Aug 13, 2010

Glossary

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Substantial equivalence

Term relating to risk assessments of food and feed products derived from genetically modified organisms

The concept of substantial equivalence is based on the basic idea of taking foods that have an established history of safe use as a comparative standard for assessing the risk of novel foods, in particular those derived from genetically modified plants.

Today, establishing that a novel food is ‘substantially equivalent’ to its conventional counterpart requires evidence obtained in accordance with scientific standards in each individual case. This can involve recording the molecular, agronomic or morphological characteristics of a genetically modified plant, or collecting data about its composition – the levels of nutrients, vitamins, minerals and trace elements it contains. Sometimes it also involves conducting feeding experiments. If the data for the novel food or feedstuff does not differ from those of its conventional counterpart except within the range of normal biological variation, substantial equivalence is said to exist.

However, the substantial equivalence concept does not cover the ‘gene product’, e.g. a protein that is produced as the result of a gene inserted into the genetically modified plant. A separate risk assessment is conducted for this protein, for instance the Bt protein in the case of insect-resistant GM plants.

The concept of substantial equivalence was developed by international bodies of experts (WHO, FAO, OECD) in the mid-90s and has been continually refined over the years since then.