Corrigendum to Commission Decision 2004/407/EC of 26 April 2004 on transitional sanitary and certification rules under Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards import from certain third countries of photographic gelatine (OJ L 151, 30.4.2004)
Date: 2004-06-10
Institutions: European Commission
Subjects: agricultural by-product, health control, health legislation, import, material of animal origin, photographic industry

10.6.2004

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Official Journal of the European Union

L 208/9

Corrigendum to Commission Decision 2004/407/EC of 26 April 2004 on transitional sanitary and certification
rules under Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards import
from certain third countries of photographic gelatine

(Official Journal of the European Union L 151 of 30 April 2004)

Decision 2004/407/EC should read as follows:

COMMISSION DECISION

of 26 April 2004

on transitional sanitary and certification rules under Regulation (EC) No 1774/2002 of the Euro-
pean Parliament and of the Council as regards import from certain third countries of photographic
gelatine

(notified under document number C(2004) 1516)

(Only the English, French and Dutch texts are authentic)

(Text with EEA relevance)

(2004/407/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

products
provided.

for which adequate justification has been

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) and
32(1) thereof,

Whereas:

(1)

(2)

(3)

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 may not be imported
into the Community,

According to the Regulation (EC) No 1774/2002, Cate-
gory 1 materials, which may contain specified risk mate-
rial, may be imported into the Community in accord-
ance with rules laid down in that Regulation or to be
established by Comitology procedure.

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
from third countries (3) provides
products
the
Commission is to propose detailed transitional rules for

the European Parliament and of

that

(1) OJ L 273, 10.10.2002, p. 1; Regulationas

last amended by
Commission Regulation (EC) No 668/20043 (OJ L 112, 19.4.2004,
p. 1).

(2) OJ L 147, 31.5.2001, p. 1; Regulation as last amended by Commis-
sion Regulation (EC) No. 2245/2003 (OJ L 333 , 20.12.2003, p.
28).

(3) OJ L 117, 13.5.2003, p. 19.

(4)

(5)

(6)

(7)

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, collagen and
tallow and derived products, which is expected in the
near future.

it

Pending such advice,
is therefore appropriate to
provide transitional measures allowing the continued
import from Japan and the United States of America of
gelatine produced from materials containing bovine
vertebral column classified as Category 1 material under
Regulation (EC) No 1774/2002, intended for the photo-
graphic industry (photographic gelatine).

The specific technical properties of photographic gela-
tine require the implementation of strict channelling and
enforcement measures, further reducing the risk of diver-
sion into the food and feed chains and other unintended
technical purposes.

The French, Dutch and United Kingdom competent
authorities have confirmed the need to maintain the
existing trade in such gelatine with USA and Japan.
Accordingly France,
the Netherlands and the United
Kingdom should continue to authorise the import of
photographic gelatine subject to compliance with the
conditions set out in this Decision.

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(8)

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

(b) disposed of as waste by incineration in accordance with
Directive 2000/76/EC of the European Parliament and of
the Council (1) or in a landfill site in accordance with
Council Directive 1999/31/EC (2); or.

HAS ADOPTED THIS DECISION:

Article 1

Derogation regarding the import of photographic gelatine

By way of derogation from Article 29(1) of Regulation (EC) No
1774/2002, France, the Netherlands and the United Kingdom
shall authorise the import of gelatine produced from materials
containing bovine vertebral column classified as Category 1
material under that Regulation, exclusively intended for the
photographic industry (photographic gelatine),
in compliance
with this Decision.

Article 2

Conditions for import of photographic gelatine

1.
Import of photographic gelatine shall be allowed only
from the third countries of origin and plants of origin, through
the border inspection posts of first entry, and to the photo-
graphic factories of destination approved by the competent
authorities of
the Member States of destination (approved
photographic factories), listed in Annex I.

Once the photographic gelatine has entered the Member
2.
State of destination,
it shall not be traded between Member
States but shall only be used in the approved photographic
factory in the same Member State of destination and solely for
photographic production purposes.

3.
A health certificate corresponding to the model laid down
in Annex III, certifying that the photographic gelatine meets
the conditions set out in Annex II and comes from the plants
of origin listed in Annex I, shall accompany all consignments
of photographic gelatine.

Article 3

(c) exported to the country of origin in accordance with
Council Regulation (EC) No 259/93 of 1 February 1993 on
the supervision and control of shipments of waste within,
into and out of the European Community (3).

The operator of the approved photographic factory shall
2.
keep records for at least two years detailing the purchases and
uses of photographic gelatine, as well as the disposal of resi-
dues and surplus material.

The records shall be made available to the competent authority
for the purpose of checking compliance with this Decision.

Article 4

Obligations of the competent authority

1.
The competent authority shall control compliance by
operators of premises and facilities with the conditions set out
in Articles 2 and 3.

2.
In accordance with the provisions for the monitoring of
channelled consignments laid down in Article 8(4) of Council
Directive 97/78/EC (4), the competent authority shall ensure
that the consignments are sent directly from the border inspec-
tion post of first entry to an approved photographic factory
listed in Annex I, by means of vehicles that at the same time
do not
transport any products intended for food or feed,
including gelatine intended for other purposes than use in the
photographic industry.

3.
The competent authority shall ensure that the approved
photographic factories on their territory use the consigned
photographic gelatin exclusively for the authorised purpose.

4.
The competent authority shall carry out documentary
checks at regular intervals, at least twice a year on the channel-
ling chain from the border inspection posts of first entry to the
approved photographic factory for the purpose of reconcilia-
tion of the quantities of products imported, used and disposed
of, ensuring compliance with the provisions of this Decision.

