Last month, the conference Regulating the Future of Foods took place in Barcelona, gathered more than hundred professionals active in the fields of precision fermentation and cellular agriculture. The purpose of the conference was to define hurdles and investigate opportunities in the current regulatory framework applicable to this sector. Many interesting presentations took place discussing the global perspective of our future food system and AXON moderated a workshop targeting tastings of cultivated foods, formulating a number of conversation topics. In this blogpost, we share the outcome of the discussions that took place during this workshop.
Regulatory frameworks for tastings
Tastings of these products already took place, for instance in Israel. So far however only two countries have developed a legal framework for this purpose, notably Singapore and the Netherlands. In the tastings workshop, the procedure and the data requirements for setting up tastings in these countries have been explained, as you can see in the powerpoint inserted below. Furthermore, the following items were discussed.
1. Should the SGP / NL template become the blueprint for tastings or rather do this under the radar?
As follows from the comparison of the regulatory frameworks in Singapore and the Netherlands, these hugely overlap. Therefore, the question arose if these frameworks should become the blueprint for tastings in other countries. Kind Earth.Tech rightfully pointed out that at the beginning of the cultivated meat industry 10 years ago, all tastings held were illegal. They were however important to demonstrate proof of principle and to create appetite for further research. At the current state of the industry, all participants in the workshop however favoured a framework for tastings. Especially for start-ups, a tastings framework is valuable for showing both press and investors what they are up to. Furthermore, the Dutch initiative is useful to convince other EU Member States to develop similar initiatives. Bluu Seafood pointed out that Germany in particular was pretty shy to do so, as it considered tastings not to be in compliance with the EU Novel Food Regulation. Now German start-ups can point to the Dutch framework and request their authorities to take such initiative.
Another reason why tastings might be useful, is that the regulatory process takes a substantial amount of time. In Singapore, predicted timelines for Novel Food approval are between 9 – 12 months, but in reality, these go up. In fact, we have not seen any approvals for cell-based meat products since those for Good Meat and Upside Foods in Q4 2020. In the EU, the theoretic term for Novel Food approvals is about 18 months, but we know from practice it is more realistic to count 2 – 3 years. For the new industries of cellular agriculture, it remains to be seen if this term will apply as well. Demonstrating proof of principle during tastings can be a welcome deliverable before the final go.
Both in Singapore and the Netherlands, tastings should be done in a confined area, not open to the general public. This was understood by all participants in the workshop. At the same time, the concern was expressed that tastings should not become too clinical. They are meant to enjoy food products after all, not to evaluate medicinal products. Provided that a confined area and a selected audience can guaranteed, they can also be set up in a restaurant. Organising tastings during regular opening hours of restaurants will not yet be feasible, as such would fall within the scope of “placing on the market” under article 3.8 of the EU General Food Law Regulation. And placing on the market of Novel Foods requires pre-market approval.
2. For those previously involved in tastings: are they worth the efforts and did they bring you the data you were looking for?
The parameters set in the regulatory tasting frameworks are meant to be high enough to ensure food security but not dissuasive for companies to demonstrate safety prior to obtaining market authorization. Nevertheless, it takes considerable efforts to accommodate these parameters. For instance, producing useful microbiology data requires a minimum quantity of the product to be produced, which at this stage is still very expensive.
Obviously, the tastings themselves require substantial product input, often in combination with various non-cultivated carriers creating a hybrid product. This requires investments which for start-up companies can be challenging.
However, tastings have proved most valuable to collect input from chefs who will be working with cultivated products and to provide proof of principle to investors. In particular, repeating tastings with the same chefs offers the advantage that they can monitor and comment progress made and provide suggestions for further improvement, especially to accommodate the local palette.
2. Is the available guidance from the regulators sufficiently clear to decide how to set up the tasting and establish the safety of your product? Has the regulator been helpful in clarifying any company queries?
Companies that already conducted tastings in Singapore considered the Singapore Food Authority (SFA) to be helpful in not only overseeing this process, but also in facilitating it. Where a first tasting takes quite some work in setting up safety documentation and addressing any potential concerns of the regulator, repeated tastings proved to require much less preparations. This is particularly true if all tastings take place at the same location, as it facilitates the medical contingency plan. This requires the indication how much time it takes to reach a medical centre if any problems occur.
