EU Novel Food Legislation

Insects as novel foods – an overview

In addition to the ‘general food hygiene requirements’, the production and marketing of insects as food in Europe is governed by the ‘Novel Foods’ legislation – i.e. Regulation (EU) No 2015/2283. This legislation applies to all categories of foods that ‘were not used for human consumption to a significant degree’ within the European Union before 15 May 1997, which is the case of insects. On this page, we aim to guide you through the key documents of relevance for the policy file ‘EU novel food legislation’, by answering the following questions:

Where do we stand?

Are insects on the EU market already?

How does the authorisation process look like?

Can edible insects be imported into the European Union?

How can IPIFF help?

 

Where do we stand?

Presently (Q3 2021), following the first EFSA opinion covering an insect species (January 2021), dried yellow mealworm (Tenebrio molitor) has been authorised on EU level as the first insect food product and the Novel Food Regulation entered into force in June 2021 (more in the IPIFF Press Release).

The European Food Safety Authority also published other scientific opinions on:

A list of Frequently Asked Questions (FAQs) on this subject may be accessed here. These FAQs are also covered by the IPIFF Briefing paper on novel foods (updated in 2021).

Are insects on the EU market already?

Transitional measure and ‘novel status’ of insects under the formerly applying legislation

In several EU countries, insect producers may continue to commercialise 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 commercialised 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 commercialise 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.

For more information on the transitional measures, please refer to the IPIFF Contribution Paper on the application of the Novel Food transitional measures.

Following the publication of the CJEU ruling in the case C-526/19,  IPIFF encouraged insect business operators to clarify the possibility to apply the transitional measure in Member States where this was denied (read the IPIFF Press Release here).  Additionally, IPIFF published a briefing note on the detailed legal analysis jointly conducted with the law firm Bird&Bird.

How does the authorisation process look like?

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 commercialise 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 commercialisation at EU level.

Download Regulation (EU) No 2015/2283 on novel foods

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.

brochure mockup

Standard Authorisation Procedure

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 ‘notification procedure for traditional foods from third countries’.

Download Regulation 2017/2469 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283.

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.

Can edible insects be imported into the European Union?

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’ 

How can IPIFF help?

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.
insects as food guidelines
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 Updated guidelines on the provisions relevant to the commercialization of insect based (PDF)

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 maximilian.beiter@ipiff.org and/or christophe.derrien@ipiff.org 

Menu