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.
From 7 – 9 May 2019, the Vitafoods conference took place again in Geneva. For a few years in a row, I presented at the Education Program. This year I was asked to discuss the application of CBD in food products, which is currently a hot topic. Below, I will share the insight from my presenation, as well as two other trends I came across at the trade show.
(1) Cannabis, cannabis, cannabis
Cannabis was omnipresent at Vitafoods 2019. I do not mean the smell of it, but its application in food, pharma and in cosmetics. FoodHealthLegal being dedicated to food products, this post will uniquely focus on food application of (parts of) Cannabis. In our practice, we also deal with the other applications thereof. As pointed out in an earlier blogpost, FBO’s in the field of Cannabis were recently confronted with a change in the Novel Food catalogue. Since 20 January this year, CBD was declared a Novel Food. In my presentation during Vitafoods, I explained that this does not necessarily mean that each FBO needs to obtain an (individual) NF authorization. In fact, I identified 5 ways to market CBD food products, as further detailed in my slides:
- no Novel Food;
- individual / joint Novel Food application;
- rely on third party authorization;
- take advantage from the transition regime;
- use national consultation procedure.
Food supplements targeting a cosmetic effect, so-called nutricosmetics, were present in great numbers too. The rationale behind these products is that cosmetic effects do not only derive from topical applications but can just as well be achieved via food (“beauty from within”). Communicating the benefits of these products is to some extent easier than communication around “regular” food supplements, as one can rely on so-called beauty claims. These are claims that uniquely target appearance of skin, hair and nails and not any beneficial nutritional or physiological effect on the body. These types of claims are not covered by the Claims Regulation, so one has flexibility in the wording thereof. In practise, these claims are usually supported by efficacy studies, as the burden of proof obviously is on the FBO marketing the nutricosmetic at stake. In addition to beauty claims, a number of health claims relate to beauty as well. The compounds covered include biotin, iodine and Vitamins A, B2 and C amongst others. As a result, attractive general health claims can be used for nutricosmetics, when specific ingredients thereof meet the parameters for these specific claims.
As an example, the product Lycoderm can be mentioned. This is a carotenoids and rosemary blend aimed at enhancing the benefits of topical skin treatment. The product is marketed stating that “antioxidants like carotenoids help balance our skin from environmental stressors such as UV rays”. The shorter version thereof could be “carotenoids help maintain healthy, smooth skin.” So far, no authorised health claim for carotenoids is in place, but it is possible to make a beauty claim regarding the effects thereof in a nutricosmetic (if powered by science). When using the authorised health claim for Vitamin E (“contributes to the protection of cells from oxidative stress”), a short attractive claim could read “beauty comes from within.”
(3) Digital nutraceuticals
This is a new phenomenon according to which nutraceuticals are powered by digital support. Various examples of apps developed by manufacturers of nutraceuticals operating in a B2B context were shown, aiming to enhance the appreciation of the consumer in a B2C context. More than once, such digital support could be customized for each individual client, so that a whole new digital business is developing around food supplements.
As an example, the product Metabolaid can be mentioned. This is a food supplement manufactured by Monteloeder aiming at weight control by controlling the appetite of consumers. Clinical studies are reported to have shown that the intake of this product, together with a healthy diet and regular exercise, helps consumers to manage their body weight, blood pressure, cholesterol and glucose levels. Monteloeder has also designed an app, enabling the consumer to monitor his/her daily habits, including eating hours, frequency and sleep. Furthermore, this app allows the connection with other wearables to detect health related parameters like heart rate, steps taken and body weight. This should enable the consumer to achieve positive changes in lifestyle habits, by offering a more thorough control over his/her overall health.
Overall the Vitafoods conference offered many new insights. When adopting these, check before going to market whether your regulatory strategy is up to standards!
Now that the US regulatory framework is shaping up, the analogies and differences with the European regulatory framework for market access for clean meat becomes more and more clear. This blogpost reports these analogies and differences, based on the agreement that the FDA and USDA recently concluded on their cooperation in the field of clean meat.
Joint action FDA-USDA in regulating cell-based meat
On 7 March 2019, the FDA and the USDA concluded a formal agreement (“7 March Agreement”) on their cooperation to oversee the production of cell-based meat from livestock and poultry. As mentioned in an earlier blogpost, in the EU the European Commission is the one stop shop for obtaining a Novel Foods authorization. In the US however, foods can be subject to regulatory oversight by multiple federal and state agencies. In general, USDA regulates meat and poultry, including the inspection of establishments that slaughter such animals or otherwise process meat and poultry products. FDA generally regulates all other food, including fish and certain other meat and poultry products, such as bison, rabbits, and wild turkeys and ducks.
Essence of the 7 March Agreement
The 7 March Agreement is quite a relief for the market players concerned. For instance, the Good Food Institute issued a press release, stating “The agreement is a significant step forward in providing a transparent and predictable regulatory path to market for cell-based meat, which will help to ensure that the U.S. does not fall behind Israel, China, Japan, the Netherlands, Singapore, and other countries that are moving quickly to ensure a clear path to market for this method of meat production”. In essence, according to the 7 March Agreement, FDA is competent to oversee cell culture and production up to harvest of the cultured meat cells, whereas USDA takes over responsibility as of harvest up to and including the actual production of clean meat products. For clarity, clean fish is not included in the 7 March Agreement, as this under the remit of FDA. It seems safe to assume however that what the agencies will do for clean meat and poultry, they will do for clean fish. This assumption is based on the agreement that the agencies will develop joint principles for product labeling to ensure that products are labeled consistently and transparently.
Analogies between EU and US
By far the most important analogy is that both regulatory systems aim to assure that clean meat products hitting the market are “safe, wholesome and unadulterated” (see point 4 B (3) of 7 March Agreement). In fact, to the EU Novel Foods Regulation aims to ensure “the effective functioning of the internal market while providing a high level of protection of human health and consumers’ interest.” In order to achieve this purpose, both regulatory systems require prior market authorization, but the way such authorization procedure is put in place is in fact quite different.