Most importantly, permission for tastings being granted is perceived as a quiet vote of confidence by the regulator, as it seems to have a minimum level of comfort with the safety of the product to be tasted.
3. Do you see any value in tastings to be set up at an EU level as opposed to national level only?
No, not really. It is important to create a product that appeals locally, and this may differ from community to community. Also, it was discussed that tastings organized at a central level could induce companies to rely on the greatest common denominator, i.e. a burger. This would in fact be a pity, as cultivated foods offer so much more opportunities than that. This was for instance demonstrated by Vow Foods who made a crème brûlée with its cultivated quail.
4. Any ideas what could be done to prevent that tastings slow down regulatory approvals?
The representative from SFA explained that the total staff available for the safety assessment of Novel Food AND the evaluation of an exemption for the tasting and sensory evaluation of Novel Foods is four to five persons. It is easy to understand that the more time is spent on the evaluation of tastings, the less time can be spent on the safety assessment of Novel Foods as such.
It was discussed that if tastings go wrong, for instance by creating a health problem, they imply a risk, not only for the product at stake, but also for the sector. On the other hand, tastings also spark enthusiasm, as was demonstrated by Solar Foods who even held tastings after obtaining market approval in Singapore.
So the communis opinion was that tastings should be dosed. Do not overdo it, but carefully weigh the advantage it can bring your company at a particular moment of its lifetime, for example during a funding round.
5. Do tastings qualify as studies under the EU Transparency Regulation, that should be notified to EFSA during an application for authorization of a Novel Food?
The EFSA representative present in Barcelona was quite outspoken regarding this question. If you have any concerns about toxicity or any other possible hazard, you do not want to expose your intended audience for tastings to such hazard. A tasting session is not a study. So no, tastings as such do not have to be notified to EFSA under the Transparency Regulation.
In the Netherlands, the CAN Expert Committee is expected to be nominated early 2024 and local companies are already gearing up for organizing tastings in situ. So soon the Dutch will continue to work on their Dutch dream. Watch that space!
Germany’s highest court, the Bundesgerichtshof, asked the European Court of Justice (ECJ) this summer to explain the use of ‘on hold’ claims for so-called ‘botanicals’. The question is whether these substances may be advertised with health claims or general, non-specific health benefits as long as the assessment by EFSA has not been completed and the European Commission has not yet taken a final decision on the authorization of these claims.
This question stems from proceedings initiated by the German unfair competition association Verband Sozialer Wettbewerb e.V.. We owe many ECJ rulings to this German association, including the famous TofuTown ruling from which it follows that milk designations are reserved for animal dairy products only. We covered the TofuTown case in an earlier blogpost. The current case is against the food supplement company Novel Nutriology, which sells, among other things, an ‘anti-stress’ supplement containing saffron and melon juice extract.
The saffron extract is said to create a more positive mood, according to the seller’s website. This expression is backed by the results of an open study on 50 participants over a 30-day period. Research has shown that the melon juice extract reduces feelings of stress and fatigue, according to the website. Verband Sozialer Wettbewerb e. V. considers these to be unpermitted health claims. It therefore requested Novel Nutriology to stop making these claims, but the supplement company did not listen.
Approved health claims
Health claims are in principle only allowed if they are included in the lists of approved claims under the EU Claims Regulation. This follows from article 10(1) Claims Regulation. References to general, non-specific health benefits such as ‘heart health’ and ‘mental energy’ are allowed if accompanied by a specific, approved claim (article 10(3) Claims Regulation). However, health claims for botanicals are ‘on hold’ and are therefore not included in the lists of approved claims. Therefore, the literal text of Article 10(1) and (3) Claims Regulation cannot be met when making health claims for botanicals.
Claims Regulation nevertheless applicable to botanicals?
To determine whether Novel Nutriology violates the prohibition on making unauthorized health claims, it is essential to know whether Article 10(1) and (3) of the Claims Regulation apply to botanicals. If not, violation of these provisions is out of the question.
As can be seen from the summary of the request for the preliminary ruling, the view is generally taken that references to general health benefits of botanicals must comply with Article 10(3) Claims Regulation. The requirements of this provision are met if the generic health benefit is accompanied by the full, specific health claim that is ‘on hold’. That full ‘on hold’ claim, although not officially authorized, may be used in accordance with the transitional measures in Article 28(5) and (6) Claims Regulation. It would not be compatible with the purpose of Article 10(1) and (3) Claims Regulation to exclude these provisions entirely for botanicals. Such would namely mean that botanical substances may be advertised with non-specific health claims without a scientific assessment of the specific claim supporting them.
