the sgs non-gmo ip supply chain standard

THE SGS NON – GMOIP SUPPLY CHAIN STANDARD

Revision: V 5.0

Approval Date: 13 May 2020

Review Date: 01 April 2025

Revision Date: 01 April 2020

Author: Johny Boerjan

Reviewed by: Chris Ranschaert/Michiel Kaizer

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1 INTRODUCTION .......................................................................................................................... 3

1.1 DEFINITIONS ......................................................................................................................... 4

1.2 CHANGES IN LEGISLATION AND SGS STANDARD ...................................................... 5

1.3 SCOPE OF THE NON-GMO CERTIFICATION ................................................................... 5

2 GENERAL REQUIREMENTS FOR THE SUPPLY CHAIN ....................................................... 6

2.1 THE NON-GMO MANAGEMENT SYSTEM ...................................................................... 7

2.2 PACKAGING AND CLEANING AGENTS .......................................................................... 8

3 SPECIFIC REQUIREMENTS FOR THE SUPPLY CHAIN ........................................................ 9

3.1 SEED SUPPLIER..................................................................................................................... 10

3.2 FARMING OF NON-GMO PRODUCTS .............................................................................. 10

3.3 TRADING................................................................................................................................. 10

3.4 PROCESSING ......................................................................................................................... 11

4 REQUIREMENTS FOR SERVICES IN THE SUPPLY CHAIN ................................................. 13

4.1 STORAGE OF NON-GMO PRODUCTS ............................................................................... 14

4.2 TRANSPORT OF NON-GMO PRODUCTS ......................................................................... 14

4.3 REQUIREMENTS REGARDING SAMPLING AND ANALYSIS ...................................... 14

5 LABELLING OF PRODUCTS AND LOGO USAGE ................................................................... 16

6 PERIODICAL EXTERNAL CERTIFICATION AUDIT ................................................................ 17

ANNEX I : NON-GMO CRITICAL ORGANISMS ........................................................................... 18

ANNEX II : REFERENCES ................................................................................................................. 19

ANNEX III : ADDITIONAL REQUIREMENTS (NON-GMO SUPPLY CHAIN STANDARD) .... 20

ANNEX IV : SGS NON-GMO ACCREDITED TESTING LABORATORIES ................................. 22

CONTENTS

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1INTRODUCTIONThe SGS NON – GMO IP Supply Chain Standard (the Standard) is designed to assist organizations (defined herein as an “operator”), irrespective of their type or size, supplying NON - Genetically Modified products. It is a robust system to verify the process of preparing NON-genetically engineered ingredients, feed or (pet)food, including beverages. The scope could include one part of the supply chain, a few parts or even the whole supply chain. The Standard is based primarily on product traceability with focus on the control of cross-contact or co-mingling between genetically modified organisms (GMO) and NON-GMO ingredients/feed/(pet)food at every level of the supply chain and manufacturing process, as well as an effective product market removal plan.

The Standard is developed in accordance with EU legislative labeling requirements for GMO (EU Regulations 1829/2003 and 1830/2003 and amendments), but the Standard has a global application and can be adapted for country-specific markets.

Certification against this standard means the independent third-party certification by SGS of the quality management system of the applicant for the supply chain of NON-GMO product, from the seed, the cultivation process and harvest, transportation, collection, storing and processing until it reaches the retail channel. The product shall keep its original, natural genetic characteristics and therefore contamination with GMO’s during the whole supply chain will be avoided.

This certification also includes the verification of legal requirements related to labelling and traceability of GMO’s, however it shall be clear that certification and the implementation of the requirements of this standard can in no way substitute the compliance with any regulation in force.

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1.1 DEFINITIONS

Action Threshold (%): The threshold that triggers an investigation by the operator into the source of cross-contact or co-mingling. Information from this investigation, such as sampling protocol, geographical origin, supplier status etc., shall be recorded and applied to prevent future cross-contact or co-mingling. The percentage shall be calculated on the individual weight of the ingredient/raw material in question.

• Option 1*: 0,9 % with an action threshold of 0,45 % for products listed in annex I.

• Option 2*: 0,1 %.

*Option 2, when chosen by the operator, this will be indicated on the certificate upon request.

Batch: A unit of products, produced within one single production plant, with the aid of uniform identifiable parameters in view of a market removal, a retreatment or its disposal, should tests show this to be necessary.

Feed (or Feedstuff): means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals.

Food (or Foodstuffs): Any substances or products, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be consumed by humans. Food includes drink, chewing gum, as well as any substance including water, intentionally added to food during production, preparation or treatment (cf. Regulation (EC) No. 178/2002).

Petfood: means any product intended for oral feeding to pet animals whether processed, partially processed or unprocessed, including dog chews, feed materials and compound feed. Pets are considered NON-food producing animal belonging to species fed, bred or kept, but normally not consumed by humans.

Genetically Modified Food/Feed: Food/Feed containing, consisting of or produced from GMO’s.

Ingredient: shall mean any substance, including additives, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form.

Market Removal: Timely removal from the market of NON-conforming products at any level of the supply chain that are not compliant with this Standard.

Market Removal Plan: A plan to facilitate the timely removal of NON-conforming products from the marketplace and notification of all affected parties along the supply chain. It defines all the measures taken to achieve the blocking/return of non-conforming product unfit for customers.

Non-Conforming Product: A product (seed, raw agricultural commodity, ingredient, or food/feed) that is not in compliance with this Standard and requires corrective action.

Operator: means the natural or legal person responsible for ensuring that the requirements of this standard are met within the food businesses or feed businesses under its control.

Processing aids (feed): any substance not consumed as a feedstuff by itself, intentionally used in the processing of feedstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed.

