Cultured meat is making its way to the market globally. Recently, we saw this movie from Super Meat, serving cultured meat in a restaurant where in the same time cultured meat was actually being cultured. Earlier, tasting sessions by Aleph Farms of its cell-based steak were shared via social media. And at the end of last year, it was reported that Eat Just had gained regulatory approval to market its cultured chicken in Singapore. This made me (and I guess many others!) wonder how the regulatory approval process is set up in the Lion City. Last week, I had an interview with the Singapore Food Agency (SFA), the outcome of which I report in this blogpost. I also compare the information received to the regulatory system for authorisation of cultured meat in place in the EU.
Which foods are considered Novel Foods in Singapore?
Before putting in place its Novel Foods regulatory framework in 2019, the SFA took inspiration from similar legislation applicable in other parts of the world, amongst others in the EU. This clearly transpires from the definition of a Novel Food. The SFA considers Novel Foods to be foods that do not have a history of safe use. This is the case if substances have not been consumed as an ongoing part of the (human) diet by a significant human population during at least 20 years. This definition is pretty similar to the one used in the EU, except that the EU definition uses (i) 15 May 1997 as a fixed point in time cut-off date and (ii) a closed-loop system of 10 Novel Food categories. In Singapore, just like in other places of the world, it goes without saying that cultured meat (“meat developed from animal cell culture”) requires prior market authorisation. Whereas in the EU this could also take place (depending on the production process applied) on the basis of a GMO authorisation, my understanding is that in Singapore the designated route is a Novel Food authorisation. In the EU, a distinction is made between foods containing GMOs and foods produced from GMOs on the one hand and food produced with GMOs on the other. Whereas the first two categories require GMO clearance, the third one does not.
Organisation Singapore Food Agency
Contrary to the EU, where EFSA operates as an external advisory body to the European Commission the National Centre for Food Science (NCFS) forms an integral part of the SFA. The NCFS consists of food inspection services and laboratory testing services and a representative thereof also took part in the interview. This setup and Singapore’s 5.7 million inhabitants (compared to over 445 million in the EU) potentially explains the shorter timelines during the regulatory approval process, as outlined below.
Regulatory Approval Process
The SFA acknowledges the science for producing cultured meat is still in an early stage. So far, it has set up a modest framework defining the Requirements for the Safety Assessment of Novel Foods. It however explicitly states the information required may change based on the developments on the science of producing cultured meat. The data required for evaluating the safety of Novel Foods largely correspond to the data required under the EU regulatory framework. They include information on the identity and the manufacturing process applied, as well as on the intended use and proposed levels of use. Toxicity studies (both in-vitro and in-vivo) and metabolism or toxicokinetic studies are requested “where relevant”. For cultured meat specifically, they include information on the cell lines, culture media and scaffolding materials used. Finally, any safety assessment reports conducted by the food safety authorities of Australia, Canada, New Zealand, Japan, the EU and the USA are considered relevant. For the EU, the SFA Guidance states that safety assessments conducted in accordance with the ESFA Guidance for submission of food additive evaluations would be accepted for review. This guidance is referred to in the EFSA Guidance for novel food applications in the context of toxicity testing and propagates a tiered approach for the type of safety parameters to be satisfied. This means that if no risk indicators are revealed in the studies performed in the first tier, no studies from the second or third tier need to be carried out.
The estimated timeline to complete an evaluation of a Novel Food in Singapore is said to be 3 – 6 months. During the interview however, SFA staff indicated this to be “slightly optimistic”. For the time being, the SFA has not yet put down any requirements regarding procedural aspects of a Novel Food application; this is still in the works. What struck me most during the interview is the informal and cooperative approach of the SFA. They seem to offer their assistance as a service rather than that they position themselves as rigid safety assessors. Also, they much encourage companies to consult SFA early in their product development process (referred to as “early-stage engagement”). This will enable mutual understanding of the production process of the cultured meat product at stake, as well as the applicable safety requirements. This may subsequently enable companies to make deliberate choices in their manufacturing setup. All of this is quite different in the EU, where interactions with EFSA is highly regulated and where detailed procedural regulations for submissions are in place, amongst others in view of protection of transparency in the safety evaluation process. Also, based on the Union studies database, it will be public what studies form the backbone of the safety evaluation for the Novel Food at stake.
Confidentiality vs. transparency
The notion of transparency was not mentioned once during my interview with the SFA. Instead, it was said that all information submitted during the application process is confidential. This may be advantageous for companies who want to make it quickly to the market. In the long run, and especially if authorisation of Novel Foods by the SFA will operate as a steppingstone for access of other Asian markets, I expect the need for a similar system as in place in the EU will arise.
Can cultured meat actually be called meat in Singapore? This may seem to be a no-brainer, but this is a highly debated question in the EU, where also the use of typical dairy names for plant-based alternatives is prohibited. The designation “meat” for cultured meat products in the EU may be limited based on the Hygiene Regulation, that reserves the name of “meat” for “edible parts” of specific animals, such as beef and pork. Now that cultivated cells (or even stem-cells) may not necessarily qualify as such edible parts, this issue still needs to be resolved. When marketing cultured meat products, the SFA does not oppose the designation of “meat”, provided that it is accompanied by a qualifier, for example cultured meat. “Clean” meat will however be a no-go, as it might have negative connotations for traditional meat. The proposed solution here seems appropriate to me to adequately inform the consumer what type of product is offered for sale and sufficient to prevent any misleading. Since that is also the cornerstone of EU food information law, I would very much advocate a similar solution to apply in the EU.
Authorisation of a Novel Food such as cultured meat takes place in a relatively informal and accelerated, yet science-based way in Singapore. It is therefore not surprising that the world’s first cultured meat product obtained regulatory clearance there. For now, we have not seen any applications being submitted in any other territory, not in the US, not in the EU and not even in Israel, where an important population of cultured meat companies is present. In order to see which regulatory approval procedure is most robust and flexible, the proof of the pudding is in the eating. Sure thing however is that companies obtaining regulatory approval in Singapore will not want to limit their offerings to this small territory, but expand to others as well. In my view, mutual approval proceedings could beneficially influence each other, as data generated or approvals obtained in the one proceedings, could be used in the other. In terms of processing Novel Foods applications, I could only wish EFSA takes inspiration from the collaborative approach the SFA seems to take.
The world of food is changing at a rapid pace – alternative proteins becoming a new reality. Examples are products using microbial fermentation or cellular agriculture in their production process. If you are a company wanting to market such a product in the EU, there is a good chance you require a prior market authorization as a regulated product, such as a novel food (NF) or a GMO. In that case, you need to get up to speed with the following four new ESFA guidance documents that will all apply as of 27 March 2021.
- Decision laying down the practical arrangements on pre-submission phase and public consultations
- Decision of EFSA’s executive director laying down practical arrangements concerning transparency and confidentiality
- Administrative guidance for the processing of applications for regulated products (update 2021)
- ESFA’s catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)
Document # 3 explains EFSA’s workflow in dealing with regulated products. It applies to applications for authorization of substances used in food and feed, food contact materials, NFs and GMO’s amongst others. The title of document # 4 is pretty self-explanatory. Examples of EFSA support initiatives range from general pre-submission and renewal advice to admin support to SMEs on applications and from EFSA guidance documents and scientific opinions to roundtables with industry associations.
Documents # 1 and 2 contain practical arrangements for companies that intend submitting scientific evidence regarding products requiring an EFSA evaluation. The full list of products is enumerated at the end of this post.* From a legal point of view, these guidelines implement the changes introduced in the General Food Law Regulation by the Transparency Regulation. We already covered the consequences of this Regulation in a previous blogpost, which in particular focuses on the relation between transparency and confidentiality.
This blogpost provides more detailed information on two topics representing a real change in the situation before 27 March, notably the general pre-submission advice and the notification of studies. To make this blogpost more concrete, it will target one specific category of regulated products within EFSA’s remit, notably NFs. For a reason. Currently, a great number of EU food companies active in the field of cultured meat are preparing their novel food applications. These companies need to be aware of these changes in the current regulatory framework.
General pre-submission advice (GPSA)
The GPSA to be provided by EFSA Staff concerns the rules applicable to and the content required for the NF application prior to its submission. It explicitly does not cover the design of the studies to be submitted. Aspects going beyond information available in any guidance documents are out of scope of pre-submission advice. Examples are questions regarding hypotheses to be tested or risk management. Furthermore, said staff shall not be involved in any preparatory scientific or technical work that is (in)directly of relevance for the NF application to be made. Also, the advice given shall be without prejudice and non-committal as to any subsequent assessment by EFSA (and the Member States via the PAFF Committee).
Prior to obtaining any GPSA, the applicant (and / or its representative) must register in the EFSA system supporting pre-submission activities and it must also request a pre-application ID. The pre-submission request can be introduced at any time before submitting a NF application. The European Commission nevertheless recommends submitting a request at least six months before introduction of the intended NF application.
