2004/407/EC: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 photographic gelatine
Date: 2004-04-26
Institutions: European Commission
Subjects: agricultural by-product, animal health, bovine spongiform encephalopathy, health control, import (EU), material of animal origin, photographic industry, third country

30.4.2004 

EN 

Official Journal of the European Union 

L 151/11

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 
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 (EC) 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) 

(2) 

(3) 

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  encephalopathies2,  specified  risk  material  may  not  be 
imported into the Community,  

According  to  the  Regulation  (EC)  No  1774/2002,  Category  1  materials,  which  may 
contain specified risk material, may be imported into the Community in accordance 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 European 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. 

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

 
  
 
                                                 
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Official Journal of the European Union 

30.4.2004 

(4) 

(5) 

(6) 

(7) 

residual risk of bovine spongiform encephalopathy (BSE) in a number of bovine-derived 
products such as gelatine, collagen and tallow and derived products, which is expected in 
the near future. 

Pending such advice, it 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  photographic  industry  (“photographic 
gelatine”). 

The specific technical properties of photographic gelatine require the implementation of 
strict  channelling  and  enforcement  measures,  further  reducing  the  risk  of  diversion  into 
the food and feed chains and other unintended technical purposes. 

The  French,  Dutch  and  United  The  Commission  has  requested  scientific  advice  on  a 
quantitative assessment of the 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. 

(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  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. 

2. 

 3. 

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 
photographic  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 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. 

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. 

 
 
 
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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) 

(b) 

(c) 

transported in sealed leak-proof containers labelled “for disposal only” in vehicles 
under satisfactory hygiene conditions; 

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. 

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

The  operator  of  the  approved  photographic  factory  shall  keep  records  for  at  least  two 
years detailing the purchases and uses of photographic 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 

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

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 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. 

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

The competent authority shall carry out documentary checks at regular intervals, at least 
twice a year on the channelling chain from the border inspection posts of first entry to 
the approved photographic factory for the purpose 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 appropriate measures immediately in the case of any 
non-compliance with this Decision. 

2. 

1. 

2. 

3. 

4. 

4 
5 
6 

OJ L 332, 28.12.2000, p. 91. 
OJ L 182, 16.7.1999, p. 1. 
OJ L 24, 30.1.1998, p. 9. 

 
  
                                                 
L 151/14

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Official Journal of the European Union 

30.4.2004 

5. 

1. 

2. 

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 

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 
permanently withdrawn in respect to any operator, premises or facilities 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. 

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 immediately take the necessary measures to 
comply with this Decision and shall publish those measures. They shall immediately inform the 
Commission thereof. 

This Decision shall apply from 1 May 2004. 

Article 8 
Applicability 

 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 

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Official Journal of the European Union 

L 151/15

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 origin 

Japan 

Japan 

USA 

Approved 
Photographic 
Factories 

Fuji Photo Film BV, 
Tilburg 

Plants of origin 

Member State of 
destination 

Border Inspection 
Post of first entry 

The Netherlands  Rotterdam 

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 

Inc.  Gelatin 

Yumizawa-Cho, 

NIPPI 
Division 
1 
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 

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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Official Journal of the European Union 

30.4.2004 

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 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) 

(ii) 

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

following  an  acid 
10-12 hours. 

treatment, 

treating  with  an  acid  solution 

for 

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”. 

 
 
 
 
30.4.2004 

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Official Journal of the European Union 

L 151/17

ANNEX III 

MODEL HEALTH CERTIFICATES FOR THE IMPORTATION FROM THIRD COUNTRIES OF TECHNICAL 
GELATINE TO BE USED BY THE PHOTOGRAPHIC INDUSTRY 

Notes 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

the 

importation  of 
for 
Veterinary  certificates 
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  guarantees  that  are  required  for  the 
exporting third country or part thereof. 

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. 

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. 

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. 

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. 

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. 

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. 

The  original  of  the  certificate  must  accompany  the 
consignment at the EU border inspection post until it 
reaches the photographic factory of destination. 

 
  
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Official Journal of the European Union 

30.4.2004 

Health certificate 

For technical gelatine not intended for human consumption to be used by the photographic industry, 
intended for dispatch to the European Community 

Note for the importer: This certificate is only for veterinary purposes and has to accompany the consignment 
until it reaches the photographic factory of destination from the border inspection post. 

1. 

2. 

5. 

5.1. 

5.2. 

7. 

7.1. 
7.2. 
7.3. 

8. 
8.1. 
8.2. 
8.3. 

Consignor (name and address in full)  
..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 

..................................................................................... 
..................................................................................... 
..................................................................................... 
Consignee (name and address in full) 

..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 
Intended  destination  of 
gelatine 
EU Member State : 
France or the Netherlands or the United Kingdom(2) 

the  photographic 

3. 
3.1. 

3.2. 
4. 
4.1. 
4.2. 

6. 

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 

Origin of the photographic gelatine 
Country : 
Japan or USA (2) 
Code of territory : ...................................................... 
Competent Authority 
Responsible Ministry :............................................... 
Certifying department :............................................. 
..................................................................................... 

of 

7.4. 

and 

transport 

consignment 

Place of loading for exportation 
..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 
..................................................................................... 
Nature of packaging : ................................................ 
..................................................................................... 
Number of packages : ............................................... 
Net weight : ................................................................ 
Lot/batch production reference number : 
..................................................................................... 
..................................................................................... 
..................................................................................... 

Name  and  address  of  the  photographic  factory  of 
destination :................................................................ 
..................................................................................... 
..................................................................................... 
..................................................................................... 
Means 
identification 
(Lorry, Rail-wagon, Ship, or Aircraft)(2) 
Number of seal (if applicable) : ................................ 
Registration number(s), ship name or flight number:
..................................................................................... 
..................................................................................... 
..................................................................................... 
Identification of the photographic gelatine 
Nature of the photographic gelatine:...............................................................................................................................................  
Photographic gelatine of: ......................................................................................................................................... (animal species) 
Address and approval number of the approved establishment of origin: ..................................................................................  
..............................................................................................................................................................................................................  
..............................................................................................................................................................................................................  
..............................................................................................................................................................................................................  
..............................................................................................................................................................................................................  

7.5. 
7.6. 
7.7. 

 
 
 
 
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Official Journal of the European Union 

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9. 

9.1. 

9.2. 

9.3. 

9.4. 

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: 

consists exclusively of photographic gelatine for photographic uses and is not intended for any other purpose; 

has been prepared and stored in a plant approved, validated 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 other technical uses intended 
for dispatch to the European Community; 

has been prepared with Category 3 animal by-products and/or bovine vertebral column classified as Category 1 material; 

(a) 

(b) 

has been wrapped, packaged, stored and transported under satisfactory hygiene conditions. 
has been produced by a process ensuring that 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) 

(ii) 

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

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  packages  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) 

 
  
 
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Notes 

(1) 

(2) 

(3) 

(4) 

Issued by the competent authority. 

Delete as appropriate. 

OJ L 273, 10.10.2002, p. 1. 

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  the  equipment  must  be  checked  daily  and  its  condition  recorded.  If  checks 
disclose the existence of particles larger than 50 millimetres, the process must be stopped and repairs made before 
the process is resumed. 

Time, temperature and pressure 

2. 

After reduction the animal by-products 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 out in batch or continuous systems.” 

(5) 

The signature and the stamp must be in a different colour to that of the printing.