EU Novel Food Legislation
Pursuant to this legislation, insect producing companies must receive an a priori authorisation – granted by the European Commission (EC) following endorsement by EU Members States – to be entitled to commercialize their products across the European Union: to this end, the European Food Safety Authority (EFSA) carries out a complete review of the documentation provided by the company and compiled in the so-called ‘Novel Food application’: this evaluation serves to assess the potential safety risks implied by the consumption of the product, and thereby to substantiate the final decision to authorise or not its commercialization at EU level.
Novel Food applications
Novel Food applications must be submitted to the European Commission services, through the e-submission system available on the DG SANTE website (European Commission).
The European Commission has developed practical guidance on how to submit an application, which is available through the following link.
Standard’ Authorisation Procedure
On one hand, Regulation (EU) 2015/2283 – in article 10.2 – sets out the main pieces of information to be included in the novel food application, whereas the required format for the organisation and presentation of this information is defined in the implementing Regulation (EU) 2017/2469.
On the other hand, Regulation (EU) 2015/2283 – in its chapter III – outlines the procedural steps to be followed by the EC, the EU Member States and EFSA during the authorisation process: with the recast of the novel foods legislation, the EU legislator introduced, for the first time, a centralised authorisation procedure that is managed by the EC and relies on EFSA as sole risk assessment body. Furthermore, the new legislation introduces compulsory deadlines for EFSA and the EC to ‘perform their duties’.
Two distinct procedures are open to insect producers:
- The ‘standard’ procedure
- The so called ‘notification procedure for traditional foods from third countries’.
Generic authorisation system
Although insect producing companies must receive an a priori authorisation – see introduction – all authorisations then become ‘generic’: this means that subsequent operators producing previously authorised insect species are entitled to place the concerned product freely on the EU market.
An exception to the above principle is however admitted when the prior authorisation is ‘data protected’– pursuant to article 26 of Regulation 2015/2283: in such a case, its producer benefits from a market exclusivity of 5 years following the authorisation of the product.
Furthermore, the ‘generic’ principle only applies if the product forming part of the subsequent novel food application complies with the same specifications (e.g. acceptable limits of biological and chemical contaminants in the concerned product) as of the previously authorised product. If that is not the case, such operator must request a so-called ‘extension’ of a novel food authorisation, and therefore submit a ‘new’ application to the European Commission.
Transitional measure and ‘novel status’ of insects under the formerly applying legislation
In several EU countries, insect producers may continue to commercialize their products, even in the absence of EU novel food authorisation. Indeed, article 35.2 of Regulation (EU) 2015/2283 provides for a transitional measure that aims to ensure that products which were lawfully commercialized in a Member State of the EU before 1st January 2018 – i.e. date of application of the ‘new’ novel food legislation – may remain on the market of this particular country for a given period of time, subject to certain conditions.
Summary overview of the respective scopes of Regulation (EC) No 258/97 and Regulation (EU) 2015/2283 in respect of whole insects, parts of whole insects and insect-based preparations
Several EU Member States however deny the benefit of this transitional measure: in a context where the qualification of ‘whole insects’ as novel foods was legally uncertain under the formerly applying Regulation (EC) No 258/97 – unlike insect derived ingredients (see scheme) – several EU Member States considered that a novel food authorisation was already required for these operators to be entitled to commercialize their products, whereas other countries did not. Such diverging interpretations have led to a very ‘heterogeneous’ application of article 35.2 transitional measure across the European Union.
Regulatory developments regarding the import of edible insects
- Standards for imports of insects as food into the EU are defined by the Official Controls Regulation (EU) 2017/625. In March 2019, the EU Legislator adopted a ‘package’ of EU Regulations – i.e. Five Regulations which set out the import conditions for animals and goods for human consumption. These documents also address the case of insects as food specifically, including its compliance with EU requirements for food and food safety, a model official certificate for insects and a list of countries authorised for imports. IPIFF has developed an Information note on the ‘Latest regulatory developments regarding the establishment of EU import conditions for insects intended for human consumption’
IPIFF has developed a series of Guidelines with the aim to assist insect producers in the preparation of application for authorisation required under the EU novel food legislation
- Administrative Guidelines which provide an overview of the different steps to be followed by insect producers with the view to submitting an application. These summary guidelines are accompanied with a briefing paper, which explains the procedural steps in further details.
- Scientific Guidelines accompanied with a database of publicly available reports which provides an overview of the pieces of evidence and scientific demonstration that may be presented by insect producers to support their application. A summary report of the Guidelines is available below.
For additional information on this topic, please consult the IPIFF ‘Briefing paper on the provisions relevant to the commercialization of insect-based products intended for human consumption in the EU’.
Download our summary report approaches to addressing data requests for insects as foods (PDF)
If you would like to have more information on our work, please write an email to email@example.com