The request for pre-submission advice shall be made in a dedicated form (“general pre-submission advice form”) made available by EFSA and a link should be made to the pre-application ID. Subsequently the applicant for an authorisation of a NF should provide all necessary information regarding the application, including a list of exhaustive questions. A maximum of two requests may be submitted under the same pre-application ID.
After a check that the questions asked are not out of scope, the applicant will be informed within 15 working days from the receipt of the advice form whether the submitted request is accepted or rejected. Companies expecting face-to-face meetings with EFSA need to know this will not happen automatically. Where possible, EFSA shall address the queries in writing. However, if EFSA considers that a discussion with the applicant might be useful to clarify certain aspects of the request, a meeting shall be organised. You then do not need to travel to Parma or elsewhere, as such meeting shall be conducted preferably by telco or webco. Only in exceptional cases a live meeting shall take place.
Any requests to be delt with in writing shall be answered within 15 working days after acceptance of the request. Any meeting to be set up shall be organised within 20 working days after acceptance of the request. EFSA shall draft a summary of the questions asked and not only send this to the applicant, but it will also publish it after the novel food application at stake has been considered admissible or valid.
Notification of studies
For transparency purposes, EFSA has established a database of studies commissioned or carried out by business operators to support any application requiring any type of scientific output, including a scientific opinion. The obligations to submit information on studies applies to both (A) potential applicants (i) having commissioned to a lab or external testing facility or (ii) carrying out such studies in in-house testing facilities and (B) to the labs or testing facilities carrying out such studies. Don’t be fooled by the wording “studies carried out” in relation to the notification required. In fact, timing is of the essence here, as all study notifications need to be submitted before the actual starting date of the study.
There may be justified justifications for not timely notifying studies. However, if EFSA does not consider the justifications provided by an applicant valid, the application needs to be re-submitted. As a consequence, the assessment of the validity of the application shall commence only six months after the notification of the studies according to the Transparency Regulation. The EFSA pre-submission guidance states the assessment of a re-submitted application shall commence 6 months after the re-submission of the application. This is not exactly the same, but it is clear that not complying with the studies notification requirement can be a serious showstopper, as a NF application supported by not-notified studies is not valid.
What exactly needs to be notified in the EFSA studies database? First of all, the study title, as well as an English translation thereof if the original title is not in English. Secondly, the applicant needs to be identified, after having first registered in the EFSA system for pre-submission activities. Thirdly the planned study starting and completion date, the laboratory where the study shall be carried out, as well as the study scope. In order to detail the study scope, the applicant should provide information on the intended study area (e.g. cultured meat), the study type (e.g. genotoxicity in vitro study) and the study objective (e.g. demonstrate that cultured meat does not pose any safety risks at the anticipated level of intake). The data entered can be modified, for instance if a study is delayed, the anticipated completion date can be aligned thereto. Information previously entered into the study database can also be withdrawn, but the applicant needs to provide a valid justification for that purpose. In the absence thereof, the same consequences will apply as when the applicant notifies its studies too late.
Once EFSA has received a valid or admissible application for a NF authorization, it shall publish this in order to launch the consultation of third parties on the application submitted. The rationale behind is that EFSA needs to have access to all relevant scientific data and studies available on the subject matter regarding the application at stake. Any communications on such consultation shall be published at EFSA’s website and shall remain open for three weeks, unless specified otherwise in sectoral Union law. For applicants, it is good to know that this public consultation in principle does not result in long delays. Upon closure of the public consultation, EFSA shall make publicly available all comments received. This will be done simultaneously with the publication of EFSA’s scientific output, which will address all relevant comments received.
What learnings can be drawn from the new EFSA Guidance documents? In the first place, that designing a safety evaluation strategy for a regulated product such as a NF has become even more important. By deciding as early stage as possible, what studies will be required to demonstrate the safety of your product, the chances that you can timely notify these studies in the EFSA study database shall increase. In this way, unnecessary delays in the appraisal of your application can be prevented. In the second place, it remains to be seen how helpful EFSA pre-submission advice will be, as it will be purely procedural and not material at all. At the same time, EFSA launched the new initiative of dedicated support for SME’s. Potentially, combination of the two reveals to be helpful.
*Products subject to transparency requirements and requiring an EFSA evaluation are the following:
- GMO’s (captured by both Directive 2001/18 and Regulation 1829/2003)
- Additives in animal nutrition
- Smoke flavouring used on food
- Food contact materials
- Food additives, enzymes and flavourings
- Plant protection materials
- Novel Foods
Consumers nowadays tend to include more and more plant-based products into their diet. For instance, a study ordered by DuPont Nutrition established double digits of growth for non-dairy ice-cream, dairy and cheese during the year preceding June 2018. More recently, NPR published an overview demonstrating which products were most consumed during the corona crisis. Amongst these, plant-based meat alternatives and oat milk were the biggest hits, demonstrating over 200 and 300 % growth respectively. Plant-based alternatives for dairy and meat will be discussed during the Protein Summit of the Vitafoods Conference in Geneva. As you may know, this conference was shifted from May to early September. In anticipation thereof, a webinar on Protein and Protein Alternatives took place on 12 May. During this webinar, I covered the labeling and advertising of these products. This blogpost offers a recap of my contribution thereto, targeting those who are interested in this topic but could not assist.
Regulatory requirements for market access
Obviously, there are other relevant aspects for alternative protein-based products than labeling and advertising, such as the regulatory requirements for market access. For some products, like those based on certain algae or on isolates from mung beans, most likely an authorization under the Novel Food Regulation will be required. This implies that the applicant will have to put together a product dossier demonstrating the safety of the product and submit this to the European Commission. This certainly applies for cultured meat products, unless they incorporate GMO steps in their production process and / or end product. In such case, market authorization will have to be obtained on the basis of the GMO Directive and the GMO Regulation. These topics will be dealt with during the Conference in September, detailing the scientific, economic and practical implications thereof.
Relevant general labelling rules
A number of labeling rules are of relevance for any food product, including those based on alternative protein. In fact, the cornerstone of labeling law, embodied in the Regulation on Food Information to Consumers, is the prevention of misleading. This can be done in various ways, but it is of the essence that at all times any confusion about the characteristics of a product is avoided. During the webinar, I brought up the example of Mylk to clarify this. Obviously, this is not a conventional dairy product, but a plant-based product. Do you think any confusion about the nature and / or the composition of this product could arise?
This should be decided based on the so-called Teekanne decision of the European Court of Justice (ECJ). According to this decision, it is prohibited to give the impression (by means of an image or a description) that a particular ingredient is present in a product, whereas this is not the case and the consumer can only find out when reading the list of ingredients. When this test is applied to the product Mylk, I am of the opinion it shall pass. Firstly, consumers will most likely not expect conventional milk, because of the twist in the product name. Secondly, FOP it states “dairy-free”. Thirdly, most plant-based dairy products are not stored in the fridge in the supermarket. Lastly, from the list of ingredients it is apparent this product is based on coconut cream.
Sector specific dairy legislation
For the dairy sector, important guidance was provided by the Tofutown decision by the ECJ. As detailed in an earlier blog post, we learnt from this decision that – in short – it is prohibited to use dairy names, such as “Tofubutter”, “Pflanzenkäse” and “Veggiecheese” for non-dairy products. This can be explained by the fact the dairy market is highly regulated, meaning that any specific dairy product has its own product standard. This standard should be met when manufacturing and marketing the product at stake. During the webinar, I mentioned the product standard for milk, defined as “normal mammary secretion obtained from one or more milkings without any addition thereto or extraction therefrom”. From this definition it follows why the use of the work milk in combination with a plant-based ingredient is, in principle, no longer allowed.
However, there are always exceptions to the rules, also in this case. These exceptions relate to so-called traditional use, like “coconut milk” (UK) and “lait d’amande” (France). Those exceptions are mentioned on a list drawn up by the European Commission. Furthermore, the word “milk” and designations used for milk products (e.g. cream, butter, yoghurt) can be used in association with one or more words designating certain composite products (famous example: “chocolate milk”). A condition precedent however is that milk is an essential part thereof, either in terms of quantity or for characterization of the product, and no constituent takes the place of milk.
Plant-based meat replacements
For these types of products, using (or not) the word “meat” is not so much an issue, because they are no conventional meat product. This issue is rather whether it is legally permitted to use certain meat product designations, such as “hamburger”, “sausage” and the like. In the US, we have seen so-called censorship bills in a great number of States. These are usually driven by the meat sector lobby, who fear unfair competition from their plant-based peers. There is fierce opposition against such censorship, amongst others from the Good Food Institute. Mid April, the GFI reported their lobby had been successful in Virginia, where the Governor vetoed label censorship.
