in specific Community rules referred to in Annex A(I) to Direc-
tive 89/662/EEC and, as regards pathogens, to Directive 90/
425/EEC (1), as last amended by Commission Decision 2003/
42/EC (2), and in particular the second paragraph of Article 15
thereof,

Whereas:

(1)

(2)

Specific public health conditions for the preparation of
collagen intended for human consumption should be
laid down. Provided that these conditions are the same
for collagen intended for human consumption and
collagen not
intended for human consumption, and
provided that hygiene conditions are also the same, it
should be possible to produce and/or store both types of
collagen in the same establishment.

authorisation and registration,

inspection and
The
the establishments preparing
hygiene conditions for
collagen should be
set. Certain health conditions
contained in Council Directive 77/99/EEC of 21
December 1976 on health problems affecting the
production and marketing of meat products and certain
other products of animal origin (3), as last amended by
Regulation (EC) No 807/2003 (4), and in Council Direc-
tive 93/43/EEC of 14 June 1993 on the hygiene of food-
stuffs (5), are relevant for the preparation of collagen.

(1) OJ L 62, 15.3.1993, p. 49.
(2) OJ L 13, 18.1.2003, p. 24.
(3) OJ L 26, 31.1.1977, p. 85.
(4) OJ L 122, 16.5.2003, p. 36.
(5) OJ L 175, 19.7.1993, p. 1.

Article 2.3.13.7 of the International Animal Health Code
(2001) issued by the International Office of Epizootics
on BSE recommends that if gelatine and collagen are
prepared exclusively from hides and skins, veterinary
administrations should authorise their import and transit
through their territories without restriction, regardless of
the status of the exporting countries.

Under 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 encephalopathies (6),
as last amended by Commission Regulation (EC) No
1234/2003 (7), hides and skins within the meaning of
Directive 92/118/EEC, derived from healthy ruminants
and collagen derived from such hides and skins are not
subject to restrictions on placing on the market.

The Scientific Steering Committee adopted an opinion
on the safety of collagen on 10 and 11 May 2001,
addressing the question of the safety in relation to trans-
missible spongiform encephalopathies (hereinafter TSE)
of collagen produced from ruminant hides.

The raw material used for the production of collagen
consists mainly of bovine connective tissue of hides and
tendons, calf skins, sheep skins and pig skins. To ensure
the safety of
it must derive from
animals that pass ante and post mortem inspections as fit
for human consumption. Such material must also be
collected, transported, stored and handled in the most
hygienic ways possible.

the raw material,

(4)

(5)

(6)

(6) OJ L 147, 31.5.2001, p. 1.
(7) OJ L 173, 11.7.2003, p. 6.

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(7)

(8)

(9)

(10)

To guarantee traceability of the raw material, collection
centres and tanneries, which intend to supply the raw
material, should be authorised and registered. A model
commercial document should also be prescribed to
accompany the raw material during transportation and
at time of delivery to the collection centres, tanneries
and collagen processing plants.

It is appropriate to amend the current commercial docu-
ment for raw material destined for the production of
gelatine for human consumption, to take into account
particulars in relation to control procedures in certain
Member States.

The standards for the finished product should be fixed to
ensure that it is not contaminated with substances or
micro-organisms presenting a risk to consumer health.
Pending a scientific evaluation of such standards, it is
appropriate to include, on a provisional basis, generally
accepted standards
contamination. The
requirements for packaging, storage and transport of the
finished product should also be laid down.

regards

as

It is necessary to lay down specific health rules for the
importation of collagen and raw material destined for
collagen intended for human
the production of
consumption. Specimens of health certificates to accom-
pany the imported collagen and raw material destined
for the production of collagen for human consumption
should be drawn up. It is also necessary for the Commis-
sion to recognise conditions offering equivalent guaran-
tees based on a proposal submitted by a third country.

(11)

The adoption of specific rules for the production of
collagen should be without prejudice to the adoption of
rules for the prevention and control of TSE.

(12) Directive 92/118/EEC should therefore be amended

accordingly.

