The world of food is changing at a rapid pace – alternative proteins becoming a new reality. Examples are products using microbial fermentation or cellular agriculture in their production process. If you are a company wanting to market such a product in the EU, there is a good chance you require a prior market authorization as a regulated product, such as a novel food (NF) or a GMO. In that case, you need to get up to speed with the following four new ESFA guidance documents that will all apply as of 27 March 2021.
- Decision laying down the practical arrangements on pre-submission phase and public consultations
- Decision of EFSA’s executive director laying down practical arrangements concerning transparency and confidentiality
- Administrative guidance for the processing of applications for regulated products (update 2021)
- ESFA’s catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)
Document # 3 explains EFSA’s workflow in dealing with regulated products. It applies to applications for authorization of substances used in food and feed, food contact materials, NFs and GMO’s amongst others. The title of document # 4 is pretty self-explanatory. Examples of EFSA support initiatives range from general pre-submission and renewal advice to admin support to SMEs on applications and from EFSA guidance documents and scientific opinions to roundtables with industry associations.
Documents # 1 and 2 contain practical arrangements for companies that intend submitting scientific evidence regarding products requiring an EFSA evaluation. The full list of products is enumerated at the end of this post.* From a legal point of view, these guidelines implement the changes introduced in the General Food Law Regulation by the Transparency Regulation. We already covered the consequences of this Regulation in a previous blogpost, which in particular focuses on the relation between transparency and confidentiality.
This blogpost provides more detailed information on two topics representing a real change in the situation before 27 March, notably the general pre-submission advice and the notification of studies. To make this blogpost more concrete, it will target one specific category of regulated products within EFSA’s remit, notably NFs. For a reason. Currently, a great number of EU food companies active in the field of cultured meat are preparing their novel food applications. These companies need to be aware of these changes in the current regulatory framework.
General pre-submission advice (GPSA)
The GPSA to be provided by EFSA Staff concerns the rules applicable to and the content required for the NF application prior to its submission. It explicitly does not cover the design of the studies to be submitted. Aspects going beyond information available in any guidance documents are out of scope of pre-submission advice. Examples are questions regarding hypotheses to be tested or risk management. Furthermore, said staff shall not be involved in any preparatory scientific or technical work that is (in)directly of relevance for the NF application to be made. Also, the advice given shall be without prejudice and non-committal as to any subsequent assessment by EFSA (and the Member States via the PAFF Committee).
Prior to obtaining any GPSA, the applicant (and / or its representative) must register in the EFSA system supporting pre-submission activities and it must also request a pre-application ID. The pre-submission request can be introduced at any time before submitting a NF application. The European Commission nevertheless recommends submitting a request at least six months before introduction of the intended NF application.
The request for pre-submission advice shall be made in a dedicated form (“general pre-submission advice form”) made available by EFSA and a link should be made to the pre-application ID. Subsequently the applicant for an authorisation of a NF should provide all necessary information regarding the application, including a list of exhaustive questions. A maximum of two requests may be submitted under the same pre-application ID.
After a check that the questions asked are not out of scope, the applicant will be informed within 15 working days from the receipt of the advice form whether the submitted request is accepted or rejected. Companies expecting face-to-face meetings with EFSA need to know this will not happen automatically. Where possible, EFSA shall address the queries in writing. However, if EFSA considers that a discussion with the applicant might be useful to clarify certain aspects of the request, a meeting shall be organised. You then do not need to travel to Parma or elsewhere, as such meeting shall be conducted preferably by telco or webco. Only in exceptional cases a live meeting shall take place.
Any requests to be delt with in writing shall be answered within 15 working days after acceptance of the request. Any meeting to be set up shall be organised within 20 working days after acceptance of the request. EFSA shall draft a summary of the questions asked and not only send this to the applicant, but it will also publish it after the novel food application at stake has been considered admissible or valid.
Notification of studies
For transparency purposes, EFSA has established a database of studies commissioned or carried out by business operators to support any application requiring any type of scientific output, including a scientific opinion. The obligations to submit information on studies applies to both (A) potential applicants (i) having commissioned to a lab or external testing facility or (ii) carrying out such studies in in-house testing facilities and (B) to the labs or testing facilities carrying out such studies. Don’t be fooled by the wording “studies carried out” in relation to the notification required. In fact, timing is of the essence here, as all study notifications need to be submitted before the actual starting date of the study.
There may be justified justifications for not timely notifying studies. However, if EFSA does not consider the justifications provided by an applicant valid, the application needs to be re-submitted. As a consequence, the assessment of the validity of the application shall commence only six months after the notification of the studies according to the Transparency Regulation. The EFSA pre-submission guidance states the assessment of a re-submitted application shall commence 6 months after the re-submission of the application. This is not exactly the same, but it is clear that not complying with the studies notification requirement can be a serious showstopper, as a NF application supported by not-notified studies is not valid.
What exactly needs to be notified in the EFSA studies database? First of all, the study title, as well as an English translation thereof if the original title is not in English. Secondly, the applicant needs to be identified, after having first registered in the EFSA system for pre-submission activities. Thirdly the planned study starting and completion date, the laboratory where the study shall be carried out, as well as the study scope. In order to detail the study scope, the applicant should provide information on the intended study area (e.g. cultured meat), the study type (e.g. genotoxicity in vitro study) and the study objective (e.g. demonstrate that cultured meat does not pose any safety risks at the anticipated level of intake). The data entered can be modified, for instance if a study is delayed, the anticipated completion date can be aligned thereto. Information previously entered into the study database can also be withdrawn, but the applicant needs to provide a valid justification for that purpose. In the absence thereof, the same consequences will apply as when the applicant notifies its studies too late.
Once EFSA has received a valid or admissible application for a NF authorization, it shall publish this in order to launch the consultation of third parties on the application submitted. The rationale behind is that EFSA needs to have access to all relevant scientific data and studies available on the subject matter regarding the application at stake. Any communications on such consultation shall be published at EFSA’s website and shall remain open for three weeks, unless specified otherwise in sectoral Union law. For applicants, it is good to know that this public consultation in principle does not result in long delays. Upon closure of the public consultation, EFSA shall make publicly available all comments received. This will be done simultaneously with the publication of EFSA’s scientific output, which will address all relevant comments received.
What learnings can be drawn from the new EFSA Guidance documents? In the first place, that designing a safety evaluation strategy for a regulated product such as a NF has become even more important. By deciding as early stage as possible, what studies will be required to demonstrate the safety of your product, the chances that you can timely notify these studies in the EFSA study database shall increase. In this way, unnecessary delays in the appraisal of your application can be prevented. In the second place, it remains to be seen how helpful EFSA pre-submission advice will be, as it will be purely procedural and not material at all. At the same time, EFSA launched the new initiative of dedicated support for SME’s. Potentially, combination of the two reveals to be helpful.
