The Dutch National Probiotic Guide: an innovative alternative for health claims on beneficial bacteria

Probiotics are known as “beneficial bacteria” that can be found in, amongst others, dairy products and food supplements. They are defined by the joint FAO/WHO expert consultation on probiotics as “live microorganisms that, when administrated in adequate amounts, confer a health benefit on the host”. Since the reference to probiotics implies a health benefit, it comes as no surprise that the statement “contains probiotics” in a commercial communication about a food product constitutes a health claim under the Claims Regulation. Moreover, “contains probiotics”, or “prebiotics”, is explicitly taken as an example of a health claim in the guidance on the implementation of Regulation 1924/2006  of the European Commission’s Standing Committee on the Food Chain and Animal Health. At this moment, no health claims for probiotics have been approved by the European Commission. The Dutch Research institute TNO and the world’s first microbe museum Micropia, located in Amsterdam, are nevertheless convinced of the health benefits of probiotics, in particular to protect against antibiotic-associated diarrhea (AAD).  At the beginning of this month, they launched a so-called National Guide on clinically proven probiotics for use during antibiotic treatment in the scientific journal BMC Gastroenterology

National Guide
The National Guide is presented as a tool for healthcare professionals, patients and other consumers to recommend or use the probiotic products listed as scientifically proven to prevent diarrhea caused by the use of antibiotics. While antibiotics fight bacterial pathogens, they also have a disruptive effect on the body’s own gut bacteria. One in four adults experiences diarrhea caused by ADD. The National Guide promotes probiotics for their function of protecting the gut flora from the disruptive effects of antibiotic treatment, fostering recovery and reducing the risk of recurring infections.

Science-based approach
The research behind the Guide involves a literature study of clinical studies that are all based on randomized, double-blind and placebo-controlled trials. Moreover, all of the trials clearly define AAD and have a probiotic administration regime for a period no shorter than the antibiotic therapy. 32 of the 128 initially identified clinical studies were selected in line with the aforementioned criteria. After the selection and review process, available probiotic products on the Dutch market were listed to be subsequently matched with the formulations as proven effective in the selected clinical studies. Only eight probiotic dairy products and food supplements marketed in the Netherlands specified on their label the respective probiotic strain(s) and number of colony-forming units (CFUs) and could therefore be used in the research. The listed probiotic products were awarded with one (lowest) to three (highest) stars for their proven effect as demonstrated in at least one to three clinical studies. The strain Lactobacillus rhamnosus GG with a minimal daily dose of 2 × 109 CFU was found in at least three clinical studies and therefore awarded with a three-star recommendation. This strain was found in 2 products, both of which are food supplements. Several multi-strain formulations resulted in a one-star recommendation; 5 food supplements and 1 dairy product matched such a formulation. The multi-strain formulation Lactobacillus rhamnosus GG, Lactobacillus acidophilus LA-5 and Bifidobacterium lactis BB-12 was present in two clinical studies and therefore assigned with a two-star recommendation. However, none of the listed probiotic products found on the Dutch market contained this formulation.

Plea for the labeling of probiotics
The research is not exhaustive as probiotic products other than the eight that were included in the study might also be effective. However, since this was not communicated on the label, they could not be included in the research. To overcome this gap, TNO and Micropia as the initiators of the National Guide call for the labeling of the probiotic strains and number of CFUs on all probiotic products EU-wide. This could also expand the potential of the Guide. At this moment, strain and CFU labeling of probiotic products is not legally mandatory under the Food Information for Consumer Regulation. The initiators also developed a special probiotic label to address this claimed deficiency. The label is based on the probiotic label used in the US as created by the International Scientific Association for Probiotics and Prebiotics (ISAPP). The labels are in line with the information that should be demonstrated on probiotic labels according to the FAO/WHO 2002  Working Group on Guidelines for the Evaluation of Probiotics in Food.

National Guide to circumvent limitations under the Claims Regulation?
The Claims Regulation applies to health (and nutrition) claims made in commercial communications of foods to end consumers. This may be in the labeling, presentation or advertising of the food. Besides information on or about the product itself, also general advertising and promotional campaigns such as those supported in whole or in part by public authorities fall within the scope of the Regulation. Moreover, since the Innova Vital case, we know that (science-based) communications made to healthcare professionals may also be regulated by the Claims regulation. The rationale thereof is that the healthcare professional can promote or recommend the food product at issue by passing the information on to the patient as end consumer. Only non-commercial communications, such as publications that are shared in a purely scientific context, are excluded from the Regulation.

It must be noted that the National Guide is, unlike health claims, not a commercial communication originating from food business operators. This does, however, not necessarily mean that food business operators are free to use the science-based Guide in their communication with (potential) consumers or even with healthcare professionals without any reservation. The Guide, which not only lists the probiotic formulations that are beneficial for the human gut flora, but even the names of products that contain those formulations, could turn commercial when referred to by a food business. Moreover, when shared in such a context, the claims made in the National Guide may even enter the medical domain due to the preventive function assigned to foods containing probiotics.

Conclusion
The history of probiotic health claim applications has shown that EFSA is not easily convinced of the evidence that is correspondingly provided. The National Guide is, however, not subject to approval from the European Commission, backed by a positive opinion from EFSA. The Guide’s publication in the peer-reviewed journal BMC Gastroenterology nevertheless contributes to the verification of its scientific substantiation. The Guide therefore appears as an innovative, science-based alternative for probiotic health claims.  At the same time, food business operators should be careful in referring to the National Guide to not act beyond the borders of the Claims Regulation and to stay away from medical claims. As a very minimum however, it seems to be valuable work to be adopted by branch organizations or research exchange platforms, such as the International Probiotics Association.


