Cultured meat is making its way to the market globally. Recently, we saw this movie from Super Meat, serving cultured meat in a restaurant where in the same time cultured meat was actually being cultured. Earlier, tasting sessions by Aleph Farms of its cell-based steak were shared via social media. And at the end of last year, it was reported that Eat Just had gained regulatory approval to market its cultured chicken in Singapore. This made me (and I guess many others!) wonder how the regulatory approval process is set up in the Lion City. Last week, I had an interview with the Singapore Food Agency (SFA), the outcome of which I report in this blogpost. I also compare the information received to the regulatory system for authorisation of cultured meat in place in the EU.
Which foods are considered Novel Foods in Singapore?
Before putting in place its Novel Foods regulatory framework in 2019, the SFA took inspiration from similar legislation applicable in other parts of the world, amongst others in the EU. This clearly transpires from the definition of a Novel Food. The SFA considers Novel Foods to be foods that do not have a history of safe use. This is the case if substances have not been consumed as an ongoing part of the (human) diet by a significant human population during at least 20 years. This definition is pretty similar to the one used in the EU, except that the EU definition uses (i) 15 May 1997 as a fixed point in time cut-off date and (ii) a closed-loop system of 10 Novel Food categories. In Singapore, just like in other places of the world, it goes without saying that cultured meat (“meat developed from animal cell culture”) requires prior market authorisation. Whereas in the EU this could also take place (depending on the production process applied) on the basis of a GMO authorisation, my understanding is that in Singapore the designated route is a Novel Food authorisation. In the EU, a distinction is made between foods containing GMOs and foods produced from GMOs on the one hand and food produced with GMOs on the other. Whereas the first two categories require GMO clearance, the third one does not.
Organisation Singapore Food Agency
Contrary to the EU, where EFSA operates as an external advisory body to the European Commission the National Centre for Food Science (NCFS) forms an integral part of the SFA. The NCFS consists of food inspection services and laboratory testing services and a representative thereof also took part in the interview. This setup and Singapore’s 5.7 million inhabitants (compared to over 445 million in the EU) potentially explains the shorter timelines during the regulatory approval process, as outlined below.
Regulatory Approval Process
The SFA acknowledges the science for producing cultured meat is still in an early stage. So far, it has set up a modest framework defining the Requirements for the Safety Assessment of Novel Foods. It however explicitly states the information required may change based on the developments on the science of producing cultured meat. The data required for evaluating the safety of Novel Foods largely correspond to the data required under the EU regulatory framework. They include information on the identity and the manufacturing process applied, as well as on the intended use and proposed levels of use. Toxicity studies (both in-vitro and in-vivo) and metabolism or toxicokinetic studies are requested “where relevant”. For cultured meat specifically, they include information on the cell lines, culture media and scaffolding materials used. Finally, any safety assessment reports conducted by the food safety authorities of Australia, Canada, New Zealand, Japan, the EU and the USA are considered relevant. For the EU, the SFA Guidance states that safety assessments conducted in accordance with the ESFA Guidance for submission of food additive evaluations would be accepted for review. This guidance is referred to in the EFSA Guidance for novel food applications in the context of toxicity testing and propagates a tiered approach for the type of safety parameters to be satisfied. This means that if no risk indicators are revealed in the studies performed in the first tier, no studies from the second or third tier need to be carried out.
The estimated timeline to complete an evaluation of a Novel Food in Singapore is said to be 3 – 6 months. During the interview however, SFA staff indicated this to be “slightly optimistic”. For the time being, the SFA has not yet put down any requirements regarding procedural aspects of a Novel Food application; this is still in the works. What struck me most during the interview is the informal and cooperative approach of the SFA. They seem to offer their assistance as a service rather than that they position themselves as rigid safety assessors. Also, they much encourage companies to consult SFA early in their product development process (referred to as “early-stage engagement”). This will enable mutual understanding of the production process of the cultured meat product at stake, as well as the applicable safety requirements. This may subsequently enable companies to make deliberate choices in their manufacturing setup. All of this is quite different in the EU, where interactions with EFSA is highly regulated and where detailed procedural regulations for submissions are in place, amongst others in view of protection of transparency in the safety evaluation process. Also, based on the Union studies database, it will be public what studies form the backbone of the safety evaluation for the Novel Food at stake.
Confidentiality vs. transparency
The notion of transparency was not mentioned once during my interview with the SFA. Instead, it was said that all information submitted during the application process is confidential. This may be advantageous for companies who want to make it quickly to the market. In the long run, and especially if authorisation of Novel Foods by the SFA will operate as a steppingstone for access of other Asian markets, I expect the need for a similar system as in place in the EU will arise.
Can cultured meat actually be called meat in Singapore? This may seem to be a no-brainer, but this is a highly debated question in the EU, where also the use of typical dairy names for plant-based alternatives is prohibited. The designation “meat” for cultured meat products in the EU may be limited based on the Hygiene Regulation, that reserves the name of “meat” for “edible parts” of specific animals, such as beef and pork. Now that cultivated cells (or even stem-cells) may not necessarily qualify as such edible parts, this issue still needs to be resolved. When marketing cultured meat products, the SFA does not oppose the designation of “meat”, provided that it is accompanied by a qualifier, for example cultured meat. “Clean” meat will however be a no-go, as it might have negative connotations for traditional meat. The proposed solution here seems appropriate to me to adequately inform the consumer what type of product is offered for sale and sufficient to prevent any misleading. Since that is also the cornerstone of EU food information law, I would very much advocate a similar solution to apply in the EU.
