Novel Foods approval support

Welcome Forums Business Forum Novel Foods approval support

This topic contains 17 replies, has 6 voices, and was last updated by Adam Banks Adam Banks 20/02/2019 at 10:37.

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  • #1896
    Nick Rousseau
    Nick Rousseau
    Moderator

    Woven has been in discussions with a couple of consultancies that are offering support for novel food approval applications. These are complex and will involve some considerable expense for the businesses involved.

    It would be good to share your thoughts on this and see what others are thinking, so we can find a way to move forward.

    Ideally we would have one consultancy that could support approvals of different types of insect product.

    We will also be seeking a conversation with the EFSA over their expectations regarding the evidence that will be required for approval.

  • #1898
    Massimo Reverberi
    Massimo Reverberi
    Participant

    Hello Nick,
    if I understand correctly, EFSA has not released their document yet (although I think they should do that within these upcoming weeks). Therefore the European Union is not able to approve a regulation based on their recommendation.
    Is this right?
    We will have a meeting between an EFSA expert and the Thai FDA on October 26 and I will attend the seminar (I am collaborating to the organization) and for sure I will ask to the EFSA expert many questions.

    My advice would be: once the regulation will be approved and the process defined, Woven Network might create a “support package” to reduce the time for application. I do not expect many bug start ups to spend money with a traditional third party consultant firm, as they may cost thousands of pounds. Usually Entrepreneurs undergo the painful process of learning by themselves, and most of the time is consumed just in digging information and understanding how to fill forms. That is the part where Woven may save time to the actors, for a fixed, very reasonable fee (most of the process will be executed by the start ups, anyway). Let.s call it Novel tutor-fee

  • #1904
    Ross Bell
    ross bell
    Participant

    I think that having a consultancy package would be a good idea.

    I agree with Massimo, starting a business that uses insects has been hard as its a new and alot of councils etc are not sure how to deal with them so having one consultancy that would deal with the approvals etc would help speed things up.

  • #1906

    Maybe there is expertise within WOVEN already that could be pooled. Regulatory consultancy is expensive, so the idea of an advice package is good, but someone has to take responsibility and be paid by the group as a whole via their membership, or on a cost-per-use basis, especially for ensuring it is up-to-date. I’ve dealt with novel foods regulation many years ago, when the topic was national not EU-based (Advisory Committee on Novel Foods and Processes) and mainly then in connection with GM technology. We could ask Defra and Innovate UK if there is scope for their supporting a study that can set up this service. But I suspect that already FERA (now it’s majority-owned by Capita) will be pitching for fees in this area.

    • #1907
      Nick Rousseau
      Nick Rousseau
      Moderator

      Woven does not have expertise like this “in-house” and would not have capacity to take on this kind of project.
      What could work is Woven acting as a commissioner for this on behalf of members.
      We have been discussing with some consultancies what they could offer on the Novel foods side and looking at ways to spread the cost but the focus is more on the full service for a given insect product, such as cricket flour, which would go from farming standards to ensure minimal risk through to testing of product materials.
      The cost for this service which could benefit multiple members who incorporate essentially the same raw material in their product and could all then be approved collectively, was still going to be very high – in the tens of thousands of pounds. Also, there was only a small number of Woven members who expressed interest in being part of this, so the price per company remains high.
      If the total cost is £20k and ten companies sign up then it is very attractive.
      Please do let us know if you are keen…

  • #1908

    If it could be of any use I have an old school class mate with some clout at Capita.

  • #1909

    Does that £20K figure include the £4k application fee for each product e.g. cricket flour.
    Next Step Foods would certainly be willing to contribute it’s fair share. I’m (fairly) confident other businesses have factored something in their business plans for this. It’s been in the pipeline for nearly a year now.

  • #1910

    I do think a priority would be to identify potential funding steams for this. NESTA maybe? Is this something WOVEN could help with?

  • #1911

    Having given it a bit more thought I think it could be worthwhile spending some of the group fund on a funding consultant IF an initial scoping exercise suggests funding is available…unless this experience exists within WOVEN.

