From May 26 this year, the personalized nutrition space has been enriched with a new piece of legislation: the Regulation (EU) 2017/745 on medical devices (hereinafter: “MDR”). The MDR is, generally speaking, applicable to all personalized nutrition (software) products, including apps and algorithms, with a medical intended purpose. Since most personal nutrition services that are currently on the market are lifestyle related, they will not be affected by the MDR. This will however be different for services that offer dietary advice for the prevention, alleviation or treatment of a disease. This blogpost aims to provide an introduction to the new rules on personalized nutrition as a medical device.
What is the MDR?
The MDR comprises of a set of rules that governs the full medical devices supply chain from manufacturer to end user in order to ensure the safety and performance of medical devices. It applies to any apparatus, application, software or other article intended by the manufacturer to be used for a medical purpose. This includes, like under the old medical devices legislation, the diagnosis, prevention, monitoring, treatment or alleviation of a disease. Since the application of the MDR, also devices designed for the prediction or prognosis of a disease qualify as a medical device. Genetic testing kits for medical purposes and other medical devices to be used in vitro for the examination of specimens such as blood are covered by the MDR’s sister, Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (hereinafter: “IVDR”). The IVDR applies from May 26 next year.
When does the MDR apply to personalized nutrition software?
The essential question for the MDR’s applicability is thus whether the article or software concerned has a medical purpose or is merely lifestyle or well-being related. For example, an app that provides dietary advice based on the users’ preferences and potential health data is a lifestyle product. But if the same app claims to help address obesity or treat hypertension, then it can be linked to a disease and transforms into a medical device. While the intention of the manufacturer of the device is leading for the application of the MDR, it should be noted that only a statement that a product is not a medical device, or is meant for lifestyle purposes only, does not constitute a reason to escape from this regulation. The intended purpose is inferred from every document and statement that expresses the intended purpose, including advertising and marketing material. Disclaiming a medical intended purpose in the instructions for use but claiming such purpose in marketing materials will still result in a finding of a medical intended purpose. The MDR contains an explicit prohibition on statements that may mislead the end user about the intended purpose or ascribes functions or properties to the device that it does not have, which would be caught in its scope.
Another example of a medical device is the wearable being developed by the Australian start-up Nutromics, which assesses dietary biomarkers to provide dietary advice to minimize users’ risk for lifestyle-related chronic diseases. This device is designed to predict the user’s likelihood of developing a particular disease and to subsequently provide advice to prevent such disease, and will therefore be subject to the MDR when placed on the Union market. On the other hand and as clarified earlier by the European Commission in its borderline manual for medical devices, a home-kit that enables the user to ascertain their blood group in order to determine whether a specific diet should be followed falls outside the medical sphere (as defined in the (old) medical devices legislation). The sidenote should however be made that this decision was not related to following a specific diet for medical purposes.
It is also relevant to state that software may as well qualify partly as a medical device and partly as a non-medical device. Think for example of an app that provides the user with personalized nutritional advice as part of the treatment or alleviation of diabetes, and additionally facilitates online contact with fellow patients. While the software module(s) that provide information on the treatment or alleviation of the disease will be subject to the MDR, the software module that is responsible for the contact amongst patients has no medical purpose and will therefore not be subject to the MDR. The manufacturer of the device is responsible for identifying the boundaries and the interfaces of the medical device and non-medical device modules contained in the software. The Medical Device Coordination Group has pointed out in its guidance on qualification and classification of software (October 2019) that if the medical device modules are intended for use in combination with other modules of the software, the whole combination must be safe and must not impair the specified performances of the modules which are subject to the MDR. This means that also the non-medical devices module(s) may have to be covered in the technical documentation that supports the device’s compliance with the MDR and as further introduced below.
Way to market of personal nutrition software
All medical devices placed on the Union market must in principle have a CE (conformité européenne) marking as proof of compliance with the law. To apply the CE-mark, the manufacturer has to prepare technical documentation and carry out a conformity assessment procedure, including clinical evaluation. The specific procedure that must be followed depends on the risk class of the device. The MDR distinguishes the risk classes I, IIa, IIb and III (from low to high). The higher the risk class of the device, the more stringent requirements for clinical evaluation apply to demonstrate safety, performance and clinical benefits. It could ironically be stated that MDR stands for More Data Required: where an analysis of available clinical data from literature may have been sufficient in the past, the MDR more often requires own clinical investigations to support the device’s safety and performance.
Under the MDR, software as medical device is classified as class IIa when it is intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, or to monitor physiological processes. Translated to personal nutrition services, this would for instance include apps that track burned calories (monitoring of physiological processes) and that provide dietary advice as part of a treatment (therapeutic purposes). Risk increasing factors will however lead to a higher risk class than class IIa. While an app with which food products’ barcodes can be scanned to detect certain ingredients for allergen control purposes would normally be a class IIa device, it will be a class III device when food intake decisions based on the app may cause life-threatening allergic reactions when based on a false negative (safe to eat while it in fact is not safe).
All other software which is not specifically addressed but still has a medical intended purpose in scope of the definition of a medical device, is classed as class I. An example would be an app that provides nutritional support with a view to conception. The risk classification rules for software are new under the MDR, which means that existing medical devices software may be scaled in a higher risk class since 26 May 2021. This is relevant not only with regard to the conformity assessment procedure that must be followed, but also to the question who can perform the required assessment of legal compliance. Manufacturers of devices in a higher class than class I must always engage a so-called notified body in this regard, while class I devices can in principle be self-certified by the manufacturer. An exception exists however for class I devices that have a measurement function, for example by using the lidar of the user’s phone to measure the body as input for the functionality of the app, which also require the engagement of a notified body.
Take away for food businesses
When personal nutrition enters into the medical sphere, the MDR will come into play. This will impact first and foremost the manufacturers, importers and distributors of actual medical devices, including apps and algorithms. Having said that, food businesses that wish to market their food products through medical devices apps are advised to be aware of the implications thereof. This will help them to find a reliable partner and to ensure their interests are contractually protected.
A more elaborate version of this blogpost has been published at Qina in cooperation with Mariette Abrahams.
What would food be without packaging? And what does packaging mostly consist of? Of course: plastic! To date, only few other materials have proved as reliable for food packaging as plastic. At the same time, we know that plastic has many disadvantages for the environment. Read this blogpost to be informed on the most important initiatives of the food sector and on the legal tools of the European Commission in this field.
The visionary number of 2030
By 2030, all plastic packaging in the EU will be recyclable or re-usable. In other words, all plastic packaging will then be collected and transformed into new packaging materials, or can be used as such more once. This goal follows, amongst others, from the European Strategy for Plastics. It is a worthy endeavor, and for some it is not even ambiguous enough. The signatories of the Plastics Pact aim to achieve this result as early as 2025. Nestlé has also announced its ambition to make 100% of its packaging recyclable or re-usable by 2025. Since this year, Lipton bottles sold in the Netherlands are already made from 100% recycled plastic. The so-called European Single-use plastics Directive (Directive 2019/904) will soon be introduced to further promote recycling of plastics as one of the measures against disposable plastics. In the Netherlands, this Directive will be implemented by means of a General Administrative Order (in Dutch: Algemene Maatregel van Bestuur, or “AMvB”) before the Directive’s date of application on 3 July 2021. In this regard, an internet consultation will be launched this month to invite citizens, companies and institutions to make suggestions to improve the quality and feasibility of the current proposal.
Recycled materials and articles
The encouragement to use recycled materials and articles in the EU for environmental reasons was already expressed in recital 24 of the European framework legislation on food contact materials (Regulation 1935/2004). However, food safety and consumer protection should not be neglected. Therefore, food packaging materials, including recycled plastics, should not endanger human health and not adversely affect the composition of foods or their sensory properties in an unacceptable way. The above-mentioned framework legislation leaves room for detailed rules on specific materials, and priority has been given to rules on recycled plastics. Their use has been increasing for a long time. Indeed, today’s sustainability initiatives cannot be imagined without the recycling of plastic food packaging. Moreover, diverging national legislation on this topic as a consequence of no harmonization at EU level would be highly undesirable.