Processing Aids (Food): Processing aids are not considered ingredients and therefore excluded from GMO labeling. It is any substance is considered a processing aid and can be legally excluded from GMO labeling if it meets one of three criteria:

1. It’s added to the food but later removed. (E.g. activated charcoal, which filters out impurities).

2. It’s added to the food but gets converted into a substance already present in the food. (E.g. a pH adjuster that converts to salt and doesn’t significantly add to the level of salt in the food).

3. It’s added for a technical effect during processing but isn’t present at “significant” levels in the food. (E.g. a preservative added to an ingredient, like anti-caking agent sodium silicoaluminate in the seasoning of some sausages).

Specific GMO definitions are based on

• EU Directive 2001/18

• EU Regulation 1829/2003 and amendments

• EU Regulation 1830/2003

Organism: Any biological entity capable of replication or of transferring genetic material.

GMO (Genetically Modified Organism): an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. In Annex 1A of the 2001/18/EC directive techniques are listed which fall under the techniques resulting in Genetic modification. In Annex 1B of directive 2001/18, techniques are listed that don’t result in genetic modification.

GMO critical: an organism or a product produced from this organism, with a serious risk that it has been subject to genetic modification; in fact all varieties of an organism of which a genetically modified event is on the market. A list of GMO critical organisms is enclosed in annex I. This also includes primary packaging which is in direct contact with the final product. Therefore, primary packaging of biological origin (e.g., vegetable origin, cotton) needs to be assessed for its GMO status. The same is valid for cleaning agents.

An organism or a product produced from this organism is not regarded as GMO critical if:

• The product is not listed as GMO critical in annex I of this standard. This list of GMO critical organisms in annex I is for the purpose of reference only. This annex is based on the ISAAA (International Service for the Acquisition of Agro-Biotech Applications) http://www.isaaa.org/gmapprovaldatabase. An analysis certificate from an independent ISO 17025 accredited laboratory, using real time PCR analysis and sampled according to GAFTA 124 sampling rules or equivalent internationally accepted sampling standards shows that the batch contains <0.9% authorised GMO’s, provided that the analyses detected plant DNA, and the eventual contamination is technically unavoidable and/or adventitious. GMO’s that are not authorised in EU or the country of destination and without favourable evaluation in EU

http://www.isaaa.org/gmapprovaldatabase


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or the country of destination, may not be detected (< LOD). In general GMO which are not authorized in the country of destination may not be detected at all (< LOD).

• The product is derived from an Identity Preserved (IP) programme which is verified and certified by a third-party certification body, accepted by SGS.

• It concerns fermentation products produced from a GMO or NON-GMO agricultural crop or a derivative through the use of GMO or NON-GMO enzymes and microorganisms, provided sufficient steps have been taken during the purification process to remove, denature or degrade any GMO enzyme or microorganisms, and the identity of the agricultural crop or its derivative is unrecognizable in, the final ingredient. Examples are alcohol and citric acid.

• It concerns animal derived products (milk, eggs, meat), as long as the animal itself is a non-genetically modified animal.

1.2 CHANGES IN LEGISLATION AND SGS STANDARD

• Change of the reference website to which annex I is referring to. Currently ISAAA (International Service for the Acquisition of Agro-Biotech Applications)

• Inclusion of requirements about primary packaging and cleaning agents

• Additional definition requirements for ‘Non-conforming products’

• Update of the NON-GMO management system

• Inclusion of crisis management procedure

• Clarification of notification procedure

• Merged paragraphs 3.4.1/2/3 Processing (Commodity Processor, Ingredient producer, Ingredient/Commodity user)

• Clarification of options to mention threshold of 0,9% or 0,1% on the certificate

• Update of annex II

• Creation of annex III: additional requirements for the NON-GMO SUPPLY CHAIN STANDARD

• Creation of annex IV: SGS Laboratories

• NON AMAZON BIOME SUPPLY CHAIN annex deleted

Obligatory implementation for certified companies of this version as per 01-07-2021 or the next Certification.

1.3 SCOPE OF THE NON-GMO CERTIFICATION

The SGS NON-GMO IP Supply Chain Standard describes the best code of practice to source and produce NON-GMO products. The requirements are based on the previous versions of SGS NON-GMO supply chain certification as well as on the EU regulations concerning NON-GMO: directive 2001/18/EC and regulations 1829/2003 and 1830/2003.

The SGS NON-GMO IP Supply Chain Standard is applicable to Food and Feed (including pet food). It applies to all

products produced from GMO’s. This includes all products produced from GMO’s, also those refined products where verification on GMO status through analysis is impossible.

The SGS NON-GMO IP Supply Chain Standard is applicable to the following processes in the supply chain:

The supply chain (chapter 3)

• Seed supply 3.1

• Farming (sowing, growing, harvesting) 3.2

• Trading 3.3

• Processing 3.4

Services to the supply chain (chapter 4)

• Storage 4.1

• Transport 4.2

• Sampling and analyses 4.3

In case transport and/or storage is performed through third party contractors, these contractors must meet the requirements in respectively chapters 4.1 for storage and 4.2 for transport. If these contractors are not certified in a NON-GMO third party auditing scheme, accepted by SGS then the auditee must perform audits, at least yearly, against the requirements of this standard. The checklists used for these audits must be approved by SGS.

In case transport and/or storage are performed by the auditee himself they must be part of the quality system and will be audited by SGS.

Sampling and analyses must meet the requirements in 4.3.

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2GENERAL REQUIREMENTS FOR THE SUPPLY CHAIN

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This section shall apply to all operators. The requirements in Chapter 2 are essential for developing and implementing an adequate system to control the NON-GMO status of a supply chain, which must be documented. An operator must have demonstrably implemented these elements in its operational management.