Differences between the EU and US
In order to visualize the differences between the two regulatory systems at each side of the Atlantic, I have created the schematic overview below. On the left side, I summarized the authority of the FDA and the USDA under the 7 March Agreement. On the right side, I outlined how legal authority is attributed in the EU and in its Member States. As a reference Member State, the Netherlands (“NL”) has been retained, as this is one of the EU countries where clean meat activities are prominent.
|1.||Pre-market consultation to evaluate production materials & processes||No formal pre-market consultation procedure in EU Novel Foods framework, except the optional consultation at Member State level in case of doubt whether the product qualifies as a Novel Food (which is clear in the case of clean meat)|
|2.||Oversee cell collection and quality of cell banks||Oversight of preparatory production steps, as well as registration of a company as a food business operator (FBO) will be done at Member State level. In the NL, FBOs working with products from animal origin, require a so-called recognition (“erkenning“). This is a more detailed procedure (average term: 8 weeks) than the mere registration of a FBO (average term: few days).|
|3.||Oversee production process until harvest|
|4.||Ensure companies comply with FDA requirements: facility registration, cGMP and other applicable food legislation|
|5.||Where needed: issuing regulations or guidance or additional requirements re. # (2) and (3) to ensure that biological materials exiting the culturing process are safe (FFDCA)||EU Hygiene regulation targeting food of animal origin (853/2004) to apply and potentially national legislation as well. In the NL, the Commodities Act Decrees on hygiene and on the preparation and packaging of foodstuffs are applicable. Additional requirements (“conditions of use”) may also be included in individual Novel Food authorizations.|
|6.||Inspections and enforcement directed at safety of cell banks and culturing facilities||Inspections and enforcement are done at Member State level. In the NL the responsible entity is the Dutch Food Safety Authority.|
|USDA (“post harvest”)|
|7.||Determine whether harvested cells are eligible to be processed in meat or poultry products||The NF-framework requires FBOs in their application for market authorization to specify the source of the product, its production process and typical compositional features. No additional eligibility test upon cell harvest prior to production of food products.|
|8.||Require each clean meat company to obtain a so-called grant of inspection||Not required under EU legal framework. Registration (or recognition) with the competent Food Safety Authority provides the authority with the legal basis for inspection. Obviously, a Novel Food authorization must also be obtained before placing the product on the market.|
|9.||Conduct inspections in establishments where cells cultured from livestock and poultry are harvested, processed, packaged or labeled to ensure that the resulting products are safe, unadulterated, wholesome and properly labeled.||Inspections will be executed at a Member State level, based on the Official Controls Regulation 854/2004 targeting products of animal origin for human consumption inter alia.|
|10.||Pre-approval of labeling of clean meat products and inspection thereof||No pre-approval of product labels under EU NF-framework. It is the responsibility of the FBO himself to comply with applicable labeling legislation, such as the Food Information to Consumers Regulation 1169/2011.|
|11.||Where needed: develop additional requirements to ensure the safety and accurate labeling of clean meat products||Safety and Labeling provisions already in place at EU level. These are embodied in the General Food Law Regulation 178/2002 and the Food Information to Consumers Regulation 1169/2011 respectively. Furthermore, specific labeling requirements may be included in Novel Food authorizations. Also, post-market monitoring requirements may be imposed. In any event, FBOs should inform the Commission of any new relevant information regarding the safety of the NF they have placed on the market.|
|12.||Enforcement actions re. adulterated or misbranded food products||See comment to # 6. Competitors, consumers and watchdog organizations may also bring cases re. misleading food information before self-regulatory bodies. From example, unpermitted references to “meat” could be a topic of such cases.|
|Both FDA and USDA|
|13.||Each entity to cooperate with the other upon transfer or regulatory oversight at harvest|
|14.||Each party to notify the other if it identifies objectionable conditions resulting in adulterated / misbranded clean meat products|
No pre-market consultation in the EU
One of the most striking differences is that under the EU Novel Foods procedure, there is no formal pre-market consultation procedure to evaluate production materials and processes. I consider this to be a flaw in the law. Under the former Novel Foods Regulation that was in place until 1 January 2018, applications had to be filed with the competent authority at a Member State level. These authorities, at least in the Netherlands, were often willing to answer questions that arose during the preparation of applications. Under the current Novel Foods Regulation, applications have to be directly filed with the European Commission via an e-portal. There are no formal procedures to contact either the European Commission, or EFSA to answer questions on applications. If you manage to have informal consultation with an EFSA representative, no questions regarding particular applications will be answered, so a sectoral approach is your best bet. In short, we will have to learn by doing!
Written EFSA guidance
Where guidance by the Commission or EFSA on a personal level is not available, there is ample guidance based on a 2016 EFSA Scientific Opinion and a 2018 EFSA Technical Report. In fact, the 2016 Opinion provides detailed comments as to the various data to be provided in the Novel Food application, for instance on the identity of the Novel Food. For clean meat in particular, the identity of the cells from which the meat product is cultured should be provided, as well as the cell substrate used during the cultivation process, which should also be described in detail. The 2018 Report provides applicants with a completeness checklist, covering all items that should be specified in a Novel Food application. It also provides a helpful overview table of study reports contained in the technical dossier.
Contrary to the US, where enforcement is done by the authorities who also define the regulatory framework, enforcement in the EU is a national affair. This means that not the European Commission, nor EFSA are involved, but the national competent authorities. In the Netherlands, this is the Dutch Food Safety Authority, whose enforcement policy is on public record. For instance, enforcement measures directed at marketing clean meat without a proper Novel Food authorization translate into a penalty and the prohibition to further market the product. Since enforcement is a national affair, measures may vary from Member State to Member state. When marketing clean meat in Europe, it is therefore not sufficient to be familiar with the EU framework but one is strongly recommended to also gain local advice.
Open ends still occur at both sides of the Atlantic. In the US, the 7 March Agreement has given a flavor on how the FDA and USDA will cooperate, but “it does not create binding, enforceable obligations against either Agency.” So, it needs to be seen how this will work out in practice, for instance regarding the pre-approval of labels. Will the authority at Federal level take away the necessity for evaluation at State level? In the EU, it remains to be seen what type of studies EFSA will want to see to specify nutritional and toxicological information, as well as allergenicity: literature studies or rather in vitro or in vivo data?
At FoodHealthLegal, we will closely monitor the regulatory developments in the clean meat space, so stay tuned!
Credits for graphics: Mosa Meat
Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products are Novel Foods. What is the current state of play regarding these products and how is enforcement going to look like?
Current state of play re. cannabis derived products
In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 % weight per weight. The Common Catalogue is embodied in the EC Plant Variety database, which currently lists 68 species of Cannabis sativa. Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour and defatted hemp seed have a history of consumption in the EU and therefore, in principle, are not novel.
This is different for extracts derived from Cannabis sativa L. and derived products containing cannabinoids, such as cannabidiol (CBD). It follows from a recent clarification of the Novel Food Catalogue that these products are considered Novel Foods, as a history of consumption regarding these products has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient. If for instance CBD is added to hemp seed oil, the product can no longer be marketed just like that and requires market authorization. The status of Novel Food also applies to extracts of other plants containing cannabinoids and to synthetically obtained cannabinoids.
How does the market of CBD food products currently look like?