Nevertheless, the Bundesgerichtshof finds it unclear whether Article 10(1) and (3) Claims Regulation apply to botanicals. As an argument against applicability, the German court states that the Union legislator would have considered an absolute ban on general health benefits as too broad. Therefore, the Union legislator intended to ban such only if the general claim is not accompanied by an approved, specific health claim.
It is currently however impossible to obtain approval for botanical claims that are ‘on hold’ due to the European Commission’s inaction. By making Article 10(3) Claims Regulation applicable to these substances, the prohibition becomes broader than the Union legislator would have intended. It should therefore be assumed that general health benefits for botanicals are not regulated until the European Commission continues the authorization procedure for ‘on hold’ claims. Based on this alternative view, Article 10(3) of the Claims Regulation should not apply until then.
A second argument raised against the applicability of Article 10(1) and (3) Claims Regulation to botanicals is that the European Commission has not taken action on ‘on hold’ claims for many years. Upholding the applicability of Article 10(1) and (3) Claims Regulation, which cannot be met for ‘on hold’ claims, would lead to a disproportionate restriction of the interests of companies making such claims.
Previous ECJ rulings
Whether the aforementioned alternative views are sufficient to exclude botanicals from the scope of Article 10(1) and (3) Claims Regulation remains to be seen. As highlighted in a report published last September, companies are able to make health claims for botanicals that are included in the ‘on hold’ list under the transitional regime of Article 28(5) and (6) of the Claims Regulation. Moreover, the ECJ ruled in previous cases that companies making ‘on hold’ claims are not disproportionately disadvantaged. Since they can make claims without EFSA having assessed these and/or without a final decision from the European Commission, they are in fact favored.
Aforementioned report also highlights that the ECJ previously made explicit that Article 28(5) Claims Regulation makes an exception for the use of specific health claims as referred to in Article 13(1)(a) Claims Regulation that have not yet been officially approved. The report therefore concludes that the mentioned transitional regime only applies to the full specific claim and not to general health benefits. General health benefits would therefore not be allowed, although it is recognized that some EU member states do accept general health benefits for botanicals when accompanied by the full ‘on hold’ claim.
Relevance for practice
Health claims for botanicals are currently accepted in the Netherlands if the roadmap of the Dutch agency regulating health products (the Keuringsraad) in cooperation with the NVWA, is met (see here, in Dutch). In brief, this means that (i) the substance and claim are present on the ‘on hold’ list, (ii) potential conditions of use such as a daily dosage are included on the label, (iii) the claim is in line with the wording accepted on KOAG KAG’s ‘indicative list’, and (iv) a disclaimer regarding the ongoing approval procedure is made.
If the ECJ rules that Article 10(1) and (3) Claims Regulation does not apply to botanicals, it is uncertain whether the Keuringsraad roadmap can be upheld. It is however more likely that the ECJ will clarify that botanicals do fall within the scope of the aforementioned provisions. In that case, various outcomes are still possible. In connection with the transitional provisions of Article 28 Claims Regulation, a difference may arise for full ‘on hold’ claims and general health benefits. Such will partly depend on whether the ECJ sticks to the literal text of the transitional provisions (which would prohibit the use of general health benefits), or takes into account current practices (in which case advertising with general health benefits remains allowed under certain conditions). To be continued!
Food businesses operators that make medical claims for their products in the Netherlands can be fined for doing so under food law. However, they also run the risk of being fined under the Dutch Medicines Act (in Dutch: “Geneesmiddelenwet”), in which case much higher fine amounts apply. The latter sometimes provokes surprise and outrage. Based on three recent rulings, we see a positive trend, which is explained below.
In principle, a medicinal product cannot be sold in the Netherlands without an authorization. Advertising a medicinal product that has not been authorized is prohibited as well. If a product is classified as such and sold without a license, the seller risks a hefty fine.