Authorisation of a Novel Food such as cultured meat takes place in a relatively informal and accelerated, yet science-based way in Singapore. It is therefore not surprising that the world’s first cultured meat product obtained regulatory clearance there. For now, we have not seen any applications being submitted in any other territory, not in the US, not in the EU and not even in Israel, where an important population of cultured meat companies is present. In order to see which regulatory approval procedure is most robust and flexible, the proof of the pudding is in the eating. Sure thing however is that companies obtaining regulatory approval in Singapore will not want to limit their offerings to this small territory, but expand to others as well. In my view, mutual approval proceedings could beneficially influence each other, as data generated or approvals obtained in the one proceedings, could be used in the other. In terms of processing Novel Foods applications, I could only wish EFSA takes inspiration from the collaborative approach the SFA seems to take.
The world of food is changing at a rapid pace – alternative proteins becoming a new reality. Examples are products using microbial fermentation or cellular agriculture in their production process. If you are a company wanting to market such a product in the EU, there is a good chance you require a prior market authorization as a regulated product, such as a novel food (NF) or a GMO. In that case, you need to get up to speed with the following four new ESFA guidance documents that will all apply as of 27 March 2021.
- Decision laying down the practical arrangements on pre-submission phase and public consultations
- Decision of EFSA’s executive director laying down practical arrangements concerning transparency and confidentiality
- Administrative guidance for the processing of applications for regulated products (update 2021)
- ESFA’s catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)
Document # 3 explains EFSA’s workflow in dealing with regulated products. It applies to applications for authorization of substances used in food and feed, food contact materials, NFs and GMO’s amongst others. The title of document # 4 is pretty self-explanatory. Examples of EFSA support initiatives range from general pre-submission and renewal advice to admin support to SMEs on applications and from EFSA guidance documents and scientific opinions to roundtables with industry associations.
Documents # 1 and 2 contain practical arrangements for companies that intend submitting scientific evidence regarding products requiring an EFSA evaluation. The full list of products is enumerated at the end of this post.* From a legal point of view, these guidelines implement the changes introduced in the General Food Law Regulation by the Transparency Regulation. We already covered the consequences of this Regulation in a previous blogpost, which in particular focuses on the relation between transparency and confidentiality.
This blogpost provides more detailed information on two topics representing a real change in the situation before 27 March, notably the general pre-submission advice and the notification of studies. To make this blogpost more concrete, it will target one specific category of regulated products within EFSA’s remit, notably NFs. For a reason. Currently, a great number of EU food companies active in the field of cultured meat are preparing their novel food applications. These companies need to be aware of these changes in the current regulatory framework.
General pre-submission advice (GPSA)
The GPSA to be provided by EFSA Staff concerns the rules applicable to and the content required for the NF application prior to its submission. It explicitly does not cover the design of the studies to be submitted. Aspects going beyond information available in any guidance documents are out of scope of pre-submission advice. Examples are questions regarding hypotheses to be tested or risk management. Furthermore, said staff shall not be involved in any preparatory scientific or technical work that is (in)directly of relevance for the NF application to be made. Also, the advice given shall be without prejudice and non-committal as to any subsequent assessment by EFSA (and the Member States via the PAFF Committee).
Prior to obtaining any GPSA, the applicant (and / or its representative) must register in the EFSA system supporting pre-submission activities and it must also request a pre-application ID. The pre-submission request can be introduced at any time before submitting a NF application. The European Commission nevertheless recommends submitting a request at least six months before introduction of the intended NF application.
The request for pre-submission advice shall be made in a dedicated form (“general pre-submission advice form”) made available by EFSA and a link should be made to the pre-application ID. Subsequently the applicant for an authorisation of a NF should provide all necessary information regarding the application, including a list of exhaustive questions. A maximum of two requests may be submitted under the same pre-application ID.
After a check that the questions asked are not out of scope, the applicant will be informed within 15 working days from the receipt of the advice form whether the submitted request is accepted or rejected. Companies expecting face-to-face meetings with EFSA need to know this will not happen automatically. Where possible, EFSA shall address the queries in writing. However, if EFSA considers that a discussion with the applicant might be useful to clarify certain aspects of the request, a meeting shall be organised. You then do not need to travel to Parma or elsewhere, as such meeting shall be conducted preferably by telco or webco. Only in exceptional cases a live meeting shall take place.
Any requests to be delt with in writing shall be answered within 15 working days after acceptance of the request. Any meeting to be set up shall be organised within 20 working days after acceptance of the request. EFSA shall draft a summary of the questions asked and not only send this to the applicant, but it will also publish it after the novel food application at stake has been considered admissible or valid.
