Many companies wonder what kind of environmental claim they can make for their product or packaging. Although there is no specific legal framework for this (yet), environmental claims fall under the general prohibition on misleading practices. Thanks to various developments at the European level, the legal framework for environmental claims is shaping up. Below is an update of the latest developments.
New guidance on the Unfair Commercial Practices Regulation
At the end of last year, the European Commission published an update of its guidance on the Unfair Commercial Practices Directive (“Revised Guidance”). The guidance provides amongst others an interpretation of the general prohibition on misleading practices in the aforementioned directive. Although the guidance has no legal status, it concerns an authoritative document. Judges and regulators such as the Netherlands Authority for Consumers and Markets (ACM) regularly refer to it. With regard to environmental claims, the Revised Guidance continues the line as set forth in its previous version from 2016. At certain points the text has been more detailed and more extensive examples are provided. However, the Revised Guidance also highlights a number of new points. The most striking additions are as follows.
Use of logos and labels
Environmental claims must be presented in a clear, specific, accurate and unambiguous manner. Simply placing a logo on a packaging will generally be insufficient to meet the above requirements since the average consumer cannot be expected to be familiar with the meaning thereof. This is not surprising considering that there are more than 100 sustainability logos in the EU. To prevent misleading practices, the Revised Guidance prescribes informing the consumer on the meaning of the logo, whether certification is done by a third party or not, and where further information can be found. These requirements are not absolutely new since they can also be found in the Guidelines sustainability claims issued by the ACM and the Code for Environmental Advertising by the Dutch self-regulatory organization of advertising (of which an update is expected this year). What is more is that the Revised Guidance sets forth additional requirements in case private instead of public quality marks are being used. The European Commission therefore seems to hint at a preference for public quality marks (e.g. EU Ecolabel, the Nordic Ecolabel ‘the Swan’ or the German ‘Blue Angel’) over private quality marks and to aim at a reduction of the total number of such marks. In this context, the ACM calls upon companies to use existing quality marks instead of developing their own.
Use asterisk for reference to additional information
It follows from the above that environmental claims (including logos) sometimes need further explanation to be well understood by the consumer. This is especially the case for general terms such as “sustainable” and “good for the environment”. A clarifying text should be placed as close as possible to the general claim, preferably right next to it. Another place may be chosen if there is no room for this, such as on the back of the packaging on which the claim is presented. An asterisk can be used to make the connection between the main claim and the additional information. A similar suggestion is made in the ACM Guidelines sustainability claims. The Revised Guidance states that when there is no room to specify the environmental claim, the claim should in principle be omitted.
Sharing information with competent authorities, but not with consumers
Environmental claims should be based on evidence that can be verified by the competent authorities. Authorities requesting such evidence are expected to take into account confidential information of the company making the environmental claim (such as certain input data for an LCA). The Revised Guidance emphasizes that the Unfair Commercial Practices Directive does not contain an obligation to provide such evidence to consumers (upon request). The ACM however takes a different position on this matter in its Guidelines sustainability claims, referring to the Guidelines for Making and Assessing Environmental Claims (2000) of the European Commission. The ACM advises placing evidence that substantiates the claim on a website and referring to it on (the packaging of) the product concerned. It also states that consumers should be provided with more information about the evidence concerned upon request. This raises the question how to deal with confidential information. A practical solution is to remove confidential information (provided this does not render the information concerned practically illegible), or to make a summary of the evidence for the claim available as a ‘consumer version’.
Completed public consultation on bio-plastics
Bio-plastics are a hot topic these days. These include ‘bio-based’, ‘biodegradable’ and ‘compostable’ plastics. Where bio-degradable plastics degrade and eventually dissolve due to changes in their chemical structure, the idea behind compostability is that a soil improver remains after the composting process. In contrast, bio-based plastics are plastics made from components derived from natural materials (as opposed to fossil-based materials). Bio-based plastics are not necessarily biodegradable or compostable. The EU is investigating the following policy areas with regard to bio-plastics.
Sustainability of natural materials vs. fossil resources
Plastics based on natural materials are often advertised as being more sustainable than fossil-based plastics. The question is, however, whether such natural materials offer real environmental benefits beyond a reduction in the use of fossil resources. To measure those benefits, the environmental impact of the full life cycle of such materials needs to be considered. This includes amongst other things the origin of the raw materials used. The use of arable land to grow natural materials for bio-plastics while this land could have been used for food is for example not necessarily ‘sustainable’.
Effective biodegradability and its role in a circular economy
As far as biodegradability is concerned, it is being investigated whether and how plastics with this property fit into a circular economy. After all, there is little ‘circular’ about products that ‘dissolve’ in nature; reuse and recycling may offer better alternatives. It may at the same time be useful for certain product groups if they break down under specific conditions. An example of this could be agricultural film, which is not always removed completely after harvest and which is not easy to recycle after use due to contamination with soil. Similar questions arise with regard to compostable plastics. At best they break down into water and CO2, and therefore cannot contribute to soil improvement. Biodegradation of so-called compostable plastics could however also be useful for certain product groups. Think for example of compostable coffee and tea bags, which create a co-benefit when their use results into more coffee and tea being disposed in the green bin and subsequently composted.
The prevention of misleading practices is also on the agenda. The European Commission recognizes that there is currently much confusion among consumers about bio-plastics. Stricter rules for the use of this and similar terms can prevent greenwashing. Moreover, it must be prevented that consumers interpret a biodegradability claim as a license to litter packaging with this characteristic.
From 18 January to 15 March 2022, a public consultation took place at European level concerning the policy framework currently being under construction. Publication of the policy framework is planned for this summer.
European policy framework PEF and OEF
Environmental footprint claims, just like other environmental claims, need to be supported by evidence. There is however no harmonized method for substantiating such claims. Having said that, EU standard methods for the ecological footprint of products (PEF) or organizations (OEF) do exist since 2013. These methods focus on the measurement of the environmental performance of a product or organization over its entire life cycle using 16 environmental impact categories, including climate change, ozone depletion and water use. The European Commission is currently exploring the possibilities of putting more emphasis on the use of the abovementioned methods for the substantiation of environmental claims. The outcome of this study was planned for the first quarter of this year, but is still pending.
There is even more happening in the field of sustainability in Brussels. On 30 March of this year, the European Commission adopted a proposal for a revised directive establishing rules for sustainable products (“Revised Ecodesign Directive”). Sustainable products will become the norm, with reusability, recyclability and energy efficiency being key concepts.
Food products are excluded from this European proposal on sustainable products. It is also unlikely that the Revised Ecodesign Directive will set specific rules for packaging materials meant for food contact. The rules to be established for packaging materials will namely be introduced via product-oriented requirements for products that do fall under the Revised Ecodesign Directive. This initiative nevertheless does mark a spot on the European sustainability horizon, which will also determine the direction for sustainability rules on packaging materials for foodstuffs.
Environmental claims are a topic of attention at national and European level. Food and food packaging businesses that make or wish to make environmental claims are therefore advised to keep an eye on current developments. Stay tuned!