The legal definition of the term medicinal product and the corresponding authorization requirement can be found in the Dutch Medicines Act, which is based on the European Directive 2001/83/EC (the “Medicinal Product Directive”). The Medicinal Product Directive provides two criteria for the definition of a medicinal product: qualification by presentation and qualification by function. If a product meets one of these two criteria, it is classified as a medicinal product. The aforementioned criteria are further elaborated in case law.
Qualification by function
A product is a medicinal product by function (see the Hecht-Pharma judgment) if it can be administered to cure or prevent disease, diagnose or otherwise affect a person’s bodily functions. Of particular importance here are the composition and properties of the product, the method of use, the extent of distribution of the product, the consumers’ familiarity with the product and the health risks associated with its use.
Qualification by presentation
When applying the presentation criterion (see the Van Bennekom judgment), consideration is – unsurprisingly – given to whether a product should be regarded as a medicinal product on the basis of its presentation. It is not necessary that the product is expressly indicated or recommended as a medicinal product. The presentation criterion is already met if the manner of presentation gives the average consumer the impression that the product has a medicinal effect. The form in which the product is presented may give an indication for this, especially in the case of tablets, pills and capsules.
In particular the presentation criterion poses a risk to food companies. If they (unintentionally) make a medical claim in respect of their product, the presentation criterion may result in this product being classified (also) as a medicinal product by the Dutch Food and Consumer Product Safety Authority (“NVWA”). In that case, the NVWA may issue a fine under the Dutch Medicines Act. The starting point for such fine is €150,000, which is then differentiated based on the Policy rules of the Dutch Ministry of Health 2019. Even if the product also falls within the legal definition of food, the Dutch Medicines Act may apply simultaneously. The foregoing follows from the so-called hierarchy provision embodied in article 2.2 of the Medicinal Products Directive, which has been implemented into Dutch law as well. On the basis of this hierarchy principle, the Dutch Medicines Act is applicable if there is any doubt about the applicable product category. The result of this provision is that even a seller of coconut oil can receive a fine under the Dutch Medicines Act.
New trend in enforcement of medical claims?
Dutch case law gives numerous examples of products being classified as medicinal products by courts based on (solely) the presentation criterion. Recently, three court rulings have been rendered which give reason to assume that there is a new trend in case law. These are a ruling of the District Court of Oost-Brabant of March 25, 2022, and two (materially identical) rulings of the District Court of The Hague of June 28, 2022, regarding food supplements and follow-on milk, respectively.
The first case concerns the sale of dietary supplements, for which medical claims were made. The NVWA therefore classifies these supplements as medicinal products based on the presentation criterion and imposes two fines under the Dutch Medicines Act (both for sale and for advertising an unregistered medicinal product). The seller’s defense is that the Dutch Medicines Act should be interpreted in accordance with the Medicinal Product Directive and that it follows from there that the contested decision of the NVWA is based on an incorrect legal basis.
The court agreed with this argumentation, referring to the amendment of the Medicinal Product Directive of 2004. The court deduces from the preamble to the amendment that the Medicinal Product Directive does not apply if there is no doubt that a product clearly exclusively belongs to another product category, such as food or food supplements. The court ruled that this was indeed the case for the specific circumstances that were under discussion. The products clearly fall under the category of food supplements and therefore solely food law applies. The court confirms that the Dutch Medicines Act must, after all, be interpreted in accordance with the Medicinal Product Directive. The court therefore does not proceed testing the medical claims made against the presentation criterion based on drug legislation at all.
The above ruling raises the question when a product is “clearly exclusively” a food and what aspects of the product are important in this respect. Indications for this can be found in the two recent decisions of the District Court of The Hague regarding specific food products for toddlers, namely follow-on formula. In its assessment of whether the follow-on formula in question could be a medicinal product by presentation, the court determined that such qualification is not obvious with regard to products sold in supermarkets and drugstores. Another factor in this case was that the detailed information about the follow-on formula, on the basis of which the Dutch Ministry of Health (the counterparty in the cases at stake) believed it to be a medicinal product by presentation, could only be found on the seller’s website.
Based on the rulings discussed, we signal a trend that judges are halting the current practice of enforcement of prohibited medical claims for food products based on the Dutch Medicines Act. The discussed rulings make clear that (prohibited) health claims for food supplements and for other food products such as follow-on formula should be assessed on the basis of the Food Information for Consumers Regulation (the “FIC Regulation”), and not via the presentation criterion based on the Dutch Medicines Act. In our opinion this is justified, because since the FIC Regulation became applicable, food law is specifically set up to do so. We are very curious to see whether the trend initiated above will be followed by other courts. Although it follows from a ruling of the District Court of Zeeland-West-Brabant of 21 October, 2022, that this is not yet the case, we trust this will only be a matter of time.