Currently, the market in CBD food products is flourishing. A variety of CBD nutraceutical products is being offered for sale, such as HempFlax CBD, CBD oil, but also CBD-infused tea, honey or sweets. Although there is no hard-scientific evidence, many health benefits are connected to CBD food products, such as stress reduction, good night rest and providing energy and increasing resistance. Contrary to products containing THC (tetrahydrocannabinol), which is also extracted from cannabis, you do not get high on CBD food products, as this is not a psychoactive substance.
Medicinal use of cannabis
The use of cannabis derived CBD in food is not to be confused with medicinal use of cannabis. In most cases of medicinally applied cannabis, the active ingredient is THC, not just CBD, or a combination of THC and CBD. Although medicinally applied cannabis does not play a role in the cure of diseases, scientific publications show it can alleviate suffering from diseases, for instance nausea, decreased appetite, slimming or weakening due to cancer.
Consequences for business of the change in legal framework
Due to the qualification of CBD food products as Novel Foods, the lively trade in these products is currently at risk. Any Novel Food has to obtain a market authorization in order to get market access. CBD food products currently marketed may face enforcement measures, unless they can benefit from the transition regime laid down in the Novel Foods Regulation. According to this transition regime, any product that did not fall within the scope of the former Novel Foods Regulation, was lawfully marketed prior to 1 January 2018 and for which an application for market authorization is filed before 2 January 2020, can continue to be marketed until an authorization decision has been taken. While this transition period is in principle drafted for Novel Foods that fall into one of the new novel food categories under the new Novel Foods Regulation, it is in the spirit of the transition regime to also include the CBD scenario.
Pending CBD-application and expected EFSA opinion
Currently, one application for the authorization of a CBD food supplement is pending. The application was made by the company Cannabis Pharma from the Czech Republic and is based on publicly available safety and toxicological information and toxicity reviews. More in particular, the scientific data has been gathered from acute and long-term toxicity studies in animals and tolerance studies in humans. The data package submitted aims to support the safety of the use of CBD in food supplements for adults with a daily intake of up to 130 mg or 1.86 mg/kg body weight. It is reported by various sources that an EFSA opinion is awaited this March (see here and here).
Any benefits for the CBD market of a positive EFSA opinion?
Contrary to the situation under the former Novel Foods Regulation, the authorizations granted under the current Regulation have a generic nature. This means that any other company meeting the conditions of use stated in the authorization, would be at liberty to market CBD food supplements as well. The pending application made by Cannabis Pharma is therefore followed with great interest by the CBD market. As they do not seem to rely on data protection, a granted authorization would pave the way for other food supplement companies. It is not certain if this will happen still this year. If and when EFSA grants a positive opinion this March, the European Commission still has 7 months to submit an implementing act to the PAFF Committee. Upon a positive opinion of the PAFF committee, such implementing act could be quickly adopted. If the PAFF Committee has no opinion or a negative opinion, 1 or 2 months should be added to the procedure as a minimum.
Ireland: some CBD food products can be marketed
Meanwhile, there is some guidance available at Member State level. The Irish Food Safety Authority notes that recently a large number of CBD food products entered the market, typically marketed as food supplements in liquid or capsule form. Depending on the manufacturing process applied, the trade in CBD oil is not prohibited, as this oil naturally contains low levels of CBD, which is considered a non-psychoactive compound. This applies to CDB oil obtained by cold-pressing the hemp seeds. If and when the oil is obtained by supercritical CO2 extraction, then a Novel Food authorization is mandatory.
Denmark: available guidance not crystal clear
According to the Danish Ministry of Environment and Food, a number of Cannabis-derived products are not considered Novel Food, notably hemp seeds, seed flour, protein powder from seeds and seed oil from the Cannabis sativa L. varieties listed in the EC Plant Variety Database that are free from or contain low levels of THC. If these products contain CBD, the regulatory status is not exactly clear. According to the guidance of the Danish Food Ministry, the current status is that pure cannabidiol as well as hemp products with high (concentrated) levels of CBD or other cannabinoids are covered by the Novel Foods Regulation. It is not explained what is understood by “high levels of CBD”, but on the other hand an absolute prohibition to market these products in Denmark does not seem to apply.
Absolute prohibitions: Belgium and Austria
Other Member States seem to be stricter than Ireland or Denmark. For instance, the Austrian Health Ministry has made it perfectly clear that food products containing any type of cannabinoid extract without a Novel Food authorization are prohibited to be put on the market. In Belgium, the Federal Agency on Safety in the Food Chain has clarified that the production and marketing of food products based on cannabis is prohibited. The rationale is that the plant Cannabis sativa is mentioned in an annex to a national Decree listing dangerous plants that cannot be used for food production. The prohibition primarily seems to target the potentially dangerous substance of THC and allows derogations on a case-by-case basis, but not regarding food products containing CBD. These are considered Novel Foods requiring a market authorization.
Enforcement directed against (medical) claims in the Netherlands
Until CBD was declared a Novel Food, the trade in CBD food products was not prohibited in the Netherlands. Contrary to the substance TCH, the substance CBD is not mentioned in the Dutch Opium Act, listing prohibited substances having a psycho active effect. This does not mean that the trade in CBD food products was allowed just like that. In practice, enforcement in the Netherlands has been directed against the use of any unauthorized medical claims. A medical claim is any information according to which a food product could have a therapeutic or prophylactic effect. When using such a claim, one comes into the realm of the Medicinal Product Act, according to which it is prohibited to market and advertise any medicinal product without a market authorization. The Dutch Food Safety Authority announced fines up to
€ 10.000 regarding the sale of CBD food products in several cases (see here and here). Any food business operator that is serious about his business in CBD food products will therefore not only check the applicability of the Novel Foods Regulation to his products, but also carefully draft his advertisement for this type of product.
The production and marketing of food products derived from Cannabis sativa L. in the EU has been considerably restricted since CDB food products were recently declared to be Novel Foods. However, not all cannabis-derived food products require market authorization. Pending the evaluation of the Novel Food application filed for a CBD food supplement by the Czech company Cannabis Pharma, it is worthwhile for other CBD food products to verify whether they can benefit from the so-called transition regime embodied in the Novel Foods Regulation. Due to differences between legislation in the Member States, this may differ from country to country. Also, it is important to carefully position your CBD food product, in order to avoid any medical claims.
The author ackowledges Jasmin Buijs, paralegal at Axon, and Max Luijkx, intern at Axon, for their valuable input.
“The FDA knows just how vital it is to ensure the safety of our nation’s food supply and the critical role science-based, modern regulatory frameworks are to fostering innovation. Recent advances in animal cell cultured food products present many important and timely technical and regulatory considerations for the FDA and our partners at USDA,” said Commissioner Gottlieb. “We look forward to the opportunity to hold a meeting with our USDA colleagues as part of an open public dialogue regarding these products.”
