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!
In a recent decision of the Board of Appeal of the Dutch Advertising Code Committee (ACC), it was made clear that providing food information to consumers is serious business. The ACC in the Netherlands is a self-regulatory body, comparable to the Advertising Standards Authority in the UK and the German Advertising Standards Council (“Deutscher Werberat”) . This means that companies (including food business operators) voluntarily submit to the competence of such body and, as far as the Netherlands are concerned, usually comply with its recommendations. In the food space, decisions of these self-regulatory bodies grow in importance, as they quite often are precursors of similar decisions in civil proceedings.
The decision from the ACC discussed here relates to the FrieslandCampina product referred to in Dutch as Optimel vanille vla, which in English comes down to vanilla custard. In the Netherlands, it’s a product that has been around for years (one of my favourite deserts as a child, especially with a boost of read jam!) The product showed FOP a picture of yellow custard but not any vanilla pods, it contained the description “soft vanilla taste” and the label indicated it contained vanilla aroma, without specifying if the vanilla was from natural or chemical origin. In fact, the vanilla was from chemical origin (in legal terms a “flavouring substance”) and the Dutch food watchdog Foodwatch considered this to be misleading.
Decision in first instance (19 February 2019)
In first instance, the claim from Foodwatch was upheld. Now that the product stated both front and back of pack the word “vanilla” in quite a striking way, the average consumer would reasonably expect the product to contain (real) vanilla, and not just a chemical flavouring substance. Both parties had submitted market surveys with (not surprisingly) the contradictory result that the average consumer would expect (Foodwatch) and would not expect (FrieslandCampina) the product to contain “real” vanilla. Both surveys had been discarded and the practise was considered misleading based on article 7 of the FIC Regulation. Friesland Campina’s defense that in the Netherlands “vanille vla” was a customary name, in the sense of article 2 (c) of the FIC Regulation, for a product of which the average Dutch consumer would understand it does not contain any “real” vanilla was not considered convincing.
Defence on appeal
On appeal, FrieslandCampina had developed three arguments. Firstly, it had argued the description of “soft vanilla taste” in fact functioned as a so-called taste disclaimer, adequately informing the consumer that product tasted like vanilla, which does not necessarily mean it contains vanilla. Secondly, FrieslandCampina opposed the way in which its market survey had been discarded. Whereas this survey demonstrated 76% of the consumers did not expect the vanilla to originate from fruits from the vanilla plant, the ACC had focused on the remaining part, stating that 26% did have opposite expectations. Thirdly, Friesland Campina had argued that the average consumer knows that the term “flavouring” does not necessarily refer to a particular source, otherwise the term “natural flavouring” would be used.
Decision on appeal (16 May 2019)
This line of defence did not produce the desired result. Overall, the ACC considered FrieslandCampina had overestimated the knowledge of the average food consumer. The name of the product specifically referring to a particular ingredient, the average consumer could undeniably expect the product to contain vanilla. This expectation had been insufficiently “neutralized” by the additional information on the product, like the description “soft vanilla taste” and the aroma in the list of ingredients. FrieslandCampina itself seemed to have understood this as well. During the oral hearing, it had announced it planned to adjust the packaging of the product at stake.
I do not consider the practice to Friesland Campina to be deliberately misleading. As mentioned above, this type of product had been around for decades and personally, I cannot recall the issue at stake to have been an issue at all. In addition, one could say that an average and reasonably well-informed consumer should reasonably understand that if the product contained “real” vanilla, it would be much more expensive. However, times have changed. Enforcement of the FIC regulation is for real and so is the position taken by consumer organisations. More and more consumers do want to know what’s in their food and what not, so FBO’s will need to be more accurate than in the old days in their product labelling and presentation. This implies, amongst other things, that a careful distinction will have to be made between food ingredients on the one hand, and flavourings on the other hand. Furthermore, when using the term “natural” in combination with “flavouring”, at least 95 % of the flavouring component should be obtained from the material referred to. In sum, I expect to see similar decisions in future, not only from self-regulatory bodies like the ACC, but also from civil courts from other EU Member States.
From 7 – 9 May 2019, the Vitafoods conference took place again in Geneva. For a few years in a row, I presented at the Education Program. This year I was asked to discuss the application of CBD in food products, which is currently a hot topic. Below, I will share the insight from my presenation, as well as two other trends I came across at the trade show.