2.1 THE NON-GMO MANAGEMENT SYSTEM

Each operator must establish a documented NON-GMO management system which includes:

• An implemented and communicated NON-GMO company policy.

• A NON-GMO management system shall be documented and maintained in either electronic and/or hard copy form. It shall outline the methods the operator will use to meet the requirements of the Standard, be made available to relevant staff and include:

• A summary of the organization’s policies and the approaches it will apply to meet the elements of this standard;

• The scope of certification;

• A list of the products that are on the GMO Critical list that are in the facility or that are proven to be from a NON-GMO plant variety;

• Policy and procedures needed to ensure the effective operation and control of these processes.

• A document review and record keeping procedure. All relevant documents and records shall be controlled and kept for at least 5 years or as required by local regulations. Examples of such records and documents include (but not limited) to inputs, segregation, cleaning and storage, training, internal audits, sampling and analysis and complaints regarding NON-GMO i.e. supply chain records, bill of ladings, invoices, supplier attestations, labels, contracts, broker statements, third party certificates, laboratory testing results, flush validations, validated process verifications.

• Tasks, responsibilities and authorities must be defined, especially those with regard to this supply chain standard. Records regarding experience, education and training for NON-GMO must be included in the Management system.

• Training program - The authorities and approach for establishing and implementing the training needs of the organization’s personnel to ensure they have the required competencies to carry out those functions affecting approved supplier, specifications, cleaning, labeling and verifications to ensure legality, and NON-GMO ingredient management shall be defined and documented. Training shall be conducted by individual knowledgeable of the Standard and auditing techniques. Internal auditor training or certification must be kept on file.

• An internal audit procedure and audit schedule. The procedure and schedule must include all relevant NON-GMO procedures, locations etc. Internal audits shall be performed by qualified people once a year. The internal audit shall be documented.

• A notification procedure to inform clients and SGS in writing of any situation (incl. market removal) or change in circumstances which has the potential to compromise the NON-GMO status of the product or to affect its compliance with its certification status. Notifications towards SGS about changing the scope (eg. adding products to the scope) is included in this procedure. Notifications to be done to SGS within 24 hours in case of non-conforming products and market removal. All other notifications within 2 weeks. Notifications to be addressed to the certification manager mentioned on the certificate.

When the threshold of 0,9% (option 1) or 0,1% (option 2) is exceeded, considering the measurement uncertainty, as indicated by the accredited laboratory, then the following actions are mandatory:

• Counter analysis

• Traceability exercise including potential root cause investigation

If the counter analysis confirms the result:

• Detailed assessment about the root cause

• Notification procedure and market removal plan activation

• Monitoring plan will be evaluated and intensified when necessary

• Preventive action

If the sampling and testing of the produced future batches confirms the exceedance of the threshold again, the certificate will be suspended until further notice. An additional audit shall be organized.

• A complaint procedure for dealing with complaints relating to the NON-GMO status or identification of the supplied products and seeds. The actions taken, and the response given to the customer, must be registered.

• Continuous improvement: the company must continue to improve the efficiency of its system. To this end, written procedures are drawn up for the implementation of corrective and precautionary measures. Record of necessary correction/precautionary measures within the agreed time frame.

• A documented risk assessment procedure to prevent (cross)-contamination or co-mingling of NON-GMO products and seeds with GMO products and seeds including preventative measures, description of Control Points (CP’s), standards and tolerances and monitoring programme on CP’s. An example of such risk assessment could be applying the HACCP principles. The result will define company-specific hazards relating to the contamination of NON-GMO product with GMO product, the company specific analysis and the control of these hazards. This will result in a fully documented risk assessment. The risk assessment shall be reviewed once a year or when changes occur which could affect the NON-GMO status.

• Contracts/Sales agreement: Contracts must be in place for the purchase of all NON-GMO products/raw materials. These contracts shall clearly state the GMO status of the purchased product. References to product specifications

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in the contracts are acceptable.

• Order receipt and processing: a supplier shall be able to demonstrate appropriate methods for confirming and recording the type, quantity and GMO status of orders received.

• Packaging and delivery documents: these documents shall be clear and unambiguous. All relevant contractual and legal information must be included on delivery documents. All relevant information required by local, national and/or international regulations shall be included.

• A market removal plan to facilitate the timely removal of non-conforming products from the marketplace and notification of all affected parties along the supply chain if a significant issue regarding the NON-GMO status of a product arises. Removed products must be clearly identified, communicated to the impacted parties and subsequent corrective and preventative actions must be documented.

This procedure shall contain the following elements, as a minimum:

• name of the person responsible for the removal

• method of external communication.

This procedure must be tested on a yearly basis, in order to verify its efficiency. Such tests must be documented and registered.

• A documented crisis management procedure to be introduced for the management of incidents that may lead to a crisis situation. This includes, in particular, incidents that affect the NON-GMO status of the product and legitimacy of NON-GMO raw materials/products. This procedure must be implemented and includes at least:

• The steps to follow in the event of an incident with reference to the market removal procedure

• Assigned responsibilities including substitute rules

• Availability (within and outside of business hours)

• List of emergency phone numbers

• Reference to the notification procedure (SGS and of affected business partners and customers)

• Legal advice (if required)

The crisis management procedure is to be tested internally at least once a year with regard to practicality, functionality and immediate implementation, with results documented.

• Identification and traceability procedures, including control of identification tools for NON-GMO batches. Tracking of lot numbers and labelling/marking on packaging and containers shall be used as

necessary to identify and segregate NON-GMO compliant materials from NON-compliant materials. Traceability exercise shall be conducted annually to demonstrate that ingredients are traceable.

