Commission Regulation (EC) No 1243/2007 of 24 October 2007 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and the Council laying down specific hygiene rules for food of animal origin (Text with EEA relevance)
Date: 2007-10-24
Institutions: European Commission
Subjects: animal product, food inspection, foodstuff, health legislation

L 281/8

EN

Official Journal of the European Union

25.10.2007

COMMISSION REGULATION (EC) No 1243/2007

of 24 October 2007

amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and the Council
laying down specific hygiene rules for food of animal origin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

burden. It is therefore appropriate to provide for a dero-
gation from that requirement for such operators.

Having regard to the Treaty
Community,

establishing the European

(5)

Having regard to Regulation (EC) No 853/2004 of the European
Parliament and of the Council of 29 April 2004 laying down
specific hygiene rules for food of animal origin (1), and in
particular Article 10(1) thereof,

Whereas:

to Regulation (EC) No
Section XIV of Annex III
853/2004 sets out the requirements for the production
of gelatine intended for human consumption. It specifies
that when manufactured from ruminant bone material,
gelatine must be produced using a unique process that
ensures that all bone material is subjected to an alkaline
treatment of saturated lime solution (pH > 12,5) for a
period of at least 20 days with a heat treatment step
of 138 °C minimum during at least four seconds, after
having been finely crushed and degreased with hot water
and treated with dilute hydrochloric acid (at minimum
concentration of 4 % and pH < 1,5) over a period of at
least two days.

(1)

(2)

(3)

(4)

Reducing the administrative burden imposed on enter-
prises by existing Community legislation is a crucial
element
for improving their competitiveness and for
achieving the objectives of the Lisbon agenda.

(6)

Regulation (EC) No 853/2004 lays down specific rules
on the hygiene of
food
business operators. That Regulation provides that food
business operators are to comply with the relevant
provisions of Annex III thereto.

food of animal origin for

associated

production

The requirements of Section VIII of Annex III to Regu-
lation (EC) No 853/2004 as regards vessels engaged in
primary
operations
and
supplement those laid down in Annex I to Regulation
(EC) No 852/2004 of the European Parliament and of
the Council of 29 April 2004 on the hygiene of food-
stuffs (2).
those vessels are to keep and
retain records relating to measures put
in place to
control hazards in an appropriate manner and for an
appropriate period.

In particular,

Experience has shown that for food business operators
involved in small-scale coastal fishing within the meaning
of Article 26 of Council Regulation (EC) No 1198/2006
of 27 July 2006 on the European Fisheries Fund (3), that
requirement may create an additional administrative

(1) OJ L 139, 30.4.2004, p. 55; corrected version OJ L 226, 25.6.2004,
p. 22. Regulation as last amended by Council Regulation (EC) No
1791/2006 (OJ L 363, 20.12.2006, p. 1).

(2) OJ L 139, 30.4.2004, p. 1; corrected version OJ L 226, 25.6.2004,

p. 3.

(3) OJ L 223, 15.8.2006, p. 1.

(7)

(8)

(9)

The Scientific Panel on Biological Hazards of
the
European Food Safety Authority adopted on 18 January
2006 an opinion on the ‘Quantitative assessment of the
to
human BSE risk posed by gelatine with respect
residual BSE risk’. On 18 May 2006,
it adopted
another opinion on the ‘Quantitative assessment of the
human BSE risk posed by bovine vertebral column
including dorsal root ganglia with respect
to residual
BSE risk’. According to both opinions, the production
involving an acid process or a heat and
processes
pressure process
and
higher BSE infectivity reduction compared to the safety
level achieved by applying the alkaline process currently
required by Section XIV of Annex III to Regulation (EC)
No 853/2004. The conditions for the production of
gelatine should therefore be amended accordingly.

respectively equivalent

ensure

There have been difficulties in interpreting provisions on
possible other use of gelatine and collagen produced in
accordance with the provisions laid down in Sections
to Regulation (EC) No
XIV and XV of Annex III
853/2004 in some Member States. It is therefore appro-
priate to clarify those provisions in order to harmonise
their implementation.