  • #1962
    Nick Rousseau
    Nick Rousseau
    Moderator

    I have been thinking about this but cannot come up with any rationale for why a funding stream would exist to help with this. It is not the sort of thing that Innovate UK would offer grants for.
    The consultants we were talking to were also thinking about this and did not see any prospect of getting public sector support for the work.
    I think the best you can hope for is for multiple businesses that all use the same raw ingredient (eg. cricket flour from a source that farms etc to the same standard) could club together and share the cost of the analyses and approval application.
    That would still divide the total cost by quite a lot for the individual businesses.

  • #1963

    A couple of thoughts on possible ways of making it cheaper:
    Can we look further afield into Europe for partner businesses using cricket flour?
    Also could there be any funding from larger food manufacturers. There are many that fund the new Hallam uni food centre in Sheffield.
    Is there a possibility that a university would want to look at part of research for a PhD project?

  • #2001
    Nick Rousseau
    Nick Rousseau
    Moderator

    We seem to have had a breakthrough with the EFSA being suddenly extremely reasonable. This is raising some new challenges but the situation is looking much more positive.

    Basically, they are saying that just one organisation needs to submit an application and they expect to approve it. They dont want duplicate applications. Just need to agree who does it and whether others who stand to benefit should contribute in some way.

    Also, looking at European funding options to help with costs.

    Hurrah!

  • #3254
    Nick Rousseau
    Nick Rousseau
    Moderator

    I am speaking to the European Commission next week about the Novel Food Regulations as they apply to insects -both the Third country route and the mainstream one. If you have any particular questions you would like answering let me know.

    Also, following being approached by a number of people claiming to offer services to create Novel Food approval applications at the Food Matters Live event I am thinking it could make sense to write out to all those and invite “tenders” where they set out their best offer in terms of price and services.

    We can then decide what is best and hopefully get a good deal to share amongst as many as possible, in UK and beyond, with a small consideration for the Woven warchest.

    Very happy to debate the pros and cons of this.

  • #3255
    Massimo Reverberi
    Massimo Reverberi
    Participant

    great Nick. I’d ask the commission if they would consider acheta domesticus and the mealworm as special cases, allowing a preliminary assessment of a dossier (to be performed by EFSA). The bigger risk with the Novel Food is that someone applies with a bad dossier, and we find out after maybe ten months that it has been rejected, and we are back at square one.
    Second question: if Acheta Domesticus is submitted both as a traditional food from third countries, and as a normal procedure, will both dossier be accepted and processed?
    If you let me know their answers I will update the page http://www.bugsolutely.com/novelfood

  • #3268
    Nick Rousseau
    Nick Rousseau
    Moderator

    I had a useful conversation with people at DG-Sante last week and have clarified a lot of details about the applications for Novel Food approval.

    I need to write these up but there was one thing about timing that I think it particularly important for everyone to understand (and I think there has been some uncertainty):

    From January 2018 it will be possible to continue to trade products with insect materials up until January 2020 without a Novel Food approval but only in your own nation, not EU-wide, and where that nation had allowed it to be traded previously (they suggested this was NL, B, UK).

    If you want to sell new products or to offer them outside of your own country after January 2018 then these will have to have been approved under Novel food regulations.

    If you wait until January 2018 to apply for approval under the new rules, you will have to wait until approval is granted before trading the products – this could take 5-6m if approval is using the traditional consumption route, or 16m if it is using the conventional route.

    It is possible to submit an approval application before January 2018, in order to minimise this delay, but at that point, it would be assessed using the current procedure (MS led) but if the process lasts into 2018 it will switch to the new procedure (EFSA led).

    This does suggest that the January 2018 deadline is not quite as problematic as some thought, but only for companies that are willing to accept these restrictions.

    We will be consulting our members on what they would like Woven to do in the light of this.

  • #3372
    Nick Rousseau
    Nick Rousseau
    Moderator

    Here is my report of the discussion with the Commission showing the questions we raised on behalf of Woven members and the responses:

    Questions for European Commission Regarding Novel Food Regulations and Insects

    Timings and deadlines

    What is the timetable for introduction of the new regulations and how will this affect businesses’ ability to sell products in EU? 