Harvard Law School
This is a new quote taken from the website of the FDA, regarding a joint FDA – USDA meeting on animal cell culture technology on 23 and 24 October 2018 in Washington. Securing regulatory clearance is pivotal for market access of this type of products, which used to be often referred to as “clean meat,” “cell-based meat,” or “lab-grown meat,” depending on whom you would ask. Since the Good Food Conference early September, there seems to be consensus to retain the term “cell-based meat”. To date, there is however no consensus on the appropriate US regulatory framework for these products, which is why this new meeting has been set. In particular, it is not clear which federal regulatory agency – the FDA or USDA or both – has jurisdiction over these products with respect to labeling, safety and inspections, or whether these products will meet regulatory definitions relating to “meat” and “poultry.” Harvard Law School, in particular its representatives from the Food Law and Animal Law groups, recognizes the potential benefits of clean meat and other cellular agriculture products. Therefore, on 9 and 10 August 2018, the school organized the Clean Meat Regulatory Roundtable in order to address the regulatory concerns surrounding this new industry. Further to an earlier post on this subject, this is take #2 on the Harvard initiative, reporting a selection of topics discussed at that table. Also a comparison with the EU regulatory framework shall be made where relevant.
Participants Regulatory Round Table and Ruled of Play
In order to let the discussion benefit from as many perspectives as possible, representatives from academia, the industry and from interest groups participated in Harvard’s Clean Meat Regulatory Roundtable. Obviously, the meeting included a number of representatives from Harvard Law School. Furthermore, the nonprofit organizations Good Food Instituteand the Animal League Defense Fund were present. The participating companies were Mosa Meat and Fork & Goode (both working on clean meat), as well as Blue Nalu (working on clean fish). From the investor side, Stray Dog Capital was represented and from the industry DuPont provided its input. Finally, a number of US lawyers participated, including Deepti Kulkarni from Sidley Austin LLP. I myself shared my insights on this topic from an EU perspective. To encourage openness and the sharing of information, all participants agreed to a Chatham House Rules + regime, meaning that the topics discussed during the meeting could be reported, but the participants were not at liberty to identify, either explicitly or implicitly, the identity of the speaker or his or her affiliation.
Cooperation on optimal regulatory pathway?
Amongst the participants, there was a common concern that if one party rushes unprepared to the market, ignoring the appropriate regulatory pathways, that could poison the well for the entire cellular agricultural industry. It was therefore discussed to what extent the cellular agriculture industry could cooperate regulatory-wise. It became clear that even though clean meat products share certain characteristics, finished products could be quite different in terms of formulation, composition, or other product characteristics. Nonetheless, general principles for assessing safety and product identity could be established under existing regulatory authorities. Such principles could for instance involve considerations relating to substances used in the production of clean meat, including scaffolds, growth factors, and cell culture medium or potential variations in the production process. In addition, it was discussed whether common interests could be effectively promoted through a trade association or industry group. The participants discussed various options, including setting up a dedicated association and connecting with existing organizations such as BIO.
Contrary to the situation in the EU, where the European Commission is the one stop shop for obtaining a Novel Foods authorization, in the US foods can be subject to regulatory oversight by multiple federal and state agencies. It is has not yet been decided which agency has jurisdiction over these products, or whether the products are subject to dual oversight. In general, USDA regulates meat and poultry, including the inspection of establishments that slaughter such animals or otherwise process meat and poultry products. FDA generally regulates all other food, including fish and certain other meat and poultry products, such as bison, rabbits, and wild turkeys and ducks. In addition, FDA regulates new ingredients (as “food additives”) used in the production of foods under its jurisdiction, as well as new ingredients used in meat and poultry products that otherwise would be subject to USDA oversight.
Meat and poultry products subject to USDA jurisdiction generally require “continuous” or daily inspection, depending upon the nature and frequency of operations. Because the production of clean meat does not involve slaughtering animals and such products would not be derived from slaughtered animals, there are open questions regarding the applicability of USDA’s inspection regime. This is even more so when clean meat products are not “harvested” daily, but on a batch-based basis. Arguments, nonetheless, can be made in favor of USDA jurisdiction with respect to “processing” inspections and other in-market activities, as well as product labeling. Nevertheless, at the Roundtable, there seemed to be a slight preference for FDA jurisdiction both pre-market and in-market.
Traditional meat industry’s concern of level playing field
The views of the traditional meat industry are somewhat fractured with respect to the clean meat industry. Some have taken considerable stakes in clean meat ventures (consider the investments of both Tyson and Cargill in Memphis Meats), particularly industry segments more closely involved with raising livestock are less supportive. For example, the US Cattleman’s Association submitted a petition to the USDA in February this year, asking it to establish labeling requirements that would prohibit clean meat from using terms like “meat” or “beef” in product labeling. Most trade groups representing the traditional meat industry have called for a “level playing field” where clean meat products would be subject to some level of USDA inspection. In general, all participants at the Harvard Panel agreed that a discussion with the traditional meat industry on how clean meat should be regulated would be critical. Notably, clean meat producer Memphis Meats and the North American Meat Institute, a trade group that represents the largest meat producers in the U.S. recently issued a joint letter to the White House outlining a regulatory regime under both FDA and USDA, and calling for a combined meeting involving the White House, USDA, FDA, and representatives of the traditional meat and clean meat industries.
Even if the FDA were to have some level of jurisdiction over clean meat products, it is still not completely clear what data would need to be submitted to demonstrate safety. One of the participants opined that, unlike a food additive approval, neither a GRAS determination, nor an FDA consultation (see here for an example of a consultation procedure on plant based products) would result in an affirmative regulatory approval. Some were of the opinion that a regulatory opinion short of approval would not benefit the clean meat industry, particularly in the eyes of the public. By contrast, others particularly those familiar with the GRAS process and the requisite scientific information needed to demonstrate safety disagreed with the position that a GRAS determination would not be rigorous or otherwise appropriate. The participants then discussed that a potential hybrid model that followed the GRAS approach, but also involved a third-party safety opinion could be an option. As to the required data, it was discussed what would be the “ingredient” that would be assessed by the competent government agency. The substances used in the culture of clean meat products most likely are of relevance, even if they may qualify as mere processing aids that normally only remain as residues in the final product without technical function. One participant mentioned such substances could easily be tested in separate toxicology studies, to which reference could be made during the pre-market evaluation (US) or in the application for a Novel Foods authorization (EU).