In the EU, we have seen similar initiatives when the AGRI Committee of the European Parliament proposed a bill restricting the use of meat product names for meat alternatives. The status of this bill is yet undecided, as the current European Parliament that was inaugurated in 2019, did not yet vote on it. Fierce lobbying pro and con is however going on. We must therefore anticipate that if this bill turns into law, it will also result into restrictions of very popular terms. The alternatives for those popular terms are not so obvious yet: “lentil slices?” or “carrot tubes?”.
Please bear in mind that restrictions can also stem from national Member State laws based on reserved product designations. In the NL for instance, the name “minced meat” and “tartar” are such reserved product designations that can only be used for products meeting exactly the relevant legal specifications.
When discussing the advantages of new over conventional protein products, certain advertising standards should be taken into account. In the EU, one of the ways to avoid misleading regarding your alternative protein product is to not emphasize certain characteristics that your product does not have. In this context, I discussed in the webinar a commercial that was made for BECEL margarine (FLORA in UK) that was shown both in the Netherlands and in Belgium. The text stated “Plants are the new cows. They are outside in the field whole year long. They provide seeds, that are a source of omega-3, which is good for your heart. BECEL is 100 % plant-based and good for your heart.”
According to a complaint filed with the Dutch Advertising Code Committee (similar to Advertising Standards Authority in UK), the comparison made between plants and cows was misleading. Rationale: it was suggested that plants had a more positive effect on the environment than dairy products made from milk. The complaint was dismissed. The ACC considered that the commercial did not at all compare the advantages of plant-based products to the disadvantages of conventional dairy. In fact, it only stressed the positive health effects of BECEL, due to its plant-based ingredients. The commercial appeared an effective (and funny!) way of advertising alternative dairy products.
Alternative protein products are food products like any other, so make sure that when marketing these, you are up to speed with all applicable general labeling requirements. Furthermore, take into account any sector specific standards, like the ones that apply for dairy products. Also, please note that at Member State level, further restrictions on the use of particular product names may apply. Finally, when advertising these products, make sure to avoid any misleading and know the rules for comparative advertising. This will be of particular relevance, especially once further labeling standards will evolve at EU level as initiated by the AGRI Committee of the European Parliament. Stay tuned – we will.
Copyright image: Nanne Meulendijks – please contact the artist for any further use.
What does the future of our meat look like? This topic was the subject of the Annual Conference of the Good Food Institute (GFI), which took place in San Francisco last month. GFI is an American non-profit organization that works with entrepreneurs, scientists and investors to make groundbreaking good food a reality. GFI focuses on the development of alternatives to animal products, consisting of plant-based products and products manufactured using cellular techniques (“cultured meat” or “cultured fish”).
Trends from Silicon Valley also in EU
The issues raised at this conference are also relevant to Europe. In the Netherlands, for example, the Nutrition Centre advises that it is better for human health to have a more plant-based diet than has been the case until now. For example, the risk of cardiovascular disease would decrease if the diet included less meat and more wholegrain cereal products, legumes, vegetables, fruit and vegetable meat substitutes.
GFI sessions: trending topics
In the country where the Beyond Meat citizen comes from, it was recognized that a large-scale breakthrough of meat alternatives has not yet taken place. The titles of the presentations were telling: “Marketing to Meat Eaters: How to Reach the Other 95 Percent of American Consumers“, “Capitalizing on Change: How Investors Accelerate the Plant-Based and Cell-Based Industries” and “Addressing the Key Challenges in Commercializing Cell-Based Meat“. Participants in the last session of the conference (“Cell-Based Meat Entrepreneurship“) were JUST and Memphis Meats, the companies that are said to be “closest to the market” with their cultured meat products. According to JUST, they will launch a cultured meat burger still this year. But that’s what they say every year.
Plant-based meat substitutes in the US
What is legally required to be able to market meat alternatives? Of course, it all starts with the name: what can you call these products? The basic rule, both in the US and in the EU, is that consumers must not be misled. In the case of plant-based products, this principle is applied in various ways in the United States. For example, the burger of Beyond Meat (which is now also available in the Netherlands) is simply referred to as the BEYOND BURGER and described as “the world’s first plant-based citizen that looks, cooks, and satisfies like beef…“. Impossible Foods also refers to its company name in its IMPOSSIBLE BURGER. This product is not yet on the market in the EU, partly because it contains a protein of which the regulatory status in the EU is not entirely clear (so-called leghomoglobin). This protein is obtained on the basis of fermented yeast, possibly using GMO techniques. Finally, Morning Star (“It easy eating green“), when selling its plant-based burgers, refers to the flavour-defining ingredient that they contain, for example “mediterranean chickpea burgers” and “spicy black bean burgers“. Confusion with conventional meat products does not seem to be an issue here.
And what about the EU? Famous example of the Vegetarian Butcher
In the meantime, more and more plant-based meat substitutes are also being sold in the EU. One of the best-known examples of (alleged) confusion about product names in the Netherlands concerned the case of the Vegetarian Butcher, a company that was acquired by Unilever in December 2018. At the end of 2017, the Dutch Food Safety Authority (NVWA) asked this company to modify the labels of the products offering a substitute for tuna, chicken and bacon (all spelled with a twist in Dutch), because these would be misleading. It turned out afterwards that the criticism concerned only the information on the website. The NVWA apologised and the Vegetarian Butcher did not have to change any product labels.
Proposal for a ban on Vegaburger in the European Parliament
The next shockwave took place at European level when, in April of this year, the Committee on Agriculture and Rural Development (AGRI Committee) of the previous European Parliament adopted a proposal to ban the use of meat names for plant-based products. On the basis of this proposal, it would no longer be possible to use the names ‘steak’, ‘sausage’, ‘ham’, etc. for plant-based products. A new European Parliament has now been elected. It has been reported from Brussels sources that the new AGRI Committee has taken the old proposal as a starting point for a working document. However, so many forces are working together against the previously envisaged ban that the chances of this happening are not considered to be very great. Arguments against this ban are that it would inhibit innovation in the EU, harm consumer rights and simply not be necessary: consumers are not so easily confused about plant-based meat substitutes. With the slogan “Stop the vegaburger ban“, Pro Veg launched a petition against this ban.
Cultivated meat in the US
Currently, about 30 companies active in the field of cultured meat worldwide. The companies that are most advanced with their innovations are located in the US. Menphis Meat, for example, focuses on the development of beef and poultry from the lab. This company has received investments from both well-known names (Bill Gates, Richard Branson) and from the “classic” meat industry (Tyson and Cargill). JUST focuses on the development of, among other things, chicken meat from the lab. The company has already launched an egg-free mayonnaise, that was the object of discussions with the FDA. According to the current product standard for mayonnaise, this product must contain eggs, otherwise it cannot be called “mayonnaise”. This problem was solved by changing the name of the product (“JUST Mayo”). How cultured meat will be named upon its market introduction is yet an open question. However, five companies have joined forces: they form the so-called Alliance for Meat Poultry and Seafood Innovation to approach the supervisory authorities with one voice. GFI has also developed a narrative framework to familiarise consumers with this technology and it published the results of market research into favorite names. For the time being, “cultivated meat” and “cultured meat” are at the top in terms of “appeal” and accuracy.
Cultured meat in the EU
In the EU, the question remains whether cultured meat can actually be called ‘meat’ at all. The number of arguments for and against is more or less balanced. We reported earlier on this topic in our blogs How do we get cellular ag products to the market and Regulatory pathways for clean meat in the EU and the US; not much progress has been made since that time. The main argument in favor is that when a product is identical to conventional meat at a molecular and nutritional level, producers want to be able to use this name as well. In addition, the use of the term ‘meat’ is very functional in terms of consumer orientation. Furthermore, there do not seem to be any direct legal objections to the use of ‘meat’ for cultured meat, since the Agricultural Products Standards Regulation does not contain a specific product standard for meat, unlike, for example, dairy products. Arguments against the use of ‘meat’ are based, among other things, on the Hygiene Regulation. This Regulation defines ‘meat’ as certain parts of a variety of animals, including bovine and porcine animals and poultry. It is questionable whether a product obtained from a single cell derived from one of these animals complies with this definition. Furthermore, the Hygiene Regulation refers in various places to the slaughter of farmed animals. Of course, slaughter does not apply to cultured meat – that’s the whole point. Finally, certain meat names are subject to specific regulations. In the Netherlands for example, the name ‘tartar’ may only be used for minced meat from cattle with a maximum fat content of 10 % based on specific Commodities Act legislation.
The future of our meat is taking shape. Plant-based meat substitutes are already on the market in large numbers and these products are getting more and more shelf space in the supermarket. The challenge for these products is to keep that shelf space. A certain amount of time will elapse before cultured meat will be available on a large scale on the shelf. It is expected that the first company will submit a request for Novel Food authorisation sometime next year. It will take about 18 – 24 months to complete such an authorisation procedure. By then we will have reached 2022. This may seem a long way off for the consumer, but the preparation by the producer has been a reality for a long time. Also, it was learned via the grapevine that EU-based cultured meat companies are getting organized. Watch that space!
