non-gmo production standard*

Non-GMO Production Standard v1.2

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Non-GMO Production Standard*

*Ingredients not genetically engineered

Version 1.2

Technical Contact Person: Ditta Fekete ([email protected])

mailto:[email protected]


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*see ‘Claim’ below

Inhoud

Disclaimer ....................................................................................................................................... 4

On-Product Claims .......................................................................................................................... 4

Off-product Claims .......................................................................................................................... 4

Copyright ........................................................................................................................................ 4

Introduction and legal background .................................................................................................. 4

How to use this Document .............................................................................................................. 5

Guidance Documents and regulative framework ............................................................................ 5

Section A – General Information ............................................................................... 6

A1 Definitions ......................................................................................................................... 6

A2 References......................................................................................................................... 8

A3 Scope ................................................................................................................................ 8

A3.1 The Non-GMO Production Standard (henceforth: NGPS) .......................................................... 8

A3.2 The following categories are out of the scope: ........................................................................... 8

A3.3 Feed criteria for livestock: ......................................................................................................... 8

A3.4 Criteria for bee keeping: ............................................................................................................ 9

A4 Principles of Non-GMO Production Certification .............................................................. 9

A4.1 Applicability of the Standard ............................................................................................ 9

A4.2 Scope Certificates ................................................................................................................... 9

A4.3 Transaction Certificates .................................................................................................. 10

Section B1. – Generic Managerial Requirements .................................................... 10

B1 Procedures ...................................................................................................................... 10

B2 Record Keeping................................................................................................................ 11

B3 Staff and Management ..................................................................................................... 11

Section B.2 – Specific Managerial Requirements .....................................................11

B4 Non-GMO Production Product Management ..................................................................... 11

B5 Managing incoming Non-GMO Production (End) Products and/or Inputs ............................ 12

B6 Packaging and Transporting Non-GMO Production Products ............................................. 13

B7 Labelling and Label Claims ............................................................................................... 13

Section B.3 - Quality assurance.............................................................................. 14

B8 Quality Control System ..................................................................................................... 14

B9 Monitoring ....................................................................................................................... 14

B10 ICS groups ...................................................................................................................... 14

Section C – Risk Assessments ............................................................................... 14

C 1 Determination of risk categories ...................................................................................... 14

C 1.1 Risk Assessment Primary Production ................................................................................... 15

C 1.2 Risk Assessment Harvest, Post-Harvest and Processing Stages ........................................... 16

C 1.3 Risk Assessment of inputs / ingredients ................................................................................ 16

C1.4 Overview three risk categorizations ...................................................................................... 17


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Section D – Operational Requirements ...................................................................17

D1 Management System (MS) ............................................................................................... 17

D2 Primary Production Stage ................................................................................................ 18

D3 (Post-)Harvest, Processing and Handling Stage ................................................................. 19

D3.2d Overview about the required documents related to inputs: .................................................... 19

Section E – Auditing Process ................................................................................. 20

E1 External audit Procedure based on Risk Assessments .................................................... 21

E1.1a External audit procedure in the primary production stage (see C1.1); .................................. 21

E1.1b External audit procedure in the (post)-harvest and/or processing stage (see C1.2); ............. 21

E1.1c Requirements for Inputs during external audit; .................................................................... 22

E1.2 Non-Compliances ............................................................................................................ 22

Section F - Determination and Implementation of Sampling Procedures ..............23

F1 Sampling and analysing .................................................................................................... 23

Annex1 ............................................................................................................... 24

Annex2 ................................................................................................................25

Annex 3 Evaluation of the inputs:........................................................................... 26

Annex 4 Test methods ...........................................................................................27

Annex 5 List of approved organic standards ............................................................ 29

List of changes: .................................................................................................................... 30


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Version 1.2 by October 11, 2019 The official language of the Non-GMO Production Standard is English. In the case of inconsistency between

any translated versions, reference shall default to the English version.

Disclaimer

Although reasonable care was taken in the preparation of this document, any party involved in the creation

of the document HEREBY STATE that the document is provided without warranty, either expressed or

implied, of accuracy or fitness for purpose, AND HEREBY DISCLAIM any liability, direct or indirect, for

damages or loss relating to the use of this document.

On-Product Claims

Companies which have had products and their related processes audited by an approved Certification Body in

accordance with the audit protocol, and where the audit has not brought to light any non-compliances to this

standard or to contractual obligations, have the right, but only in direct relation to the certified product, to

communicate the claim ‘Certified Non-GMO Production’ on the product label, but can only do so with reference

to this standard. In addition, reference must be made to the certified entity. The right to use this claim and

associated logo ceases when the product no longer has the ‘certified’ status.

Off-product Claims

Are only permitted upon written approval by the Certification Body, who is entitled to request the exact manner

of intended off-product claim for its assessment of such a claim.

Copyright

This publication is protected by copyright. Information or material from this publication may be reproduced

in unaltered form for personal, non-commercial use. All other rights are reserved. Information or material

from this publication may be used for the purposes of private study, research, criticism or review permitted

under the Copyright Act 1976.

Any reproduction permitted in accordance with the Copyright Act 1976 shall acknowledge the Non-GMO

Production Standard as the source of any selected passage, extract, diagram or other information.

Introduction and legal background

The Goal of the Non-GMO Production Standard (hereafter referred to as ‘NGPS’) is to verify the

accuracy of Non-GMO Production claims in products as far as possible. The NGPS does not address

environmental aspects of processing (e.g. energy or water usage), social issues, safety issues, or legal

compliance.

The NGPS accomplishes this goal by verifying the that the ‘ingredients were not genetically engineered

by use of modern biotechnology’. It provides a strong chain of custody system from the source to the

final product and is certified by an accredited third-party Certification Body. It allows for transparent,

consistent, and comprehensive independent evaluation and verification that no modern

biotechnology was used to genetically engineer a product.

Intended users of this Standard are agricultural producers, food or feed processing facilities, traders,

Certification bodies, and organizations supporting specific Non-GMO Production initiatives.

This is a voluntary, international standard that is not intended to replace the legal or regulatory

requirements of any country. It is the responsibility of each operation to demonstrate compliance

with all applicable laws and regulations related to marketing, labour and business practices. Where

local legislation and the Non-GMO Production Standard requirements conflict, the Certification Body


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shall seek the most practical solution. When there is confusion about the interpretation of the

Standard, the first point of contact shall be the Certification Body.