How to strike the right balance between freedom of speech and preventing unfair advertising targeting the dairy industry? This is the object of a Q4 2021 decision of the Appeal Board of the Dutch Advertising Code Committee, consisting of an advertising campaign on bus shelters in the Netherlands and a website campaign. If you are interested to know how broad the scope of “advertising” is and how a rather aggressive campaign was evaluated, continue reading. This post will be limited to the bus shelter campaign only since that already demonstrates the operation of the applicable legal framework.
Bus shelter campaign attacking dairy industry
The bus shelter campaign showed several very explicit pictures demonstrating the misery life of young calves. Under the title “Do you need help quitting?” information was provided on the consequences of the dairy industry for these calves. The text on the various posters in the bus shelters stated the question “Do you need help quitting?”, followed by the following texts:
- Poster 1: “ “Dairy causes serious animal suffering. Calves are taken away from their mothers immediately after birth.”
- Poster 2: “Dairy is deadly. On a yearly basis, 1.5 million calves are slaughtered for dairy”.
- Poster 3: “Milk destroys more than you like. Calves are being fed artificial milk because the cow’s milk ended up in your cappuccino.”
The wording used above appeals to two well-known anti-smoking and anti-alcohol campaigns in the Netherlands, notably “quit smoking” and “alcohol destroys more than you like (your marriage for example).” The driver behind the anti-diary campaign is the Dutch organisation Animal & Law (“Dier & Recht”) that claims to be voice of the animals. This campaign was opposed by the Dutch dairy organization DairyNL (“ZuivelNL”), that aims to strengthen the Dutch dairy chain in a way that respects the environment and society. DairyNL considered this campaign misleading and therefore unfair.
Scope of the Dutch Advertising Code
The Netherlands knows a system of a self-regulation for advertising, embodied in the Dutch Advertising Code. Companies and other organisations can choose to submit to this system and the outcome (so-called recommendations) of cases based on complaints by whoever considers an advertisement misleading has a high degree of compliance (97 % in 2020). Animal & Law argued that their campaign was out of scope, as it did not envisage selling any products or services. Instead, it alleged to be a non-profit organisation that by public campaigns aims to improve the (legal) position of animals. Alternatively, it argued that if their campaign was captured by the scope of the Dutch Advertising Code, it would benefit from the principle of freedom of expression, as protected by the European Convention on Human Rights. Animal & Law overlooked however that the Dutch Advertising Code also captures ideas that are systematically recommended by an advertiser. The anti-dairy campaign by Animal & Law was found to meet this test. The Advertising Code Committee (“Reclame Code Commissie”) subsequently assessed for each bus shelter poster whether the information constituted misleading advertising.
Test for misleading advertising
The test applied is as follows: Advertising is unfair if it contravenes with standards of professional conduct and if it substantially disrupts or may disrupt the economic behaviour of the average consumer. One could consider this is exactly what Animal & Law was after and for a good cause. Under the Dutch Advertising Code however, aggressive advertising is at any rate considered unfair. Furthermore, all advertising containing incorrect or ambiguous information regarding specific aspects of the product at stake is considered misleading, if such information entices or may entice the average consumer to take a transaction decision (including refraining therefrom) that such consumer otherwise would not have made.
Just below the text “Do you need help quitting?” a milk carton is shown depicting a young calf being led away in a wheelbarrow followed by the text “Dairy causes serious animal suffering. Calves are taken away from their mothers immediately after birth.” All of this is depicted within a black framework, just like the health warning on a box of cigarettes. DairyNL argued, amongst other things, that according to the Netherlands Nutrition Centre, the consumption of dairy fits into a healthy diet, whereas the reference to quitting creates the impression dairy is very bad for human health. During the hearing, Animal & Law acknowledged that it is incorrect to state in general that dairy is not healthy. The Advertising Code Committee therefore considered the information re the quitting provided on poster 1 to be ambiguous and thus misleading. This results in unfair advertising.
This poster shows the same setting as poster 1, namely a milk carton depicting an earmarked calf surrounded by a black framework. According to DairyNL, in this context the text “Dairy is deadly. On a yearly basis, 1.5 million calves are slaughtered for dairy” can only be understood as a health warning. Furthermore, the absolute claim on the number of slaughtered calves creates the impression that this slaughter can only be attributed to the dairy industry, whereas it also serves meat production. Animal & Law had responded that calves are merely a by-product of dairy. It had used the warning that “dairy is deadly” to awaken the conscience of consumer. Obviously, the consumer understands the calf is going to die, not the consumer. The Advertising Code Committee considered this warning to be misleading, for the same reason as mentioned above. This part of the advertising was therefore considered unfair. The complaint regarding the slaughter was strikingly not addressed. I deduce therefrom that at any rate it was not concurred with.
On this poster, a calf is shown behind the bars of its small cage. DairyNL argued the setting of this poster (identical as described above) and the text “Milk destroys more than you like” links milk to two health hazard products, i.e. cigarettes and alcohol. DairyNL also argued that the claim “Calves are being fed artificial milk because the cow’s milk ended up in your cappuccino” creates the impression calves only drink artificial milk. Animal & Law refuted this complaint by explaining the claim does not state that calves only drink artificial milk. Animal & Law did not deny calves are being fed colostrum right after birth. However, this only takes 2 days, whereas the natural weaning period of calves amounts to 6 – 12 months. Here the Advertising Code Committee did not consider DairyNL’s claim founded, as DairyNL did not dispute that after a few days, the calves are being fed artificial milk instead of cow’s milk.
So what is the result of all this and what can we learn from this advertising decision? If the campaign of Animal & Law was mainly after shock and awe, it certainly succeeded. The pictures of the calves shown in the context of health warnings for cigarettes did not miss their effect. Potentially, a number of consumers became aware of certain facts it did not realise before. But will these consumers say a definite no to dairy? That’s the question, as the campaign may also have a counterproductive effect. Personally, I expect the chances of a seductive dairy alternative much higher for inducing consumers to eat no more (or just less) dairy. The learning from this decision is that even if the freedom of expression is a major public good, it also has its limits. No purpose justifies providing incorrect or ambiguous information. This learning applies equally to those outlining the pro’s of dairy alternatives, but certainly also to those emphasizing the con’s of dairy.
Food packaging materials (and other products) are more and more often advertised as environmentally friendly, compostable, recyclable, or otherwise sustainable. In general, this is a positive development: it helps consumers to make (more) sustainable choices. But there is also a danger lurking, namely greenwashing. Greenwashing occurs when a product (including packaging) is being advertised as more sustainable than it actually is. In such cases, the consumer is not helped by the information conveyed and in fact the opposite is true: the consumer is misled. This blogpost explains what environmental claims are, the applicable legal framework, and, most importantly, how to prevent greenwashing.
Definition of environmental claims
There is no legal definition of environmental claims. However, the term is described in the European Commission guidance on unfair commercial practices legislation and by Dutch self-regulation. In short, environmental claims refer to the practice of suggesting in commercial communications that a product or service has a positive or no impact on the environment or causes less damage to the environment than other products or services (for example by text, images or the use of color). The Dutch Code for Environmental Advertising clarifies that environmental claims may concern the entire life cycle of a product, from production to waste processing.