Notification of studies
For transparency purposes, EFSA has established a database of studies commissioned or carried out by business operators to support any application requiring any type of scientific output, including a scientific opinion. The obligations to submit information on studies applies to both (A) potential applicants (i) having commissioned to a lab or external testing facility or (ii) carrying out such studies in in-house testing facilities and (B) to the labs or testing facilities carrying out such studies. Don’t be fooled by the wording “studies carried out” in relation to the notification required. In fact, timing is of the essence here, as all study notifications need to be submitted before the actual starting date of the study.
There may be justified justifications for not timely notifying studies. However, if EFSA does not consider the justifications provided by an applicant valid, the application needs to be re-submitted. As a consequence, the assessment of the validity of the application shall commence only six months after the notification of the studies according to the Transparency Regulation. The EFSA pre-submission guidance states the assessment of a re-submitted application shall commence 6 months after the re-submission of the application. This is not exactly the same, but it is clear that not complying with the studies notification requirement can be a serious showstopper, as a NF application supported by not-notified studies is not valid.
What exactly needs to be notified in the EFSA studies database? First of all, the study title, as well as an English translation thereof if the original title is not in English. Secondly, the applicant needs to be identified, after having first registered in the EFSA system for pre-submission activities. Thirdly the planned study starting and completion date, the laboratory where the study shall be carried out, as well as the study scope. In order to detail the study scope, the applicant should provide information on the intended study area (e.g. cultured meat), the study type (e.g. genotoxicity in vitro study) and the study objective (e.g. demonstrate that cultured meat does not pose any safety risks at the anticipated level of intake). The data entered can be modified, for instance if a study is delayed, the anticipated completion date can be aligned thereto. Information previously entered into the study database can also be withdrawn, but the applicant needs to provide a valid justification for that purpose. In the absence thereof, the same consequences will apply as when the applicant notifies its studies too late.
Once EFSA has received a valid or admissible application for a NF authorization, it shall publish this in order to launch the consultation of third parties on the application submitted. The rationale behind is that EFSA needs to have access to all relevant scientific data and studies available on the subject matter regarding the application at stake. Any communications on such consultation shall be published at EFSA’s website and shall remain open for three weeks, unless specified otherwise in sectoral Union law. For applicants, it is good to know that this public consultation in principle does not result in long delays. Upon closure of the public consultation, EFSA shall make publicly available all comments received. This will be done simultaneously with the publication of EFSA’s scientific output, which will address all relevant comments received.
What learnings can be drawn from the new EFSA Guidance documents? In the first place, that designing a safety evaluation strategy for a regulated product such as a NF has become even more important. By deciding as early stage as possible, what studies will be required to demonstrate the safety of your product, the chances that you can timely notify these studies in the EFSA study database shall increase. In this way, unnecessary delays in the appraisal of your application can be prevented. In the second place, it remains to be seen how helpful EFSA pre-submission advice will be, as it will be purely procedural and not material at all. At the same time, EFSA launched the new initiative of dedicated support for SME’s. Potentially, combination of the two reveals to be helpful.
*Products subject to transparency requirements and requiring an EFSA evaluation are the following:
- GMO’s (captured by both Directive 2001/18 and Regulation 1829/2003)
- Additives in animal nutrition
- Smoke flavouring used on food
- Food contact materials
- Food additives, enzymes and flavourings
- Plant protection materials
- Novel Foods
Last week I received a call from an entrepreneur who wanted to know what requirements he had to bear in mind when distributing food supplements from Finland to other EU Member States. I told him about the language requirements for mandatory food information. I also informed him that the allowed level of vitamins and minerals could differ from Member State to Member State. Furthermore, in some countries a so-called notification system for market access has been put in place, whereas in others, no such system applies. Finally, I informed him that there is no harmonised approach on prohibited substances in the EU either. In fact, he was quite surprised to learn about all this, as he thought food supplements to be subject to the principle of free circulation of goods in the internal market. Is not that correct? Yes, it is. However, as follows from the above, a number of exceptions apply to this principle. This blogpost explains what is being done to achieve more harmonisation in the food supplements market.
Food supplements: what are they in fact and what happens in practice?
According to the Food Supplements Directive, food supplements are meant to supplement the normal diet. They are concentrated sources of nutrients or other substances having a nutritional or physiological effect that are mostly sold in the form of pills or powders. While nutrients are vitamins and/or minerals, such other substances are, for example, amino acids, glucosamine or certain substances contained in herbs or plants. What we see in practice, is that more and more consumers use food supplements not only to supplement their diet, but for a targeted health effect. Increasing concentration or improving sport achievements are two examples thereof. Another trend is that a broad number of food supplements is nowadays offered for sale online. As many of them come with striking health claims, it is not always sufficiently clear for consumers what they are actually buying. In these COVID-times, many supplements claimed for example to boost the immune system without meeting the specific requirements for such claim. This may create a dangerous situation if and when dangerous substances are involved.
