30.4.2004 EN Official Journal of the European Union 
 
  L 151/11
COMMISSION DECISION 
of 26 April 2004 
on transitional sanitary and certification ru les under Regulation (E C) No 1774/2002 of the 
European Parliament and of the Council as re gards 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, 
Having regard to the Treaty establishing the European Community, 
Having regard to Regulation (E C) No 1774/2002 of the European Parliament and of the Council 
of 3 October 2002 laying down health rules concerning animal  by-products not intended for 
human consumption1, and in particular Articles 4(4) and 32(1) thereof, 
Whereas: (1) According to the Regulation (EC) No 999/2 001 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 17 74/2002, Category 1 ma terials, which may 
contain specified risk material, may be import ed 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 the Eu ropean Parliament and of the Council as 
regards the importation and transit of certain products from third countries3 provides that 
the Commission is to propose detailed transitional rules for products for which adequate 
justification has been provided. 
                                                 
1 OJ L 273, 10.10.2002, p. 1. as last amended by Regulation (EC) No 808/2003 (OJ L 117, 13.5.2003, p. 1). 
2 OJ L 147, 31.5.2001, p. 1. as last amended by Regulation (EC) No. 2245/2003 (OJ L 333 , 20.12.2003, p. 
28). 
3 OJ L 117, 13.5.2003, p. 19. 
 EN Official Journal of the European Union 30.4.2004 
 
 L 151/12
(4) residual risk of bovine spongiform enceph alopathy (BSE) in a number of bovine-derived 
products such as gelatine, collagen and tallow and derived products, which is expected in 
the near future. 
(5) Pending such advice, it is therefore appropri ate to provide transitional measures allowing 
the continued import from Japan and the United  States of America of gelatine produced 
from materials containing bovine vertebral colu mn classified as Category 1 material under 
Regulation (EC) No 1774/2002, intended for the photographic industry (“photographic gelatine”). 
(6) The specific technical properties of photog raphic gelatine require the implementation of 
strict channelling and enforcement measures, fu rther reducing the risk of diversion into 
the food and feed chains and other unintended technical purposes. 
(7) The French, Dutch and United The Commissi on has requested scientific advice on a 
quantitative assessment of the Kingdom compet ent 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 wi th the conditions set out in this Decision. 
(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, 
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 author ise the import of gelatine produced from 
materials containing bovine vertebral column cl assified 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 a llowed only from the third countries of origin 
and plants of origin, through the border in spection posts of first entry, and to the 
photographic factories of destination approved by the competent authorities of the Member States of destination (“approved ph otographic 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 on ly be used in the approved photographic 
factory in the same Member State of destinati on and solely for phot ographic production 
purposes. 
 3. A health certificate corresponding to the model laid down in Annex III, certifying that 
the photographic gelatine meets the conditio ns set out in Annex II and comes from the 
plants of origin listed in Annex I, shall accompany all consignments of photographic 
gelatine. 
30.4.2004 EN Official Journal of the European Union 
 
  L 151/13
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 the photographic gelatine are – 
(a) transported in sealed leak-proof containe rs 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 Council4 or in a landfill site in accordance with 
Council Directive 1999/31/EC5; or. 
(c) exported to the country of origin in accordance with Regulation (EC) No 259/93 
on the supervision and control of shipmen ts of waste within, into and out of the 
European Community. 
2. The operator of the approved photographic factory shall keep records for at least two 
years detailing the purchases and uses of photog raphic gelatine, as well as the disposal of 
residues and surplus material.  
The records shall be made available to th e competent authority for the purpose of 
checking compliance with this Decision. 
Article 4 
Obligations of the competent authority 
1. The competent authority shall control complian ce 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/EC6, the competent authority shall 
ensure that the consignments are sent directly  from the border inspection post of first 
entry to an approved photographic factory liste d in Annex I, by means of vehicles that at 
the same time do not transport any produc ts intended for food or feed, including 
gelatine intended for other purposes th an use in the photographic industry. 
3. The competent authority shall ensure that the approved photographic factories on their 
territory use the consigned photographic gela tin exclusively for the authorised purpose. 
4. The competent authority shall carry out docume ntary checks at regular intervals, at least 
twice a year on the channelling chain from th e border inspection posts of first entry to 
the approved photographic factory for the purp ose of reconciliation of the quantities of 
products imported, used and disposed of, ensuring compliance with the provisions of this Decision.  
The competent authority shall take appropriat e measures immediately in the case of any 
non-compliance with this Decision. 
                                                
