When we asked these questions to the FSA the first time round, we received very poor replies. So we raised a formal complaint and the replies have now been rectified as per below. There is still some ambiguity, but please make of it what you wish.
It is interesting that insects legally marketed in the EU, continue to remain illegal in GB and cannot even be imported. It is also interesting that a mealworm fritter will need a separate set of scientific data to a mealworm biscuit, and that in theory each primary producer [farmer] and each manufacturer must submit a scientific dossier. The preparation method is also a very interesting point; if I sell freeze dried mealworms and suggest that people incorporate them into a recipe which requires further heating [baking ?], we are not sure whose responsibility it is to assess the genotoxicity, subacute toxicity and sub-chronic toxicity of mealworms which have been freeze dried and then roasted.
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Dear Sir/Madam,
We run a small operation from a shed in our back garden . We have been breeding mealworms {Tenebrio Molitor larvae] for our own consumption since 2014. In 2017 we started selling them to the public. Although we no longer sell these fresh, we continue to host regular cookery classes and we have been promoting edible insect food in schools and the community.
Registered with our Local Health Authority, we work to HACCP principles and have been carrying out regular microbiological assessments on both the product and the process.
Up until the end of the Brexit transition period, we had been operating in accordance with the transitional measures specified in [EU 2285/2015 on Novel food, Article 35(2)]. We understand that the FSA is now saying that these measures have not been retained in UK law, and that we must submit a novel food application. Consequently, we have some questions:
1) Is there an expectation that a novel food application is submitted only by primary producers or also by manufacturers of foods containing insects? A novel food application for authorisation will be required, this may be submitted by a food business operator, manufacturer or individual. An application will need to be submitted for each insect that is intended on being marketed and consumed in GB. All final product uses should be included in the dossier. Under Article 26 of retained EU novel food regulations 2015/2283, applicants may request data protection of the proprietary data which could therefore result in the application being authorised for the applicant only. If data protection is not considered, then applications can be public.
2) Is an application required for the food in its natural state, the process, or both? In our classes we cook and serve different recipes; if we farm mealworms, freeze some for later use, fry some in our fritters, roast some in our biscuits, grind some to make powder, use some in soups, will we need to supply different sets of scientific data for – fresh + frozen + fried + oven dried + flour + boiled?
An application will be required to be submitted for each species of insect with all proposed or intended uses of the final products. You will need to provide relevant safety data to support the risk assessment.
3) Does the quantity of mealworm we use in each recipe matter? Looking at the many applications lodged with the EFSA for mealworms, each applicant has submitted a dossier for the same thing but in different quantities. For example, one dossier may cover baked goods containing up to 10% of insects, and another up to 20%. Can you please clarify? With reference to question 1) this would indicate that in Europe the application process applies to both product manufacturers and farmers.
This should be covered in the intended uses of the final products, i.e which would confirm the percentage content in the final product. This would form part of the specification of any potential novel food authorisation.
4) Following on from question 3. In March 2021, we were awarded EU vouchers to develop a mealworm-based food product. Determining the technology and exact formulation will be part of our R&D effort. We will have no scientific data until after we have put a substantial amount of capital into the project. Due to the uncertainty created by Brexit and the lack of transitional measures, we have had to put the project on hold and we are risking losing the funds. How do you suggest we proceed?
Insects whole & ground were identified as a novel food and transitional measures were granted when we were an EU member state. Should you wish to market your product in GB, you will need to submit an application.
Retained novel food legislation (EU 2015/2283) captured insects whole and ground as they were not in scope of the previous novel food framework (EU 258/97). As part of the current novel food legislation under Article 35(2) transitional measures were implemented when the UK was an EU Member State. Whilst Regulation (EU) 2015/2283 is retained in GB law, the transitional measures for the marketing of insects no longer apply in GB, as the transitional period has expired. Should you wish to market your product in GB, you will need to submit an application.
5) The new Novel Food Regulation includes data protection rules, allowing the applicant to protect its innovations; scientific evidence and proprietary data cannot be used for the benefit of another applicant for a five-year period following the authorization. Have these data protection provisions been retained? Will companies who have received a great deal of public funding be able to now obtain exclusivity to the disadvantage of others?
All novel food legislation has been retained in UK law. Therefore, this includes data protection and confidentiality for applicants under Article 26 of (EU 2015/2283).
6) Can you supply a list of current UK applications and whether they are ‘data protected’ or not?
This information is not published for any application at this stage.
7) Can scientific data, like research papers, scientific journals etc, which are already in the public domain, be used to support an application?
Literature studies can be used to support an application, but scientific studies would be more beneficial and appropriate to support the assessment process.
8) In November 2021 our public and product liability insurance will expire. Our broker has told us that operating the uncertain legal status of our business will have a bearing on both their ability to insure us and the cost of the premium. This is the reason why we are asking: is our business legal? If we were to submit an application today, what would be the status of our business during the 12-16 months required to process the application?
(As an aside, we are writing a paper for Reading University about our farm, and this must include our current status.)
It remains the case that insects are considered a ‘novel food’ and need to be legally authorised before they are marketed. Therefore, should you wish to market your product in GB then please submit an application to the FSA for consideration.
9) Based on the recommendation of their Advisory Committee on Novel Food, Food Standards Australia New Zealand (FSANZ) have assessed and categorized, species such as Yellow Mealworm, as non-traditional but not novel, meaning the food doesn’t have a history of human consumption but no safety risks have been identified. In contrast, in the EU, edible insects were classified as a novel food in 2015, under the definition “foods which have not been widely consumed by people in the UK or EU before May 1997”. Are there any plans to review the current scientific opinion and align the UK to FSANZ, therefore regulating products containing insects under general food law?
The Novel Food Regulations are retained law so reflect the rules currently in the EU. As such we do not have the legal ability to authorise insects without having gone through the regulated products process. The applicant has the ability to include in their safety case suitable evidence and so they may use the evidence you mentioned if they so desire.
10) If we have to resort to importing mealworms from the EU rather than using our own, would we be restricted to purchasing these from the only company currently authorised by the EFSA? As I am sure you are aware, the only approval has been granted by the EFSA to the French Agronutris, and their application is protected (as per point 5 above).
In order to market edible insects (excluding the German cheesemite) in the GB market, a novel food must be authorised.
Mealworms are not authorised in GB, the EU is not in the list of third countries for imports.
Please find details of the changes to legislation of import of Insects into GB below which includes a list of third countries. Regulation (EU) 2020/1572 added Thailand to Annex IIIa of 2019/626 on the 28th October 2020 for importation into GB. Our advice would be to consider Regulation (EU2019/1981), Regulation (EU) 2020/1572 and Regulation (EU2019/626) which complements all listed countries for Import of insects into the Union.