Last month, the European Council formally adopted the new Regulation on the transparency of the EU risk assessment in the food chain, which will be applicable as of 26 March 2021. As is in the name, the new provisions aim at increased transparency of EU risk assessment, which for a large deal means strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (“EFSA”). As EFSA has been accused more than once of conflicts of interest, this is, in principle, a welcome development. For FBOs, the implications are however important – as will be demonstrated below.
The upcoming changes follow from the Commission Communication on the European Citizens Initiative on glyphosate, in which initiative EU citizens called for more transparency in scientific assessments and decision-making, and build upon the findings of the fitness check of the General Food Law. The new provisions will mainly amend the General Food Law. For reasons of consistency, the new provisions also introduce changes to eight legislative acts dealing with specific sectors of the food chain, including the Novel Food Regulation, the Additives Regulation and the GMO Regulation. Based on the publicly available proposal for the meanwhile adopted provisions on the transparency of EU risk assessment, this blogpost provides an overview of what applicants will be facing in authorization procedures for innovative food products in terms of transparency and confidentiality.
Pre-submission phase: union register of commissioned studies and general advice
Before submitting an authorization application, for instance for a Novel Food like cultured meat or insects or for a new additive, applicants will have to notify EFSA of any study they commissioned to support a future authorization application. These studies will become part of the union register of commissioned studies as managed by EFSA. The submitted studies will be made public only when an actual application follows and insofar the studies do not contain confidential information, regarding which a request for confidential treatment has been granted. The idea behind the union register is that companies (potentially) applying for an authorization submit all related information, which subsequently allows EFSA to cross-check the information on the studies performed. This way, applicants can no longer hold back unfavorable studies. This notification obligation also applies to laboratories in the EU that carry out those studies, but obviously not to non-EU laboratories as they fall outside the scope of new provisions. According to the EC’s fact sheet of 13 June 2019, consequences of non-compliance with the notification obligation shall result in a negative temporary stop in the risk assessment.
At the same time, applicants have the right to request EFSA for advice on the relevant provisions and the required content of the application for authorization in the pre-submission phase. This procedure is a response to industry demand, especially of SMEs, for further support in the preparation of applications. The advice shall, however, be provided without the input of the Scientific Panels that are in charge of the actual scientific assessment and shall not cover the specific design of a study. Furthermore, EFSA’s advice shall be made public. Based on the publicly available proposal for the transparency provisions, it seems that this will be done before an actual authorization application is being submitted.
Submission phase: citizens’ access to studies vs. confidentiality
The default setting under the new provisions is that all scientific data, studies and other information supporting applications for authorizations shall be made public by EFSA. While the new provisions aim at ensuring that stakeholders and the public have access to key safety related information being assessed by EFSA, duly justified confidentiality information shall not be made public. The new rules specify which types of information may be considered as such. As listed in the publicly available proposal, this includes production methods, the quantitative composition of the substance or product at stake, certain commercial relationships and other sensitive business information. It is the responsibility of the applicant to demonstrate that making public the information concerned would significantly harms the (commercial) interests concerned. Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, confidential information shall be disclosed.
Specific sectoral food legislation will also include a list of certain types of information that may be treated confidentially. For example, a proposed change to the GMO Regulation includes the specification that certain DNA sequence information and breeding patterns and strategies may be treated confidentially. Next to the confidentiality rules, existing intellectual property rights, data protection rights and data exclusivity provisions for proprietary data, remain applicable.
When an applicant submits a request for confidentiality, it shall
provide a non-confidential version and a confidential version of the submitted information. If and when EFSA receives the submitted information, for example in case the Commission requires a scientific opinion as part of a novel food procedure, it shall publish the non-confidential version without delay and shall decide on the requested confidentiality within 10 days. Insofar the confidentiality request has not been accepted, EFSA shall subsequently publish the additional information after 2 weeks from the notification of its decision. Applicants that do not agree with EFSA’s decision may, under certain circumstances, challenge the decision before the Court of Justice of the European Union.
Once EFSA has published all the non-confidential information and before it carries out its scientific assessment, EFSA may consult third parties, including citizens, to identify whether other relevant information is available on the substance at stake. This new provision serves to mitigate the public concerns that EFSA’s assessment is primarily based on industry studies, more in particular on studies ordered by the applicant. The results of these consultations shall also be made public, as will be minority opinions to EFSA’s scientific output.
In case of a request for the renewal of an authorization, the applicant of the renewal will have the obligation to inform EFSA on its planned studies under the new rules. EFSA shall subsequently consult stakeholders and the public on the planned studies and, taking into account the received comments, provide the applicant with advice on the content of the intended renewal application. The reason behind this pre-submission procedure is to make use of the existing experience and knowledge on the substance or product in question. The European Commission expects that the notification obligation will have a positive effect on the evidence base of EFSA, avoids the unnecessary repetition of studies, and will provide the potential applicant with useful advice. It should, however, be noted that also in this case EFSA’s advice will not stand in the way of the subsequent assessment of the renewal application by the Scientific Panels.
Additional controls on the conduct of studies
The new provisions also include measures to ensure the quality and objectivity of the studies used by EFSA for its risk assessment. First of all, the European Commission will have the right to perform controls, including audits, to verify the compliance of testing facilities with relevant standards. Competent authorities of the Member States will be involved in these controls. Through coordination with OECD GLP auditing programs, the control in non-EU countries will be facilitated as well. Secondly, the European Commission will have the right to request EFSA to commission verification studies. Such action shall only be taken in exceptional circumstances, such as in case of serious controversies or conflicting results, and will be financed by the EU.
The new provisions address public concerns regarding transparency, while on the other hand acknowledge that confidentiality is key to not cut down on incentives for innovation by food businesses. In other words: the new provisions seek to balance transparency and confidentiality. Food businesses are advised to substantively consider their commercial interests when submitting a dossier for authorization, since confidentiality will only be granted upon duly justified requests. Moreover, the union register for submitted studies forces food businesses to carefully plan their studies at an early stage since also studies with less favorable outcomes will in principle be made public and scrutinized on inconsistencies with later studies. At the same time, more guidance is expected from EFSA in the pre-submission phase, possibly speeding up the actual authorization procedure. Given the fact that the new provisions will apply from less than 20 months from now, food businesses may consider speeding up or delaying their application for authorization, depending on their needs.
Now that the US regulatory framework is shaping up, the analogies and differences with the European regulatory framework for market access for clean meat becomes more and more clear. This blogpost reports these analogies and differences, based on the agreement that the FDA and USDA recently concluded on their cooperation in the field of clean meat.
Joint action FDA-USDA in regulating cell-based meat
On 7 March 2019, the FDA and the USDA concluded a formal agreement (“7 March Agreement”) on their cooperation to oversee the production of cell-based meat from livestock and poultry. As mentioned in an earlier blogpost, in the EU the European Commission is the one stop shop for obtaining a Novel Foods authorization. In the US however, foods can be subject to regulatory oversight by multiple federal and state agencies. In general, USDA regulates meat and poultry, including the inspection of establishments that slaughter such animals or otherwise process meat and poultry products. FDA generally regulates all other food, including fish and certain other meat and poultry products, such as bison, rabbits, and wild turkeys and ducks.
Essence of the 7 March Agreement
The 7 March Agreement is quite a relief for the market players concerned. For instance, the Good Food Institute issued a press release, stating “The agreement is a significant step forward in providing a transparent and predictable regulatory path to market for cell-based meat, which will help to ensure that the U.S. does not fall behind Israel, China, Japan, the Netherlands, Singapore, and other countries that are moving quickly to ensure a clear path to market for this method of meat production”. In essence, according to the 7 March Agreement, FDA is competent to oversee cell culture and production up to harvest of the cultured meat cells, whereas USDA takes over responsibility as of harvest up to and including the actual production of clean meat products. For clarity, clean fish is not included in the 7 March Agreement, as this under the remit of FDA. It seems safe to assume however that what the agencies will do for clean meat and poultry, they will do for clean fish. This assumption is based on the agreement that the agencies will develop joint principles for product labeling to ensure that products are labeled consistently and transparently.
Analogies between EU and US
By far the most important analogy is that both regulatory systems aim to assure that clean meat products hitting the market are “safe, wholesome and unadulterated” (see point 4 B (3) of 7 March Agreement). In fact, to the EU Novel Foods Regulation aims to ensure “the effective functioning of the internal market while providing a high level of protection of human health and consumers’ interest.” In order to achieve this purpose, both regulatory systems require prior market authorization, but the way such authorization procedure is put in place is in fact quite different.
