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.


Take # 1 on Harvard’s Clean Meat Regulatory Roundtable (9-10 August 2018)

Cultured meat has been an increasingly hot topic since the first “clean meat” hamburger was introduced in London in 2013. The technology involves using cell culturing techniques to multiply a small amount of cells taken from an animal to produce foods that resemble traditional meat, poultry, and seafood. As commercial-scale production of cultured meat becomes foreseeable, regulatory agencies must determine how these products fit into their food compliance programs.”

Harvard Law School

This is a quote taken from the website of the FDA, who organized a public meeting on 12 July 2018 to discuss safety-related data and information that the FDA is seeking on foods produced using animal cell culture techniques. Securing regulatory approval is pivotal for market access of this type of products. To date, there is no consensus how the US regulatory apparatus will classify Clean Meat products. It is neither clear which authority has jurisdiction over these products as to labeling, safety and inspections. Harvard Law School, in particular its representatives from the Food Law and Animal Law groups, is convinced of the potential benefits of Clean Meat and other cellular agriculture products. Therefore, on 9 and 10 August 2018, it organized the Clean Meat Regulatory Roundtable in order to address the regulatory concerns surrounding this new industry. A selection of topics discussed will be covered in two subsequent blogposts. The first one will cover some background information and a summary. The second one will provide an overview of the most important subjects discussed and a comparison with the EU regulatory framework where relevant.

Participants Regulatory Round Table and Ruled of Play

In order to let the discussion benefit from as many perspectives as possible, representatives from academia, the industry and from interest groups participated in Harvard’s Clean Meat Regulatory Round Table. Obviously, the meeting included a number of representatives from Harvard Law School. Furthermore, the nonprofit organizations Good Food Institute and the Animal League Defense Fund were present. The participating companies were Mosa Meat and Fork & Goode (both working on clean meat), as well as Blue Nalu (working on clean fish). From the investor side, Stray Dog Capital was represented and from the industry DuPont provided its input. Finally, a number of US lawyers were participating and I myself shared my insights from an EU perspective. All participants agreed to a Chattam House Rules + regime, meaning that the general flush of the conversation during the meeting can be reported, but the participant are not at liberty to identify, either explicitly or implicitly, what was the source of particular information.

Summary

 Clean meat and clean fish represent an emerging sector, with the promise of revolutionary innovative products. Public perception of these products, as well as trust in the safety thereof, will be of utmost importance for market success. Reliable and effective regulatory procedures as a basis for market access will therefore be pivotal. In the US, the regulatory framework applicable to clean meat products is far from clear. Firstly, it is yet to be decided which government agency has jurisdiction over these products. Secondly, the regulatory pathway is still open, whereas the available procedures of do not provide an affirmative blessing from which the sector could benefit. In the European Union, the regulatory pathway for clean meat products is relatively clear. Under the new Novel Foods Regulation (effective as per 1 January 2018), these products qualify as Novel Foods and require a market authorization from the European Commission. The Regulation as well as various EFSA guidance documents detail at length what information should be contained in a Novel Foods application. In an optimal situation, the authorization procedure could be finalized in 18 months. In both the US and the EU however, the exact designation of these products (“meat” or not?) requires further thought. On the one hand, this will require interpretation of legal product definitions and case-law and on the other hand, the interests of the traditional meat and fish sector should be taken into account.


Dutch scoop: new Advisory Group on the Status of Borderline Products

Last week, the creation of the new Advisory Group on the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects. Its task is to issue advice on the legislation to be applied to individual products / product groups / substances belonging to a group of so-called borderline products. The reason that this Advisory Group was created is that the regulations in the field of market authorization and research with such products are complex and that it is not always clear which law is applicable. In such case it is also not clear which enforcement authority is competent to act in case of violations of the law. This is deemed undesirable by both the marketplace and the government authorities and the Advisory Group aims to change this.

