Editing Substantial equivalence (section)

==Assessment process==
Substantial equivalence is the starting point for GM food safety assessment: significant differences between a new food item and its conventional counterpart would indicate the need for further testing. A "targeted approach" is taken, by selecting specific relevant molecules for comparison. For plants, selection of a suitable comparator may involve growing the new plant side by side with genetically closely-related varieties, or using publicly available composition data for closely-related varieties.<ref name=":0" />

Evaluation for substantial equivalence can be applied at different points in the food chain, from unprocessed harvested crop to final ingredient or product, depending on the nature of the food item and its intended use.<ref name="faotools" /> 

For a GM plant, the overall evaluation process may be viewed in four phases:<ref name="kok">{{cite journal |author=Kok EJ, Kuiper HA |title=Comparative safety assessment for biotech crops |journal=Trends Biotechnol. |volume=21 |url=http://www.ask-force.org/web/Food/Kok-Comparative-Safety-2003.pdf |issue=10 |pages=439–44 |date=October 2003 |pmid=14512230 |doi=10.1016/j.tibtech.2003.08.003 |url-status=live |archive-url=https://web.archive.org/web/20160214044505/http://www.ask-force.org/web/Food/Kok-Comparative-Safety-2003.pdf |archive-date=2016-02-14 }} ()</ref>

# '''Substantial equivalence analysis'''<br />Considering introduced genes, newly expressed proteins, and new secondary metabolites
# '''Toxicological and nutritional analysis''' of detected differences<br />Gene transfer, allergenicity, degradation characteristics, bioavailability, toxicity, and estimated intake levels
# '''Toxicological and nutritional evaluation'''<br />If necessary, additional toxicity testing, possibly including whole foods (return to Phase 2).
# '''Final safety assessment of GM plant'''
<!--A 2003 review in ''[[Trends (journals)|Trends in Biotechnology]]'' identifies seven main components of a standard safety test:<ref name="kok">
# Study of the introduced DNA and the new proteins or [[metabolite]]s that it produces;
# Analysis of the chemical composition of the relevant plant parts, measuring nutrients, antinutrients, and any natural toxins or known allergens;
# Assess the risk of gene transfer from the food to microorganisms in the [[Gut (anatomy)|human gut]];
# Study the possibility that any new components in the food might be allergens;
# Estimate how much of a normal diet the food will make up;
# Estimate any toxicological or nutritional problems revealed by data comparison with equivalent foods;
# Additional animal toxicity tests if there is the possibility that the food might pose a risk.-->