• The management must provide means, staff, and information, allowing the practical implementation of the system. The NON-GMO management system shall be evaluated through the management review process, at least annually. These evaluations must be documented and archived.

2.2 PACKAGING AND CLEANING AGENTS

2.1.1 Primary packaging is in direct contact with the product. Therefore, primary packaging of biological origin (e.g., paper, cotton) needs to be assessed for its NON-GMO status and the impact on cross contamination.

Glass, metal and plastic primary packaging, as well as secondary packaging, which by definition is not in contact with the products, is exempt from this consideration.

2.1.2 Cleaning agents will be approved for use based on evaluation of their components and production process for potential of cross-contact or co-mingling and/or presence of GMO.

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3SPECIFIC REQUIREMENTS FOR THE SUPPLY CHAIN

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The requirements in Chapter 3 are applied to the specific roles of operators within the supply chain. An operator must have demonstrably implemented these elements appropriately to its role in the supply chain.

3.1 SEED SUPPLIER (A SEED SUPPLIER MEANS ANY OPERATOR THAT PRODUCES AND PACKS THE SEEDS TO SELL TO THE FARMER)

• NON-GMO purchase procedure, which must contain following elements:

• Purchase of NON-GMO products must be performed against a mutually agreed product specification

• For GMO critical products, the product specification must clearly describe the NON-GMO status of the products. It shall also indicate the product NON-GMO identification and a description of batch identification

• Incoming products must be checked against the product specification

• A monitoring, sampling and analysis program must be in place for incoming seeds based on a risk assessment.

• An up to date lay-out and process description for receiving storing and transport of NON-GMO and GMO products must be available.

• NON-GMO monitoring, sampling and analysis program must be in place for seeds in storage and outgoing batches.

• A specification must be available clearly describing the NON-GMO status of each product the seed supplier introduces into the NON-GMO supply chain.

3.2 FARMING OF NON-GMO PRODUCTS (A FARMER MEANS ANY OPERATOR THAT SOWS, GROWS, HANDLES, HARVESTS, STORES AND/OR MANAGES CROPS UNTIL THEY ARE SOLD OR TRANSFERRED TO ANOTHER OPERATOR


• Purchase of NON-GMO products (seeds) must be performed against a mutually agreed product specification and from a seed supplier, third party NON-GMO certified for the relevant scope.

• For GMO critical products, the product specification must clearly describe the NON-GMO status of the products. It shall also indicate the product NON-GMO identification and a description of batch identification. Incoming products must be checked against the product specification.

• A monitoring, sampling and analysis programme must be in place for incoming seeds based on a risk assessment. Seeds allowed for cultivation: result must be below the detection limit.

• An up to date lay out and process description for receiving storing and transport of NON-GMO and GMO products must be available.

• Maintenance of documented records on planting, harvesting, storage and cleaning of equipment.

• The seed shall be planted in the ground which has not been used for a genetically modified variety of the same crop in the previous year.

• Farm plan/map shall be available for own and rented land, and identification of neighbouring fields.

• Clear separation and identification of fields, from adjacent fields.

• Clear separation and identification of fields and establishment of “isolation distances” and “pollen barriers”. Isolation distances are the minimum distances required between GMO and NON-GMO cultivations for most of the GM pollen to fall to the ground before reaching NON-GM plants. Pollen barriers attempt actively catch pollen and can consist of hedges and trees which physically hinder pollen movement. Pollen barriers consisting of conventional crops of the same species as the GM crop have a special advantage, as the conventional plants not only physically limit the GM pollen flow, but also produce competitive, conventional pollen. During harvest, the buffer strip of conventional crops is considered part of the GM crop yield.

• Suitable measures during cultivation are needed in order to manage the possible accidental mixing of GM and NON-GM crops resulting from seed impurities, volunteers, cross-pollination

• Procedures regarding cleaning and inspection of all equipment and storage facilities used for harvesting.

• NON-GMO monitoring, sampling and analysis program for products in storage and outgoing batches.

3.3 TRADING (TRADER MEANS ANY OPERATOR THAT BUYS AND SELLS PRODUCTS, EVEN WITHOUT PHYSICALLY HANDLING THEM

• NON-GMO purchase procedure, which must contain the following elements:

• Purchase of NON-GMO products must be performed against a mutually agreed product specification.

• Suppliers shall participate in third party NON-GMO certification schemes.

• If the supplier is not participating in a third-party NON-GMO certification scheme then the following options apply:

• The Trader operator shall audit the supplier himself (or on behalf of Himself) to verify the NON-GMO status of the supplied products (this must done through a checklist approved by SGS). This audit shall be documented with objective evidences, analysis reports and other relevant documentation and/or

• The supplier shall make available to the trader operator, the risk assessments and all other information on how the NON-GMO status was achieved. This information at least contains of GMO detection analysis reports coming from accredited laboratories, flow charts of the process, declarations, questionnaires etc… Based on this information and the available historical data / performance details of the supplier, the operator shall determine the risk level of this supplier in relation to the product and the amount of controls on incoming

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products ( monitoring plan) and/or the amount of control on the processes/systems of the supplier (supplier audits).

• And/or all incoming batches shall be sampled and analyzed according to the requirements of this scheme. If the analysis of these batches is not conclusive (i.e., no DNA can be detected), then that analysis cannot be taken into consideration in the assessment.




• Procedure for identification and separation of NON-GMO and GMO products.

• Process control documents must prescribe clearly the status of the raw materials/ingredients/products to be traded with regard to their NON-GMO status. Batch/lot identification records must be kept at all stages of the processes.