The new Organic Regulation: from farm to fork approach reinforced

The organic sector has developed from a niche market to one of the most dynamic sectors of EU agriculture. To recall some numbers provided by the European Commission, the amount of land used for organic farming grows at around 400,000 hectares a year. The organic market in the EU is worth around €27 billion, some 125% more than ten years ago. The EU encourages more farmers into the organic sector and aims to increase consumers’ trust in certified organic products to further boost those numbers. For some background on the regulatory framework, we refer to our earlier blogpost on the Organics Regulation. As already announced in that post, the current Council Regulation (EC) No 834/2007 needs an update as it is based on practices of over 20 years ago. The first proposal for a new EU Regulation on organic production dates back to 2014. Last month, the European Parliament Committee on Agriculture and Rural Development gave green light to the new Organic Regulation. This new regulation aims to guarantee organic production throughout the supply chain by phasing out the many exemptions that are allowed under the current Regulation, such as the use of non-organic seeds as further covered below. In other words, the new regulation shifts from an à la carte system of exceptions to a set menu of harmonized rules. This contribution sets out the most important changes by answering relevant questions in the light of the new Organic Regulation.

Which products are covered under the new Organic Regulation?
Similar to the current Organic Regulation, the new Organic Regulation applies to live and unprocessed agricultural products, including seeds and other plant reproductive material and processed agricultural products used as food and feed. Processed products can be labelled as organic only if at least 95% by weight of their ingredients of agricultural origin are organic. Unlike the current Organic Regulation, the new Organic Regulation also covers certain other products closely linked to agriculture. Those products are listed in Annex I and include, among others, salt, essential oils, cork, cotton, and wool. Other products may be added in future.

To what extent can non-organic seeds still be used?
Derogations that allow non-organic seeds to be used in organic production will expire in 2035. A couple of measures will be taken to increase the organic seed supply and to help it meet high demands before that time. First of all, Member States shall establish a database of organic plant reproductive material as well as national systems that connect organic farmers with suppliers of organic reproductive material. Secondly, the use non-organic seeds may temporarily remain allowed if the collected data demonstrates insufficient quality and quantity of the organic reproductive material. Also, to meet the demands of organic seeds, organic heterogeneous material is explicitly allowed for in Article 13 of the new Organic Regulation and production criteria for organic varieties are adapted taking into account the specific needs and constraints of organic production. The derogations may be phased out earlier than 2035 or extended based on a report due in 2025, which will examine the situation of plant reproductive material on the market.

Are mixed farms still allowed under the new Organic Regulation?
While the initial proposal of the Commission proposed to ban the production of organic products and conventional products at the same farm, mixed farms continue to exist under the new Organic Regulation. Mixed farms are allowed provided that the two production activities are effectively separated into clearly distinct production units. This means, among others, that inputs for production as well as the final products must be separated to avoid contamination and potential fraud. Also, the two production activities should involve different livestock species and plant varieties.

What measures must be taken to avoid contamination from non-authorized substances?
EU thresholds for conventional products automatically apply to organic ones too. Stricter thresholds for non-authorized substances in organic products are not introduced. This would include high costs, especially for small farmers, to control for example contamination from neighbouring conventional farming. Instead, food business operators are obliged to take precautionary measures to avoid contamination. The responsibility and accountability of organic producers will thus be emphasized. Final products are not allowed to bear the organic label when the contamination was deliberate or caused by irresponsible food business operators that failed to take precautionary measures. Meanwhile, Member States remain at liberty to set specified thresholds for non-authorized substances in organic products, provided that these national rules will not affect the trade of organic products that are legally placed on the market in other Member States. Based on a report due by the end of 2024, anti-contamination rules and national thresholds may be further harmonized in future.

How does the new Organic Regulation ensure the high quality of organic products?
Rather than moving all the control provisions into the regulation on official controls for food and feed, as initially proposed by the Commission, specific rules will apply to the control of organic farming. Organic production refers to the use of production methods that contribute to the protection of the environment, animal welfare, and rural development. Risk-based checks will therefore not be limited to final products but take place along the supply chain to guarantee that organic products are truly organic. Physical on-site checks will take place at least annually; the on-site check may be reduced to once every two years if the food business operator has been fully compliant for three years. In the Netherlands, those inspections are carried out by SKAL as the the designated Control Authority responsible for the inspection and certification of organic companies.

What does the new Organic Regulation mean for products imported into the EU?
Under the current Organic Regulation, organic products produced in third countries are allowed on the EU market when the organic standards of the exporting country are similar to EU rules. This means that organic products are in fact regulated by over 60 different standards. Under the new Organic Regulation, all imported products will have to comply with EU standards. Taking into account the date of application of the new Organic Regulation as well as the transitional period granted for imported products, this rule will only apply as from 2026. Moreover, certain exceptions are introduced to avoid disruptions of supply on the EU market. First of all, the Commission is empowered to grant specific authorization for the use of products and substances in organic production in third countries with specific climatic and local conditions, which therefore cannot comply with the new requirements. This exception also applies to organic production in the EU’s outermost regions, such as the Nordics. Secondly, equivalent production methods in third countries could be recognised under trade agreements.

Conclusion
The new Organic Regulation promises to further boost EU organic production. Measures to increase the supply of organic seeds and animals, allowing mixed farming, and no harmonized thresholds for non-authorized substances aim to attract more farmers into organic production. Meanwhile, measures are taken to increase consumers’ trust in organic products, such as through risk-based checks along the supply chain and the switch from the principle of equivalence to an EU single set of rules for imported products. We expect this to be a major improvement for the algae sector, that suffers unfair competition from Asian countries, where organic standards are not necessarily the same as in the EU.

It takes some more years to see to what extent the Regulation will live up to its promises. While the Regulation itself only becomes applicable from 2021, many rules are subject to further implementation depending on the development of the sector. This illustrates the dynamic character of the organic sector, which creates many opportunities for food business operators active in this field.