Environmental claims, also known as ‘green claims’, are not the same as sustainability claims. Both the Dutch Advertising Code Committee (in Dutch: Reclame Code Commissie, or ‘RCC’) and the Netherlands Authority for Consumers and Markets (in Dutch: Autoriteit Consument & Markt, or ‘ACM’) specified that ‘sustainability claim’ is an umbrella term including claims referring to environmental aspects, animal welfare and/or labor conditions.
Since there is no legal definition of environmental claims, it comes as no surprise that there is no specific legal framework either. At least not yet, because the regulation of environmental claims is a topic of debate under the European Green Deal. Having said that, at present companies making environmental claims are free to decide how to substantiate such claim. As a result of this, environmental claims are not comparable, more difficult to verify and not always reliable.
The fact that there is no specific legal framework does however not mean that no rules apply to environmental claims. Such claims must namely comply with general rules, guidelines and self-regulation on misleading advertisements. This includes first and foremost the Dutch Unfair Commercial Practices Act (in Dutch: Wet oneerlijke handelspraktijken), which prohibits misleading advertisements and which is supervised by the ACM. What the Dutch Unfair Commercial Practices Act means for environmental claims is explained in the above-mentioned guidelines of the European Commission. Furthermore, the ACM launched the Guidelines Sustainability Claims early this year, which document provides general tools to make clear, correct and relevant sustainability claims (and so environmental claims). With regard to food packaging materials in particular, the EU Framework Regulation on Food Contact Materials states that the labeling, advertising and presentation of a material or article must not mislead the consumer. Last but not least, there are several ISO standards that help meet the legal requirements for environmental claims. For example, ISO 14021:2016 contains requirements for so-called self-declared environmental claims, which are made without independent third-party certification. Based on this ISO standard, the European Commission developed a guideline to help formulating environmental claims and evaluating existing environmental claims.
The 7 sins of greenwashing
Environmental claims, unlike for example health claims for foods, are not part of a closed system with an exhaustive list of claims that can be made. On the one hand, this means that advertisers have more room to make such claims. At the same time, it means that there is more ambiguity about what is and is not allowed. The key question “What may and may not be claimed?” requires an individual assessment. What is clear, however, is that the following seven sins of greenwashing are absolute no-gos.
- Hidden trade-offs
Describing the product as ‘sustainable’ or ‘environmentally friendly’ on the basis of only a limited number of properties without considering the environmental impact of the total life cycle of the product. For example, if a new production process saves water while it increases the total footprint of the product in question, then a claim on the water saving is not justified.
- No evidence
Making environmental claims without providing easily accessible evidence that supports the claim. If a package is for instance being advertised as ‘CO2 neutral’, inform the consumer where the outcome of the underlying life cycle assessment (LCA) and/or other relevant test reports are explained in a way that is understandable to the consumer (e.g. on your company’s website).
Using terms that are too broad and/or too general to understand the correct meaning thereof. The more general a claim is, the higher the burden of proof is to substantiate the claim. Make environmental claims therefore as specific as possible.
- Use of false labels
Using designations and symbols that falsely give the impression that the claim has been externally verified. It is therefore preferred to make use of an existing quality mark rather than inventing your own designation or symbol. This also helps the consumer not to get lost in the jungle of quality marks.
- Irrelevant claims
Claiming something about the product that is technically true, but which is not important when looking at distinctions in terms of environmental performance. For example, glass is factually speaking BPA-free, but such a claim would be misleading since this substance never occurs in glass.
- Smaller evil
Claiming to be more sustainable than other products within the same category, while the sustainability of these types of products in general is in question. Consider, for example, an environmental claim on cigarette packaging. This is not done.
Claiming something about the product while it is not (entirely) true. Is the packaging for example recyclable or compostable? Substantiate this claim with a validated test before communicating this to the consumer.
Companies wishing to make environmental claims on food packaging materials (or other products or services) are advised to take into account the following tips. First, put yourself in the shoes of the consumer. Can there be confusion about the environmental benefit being claimed? If so, adjust the claim accordingly. Secondly, be honest. Make sure the environmental claim does not give the impression that the packaging is more sustainable than it actually is. Finally, support your claim with evidence. This could be done by having the packaging material and its environmental impact independently assessed. The results of such assessment should subsequently be expressed on the packaging in a way that the consumer can understand, or, if there is no room for this, on a website. In the latter case, don’t forget to make a reference to that website on the packaging!
A Dutch version of this blogpost has been published at VMT.
Over the last ten years, the trend of clean labelling in consumer food products has gained ever more ground. Clean labelling consists of replacing E numbers such as citric acid (E 330) and beetroot (E 162) by their natural counterparts, such as plant extracts. There is nothing wrong with E numbers per se. The use thereof is subject to specific purity criteria and their safety has been evaluated and approved. Consumers however tend to less appreciate E numbers as not being ‘natural’. This is not an unambiguous notion, as shown by this blogpost. Designing food products based on these consumer preferences can however become a tricky business, which was shown by a letter of the Dutch Ministry of Health, Welfare and Sport of 16 June this year as sent to the Dutch food industry associations. Even if this letter dates back to this Summer, it recently gained again traction on social media. We therefore consider it helpful to highlight the strict measures announced therein.
Fact-finding mission FVO in 2015
Some background information may be useful. In 2015, the Dutch Food Safety Authority NVWA received a visit from the Food and Veterinary office of the European Commission in the framework of a fact-finding mission. During this visit, non-authorised use of food additives in meat preparations was established that had not been detected by the Dutch authorities during official controls. After this visit, the NVWA announced the Action program on EU Food Additives (see paragraph 1.2 of this recent decision of the highest Dutch administrative law Appeal Court for further context). The Dutch Food Safety authority was thus confronted with its lack of oversight, which it clearly wanted to compensate.
NVWA published Additives Handbook in 2019
In June 2019, the NVWA published its Additives Handbook, which was updated in September 2020. The Additives Handbook also contains a chapter on clean labelling. In this chapter it is stated that the use of plant extracts in consumer food products, that are merely applied for their technological function, should be regarded as unauthorized use of additives. An example is beetroot extract containing high levels of nitrate that can be converted into nitrite for use in meat preparations. The converted nitrite is identical to the additive nitrite, except that it does not necessarily meet the additives purity criteria. The PAFF Committee also considers that such cases represent targeted use of food additives, because the plant extracts at stake are merely used for their technological function, such as preservative, antioxidant or colorant. This use of plant extracts should therefore meet all applicable criteria to food additives, including being authorized as such. To easily verify which additives can be used in which foods and under which conditions, the NVWA also recently launched an interactive tool on its website.
Health Ministry’s letter of 6 June 2021
This Summer’s letter of the Dutch Ministry of Health, Welfare and Sport (in consultation with the NVWA) is even more concrete. It announces active enforcement regarding the unauthorised use of additives, as set out above, which it also considers as misleading information for consumers. As an additional example, the letter also states the use of microcultures, that are mainly used because of their preservative function. Enforcement measures can be avoided when four cumulative conditions have been met:
- an application for the clean label ingredient at stake as an authorised additive has been filed to the European Commission, who has confirmed the application is complete;
- the application was done before 1 January 2022;
- the clean label ingredient at stake has been used in food products since 16 June 2021 or before;
- the declaration of the clean label ingredient at stake includes its technological function.