Regulation (EC) No 853/2004 should therefore be
amended accordingly.

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

opinion

the

the

of

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HAS ADOPTED THIS REGULATION:

Article 1

Annex III to Regulation (EC) No 853/2004 is amended in accordance with the Annex to this Regulation.

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 2

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

Done at Brussels, 24 October 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

L 281/10

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Official Journal of the European Union

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ANNEX

Annex III to Regulation (EC) No 853/2004 is amended as follows:

1.

in point 3 of Section VIII, the following paragraph is added:

‘By way of derogation from point (a), point 7 of Part A of Annex I to Regulation (EC) No 852/2004 may not apply to
operators engaged in small-scale coastal fishing within the meaning of Article 26(1) of Council Regulation (EC) No
1198/2006 (*), and carrying out their activities only for short periods of less than 24 hours.

___________
(*) OJ L 223, 15.8.2006, p. 1.’;

2.

in Section XIV, Chapters III, IV and V are replaced by the following:

‘CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

1. The production process for gelatine must ensure that:

(a) all ruminant bone material derived from animals born, reared or slaughtered in countries or regions with a
controlled or undetermined BSE risk in accordance with Community legislation is subjected to a process which
ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydro-
chloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days. This treatment
is followed either by:

— an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a heat

treatment step of 138 °C minimum during at least four seconds, or

— an acid treatment (pH < 3,5) during 10 hours minimum with a heat treatment step of 138 °C minimum

during at least four seconds, or

— a heat-and-pressure process for at least 20 minutes with saturated steam of 133 °C at more than 3 bars, or

— any approved equivalent process;

(b) other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must
be adjusted subsequently. Gelatine must be extracted by heating one or more times in succession, followed by
purification by means of filtration and heat treatment.

2. A food business operator may produce and store both gelatine intended for human consumption and gelatine not
intended for human consumption in the same establishment provided that the raw materials and the production
process comply with the requirements applying to gelatine intended for human consumption.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that gelatine complies with the residue limits set out in the following table:

Residue

As

Pb

Cd

Hg

Cr

Cu

Zn

SO2 (European Pharmacopoeia 2005)

H2O2 (European Pharmacopoeia 2005)

Limit

1 ppm

5 ppm

0,5 ppm

0,15 ppm

10 ppm

30 ppm

50 ppm

50 ppm

10 ppm

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CHAPTER V: LABELLING
Wrapping and packaging containing gelatine must bear the words “gelatine fit for human consumption” and must
indicate the date of minimum durability.’;

3.

in Section XV, Chapter III, point 3 is replaced by the following:

‘3. A food business operator may produce and store both collagen intended for human consumption and collagen not
intended for human consumption in the same establishment provided that the raw materials and the production
process comply with the requirements applying to collagen intended for human consumption.’;

4. the Appendix is replaced by the following:

‘Appendix to ANNEX III

MODEL DOCUMENT TO ACCOMPANY RAW MATERIAL DESTINED FOR THE PRODUCTION OF
GELATINE OR COLLAGEN INTENDED FOR HUMAN CONSUMPTION

Number of the commercial document:

...................................................................................................................................................

I. Identification of raw material

Nature of the raw material:

.................................................................................................................................................................

Animal species:

.........................................................................................................................................................................................

Type of packaging:

..................................................................................................................................................................................

Number of packages:

..............................................................................................................................................................................

Net weight (kg):

.......................................................................................................................................................................................

II. Origin of raw material

Type, name, address and approval/registration/special authorisation number of the establishment of origin:

........................................................................................................................................................................................................................

Name and address of the consignor (1):

...........................................................................................................................................

III. Destination of raw material

Type, name, address and approval/registration/special authorisation number of the production establishment of
destination:

........................................................................................................................................................................................................................

Name and address of the consignee (2):

...........................................................................................................................................

IV. Means of transport:

.................................................................................................................................................................................

Done at .................................................................................................., on ..................................................................................................

...............................................................................................................................................................................................................................

(Signature of the operator of the establishment of origin or its representatives)

(1) Only if different from the establishment of origin.
(2) Only if different from the establishment of destination.’