New working arrangements between Dutch Food Safety Authority and Inspection Board Health Products

Posted: April 15, 2026 | Author: Karin Verzijden | Filed under: Advertising, Authors, Food, Food Supplements, Health claims, Nutrition claims | Comments Off

Context

In the Netherlands, self-regulation takes an important place in the legal & regulatory food enforcement landscape. Contrary to for example Germany, where food litigation takes place quite often before the civil courts, in the Netherlands many disputes between food business operators end up before the Dutch Advertising Code Committee (Reclame Code Commissie or “ACC”). Also, the ACC offers a very low threshold for consumer complaints on food products. “Self-regulation” in this context covers the set of rules for public advertising drawn up by the industry, the media and advertisers in consultation with the regulators. The Inspection Board (“Keuringsraad”), being a private body operating on behalf of the health products industry, actively monitors compliance with these rules.

Code for health products promotion

One set of these rules consists of the Code for health products promotion. One group of products covered by this code are food supplements, that usually are sold in the form of capsules, tablets, powders etc. Furthermore, this code relates to products covered by the Dutch Commodities Act (“Warenwet”) having a pharmaceutical presentation and/or for which a health-related primary function is claimed. This category of products mainly concerns products to be used externally, and their health-related primary function distinguishes them from cosmetics. The Code for health products promotion prescribes, amongst other things, that advertising of health products should be in conformity with the EU Health Claims Regulation and it should not contain medical claims.

Working arrangements

On 16 March 2026, the new working arrangements made between the Dutch Food Safety Authority (“NVWA”) and the Inspection Board were published. They are in force for a period of two years until 31 December 2027. These arrangements lay down the parties’ agreement that:

NVWA is responsible for the interpretation and enforcement of legislation relating to health products;
The Inspection Board is a private organization responsible for the execution of self-regulation targeting health products;
NVWA recognizes this self-regulation driven by the Inspection Board, stimulating a high compliance rate with the health products legislation and therefore considers it appropriate to record a formal written cooperation arrangement;
The Code for health products promotion adequately reflects the relevant content of the Dutch Commodities Act, the EU Health Claims Regulation and the Dutch Advertising Code.
NVWA will update the Inspection Board on any changes of interpretation of this legislation and the Inspection Board will adjust the Code for health products promotion accordingly;
The parties will regularly consult with each other for proper execution of these working arrangements.

How working arrangements shape enforcement

The above demonstrates the close links between the public body NVWA and the private body of the Inspection Board. These are also reflected in the enforcement of the Code for health products promotion, working in two complementary ways.

Inspection Board level – On the one hand, the Inspection Board offers pre-market monitoring for advertising campaigns covering health products. This is a paid service, resulting in an admission ID when found compliant. Companies that have received such admission ID will, in principle, not face any enforcement measures with respect to the advertising campaign covered by such ID. On the other hand, the Inspection Board reports to the NVWA any cases found non-compliant by means of self-regulation. Obviously, once a company is on the radar of NVWA for such non-compliance, enforcement measures such as fines and/or prohibitions to make certain marketing statements can be readily expected.

NVWA level – When food business operators or consumers report a suspected breach of food law to the NVWA, this food safety authority can revert such company or individual to the Inspection Board. However, according to the new working arrangements, this will not happen in the following cases:

In case the notification according to the NVWA covers a serious threat for public health;
In case the notification otherwise implies a serious risk, either in scope or in consequences, of violation of the legal provisions for advertising health products;
If the advertising food business operator was involved in a series of violations subject to either enforcement by NVWA or regarding which it was contacted by the Inspection Board;
If the notification cannot be evaluated, according to the NVWA, without making use of its legal powers (such as administrative coercion).

Conclusion

The rules contained in the Code for health products promotion may seem obvious, but there is a thin line between authorised health claims and unauthorised medical claims. To make this distinction is crucial, as it will be of vital importance for the qualification of a product as either a food product or potentially a medicinal product. Marketing medicinal products for which no marketing authorisation has been granted is prohibited and subject to huge fines. This is not a trivial topic, as demonstrated by the fact that recently a request for preliminary questions was made to the ECJ, covering exactly the difference between food supplements and medicinal products based on advertising of these products. Clearance of marketing campaigns for health products before launch therefore makes perfect sense.

Images by Freepik

Oat beta-glucans and the glucose peak: a new health claim is on its way

Posted: March 11, 2026 | Author: Maartje Hop | Filed under: Food, Health claims | Comments Off

You have probably experienced it: that familiar afternoon slump after a lunch heavy on pasta or bread. Blood sugar spikes sharply after a carbohydrate-rich meal, only to drop again shortly after, leaving you tired and unfocused. This postprandial glucose peak is not just a matter of energy levels; it is increasingly a focus of nutrition science and, as it turns out, of EU food law.

Positive outcomes in the EU health claim authorisation process are rare: the EU Register of Health Claims currently lists only 262 authorised health claims, against 2,067 that were not authorised. Regulation (EC) No 1924/2006 (hereinafter: Claims Regulation) harmonises the provisions relating to nutrition and health claims made on food and establishes rules governing the authorisation of health claims across the EU. Health claims are prohibited unless they comply with the requirements of the Claims Regulation, are authorised in accordance with it, and are included in the lists of authorised claims. The majority of health claim applications fail at the scientific hurdle. That alone makes a January 2026 positive opinion from the European Food Safety Authority (EFSA) on oat beta-glucans noteworthy. But there is a second reason this opinion stands out: the application was submitted under article 13(5) of the Claims Regulation. This route is rarely used, and even more rarely with success. At present, only 8 claims have been successfully evaluated via that route.

Article 13(1) versus article 13(5)

Most authorised health claims reached the permitted list via article 13(1) of the Claims Regulation, relating to general function claims. As an example “calcium is needed for the maintenance of normal bones” could be mentioned. These claims are based on generally accepted scientific evidence. Article 13(5) also target general function claims but through a fundamentally different route: it is reserved for claims based on newly developed scientific evidence. Unlike article 13(1), an applicant under article 13(5) must submit an individual application and bear the full burden of demonstrating that the claim is supported by newly developed scientific evidence. It is precisely this route that is at issue in the January 2026 EFSA opinion discussed below.

A new positive scientific opinion on oat beta-glucans

The Swedish industrial research centre ScanOats submitted a health claim for authorisation pursuant to article 13(5) of the Claims Regulation. The health claim was submitted via the Competent Authority of Ireland, and the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of this claim relating to oat beta-glucans and the reduction of postprandial glucose peaks. In its opinion, the EFSA Panel concludes that a cause-and-effect relationship has been established between the consumption of oat beta-glucans and the reduction of postprandial blood glucose peaks. In doing so, the Panel delivers a positive scientific opinion: a crucial step in the authorisation process, though formal authorisation remains with the European Commission.

How does this claim differ from the 2012 authorised health claim?

In its current opinion, the EFSA Panel considers that the following wording reflects the scientific evidence: ‘Consumption of beta-glucans from oats contributes to the reduction of the glucose peak after a meal’. This wording differs from the health claim that was already authorised back in 2012, which reads: ‘Consumption of beta-glucans from oats or barley as part of a meal contributes to the reduction of the blood glucose rise after that meal’. The difference is scientifically and legally significant. Also, the current claim seems easier to understand for the average consumer and, from a commercial point of view, is therefore more attractive.

