ISSUING AUTHORIZATION Working Group Coordinator Committee Secretary SINCERT President Mr. Francesco Santini Ing. Alberto Musa Ing.

Transcription

1 Title MINIMUM REQUIREMENTS FOR CERTIFICATION OF PRODUCTS WITH NON-GMO CHARACTERISTICS / RE- QUIREMENTS Requisiti minimi per la certificazione di prodotti con caratteristica/requisito non OGM Code RT 11 Revision 01 Date PREPARED BY: APPROVAL BY: ACCREDITATION COMMITTEE ISSUING AUTHORIZATION Working Group Coordinator Committee Secretary SINCERT President Mr. Francesco Santini Ing. Alberto Musa Ing. Lorenzo Thione This is a translation of the official Italian version; In case of conflicts Italian version prevails. Technical Regulation RT-11 Page 1 of 9

2 TABLE OF CONTENTS 1. Scope and field of application Requirements object of the certification Definitions Reference standards Identification and Traceability Sampling Tests, controls and testing methods Non compliant products Requirements of the supplier of GMO-risk food Use of the scope of the certification...8 NOTE RELATED THE ENGLISH TRANSLATION Abbreviations, Official denominations, References of legislative document are maintained in Italian Technical Regulation RT-11 Page 2 of 9

3 1. Scope The scope of the present document (Technical Regulation) is the definition of the minimum requirements that reference documents, issued by each Certification Body (CB), must contain for the certification of products commonly defined as Non GMO products. The contents of this document are applied exclusively to: 1. Food products of human use that contain or that may contain soy, maize and/or their derivates. 2. Additives that contain or that may contain, in their formulation, soy, maize and/or their derivates. 3. Maize and soy seeds 4. Zoo technical foods that contain or that may contain, in their formulation, soy, maize and/or their derivates. 5. Animals nourished with zoo technical foods as per previous point 4. Therefore, products that, in their composition do not have dangerous OGM row material, soy and/or maize or their aforesaid derivates can non be certified under SINCERT accreditation. The products object of the certification from CB, according to this Technical Report, can be divided in two classes, defined as follows: Class 1 Class 2 Products at risk of crossed contamination; products that in their historical composition foresee the use of raw materials at risk; products that in their composition could preview the employ of dangerous materials) Products that contain raw materials at risk 2. Requirements object of the certification The requirements indicated in the certification object in technical documents prepared by each CB s shall satisfy, at least, the followings: a) for the products related to previous points 1.1 and 1.2, the use of raw materials not containing, not consisting and not deriving from soy and maize genetically modified, and/or absence of crossed contamination (DNA genetically modified concentration lower than 0,1% compared to DNA specie specific total; for values included between 0,01% and 0,1 the fortuities of the occurrence from the applicant/licensee shall be demonstrated). b) for seeds related to previous point 1.3, the use of row materials non consisting of soy and maize genetically modified and absence of crossed contamination (DNA genetically modified concentration lower than 0.01% compared to DNA specie specific total). c) for zoo technical foods, related to previous point 1.4, that contain or that may contain soy, maize and/or their derivates in their formulation, the object of certification is the control activity, carried out by the organizations in order to guarantee the respect of the law limits (0,9%), at least equal: d) row material: analytic assurance on each lot, that may be done through tests made directly by the licensee or by its suppliers, however, it is not possible to rely only on supplier analysis. Finished product: validation of the activities/procedures implemented by organizations in order to assurance the absence of an eventual crossed contamination. d) for the animals of previous point 1.5 the exclusive use of foods as described in previous point c. Technical Regulation RT-11 Page 3 of 9

