Authorisation of genetically modified food and feed

The approval procedure as layed down in Regulation (EC) No. 1829/2003 on genetically modified food and feed requires a safety assessment by the European Food Safety Agency (EFSAshort forEuropean Food Safety Authority).

An authorisation can only be granted for genetically modified food and feed which do not have adverse effects on human health, animal health or the environment and if consumers or users are not misled. Moreover, the genetically modified food and feed must not differ from the products which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for consumers or animals. Genetically feed must not harm or mislead the consumer by impairing the distinctive features of the animal products.

The safety assessment of food and feed derived from genetically modified organisms (GMOs) is based on the comparison of the GMO in question with its conventional comparatort. This comprises the molecular characterisation of the genetic modification and the resulting new protein(s) as well as a comparative analysis of the nutritients, and anti-nutrients as well as endogenous toxins and allergens that are of relevanceClose dialogrelevancePositive Predictive ValueTo glossary for the specific organism. This permits a conclusion of whether the genetic modification may have causedany unintended changes. If changes in content of coumpounds are found, a decision is to be made depending on the type and scope of differences which further testing is necessary in order to provide evidence that the GMO derived products are as safe as their conventional counterparts.

Authorisations for the placing on the market of genetically modified food and feed are granted by the European Commission.

It is the task of EFSAshort forEuropean Food Safety Authority to examine, on the basis of the documents enclosed with the application, whether the product corresponds to the requirements in terms of placing on the market and labelling.

Taking into account the opinion of EFSAshort forEuropean Food Safety Authority, the European Commission prepares a draft decision; for it to be approved it requires a qualified majority of the Member States.

The competent authorities of the EU Member States are provided with the applications and can provide EFSAshort forEuropean Food Safety Authority with their opinion on the n the safety assessment. In accordance with article 1, para1 4, number 4 of the German law implementing the EC Regulations on Genetic Engineering, the German competent authority for providing EFSAshort forEuropean Food Safety Authority with national comments is the Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety).The comments are elaborated in consultation with the Federal Office for Nature Conservation (BfN) and the Robert Koch Institute (RKI). In addition, the BVLshort forGerman Federal Office of Consumer Protection and Food Safety requests statements from the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) and the Julius Kühn Institute (JKIshort forJulius Kühn Institute).

Regulation (EC) No. 1829/2003 requires specific labelling in order to inform consumers about any characteristic or property which renders a genetically modified food or feed different from its conventional counterpart with respect to

• composition, nutritional value or properties and nutritional effects, intended use;
• implications for the health of certain sections of the population groups or certain species or categories of animals;
• ethical or religious concerns.

Moreover, it must also be evident from the label that the food or feed is genetically modified.

Irrespective of the detectability of the genetic modification, Regulation (EC) No. 1829/2003 requires labelling of all foods and feeds produced from GMO including those not containing any GMO derived material, such as refined oils produced from from GM oilseeds that are not distinguishable from conventional oil. The words "genetically modified" or "produced from genetically modified (e.g. corn)" shall appear on the label. Labelling is not required to foods and feeds containing GMO derived material in a proportion no higher than 0.9 per cent, provided that there is evidence that the presence of this material is adventitious or technically unavoidable due to traces of GMOs that might accidentally have entered the supply chain during cultivation, transport or processing.

Regulation (EC) No. 1830/2003 provides a framework for the traceability of GMO derived food and feed with the objective of facilitating accurate labelling, monitoring the effects on the environment and, where appropriate, on health, and, if necessary, withdrawal of products. To this end, the Commission has adopted Regulation (EC) No. 65/2004, which lays down a system for the development and assignment of unique identifiers to all GMOs. The parties involved in placing such products on the market must establish systems and standardised procedures to ensure that the data on GMOs can be stored for a period of five years.

In addition to a labelling proposal, applications for authorisation must be accompanied by methods for the identification of the GMOs as well as reference material  necessary for monitoring compliance with the labelling requirements and traceability provisions, which in Germany is performed by the competent authorities of the federal states.

The testing and evaluation of the detection methods is within the remit of the Joint Research Centre of the EU Commission (JRC), who established a European Network of GMO Laboratories (ENGL) for this purpose back in December 2002. The German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment), whose staff began with the development of detection methods for genetically modified even earlier in 1995, is one of the founding members of this network.

The international standardisation of methods for the detection of genetically modified foods and for the quantification of the GMO derived material is performed by working groups of the German and European standardisation institutes DIN and CEN under the lead and with participation of BfRshort forGerman Federal Institute for Risk Assessment scientists.

The collective terms ‘new molecular biological techniques (NMT)’ or ‘new breeding techniques (NBT)’ are used to describe modern genetic engineering methods that, in contrast to conventional methods, enable targeted interventions in the genetic material of organisms (e.g. genome editing). NMT can be used to create different types of genetic modifications. In some cases, it is not possible to distinguish analytically whether the change has occurred naturally or has been deliberately introduced by NMT. This is particularly the case if the existing genetic information has merely been ‘rewritten’ and no foreign DNA has been incorporated. Furthermore, certain changes to the genetic material can be brought about by both NMT and by so-called classical mutagenesis methods (e.g. radiation- or chemical-induced mutagenesis), which is why it is not always possible to distinguish between them using analytical methods. Due to an exemption in EU genetic engineering law, classical mutagenesis methods are currently exempt from the authorisation and labelling requirements.

In 2018, the Court of Justice of the European Union (CJEU) addressed the question of whether organisms obtained by mutagenesis are to be regarded as GMOs and are therefore subject to the obligations provided for in the GMO Directive (Directive 2001/18/EC). The resulting decision of the ECJ of 25 July 2018 states that organisms produced by mutagenesis are GMOs within the meaning of the GMO Directive, although classical mutagenesis methods, which have long been considered safe, continue to be exempt from the obligations of the GMO Directive. However, the exemption does not apply to NMT, which means that food and feed produced from GMOs using NMT are also subject to authorisation and labelling requirements.