Moving in high spirits towards crystal clear alcoholic beverage information

Last month, the European alcoholic beverages sectors handed over to the European Commission a self-regulatory proposal on the provision of nutrition information and ingredients listing. Article 16(4) of the Food Information for Consumers (FIC) Regulation exempts alcoholic beverages containing more than 1.2% by volume of alcohol from the mandatory list of information and nutrition declaration. Nevertheless, it also attributes the Commission with the task to investigate whether and to what extent alcoholic beverages should nevertheless be covered. Last year, the Commission established in its report, amongst others, that the provision of nutrition information and ingredients listing could help consumers to make informed choices about what and how much to drink. The alcoholic beverages sectors have been asked to present a self-regulatory proposal to respond to consumers’ expectations as they have done last month.

In their proposal, the alcoholic beverages sectors elaborate on the details on the communication of the nutrition information, the list of ingredients, and the means of delivering this information to consumers. The sectors aim to provide consumers with meaningful information while preventing to create new burdens for SMEs. In this blog we give a short overview of the proposal, which should be read together with the sector-specific annexes for beer, cider, spirits and wine that allow for sector-specific implementation of the proposal.

According to the FIC Regulation, nutrition information must be given per value of 100 ml of the product and may additionally be provided per portion size. Nutrition information involves the energy value and the amounts of fat, saturates, carbohydrate, sugars, protein and salt, but may also be limited to the energy value only. The spirit sector emphasizes in its annex that it is most meaningful for consumers to provide the information in portion size and adds that the energy value per 100 ml might be misleading, as spirits are never served in this quantity. To provide accurate nutrition information, food business operators may carry out analysis on their products or they can use generally established and accepted data. The alcohol beverages sectors stress the importance of the latter option due to the changing nature of certain alcoholic beverages as they age (wine) and depending on the harvest (e.g. cider). Moreover, said data will also reduce the burden for analysis by SMEs. The wine and spirits sector have already provided such a toolkit in their annexes to the proposal, using average values of typical and characteristic wines. For instance, 100 ml of brut, sparkling wine provides 70 kcal.

As for the list of ingredients, Article 20 of the FIC Regulation excludes food additives or food enzymes used as processing aids from this list. The wine sector specifies that this means that only additives permitted for wine-making not considered processing aids during the wine-making process shall be included in the list of ingredients. Moreover, the sector notes that natural substances used to adjust the grape composition (acidity and natural sugar content) do not have to be listed; those substances only aim to restore the basic balance and composition where harvest conditions are not optimal. The wine annex is already rather concrete in the sense that it shows in its appendix I a list of oenological compounds that, when used, will have to be included in the list of ingredients.

Lastly, the proposal embraces new information and communication technologies to inform the consumer on the nutrition declaration and list of ingredients. This is in line with recital 51 of the FIC Regulation, according to which food information rules should be able to adapt to, amongst others, a rapidly changing technological environment. Next to traditional on label information, off-label information that can be accessed via a web-link, QR code, bar code or other direct means of using smart technologies are suggested in the proposal. The wine sector refers in its annex for example to the website of ‘Wine in Moderation’ as a tool to comply with labeling requirements by off-label means. The alcoholic beverages sectors propose to leave it up to the food business operators how to display the information.

The alcoholic beverages sectors commit themselves to report on implementation in March 2021. The proposal will now be assessed by the Commission. Green light will allow for high spirits to make information on alcoholic beverages crystal clear. However, all four sectors (beer, cider, spirits and wine) must be working hard on more concrete implementation guidelines that can be used by their member companies, who have to do the actual job. For the time being, the wine and spirits sector so far have elaborated the most concrete proposals. We will continue to monitor and report on further developments in this field.

 


Nutrition & cognition – how to communicate on innovative food products in this particular field?

Consumers across all demographics are increasingly concerned about cognitive health and performance. For that reason, Food Matters Live, held in London from 21 – 23 November last, dedicated one of its Seminars to the exploration of new R&D advancing the understanding of nutrition and cognitive health and performance. I was asked to give a presentation on meeting standards for cognitive claims, of which you will find a summary below. You will note that in addition to the system of currently authorised claims, I will explore its flexibility, as well as the options outside its scope.

FIC Regulation

The general framework for health claims is contained both in the FIC Regulation and in the Claims Regulation. The FIC Regulation embodies the principle of fair information practises.  According to this principle food information should not be misleading as to the characteristics of the food, for example by attributing it effects it does not possess. Furthermore, the FIC Regulation prohibits any medical claims to be made in connection with food products. A medical claim is to be understood as any claim targeting the prevention or treatment of a particular disease. It is for instance not permitted to state that a food supplement alleviates the symptoms of rheumatoid arthritis.

Claims Regulation

The Claims Regulation lays down the very concept of a health claim, being a voluntary message in any form that states or suggests that a food has particular characteristics. Basically, a health claims conveys the message “What does the product do?” Health claims can only be made with regard to a particular nutrient that has been shown to have a beneficial nutritional of physiological effect. Such nutrient should be present in the end product in a form that is bio available and to such extent that it produces the claimed effect. The scope of the Claims Regulation includes all commercial communications regarding food products to be delivered to the final consumer. Based on the Innova / Vital decision of the ECJ, it was clarified that such final consumer can also be a health care professional.

Legal framework for cognitive claims

Currently, authorised claims for cognition can be linked to iodine, iron and zinc. For all of these compounds, the claim “contributes to the normal cognitive function” can be made. In addition, for iodine the claim “contributes to the normal functioning of the nervous system” is available and for iron a claim specifically targeting children can be made. The conditions of use for these claims are calculated on the reference intake (“RI”) applicable to each mineral. As such, a distinction is being made between solids (15 % RI) and fluids (7.5% RI). For instance, in order to allow a cognition claim linked to iron, the end product should at least contain 2.1 mg iron / 100 g or 1.05 mg / 100 ml. Any claim should refer to a food product ready for consumption, prepared in accordance with the manufacturer’s instructions.

