• Note – this consultation is now closed. We explore the resulting disastrous consequences for the edible insect industry in the U.K. in our 2023 post.

The slapdash consultation on edible insects, launched by the Food Standards Agency on the 13th July 2022, is full of ambiguities and mistakes. Far from bringing clarity, it will plunge the UK edible insect sector into further chaos and generate another regulatory mess. We are making our reply to the consultation public, and encourage everyone to reply to the FSA by the 10th August deadline. Please feel free to copy paste from our answers, if you agree with us: edible insects should be regulated under general food law, as in many countries outside the EU.

In our previous blog post , you will also find a ready to copy & paste simplified version of our reply.

Last year we expressed our concern to the FSA Board, regarding the FSA’s wrong interpretation of the EU transitional measures, that eventually led to businesses failing to take off or having to shut down all together. The Board rejected our explanation and defended the indefensible position of the FSA. Now, 17 months too late, the FSA admits it made a mistake.

We are now expressing our concern over this new regulatory blunder in the making. Will the FSA Board turn a blind eye again?

OUR DETAILED REPLY TO THE FSA BELOW

1 Introduction

Dear Novel Food Team,

Before delving into the specific questions raised by the consultation, we would like to provide some overall comments.

The consultation document states that insects are “permitted to remain on the market”, yet at the Novel Proteins Industry Event on 14 July 2022 and during the online meeting on 22 July 2022, the FSA said they are “not authorised” until they have gone through the GB authorisation process. At both forums we explained that this does not change the status quo:

•  We will continue to be unable to obtain liability insurance for our products
•  Online retailers, shops and supermarkets will refuse to stock them
• The lack of liability insurance will spill onto public events and venues where insects are being served (i.e. food festivals, schools, restaurants etc.)
•   Food safety certification bodies will not certify or renew businesses’ certifications

The industry requires clarity. The hands-off, ‘yes but no’ approach adopted by the FSA over the past 17 months must end.

We want to take this opportunity to once again ask the FSA to:

– list which edible insects are permitted

– confirm that they will be provisionally regarded as authorised. This is until the deadline set out by the proposed UK Transitional Measures, or until a specific species is assessed by the FSA and found to be unsafe.

The FSA has recently admitted that its position to invalidate the EU Transitional measures under Article 35(2) of the EU Novel Food Regulation post Brexit, was its mistake. Now we are faced with another mistake of interpretation; if the EU Transitional measures apply, surely there should be no issue for the FSA to declare edible insects as provisionally authorised.

Why is the FSA refusing to provide a much-needed statement to this effect?

 2.  Does the Novel Food approach make sense?

Brexit provided an opportunity for the FSA to disentangle the industry from the classification of edible insects as #novelfood . After all, competent authorities of many countries outside the EU, managed to form their own independent scientific opinion and concluded that insects are safe to eat, provided that appropriate hygiene and hazard management practices are in place.

It is our view that the EU decision to apply the cumbersome, lengthy and expensive Novel Food regulation to insects, had little to do with food safety and a lot to do with the EU food lobbies. Applying the Novel Food regulation to edible insects, was a strategic move that has allowed a handful of capital venture backed companies to obtain exclusivity over their dried insects, thanks to the data protection provision within the Novel Food Regulation.

Dried mealworms for example, have already been approved 4 times by the EFSA, each time for a different company. Is there really a scientific basis for a mealworm dried by one company to pose a greater risk than the mealworm dried by another? Does the FSA really foresee differences in allergenicity and toxicity depending on which company dried it?

3.  If edible insects are to be classed as Novel Food

The FSA may decide not to review the ‘Novel Food’ classification of edible insects, but persist in pursuing the EU’s ‘Novel Food’ route.

The current FSA’s consultation proposal, aims at implementing UK Transitional measures, whilst retaining EU transitional measures. Even if ambiguities within the consultation paper are removed, this will not change the fact that the proposal is fundamentally unworkable. We’ve illustrated this with examples in the next section. (.4)

Our recommendation is:

– Do away with the EU Transitional measures Article 35(2) and introduce the UK specific transitional measures.

a.   Produce a detailed list of insects that are authorised in GB, albeit provisionally. The insects will remain provisionally authorised, until the deadline set out by the UK Specific Transitional period, or until a specific species is assessed by the FSA and found to be unsafe.

b.   If an application is received before the end of the UK Specific Transitional period, the product/insect will remain authorised, albeit provisionally, until such time as the FSA has made a final decision or the application is withdrawn. Because of the time lapse between submitting an application and the application undergoing the initial validation process, an application is considered as ‘received’ as soon as it is submitted and before the completion of the validation step (we are aware that an application submitted to the FSA in December 2021, has still not completed validation in July 2022)

c.   The list of insects as per point a. above should indicate intended use and processing method and any other parameters that FSA considers relevant to the provisional authorization; more information for the reason of this remark in section 4.