How to use this Document

This document sets forth the overall requirements for compliance with the NGPS. The following verbal

forms are used to indicate requirements, recommendations, permissions, or capabilities:

1. “shall” indicates a requirement

2. “should” indicates a recommendation

3. “may” indicates a permission

4. “can” indicates a possibility or capability

Guidance Documents and regulative framework

The following guidance and regulative documents were used in the development and/or revision of this

standard:

• ISO/IEC Directives, Part 2: Rules for the structure and drafting of International Standards

• ISO/IEC Guide 59: Code of Good Practice for Standardization

• ISEAL Code of Good Practice for Setting Social and Environmental Standards


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Section A – General Information

A1 Definitions For the purpose of this document, the following terms and definitions apply:

Approved supplier:

Accreditation: A procedure by which an authoritative body evaluates and gives formal recognition that a

Certification program of a Certification Body is in accordance with a given standard.

Audit: A means to verify compliance with a standard. It can involve visual inspection, interviews, and/or

document reviews.

Auditor: A person that examines and evaluates compliance with a standard. Can also be referred to as

“Inspector” or “assessor” in other standards.

Certification Body (CB): An authorized third party carrying out the audit and Certification procedures in

accordance with the provisions set out in this standard. They may issue Scope Certificates and Transaction

Certificates.

Certification: The provision by an independent body of written assurance (a certificate) that the product, service

or system in question meets specific requirements.

Chain of Custody: A system to document and verify the path taken by a defined input material through all stages

of transfer and production, to the final product. The chain of custody preserves the identity of the input material.

Claim: An oral, written, implied, representation, statement, advertising or other form of communication that is

presented to the public or buyer that relates to the presence of a Claimed Material in the content of a product.

Claimed Material: The specific material that is being verified by the NGPS as a content claim in a final product.

Commingling: Physical contact between certified and non-certified materials during production, processing,

transportation, storage or handling up to the time the product is packaged for the consumer.

GM: Genetic Modification or Genetically Modified. A biotechnological process for the production of GMOs.

GMO: See below.

HACCP-based risk assessment: A risk assessment done by the Company based on the principles of the HACCP.

That is, for example, identifying Critical Control Point and how to manage them appropriately.

Identification: That process in which using the traceability and segregation procedures we can ensure the origin

of a specified batch trough all stages of the product.

Inputs: All substances and materials used in the production of the NGPS Product (including: seeds, propagational

materials, pesticides, fertilizers, unprocessed agricultural materials, feed materials, livestock productional

materials, processing aids and manufacturing materials).

Label: Descriptive, informative or pictorial material on or accompanying a product or its immediate container.

NGPS: The abbreviation of the name of the standard.

NGPS Input: NGPS Certified Product entering the supply chain of another product.


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NGPS Product: A product that has been certified to the Non-GMO Production Standard.

Noncompliance: Lack of conformity with the Non-GMO Production Standard.

Major non-conformity (major NC): those deviations which could not have impact on the Non-GMO status of the

certified product.

Management System (MS): set of interrelated or interacting elements of an Organization to establish policies,

objectives and processes to achieve those objectives (ISO 9000:2015)

Minor non-conformity (minor NC): those deviation which could have effect on Non-GMO integrity.

On Site Audit: The act of examining and evaluating compliance with a standard at the physical site. Also referred

to as “Inspection” in other standards.

Organization: Entity being certified to the NGPS; involved in the manufacturing, handling, trading and processing

of NGPS Products. Organizations take legal ownership of NGPS Products.

Parallel production: We talk about parallel production in case a unit process, produce or handle GMO and Non-

GMO products/inputs.

PRC testing (poly chain reaction): A method of the molecular biology in which they can isolate and quantify the

DNA.

Producer: Entity responsible for the production of inputs into the manufacturing process.

Products: The physical goods that result from each stage of production. These can include finished or unfinished

goods.

Quality Management System: part of MS that concerns the management of the consistent quality of the product

meeting the applicable requirements (based on ISO 9000:2015)

Records: The information in written, visual, or electronic form that documents the activities undertaken by a

user to demonstrate accordance with requirements.

Scope Certificate (SC): A document issued by the Certification Body that verifies that an Organization is qualified

to produce goods in compliance with a standard. Scope Certificates list the products and/or product categories

as well as the processing, manufacturing, and trading activities qualified under the scope of Certification of the

Organization. See Policy and Template for Issuing Certificates of Compliance (Scope Certificates, SCs).

Site: A single functional unit of an Organization or a combination of units situated at one physical location, which

is geographically distinct from other units of the same Organization.

Standard: When capitalized, refers to this Standard (NGPS). A standard is a set of defined requirements that

shall be attained to be awarded Certification.

Standard Operating Procedure (SOP): a collection of step-by-step work instructions to assist workers in carrying

out specific routine operations to achieve efficiency, uniformity and quality of the output.

Subcontractor: An individual or company hired by a producer to perform services. The subcontractor shall not

take ownership of the goods being processed. Subcontractors and their relevant processing and manufacturing

steps become listed on the Scope Certificate of the certified Organization assigning the Certification.


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Supplier Program: A detailed list of approved and contracted suppliers and their specifications that includes

information about the facilities they operate, the products they produce and where they source their inputs

from.

Transaction certificate (TC): A transport document about a specified lot or lots which issued by the Control Union

on the behalf of the certified seller. This document demonstrate that the products are incompliance with the

NGPS.

Unintentional Contamination: The contamination happens unwitting of the operator. The evidences

demonstrate that the operator unknowingly used GMO contaminated inputs and he tried everything to prevent

the contamination.

Understanding of Genetically Modified Organism and Genetically Engineered Ingredients:

A genetically modified organism (GMO), refers to an organism such as a plant, an animal or any other (micro-)

organism that has been genetically engineered by the use of modern biotechnology to alter its DNA and

therewith its characteristics. The result of a genetically modified organism by the use of genetic engineering is

an organism that does not naturally occur or could be created through traditional breeding techniques.

A2 References The following documents support the understanding and implementation of the Non-GMO Production

Standard;

Logo Rules

A3 Scope

A3.1 The Non-GMO Production Standard (henceforth: NGPS) certification is applicable at all levels of

the supply chain to organizations that provide cultivation, production, processing, storage,

distribution, logistics, and/or trade. Applications for product certification include raw materials,

derivatives, multi-ingredient products, additives, and processing aids. Products falling within the scope

should be comprised of one or more agricultural products, regardless of their purpose (e.g. food

industry, animal feed, textile industry, cosmetics, packaging, food supplementary, etc.). The scope of

the assessment is based on the ownership of the claimed material. The scope of assessment could be

either one or more stages in the entire value chain of a product.

A3.2 The following categories are out of the scope:

- Live animals

A3.3 Feed criteria for livestock:

- mammal animals after ablactating

- poultry from the 3rd month

- other cases from the descent or hatching of the animals

only Non-GMO feed can be used.


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- Wild animals and derivatives (egg, meat, milk, etc.)