EU market entry of Novel Foods
Compared to the US, the regulatory pathway for clean meat products in the European Union is relatively clear. Under the new Novel Foods Regulation (effective as per 1 January 2018), an application for an authorization of a Novel Food should be made with the European Commission, who will subsequently distribute this to all EU Member States. The application should in the first place contain a detailed description of the product for which an authorization is sought, as well as of its production process. Furthermore, a proposal for the purported conditions of use should be handed in and a labelling proposal that does not mislead the consumer. Last but not least, the applicant should provide scientific evidence, demonstrating the purported Novel Food does not pose a safety risk. For this purpose, tox studies that comply with Good Laboratory Practices are mandatory, as is an evaluation of the total safety strategy. This should be based on proposed uses and likely exposure, with justification to include or exclude certain studies in order to prevent cherry picking. Upon receipt of the Novel Food application, it is anticipated that the Commission will request a safety opinion from EFSA, who will evaluate, amongst other things, if the Novel Food concerned is as safe as food from a comparable food category already placed on the EU market. The EFSA evaluation should not exceed a 9 months term. Within 7 months after receipt of a positive safety opinion, the Commission should publish its implementing act, which will result in the inclusion of the approved Novel Food in the Union List. The single open end in this procedure is the term for response for the Member States, which in the former Novel Food Regulation used to be 60 days. Surprisingly enough, this term is not mentioned in the new Novel Food Regulation that applies as of 1 January this year. However, there are no reasons to believe this should be any different under the current Novel Foods Regulation.
In order to inspire consumer confidence in clean meat products, the participants discussed how to best ensure the products’ short and long-term safety, particularly against the backdrop of public fear and aversion to genetically modified foods. Despite the assurance that FDA provided regarding the safety of these foods, many consumers remain fearful or otherwise suspicious of such foods. The participants agreed that steps should be taken to avoid a similar unwarranted aversion to clean meat products, including transparency initiatives and consumer education. In this framework, it was suggested that the clean meat industry could pro-actively develop its own HACCP program, provided that the industry could reach agreement on what would be the best way to identify the hazards and applicable critical control points. To this respect, it is relevant that both FDA and USDA have HACCP regulations and have identified hazards of chemical, biological and physical nature that might be applicable to this new sector.
Labeling, marketing, product identity
Vivid discussions took place regarding whether or not clean meat or fish products could be called “meat” or “fish” respectively. Whereas some argued: “Meat is what it is, so meat it should be called”, others considered the actual name less important. Most likely, we will not see the plain term “meat” on product packaging, but rather “ground beef,” “meatballs,” or “chicken tenders”. Some participants cautioned that, in order for products to be labeled with such product-specified terms, they generally would have to meet the general definitions for “meat” or “poultry,” unless the labeling adequately described or qualified the product. For product placement, it is of relevance whether the clean meat products belong to the “meat department” or somewhere else, though several participants clarified that such placement is decided by agreements with retailers, rather than by regulatory oversight. All participants agreed that a so-called qualifier that would explain the exact nature of the product, could benefit the industry. Such qualifier should be a neutral term, explaining concisely how clean meat products differ positively from traditional meat products, without being pejorative vis-à-vis said traditional industry. This is easier said than done and the participants so far did not reach a common view at this point. Notably, in their joint letter to the White House, Memphis Meats and the North American Meat Institute, propose use of the term “cell-based” meat or poultry to describe products that are the result of animal cell culture. The echo of this letter was heard at the Good Food Conference, as reported above.
Information requirements in the EU
Looking at the EU framework, it is questionable whether the designation “meat” can be used for clean meat products. As an argument in favor thereof, it could be mentioned such use would make it immediately apparent that these products equal traditional meat in terms of composition. Arguments countering the use of “meat” are based on the EU Hygiene Regulation. When using a grammatical approach, it should be observed that “meat” is defined as “edible parts of [a number of defined]animals” and one could wonder if cells qualify as such. When using a functional interpretation, it can be noted that hygiene requirements applicable to meat mainly relate to slaughtering, whereas clean meat obviously is not subject to slaughter. Another argument countering the use of “meat” for clean meat products is derived from the ECJ’s TofuTown case, related to veggie cheese and soy yoghurt. In legal terms, this decision answered the question whether it was permitted to use regulated product names for new product types. The answer was a clear “no”. It is anticipated that the traditional meat industry will rely on this case to counter the use of the name “meat” for clean meat product, at least without a qualifier that will prevent any misleading of the consumer. By way of background, it is helpful to remember that under EU labeling laws, it is mandatory to designate a food product by its legal name. In the absence thereof, a descriptive name can be used or alternatively, a customary name.
Clean meat and clean fish represent an emerging sector, with the promise of revolutionary innovative products. Public perception of these products, as well as trust in the safety thereof, will be of utmost importance for market success. Reliable and effective regulatory procedures as a basis for market access will therefore be pivotal. In the US, the regulatory framework applicable to clean meat products is far from clear. Firstly, it is yet to be decided which government agency has jurisdiction over these products or whether both FDA and USDA share oversight. Secondly, there are open questions regarding the appropriate regulatory pathway and in-market inspection regime. In the European Union, the regulatory pathway for clean meat products is relatively clear. Under the new EU Novel Foods Regulation, these products qualify as Novel Foods and require a market authorization from the European Commission. The Regulation as well as various EFSA guidance documents detail at length what information should be contained in a Novel Foods application. In an optimal situation, the authorization procedure could be finalized in 18 months. In both the US and the EU however, the exact designation of these products (“meat” or not?) requires further thought. On the one hand, this will require interpretation of legal product definitions and case-law and on the other hand, the interests of the traditional meat and fish sector should be taken into account.
The Dutch National Probiotic Guide: an innovative alternative for health claims on beneficial bacteriaPosted: August 24, 2018 | |
Probiotics are known as “beneficial bacteria” that can be found in, amongst others, dairy products and food supplements. They are defined by the joint FAO/WHO expert consultation on probiotics as “live microorganisms that, when administrated in adequate amounts, confer a health benefit on the host”. Since the reference to probiotics implies a health benefit, it comes as no surprise that the statement “contains probiotics” in a commercial communication about a food product constitutes a health claim under the Claims Regulation. Moreover, “contains probiotics”, or “prebiotics”, is explicitly taken as an example of a health claim in the guidance on the implementation of Regulation 1924/2006 of the European Commission’s Standing Committee on the Food Chain and Animal Health. At this moment, no health claims for probiotics have been approved by the European Commission. The Dutch Research institute TNO and the world’s first microbe museum Micropia, located in Amsterdam, are nevertheless convinced of the health benefits of probiotics, in particular to protect against antibiotic-associated diarrhea (AAD). At the beginning of this month, they launched a so-called National Guide on clinically proven probiotics for use during antibiotic treatment in the scientific journal BMC Gastroenterology
The National Guide is presented as a tool for healthcare professionals, patients and other consumers to recommend or use the probiotic products listed as scientifically proven to prevent diarrhea caused by the use of antibiotics. While antibiotics fight bacterial pathogens, they also have a disruptive effect on the body’s own gut bacteria. One in four adults experiences diarrhea caused by ADD. The National Guide promotes probiotics for their function of protecting the gut flora from the disruptive effects of antibiotic treatment, fostering recovery and reducing the risk of recurring infections.