Differences between the EU and US
In order to visualize the differences between the two regulatory systems at each side of the Atlantic, I have created the schematic overview below. On the left side, I summarized the authority of the FDA and the USDA under the 7 March Agreement. On the right side, I outlined how legal authority is attributed in the EU and in its Member States. As a reference Member State, the Netherlands (“NL”) has been retained, as this is one of the EU countries where clean meat activities are prominent.
|1.||Pre-market consultation to evaluate production materials & processes||No formal pre-market consultation procedure in EU Novel Foods framework, except the optional consultation at Member State level in case of doubt whether the product qualifies as a Novel Food (which is clear in the case of clean meat)|
|2.||Oversee cell collection and quality of cell banks||Oversight of preparatory production steps, as well as registration of a company as a food business operator (FBO) will be done at Member State level. In the NL, FBOs working with products from animal origin, require a so-called recognition (“erkenning“). This is a more detailed procedure (average term: 8 weeks) than the mere registration of a FBO (average term: few days).|
|3.||Oversee production process until harvest|
|4.||Ensure companies comply with FDA requirements: facility registration, cGMP and other applicable food legislation|
|5.||Where needed: issuing regulations or guidance or additional requirements re. # (2) and (3) to ensure that biological materials exiting the culturing process are safe (FFDCA)||EU Hygiene regulation targeting food of animal origin (853/2004) to apply and potentially national legislation as well. In the NL, the Commodities Act Decrees on hygiene and on the preparation and packaging of foodstuffs are applicable. Additional requirements (“conditions of use”) may also be included in individual Novel Food authorizations.|
|6.||Inspections and enforcement directed at safety of cell banks and culturing facilities||Inspections and enforcement are done at Member State level. In the NL the responsible entity is the Dutch Food Safety Authority.|
|USDA (“post harvest”)|
|7.||Determine whether harvested cells are eligible to be processed in meat or poultry products||The NF-framework requires FBOs in their application for market authorization to specify the source of the product, its production process and typical compositional features. No additional eligibility test upon cell harvest prior to production of food products.|
|8.||Require each clean meat company to obtain a so-called grant of inspection||Not required under EU legal framework. Registration (or recognition) with the competent Food Safety Authority provides the authority with the legal basis for inspection. Obviously, a Novel Food authorization must also be obtained before placing the product on the market.|
|9.||Conduct inspections in establishments where cells cultured from livestock and poultry are harvested, processed, packaged or labeled to ensure that the resulting products are safe, unadulterated, wholesome and properly labeled.||Inspections will be executed at a Member State level, based on the Official Controls Regulation 854/2004 targeting products of animal origin for human consumption inter alia.|
|10.||Pre-approval of labeling of clean meat products and inspection thereof||No pre-approval of product labels under EU NF-framework. It is the responsibility of the FBO himself to comply with applicable labeling legislation, such as the Food Information to Consumers Regulation 1169/2011.|
|11.||Where needed: develop additional requirements to ensure the safety and accurate labeling of clean meat products||Safety and Labeling provisions already in place at EU level. These are embodied in the General Food Law Regulation 178/2002 and the Food Information to Consumers Regulation 1169/2011 respectively. Furthermore, specific labeling requirements may be included in Novel Food authorizations. Also, post-market monitoring requirements may be imposed. In any event, FBOs should inform the Commission of any new relevant information regarding the safety of the NF they have placed on the market.|
|12.||Enforcement actions re. adulterated or misbranded food products||See comment to # 6. Competitors, consumers and watchdog organizations may also bring cases re. misleading food information before self-regulatory bodies. From example, unpermitted references to “meat” could be a topic of such cases.|
|Both FDA and USDA|
|13.||Each entity to cooperate with the other upon transfer or regulatory oversight at harvest|
|14.||Each party to notify the other if it identifies objectionable conditions resulting in adulterated / misbranded clean meat products|
No pre-market consultation in the EU
One of the most striking differences is that under the EU Novel Foods procedure, there is no formal pre-market consultation procedure to evaluate production materials and processes. I consider this to be a flaw in the law. Under the former Novel Foods Regulation that was in place until 1 January 2018, applications had to be filed with the competent authority at a Member State level. These authorities, at least in the Netherlands, were often willing to answer questions that arose during the preparation of applications. Under the current Novel Foods Regulation, applications have to be directly filed with the European Commission via an e-portal. There are no formal procedures to contact either the European Commission, or EFSA to answer questions on applications. If you manage to have informal consultation with an EFSA representative, no questions regarding particular applications will be answered, so a sectoral approach is your best bet. In short, we will have to learn by doing!
Written EFSA guidance
Where guidance by the Commission or EFSA on a personal level is not available, there is ample guidance based on a 2016 EFSA Scientific Opinion and a 2018 EFSA Technical Report. In fact, the 2016 Opinion provides detailed comments as to the various data to be provided in the Novel Food application, for instance on the identity of the Novel Food. For clean meat in particular, the identity of the cells from which the meat product is cultured should be provided, as well as the cell substrate used during the cultivation process, which should also be described in detail. The 2018 Report provides applicants with a completeness checklist, covering all items that should be specified in a Novel Food application. It also provides a helpful overview table of study reports contained in the technical dossier.
Contrary to the US, where enforcement is done by the authorities who also define the regulatory framework, enforcement in the EU is a national affair. This means that not the European Commission, nor EFSA are involved, but the national competent authorities. In the Netherlands, this is the Dutch Food Safety Authority, whose enforcement policy is on public record. For instance, enforcement measures directed at marketing clean meat without a proper Novel Food authorization translate into a penalty and the prohibition to further market the product. Since enforcement is a national affair, measures may vary from Member State to Member state. When marketing clean meat in Europe, it is therefore not sufficient to be familiar with the EU framework but one is strongly recommended to also gain local advice.
Open ends still occur at both sides of the Atlantic. In the US, the 7 March Agreement has given a flavor on how the FDA and USDA will cooperate, but “it does not create binding, enforceable obligations against either Agency.” So, it needs to be seen how this will work out in practice, for instance regarding the pre-approval of labels. Will the authority at Federal level take away the necessity for evaluation at State level? In the EU, it remains to be seen what type of studies EFSA will want to see to specify nutritional and toxicological information, as well as allergenicity: literature studies or rather in vitro or in vivo data?
At FoodHealthLegal, we will closely monitor the regulatory developments in the clean meat space, so stay tuned!
Credits for graphics: Mosa Meat
Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products are Novel Foods. What is the current state of play regarding these products and how is enforcement going to look like?
Current state of play re. cannabis derived products
In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 % weight per weight. The Common Catalogue is embodied in the EC Plant Variety database, which currently lists 68 species of Cannabis sativa. Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour and defatted hemp seed have a history of consumption in the EU and therefore, in principle, are not novel.
This is different for extracts derived from Cannabis sativa L. and derived products containing cannabinoids, such as cannabidiol (CBD). It follows from a recent clarification of the Novel Food Catalogue that these products are considered Novel Foods, as a history of consumption regarding these products has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient. If for instance CBD is added to hemp seed oil, the product can no longer be marketed just like that and requires market authorization. The status of Novel Food also applies to extracts of other plants containing cannabinoids and to synthetically obtained cannabinoids.
How does the market of CBD food products currently look like?
Currently, the market in CBD food products is flourishing. A variety of CBD nutraceutical products is being offered for sale, such as HempFlax CBD, CBD oil, but also CBD-infused tea, honey or sweets. Although there is no hard-scientific evidence, many health benefits are connected to CBD food products, such as stress reduction, good night rest and providing energy and increasing resistance. Contrary to products containing THC (tetrahydrocannabinol), which is also extracted from cannabis, you do not get high on CBD food products, as this is not a psychoactive substance.
Medicinal use of cannabis
The use of cannabis derived CBD in food is not to be confused with medicinal use of cannabis. In most cases of medicinally applied cannabis, the active ingredient is THC, not just CBD, or a combination of THC and CBD. Although medicinally applied cannabis does not play a role in the cure of diseases, scientific publications show it can alleviate suffering from diseases, for instance nausea, decreased appetite, slimming or weakening due to cancer.
Consequences for business of the change in legal framework
Due to the qualification of CBD food products as Novel Foods, the lively trade in these products is currently at risk. Any Novel Food has to obtain a market authorization in order to get market access. CBD food products currently marketed may face enforcement measures, unless they can benefit from the transition regime laid down in the Novel Foods Regulation. According to this transition regime, any product that did not fall within the scope of the former Novel Foods Regulation, was lawfully marketed prior to 1 January 2018 and for which an application for market authorization is filed before 2 January 2020, can continue to be marketed until an authorization decision has been taken. While this transition period is in principle drafted for Novel Foods that fall into one of the new novel food categories under the new Novel Foods Regulation, it is in the spirit of the transition regime to also include the CBD scenario.