Flexibility in wording

In practise, I see that many food business operators try to reword the authorised claims, as they are not considered to be a major add-on. In the Netherlands, this practise has been facilitated by the Council for the Public Advertising of Health Products (Keuringsraad KOAG-KAG), who has published a list of alternative, authorized claims. For instance, for a claim on zinc, the Dutch translation of the wording “contributes to a regular problem-solving ability” is permitted as an alternative. Regarding a claim on iodine, you could think of “plays an important role in mental activity.” Furthermore, it is also permitted to state that a food product containing the required minimum of iron “contributes to regular intelligence”. Now we are talking!

Examples found in practise

An internet search for products targeting cognition revealed that many of them are not linked to the EU authorized claims at all. For instance, the company Flora Health is marketing the food supplement ginkgo biloba, claiming that it “helps to enhance cognitive function and memory in an aging population.” Also, the food supplement Mind Focus containing various vitamins, minerals and green tea extract from the company Bio Fusion was found, which allegedly “improves mind focus and concentration instantly”. Furthermore, the green oat product Neuravena was found, regarding which five clinical studies confirm it benefits to cognitive function. How can this be explained? The first two examples contain claims that in the EU would no doubt qualify as medical claims and as such are prohibited.

Non-EU products and options outside cognitive claims framework

Products that do not comply with EU standards may originate from other countries or territories that are subject to a different regulatory regime than applicable in the EU. Without endorsing any claims made, it was found that the gingko and Mind Focus products originated from Canada and the US respectively. The same is not true for the product Neuravena, as its manufacturer Frutarom claims to be a “global manufacturer of health ingredients backed by the science, and supported with documentation and the regulatory compliance our customers demand.” The difference here is that Neuravena is not advertised on a commercial setting targeting end consumers, but in a scientific portal. The website even contains a disclaimer to that extent. In a non-commercial, purely scientific environment, the Claims Regulation is not applicable. This allows FBO’s, provided that the same website does not contain a click through ordering portal, to communicate on their R&D and cognition even outside the authorised EU framework.

Conclusion

The EU authorised claims for cognition are limited in number and scope. Several EU Member States offer considerable flexibility in wording, which makes the use of claims much more appealing. Furthermore, in a science-based context, the Claims Regulation is not applicable, which allows you plenty of opportunity to communicate your latest R&D on nutrition & cognition, provided that the message is strictly scientific and not commercial.

 

 

 

 

 

 


The EU Tofutown case – don’t mess around with dairy product names

The European Court of Justice (ECJ) recently took its decision in the TofuTown case, providing clarity on the interpretation of the Agricultural Product Standards Regulation (APS Regulation). In short, this case dealt with the question: “Is it possible to use regulated product names for new product types?” The answer to this question is a clear “no”.  This came as quite a shock to the emerging vegetarian and vegan market. Many companies marketing alternative protein products use traditional product names for their dairy replacements. They may have to change these names, as they are no longer in line with the view of the highest EU Court.

Initiator: Verband Sozialer Wettbewerb

The TofuTown case was initiated by the German unfair competition association Verband Sozialer Wettbewerb (“VSW”). This activist organisation was also at the origin of the Innova Vital case, clarifying the scope of the EU Claims Regulation. Based on this decision, we now know that the Claims Regulations not only targets commercial communications addressing final consumers, but under certain circumstances, it also addresses communications made to health care professionals. VSW initiated the present case against the German company TofuTown, as it claimed the promotion of strictly plant-based products under denominations such as “Soyatoo Tofubutter”, “Pflanzenkäse” and “Veggiecheese” infringed the EU competition rules.

Main rule of Agricultural Product Standards Regulation

The legal framework of this dispute is constituted by the APS Regulation, containing detailed agricultural products definitions in various sectors, such as cereals, olive oil, wine, milk and milk products. The main rule following from the APS Regulation is that the names of regulated products may not be used for other products. TofuTown had argued, in essence, that this principle is outdated. In the past, such rule may have been justified to protect consumers against manufacturers distributing cheap products as dairy products, thereby gaining a competitive advantage. Nowadays, consumer awareness has changed considerably and many consumers want to be informed about alternatives to dairy products. Using regulated dairy names for plant-based alternatives is not meant to mislead consumers. Quite to the contrary, such use enables to inform the consumer on plant-based origin of their products as opposed to the animal derived dairy products they intend to replace. The ECJ did not agree with this argument. It is nevertheless worthwhile to investigate if any other argument could escape the strict product name regime embodied in the APS Regulation.

Room for manoeuvre in APS framework?

On the face of it, there is. The Commission is empowered to adopt delegated acts concerning exemptions to the strict product definitions laid down in the APS Regulation, provided these shall be strictly limited to demonstrated needs resulting from evolving consumer demand, technical progress or the need for product innovation (see article 78.3 APS Regulation). Tofutown’s plea for informing consumers about plant-based alternatives to dairy products seems to fit in seamlessly in this derogation. However, for the time being, there is no such delegated act, so that it is worth while exploring if there any further exceptions to the strict product names principle embodied in the APS Regulation.

Composite products

In fact, two of these exceptions are being mentioned in the TofuTown case. In the first place, designations for milk products may also be used in association with words designating composite products. The condition precedent is that no part takes the place of any milk constituent. Furthermore, milk should also be the essential part of such composite product, either in terms of quantity or for the characterisation (see Annex VII belonging to the APS Regulation, in particular Part III, nr. 3  thereof). An examples of such composite product names is chocolate milk.

Traditional usage

Another exception to the system of strict product names relates in the first place to products the exact nature of which is clear from traditional usage. In the second place it covers designations that are clearly used to describe a characteristic quality of the product. The Commission has drawn up a limitative list of such product names that can be found here. Examples of such product names are the following:

  • UK: horseradisch cream, cream crackers and coconut milk
  • France: almond milk (lait d’amande) and oat cream (crême d’avoine)
  • Spain: almond milk (leche de almendras)
  • Netherlands: butter beans (boter bonen) and cacao butter (cacao boter)

This list has a highly cultural character and does not allow for translations of the product names mentioned therein into other Member States languages. As such, it would be prohibited to market almond milk in or any other EU country than France and Spain. The same goes for butter beans outside the Netherlands.

