2004D9407 — EN — 01.05.2004 — 000.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Corrected by:

▼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 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 consumption ►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 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 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 quantitative assessment of the 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 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, Whereas: 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.

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 Council ( 4 ) or in a landfill site in accordance with Council Directive 1999/31/EC ►C1 ( 5 ) ◄ ; or.

(c) exported to the country of origin in accordance with Council Regulation (EC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community ( 6 ).

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/EC ( 7 ), 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.

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.

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 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 Japan Nitta Gelatin Inc. 2-22 Futamata Yao-City Osaka 581 – 0024, Japan France Le Havre Kodak Zone Industrielle Nord, 71100 Châlon sur Saône United Kingdom Liverpool Felixstowe Kodak 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 USA France Le Havre Kodak Zone Industrielle Nord, 71100 Châlon sur Saône United Kingdom Liverpool Felixstowe Kodak Ltd Headstone Drive, Harrow MIDDX HA4 4TY

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 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’.

ANNEX III

►() C1

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:

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 destination:

7. Means of transport and consignment identification

7.4. Means of transport and consignment 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:

( 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 Regulation (EC) No. 2245/2003 (OJ L 333, 20.12.2003, p. 28).

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

( 4 ) OJ L 332, 28.12.2000, p. 91.

( 5 ) 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).

( 6 ) OJ L 30, 6.2.1993, p. 1; Regulation as last amended by Commission Regulation (EC) No 2557/2001 (L 349, 31.12.2001, p. 1).

( 7 ) OJ L 24, 30.1.1998, p. 9; Directive as last amended by the 2003 Act of Accession.