The research behind the Guide involves a literature study of clinical studies that are all based on randomized, double-blind and placebo-controlled trials. Moreover, all of the trials clearly define AAD and have a probiotic administration regime for a period no shorter than the antibiotic therapy. 32 of the 128 initially identified clinical studies were selected in line with the aforementioned criteria. After the selection and review process, available probiotic products on the Dutch market were listed to be subsequently matched with the formulations as proven effective in the selected clinical studies. Only eight probiotic dairy products and food supplements marketed in the Netherlands specified on their label the respective probiotic strain(s) and number of colony-forming units (CFUs) and could therefore be used in the research. The listed probiotic products were awarded with one (lowest) to three (highest) stars for their proven effect as demonstrated in at least one to three clinical studies. The strain Lactobacillus rhamnosus GG with a minimal daily dose of 2 × 109 CFU was found in at least three clinical studies and therefore awarded with a three-star recommendation. This strain was found in 2 products, both of which are food supplements. Several multi-strain formulations resulted in a one-star recommendation; 5 food supplements and 1 dairy product matched such a formulation. The multi-strain formulation Lactobacillus rhamnosus GG, Lactobacillus acidophilus LA-5 and Bifidobacterium lactis BB-12 was present in two clinical studies and therefore assigned with a two-star recommendation. However, none of the listed probiotic products found on the Dutch market contained this formulation.
Plea for the labeling of probiotics
The research is not exhaustive as probiotic products other than the eight that were included in the study might also be effective. However, since this was not communicated on the label, they could not be included in the research. To overcome this gap, TNO and Micropia as the initiators of the National Guide call for the labeling of the probiotic strains and number of CFUs on all probiotic products EU-wide. This could also expand the potential of the Guide. At this moment, strain and CFU labeling of probiotic products is not legally mandatory under the Food Information for Consumer Regulation. The initiators also developed a special probiotic label to address this claimed deficiency. The label is based on the probiotic label used in the US as created by the International Scientific Association for Probiotics and Prebiotics (ISAPP). The labels are in line with the information that should be demonstrated on probiotic labels according to the FAO/WHO 2002 Working Group on Guidelines for the Evaluation of Probiotics in Food.
National Guide to circumvent limitations under the Claims Regulation?
The Claims Regulation applies to health (and nutrition) claims made in commercial communications of foods to end consumers. This may be in the labeling, presentation or advertising of the food. Besides information on or about the product itself, also general advertising and promotional campaigns such as those supported in whole or in part by public authorities fall within the scope of the Regulation. Moreover, since the Innova Vital case, we know that (science-based) communications made to healthcare professionals may also be regulated by the Claims regulation. The rationale thereof is that the healthcare professional can promote or recommend the food product at issue by passing the information on to the patient as end consumer. Only non-commercial communications, such as publications that are shared in a purely scientific context, are excluded from the Regulation.
It must be noted that the National Guide is, unlike health claims, not a commercial communication originating from food business operators. This does, however, not necessarily mean that food business operators are free to use the science-based Guide in their communication with (potential) consumers or even with healthcare professionals without any reservation. The Guide, which not only lists the probiotic formulations that are beneficial for the human gut flora, but even the names of products that contain those formulations, could turn commercial when referred to by a food business. Moreover, when shared in such a context, the claims made in the National Guide may even enter the medical domain due to the preventive function assigned to foods containing probiotics.
The history of probiotic health claim applications has shown that EFSA is not easily convinced of the evidence that is correspondingly provided. The National Guide is, however, not subject to approval from the European Commission, backed by a positive opinion from EFSA. The Guide’s publication in the peer-reviewed journal BMC Gastroenterology nevertheless contributes to the verification of its scientific substantiation. The Guide therefore appears as an innovative, science-based alternative for probiotic health claims. At the same time, food business operators should be careful in referring to the National Guide to not act beyond the borders of the Claims Regulation and to stay away from medical claims. As a very minimum however, it seems to be valuable work to be adopted by branch organizations or research exchange platforms, such as the International Probiotics Association.
Cultured meat has been an increasingly hot topic since the first “clean meat” hamburger was introduced in London in 2013. The technology involves using cell culturing techniques to multiply a small amount of cells taken from an animal to produce foods that resemble traditional meat, poultry, and seafood. As commercial-scale production of cultured meat becomes foreseeable, regulatory agencies must determine how these products fit into their food compliance programs.”
Harvard Law School
This is a quote taken from the website of the FDA, who organized a public meeting on 12 July 2018 to discuss safety-related data and information that the FDA is seeking on foods produced using animal cell culture techniques. Securing regulatory approval is pivotal for market access of this type of products. To date, there is no consensus how the US regulatory apparatus will classify Clean Meat products. It is neither clear which authority has jurisdiction over these products as to labeling, safety and inspections. Harvard Law School, in particular its representatives from the Food Law and Animal Law groups, is convinced of the potential benefits of Clean Meat and other cellular agriculture products. Therefore, on 9 and 10 August 2018, it organized the Clean Meat Regulatory Roundtable in order to address the regulatory concerns surrounding this new industry. A selection of topics discussed will be covered in two subsequent blogposts. The first one will cover some background information and a summary. The second one will provide an overview of the most important subjects discussed and a comparison with the EU regulatory framework where relevant.
Participants Regulatory Round Table and Ruled of Play
In order to let the discussion benefit from as many perspectives as possible, representatives from academia, the industry and from interest groups participated in Harvard’s Clean Meat Regulatory Round Table. Obviously, the meeting included a number of representatives from Harvard Law School. Furthermore, the nonprofit organizations Good Food Institute and the Animal League Defense Fund were present. The participating companies were Mosa Meat and Fork & Goode (both working on clean meat), as well as Blue Nalu (working on clean fish). From the investor side, Stray Dog Capital was represented and from the industry DuPont provided its input. Finally, a number of US lawyers were participating and I myself shared my insights from an EU perspective. All participants agreed to a Chattam House Rules + regime, meaning that the general flush of the conversation during the meeting can be reported, but the participant are not at liberty to identify, either explicitly or implicitly, what was the source of particular information.