- Medicines

A3.4 Criteria for bee keeping:

- 5,5 km around the beehive the plants doesn’t contain GMO modified varieties and

- the feed of the bees are derives Non-GMO production.

A4 Principles of Non-GMO Production Certification

A4.1 Applicability of the Standard

A4.1a The standard covers the procurement, production, handling, processing, storage l, distribution

and labelling of foods and agriculture products of plant, animal and microbial origin. The applicability

therefore starts with the production, and it further covers the processing, storage, handling and final

transport of a product.

A4.1b Compliance with the NGPS by all Organizations shall be certified by a Certification Body

exclusively authorized by the standard owner to carry out this activity.

A4.1c Every party that takes legal ownership of the product needs to be certified. However, there

are certain conditions in which traders are exempt from the certification requirement. These

exemption rules are available on the website. (www.controlunion.com)

A4.1d If the operator can provide the evidence that the operation is incompliance with the NGPS they

need to have in place the following systems:

a. Testing system: to provide the control under the high-risk inputs

b. Traceability: to control and check the identity of a special lot.

c. Segregation: to ensure the separated handling and processing of the inputs or products.

d. Formulation system: to ensure the origin of the purchased goods.

e. Labelling: according to the NGPS and the local regulations.

f. Quality assurance: to ensure the control under the operation in accordance with the NGPS.

A4.2 Scope Certificates

A4.2a An Organization shall be considered certified when they have undergone a CB’s assessment (e.g.

document review and/or On-Site Audit) and have been verified by the CB to be operating in

accordance with the NGPS. Certified Organizations are issued a Non-GMO Production Scope

Certificate (SC) after this Certification decision is made.

A4.2b Organizations shall renew their Certification on an annual basis. SC expiration dates shall not

exceed 12 months from the date of certification and shall be renewed after successful reassessment

by the CB. The validity date of the SC shall begin on the date of a positive Certification decision.

A4.2c Organizations producing Non-GMO Production Products must hold a valid SC at the time of

production in order to the products to be considered Certified.

http://www.controlunion.com/


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A4.3 Transaction Certificates

A4.3a Transaction Certificates (TCs) are issued by a Certification Body to verify a product as Certified.

Certified Organizations purchasing Claimed Material or Non-GMO Production Product shall receive

and maintain valid TCs for all incoming certified products purchased.

A4.3b TCs shall only be issued to a Certified Organization with a valid SC that is selling the Non-GMO

Production Product. TCs shall be issued by the same CB that issued the Certified Organization’s SC.

A4.3c Certification Bodies accept transaction certificates from any ISO 17065 accredited Certification

Body that has been accredited to certify against IFOAM based standards, NPOP or EU Organic (EC

834/2007). They additionally accept proof of purchase of products that have been certified against

USDA-NOP standard by Certification Bodies that are registered as approved certification bodies by the

USDA. Approved organic standards listed in Annex 5.

A4.3d In case of commingling, mixing or contamination with GM the operator must be inform the TC

issuing CB about the incident immediately. The certified operator must be taking the corrective actions

in 3 days.

Section B1. – Generic Managerial Requirements

B1 Procedures B1.1 The Organization shall establish and maintain a written Management System (MS), which

includes procedures, a Document Control Procedure, risk assessment, work instructions or Standard

Operational Procedures (SOPs) and records, covering all applicable requirements of the NGPS.

B1.2 The Organization shall adhere to the Targeted Threshold Tolerance Level of this standard, which

is based on the EU Regulations on genetically modified food and feed (Regulation (EC) No 1829/2003).

The Targeted Threshold Tolerance Level is set as being a strictly adventitious or technically

unavoidable1 presence of GENETICALLY ENGINEERED MATERIAL in the material.

B1.2a The Target Threshold Tolerance Level specified by categories:

- plant original food: 0,1%

- seeds propagation material: 0,1 %

- inputs to human food, ingredients, supplements, personal care products, pet food, feed,

products which ingested or applied directly to the skin: 0,9%

- livestock feed and supplements, incl. animal derived inputs to human foods: 0,9%

- packaging, cleaning products, textiles and not ingested or applied directly to the skin: 1,5%

1whether the presence of GENETICALLY ENGINEERED MATERIAL can be regarded as adventitious or technically unavoidable

is based on the interpretation by the EU Directive No 1829/2003

B1.3 An internally binding policy statement shall be written, signed by management and documented

by an Organization to signify its determination to deliver a Non-GMO Production product.


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B2 Record Keeping B2.1a The Organization shall maintain complete, up to date, easily auditable and understandable

written records to demonstrate conformity with all requirements of the NGPS. Records regarding the

implementation/verification of the NGPS shall be retained for a minimum of five years.

B2.1b A designated employee shall be put in charge of the Document Control Procedure to ensure all

records mentioned in section B2 are kept current including changes to operations, facilities and

procedures.

B2.2 The Organization shall keep complete and up to date records of the description, quantities,

origins and/or destinations of all NGPS Products received and delivered as well as all TCs for any

incoming NGPS Product.

B2.3a For each production step, the records shall demonstrate the balance between the NGPS inputs

and the outputs containing the declared final amount of Claimed Material. These records shall enable

the CB to perform Volume Reconciliations. Diminishing or losses of goods due to spoilage, shrinkage

etc. shall be taken into account.

D2.3b The Organization shall check these balances on the basis of the documented inventory of stocks. In case of any identified discrepancies, for instance when the outgoing Non-GMO Production exceeds the incoming, verified Non-GMO Production material, an investigation shall be done so as to scrutinize whether batches need to be decertified or recalled. B2.4 The certified Organization shall have a valid contract with each subcontractor and NGPS-relevant

service provider stipulating the conditions of the relevant job work assigned. Certified Organizations

shall remain fully responsible for compliance with all requirements of the NGPS. These contracts shall

be made available to the CB auditing the organization.

B3 Staff and Management B3.1 The Organization shall maintain and communicate clearly defined roles and responsibilities for

all staff and management that may have an impact on the implementation of the NGPS. The

Organization shall appoint a management representative to be responsible for the overall compliance

to the NGPS.

B3.2 The staff responsible for each procedure impacted by NGPS shall be given proper and yearly

training with regards to the implementation of the Standard. Auditable records shall be kept of staff

training related to the NGPS.

Section B.2 – Specific Managerial Requirements

B4 Non-GMO Production Product Management B4.1 Production Controls - The Organization shall demonstrate control over the flow of Products

within the unit (e.g. processing/manufacturing steps performed), recipes used, composition, and stock

quantities.


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B4.2 Identification - Claimed Materials or Non-GMO Production Products shall be clearly identified

as they move through production. This may include, but is not limited to, direct labelling of Claimed

Materials or Non-GMO Production Products, machines, storage vessels, or storage areas.