The above does however not mean that food business operators would be allowed to make medical claims for their products. Also, the FIC Regulation contains a ban on medical claims for food products and the Nutrition and Health Claims Regulation sets forth a strict regime for authorized health claims. Having said that, fines following a violation of food legislation are far lower than fines based on the Dutch Medicines Act. On balance, food companies are therefore better off with fines based on food legislation.
This blogpost is written by Max Baltussen, Karin Verzijden and Jasmin Buijs.
The authors want to acknowledge Ebba Hoogenraad and Irene Verheijen for sharing the case law discussed here.
Last summer, the European Single-Use Plastics (SUP) Directive became applicable. This Directive places restrictions on the use of single-use plastic food packaging (and other plastic products). Where do we stand 1 year after the SUP Directive’s date of application? How has this Directive been implemented in the Netherlands, what are the bottlenecks and what can we still expect?
The EU has set itself the goal of becoming a leader in the global fight against marine waste and pollution from plastic products. The SUP Directive contains several measures to help reaching this goal. These range from marking requirements on the presence of plastic and its negative impact on the environment (e.g. on to-go coffee cups) to a total ban for products for which more sustainable alternatives are already available (such as for plastic plates and cutlery). However, the scope of the SUP Directive is not crystal clear. For example, the definition of ‘single-use plastic product’ is interpreted differently in different countries.
Scope of the SUP Directive
All types of plastics
The SUP Directive defines plastic as a material consisting of a polymer as defined in the REACH Regulation (and which can function as a main structural component of final products – more about this requirement below). Additives or other substances may have been added to the polymer. Natural polymers that have not been chemically modified are not covered by the definition of plastic in the SUP Directive. While the Directive does not provide a further explanation of this concept, the European Commission’s Guidelines (“EC Guidelines” or “Guidelines”) provide further clarification. The aim of the Guidelines is to ensure a harmonized interpretation of the SUP Directive. According to these Guidelines, practically all types of plastics are covered by the SUP Directive, including so-called bio plastics. The Netherlands follows this interpretation in its Explanatory Memorandum to the Dutch SUP Regulation. What supported this approach by the Dutch government is its intention to prevent a shift from single-use plastic packaging to other types of disposable packaging that may also end up as litter and has a negative impact on the environment.
Even products with a small amount of plastic
Both products that consist wholly and partially of plastic can fall under the scope of the SUP Directive. The Directive does not refer to a certain minimum percentage of plastic that must be present. The EC Guidelines clarify that a qualitative assessment should be made, taking into account the objectives of the Directive. Thus, according to the EC Guidelines, otherwise non-plastic products fall under the definition of plastic as referred to in the SUP-Directive if a plastic layer or coating is applied to provide protection against water or fat. Think, for example, of paper- or cardboard-based cups for beverages. Such products often end up as litter. Continuing to allow these products without restrictions does not fit the transition to a circular economy, as part of which waste must be reduced and reuse encouraged. Having said that, non-plastic products seem to be excluded from the scope of the SUP Directive if these contain polymeric materials solely in the form of paints, inks and adhesives (recital 11 to the SUP Directive).
In practice, there is (still) a lot of discussion about the question when a product is or is not a plastic product as referred to in the SUP Directive. Some EU Member States introduced a certain threshold value. As a result, paper and cardboard beverage cups and other food packaging that contain polymers in amounts below the maximum threshold do not fall under the SUP Directive in those Member States. The Netherlands purposely did not introduce such limit. Moreover, the Netherlands considers polymers applied as water or fat barriers to be a structural main component of food packaging. The reasoning behind this is that the packaging does not function for its intended use without such barrier. As a result of this approach, almost every material used for disposable food (incl. beverage) packaging falls within the scope of the Dutch SUP measures. As stated in the above-mentioned Explanatory Memorandum, this facilitates enforcement of the measures and makes them better fraud-proof.