The first claim focused on the overall rise and fall of glucose over time. The current claim focuses specifically on how high the blood sugar spike gets at its highest point. Because this concerns a different, more precise endpoint supported by new scientific evidence, a fresh authorisation procedure was required.

In order to bear the current claim, food or meals should contain at least 30 grams of available carbohydrates per portion and at least 3 grams of beta-glucans from oats for each 30 grams of available carbohydrates.

Status of this 2026 opinion

It is important to note that a scientific opinion of the EFSA Panel is not an authorisation yet. Following a positive EFSA opinion, the European Commission must still draw up a draft implementing regulation to add the claim to the EU register of permitted health claims. That proposal goes through a comitology procedure involving the Member States, after which the Commission formally adopts and publishes the regulation in the Official Journal of the EU. Only at that point is the claim officially authorised and may it lawfully appear on product labels.

The field is in full development

This latest development illustrates that the field of nutrition and health claims in the EU is far from static. New science can open doors that were previously closed, provided the evidence meets EFSA’s demanding standards. This 2026 opinion on oat beta-glucans is a prime example: built on 16 human intervention studies, it has cleared that bar under the demanding article 13(5) route. Successful article 13(5) applications are rare, but this EFSA opinion is a reminder that the route exists and that it can work. The next steps are now in the hands of the European Commission. For manufacturers, regulators and legal practitioners alike, this is a development worth following closely.

Image is by freepik.

EU Biotech Act and Food and Feed Safety Simplification Omnibus: what’s in it for the food and feed sector?

Posted: January 8, 2026 | Author: Maartje Hop | Filed under: Food | Comments Off

A new era for biotechnology innovation

December 2025 brought not one but two major regulatory proposals from the European Commission: the long-awaited first part of the EU Biotech Act and the Food and Feed Safety Simplification Omnibus. Together, these proposals signal a fundamental shift in how the EU approaches biotechnology and food innovation.

The EU Biotech Act aims to strengthen the competitiveness of the EU biotechnology sector whilst maintaining the highest safety standards for people, animals and the environment. The Food and Feed Safety Simplification Omnibus complements this by proposing amendments to ten existing regulations, simplifying procedures, reducing administrative burdens and accelerating market access for innovative products.

Whilst the EU Biotech Act focuses primarily on health biotech, both proposals contain significant changes for the food and feed sector. In this blog, we break down what these two proposals mean for food and feed businesses, so you can start 2026 fully up to speed!

EU Biotech Act

Expanded pre-submission advice and EFSA’s broader mandate

If it is up to the European Commission, the days of incomplete dossiers and lengthy EFSA procedures are numbered. Under the EU Biotech Act proposal, article 32a(1) of the General Food Law Regulation (GFL) will be revised. Whereas EFSA previously only provided advice regarding procedural aspects of the application for innovative foods or the notification thereof, this is now being expanded to include advice on the design of studies and testing strategies to support such an application or notification. This is particularly valuable for SMEs, helping them submit more complete dossiers and shorten time-to-market.

Additionally, EFSA’s general mandate in the field of human nutrition is being adjusted. Article 22(5)(a) GFL is being amended from “scientific advice and scientific and technical support on human nutrition in relation to Community legislation” to simply “scientific advice and scientific and technical support on human nutrition”. By removing the restriction “in relation to Community legislation”, EFSA is given more scope to provide broad advice on human nutrition, even outside the strict framework of existing EU legislation. Welcome expansions that will benefit biotech companies and ultimately support innovation, without compromising on safety standards.

Regulatory sandboxes: testing innovation in a controlled environment

In addition to expanding EFSA’s pre-submission advice, the European Commission is introducing regulatory sandboxes through the EU Biotech Act. These sandboxes provide a controlled environment where participants can test innovative products or substances and related processes under a set of defined rules and monitoring and for a limited period of time. Participants can be any natural or legal person. To enable these sandboxes, definitions are being added to article 3 GFL and new articles 49a to 49c GFL are being inserted. These articles govern the establishment, operation and conditions of the regulatory sandboxes.

Regulatory sandboxes enable innovative biotech companies to test their new products and processes in a safe, controlled environment before they enter the market. Rather than having to comply immediately with all existing regulations, participants can experiment with new technologies under the supervision of the authorities whilst simultaneously learning what data and studies are required for full market authorisation. This lowers the barrier to innovation, shortens development time and helps companies better understand what is expected of them, whilst safety and oversight remain guaranteed.

Amendments to the GMO Directive: a tailored framework for micro-organisms

A separate proposal accompanying the EU Biotech Act presents substantial changes to Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment. With the addition of new articles 24a to 24g, a specific extension for genetically modified micro-organisms (GMMs) within the existing GMO framework is being introduced.

The extension is intended to make the regulatory framework more fit for purpose for GMMs, acknowledging that the existing rules were largely designed with genetically modified plants in mind and do not always align well with the distinct characteristics, applications and risk profiles of micro-organisms. By tailoring Directive 2001/18/EC to the specificities of GMMs, the EU aims to strengthen its attractiveness as a location for their development, production and commercialisation. In particular, low-risk GMMs will benefit from faster market access procedures under the proposed changes. For the food and feed sector, this is widely viewed as a positive development: clearer and more proportionate rules should reduce regulatory uncertainty and lower barriers to market entry, while continuing to ensure a high level of safety. In the agri-food sector, GMMs offer significant potential, e.g. in the development of biofertilisers, biopesticides and biological food preservatives. A more tailored regulatory approach could therefore support innovation in sustainable food production, enhance efficiency and enable the introduction of new products to the market.

EU Food and Feed Safety Simplification Omnibus

The Food and Feed Safety Simplification Omnibus amends ten regulations with three overarching objectives: reducing administrative burdens, accelerating market access for safe products, and modernising outdated procedures. Here’s what’s changing:

Accelerating market access for safe products

Several regulations are moving away from time-limited approvals to unlimited authorisations for substances with proven safety profiles, freeing up regulatory capacity to focus on high-risk substances.

The proposed modification of the Plant Protection Products Regulation (No 1107/2009) introduces unlimited approval periods for active substances (article 5), whilst accelerating market access for biocontrol substances through EFSA’s new role as rapporteur Member State (article 7), priority assessment (article 11), tacit approval after 120 days (article 37), and treating the EU as one zone for products containing only biocontrol or low-risk substances (article 3, point 17). The regulation also provides a clear definition of biocontrol substances as occurring in nature (excluding heavy metals) and substances of biological origin or synthetically produced that are functionally identical and structurally similar. Additionally, article 3, point 36 introduces a definition for basic substances as active substances not predominantly used for plant protection but nevertheless useful in plant protection, with articles 23 and 23a clarifying their approval criteria and allowing their placing on the market without Member State authorisation to ensure easier access for farmers.

Similarly, the proposed modification of the Biocidal Products Regulation (528/2012) introduces unlimited approval duration for active substances (article 4), whilst the proposed modification of the Feed Additives Regulation (1831/2003) follows suit with unlimited authorisations (article 9(8)).

Finally, the proposed modification of the Official Controls Regulation (2017/625) tackles potential delays at borders by allowing border control posts to split consignments of plants and plant products and release parts for which controls are completed (article 50(3)), preventing food waste caused by lengthy laboratory analyses.

Reducing administrative burdens

Multiple regulations are being simplified to reduce unnecessary paperwork and duplicate procedures.

The proposed modification of the Plant Protection Products Regulation removes record-keeping obligations for products containing only biocontrol substances (article 67), whilst the proposed modification of the Biocidal Products Regulation simplifies EU authorisation procedures by publishing only summaries in the Official Journal rather than full decisions (article 44).