Demarcation issues not new

Demarcation issues at the interface of the laws applicable to food products and medicinal products are not new. Already in a 2008 Letter to Parliament, the Dutch Health Minister reported that there was insufficient clarity about the demarcation between medicinal products and herbal remedies. The Minister reported the issue that a herbal remedy could also be a medicinal product within the meaning of the Dutch Act of Medicinal Products (in which the Medicinal Products Directive 2001/83 has been implemented). This is a consequence of the fact that the Act does not make a distinction between the origin of any active substance, which can be of human, animal, vegetable or chemical origin. When a herbal preparation qualifies as a medicinal product by function or by presentation, the Act on Medicinal Products is equally applicable.

Measures announced in the Letter of Parliament

At the time, the Health Minister did not consider it necessary to adjust the regulations to prevent demarcation issues between food products and medicinal products. He considered the criteria of “medicinal product by presentation” and “medicinal product by function” to be sufficiently clear in the first place. Secondly, he expected a beneficial effect from the list of permitted health claims that still had to be published back in 2008. He anticipated that products bearing such claims would not qualify as a medicinal product by presentation. He did, however, consider it desirable to improve cooperation between the Heath Care Inspectorate and the Food Safety Authority. This was implemented by adjusting the Decree on Supervision of Public Health, as a result of which the Food Safety Authority gained authority to enforce violations of the Act on Medicinal Products. Furthermore, it was stipulated that the structured consultation between the Heath Care Inspectorate, the Food Safety Authority and the Medicines Evaluation Board should be intensified, particularly regarding the discussion of the status of borderline products. One can say that this consultation in fact operated as an Advisory Group avant la lettre. Finally, it was determined that the already existing cooperation agreement between the Heath Care Inspectorate and Food Safety Authority had to be updated.

Demarcation issues more topical than ever

We now know that the clarification brought by the list of authorized health claims published in 2012 should not be overestimated. Nowadays many functional foods and nutraceuticals are marketed that claim medical properties. It quite often happens that it is not clear what is the applicable legislation to these products, because the boundary between health claims, disease risk reduction claims and medical claims is not immediately clear in all cases. Even when no specific claim is used, it can be debatable whether a product is a medicinal product by function or any other health product. It also happens that more or less the same products are marketed simultaneously as a medicinal product and as a foodstuff. Consider, for example, products containing glucosamine or St. John’s Wort. This means that food products containing the same active substance as medicinal products have not passed the prior testing for quality, safety and efficacy, which can be confusing for the consumer.

Consequences of product qualification

There are many examples of food products that were considered medicinal products by presentation. Consider, for example, the melatonin products which, after a remarkable turn in the Health Care Inspectorate policy, initially not but later on were considered to be medicinal products. More recently, a medical claim that Milk Thistle could prevent liver fattening was considered misleading. Furthermore, it was determined that a dietary supplement that would promote the natural immune system, would have a beneficial effect on heart and blood vessels and would help to treat fatigue qualified as a medicinal product. When such disputes are dealt with before the Civil Court, quite often fines are imposed for violations of the Act on Medicinal Products, prohibiting, among other things, the marketing and advertising of medicinal product without a marketing authorization. When these disputes are submitted to the Advertising Code Committee, usually a recommendation is made to no longer use such misleading information based on these regulations and the Code on Public Advertising of Medicinal Products. In order to prevent such enforcement activities, manufacturers of health products have every interest in knowing in advance how their product qualifies. They then know which regime applies to their product and can take this into account in their communication (advertising campaigns).