*Products subject to transparency requirements and requiring an EFSA evaluation are the following:
- GMO’s (captured by both Directive 2001/18 and Regulation 1829/2003)
- Additives in animal nutrition
- Smoke flavouring used on food
- Food contact materials
- Food additives, enzymes and flavourings
- Plant protection materials
- Novel Foods
A number of legal developments in the field of cannabidiol (CBD) took place in the last few months of the previous year. For example, the European Court of Justice (ECJ) ruled in November that a member state cannot prohibit the marketing of CBD that was lawfully manufactured and marketed in another member state. Less than a month later, the United Nations Commission on Narcotic Drugs (CND) voted on six recommendations of the World Health Organization (WHO) regarding the reclassification of cannabis in the Single Convention on Narcotic Drugs (Single Convention). In practice, there appears to be confusion about the meaning of these developments for CBD as a food product. This confusion seems to arise from the interaction between food and opium legislation, both of which are applicable to this product. This article aims to provide clarity on these latest developments.
CBD is not a narcotic according to the ECJ
On 19 November 2020, the ECJ ruled, in summary, that the free movement of goods entails that when CBD is lawfully manufactured and marketed in one member state, it may, in principle, also be marketed in another member state. This is, however, different when Article 36 of the Treaty on the Functioning of the European Union (TFEU) justifies an exception to the free movement of goods, such as for the protection of health and life of humans. Yet, the trade restricting or prohibiting measure must in such a case be appropriate for securing the attainment of the objective pursued (the protection of health and life of humans) and must not go beyond what is necessary in order to attain it. To reach the aforementioned conclusion, the preliminary question had to be answered whether CBD falls within the scope of the free movement of goods. This principle does namely not apply to narcotics, which are prohibited throughout the Union (with the exception of strictly controlled trade for use for medical and scientific purposes). Based on the Single Convention and the Convention on Psychotropic Substances, the ECJ reasoned that CBD is subject the free movement of goods. Both conventions codify internationally applicable control measures to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes and to prevent them from entering illicit channels. The Convention on Psychotropic Substances regulates psychoactive substances, whether natural or synthetic, and natural products listed in the schedules to the Convention, including tetrahydrocannabinol (THC). CBD is not included. The Single Convention applies, inter alia, to cannabis (defined as “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated”). Although a literal interpretation of the above provision would lead to the conclusion that CBD (not obtained from the seeds and leaves of the cannabis plant) falls within the definition of cannabis, such an interpretation is not consistent with the purpose of the Single Convention, namely protecting the health and welfare of mankind. Indeed, according to the current state of scientific knowledge, CBD is not a psychoactive substance.
UN Commission on Narcotic Drugs reclassifies cannabis
Shortly after the ECJ ruling regarding, among others, the Single Convention, the CND put six WHO recommendations to vote on 2 December 2020. This voting session would have taken place earlier, though had been postponed so that the voting countries had more time to study the matter and to determine their position. The WHO recommendations dealt with the reclassification, removal and addition of cannabis (substances) in the various schedules (Schedule I, II, III and IV) to the Single Convention. These four schedules represent four categories of narcotics and each category has its own rules. The substances in Schedule VI are controlled most strictly; they are considered dangerous without relevant medicinal applications. Schedule I concerns the second most strictly controlled category. The substances in this Schedule are subject to a level of control that prevents harm caused by their use while not hindering access and research and development for medical use. The lightest criteria apply to Schedule II and III. For example, Schedule II lists substances normally used for medicinal purposes and with a low risk of abuse.
Bedrocan (currently the sole supplier of medicinal cannabis to the Dutch government) has summarized these six WHO recommendations as follows:
- Extracts and tinctures are removed from Schedule I.
- THC (dronabinol) is added to Schedule I under the category Cannabis & Resin. Subsequently, THC is removed from Schedule II of the Convention on Psychotropic Substances.
- THC isomers are added to Schedule I under the category Cannabis & Resin. Subsequently, THC isomer is removed from the Convention on Psychotropic Substances.
- Pure CBD and CBD preparations with maximum 0.2 % THC are not included in the international conventions on controlling drugs.
- If they comply with certain criteria, pharmaceutical preparations that contain delta-9-THC should be added to Schedule III, recognizing the unlikelihood of abuse and for which a number of exemptions apply.
- Cannabis and cannabis resin are removed from Schedule IV, the category reserved for the most dangerous substances.
In the end, only the recommendation to remove cannabis from Schedule IV (i.e., recommendation 6) was approved, on the grounds that there are also positive aspects to cannabis. However, this does not mean that cannabis can now be freely traded. Cannabis is still included in Schedule I and is therefore in principle a prohibited substance. Having said that, research and product development for medical purposes is permitted if a country so desires. In the Netherlands, the Dutch Opium Act already allowed for this under certain conditions. The reclassification of cannabis is therefore more symbolic in nature than that it brings about practical changes.
The recommendation to explicitly exclude CBD from the scope of the Single Convention has thus been rejected. The industry considers this a missed opportunity to clarify the (legal) status of CBD with traces of THC. This rejection was on the other hand in line with the viewpoint of the European Commission, which advised its member states that sit on the CND (i.e. Belgium, Germany, France, Hungary, Italy, Croatia, the Netherlands, Austria, Poland, Spain, Czech Republic and Sweden) to vote against this recommendation since more research would be needed. For example, the European Commission takes the position that the proposed THC limit of 0.2 % is not sufficiently supported by scientific evidence. The WHO Expert Committee on Drug Dependence (ECDD) notes in this regard that medicines without psychoactive effects that are produced as preparations from the cannabis plant will contain traces of THC and provides the example of the CBD preparation Epidiolex as approved for the treatment of childhood-onset epilepsy, which contains no more than 0.15 % THC by weight. At the same time, WHO ECDD recognizes that it may be difficult for some countries to conduct chemical analyses of THC with an accuracy of 0.15%. Hence, it recommends the limit of 0.2 % THC. This limit is already known to food companies from the so-called Novel Food Catalogue of the European Commission, which recalls that in the EU, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the THC content does not exceed 0.2 % (w/w). This does, however, not necessarily mean that products derived from such cannabis varieties can be freely marketed as food.
CBD as food product
With respect to cannabis extracts such as CBD, as well as its synthetic equivalent, no history of safe use has been demonstrated. As a result, these products qualify as novel foods and can only be placed on the EU market after approval by the European Commission. Several food companies such as the Swiss company Cibdol AG, Chanelle McCoy CBD LTD from Ireland and the Czech CBDepot, have already applied for the required novel food authorization. However, the assessment of the relevant dossiers has been paused, presumably because it was still unclear whether CBD qualified as a psychotropic substance and narcotic. Such a qualification would exclude use as a foodstuff. Thanks to the ECJ ruling, this has now been clarified, on the basis of which the European Commission will likely resume the evaluation of the various applications for CBD as a novel food.
CBD under the Dutch Opium Act
A potential approval of CBD as a novel food does, however, not automatically mean that CBD can be sold in the EU without any (legal) obstacles. The Novel Food Catalogue makes this reservation explicit by indicating that specific national legislation, other than food legislation, may restrict the placing on the market of a cannabis product as a food. In practice, it will in particular come down to opium legislation.
Although the ECJ clarified that CBD is not a narcotic, it did not specify how pure CBD must be to fall outside the scope of the Single Convention and to be freely traded. The respective rejected WHO recommendation referred to a THC content of up to 0.2 %. In the Netherlands is, however, only a contamination level of at most 0.05 % allowed. This impurity can be caused by traces of THC, but also by the presence of other cannabinoids. Only pure CBD, i.e. with a purity level of 99.95 %, falls outside the scope of the Dutch Opium Act. Having said that, there is another catch: although the Dutch Opium Act does not cover CBD, this Act is applicable to the cannabis plant (or its parts) from which the CBD is extracted. The production of (natural) CBD can therefore not take place in the Netherlands.