The proposed modification of the Feed Additives Regulation modernises labelling requirements by permitting digital labels for non-safety-critical information (article 16) and simplifies administrative changes such as transfers of authorisation holders.

The proposed modifications of the Hygiene Regulations (852/2004 and 853/2004) streamline notification procedures for national measures by adopting one uniform procedure instead of two different procedures, whilst the proposed modification of the Regulation 1099/2009 on animal welfare at slaughter removes duplicate reporting obligations on depopulation operations (article 18, paragraphs 4 and 6), as existing reporting under the Official Controls Regulation is sufficient.

The proposed modification of the Official Controls Regulation introduces flexibility in laboratory accreditation requirements, allowing alternative standards and permitting designation of reference laboratories without full accreditation for all methods under certain conditions (articles 41, 93 and 100), reducing costs whilst maintaining reliability.

Modernising outdated procedures

Several regulations are being updated to reflect current scientific knowledge, international standards and market realities.

Regulation 396/2005 on maximum residue levels (MRLs) is being amended to set MRLs at zero (limit of quantification) for hazardous substances not approved in the EU (article 14), aligning import standards with EU production standards. Simultaneously, new paragraphs in articles 14 and 18 allow for transitional measures for products subject to the old MRLs, preventing unnecessary food waste. Additionally, article 3(2)(f) is amended to replace the term ‘limit of determination (LOD)’ with ‘limit of quantification (LOQ)’.

The proposed modification of the Regulation 1829/2003 on genetically modified food and feed clarifies that products obtained using genetically modified micro-organisms (GMMs) as production strains are not considered ‘produced from GMOs’ where the GMMs are not present in the final product and any residues are limited to non-viable cells (article 2(10)), resolving long-standing uncertainty for the fermentation sector. This clarification represents a parallel approach to the GMM framework introduced under the EU Biotech Act as discussed above. The EU Biotech Act adapts Directive 2001/18/EC to the specificities of GMMs that are deliberately released or placed on the market for various applications, providing tailored regulatory rules and faster procedures for low-risk micro-organisms. The Food and Feed Safety Simplification Omnibus focuses specifically on GMMs used as production strains for food and feed, ensuring legal certainty for businesses by clarifying when they fall out of scope of the regulation.

The TSE Regulation (999/2001) is being modernised to enable swift updates to BSE control measures through delegated acts (articles 5, 6, 8 and 16) and removes outdated restrictions on gelatine and collagen from ruminant bones (article 16).

Conclusion

The EU Biotech Act and the Food and Feed Safety Simplification Omnibus represent a pragmatic recalibration of EU food and feed regulation. By introducing regulatory sandboxes, expanding EFSA’s advisory role and removing time-limited approvals for proven-safe substances, the European Commission is creating space for innovation whilst maintaining rigorous safety standards.

For food and feed businesses, these proposals offer tangible benefits: faster market access for biocontrol substances and feed additives, reduced administrative burdens through digital labelling and streamlined procedures, and greater legal certainty for fermentation-based products. At the same time, stricter import standards for hazardous pesticide residues and modernised BSE controls demonstrate that simplification does not mean compromising on safety.

The second part of the EU Biotech Act is expected to be released in Q3 2026. Meanwhile, the European Parliament and Council will review the legislative proposals under the Food and Feed Safety Simplification Omnibus, for which a plenary session is planned for March 2026. As these proposals move through the legislative process, business should prepare for a regulatory landscape that rewards innovation, values efficiency and maintains Europe’s reputation for the highest food safety standards. The message is clear: the EU is open for biotech business, but safety remains non-negotiable.

Curious to know what these proposals mean to your business? Let’s get in touch!

This blogpost is written by Karin Verzijden, Jasmin Buijs and Maartje Hop.

Images are by Freepik.

Probiotic health claims remain tricky

Posted: September 11, 2025 | Author: Maartje Hop | Filed under: Advertising, Food, Health claims | Comments Off

“Supports your intestinal flora” sounds harmless. Yet that promise cannot simply be used in advertising. This becomes extra clear in a recent ruling by the Dutch Advertising Code Committee (ACC). In this blog, I will analyse how the ACC reaches its decision, and what it reveals about the scope, or rather the limitations, for such and similar health claims.

The case
The label of the product Beautiful Immunity Kefir Mild contains, among others, the statements that kefir supports the intestinal flora (in Dutch: kefir ondersteunt de darmflora) and that their kefir drinks are high in protein, low in fat and a source of calcium and vitamin B12 (In Dutch: onze Kefir-drankjes bevatten veel eiwitten, weinig vet en zijn een bron van calcium en vitamine B12). Furthermore, two claims are made: calcium and vitamin B12 for your gut health* and support of your immune system** (In Dutch: calcium en vitamine B12 voor uw darmgezondheid* en ondersteuning van uw immuunsysteem**). The label also contains claims about *calcium supporting the normal function of digestive enzymes (in Dutch: *Calcium draagt bij tot de normale werking van spijsverteringsenzymen) and **vitamin B12 supporting the normal function of the immune system (in Dutch: **Vitamine B12 draagt bij tot de normale werking van het immuunsysteem).

Designation kefir mild
According to the complainant, the naming of the product “kefir mild” is confusing consumers. They would think this variant of kefir contains yeasts and alcohol, like the traditional kefir does, but in reality, it doesn’t. The ACC mentions that the advertiser must use a customary or descriptive name for the product. Kefir is designated as a milk product. In the Netherlands, kefir is not a protected product name or a legally established designation, like other dairy products as milk or cheese. According to Beautiful Immunity, a distinction must be made between commercial and traditional kefir. Since shops will mainly sell the commercial variety, which, like “mild kefir”, does not contain yeasts, the ACC does not consider this designation for “mild kefir” to be incorrect or insufficiently specific. The average consumer will think that it is kefir with a mild taste and not traditional kefir with yeasts. Therefore, the naming of the product “kefir mild” isn’t confusing for consumers. The ACC rejects this complaint. Nevertheless, Beautiful Immunity currently designates its product just as “kefir”.

Health claim
Secondly, the complaint states the text displayed on the label contains a misleading health claim. This concerns the claim that the kefir product supports the intestinal flora and contains billions of live cultures. According to the complainant, this suggests a broader effect than the product actually offers, especially since the product does not contain yeasts and does not undergo a traditional fermentation process. The ACC rules that the claim “supports the intestinal flora” qualifies as a health claim. According to article 10 of the Claims Regulation, only authorised health claims can be used. A quick research in the EU Health Claims Register reveals there is no authorised health claim linked to kefir.

Furthermore, article 5(1)(b) of the Claims Regulation requires a health claim to be specifically linked to ingredients or substances. In this case, the advertiser attributes the claimed effect to kefir and not to the ingredients calcium or vitamin B12. More specifically, Beautiful Immunity indicates that the health claim about kefir supporting the intestinal flora is a generic health claim that is accompanied by to the authorised claim for calcium stated on the back of the packaging (article 10(3) of the Claims Regulation).

The ACC does not agree. According to the ACC, the health claim “supports the intestinal flora” is located under the word “kefir” on the front of the packaging. Consumers will read that Beautiful Immunity claims that kefir supports intestinal flora. The name of the product and the health claim follow each other directly and appear to be related. This claim cannot be linked to the claim “Calcium contributes to the normal function of digestive enzymes”. The reason is that the claim is located on the back of the packaging and an asterisk that can clarify the link between the claims is missing. It is therefore an independent health claim, see the ruling of the Court of Justice of 30 January 2020, case C-524/18.