Specific rules on recycled plastic materials and articles intended to come into contact with foods can be found in Regulation 282/2008. Such rules are important because plastic packaging waste can be contaminated by residues from previous use, but also by contaminants from misuse and from non-authorized substances. In order to ensure that possible contamination is removed and that recycled plastics therefore do not adversely affect human health and foodstuffs with which they come into contact, an appropriate sorting and recycling process is essential. It should be noted that Regulation 282/2008 refers to mechanical recycling, which does not involve any significant change in the chemical structure of the plastic material. This process is less suitable for composites and multilayered plastics, which means that not all plastics are eligible for recycling under Regulation 282/2008.
Authorization procedure plastic recycling processes in a nutshell
Before a recycling process can be applied to plastics to create food packaging, the process must be approved by the European Commission. Such authorizations are process specific. This means that authorizations cover a specific recycling process used in a specific company by applying specific technologies and process parameters. Authorization holders are of course free to license out the authorized recycling process to other companies. Applications for the approval of recycling processes shall be submitted to the competent authority at Member State level. The European Commission published a list of contact points for competent authorities. In the Netherlands, applications can be submitted to the Ministry of Health, Welfare and Sport (in Dutch: Ministerie van Volksgezondheid, Welzijn en Sport, or “VWS”) and the National Institute for Public Health and the Environment (in Dutch, Rijksinstituut voor Volksgezondheid en Milieu, or “RIVM”).
As part of the application, a technical dossier is to be provided. This dossier will subsequently be subject to a safety assessment by EFSA, followed by a scientific opinion. In fact, here we very much see the parallel with the safety evaluations EFSA performs regarding for instance Novel Foods and additives. Topics to be covered to evaluate the safety of a particular recycling process include input characterization, description of the recycling process, determination of the decontamination efficiency of the recycling process, output characterization, and intended application in contact with food. For example, the dossier must demonstrate that and how it is ensured that the input material does not contain any chemical substances that could survive the recycling process and migrate to our foods in irresponsible quantities. In order to evaluate potential migration, detailed information on the type of food(s) intended to come into contact with the final product shall be provided. This will also include information on time, temperature and contact surface. Another important aspect concerns single or repeated use of the final product. All of this data serves to exclude possible health hazards and unacceptable influences on foods due to migration of substances. Further details can be found in the guidelines published by EFSA.
After receipt of a valid dossier, EFSA has, in principle, six months to evaluate the dossier. Thereafter, it is up to the European Commission to take an authorization decision. In doing so, it will take into account EFSA’s scientific advice. The final authorization may be subject to conditions and/or restrictions, such as with regard to the plastic input, the recycling process and/or the field of application of the recycled plastic. Authorized recycling processes are listed in a Community register established by the European Commission.
Many companies like to inform consumers that the food packaging they use is made from recycled plastics. However, it is essential that consumers are not misled about, for example, the actual content of recycled plastics used. Companies are therefore advised to follow ISO 14021 on environmental labels and declarations, or equivalent rules. In addition, the Dutch Advertising Code Committee (in Dutch: Reclame Code Commissie, or “RCC”) also explains what is possible and what is not, such as regarding packaging made of recycled plastics being environmentally friendly or friendlier. Environmental claims, i.e. advertisements in which implicit or explicit reference is made to environmental aspects associated with the production, distribution, consumption or waste processing of goods or services, must be verifiable. For instance, communicating that an article is “good for nature” because of the material used is perceived as misleading when this statement cannot be checked. It is no problem to use environmental symbols, as long as there is no confusion about the symbol’s origin and meaning. Examples of this include the Mobius Loop accompanied by the percentage of recycled material used in or near the symbol, as well as Lipton’s variation thereof.
While food business operators shall normally not be involved in the recycling of packaging themselves, they are advised to closely follow developments in this regard. Packaging namely plays an essential role in protecting foodstuffs and in providing information about the food it contains. Food business operators will therefore benefit from being aware of sustainable packaging possibilities. Moreover, food business operators can strengthen their legal position by being familiar with the legal requirements of the parties they cooperate with as well as with their own responsibilities set out by law. An example of the latter concerns making verifiable and non-misleading environmental claims, which is not always as easily done as said.
Last month, the European Council formally adopted the new Regulation on the transparency of the EU risk assessment in the food chain, which will be applicable as of 26 March 2021. As is in the name, the new provisions aim at increased transparency of EU risk assessment, which for a large deal means strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (“EFSA”). As EFSA has been accused more than once of conflicts of interest, this is, in principle, a welcome development. For FBOs, the implications are however important – as will be demonstrated below.
The upcoming changes follow from the Commission Communication on the European Citizens Initiative on glyphosate, in which initiative EU citizens called for more transparency in scientific assessments and decision-making, and build upon the findings of the fitness check of the General Food Law. The new provisions will mainly amend the General Food Law. For reasons of consistency, the new provisions also introduce changes to eight legislative acts dealing with specific sectors of the food chain, including the Novel Food Regulation, the Additives Regulation and the GMO Regulation. Based on the publicly available proposal for the meanwhile adopted provisions on the transparency of EU risk assessment, this blogpost provides an overview of what applicants will be facing in authorization procedures for innovative food products in terms of transparency and confidentiality.
Pre-submission phase: union register of commissioned studies and general advice
Before submitting an authorization application, for instance for a Novel Food like cultured meat or insects or for a new additive, applicants will have to notify EFSA of any study they commissioned to support a future authorization application. These studies will become part of the union register of commissioned studies as managed by EFSA. The submitted studies will be made public only when an actual application follows and insofar the studies do not contain confidential information, regarding which a request for confidential treatment has been granted. The idea behind the union register is that companies (potentially) applying for an authorization submit all related information, which subsequently allows EFSA to cross-check the information on the studies performed. This way, applicants can no longer hold back unfavorable studies. This notification obligation also applies to laboratories in the EU that carry out those studies, but obviously not to non-EU laboratories as they fall outside the scope of new provisions. According to the EC’s fact sheet of 13 June 2019, consequences of non-compliance with the notification obligation shall result in a negative temporary stop in the risk assessment.
At the same time, applicants have the right to request EFSA for advice on the relevant provisions and the required content of the application for authorization in the pre-submission phase. This procedure is a response to industry demand, especially of SMEs, for further support in the preparation of applications. The advice shall, however, be provided without the input of the Scientific Panels that are in charge of the actual scientific assessment and shall not cover the specific design of a study. Furthermore, EFSA’s advice shall be made public. Based on the publicly available proposal for the transparency provisions, it seems that this will be done before an actual authorization application is being submitted.
Submission phase: citizens’ access to studies vs. confidentiality
The default setting under the new provisions is that all scientific data, studies and other information supporting applications for authorizations shall be made public by EFSA. While the new provisions aim at ensuring that stakeholders and the public have access to key safety related information being assessed by EFSA, duly justified confidentiality information shall not be made public. The new rules specify which types of information may be considered as such. As listed in the publicly available proposal, this includes production methods, the quantitative composition of the substance or product at stake, certain commercial relationships and other sensitive business information. It is the responsibility of the applicant to demonstrate that making public the information concerned would significantly harms the (commercial) interests concerned. Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, confidential information shall be disclosed.
Specific sectoral food legislation will also include a list of certain types of information that may be treated confidentially. For example, a proposed change to the GMO Regulation includes the specification that certain DNA sequence information and breeding patterns and strategies may be treated confidentially. Next to the confidentiality rules, existing intellectual property rights, data protection rights and data exclusivity provisions for proprietary data, remain applicable.