    For businesses selling products with a given insect material (e.g. domestic cricket), when will they no longer be able to sell these from and what must have happened for them to be able to continue?

    Legally speaking. New regulations are applicable from 1 January 2018.

    If you submit an application under the current regulations (each member state is responsible for evaluating the dossier) but it is not approved before end dec 2017, the application will be treated as if it is under the new regulations (ie EFSA will take over).

    In relation to the new novel food regulations, they will set themselves a deadline to finalise their side of the process. Risks assessment and management exercise by the EFSA will be conducted within 9 months, and the Euro Commission will then take no more than 7 months to report/publish its final decision. So the whole process will take at most 16 months.

    In relation to an application for traditional food from a third country, the turnaround time will be shorter – just 4 months of risk assessment by both EFSA and Member States. Should be able to announce a decision by 5-6 months.

    In general, under the Novel Food regulations you cannot trade until you get authorization, with either route. However, with the insects there is an exception as under the existing regulations food isolated from animals can be considered novel and some member states have interpreted this to mean that the novel food regulations only apply if some element is isolated from an insect and whole insects are exempt. So states (B, NL, UK) allow insects to be tolerated on the market not as novel foods.

    This will no longer be allowed.

    Given this situation, businesses can continue to trade if the product is legal on the specific market before jan 2018, and if they can put an application in before jan 2020. But this will only apply to the domestic market of these countries. It will not be legal to sell the products elsewhere in the EU.

    No new products can be brought to market during the 2018-2020 period, just existing products. The products must have been lawfully placed on the market in accordance with national legislation.

    Nature of Evidence Required

    In relation to the third country route requiring evidence of a history of safe consumption, what evidence will be acceptable?  How robustly documented vs anecdotal?  Will this also require toxicological, laboratory etc. tests to back up the statements and show the current product is safe?

    During the event in Bangkok Leena mentioned a case where a recipe from a recipe book was used as evidence of a traditional consumption and she explicitly said that we can be creative in proofing the history of safe consumption.

    What form of documents? Could interviews with elder people in the countryside be accepted?

    For the crickets it should be easy as in Thailand 7,500 tons are consumed yearly, and it’s clearly traditional – maybe a couple of academic papers, some photos and some statistical data may be sufficient.

    In terms of the evidence requirement: The EFSA has published guidance. It will decide what is acceptable.

    The section on experience of consumption of the product, this can include a wide range of sources of evidence – scientific documents, mongraphs, national or international govt. documents, cultivation evidence, figures, recipes, photos.

    It is important to substantiate it was eaten without any problem. Not just that it was eaten.

    If there is good third country evidence, there should be no requirement for toxicological data.

    In past with other things, eg baobab fruit, widely eaten in Africa, applicants provided a range of sources of info, including questionnaires of African citizens.

    Each insect will need its own case to be made. Some may be harder with less evidence.

    If the evidence is felt to be insufficient, then they will ask for more evidence. There will be an opportunity to fill any gaps that exist rather than just immediately rejecting the application.

    In the case of traditional food route, both EFSA and Member States will evaluate it. If any raise safety objections, then it will have to be addressed through the conventional route and it will not be possible to be approved under the traditional food route.

    Even with evidence of traditional consumption, the application will still need to provide evidence of current production maintaining standards and addressing any safety risks.

    Costs of Applying

    What are the costs for an application for a generic approval?

    No costs. For EC and EFSA. No admin costs will be charged.

    Applying for a single generic approval for one species

    If Woven were to coordinate the preparation of a single generic approval for the acheta domesticus, for example, are there any particular requirements we should be aware of? 

    Would you consider acheta domesticus and the mealworm as special cases, allowing a preliminary assessment of a dossier (to be performed by EFSA)?

    How would this be affected if someone else submitted a generic application just before us?  What if it is poorly presented and you reject it?

    Will difference companies farming the same species in the same way have to apply for separate Novel Foods Apps, or can they collaborate and produce one application?
      
    Can you confirm whether there would be any circumstances where people producing products such as protein bars (or making restaurant dishes) containing insects would need to apply for Novel Foods App if the insects that are included in the product have been approved under a generic approval?