Because there is no authorised health claim for kefir, the health claim that kefir supports the intestinal flora is contrary to article 10(1) of the Claims Regulation. This results in the ACC concluding that this claim is not in accordance with the law as referred to in article 2 of the Dutch Advertising Code, so the ACC upholds the complaint.

For gut health
Beautiful Immunity states that it regularly updates its labelling and that the claim “supports intestinal flora” no longer appears on the new label. Instead, the text “For gut health” is used. This claim is more generic, but if it substitutes the text “supports the intestinal flora”, it is still displayed under the word “kefir”. So, it remains an independent claim about kefir, that is unauthorised. This shows claims about gut health, intestinal flora and probiotics remain tricky.

Intestinal flora and probiotic claims
In this procedure the ACC rules that the health claim that kefir supports the intestinal flora is not permitted and therefore contrary to article 2 of the Dutch Advertising Code. The health claim was actually intended for calcium. What is striking is that the ACC attributes the unauthorised nature of the health claim to the fact that it refers to kefir rather than calcium. The ACC does not assess the admissibility of claims about intestinal flora in general here. Would the health claim “supports the intestinal flora” be permitted if it referred to calcium rather than kefir?

One could argue that in this case article 10(3) of the Claims Regulation is complied with, assuming that the claim is accompanied by the authorised calcium health claim, but caution should still be exercised with health claims about intestinal flora. In the Netherlands, the list of the on hold claims, drawn up by the Dutch Health Advertising Knowledge and Advice Council (in Dutch: Keuringsraad), distinguishes between the categories of digestion and intestinal flora. This suggests that the claim about intestinal flora cannot be accompanied by the authorised claim that calcium contributes to the normal function of digestive enzymes. In fact, there still aren’t any authorised health claims on intestinal flora or probiotics, see our previous blog about probiotic claims.

In the meantime, the European Ombudsman closed a case about probiotic health claims. This case was about the interpretation of the term probiotics by the European Commission. According to the European Commission, the word probiotics suggests a health claim, while the complainant, an association of producers of probiotics, argued that this word rather suggests a nutrition claim. The European Commission intends to protect consumers from potentially misleading information about food. As such, it is not surprising for the Commission to interpret claims about probiotics as health claims. The European Ombudsman accepts the explanation of the European Commission that it does not rule out submitting new applications to authorise probiotic health claims in the future, if the health benefits are scientifically proven.

Conclusion
The ACC rejects the complaint about the name “kefir mild”, as it is accurate and sufficiently specific. The average consumer will think that the term “kefir mild” refers to kefir with a mild taste, and not to traditional kefir containing yeast (including alcohol). The ACC however upholds the complaint regarding the health claim “supports the intestinal flora”. In essence, the ACC rules that consumers would think that the claim is about kefir. And the claim that kefir supports the intestinal flora is an unauthorised health claim. In fact, all health claims about intestinal flora are unauthorised. The same applies to health claims about probiotics. This may change in future, if and when these types of claims are substantiated by scientific evidence regarding the health benefits offered. So, think twice, when selling the health benefits of your gut health product. And of course, I would be happy to help out in case of doubt.

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

Image: https://nl.beautifulimmunity.eu/

No health claims for botanicals, unless… – implications for the Dutch market

Posted: May 19, 2025 | Author: Jasmin Buijs | Filed under: Advertising, Food Supplements, Health claims | Comments Off

Last April 30^th, the European Court of Justice (ECJ) answered the question whether so-called ‘on-hold’ health claims related to botanical substances are permitted (case C-386/23). As covered in an earlier blogpost, this question was submitted to the ECJ by the German Bundesgerichtshof in the summer of 2023. In this blogpost, we discuss the outcome of the case, the transitional regimes of article 28(5) and (6) Claims Regulation, and the implications of the case for the Netherlands.

The case
The question at hand came up during national German court proceedings concerning a food supplement of the company Novel Nutriology, which was advertised as mood enhancing and reducing feelings of stress and fatigue thanks to its extracts of saffron and melon juice. Health claims for botanical substances like the above are currently on-hold, since the European Commission has not yet completed its examination of such claims for the purposes of their inclusion in the positive lists of authorized health claims. Due to the absence of botanical-related claims on these lists, such claims can therefore not be used based on article 10(1) and (3) Claims Regulation. It namely follows from this article that the use of a specific health claim is only permitted if it is included on one of the positive lists, and any generic health claim must be accompanied by such a specific claim. The referring court therefore wanted to know whether it is indeed prohibited to promote botanicals with health claims as long as such claims are not included on the positive lists.

Prohibited, unless….
The ECJ confirmed that until inclusion of the so-called on-hold claims on the positive lists, it is prohibited to promote botanicals using health claims. This is however different if the use of such claims is permitted under the transitional measures provided for in article 28(6) Claims Regulation. Unlike earlier speculations, this applies not only to specific (art. 10(1)) claims but also to generic (art. 10(3)) claims. In other words: generic health claims for botanicals are prohibited, unless they are accompanied with a specific claim that meets the requirements of the transitional regime. Since the referring court starts from the premise that the health claims at issue are psychological claims, we note that the ECJ only covers such claims and no physiological function claims in its ruling, on which more later.

Transitional measures deepened
Article 28 of the Claims Regulation includes transitional measures that were intended to enable food businesses to adapt to the requirements of the regulation when it became applicable back in 2007. The transitional measures in art. 28(5) and (6) Claims Regulation however also apply to the botanical-related health claims that are currently still on-hold. This is made explicit in recitals 10 and 11 of Regulation 432/2012, which establishes a list of authorized function health claims (also known as Article 13 claims). As referred to by the ECJ in its ruling, the foregoing also follows from recital 9 of Regulation 536/2013, which amends Regulation 432/2012.

Article 28(5) and (6) Claims Regulation set forth different transitional regimes for respectively physiological function claims and other health claims. As relevant for the type of health claims made by Novel Nutriology, the ECJ applies the test set forth in article 28(6). The first question to be answered is whether the health claim has been used in compliance with national provisions before the date of entry into force of the Claims Regulation. Based on the input of the referring court, the ECJ relies here on the premise that this is the case. The claim can therefore continue to be used, provided that it either has been subject to evaluation and authorization in a Member State, or has been submitted for EU authorization prior to 19 January 2008.

Although not specified by the ECJ, it does not seem a requirement that the food business at stake has been using the claim before the data of application of the Claims Regulation itself and has, where relevant, made itself an application for authorization. The literal text of article 28(6) Claims Regulation does also not require this as it doesn’t specify the required user or applicant. A food business that wishes to use an on-hold claim does therefore not need to be the original user and applicant of the claim.

Novel Nutriology nevertheless fails to comply with the requirements of article 28(6). As was noted by the referring court, the health claim related to the saffron extract was the subject of a late application past the deadline set in the transitional measures. For the melon extract claim, no application has been submitted at all. Novel Nutriology can therefore not make the health claims at stake.

What about physiological function claims?
While the ECJ did not see reason to elaborate on the transitional measures for physiological function claims as dealt with in article 28(5) Claims Regulation, the Advocate-General does indicate in his Opinion what if the respective health claims were to be considered as such. These claims may than continue to be used under the conditions set forth in that article so long as the positive list of health claims has not been adopted in respect of botanical substances.