Practical consequences

It could be argued that names like “Tofubutter” and “Veggiecheese” are clearly used to describe a characteristic quality of the product. However, as long as they are not mentioned on the Commission exemption list, these cannot be legally used for marketing plant-based alternatives to dairy products. More in general, the practical consequences of the TofuTown decision are expected to bring about serious restrictions for marketing plant-based products. Is this to be considered a setback for the consumer or to the contrary, will this prevent any consumers being misled? In fact, this is besides the point, as based on this decision, the enforcement authorities, like the Dutch Food Safety Authority (“NVWA”) in the Netherlands, will be authorised to prohibit further use of strictly regulated product names for their vegetarian peers. It will be interesting to see though if any enforcement actions will take place based on the mere product name. And also, will this be in the interest of the educated consumers of today? That’s certainly not beside the point.

 

 

 

 

 

 


The US milk debate –what’s in a name?

Traditionally milk comes from cows or other animals such as goats. However, in recent decades, a large number of alternatives to traditional milk were introduced to the market. From a consumer perspective, these alternatives are similar to “traditional milk” in terms of purpose of use. These alternative food products are produced using plant-based protein derived from soy, coconut or other sources. There is an ongoing debate in the US regarding whether or not these ‘alternative milks’ are to be considered ‘milk’ and can be sold as such. This debate could be the precursor to a much more encompassing debate on whether alternative sources for traditionally produced foods from animal origin can be named after the product they are meant to replace, or rather marketed to be the plant based alternative for. This post will elaborate on this discussion, and will discuss the relevant EU framework and prejudicial questions in the Tofutown case pending at the Court of Justice of the European Union (“ECJ”)

The dairy controversy

The dairy controversy has arisen as more and more plant-based food companies are marketing their products as ‘milk’ (“Alternatives”), be it as almond milk or soymilk, but nonetheless as ‘milk’. In the US, the traditional dairy industry (mostly cow milk) has tried to stop the use of the word ‘milk’ for Alternatives, because, its representatives are of the opinion that the term is misleading when used to describe what are in fact Alternatives. This plea did not go unheard and the milk lobby, in combination with a number of lawmakers in the American congress, presented the draft Dairy pride act. The Dairy pride act limits the use of the term ‘milk’, to milk produced from animals (including products such as ‘traditional’ butter). In reaction, the NGO Good Food Institute filed a report claiming that the arguments presented by the traditional dairy industry are invalid. This NGO is of the opinion that no consumer is misled as long as the name of the product ‘milk’ is combined with the alternative source for the milk production. If, and when, the Dairy pride act will enter into force is still unclear.

EU landscape

If you think a similar regulation would be inconceivable in the EU, think again. In fact,  in the EU a number of products have a legal definition included in marketing standards. The purpose of these legal definitions is to protect consumers against misleading and to create a level playing field for food business operators (“FBO’s”). For products such as honey, chocolate, and olive oil such legislation exists, which regulates the production process and name under which the product can be sold. In addition to such marketing standards mostly laid down in EU Directives, regulating single products or production chains, there is a general Regulation on agricultural production. This Regulation includes marketing standards for certain agricultural products.

CAP Regulation

Regulation 1308/2013 establishes a common organization of the markets in agricultural products (hereinafter: CAP Regulation). This regulation lays down production rules for particular agricultural products such as, but not limited to, wheat, wine, and several meat products. The CAP Regulation also applies to milk and milk derived products, and contains the following definition of milk:

‘”Milk” means exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom.’

Apart from the product ‘milk’, Annex VII part 3 of the CAP Regulation reserves the following terms exclusively for milk products: whey, cream, butter, buttermilk etc. (the list contains 16 products traditionally produced using milk).

A strict interpretation of article 78.1 in combination with article 78.2 and Annex VII part III of the CAP Regulation would mean that the term ‘milk’ should only be used for milk products from animal origin. The norm does not contain an exception for plant-based alternatives. However, it is unclear whether milk can be used if it is combined with an explicit mention of the plant-based origin of the product such as soy. It can be argued that the Alternatives do not qualify as ‘milk’, and that, therefore, the Regulation does not apply to Alternatives. This precise issue is currently the subject of a the Tofutown case pending at the ECJ (C-442/16).

The Tofutown case

Tofu is made from soya beans. The German company TofuTown.com sells alternatives to butter and cheese from mammalian origin. The company markets their Tofucheese and Tofubutter as plant-based alternative to the traditional cheese and butter. Neither products contain any ‘milk’, and are marketed towards vegetarians and/or vegans who prefer plant-based alternatives for cheese and butter. The Verband Sozialer Wettbewerb (German Competition Authority) objected to the use of the words ‘butter’ and ‘cheese’ in the tofu products because, in their view, tofutown.com did not comply with the CAP Regulation as the products were not milk-based. The German court requested the answering of preliminary questions by the Court of Justice of the European Union on the interpretation of the above-mentioned rules regarding the product names. The following prejudicial questions were put forward:

  1. Can Article 78(2) of the CAP Regulation be interpreted as meaning that the definitions, designations and sales descriptions defined in its Annex VII need not satisfy the relevant requirements of this Annex if the relevant definitions, designations and sales descriptions are expanded upon by clarifying or descriptive additions (such as ‘tofubutter’ for a pure plant-based product)?
  2. Is Annex VII, Part III, point 1, to the CAP Regulation to be interpreted as meaning that the expression ‘milk’ is exclusively the normal mammary secretion obtained from one or more milkings without either addition thereto or extraction therefrom, or may the expression ‘milk’ — where necessary with the addition of explanatory terms such as ‘soya-milk’ — also be used in the marketing of plant-based (vegan) products?
  3. Is Annex VII, Part III, point 2, to the CAP Regulation, in conjunction with Article 78, to be interpreted as meaning that the descriptions listed in detail in point 2(a), such as, in particular, ‘whey’, ‘cream’, ‘butter’, ‘buttermilk’, ‘cheese’, ‘yoghurt’ or the term ‘cream’ etc., are reserved exclusively for milk products, or can pure plant-based/vegan products, which are produced without (animal) milk, also fall within the scope of Annex VII, Part III, point 2, to the CAP Regulation?

