Advocate General opinion reversed: no meaty names ban for plant-based meat substitutes

Posted: October 7, 2024 | Author: Jasmin Buijs | Filed under: Advertising, alternative protein, Authors, clean meat, cultivated meat, Food, Information | Comments Off

On 4 October 2024, the European Court of Justice (ECJ) provided its judgement in the case C-438/23 on the question whether the French national Decree limiting the use of meaty names for plant-based products is in compliance with the Food Information to Consumers Regulation (FIC Regulation). A month earlier, Advocate General (AG) Capeta rendered her opinion in this case, which we analyzed in this blogpost. While this opinion was not very promising for plant-based meat companies, the ECJ did not follow the AG and ruled that no meaty names ban can be implemented at national level. In this blogpost, we explain why, and what this all means for the alternative protein sector. For more background on the French Decree and the preliminary ruling by the ECJ, we refer to our previous blogpost on this topic.

Legal names can be set, but the French Decree does not contain legal names
The ECJ starts the motivation of its decision with acknowledging that the FIC Regulation leaves room to adopt legal names at Member State level where such do not exist at EU level. Where legal names are set, these cannot be used for products not complying with the specifications of that name. As an example, the ECJ refers to the term ‘meat’, which is legally defined as ‘the edible parts of animals’. A food not containing such parts can therefore not use the name ‘meat’, even if it is accompanied by specifying terms such as ‘vegetarian’. The same applies to milk and certain milk products, for which the legal name is laid down in the COM Regulation. Indeed, as we know well from the Tofutown decision, names such as ‘plant-based milk’ are a no-go.

According to AG Capeta, the French Decree under attack established legal names. This was done on the one hand by establishing a list of meaty names of which the use is prohibited for the designation of their plant-based counterpart (such as steak), and on the other hand by authorizing the use of certain meaty names for foods containing vegetable proteins provided that they do not exceed a certain proportion (such as cordon bleu (maximum 3,5 % vegetable protein)).

The ECJ ruled however differently. In the first place, it recalls that the French authorities themselves rejected the hypothesis that Decree No 2022-947 lays down a legal name. Therefore, the learnings from the Tofutown decision cannot be applied to the case at hand. In the second place, it also states that legal names must, according to the definition thereof in the FIC Regulation, be defined in order to designate a foodstuff. The adoption of a legal name thus means associating a specific expression with a given food. This is done by setting certain conditions, especially with regard to the composition of the food. The French Decree contains a measure prohibiting the use of certain meaty names, which are not legally defined by the Decree, for plant-based foods. This is not the same.

Use of customary and descriptive names fully harmonized
Given that there are no legal names for plant-based foods at EU level and neither in France as far as is known to the ECJ based on the file of the case, plant-based foods must be indicated by their customary name or descriptive name. Where a customary name is the accepted name of the food that does not need further explanation, a descriptive name must explain the main characteristics of the food.

Obviously, Member States cannot prevent plant-based food companies from complying with their obligation under the FIC Regulation to indicate the name of their products by using customary or descriptive names where no legal name exists. Having said that, customary and descriptive names must of course comply with the FIC Regulation and therefore not be misleading in the meaning of art. 7 thereof. As the ECJ indicates, consumers are not easily misled where the substitution of a component or ingredient of a (in this case animal-derived) food is clearly indicated in accordance with art. 7(1)(d) of, and Annex VI, Part A, point 4, to the FIC Regulation. The ECJ motivates that this set of rules also covers the situation where the composition of the food changes completely because the respective component or ingredient constitutes the only component or ingredient of the food (as is the case for e.g. a vegetarian steak). The ECJ therefore concludes that the protection of consumers from the risk of being misled by the use of meaty customary or descriptive names for foods that are fully or partly plant-based is fully harmonized by the FIC Regulation. Therefore, Member State cannot enact national measures regulating or prohibiting the use of such meaty names. The ECJ specifies that this includes that Member States cannot establish maximum permitted levels of vegetable proteins that can be contained in foods to be designated by meaty customary or descriptive names, either.

No distinction between domestic and imported products
Where the AG made in her opinion a distinction between rules covering domestic production and rules covering production abroad, this topic was no longer covered in the ECJ’s preliminary ruling. The question whether the French Decree could only apply to foods manufactured in its territory was initiated by the highest French administrative court (“Conseil d’Etat”), but became redundant since the ECJ came to the conclusion that national measures regulating or prohibiting the use of meaty names for plant-based products (other than by means of legal names) is not allowed in the first place.

We nevertheless conclude from the case that since the limitative legislation applying at a national level is not considered in conformity with Union legislation, this surely goes for national legislation applying similar restrictions on a Union level. This is justified by the fact that the ECJ recalls at the beginning of its decision the two paramount principles of Union legislation. In addition to consumer protection, this is also the smooth functioning of the internal market.