Clean meat and clean fish represent an emerging sector, with the promise of revolutionary innovative products. Public perception of these products, as well as trust in the safety thereof, will be of utmost importance for market success. Reliable and effective regulatory procedures as a basis for market access will therefore be pivotal. In the US, the regulatory framework applicable to clean meat products is far from clear. Firstly, it is yet to be decided which government agency has jurisdiction over these products. Secondly, the regulatory pathway is still open, whereas the available procedures of do not provide an affirmative blessing from which the sector could benefit. In the European Union, the regulatory pathway for clean meat products is relatively clear. Under the new Novel Foods Regulation (effective as per 1 January 2018), these products qualify as Novel Foods and require a market authorization from the European Commission. The Regulation as well as various EFSA guidance documents detail at length what information should be contained in a Novel Foods application. In an optimal situation, the authorization procedure could be finalized in 18 months. In both the US and the EU however, the exact designation of these products (“meat” or not?) requires further thought. On the one hand, this will require interpretation of legal product definitions and case-law and on the other hand, the interests of the traditional meat and fish sector should be taken into account.
Last week, the creation of the new Advisory Group on the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects. Its task is to issue advice on the legislation to be applied to individual products / product groups / substances belonging to a group of so-called borderline products. The reason that this Advisory Group was created is that the regulations in the field of market authorization and research with such products are complex and that it is not always clear which law is applicable. In such case it is also not clear which enforcement authority is competent to act in case of violations of the law. This is deemed undesirable by both the marketplace and the government authorities and the Advisory Group aims to change this.
Demarcation issues not new
Demarcation issues at the interface of the laws applicable to food products and medicinal products are not new. Already in a 2008 Letter to Parliament, the Dutch Health Minister reported that there was insufficient clarity about the demarcation between medicinal products and herbal remedies. The Minister reported the issue that a herbal remedy could also be a medicinal product within the meaning of the Dutch Act of Medicinal Products (in which the Medicinal Products Directive 2001/83 has been implemented). This is a consequence of the fact that the Act does not make a distinction between the origin of any active substance, which can be of human, animal, vegetable or chemical origin. When a herbal preparation qualifies as a medicinal product by function or by presentation, the Act on Medicinal Products is equally applicable.
Measures announced in the Letter of Parliament
At the time, the Health Minister did not consider it necessary to adjust the regulations to prevent demarcation issues between food products and medicinal products. He considered the criteria of “medicinal product by presentation” and “medicinal product by function” to be sufficiently clear in the first place. Secondly, he expected a beneficial effect from the list of permitted health claims that still had to be published back in 2008. He anticipated that products bearing such claims would not qualify as a medicinal product by presentation. He did, however, consider it desirable to improve cooperation between the Heath Care Inspectorate and the Food Safety Authority. This was implemented by adjusting the Decree on Supervision of Public Health, as a result of which the Food Safety Authority gained authority to enforce violations of the Act on Medicinal Products. Furthermore, it was stipulated that the structured consultation between the Heath Care Inspectorate, the Food Safety Authority and the Medicines Evaluation Board should be intensified, particularly regarding the discussion of the status of borderline products. One can say that this consultation in fact operated as an Advisory Group avant la lettre. Finally, it was determined that the already existing cooperation agreement between the Heath Care Inspectorate and Food Safety Authority had to be updated.
Demarcation issues more topical than ever
We now know that the clarification brought by the list of authorized health claims published in 2012 should not be overestimated. Nowadays many functional foods and nutraceuticals are marketed that claim medical properties. It quite often happens that it is not clear what is the applicable legislation to these products, because the boundary between health claims, disease risk reduction claims and medical claims is not immediately clear in all cases. Even when no specific claim is used, it can be debatable whether a product is a medicinal product by function or any other health product. It also happens that more or less the same products are marketed simultaneously as a medicinal product and as a foodstuff. Consider, for example, products containing glucosamine or St. John’s Wort. This means that food products containing the same active substance as medicinal products have not passed the prior testing for quality, safety and efficacy, which can be confusing for the consumer.
Consequences of product qualification
There are many examples of food products that were considered medicinal products by presentation. Consider, for example, the melatonin products which, after a remarkable turn in the Health Care Inspectorate policy, initially not but later on were considered to be medicinal products. More recently, a medical claim that Milk Thistle could prevent liver fattening was considered misleading. Furthermore, it was determined that a dietary supplement that would promote the natural immune system, would have a beneficial effect on heart and blood vessels and would help to treat fatigue qualified as a medicinal product. When such disputes are dealt with before the Civil Court, quite often fines are imposed for violations of the Act on Medicinal Products, prohibiting, among other things, the marketing and advertising of medicinal product without a marketing authorization. When these disputes are submitted to the Advertising Code Committee, usually a recommendation is made to no longer use such misleading information based on these regulations and the Code on Public Advertising of Medicinal Products. In order to prevent such enforcement activities, manufacturers of health products have every interest in knowing in advance how their product qualifies. They then know which regime applies to their product and can take this into account in their communication (advertising campaigns).
Working method Advisory Group
How does the Advisory Group work and which aspects are covered by its advice? Upon request of one of the competent authorities, the Advisory Group advises on the applicable legislation to individual products, product groups or substances. This advice gives a motivated indication of the law that applies to the opinion of the Advisory Group at the time of assessment and given the available information. “Available information” refers not only to factual information but also to applicable case law, both in the Netherlands and abroad. The advice will be presented to the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects, who will subsequently respond to this within four weeks if so desired. If the responses give cause to do so, the Advisory Group reconsiders the advice and if necessary adjusts it. The advice is then recorded in its database, which is managed by its secretariat. There is also a possibility that the Advisory Council will not reach agreement on the applicable legislation. In such a case no advice is issued; this is also recorded in the database. The Advisory Group can also change its advice in the event of changes in the legal framework. The competent enforcement authorities must report those change to the Advisory Group, which registers an amendment to a previous advice in its database, if and when applicable. For clarity, the advice assesses neither the efficacy, safety or efficacy of medical products nor the content of any research protocols.
Added value Advisory Group
Can it be expected that the Advisory Group will make a substantial contribution to demarcation issues? In itself, the intensified co-operation between all the authorities involved, at market entry rather than upon enforcement during marketing, is to be welcomed. For example, in practice, food business operators also benefit from the working agreements between the Council on Advertising Health Products and the Food Safety Authority, on the basis of which health products bearing a “stamp” of said Council are in principle not exposed to enforcement actions by the Food Safety Authority. However, it appears from the currently published agreement between the parties involved in the Advice Group that only the enforcement authorities and not the individual manufacturers can request advice from the Advisory Group. This appears to be a missed opportunity, as is the fact that the efficacy of medicinal products remains explicitly outside the Advisory Council’s assessment. To qualify the essential character of a health product, efficacy is one of the essential factors. Furthermore, it is noteworthy that the Advisory Group does not seem to address the issue of medical devices, while this qualification is closely linked to that of medicinal or food products. For example, cranberry pills against bladder infection qualify as medical devices and osmotic laxatives can be either medicinal products or medical devices.