Consequences of the Health Ministry’s letter
The letter of the Dutch Ministry of Health, Welfare and Sport in fact introduces a (very short) transition regime for food business operators using plant extracts and other ‘clean label ingredients’ mainly for their technological function in food products sold to consumers. These companies have two options. The first one is to make the investment for an application regarding an authorised additive in due course and revising their product labels as set out above (i.e. specification of the technical function of the clean label ingredient). This is for sure a costly and lengthy option, so it may be worthwhile to make such application on an industry level, as authorisations are generic. This is however only a viable option when the clean label ingredient was already used in food products for its technological function on or prior to 16 June of this year. The second option is to reformulate their product by using the ‘conventional’ additives and mentioning the appropriate E numbers on their product labels. In case neither option is retained, it follows from the NVWA’s food information intervention policy that a written warning can be triggered, followed up by a fine if the warning does not result in compliance. If and when any such warning is received, it should of course be meticulously studied if the correct legal basis was cited and if indeed a warning logically follows therefrom. If not, an administrative complaint before the NVWA can be lodged in first instance and an administrative appeal in second instance. We expect to see a lot of these in the near future if clean label enforcement will be as tight as announced in the letter of 16 June of this year.
On 7 October 2021, Food Valley NL published its personalised nutrition position paper. With no less than 53 stakeholders, this paper was written to create a business definition of ‘personalised nutrition’ and to give insights into profitable business models. Axon Lawyers, together with Alie de Boer and Sabrina Röttger-Wirtz from Maastricht University, contributed to this paper a chapter summarizing the three main legal challenges related to personalised nutrition: (1) processing of personalised data, (2) the borderline between certain regulated products and (3) nutrition and health claims. Alie de Boer and Sabrina Röttger-Wirtz wrote earlier about the applicable legal framework to personalised nutrition (see here). In this blogpost, we present an extended version of our contribution to the Food Valley personalised nutrition position paper.
Processing of personal data
The essence of personalised nutrition is that it targets individuals, including their phenotypic and/or genotype information, their specific lifestyle and/or their dietary requirements. In order to do so, any supplier of personalised nutrition will have to process personal data, more in particular data concerning health. Under EU standards, personal data is defined as any information related to an identified or an identifiable person (art. 4.1 General Data Protection Regulation, or “GDPR”). While anonymised data does not fall under this definition, the bar for considering data to be anonymised is set very high. Health data are data relating to the physical or mental health of a person, including the provision of health care services, revealing information about his or her health status (art. 4.15 GDPR). Genetic data may also be relevant in the context of personalised nutrition, which are data relating to the inherited or acquired genetic characteristics of a person which give unique information about the physiology or the health of that person (art. 4.13 GDPR). For clarity, the “processing” of personal data includes but is not limited to each of the following actions with respect to such data: collection / storage / structuring / adaptation / consultation / transmission / destruction (art. 4.2 GDPR).
For any supplier of personalised nutrition products and/or solutions, it is of the essence to only process personal data based on a valid legal basis, such as consent (art. 6 GDPR). “Consent” is defined as any freely given, specific, informed and unambiguous indication of a data subject’s agreement with the processing of his/her personal data based on a statement or clear affirmative action (art. 4.11 GDPR). The use of consent as a legal basis for the processing of personal data is further detailed in Guidelines 05/2020 by the European Data Protection Board.
Even in case of a valid legal basis, the processing of health, genetic and other sensitive data remains however prohibited unless specific conditions have been met (article 9 GDPR). This is for instance the case when the data subject has given its specific consent for processing for a specific purpose (art. 9.2 (a) GDPR), or when processing is necessary for scientific purposes (art. 9.2 (j) GDPR).
Suppliers of personalised nutrition products and / or solutions should be able to demonstrate with respect to the personal data of each individual they are processing that the conditions of article 6 and 9 GDPR have been met. This could be done for example by documentation of written consent forms. Other grounds for processing than consent as provided for in article 6 and 9 GDPR may be used as well, although this is not very obvious in a commercial context.
By definition, any product that is intended for human consumption or which can be expected to be ingested – whether it is processed or not – is considered to be a food product. Due to the effects that products have or due to the nature of presenting their effects, it can become unclear how a particular product should be classified, i.e. whether it falls under the definition of a medicinal product, a medical device, or under other sectorial legislation. In the case of these ‘borderline products’, the decision on a product’s classification must be taken on a case-by-case basis. In the case of personalised nutrition products, the way in which their effect on health is communicated (for example through claims, further described in paragraph iii) is decisive for the qualification of the product being offered. For example, such a product could qualify as a medicinal product either by way of presentation or by function. A medicinal product is understood to be any substance or combination of substances presented for treating or preventing a disease in human beings (art. 1.2 Medicinal Products Directive). A product qualifies as a medicinal product by presentation if consumers are entitled to expect it to have a medicinal effect (even without a genuine therapeutic or medicinal effect – see Van Bennekom case (1983) of the European Court of Justice (“ECJ”)). A product is a medicinal product by function if it is capable of exerting a pharmacological action (see ECJ Hecht-Pharma case (2009)). Thus, food products that are customised to the nutritional needs of a specific individual and are claimed to treat, cure or alleviate the symptoms of a disease may be classified as medicinal products rather than as foods.
Personalised nutrition products or solutions, or certain components thereof, could also qualify as a medical device (e.g. a personalised nutrition app) or an in vitro medical device (e.g. a genetic testing kit). Unlike medicinal products that tend to improve physical functions by creating a pharmacologic, immunologic or a metabolic effect, medical devices do not achieve their principal intended action by these means (but they may be assisted in their function by such means). Medical devices are any device, software or other article intended by the manufacturer to be used for specific medical purposes, such as the diagnosis, prevention, monitoring or treatment of a disease (art. 2 Medical Devices Regulation or “MDR”).
The essential question for the MDR’s applicability is therefore whether the product concerned has a medical purpose or is merely lifestyle or well-being related. For example, an app that provides dietary advice even when based on potential health data is a lifestyle product, but transforms into a medical device where it claims to help address or treat a medical condition like obesity or hypertension. While the intention of the manufacturer of the device is leading for the application of the MDR, it should be noted that only a statement from the manufacturer that a product is not a medical device, or is meant for lifestyle purposes only, is insufficient to escape from this regulation. The intended purpose is inferred from every document and statement that expresses the intended purpose, including advertising and marketing material. See also our earlier blogpost on personalised nutrition as a medical device.
How a personalised nutrition product or solution is qualified determines the applicable regulatory framework and significantly changes the legal requirements. Entrepreneurs should be open to a thorough product qualification analysis before market entry. This does not per se hinder the development of personalised nutrition, but unawareness of the regulatory borderlines can be a pitfall.
Nutrition & health claims
Even if personalised nutrition qualifies as a food product as opposed to medicinal product or medical device, this does not mean that just any health benefit can be claimed on such a product. In fact, there is a pretty strict legal framework that applies here, not only to mandatory food information, but also to voluntary food information. As to the latter, we refer to the framework on health & nutrition claims.