Pending CBD-application and expected EFSA opinion
Currently, one application for the authorization of a CBD food supplement is pending. The application was made by the company Cannabis Pharma from the Czech Republic and is based on publicly available safety and toxicological information and toxicity reviews. More in particular, the scientific data has been gathered from acute and long-term toxicity studies in animals and tolerance studies in humans. The data package submitted aims to support the safety of the use of CBD in food supplements for adults with a daily intake of up to 130 mg or 1.86 mg/kg body weight. It is reported by various sources that an EFSA opinion is awaited this March (see here and here).
Any benefits for the CBD market of a positive EFSA opinion?
Contrary to the situation under the former Novel Foods Regulation, the authorizations granted under the current Regulation have a generic nature. This means that any other company meeting the conditions of use stated in the authorization, would be at liberty to market CBD food supplements as well. The pending application made by Cannabis Pharma is therefore followed with great interest by the CBD market. As they do not seem to rely on data protection, a granted authorization would pave the way for other food supplement companies. It is not certain if this will happen still this year. If and when EFSA grants a positive opinion this March, the European Commission still has 7 months to submit an implementing act to the PAFF Committee. Upon a positive opinion of the PAFF committee, such implementing act could be quickly adopted. If the PAFF Committee has no opinion or a negative opinion, 1 or 2 months should be added to the procedure as a minimum.
Ireland: some CBD food products can be marketed
Meanwhile, there is some guidance available at Member State level. The Irish Food Safety Authority notes that recently a large number of CBD food products entered the market, typically marketed as food supplements in liquid or capsule form. Depending on the manufacturing process applied, the trade in CBD oil is not prohibited, as this oil naturally contains low levels of CBD, which is considered a non-psychoactive compound. This applies to CDB oil obtained by cold-pressing the hemp seeds. If and when the oil is obtained by supercritical CO2 extraction, then a Novel Food authorization is mandatory.
Denmark: available guidance not crystal clear
According to the Danish Ministry of Environment and Food, a number of Cannabis-derived products are not considered Novel Food, notably hemp seeds, seed flour, protein powder from seeds and seed oil from the Cannabis sativa L. varieties listed in the EC Plant Variety Database that are free from or contain low levels of THC. If these products contain CBD, the regulatory status is not exactly clear. According to the guidance of the Danish Food Ministry, the current status is that pure cannabidiol as well as hemp products with high (concentrated) levels of CBD or other cannabinoids are covered by the Novel Foods Regulation. It is not explained what is understood by “high levels of CBD”, but on the other hand an absolute prohibition to market these products in Denmark does not seem to apply.
Absolute prohibitions: Belgium and Austria
Other Member States seem to be stricter than Ireland or Denmark. For instance, the Austrian Health Ministry has made it perfectly clear that food products containing any type of cannabinoid extract without a Novel Food authorization are prohibited to be put on the market. In Belgium, the Federal Agency on Safety in the Food Chain has clarified that the production and marketing of food products based on cannabis is prohibited. The rationale is that the plant Cannabis sativa is mentioned in an annex to a national Decree listing dangerous plants that cannot be used for food production. The prohibition primarily seems to target the potentially dangerous substance of THC and allows derogations on a case-by-case basis, but not regarding food products containing CBD. These are considered Novel Foods requiring a market authorization.
Enforcement directed against (medical) claims in the Netherlands
Until CBD was declared a Novel Food, the trade in CBD food products was not prohibited in the Netherlands. Contrary to the substance TCH, the substance CBD is not mentioned in the Dutch Opium Act, listing prohibited substances having a psycho active effect. This does not mean that the trade in CBD food products was allowed just like that. In practice, enforcement in the Netherlands has been directed against the use of any unauthorized medical claims. A medical claim is any information according to which a food product could have a therapeutic or prophylactic effect. When using such a claim, one comes into the realm of the Medicinal Product Act, according to which it is prohibited to market and advertise any medicinal product without a market authorization. The Dutch Food Safety Authority announced fines up to
€ 10.000 regarding the sale of CBD food products in several cases (see here and here). Any food business operator that is serious about his business in CBD food products will therefore not only check the applicability of the Novel Foods Regulation to his products, but also carefully draft his advertisement for this type of product.
The production and marketing of food products derived from Cannabis sativa L. in the EU has been considerably restricted since CDB food products were recently declared to be Novel Foods. However, not all cannabis-derived food products require market authorization. Pending the evaluation of the Novel Food application filed for a CBD food supplement by the Czech company Cannabis Pharma, it is worthwhile for other CBD food products to verify whether they can benefit from the so-called transition regime embodied in the Novel Foods Regulation. Due to differences between legislation in the Member States, this may differ from country to country. Also, it is important to carefully position your CBD food product, in order to avoid any medical claims.
The author ackowledges Jasmin Buijs, paralegal at Axon, and Max Luijkx, intern at Axon, for their valuable input.
“The FDA knows just how vital it is to ensure the safety of our nation’s food supply and the critical role science-based, modern regulatory frameworks are to fostering innovation. Recent advances in animal cell cultured food products present many important and timely technical and regulatory considerations for the FDA and our partners at USDA,” said Commissioner Gottlieb. “We look forward to the opportunity to hold a meeting with our USDA colleagues as part of an open public dialogue regarding these products.”
Harvard Law School
This is a new quote taken from the website of the FDA, regarding a joint FDA – USDA meeting on animal cell culture technology on 23 and 24 October 2018 in Washington. Securing regulatory clearance is pivotal for market access of this type of products, which used to be often referred to as “clean meat,” “cell-based meat,” or “lab-grown meat,” depending on whom you would ask. Since the Good Food Conference early September, there seems to be consensus to retain the term “cell-based meat”. To date, there is however no consensus on the appropriate US regulatory framework for these products, which is why this new meeting has been set. In particular, it is not clear which federal regulatory agency – the FDA or USDA or both – has jurisdiction over these products with respect to labeling, safety and inspections, or whether these products will meet regulatory definitions relating to “meat” and “poultry.” Harvard Law School, in particular its representatives from the Food Law and Animal Law groups, recognizes the potential benefits of clean meat and other cellular agriculture products. Therefore, on 9 and 10 August 2018, the school organized the Clean Meat Regulatory Roundtable in order to address the regulatory concerns surrounding this new industry. Further to an earlier post on this subject, this is take #2 on the Harvard initiative, reporting a selection of topics discussed at that table. Also a comparison with the EU regulatory framework shall be made where relevant.
Participants Regulatory Round Table and Ruled of Play
In order to let the discussion benefit from as many perspectives as possible, representatives from academia, the industry and from interest groups participated in Harvard’s Clean Meat Regulatory Roundtable. Obviously, the meeting included a number of representatives from Harvard Law School. Furthermore, the nonprofit organizations Good Food Instituteand the Animal League Defense Fund were present. The participating companies were Mosa Meat and Fork & Goode (both working on clean meat), as well as Blue Nalu (working on clean fish). From the investor side, Stray Dog Capital was represented and from the industry DuPont provided its input. Finally, a number of US lawyers participated, including Deepti Kulkarni from Sidley Austin LLP. I myself shared my insights on this topic from an EU perspective. To encourage openness and the sharing of information, all participants agreed to a Chatham House Rules + regime, meaning that the topics discussed during the meeting could be reported, but the participants were not at liberty to identify, either explicitly or implicitly, the identity of the speaker or his or her affiliation.
Cooperation on optimal regulatory pathway?
Amongst the participants, there was a common concern that if one party rushes unprepared to the market, ignoring the appropriate regulatory pathways, that could poison the well for the entire cellular agricultural industry. It was therefore discussed to what extent the cellular agriculture industry could cooperate regulatory-wise. It became clear that even though clean meat products share certain characteristics, finished products could be quite different in terms of formulation, composition, or other product characteristics. Nonetheless, general principles for assessing safety and product identity could be established under existing regulatory authorities. Such principles could for instance involve considerations relating to substances used in the production of clean meat, including scaffolds, growth factors, and cell culture medium or potential variations in the production process. In addition, it was discussed whether common interests could be effectively promoted through a trade association or industry group. The participants discussed various options, including setting up a dedicated association and connecting with existing organizations such as BIO.
Contrary to the situation in the EU, where the European Commission is the one stop shop for obtaining a Novel Foods authorization, in the US foods can be subject to regulatory oversight by multiple federal and state agencies. It is has not yet been decided which agency has jurisdiction over these products, or whether the products are subject to dual oversight. In general, USDA regulates meat and poultry, including the inspection of establishments that slaughter such animals or otherwise process meat and poultry products. FDA generally regulates all other food, including fish and certain other meat and poultry products, such as bison, rabbits, and wild turkeys and ducks. In addition, FDA regulates new ingredients (as “food additives”) used in the production of foods under its jurisdiction, as well as new ingredients used in meat and poultry products that otherwise would be subject to USDA oversight.
