Application form for Designated Point of Entry status for specific rice products from China – port / airport operator application Please send this application to the Imported Food Team, Food Standards Agency at the following email address: Imported.food@foodstandards.gsi.gov.uk Please mark the email title box “DPE designation for rice products from China” I [name and position] on behalf of [name of port / airport operator] wish to apply for [name of port / airport] to be a Designated Point of Entry (DPE) for the purposes of carrying out controls for unauthorised genetically modified rice in specific rice products originating or consigned from China. Minimum requirements for a DPE 1. I confirm that the point of entry meets the minimum requirements for a DPE as listed in Annex A to this form. 2. I have set down in Annex B to this form an explanation of how this point of entry will meet each of the minimum requirements as a DPE and the resources (e.g. equipment, storage facilities etc.) in place at the point of entry. Please say if there is any agreement with relevant businesses to make use of the facilities. 3. I understand that if the continued operation of the DPE presents a serious risk to public health, the designated status may be suspended by the Food Standards Agency. 4. This application has been discussed with the local / port health authority [give name of authority or authorities] because minimum requirements listed in Annex A to this form are to be fulfilled by them. Feed and Food Products to be covered by the designation 5. I request that the designation cover the following rice products originating or consigned from China, subject to controls at the DPE for unauthorised genetically modified rice (please tick one option): (a) all feed products listed in Annex C of this form (b) Or all food products listed in Annex C of this form (c) Or all feed and food products listed in Annex C of this form Please note - 6. Article 6 of the Regulation requires reports to be made to the Commission giving details of the controls carried out on products listed in Annex C. Signature: Name: Port Operator: Address: Contact No: Date: Confirmation in relation to paragraph 4 by local / port health authority responsible for feed and food controls as necessary. Signature: Signature: Name: Name: Food Authority: Feed Authority: Date: Date: Annex A- Minimum requirements for DPEs to carry out controls on specific rice products from China for unauthorised genetically modified rice DPEs shall have at least the following available. Please note that points (a), (c) and (g) in particular are issues for the enforcement authorities to address, hence proper liaison with the relevant parties is essential. a) a sufficient number of suitably qualified and experienced staff to perform the prescribed checks on consignments; b) appropriate facilities for the enforcement authority to undertake the necessary checks; c) detailed instructions regarding sampling for analysis and the sending of such samples for analysis to a laboratory designated pursuant to Article 12(1) of Regulation (EC) No 882/2004 ("the designated laboratory”); d) facilities to store consignments (and containerised consignment) in appropriate conditions during the period of detention, where appropriate, awaiting the results of the analysis referred to in point (c), and a sufficient number of storage rooms; e) unloading equipment and appropriate equipment for carrying out sampling for analysis; f) the possibility to perform the unloading and the sampling for analysis in a sheltered place, where appropriate; g) a designated laboratory which can perform the analysis referred to in point (c), situated at a place to which the samples can be transported within a short period of time. NOTE: The designation of the point of entry may be suspended, either in full or part, by the Agency. This will occur when the Agency is satisfied that the continued operation of the DPE presents a serious risk to animal or public health or, there has been a serious breach of the minimum requirements. Annex B- How the DPE will meet the minimum requirements in Annex A Please give an explanation of the facilities available at the port or airport to enable the import controls required (in Annex A) to be carried out. Please liaise with the local / port health authority at the port or airport when completing this annex. The facilities needed include: Appropriate facilities for the local or port health authorities to undertake the necessary checks, such as sampling (including whether sampling will be under cover); Facilities to store consignments under appropriate conditions whilst awaiting the results of analysis; Appropriate equipment such as unloading equipment (such as fork lift truck if appropriate). The local and port health authority with responsibility for carrying out the controls will need: A sufficient number of appropriately qualified staff to perform the prescribed checks on consignments (please give number and grade of staff); Access to a laboratory capable of performing the analysis in Annex D of this form. Please give the name and address of the laboratory; Written instructions or work procedures on sampling products for analysis and the sending of such samples for analysis to the laboratory. Annex C- List of rice products originating or consigned from China, subject to controls for unauthorised genetically modified rice Product Rice in the husk (‘paddy’ or rough) Husked (brown) rice Semi-milled or wholly milled rice, whether or not polished or glazed Broken rice Rice flour Rice groats and meal Rice pellets Flaked rice grains Rolled or flaked cereal grains (excluding grains of oats, wheat, rye, maize and barley, and flaked rice) Rice starch Preparations for infant use, put up for retail sale Uncooked pasta, not stuffed or otherwise prepared, containing eggs Uncooked pasta, not stuffed or otherwise prepared, not containing eggs Stuffed pasta, whether or not cooked or otherwise prepared Other pasta (other than uncooked pasta, not stuffed