Misleading?

One of the core principles of food law, besides safety, is the principle that foodstuffs shall not mislead consumers. This ‘misleading argument’ is the main argument used by the dairy lobby in the US to justify the restriction of the use of the term ‘milk’ solely for milk from cows or other animals. We share the view of the Good food institute that the names would be misleading is not acceptable. No consumer is misled when buying an alternative plant based product such as ‘soy milk’, because the products are clearly marketed as alternative and the origin is mentioned in the product name and on the front of the pack, as well as in the legal name. However, we are of the opinion that labeling of these Alternatives should never be similar to traditional milk products, or carry pictures of cows or other animals that provide milk.

Precursor to bigger debate on plant-based alternatives

Milk is not the only product definition under scrutiny; the discussion is already spreading to meat products. Traditional food producers feel the heat from competitors producing Alternatives for their products. These Alternatives are not only suitable for vegetarians and vegans, but also for the mainstream consumer who could be concerned with the environmental impact of meat or perhaps is lactose intolerant. The Alternatives are plenty and range from the use of soy to algae or even insects to replace the traditional product. Many Alternatives have not only animal welfare in mind, but also sustainability.

Vegetarian Butcher

In the Netherlands the Vegetarian Butcher made headlines, because he used terms reserved for meat products for his vegetarian alternatives. Instead of waiting for a court to rule on the matter, the vegetarian butcher chose to change his terms slightly to avoid being penalized for using the wrong terms. To give an example, “gehakt” (mincemeat) became “gehacked”, which, in Dutch sounds the same, but formally has a different definition. The Vegetarian Butcher also published a statement on YouTube to clarify why he changed the product names. Perhaps this could be the solution for producers of alternatives for traditional animal derived products, in case the ruling of the CJEU is in favor of the traditional producers. Another idea would be to introduce the term ‘malk’ (‘a’ is derived from plant); ‘milk’ or milk products produced using plant-based sources.

Conclusion

A debate is ongoing in the US regarding the definition of milk and whether plant-based alternatives can use the term ‘milk’ to describe their products. In the EU, the definition is already part of a Regulation, which forbids the use of the term ‘milk’ in other products than milk of animal origin. The Tofutown case will hopefully clarify if producers of Alternatives will be able to use terms such as milk, which are traditionally linked to products from animal origin, if the producer mentions the source of the milk together with the term ‘milk’. We have seen this debate is not limited to ‘milk’, but also includes other products for which non-animal alternatives are available and marketing standards such as the CAP Regulation apply to. We will keep you posted on developments in the debate on definitions of Alternatives. Please do not hesitate to share your view on this topic with us!


Investors meet food and agro start-ups

F&A Next logoDuring the two days event in Wageningen, on 17 and 18 May this year, food start-ups will have the opportunity to give their best before an audience of seasoned investors. In the same time, those investors will have the chance to satisfy their appetite for tasty food start-ups. During this event, Karin Verzijden will moderate a debate between food start-ups on the convergence of food and health. The Q&A below provides a sneak peak into the topics that will be touched upon during that debate.

F&A Next: What is “healthy food” and to what extent food can contribute to health?

Karin: Although there is no such thing as a definition of healthy food, there are numerous guidelines on healthy diets. At the end of 2015, the WHO published a report that shocked food business operators (“FBO’s”), especially those involved in the meat industry. One of the WHO recommendations was to eat less processed meat, as the consumption of 50 g processed meat per day would increase the chance to develop colon cancer with 18 %. In line therewith, the Dutch dietary guidelines 2015 (“Richtlijnen Goede Voeding”) published by The Health Council propagate that a shift in the direction of a more plant-based and less animal-based dietary pattern improves health. In general it can be stated that according to various different health organisations, the consumption of certain foods or refraining therefrom can certainly contribute to health.

F&A Next: How do specific groups benefit from e.g. personalized food?

Karin: Specific groups of people may require specific types of food. For instance, it is known that elderly people recovering from surgery in the hospital lose a lot of muscle mass. They could benefit from so-called food for special medical purposes rich in protein. Anticipating that such food will enhance their recovery, this may in the end reduce hospitalization time and thereby costs. For the time being, this is as close as its gets to personalized food, but this may be different in future.

F&A Next: How “personal” is food likely to become and what type of legal issues may come into play?

Karin: In the future, it is conceivable that food will be delivered through the use of 3D-printing, both in a care setting and at home. In a care setting, one could imagine that very fragile patients having swallow problems could benefit from smooth printed food delivered on their plate in a very attractive way. When a hospital nutritionist would like to add extra vitamins or minerals, it is very likely that the upper limits laid down in the legislation on fortified foods needs to be taken into account. Furthermore, both in a home and care setting, interesting questions as to food safety may occur. For instance, when safety of 3D-printed food is compromised, who would be responsible for that? The manufacturer of the 3-D printing machine, the supplier of the raw materials or the user of the 3D-printing device, who in fact has promoted from a consumer into a “prosumer”? Finally, when 3D-printed foods hit the market as end products, they may be covered by the Novel Food legislation on new production methods. This would imply that such product would require a market authorization prior to marketing.

F&A Next: How can FBO’s communicate on potential health benefits of food without incurring the risk that they advertise a medicinal product or a medical device?

Karin: In the EU, there is a well-defined framework for nutrition and health claims to advertise health benefits of food products. A nutrition claim implies that a food product has certain beneficial properties in terms of nutrients and energy (“What’s in the product?”). Health claims state there is a relationship between food and health (“What does the product do?”) As long as the FBO sticks to the authorized claims (of the allowed variations) and they satisfy their conditions of use, there is no problem to be expected. FBO’s should however stay away from claiming that their food product can prevent or cure certain diseases, as they then clearly enter in to the medical arena. Based on criteria laid down medicinal products legislation, food and health authorities are authorized to take enforcement measures regarding food products that are advertised as having such medicinal properties. This can result into serious fines of six digits.