Any statement that describes, suggests or implies that a food product either has certain beneficial nutritional characteristics (nutrition claim) or that its consumption will result in certain health benefits (health claim) is regulated within the EU (Regulation (EC) No 1924/2006). Only pre-authorised claims which are considered substantiated by scientific evidence, based on an assessment by the European Food Safety Authority (EFSA), can be used on foods. Health claims can exclusively be used to address health benefits of foods, and no suggestions or implications can be made that consuming a food may result in treating, curing or alleviating symptoms of a disease (Regulation (EC) No 1924/2006). Only when health benefits are supported by pre-authorised claims and the product meets the conditions of use for this claim, health benefits of personalised nutrition products can be put forward. At the same time, food business operators may consider submitting authorisation requests for new health claims on personalised nutrition products. Currently, it is however uncertain whether referring to genetic predispositions in claims would be considered making a medicinal claim or a health claim (Ballke & Meisterernst, 2014; Röttger-Wirtz & de Boer, 2021). Also, it is unknown whether health claims, currently mainly targeting the general population, could be directed to specific target groups who would benefit from these personalised or tailored products (Röttger-Wirtz & de Boer, 2021).
Overall, personalised nutrition is subject to extensive regulation under existing EU legislation. In a birds-eye view of legal frameworks applicable globally, data protection, product qualification and the regulation of voluntary food information comprise similar concepts although the detailed rules differ. For example, globally, health claims are allowed to be used in different jurisdictions. Whereas pre-market authorisation is required – in different forms – in some jurisdictions including the EU as well as Australia/New Zealand, this is not necessarily the case for other jurisdictions such as Japan and the United States of America (de Boer & Bast, 2015; Dominguez Diaz et al, 2020). Awareness of the different regulatory frameworks is key before market entry.
Authors: Karin Verzijden, Jasmin Buijs, Alie de Boer & Sabrina Röttger-Wirtz
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- European Data Protection Board (2020), Guidelines 05/2020 on consent under Regulation 2016/679.
- JM Ordovas, LR Ferguson, ES Tai, JC Mathers (2018). Personalised nutrition and health. BMJ 2018; 361:bmj.k2173.
- S Röttger-Wirtz, A de Boer (2021). Personalised Nutrition: the EU’s fragmented legal landscape and the overlooked implications of EU food law. European Journal of Risk Regulation 12(1), 212-235.
Last month, the European Single Use Plastics (SUP) Directive came into force. The purpose of this Directive is to reduce plastic litter, especially in the sea. Think for example of styrofoam hamburger trays or disposable plastic salad boxes for a meal on the go. The SUP Directive is part of the European action plan towards a circular economy (part of the Green Deal), to which re-use and recycling of products is central. The SUP Directive includes a phased introduction of various measures, with the goal of all plastic packaging being reusable or easily recyclable by 2030.
Scope SUP Directive
The SUP Directive primarily covers single-use plastic products. This includes packaging and other products that are partially made of plastic, such as cardboard boxes with a plastic coating. Plastics are materials consisting of a polymer, to which additives may have been added. Natural polymers that occur naturally in the environment are excluded from the definition of ‘plastic’. Bio-based and biodegradable plastics (based on natural polymers that have been chemically modified) are instead covered under the Directive. Single-use refers to the situation in which the product is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-sued for the same purpose for which it was conceived. What exactly constitutes a single-use plastic product is further clarified in a guideline issued by the European Commission. Among other things, the composition and potential washability and repairability of the product play a role in this.
In addition to single-use plastic products, the SUP Directive also pays attention to products made of oxo-degradable plastics and fishing gear. Fishing gear is namely responsible for a large percentage of the plastics in marine litter. Oxo-degradable plastics are addressed by the Directive because these plastics have a negative impact on the environment and do not fit within a circular economy. This is because oxo-degradable plastics fragment into tiny particles, which then disappear in the environment.
Restrictions on placing on the market
Since 3 July 2021, the date of application of the SUP Directive, it has been prohibited to market products made of oxo-degradable plastics and the plastic products listed in Part B of the Annex to the SUP Directive. This includes plates, beverage stirrers, certain food containers as well as cups and containers for beverages made of expanded polystyrene (a type of styrofoam), sticks to be attached to and to support balloons, including the mechanisms of such sticks (unless for professional applications) and cotton bud sticks and straws (unless they qualify as medical devices).
The trade ban applies to the above-mentioned packaging and other plastic products placed on the market from 3 July 2021. The term ‘placing on the market’ refers to a product being supplied for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge, for the first time. Plastic products that have already become part of the supply chain in a given Member State before the trade ban entered into force, for example because a food business operator purchased such from its supplier prior to the aforementioned date, may therefore continue to be used in that Member State even after the trade ban has become applicable. However, the foregoing does not apply to products that were placed on the market in a certain Member State before 3 July 2021, and that are further distributed in another Member State after that date (in the context of a commercial activity). Thus, if a Dutch food company has in stock food packaging covered by the trade ban that it purchased from its supplier prior to 3 July 2021, it can continue using this packaging for food products to be marketed in the Netherlands. However, the Dutch food company can no longer use this packaging for its food products destined for the Spanish market. Although this seems to go against the internal market principles of the EU, the SUP Directive explicitly refers to placing on the market of a Member State (and not on the EU market).
Disposal instructions for beverage cups
Conspicuous, clearly legible and indelible marking on plastic products should, since 3 July 2021, ensure that consumers are aware of how to dispose of these and are aware of the negative impact of littering or other improper means of waste disposal on the environment. The European Commission has established marking specifications for this purpose. These markings may be affixed by means of stickers in case of products placed on the market before 4 July 2022. Thereafter, the markings must be printed on the product itself, or on its packaging. The text of the marking must be in the official language(s) of the Member State(s) where the product is marketed. Where the product is marketed in several Member States, it will usually be necessary to include the text of the markings in several languages. Based on Part D of the Annex to the SUP Directive, the above marking requirements apply to beverage cups and several non-food related plastic products.
Other litter-reducing measures
The SUP Directive includes many other rules, such as that caps and lids must remain attached to plastic beverage containers during their entire intended use stage (as of 3 July 2024). In addition, beverage bottles must contain at least 25% recycled plastic from 2025, and at least 30% recycled plastic from 2030. However, the above measures only apply to beverage containers and bottles of up to 3 liters. Furthermore, glass and metal beverage bottles with caps and lids made from plastic are exempt from the above rules, as well as such beverage bottles for food for special medical purposes.
In addition, the SUP Directive calls on Member States to take awareness raising measures to prevent and reduce litter, to ensure the separate collection for recycling, to take the necessary measures to achieve consumption reduction, and to establish extended producer responsibility schemes. The latter means, in short, that ‘the polluter pays’ and that the producer or importer thus pays the cost of cleaning up litter. The Annex to the SUP Directive indicates the plastic products to which the above measures apply.
Measures differ between Member States
Although the SUP Directive was adopted at European level, this does not mean that measures to prevent litter and stimulate a circular economy will be the same in all Member States. To achieve reduction in the consumption of single-use plastics, a Member State may for instance set national targets, take measures to ensure that re-usable alternatives are made available at the point of sale to the final consumer, or ensure that single-use plastic food and beverage containers are no longer provided free of charge to the final consumer. Next to the above-mentioned examples, there are many other possibilities that Member States may exploit.