When an applicant submits a request for confidentiality, it shall
provide a non-confidential version and a confidential version of the submitted information. If and when EFSA receives the submitted information, for example in case the Commission requires a scientific opinion as part of a novel food procedure, it shall publish the non-confidential version without delay and shall decide on the requested confidentiality within 10 days. Insofar the confidentiality request has not been accepted, EFSA shall subsequently publish the additional information after 2 weeks from the notification of its decision. Applicants that do not agree with EFSA’s decision may, under certain circumstances, challenge the decision before the Court of Justice of the European Union.
Once EFSA has published all the non-confidential information and before it carries out its scientific assessment, EFSA may consult third parties, including citizens, to identify whether other relevant information is available on the substance at stake. This new provision serves to mitigate the public concerns that EFSA’s assessment is primarily based on industry studies, more in particular on studies ordered by the applicant. The results of these consultations shall also be made public, as will be minority opinions to EFSA’s scientific output.
In case of a request for the renewal of an authorization, the applicant of the renewal will have the obligation to inform EFSA on its planned studies under the new rules. EFSA shall subsequently consult stakeholders and the public on the planned studies and, taking into account the received comments, provide the applicant with advice on the content of the intended renewal application. The reason behind this pre-submission procedure is to make use of the existing experience and knowledge on the substance or product in question. The European Commission expects that the notification obligation will have a positive effect on the evidence base of EFSA, avoids the unnecessary repetition of studies, and will provide the potential applicant with useful advice. It should, however, be noted that also in this case EFSA’s advice will not stand in the way of the subsequent assessment of the renewal application by the Scientific Panels.
Additional controls on the conduct of studies
The new provisions also include measures to ensure the quality and objectivity of the studies used by EFSA for its risk assessment. First of all, the European Commission will have the right to perform controls, including audits, to verify the compliance of testing facilities with relevant standards. Competent authorities of the Member States will be involved in these controls. Through coordination with OECD GLP auditing programs, the control in non-EU countries will be facilitated as well. Secondly, the European Commission will have the right to request EFSA to commission verification studies. Such action shall only be taken in exceptional circumstances, such as in case of serious controversies or conflicting results, and will be financed by the EU.
The new provisions address public concerns regarding transparency, while on the other hand acknowledge that confidentiality is key to not cut down on incentives for innovation by food businesses. In other words: the new provisions seek to balance transparency and confidentiality. Food businesses are advised to substantively consider their commercial interests when submitting a dossier for authorization, since confidentiality will only be granted upon duly justified requests. Moreover, the union register for submitted studies forces food businesses to carefully plan their studies at an early stage since also studies with less favorable outcomes will in principle be made public and scrutinized on inconsistencies with later studies. At the same time, more guidance is expected from EFSA in the pre-submission phase, possibly speeding up the actual authorization procedure. Given the fact that the new provisions will apply from less than 20 months from now, food businesses may consider speeding up or delaying their application for authorization, depending on their needs.
“The FDA knows just how vital it is to ensure the safety of our nation’s food supply and the critical role science-based, modern regulatory frameworks are to fostering innovation. Recent advances in animal cell cultured food products present many important and timely technical and regulatory considerations for the FDA and our partners at USDA,” said Commissioner Gottlieb. “We look forward to the opportunity to hold a meeting with our USDA colleagues as part of an open public dialogue regarding these products.”
Harvard Law School
This is a new quote taken from the website of the FDA, regarding a joint FDA – USDA meeting on animal cell culture technology on 23 and 24 October 2018 in Washington. Securing regulatory clearance is pivotal for market access of this type of products, which used to be often referred to as “clean meat,” “cell-based meat,” or “lab-grown meat,” depending on whom you would ask. Since the Good Food Conference early September, there seems to be consensus to retain the term “cell-based meat”. To date, there is however no consensus on the appropriate US regulatory framework for these products, which is why this new meeting has been set. In particular, it is not clear which federal regulatory agency – the FDA or USDA or both – has jurisdiction over these products with respect to labeling, safety and inspections, or whether these products will meet regulatory definitions relating to “meat” and “poultry.” Harvard Law School, in particular its representatives from the Food Law and Animal Law groups, recognizes the potential benefits of clean meat and other cellular agriculture products. Therefore, on 9 and 10 August 2018, the school organized the Clean Meat Regulatory Roundtable in order to address the regulatory concerns surrounding this new industry. Further to an earlier post on this subject, this is take #2 on the Harvard initiative, reporting a selection of topics discussed at that table. Also a comparison with the EU regulatory framework shall be made where relevant.
Participants Regulatory Round Table and Ruled of Play
In order to let the discussion benefit from as many perspectives as possible, representatives from academia, the industry and from interest groups participated in Harvard’s Clean Meat Regulatory Roundtable. Obviously, the meeting included a number of representatives from Harvard Law School. Furthermore, the nonprofit organizations Good Food Instituteand the Animal League Defense Fund were present. The participating companies were Mosa Meat and Fork & Goode (both working on clean meat), as well as Blue Nalu (working on clean fish). From the investor side, Stray Dog Capital was represented and from the industry DuPont provided its input. Finally, a number of US lawyers participated, including Deepti Kulkarni from Sidley Austin LLP. I myself shared my insights on this topic from an EU perspective. To encourage openness and the sharing of information, all participants agreed to a Chatham House Rules + regime, meaning that the topics discussed during the meeting could be reported, but the participants were not at liberty to identify, either explicitly or implicitly, the identity of the speaker or his or her affiliation.
Cooperation on optimal regulatory pathway?
Amongst the participants, there was a common concern that if one party rushes unprepared to the market, ignoring the appropriate regulatory pathways, that could poison the well for the entire cellular agricultural industry. It was therefore discussed to what extent the cellular agriculture industry could cooperate regulatory-wise. It became clear that even though clean meat products share certain characteristics, finished products could be quite different in terms of formulation, composition, or other product characteristics. Nonetheless, general principles for assessing safety and product identity could be established under existing regulatory authorities. Such principles could for instance involve considerations relating to substances used in the production of clean meat, including scaffolds, growth factors, and cell culture medium or potential variations in the production process. In addition, it was discussed whether common interests could be effectively promoted through a trade association or industry group. The participants discussed various options, including setting up a dedicated association and connecting with existing organizations such as BIO.
Contrary to the situation in the EU, where the European Commission is the one stop shop for obtaining a Novel Foods authorization, in the US foods can be subject to regulatory oversight by multiple federal and state agencies. It is has not yet been decided which agency has jurisdiction over these products, or whether the products are subject to dual oversight. In general, USDA regulates meat and poultry, including the inspection of establishments that slaughter such animals or otherwise process meat and poultry products. FDA generally regulates all other food, including fish and certain other meat and poultry products, such as bison, rabbits, and wild turkeys and ducks. In addition, FDA regulates new ingredients (as “food additives”) used in the production of foods under its jurisdiction, as well as new ingredients used in meat and poultry products that otherwise would be subject to USDA oversight.
Meat and poultry products subject to USDA jurisdiction generally require “continuous” or daily inspection, depending upon the nature and frequency of operations. Because the production of clean meat does not involve slaughtering animals and such products would not be derived from slaughtered animals, there are open questions regarding the applicability of USDA’s inspection regime. This is even more so when clean meat products are not “harvested” daily, but on a batch-based basis. Arguments, nonetheless, can be made in favor of USDA jurisdiction with respect to “processing” inspections and other in-market activities, as well as product labeling. Nevertheless, at the Roundtable, there seemed to be a slight preference for FDA jurisdiction both pre-market and in-market.