4 In order to better identify the risks that may come from the raw materials they must be classified as follows: Class A Raw materials that contain DNA analytically detectable (see the next point 7). Class B Raw materials that do not contain DNA, but that may derive from genetically modified products The risk of crossed contamination must however be considered in the above classification. 3. Definitions Raw material: food matrix including the ingredients, additives, flavours and technological additives used to prepare and process food products. Cross contamination: unexpected event whose analysis of the causes shows the accidental and not intentional presence of raw materials containing, consistent of and deriving from GMO in the manufacturing of the product. GMO: Organism whose genetic material was modified in a different way compared to what happens in nature through cross-genetic procedures or through natural genetic recombination. Technological adjuvant: substance that is not consumed as food ingredient itselves, which is voluntarily used in the processing of raw materials, food products or their ingredients to respect a specific technological objective during the production or transformation, phase which can lead to the presence, not intentional but technically unavoidable, of residues of this substance or its derived in the finished product, provided that these residues do not constitute risks to health and do not have technological effects on the finished product (DM n 209 of 27 February 1996). Additive: Any substance, normally not consumed as food in as it is and not used as typical ingredient for food preparations, regardless to the fact of having a nutritional value, added intentionally to food products for a technological purpose in the production processing, treatment, attainment, packaging, transportation or food storage phases, that may be reasonably expected to become, the substance itself or its derivates, a component of such food directly or indirectly. PCR): Polimerase Chain Reaction, a procedure used to amplify the DNA which allows to multiply a specific sequence of this nucleic acid n times, quickly and in a reproducible way. Batch sample: it is intended as the raw material and/or finished product in the company at the time of the audit. 4. Reference standards - EC Regulation n 1829 dated 22 September 2003, regarding to the foods genetically modified. - EC Regulation n 1830 dated 22 September 2003, the traceability and the labelling of GMO and the traceability of foods and feedstuff obtained by organisms genetically modified, containing also the revision of EC standard 2001/18 - EC Regulation n 258/97 regarding new products and new alimentary ingredients. - EC Directive 22/2001 on cereals sampling. - EC Directive 18/2001 on the issued emission in environment of organism genetically modified and that abrogate the Council directive 90/220/ EEC. Technical Regulation RT-11 Page 4 of 9

5 - Ministerial Circular 28 December 2001 on the payment of amounts in Euro for the assessment regarding the issued emission of genetically modified organisms in the environment. - (UNI) EN ISO 5555 Animal and vegetable fats and oils - Sampling. - (UNI CEI) EN General requirements for bodies operating product certification systems. - EA 6/01 Guidelines on the Application of EN UNI Traceability system in agricultural food chain-. General principles for design and development. - UNI Traceability system in agricultural industries. Principles and requirements for development. - Ministry of Health Circular Letter N. 25 November DM 31.May 2001 n Sincert Technical Regulation RT-06 Directive for accreditation of Bodies operating product/service certification - Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms The above-mentioned regulations and specifications references documents are those in the version in force when this document was issued. However, the documents have to be applied in the version in force when they have been used for their application. 5. Identification and Traceability The traceability principle (see UNI and UNI for application) must be applied to all raw materials at risk. After identifying raw materials at risk, traceability must be followed up to the point in which the DNA of the species object of the research is detectable; hence the traceability of a raw material at risk, must be extended until the analytical test is positive (presence of detectable DNA of the original specie in the ingredient) 1. Traceability may have limited extension if, in tracing back the production chain, will come up products originated from companies certified by accredited bodies according this technical document. 6. Sampling The sampling methodology adopted by CB s depends is related to the physical state of the product: a) solids b) liquids to form the sample, the sample batch is considered as the substances present in the company during the audit for each ingredient at risk. a) Solids As regards the solids, the sampling method is described in Annex 1 of the EC Directive n 22 of 2001 Technical Regulation RT-11 Page 5 of 9

6 SUBJECT Sample batch Number of samples 1 Animal farm Feedstuff factory VERTICAL SILOS 3, Feedstuff factory HORIZONTAL SILOS SACKS Feedstuff factory Molino VERTICAL SILOS MillPACKAGING (example of maize flour) Storage VERTICAL SILOS Storage HORIZONTAL SILOS Storage SACKS (seeds) Processing All the zoo technical food products present in the farm on the day of the audit. All the zootechnical FINISHED products related to a specific animal specie present in the feedstuff factory on the day of the audit (ex. avicultural, bovine etc..). The certification body, at its discretion, has the possibility of sampling the raw materials. Whatever is present in the company (total) for each product typology (ex. Soy warehouse, maize warehouse). typology (ex. for avicultural, etc.). typology. typology. typology (ex. Maize or soy). Whatever is present in the company (total) for each product typology (ex. Soy warehouse, maize warehouse). typology. On FP = Finished Product if there is a possibility for cross contamination the sample must be prepared (the sample batch is sampled and this matches with whatever is present in the warehouses as product typology ex. biscuits, panettoni etc) If there is not cross contamination risk, it is not compulsory to make analysis on FP. Even the raw materials must be analyzed (always). A sample for the analysis (global) for each sample batch (the sample for the analysis is made of 10 elementary samples of zootechnical 2 food ready for use); Each elementary sample must be at least of 200 grams; (see Tab. 1 of Directive n 22 of 2001). A sample for the analysis (global) for each sample batch (the sample for the analysis is made 10 elementary samples of zootechnical 3 food ready for use); Each elementary sample must be at least of 200 grams (see Tab. 1 of Directive n 22 of 2001). See Tab. 1 of Directive n 22 of This principle can be derogated in case of flavours/additives used as ingredients of a complex product, provided to keep the obligation to obtain evidences regarding its conformity. 2 The elementary samples are taken in groups of threes in order to make three global samples (one for the applicant, one for the laboratory and one for the CB). The global samples must be sealed (def. Sealing in Directive 22) 3 The sample must be taken in more than one section along the consumption point, or the automatic feeder or hopper, etc. 4 The sample may be taken either from the silos while the truck is being loaded (ideal situation), or during the processing phase (right before the silos is loaded) or from the silos itself (possibly in different points of the silos) Technical Regulation RT-11 Page 6 of 9

