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►B COMMISSION DECISION
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 photo-
graphic gelatine
(notified under document number C(2004) 1516)
(Only the English, French and Dutch texts are authentic)
(Text with EEA relevance)
(2004/407/EC)
(OJ L 208, 10.6.2004, p. 9)
Amended by:
Official Journal
No page date
►M1 Commission Decision 2006/311/EC, of 21 April 2006 L 115 40 28.4.2006
Corrected by:
►C1 Corrigendum, OJ L 396 , 31.12.2004, p. 63 (2004/407/EC)2004D9407 —EN—01.05.2006 —001.001 —1
▼B
COMMISSION DECISION
of 26 April 2004
on transitional sanitary and certification rules under Regulation
(EC) No 1774/2002 of the European Parliament and of the Councilas regards import from certain third countries of photographic gela-
tine
(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,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1774/2002 of the European Parlia-
ment and of the Council of 3 October 2002 laying down health rules
concerning animal by-products not intended for human consump-tion►
C1(1)◄, and in particular Articles 4(4) and 32(1) thereof,
Whereas:
(1) 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 encephalopathies (2), specified risk material may not
be imported into the Community,
(2) According to the Regulation (EC) No 1774/2002, Category 1materials, which may contain specified risk material, may beimported into the Community in accordance with rules laid down
in that Regulation or to be established by Comitology procedure.
(3) Commission Regulation (EC) No 812/2003 of 12 May 2003 on
transitional measures under Regulation (EC) No 1774/2002 of theEuropean Parliament and of the Council as regards the importa-tion and transit of certain products from third countries (
3)
provides that the Commission is to propose detailed transitional
rules for products for which adequate justification has been
provided.
(4) The Commission has requested scientific advice on a quantitativeassessment of the residual risk of bovine spongiform encephalo-pathy (BSE) in a number of bovine-derived products such asgelatine, collagen and tallow and derived products, which is
expected in the near future.
(5) Pending such advice, it is therefore appropriate to provide transi-
tional measures allowing the continued import from Japan andthe United States of America of gelatine produced from materialscontaining bovine vertebral column classified as Category 1 mate-rial under Regulation (EC) No 1774/2002, intended for the photo-
graphic industry (photographic gelatine).
(6) The specific technical properties of photographic gelatine require
the implementation of strict channelling and enforcementmeasures, further reducing the risk of diversion into the food andfeed chains and other unintended technical purposes.
(7) 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 Nether-2004D9407 —EN—01.05.2006 —001.001 —2
(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by Commission
Regulation (EC) No 668/2004 (OJ L 112, 19.4.2004, p. 1).
(2) OJ L 147, 31.5.2001, p. 1; Regulation as last amended by Commission Regu-
lation (EC) No. 2245/2003 (OJ L 333, 20.12.2003, p. 28).
(3) OJ L 117, 13.5.2003, p. 19.
▼B
lands and the United Kingdom should continue to authorise the
import of photographic gelatine subject to compliance with theconditions set out in this Decision.
(8) The measures provided for in this Decision are in accordancewith the opinion of the Standing Committee on the Food Chainand Animal Health,
HAS ADOPTED THIS DECISION:
▼M1
Article 1
Derogation regarding the import of photographic gelatine
By way of derogation from Article 29(1) of Regulation (EC) No
1774/2002, Belgium, France, Luxembourg, the Netherlands and the
United Kingdom shall authorise the import of gelatine produced from
materials containing bovine vertebral column classified as Category 1material under that Regulation, exclusively intended for the photo-graphic industry (photographic gelatine), in compliance with this Deci-sion.
▼
B
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 inspec-
tion posts of first entry, and to the photographic factories of destination
approved by the competent authorities of the Member States of destina-tion (approved photographic factories), listed in Annex I.
2. Once the photographic gelatine has entered the Member State of
destination, it shall not be traded between Member States but shall onlybe used in the approved photographic factory in the same Member Stateof 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 AnnexI, shall accompany all consignments of photographic gelatine.
Article 3
Obligations of the operator of the approved photographic factory
1. The operator of the approved photographic factory shall ensure
that any surpluses or residues of and other waste derived from thephotographic gelatine are –
(a)transported in sealed leak-proof containers labelled ’for disposal
only’ in vehicles under satisfactory hygiene conditions;
(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►
C1(2)◄; or.
(c)exported to the country of origin in accordance with Council Regula-
tion (EC) No 259/93 of 1 February 1993 on the supervision and
control of shipments of waste within, into and out of the EuropeanCommunity (
3).2004D9407 —EN—01.05.2006 —001.001 —3
(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
1882/2003 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 Commission Regula-
tion (EC) No 2557/2001 (L 349, 31.12.2001, p. 1).
▼B
2. The operator of the approved photographic factory shall keep
records for at least two years detailing the purchases and uses of photo-graphic gelatine, as well as the disposal of residues 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 (
1), the competent authority shall ensure that the consignments are
sent directly from the border inspection post of first entry to anapproved photographic factory listed in Annex I, by means of vehiclesthat 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 photo-
graphic factories on their territory use the consigned photographicgelatin exclusively for the authorised purpose.