Traditional meat industry’s concern of level playing field
The views of the traditional meat industry are somewhat fractured with respect to the clean meat industry. Some have taken considerable stakes in clean meat ventures (consider the investments of both Tyson and Cargill in Memphis Meats), particularly industry segments more closely involved with raising livestock are less supportive. For example, the US Cattleman’s Association submitted a petition to the USDA in February this year, asking it to establish labeling requirements that would prohibit clean meat from using terms like “meat” or “beef” in product labeling. Most trade groups representing the traditional meat industry have called for a “level playing field” where clean meat products would be subject to some level of USDA inspection. In general, all participants at the Harvard Panel agreed that a discussion with the traditional meat industry on how clean meat should be regulated would be critical. Notably, clean meat producer Memphis Meats and the North American Meat Institute, a trade group that represents the largest meat producers in the U.S. recently issued a joint letter to the White House outlining a regulatory regime under both FDA and USDA, and calling for a combined meeting involving the White House, USDA, FDA, and representatives of the traditional meat and clean meat industries.
Even if the FDA were to have some level of jurisdiction over clean meat products, it is still not completely clear what data would need to be submitted to demonstrate safety. One of the participants opined that, unlike a food additive approval, neither a GRAS determination, nor an FDA consultation (see here for an example of a consultation procedure on plant based products) would result in an affirmative regulatory approval. Some were of the opinion that a regulatory opinion short of approval would not benefit the clean meat industry, particularly in the eyes of the public. By contrast, others particularly those familiar with the GRAS process and the requisite scientific information needed to demonstrate safety disagreed with the position that a GRAS determination would not be rigorous or otherwise appropriate. The participants then discussed that a potential hybrid model that followed the GRAS approach, but also involved a third-party safety opinion could be an option. As to the required data, it was discussed what would be the “ingredient” that would be assessed by the competent government agency. The substances used in the culture of clean meat products most likely are of relevance, even if they may qualify as mere processing aids that normally only remain as residues in the final product without technical function. One participant mentioned such substances could easily be tested in separate toxicology studies, to which reference could be made during the pre-market evaluation (US) or in the application for a Novel Foods authorization (EU).
EU market entry of Novel Foods
Compared to the US, the regulatory pathway for clean meat products in the European Union is relatively clear. Under the new Novel Foods Regulation (effective as per 1 January 2018), an application for an authorization of a Novel Food should be made with the European Commission, who will subsequently distribute this to all EU Member States. The application should in the first place contain a detailed description of the product for which an authorization is sought, as well as of its production process. Furthermore, a proposal for the purported conditions of use should be handed in and a labelling proposal that does not mislead the consumer. Last but not least, the applicant should provide scientific evidence, demonstrating the purported Novel Food does not pose a safety risk. For this purpose, tox studies that comply with Good Laboratory Practices are mandatory, as is an evaluation of the total safety strategy. This should be based on proposed uses and likely exposure, with justification to include or exclude certain studies in order to prevent cherry picking. Upon receipt of the Novel Food application, it is anticipated that the Commission will request a safety opinion from EFSA, who will evaluate, amongst other things, if the Novel Food concerned is as safe as food from a comparable food category already placed on the EU market. The EFSA evaluation should not exceed a 9 months term. Within 7 months after receipt of a positive safety opinion, the Commission should publish its implementing act, which will result in the inclusion of the approved Novel Food in the Union List. The single open end in this procedure is the term for response for the Member States, which in the former Novel Food Regulation used to be 60 days. Surprisingly enough, this term is not mentioned in the new Novel Food Regulation that applies as of 1 January this year. However, there are no reasons to believe this should be any different under the current Novel Foods Regulation.
In order to inspire consumer confidence in clean meat products, the participants discussed how to best ensure the products’ short and long-term safety, particularly against the backdrop of public fear and aversion to genetically modified foods. Despite the assurance that FDA provided regarding the safety of these foods, many consumers remain fearful or otherwise suspicious of such foods. The participants agreed that steps should be taken to avoid a similar unwarranted aversion to clean meat products, including transparency initiatives and consumer education. In this framework, it was suggested that the clean meat industry could pro-actively develop its own HACCP program, provided that the industry could reach agreement on what would be the best way to identify the hazards and applicable critical control points. To this respect, it is relevant that both FDA and USDA have HACCP regulations and have identified hazards of chemical, biological and physical nature that might be applicable to this new sector.
Labeling, marketing, product identity
Vivid discussions took place regarding whether or not clean meat or fish products could be called “meat” or “fish” respectively. Whereas some argued: “Meat is what it is, so meat it should be called”, others considered the actual name less important. Most likely, we will not see the plain term “meat” on product packaging, but rather “ground beef,” “meatballs,” or “chicken tenders”. Some participants cautioned that, in order for products to be labeled with such product-specified terms, they generally would have to meet the general definitions for “meat” or “poultry,” unless the labeling adequately described or qualified the product. For product placement, it is of relevance whether the clean meat products belong to the “meat department” or somewhere else, though several participants clarified that such placement is decided by agreements with retailers, rather than by regulatory oversight. All participants agreed that a so-called qualifier that would explain the exact nature of the product, could benefit the industry. Such qualifier should be a neutral term, explaining concisely how clean meat products differ positively from traditional meat products, without being pejorative vis-à-vis said traditional industry. This is easier said than done and the participants so far did not reach a common view at this point. Notably, in their joint letter to the White House, Memphis Meats and the North American Meat Institute, propose use of the term “cell-based” meat or poultry to describe products that are the result of animal cell culture. The echo of this letter was heard at the Good Food Conference, as reported above.
Information requirements in the EU
Looking at the EU framework, it is questionable whether the designation “meat” can be used for clean meat products. As an argument in favor thereof, it could be mentioned such use would make it immediately apparent that these products equal traditional meat in terms of composition. Arguments countering the use of “meat” are based on the EU Hygiene Regulation. When using a grammatical approach, it should be observed that “meat” is defined as “edible parts of [a number of defined]animals” and one could wonder if cells qualify as such. When using a functional interpretation, it can be noted that hygiene requirements applicable to meat mainly relate to slaughtering, whereas clean meat obviously is not subject to slaughter. Another argument countering the use of “meat” for clean meat products is derived from the ECJ’s TofuTown case, related to veggie cheese and soy yoghurt. In legal terms, this decision answered the question whether it was permitted to use regulated product names for new product types. The answer was a clear “no”. It is anticipated that the traditional meat industry will rely on this case to counter the use of the name “meat” for clean meat product, at least without a qualifier that will prevent any misleading of the consumer. By way of background, it is helpful to remember that under EU labeling laws, it is mandatory to designate a food product by its legal name. In the absence thereof, a descriptive name can be used or alternatively, a customary name.
Clean meat and clean fish represent an emerging sector, with the promise of revolutionary innovative products. Public perception of these products, as well as trust in the safety thereof, will be of utmost importance for market success. Reliable and effective regulatory procedures as a basis for market access will therefore be pivotal. In the US, the regulatory framework applicable to clean meat products is far from clear. Firstly, it is yet to be decided which government agency has jurisdiction over these products or whether both FDA and USDA share oversight. Secondly, there are open questions regarding the appropriate regulatory pathway and in-market inspection regime. In the European Union, the regulatory pathway for clean meat products is relatively clear. Under the new EU Novel Foods Regulation, these products qualify as Novel Foods and require a market authorization from the European Commission. The Regulation as well as various EFSA guidance documents detail at length what information should be contained in a Novel Foods application. In an optimal situation, the authorization procedure could be finalized in 18 months. In both the US and the EU however, the exact designation of these products (“meat” or not?) requires further thought. On the one hand, this will require interpretation of legal product definitions and case-law and on the other hand, the interests of the traditional meat and fish sector should be taken into account.