Recent developments in the field of CBD have clarified that CBD is not a narcotic and therefore does not fall under the Single Convention. Food businesses are nevertheless warned to not yet start celebrating. If they want to market CBD as a food, they will still have to go through the novel food procedure, or market a product in accordance with the terms of an already approved CBD product. The latter is possible insofar data protection does not prevent this. Besides this, the purity level of CBD is decisive to stay away from opium legislation. There is still no international agreement on what this level should be. Food businesses operating in different member states are therefore advised to seek local advice when marketing CBD in the EU.
Last week I received a call from an entrepreneur who wanted to know what requirements he had to bear in mind when distributing food supplements from Finland to other EU Member States. I told him about the language requirements for mandatory food information. I also informed him that the allowed level of vitamins and minerals could differ from Member State to Member State. Furthermore, in some countries a so-called notification system for market access has been put in place, whereas in others, no such system applies. Finally, I informed him that there is no harmonised approach on prohibited substances in the EU either. In fact, he was quite surprised to learn about all this, as he thought food supplements to be subject to the principle of free circulation of goods in the internal market. Is not that correct? Yes, it is. However, as follows from the above, a number of exceptions apply to this principle. This blogpost explains what is being done to achieve more harmonisation in the food supplements market.
Food supplements: what are they in fact and what happens in practice?
According to the Food Supplements Directive, food supplements are meant to supplement the normal diet. They are concentrated sources of nutrients or other substances having a nutritional or physiological effect that are mostly sold in the form of pills or powders. While nutrients are vitamins and/or minerals, such other substances are, for example, amino acids, glucosamine or certain substances contained in herbs or plants. What we see in practice, is that more and more consumers use food supplements not only to supplement their diet, but for a targeted health effect. Increasing concentration or improving sport achievements are two examples thereof. Another trend is that a broad number of food supplements is nowadays offered for sale online. As many of them come with striking health claims, it is not always sufficiently clear for consumers what they are actually buying. In these COVID-times, many supplements claimed for example to boost the immune system without meeting the specific requirements for such claim. This may create a dangerous situation if and when dangerous substances are involved.
Food supplements: a boosting market but not without risks
The market of food supplements in the Netherlands alone was valued in 2019 by Neprofarm at € 143 million. In that same year, the Netherlands pharmacovigilance centre Lareb received 165 notifications of adverse reactions regarding food supplements. Even worse, the Netherlands Intoxications Information Centre NVIC reported 891 cases of intoxications through the use of food supplements in 2019. These adverse effects or intoxications may result in stomach complaints, headaches or dizziness, but also in more severe conditions such as hart complaints or even cerebral haemorrhage. It follows from inspection results of the Dutch Food Safety Authority NVWA that only 45 % of the food business operators comply with all applicable food safety requirements. Due to the lack of regulatory harmonisation in this field and the open norm laid down in the General Food Law Regulation (article 14 thereof states “food shall not be placed on the market if it is unsafe”), this makes effective enforcement of food safety for food supplement a complex task.
Dutch initiatives aimed at more EU harmonization for food supplements
In an ideal world, dangerous substances are prohibited on an EU-wide basis. Currently, an initiative is ongoing to add substances to the list of unsafe substances under the Fortification Directive. Furthermore, in February 2020, an initiative was launched by the enforcement authorities of 18 Member States including those of the Netherlands, to draft a joint list of prohibited substances for food supplements. Since both initiatives are not expected to materialize overnight, the Dutch Health Minister has decided, in cooperation with the Dutch Food Safety Authority and the Dutch Medicines Evaluation Board CBG amongst others, to draft a national list of unsafe substances. This list will be based on risk evaluations pertaining thereto and the aim is to give this list a statutory basis, by integrating it in the Dutch Commodities Act (“Warenwet”). Furthermore, the Dutch Food Safety Authority has designed a targeted approach of sales of food supplements via the internet. Based on the Dutch polder tradition, this approach is consensus-based, aiming to agree with online marketplaces that they remove from their offerings any food supplements containing prohibited substances. Also, the Dutch Health Minister oversees that the communications to consumers on food supplements by a number of channels, such as the Netherlands Nutrition Centre (“Voedingscentrum”), the Health Inspectorate IGJ and the National Institute for Public Health RIVM, provides proper risk information. Finally, the Health Minister considers introducing a system of prior notification and some level of safety evaluation into the Netherlands as well.
Are these initiatives a good thing or a bad thing?
In order to enhance consumer safety, the above initiatives are certainly a good thing. For food business operators however, they may entail further obstacles to the free circulation of goods in the internal market. Based on the new Official Controls Regulation, enforcement authorities are allowed to do “mystery shopping”, i.e. ordering food supplements without identifying themselves. Once the Dutch national list of dangerous substances will have a statutory basis, the Dutch Food Safety Authority could do online test purchases with EU food business operators that may not be aware of such list. If their products are not in line therewith, they are subject to enforcement measures. As to the intended introduction of the notification requirement of food supplements in the Dutch market, this will certainly make market access less smooth.
On the other hand, in a number of EU countries, such as Belgium and France, a system of prior notification for food supplements is already in place. In practice, we see this can operate as a “safety seal”, meaning that supplements that were allowed on those markets, potentially earn more easily market access in other Member States as well. Furthermore, a new tool is available to food business operators since the new Regulation on mutual recognition became applicable in April 2020. Article 4 thereof offers the possibility to draw up a voluntary declaration to demonstrate to the competent authorities of other Member States that a food product is lawfully marketed, for instance in the Netherlands. The competent authorities in the Member State of destination can only oppose the further marketing thereof based on legitimate public interest, for instance public health. I expect this to be as useful tool for the further circulation of food supplements in the internal market.
Finally, I expect the Dutch national list of unsafe and hence prohibited substances for food supplements also to provide some more clarity in this field, provided that it will also be easily accessible to food business operators abroad. When these food business operators indeed duly inform themselves, this list could facilitate the successful EU-wide launch of food supplements, with less unclarity pre-launch and less surprises after launch. Which is supposed to be a good thing.
The information shared in this blogpost stems from a letter of the Dutch Health Minister to the Dutch House of representatives dated 14 December 2020, which can be viewed here (in Dutch only).
Since 1 September 2020, the Dutch Food Safety Authority (NVWA) has been given the power to publish certain inspection results (including identification details of the inspected FBO) faster than before. Prior to that date, the legal basis for disclosure could primarily be found in article 8 of the Dutch Freedom of Information Act (in Dutch: Wet openbaarheid van bestuur). This act creates a duty for the administrative body concerned, for example the NVWA, to publicly provide information when this is in the interest of good and democratic governance. However, article 10 of the Freedom of Information Act requires an individual balancing of interests in order to avoid disproportionate disadvantage for the parties involved as a result of the publication. It also prohibits disclosure of certain sensitive information, such as company and manufacturing data that has been confidentially communicated to the government. This blog post explains what has changed since 1 September 2020, which FBOs are affected and what arguments they can use to prevent disclosure.