4. The competent authority shall carry out documentary checks at
regular intervals, at least twice a year on the channelling chain from theborder inspection posts of first entry to the approved photographicfactory for the purpose of reconciliation of the quantities of productsimported, used and disposed of, ensuring compliance with the provisionsof this Decision.
The competent authority shall take appropriate measures immediately in
the case of any non-compliance with this Decision.
5. Notwithstanding the provisions of Article 2(1) above, the compe-
tent authority of the Member State of destination may by way of excep-tion 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 inAnnex I shall be immediately and permanently withdrawn in respect toany operator, premises or facilities if the conditions set out in this Deci-sion are no longer fulfilled. The competent authority shall inform theCommission 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 thecompetent authority.
Article 6
Review
The Commission shall review the operation of this Decision as appro-
priate in the light of new scientific advice.2004D9407 —EN—01.05.2006 —001.001 —4
(1) OJ L 24, 30.1.1998, p. 9; Directive as last amended by the 2003 Act of
Accession.
▼B
Article 7
Compliance with this Decision by the concerned Member States
France, the Netherlands and the United Kingdom shall immediately take
the necessary measures to comply with this Decision and shall publishthose measures. They shall immediately inform the Commission thereof.
Article 8
Applicability
This Decision shall apply from 1 May 2004.
▼
M1
Article 9
Addresses
This Decision is addressed to the Kingdom of Belgium, the French
Republic, the Grand Duchy of Luxembourg, the Kingdom of the Nether-lands and the United Kingdom of Great Britain and Northern Ireland.2004D9407 —EN—01.05.2006 —001.001 —5
▼M1
ANNEX I
Third countries and plants of origin, Member States of destination, border inspection posts of first
entry and approved photographic factories
Third Country of
originPlants of originMember State
of destinationBorder
Inspection Post
of first entryApproved Photographic
Factories
Japan —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 JapanThe Nether-
landsRotterdam Fuji Photo Film BV,
Tilburg
Japan Nitta Gelatin Inc
2-22 Futamata
Yao-City Osaka
581—0024, JapanFrance Le Havre Kodak
Zone Industrielle Nord,
71100 Châlon sur Saône
The United
KingdomLiverpool
FelixstoweKodak Ltd
Headstone Drive,
Harrow,
MIDDX HA4 4TY
USA —Eastman Gelatine
Corporation,
227 Washington
Street,
Peabody, MA,
01960 USA
—Gelita North
America,
2445 Port Neal
Industrial Road
Sergeant Bluff,
Iowa,
51054 USALuxembourg Antwerp
Zaventem
LuxembourgDuPont Teijin Luxem-
bourg SA
PO Box 1681
L-1016 Luxembourg
France Le Havre Kodak
Zone Industrielle Nord,
71100 Châlon sur Saône
The United
KingdomLiverpool
FelixstoweKodak Ltd
Headstone Drive,
Harrow,
MIDDX HA4 4TY2004D9407 —EN—01.05.2006 —001.001 —6
▼B
ANNEX II
PRODUCTION OF PHOTOGRAPHIC GELATINE, WRAPPING AND
PACKAGING
1. Photographic gelatine shall be produced only in plants, which do not produce
gelatine for food, feed or other technical uses intended for dispatch to the
European Community, and which are approved for this purpose by the compe-tent 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 filtra-
tion and sterilisation at 138-140
oC 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’.2004D9407 —EN—01.05.2006 —001.001 —7
▼M1
ANNEX III
Model health certificates for the importation from third countries of technical gelatine to be used by the photo-
graphic industry
Notes
(a) Veterinary certificates for the importation of technical
gelatine to be used by the photographic industry shall
be produced by the exporting country, based on the
model appearing in this Annex III. They shall contain
the attestations that are required for any third country
and, as the case may be, those supplementary guaran-
tees that are required for the exporting third country
or part thereof.
(b) The original of each certificate shall consist of a
single page, both sides, or, where more text is
required, it shall be in such a form that all pages
needed are part of an integrated whole and indivi-
sible.
(c) It shall be drawn up in at least one of the official
languages of the EU Member State in which the
inspection at the EU border inspection post shall be
carried out and of the EU Member State of destina-
tion. However, these Member States may allow other
languages, if necessary, accompanied by an official
translation.
(d) If for reasons of identification of the items of the
consignment, additional pages are attached to the
certificate, these pages shall also be considered as
forming part of the original of the certificate by the
application of the signature and stamp of the certi-
fying official veterinarian, in each of the pages.(e) When the certificate, including additional schedules
referred to in (d), comprises more than one page,
each page shall be numbered —(page number) of
(total number of pages) —on its bottom and shall
bear the code number of the certificate that has been
designated by the competent authority on its top.
(f) The original of the certificate must be completed and
signed by an official veterinarian. In doing so, the
competent authorities of the exporting country shall
ensure that the principles of certification equivalent
to those laid down in Council Directive 96/93/EC are
followed.
(g) The colour of the signature shall be different to that
of the printing. The same rule applies to stamps otherthan those embossed or watermark.
(h) The original of the certificate must accompany the
consignment at the EU border inspection post until it
reaches the photographic factory of destination.2004D9407 —EN—01.05.2006 —001.001 —8
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2004D9407 —EN—01.05.2006 —001.001 —9
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2004D9407 —EN—01.05.2006 —001.001 —10