The Dutch National Probiotic Guide: an innovative alternative for health claims on beneficial bacteriaPosted: August 24, 2018 | |
Probiotics are known as “beneficial bacteria” that can be found in, amongst others, dairy products and food supplements. They are defined by the joint FAO/WHO expert consultation on probiotics as “live microorganisms that, when administrated in adequate amounts, confer a health benefit on the host”. Since the reference to probiotics implies a health benefit, it comes as no surprise that the statement “contains probiotics” in a commercial communication about a food product constitutes a health claim under the Claims Regulation. Moreover, “contains probiotics”, or “prebiotics”, is explicitly taken as an example of a health claim in the guidance on the implementation of Regulation 1924/2006 of the European Commission’s Standing Committee on the Food Chain and Animal Health. At this moment, no health claims for probiotics have been approved by the European Commission. The Dutch Research institute TNO and the world’s first microbe museum Micropia, located in Amsterdam, are nevertheless convinced of the health benefits of probiotics, in particular to protect against antibiotic-associated diarrhea (AAD). At the beginning of this month, they launched a so-called National Guide on clinically proven probiotics for use during antibiotic treatment in the scientific journal BMC Gastroenterology
The National Guide is presented as a tool for healthcare professionals, patients and other consumers to recommend or use the probiotic products listed as scientifically proven to prevent diarrhea caused by the use of antibiotics. While antibiotics fight bacterial pathogens, they also have a disruptive effect on the body’s own gut bacteria. One in four adults experiences diarrhea caused by ADD. The National Guide promotes probiotics for their function of protecting the gut flora from the disruptive effects of antibiotic treatment, fostering recovery and reducing the risk of recurring infections.
The research behind the Guide involves a literature study of clinical studies that are all based on randomized, double-blind and placebo-controlled trials. Moreover, all of the trials clearly define AAD and have a probiotic administration regime for a period no shorter than the antibiotic therapy. 32 of the 128 initially identified clinical studies were selected in line with the aforementioned criteria. After the selection and review process, available probiotic products on the Dutch market were listed to be subsequently matched with the formulations as proven effective in the selected clinical studies. Only eight probiotic dairy products and food supplements marketed in the Netherlands specified on their label the respective probiotic strain(s) and number of colony-forming units (CFUs) and could therefore be used in the research. The listed probiotic products were awarded with one (lowest) to three (highest) stars for their proven effect as demonstrated in at least one to three clinical studies. The strain Lactobacillus rhamnosus GG with a minimal daily dose of 2 × 109 CFU was found in at least three clinical studies and therefore awarded with a three-star recommendation. This strain was found in 2 products, both of which are food supplements. Several multi-strain formulations resulted in a one-star recommendation; 5 food supplements and 1 dairy product matched such a formulation. The multi-strain formulation Lactobacillus rhamnosus GG, Lactobacillus acidophilus LA-5 and Bifidobacterium lactis BB-12 was present in two clinical studies and therefore assigned with a two-star recommendation. However, none of the listed probiotic products found on the Dutch market contained this formulation.
Plea for the labeling of probiotics
The research is not exhaustive as probiotic products other than the eight that were included in the study might also be effective. However, since this was not communicated on the label, they could not be included in the research. To overcome this gap, TNO and Micropia as the initiators of the National Guide call for the labeling of the probiotic strains and number of CFUs on all probiotic products EU-wide. This could also expand the potential of the Guide. At this moment, strain and CFU labeling of probiotic products is not legally mandatory under the Food Information for Consumer Regulation. The initiators also developed a special probiotic label to address this claimed deficiency. The label is based on the probiotic label used in the US as created by the International Scientific Association for Probiotics and Prebiotics (ISAPP). The labels are in line with the information that should be demonstrated on probiotic labels according to the FAO/WHO 2002 Working Group on Guidelines for the Evaluation of Probiotics in Food.
National Guide to circumvent limitations under the Claims Regulation?
The Claims Regulation applies to health (and nutrition) claims made in commercial communications of foods to end consumers. This may be in the labeling, presentation or advertising of the food. Besides information on or about the product itself, also general advertising and promotional campaigns such as those supported in whole or in part by public authorities fall within the scope of the Regulation. Moreover, since the Innova Vital case, we know that (science-based) communications made to healthcare professionals may also be regulated by the Claims regulation. The rationale thereof is that the healthcare professional can promote or recommend the food product at issue by passing the information on to the patient as end consumer. Only non-commercial communications, such as publications that are shared in a purely scientific context, are excluded from the Regulation.
It must be noted that the National Guide is, unlike health claims, not a commercial communication originating from food business operators. This does, however, not necessarily mean that food business operators are free to use the science-based Guide in their communication with (potential) consumers or even with healthcare professionals without any reservation. The Guide, which not only lists the probiotic formulations that are beneficial for the human gut flora, but even the names of products that contain those formulations, could turn commercial when referred to by a food business. Moreover, when shared in such a context, the claims made in the National Guide may even enter the medical domain due to the preventive function assigned to foods containing probiotics.
The history of probiotic health claim applications has shown that EFSA is not easily convinced of the evidence that is correspondingly provided. The National Guide is, however, not subject to approval from the European Commission, backed by a positive opinion from EFSA. The Guide’s publication in the peer-reviewed journal BMC Gastroenterology nevertheless contributes to the verification of its scientific substantiation. The Guide therefore appears as an innovative, science-based alternative for probiotic health claims. At the same time, food business operators should be careful in referring to the National Guide to not act beyond the borders of the Claims Regulation and to stay away from medical claims. As a very minimum however, it seems to be valuable work to be adopted by branch organizations or research exchange platforms, such as the International Probiotics Association.
The organic sector has developed from a niche market to one of the most dynamic sectors of EU agriculture. To recall some numbers provided by the European Commission, the amount of land used for organic farming grows at around 400,000 hectares a year. The organic market in the EU is worth around €27 billion, some 125% more than ten years ago. The EU encourages more farmers into the organic sector and aims to increase consumers’ trust in certified organic products to further boost those numbers. For some background on the regulatory framework, we refer to our earlier blogpost on the Organics Regulation. As already announced in that post, the current Council Regulation (EC) No 834/2007 needs an update as it is based on practices of over 20 years ago. The first proposal for a new EU Regulation on organic production dates back to 2014. Last month, the European Parliament Committee on Agriculture and Rural Development gave green light to the new Organic Regulation. This new regulation aims to guarantee organic production throughout the supply chain by phasing out the many exemptions that are allowed under the current Regulation, such as the use of non-organic seeds as further covered below. In other words, the new regulation shifts from an à la carte system of exceptions to a set menu of harmonized rules. This contribution sets out the most important changes by answering relevant questions in the light of the new Organic Regulation.
Which products are covered under the new Organic Regulation?
Similar to the current Organic Regulation, the new Organic Regulation applies to live and unprocessed agricultural products, including seeds and other plant reproductive material and processed agricultural products used as food and feed. Processed products can be labelled as organic only if at least 95% by weight of their ingredients of agricultural origin are organic. Unlike the current Organic Regulation, the new Organic Regulation also covers certain other products closely linked to agriculture. Those products are listed in Annex I and include, among others, salt, essential oils, cork, cotton, and wool. Other products may be added in future.
To what extent can non-organic seeds still be used?
Derogations that allow non-organic seeds to be used in organic production will expire in 2035. A couple of measures will be taken to increase the organic seed supply and to help it meet high demands before that time. First of all, Member States shall establish a database of organic plant reproductive material as well as national systems that connect organic farmers with suppliers of organic reproductive material. Secondly, the use non-organic seeds may temporarily remain allowed if the collected data demonstrates insufficient quality and quantity of the organic reproductive material. Also, to meet the demands of organic seeds, organic heterogeneous material is explicitly allowed for in Article 13 of the new Organic Regulation and production criteria for organic varieties are adapted taking into account the specific needs and constraints of organic production. The derogations may be phased out earlier than 2035 or extended based on a report due in 2025, which will examine the situation of plant reproductive material on the market.
Are mixed farms still allowed under the new Organic Regulation?