• From all raw materials traded, agreed specifications must be available clearly describing the NON-GMO status of its ingredients, including, where applicable, the NON-GMO verification scheme.

• Document/record keeping of all inputs, segregation, cleaning and storage, training, internal audits, sampling and analysis and complaints regarding NON-GMO.

• When a NON-GMO refined derivative is traded, in which no plant protein can be analyzed no other derivative of that kind, not having a NON-GMO status may be used in the same processing/storage site, where a NON-GMO certificate is applicable. There may be no commingling possible between NON-GMO and GMO derivatives. Derivatives must be clearly identified and separated. Correct use of derivatives must be monitored by input/output balance.

• A NON-GMO monitoring, sampling and analysis program must be in place for incoming, stored and outgoing products based on a risk assessment. If local authorities require the implementation of certain sampling plans then these must be followed, otherwise the guidelines in the requirements for sampling and analyses (§4.3) should be followed (Gafta 124 or equivalent).

• Monitoring for GMO contamination against an Action Threshold, which, if exceeded, triggers the participant to investigate the cause of the contamination and to correct that cause when identified. Corrective action procedures, including control and market removal procedures for NON-conforming product to be applied.

• A trading company who owns itself storage facilities and/or transport means shall apply the specific requirements for storage facilities (4.1) respectively transport requirements (4.2).

3.4 PROCESSING (COMMODITY PROCESSOR, INGREDIENT PRODUCER, INGREDIENT/COMMODITY USER)


• Purchase of NON-GMO products must be performed against a mutually agreed product specification

• Suppliers shall participate in third party NON-GMO certification schemes

• If the supplier is not participating in a third-party NON-GMO certification schemes, then the following options apply

• The process operator shall audit the supplier himself (or on behalf of Himself) to verify the NON-GMO status of the supplied products (this must be done through a checklist approved by SGS). This audit shall be documented with objective evidences, analysis reports and other relevant documentation and/or

• The supplier shall make available to the process operator, the risk assessments and all other information on how the NON-GMO status was achieved. This information at least contains of GMO detection analysis reports coming from accredited laboratories, flow charts of the process, declarations, questionnaires etc… Based on this information and the available historical data / performance details of the supplier, the operator shall determine the risk level of this supplier in relation to the product and the amount of controls on incoming products ( monitoring plan) and/or the amount of control on the processes/systems of the supplier (supplier audits).

• And/or all incoming batches shall be sampled and analyzed according to requirements of this scheme. If the analysis of these batches is not conclusive (i.e., no DNA can be detected), then that analysis result cannot be taken into consideration.

• For GMO critical products, the product specification must clearly describe the NON-GMO status of the products, it shall also indicate the product NON-GMO identification and a description of batch identification


• A monitoring, sampling and analysis programme must be in place for incoming products based on a risk assessment


• A documented cleaning program and validated flushing program, including materials, cleaning processes, inspections, tasks and responsibilities for use of all materials, handling and processing equipment, storage (e.g. silos) and transportation facilities, used for both GMO and NON-GMO products must be in place.

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• Procedure for identification and separation of NON-GMO and GMO products. Physical segregation is mandatory for bulk products. Packed products can be stored in the same warehouse(s) as long as they are clearly identified and cross contamination or co-comingling is avoided at all times.

• Where NON-GMO batches are mixed in e.g. silos, where the silo is not emptied between the batches, all incoming batches should be recorded and be traceable to all outgoing batches. Of every produced batch, it should be clear from which incoming batch it has been produced and vice versa. In case of an identified contamination to the batches with GMO positive material, all batches in the silo and the batches produced from the silo should be identified and degraded to GMO positive batches.

• Process control documents and recipes must prescribe clearly the status of the raw materials/ingredients/products to be used with regard to their NON-GMO status. Batch identification records must be kept at all stages of the processes.

• From all raw materials and additives used in the recipes, agreed specifications must be available clearly describing the NON-GMO status of its ingredients, including, where applicable, the NON-GMO verification scheme.

• Document/record keeping of all inputs, segregation, cleaning and storage, training, internal audits, sampling and analysis and complaints regarding NON-GMO.

• When a NON-GMO refined derivative is used, in which no plant protein can be analyzed no other derivative of that kind, not having a NON-GMO status may be used in the same processing/storage site, where a NON-GMO certificate is applicable. There may be no commingling possible between NON-GMO and GMO derivates. Derivatives must be clearly identified and separated. Correct use of derivatives must be monitored by input/output balance.

• A NON-GMO monitoring, sampling and analysis program must be in place for incoming, stored and outgoing products based on a risk assessment. If local authorities require the implementation of certain sampling plans then these must be followed, otherwise the guidelines in the requirements for sampling and analyses (§4.3) should be followed (Gafta 124 or equivalent).

• Monitoring for GMO contamination against an Action Threshold, which, if exceeded, triggers the participant to investigate the cause of the contamination and to correct that cause when identified. Corrective action procedures, including control and market removal procedure or NON-conforming product to be applied.

• A processing company who owns itself storage facilities and/or transport means shall apply the specific requirements for storage facilities (4.1) respectively transport requirements (4.2).

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4REQUIREMENTS FOR SERVICES IN THE SUPPLY CHAIN

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4.1 STORAGE OF NON-GMO PRODUCTS

• NON-GMO acceptance procedure, which must contain following elements:

• For all NON-GMO products to be stored must a product specification/product description, of the owner be available.



• An up to date lay-out and process description for receiving, storing and transport of NON-GMO and GMO products must be available.

