Novel Food Guidance – an overview
The European Parliament published the new Novel Food Regulation (EU)2015/2283 in December 2015. It will enter into force at the beginning of next year (January 2018). The new regulation differs from the current one (EC) 258/97 as follows:
- It implements a more straightforward and more efficient application procedure, with EFSA being the only risk assessment body. The initial assessment by national authorities becomes obsolete. Applications will be directly submitted to the European Commission (EC).
- Generic authorizations will be granted, and a Community List of authorized food ingredients will be established.
- It implements a simplified notification procedure that enables a faster authorization of foods from non-EU countries with a history of safe use of at least 25 years.
Following the new European regulation on novel food, EFSA published two long awaited guidance documents in September 2016:
- Guidance on the preparation and presentation of an application for authorisation of anovel food in the context of Regulation (EU) 2015/2283 and
- Guidance on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283.
The guidance attempts to provide clear information to applicants concerning the expected structure of the applications, the information that is absolutely indispensable as well as information on how potential health hazards should be discussed, while providing some flexibility for case-by-case decisions. Both types of applications follow a common structure, but whereas safety for traditional foods from third countries results from the demonstrated history of safe use, “typical” novel foods require detailed information on the anticipated intake and the safety of the novel foods.
In general, the requests and recommendations in the guidance represent the desirable best case. If deviations are necessary, their justification must be explained. The documents not only explain which information is deemed essential but also how it should be gathered, presented and discussed to facilitate efficient evaluations. Cross-references to existing EFSA guidelines are given where appropriate.
Future novel food applications – What to keep in mind:
- Analysis should be conducted by accredited laboratories and using validated methods;
- Literature research should follow the EFSA guidance on systematic reviews;
- Compositional data for at least 5 independent batches should be provided;
- Stability tests should be conducted on five independently manufactured batches, preferably in the final applications or in suitable model systems;
- Uncertainties should be addressed and discussed;
- Consulting other EFSA guidance documents is advised (e.g. on botanicals, systematic reviews, the safety evaluation of GMMs, characterization of microorganisms on strain level (Annex B of recent claim guidance).
- The protocol for the 90-day oral toxicity study (OECD 408) should be modified by a number of additional parameters that are described in the recent guidance for 28-day oral toxicity studies in rodents (OECD 407), which may identify substances with the potential to cause neurotoxic, immunological, reproductive organ effects, or endocrine-mediated effects.
Planning a novel food application? Pay special attention to:
Applications for the authorization of traditional foods from non-EU countries follow a similar structure as applications for the authorization of novel foods, although the procedure is different. A notification for the placing on the market of a traditional food from a third country is sent to the Commission who forwards it to all Member States and EFSA. If a Member State or EFSA submits reasoned safety objections on the placing on the market of the notified food, the notification may be transformed into a regular application. The challenge for applicants consists of providing sufficient evidence for the history of safe use of the traditional food. This guidance covers the requirements for both notifications and applications.
New Medical Device Regulation
The Council of the European Union has adopted a final version of the new Medical Device Regulation (MDR). The publication of the regulation in the EU Official Journal is expected for June/July 2017. Half a year later, the regulation will come into force.
The new regulation will handle borderline products more strictly. As a consequence, substance-based medical devices can no longer be classified as class I, but will be at least class II-a or II-b. Probiotics (live bacteria) are explicitly mentioned as no longer being acceptable as ingredients for Medical devices.
This means that many of the currently marketed oral medical devices will have to either be re-classified or transferred to a new product category.
The new regulation is expected to come into force this year. For a time frame of 3 years, until 2020, manufacturers may decide to certify their products either under the new MDR or under the old Medical Device Directive (MDD). After 2020, this will no longer be possible. However, existing products may stay on the market for another 4 years.
However, marketers should be prepared to upgrade their substance-based products. If you need support for updating the technical documentation of your products (e.g. biological and clinical evaluation, literature based or based on your own clinical data), please contact us.
A recent update of the Belgian botanical lists is the result of the close cooperation between Belgium, France, and Italy under the “BELFRIT” project. On February 10, a new Belgium Decree was published, authorizing more than 1000 botanicals in foods and food supplements. New maximum levels and mandatory warnings for about 250 plants were also included. This will need to be taken into account when notifying food supplements. The new Royal Decree was published in both French and Dutch.
a&r comments: The number of authorized plants increased from about 645 to more than 1000 plants in food supplements. This decree has a direct impact on Belgium food business operators. However, for products that have entered the market by February 20, 2017, there is a transitional period of 2 years (until February 20, 2019).
It is common practice for exporters of food supplements containing botanicals to register their products first in Belgium, as doing so opens the door to authorization in other Member States’ markets under the Mutual Recognition principle. Thus, this new Decree can be seen as the first step into the harmonization of botanicals in the EU.