The question however remains whether generic claims accompanied with physiological function claims can be made under the applicable transitional measures to promote botanicals. An analogical application of the ECJ’s ruling to the transitional measures of article 28(5) Claims Regulation suggests that this should be possible, which is also the conclusion of the Advocate-General in his Opinion. A difference between article 28(5) and 28(6) Claims Regulation is however that the former explicitly refers to physiological function claims as meant in article 13(1)(a) Claims Regulation, whereas the latter covers “health claims other than those referred to in Article 13(1)(a) and in Article 14(1)(a)”. In accordance with this European implementation assessment, it may therefore as well be concluded that generic claims are not dealt with under the transitional measures of article 28(5). Whether such a strict (literal) interpretation should indeed be applied, remains unanswered.

Implications for the Netherlands
As explained in our earlier blogpost on this topic, health claims for botanicals are accepted in the Netherlands if the roadmap of the Dutch agency regulating health products (the Keuringsraad) in cooperation with the Dutch food safety authority (NVWA), is met. Also the NVWA Handbook on Nutrition and Health Claims provides a detailed guidance on the use of on-hold claims for botanical substances.

While the roadmap and NVWA handbook only accept on-hold claims with an ID number that is present on the so-called ‘on-hold’ list, we notice that in practice little attention is paid to the exact requirements of the transitional measures under the Claims Regulation. The ruling at stake may therefore be seen as a wake-up call for compliance. We recognize at the same time that it may not always be easy to prove e.g. that an on-hold claim has been used in compliance with national provisions before the date of entry into force of the Claims Regulation. So far we have not seen enforcement on this point, so future will have to tell whether this may change.

We further notice that the topic of generic claims that are substantiated with on-hold claims is not covered in the Dutch guidance materials. The case at stake however taught us that this also falls under the transitional regime of article 28(6) Claims Regulation. Since it remains unclear how this plays out under the transitional regime of article 28(5), it would be helpful for businesses if the Dutch enforcement body can share its take on this in its Handbook.

Conclusion
When it comes to psychological and behavioral function claims, the case at stake clarifies that the transitional measures of the Claims Regulation apply both to specific and generic claims. How this plays out for physiological function claims has not been covered by the ECJ, and could be argued different ways. It would be helpful if this question could therefore be answered in national guidance materials, and until that time we recommend that food businesses have a robust legal justification for their interpretation of the transitional measures, if these are what they rely on for their use.

Images are by freepik.

Ask and you shall receive: enforcement on sustainability claims

Posted: March 13, 2025 | Author: Jasmin Buijs | Filed under: Advertising, Authors, Disclosure of information, Enforcement, Food, Information | Comments Off

Misleading sustainability claims are prominently present on food products in the Netherlands. This is the conclusion of the research (see here, in Dutch) that the European think thank Questionmark conducted on behalf of the Dutch Ministry of Agriculture, Fisheries, Food Security and Nature (Dutch Ministry). Last month, the Dutch Ministry presented the outcomes of Questionmark’s research to the Dutch House of Representatives (see here for the letter, in Dutch). In this blogpost, we provide a summary of Questionmark’s report and look to the future of sustainability claims enforcement in the Netherlands.

Sustainability claims report
Questionmark collected over sixty potentially misleading sustainability claims and tested them against the Guidelines Sustainability Claims by the Netherlands Authority for Consumers and Markets (ACM), and the Code for Sustainability Advertising (CSA) by the Dutch self-regulatory Advertisement Code Committee (ACC). It appeared not difficult to find ambiguous claims in the food sector. Absolute claims and vague terms like ‘sustainable’ were found on ordinary Dutch food products like peanut butter and coffee. Below we present 7 categories of questionable claims that Questionmark details in its report.

#1 ‘Sustainable’ and other vague terms
The most commonly found type of questionable claims concerns vague terms. Examples include “we use sustainably grown peanuts” and “we support the plant”. Such claims give the impression that all sustainability problems are addressed in the production of the respective food, while in reality it often concerns the improvement of only one or a few aspects of the production of the food. Furthermore, consumers do not know what the sustainability benefit of the food is if vague terms are being used. Both the ACM Guidelines Sustainability Claims (rule 1) and the CSA (explanation to art. 3) therefore require sustainability claims to be specific.

#2 ‘100%’ and other absolute claims
Absolute terms leave the impression that (the production of) the food has no negative impact, or even a positive impact, on the environment. Examples include “100% sustainably sourced coffee” and “good for nature and farmland birds”. Food products can however not ‘improve’ the environment. Both the ACM Guidelines Sustainability Claims (rule 1) and the CSA (explanation to art. 4) require claims to be factually correct. Absolute claims are normally difficult to substantiate and should therefore not be used without the required nuance.

#3 ‘Calculated’ sustainability
Certain sustainability claims are based on a ‘calculated’ solution, such as the claim “climate neutral”. In reality, it is impossible to produce a climate neutral product. The claimed neutrality is usually based on the purchase of CO2-compensation certificates. Claiming that a food is climate neutral therefore gives a distorted picture of reality. The ACM Guidelines Sustainability Claims (p.15) therefore calls to not use claims based on CO2-compensation. These claims can easily be misleading, even if the procedure behind it is explained.

Other calculated solutions include the use of a ‘mass balance’ system, whereby certified ‘sustainable’ raw materials are mixed with uncertified raw materials. The use of this calculation method is not always specified in the sustainability claim, leaving the consumer with the impression that the product at stake effectively contains sustainable ingredients. The ACM Guidelines Sustainability Claims (p. 25) require in such case clarification that the product at stake ‘contributes’ towards the production of more-sustainable raw materials, but that it is not a guarantee that the product itself contains such.

#4 Disposal route presented as sustainable
Claims like “100% recyclable” or “compostable” (usually used for the packaging of food) give the impression that the waste problem for this product is resolved. The claim that a product may be disposed in a certain way does however not mean that the product will actually be recycled or composted end of life. This partly depends on the disposal route the consumer chooses after having consumed the food, and partly on the available techniques to really recycle or compose products.

The ACM Guidelines Sustainability Claims (p. 10) call to be clear about conditional claims, which are only true under certain circumstances or conditions. The CSA (art. 9) only allows environmental claims relating to (separate) waste collection and/ or waste processing if the recommended method of collection or processing is available and can be applied in practice.

#5 Questionable quality marks
Some foods are advertised with a logo that looks like an independent and trustworthy quality mark while the logo is in fact developed by the producer of the food itself, or is based on a quality mark with little distinctive environmental requirements or without compliance control. The picture below shows examples of such logos as illustrated in Questionmark’s report.

Picture: Examples of quality marks in the report ‘Duurzaamheidsclaims in de voedselmarkt’, Questionmark, October 2024, p. 12.

The ACM Guidelines Sustainability Claims (p. 24) call on companies to limit the number of logos and labels, and to make greater efforts to use labels that are introduced and checked by an independent organization. The CSA (explanation to art. 8) refers in this regard to the Quality Mark Guide by the Dutch public information organization Milieu Centraal, which provides information about the requirements set by quality marks and about control and transparency.

#6 Presenting ambitions as reality
The ambition to produce a more sustainable food in the future is sometimes presented as a current sustainability benefit of the food, which may be misleading. Such sustainability ambitions are sometimes based on a quality mark. Examples include the quality mark ‘Climate Neutral Certified’, which helps companies achieving net zero greenhouse gas emissions by 2025. Another example is the quality mark ‘On the way to Planet Proof.’ The CSA (art. 3.2) requires that in case of sustainability ambitions, it should be made sufficiently clear that it concerns an aim and not the current situation. More details on how to formulate sustainability ambitions can be found in rule 4 of the ACM Guidelines Sustainability Claims.