(1) Cannabis, cannabis, cannabis
Cannabis was omnipresent at Vitafoods 2019. I do not mean the smell of it, but its application in food, pharma and in cosmetics. FoodHealthLegal being dedicated to food products, this post will uniquely focus on food application of (parts of) Cannabis. In our practice, we also deal with the other applications thereof. As pointed out in an earlier blogpost, FBO’s in the field of Cannabis were recently confronted with a change in the Novel Food catalogue. Since 20 January this year, CBD was declared a Novel Food. In my presentation during Vitafoods, I explained that this does not necessarily mean that each FBO needs to obtain an (individual) NF authorization. In fact, I identified 5 ways to market CBD food products, as further detailed in my slides:
- no Novel Food;
- individual / joint Novel Food application;
- rely on third party authorization;
- take advantage from the transition regime;
- use national consultation procedure.
Food supplements targeting a cosmetic effect, so-called nutricosmetics, were present in great numbers too. The rationale behind these products is that cosmetic effects do not only derive from topical applications but can just as well be achieved via food (“beauty from within”). Communicating the benefits of these products is to some extent easier than communication around “regular” food supplements, as one can rely on so-called beauty claims. These are claims that uniquely target appearance of skin, hair and nails and not any beneficial nutritional or physiological effect on the body. These types of claims are not covered by the Claims Regulation, so one has flexibility in the wording thereof. In practise, these claims are usually supported by efficacy studies, as the burden of proof obviously is on the FBO marketing the nutricosmetic at stake. In addition to beauty claims, a number of health claims relate to beauty as well. The compounds covered include biotin, iodine and Vitamins A, B2 and C amongst others. As a result, attractive general health claims can be used for nutricosmetics, when specific ingredients thereof meet the parameters for these specific claims.
As an example, the product Lycoderm can be mentioned. This is a carotenoids and rosemary blend aimed at enhancing the benefits of topical skin treatment. The product is marketed stating that “antioxidants like carotenoids help balance our skin from environmental stressors such as UV rays”. The shorter version thereof could be “carotenoids help maintain healthy, smooth skin.” So far, no authorised health claim for carotenoids is in place, but it is possible to make a beauty claim regarding the effects thereof in a nutricosmetic (if powered by science). When using the authorised health claim for Vitamin E (“contributes to the protection of cells from oxidative stress”), a short attractive claim could read “beauty comes from within.”
(3) Digital nutraceuticals
This is a new phenomenon according to which nutraceuticals are powered by digital support. Various examples of apps developed by manufacturers of nutraceuticals operating in a B2B context were shown, aiming to enhance the appreciation of the consumer in a B2C context. More than once, such digital support could be customized for each individual client, so that a whole new digital business is developing around food supplements.
As an example, the product Metabolaid can be mentioned. This is a food supplement manufactured by Monteloeder aiming at weight control by controlling the appetite of consumers. Clinical studies are reported to have shown that the intake of this product, together with a healthy diet and regular exercise, helps consumers to manage their body weight, blood pressure, cholesterol and glucose levels. Monteloeder has also designed an app, enabling the consumer to monitor his/her daily habits, including eating hours, frequency and sleep. Furthermore, this app allows the connection with other wearables to detect health related parameters like heart rate, steps taken and body weight. This should enable the consumer to achieve positive changes in lifestyle habits, by offering a more thorough control over his/her overall health.
Overall the Vitafoods conference offered many new insights. When adopting these, check before going to market whether your regulatory strategy is up to standards!
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.
Last week, the creation of the new Advisory Group on the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects. Its task is to issue advice on the legislation to be applied to individual products / product groups / substances belonging to a group of so-called borderline products. The reason that this Advisory Group was created is that the regulations in the field of market authorization and research with such products are complex and that it is not always clear which law is applicable. In such case it is also not clear which enforcement authority is competent to act in case of violations of the law. This is deemed undesirable by both the marketplace and the government authorities and the Advisory Group aims to change this.
Demarcation issues not new
Demarcation issues at the interface of the laws applicable to food products and medicinal products are not new. Already in a 2008 Letter to Parliament, the Dutch Health Minister reported that there was insufficient clarity about the demarcation between medicinal products and herbal remedies. The Minister reported the issue that a herbal remedy could also be a medicinal product within the meaning of the Dutch Act of Medicinal Products (in which the Medicinal Products Directive 2001/83 has been implemented). This is a consequence of the fact that the Act does not make a distinction between the origin of any active substance, which can be of human, animal, vegetable or chemical origin. When a herbal preparation qualifies as a medicinal product by function or by presentation, the Act on Medicinal Products is equally applicable.
