1.1. The concept of substantial equivalence to GMMs

GMM and the products derived and applied for human and animal consumption are ranging from a group of single compound to pure cultures of viable GMMs. Purified products like amino acids and vitamins are typical example for the first group, but the probiiotic culture or diary starters represent the second one. An intermediary place is given to both products from genetically modified microorganisms such as diary products where the viable GMMs persist, as well as products without presence of viable GMMs. The last one could contain traces of the transgenic event, e.g. crude enzyme preparations produced by the lysis of microbial cells. On the basis of these considerations three groups of GMMs or derived food and feed may be distinguished (see Table 1 below).

Table 1:

Group Description
Group 1 Defined mixture of compounds or single compounds derived from GMMs (e.g. amino acids, vitamins, pure enzymes).
Group 2 Complex products without viable GMMs and not containing unit length of any cloned (foreign) open reading frames (e.g. lysed cell extracts, some feed enzymes, wine, some beers, etc.)
Group 3 Cultures and products containing viable GMMs or genetically intact cloned (foreign) DNA (e.g. live or heat killed starter cultures and probiotic cultures, some beers, cheese, yogurts, etc.)

Different assessment procedures are applicable when the foods and feeds contain products obtained from mentioned above groups (Fig. 1). The most intense scrutiny is foreseen for products containing viable GMMs. Limited information regarding production system is required to perform a risk assessment on single compound. In case GMMs are not recoverable from a product, but its purification is limited, the required information for risk assessment is more extensive then for the single products. There is necessity to understand the process by which the GMM has been inactivated in the product and the degree to which traces of the transgenic event could be detected in the product. If alive GMMs persist in a product, the required information will be comprehensive in order to allow a scientific risk assessment.

The scrutiny level of the risk assessment is related to the history of use of the recipient and donor strains (depending on the sequences to be cloned) as well as the modification itself. The procedures for the risk assessment of GMMs will become less scrutiny when the qualified presumption of safety (QPS) of microorganisms in the food and feed chains has been embedded. In such case, the risk assessment should target relevant information, which is not listed in QPS qualification already granted to the parental / recipient / donor strains, or to the taxonomic group with QPS status for the same end-use.

LO4 1

Fig. 1: Approach to the environmental risk assessment of GMMs and their products