Working method Advisory Group

How does the Advisory Group work and which aspects are covered by its advice? Upon request of one of the competent authorities, the Advisory Group advises on the applicable legislation to individual products, product groups or substances. This advice gives a motivated indication of the law that applies to the opinion of the Advisory Group at the time of assessment and given the available information. “Available information” refers not only to factual information but also to applicable case law, both in the Netherlands and abroad. The advice will be presented to the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects, who will subsequently respond to this within four weeks if so desired. If the responses give cause to do so, the Advisory Group reconsiders the advice and if necessary adjusts it. The advice is then recorded in its database, which is managed by its secretariat. There is also a possibility that the Advisory Council will not reach agreement on the applicable legislation. In such a case no advice is issued; this is also recorded in the database. The Advisory Group can also change its advice in the event of changes in the legal framework. The competent enforcement authorities must report those change to the Advisory Group, which registers an amendment to a previous advice in its database, if and when applicable. For clarity, the advice assesses neither the efficacy, safety or efficacy of medical products nor the content of any research protocols.

Added value Advisory Group

Can it be expected that the Advisory Group will make a substantial contribution to demarcation issues? In itself, the intensified co-operation between all the authorities involved, at market entry rather than upon enforcement during marketing, is to be welcomed. For example, in practice, food business operators also benefit from the working agreements between the Council on Advertising Health Products and the Food Safety Authority, on the basis of which health products bearing a “stamp” of said Council are in principle not exposed to enforcement actions by the Food Safety Authority. However, it appears from the currently published agreement between the parties involved in the Advice Group that only the enforcement authorities and not the individual manufacturers can request advice from the Advisory Group. This appears to be a missed opportunity, as is the fact that the efficacy of medicinal products remains explicitly outside the Advisory Council’s assessment. To qualify the essential character of a health product, efficacy is one of the essential factors. Furthermore, it is noteworthy that the Advisory Group does not seem to address the issue of medical devices, while this qualification is closely linked to that of medicinal or food products. For example, cranberry pills against bladder infection qualify as medical devices and osmotic laxatives can be either medicinal products or medical devices.

Advice on market access for health products

For the time being, manufacturers of health products will continue to rely on private advice from qualified advisors on market access for health products. Nevertheless, the body of opinions to be produced by the Advice Group can be a valuable source of information, provided that its database will be publicly searchable. The rules of procedure of the Advice Group, which are yet to be made available, will have to provide clarity in this respect.

 


The 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.

 


Natural foods – what’s in a name?

In their search for healthy foods, consumers nowadays often favour natural food products. But what is “natural” after all? Various interpretations could be given to this term. Amongst those figure unprocessed foods, foods without any chemical ingredients and organic foods. In reality, there is no harmonized concept of “natural foods” under EU food law. Food business operators should therefore mainly rely on the general principles of food information. In addition, they can use the nutrition claim “natural(ly)”, if and when applicable. Finally, they can turn to some specific pieces of EU legislation implementing the concept of “natural” for specific product an to a new ISO standard. This post aims to investigate what are the options for using the term “natural” based on the EU framework.

The most important principle under EU food law is that food information should not be misleading, in particular as to its characteristics, its nature and its composition. As such, it is prohibited to suggest that a food has particular characteristics, whereas in fact all similar foods possess such characteristics. For instance, certain additives, such as sweeteners or acids, may have a natural source, but the EU Additives Regulation does not make a distinction between “natural” or “artificial” (chemical) additives. Therefore, stating that a food product only contains natural preservatives could be misleading. The industry seems to have found its way around this issue. Instead of declaring an additive using the applicable E-number (for instance E 250 for sodium nitrate), the description of a natural compound having a similar technical function is used (for instance chard, having a similar preservative effect to sodium nitrate).

Where a food product naturally meets the conditions laid down in in the EU Claims Regulation for the use of a nutrition claim, the term “natural(ly) may be used as a prefix in the claim. For instance, if at least 20 % of the energy of the food product is naturally provided by protein, the claim “naturally high in protein” could be made regarding such product. Likewise, if a food product naturally contains at least 6 g fibre per 100 g product, the claim “naturally high in fibre” could be made. These claims should all relate to end products presented to consumers. As a B2B supplier of ingredients, you should therefore make the reservation to your clients that the admissibility of these claims depends on the mix of ingredients present in the end product.