While the initial proposal of the Commission proposed to ban the production of organic products and conventional products at the same farm, mixed farms continue to exist under the new Organic Regulation. Mixed farms are allowed provided that the two production activities are effectively separated into clearly distinct production units. This means, among others, that inputs for production as well as the final products must be separated to avoid contamination and potential fraud. Also, the two production activities should involve different livestock species and plant varieties.
What measures must be taken to avoid contamination from non-authorized substances?
EU thresholds for conventional products automatically apply to organic ones too. Stricter thresholds for non-authorized substances in organic products are not introduced. This would include high costs, especially for small farmers, to control for example contamination from neighbouring conventional farming. Instead, food business operators are obliged to take precautionary measures to avoid contamination. The responsibility and accountability of organic producers will thus be emphasized. Final products are not allowed to bear the organic label when the contamination was deliberate or caused by irresponsible food business operators that failed to take precautionary measures. Meanwhile, Member States remain at liberty to set specified thresholds for non-authorized substances in organic products, provided that these national rules will not affect the trade of organic products that are legally placed on the market in other Member States. Based on a report due by the end of 2024, anti-contamination rules and national thresholds may be further harmonized in future.
How does the new Organic Regulation ensure the high quality of organic products?
Rather than moving all the control provisions into the regulation on official controls for food and feed, as initially proposed by the Commission, specific rules will apply to the control of organic farming. Organic production refers to the use of production methods that contribute to the protection of the environment, animal welfare, and rural development. Risk-based checks will therefore not be limited to final products but take place along the supply chain to guarantee that organic products are truly organic. Physical on-site checks will take place at least annually; the on-site check may be reduced to once every two years if the food business operator has been fully compliant for three years. In the Netherlands, those inspections are carried out by SKAL as the the designated Control Authority responsible for the inspection and certification of organic companies.
What does the new Organic Regulation mean for products imported into the EU?
Under the current Organic Regulation, organic products produced in third countries are allowed on the EU market when the organic standards of the exporting country are similar to EU rules. This means that organic products are in fact regulated by over 60 different standards. Under the new Organic Regulation, all imported products will have to comply with EU standards. Taking into account the date of application of the new Organic Regulation as well as the transitional period granted for imported products, this rule will only apply as from 2026. Moreover, certain exceptions are introduced to avoid disruptions of supply on the EU market. First of all, the Commission is empowered to grant specific authorization for the use of products and substances in organic production in third countries with specific climatic and local conditions, which therefore cannot comply with the new requirements. This exception also applies to organic production in the EU’s outermost regions, such as the Nordics. Secondly, equivalent production methods in third countries could be recognised under trade agreements.
The new Organic Regulation promises to further boost EU organic production. Measures to increase the supply of organic seeds and animals, allowing mixed farming, and no harmonized thresholds for non-authorized substances aim to attract more farmers into organic production. Meanwhile, measures are taken to increase consumers’ trust in organic products, such as through risk-based checks along the supply chain and the switch from the principle of equivalence to an EU single set of rules for imported products. We expect this to be a major improvement for the algae sector, that suffers unfair competition from Asian countries, where organic standards are not necessarily the same as in the EU.
It takes some more years to see to what extent the Regulation will live up to its promises. While the Regulation itself only becomes applicable from 2021, many rules are subject to further implementation depending on the development of the sector. This illustrates the dynamic character of the organic sector, which creates many opportunities for food business operators active in this field.
Last month, the European alcoholic beverages sectors handed over to the European Commission a self-regulatory proposal on the provision of nutrition information and ingredients listing. Article 16(4) of the Food Information for Consumers (FIC) Regulation exempts alcoholic beverages containing more than 1.2% by volume of alcohol from the mandatory list of information and nutrition declaration. Nevertheless, it also attributes the Commission with the task to investigate whether and to what extent alcoholic beverages should nevertheless be covered. Last year, the Commission established in its report, amongst others, that the provision of nutrition information and ingredients listing could help consumers to make informed choices about what and how much to drink. The alcoholic beverages sectors have been asked to present a self-regulatory proposal to respond to consumers’ expectations as they have done last month.
In their proposal, the alcoholic beverages sectors elaborate on the details on the communication of the nutrition information, the list of ingredients, and the means of delivering this information to consumers. The sectors aim to provide consumers with meaningful information while preventing to create new burdens for SMEs. In this blog we give a short overview of the proposal, which should be read together with the sector-specific annexes for beer, cider, spirits and wine that allow for sector-specific implementation of the proposal.
According to the FIC Regulation, nutrition information must be given per value of 100 ml of the product and may additionally be provided per portion size. Nutrition information involves the energy value and the amounts of fat, saturates, carbohydrate, sugars, protein and salt, but may also be limited to the energy value only. The spirit sector emphasizes in its annex that it is most meaningful for consumers to provide the information in portion size and adds that the energy value per 100 ml might be misleading, as spirits are never served in this quantity. To provide accurate nutrition information, food business operators may carry out analysis on their products or they can use generally established and accepted data. The alcohol beverages sectors stress the importance of the latter option due to the changing nature of certain alcoholic beverages as they age (wine) and depending on the harvest (e.g. cider). Moreover, said data will also reduce the burden for analysis by SMEs. The wine and spirits sector have already provided such a toolkit in their annexes to the proposal, using average values of typical and characteristic wines. For instance, 100 ml of brut, sparkling wine provides 70 kcal.
As for the list of ingredients, Article 20 of the FIC Regulation excludes food additives or food enzymes used as processing aids from this list. The wine sector specifies that this means that only additives permitted for wine-making not considered processing aids during the wine-making process shall be included in the list of ingredients. Moreover, the sector notes that natural substances used to adjust the grape composition (acidity and natural sugar content) do not have to be listed; those substances only aim to restore the basic balance and composition where harvest conditions are not optimal. The wine annex is already rather concrete in the sense that it shows in its appendix I a list of oenological compounds that, when used, will have to be included in the list of ingredients.
Lastly, the proposal embraces new information and communication technologies to inform the consumer on the nutrition declaration and list of ingredients. This is in line with recital 51 of the FIC Regulation, according to which food information rules should be able to adapt to, amongst others, a rapidly changing technological environment. Next to traditional on label information, off-label information that can be accessed via a web-link, QR code, bar code or other direct means of using smart technologies are suggested in the proposal. The wine sector refers in its annex for example to the website of ‘Wine in Moderation’ as a tool to comply with labeling requirements by off-label means. The alcoholic beverages sectors propose to leave it up to the food business operators how to display the information.
The alcoholic beverages sectors commit themselves to report on implementation in March 2021. The proposal will now be assessed by the Commission. Green light will allow for high spirits to make information on alcoholic beverages crystal clear. However, all four sectors (beer, cider, spirits and wine) must be working hard on more concrete implementation guidelines that can be used by their member companies, who have to do the actual job. For the time being, the wine and spirits sector so far have elaborated the most concrete proposals. We will continue to monitor and report on further developments in this field.
Consumers across all demographics are increasingly concerned about cognitive health and performance. For that reason, Food Matters Live, held in London from 21 – 23 November last, dedicated one of its Seminars to the exploration of new R&D advancing the understanding of nutrition and cognitive health and performance. I was asked to give a presentation on meeting standards for cognitive claims, of which you will find a summary below. You will note that in addition to the system of currently authorised claims, I will explore its flexibility, as well as the options outside its scope.
The general framework for health claims is contained both in the FIC Regulation and in the Claims Regulation. The FIC Regulation embodies the principle of fair information practises. According to this principle food information should not be misleading as to the characteristics of the food, for example by attributing it effects it does not possess. Furthermore, the FIC Regulation prohibits any medical claims to be made in connection with food products. A medical claim is to be understood as any claim targeting the prevention or treatment of a particular disease. It is for instance not permitted to state that a food supplement alleviates the symptoms of rheumatoid arthritis.