Additional basis of disclosure as of 1 September 2020
As of 1 September 2020, the NVWA is additionally bound by the Decree on the Disclosure of Supervision and Implementation Data under the Health and Youth Act (in Dutch: Besluit openbaarmaking toezicht- en uitvoeringsgegevens Gezondheidswet en Jeugdwet, hereinafter: Decree on Disclosure), as further elaborated in the Policy Rule on Active Disclosure of Inspection Data by the NVWA (in Dutch: Beleidsregel omtrent actieve openbaarmaking van inspectiegegevens door de NVWA, hereinafter: Policy Rule on Disclosure). This power of disclosure is based on article 44 of the Dutch Health Act (in Dutch: Gezondheidswet). Disclosure in accordance with the Decree on Disclosure does not require the balancing of interests: disclosure of information will simply take place when indicated in the relevant annex to the Decree on Disclosure. Companies that wish to prevent publication of information related to their business will therefore have to invoke factual criteria, such as that the information to be disclosed contains incorrect information or concerns information that is excluded from disclosure in Article 44(5) of the Health Act.
Required actions when companies disagree with disclosure
The publication of information as based on the Decree on Disclosure has consequences for the way affected companies can stand up to prevent disclosure and the speed with which they will need to object. Where the Freedom of Information Act offers affected companies the possibility to share their opinion (in Dutch: zienswijze) in reaction to the administrative body’s intention to disclose the information in question, this possibility does not exist under the Decree on Disclosure. If and when an affected company does not agree with disclosure on the basis of the latter decree, this company has two weeks to object to the respective administrative body’s intention of disclosure and needs to seek interim relief measures within this time frame in order to actually suspend the disclosure. In addition, under the Decree on Disclosure companies are provided the option to write a short response that will be published together with the information subject to disclosure. In this way, affected companies are given the opportunity to provide the outside world with a substantive (but very summary) response to the information to be made public. The Policy Rule on Disclosure in fact also grants this right of response to information disclosed by the NVWA under the Freedom of Information Act.
Relevant for all FBOs?
The aforementioned additional legal basis for disclosure by the NVWA applies for the time being to a limited number of supervisory areas only, namely the inspection results of the NVWA with regard to (i) fish auctions, (ii) the catering industry, and (iii) project-based studies into the safety of goods other than food and beverages. These areas may be expanded in the future, according to the explanatory notes to the Decree on Disclosure.
However, for companies with so-called borderline products that navigate between different regulatory regimes, it is relevant to know that Dutch Health and Youth Care Inspectorate (IGJ) has broader powers to actively disclose inspection results under the Decree on Disclosure. Since 1 February 2019, the IGJ has already been publishing information on the basis of this decree regarding, amongst other, compliance with the Dutch Medicines Act (in Dutch: Geneesmiddelenwet). This means that when the IGJ takes enforcement measures against a FBO handling food supplements or other foodstuffs that qualify as (unregistered) medicines, it may be obliged to make public the respective supervisory information. The same applies to enforcement under the Dutch Medical Devices Act (in Dutch: Wet op de medische hulpmiddelen) – think diet preparations – and the Opium Act (in Dutch: Opiumwet) – think CBD and other cannabis products.
An example: melatonin-containing foodstuff labeled as a medicine
An example of a FBO that was faced with disclosure in accordance with the Decree on Disclosure by the IGJ concerns a company involved in melatonin-containing products. The IGJ intended to publish an inspection report on these products, from which it would follow that the products in question qualify as medicines and that the FBO concerned would therefore illegally place them on the market (namely without the required licenses under the Medicines Act). The FBO at stake applied for a preliminary injunction suspending the publication decree. On 8 July 2020, the preliminary relief judge rendered a judgment in this case.
Possible factual criteria to prevent naming & shaming
Although disclosure under the Decree on Disclosure is obligatory and disclosure decisions thus do not require the balancing of interests, the above-mentioned melatonin case gives good insights into the factual criteria that can nevertheless be invoked to prevent disclosure. In this case, the respective FBO brought forward the following arguments.
The respective inspection report excluded from disclosure
Article 3.1(a) of Part II of the Annex to the Decree on Disclosure excludes certain supervisory information from disclosure, including the results of inspections and investigations established as a result of a notification by a third party. The FBO at stake (hereinafter: “Applicant’) takes the position that the present inspection report was initiated as a result of a notification or enforcement request by a competitor. This would mean that the respective inspection report must not be made public.
The preliminary relief judge cannot agree with this position in the present case and rules that the inspection report is clearly related to an earlier letter from the IGJ to the applicant in which it announced the intensification of supervision of melatonin-containing products. Moreover, the case file was silent on a notification or enforcement request by a competitor.
The preliminary relief judge additionally states that it agrees with the IGJ’s viewpoint that the inspection report does not concern a penalty report (the report was drafted within the context of supervision and only indicates that Applicant will be informed about the to be imposed enforcement measure by separate notice). The fact that Applicant had earlier received a written warning for violation of the Medicines Act has no influence on this. The inspection report is therefore neither excluded from publication pursuant to article 3.1(a)(ii) of Part II of the Annex to the Decree on Disclosure, which makes an exception for “results of inspections and investigations that form the basis of decisions to impose an administrative fine”.
Disclosure in violation of the goal of the Health Law: outdated scientific foundation conclusions IGJ
The purpose of disclosure under the Health Act, in the wording of article 44(1) of that act, is to promote compliance with the regulations, to provide the public with insight into the way in which supervision and implementation of the Decree on Disclosure is carried out and into the results of those operations. Pursuant to Article 44a(9) of the Health Act, information should not be made public where this is or may violate aforementioned purpose of disclosure. Applicant takes the position that publication of the present inspection report does not contribute to improved protection of the public or to better information about the effects of melatonin, as a result of which the report should not be disclosed. More specifically, the applicant complains that the report (i) contains obvious errors and inaccuracies, (ii) gives the impression that it concerns a penalty decision, and (iii) is based on an incorrectly used framework to determine whether the qualification of a medicine is met.
The preliminary relief judge first of all notes that the fact that Applicant does not agree with the conclusions of the inspection report does not mean that the report therefore contains obvious inaccuracies. The preliminary relief judge further summarizes Applicant’s position as follows: (i) the IGJ wrongly took a daily dosage of 0.3 mg melatonin to determine the borderline between foodstuff and medicines; (ii) in doing so, the IGJ did not demonstrate that products with a daily dose of 0.3 mg melatonin actually acts as a medicine; (iii) moreover, the product reviews refer to outdated scientific publications (a more recent study by one of the authors thereof as well as more recent EFSA reports have not been included in the inspection report), whereas the current state of scientific knowledge must be taken into account according to established case-law. For these reasons, the preliminary relief judge agreed with Applicant that the IGJ has not made it sufficiently clear that from a daily dose of melatonin of 0.3 mg or more a ‘significant and beneficial effect on various physiological functions of the body’ occurs scientifically – according to the current state of scientific knowledge – and that products with a daily dose of melatonin of 0.3 mg or more act as a medicine”. Having said that, the preliminary relief judge did not accept Applicant’s statement that disclosure is contrary to the purpose of disclosure under the Health Act. Instead, the preliminary relief judge sought to comply with the so-called principles of sounds administration (in Dutch: algemene beginselen van behoorlijk bestuur) and ruled that the disclosure decision was not diligently prepared and insufficiently substantiated.