The EU Flavouring Regulation constitutes a good example of targeted legislation with specific provisions on the use of “natural”. For instance, if the term “natural” is used to describe a flavour, the flavouring components should be entirely of a natural origin. Nevertheless, the term “natural flavouring” can be used in a situation where a clear relationship between different source materials in the flavouring component and the overall flavour-profile is lacking. For instance, an umami flavouring preparation consisting of certain vitamins and minerals in combination with certain fermentation media can still be labelled as “natural flavouring”.

The Dutch Advertising Code Committee (DACC) demonstrated in one of its decisions last year that the rules on the use of the term ‘‘natural’’ under the EU Flavouring Regulation can also be applied by analogy. The claim in the case in question related to BenBits chewing gum advertised as being “100 % natural”. A competitor denied that all ingredients used in this chewing gum were of a natural character. In deciding the dispute, the DACC took the expectation of the average, reasonably well-informed consumer as a starting point. Such consumer would expect the term “natural” to cover both the ingredients and the preparation processes used. BenBits could not demonstrate that the xylitol used in its product had been manufactured in accordance with one of the traditional preparation processes referred to in the EU Aroma Regulation, such as fermentation. The use of the claim “100 % natural chewing gum” was therefore considered misleading.

Recently, a new ISO standard was made available, containing technical criteria for food ingredients to be considered as natural. This standard is intended for use in B2B communications and conformity thereto helps to assure a level playing field and fair practices. According to this standard, food ingredients shall be considered as natural when certain criteria regarding both their source materials and their ways of processing are met. When a food product consists of various ingredients, for each ingredient these cumulative criteria should be met. An informative decision three in this standard helps its user decide whether or not a food ingredient is to be considered natural.

At Member State level, such as in the UK and in France, national guidance has been formulated for the use of the term “natural”. For instance, the UK Food Standard Agency issued guidelines for the use of this term and in France the Directorate General on Competition developed similar guidelines specifically targeting dairy products. These Guidelines, as well as relevant EU and national case law will be discussed during the Vitafoods session planned on 16 May from 11.20 – 12.00 AM. Hope to see you there!

 


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.

 

 

 

 

 

 


Can unhealthy foods enter the ‘health halo’? The boundaries of health claims in the absence of nutrient profiles

To date, about 30% of pre-packed food products marketed in the EU have entered the ‘health halo’, attracting consumers by scientifically proven health benefits. The Claims Regulation provides that food products must comply with so-called nutrient profiles in order to bear health claims. Although the Commission had to establish these nutrient profiles by 2009, it is a well-known fact this has not yet been achieved. This might sound like a carte blanche for the food industry to guide consumers in their dietary decisions. Quite to the contrary, ‘common sense’ seems to set the boundary for food products that can carry health claims. The Court of Justice of the European Union (“ECJ”) recently demonstrated in the Dextro case (for an English summary, see here) that there is no unlimited freedom for advertising essentially unhealthy foods. This decision must be seen in the light of society’s battle against obesity and other adverse health effects related to food products high in fat, salt and sugar (“HFSS foods”). The current post puts the Dextro decision into context and aims to deduce some learning therefrom.

Dextro case

The German company Dextro Energy is known for its cubes almost entirely consisting of glucose. Back in 2011, the company requested the authorization of 5 claims stating the positive effects related to energy and muscle function that consumption of the cubes brings about. Examples include: “glucose supports normal physical activity” and “glucose contributes to normal muscle function.” Following the official procedure to have such a claim authorized, the cause-and-effect relationship between the consumption of the glucose cubes and the claimed health benefits needs to be proven by EFSA. While EFSA did provide a positive opinion, this did not result in an authorized health claim. The Commission has the last say in the procedure, including political, social and economic concerns into its decision. In the Dextro case, the Commission reasoned that the claims conveyed a ‘contradictory and ambiguous message’ to consumers. Although the human body needs a certain amount of glucose, the claim contradicts the current trend of the equally scientifically underpinned advice to reduce of sugar intake. According to the Commission, additional statements or warnings would not make up for the misleading claims. Dextro Energy challenged, amongst others, the Commission’s discretion to disallow a scientifically proven health claim. Both the Court in First Instance and the Court of Appeal countered the company’s arguments.