• Documented cleaning, validated flushing and inspection procedures including materials, cleaning processes, inspections, tasks and responsibilities for use of all materials, handling and processing equipment, storage (e.g. silos), and records for silos and other storage facilities in use for GMO and NON-GMO batches must be in place.

• Where NON-GMO batches are mixed, silo/tank records must identify constituent batches and proportions. Where NON-GMO batches are mixed in e.g. silos, where the silo is not emptied between the batches, all incoming batches should be recorded and be traceable to all outgoing batches. Of every produced batch it should be clear from which incoming batch it has been produced and vice versa. In case of an identified contamination of the batches with GMO positive material, all batches in the silo and the batches produced from the silo, should be identified, and degraded to GMO positive batches. The owner and SGS to be notified through the notification procedure.

• Packed products can be stored in the same warehouse(s) as long as they are clearly identified and cross contamination or co-comingling is avoided at all times.

• Maintenance of documented records on the origin of all product inputs (including GMO status), on traceability (lot ID), cleaning of transport elements, separation of conventional and GMO products.

• Silos/warehouses should be adequately identified.

• Procedures regarding cleaning and/or a validated flushing program and inspection of all equipment and storage facilities.

4.2 TRANSPORT OF NON-GMO PRODUCTS

• NON-GMO acceptance procedure, which must contain following elements:

• For all NON-GMO products to be transported must a product specification/product description of the owner be available



• An up to date lay out and process description for receiving and transport of NON-GMO and GMO products must be available

• Maintenance of documented records on cleaning of the transport elements.

• Maintenance of documented records on the origin of all product inputs (including GMO status) on traceability (lot ID), cleaning, separation of conventional and GMO products. The previous cargo must always be traceable if transporting a NON-GMO product.

• Transport elements should be adequately identified.

• Validated cleaning and inspection procedures and records for transport elements between usage for GMO and NON-GMO batches.

• Procedures and maintenance of records on identification, traceability, separation of conventional and NON-GMO products.

• Packed products can be transported in the same load compartments as long as they are clearly identified and cross contamination or co-comingling is avoided at all times.

• Documentation should accompany each transport.

4.3 REQUIREMENTS REGARDING SAMPLING AND ANALYSIS

4.3.1 Sampling

• A sampling protocol shall be developed to validate the NON-GMO status of the supply chain.

• The sampling frequency shall be based on a risk assessment for each ingredient/commodity, taking into consideration the source material and its NON-GMO risk and the nature of the ingredient/commodity (e.g. primary material like oilseeds, derivative, origin etc…). If local authorities require the implementation of certain sampling plans then these must be followed.

• Due to the heterogeneous nature of NON-GMO materials, the operator shall follow sampling procedures that meet legal requirements and good sampling practices to ensure representative samples are obtained.

• Sampling of bulk commodities (primary materials as oilseeds, cereals…) must be performed by SGS according to the relevant sampling procedures, i.e. according to GAFTA/FOSFA sampling rules, where applicable (up until commodity processor, in further stages procedures for sampling should be in place that meet legal requirements and good sampling practices).

4.3.2 Analysis

• Analyses of the samples shall be performed by a laboratory that is ISO 17025 accredited for GMO DNA based testing using the real time PCR analyses for the crops and inputs in question. In the analysis report, sampling methods, uncertainty and detection limits and methods shall be specified.

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• The participant must have assessed which GMO events can reasonably be present. The cultivation in country of origin should be part of this assessment, as well as common seen GMO events and occurred incidents. Those genes shall be tested for, in order to ensure the products comply. If genes are tested positive, further analysis should take place to determine the specific target events. Forbidden events shall be taken into consideration when applicable and also events of other species (for instance Roundup ready soy in maize).

• If no DNA is detected in the sample and therefore not “testable” through PCR, the NON-GMO status of the sample must be verified by batch-specific traceability back to testable inputs to the ingredient or product. Analysis reports for which no DNA is detected will therefore not be accepted to confirm any NON-GMO status of a product.

• The SGS NON-GMO IP Supply Chain Standard has established the following long-term thresholds:

• Not authorized GMO’s shall not be detectable (< LOD)

• The operator will handle the following compliance thresholds:

• Option 1*: 0,9 % with an action threshold of 0,45 % for products listed in annex I

• Option 2*: 0,1 %. Option 2 only is valid if there are no more than 2 exceedances (>0,1%) in a certification period. An exceedance must be rare and incidental

• Interpretation of analysis results: Commission Recommendation 2004/787/EC of 4 October 2004 provides detailed technical guidance for sampling and detection of GMOs related to Regulation (EC) No. 1830/2003 in bulk. For packed food and feed products the SGS standard will follow the same principle. Where the obtained analytical result is close to the established threshold (± 50% of its value), an estimation of the associated uncertainty will be necessary to interpret the result. Uncertainty to be included in the analysis report by the laboratory.

[GMO content = analysis result - analytical uncertainty]

This means the limit is 1,35% in case of 0,45% uncertainty (for option 1)

Specifically, for feed containing, a GMO-containing material, consisting in such organisms or produced from such organism in a proportion less than or equal to 0.9% of the feed and each of its components is therefore not labelled in the meaning of the regulation, provided that this presence is fortuitous or technically unavoidable.

• Botanical impurities in relation to feed materials (single): every single feed material needs to be at least 95 % pure. The 5 % impurities are identified as straw, little stones, other cereals, oilseeds etc. and in fact a result of their growing and harvesting (nature). These impurities could however lead to an analysis of 100 % GMO contamination in a

compound/complementary feed of one ingredient. For example 95 % of pure wheat with 4 % GMO soybean impurity can result in an analyses in compound feed of 100 % GMO soybean, even if no soybean was formulated in the recipe. Base is that the individual raw materials are not subject to labelling.Limit of GMO botanical impurity in compound feed is 0,9% on product base.