Food supplements: a boosting market but not without risks
The market of food supplements in the Netherlands alone was valued in 2019 by Neprofarm at € 143 million. In that same year, the Netherlands pharmacovigilance centre Lareb received 165 notifications of adverse reactions regarding food supplements. Even worse, the Netherlands Intoxications Information Centre NVIC reported 891 cases of intoxications through the use of food supplements in 2019. These adverse effects or intoxications may result in stomach complaints, headaches or dizziness, but also in more severe conditions such as hart complaints or even cerebral haemorrhage. It follows from inspection results of the Dutch Food Safety Authority NVWA that only 45 % of the food business operators comply with all applicable food safety requirements. Due to the lack of regulatory harmonisation in this field and the open norm laid down in the General Food Law Regulation (article 14 thereof states “food shall not be placed on the market if it is unsafe”), this makes effective enforcement of food safety for food supplement a complex task.
Dutch initiatives aimed at more EU harmonization for food supplements
In an ideal world, dangerous substances are prohibited on an EU-wide basis. Currently, an initiative is ongoing to add substances to the list of unsafe substances under the Fortification Directive. Furthermore, in February 2020, an initiative was launched by the enforcement authorities of 18 Member States including those of the Netherlands, to draft a joint list of prohibited substances for food supplements. Since both initiatives are not expected to materialize overnight, the Dutch Health Minister has decided, in cooperation with the Dutch Food Safety Authority and the Dutch Medicines Evaluation Board CBG amongst others, to draft a national list of unsafe substances. This list will be based on risk evaluations pertaining thereto and the aim is to give this list a statutory basis, by integrating it in the Dutch Commodities Act (“Warenwet”). Furthermore, the Dutch Food Safety Authority has designed a targeted approach of sales of food supplements via the internet. Based on the Dutch polder tradition, this approach is consensus-based, aiming to agree with online marketplaces that they remove from their offerings any food supplements containing prohibited substances. Also, the Dutch Health Minister oversees that the communications to consumers on food supplements by a number of channels, such as the Netherlands Nutrition Centre (“Voedingscentrum”), the Health Inspectorate IGJ and the National Institute for Public Health RIVM, provides proper risk information. Finally, the Health Minister considers introducing a system of prior notification and some level of safety evaluation into the Netherlands as well.
Are these initiatives a good thing or a bad thing?
In order to enhance consumer safety, the above initiatives are certainly a good thing. For food business operators however, they may entail further obstacles to the free circulation of goods in the internal market. Based on the new Official Controls Regulation, enforcement authorities are allowed to do “mystery shopping”, i.e. ordering food supplements without identifying themselves. Once the Dutch national list of dangerous substances will have a statutory basis, the Dutch Food Safety Authority could do online test purchases with EU food business operators that may not be aware of such list. If their products are not in line therewith, they are subject to enforcement measures. As to the intended introduction of the notification requirement of food supplements in the Dutch market, this will certainly make market access less smooth.
On the other hand, in a number of EU countries, such as Belgium and France, a system of prior notification for food supplements is already in place. In practice, we see this can operate as a “safety seal”, meaning that supplements that were allowed on those markets, potentially earn more easily market access in other Member States as well. Furthermore, a new tool is available to food business operators since the new Regulation on mutual recognition became applicable in April 2020. Article 4 thereof offers the possibility to draw up a voluntary declaration to demonstrate to the competent authorities of other Member States that a food product is lawfully marketed, for instance in the Netherlands. The competent authorities in the Member State of destination can only oppose the further marketing thereof based on legitimate public interest, for instance public health. I expect this to be as useful tool for the further circulation of food supplements in the internal market.
Finally, I expect the Dutch national list of unsafe and hence prohibited substances for food supplements also to provide some more clarity in this field, provided that it will also be easily accessible to food business operators abroad. When these food business operators indeed duly inform themselves, this list could facilitate the successful EU-wide launch of food supplements, with less unclarity pre-launch and less surprises after launch. Which is supposed to be a good thing.
The information shared in this blogpost stems from a letter of the Dutch Health Minister to the Dutch House of representatives dated 14 December 2020, which can be viewed here (in Dutch only).
What can we learn from the Impossible vs. Incredible case in the Netherlands?
At the end May this year, the Court of The Hague rendered a remarkable judgment: at the request of Impossible Foods, Nestlé was banned from launching its INCREDIBLE BURGER in the EU. How is this possible? Impossible Foods is not even on the market in the EU yet. This article examines the court’s considerations and discusses the lessons that can be learnt by companies wishing to enter the EU market with meat substitutes.
Impossible Foods has been marketing its vegetable burger under the brand IMPOSSIBLE BURGER in the US since 2016. It also aims entering the EU market, but is still awaiting a marketing authorisation under the GMO Regulation. The burger of Impossible Foods contains genetically modified heme, which makes such authorisation necessary. Nestlé is seeking to meet the demand for more plant-based products as well and therefore also developed a plant-based burger. Nestlé had announced at the end of 2018 that it would market this product under the name INCREDIBLE BURGER. After Impossible Foods warned that this name would violate its trademark rights vested in IMPOSSIBLE BURGER, Nestlé decided to introduce its burger under the name AWESOME BURGER in the US. In the EU, however, Nestlé continued the original plan and marketed its vegetable burger under the name INCREDIBLE BURGER as of February 2019. Meanwhile, Impossible Foods had obtained a registration of its EU trademark IMPOSSIBLE BURGER. Nestlé filed a so-called nullity action against this mark with the EUIPO (the European Union Intellectual Property Office). According to Nestlé, this trademark is insufficiently distinctive, which is one of the requirements to obtain a valid trademark. In the meantime, however, Impossible Foods had initiated a court case before the District Court of The Hague in the Netherlands. In this case, Impossible Foods sued ten Nestlé companies, claiming that these should be prohibited from further use of the trademark INCREDIBLE BURGER in the EU. As of that moment quite some procedural spaghetti evolved, which I will explain below.