F&A Next: What actions are required from FBO’s to substantiate the health effects of their food products?

Karin: This depends on the type of claim made. For instance if the FBO claims his product is high in protein, he has to be able to justify upon request that the 20 % of the energy value of the product is provided by protein. When a FBO claims regarding a barley product that barley beta-glucans may reduce blood cholesterol, whereas high cholesterol is a risk factor in the development of coronary heart disease, he should meet very specific criteria on the level of barley beta-glucan (3 g per day). Finally, when a FBO wants to obtain a so-called proprietary claim, he should initiate clinical trials in order to identify the relationship of cause and effect between a particular nutrient and its alleged health effect.


Cross sector innovations and legal loopholes

dls-beeldOn 24 November last, the Dutch Life Sciences Conference took place in Leiden, the Netherlands. This conference brings together a large number of life sciences professionals from the Netherlands and abroad. One of this year’s sessions was dedicated to cross sector innovations, during which DSM, NutriLeads, i-Optics and Axon Lawyers shared their take on this topic. This post captures the legal presentation made during this session on cross over innovations, focussing on the applicable rules to borderline products. These rules are explained on the basis of landmark ECJ decisions and recent Dutch case law. The slides belonging thereto can be viewed here.

Product qualification

In order to demonstrate that it is not always easy to correctly qualify life sciences products, a few decisions from Dutch Courts and the Advertising Code Committee were discussed (see slides 3 – 7). According to a recent decision of the Dutch Supreme Court in the field of tax law, toothpaste and sun cream were surprisingly qualified as medicinal products. This case had been initiated in 2010 by two drugstores that were unhappy they had to pay the regular VAT rate of 21 % with respect to these products. According to the drugstores, these products qualified as medicinal products, to which a VAT rate of 6 % is applicable. Although their plea had been dismissed in two instances, the Supreme Court agreed with the drugstores that based on the presentation criterion (see below), both products indeed qualified as medicinal products, as they advertised therapeutic or prophylactic effects. With respect to toothpaste, this was due to the natrium fluoride protecting against caries and with respect to sun cream, the UVA and UVB filters were supposed to protect the skin against sunburn.

Legal framework

The case discussed above so far stands in isolation, but here are many cases that have shed light on the distinction between two categories of life sciences products, being food and medicinal products. Below you will find 5 criteria that will help you to apply this distinction. In slides 8 – 12, you will find the applicable legal sources.

  1. The legal product definitions should be taken as a starting point. Bottom line, medicinal products are products aimed curing, prevention or diagnosis of a disease, whereas food products are products intended to be ingested by humans.
  2. A distinction is being made between medicinal products by presentation and medicinal products by function. Extensive case law is available for the interpretations of these notions (see below). In case of doubt, the rules relating to medicinal products shall prevail.
  3. It is prohibited to advertise medicinal products without having a market authorisation. For advertising of food products, it is permitted to use authorised health claims, but it is prohibited to use medical claims.
  4. Medical claims are communications claiming that the advertised products improve health problems. It is a thin line between non-authorised medical claims and authorised disease risk reduction claims.
  5. The notion of advertising can be pretty broad. According to the Dutch Advertising Code it comprises any public and/or systematic direct or indirect recommendation of goods, services or views for the benefit of an advertiser, whether or not using third parties.

Medicinal Products by presentation

In the landmark ECJ case Van Bennekom, the presentation criterion to qualify medicinal products was introduced. The case related to a Dutch national, who was caught with large quantities of vitamin preparations for medicinal purposes in pharmaceutical form, however without any required pharmaceutical authorisations. Van Bennekom did not deny the facts, but he alleged that he was not marketing medicinal products, but food products. The ECJ ruled that for the sake of consumer protection, the presentation criterion not only covers products having a genuine therapeutic or medical effect but also those regarding which consumers are entitled to expect they have such effect. In sum, the presentation criterium should be broadly interpreted on a case-by-case basis, taking into account all relevant factors. The concentration level of active ingredients forms only one of those factors.

Medicinal products by function

The ECJ Hecht-Pharma decision is still leading to set the parameters to decide if a product qualifies as a medicinal product by function. Hecht Pharma was marketing in Germany a fermented rice product in the form of capsules presented as being food supplements. Further marketing was prohibited, as the product contained significant levels of monalin k, which is an inhibitor of cholesterol synthesis. The product was considered as a medicinal product by function, for the marketing of which a market authorisation would be required. The ECJ ruled in this case that for the purposes of deciding if a product falls within the definition of medicinal product by function, the national courts must decide on a case-by-case basis, taking into account all characteristics of the product, such as its composition, its pharmacological properties and manner of use, the extent of its distribution, its familiarity to consumers and the risks, which its use may entail. As reported in a recent post, these criteria are still valid.

Functional foods

A recent Dutch decision on a licensing dispute entailed so-called functional foods. Although this notion does not have a legal definition under EU standards, it is usually understood as food having certain medicinal properties. The dispute divided Unilever and Ablynx, who both had obtained a license from the Brussels University (VUB) under certain antibody patents owned by VUB. Unilever’s licensed related to (roughly speaking) food products, whereas Ablynx’ license related to medicinal products. Under its license, Unilever developed so-called functional foods having certain beneficial effects against infections caused by the rotavirus. Ablynx claimed that Unilever had thus operated outside its licensed field and thereby acted unlawfully vis-à-vis Ablynx. The Hague Appeal Court endorsed Ablynx’ claims, on the assumption that Unilever’s license was clearly directed against non-pharmaceutical products. As such, it could target general health benefits (such as lowering cholesterol), but not specific pathogens.

