Scientific and technical support note by the french agency for food, environmental and occupational health & safety concerning the studies necessary for the assessment of GMOs developed for non-EU countries and that could be unintendedly present at low levels on the european market

In September 2014, the European Commission mandated EFSA to identify the studies necessary for preparing applications for marketing authorisation of GMOs developed for non-EU countries and not intended for the European market, but that could be present at low levels on this market. This is because the marketing of certain GMOs developed in non-EU countries for local needs seems to have been frozen for fear about their unauthorised possible presence in export channels.

According to the European Commission, there are two possible options to prevent these GMOs from being regarded as unauthorised in Europe:

• submitting traditional applications, as if these GMOs were intended for the European market. However, it may be the case that these GMOs do not meet all the European evaluation criteria;
• exploring the possibility of submitting applications that take account of the fact that the GMOs in question should only be present in trace amounts, as they are not intended for the European market. Article 5(2) of Implementing Regulation (EU) No 503/2013 states that all scientific requirements provided for in Annex II of the said Regulation need not be met owing to the nature of the product, or because they are not justified from a scientific perspective.

If this second option should ultimately be chosen by the European Union, the product would be assessed according to criteria that would differ from those in a traditional authorisation application, before being permitted at a maximum level of 0.9%: the GMO would then be subject to a decision authorising traces of less than 0.9%.

As there is no overall consensus regarding the 0.9% threshold set by the European Commission, the purpose of the Request is to establish:

• which studies would be indispensable in the case of trace amounts lower than 0.9%;
• whether some of the studies thus identified would become irrelevant if the threshold were to be lowered (for example to 0.5 or 0.1%).

At present, it seems that the only GMOs that would be affected by these provisions are plants (rice enriched with vitamin A and iron (Golden Rice), virus-resistant cassava, etc.). As a result, only Genetically Modified Plants (GMPs) were studied (the cases of genetically modified microorganisms and animals were not considered). In addition, the Request concerns both raw products and processed products derived from GMPs.