To make an interpretation of such analysis results the following examples about decision of labelling can be used as guidance:

Compound feed: Recipe 10% soy, 90% maize. Raw material soy: 0,4% technical unavoidable soy GMO no GMO labelling required; Raw material corn: 0,4% technical unavoidable corn GMO no GMO labelling required; Raw material soy: 1,5% soy GMO and compound feed 0,2% GMO GMO labelling required;

Compound feed: 10% rape seed, 90% maize.Compound feed: technical unavoidable 80% soy GMO analysis of raw materials. When raw material has >0,9% soy GMO labelling required. When raw materials do not need to be labelled as GMO, amount of soy in compound feed needs to be <0,9% on compound feed base, otherwise GMO soy, needs to be declared on the label.

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5LABELLING OF PRODUCTS AND LOGO USAGE

Labelling includes a display of written, printed or graphic matter upon the immediate or shipping container of the food/feed as well as any related print or electronic advertising or promotional materials, brochures, websites, and social media.

The use of labelling covers all products in the supply chain covered by this Standard, namely, seeds, raw agricultural commodities, processed commodities, ingredients and finished foods/feed, packed or in bulk.

SGS has not created a logo or other mark that represents this Standard or an operator’s compliance with this Standard. The operator however has the choice to develop its own logo which must be approved on technical content by SGS in writing before use.

Any reference to SGS, the verification of the operator’s process(es) by SGS, or this Standard in product labelling must also be approved by SGS in writing before use.

Any “NON-GMO” or similar statement used by an operator used in product labelling must comply with any relevant regulations and must be truthful and not misleading.

Sample label statements not consistent with this Standard and therefore not acceptable include, but are not limited to, “zero GMOs”, GMO-free”, “GE-free”.

SGS is not responsible for any costs incurred by an operator

• for the preparation of any printed or electronic examples of product labelling that include statements referring to this Standard without the written approval of SGS, or

• for the operator’s inability to use any printed or electronic examples of product labelling due to the operator’s NON-compliance with regulatory labelling laws, regulations or guidelines, or

• for the operator’s inability to use any printed or electronic examples of product labelling due to the operator’s NON-compliance with any part of this Standard.

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6PERIODICAL EXTERNAL CERTIFICATION AUDIT

The contents and compliance with this SGS NON-GMO IP Supply Chain Standard must be verified at least once a year, by SGS through an audit.

Audits can be conducted to verify specific components of the operator’s process at different locations, as appropriate. For example, the operator may implement certain sub-processes at a headquarters location and other sub-processes at one or more manufacturing locations. In any event, documentation of a successful SGS audit applies to the operator’s entire process, regardless of location, provided it was encompassed by the audit process.

Full details of the certification process are described in the certification rules of the SGS NON-GMO IP Supply Chain Standard, which support this Standard.

The Certification Rules describe the requirements imposed on SGS and on their auditors, as well as the way in which participants in this system should be evaluated, and the way in which the actual issuance of certificates takes place. The regulation also includes the specific rights and obligations of the participant.

This Standard and the Certification Rules are companion documents, integral to each other, and must be used together during the initial and annual audits.

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ANNEX IGMO CRITICAL ORGANISMS1. PLANT RELATED GMO CRITICAL ORGANISMS

2. NON PLANT RELATED NON GMO CRITICAL ORGANISMS

• Alfalfa

• Apple

• Canola (Argentine, Polish)

• Carnation

• Chicory

• Common Bean

• Cotton

• Cowpea

• Creeping Bentgrass

• Eggplant

• Eucalyptus

• Bacteria

• Salmon

• Virus

• Flax/Linseed

• Lentil

• Maize/Corn

• Melon

• Papaya

• Petunia

• Pineapple

• Plum

• Poplar

• Potato

• Rice

*Based on http://www.isaaa.org/gmapprovaldatabase/. This list of GMO critical organisms is for the purpose of reference only. Always verify this database for latest updates. If new approvals are listed in this database and not yet taken into the SGS standard, the database is final to determine GMO critical organisms. Risk assessments to be done with a clear understanding of which species have been commercialized within the supply chain from which they are sourced.

• Rose

• Safflower

• Soybean

• Squash

• Sugar beet

• Sugarcane

• Sweet pepper

• Tobacco

• Tomato

• Wheat

http://www.isaaa.org/gmapprovaldatabase/

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ANNEX IIREFERENCESThe Standard was originally developed in accordance with EU legislative labeling requirements for GMO ingredients (EU Regulations 1829/2003 and 1830/2003), but the Standard has a global application and can be adapted for country-specific markets.

Other relevant references are included here as well.

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC

http://eur-lex.europa.eu/resource.html?uri=cellar:303dd4fa-07a8-4d20-86a8-0baaf0518d22.0004.02/DOC_1&format=PDF

Commission Declaration:


GM approval database from International Service for the Acquisition of Agri-Biotech Applications:

ISAAA (International Service for the Acquisition of Agro-Biotech Applications) http://www.isaaa.org/gmapprovaldatabase

ISO 19011:2011 Guidelines for auditing management systems

EU Regulation (EC) No. 178/2002

FAO guideline with regard to conversion periods of animals:

http://www.fao.org/docrep/005/Y2772E/y2772e0b.htm#bm11.2.3















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ANNEX IIIADDITIONAL REQUIREMENTS (NON-GMO IP SUPPLY CHAIN STANDARD)1. INTRODUCTION

By legislation animal products (such as, but not limited to: meat, eggs and dairy products), processing aids and certain other products do not require GMO labelling and are therefore regarded as NON-GMO. The same is valid for e.g. products produced through fermentation processes for which the used enzymes and micro-organisms can be of GMO status and the end products, as long as the purification process is sufficient, are not part of labelling. Another example can be honey which is not part of the labelling legislation.

