Novel Foods and the New European Legislation to Evaluate them
Regulation (EU) No. 2015/2283, implementing a centralised authorisation and assessment procedure for novel foods, will apply from 1st January 2018. Replacing the current EU process. The designation ‘novel food’ is not one in everyday use but would logically be interpreted by a consumer as something that is new, unusual, unconventional or innovative, or indeed a combination of these concepts.
When considering this concept, it is necessary to consider a reference point of first usage after which a food should be treated as new or ‘novel’. Within the European Union this time point is May 1997. Foods not consumed in the EU to a significant degree before this date are considered novel.
Throughout history new foods have entered Europe from elsewhere, potatoes, tomatoes, rice, noodles and coffee being some obvious examples, these foods are all now mainstream but were at one time considered new or novel. More recently, Chia Seeds, Baobab Fruit and Quinoa have arrived in Europe. Crickets, lava and insect legs are part of the normal diet in other parts of the world and may in due course be seen as attractive protein sources in Europe.
Naturally regulators are keen to be sure that novel foods are safe to eat and hence they must be subject to a safety assessment to authorise them before they can be placed on the market in the EU. Presently this forms part of Regulation EC 258/97 and this legislation is commonly referred to as the ‘Novel Food Regulations’. The approval process under EC 258/97 is a two-stage system requiring endorsement by all EU member states after preliminary assessment in the state of application (In the UK, the responsibility lay with the Food Standards Agency Advisory Committee on Novel Foods and Processes [ACNFP]). It is also a process that grants authorisation only to the applicant, anyone else wanting to bring in the same novel food must make a separate application.
Although nominally a process that would take less than 6 months in total, a typical approval would take three-and-a-half-years. It was felt that change was needed because the existing rules date back twenty years, and technological and scientific developments have been considerable in that timeframe, to reduce the time taken by the authorisation procedure, and to reduce the cost to applicants.
The changes brought in by Regulation (EU) No. 2015/2283 will facilitate the following:
1. Quicker delivery whilst not compromising safety by creating a centralised authorisation system for simplicity and efficiency. EFSA will conduct the risk assessment the Commission will manage the administration. Individual member states will no longer be involved in authorisation. This will remove barriers to business and allow for innovation.
2. A simpler means of dealing with foods that are traditional in other countries, if guarantees can be provided a basic notification from the food business operator will suffice.
3. A generic approval for the novel food rather than an approval being granted to each applicant individually (resulting in multiple applications for the same novel food), with some protections based on proprietary data used in support of the application.
More specifically, the new measures introduce a centralised assessment and authorisation process in relation to which deadlines are given to both the Commission and the European Food Safety Authority [EFSA]. The regulations require that the Commission receives all applications for authorisation and in turn the Commission may request risk assessments from EFSA.
When EFSA carries out this assessment under the new process, consideration is to be made of the following:
When looking at the novel food submitted, can it be confirmed that the food is as safe as other foods in this category that already exist in the EU market? Does the composition of the novel food pose any type of safety risk to human health in the EU? When there is an intention that a novel food replace another food, is there any detriment to the consumer from a nutrition perspective as a result of this substitution?
Also, new in relation to the legislation, is the process whereby foods that are deemed to be traditional outside the EU are assessed for suitability within the EU. In this case, the Commission is to receive a submission concerning the food based on a history of safe use elsewhere. The Commission will then send details to all member states and also to EFSA. A member state and/or EFSA may provide duly reasoned objections to the submitted data. Guidance provides details as to what should be considered for this assessment and includes conditions relating to the reliability of submitted material, whether the composition could provide a risk to health and if there would be any detriment to a consumer from a nutrition perspective if the new food is to replace something that already exists on the market.
The new rules for novel foods still require that detailed scientific and technical guidance is provided in support of the submission. Guidance, specifying what is required to support a submission, has been published by EFSA. The absence of guidance was a particular issue with the previous regime.
The new legislation contains data protection provisions whereby newly developed scientific evidence and proprietary data will not be usable for the benefit of another applicant for a five-year period after the novel food has been authorised.
Nano materials are covered by the new rules. These are materials that are engineered at the scale of atoms and molecules and they require authorisation before use, it must be demonstrated that the most up-to-date test methodologies have been used before the authorisation is applied for.
Several applications such as Ecklonia cava phlorotannins, xylo-oligosaccharide and spray dried extract of Terminalia ferdinandiana EXELL, are currently being assessed by the Member States. As authorisation will not be gained by the time that the new legislation applies, the Commission will take care of the finalisation of the requests by applying the new provisions.
In conclusion, then, the purpose behind the new legislation is to make the procedure for novel foods and for foods of a traditional nature outside the EU, much more simple, speedy and efficient. It is thus hoped that innovation will be encouraged within the food industry without cause for concern relating to safety. Additionally, the data protection provisions will protect the interests of companies which produce new and innovative products and hence encourage further innovation within the food sector.
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