    If Acheta Domesticus is submitted both as a traditional food from third countries, and as a normal procedure, will both dossier be accepted and processed?

    How would this be affected if someone else submitted a proprietary application?

    In the application, how do you answer questions about proposed use and extent of consumption, when it is about a generic approval?

    In regulations an applicant can be a Member State, country, international parties representing several interested parties. All are acceptable.

    Generic approval. Can refer to acheta domesticus, house cricket. Could be that they receive more than one application for the same insect.

    EC is required to make publically available a summary of the application, once it has been received and checked. The summary may not say who has submitted the application. (They will reflect on this.)

    The scope of the application is a key issue. Is it about a whole insect or just a part. Is it for selling it or for hydrolysed protein? For processing insect material or farming insects.

    There may be a proprietary element

    Under the new regulations, one can apply with a confidentiality treatment. In the dossier you pinpoint info to be treated as confidential. EC will issue the decision and protect this info.

    If there is a proprietary element, there are a number of implications:
    • Firstly need to designate what data is proprietary. Eg. Scientific data. At time of submission must not be published.
    • Second that applicant must have exclusive right of ref to the scientific data. At time of submitting the application.
    • Third require – novel food application cannot be assessed without the data.
    • Then your company can place product on market and no-one else can do it. unless they get another application. Granted for 5 years.

    This is not applicable to traditional food applications.

    Important the application sets out proposed uses and expected consumption levels. In the past when applicant applies for for novel food approval they can use any food category – no clear food categories. Now we discussing if an applicant could follow a food categorisation system. Currently have the one in relation to food allergies. 18 categories .

    If not mention a certain use in the application and then someone wants to use it in that new way, they need to apply for an extension of use.

    So when apply need to see what category they apply for.

    This could mean that there are multiple applications for one insect with different parts/processed natures/uses… A truly all-covering and generic application could be a great deal of work.

    In putting in application need to decide scope.

    Ensuring consistency of quality of product

    What about production standards to guarantee quality in future?

    No standards. Only one is every application is EFSA guidance.

    – First is to prove the insect is safe and provide specifications. Verified by EFSA, relate to the standard in the guidance.
    – Need characteristic on farming, and
    – composition of product that will be put it on the market.

    EU regulations will never require private standards. Possibly ISO – good manufacturing or farming practices. Up to company to show it can deliver consistency. They are responsible ot the consumer for this anyway. Must not mislead. If one month have one quality and different another month this needs addressing.

    Laboratory needs to be show it is ISO certified.

    Prod food regulations 852 2004 apply. Must have safety procedures based on HACID principles. Required to have these but not a specific ISO…

    Ongoing discussion on hygiene package – in context of insects, what requirement should comply with. Parts of animal origin – should get farm authorized by EU regulations.

    Reg 178 2002 – basic food law. Requires traceability. One step back and forward approach. Then as food operator selling insects as food. Also 852 2004 and possibly 853 2004 – being discussed.

    EFSA might decide issue of allergenicity – there may be new requirements.

  • #4573
    Nick Rousseau
    Nick Rousseau
    Moderator

    Just to start this up again. I am aware that there are other insects that have not been submitted for approval to the EU but that could be significant for some businesses. The Chinese Research Institute of Resource Insects could have the specialist expertise and capacity to carry out the necessary laboratory trials at a lower cost than European laboratories. Does anyone know what standards or certification they would need to have their findings accepted by the EFSA?

  • #4601
    Adam Banks
    Adam Banks
    Moderator

    You’re right – Gryllus bimaculatus and Zophobas morio are both popular edible insects which have not been submitted for approval.
    I believe novel food lab testing could be done in China – implementing regulation EU 2017/2469 says “(8) In order to ensure that toxicological tests are performed to a certain standard, they should be carried out in accordance with the rules set out in Directive 2004/10/EC of the European Parliament and of the Council (2). Where those tests are carried out outside the territory of the Union, they should follow the OECD Principles of Good Laboratory Practice (3).”
    The RDA Advisory Report: ‘The Emerging Insect Industry’ says the cost of submitting an application is over €200,000 – it would be interesting to know how much of this cost is associated with lab testing.

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