Outlook for the alternative protein sector a whole
Now the ECJ has given its interpretation of the FIC Regulation in response to the questions of the French referring court, it is now up to the latter to decide the dispute at national level in accordance with the ECJ’s preliminary ruling.

It should be noted that the ECJ’s ruling is similarly binding on other national courts or tribunals before which a similar issue is raised. This means that the prohibition to enact national measures regulating or prohibiting the use of meaty names in the absence of legal names in principle also applies to other meat analogues such as cultivated meat and those produced by precision fermentation. Having said that, these products may face other challenges, such as the question whether such products can actually be called meat (for which they must be edible parts of animals as indicated above), and to what extent the production technique used must be indicated in accordance with art. 7(1)(a) of, and Annex VI, Part A, point 1 to, the FIC Regulation. We will keep you posted!

Dutch sequels of Tofutown saga: Thou Shall Not Touch Dairy Names!

Posted: July 25, 2024 | Author: Karin Verzijden | Filed under: Advertising, alternative protein, Authors, Enforcement, Food, Information | Comments Off

On 23 July 2024 a Dutch Court ruled in summary relief proceedings that Upfield cannot use the name “roombeter” for a plant-based alternative for butter, as this is in violation of the Regulation establishing a common organization of the markets for agricultural products (“COM Regulation”). You should know that “roombeter” translates in English as a composition of “cream” and “better”, whereas “cream” is a reserved designation under the COM Regulation that can only be used for dairy products. Furthermore, “beter” is close to “boter”, being the Dutch designation for butter.

Facts of the case at hand

In the case at hand, Upfield markets a plant-based alternative for butter under the brand BLUE BAND and the product name ROOMBETER. The packaging of the product furthermore states “100 % plant-based alternative for butter” and “81 % less climate impact than butter”. The packaging itself consists of golden coloured paper that is also used for conventional butter in the Netherlands and it displays a curl of butter as shown below. The Dutch Dairy Association opposed the use of the product name ROOMBETER, as it is considered this a violation of the COM Regulation, as explained below.

Case before Dutch Advertisement Code Committee

Prior to this legal procedure , the Dutch Dairy Association had submitted a complaint regarding this product before the Dutch Advertisement Code Committee. This self-regulatory body ruled on March 21 last that the presentation of the product was misleading, since it could be understood to contain butter. The “e” in “beter” could be confused for an “o”, resulting in “boter”, which is Dutch for butter. And furthermore the golden coloured packaging added to the misleading character of the product. The topic of violation of the COM Regulation was left to civil law proceedings, as it exceeded the competence of the Committee.

Applicable legislation

Article 78.2 of the COM Regulation states that the definitions, designations and sales descriptions provided for in its Annex VII may be used in the Union only for the marketing of a product that conforms to the corresponding requirements laid down in that Annex. Annex VII contains, amongst other things, a product definition for milk and a list of milk products. It furthermore states that these designations may not be used for any other product than milk and milk products. The purpose of this provision is to protect dairy names from being used for non-dairy products.

Tofutown

You may recall that in its Tofutown decision back in 2017, the ECJ formulated a very strict prohibition of the use of diary names for non-dairy products (check out our blog on this case here). As a result of that prohibition, the use of the designation “Tofubutter” for a tofu-based product was in violation of the COM Regulation. As a general rule, the ECJ precluded the term ‘milk’ and the designations reserved by the COM Regulation exclusively for milk products from being used to designate a purely plant based product in marketing or advertising. This even applies if those terms are expanded upon by clarifying or descriptive terms indicating the plant origin of the product at issue

Arguments in favour of ROOMBETER

Upfield had argued it did not market its product under the designation ROOMBETER but under the designation BLUE BAND ROOMBETER. The brand BLUE BAND has been used for more than 100 years for margarine, so it is obvious for the consumer this is a plant-based product This is even strengthened by the Dutch translation of the designations “100 % plant-based alternative for butter” and “81 % less climate impact than butter”. So the name ROOMBETER does not designate, imply or suggest it is about a dairy product.

Court decision

The Court did not eat it. Instead, it very strictly applied the Tofutown doctrine, stating that a reserved designation under the COM Regulation cannot be used for a plant-based product. It went on to explain that if it is prohibited to use the designation “tofubutter” for a plant-based product, as it contains the reserved designation “butter”, for sure it is prohibited to use the designation “roombeter” for a plant-based product, as it contains another reserved designation under the COM Regulation. Also, the element “beter” (“better” in English) can hardly be perceived as a clarifying or descriptive term, as it does not refer (contrary to “tofu”) to a plant-based origin. In fact, its reference to plant-based origins can only be understood by those consumers who know the “skip the cow” ad or who further study the packaging of this product.

Upfield was therefore ordered to stop using the designation ROOMBETER within three months after the date of the legal decision.