The case concerned regular proceedings on the merits, which can easily take a year and a half before any judgment being made. Of course, this would be too long to prevent the intended market introduction of the INCREDIBLE BURGER. Impossible Foods had therefore made use of the possibility to apply for an interim injunction during these main proceedings. Nestlé obviously opposed such interim injunction. In essence, Nestlé argued that the court in The Hague should refrain from ruling as long as the EUIPO in Alicante had not decided whether Impossible Foods has a valid trademark at all. Nestlé’s application for a stay of proceedings related to both the proceedings on the merits and to the interim injunction. In the main proceedings, that request was granted in order to prevent any conflicting rulings in the EU regarding the same trademark. With regard to the interim injunction, that request was rejected because a trademark proprietor must always be able to protect its trademark rights. Moreover, based on the Regulation on the Union Trademark and two European treaties, the court in The Hague declared itself competent to hear Impossible Foods’ claim in respect of all ten defendants. The fact that these proceedings had not been initiated in the country where Nestlé has the largest market share within the EU (Germany), nor in the country where Nestlé’s parent company is established (Switzerland), did not change this.
IMPOSSIBLE BURGER complies as a brand
Impossible Foods’ claim for an injunction was based on trademark infringement. Before the court could assess this claim, Nestlé’s defences had to be assessed first. The court did not agree with Nestlé’s assertion that IMPOSSIBLE BURGER for meat substitutes is exclusively descriptive. On the basis of this name, the average consumer does not automatically conclude that this is a vegetarian burger that resembles meat as much as possible. In fact, “impossible” is anti-descriptive for a burger that does exist. On the same grounds, the court ruled that IMPOSSIBLE BURGER does not lack any distinctive character for meat substitutes. Also, the use of this trademark did not have a purely laudatory message. IMPOSSIBLE BURGER can indeed fulfil a designation of origin function as a trademark, which is further enhanced by the relationship with the name of the trademark owner. IMPOSSIBLE BURGER therefore qualifies as a trademark, at least in the context of the interim relief in the present case. The EUIPO may decide otherwise in due course, which will influence the decision of the court in the proceedings on the merits.
Preconditions for trademark infringement
Trademark infringement exists, inter alia, if there is a likelihood of confusion between two trademarks. In order to assess this, it needs to be examined whether there is similarity between the two trademarks visually, aurally and conceptually. Also relevant are (i) the degree of similarity between the goods for which the trademark is registered and for which the sign is used, (ii) the degree of distinctiveness of the trademark and (iii) the relevant public when assessing the likelihood of confusion. According to Nestlé, the relevant public in this case is in fact the general public, now that most people consume meat, fish and poultry or substitutes for these products. The judge agreed. He further ruled that the level of attention when purchasing such everyday consumer products is relatively low.
Likelihood of confusion deemed plausible
The judge ruled that visually there is a considerable degree of similarity between IMPOSSIBLE BURGER and INCREDIBLE BURGER. Mark and sign each have six syllables, the first word is constructed in the same way and the second word is identical. Phonetically, trademark and sign are to a certain extent similar according to the judge, although there is also a difference in this respect. Because of the identical number of syllables, the cadence is the same, but the second syllable clearly differs. There is only a low degree of conceptual similarity: “impossible” is simply something different than “incredible”. The judge thereby assumes that the average consumer of meat substitutes in the EU is able to grasp the meaning of these English words. Some conceptual similarity between the trademark and the sign lies in the fact that both raise a question: ‘What, then, is so impossible or incredible? Considering that both IMPOSSIBLE BURGER and INCREDIBLE BURGER are used for meat substitutes and it has been established that the level of attention paid to the purchase of such products is low, the court deems the risk of confusion plausible. Two aggravating facts contributed to this.
Firstly, even before the IMPOSSIBLE BURGER was on the market in the EU, actual confusion had taken place between the two products. Secondly, Impossible Foods had argued undisputedly that in the summer of 2018, negotiations had taken place between the parties about a possible cooperation. This would allegedly take the form of a licence granted by Impossible Foods to Nestlé to use the IMPOSSIBLE BURGER brand. In such a context, it is likely that exchanges of confidential information took place, whereas Nestlé had launched the INCREDIBLE BURGER during the ongoing negotiations. This creates the impression in court that Nestlé has chosen a deliberate strategy to frustrate the successful launch of the IMPOSSIBLE BURGER in the EU.
Prohibition action justified
Under these circumstances, the court ruled that the injunction sought was justified. Nestlé objected that such an injunction, even in the form of a temporary injunction for the duration of the main proceedings, would require it to ‘re-brand’ its product and destroy its current stock. This would in fact amount to definitive measures, which should only be taken in the proceedings on the merits. On the other hand, the court held that Nestlé’s market launch of the INCREDIBLE BURGER in February 2019 was actually undertaken at risk. It knew that, according to Impossible Foods, its brand was infringing the IMPOSSBLE FOODS brand and had nevertheless chosen to do so. The infringement action was therefore granted for the entire EU, with the exception of purely descriptive use (i.e. as part of an English-language sentence without any emphasis in font size or capital letters).