In the Netherlands, the SUP Directive is implemented in the Single-use Plastic Products Decree (in Dutch: Besluit kunststofproducten voor eenmalig gebruik) and in the Packaging Management Decree 2014 (in Dutch: Besluit beheer verpakkingen 2014). To achieve reduction in the consumption of single-use plastics, the Netherlands is keeping open the possibility of no longer providing food packaging and beverage cups (as defined in article 15d of the Packaging Management Decree 2014) free of charge to the final consumer, having available a re-usable alternative to the final consumer at the point of sale and/or prohibiting the provision of the above-mentioned products to the final consumer at certain locations or occasions. Such measures will apply as per 1 January 2023.
Companies operating in several Member States would do well to become familiar with the national measures relevant to them. For plastic products listed in Part E of the Annex to the SUP Directive (including certain single-use food and beverage containers), the Directive even explicitly requires producers that sell such products in a Member State other than where they are established to appoint an authorized representative in the Member State of sale. The authorized representative is responsible for ensuring that the producer’s obligations in the Member State of sale are met.
Although the SUP Directive appears to be a set of restrictions, it is also meant to encourage the production and use of sustainable alternatives to single-use plastic products. For example, food companies that depend on packaging for the shelf life and quality of their products, or to convey information to consumers, may want to explore their options to switch to reusable packaging, to set up collection and recycling systems, or to use other materials such as paper and cardboard (without plastic coating). Of course, such sustainable initiatives should not come at the expense of food hygiene and food safety.
Plastic products are increasingly being restricted to protect the environment and human health. Food companies using packaging consisting wholly or partly of plastic are advised to check whether the packaging they use is covered by the SUP Directive, what measures apply to it and whether alternatives are available. It should also be borne in mind here that measures under the SUP Directive are introduced gradually and may differ per EU Member State. For entrepreneurs who operate intra-Community, the correct implementation of the new rules will require the necessary efforts. But who does not want to move towards a more liveable world and a sustainable production chain? The reduction of plastic could make a valuable contribution to that purpose.
From May 26 this year, the personalized nutrition space has been enriched with a new piece of legislation: the Regulation (EU) 2017/745 on medical devices (hereinafter: “MDR”). The MDR is, generally speaking, applicable to all personalized nutrition (software) products, including apps and algorithms, with a medical intended purpose. Since most personal nutrition services that are currently on the market are lifestyle related, they will not be affected by the MDR. This will however be different for services that offer dietary advice for the prevention, alleviation or treatment of a disease. This blogpost aims to provide an introduction to the new rules on personalized nutrition as a medical device.
What is the MDR?
The MDR comprises of a set of rules that governs the full medical devices supply chain from manufacturer to end user in order to ensure the safety and performance of medical devices. It applies to any apparatus, application, software or other article intended by the manufacturer to be used for a medical purpose. This includes, like under the old medical devices legislation, the diagnosis, prevention, monitoring, treatment or alleviation of a disease. Since the application of the MDR, also devices designed for the prediction or prognosis of a disease qualify as a medical device. Genetic testing kits for medical purposes and other medical devices to be used in vitro for the examination of specimens such as blood are covered by the MDR’s sister, Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (hereinafter: “IVDR”). The IVDR applies from May 26 next year.
When does the MDR apply to personalized nutrition software?
The essential question for the MDR’s applicability is thus whether the article or software concerned has a medical purpose or is merely lifestyle or well-being related. For example, an app that provides dietary advice based on the users’ preferences and potential health data is a lifestyle product. But if the same app claims to help address obesity or treat hypertension, then it can be linked to a disease and transforms into a medical device. While the intention of the manufacturer of the device is leading for the application of the MDR, it should be noted that only a statement that a product is not a medical device, or is meant for lifestyle purposes only, does not constitute a reason to escape from this regulation. The intended purpose is inferred from every document and statement that expresses the intended purpose, including advertising and marketing material. Disclaiming a medical intended purpose in the instructions for use but claiming such purpose in marketing materials will still result in a finding of a medical intended purpose. The MDR contains an explicit prohibition on statements that may mislead the end user about the intended purpose or ascribes functions or properties to the device that it does not have, which would be caught in its scope.
Another example of a medical device is the wearable being developed by the Australian start-up Nutromics, which assesses dietary biomarkers to provide dietary advice to minimize users’ risk for lifestyle-related chronic diseases. This device is designed to predict the user’s likelihood of developing a particular disease and to subsequently provide advice to prevent such disease, and will therefore be subject to the MDR when placed on the Union market. On the other hand and as clarified earlier by the European Commission in its borderline manual for medical devices, a home-kit that enables the user to ascertain their blood group in order to determine whether a specific diet should be followed falls outside the medical sphere (as defined in the (old) medical devices legislation). The sidenote should however be made that this decision was not related to following a specific diet for medical purposes.
It is also relevant to state that software may as well qualify partly as a medical device and partly as a non-medical device. Think for example of an app that provides the user with personalized nutritional advice as part of the treatment or alleviation of diabetes, and additionally facilitates online contact with fellow patients. While the software module(s) that provide information on the treatment or alleviation of the disease will be subject to the MDR, the software module that is responsible for the contact amongst patients has no medical purpose and will therefore not be subject to the MDR. The manufacturer of the device is responsible for identifying the boundaries and the interfaces of the medical device and non-medical device modules contained in the software. The Medical Device Coordination Group has pointed out in its guidance on qualification and classification of software (October 2019) that if the medical device modules are intended for use in combination with other modules of the software, the whole combination must be safe and must not impair the specified performances of the modules which are subject to the MDR. This means that also the non-medical devices module(s) may have to be covered in the technical documentation that supports the device’s compliance with the MDR and as further introduced below.
Way to market of personal nutrition software
All medical devices placed on the Union market must in principle have a CE (conformité européenne) marking as proof of compliance with the law. To apply the CE-mark, the manufacturer has to prepare technical documentation and carry out a conformity assessment procedure, including clinical evaluation. The specific procedure that must be followed depends on the risk class of the device. The MDR distinguishes the risk classes I, IIa, IIb and III (from low to high). The higher the risk class of the device, the more stringent requirements for clinical evaluation apply to demonstrate safety, performance and clinical benefits. It could ironically be stated that MDR stands for More Data Required: where an analysis of available clinical data from literature may have been sufficient in the past, the MDR more often requires own clinical investigations to support the device’s safety and performance.
Under the MDR, software as medical device is classified as class IIa when it is intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, or to monitor physiological processes. Translated to personal nutrition services, this would for instance include apps that track burned calories (monitoring of physiological processes) and that provide dietary advice as part of a treatment (therapeutic purposes). Risk increasing factors will however lead to a higher risk class than class IIa. While an app with which food products’ barcodes can be scanned to detect certain ingredients for allergen control purposes would normally be a class IIa device, it will be a class III device when food intake decisions based on the app may cause life-threatening allergic reactions when based on a false negative (safe to eat while it in fact is not safe).