#7 Uncontrolled ‘top’ quality marks
‘Top’ quality marks mentioned in the Quality Mark Guide by Milieu Centraal are not verified against the Dutch rules on sustainability claims. It happens therefore that ‘top’ quality marks use absolute claims such as “sustainable” or “planet proof” in their logo, or that it is not clear that a part of the claim concerns an ambition for the future. While these quality marks do not deliberately mislead consumers, it is confusing that they communicate in a way that is not allowed for other advertisers. Examples include the MSC quality mark referring to ‘sustainable fishing’ as well as the quality marks mentioned under #6 above.

Not all bad
To show that not all sustainability claims in the food sector are (potentially) misleading, Questionmark also discusses clear and unambiguous claims. Although claims like “100% plant-based”, “vegan” and “palm oil free” have an absolute character, it is not impossible to substantiate such statements. These claims are therefore not necessarily misleading. Claims made by the dairy industry are furthermore highlighted for the efforts this industry makes to explain the specific sustainability benefits of their products rather than using absolute, unsubstantiated terms.

Questionmark’s recommendations
Questionmark contacted the advertisers of the ambiguous claims with the request to these. Some of these advertisers agreed to improve their claims only after Questionmark submitted a claim to the ACC, or after the ACC ruled in favor of Questionmark. Questionmark therefore concludes that the complaint mechanism through the ACC works well, but cannot serve as an alternative to structural enforcement by the government. It therefore has the following recommendations to the Dutch Ministry:

Actively enforce the rules on sustainability claims.
Keep the government’s approach complementary to that of the ACC. The government can primarily take a proactive approach, while the ACC works reactively based on complaints. The government’s approach could be more focused on preventing misleading claims, for example through the deterrent effect of fines.

In addition to these main recommendations, Questionmark recommends the following steps:

Explore the role of better education of advertisers (in the food industry) about the ACM Guidelines Sustainability Claims.
Embrace the EU’s proposed Green Claims Directive (for which the inter-institutional negotiations started on 28 January 2025), which establishes a prior approval system for sustainability claims.
Ensure that the logos of the (top) quality marks included in the Quality Mark Guide by Milieu Centraal comply with the ACM Guidelines Sustainability Claims.

Our recommendations
The timing of Questionmark’s recommendations for improved governmental oversight could not be more accurate: the ACM communicated last month that sustainability claims in the food sector is one of its focus areas for 2025. The Dutch Ministry also communicated to be working on sustainability claims, in the context of greater transparency in the food chain (see the letter linked to in the introduction of this blogpost).

The legal basis for enforcement by the ACM can be found in the general ban on misleading practices in the Unfair Commercial Practices Directive (UCPD), as implemented in the Netherlands in book 6 of the Dutch Civil Code. The ACM Guidelines Sustainability Claims provide an interpretation of these rules when it comes to sustainability claims. We do not exclude that the ACM will with one eye also have a look at the Anti-Greenwashing Directive (see here for a presentation we held on this topic). These rules shall apply from 27 September 2026. The implementation of these EU rules into Dutch law is on schedule. When it comes to claims on disposal routes, we recommend taking into account the recently adopted Packaging and Packaging Waste Regulation (PPWR), which will apply as of 12 August 2026 and contains rules on claims such as ‘recyclable’ and ‘compostable’.

What can companies do to be well-armed, both against governmental enforcement and complaints from competitors or consumers via the ACC? In our view, Questionmark hits the nail on the head: education, education and education. If you are a food business, make sure that you are familiar with the above. We are happy to help navigating the landscape of sustainability claims, whether it is via an (online) in-house training, a check on any specific claim, or otherwise.

Farmers love cows: image campaign for young farmers or commercial message for dairy sales?

Posted: February 5, 2025 | Author: Karin Verzijden | Filed under: Advertising, alternative protein, Authors, cultivated meat, Food | Tags: Advertizing | Comments Off

The Dutch Dairy Organisation (NZO) launched a campaign starring young farmers. This initiative took shape through a website and a TV commercial. It was however not entirely clear if the primary purpose of this campaign was to boost the image of young farmers or to boost dairy sales. In a decision provided at the end of last year, the Appeal Board of the Dutch Advertising Code Committee (ACC) explains why transparency around sponsorship of a nonprofit campaign is necessary. It also clarifies when a party is considered a co-advertiser.

Website

Under the heading “farmers love cows”, the website states, among other things, “As young farmers of the Netherlands, we would like to tell people that we take good care of our animals. You can see that in these commercials.” The TV commercial is then shown, followed by the text: “What dairy cows want”. What follows is an enumeration of cows’ wishes with pictures: “being able to walk around freely”, “always having enough water and feed”, “milked with care”, “always having fresh air” and “chilling out”. Following this, under the heading “what our farmers do” are short stories from three farmers. At the bottom of the page, it is stated “This campaign was created with the support of the NZO”. The NZO logo is provided next to this announcement.

TV commercial

The TV commercial shows images of young farmers, working on the farm, and of dairy cows, both in the barn and in the meadow. The voice-over in the TV-commercial says: “We farmers take good care of our dairy cows. They can walk around if they want to. Brush themselves if they want to. Chill out if they want to. And eat and drink when they want. They are milked with care. And there is always fresh air. See, that makes them happy. And if the cow is happy, so am I. Farmers love cows. This is a message from the Dutch Young Farmers Association.” At the end of the television commercial, both the web address of the campaign and the logo of the Young Farmers Association is mentioned.

Message on behalf of whom?

Both the website and the TV commercial are displayed by the Dutch Young Farmers Association. This is an organisation that represents the interests of agricultural young people in The Hague and Brussels, with the aim of helping them with personal and business development. However, in the background, the NZO is also involved. The website states this in so many words. In the TV commercial, this appears indirectly, namely by reference to the website of the campaign. In first instance, the ACC did not consider NZO as a co-advertiser. Wrongly, according to the complainant, because NZO was in fact instrumental in the creation of this campaign.

Image campaign for young farmers or statement on behalf of NZO?

Advertising is a broad concept, covering not only the recommendation of products and services, but also of ideas. It makes a difference to consumers’ interpretation whether these ideas are proclaimed by an idealistic or a commercial organisation. Is this an idealistic campaign to boost the image of young farmers or a commercial expression by an organisation that aims to promote dairy production and marketing on behalf of its members? If there is no clarity on the involvement of NZO, this could be interpreted as a lack of essential information. This could potentially make this campaign misleading.

Misleading campaign?

To start with the latter, the Appeal Board distinguishes between the website and the TV commercial in its assessment of whether the campaign would be misleading. Indeed, the Appeal Board rules that consumers should be informed about the commercial aspect of the message. This should prevent consumers from putting the TV commercial in the wrong context, so that they will see it exclusively as an image campaign for young farmers. If the consumer does not recognise the underlying commercial interest of NZO, what is left is a romanticised image of how young farmers treat and love cows. And it is not unlikely this will boost sales of dairy products. The Appeal Board considers it plausible that the lack of information about the fact that the campaign is (partly) a commercial expression in the interest of the dairy sector may lead the average consumer to buy dairy products, which they would not have done otherwise. Information about this interest is therefore essential information for the average consumer.