Measures announced in the Letter of Parliament
At the time, the Health Minister did not consider it necessary to adjust the regulations to prevent demarcation issues between food products and medicinal products. He considered the criteria of “medicinal product by presentation” and “medicinal product by function” to be sufficiently clear in the first place. Secondly, he expected a beneficial effect from the list of permitted health claims that still had to be published back in 2008. He anticipated that products bearing such claims would not qualify as a medicinal product by presentation. He did, however, consider it desirable to improve cooperation between the Heath Care Inspectorate and the Food Safety Authority. This was implemented by adjusting the Decree on Supervision of Public Health, as a result of which the Food Safety Authority gained authority to enforce violations of the Act on Medicinal Products. Furthermore, it was stipulated that the structured consultation between the Heath Care Inspectorate, the Food Safety Authority and the Medicines Evaluation Board should be intensified, particularly regarding the discussion of the status of borderline products. One can say that this consultation in fact operated as an Advisory Group avant la lettre. Finally, it was determined that the already existing cooperation agreement between the Heath Care Inspectorate and Food Safety Authority had to be updated.
Demarcation issues more topical than ever
We now know that the clarification brought by the list of authorized health claims published in 2012 should not be overestimated. Nowadays many functional foods and nutraceuticals are marketed that claim medical properties. It quite often happens that it is not clear what is the applicable legislation to these products, because the boundary between health claims, disease risk reduction claims and medical claims is not immediately clear in all cases. Even when no specific claim is used, it can be debatable whether a product is a medicinal product by function or any other health product. It also happens that more or less the same products are marketed simultaneously as a medicinal product and as a foodstuff. Consider, for example, products containing glucosamine or St. John’s Wort. This means that food products containing the same active substance as medicinal products have not passed the prior testing for quality, safety and efficacy, which can be confusing for the consumer.
Consequences of product qualification
There are many examples of food products that were considered medicinal products by presentation. Consider, for example, the melatonin products which, after a remarkable turn in the Health Care Inspectorate policy, initially not but later on were considered to be medicinal products. More recently, a medical claim that Milk Thistle could prevent liver fattening was considered misleading. Furthermore, it was determined that a dietary supplement that would promote the natural immune system, would have a beneficial effect on heart and blood vessels and would help to treat fatigue qualified as a medicinal product. When such disputes are dealt with before the Civil Court, quite often fines are imposed for violations of the Act on Medicinal Products, prohibiting, among other things, the marketing and advertising of medicinal product without a marketing authorization. When these disputes are submitted to the Advertising Code Committee, usually a recommendation is made to no longer use such misleading information based on these regulations and the Code on Public Advertising of Medicinal Products. In order to prevent such enforcement activities, manufacturers of health products have every interest in knowing in advance how their product qualifies. They then know which regime applies to their product and can take this into account in their communication (advertising campaigns).
Working method Advisory Group
How does the Advisory Group work and which aspects are covered by its advice? Upon request of one of the competent authorities, the Advisory Group advises on the applicable legislation to individual products, product groups or substances. This advice gives a motivated indication of the law that applies to the opinion of the Advisory Group at the time of assessment and given the available information. “Available information” refers not only to factual information but also to applicable case law, both in the Netherlands and abroad. The advice will be presented to the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects, who will subsequently respond to this within four weeks if so desired. If the responses give cause to do so, the Advisory Group reconsiders the advice and if necessary adjusts it. The advice is then recorded in its database, which is managed by its secretariat. There is also a possibility that the Advisory Council will not reach agreement on the applicable legislation. In such a case no advice is issued; this is also recorded in the database. The Advisory Group can also change its advice in the event of changes in the legal framework. The competent enforcement authorities must report those change to the Advisory Group, which registers an amendment to a previous advice in its database, if and when applicable. For clarity, the advice assesses neither the efficacy, safety or efficacy of medical products nor the content of any research protocols.
Added value Advisory Group
Can it be expected that the Advisory Group will make a substantial contribution to demarcation issues? In itself, the intensified co-operation between all the authorities involved, at market entry rather than upon enforcement during marketing, is to be welcomed. For example, in practice, food business operators also benefit from the working agreements between the Council on Advertising Health Products and the Food Safety Authority, on the basis of which health products bearing a “stamp” of said Council are in principle not exposed to enforcement actions by the Food Safety Authority. However, it appears from the currently published agreement between the parties involved in the Advice Group that only the enforcement authorities and not the individual manufacturers can request advice from the Advisory Group. This appears to be a missed opportunity, as is the fact that the efficacy of medicinal products remains explicitly outside the Advisory Council’s assessment. To qualify the essential character of a health product, efficacy is one of the essential factors. Furthermore, it is noteworthy that the Advisory Group does not seem to address the issue of medical devices, while this qualification is closely linked to that of medicinal or food products. For example, cranberry pills against bladder infection qualify as medical devices and osmotic laxatives can be either medicinal products or medical devices.