Consequences of this decision

Should the conclusion of this decision be that any reference to dairy products should be meticulously avoided when marketing plant-based dairy replacements? This seems a very hard task, as manufacturers of these replacement products will want to indicate how their products can be used. Happily, this is not the case. It is still permitted to mention that your plant-based product is for instance a “yoghurt variation”, as this is perceived as a product explanation rather than a product designation. This is not in violation of the Tofutown doctrine and in line with a 2019 Dutch Supreme Court decision relating to a soy-based product marketed by Alpro. Advertising plant-based dairy alternatives nevertheless remains a delicate balancing act.

Advertisement restrictions for formula milk; what about cell-based solutions?

Posted: July 23, 2024 | Author: Jasmin Buijs | Filed under: Advertising, alternative protein, Food, Information | Comments Off

Claims for formula milk that refer to nature can be understood as a (prohibited) discouragement of breastfeeding, as was recently ruled in two instances by the Dutch Advertising Code Foundation. This case captured our attention, especially with an eye to future possibilities of cell-based breastmilk alternatives.

What is the case about? Advertiser, a food business marketing infant and follow-on formula, published statements on its website about its products such as:

“Unique combination of natural lactic acid cultures and valuable fibers.”
“Where organic ends, […] continues: […] guarantees an excellent quality and supersedes the legal requirements concerning organic.”
“Inspired by nature.”
“With the first milk that is non mom’s, I want to do all well” (next to a picture of a baby in the arms of a woman).

The question is whether (a) these texts qualify as advertisements, and (b) whether the texts give the impression that the follow-on formula is as good as breastmilk.

What is the legal rule? Consumer-oriented advertising for infant formula is prohibited. Advertisements for follow-on formula are possible, but should not dissuade or discourage breastfeeding. This is laid down in articles 4.1 and 5.2 of the Dutch Advertising Code for Infant Formula, in line with EU Regulation 2016/127. As follows from article 6(6) of aforementioned Regulation, the labelling, presentation and advertising of infant and follow-on formula shall not include terms like ‘humanized’, ‘maternalized’ or ‘adapted’. The Dutch Advertising Code for Infant Formula further lists ‘inspired by breastmilk’, ‘protected effect of breastmilk’, and ‘contains nutrients that are also found in breastmilk’ as examples of prohibited statements to avoid discouragement of breastfeeding.

What was decided? The Board of Appeal upheld the decision of the Advertising Code Committee and ruled that (a) the texts on advertiser’s website are clearly promotional in nature, and that (b) the consumer will understand the references to nature to be references to breastmilk (and not to the products having organic qualities, as was explained by advertiser). As this is in violation of the Dutch Advertising Code for Infant Formula, advertiser is requested to no longer make such advertisements.

Our analysis and future outlook: It is commonly agreed that breastfeeding, where possible, should be supported. This is one of the principles laid down in the WHO International Code of Marketing of Breast-Milk Substitutes and the subsequent relevant resolutions of the World Health Assembly. We are therefore not surprised by the ruling.

Looking into the future, it is interesting to note that the same rules shall in principle apply to cultivated breastmilk made in a lab. Various companies are already working on this concept such as French Nūmi and BIOMILQ in the US. Giants like Danone and FrieslandCampina have announced strategic partnerships with cell-based human milk component start-ups. Companies working on such substitute products obviously want to (and should) explain their products to the public. Statements such as ‘inspired by breastmilk’ and ‘contains nutrients that are also found in breastmilk’ may not seem unreasonable in this context. Currently this is however not allowed. Will the Dutch self-regulatory code (which is more specific in prohibited terms than EU Regulation 2016/127 and the WHO Code) be updated, so that such innovations can be appropriately explained to the public? Stay tuned – we will keep you posted!

The full case can be read here (in Dutch).

Singapore cultured meat regulatory approval process compared to EU

Posted: April 26, 2021 | Author: Karin Verzijden | Filed under: alternative protein, Authors, clean meat, Food, novel food | Comments Off

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.

Procedural aspects

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.

Denomination

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.

Conclusion

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.

EFSA Guidelines bonanza: how to smoothly navigate the new transparency requirements?

Posted: March 26, 2021 | Author: Karin Verzijden | Filed under: alternative protein, Authors, Food, novel food | Comments Off

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.

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.

Conclusion

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.

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*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

Impossible and Incredible And Yet Really Happened

Posted: July 10, 2020 | Author: Karin Verzijden | Filed under: alternative protein, Authors, clean meat, Food | Comments Off

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.

Background

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.

Procedural spaghetti

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.

Aggravating facts

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).

Analysis

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.

Labeling and Advertising of Alternative Protein

Posted: May 12, 2020 | Author: Karin Verzijden | Filed under: alternative protein, Authors, Food, novel food | Comments Off

Sneak peek of Vitafoods Protein Summit

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.

Comparative advertising

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.

Takeaway

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.