New EU Regulation to speed up approval of Novel Foods
By Alison Sharper - 17 December 2015
A new EU Novel Foods Regulation (EU) No. 2015/2283 will come into force on 31st December 2015 and apply from 1 January 2018. It will allow companies to get novel foods and ingredients on the market more quickly. It is expected the new regulation will reduce the length of the authorisation procedure significantly to approximately eighteen months from the current average of three and a half years.
The European Commission has created a new centralised authorisation system and updated the rules to take into account technological developments and scientific advice. In the new system, the European Food Safety Authority (EFSA) will conduct a scientific risk assessment of each novel food or ingredient and the Commission will manage the files of each applicant and put forward a proposal for the authorisation.
So what are the main changes introduced by the new EU Regulation?
Traditional foods from third countries
Traditional foods from third countries having a history of safe food use will have easier access providing the applicant is able to demonstrate that the food/ingredient has been safely consumed by a significant part of a third country’s population for at least 25 years. If the traditional food can historically be demonstrated as being safe and there are no safety concerns raised by the EU Member States or EFSA, that food will be allowed to be placed on the market on the basis of a notification from the FBO.
The list of categories of foods covered by the scope of the Regulation has also been revised. Food consisting of ‘engineered nanomaterials’ is now included within the scope. The safety of the nanomaterials must be assessed by EFSA.
Currently in the EU whole insects do not fall within the scope of the Novel Foods Regulation whilst the consumption of parts of insects do fall under it. This is due to the current wording of the regulation which captures products isolated from animals but not whole animals. The whole animal can also be ground or milled into flour and this would also not be classed as novel! This will change with the wording in the newly agreed EU Regulation. The new Regulation clarifies that also whole animals, such as whole insects, if not consumed to a significant degree prior to 15 May 1997 will fall within the definition of ‘novel food’.
What about data protection?
Data protection provisions are also included in the Regulation. Newly developed scientific evidence and proprietary data will not be able to be used for the benefit of another application for five years after the novel food has been authorised.
Up until the beginning of 2015 there have been approximately 180 applications and some 90 or more novel foods have been authorised in the EU. According to the current EU novel foods Regulation, foods which have not been used for human consumption to a significant degree within the European Community before 15 May 1997 would be considered as novel foods.