Setting the scene: health claims on other sugary products

The decision of the ECJ did not come as a surprise. Last summer, the European Parliament rejected controversial caffeine claims on energy drinks. Similar to the considerations in the Dextro case, health claims on sugary products were feared to nudge consumers towards poor consumption choices. Also, the request by Kinder Chocolate for authorization of a health claim on milk contributing the child development has been rejected. This rejection took place on a different ground, as the request was considered to lack the required scientific underpinning. Barry Callebaut was more lucky with its request for authorization of a health claim on cocoa flavanols in cocoa beverages with cocoa powder, dark chocolate, capsules or tablets. The claim refers to a beneficial contribution to the normal blood circulation and so the maintenance of elasticity of blood vessels. Of course, this claim might stimulate chocolate consumption. The difference, however, lays in the fact that the focus is on cocoa flavanols as bioactive compounds in cocoa extract. As opposed to the aforementioned substances glucose and caffeine – which are already controversial themselves – no HFSS food is directly involved. The claim was approved in 2015, being the first in kind in the chocolate field.

Industry pleas for nutrition profiles

Nutrition profiles were meant to prohibit nutrition and health claims on essentially unhealthy foods. As their establishment took so long, thereby creating uncertainty for the industry, the European Parliament initially considered to call them off. However, as shown in the Dextro case, the absence of nutrient profiles caused the Commission to rely on the very general principle of misleading in the appreciation of the claims at stake. This is the key item in food information matters both embodied in the Claims Regulation (article 3 (a)) and the Food Information to Consumers Regulation (article 7 (1)). As this concept of misleading is pretty broad and thereby not well-defined, food companies introduced a plea in favor of the establishment of nutrient profiles. This would shape the level playing field for all FBO’s and ensure that unhealthy foods cannot be promoted using health claims. Five leading food companies have recently called on the Commission in a public letter to take up its task of establishing nutrient profiles. Health and consumer organizations were also involved in the letter, arguing that a clear exclusion of nutrition and health claims on HFSS foods will benefit consumer behavior.

 The road forward

To prevent ambiguous health claims, the prohibition of such claims on beverages containing more than 1,2% alcohol is already explicitly mentioned in Health Claims Regulation. Will claims on HFSS foods be limited in the same manner? The open letter by the industry and other relevant parties is a push into that direction. The establishment of nutrient profiles could mean that the beneficial health effects attributed to cocoa flavanols can no longer be used on those chocolate products classified as ‘unhealthy’, for instance due to their high sugar content usually present in milk choclate. However, at this moment, it cannot be predicted whether the Commission will take up its task after about 10 years of delay. Meanwhile, the ECJ backs the criterion of misleading to fill the regulatory gap. Based on the examples mentioned above, ‘common sense’ based on generally accepted scientific principles provides the line between acceptable use of health claims and misleading practices.

Conclusion

As demonstrated in the Dextro case, health claims on HFSS foods are perceived misleading in society’s current fight against obesity and other diet-related disorders. The ECJ backed a Commission decision rejecting Dextro’s claims, considering the pro-glucose plea contained therein to be in violation of the principle that food information should not be ambiguous and misleading This case is not the first of its kind. Other examples of claims possibly driving consumers towards unintended unhealthy food choices include caffeine in energy drinks. As a consequence, those claims were rejected too. The general learning that can be drawn from these cases is that claims should not be considered in isolation, but in the context of generally accepted scientific standards. As an advice to FBO’s considering filing or using such claim, I recommend not to lose an eye for the context in which the claim is used. This basically comes down using common sense when using or applying for health claims. Does not that make sense?