Meat and poultry products subject to USDA jurisdiction generally require “continuous” or daily inspection, depending upon the nature and frequency of operations. Because the production of clean meat does not involve slaughtering animals and such products would not be derived from slaughtered animals, there are open questions regarding the applicability of USDA’s inspection regime. This is even more so when clean meat products are not “harvested” daily, but on a batch-based basis. Arguments, nonetheless, can be made in favor of USDA jurisdiction with respect to “processing” inspections and other in-market activities, as well as product labeling. Nevertheless, at the Roundtable, there seemed to be a slight preference for FDA jurisdiction both pre-market and in-market.
Traditional meat industry’s concern of level playing field
The views of the traditional meat industry are somewhat fractured with respect to the clean meat industry. Some have taken considerable stakes in clean meat ventures (consider the investments of both Tyson and Cargill in Memphis Meats), particularly industry segments more closely involved with raising livestock are less supportive. For example, the US Cattleman’s Association submitted a petition to the USDA in February this year, asking it to establish labeling requirements that would prohibit clean meat from using terms like “meat” or “beef” in product labeling. Most trade groups representing the traditional meat industry have called for a “level playing field” where clean meat products would be subject to some level of USDA inspection. In general, all participants at the Harvard Panel agreed that a discussion with the traditional meat industry on how clean meat should be regulated would be critical. Notably, clean meat producer Memphis Meats and the North American Meat Institute, a trade group that represents the largest meat producers in the U.S. recently issued a joint letter to the White House outlining a regulatory regime under both FDA and USDA, and calling for a combined meeting involving the White House, USDA, FDA, and representatives of the traditional meat and clean meat industries.
Even if the FDA were to have some level of jurisdiction over clean meat products, it is still not completely clear what data would need to be submitted to demonstrate safety. One of the participants opined that, unlike a food additive approval, neither a GRAS determination, nor an FDA consultation (see here for an example of a consultation procedure on plant based products) would result in an affirmative regulatory approval. Some were of the opinion that a regulatory opinion short of approval would not benefit the clean meat industry, particularly in the eyes of the public. By contrast, others particularly those familiar with the GRAS process and the requisite scientific information needed to demonstrate safety disagreed with the position that a GRAS determination would not be rigorous or otherwise appropriate. The participants then discussed that a potential hybrid model that followed the GRAS approach, but also involved a third-party safety opinion could be an option. As to the required data, it was discussed what would be the “ingredient” that would be assessed by the competent government agency. The substances used in the culture of clean meat products most likely are of relevance, even if they may qualify as mere processing aids that normally only remain as residues in the final product without technical function. One participant mentioned such substances could easily be tested in separate toxicology studies, to which reference could be made during the pre-market evaluation (US) or in the application for a Novel Foods authorization (EU).
EU market entry of Novel Foods
Compared to the US, the regulatory pathway for clean meat products in the European Union is relatively clear. Under the new Novel Foods Regulation (effective as per 1 January 2018), an application for an authorization of a Novel Food should be made with the European Commission, who will subsequently distribute this to all EU Member States. The application should in the first place contain a detailed description of the product for which an authorization is sought, as well as of its production process. Furthermore, a proposal for the purported conditions of use should be handed in and a labelling proposal that does not mislead the consumer. Last but not least, the applicant should provide scientific evidence, demonstrating the purported Novel Food does not pose a safety risk. For this purpose, tox studies that comply with Good Laboratory Practices are mandatory, as is an evaluation of the total safety strategy. This should be based on proposed uses and likely exposure, with justification to include or exclude certain studies in order to prevent cherry picking. Upon receipt of the Novel Food application, it is anticipated that the Commission will request a safety opinion from EFSA, who will evaluate, amongst other things, if the Novel Food concerned is as safe as food from a comparable food category already placed on the EU market. The EFSA evaluation should not exceed a 9 months term. Within 7 months after receipt of a positive safety opinion, the Commission should publish its implementing act, which will result in the inclusion of the approved Novel Food in the Union List. The single open end in this procedure is the term for response for the Member States, which in the former Novel Food Regulation used to be 60 days. Surprisingly enough, this term is not mentioned in the new Novel Food Regulation that applies as of 1 January this year. However, there are no reasons to believe this should be any different under the current Novel Foods Regulation.
In order to inspire consumer confidence in clean meat products, the participants discussed how to best ensure the products’ short and long-term safety, particularly against the backdrop of public fear and aversion to genetically modified foods. Despite the assurance that FDA provided regarding the safety of these foods, many consumers remain fearful or otherwise suspicious of such foods. The participants agreed that steps should be taken to avoid a similar unwarranted aversion to clean meat products, including transparency initiatives and consumer education. In this framework, it was suggested that the clean meat industry could pro-actively develop its own HACCP program, provided that the industry could reach agreement on what would be the best way to identify the hazards and applicable critical control points. To this respect, it is relevant that both FDA and USDA have HACCP regulations and have identified hazards of chemical, biological and physical nature that might be applicable to this new sector.
Labeling, marketing, product identity
Vivid discussions took place regarding whether or not clean meat or fish products could be called “meat” or “fish” respectively. Whereas some argued: “Meat is what it is, so meat it should be called”, others considered the actual name less important. Most likely, we will not see the plain term “meat” on product packaging, but rather “ground beef,” “meatballs,” or “chicken tenders”. Some participants cautioned that, in order for products to be labeled with such product-specified terms, they generally would have to meet the general definitions for “meat” or “poultry,” unless the labeling adequately described or qualified the product. For product placement, it is of relevance whether the clean meat products belong to the “meat department” or somewhere else, though several participants clarified that such placement is decided by agreements with retailers, rather than by regulatory oversight. All participants agreed that a so-called qualifier that would explain the exact nature of the product, could benefit the industry. Such qualifier should be a neutral term, explaining concisely how clean meat products differ positively from traditional meat products, without being pejorative vis-à-vis said traditional industry. This is easier said than done and the participants so far did not reach a common view at this point. Notably, in their joint letter to the White House, Memphis Meats and the North American Meat Institute, propose use of the term “cell-based” meat or poultry to describe products that are the result of animal cell culture. The echo of this letter was heard at the Good Food Conference, as reported above.
Information requirements in the EU
Looking at the EU framework, it is questionable whether the designation “meat” can be used for clean meat products. As an argument in favor thereof, it could be mentioned such use would make it immediately apparent that these products equal traditional meat in terms of composition. Arguments countering the use of “meat” are based on the EU Hygiene Regulation. When using a grammatical approach, it should be observed that “meat” is defined as “edible parts of [a number of defined]animals” and one could wonder if cells qualify as such. When using a functional interpretation, it can be noted that hygiene requirements applicable to meat mainly relate to slaughtering, whereas clean meat obviously is not subject to slaughter. Another argument countering the use of “meat” for clean meat products is derived from the ECJ’s TofuTown case, related to veggie cheese and soy yoghurt. In legal terms, this decision answered the question whether it was permitted to use regulated product names for new product types. The answer was a clear “no”. It is anticipated that the traditional meat industry will rely on this case to counter the use of the name “meat” for clean meat product, at least without a qualifier that will prevent any misleading of the consumer. By way of background, it is helpful to remember that under EU labeling laws, it is mandatory to designate a food product by its legal name. In the absence thereof, a descriptive name can be used or alternatively, a customary name.
Clean meat and clean fish represent an emerging sector, with the promise of revolutionary innovative products. Public perception of these products, as well as trust in the safety thereof, will be of utmost importance for market success. Reliable and effective regulatory procedures as a basis for market access will therefore be pivotal. In the US, the regulatory framework applicable to clean meat products is far from clear. Firstly, it is yet to be decided which government agency has jurisdiction over these products or whether both FDA and USDA share oversight. Secondly, there are open questions regarding the appropriate regulatory pathway and in-market inspection regime. In the European Union, the regulatory pathway for clean meat products is relatively clear. Under the new EU Novel Foods Regulation, these products qualify as Novel Foods and require a market authorization from the European Commission. The Regulation as well as various EFSA guidance documents detail at length what information should be contained in a Novel Foods application. In an optimal situation, the authorization procedure could be finalized in 18 months. In both the US and the EU however, the exact designation of these products (“meat” or not?) requires further thought. On the one hand, this will require interpretation of legal product definitions and case-law and on the other hand, the interests of the traditional meat and fish sector should be taken into account.
Cultured meat has been an increasingly hot topic since the first “clean meat” hamburger was introduced in London in 2013. The technology involves using cell culturing techniques to multiply a small amount of cells taken from an animal to produce foods that resemble traditional meat, poultry, and seafood. As commercial-scale production of cultured meat becomes foreseeable, regulatory agencies must determine how these products fit into their food compliance programs.”