Doing away with Article 35(2) will allow baselining the new regulations and provide much needed clarity. Please note that FSA had also previously produced a list of allowed insects (by mail 23rd January 2020). The same list should be reviewed and updated by the FSA, in accordance with dossiers submitted to the EFSA in 2019, over which the FSA should have visibility.

Note – we have already put forward the above suggestion to the FSA. It was rejected by an FSA Senior Novel Food Advisor, on the basis that the there is no legislative instrument within the European Withdrawal Act that will allow such amendment. We suggest this is double-checked with your legal advisors.

4.  The inoperability of the current consultation proposal

The inaccuracies and ambiguities in the consultation paradoxically create a situation whereby companies that have already applied to the FSA or will apply before December 2023, will be excluded by the UK transitional measures.

According to “Policy proposal” – second and third bullet points on page 4 of the consultation [quoted below)], both these conditions have to be met.

“were the subject of an application to the EU (by any food business operator) by  1 January 2019; and are the subject of an application made to GB authorities (by any food business operator) before 31 December 2023.”

Take Company X that had been selling Scorpions since 2011 in the UK. The Company did not apply to the EFSA in 2019 because of the cost, and it was forced to stop selling its Scorpions. The company now wants to apply to the FSA. Under the current proposal, UK Transitional measures will not apply to Company X.

Or take Company Y that had been selling Tarantulas since 2011 in the UK, applied to the EFSA in 2019, but its application either did not pass the EFSA validation phase or was rejected as a later stage, or it was withdrawn later by the Company, because of the change of the authorization regime announced by the FSA after Brexit. Are Tarantulas to be regarded as having been “the subject of an application” in this case? If not, UK Transitional measures will not apply to Company X under the current FSA’s proposal.

This we hope reinforces our view that the EU Transitional measures are not needed and should not be made a prerequisite to the UK Transitional measures. Pursuing this approach makes a travesty of both the EU and the proposed UK Transitional measures.

Because of the above, and because of the many ambiguities listed below, we regard the consultation, as it stands, unsound. A revised consultation should be launched to clarify:

–    The meaning of “Were the subject of an application”

a.   Are these applications that are still under EFSA’s scrutiny, plus those for which the EFSA has expressed a scientific opinion?

b.   Does this include applications for authorisation of a novel food or also a notification of a traditional food from a third country?

c.   Does this include an application made for an insect species, irrespective of the processing method, quantity of insect within the product, intended use etc?

d.   Does this include all applications, irrespective of the stage they reached in the EFSA approval process?

–    The meaning of “Any food business operator”.

e.   Does this also include those food operators protected under Article 26(1) of the EU Novel Food Regulation?

f.   If the above under d. are excluded, is there an exception for those data protected applications, for which the EFSA has already published a comprehensive scientific option in its journals?

 5. Additional considerations on the EU Transitional measures

We know that at least 3 insect species were the subject of the Belgian Insect Industry Federation [Biif] dossiers, submitted to the EFSA in 2019. These were not data protected (under Article 26(1) of the EU Novel Food Regulation), and therefore all companies in the EU/UK plus 3rd countries allowed to export to the EU (as per Regulation EU 2021/405) could continue to sell their products in the EU/UK.

Unless companies had themselves applied to the EFSA, they were bound to sell products matching the description/intended use/processing method of those applied for by the BiiF.

In other words, because insects are regulated as Novel Food, the authorization is intrinsically linked to scientific data, that is in turn linked, amongst other things, to specifics of processing, intended use, quantity of insect in each product, etc.

In fact, following our request for clarification on the above, the FSA confirmed [Dec 2021], that indeed different sets of scientific data are required to support different preparation methods and different percentages of insect protein within products.

It is remarkable that now the FSA, with its simple statement, that permitted insects are those that “were the subject of an application”, considers it has provided any degree of clarity to businesses.

“Were the subject of an application is a very broad and unclear statement and does not cater for cases where an application to the EFSA in 2019 diverges from an application made to the FSA.

Suppose, for example, the BiiF only applied to the EFSA for heat treated mealworms but not freeze dried.

– A Company Z in the UK should not be permitted to sell freeze dried mealworms.

– What is the view of the FSA on this?

– What about other drying methods? Will microwave drying be potentially considered?

A Company J in the UK, which has developed and insect based mince, using a patented process, and has now applied to the FSA using data protection, will not be allowed to sell its mince during the UK transitional measures, because no other company applied to the EU in 2019.

– What is the view of the FSA on this?

The same would apply to a company that wants to use more than x% insects in its products.

Suppose, for example, the BiiF only applied to the EFSA for pasta containing up to 50% of mealworms.

A Company K in the UK should not be permitted to sell pasta with a 51% content.

– What is the view of the FSA on this?

This is another reason that an application to the EU, being a prerequisite for the validity of GB transitional measures, is unworkable. Furthermore, the BiiF dossier submitted to the EFSA in 2019 is based on criteria and guidelines set out by FASFC (Federal Agency for the Safety of Food Chain in Belgium). So now a prerequisite for products to remain on the GB market (albeit unauthorised) is based on the criteria set out by a 3rd country.