This is a far-reaching decision based on only convincing visual similarity between the mark and the sign. This is all the more so, now that the IMPOSSIBLE BURGER is not yet on the market here. From that perspective, it is important to know that in an injunction based on a trademark right, it is not a requirement that that trademark is actually used. Such a requirement only applies five years after registration, failing which the unused trademark will be vulnerable to cancellation. Furthermore, in this case the (somewhat) limited similarity between the trademark and sign is amply compensated by the identity between the goods, i.e. meat substitutes. On top of this are the aggravating facts on the basis of which the court seems to rule that Nestlé brought this situation upon itself. Because of the unitary character of the Union trademark, this situation is not limited to the Netherlands, but Nestlé was imposed an EU-wide injunction.
Knowing just the rules is not enough
What can companies that want to introduce new meat substitutes or other alternative protein-based products on the EU market learn from this decision? In an earlier post at FoodHealthLegal, we informed about the possible names for alternative proteins-based products within the applicable regulatory framework. This showed that according to specific EU labelling rules and case law there are some restrictions in the choice of such name. For instance, the use of dairy names is not permitted for non-dairy products. Also, at Member State level there are sometimes restrictions based on so-called reserved designations. As such, ‘minced meat‘ may only be used for minced beef with a fat percentage of at least six percent in the Netherlands. This court decision shows that it is not enough to know the rules; knowledge of the market is also indispensable upon market introduction of a new meat replacement. Research this market and its players before introducing new innovative food products, not only in the home market but also in other possible markets. Investigate the availability of the intended product name and act in accordance with the outcome. This may take the form of an alternative name or a co-existence agreement with the company that markets a product with a similar name. This will avoid spending a fortune on re-branding and in the end it will prevent food waste.
Consumers nowadays tend to include more and more plant-based products into their diet. For instance, a study ordered by DuPont Nutrition established double digits of growth for non-dairy ice-cream, dairy and cheese during the year preceding June 2018. More recently, NPR published an overview demonstrating which products were most consumed during the corona crisis. Amongst these, plant-based meat alternatives and oat milk were the biggest hits, demonstrating over 200 and 300 % growth respectively. Plant-based alternatives for dairy and meat will be discussed during the Protein Summit of the Vitafoods Conference in Geneva. As you may know, this conference was shifted from May to early September. In anticipation thereof, a webinar on Protein and Protein Alternatives took place on 12 May. During this webinar, I covered the labeling and advertising of these products. This blogpost offers a recap of my contribution thereto, targeting those who are interested in this topic but could not assist.
Regulatory requirements for market access
Obviously, there are other relevant aspects for alternative protein-based products than labeling and advertising, such as the regulatory requirements for market access. For some products, like those based on certain algae or on isolates from mung beans, most likely an authorization under the Novel Food Regulation will be required. This implies that the applicant will have to put together a product dossier demonstrating the safety of the product and submit this to the European Commission. This certainly applies for cultured meat products, unless they incorporate GMO steps in their production process and / or end product. In such case, market authorization will have to be obtained on the basis of the GMO Directive and the GMO Regulation. These topics will be dealt with during the Conference in September, detailing the scientific, economic and practical implications thereof.
Relevant general labelling rules
A number of labeling rules are of relevance for any food product, including those based on alternative protein. In fact, the cornerstone of labeling law, embodied in the Regulation on Food Information to Consumers, is the prevention of misleading. This can be done in various ways, but it is of the essence that at all times any confusion about the characteristics of a product is avoided. During the webinar, I brought up the example of Mylk to clarify this. Obviously, this is not a conventional dairy product, but a plant-based product. Do you think any confusion about the nature and / or the composition of this product could arise?
This should be decided based on the so-called Teekanne decision of the European Court of Justice (ECJ). According to this decision, it is prohibited to give the impression (by means of an image or a description) that a particular ingredient is present in a product, whereas this is not the case and the consumer can only find out when reading the list of ingredients. When this test is applied to the product Mylk, I am of the opinion it shall pass. Firstly, consumers will most likely not expect conventional milk, because of the twist in the product name. Secondly, FOP it states “dairy-free”. Thirdly, most plant-based dairy products are not stored in the fridge in the supermarket. Lastly, from the list of ingredients it is apparent this product is based on coconut cream.
Sector specific dairy legislation
For the dairy sector, important guidance was provided by the Tofutown decision by the ECJ. As detailed in an earlier blog post, we learnt from this decision that – in short – it is prohibited to use dairy names, such as “Tofubutter”, “Pflanzenkäse” and “Veggiecheese” for non-dairy products. This can be explained by the fact the dairy market is highly regulated, meaning that any specific dairy product has its own product standard. This standard should be met when manufacturing and marketing the product at stake. During the webinar, I mentioned the product standard for milk, defined as “normal mammary secretion obtained from one or more milkings without any addition thereto or extraction therefrom”. From this definition it follows why the use of the work milk in combination with a plant-based ingredient is, in principle, no longer allowed.