Lack of “essential information”

Because the TV commercial omits information about the involvement of NZO or other information about the underlying commercial interest, there is a lack of essential information as referred to in article 8.3 of the Dutch Advertising Code (NRC). Like the ACC, the Appeal Board rules that the campaign is unfair for that reason within the meaning of Article 7 NRC. This finding is without prejudice to the right to freedom of expression by the Young Farmers Association and NZO. They are allowed to propagate a viewpoint regarding young farmers in the television commercial but must also comply with the requirement that no unfair advertising is made. Freedom of expression as guaranteed in Article 10(2) of the European Convention on Human Rights does not imply the freedom to engage in unfair advertising.

The NRC’s provisions on unfair advertising are a direct implementation of the corresponding provisions of Dutch statutory laws on this point. It thus concerns an exception to freedom of expression provided by law. Moreover, the restriction in this case relates exclusively to the disclosure of the underlying commercial interest and not to the idea itself. NZO and the Young Farmers Association therefore fail on this point as far as the TV commercial is concerned. This does not apply to the website. The Appeal Board rules on this point that the announcement that the campaign was created “with the support of NZO” makes it sufficiently clear that the dairy industry as such is involved in and supports this campaign.

NZO co-advertiser

The NZO is closely involved in the TV commercial, as it (i) financed the production thereof, (ii) registered the domain name of the campaign website and (iii) took care of the procurement of airtime of the TV commercial. As mentioned above, promotion of dairy products should be seen as the primary objective of the campaign. With NZO on the one hand enabling the campaign and on the other hand promoting its own commercial interest, the Appeal Board sees sufficient reason to consider NZO co-responsible for the content of the TV commercial. NZO actively helped the Young Farmers Association to advertise the dairy sector. This constitutes the promotion of dairy products by or on behalf of an advertiser, whether or not with the help of third parties as referred to in article 1 NRC. This gives the NZO its own responsibility to ensure that the campaign complies with the NRC, which it failed to do. That unfair advertising is made through the TV commercial is therefore partly attributed to NZO.

What can we learn from this decision?

This decision shows that it is perfectly permissible to convey an idealistic message by or on behalf of a commercial organisation. But it must be transparent who is proclaiming this message. This lesson applies equally to conventional and alternative dairy and meat products. If manufacturers of alternative proteins conduct an idealistic campaign in which they emphasize that manufacturing their products does not involve animal suffering, it must be clear who is sending this message. These are just the rules of fair advertising, which benefit to all of us. Just like alternative protein options.

Picture sourced from the website https://boerenhoudenvankoeien.nl.

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

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

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

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

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

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

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

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

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

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

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

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

Sustainable packaging under the PPWR: from ‘nice to have’ to ‘need to have’

Posted: September 20, 2024 | Author: Jasmin Buijs | Filed under: Advertising, Authors, Food | Comments Off

Under the new packaging law, sustainability is no longer a ‘nice to have’ but a ‘need to have’. While companies currently distinguish themselves with recyclable and reusable packaging, this becomes the new normal under the Packaging and Packaging Waste Regulation (‘PPWR’). The PPWR is not yet formally adopted, though informal agreement has been reached at European level on the legislative proposal that was published by the European Commission in November 2022. The new regulation is expected to enter into force later this year.

The PPWR contributes to the transition towards a circular economy and builds on the current Packaging and Packaging Waste Directive, which it will replace. The first major difference can be seen in the mechanism of the law. It is no longer a directive that imposes obligations on Member States, but directly addresses economic operators such as food businesses. This includes shops and catering establishments offering refill and reuse items. The PPWR is a comprehensive piece of legislation. In this blogpost, we list three sustainability requirements under the PPWR that food businesses will face.

(1) Recyclability

One of the first sustainability requirements mentioned in the PPWR is recyclability. This goal must be achieved in two steps. From 2030 onwards, packaging must be designed to be recyclable. A list of criteria showing when this requirement is met is yet to follow. This may mean, for example, that certain hazardous substances that affect the recycling process and make the recycled material unsafe are no longer allowed in packaging. Five years later, from 2035, packaging should actually be recycled in practice. The abovementioned entry deadlines will shift in case the European Commission does not publish on time its clarifying rules as required under the regulation.

For now, food packaging intended for vulnerable groups (think about persons using medical food and baby food), among others, is exempted. For innovative packaging that cannot meet the recyclability requirements taking into account current collection and recycling methods, a temporary five-year exemption can be applied for at national level.

(2) Percentage of recycled material

Plastic packaging still contains relatively little recycled material. In view of the European circularity targets, minimum percentages are now set for this. Taking into account the limited recycling possibilities and food safety, a lower minimum percentage will apply to food packaging than to non-food packaging (namely 30% and 10% from 2030 for PET and non-PET food packaging respectively, compared to 35% from 2030 for non-food packaging). With regard to single-use plastic beverage bottles, the PPWR will replace the minimum percentage of recycled material set for such in the Single Use Plastics Directive as from 2030 (30% by that year). From 2040, the minimum percentages will be further increased for all categories.

How the percentage of recycled plastic in packaging shall be calculated exactly is still to be defined. In any case, exceptions also apply to this sustainability requirement, especially where food safety may be at stake. Packaging with a plastic part representing less than 5% of the total weight of the whole packaging unit is also exempted from the mandatory minimum percentage.

(3) Compostable

Three years after the PPWR comes into force, certain packaging may only be offered in compostable form. In contrast, other packaging may explicitly not be marketed as such, unless such packaging was subject to national compostability requirements before the date of application of the PPWR. The compostability requirement will initially apply to sticky labels attached to fruit and vegetables, and to packaging like permeable tea bags and coffee pads. Aluminum coffee capsules are thus not covered. Non-permeable coffee capsules made of other material may be accepted for composting at national level.

‘Compostable’ under the PPWR means that the packaging complies with the European standard for industrial composting (13432). However, this standard does not match real life industrial composting and will therefore be updated. Member States may as well require that the packaging complies with the standard for home composting. Needless to say, this is a tougher standard. For the time being, the Netherlands has not indicated its intention to make use of this policy freedom.

Chain responsibility

The responsibility to meet the above sustainability requirements lies primarily with manufacturers. These are the (legal) persons who manufacture packaging or a packaged product, or who have such designed or manufactured under their own name or trademark (save for some exceptions). A food company that manufactures (itself) or has manufactured (by a third party) packaged food products is therefore a manufacturer under the PPWR. Manufacturers will have to carry out a conformity assessment. In doing so, they guarantee and declare under their own responsibility that the packaging complies with the relevant provisions of the PPWR. As part of this, the manufacturer shall draw up a dossier demonstrating compliance.

Food companies importing packaging or packaged products from third countries (importers) will have the responsibility to check whether such packaging complies with the Union rules laid down in the PPWR. Should there be a suspicion that the packaging does not comply with the law, this must be corrected. Importers must in such case also inform the competent authority. To avoid misunderstandings and conflicting interests, it is recommended that food companies make contractual agreements on this with their suppliers and/or customers. This also applies to food companies that further market packaging or packaged products on the Union market (distributors). Distributors should also actively ensure that the packaging meets the labelling requirements under the PWWR. This includes facilitating the correct disposal route and combating ‘greenwashing’.