7 MIPAF (*) document of 27 November 2003 applies for seed sampling, (*) Italian Ministry of Agriculture and Forests politics 6.2. Liquids As regards the sampling of liquids please refer to UNI EN ISO 5555 Animal and vegetable fats and oils - Sampling. 7. Tests, controls and testing methods 7.1 Laboratories used by the CB The laboratories appointed to carry out the analysis must be accredited according to ISO/IEC for the PCR Real time tests, with the following analytical detection limits: - 0,01% (at least) for qualitative analysis - 0,01% (at least) for quantitative analysis 7.2 Number of analytical tests carried out by the CB In the case of animal production chains, the CB must sample and analyze (during the certification phase and then for each following year of maintenance) a sample for each specific feedstuff (the sampling may be carried out at the feedstuff factory and/ or the farm). In case of products processed during the certification phase, it must be sampled a number of raw materials equal to the 60% of the RM = Raw Materials at risk present in the factory during the certification audit. During the first year of surveillance, a quantity of raw materials at risk equal to 30% must be sampled during the first year, 30% in the second year and 30% in the third year. 7.3 Number of audits During the certification phase, a number of sites equal to n (n squared) must be checked (n= number of sites involved that are production plants and suppliers of critical raw materials); the following years at least 0,6 n involved sites must be checked (yearly surveillance). The 60% of the n must be each year calculated in case the number of sites involved in the object of the certification differs from the number present in the certification stage. 8. Non compliant products For products of points 2 a), b) and c), analytical evidence of DNA genetically modified over the stated limits, involves the down-grading of them and therefore the non use of the certification. As far as the animals of point 2 e) are concerned, in case of evidence of not conforming feeding, the organization requiring the certification shall give evidence to have immediately suspended its use. 9. Requirements for the supplier of GMO-risk food In case of risk food suppliers, the Certification Bodies will require to the industry, that applies for certification, the implementation of the following criteria for the selection of its risk material suppliers: - Product certification for the Non GMO requirement, or the capacity to offer assurance on the supplied lot (Certification on purchased product and Certificate of Analysis on the lots); - Contractual relationship defined among the parties; - Control Plans and supplier audit. Technical Regulation RT-11 Page 7 of 9

8 If the result of the analytical tests carried out on the samples obtained by the suppliers is not significant, the sampling must be carried out on the sub-suppliers 5, that must be verified and sampled by the CB in the three year period according to defined frequencies. The supplier audits must be carried out with two objectives: - perform the sampling (see point 6) of the single ingredients/raw materials with A and B criticality; - verify the requirement management the Non GMO (analytical plans, declarations, sub-supplier audits, etc.) for the products supplied to the company and considered of A and B critical level. Therefore, the organizations must include in their technical specification the management modalities of Non OGM by the supplier, also considering the case that the supplier may do spot purchasing. Alternatively, although referring, in the technical specifications, to this issue, the Certification Body must assess the contractual agreement among the parties in which the supplier defines the management modality of the GMO requirement. 10. Use of the scope of the certification requirement The certified products cannot place the indication GMO free product on the primary and/or secondary packaging, whereas they can have the indication NON GMO (SOY, MAIZE AND DERIVATES) excluding the animals nourished with products of this document; in such cases it is possible to employ the generic indication: ANIMALS FED WITH NON GMO (SOY, MAIZE AND DERIVATES). These packages must also contain the following minimum information: - the technical reference document; - the certification number and/or the job number. 5 This principle can be derogated in the following cases: flavours/additives used as ingredients of a complex product; 2) circumstance in which on the sub-supplier it will be carried out a traceability test that gives analytic guarantees of the tested lot or that will be available to sustain an audit. Technical Regulation RT-11 Page 8 of 9