The Claims Regulation lays down the very concept of a health claim, being a voluntary message in any form that states or suggests that a food has particular characteristics. Basically, a health claims conveys the message “What does the product do?” Health claims can only be made with regard to a particular nutrient that has been shown to have a beneficial nutritional of physiological effect. Such nutrient should be present in the end product in a form that is bio available and to such extent that it produces the claimed effect. The scope of the Claims Regulation includes all commercial communications regarding food products to be delivered to the final consumer. Based on the Innova / Vital decision of the ECJ, it was clarified that such final consumer can also be a health care professional.
Legal framework for cognitive claims
Currently, authorised claims for cognition can be linked to iodine, iron and zinc. For all of these compounds, the claim “contributes to the normal cognitive function” can be made. In addition, for iodine the claim “contributes to the normal functioning of the nervous system” is available and for iron a claim specifically targeting children can be made. The conditions of use for these claims are calculated on the reference intake (“RI”) applicable to each mineral. As such, a distinction is being made between solids (15 % RI) and fluids (7.5% RI). For instance, in order to allow a cognition claim linked to iron, the end product should at least contain 2.1 mg iron / 100 g or 1.05 mg / 100 ml. Any claim should refer to a food product ready for consumption, prepared in accordance with the manufacturer’s instructions.
Flexibility in wording
In practise, I see that many food business operators try to reword the authorised claims, as they are not considered to be a major add-on. In the Netherlands, this practise has been facilitated by the Council for the Public Advertising of Health Products (Keuringsraad KOAG-KAG), who has published a list of alternative, authorized claims. For instance, for a claim on zinc, the Dutch translation of the wording “contributes to a regular problem-solving ability” is permitted as an alternative. Regarding a claim on iodine, you could think of “plays an important role in mental activity.” Furthermore, it is also permitted to state that a food product containing the required minimum of iron “contributes to regular intelligence”. Now we are talking!
Examples found in practise
An internet search for products targeting cognition revealed that many of them are not linked to the EU authorized claims at all. For instance, the company Flora Health is marketing the food supplement ginkgo biloba, claiming that it “helps to enhance cognitive function and memory in an aging population.” Also, the food supplement Mind Focus containing various vitamins, minerals and green tea extract from the company Bio Fusion was found, which allegedly “improves mind focus and concentration instantly”. Furthermore, the green oat product Neuravena was found, regarding which five clinical studies confirm it benefits to cognitive function. How can this be explained? The first two examples contain claims that in the EU would no doubt qualify as medical claims and as such are prohibited.
Non-EU products and options outside cognitive claims framework
Products that do not comply with EU standards may originate from other countries or territories that are subject to a different regulatory regime than applicable in the EU. Without endorsing any claims made, it was found that the gingko and Mind Focus products originated from Canada and the US respectively. The same is not true for the product Neuravena, as its manufacturer Frutarom claims to be a “global manufacturer of health ingredients backed by the science, and supported with documentation and the regulatory compliance our customers demand.” The difference here is that Neuravena is not advertised on a commercial setting targeting end consumers, but in a scientific portal. The website even contains a disclaimer to that extent. In a non-commercial, purely scientific environment, the Claims Regulation is not applicable. This allows FBO’s, provided that the same website does not contain a click through ordering portal, to communicate on their R&D and cognition even outside the authorised EU framework.
The EU authorised claims for cognition are limited in number and scope. Several EU Member States offer considerable flexibility in wording, which makes the use of claims much more appealing. Furthermore, in a science-based context, the Claims Regulation is not applicable, which allows you plenty of opportunity to communicate your latest R&D on nutrition & cognition, provided that the message is strictly scientific and not commercial.
The European Court of Justice (ECJ) recently took its decision in the TofuTown case, providing clarity on the interpretation of the Agricultural Product Standards Regulation (APS Regulation). In short, this case dealt with the question: “Is it possible to use regulated product names for new product types?” The answer to this question is a clear “no”. This came as quite a shock to the emerging vegetarian and vegan market. Many companies marketing alternative protein products use traditional product names for their dairy replacements. They may have to change these names, as they are no longer in line with the view of the highest EU Court.
Initiator: Verband Sozialer Wettbewerb
The TofuTown case was initiated by the German unfair competition association Verband Sozialer Wettbewerb (“VSW”). This activist organisation was also at the origin of the Innova Vital case, clarifying the scope of the EU Claims Regulation. Based on this decision, we now know that the Claims Regulations not only targets commercial communications addressing final consumers, but under certain circumstances, it also addresses communications made to health care professionals. VSW initiated the present case against the German company TofuTown, as it claimed the promotion of strictly plant-based products under denominations such as “Soyatoo Tofubutter”, “Pflanzenkäse” and “Veggiecheese” infringed the EU competition rules.
Main rule of Agricultural Product Standards Regulation
The legal framework of this dispute is constituted by the APS Regulation, containing detailed agricultural products definitions in various sectors, such as cereals, olive oil, wine, milk and milk products. The main rule following from the APS Regulation is that the names of regulated products may not be used for other products. TofuTown had argued, in essence, that this principle is outdated. In the past, such rule may have been justified to protect consumers against manufacturers distributing cheap products as dairy products, thereby gaining a competitive advantage. Nowadays, consumer awareness has changed considerably and many consumers want to be informed about alternatives to dairy products. Using regulated dairy names for plant-based alternatives is not meant to mislead consumers. Quite to the contrary, such use enables to inform the consumer on plant-based origin of their products as opposed to the animal derived dairy products they intend to replace. The ECJ did not agree with this argument. It is nevertheless worthwhile to investigate if any other argument could escape the strict product name regime embodied in the APS Regulation.
Room for manoeuvre in APS framework?
On the face of it, there is. The Commission is empowered to adopt delegated acts concerning exemptions to the strict product definitions laid down in the APS Regulation, provided these shall be strictly limited to demonstrated needs resulting from evolving consumer demand, technical progress or the need for product innovation (see article 78.3 APS Regulation). Tofutown’s plea for informing consumers about plant-based alternatives to dairy products seems to fit in seamlessly in this derogation. However, for the time being, there is no such delegated act, so that it is worth while exploring if there any further exceptions to the strict product names principle embodied in the APS Regulation.
In fact, two of these exceptions are being mentioned in the TofuTown case. In the first place, designations for milk products may also be used in association with words designating composite products. The condition precedent is that no part takes the place of any milk constituent. Furthermore, milk should also be the essential part of such composite product, either in terms of quantity or for the characterisation (see Annex VII belonging to the APS Regulation, in particular Part III, nr. 3 thereof). An examples of such composite product names is chocolate milk.
Another exception to the system of strict product names relates in the first place to products the exact nature of which is clear from traditional usage. In the second place it covers designations that are clearly used to describe a characteristic quality of the product. The Commission has drawn up a limitative list of such product names that can be found here. Examples of such product names are the following:
- UK: horseradisch cream, cream crackers and coconut milk
- France: almond milk (lait d’amande) and oat cream (crême d’avoine)
- Spain: almond milk (leche de almendras)
- Netherlands: butter beans (boter bonen) and cacao butter (cacao boter)
This list has a highly cultural character and does not allow for translations of the product names mentioned therein into other Member States languages. As such, it would be prohibited to market almond milk in or any other EU country than France and Spain. The same goes for butter beans outside the Netherlands.
It could be argued that names like “Tofubutter” and “Veggiecheese” are clearly used to describe a characteristic quality of the product. However, as long as they are not mentioned on the Commission exemption list, these cannot be legally used for marketing plant-based alternatives to dairy products. More in general, the practical consequences of the TofuTown decision are expected to bring about serious restrictions for marketing plant-based products. Is this to be considered a setback for the consumer or to the contrary, will this prevent any consumers being misled? In fact, this is besides the point, as based on this decision, the enforcement authorities, like the Dutch Food Safety Authority (“NVWA”) in the Netherlands, will be authorised to prohibit further use of strictly regulated product names for their vegetarian peers. It will be interesting to see though if any enforcement actions will take place based on the mere product name. And also, will this be in the interest of the educated consumers of today? That’s certainly not beside the point.