(13) Decision 2003/42/EC amended Directive 92/118/EEC,
with effect from 30 September 2003, as regards the
specific health conditions for collagen intended for
human consumption and certification requirements for
collagen and raw material
for collagen production,
intended for dispatch to the European Community for
human consumption.

(14)

(15)

The Community imports from third countries raw mate-
rial and collagen,
including collagen meeting certain
technical requirements which is not available in the
Community.

The United Kingdom has requested a postponement of
the application of the new specific health conditions to
enable account to be taken of its producers who are
dependent on imports from third countries.

(16)

The negotiations to find a resolution to problems in rela-
tion to imports of collagen aimed at allowing such
imports to continue in full compliance with the new
specific health conditions can now be
considered
concluded.

(17)

It is appropriate to allow time for the conclusion of the
administrative steps of those negotiations but that period
should be as short as possible.

(18) An error has been found in the Annex to Decision
2003/42/EC in that the commercial document model for
raw material destined for the production of collagen
unintentionally requires a stamp of an official veteri-
narian. That error should be corrected.

(19)

(20)

For the sake of clarity, Decision 2003/42/EC should
therefore be repealed and replaced by the present
Decision.

The measures provided for in this Decision are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Annex II to Directive 92/118/EEC is amended in accordance
with the Annex to this Decision.

Article 2

Article 1 of this Decision shall apply from 31 December 2003.

It shall not apply to collagen intended for human consumption
that was produced or imported before that date.

Article 3

Decision 2003/42/EC is repealed with immediate effect.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 29 September 2003.

For the Commission

David BYRNE

Member of the Commission

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Chapter 4 of Annex II to Directive 92/118/EEC is amended as follows:

1. The heading ‘Section A’ is inserted before the title.

ANNEX

2. In Part VIII, point II, under the headings ‘Other animal products plant’,

‘Centres of collection’ and ‘Tannery’, the

second line is replaced by the following: ‘Registration number’.

3. The following section B is added:

SPECIFIC HEALTH CONDITIONS FOR THE COLLAGEN INTENDED FOR HUMAN CONSUMPTION

‘SECTION B

I. General

1. This Section lays down the health conditions for putting on the market and imports of collagen intended for

human consumption.

2. For the purposes of this Section, the definitions of “hides and skins” and “tanning” in section A shall apply.

The following definitions shall also apply:

(a) “collagen” means protein-based product derived from hides, skins and tendons of animals, including bones in

the case of pigs, poultry and fish only, manufactured using the method set in Part V below.

(b) “collagen intended for human consumption” means collagen intended for consumption either as food or incor-

porated into or wrapped around food or product to be consumed by humans.

3. Collagen intended for human consumption shall comply with the conditions in Parts II to X below.

II. Establishments producing collagen

Collagen intended for human consumption shall come from establishments that fulfil the conditions in Part I of
Section A.

III. Raw materials and establishments supplying them

1. The following raw materials may be used for the production of collagen intended for human consumption:

(a) hides and skins of farmed ruminant animals;

(b) pig skins, bones and intestines;

(c) poultry skin and bones;

(d) tendons;

(e) wild game hides and skins; and

(f) fish skin and bones.

2. The use of hides and skins submitted to tanning processes is prohibited.

3. The raw materials shall meet the following requirements:

— for the raw materials listed in paragraph 1(a) to (d) above, the requirements set in Paragraph 4 of Part II of

Section A apply;

— for the raw material referred to in paragraph 1(e) above, the requirements set in Paragraph 5 of Part II of

Section A apply;

— for the raw materials listed in paragraph 1(a) to (e) above, the requirements set in Paragraph 6 of Part II of

Section A apply, except that no raw material shall come from plants degreasing ruminant bones; and

— for the raw material referred to in paragraph 1(f) above, the requirements set in Paragraph 7 of Part II of

Section A apply.

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4. The collection centres and tanneries supplying the raw material for the production of collagen intended for human
consumption shall be specifically authorised for the purpose and registered by the competent authorities and fulfil
the requirements set in Paragraph 8 of Part II of Section A.

