The considered Food products are intended for sale in the United States (U.S.) and on the European market (EU).

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What does this Technical Specification for Products offer to manufacturers?

The DNV Technical Specification for Products (STP) aims to give a robust system to define the process of preparing Food products without non-genetically engineered (non-GE) ingredients.

The DNV Technical Specification for Products may be used by a Food manufacturer (defined herein as an “operator"). The Technical Specification is based primarily on product traceability with focus on the control of cross-contact or co-mingling between genetically engineered (GE) and non-GE ingredients at every level of the supply chain and manufacturing process, as well as an effective product market removal plan.

The DNV STP is developed in accordance with EU legislative labeling requirements for GMOs (EU Regulations 1829/2003 and 1830/2003) and with the U.S. market needs and specific approaches, taking into consideration US federal and State guidance, proposed and passed laws, and subsequent regulations related to GE (Vermont Law 121 and FDA guidance for industry 2015).

This DNV STP can be applied to the processing of single ingredients or multi-ingredient products intended for human consumption, when some ingredients may derive both from commercially available GE and non-GE crops. For management of facilities producing both GE and non-GE products, the impact of the GE products will need to be considered.

What is the verification process?

The DNV STP is applicable as additional requirement in concordance to the international standard for product certification ISO/IEC 17065:2012.

DNV is an independent third party organism and has developed this STP to organize the verification of food products manufacturing sites. The implementation of the requirements of the STP does not substitute the compliance with any applicable law or regulation in force. The STP is intended to be applied in combination with existing laws and regulations governing the labeling of food products.

The Food product must maintain its original non-GE status, and it must be managed to avoid cross-contact or co-mingling with GMO raw materials and ingredients throughout the supply chain. This shall be demonstrated through control measures at all steps of production:

• Risk analysis: an analysis of risks must be performed for the purpose of identifying the products / ingredients / raw materials of interest.
• Traceability:  as guidance, the international standard ISO 22005:2008 Food Chain Traceability will apply to assess the Supply Chain and food processes.
• Monitoring plan: a robust monitoring plan shall be developed to achieve high customer expectations related to non-GE ingredients into the Supply Chain.
• Results: the content target for GE-ingredients is clearly measured and defined.

Further information available into the DNV STP non-Genetically Engineered ingredients process verified.

You may download the DNV STP here.


Some useful definitions as a starting point

Genetic Engineering (GE): “Manipulation of an organism's genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular biology, particularly those techniques referred to as recombinant DNA techniques.”

Genetic Modification (GM): “The production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods. Some countries other than the United States use this term to refer specifically to genetic engineering.”

Genetically Modified organism (GMO): an organism, other than a human being, whose genetic material has been altered in a way that does not occur naturally by mating and / or genetic recombination.

Genetically Engineered (GE) Critical: An organism, or a product produced from this organism, which has commercially available GE versions. A list of food-related GE critical organisms is enclosed in Annex I of the STP. An organism or a product produced from this organism is not regarded as GE critical if it is not listed as GE critical in Annex I. This Annex is based on the Center for Environmental Risk Assessment (CERA) GM Crop Database.

Food: "food" means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be eaten by humans.

Ingredient: Any substance, including food or color additives, used in the manufacture or preparation of food and still present in the finished food, even if in altered form.

Regulatory and normative references

• Reg (CE) n. 1829/2003 - 22 September 2003: relating to genetically modified food and feed;
  
  
• Reg (CE) n. 1830/2003 - 22 September 2003: concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC;
  
  
• 2015 – FDA - Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants;
  
  
• Vermont Law No. 120. An act relating to the labeling of food produced with genetic engineering;
  
  
• Vermont Annotated – Consumer Protection Rule 121;
  
  
• 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;
  
  
• Center for Environmental Risk Assessment (CERA) GM Crop Database;
  
  
• UNI EN ISO 22005:2008: Food Chain traceability;
  
  
• ACCREDIA (SINCERT) document RT-11 14/12/2004 version 01 “Minimum requisites for the certification of products having Non-GMO characteristics/requisites”.