PPWR: Dynamic legislation

The PPWR is a dynamic legislative document. Several criteria still need to be fleshed out in secondary legislation and the PPWR leaves a lot of room for evaluation, additions and deletions (the latter especially with regard to the exemptions it currently contains). However, sitting still and waiting for more clarity is not recommended since developments are moving fast. Our advice: take stock of the current situation within your company, start talking to your suppliers and customers, and check whether current contracts need to be adjusted. And above all, evaluate which sustainability improvements can be made. Because one thing is certain: the EU needs to step up its efforts to become climate neutral by 2050.

A Dutch version of this blogpost is available at VMT.nl.

All images are by freepik.

Is it allowed to use meaty names for meat substitutes?

Posted: September 6, 2024 | Author: Karin Verzijden | Filed under: Food | Comments Off

On 5 September 2024, Advocate General (AG) Capeta rendered her opinion in the case initiated by Protéines France, Union Végétarienne, Beyond Meat and others against the French state, disputing a French national Decree limiting the use of meaty names for meat replacements. This Decree dates back to 2022, implementing a specific article of the French Consumer Code. According to this article, the names used to designate foods of animal origin cannot be used to describe, market or promote foods containing vegetable proteins.

Two French Decrees

This Decree was immediately under fire by the same parties mentioned above before the French Council of State. According to them, the Decree was unlawful since, roughly speaking, the subject matter was fully harmonized at EU level by the Food Information to Consumers Regulation (FIC Regulation). The French Council of State then stayed the proceedings to ask four explanatory questions to the European Court of Justice (ECJ). Meanwhile, France repealed the 2022 Decree replacing it by a 2024 Decree, essentially similar to the previous one. The question then arose if the request for a preliminary ruling became devoid of purpose. The good news is that according to the AG this is not the case, essentially because the Council of State had informed the ECJ that the interpretation sought remained necessary to enable it to rule on the dispute in the mean proceedings.

System of 2024 Decree

The system of the 2024 Decree is twofold. First, it establishes a list of terms of the use of which is prohibited for the designation of foods containing vegetable proteins (examples: entrecôte, steak, jambon). Second, it authorizes the use of certain terms for the designation of foods of animal origin containing vegetable proteins, provided they do not exceed a certain proportion (examples: cordon bleu (maximum 3,5 % vegetable protein), merguez (maximum 2 % vegetable protein of which 1 % should consist of herbes), terrine de campagne (maximum 5 % of vegetable protein). Products legally manufactured or marketed in another Member State of the European Union or in a third country are not subject to the requirements of this Decree. French companies are however subject to a fine of € 7.500 if they act in violation thereof.

International context

These days, France is not the only Member State where naming issues of meat replacements arise. In fact, in several EU countries such as Italy, Poland and Romania, similar rules as in France have been adopted. Also outside the EU like in the US, in South-Africa and in Switzerland, similar legislative initiatives took place. At the same time, in countries like the Netherlands and in Germany, measures have been adopted expressly allowing the use of meaty names for non-meat products, specifically aiming to prevent any misleading of consumers. For example, in the Netherlands a product can be legally sold under the designation of “vegaschnitzel” (vegetarian Schnitzel) or “vegetarisch krabsalade” (vegetarian crab salad). So, it is about time to have a decision on this topic at European level. Should we be happy with the opinion of AG Cadeta? This most likely depends which side you are on. If you are a manufacturer of conventional meat products, this opinion will most likely meet your approval. If you are a food innovator, proposing alternatives to conventional meat, you will most likely be disappointed. This is why.

AG does not consider use of substitute products harmonized at EU level

The basic question in this debate is whether European legislation has specifically harmonized the naming of substitute products. According to the AG, this is not the case. As a consequence, this leaves room for Member States for establishing legal names, reserving those names for particular foods. Legal names should be distinguished from customary or descriptive names according to their intended effect. If the effect of national rules is that certain names are reserved for certain types of products, then they qualify as legal names. By adopting national measures prohibiting the use of certain customary and descriptive names, including when they are accompanied by additional indications that the product at issue contains plant-based, instead of meat-based, proteins, a Member State turns those customary and descriptive names into legal names. This is precisely the effect of the 2024 Decree and Member States are entitled to do so. The AG goes on to reason that the FIC Regulation does not preclude Member States from adopting national measures according to which meat replacement products can only have a maximum of vegetable proteins when using meaty names. Relevant here is that a distinction is made between domestic production and production abroad. In fact, the 2024 Decree stipulates that its rules do not apply to any imported products. The AG therefore considers the France Decree a purely internal matter. Finally, national administrative penalties sanctioning this regime are not counter to the FIC Regulation.

FIC Regulation does provide for harmonization of replacement products

I do not dispute that Member States can establish legal names at national level; this follows indeed from the FIC Regulation. This may be suitable in the context that food is highly cultural – certain dishes are found in one Member State and not in the other. This is the cultural wealth of Europe, where you only need to travel a few hundred kilometers to find entirely different landscapes, languages and cultural habits. I have however troubles to digest the conclusion that because of the fact that Member States can establish legal names for their specific food products, the subject matter would not be specifically harmonized at EU level. In fact, the FIC Regulation specifically addresses the topic of replacement products in its Annex VI. According to the AG, the rule laid down therein covers the use of meaty names for plant-based substitute products. From the Tofutown decision she however draws the learning that the Annex VI rule only applies if the meaty name is not a legal name. The difference between that case and the present one is that the legal names prohibiting the use of dairy names for dairy replacement products were embodied in the COM Regulation. This is specific harmonization at EU level indeed. In my view, it is questionable if legal names at national level that were newly established for a specific goal (see below) should be attributed the same weight as legal names that have been around for long at EU level, also taking into account the consequences thereof. This is all the more so, now that legal names are usually not prohibited terms as in the 2024 Decree, but positively phrased (example: “The beef and veal sector shall cover the products in the following table: live animals of the domestic bovine species… meats of bovine animals… fats of bovine animals….” – see COM Regulation Annex I, Part XV).

Consequences if ECJ adopts opinion AG Cadeta

If the ECJ embraces this opinion in its decision, there is a good chance that the 2024 Decree will stay in effect and will be enforced in France. Therefore, France national manufacturers of meat substitutes will be very much limited in the designation of their products. As such, they will be put at disadvantage in comparison to manufacturers in countries without such limitative legislation. Furthermore, other Member States having similar legislation in place most likely will feel confirmed in their policy and also enforce these provisions in their home turf. Companies formulating innovative food products thereby get the short end of the bargain on an EU wide basis. And this is not how the internal market was meant.

Two basic principles of internal market under threat

Two starting principles of the internal market are the free circulation of goods and a high level of consumer protection. Allegedly, the rationale behind the French Decrees was consumer protection. The AG explicitly addresses this topic. She states that it does not matter if the French authorities intended to protect consumers or the meat industry, or whether the reason behind such rules is the protection of national gastronomical heritage. At first sight, such a neutral approach could possibly make sense. At second sight, I tend to disagree. In the first place, because experience in the Netherlands has shown that consumers are not misled if meaty names are used for meat replacements. While the Netherlands may be considered very progressive in this regard, it was already established by ProVeg research in 2022 that plant-based labels do not confuse consumers. Secondly, restrictive measures are not needed to protect a certain industry or cultural heritage, since substitute products are not meant to entirely replace conventional meat products. Instead, they offer additional choice to the consumer, who decides to eat less or no meat. This should by no means be a threat to the meat industry, but an increase of food options for consumers. Exactly the purpose of the internal market.

For the reasons set out above, I sincerely hope that the ECJ will not adopt the current opinion of AG Capeta.

Credits image: Vegconomist, 11 April 2024