Advice on market access for health products
For the time being, manufacturers of health products will continue to rely on private advice from qualified advisors on market access for health products. Nevertheless, the body of opinions to be produced by the Advice Group can be a valuable source of information, provided that its database will be publicly searchable. The rules of procedure of the Advice Group, which are yet to be made available, will have to provide clarity in this respect.
In their search for healthy foods, consumers nowadays often favour natural food products. But what is “natural” after all? Various interpretations could be given to this term. Amongst those figure unprocessed foods, foods without any chemical ingredients and organic foods. In reality, there is no harmonized concept of “natural foods” under EU food law. Food business operators should therefore mainly rely on the general principles of food information. In addition, they can use the nutrition claim “natural(ly)”, if and when applicable. Finally, they can turn to some specific pieces of EU legislation implementing the concept of “natural” for specific product an to a new ISO standard. This post aims to investigate what are the options for using the term “natural” based on the EU framework.
The most important principle under EU food law is that food information should not be misleading, in particular as to its characteristics, its nature and its composition. As such, it is prohibited to suggest that a food has particular characteristics, whereas in fact all similar foods possess such characteristics. For instance, certain additives, such as sweeteners or acids, may have a natural source, but the EU Additives Regulation does not make a distinction between “natural” or “artificial” (chemical) additives. Therefore, stating that a food product only contains natural preservatives could be misleading. The industry seems to have found its way around this issue. Instead of declaring an additive using the applicable E-number (for instance E 250 for sodium nitrate), the description of a natural compound having a similar technical function is used (for instance chard, having a similar preservative effect to sodium nitrate).
Where a food product naturally meets the conditions laid down in in the EU Claims Regulation for the use of a nutrition claim, the term “natural(ly) may be used as a prefix in the claim. For instance, if at least 20 % of the energy of the food product is naturally provided by protein, the claim “naturally high in protein” could be made regarding such product. Likewise, if a food product naturally contains at least 6 g fibre per 100 g product, the claim “naturally high in fibre” could be made. These claims should all relate to end products presented to consumers. As a B2B supplier of ingredients, you should therefore make the reservation to your clients that the admissibility of these claims depends on the mix of ingredients present in the end product.
The EU Flavouring Regulation constitutes a good example of targeted legislation with specific provisions on the use of “natural”. For instance, if the term “natural” is used to describe a flavour, the flavouring components should be entirely of a natural origin. Nevertheless, the term “natural flavouring” can be used in a situation where a clear relationship between different source materials in the flavouring component and the overall flavour-profile is lacking. For instance, an umami flavouring preparation consisting of certain vitamins and minerals in combination with certain fermentation media can still be labelled as “natural flavouring”.
The Dutch Advertising Code Committee (DACC) demonstrated in one of its decisions last year that the rules on the use of the term ‘‘natural’’ under the EU Flavouring Regulation can also be applied by analogy. The claim in the case in question related to BenBits chewing gum advertised as being “100 % natural”. A competitor denied that all ingredients used in this chewing gum were of a natural character. In deciding the dispute, the DACC took the expectation of the average, reasonably well-informed consumer as a starting point. Such consumer would expect the term “natural” to cover both the ingredients and the preparation processes used. BenBits could not demonstrate that the xylitol used in its product had been manufactured in accordance with one of the traditional preparation processes referred to in the EU Aroma Regulation, such as fermentation. The use of the claim “100 % natural chewing gum” was therefore considered misleading.
Recently, a new ISO standard was made available, containing technical criteria for food ingredients to be considered as natural. This standard is intended for use in B2B communications and conformity thereto helps to assure a level playing field and fair practices. According to this standard, food ingredients shall be considered as natural when certain criteria regarding both their source materials and their ways of processing are met. When a food product consists of various ingredients, for each ingredient these cumulative criteria should be met. An informative decision three in this standard helps its user decide whether or not a food ingredient is to be considered natural.
At Member State level, such as in the UK and in France, national guidance has been formulated for the use of the term “natural”. For instance, the UK Food Standard Agency issued guidelines for the use of this term and in France the Directorate General on Competition developed similar guidelines specifically targeting dairy products. These Guidelines, as well as relevant EU and national case law will be discussed during the Vitafoods session planned on 16 May from 11.20 – 12.00 AM. Hope to see you there!