B4.3 Segregation - Claimed Materials shall be stored and processed separately (in time and/or

place) from non-Claimed Materials and Non-GMO Production Products shall be separated from other

products of the same type. Additional caution shall be taken where Claimed Materials or Non-GMO

Production Products are handled or produced together with non-Claimed Materials or products of the

same type to ensure continuous separation. The documented MS describes how the requirements are

warranted.

B4.4 Traceability - The certified material should be traceable back throughout the production till

the inputs. In order to the operator can be provide the traceability they need to be manage a

documented traceability procedure in place. According to this procedure the operator should be able

to track a lot number at all stage of the production flow.

B4.5 In order to ensure the segregation, the operator need to implement the following points:

- Inspection and cleaning methods and procedures

- Systematic segregation procedures for ensuring the status of the product

- Separated segregation procedure for those inputs which are under investigation (e.g. under

testing to verify the status of the input).

B5 Managing incoming Non-GMO Production (End) Products and/or Inputs B5.1 Input and/or Product Inspection - Organizations shall inspect the documents

accompanying the input and/or products to confirm that the description, quantity and source

described in the document match the goods themselves. Depending on the risk assessment’s

outcome (section E), samples have to be taken. The supplier shall always be part of the Approved

Supplier Program.

B5.1a Approved supplier program is a procedure which need to be handled by all Operator for

supplier approval. The procedure needs to include the spot purchases also, to improve the Non-

GMO integrity and to determine the risk of contamination/cross-contamination with GM

materials. The suppliers need to provide Non-GMO declaration, test reports and/or traceability

check

B5.2 Claimed Materials entering the supply chain from an outside source - For materials

entering the supply chain, there shall be documentation including the name and address of the

supplier, the quantity and description of the goods, reference to claims being made about the

material, and any corresponding verification or Certification. The supplier shall always be part of

the Approved Supplier Program.

B5.3 For products already certified to Non-GMO Production Standard - A TC shall accompany

the certified Non-GMO Production inputs, confirming they were produced by an Organization

certified to the Non-GMO Production Standard or an accepted organic standard. See Accepted

Organic Standards. The Organization shall check the supplier invoice and supporting documents

to confirm that the date, quantity and material description all correspond to the TC.


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B5.4 For Non-GMO Production Products received from an internal source - For goods flowing

from one production unit to another within the same Organization there shall be corresponding

documentation that references the initial Claimed Materials, the quantity, blend percentage, and

description of the Non-GMO Production Products being received.

B5.5 Products suspected of not complying to the Non-GMO Production Standard - Claimed

Material and Non-GMO Production Product shall be checked for the integrity of the packaging or

container to verify the origin and nature of the certified products from the information contained

in the product marking and corresponding documentation (e.g. invoice, bill of lading, TC) upon

receipt of the certified product.

When an Organization suspects that any input or product is not in compliance with this Standard,

they shall withdraw references to the Claimed Material content of the related product until they

can confirm the valid Certification of the product, and shall inform the CB immediately.

B6 Packaging and Transporting Non-GMO Production Products B6.1 The Organization shall ensure that the products containing Claimed Material shall be

transported to other units, including wholesalers and retailers, only in appropriate packaging,

containers, or transportation vehicles that are securely closed in such a way that the content is secured

from any contamination or mixing.

B6.2 All deliveries of Non-GMO Production Products shall be labelled with identification that clearly

links them to the relevant invoices or shipping documents. This information may be presented on an

accompanying document, as long as such document can be undeniably linked with the packaging,

container or transport vehicle of the Non-GMO Production Product.

B6.3 The storage of finished products shall be managed in order to segregate Claimed Materials

and GENETICALLY ENGINEERED MATERIAL Products and ensure easy identification of lots. Procedures

shall be in place to prevent commingling or substitution of the Claimed Materials and GENETICALLY

ENGINEERED MATERIAL Products with other materials or products.

B7 Labelling and Label Claims

B7.1 The Organization shall merely claim Non-GMO Production certification for the specific

products which Non-GMO Production certification status has been granted to by an authorized CB.

B7.2a The Non-GMO Production logo and/or the Non-GMO Production claim shall only be used on

products that abide to the applicable requirements and in the countries where the products are

produced and processed and where final products are sold.

B7.2b The Organization alone bears the responsibility to stay updated on and abide to the latest

legal requirements concerning, but not limited to, (Non-GMO Production) practices, labelling and

claims in the countries in which they operate/sell their product. A managerial system shall be in place

to ensure the adherence to these latest legal requirements.

B7.3 The NGP Standard owner and the certifying CBs cannot be held accountable for any violations

of these legal requirements in any way.


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B7.4 Specific requirements of the use of the logo are described in the document ‘Logo Rules Non-

GMO Production Standard’.

Section B.3 - Quality assurance

B8 Quality Control System B8.1 The Operator need to manage a quality control system to ensure that the operation and the

product is incompliance with the NGPS. The effectiveness of this quality assurance system should be

revised in specified frequency.

B8.2 The Client need to be managed an SOP (System Organisation Plan) which need to be reviewed

each year, before the audits, and if significant change occurs in the process which may has impact on

the integrity of NGPS.

B8.3 The workers who are related to the NGPS certified product need to be trained frequently. The

training needs to ensure that the employees are in possession of the necessary knowledge so they

can insure the incompliance of the product with the standard.

B9 Monitoring The Operator need to define the critical points in the processing, and they need to keep under

control. They need to handle evidences to verify the compliance of the inputs, processes and final

product with the Standard. The key points should include the traceability, cleaning, segregation and

testing.

B10 ICS groups The farmers and processors in a group must apply similar production systems and farms should be in

same geographical location.

The ICS Group need to handle an Internal Quality System in which they are comprising the

implementation of the internal control system, internal standards, risk assessment.

The risk-analyses should be assessed by IQS manager for the ICS each year.

The IQS need to investigate all farmers once a year and in case of non-compliance the IQS need to

take corrective actions. The IQS manager also need to handle a defined procedure to approve or

impose sanction on the farmers.

Each internal inspector needs to be trained annually by a competent person.

The IQS manager should organize annual trainings to the farmers.

Section C – Risk Assessments

C 1 Determination of risk categories The classification of the risk of contamination is divided into two separate stages wherein

contamination by genetically modified organisms may occur through an activity of the Organization;

1. the primary production of (parts of) the claimed material (not including the harvest) (C1.1)

2. the harvest, post-harvest and processing (manufacturing) of the claimed material (C1.2)


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A third risk-based categorization concerns the origin and nature of the inputs entering the supply

chain. When applicable, in C1.3, a risk-based categorization of inputs / ingredients entering the supply

chain of the claimed material, at any stage, is described.