or otherwise prepared, and other than stuffed pasta, whether or not cooked or otherwise prepared) Prepared foods obtained by swelling or roasting cereals or cereal products, obtained from rice Preparations of the muesli-type based on unroasted cereal flakes Prepared foods obtained from unroasted cereal flakes or from mixtures of unroasted cereal flakes or swelled cereals, obtained from rice (excluding preparations of the muesli-type on the basis of unroasted cereal flakes) Rice, pre-cooked or otherwise prepared, not elsewhere specified or included (excluding flour, groats and meal, food preparations obtained by swelling or roasting or from unroasted cereal flakes or from mixtures of unroasted cereal flakes and roasted cereal flakes or swelled cereals) Ricepaper Biscuits Extruded or expanded products, savoury or salted Bran, sharps and other residues, whether or not in the form of pellets, derived from the sifting, milling or other working of rice with a starch content not exceeding 35 % by weight Bran, sharps and other residues, whether or not in the form of pellets, derived from the sifting, milling or other working of rice other than with a starch content not exceeding 35 % by weight Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed CN code 1006 10 1006 20 1006 30 1006 40 00 1102 90 50 1103 19 50 1103 20 50 1104 19 91 1104 19 99 1108 19 10 1901 10 00 1902 11 00 1902 19 1902 20 1902 30 1904 10 30 1904 20 10 1904 20 95 1904 90 10 Ex 1905 90 20 1905 90 45 1905 90 55 2302 40 02 2302 40 08 3504 00 00 Annex D- Methods of sampling and analysis for official controls on unauthorised genetically modified rice in rice products originating from China 1. General provisions Samples intended for the official control for the absence of GM rice in rice products shall be taken according to the methods described in this Annex. The bulk samples thus obtained shall be considered as representative of the lots from which they are taken. 2. Sampling 2.1 Sampling lots of bulk commodities and preparation of the analytical samples The number of incremental samples which make up the bulk sample and the preparation of the analytical samples shall be made in accordance with Recommendation 2004/787/EC and Commission Regulation (EC) No 152/2009 for feed. The size of the laboratory sample shall be 2,5 kg but may be reduced to 500 grams for processed food or feed. For the purpose of Article 11(5) of Regulation (EC) 882/2004, a second laboratory sample shall be constituted from the aggregate sample. 2.2 Sampling of prepacked food and feed The number of incremental samples for the constitution of the bulk sample and the preparation of the analytical samples shall be made in accordance with CEN/ISO 15568 or equivalent. The size of the laboratory sample shall be 2,5 kg but may be reduced to 500 grams for processed food or feed. For the purpose of Article 11(5) of Regulation (EC) 882/2004, a second laboratory sample shall be constituted from the aggregate sample. 3. Analysis of the laboratory sample The laboratory analysis at the point of origin shall be carried out in a designated AQSIQ laboratory, and prior to release for free circulation in the Union in a Member State designated official control laboratory. Screening tests shall be performed by real-time PCR according to the method published by the EU-RL GMFF7, for at least the following genetic elements: the CAMV (Cauliflower Mosaic Virus) 35S promoter, the NOS (nopaline synthase) terminator from Agrobacterium tumefaciens and the engineered CryIAb, CryIAc and/or CryIAb/CryIAc from Bacillus thuringiensis. In the case of grain samples the designated control laboratory shall take from the homogenised laboratory sample four analytical samples of 240 grams (equivalent 10,000 rice grains). For processed products such as flour, pasta or starch the analytical samples this may be reduced to 125 grams. The four analytical samples shall be ground and further analysed separately. Two extractions shall be made from each analytical sample. One PCR test for each GM genetic element shall be made for each extraction in accordance with the screening methods detailed under point 4 below. The consignment shall be considered non compliant if at least one GM genetic element is considered detectable in at least one analytical sample of the consignment according to the guidelines provided in the EU-RL report. 4. The following analytical methods shall be used: (a) For screening for the CAMV (Cauliflower Mosaic Virus) 35S promoter and the NOS (nopaline synthase) terminator from Agrobacterium tumefaciens. 1ISO 21570: 2005 Methods of analysis for the detection of genetically modified organisms and derived products—quantitative nucleic acid based methods. Annex B1. 2H.-U. Waiblinger et al., (2008) "Validation and collaborative study of a P35S and T-nos duplex real-time screening method to detect genetically modified organisms in food products" Eur. Food Res. and Technol., Volume 226, 1221-1228. 3E. Barbau-Piednoir et al., (2010) "SYBR®Green qPCR screening methods for the presence of "35S promoter" and "NOS terminator" elements in food and feed products" Eur. Food Res. and Technol Volume 230, 383-393. 4Reiting R, Broll H, Waiblinger HU, Grohmann L (2007) Collaborative study of a T-nos real-time PCR method for screening of genetically modified organisms in food products. J Verbr Lebensm 2:116–121. (b) For screening for the engineered CryIAb, CryIAc and/or CryIAb/CryIAc from Bacillus thuringiensis. E. Barbau-Piednoir et al., (in press) "Four new SYBR®Green qPCR screening methods for the detection of Roundup Ready®, LibertyLink® and CryIAb traits in genetically modified products" Eur. Food Res. and Technol DOI 10.1007/s00217-011-1605-7; Following verification of the specificity of the methods by the EU-RL GMFFon a wide variety of Chinese rice samples such method shall be considered as appropriate for these screening purposes. 5. The application of the above screening methods shall take into consideration the guidance document published by the EU RL GMFF.