Applicant claims that the inspection report contains various inaccuracies, including the incorrect information that Applicant would produce melatonin itself. Applicant had already raised these inaccuracies in her response to the draft version of the report, but this had not resulted into adjustments in the final, to be published version of the report. The preliminary relief judge ruled on this matter that the IGJ should further investigate Applicant’s concerns and should amend the report where relevant. After all, the content of the report must be correct and diligently compiled. The mere fact that Applicant was given the opportunity to respond to the draft version of the report and that the IGJ responded to this in its decision to disclose the report does not mean that this requirement is met.
Violation of article 8 ECHR: disclosure has a major impact on Applicant’s image
Applicant claims that the planned disclosure will have a major impact on Applicant’s image and that of the natural person involved in the company. This is in violation of article 8 of the European Convention on Human Rights (ECHR) concerning the right to respect for private and family life. The Explanatory Memorandum to the Amendment to the Health and the Youth Care Act (in Dutch: Memorie van Toelichting op de Wijziging van de Gezondheidswet en de Wet op de Jeugdzorg) deals with this in detail. It emphasizes that the disclosure of inspection data does normally not constitute an interference with private life, because the data normally relates to legal persons and not to natural persons. The aforementioned Explanatory Memorandum therefore concludes that article 8 ECHR does not preclude disclosure on the grounds of the Health Act. Nevertheless, the court has at all times the competence to review a disclosure decision in the light of that article, in which case it will in fact have to balance the interests involved. In the present case, preliminary relief judge sees however no reason to assume a violation of article 8 ECHR.
Although the above shows that the preliminary relief judge in the respective melatonin case does not agree with all arguments put forward by Applicant, the request for suspension of publication of the contested inspection report was nevertheless granted thanks to factual criteria that were sufficiently substantiated. In particular the (implicit) argument that the conclusions in the inspection report lack a sufficient factual basis affects the essence of the information to be disclosed.
Rapid action is required to prevent active disclosure of inspection results under the Decree on Disclosure as these will usually be published after two weeks. This is not only relevant for FBOs active in the supervisory areas of the NVWA as designated in the Decree on Disclosure, but also for FBOs that operate at the interface of legal regimes under the supervision of the IGJ. To suspend disclosure, interim relief proceedings will have to be instituted as the Decree on Disclosure no longer provides for the possibility of submitting an opinion prior to publication. Moreover, affected companies cannot invoke the argument of suffering a disproportionate disadvantage as a result of the publication. Publication on the basis of the Decree on Disclosure is namely not subject to an individual balancing of interests (apart from an assessment on the basis of article 8 ECHR, insofar relevant). Although the arguments that companies can bring forward to prevent publication are therefore more limited than in the case of disclosure under the Freedom of Information Act, this does not mean that companies cannot successfully object an intention of disclosure. The melatonin case mentioned above is an example of this: conclusions that are not based on most recent science may not be published without adequate justification. Also, facts that are alleged to be incorrect should be further investigated before disclosure.
What can we learn from the Impossible vs. Incredible case in the Netherlands?
At the end May this year, the Court of The Hague rendered a remarkable judgment: at the request of Impossible Foods, Nestlé was banned from launching its INCREDIBLE BURGER in the EU. How is this possible? Impossible Foods is not even on the market in the EU yet. This article examines the court’s considerations and discusses the lessons that can be learnt by companies wishing to enter the EU market with meat substitutes.
Impossible Foods has been marketing its vegetable burger under the brand IMPOSSIBLE BURGER in the US since 2016. It also aims entering the EU market, but is still awaiting a marketing authorisation under the GMO Regulation. The burger of Impossible Foods contains genetically modified heme, which makes such authorisation necessary. Nestlé is seeking to meet the demand for more plant-based products as well and therefore also developed a plant-based burger. Nestlé had announced at the end of 2018 that it would market this product under the name INCREDIBLE BURGER. After Impossible Foods warned that this name would violate its trademark rights vested in IMPOSSIBLE BURGER, Nestlé decided to introduce its burger under the name AWESOME BURGER in the US. In the EU, however, Nestlé continued the original plan and marketed its vegetable burger under the name INCREDIBLE BURGER as of February 2019. Meanwhile, Impossible Foods had obtained a registration of its EU trademark IMPOSSIBLE BURGER. Nestlé filed a so-called nullity action against this mark with the EUIPO (the European Union Intellectual Property Office). According to Nestlé, this trademark is insufficiently distinctive, which is one of the requirements to obtain a valid trademark. In the meantime, however, Impossible Foods had initiated a court case before the District Court of The Hague in the Netherlands. In this case, Impossible Foods sued ten Nestlé companies, claiming that these should be prohibited from further use of the trademark INCREDIBLE BURGER in the EU. As of that moment quite some procedural spaghetti evolved, which I will explain below.
The case concerned regular proceedings on the merits, which can easily take a year and a half before any judgment being made. Of course, this would be too long to prevent the intended market introduction of the INCREDIBLE BURGER. Impossible Foods had therefore made use of the possibility to apply for an interim injunction during these main proceedings. Nestlé obviously opposed such interim injunction. In essence, Nestlé argued that the court in The Hague should refrain from ruling as long as the EUIPO in Alicante had not decided whether Impossible Foods has a valid trademark at all. Nestlé’s application for a stay of proceedings related to both the proceedings on the merits and to the interim injunction. In the main proceedings, that request was granted in order to prevent any conflicting rulings in the EU regarding the same trademark. With regard to the interim injunction, that request was rejected because a trademark proprietor must always be able to protect its trademark rights. Moreover, based on the Regulation on the Union Trademark and two European treaties, the court in The Hague declared itself competent to hear Impossible Foods’ claim in respect of all ten defendants. The fact that these proceedings had not been initiated in the country where Nestlé has the largest market share within the EU (Germany), nor in the country where Nestlé’s parent company is established (Switzerland), did not change this.
IMPOSSIBLE BURGER complies as a brand
Impossible Foods’ claim for an injunction was based on trademark infringement. Before the court could assess this claim, Nestlé’s defences had to be assessed first. The court did not agree with Nestlé’s assertion that IMPOSSIBLE BURGER for meat substitutes is exclusively descriptive. On the basis of this name, the average consumer does not automatically conclude that this is a vegetarian burger that resembles meat as much as possible. In fact, “impossible” is anti-descriptive for a burger that does exist. On the same grounds, the court ruled that IMPOSSIBLE BURGER does not lack any distinctive character for meat substitutes. Also, the use of this trademark did not have a purely laudatory message. IMPOSSIBLE BURGER can indeed fulfil a designation of origin function as a trademark, which is further enhanced by the relationship with the name of the trademark owner. IMPOSSIBLE BURGER therefore qualifies as a trademark, at least in the context of the interim relief in the present case. The EUIPO may decide otherwise in due course, which will influence the decision of the court in the proceedings on the merits.
Preconditions for trademark infringement
Trademark infringement exists, inter alia, if there is a likelihood of confusion between two trademarks. In order to assess this, it needs to be examined whether there is similarity between the two trademarks visually, aurally and conceptually. Also relevant are (i) the degree of similarity between the goods for which the trademark is registered and for which the sign is used, (ii) the degree of distinctiveness of the trademark and (iii) the relevant public when assessing the likelihood of confusion. According to Nestlé, the relevant public in this case is in fact the general public, now that most people consume meat, fish and poultry or substitutes for these products. The judge agreed. He further ruled that the level of attention when purchasing such everyday consumer products is relatively low.