Traditionally milk comes from cows or other animals such as goats. However, in recent decades, a large number of alternatives to traditional milk were introduced to the market. From a consumer perspective, these alternatives are similar to “traditional milk” in terms of purpose of use. These alternative food products are produced using plant-based protein derived from soy, coconut or other sources. There is an ongoing debate in the US regarding whether or not these ‘alternative milks’ are to be considered ‘milk’ and can be sold as such. This debate could be the precursor to a much more encompassing debate on whether alternative sources for traditionally produced foods from animal origin can be named after the product they are meant to replace, or rather marketed to be the plant based alternative for. This post will elaborate on this discussion, and will discuss the relevant EU framework and prejudicial questions in the Tofutown case pending at the Court of Justice of the European Union (“ECJ”)
The dairy controversy
The dairy controversy has arisen as more and more plant-based food companies are marketing their products as ‘milk’ (“Alternatives”), be it as almond milk or soymilk, but nonetheless as ‘milk’. In the US, the traditional dairy industry (mostly cow milk) has tried to stop the use of the word ‘milk’ for Alternatives, because, its representatives are of the opinion that the term is misleading when used to describe what are in fact Alternatives. This plea did not go unheard and the milk lobby, in combination with a number of lawmakers in the American congress, presented the draft Dairy pride act. The Dairy pride act limits the use of the term ‘milk’, to milk produced from animals (including products such as ‘traditional’ butter). In reaction, the NGO Good Food Institute filed a report claiming that the arguments presented by the traditional dairy industry are invalid. This NGO is of the opinion that no consumer is misled as long as the name of the product ‘milk’ is combined with the alternative source for the milk production. If, and when, the Dairy pride act will enter into force is still unclear.
If you think a similar regulation would be inconceivable in the EU, think again. In fact, in the EU a number of products have a legal definition included in marketing standards. The purpose of these legal definitions is to protect consumers against misleading and to create a level playing field for food business operators (“FBO’s”). For products such as honey, chocolate, and olive oil such legislation exists, which regulates the production process and name under which the product can be sold. In addition to such marketing standards mostly laid down in EU Directives, regulating single products or production chains, there is a general Regulation on agricultural production. This Regulation includes marketing standards for certain agricultural products.
Regulation 1308/2013 establishes a common organization of the markets in agricultural products (hereinafter: CAP Regulation). This regulation lays down production rules for particular agricultural products such as, but not limited to, wheat, wine, and several meat products. The CAP Regulation also applies to milk and milk derived products, and contains the following definition of milk:
‘”Milk” means exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom.’
Apart from the product ‘milk’, Annex VII part 3 of the CAP Regulation reserves the following terms exclusively for milk products: whey, cream, butter, buttermilk etc. (the list contains 16 products traditionally produced using milk).
A strict interpretation of article 78.1 in combination with article 78.2 and Annex VII part III of the CAP Regulation would mean that the term ‘milk’ should only be used for milk products from animal origin. The norm does not contain an exception for plant-based alternatives. However, it is unclear whether milk can be used if it is combined with an explicit mention of the plant-based origin of the product such as soy. It can be argued that the Alternatives do not qualify as ‘milk’, and that, therefore, the Regulation does not apply to Alternatives. This precise issue is currently the subject of a the Tofutown case pending at the ECJ (C-442/16).
The Tofutown case
Tofu is made from soya beans. The German company TofuTown.com sells alternatives to butter and cheese from mammalian origin. The company markets their Tofucheese and Tofubutter as plant-based alternative to the traditional cheese and butter. Neither products contain any ‘milk’, and are marketed towards vegetarians and/or vegans who prefer plant-based alternatives for cheese and butter. The Verband Sozialer Wettbewerb (German Competition Authority) objected to the use of the words ‘butter’ and ‘cheese’ in the tofu products because, in their view, tofutown.com did not comply with the CAP Regulation as the products were not milk-based. The German court requested the answering of preliminary questions by the Court of Justice of the European Union on the interpretation of the above-mentioned rules regarding the product names. The following prejudicial questions were put forward:
- Can Article 78(2) of the CAP Regulation be interpreted as meaning that the definitions, designations and sales descriptions defined in its Annex VII need not satisfy the relevant requirements of this Annex if the relevant definitions, designations and sales descriptions are expanded upon by clarifying or descriptive additions (such as ‘tofubutter’ for a pure plant-based product)?
- Is Annex VII, Part III, point 1, to the CAP Regulation to be interpreted as meaning that the expression ‘milk’ is exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom, or may the expression ‘milk’ — where necessary with the addition of explanatory terms such as ‘soya-milk’ — also be used in the marketing of plant-based (vegan) products?
- Is Annex VII, Part III, point 2, to the CAP Regulation, in conjunction with Article 78, to be interpreted as meaning that the descriptions listed in detail in point 2(a), such as, in particular, ‘whey’, ‘cream’, ‘butter’, ‘buttermilk’, ‘cheese’, ‘yoghurt’ or the term ‘cream’ etc., are reserved exclusively for milk products, or can pure plant-based/vegan products, which are produced without (animal) milk, also fall within the scope of Annex VII, Part III, point 2, to the CAP Regulation?
One of the core principles of food law, besides safety, is the principle that foodstuffs shall not mislead consumers. This ‘misleading argument’ is the main argument used by the dairy lobby in the US to justify the restriction of the use of the term ‘milk’ solely for milk from cows or other animals. We share the view of the Good food institute that the names would be misleading is not acceptable. No consumer is misled when buying an alternative plant based product such as ‘soy milk’, because the products are clearly marketed as alternative and the origin is mentioned in the product name and on the front of the pack, as well as in the legal name. However, we are of the opinion that labeling of these Alternatives should never be similar to traditional milk products, or carry pictures of cows or other animals that provide milk.
Precursor to bigger debate on plant-based alternatives
Milk is not the only product definition under scrutiny; the discussion is already spreading to meat products. Traditional food producers feel the heat from competitors producing Alternatives for their products. These Alternatives are not only suitable for vegetarians and vegans, but also for the mainstream consumer who could be concerned with the environmental impact of meat or perhaps is lactose intolerant. The Alternatives are plenty and range from the use of soy to algae or even insects to replace the traditional product. Many Alternatives have not only animal welfare in mind, but also sustainability.
In the Netherlands the Vegetarian Butcher made headlines, because he used terms reserved for meat products for his vegetarian alternatives. Instead of waiting for a court to rule on the matter, the vegetarian butcher chose to change his terms slightly to avoid being penalized for using the wrong terms. To give an example, “gehakt” (mincemeat) became “gehacked”, which, in Dutch sounds the same, but formally has a different definition. The Vegetarian Butcher also published a statement on YouTube to clarify why he changed the product names. Perhaps this could be the solution for producers of alternatives for traditional animal derived products, in case the ruling of the CJEU is in favor of the traditional producers. Another idea would be to introduce the term ‘malk’ (‘a’ is derived from plant); ‘milk’ or milk products produced using plant-based sources.
A debate is ongoing in the US regarding the definition of milk and whether plant-based alternatives can use the term ‘milk’ to describe their products. In the EU, the definition is already part of a Regulation, which forbids the use of the term ‘milk’ in other products than milk of animal origin. The Tofutown case will hopefully clarify if producers of Alternatives will be able to use terms such as milk, which are traditionally linked to products from animal origin, if the producer mentions the source of the milk together with the term ‘milk’. We have seen this debate is not limited to ‘milk’, but also includes other products for which non-animal alternatives are available and marketing standards such as the CAP Regulation apply to. We will keep you posted on developments in the debate on definitions of Alternatives. Please do not hesitate to share your view on this topic with us!