Consumers across all demographics are increasingly concerned about cognitive health and performance. For that reason, Food Matters Live, held in London from 21 – 23 November last, dedicated one of its Seminars to the exploration of new R&D advancing the understanding of nutrition and cognitive health and performance. I was asked to give a presentation on meeting standards for cognitive claims, of which you will find a summary below. You will note that in addition to the system of currently authorised claims, I will explore its flexibility, as well as the options outside its scope.
The general framework for health claims is contained both in the FIC Regulation and in the Claims Regulation. The FIC Regulation embodies the principle of fair information practises. According to this principle food information should not be misleading as to the characteristics of the food, for example by attributing it effects it does not possess. Furthermore, the FIC Regulation prohibits any medical claims to be made in connection with food products. A medical claim is to be understood as any claim targeting the prevention or treatment of a particular disease. It is for instance not permitted to state that a food supplement alleviates the symptoms of rheumatoid arthritis.
The Claims Regulation lays down the very concept of a health claim, being a voluntary message in any form that states or suggests that a food has particular characteristics. Basically, a health claims conveys the message “What does the product do?” Health claims can only be made with regard to a particular nutrient that has been shown to have a beneficial nutritional of physiological effect. Such nutrient should be present in the end product in a form that is bio available and to such extent that it produces the claimed effect. The scope of the Claims Regulation includes all commercial communications regarding food products to be delivered to the final consumer. Based on the Innova / Vital decision of the ECJ, it was clarified that such final consumer can also be a health care professional.
Legal framework for cognitive claims
Currently, authorised claims for cognition can be linked to iodine, iron and zinc. For all of these compounds, the claim “contributes to the normal cognitive function” can be made. In addition, for iodine the claim “contributes to the normal functioning of the nervous system” is available and for iron a claim specifically targeting children can be made. The conditions of use for these claims are calculated on the reference intake (“RI”) applicable to each mineral. As such, a distinction is being made between solids (15 % RI) and fluids (7.5% RI). For instance, in order to allow a cognition claim linked to iron, the end product should at least contain 2.1 mg iron / 100 g or 1.05 mg / 100 ml. Any claim should refer to a food product ready for consumption, prepared in accordance with the manufacturer’s instructions.
Flexibility in wording
In practise, I see that many food business operators try to reword the authorised claims, as they are not considered to be a major add-on. In the Netherlands, this practise has been facilitated by the Council for the Public Advertising of Health Products (Keuringsraad KOAG-KAG), who has published a list of alternative, authorized claims. For instance, for a claim on zinc, the Dutch translation of the wording “contributes to a regular problem-solving ability” is permitted as an alternative. Regarding a claim on iodine, you could think of “plays an important role in mental activity.” Furthermore, it is also permitted to state that a food product containing the required minimum of iron “contributes to regular intelligence”. Now we are talking!
Examples found in practise
An internet search for products targeting cognition revealed that many of them are not linked to the EU authorized claims at all. For instance, the company Flora Health is marketing the food supplement ginkgo biloba, claiming that it “helps to enhance cognitive function and memory in an aging population.” Also, the food supplement Mind Focus containing various vitamins, minerals and green tea extract from the company Bio Fusion was found, which allegedly “improves mind focus and concentration instantly”. Furthermore, the green oat product Neuravena was found, regarding which five clinical studies confirm it benefits to cognitive function. How can this be explained? The first two examples contain claims that in the EU would no doubt qualify as medical claims and as such are prohibited.
Non-EU products and options outside cognitive claims framework
Products that do not comply with EU standards may originate from other countries or territories that are subject to a different regulatory regime than applicable in the EU. Without endorsing any claims made, it was found that the gingko and Mind Focus products originated from Canada and the US respectively. The same is not true for the product Neuravena, as its manufacturer Frutarom claims to be a “global manufacturer of health ingredients backed by the science, and supported with documentation and the regulatory compliance our customers demand.” The difference here is that Neuravena is not advertised on a commercial setting targeting end consumers, but in a scientific portal. The website even contains a disclaimer to that extent. In a non-commercial, purely scientific environment, the Claims Regulation is not applicable. This allows FBO’s, provided that the same website does not contain a click through ordering portal, to communicate on their R&D and cognition even outside the authorised EU framework.
The EU authorised claims for cognition are limited in number and scope. Several EU Member States offer considerable flexibility in wording, which makes the use of claims much more appealing. Furthermore, in a science-based context, the Claims Regulation is not applicable, which allows you plenty of opportunity to communicate your latest R&D on nutrition & cognition, provided that the message is strictly scientific and not commercial.