The audit procedure is based on these risk assessments, which will be elaborated in Section E. The CB

always retains the right to change the risk level in any of the three risk assessments described below

when deemed appropriate and based on documented and fact-based argumentation.

C 1.1 Risk Assessment Primary Production

This risk assessment assesses the risk of GENETICALLY ENGINEERED MATERIAL contamination in the

primary production stage of the claimed material.

1. The first consideration concerns the existence of a Genetically Modified variety of the respective

crop. This is based on the GENETICALLY ENGINEERED MATERIAL-database of approved

GENETICALLY ENGINEERED MATERIAL varieties maintained by ISAAA (ISAAA.org) (see Annex1)1.

2. If so, the second consideration concerns the geographical location of production of the claimed

material. A risk region is a country wherein the respective GM variety of the claimed material is

legally approved for agricultural production purposes. This is determined based on a list by ISAAA

of countries where GENETICALLY ENGINEERED MATERIALs are approved (ISAAA.org) (see

Annex1)1.

The resulting score on the risk assessment determines the audit procedure (see E1). Risks may be

altered on a case-by-case basis based on the considerations described in Annex.

Requirement: This risk assessment has to be documented and the correctness has to supported by

auditable evidence.


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C 1.2 Risk Assessment Harvest, Post-Harvest and Processing Stages

1. The first consideration concerns whether there are any GENETICALLY ENGINEERED MATERIALs

present at the processing site during the handling of the claimed material. If there were

GENETICALLY ENGINEERED MATERIALs present prior to the processing of the claimed material,

proof of sufficient purging is required2

2. If so, the second consideration is whether there is a dedicated Non-GMO Production processing

line that has been sufficiently cleaned/purged before becoming one.


auditable evidence.

1Note, this list is updated up until date of publishing this standard. We refer to the website to check latest updates. In case of any

discrepancies, information on this website is always leading

2this could for example mean that the first 3 batches coming out of a processing line cannot be certified

C 1.3 Risk Assessment of inputs / ingredients

1. The first consideration questions whether the input is, or is comprised of any, biological

organism(s)?

2. If the input is a single ingredient, does it have an approved GM variety in country of production

(based on ISAAA)?

3. If the input is comprised of multiple ingredients, does any part have an GM variety in country

of production (based on ISAAA)?


17

C1.3a If any part of the input is processed to the extent that it is rendered untestable for GM traces,

and it could be classified as high risk, it is inadmissible without having been sampled and certified as

a NGPS input (i.e. a Non-GMO Production certified input) or Organic Certified (see Approved Organic

Standards document).

C1.3b The final determination of risk may be altered by the respective CB on a case-by-case basis,

based on ISAA monitored inputs / ingredients (see Annex1).


auditable evidence.

C1.4 Overview three risk categorizations

Section D – Operational Requirements

D1 Management System (MS) D1.1 As part of the MS, the Organization shall make a documented and detailed risk assessment of

its entire operation with the main purpose of identifying and controlling Critical Points where

contamination of GENETICALLY ENGINEERED MATERIAL is possible.

D1.2 All identified risks should be addressed by appropriate measures to control for the risk of

contamination by GENETICALLY ENGINEERED MATERIAL sources. One could think of measures such as

structurally physical segregation (i.e. dedicated and completely separated production line) or

organizational set-ups that ensure the correct segregation in time through appropriate cleaning and

purging methods and/or the use of dedicated tools and machines.

D1.3 The identified critical control points and their associated control measures shall be monitored

continuously. Operations categorized as high risk in C1.2 shall frequently be monitored and checked.


18

D1.4 An elaborated, implemented and documented Sampling and Testing Plan shall be written and

used based on the risks identified in the risk assessment. This Plan shall be evaluated and updated at

least on annual basis, or whenever a significant change in operations occur.

D1.5 The MS shall be updated at least once a year or every time a significant change occurs that could affect the Non-GMO Production status of the product, example include a change of processing methods, a change of supplier or legislative change in sourcing or domestic markets. D1.6 As part of the MS, an Internal Control System (ICS) shall be elaborated to ensure that all processes are monitored and regularly checked for their performance against the requirements of this standard. The ICS shall at least stipulate the regular process of internal audits, the rectifying activities after the event of a non-compliance and a management review system. D1.7 The changeover of products and/or flushing shall be checked and evaluated with regular appropriate sampling and testing measures to confirm the flushing/cleaning methods are fully preventing any GENETICALLY ENGINEERED MATERIAL to remain in the production line. The sampling must be statistically valid (representative) and the part of the Sampling Plan. To provide the representativeness the operator should take consider the sampling frequency and the sample size. D1.8 The sampling method need to be ensured that doesn’t cause cross contamination in the claimed material.

D2 Primary Production Stage D2.1 Agricultural land in the primary production stage shall not have been used for the cultivation of any known GM variety for a period of at least 1 years prior to the planting of the Claimed Material. D2.2 If the Claimed Material could be categorized as high risk in C1.1, effective practical measures such as buffer zones shall be taken to minimize cross-pollination risks with GM crops in the region of production. D2.3aThe (agricultural) land use in the area of the production site(s) shall be assessed for contamination and/or cross-pollination risk. For a high risk operation (C1.1), the Organization should make use of high quality (satellite) imagery about the agricultural production area(s) that allows reliable identification of cropping areas in the region. D2.3b If the Claimed Material could be categorized as medium risk in C1.1, but neighbouring countries do approve GM varieties of the Claimed Material, effective practical measures shall be taken to minimize cross-pollination risks with GM crops in country border regions. D2.4 Detailed documentation shall be maintained of all major activities in the production process. This includes documentation of all inputs used, but also documentation of all major activities such as specifications of the harvest (date, place, methods etc.) and other major work concerning the land. D2.5 All materials used for propagation (including seeds) shall not be or contain genetically modified material. When propagation material (incl. seeds) can be categorized as ‘high risk’ under section C1.3, laboratory testing is required for every batch to verify the absence of GENETICALLY ENGINEERED MATERIAL content, which is a GENETICALLY ENGINEERED MATERIAL level below the Targeted Threshold.


19

D2.6 Inputs, whether plant-based (e.g. compost) or otherwise (chemical fertilisers and pesticides etc.), shall not contain or be Genetically Engineered material. Any input comprised of one or more crop variety that could be categorized as ‘high risk’ under section C1.3, shall be verifiably Non-GMO Production by being Non-GMO Certified or Organic Certified or verified compliance with the NGPS. Detailed records and vendor declarations shall be kept.