Advice on market access for health products
For the time being, manufacturers of health products will continue to rely on private advice from qualified advisors on market access for health products. Nevertheless, the body of opinions to be produced by the Advice Group can be a valuable source of information, provided that its database will be publicly searchable. The rules of procedure of the Advice Group, which are yet to be made available, will have to provide clarity in this respect.
The organic sector has developed from a niche market to one of the most dynamic sectors of EU agriculture. To recall some numbers provided by the European Commission, the amount of land used for organic farming grows at around 400,000 hectares a year. The organic market in the EU is worth around €27 billion, some 125% more than ten years ago. The EU encourages more farmers into the organic sector and aims to increase consumers’ trust in certified organic products to further boost those numbers. For some background on the regulatory framework, we refer to our earlier blogpost on the Organics Regulation. As already announced in that post, the current Council Regulation (EC) No 834/2007 needs an update as it is based on practices of over 20 years ago. The first proposal for a new EU Regulation on organic production dates back to 2014. Last month, the European Parliament Committee on Agriculture and Rural Development gave green light to the new Organic Regulation. This new regulation aims to guarantee organic production throughout the supply chain by phasing out the many exemptions that are allowed under the current Regulation, such as the use of non-organic seeds as further covered below. In other words, the new regulation shifts from an à la carte system of exceptions to a set menu of harmonized rules. This contribution sets out the most important changes by answering relevant questions in the light of the new Organic Regulation.
Which products are covered under the new Organic Regulation?
Similar to the current Organic Regulation, the new Organic Regulation applies to live and unprocessed agricultural products, including seeds and other plant reproductive material and processed agricultural products used as food and feed. Processed products can be labelled as organic only if at least 95% by weight of their ingredients of agricultural origin are organic. Unlike the current Organic Regulation, the new Organic Regulation also covers certain other products closely linked to agriculture. Those products are listed in Annex I and include, among others, salt, essential oils, cork, cotton, and wool. Other products may be added in future.
To what extent can non-organic seeds still be used?
Derogations that allow non-organic seeds to be used in organic production will expire in 2035. A couple of measures will be taken to increase the organic seed supply and to help it meet high demands before that time. First of all, Member States shall establish a database of organic plant reproductive material as well as national systems that connect organic farmers with suppliers of organic reproductive material. Secondly, the use non-organic seeds may temporarily remain allowed if the collected data demonstrates insufficient quality and quantity of the organic reproductive material. Also, to meet the demands of organic seeds, organic heterogeneous material is explicitly allowed for in Article 13 of the new Organic Regulation and production criteria for organic varieties are adapted taking into account the specific needs and constraints of organic production. The derogations may be phased out earlier than 2035 or extended based on a report due in 2025, which will examine the situation of plant reproductive material on the market.
Are mixed farms still allowed under the new Organic Regulation?
While the initial proposal of the Commission proposed to ban the production of organic products and conventional products at the same farm, mixed farms continue to exist under the new Organic Regulation. Mixed farms are allowed provided that the two production activities are effectively separated into clearly distinct production units. This means, among others, that inputs for production as well as the final products must be separated to avoid contamination and potential fraud. Also, the two production activities should involve different livestock species and plant varieties.
What measures must be taken to avoid contamination from non-authorized substances?
EU thresholds for conventional products automatically apply to organic ones too. Stricter thresholds for non-authorized substances in organic products are not introduced. This would include high costs, especially for small farmers, to control for example contamination from neighbouring conventional farming. Instead, food business operators are obliged to take precautionary measures to avoid contamination. The responsibility and accountability of organic producers will thus be emphasized. Final products are not allowed to bear the organic label when the contamination was deliberate or caused by irresponsible food business operators that failed to take precautionary measures. Meanwhile, Member States remain at liberty to set specified thresholds for non-authorized substances in organic products, provided that these national rules will not affect the trade of organic products that are legally placed on the market in other Member States. Based on a report due by the end of 2024, anti-contamination rules and national thresholds may be further harmonized in future.
How does the new Organic Regulation ensure the high quality of organic products?
Rather than moving all the control provisions into the regulation on official controls for food and feed, as initially proposed by the Commission, specific rules will apply to the control of organic farming. Organic production refers to the use of production methods that contribute to the protection of the environment, animal welfare, and rural development. Risk-based checks will therefore not be limited to final products but take place along the supply chain to guarantee that organic products are truly organic. Physical on-site checks will take place at least annually; the on-site check may be reduced to once every two years if the food business operator has been fully compliant for three years. In the Netherlands, those inspections are carried out by SKAL as the the designated Control Authority responsible for the inspection and certification of organic companies.
What does the new Organic Regulation mean for products imported into the EU?
Under the current Organic Regulation, organic products produced in third countries are allowed on the EU market when the organic standards of the exporting country are similar to EU rules. This means that organic products are in fact regulated by over 60 different standards. Under the new Organic Regulation, all imported products will have to comply with EU standards. Taking into account the date of application of the new Organic Regulation as well as the transitional period granted for imported products, this rule will only apply as from 2026. Moreover, certain exceptions are introduced to avoid disruptions of supply on the EU market. First of all, the Commission is empowered to grant specific authorization for the use of products and substances in organic production in third countries with specific climatic and local conditions, which therefore cannot comply with the new requirements. This exception also applies to organic production in the EU’s outermost regions, such as the Nordics. Secondly, equivalent production methods in third countries could be recognised under trade agreements.
The new Organic Regulation promises to further boost EU organic production. Measures to increase the supply of organic seeds and animals, allowing mixed farming, and no harmonized thresholds for non-authorized substances aim to attract more farmers into organic production. Meanwhile, measures are taken to increase consumers’ trust in organic products, such as through risk-based checks along the supply chain and the switch from the principle of equivalence to an EU single set of rules for imported products. We expect this to be a major improvement for the algae sector, that suffers unfair competition from Asian countries, where organic standards are not necessarily the same as in the EU.
It takes some more years to see to what extent the Regulation will live up to its promises. While the Regulation itself only becomes applicable from 2021, many rules are subject to further implementation depending on the development of the sector. This illustrates the dynamic character of the organic sector, which creates many opportunities for food business operators active in this field.