Single-use vs. reuse
Once it has been determined that a product qualifies as a plastic product under the SUP Directive, it is relevant to determine whether the product is intended for single-use or reuse. Obviously, the SUP Directive only applies in case of the former. The mere fact that a product may be sold for multiple use cycles is insufficient to pass this test; relevant is whether reuse is included in the design of the product. For example, can the product be adequately cleaned without creating (food safety) hazards for the expected use? The possible reuse of packaging may be determined on the basis of the essential requirements in the Packaging and Packaging Waste Directive. Packaging being suitability for reuse can also be proven if part of a system that guarantees such reuse. Consider, for example, plastic beverage cups that, after use, are taken back by the dispensing location to be cleaned and then refilled. Whether a product is intended for one-time use must be considered on a case-by-case basis. The Dutch competent authority in the Netherlands, Human Environment and Transport Inspectorate (in Dutch: Inspectie Leefomgeving en Transport, or “ILT”), may issue additional guidelines for this purpose for the Dutch market.
Implementation in the Netherlands
In the Netherlands, the SUP Directive has been implemented through the SUP Decree (in Dutch: “Besluit kunststofproducten voor eenmalig gebruik“). This decree required amendments to the Packaging Management Decree 2014 (in Dutch: “Besluit beheer verpakkingen 2014”). The measures under the Decree are further detailed in the SUP Regulation (in Dutch: “Regeling kunststofproducten voor eenmalig gebruik”). The Dutch SUP Regulation gives substance to the freedom of policy granted to EU Member States under the EU SUP Directive. In concrete terms it sets rules for consumption reduction. For this purpose, different regimes will apply to consumption on-the-go on the one hand, and onsite use of disposables on the other hand. Extended producer responsibility, awareness raising measures (such as through national campaigns) and monitoring and reporting obligations are also covered by the Dutch SUP Regulation. The Regulation knows a phased implementation from January 1, 2023. The Dutch Ministry of Infrastructure and Water Management (in Dutch: Ministerie van Infrastructuur en Waterstaat, or “I&W”) keeps stakeholders informed of SUP-related developments in the Netherlands through online newsletters and webinars. A lot of information about the SUP Directive can also be obtained via the Netherlands Institute for Sustainable Packaging (in Dutch: “Kennisinstituut Duurzaam Verpakken”, or “KIDV”), such as a handy decision tree.
Practice in the Netherlands
The new rules have not gone unnoticed by consumers. Packaging for food on-the-go and other single-use plastic products now carry a marking that confronts the consumer with their use of such products. Several beverage dispensing locations have already taken a lead on the abovementioned Dutch SUP Regulation and have in place a deposit system for collection and reuse. The above examples show that various producers and importers have taken the necessary measures to act in accordance with the SUP Directive. At the same time, we notice that companies involved in the single-use plastics supply chain still have many questions. In our experience, most of these questions can be answered by carefully reading the detailed EC Guidelines. Since these Guidelines have an authoritative but no legal status, they may however leave the door open for alternative interpretations. So far, we are not aware of any relevant enforcement examples as a result of interpretation disputes. While these may emerge in the future, sufficient enforcement capacity will be a point of attention. Concerns for such are being expressed in Dutch politics, particularly in relation to the upcoming Dutch Single-Use Plastics Regulation. The ILT is currently assessing the required additional enforcement capacity.
Differences in Member States
Looking outside our own borders, we notice differences in the implementation of the SUP Directive among EU Member States. For example, some Member States such as Italy apply a threshold value for polymers in non-plastic products (10% by weight), while others don’t. Another example concerns an extended ban on single-use plastic products beyond the products banned under the SUP Directive, such as in France. Consumption reduction measures also vary from Member State to Member State, as shown by the report on reuse systems (in Dutch) commissioned by the Dutch Ministry of Infrastructure and Water Management. As a result of the above, companies that market their products in several Member States face challenges to ensure compliance in all markets in which they are active.
The SUP Directive became applicable over a year ago. The Directive provides for a phased implementation, which we see reflected in the Dutch SUP legislation. The implementation of the SUP-Directive is therefore still in full swing, both at home and abroad. Interpretation and implementation differences are not to be overlooked and companies are challenged to deal with this efficiently. Sharing best practices can be useful here, particularly when the phased implementation progresses and concrete enforcement actions start to take place. Feel free to reach out in case of any implementation issues you want to discuss.