Likelihood of confusion deemed plausible
The judge ruled that visually there is a considerable degree of similarity between IMPOSSIBLE BURGER and INCREDIBLE BURGER. Mark and sign each have six syllables, the first word is constructed in the same way and the second word is identical. Phonetically, trademark and sign are to a certain extent similar according to the judge, although there is also a difference in this respect. Because of the identical number of syllables, the cadence is the same, but the second syllable clearly differs. There is only a low degree of conceptual similarity: “impossible” is simply something different than “incredible”. The judge thereby assumes that the average consumer of meat substitutes in the EU is able to grasp the meaning of these English words. Some conceptual similarity between the trademark and the sign lies in the fact that both raise a question: ‘What, then, is so impossible or incredible? Considering that both IMPOSSIBLE BURGER and INCREDIBLE BURGER are used for meat substitutes and it has been established that the level of attention paid to the purchase of such products is low, the court deems the risk of confusion plausible. Two aggravating facts contributed to this.
Firstly, even before the IMPOSSIBLE BURGER was on the market in the EU, actual confusion had taken place between the two products. Secondly, Impossible Foods had argued undisputedly that in the summer of 2018, negotiations had taken place between the parties about a possible cooperation. This would allegedly take the form of a licence granted by Impossible Foods to Nestlé to use the IMPOSSIBLE BURGER brand. In such a context, it is likely that exchanges of confidential information took place, whereas Nestlé had launched the INCREDIBLE BURGER during the ongoing negotiations. This creates the impression in court that Nestlé has chosen a deliberate strategy to frustrate the successful launch of the IMPOSSIBLE BURGER in the EU.
Prohibition action justified
Under these circumstances, the court ruled that the injunction sought was justified. Nestlé objected that such an injunction, even in the form of a temporary injunction for the duration of the main proceedings, would require it to ‘re-brand’ its product and destroy its current stock. This would in fact amount to definitive measures, which should only be taken in the proceedings on the merits. On the other hand, the court held that Nestlé’s market launch of the INCREDIBLE BURGER in February 2019 was actually undertaken at risk. It knew that, according to Impossible Foods, its brand was infringing the IMPOSSBLE FOODS brand and had nevertheless chosen to do so. The infringement action was therefore granted for the entire EU, with the exception of purely descriptive use (i.e. as part of an English-language sentence without any emphasis in font size or capital letters).
This is a far-reaching decision based on only convincing visual similarity between the mark and the sign. This is all the more so, now that the IMPOSSIBLE BURGER is not yet on the market here. From that perspective, it is important to know that in an injunction based on a trademark right, it is not a requirement that that trademark is actually used. Such a requirement only applies five years after registration, failing which the unused trademark will be vulnerable to cancellation. Furthermore, in this case the (somewhat) limited similarity between the trademark and sign is amply compensated by the identity between the goods, i.e. meat substitutes. On top of this are the aggravating facts on the basis of which the court seems to rule that Nestlé brought this situation upon itself. Because of the unitary character of the Union trademark, this situation is not limited to the Netherlands, but Nestlé was imposed an EU-wide injunction.
Knowing just the rules is not enough
What can companies that want to introduce new meat substitutes or other alternative protein-based products on the EU market learn from this decision? In an earlier post at FoodHealthLegal, we informed about the possible names for alternative proteins-based products within the applicable regulatory framework. This showed that according to specific EU labelling rules and case law there are some restrictions in the choice of such name. For instance, the use of dairy names is not permitted for non-dairy products. Also, at Member State level there are sometimes restrictions based on so-called reserved designations. As such, ‘minced meat‘ may only be used for minced beef with a fat percentage of at least six percent in the Netherlands. This court decision shows that it is not enough to know the rules; knowledge of the market is also indispensable upon market introduction of a new meat replacement. Research this market and its players before introducing new innovative food products, not only in the home market but also in other possible markets. Investigate the availability of the intended product name and act in accordance with the outcome. This may take the form of an alternative name or a co-existence agreement with the company that markets a product with a similar name. This will avoid spending a fortune on re-branding and in the end it will prevent food waste.
Consumers nowadays tend to include more and more plant-based products into their diet. For instance, a study ordered by DuPont Nutrition established double digits of growth for non-dairy ice-cream, dairy and cheese during the year preceding June 2018. More recently, NPR published an overview demonstrating which products were most consumed during the corona crisis. Amongst these, plant-based meat alternatives and oat milk were the biggest hits, demonstrating over 200 and 300 % growth respectively. Plant-based alternatives for dairy and meat will be discussed during the Protein Summit of the Vitafoods Conference in Geneva. As you may know, this conference was shifted from May to early September. In anticipation thereof, a webinar on Protein and Protein Alternatives took place on 12 May. During this webinar, I covered the labeling and advertising of these products. This blogpost offers a recap of my contribution thereto, targeting those who are interested in this topic but could not assist.
Regulatory requirements for market access
Obviously, there are other relevant aspects for alternative protein-based products than labeling and advertising, such as the regulatory requirements for market access. For some products, like those based on certain algae or on isolates from mung beans, most likely an authorization under the Novel Food Regulation will be required. This implies that the applicant will have to put together a product dossier demonstrating the safety of the product and submit this to the European Commission. This certainly applies for cultured meat products, unless they incorporate GMO steps in their production process and / or end product. In such case, market authorization will have to be obtained on the basis of the GMO Directive and the GMO Regulation. These topics will be dealt with during the Conference in September, detailing the scientific, economic and practical implications thereof.
Relevant general labelling rules
A number of labeling rules are of relevance for any food product, including those based on alternative protein. In fact, the cornerstone of labeling law, embodied in the Regulation on Food Information to Consumers, is the prevention of misleading. This can be done in various ways, but it is of the essence that at all times any confusion about the characteristics of a product is avoided. During the webinar, I brought up the example of Mylk to clarify this. Obviously, this is not a conventional dairy product, but a plant-based product. Do you think any confusion about the nature and / or the composition of this product could arise?
This should be decided based on the so-called Teekanne decision of the European Court of Justice (ECJ). According to this decision, it is prohibited to give the impression (by means of an image or a description) that a particular ingredient is present in a product, whereas this is not the case and the consumer can only find out when reading the list of ingredients. When this test is applied to the product Mylk, I am of the opinion it shall pass. Firstly, consumers will most likely not expect conventional milk, because of the twist in the product name. Secondly, FOP it states “dairy-free”. Thirdly, most plant-based dairy products are not stored in the fridge in the supermarket. Lastly, from the list of ingredients it is apparent this product is based on coconut cream.
Sector specific dairy legislation
For the dairy sector, important guidance was provided by the Tofutown decision by the ECJ. As detailed in an earlier blog post, we learnt from this decision that – in short – it is prohibited to use dairy names, such as “Tofubutter”, “Pflanzenkäse” and “Veggiecheese” for non-dairy products. This can be explained by the fact the dairy market is highly regulated, meaning that any specific dairy product has its own product standard. This standard should be met when manufacturing and marketing the product at stake. During the webinar, I mentioned the product standard for milk, defined as “normal mammary secretion obtained from one or more milkings without any addition thereto or extraction therefrom”. From this definition it follows why the use of the work milk in combination with a plant-based ingredient is, in principle, no longer allowed.