 
4 OJ L 332, 28.12.2000, p. 91. 
5 OJ L 182, 16.7.1999, p. 1. 
6 OJ L 24, 30.1.1998, p. 9. 
 EN Official Journal of the European Union 30.4.2004 
 
 L 151/14
5. Notwithstanding the provisions of Article 2(1) above, the competent authority of the 
Member State of destination may by way of ex ception designate a different or additional 
border inspection post of first entry in the same Member Sates prov ided the conditions 
of this Decision are met. 
Article 5 
Withdrawal of approvals and disposal of ma terial not complying with this Decision 
1. Individual approvals by the competent author ity for the use of photographic gelatine in 
the approved photographic factories listed in Annex I shall be immediately and permanently withdrawn in respect to any operator , premises or facilities if the conditions 
set out in this Decision are no longer fulfi lled. 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 in structions 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 sh all immediately take the necessary measures to 
comply with this Decision and shall publish thos e 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 
30.4.2004 EN Official Journal of the European Union 
 
  L 151/15
ANNEX I 
THIRD COUNTRIES AND PLANTS OF ORIGIN , M EMBER STATES OF DESTINATION , BORDER INSPECTION 
POSTS OF FIRST ENTRY AND APPR OVED PHOTOGRAPHIC FACTORIES  
Third 
Country 
of origin Plants of origin Member State of 
destination Border Inspection 
Post of first entry Approved 
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 Japan The Netherlands Rotterdam Fuji Photo Film BV, 
Tilburg 
France Le Havre Kodak 
Zone Industrielle Nord, 71100 Châlon sur Saône Japan Nitta Gelatin Inc 
2-22 Futamata Yao-City Osaka 581 – 0024, Japan United Kingdom Liverpool 
Felixstowe Kodak Ltd 
Headstone Drive, Harrow, MIDDX HA4 4TY 
France Le Havre Kodak 
Zone Industrielle Nord, 71100 Châlon sur Saône USA Eastman Gelatine 
Corporation, 227 Washington Street, Peabody, MA, 01960 USA 
Gelita North America,  
2445 Port Neal Industrial Road Sergeant Bluff, Iowa, 
51054 USA United Kingdom Liverpool 
Felixstowe Kodak Ltd 
Headstone Drive, Harrow, MIDDX HA4 4TY 
 EN Official Journal of the European Union 30.4.2004 
 
 L 151/16
ANNEX II 
PRODUCTION OF PHOTOGRAPHIC GELATINE , WRAPPING AND PACKAGING  
1. Photographic gelatine shall be produced on ly in plants, which do not produce gelatine 
for food, feed or other technical uses intend ed 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 produc ed 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 materi al purified by means of filtration and 
sterilisation at 138-140 ˚C for 4 seconds. 
(b) After having been subjected to the proc ess 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 wra pped, packaged in new packages, stored 
and transported in sealed leak-proof, labelled containers in a vehicle under 
satisfactory hygiene conditions. If leakag e is observed, the ve hicle 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”. 
30.4.2004 EN Official Journal of the European Union 
 
  L 151/17
ANNEX III 
MODEL HEALTH CERTIFICATES FOR THE IMPORT ATION FROM THIRD COUNTRIES OF TECHNICAL 
GELATINE TO BE USED BY THE PHOTOGRAPHIC 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 appearin g in this Annex III. They 
shall contain the attestations that are required for any third country and, as the case may be, those supplementary guarantees th at 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 indivisible. 
(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 border post shall be carried out and of the EU Member State of destination. 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 certifying official veterinarian, in each of the pages. (e) When the certificate, incl uding 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 other than 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. 
 EN Official Journal of the European Union 30.4.2004 
 
 L 151/18
Health certificate 
For technical gelatine not intended for human consum ption to be used by the photographic industry, 
intended for dispatch to  the European Community 
Note for the importer: This certificate is only for ve terinary purposes and has to accompany the consignment 
until it reaches the photographic factory of destination from the border inspection post. 
1. Consignor  (name and address in full)  
..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... ..................................................................................... VETERINARY CERTIFICATE 
For technical gelatine not intended for human consumption 
to be used by the photographic industry, intended for 
dispatch to the European Community 
 
