Source: European Parliament
It is the responsibility of food business operators to verify if the food they intend to place on the EU market falls in the scope of the Novel Food Regulation[1]. Food obtained from Category c New Genomic Techniques (NGT) plants will fall under that regulation if it contains significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances as provided in its Article 3(2)(iv).
The Commission’s proposal on plants obtained by certain NGTs contains transparency measures for Category c NGT plants: the foreseen public database will contain a description of the trait(s) and characteristics introduced or modified in a Category c NGT plant. This will support food business operators in the assessment of whether those traits give rise to the significant changes in the food that would qualify it as novel. It can be expected that food obtained from Category c NGT plants with such significant changes will be part of specialised supply chains as the purpose of developing such traits is to offer identifiable benefits to the consumer.
The Commission does not have specific information on the costs of safety testing under the Novel Food Regulation. Such costs depend on the type of novel food and the necessary tests to prove its safety[2].
The Commission estimated in its impact assessment[3] that of a total of 15 applications per year from the first year of operation of the regulation (two years after entry into force), 10 would be Category c NGT plants. It is not possible to predict how many of those would be intended for placing on the market as food and what proportion thereof would contain traits that would require an assessment of the food concerned under the Novel Food Regulation.