All other software which is not specifically addressed but still has a medical intended purpose in scope of the definition of a medical device, is classed as class I. An example would be an app that provides nutritional support with a view to conception. The risk classification rules for software are new under the MDR, which means that existing medical devices software may be scaled in a higher risk class since 26 May 2021. This is relevant not only with regard to the conformity assessment procedure that must be followed, but also to the question who can perform the required assessment of legal compliance. Manufacturers of devices in a higher class than class I must always engage a so-called notified body in this regard, while class I devices can in principle be self-certified by the manufacturer. An exception exists however for class I devices that have a measurement function, for example by using the lidar of the user’s phone to measure the body as input for the functionality of the app, which also require the engagement of a notified body.
Take away for food businesses
When personal nutrition enters into the medical sphere, the MDR will come into play. This will impact first and foremost the manufacturers, importers and distributors of actual medical devices, including apps and algorithms. Having said that, food businesses that wish to market their food products through medical devices apps are advised to be aware of the implications thereof. This will help them to find a reliable partner and to ensure their interests are contractually protected.
A more elaborate version of this blogpost has been published at Qina in cooperation with Mariette Abrahams.
Cultured meat is making its way to the market globally. Recently, we saw this movie from Super Meat, serving cultured meat in a restaurant where in the same time cultured meat was actually being cultured. Earlier, tasting sessions by Aleph Farms of its cell-based steak were shared via social media. And at the end of last year, it was reported that Eat Just had gained regulatory approval to market its cultured chicken in Singapore. This made me (and I guess many others!) wonder how the regulatory approval process is set up in the Lion City. Last week, I had an interview with the Singapore Food Agency (SFA), the outcome of which I report in this blogpost. I also compare the information received to the regulatory system for authorisation of cultured meat in place in the EU.
Which foods are considered Novel Foods in Singapore?
Before putting in place its Novel Foods regulatory framework in 2019, the SFA took inspiration from similar legislation applicable in other parts of the world, amongst others in the EU. This clearly transpires from the definition of a Novel Food. The SFA considers Novel Foods to be foods that do not have a history of safe use. This is the case if substances have not been consumed as an ongoing part of the (human) diet by a significant human population during at least 20 years. This definition is pretty similar to the one used in the EU, except that the EU definition uses (i) 15 May 1997 as a fixed point in time cut-off date and (ii) a closed-loop system of 10 Novel Food categories. In Singapore, just like in other places of the world, it goes without saying that cultured meat (“meat developed from animal cell culture”) requires prior market authorisation. Whereas in the EU this could also take place (depending on the production process applied) on the basis of a GMO authorisation, my understanding is that in Singapore the designated route is a Novel Food authorisation. In the EU, a distinction is made between foods containing GMOs and foods produced from GMOs on the one hand and food produced with GMOs on the other. Whereas the first two categories require GMO clearance, the third one does not.
Organisation Singapore Food Agency
Contrary to the EU, where EFSA operates as an external advisory body to the European Commission the National Centre for Food Science (NCFS) forms an integral part of the SFA. The NCFS consists of food inspection services and laboratory testing services and a representative thereof also took part in the interview. This setup and Singapore’s 5.7 million inhabitants (compared to over 445 million in the EU) potentially explains the shorter timelines during the regulatory approval process, as outlined below.
Regulatory Approval Process
The SFA acknowledges the science for producing cultured meat is still in an early stage. So far, it has set up a modest framework defining the Requirements for the Safety Assessment of Novel Foods. It however explicitly states the information required may change based on the developments on the science of producing cultured meat. The data required for evaluating the safety of Novel Foods largely correspond to the data required under the EU regulatory framework. They include information on the identity and the manufacturing process applied, as well as on the intended use and proposed levels of use. Toxicity studies (both in-vitro and in-vivo) and metabolism or toxicokinetic studies are requested “where relevant”. For cultured meat specifically, they include information on the cell lines, culture media and scaffolding materials used. Finally, any safety assessment reports conducted by the food safety authorities of Australia, Canada, New Zealand, Japan, the EU and the USA are considered relevant. For the EU, the SFA Guidance states that safety assessments conducted in accordance with the ESFA Guidance for submission of food additive evaluations would be accepted for review. This guidance is referred to in the EFSA Guidance for novel food applications in the context of toxicity testing and propagates a tiered approach for the type of safety parameters to be satisfied. This means that if no risk indicators are revealed in the studies performed in the first tier, no studies from the second or third tier need to be carried out.
The estimated timeline to complete an evaluation of a Novel Food in Singapore is said to be 3 – 6 months. During the interview however, SFA staff indicated this to be “slightly optimistic”. For the time being, the SFA has not yet put down any requirements regarding procedural aspects of a Novel Food application; this is still in the works. What struck me most during the interview is the informal and cooperative approach of the SFA. They seem to offer their assistance as a service rather than that they position themselves as rigid safety assessors. Also, they much encourage companies to consult SFA early in their product development process (referred to as “early-stage engagement”). This will enable mutual understanding of the production process of the cultured meat product at stake, as well as the applicable safety requirements. This may subsequently enable companies to make deliberate choices in their manufacturing setup. All of this is quite different in the EU, where interactions with EFSA is highly regulated and where detailed procedural regulations for submissions are in place, amongst others in view of protection of transparency in the safety evaluation process. Also, based on the Union studies database, it will be public what studies form the backbone of the safety evaluation for the Novel Food at stake.
Confidentiality vs. transparency
The notion of transparency was not mentioned once during my interview with the SFA. Instead, it was said that all information submitted during the application process is confidential. This may be advantageous for companies who want to make it quickly to the market. In the long run, and especially if authorisation of Novel Foods by the SFA will operate as a steppingstone for access of other Asian markets, I expect the need for a similar system as in place in the EU will arise.
Can cultured meat actually be called meat in Singapore? This may seem to be a no-brainer, but this is a highly debated question in the EU, where also the use of typical dairy names for plant-based alternatives is prohibited. The designation “meat” for cultured meat products in the EU may be limited based on the Hygiene Regulation, that reserves the name of “meat” for “edible parts” of specific animals, such as beef and pork. Now that cultivated cells (or even stem-cells) may not necessarily qualify as such edible parts, this issue still needs to be resolved. When marketing cultured meat products, the SFA does not oppose the designation of “meat”, provided that it is accompanied by a qualifier, for example cultured meat. “Clean” meat will however be a no-go, as it might have negative connotations for traditional meat. The proposed solution here seems appropriate to me to adequately inform the consumer what type of product is offered for sale and sufficient to prevent any misleading. Since that is also the cornerstone of EU food information law, I would very much advocate a similar solution to apply in the EU.
Authorisation of a Novel Food such as cultured meat takes place in a relatively informal and accelerated, yet science-based way in Singapore. It is therefore not surprising that the world’s first cultured meat product obtained regulatory clearance there. For now, we have not seen any applications being submitted in any other territory, not in the US, not in the EU and not even in Israel, where an important population of cultured meat companies is present. In order to see which regulatory approval procedure is most robust and flexible, the proof of the pudding is in the eating. Sure thing however is that companies obtaining regulatory approval in Singapore will not want to limit their offerings to this small territory, but expand to others as well. In my view, mutual approval proceedings could beneficially influence each other, as data generated or approvals obtained in the one proceedings, could be used in the other. In terms of processing Novel Foods applications, I could only wish EFSA takes inspiration from the collaborative approach the SFA seems to take.