..................................................................................... 
..................................................................................... Reference number(1) ORIGINAL 
..................................................................................... 3. Origin of the photographic gelatine  
2. Consignee  (name and address in full) 3.1. Country : 
Japan or USA (2) 
..................................................................................... 3.2. Co de of terri tory : ................. ..................................... 
..................................................................................... 4. Competent Authority  
..................................................................................... 4.1. Re sponsible Mi nistry :.............. ................................. 
..................................................................................... 4.2. Ce rtifying department :............. ................................ 
5. Intended destination of the photographic 
gelatine  ..................................................................................... 
5.1. EU Member State : 
France or the Netherlands or the United Kingdom(2) 6. Place of loading for exportation 
..................................................................................... ..................................................................................... 
5.2. Name and address of the photographic factory of 
destinatio n :................................................................ ..................................................................................... 
..................................................................................... 
..................................................................................... ......................................... ............................................ 
..................................................................................... ......................................... ............................................ 
..................................................................................... ......................................... ............................................ 
7. Means of transport and consignment 
identification  7.4. Nature of packaging : ................................................ 
..................................................................................... 
7.1. (Lorry, Rail-wagon , Ship, or Aircraft)(2) 7.5. Number of  packages : ............................................... 
7.2. Number of seal (if applic able) : ................................ 7.6. Net weight : ........................................ ........................ 
7.3. Registrat ion number(s), ship name or flight number:
..................................................................................... ..................................................................................... 7.7. Lot/batch production reference number : 
..................................................................................... ..................................................................................... 
..................................................................................... ......................................... ............................................ 
8. Identification of the photographic gelatine  
8.1. Nature of the ph otographic gelatine:...................................................................................... .........................................................  
8.2. Photographic  gelatine of: ................................................................................................. ........................................ (animal species)  
8.3. Address and approval number of th e approved establis hment of origin: ...................................................... ............................  
............................................................................................................................... ...............................................................................  
............................................................................................................................... ...............................................................................  
............................................................................................................................... ...............................................................................  
............................................................................................................................... ...............................................................................  
30.4.2004 EN Official Journal of the European Union 
 
  L 151/19
9. Health attestation 
I, the undersigned official, declare hat I have  read and understood Regulation (EC) No 1774/2002 (3) and certify that the 
photographic gelatine described above:  
9.1. consists exclusively of photograph ic gelatine for photographic uses and is not intended for any other purpose;  
9.2. has been prepared and stored in a plant approved, validate d and supervised by the competent authority in accordance with 
Article 18 of Regulation (EC) No 1774/2002, which do not produce gelatine for food, feed or ot her technical uses intended 
for dispatch to the European Community;  
9.3. has been prepared with Category 3 an imal by-products and/or bovine vertebral co lumn classified as Category 1 material;  
9.4. (a) has been wrapped, packaged, stored and transported under satisfactory hygiene conditions.  
(b) has been produced by a process ensuring th at the raw material is treated by Method 1(4) of Annex V of 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 was adjusted and the material purified by means of filtration and sterilised at 138-140 ˚C for 4 seconds. 
9.5. has been wrapped and packaged in wrappings and pack ages carrying the words “PHOTGRAPHIC GELATINE FOR THE 
PHOTOGRAPHIC INDUSTRY ONLY”  
Official stamp and signature 
Done at ....................................................................................... on............................... ....................................................................  
(place) (date) 
.......................................................................................................  
(stamp) (5) (Signature of the official veterinarian/official  
of the competent authority) (5) 
.......................................................................................................  
 (name, qualifications and title, in capital letters) 
 EN Official Journal of the European Union 30.4.2004 
 
 L 151/20
Notes  
(1) Issued by the competent authority. 
(2) Delete as appropriate. 
(3) OJ L 273, 10.10.2002, p. 1. 
(4) Method 1 is as follows - 
“Reduction 1. If the particle size of the animal by-products to be processed is more than 50 millimetres, the animal by-products 
must be reduced in size using appropriate equipment, set so that the particle size after reduction is no greater than 
50 millimetres. The effectiveness of th e equipment must be checked daily an d its condition recorded. If checks 
disclose the existence of particles larger than 50 millimet res, the process must be stopped and repairs made before 
the process is resumed. 
Time, temperature and pressure 2. After reduction the animal by-product s must be heated to a core temperature of more than 133°C for at least 20 
minutes without interruption at a pressure (absolute) of at least 3 bars produced by saturated steam; the heat 
treatment may be applied as the sole process or as a pre- or post-process sterilisation phase. 
3. The processing may be carried ou t in batch or continuous systems.” 
(5) The signature and the stamp must be in a different colour to that of the printing.