However, there are always exceptions to the rules, also in this case. These exceptions relate to so-called traditional use, like “coconut milk” (UK) and “lait d’amande” (France). Those exceptions are mentioned on a list drawn up by the European Commission. Furthermore, the word “milk” and designations used for milk products (e.g. cream, butter, yoghurt) can be used in association with one or more words designating certain composite products (famous example: “chocolate milk”). A condition precedent however is that milk is an essential part thereof, either in terms of quantity or for characterization of the product, and no constituent takes the place of milk.
Plant-based meat replacements
For these types of products, using (or not) the word “meat” is not so much an issue, because they are no conventional meat product. This issue is rather whether it is legally permitted to use certain meat product designations, such as “hamburger”, “sausage” and the like. In the US, we have seen so-called censorship bills in a great number of States. These are usually driven by the meat sector lobby, who fear unfair competition from their plant-based peers. There is fierce opposition against such censorship, amongst others from the Good Food Institute. Mid April, the GFI reported their lobby had been successful in Virginia, where the Governor vetoed label censorship.
In the EU, we have seen similar initiatives when the AGRI Committee of the European Parliament proposed a bill restricting the use of meat product names for meat alternatives. The status of this bill is yet undecided, as the current European Parliament that was inaugurated in 2019, did not yet vote on it. Fierce lobbying pro and con is however going on. We must therefore anticipate that if this bill turns into law, it will also result into restrictions of very popular terms. The alternatives for those popular terms are not so obvious yet: “lentil slices?” or “carrot tubes?”.
Please bear in mind that restrictions can also stem from national Member State laws based on reserved product designations. In the NL for instance, the name “minced meat” and “tartar” are such reserved product designations that can only be used for products meeting exactly the relevant legal specifications.
When discussing the advantages of new over conventional protein products, certain advertising standards should be taken into account. In the EU, one of the ways to avoid misleading regarding your alternative protein product is to not emphasize certain characteristics that your product does not have. In this context, I discussed in the webinar a commercial that was made for BECEL margarine (FLORA in UK) that was shown both in the Netherlands and in Belgium. The text stated “Plants are the new cows. They are outside in the field whole year long. They provide seeds, that are a source of omega-3, which is good for your heart. BECEL is 100 % plant-based and good for your heart.”
According to a complaint filed with the Dutch Advertising Code Committee (similar to Advertising Standards Authority in UK), the comparison made between plants and cows was misleading. Rationale: it was suggested that plants had a more positive effect on the environment than dairy products made from milk. The complaint was dismissed. The ACC considered that the commercial did not at all compare the advantages of plant-based products to the disadvantages of conventional dairy. In fact, it only stressed the positive health effects of BECEL, due to its plant-based ingredients. The commercial appeared an effective (and funny!) way of advertising alternative dairy products.
Alternative protein products are food products like any other, so make sure that when marketing these, you are up to speed with all applicable general labeling requirements. Furthermore, take into account any sector specific standards, like the ones that apply for dairy products. Also, please note that at Member State level, further restrictions on the use of particular product names may apply. Finally, when advertising these products, make sure to avoid any misleading and know the rules for comparative advertising. This will be of particular relevance, especially once further labeling standards will evolve at EU level as initiated by the AGRI Committee of the European Parliament. Stay tuned – we will.
Copyright image: Nanne Meulendijks – please contact the artist for any further use.
What does the future of our meat look like? This topic was the subject of the Annual Conference of the Good Food Institute (GFI), which took place in San Francisco last month. GFI is an American non-profit organization that works with entrepreneurs, scientists and investors to make groundbreaking good food a reality. GFI focuses on the development of alternatives to animal products, consisting of plant-based products and products manufactured using cellular techniques (“cultured meat” or “cultured fish”).
Trends from Silicon Valley also in EU
The issues raised at this conference are also relevant to Europe. In the Netherlands, for example, the Nutrition Centre advises that it is better for human health to have a more plant-based diet than has been the case until now. For example, the risk of cardiovascular disease would decrease if the diet included less meat and more wholegrain cereal products, legumes, vegetables, fruit and vegetable meat substitutes.
GFI sessions: trending topics
In the country where the Beyond Meat citizen comes from, it was recognized that a large-scale breakthrough of meat alternatives has not yet taken place. The titles of the presentations were telling: “Marketing to Meat Eaters: How to Reach the Other 95 Percent of American Consumers“, “Capitalizing on Change: How Investors Accelerate the Plant-Based and Cell-Based Industries” and “Addressing the Key Challenges in Commercializing Cell-Based Meat“. Participants in the last session of the conference (“Cell-Based Meat Entrepreneurship“) were JUST and Memphis Meats, the companies that are said to be “closest to the market” with their cultured meat products. According to JUST, they will launch a cultured meat burger still this year. But that’s what they say every year.