However, there are always exceptions to the rules, also in this case. These exceptions relate to so-called traditional use, like “coconut milk” (UK) and “lait d’amande” (France). Those exceptions are mentioned on a list drawn up by the European Commission. Furthermore, the word “milk” and designations used for milk products (e.g. cream, butter, yoghurt) can be used in association with one or more words designating certain composite products (famous example: “chocolate milk”). A condition precedent however is that milk is an essential part thereof, either in terms of quantity or for characterization of the product, and no constituent takes the place of milk.
Plant-based meat replacements
For these types of products, using (or not) the word “meat” is not so much an issue, because they are no conventional meat product. This issue is rather whether it is legally permitted to use certain meat product designations, such as “hamburger”, “sausage” and the like. In the US, we have seen so-called censorship bills in a great number of States. These are usually driven by the meat sector lobby, who fear unfair competition from their plant-based peers. There is fierce opposition against such censorship, amongst others from the Good Food Institute. Mid April, the GFI reported their lobby had been successful in Virginia, where the Governor vetoed label censorship.
In the EU, we have seen similar initiatives when the AGRI Committee of the European Parliament proposed a bill restricting the use of meat product names for meat alternatives. The status of this bill is yet undecided, as the current European Parliament that was inaugurated in 2019, did not yet vote on it. Fierce lobbying pro and con is however going on. We must therefore anticipate that if this bill turns into law, it will also result into restrictions of very popular terms. The alternatives for those popular terms are not so obvious yet: “lentil slices?” or “carrot tubes?”.
Please bear in mind that restrictions can also stem from national Member State laws based on reserved product designations. In the NL for instance, the name “minced meat” and “tartar” are such reserved product designations that can only be used for products meeting exactly the relevant legal specifications.
When discussing the advantages of new over conventional protein products, certain advertising standards should be taken into account. In the EU, one of the ways to avoid misleading regarding your alternative protein product is to not emphasize certain characteristics that your product does not have. In this context, I discussed in the webinar a commercial that was made for BECEL margarine (FLORA in UK) that was shown both in the Netherlands and in Belgium. The text stated “Plants are the new cows. They are outside in the field whole year long. They provide seeds, that are a source of omega-3, which is good for your heart. BECEL is 100 % plant-based and good for your heart.”
According to a complaint filed with the Dutch Advertising Code Committee (similar to Advertising Standards Authority in UK), the comparison made between plants and cows was misleading. Rationale: it was suggested that plants had a more positive effect on the environment than dairy products made from milk. The complaint was dismissed. The ACC considered that the commercial did not at all compare the advantages of plant-based products to the disadvantages of conventional dairy. In fact, it only stressed the positive health effects of BECEL, due to its plant-based ingredients. The commercial appeared an effective (and funny!) way of advertising alternative dairy products.
Alternative protein products are food products like any other, so make sure that when marketing these, you are up to speed with all applicable general labeling requirements. Furthermore, take into account any sector specific standards, like the ones that apply for dairy products. Also, please note that at Member State level, further restrictions on the use of particular product names may apply. Finally, when advertising these products, make sure to avoid any misleading and know the rules for comparative advertising. This will be of particular relevance, especially once further labeling standards will evolve at EU level as initiated by the AGRI Committee of the European Parliament. Stay tuned – we will.
Copyright image: Nanne Meulendijks – please contact the artist for any further use.
What 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.
What does the future of our meat look like? This topic was the subject of the Annual Conference of the Good Food Institute (GFI), which took place in San Francisco last month. GFI is an American non-profit organization that works with entrepreneurs, scientists and investors to make groundbreaking good food a reality. GFI focuses on the development of alternatives to animal products, consisting of plant-based products and products manufactured using cellular techniques (“cultured meat” or “cultured fish”).
Trends from Silicon Valley also in EU
The issues raised at this conference are also relevant to Europe. In the Netherlands, for example, the Nutrition Centre advises that it is better for human health to have a more plant-based diet than has been the case until now. For example, the risk of cardiovascular disease would decrease if the diet included less meat and more wholegrain cereal products, legumes, vegetables, fruit and vegetable meat substitutes.
GFI sessions: trending topics
In the country where the Beyond Meat citizen comes from, it was recognized that a large-scale breakthrough of meat alternatives has not yet taken place. The titles of the presentations were telling: “Marketing to Meat Eaters: How to Reach the Other 95 Percent of American Consumers“, “Capitalizing on Change: How Investors Accelerate the Plant-Based and Cell-Based Industries” and “Addressing the Key Challenges in Commercializing Cell-Based Meat“. Participants in the last session of the conference (“Cell-Based Meat Entrepreneurship“) were JUST and Memphis Meats, the companies that are said to be “closest to the market” with their cultured meat products. According to JUST, they will launch a cultured meat burger still this year. But that’s what they say every year.
Plant-based meat substitutes in the US
What is legally required to be able to market meat alternatives? Of course, it all starts with the name: what can you call these products? The basic rule, both in the US and in the EU, is that consumers must not be misled. In the case of plant-based products, this principle is applied in various ways in the United States. For example, the burger of Beyond Meat (which is now also available in the Netherlands) is simply referred to as the BEYOND BURGER and described as “the world’s first plant-based citizen that looks, cooks, and satisfies like beef…“. Impossible Foods also refers to its company name in its IMPOSSIBLE BURGER. This product is not yet on the market in the EU, partly because it contains a protein of which the regulatory status in the EU is not entirely clear (so-called leghomoglobin). This protein is obtained on the basis of fermented yeast, possibly using GMO techniques. Finally, Morning Star (“It easy eating green“), when selling its plant-based burgers, refers to the flavour-defining ingredient that they contain, for example “mediterranean chickpea burgers” and “spicy black bean burgers“. Confusion with conventional meat products does not seem to be an issue here.
And what about the EU? Famous example of the Vegetarian Butcher
In the meantime, more and more plant-based meat substitutes are also being sold in the EU. One of the best-known examples of (alleged) confusion about product names in the Netherlands concerned the case of the Vegetarian Butcher, a company that was acquired by Unilever in December 2018. At the end of 2017, the Dutch Food Safety Authority (NVWA) asked this company to modify the labels of the products offering a substitute for tuna, chicken and bacon (all spelled with a twist in Dutch), because these would be misleading. It turned out afterwards that the criticism concerned only the information on the website. The NVWA apologised and the Vegetarian Butcher did not have to change any product labels.
Proposal for a ban on Vegaburger in the European Parliament
The next shockwave took place at European level when, in April of this year, the Committee on Agriculture and Rural Development (AGRI Committee) of the previous European Parliament adopted a proposal to ban the use of meat names for plant-based products. On the basis of this proposal, it would no longer be possible to use the names ‘steak’, ‘sausage’, ‘ham’, etc. for plant-based products. A new European Parliament has now been elected. It has been reported from Brussels sources that the new AGRI Committee has taken the old proposal as a starting point for a working document. However, so many forces are working together against the previously envisaged ban that the chances of this happening are not considered to be very great. Arguments against this ban are that it would inhibit innovation in the EU, harm consumer rights and simply not be necessary: consumers are not so easily confused about plant-based meat substitutes. With the slogan “Stop the vegaburger ban“, Pro Veg launched a petition against this ban.