D3 (Post-)Harvest, Processing and Handling Stage This includes all stages after primary production (i.e. (post-) harvest, handling, storage, distribution, processing, manufacturing, packaging and labelling). D3.1a Suppliers shall be assessed for their ability to meet quality and the Non-GMO Production status expectations, requirements and specifications. An assessment could also entail a screening of relevant third-party certificates held by the supplier. D3.1b Delivery vehicles shall be checked prior to, and during unloading to verify that the quality and the Non-GMO Production status of the obtained material was not comprised during transport (e.g. integrity of seals, packaging) (ISO TS 22002). D3.2a Category ‘Non-Risk Inputs’: these are inputs from non-biological sources and therefore have no restrictions of use. Documentation shall confirm that the input is non-biological, based on detailed specifications of all of the ingredients and a declaration stating the method of manufacturing not to have compromised the Non-GMO Production status of the input (based on ‘Vendor declaration according to Article 9(3) of Council Regulation (EC) No 834/2007’). D3.2b Category ‘Low-Risk Input’: these single inputs are (derivatives of) crops which do not have an

approved GM variety in the country of production. Their supplier must be adhere to rigorous

segregation and tracing procedures to prevent any contamination with any type of GM material. Also,

the supplier needs to declare the product complies to the Non-GMO Production requirement (Vendor

Declaration). Self-samples must be taken and tested of every incoming batch.

D3.2c Category ‘High-Risk Input’: Inputs which are (derived of) crops that have an approved GM

variety in the country of production, shall be NGPS Certified or Organic Certified with one of the

approved standards (see Annex 5). These inputs shall, per batch, be tested by an accredited laboratory

to demonstrate a GENETICALLY ENGINEERED MATERIAL content below the Targeted Threshold.

Sampling and testing shall be performed immediately after receiving the inputs from a supplier.

D3.2d Overview about the required documents related to inputs:

High Risk Inputs:

- Ascertaining origin

- Certified against NGPS, or accepted organic standards

- Sampling and testing of every incoming batch

- Vendor declaration


20

Low Risk Inputs


- Sampling and testing of every incoming batch


Non-Risk Inputs



D3.3a All raw materials, inputs, materials in process and finished goods shall be indubitably

traceable through verifiable documentation to the primary production stage of the input/product.

These records shall be maintained and kept up to date.

D3.4a The processing, handling and distribution of Claimed Non-GMO Production material shall be

completely kept separate in time and space from products that are not compliant with the NGPS. This

should ideally be accomplished by means of a dedicated production line, with dedicated equipment,

storage, cleaning and transportation methods.

D3.4c To avoid any commingling or contamination of Claimed Material by non NGPS compliant

material the production line, with all its processing and handling equipment, shall be cleaned so as to

ensure no traces of non NGPS compliant material compromises the integrity of the Claimed Material.

The appropriate cleaning procedures shall be followed, and verifiable documentation shall record

these procedures. When flushing and/or purging is used as a cleaning measure, the quantity of

material needed for sufficiently clean the production line shall be verifiably set.

D3.5 Transportation shall not threaten the integrity of the Non-GMO Production status of the

Claimed Material at any point. For any (bulk) transportation, appropriate cleaning procedures shall be

operational, and records of these cleaning activities kept, including the use of equipment that is

cleaned sufficiently. In bulk transportation, Claimed Material shall be kept isolated from non-

compliant material at any point during transportation.

D3.6 Additional procedure shall be established for processors who buy raw material from local

market. In case if the input is categorised high risk, laboratory testing (by an accredited laboratory)

shall be carried out for every bulk batch and sampling protocol shall be established wherein testing

frequency is determined.

Section E – Auditing Process The following requirements are related to the auditing process performed by the Certification

Body to verify compliance with the NGPS. Note, the audit procedures below are merely an

indication. The CB will establish an audit plan based on this standard and the contextual

circumstances.


21

E1 External audit Procedure based on Risk Assessments

A √ stands for a minimum requirement of the audit procedure based on the risk assessment. A (√)

means that is up to the CB to assess whether the procedure is mandatory, based on case-by-case

considerations.

E1.1a External audit procedure in the primary production stage (see C1.1);

Risk Doc.

check

Number of

fields/facilities

checked?

Testing

Frequency by

third-party

Un-

announced

3 √ √n* At least 1 per

year Yes (15% )


year Yes (5%)

1 √ √n At least 1 per

year Yes (1%)

* adjusted with risk

factor as

determined by CB

on the basis of

Annex 2

E1.1b External audit procedure in the (post)-harvest and/or processing stage (see C1.2);

Risk Doc.

Check

Number of

facilities

checked?

Testing

Frequency by

third-party

Un-

announced

3 √ 100% At least 1 per

year Yes (15% )


year Yes (5%)

1 √ √n Case-by-case Yes (1%)

* adjusted with risk

factor as

determined by CB

on the basis of

Annex 2


22

Note1, the two audit procedures will be combined when the scope of the certificate entails both stages.

Note2, the detailed audit procedure is described in the audit procedure document, which may differ per type of

claimed material.

E1.1c Requirements for Inputs during external audit;

Risk Requirement 1 Requirement 2

Requirement 3

3 Traceability

documentation

Non-GMO-certified or

Organic Certified or

verifiable in compliance

with NGPS

Sampling during audit

2 Traceability

documentation




with NGPS

Sampling during audit

1 Traceability

documentation




with NGPS

*approved organic

certification schemes are

published separately

E1.2 Non-Compliances

E1.2a The CB shall notify the Organization of any non-compliances (i.e. failure to meet a requirement

of the Non-GMO Production standard). Before a CB can take a positive certification decision, the

operator should provide corrective actions. The corrective actions should be taken place according to

the severity of the NC. The non-compliances can require immediate corrective action (Critical NC),

within 30 days (Major NC) or within 60 days (Minor NC). Three Minor NC’s amount to one major NC,

which results in having to close these within 30 days.

E1.2b For any non-compliance, the Organization shall submit to the CB a Corrective Action Plan (CAP)

describing operational changes to comply with the Non-GMO Production standard. This CAP will be

evaluated by the CB. After evaluation the NC can be either closed, in which case this NC will not

prevent a positive certification decision from being taken or will remain outstanding if the corrective


23

action is deemed insufficient by the CB. In such cases the Organization may have to submit additional

measures.

E1.2c A non-compliance considered a severe non-compliance (NC type 1) might have to be acted

upon immediately and satisfactorily and the evidence need to provide within 3 days. A certificate can

also be withheld, or withdrawn when encountering such a non-compliance, depending on the extent

of 1) awareness of acting in non-compliance, 2) the threat to the functioning of the management

system and 3) the extent to which immediate corrections are possible.

