CELEX: 32004D0407(01)
Language: en
Date: 2004-04-26 00:00:00
Title: 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

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)     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,
(2)     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.
(3)     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.
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.
 ---pagebreak--- L 151/12                 EN                 Official Journal of the European Union       30.4.2004
(4)     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.
(5)     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”).
(6)     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.
(7)     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.        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.
2.        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.
 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.
 ---pagebreak--- 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 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 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 shipments 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 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
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/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.
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 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.
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.
 ---pagebreak--- L 151/14                   EN               Official Journal of the European Union             30.4.2004
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
           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.
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 immediately 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
 ---pagebreak--- 30.4.2004                EN            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         Plants of origin     Member State of           Border Inspection          Approved
 Country                                destination             Post of first entry      Photographic
 of origin                                                                                 Factories
Japan      Nitta Gelatin Inc.       The Netherlands          Rotterdam              Fuji Photo Film BV,
           2-22 Futamata                                                            Tilburg
           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
Japan      Nitta Gelatin Inc        France                   Le Havre               Kodak
           2-22 Futamata                                                            Zone Industrielle
           Yao-City                                                                 Nord, 71100
           Osaka                                                                    Châlon sur Saône
           581 – 0024, Japan                                                        Kodak Ltd
                                    United Kingdom           Liverpool
                                                                                    Headstone Drive,
                                                             Felixstowe             Harrow, MIDDX
                                                                                    HA4 4TY
USA        Eastman Gelatine         France                   Le Havre               Kodak
           Corporation, 227                                                         Zone Industrielle
           Washington Street,                                                       Nord, 71100
           Peabody, MA, 01960                                                       Châlon sur Saône
           USA                                                                      Kodak Ltd
                                    United Kingdom           Liverpool
                                                                                    Headstone Drive,
           Gelita North America,                                                    Harrow, MIDDX
                                                             Felixstowe
           2445 Port Neal                                                           HA4 4TY
           Industrial Road
           Sergeant Bluff, Iowa,
           51054 USA
 ---pagebreak--- L 151/16                  EN               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)     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”.
 ---pagebreak--- 30.4.2004                      EN                    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)       Veterinary certificates for the importation of             (e)         When the certificate, including additional schedules
          technical gelatine to be used by the photographic                      referred to in d), comprises more than one page, each
          industry shall be produced by the exporting country,                   page shall be numbered -(page number) of (total number
          based on the model appearing in this Annex III. They                   of pages)– on its bottom and shall bear the code
          shall contain the attestations that are required for any               number of the certificate that has been designated by
          third country and, as the case may be, those                           the competent authority on its top.
          supplementary guarantees that are required for the         (f)         The original of the certificate must be completed and
          exporting third country or part thereof.                               signed by an official veterinarian. In doing so, the
(b)       The original of each certificate shall consist of a single             competent authorities of the exporting country shall
          page, both sides, or, where more text is required, it                  ensure that the principles of certification equivalent to
          shall be in such a form that all pages needed are part                 those laid down in Council Directive 96/93/EC are
          of an integrated whole and indivisible.                                followed.
(c)       It shall be drawn up in at least one of the official       (g)         The colour of the signature shall be different to that of
          languages of the EU Member State in which the                          the printing. The same rule applies to stamps other
          inspection at the border post shall be carried out and                 than those embossed or watermark.
          of the EU Member State of destination. However,            (h)         The original of the certificate must accompany the
          these Member States may allow other languages, if                      consignment at the EU border inspection post until it
          necessary, accompanied by an official translation.                     reaches the photographic factory of destination.
(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.
 ---pagebreak--- L 151/18                                    EN                                       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.         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.                 Code of territory : ......................................................
            .....................................................................................              4.                   Competent Authority
            .....................................................................................              4.1.                 Responsible Ministry :...............................................
            .....................................................................................              4.2.                 Certifying department :.............................................
5.         Intended destination of the photographic                                                                                  .....................................................................................
           gelatine
5.1.       EU Member State :                                                                                   6.                   Place of loading for exportation
           France or the Netherlands or the United Kingdom(2)                                                                        .....................................................................................
                                                                                                                                     .....................................................................................
5.2.       Name and address of the photographic factory of                                                                           .....................................................................................
           destination :................................................................                                             .....................................................................................
            .....................................................................................                                    .....................................................................................
            .....................................................................................                                    .....................................................................................
            .....................................................................................                                    .....................................................................................
7.         Means               of        transport                and           consignment 7.4.                                    Nature of packaging : ................................................
           identification                                                                                                            .....................................................................................
7.1.       (Lorry, Rail-wagon, Ship, or Aircraft)(2)                                                           7.5.                 Number of packages : ...............................................
7.2.       Number of seal (if applicable) : ................................                                   7.6.                 Net weight : ................................................................
7.3.       Registration 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 photographic gelatine:...............................................................................................................................................
8.2.       Photographic gelatine of: ......................................................................................................................................... (animal species)
8.3.       Address and approval number of the approved establishment of origin: ..................................................................................
            ..............................................................................................................................................................................................................
            ..............................................................................................................................................................................................................
            ..............................................................................................................................................................................................................
            ..............................................................................................................................................................................................................
 ---pagebreak--- 30.4.2004                           EN                                   Official Journal of the European Union                                                                                 L 151/19
9.        Health attestation
                                                                                                                                                                                   (3)
          I, the undersigned official, declare hat I have read and understood Regulation (EC) No 1774/2002                                                                              and certify that the
          photographic gelatine described above:
9.1.      consists exclusively of photographic gelatine for photographic uses and is not intended for any other purpose;
9.2.      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;
9.3.      has been prepared with Category 3 animal by-products and/or bovine vertebral column 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 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)          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 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
                                                                                                                                                                                               (5)
                                                                                                                                             of the competent authority)
                                                                                                          .......................................................................................................
                                                                                                                        (name, qualifications and title, in capital letters)
 ---pagebreak--- L 151/20                     EN                      Official Journal of the European Union                          30.4.2004
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 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.