Cultivated meat in the US
Currently, about 30 companies active in the field of cultured meat worldwide. The companies that are most advanced with their innovations are located in the US. Menphis Meat, for example, focuses on the development of beef and poultry from the lab. This company has received investments from both well-known names (Bill Gates, Richard Branson) and from the “classic” meat industry (Tyson and Cargill). JUST focuses on the development of, among other things, chicken meat from the lab. The company has already launched an egg-free mayonnaise, that was the object of discussions with the FDA. According to the current product standard for mayonnaise, this product must contain eggs, otherwise it cannot be called “mayonnaise”. This problem was solved by changing the name of the product (“JUST Mayo”). How cultured meat will be named upon its market introduction is yet an open question. However, five companies have joined forces: they form the so-called Alliance for Meat Poultry and Seafood Innovation to approach the supervisory authorities with one voice. GFI has also developed a narrative framework to familiarise consumers with this technology and it published the results of market research into favorite names. For the time being, “cultivated meat” and “cultured meat” are at the top in terms of “appeal” and accuracy.
Cultured meat in the EU
In the EU, the question remains whether cultured meat can actually be called ‘meat’ at all. The number of arguments for and against is more or less balanced. We reported earlier on this topic in our blogs How do we get cellular ag products to the market and Regulatory pathways for clean meat in the EU and the US; not much progress has been made since that time. The main argument in favor is that when a product is identical to conventional meat at a molecular and nutritional level, producers want to be able to use this name as well. In addition, the use of the term ‘meat’ is very functional in terms of consumer orientation. Furthermore, there do not seem to be any direct legal objections to the use of ‘meat’ for cultured meat, since the Agricultural Products Standards Regulation does not contain a specific product standard for meat, unlike, for example, dairy products. Arguments against the use of ‘meat’ are based, among other things, on the Hygiene Regulation. This Regulation defines ‘meat’ as certain parts of a variety of animals, including bovine and porcine animals and poultry. It is questionable whether a product obtained from a single cell derived from one of these animals complies with this definition. Furthermore, the Hygiene Regulation refers in various places to the slaughter of farmed animals. Of course, slaughter does not apply to cultured meat – that’s the whole point. Finally, certain meat names are subject to specific regulations. In the Netherlands for example, the name ‘tartar’ may only be used for minced meat from cattle with a maximum fat content of 10 % based on specific Commodities Act legislation.
The future of our meat is taking shape. Plant-based meat substitutes are already on the market in large numbers and these products are getting more and more shelf space in the supermarket. The challenge for these products is to keep that shelf space. A certain amount of time will elapse before cultured meat will be available on a large scale on the shelf. It is expected that the first company will submit a request for Novel Food authorisation sometime next year. It will take about 18 – 24 months to complete such an authorisation procedure. By then we will have reached 2022. This may seem a long way off for the consumer, but the preparation by the producer has been a reality for a long time. Also, it was learned via the grapevine that EU-based cultured meat companies are getting organized. Watch that space!
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.
In a recent decision of the Board of Appeal of the Dutch Advertising Code Committee (ACC), it was made clear that providing food information to consumers is serious business. The ACC in the Netherlands is a self-regulatory body, comparable to the Advertising Standards Authority in the UK and the German Advertising Standards Council (“Deutscher Werberat”) . This means that companies (including food business operators) voluntarily submit to the competence of such body and, as far as the Netherlands are concerned, usually comply with its recommendations. In the food space, decisions of these self-regulatory bodies grow in importance, as they quite often are precursors of similar decisions in civil proceedings.
The decision from the ACC discussed here relates to the FrieslandCampina product referred to in Dutch as Optimel vanille vla, which in English comes down to vanilla custard. In the Netherlands, it’s a product that has been around for years (one of my favourite deserts as a child, especially with a boost of read jam!) The product showed FOP a picture of yellow custard but not any vanilla pods, it contained the description “soft vanilla taste” and the label indicated it contained vanilla aroma, without specifying if the vanilla was from natural or chemical origin. In fact, the vanilla was from chemical origin (in legal terms a “flavouring substance”) and the Dutch food watchdog Foodwatch considered this to be misleading.
Decision in first instance (19 February 2019)
In first instance, the claim from Foodwatch was upheld. Now that the product stated both front and back of pack the word “vanilla” in quite a striking way, the average consumer would reasonably expect the product to contain (real) vanilla, and not just a chemical flavouring substance. Both parties had submitted market surveys with (not surprisingly) the contradictory result that the average consumer would expect (Foodwatch) and would not expect (FrieslandCampina) the product to contain “real” vanilla. Both surveys had been discarded and the practise was considered misleading based on article 7 of the FIC Regulation. Friesland Campina’s defense that in the Netherlands “vanille vla” was a customary name, in the sense of article 2 (c) of the FIC Regulation, for a product of which the average Dutch consumer would understand it does not contain any “real” vanilla was not considered convincing.
Defence on appeal
On appeal, FrieslandCampina had developed three arguments. Firstly, it had argued the description of “soft vanilla taste” in fact functioned as a so-called taste disclaimer, adequately informing the consumer that product tasted like vanilla, which does not necessarily mean it contains vanilla. Secondly, FrieslandCampina opposed the way in which its market survey had been discarded. Whereas this survey demonstrated 76% of the consumers did not expect the vanilla to originate from fruits from the vanilla plant, the ACC had focused on the remaining part, stating that 26% did have opposite expectations. Thirdly, Friesland Campina had argued that the average consumer knows that the term “flavouring” does not necessarily refer to a particular source, otherwise the term “natural flavouring” would be used.
Decision on appeal (16 May 2019)
This line of defence did not produce the desired result. Overall, the ACC considered FrieslandCampina had overestimated the knowledge of the average food consumer. The name of the product specifically referring to a particular ingredient, the average consumer could undeniably expect the product to contain vanilla. This expectation had been insufficiently “neutralized” by the additional information on the product, like the description “soft vanilla taste” and the aroma in the list of ingredients. FrieslandCampina itself seemed to have understood this as well. During the oral hearing, it had announced it planned to adjust the packaging of the product at stake.
I do not consider the practice to Friesland Campina to be deliberately misleading. As mentioned above, this type of product had been around for decades and personally, I cannot recall the issue at stake to have been an issue at all. In addition, one could say that an average and reasonably well-informed consumer should reasonably understand that if the product contained “real” vanilla, it would be much more expensive. However, times have changed. Enforcement of the FIC regulation is for real and so is the position taken by consumer organisations. More and more consumers do want to know what’s in their food and what not, so FBO’s will need to be more accurate than in the old days in their product labelling and presentation. This implies, amongst other things, that a careful distinction will have to be made between food ingredients on the one hand, and flavourings on the other hand. Furthermore, when using the term “natural” in combination with “flavouring”, at least 95 % of the flavouring component should be obtained from the material referred to. In sum, I expect to see similar decisions in future, not only from self-regulatory bodies like the ACC, but also from civil courts from other EU Member States.