Obligations of the operator of the approved photographic
factory

take appropriate measures
The competent authority shall
immediately in the case of any non-compliance with this Deci-
sion.

1.
The operator of the approved photographic factory shall
ensure that any surpluses or residues of and other waste
derived from the photographic gelatine are –

(a) transported in sealed leak-proof containers labelled 'for
disposal only' in vehicles under satisfactory hygiene condi-
tions;

(1) OJ L 332, 28.12.2000, p. 91.
(2) OJ L 182, 16.7.1999, p. 1; Directive as last amended by Regulation
(EC) No 882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p.1).

(3) OJ L 30, 6.2.1993, p. 1; Regulation as last amended by Commis-
sion Regulation (EC) No 2557/2001 (L 349, 31.12.2001, p. 1).
(4) OJ L 24, 30.1.1998, p. 9; Directive as last amended by the 2003

Act of Accession.

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5.
Notwithstanding the provisions of Article 2(1) above, the
competent authority of the Member State of destination may
by way of exception designate a different or additional border
inspection post of
first entry in the same Member Sates
provided the conditions of this Decision are met.

Article 5

Withdrawal of approvals and disposal of material not
complying with this Decision

1.
Individual approvals by the competent authority for the
use of photographic gelatine in the approved photographic
factories listed in Annex I shall be immediately and perma-
nently withdrawn in respect to any operator, premises or facil-
ities if the conditions set out in this Decision are no longer
fulfilled. The competent authority shall inform the Commission
immediately in writing of such withdrawal.

2.
Any material that does not comply with the requirements
of this Decision shall be disposed of in accordance with the
instructions of the competent authority.

Article 6

Review

The Commission shall review the operation of this Decision as
appropriate in the light of new scientific advice.

Article 7

Compliance with this Decision by the concerned Member
States

France, the Netherlands and the United Kingdom shall immedi-
ately take the necessary measures to comply with this Decision
and shall publish those measures. They shall
immediately
inform the Commission thereof.

Article 8

Applicability

This Decision shall apply from 1 May 2004.

Article 9

Addressees

This Decision is addressed to the French Republic,
the
Kingdom of the Netherlands and the United Kingdom of Great
Britain and Northern Ireland.

Done at Brussels, 26 April 2004.

For the Commission

David BYRNE

Member of the Commission

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THIRD COUNTRIES AND PLANTS OF ORIGIN, MEMBER STATES OF DESTINATION, BORDER INSPECTION
POSTS OF FIRST ENTRY AND APPROVED PHOTOGRAPHIC FACTORIES

ANNEX I

Third Country of origin

Plants of origin

Member State of destina-
tion

Border Inspection Post of
first entry

Approved Photographic Factories

Japan

Japan

USA

Nitta Gelatin Inc.
2-22 Futamata
Yao-City,
Osaka
581 – 0024 Japan
Jellie Co., Ltd.
7-1, Wakabayashi 2-Chome,
Wakabayashi-ku,
Sendai-city,
Miyagi,
982 Japan
NIPPI Inc. Gelatin Division
1 Yumizawa-Cho,
Fujinomiya City
Shizuoka
418 – 0073 Japan

Nitta Gelatin Inc.
2-22 Futamata
Yao-City
Osaka
581 – 0024, Japan

Eastman Gelatine Corporation,
227 Washington Street,
Peabody,
MA,
01960 USA
Gelita North America,
2445 Port Neal Industrial Road
Sergeant Bluff,
Iowa,
51054 USA

The Netherlands

Rotterdam

Fuji Photo Film BV,
Tilburg

France

Le Havre

United Kingdom

Liverpool
Felixstowe

France

Le Havre

United Kingdom

Liverpool
Felixstowe

Kodak
Zone Industrielle Nord,
71100 Châlon sur Saône

Kodak Ltd
Headstone Drive,
Harrow
MIDDX HA4 4TY

Kodak
Zone Industrielle Nord,
71100 Châlon sur Saône

Kodak Ltd
Headstone Drive,
Harrow
MIDDX HA4 4TY

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PRODUCTION OF PHOTOGRAPHIC GELATINE, WRAPPING AND PACKAGING

ANNEX II

1. Photographic gelatine shall be produced only in plants, which do not produce gelatine for food, feed or other tech-
nical uses intended for dispatch to the European Community, and which are approved for this purpose by the
competent authority of the third country concerned.

2.

(a) Photographic gelatine shall be produced by a process that ensures that the raw material is treated by processing
Method 1 set out in Chapter III of Annex V to Regulation (EC) No 1774/2002 or subjected to a treatment with
acid or alkali for at least two days, washing with water and –

(i) following an acid treatment, treating with an alkaline solution for at least 20 days; or

(ii) following an acid treatment, treating with an acid solution for 10-12 hours.

The pH must then be adjusted and the material purified by means of filtration and sterilisation at 138-140 °C for
4 seconds.

(b) After having been subjected to the process referred to in sub-paragraph (a), the photographic gelatine may

undergo a drying process and, where appropriate a process of pulverisation or lamination.

(c) The photographic gelatine must be wrapped, packaged in new packages, stored and transported in sealed leak-
proof, labelled containers in a vehicle under satisfactory hygiene conditions. If leakage is observed, the vehicle
and containers shall be thoroughly cleaned and inspected before re-use.

(d) Wrapping and packages containing the photographic gelatine must carry the words ‘photographic gelatine for

the photographic industry only’.

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ANNEX III

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