Plant-based meat substitutes in the US
What is legally required to be able to market meat alternatives? Of course, it all starts with the name: what can you call these products? The basic rule, both in the US and in the EU, is that consumers must not be misled. In the case of plant-based products, this principle is applied in various ways in the United States. For example, the burger of Beyond Meat (which is now also available in the Netherlands) is simply referred to as the BEYOND BURGER and described as “the world’s first plant-based citizen that looks, cooks, and satisfies like beef…“. Impossible Foods also refers to its company name in its IMPOSSIBLE BURGER. This product is not yet on the market in the EU, partly because it contains a protein of which the regulatory status in the EU is not entirely clear (so-called leghomoglobin). This protein is obtained on the basis of fermented yeast, possibly using GMO techniques. Finally, Morning Star (“It easy eating green“), when selling its plant-based burgers, refers to the flavour-defining ingredient that they contain, for example “mediterranean chickpea burgers” and “spicy black bean burgers“. Confusion with conventional meat products does not seem to be an issue here.
And what about the EU? Famous example of the Vegetarian Butcher
In the meantime, more and more plant-based meat substitutes are also being sold in the EU. One of the best-known examples of (alleged) confusion about product names in the Netherlands concerned the case of the Vegetarian Butcher, a company that was acquired by Unilever in December 2018. At the end of 2017, the Dutch Food Safety Authority (NVWA) asked this company to modify the labels of the products offering a substitute for tuna, chicken and bacon (all spelled with a twist in Dutch), because these would be misleading. It turned out afterwards that the criticism concerned only the information on the website. The NVWA apologised and the Vegetarian Butcher did not have to change any product labels.
Proposal for a ban on Vegaburger in the European Parliament
The next shockwave took place at European level when, in April of this year, the Committee on Agriculture and Rural Development (AGRI Committee) of the previous European Parliament adopted a proposal to ban the use of meat names for plant-based products. On the basis of this proposal, it would no longer be possible to use the names ‘steak’, ‘sausage’, ‘ham’, etc. for plant-based products. A new European Parliament has now been elected. It has been reported from Brussels sources that the new AGRI Committee has taken the old proposal as a starting point for a working document. However, so many forces are working together against the previously envisaged ban that the chances of this happening are not considered to be very great. Arguments against this ban are that it would inhibit innovation in the EU, harm consumer rights and simply not be necessary: consumers are not so easily confused about plant-based meat substitutes. With the slogan “Stop the vegaburger ban“, Pro Veg launched a petition against this ban.
Cultivated meat in the US
Currently, about 30 companies active in the field of cultured meat worldwide. The companies that are most advanced with their innovations are located in the US. Menphis Meat, for example, focuses on the development of beef and poultry from the lab. This company has received investments from both well-known names (Bill Gates, Richard Branson) and from the “classic” meat industry (Tyson and Cargill). JUST focuses on the development of, among other things, chicken meat from the lab. The company has already launched an egg-free mayonnaise, that was the object of discussions with the FDA. According to the current product standard for mayonnaise, this product must contain eggs, otherwise it cannot be called “mayonnaise”. This problem was solved by changing the name of the product (“JUST Mayo”). How cultured meat will be named upon its market introduction is yet an open question. However, five companies have joined forces: they form the so-called Alliance for Meat Poultry and Seafood Innovation to approach the supervisory authorities with one voice. GFI has also developed a narrative framework to familiarise consumers with this technology and it published the results of market research into favorite names. For the time being, “cultivated meat” and “cultured meat” are at the top in terms of “appeal” and accuracy.
Cultured meat in the EU
In the EU, the question remains whether cultured meat can actually be called ‘meat’ at all. The number of arguments for and against is more or less balanced. We reported earlier on this topic in our blogs How do we get cellular ag products to the market and Regulatory pathways for clean meat in the EU and the US; not much progress has been made since that time. The main argument in favor is that when a product is identical to conventional meat at a molecular and nutritional level, producers want to be able to use this name as well. In addition, the use of the term ‘meat’ is very functional in terms of consumer orientation. Furthermore, there do not seem to be any direct legal objections to the use of ‘meat’ for cultured meat, since the Agricultural Products Standards Regulation does not contain a specific product standard for meat, unlike, for example, dairy products. Arguments against the use of ‘meat’ are based, among other things, on the Hygiene Regulation. This Regulation defines ‘meat’ as certain parts of a variety of animals, including bovine and porcine animals and poultry. It is questionable whether a product obtained from a single cell derived from one of these animals complies with this definition. Furthermore, the Hygiene Regulation refers in various places to the slaughter of farmed animals. Of course, slaughter does not apply to cultured meat – that’s the whole point. Finally, certain meat names are subject to specific regulations. In the Netherlands for example, the name ‘tartar’ may only be used for minced meat from cattle with a maximum fat content of 10 % based on specific Commodities Act legislation.
The future of our meat is taking shape. Plant-based meat substitutes are already on the market in large numbers and these products are getting more and more shelf space in the supermarket. The challenge for these products is to keep that shelf space. A certain amount of time will elapse before cultured meat will be available on a large scale on the shelf. It is expected that the first company will submit a request for Novel Food authorisation sometime next year. It will take about 18 – 24 months to complete such an authorisation procedure. By then we will have reached 2022. This may seem a long way off for the consumer, but the preparation by the producer has been a reality for a long time. Also, it was learned via the grapevine that EU-based cultured meat companies are getting organized. Watch that space!
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.