E1.2d Corrective actions should be documented:

- root-cause of the NC

- appointed responsible person in charge to the NC closure (reporting, solving, verifying)

- detailed description for the segregation

- further preventive actions, changes which avoid the reoccurrence of the NCs.

Section F - Determination and Implementation of Sampling Procedures

F1 Sampling and analysing

F1.1 The MS shall have a documented Sampling Plan that is based on the MS and the associated

risk assessment. Depending on the audit procedure required (see E1), this sampling plan provides a

description of how the sampling by an auditor is facilitated as well as how self-sampling is rigorously

performed. This Plan shall be evaluated and updated at least on annual basis, or whenever a

significant change in operations occur.

F1.2 Inputs or products categorized as high risk in C1.3 should have testable protein or DNA or have been tested prior to the processes that rendered the input/product as untestable. F1.3 Samples shall be retained as individual samples rather than composites at least until the

expiration date of the product and shall be kept in appropriate conditions. Also, such samples shall be

identifiable by corresponding batch codes.

F1.4 Test results shall test for the GM allowance thresholds for the presence of GM that is the

Targeted Threshold Tolerance Level(s) of the European Union Regulation (EC) No 1829/2003, which

stipulates a threshold of no higher than 0,9 per cent presence of adventitious or technically

unavoidable GENETICALLY ENGINEERED MATERIAL.

F1.5 Laboratories performing tests to assess the GENETICALLY ENGINEERED MATERIAL content of

a sample shall be certified with ISO 17025 for the specific activity of GENETICALLY ENGINEERED

MATERIAL testing.


24

Annex1 List 1: GM Crops List

• Alfalfa (Medicago sativa)

• Apple (Malus x Domestica)

• Argentine Canola (Brassica napus)

• Bean (Phaseolus vulgaris)

• Carnation (Dianthus caryophyllus)

• Chicory (Cichorium intybus)

• Cotton (Gossypium hirsutum L.)

• Creeping Bentgrass (Agrostis stolonifera)

• Eggplant (Solanum melongena)

• Eucalyptus (Eucalyptus sp.)

• Flax (Linum usitatissimum L.)

• Maize (Zea mays L.)

• Melon (Cucumis melo)

• Papaya (Carica papaya)

• Petunia (Petunia hybrida)

• Plum (Prunus domestica)

• Polish canola (Brassica rapa)

• Poplar (Populus sp.)

• Potato (Solanum tuberosum L.)

• Rice (Oryza sativa L.)

• Rose (Rosa hybrida)

• Soybean (Glycine max L.)

• Squash (Cucurbita pepo)

• Sugar Beet (Beta vulgaris)

• Sugarcane (Saccharum sp)

• Sweet pepper (Capsicum annuum)

• Tobacco (Nicotiana tabacum L.)

• Tomato (Lycopersicon esculentum)

• Wheat (Triticum aestivum)

Source: ISAAA (International Service for the Acquisition of Agri-biotech Applications) on 03-07-2018

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=1&Crop=Alfalfa

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=28&Crop=Apple

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=2&Crop=Argentine%20Canola

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=3&Crop=Bean

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=4&Crop=Carnation

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=5&Crop=Chicory

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=7&Crop=Cotton

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=8&Crop=Creeping%20Bentgrass

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=29&Crop=Eggplant

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=30&Crop=Eucalyptus

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=9&Crop=Flax

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=6&Crop=Maize

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=10&Crop=Melon

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=11&Crop=Papaya

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=12&Crop=Petunia

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=13&Crop=Plum

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=14&Crop=Polish%20canola

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=15&Crop=Poplar

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=16&Crop=Potato

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=17&Crop=Rice

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=18&Crop=Rose

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=19&Crop=Soybean

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=20&Crop=Squash

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=21&Crop=Sugar%20Beet

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=27&Crop=Sugarcane

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=22&Crop=Sweet%20pepper

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=23&Crop=Tobacco

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=24&Crop=Tomato

http://www.isaaa.org/gmapprovaldatabase/crop/default.asp?CropID=25&Crop=Wheat


25

Annex2 Certification Bodies need to base the audit process on contextual risk factors. A CB must take the

following circumstances into account, that could heighten the risk and therefore the need for

control;

- Location of primary production

- High value products

- Date of conversion

- NCs in the last 12 months

- Parallel production

- Contextual contamination risks

o Drift by wind

o Water flows

o Etc.


26

Annex 3 Evaluation of the inputs: The evaluation of the inputs based on 3 pillars.

I. Category of the inputs

1. Must be evaluate:

A. Unprocessed agricultural inputs

B. Animal derived inputs

C. Manufacturing auxiliaries

D. Processed agricultural ingredients

E. Components of the feeds and pet foods

F. Primary packaging

G. Components of the textiles and cosmetics (except the above mentioned)

H. Microbes and their derivatives, enzymes and deratives

I. Diary supplements, herbal products and vitamins

J. Seeds

2. The evaluation can take consider based on the origin of the product

A. Manure, compost

B. Herbicide, fungicide, pesticide, fertilizers

C. Cleaning, sanitizing substances

D. Secondary packaging material

E. Medicines, veterinary products

II. Risk base analyses

(table about the risk categories)

III. The weight percentage of the ingredient

A. Major ingredients: the ingredient represent more than 5% in the final product or it is

characteristic in it

B. Minor ingredients: are those ingredients which are represent minimum 0,5% but not more

than 5 % in the final product.

C. Micro ingredients: those elements in the final product which represents less that 0,5%


27

Annex 4 Test methods

If the PRC test reflects a positive result (higher or equal than the Threshold level) the CB should be

informed, and the usage/or selling of that lot is banned.

Immunological analysis, or immuno-analysis for short, is a protein detection GMO test method.

Currently, there are two available types of GMO tests that use immunological method: the Strip Test

and ELISA Method. Antibody-based tests are not applicable for heat or chemically processed products

(e.g., soy protein isolate, lecithin, etc.) in which the protein is denatured resulting in destruction of

the antibody binding site.

Genetic analysis is a testing method for GMO that detects the presence of a transgene in a plant

cell’s genome. The specific GMO test based on this method is called the polymerase chain reaction

(PCR) test.

Self-testing methods:

1. Strip test: Immunologic, protein based, rapid, 0,1-1 % limit of detection) measurement. This

method not appropriate for processed products.

This is an antibody-based method used for measuring GMO protein in unprocessed material

such as seed, grain, or leaves, surface water or soil samples (applicable for field testing). Uses

a detection surface comprised of immobilized GMO protein-specific antibodies on a solid

strip. Suitable for qualitative or semi-quantitative testing.

2. ELISA: Immunologic, protein based, rapid, high sensitivity (0,01-0,1 % limit of detection)

measurement. This method is antibody-based which measure the GMO in unprocessed

materials such as seed, grain, or leaves. This method not appropriate for processed products.