Take home

What can you learn from the above? It is important to obtain pre-market clearance for the communication on health products. For this purpose, you can take guidance from the Advertising Code on Health Products (Code aanprijzing gezondheidsproducten), applicable to products having a pharmaceutical form and a health related primary function, however without being medicinal products. You could also request pre-market clearance from KOAG-KAG, whom actively evaluates claims on health products and provide endorsements. If and when you are confronted with enforcement measures by either the Dutch Health Care Inspectorate (Inspectie Gezondheidszorg or IGZ) or the Dutch Food Safety Authority (Nederlandse Voedsel en Waren Autoriteit or NVWA), first try to buy some time by claiming an extension for response. Subsequently, carefully consider if the claims made by the enforcement authorities are factually correct and legally enforceable. Whenever helpful or necessary, obtain professional support.


What Do Medical Devices Have To Do With Food?

In the last post of last year, we reported on the use of health claims for food products directed at weight loss. In essence, the level playing field is pretty limited. The Claims Regulation does not allow using any claims that make reference to the rate or amount of weight loss. Under certain conditions, it is allowed to market a food product stating that its consumption will decrease the sense of hunger or increase the sense of satiety, but that’s about it. Early this summer, the Dutch Advertising Code Committee (Reclame Code Commissie, “RCC) ruled in a case relating to weight loss, but considered the claims made therein were not inappropriate. What was the background of this case and what type of product was involved? All those who are interested in advertising products targeting weight loss, keep on reading.

Self-regulation of Marketing Food Products in the Netherlands

The RCC is a self-regulatory body of the Dutch Advertising Code Authority, ruling on complaints that can be lodged by both companies and individuals. Rulings are made based on the Dutch Advertising Code and a number of satellite codes, such as The Advertising Code for Food Products and the Code for Advertising directed at Children and Young People. The RCC also bases its Rulings on the advertising provisions contained in the Dutch Civil Code, as well as on particular provisions from the Claims Regulation and the Food Information to Consumers Regulation. Although the RCC Rulings are not legally binding, there is a high degree of compliance (about 96%). This is explained by the fact that the Dutch Advertising Code Authority has been put in place by joint decision of the Dutch advertising companies, whom make a yearly contribution for its operation in proportion to their marketing budget.

Clearance and monitoring services

Clearing and monitoring services regarding the advertising of products based on various self-regulatory codes used by the RCC are offered by Inspection Board Health Products (Keuringsraad “KOAG/KAG”). The products targeted by KOAG/KAG are pharmaceuticals, medical devices and health products. The latter are described as products presented in a pharmaceutical form or claiming a health related primary function without qualifying as a pharmaceutical. Those are what we typically call borderline products. Hiring the clearance services of KOAG/KAG for the advertising of one of the products within its remit has certain advantages, as KOAG/KAG has the informal arrangement with the Dutch Food Authority that approved commercials shall not be subject to enforcement actions.

Facts of the XL-S Medical Case

The case in which the RCC ruled this summer, related to the product XL-S Medical marketed by Omega Pharma. The product is marketed in pills and promotes the formula of a healthy diet, enough exercise and using XL-S Medical. In the TV commercial subject to complaint, the famous Dutch singer René Froger arrives on his bike with a basket plenty of fruits and vegetables hanging from its steering wheel. Two ladies along the road enthousiastically greet him and ask “Hey René, what’s the score?” Before the singer replies to the ladies, one sees him attach to the wall a paper stating: “interim score: minus 8 kilo”. And the singer to confirm to the ladies, “Oh yes, I already lost 8 kilos, I feel great!” Finally a voice-over states: “Follow René and also lose 8 kilos. Before using this medical device, read the instructions.”

The Complaint

According to the plaintiff, it is prohibited to make this type of claims for this type of product. In order to substantiate the complaint, reference is made to particular information displayed at the website of the Dutch Food Safety Authority translating the prohibition laid down in article 12 (b) of the Claims Regulation. More concretely, according to this information it is prohibited to state that the consumption of a particular food product will result in the loss of X kilo’s in Y weeks. Also, it is not permitted to show testimonials “before” and “after” the use of a particular food product. The rationale is that the extent to which weight loss is achieved not only depends from the use of a particular food product, but also on what more the consumer at stake will eat and on how much exercise he/she gets.

Complaint rebutted

In defence, Omega Pharma states that XL-S Medical is not a food product, but a medical device. In fact, this is a class IIb medical device market under CE-number CE0197. It is recommended that this product is taken in addition to regular food and it contains ingredients that lower the appetite and calorie uptake from food. Such product is not subject to the rules applicable on advertising food products, but to the Advertising Code Medical Devices. According to this code, it is not allowed to claim that the consumption of a particular product shall result in the loss of a certain amount of weight in a certain amount of time. It is allowed however to state the actual weight loss as a result of its use. Moreover, the singer René Froger indeed lost 8 kilos, by doing a lot of exercise, having a healthy diet and using XL-S Medical. As the commercial does not state a specific time frame during which this was achieved, the commercial is in line with article 7.2 of the Advertising Code for Medical Devices. The defence presented by Omega Pharma was endorsed by the RCC. Moreover, this commercial obtained pre-market clearance from KOAG/KAG.

Conclusion

This Ruling shows that depending on the qualification of a product, different rules may be applicable on the marketing thereof. The decisive factor in order to decide whether a product qualifies as a food product or a medical device, is it actual activity. Most slimming products, based on their physiological or nutritional activity, qualify as food supplements and are subject to the Claims Regulation. The product at stake however had a particular physical activity and as a result, it qualified as a medical device. On the one hand, this entails more preparatory actions before marketing, such as assessment by a notified body when a class IIb device is involved, like the in the present case. On the other hand, this qualification may offer advantages in the marketing thereof. It is therefore of the essence to begin with the end in mind when marketing borderline products: know what type of product is at stake and what is the applicable regulatory framework. Also, consider using pre-launch clearing services as described herein.

 

 

 


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