Due to increasing market demand and consumers interest, this annex offers operators to go beyond the existing labelling legislation.

Therefore, this annex is created to allow the certification of a full NON-GMO production process in the broadest sense, meaning but not limited to:

• Products of animals which are fed with NON-GMO feed

• All processing aids, enzymes, microorganisms, used in production processes, that need to be of NON-GMO status

This annex is voluntary and is extra-legal. If an operator complies with this annex, this will be mentioned on the certificate.

Demands from the main part of this standard are undiminished in force. This means the general requirements in chapter 2 of this standard, definitions etc are also part of this annex.

2. SCOPE OF CERTIFICATION

The scope must be clear and unambiguous with regards to the NON-GMO status of the products.

The following options are examples of the additional scope to be inserted on the certificate (it is not possible to get certified for this annex only):

The operator complies also with annex III of the SGS NON-GMO IP SUPPLY CHAIN STANDARD for:

• Dairy products derived from animals which are fed with NON-GMO feed

• Animal products (eggs) derived from laying hens which are fed with NON-GMO feed

• Animal products (meat) derived from animals which are fed with NON-GMO feed

• Citric acid produced through micro-organisms which are NON-GMO including the substrate used

• Etc…

Annex III is applicable to the following processes in the supply chain:

• Farming (livestock farming)

• Processing of animal products derived from animals fed with NON-GMO feed.

• Processing of fermented products for which the fermentation process was “GMO-FREE” and in general all other products like honey, citric acid…

Note: the production of NON-GMO animal feed, storage and transport can be certified using the main part of the standard.

3. . SPECIFIC REQUIREMENTS FOR THE SUPPLY CHAIN

3.1 Livestock Farming

• Fundamental part is that animals are fed with NON-GMO feed from birth.

• For operators switching from GMO feed to NON-GMO feed, the following conversion periods apply:

• Broilers: minimum from day 2 after hatching;

• Layers (eggs): minimum six weeks before laying, or before eggs are marketed under the scope of this standard;

• Milk producing animals: minimum 90 days before milking, or before milk is marketed under the scope of this standard;

• Meat producing animals

• Poultry: minimum from day 2 after hatching

• Pigs: No exception

• Ruminants/Equines: 12 months or ¾ of their lifespan

• Small ruminants (eg calves): 6 months when brought in as soon as they are weaned and less then 6 months old.

• The livestock farmer must have a clear physical separation between animals held according to this annex and other animals.

• The livestock farmer must have a clear physical separation between NON-GMO and GMO feed.

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• The livestock farmer must have a clear separation in administration between animals and their products, held according to this annex and other animals and/or their products.

• Animal products send into the supply chain must be accompanied with clear and unambiguous documentation regarding this standard. It must be ensured that only such products and animals that meet in full the standard requirements for NON-GMO labelling leave the business. Products/animals in compliance with this standard must be labelled on all bills of lading using the wording “NON-GMO”. If no waybills/bills of lading are produced due to the nature of the system (e.g. milk collection), an unequivocal contractual regulation is to be made concerning delivery which ensures the abovementioned labelling.

Note: a livestock farmer, can also be an (arable) farmer. In case of use of own grown arable products the farmer demands from the general part of this standard are also applicable.

3.2 Processing of animal products derived from animals fed with NON-GMO feed.


• Purchase of animal products must be performed against a mutually agreed product specification. The product specification must clearly describe the NON-GMO status of the products

• Suppliers shall participate in third party NON-GMO certification schemes

• If the supplier is not participating in a third party NON-GMO certification schemes then the following option applies:

• A program of supplier audits must be in place. All suppliers must be audited every certification cycle, with a minimum of 1/3rd the first year (number rounded up to the whole number);

• Square root of the number of suppliers must be yearly audited by SGS (number rounded up to the whole number). At every audited supplier, the auditor takes and seals a feed sample which will be send for analysis by the participant

3.3 Processing of fermented products for which the fermentation process was without-GMO and in general all other products like honey, citric acid…

• Same requirements apply as in 3.2

4. EXEMPTIONS

• Purified Carbon Dioxide (CO2) from either biological or NON-biological sources.

• Processing Aids which are used in the processing of a finished product/ingredient shall be out of the scope of this annex if present in the finished product at less than 0.5% and not declared on the label or the input disclosure documentation of a wholesale product. For the purposes of this annex, fermentation microorganisms are not considered to be Processing Aids.

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ANNEX IVSGS NON-GMO ACCREDITED TESTING LABORATORIESOur GMO testing services offer you both a proven methodology and results that will be recognized worldwide. Using a standardized polymerase chain reaction (PCR) technology that quantifies any GMOs present in your samples, our testing gives you the independent verification needed to trade and process products with confidence.

CONTACT DETAILS:

SGS HEADQUARTERS

1 Place des Alpes P.O. Box 2152 1211 Geneva 1 Switzerland

Telephone: +41 22 739 91 11

Fax: +41 22 739 98 86

Website: https://www.sgs.com/en/agriculture-food

Contact form: https://www.sgs.com/en/ contact?id=8f4377d510774055b684509 72e9ed88a

https://www.sgs.com/en/agriculture-food

https://www.sgs.com/en/contact?id=8f4377d510774055b68450972e9ed88a

https://www.sgs.com/en/contact?id=8f4377d510774055b68450972e9ed88a

WWW.SGS.COM

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