IV. Transport and storage of the raw material

1. Transport and storage of the raw material destined for the production of collagen shall be done in accordance

with Part III of Section A.

2. During transportation and at the time of delivery at the collection centres, tanneries and collagen processing
plants, raw materials must be accompanied by a commercial document in conformity with the model laid down
in Part IX of this Section.

V. Manufacture of collagen

1. Collagen must be produced by a process that ensures that the raw material is subjected to a treatment involving
washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion; or by an
equivalent process approved by the Commission after consultation of the appropriate Scientific Committee.

2. After having been subjected to the process referred to at paragraph 1 above, collagen may undergo a drying

process.

3. Collagen not intended for human consumption may be produced and stored in the same establishment as collagen
intended for human consumption only if it is produced and stored using exactly the same conditions set in this
Section.

4. The use of preservatives other than those permitted under Community legislation is prohibited.

VI. Finished products

Appropriate measures, including tests shall be carried out to ensure that each production batch of collagen meets the
microbiological and residues criteria set in Part V of Section A, but where necessary to achieve desired products such
as collagen-based casings, no moisture and ash limit shall apply.

VII. Packaging, storage and transport

1. Collagen intended for human consumption must be wrapped, packaged, stored and transported under satisfactory

hygiene conditions and, in particular, fulfil the conditions set in Paragraph 1 of Part VI of Section A.

2. Wrappings and packages containing collagen must bear an identification mark giving the particulars listed in the
first indent of Paragraph 2 of Part VI of Section A, and carry the words “Collagen fit for human consumption”
and the date of preparation and the batch number.

3. During transportation collagen must be accompanied by a commercial document, in accordance with Article
3(A)(9)(a) of Directive 77/99/EEC, bearing the words “Collagen fit for human consumption” and the date of
preparation and the batch number.

VIII. Import from third countries of collagen and raw materials intended for the production of collagen for
human consumption

1. Member States shall authorise import into the Community of collagen intended for human consumption only if it:

(a) comes from third countries listed in Part XIII of the Annex to Commission Decision 94/278/EC (1);

(b) comes from establishments meeting the conditions laid down in Part II of this Section;

(1) OJ L 120, 11.5.1994, p. 44.

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(c) has been produced from raw material that met the requirements of Parts III and IV of this Section;

(d) has been manufactured in compliance with the conditions set out in Part V of this Section;

(e) satisfies the criteria in Part VI and the wrapping, packaging, storage and transport conditions in Part VII(1) of

this Section;

(f) bears on its wrappings and packages an identification mark giving the particulars specified in the sixth indent

of Part VII(A) of Section A; and

(g) is accompanied by a health certificate that conforms to the model laid down in Part X(a) of this Section.

2. Member States shall authorise import into the Community of the raw material listed in Part III(1) of this Section

for the production of collagen intended for human consumption only if:
(a) it comes from third countries listed in Council Decision 79/542/EEC (1) or in Commission Decision 94/85/

EC (2) or in Decision 94/86/EC (3) or in Commission Decision 97/296/EC (4), as appropriate; and

(b) a health certificate conforming to the model laid down in Part X(b) of this Section accompanies each consign-

ment of the raw material.

3. The health certificates referred to in paragraphs 1(g) and 2(b) above shall consist of one sheet, and shall be
completed in at least one official language of the Member State through which the consignment first enters the
Community, and in at least one official language of the Member State of destination.

4. The Commission may recognise, in accordance with the procedure of Article 18, the health measures applied by a
third country for the production of collagen intended for human consumption as offering guarantees equivalent
to those offered for putting collagen on the market in the Community, if the third country concerned supplies
objective proof in this respect. When the Commission recognises such equivalence, it shall adopt in accordance
with the same procedure, the conditions governing the importation of collagen for human consumption.

(1) OJ L 146, 14.6.1979, p. 15.
(2) OJ L 44, 17.2.1994, p. 31.
(3) OJ L 44, 17.2.1994, p. 33.
(4) OJ L 122, 14.5.1997, p. 21.

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