Harvard Law School
This is a quote taken from the website of the FDA, who organized a public meeting on 12 July 2018 to discuss safety-related data and information that the FDA is seeking on foods produced using animal cell culture techniques. Securing regulatory approval is pivotal for market access of this type of products. To date, there is no consensus how the US regulatory apparatus will classify Clean Meat products. It is neither clear which authority has jurisdiction over these products as to labeling, safety and inspections. Harvard Law School, in particular its representatives from the Food Law and Animal Law groups, is convinced of the potential benefits of Clean Meat and other cellular agriculture products. Therefore, on 9 and 10 August 2018, it organized the Clean Meat Regulatory Roundtable in order to address the regulatory concerns surrounding this new industry. A selection of topics discussed will be covered in two subsequent blogposts. The first one will cover some background information and a summary. The second one will provide an overview of the most important subjects discussed and a comparison with the EU regulatory framework where relevant.
Participants Regulatory Round Table and Ruled of Play
In order to let the discussion benefit from as many perspectives as possible, representatives from academia, the industry and from interest groups participated in Harvard’s Clean Meat Regulatory Round Table. Obviously, the meeting included a number of representatives from Harvard Law School. Furthermore, the nonprofit organizations Good Food Institute and the Animal League Defense Fund were present. The participating companies were Mosa Meat and Fork & Goode (both working on clean meat), as well as Blue Nalu (working on clean fish). From the investor side, Stray Dog Capital was represented and from the industry DuPont provided its input. Finally, a number of US lawyers were participating and I myself shared my insights from an EU perspective. All participants agreed to a Chattam House Rules + regime, meaning that the general flush of the conversation during the meeting can be reported, but the participant are not at liberty to identify, either explicitly or implicitly, what was the source of particular information.
Clean meat and clean fish represent an emerging sector, with the promise of revolutionary innovative products. Public perception of these products, as well as trust in the safety thereof, will be of utmost importance for market success. Reliable and effective regulatory procedures as a basis for market access will therefore be pivotal. In the US, the regulatory framework applicable to clean meat products is far from clear. Firstly, it is yet to be decided which government agency has jurisdiction over these products. Secondly, the regulatory pathway is still open, whereas the available procedures of do not provide an affirmative blessing from which the sector could benefit. In the European Union, the regulatory pathway for clean meat products is relatively clear. Under the new Novel Foods Regulation (effective as per 1 January 2018), these products qualify as Novel Foods and require a market authorization from the European Commission. The Regulation as well as various EFSA guidance documents detail at length what information should be contained in a Novel Foods application. In an optimal situation, the authorization procedure could be finalized in 18 months. In both the US and the EU however, the exact designation of these products (“meat” or not?) requires further thought. On the one hand, this will require interpretation of legal product definitions and case-law and on the other hand, the interests of the traditional meat and fish sector should be taken into account.
The People’s Republic of China first law on Traditional Chinese Herbal Medicine came into force on the 1st of July 2017. This law encompasses industrial normalization by guaranteeing the quality and safety of herbs in cultivation, collection, storage and processing. Producers of Traditional Chinese Medicine (hereinafter TCM) are not only targeting the Chinese market, but are also looking for access to the European market. With this new legislation in force in China, it is a good time to have a look at the current possibilities for market access of TCM on the European market. The name “TCM” would suggest the product could only be qualified as a medicinal product. However, other product qualifications are possible as well. In this post, it will be investigated how Chinese herbal remedies and products fit into the EU framework.
For market access, product qualification is vital. Qualification of TCM as medicinal products might seem obvious. However, western medicine is mostly focused on curing a certain disease or disorder, whereas TCM is focused on healing the body itself. Healing in short means the body should be strengthened to ‘treat itself’. Many of the traditional herbal remedies have healing properties, such as strengthening the immune system. As an alternative to medicinal products, other qualifications of TCM could be botanicals, so that they could be marketed as food supplements or as other foodstuffs. We previously reported on product qualification in this blog, explaining what legal tools have been developed for this purpose over time in case law. These criteria equally apply to TCM.
Simplified registration procedure for traditional herbal medicinal products
An example of a traditional herbal medicinal product we can mention sweet fennel, which is indicated for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. For this group of traditional herbal medicinal products, just like for TCM, a simplified registration regime can be found in the EU Medicinal Products Regulation. In short, the efficacy of the product containing the herb used in TCM’s can be substantiated with data on usage of the herb. This eliminates the need for costly clinical trails to prove the efficacy of the active ingredient(s) in the product. However, safety and quality of the TCM still need to be substantiated.
Eligibility for simplified registration procedure
To qualify as traditional herbal medicinal product, a number of cumulative criteria should be met, including the following.
- Evidence is available on medicinal use of the product during at least 30 years prior to application for EU market authorization, of which at least 15 years within the EU.
- Such evidence sufficiently demonstrates the product is not harmful in the specified conditions of use and the efficacy is plausible on the basis of longstanding use and experience.
- The product is intended and designed for use without the supervision of a medical practitioner and can only be administrated orally, externally and/or via inhalation.
The presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for the simplified registration referred to above. At least, this is the case as the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). TCM intended and designed to be prescribed by a medical practitioner can enter the EU market, but cannot benefit from the simplified registration procedure for traditional herbal medicinal products.
Currently the focus of healthcare is shifting from purely curing diseases to prevention thereof. TCM could play an interesting role in such paradigm shift. Although food business operators (hereinafter FBOs) cannot claim a foodstuff can cure a disease, such product can contribute to prevention of a disease. As such, FBOs can inform the public that consumption of a particular foodstuff can support the regular action of particular body functions. An example of a herbal remedy used in TCM and currently on the EU market is cinnamon tea; used in Chinese medicine to prevent and treat the common cold and upper-respiratory congestion. Obviously, the advantage of bringing a foodstuff (for instance, a food supplement) to the market as opposed to a medicinal product is that unless the foodstuff is a Novel Food, you do not need a prior authorization.
As long as a foodstuff has a history of safe use in the EU dating back prior to 1997, FBOs do not need prior approval for market introduction. If no such history of safe use can be established, both the current and new Novel Food Regulation prescribe that the FBO receives a Novel food authorization. A helpful tool for establishing a history of safe use is the novel foods catalogue, being a non-exhaustive list of products and ingredients and their regulatory status. Another source is Tea Herbal and infusions Europe (hereinafter THIE); the European association representing the interests of manufactures and traders of tea and herbal infusions as well as extracts thereof in the EU. THIE’s Compendium, which should be read in combination with THIE’s inventory list (also non-exhaustive), contains numerous herbs and aqueous extracts thereof, which are used in the EU. Other herbs might not be considered Novel Foods, as long as the FBO can prove a history of safe use in the EU prior to 1997. For instance, the history of safe use of Goji berries has been successfully substantiated.
Traditional foodstuffs from third countries
In previous blogs we already pointed to a new procedure to receive a Novel Food authorization as of 1 January 2018, relating to ‘traditional foods from third countries’. EFSA published a guidance document for FBOs wishing to bring traditional foods to the EU market, enabling them to use data from third counties instead of European data for the substantiation of the safety of the foodstuff. The procedure is a simplified procedure to obtain a Novel Food authorization for a foodstuff, which has been consumed in a third country for at least a period of 25 years. For sure, this is not an easy one, but we have high hopes that such data can be established for TCM being used in Asia. In the affirmative, the FBO can use these data to substantiate the safety of the product and receive a Novel Foods authorization via a 4 months short track procedure, enabling the FBO to market the foodstuff at stake in the EU.
Health claims for herbal products
The EU Claims Regulation provides the legal framework for health and nutrition claims to be used on foodstuffs. In previous blogs we elaborated how such claims can be used for botanicals, being herbs and extracts thereof. So far, no authorized claims for botanicals are available, but their use is nevertheless possible under certain circumstances. In sum, an on-hold claim can be used when the FBO clearly states the conditional character thereof (by stating the number of such on hold claim on this claims spreadsheet. Upon dispute, the FBO should furthermore be able to substantiate that the compound in the final product can have the claimed effect when consumed in reasonable amounts. TCM can take advantage of this current practice, thereby communicating the healing effect thereof, which basically comes down to a contribution to general health. It should be carefully checked though, if the claim for the herbal remedy at stake has not been rejected, as happened to four claims regarding caffeine.
EU market introduction of TCM could take place in various ways, depending on the qualification of the product at stake. Qualification as a regular foodstuff certainly ensures the quickest way to market, as no prior market approval is required. This will be different if the product qualifies as a Novel Food. However, as of 1 January 2018, a fast track authorization procedure will be available for traditional foods from third countries, from which TCM might benefit as well. TCM could furthermore use so-called botanical claims, in order to communicate the healing effects thereof. When the TCM qualifies as a medicinal product, the good news is that for traditional herbal medicinal products, a simplified registration procedure is available under the EU Medicinal Product Directive, provided that certain criteria are met. Registration takes place via the national competent authorities in each Member State, which in the Netherlands is the Medicines Evaluation Board (CBG).