Must be performed in laboratory. The method appropriate for qualitative and quantitative

measure.

3. Real time PRC: DNA based genetic analyse. It has high sensitivity. This method appropriate

for qualitative and quantitative measure. Must be performed in a laboratory.

The antibody-based strip tests are not available for all commercialized GMOs so the operator can be

using this testing method in the unit for those products which are belongs to the low or medium risk

category (according to the sampling plan).

This method can be used when the accuracy, sensitivity and risk of false negatives are not major

concerns.

In case of positive results, the samples should be confirmed by PCR method.

Accredited laboratory-based test:

The tests should be performed in ISO 17025 standard accredited laboratories (from the labor list).


28

If the PRC test reflects a positive result (higher or equal than the Threshold level) the CB should be

informed, and the usage/or selling of that lot is banned.

1. PRC: DNA based genetic analyse. It has high sensitivity (limit of detection 0,01%). This

method appropriate for qualitative and quantitative measure. Must be performed in

laboratory.

During the decision which type of GMO test is the most appropriate, we should take consideration

the following factors:

- Nature of the sample

- What kind of GMO(s) need to be analysed

- Required test sensitivity

- Whether qualitative or quantitative analysis is required

- Product’s intended market

EU Database of Reference Methods for GMO Analysis: http://gmo-

crl.jrc.ec.europa.eu/gmomethods/search?db=gmometh&q=id%3AQT-eve-zm*


29

Annex 5 List of approved organic standards

- EU organic

- NPOP

- USDA organic

- IFOAM based organic standards


30

List of changes:

changes in version 1.2.

Section A

A1 Added the definition of GM, Identification, Major Nonconformity, Minor Nonconformity, Parallel

production, PRC testing, Transactional certificate, Unintentional Contamination. Expanded the

definition of Inputs.

A3 Scope: the scope was expanded with the following products in the explanation: cosmetics,

packaging, food supplementary, etc.

Added the point A3.2, A3.3 and A3.4.

A4.1a Added the covered steps:”The standard covers the procurement, production, handling,

processing, storage l, distribution and labelling of foods and agriculture products of plant, animal and

microbial origin. “And removed: Non-GMO Production Standard Certification could apply to each

Organization in the full agriculture-based supply chain. We also removed the for the applicability the

“agricultural based” products needed.

A4.1c Added “However, there are certain conditions in which traders are exempt from the

certification requirement.” Deleted the following sentence: That is usually when the trader does not

re-package and/or re-label certified products. Added the website in which the exceptions are

available.

Add the point 4.1d.

A4.2b Modified the expiry date for 12 month and added the starting date of the certificate: “shall

begin on the date of a positive Certification decision”.

A4.3c Added “against IFOAM based standards”, and the location where the approved organic

standards are listed: “Approved organic standards listed in Annex 5”.

Section B

Added point B1.1.

B1.2 Deleted the following part of the point: which is ‘no higher than 0,9 per cent of the food

ingredients considered individually or food consisting of a single ingredient’ (Regulation (EC) No

1829/2003). This is valid at the time of publishing the current version of this standard.

Added the B1.2a “The Target Threshold Tolerance Level specified by categories”part.

B2.1a Clarified that written documentations are necessary.

B3.2 Change the regularly training to yearly.

Added point B4.4, B4.5 and B5.1a.


31

B5.3 deleted the following sentence: “The supplier shall always be part of the Approved Supplier

Program.”

Added the Section B3.

Section D

Deleted the following from point D1.1 It should at least include the description and implementation

of;

- The scope of the HACCP-risk assessment shall not be limited to the Organization itself, but

shall also include the GENETICALLY ENGINEERED MATERIAL contamination risks posed by

operations of suppliers and of all handling, processing, distribution or storage done by (sub-)

contractors.

- The risks posed by a changeover from GENETICALLY ENGINEERED MATERIAL containing inputs/products to Non-GMO production shall be part of the risk assessment.

- The HACCP-based risk assessment as part of the MS shall take potential GENETICALLY ENGINEERED MATERIAL contamination by non-testable sources into account (e.g. highly processed inputs).

- Risks assessed and controlled with taking the Targeted Threshold Tolerance Level(s) against

which the Organization is seeking certification in account.

- The risks that are associated with inputs are assessed as part of the risk assessment. The outcome shall determine the specific requirements for these inputs (more in E1.1c). Documentation shall at least describe the origin, amount and content of the input.

And also deleted that the risk analize need to be HACCP based. D1.3 deleted: “by sampling and testing methods”.

D1.5 deleted: “shall be regularly checked and evaluated”. D1.7 added: “The sampling must be statistically valid (representative) and the part of the Sampling Plan. To provide the representativeness the operator should take consider the sampling frequency and the sample size.” Point D1.8 added. D2.1 changed the 3 year conversion period to 1 year. D2.3a removed the requirement about the 6km radius: “This shall at least be done for a 6 kilometre radius around the farm.” D2.3b changed the following part “in the country border regions of production’. D2.6 Expand with “or verified compliance with the NGPS.” Deleted the point D3.1a, D3.2. D3.2b In case of ‘Low-Risk Input’ deleted that the input need to be part of the Supplier Program as

it was mentioned above: must be part of the Supplier Program and thereby. And clarified that self-

sampling is the requirement.


32

D3.2c Category ‘High-Risk Input’ clarified the time period for the sampling: :Sampling and testing

shall be performed as soon as possible immediately after receiving the inputs from a supplier (that is

part of the Supplier Program). And deleted the sentence about Supplier Program.

Added point D3.2d.

Deleted the point D3.3b and 3.4a. Added D3.6. Section E

Modified the Number of fields/facilities checked in case of High-risk in point E1.1a from 100% to

√n*. Deleted the following columns: Seed Sampling, sampling directly after transfer of ownership

and self-Sampling.

Modified the Requirement 2 in case of High-risk in point E1.1c to Non-GMO-certified or Organic

Certified or verifiable in compliance with NGPS.

E1.2a Modified the timelines for the corrective actions. Deleted of the columns about Sampling

directly after transfer of ownership and self-Sampling

E1.2c Modified the timeline for the corrective actions in case of critical NCs. Deleted the

Requirement4. column.

Added point E1.2d.

Section F

F1.1 Deleted: If sampling is required, and add: This Plan shall be evaluated and updated at least on

annual basis, or whenever a significant change in operations occur.

Modified Annex2.

Added Annex 3 , Annex 4 and Annex 5.

Changes in numbering:

D3.1b → D3.1a

D3.1c → D3.1b

D3.4b → D3.4a

D3.4c → D3.4b