The world of food is changing at a rapid pace – alternative proteins becoming a new reality. Examples are products using microbial fermentation or cellular agriculture in their production process. If you are a company wanting to market such a product in the EU, there is a good chance you require a prior market authorization as a regulated product, such as a novel food (NF) or a GMO. In that case, you need to get up to speed with the following four new ESFA guidance documents that will all apply as of 27 March 2021.
- Decision laying down the practical arrangements on pre-submission phase and public consultations
- Decision of EFSA’s executive director laying down practical arrangements concerning transparency and confidentiality
- Administrative guidance for the processing of applications for regulated products (update 2021)
- ESFA’s catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)
Document # 3 explains EFSA’s workflow in dealing with regulated products. It applies to applications for authorization of substances used in food and feed, food contact materials, NFs and GMO’s amongst others. The title of document # 4 is pretty self-explanatory. Examples of EFSA support initiatives range from general pre-submission and renewal advice to admin support to SMEs on applications and from EFSA guidance documents and scientific opinions to roundtables with industry associations.
Documents # 1 and 2 contain practical arrangements for companies that intend submitting scientific evidence regarding products requiring an EFSA evaluation. The full list of products is enumerated at the end of this post.* From a legal point of view, these guidelines implement the changes introduced in the General Food Law Regulation by the Transparency Regulation. We already covered the consequences of this Regulation in a previous blogpost, which in particular focuses on the relation between transparency and confidentiality.
This blogpost provides more detailed information on two topics representing a real change in the situation before 27 March, notably the general pre-submission advice and the notification of studies. To make this blogpost more concrete, it will target one specific category of regulated products within EFSA’s remit, notably NFs. For a reason. Currently, a great number of EU food companies active in the field of cultured meat are preparing their novel food applications. These companies need to be aware of these changes in the current regulatory framework.
General pre-submission advice (GPSA)
The GPSA to be provided by EFSA Staff concerns the rules applicable to and the content required for the NF application prior to its submission. It explicitly does not cover the design of the studies to be submitted. Aspects going beyond information available in any guidance documents are out of scope of pre-submission advice. Examples are questions regarding hypotheses to be tested or risk management. Furthermore, said staff shall not be involved in any preparatory scientific or technical work that is (in)directly of relevance for the NF application to be made. Also, the advice given shall be without prejudice and non-committal as to any subsequent assessment by EFSA (and the Member States via the PAFF Committee).
Prior to obtaining any GPSA, the applicant (and / or its representative) must register in the EFSA system supporting pre-submission activities and it must also request a pre-application ID. The pre-submission request can be introduced at any time before submitting a NF application. The European Commission nevertheless recommends submitting a request at least six months before introduction of the intended NF application.
The request for pre-submission advice shall be made in a dedicated form (“general pre-submission advice form”) made available by EFSA and a link should be made to the pre-application ID. Subsequently the applicant for an authorisation of a NF should provide all necessary information regarding the application, including a list of exhaustive questions. A maximum of two requests may be submitted under the same pre-application ID.
After a check that the questions asked are not out of scope, the applicant will be informed within 15 working days from the receipt of the advice form whether the submitted request is accepted or rejected. Companies expecting face-to-face meetings with EFSA need to know this will not happen automatically. Where possible, EFSA shall address the queries in writing. However, if EFSA considers that a discussion with the applicant might be useful to clarify certain aspects of the request, a meeting shall be organised. You then do not need to travel to Parma or elsewhere, as such meeting shall be conducted preferably by telco or webco. Only in exceptional cases a live meeting shall take place.
Any requests to be delt with in writing shall be answered within 15 working days after acceptance of the request. Any meeting to be set up shall be organised within 20 working days after acceptance of the request. EFSA shall draft a summary of the questions asked and not only send this to the applicant, but it will also publish it after the novel food application at stake has been considered admissible or valid.
Notification of studies
For transparency purposes, EFSA has established a database of studies commissioned or carried out by business operators to support any application requiring any type of scientific output, including a scientific opinion. The obligations to submit information on studies applies to both (A) potential applicants (i) having commissioned to a lab or external testing facility or (ii) carrying out such studies in in-house testing facilities and (B) to the labs or testing facilities carrying out such studies. Don’t be fooled by the wording “studies carried out” in relation to the notification required. In fact, timing is of the essence here, as all study notifications need to be submitted before the actual starting date of the study.
There may be justified justifications for not timely notifying studies. However, if EFSA does not consider the justifications provided by an applicant valid, the application needs to be re-submitted. As a consequence, the assessment of the validity of the application shall commence only six months after the notification of the studies according to the Transparency Regulation. The EFSA pre-submission guidance states the assessment of a re-submitted application shall commence 6 months after the re-submission of the application. This is not exactly the same, but it is clear that not complying with the studies notification requirement can be a serious showstopper, as a NF application supported by not-notified studies is not valid.
What exactly needs to be notified in the EFSA studies database? First of all, the study title, as well as an English translation thereof if the original title is not in English. Secondly, the applicant needs to be identified, after having first registered in the EFSA system for pre-submission activities. Thirdly the planned study starting and completion date, the laboratory where the study shall be carried out, as well as the study scope. In order to detail the study scope, the applicant should provide information on the intended study area (e.g. cultured meat), the study type (e.g. genotoxicity in vitro study) and the study objective (e.g. demonstrate that cultured meat does not pose any safety risks at the anticipated level of intake). The data entered can be modified, for instance if a study is delayed, the anticipated completion date can be aligned thereto. Information previously entered into the study database can also be withdrawn, but the applicant needs to provide a valid justification for that purpose. In the absence thereof, the same consequences will apply as when the applicant notifies its studies too late.
Once EFSA has received a valid or admissible application for a NF authorization, it shall publish this in order to launch the consultation of third parties on the application submitted. The rationale behind is that EFSA needs to have access to all relevant scientific data and studies available on the subject matter regarding the application at stake. Any communications on such consultation shall be published at EFSA’s website and shall remain open for three weeks, unless specified otherwise in sectoral Union law. For applicants, it is good to know that this public consultation in principle does not result in long delays. Upon closure of the public consultation, EFSA shall make publicly available all comments received. This will be done simultaneously with the publication of EFSA’s scientific output, which will address all relevant comments received.
What learnings can be drawn from the new EFSA Guidance documents? In the first place, that designing a safety evaluation strategy for a regulated product such as a NF has become even more important. By deciding as early stage as possible, what studies will be required to demonstrate the safety of your product, the chances that you can timely notify these studies in the EFSA study database shall increase. In this way, unnecessary delays in the appraisal of your application can be prevented. In the second place, it remains to be seen how helpful EFSA pre-submission advice will be, as it will be purely procedural and not material at all. At the same time, EFSA launched the new initiative of dedicated support for SME’s. Potentially, combination of the two reveals to be helpful.
*Products subject to transparency requirements and requiring an EFSA evaluation are the following:
- GMO’s (captured by both Directive 2001/18 and Regulation 1829/2003)
- Additives in animal nutrition
- Smoke flavouring used on food
- Food contact materials
- Food additives, enzymes and flavourings
- Plant protection materials
- Novel Foods
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 < 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.