Furthermore, UK companies have no full visibility over what insects, processes etc are currently covered by applications made to the EFSA, therefore we would not know what is permitted and what is not.

This is why the FSA‘s guidance needs to be clear and conclusive.

We see two possibilities:

a.   As well as the list of the list of insects that we request the FSA produces under 2a) , the FSA should produce a list of parameters, like for example the drying method, quantity allowed in each product type etc. (We assume that UK companies will only be allowed to sell products that match exactly what the BiiF applied for [to the EFSA in 2019].

or

b.   As well as the above list, the FSA clarifies that these insects will be allowed irrespective of processing method etc. provided the finished product is compliant with current food law, plus any other checks the FSA deems necessary at this stage, to ensure the product is safe.

6. Minor corrections

[page 4 “policy proposal” – first and second bullet points [quoted below]. Please clarify if both (and in fact all 3 conditions under the bullet points) have to be met.

Rapid risk assessment page 5. What are “the remaining six categories examined”, and why are they mentioned at all in this document?

7.  Response to the specific questions within the consultation

Questions asked in this consultation:

q1. What effects do you think there would be from the outlined policy proposal? How could positive effects be increased, or negative effects be mitigated?

R1. This consultation is unsound and the proposed policy contains too many ambiguities to provide sufficient clarity to businesses. If approved without the required amendments, it will prolong the uncertainty surrounding the legality of commercialising edible insects in Great Britain. We object in principle to further transitional measures, and ask for the FSA to reclassify insects as ‘not traditional but not novel’ as done already in countries outside the EU. The FSA should also carry out its own risk assessment, establish microbiological criteria and regulate edible insects under general food law. Please refer to our introduction for recommended changes and required clarifications.

q2.q3.q4.The outlined policy proposal provides a deadline of 31 December 2023 for food business operators (FBOs) to submit their application to the FSA or FSS. This deadline has been identified as a date which takes into account the need to provide FBOs with sufficient time to prepare an application, and the public interest in novel foods progressing through the relevant authorisation process as quickly as possible. Do you feel this deadline is appropriate, having regard to the balance between these considerations? If not, please propose the timeframe you consider to be acceptable with a justification.

R2-4 Should the FSA decide to pursue the Novel Food route for edible insects, Small and Medium Enterprises will need time to raise funds to be able to afford the Novel Food Application process. As published by several Local Health Authorities (see for example Bromley), small businesses will not be able to easily gather the necessary funds. “https://www.bromley.gov.uk/leaflet/329070/3/757/d “The evidence you submit should be specific to your product; therefore gathering together publicly available information will not be sufficient. Any business seeking approval for a novel food will probably need to conduct independent scientific research (which will be beyond the technical / financial means of some small and medium-sized businesses).” On this basis we suggest a deadline of 31 December 2024. Please note however that, unless Article35(2) is scrapped, as we suggested above, a longer deadline will prolong this new status of legal limbo, during which businesses will continue to be unable to obtain liability insurance, hence cannot legitimately place products in supermarkets and cannot obtain food accreditations.

We also note that the estimated cost in the consultation paper “of £10,700 to businesses and Local Authorities in Great Britain”, has been badly miscalculated. The cost to businesses alone is approximately £100; this is the estimated cost for each insect species. Since the UK edible Insect industry sector comprises small and micro businesses and since the risks identified thus far only concern allergenicity, which can be mitigated with clear labelling, we request that the FSA conducts a review into identifying ways to minimise the burden on small and micro businesses.

q5. For businesses producing insect protein, will the policy proposal affect your plans for your business (for example, expansion, or a change in the kinds of products produced)?

R5. Our business has already been impacted and European funds vouchers awarded to the company via the Valusect Interreg scheme in March 2021 for product development had to be forfeit. Even if we were to resurrect our expansion and product development plans, the Novel Food categorization of insects will be a show stopper; we would have to invest in expensive equipment to develop the product prototypes, commission the scientific data for a Novel Food dossier, submit this to the FSA, wait a couple of years, hoping that the product would eventually be approved. Applying Novel Food regulations to insects staves off innovation.

We believe our case is not unique. There is a clear case for the FSA to shelve the proposal under this consultation and take a more proactive approach, as other countries outside the EU have done. Edible insects should be regulated in GB under general food law like it is already the case in countries like Australia, New Zealand ( Food Standards Australia and New Zealand, Insect Protein Association of Australia), Canada (Canadian Agri-Food Policy Institute), and the US. The FSA should also refer to the recent work from other countries within the Commonwealth, like Uganda (Uganda National Bureau of Standards), that has recently created comprehensive set of food standards for edible insects.

q6. Please provide the name and location of your business in your response, noting the data received will be treated in accordance with the privacy policy.

Horizon Insects Ltd, Ealing, London W5 3XP

q7. Please include any other factors that you think should be considered by the FSA or FSS in relation to the regulation of edible insects in GB, or any other feedback

R7. Refer to comments under the Introduction and sections 2-6.