The author is grateful to Jasmin Buijs, intern at AXON, who co-wrote this post.

 

 


Market access of Chinese traditional herbal remedies in the EU

The People’s Republic of China first law on Traditional Chinese Herbal Medicine came into force on the 1st of July 2017. This law encompasses industrial normalization by guaranteeing the quality and safety of herbs in cultivation, collection, storage and processing. Producers of Traditional Chinese Medicine (hereinafter TCM) are not only targeting the Chinese market, but are also looking for access to the European market. With this new legislation in force in China, it is a good time to have a look at the current possibilities for market access of TCM on the European market. The name “TCM” would suggest the product could only be qualified as a medicinal product. However, other product qualifications are possible as well. In this post, it will be investigated how Chinese herbal remedies and products fit into the EU framework.

Qualification

For market access, product qualification is vital. Qualification of TCM as medicinal products might seem obvious. However, western medicine is mostly focused on curing a certain disease or disorder, whereas TCM is focused on healing the body itself. Healing in short means the body should be strengthened to ‘treat itself’. Many of the traditional herbal remedies have healing properties, such as strengthening the immune system. As an alternative to medicinal products, other qualifications of TCM could be botanicals, so that they could be marketed as food supplements or as other foodstuffs. We previously reported on product qualification in this blog, explaining what legal tools have been developed for this purpose over time in case law. These criteria equally apply to TCM.

Simplified registration procedure for traditional herbal medicinal products

An example of a traditional herbal medicinal product we can mention sweet fennel, which is indicated for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. For this group of traditional herbal medicinal products, just like for TCM, a simplified registration regime can be found in the EU Medicinal Products Regulation. In short, the efficacy of the product containing the herb used in TCM’s can be substantiated with data on usage of the herb. This eliminates the need for costly clinical trails to prove the efficacy of the active ingredient(s) in the product. However, safety and quality of the TCM still need to be substantiated.

Eligibility for simplified registration procedure

To qualify as traditional herbal medicinal product, a number of cumulative criteria should be met, including the following.

  • Evidence is available on medicinal use of the product during at least 30 years prior to application for EU market authorization, of which at least 15 years within the EU.
  • Such evidence sufficiently demonstrates the product is not harmful in the specified conditions of use and the efficacy is plausible on the basis of longstanding use and experience.
  • The product is intended and designed for use without the supervision of a medical practitioner and can only be administrated orally, externally and/or via inhalation.

The presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for the simplified registration referred to above. At least, this is the case as the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). TCM intended and designed to be prescribed by a medical practitioner can enter the EU market, but cannot benefit from the simplified registration procedure for traditional herbal medicinal products.

Foodstuff

Currently the focus of healthcare is shifting from purely curing diseases to prevention thereof. TCM could play an interesting role in such paradigm shift. Although food business operators (hereinafter FBOs) cannot claim a foodstuff can cure a disease, such product can contribute to prevention of a disease. As such, FBOs can inform the public that consumption of a particular foodstuff can support the regular action of particular body functions. An example of a herbal remedy used in TCM and currently on the EU market is cinnamon tea; used in Chinese medicine to prevent and treat the common cold and upper-respiratory congestion. Obviously, the advantage of bringing a foodstuff (for instance, a food supplement) to the market as opposed to a medicinal product is that unless the foodstuff is a Novel Food, you do not need a prior authorization.

Novel Foods

As long as a foodstuff has a history of safe use in the EU dating back prior to 1997, FBOs do not need prior approval for market introduction. If no such history of safe use can be established, both the current and new Novel Food Regulation prescribe that the FBO receives a Novel food authorization. A helpful tool for establishing a history of safe use is the novel foods catalogue, being a non-exhaustive list of products and ingredients and their regulatory status. Another source is Tea Herbal and infusions Europe (hereinafter THIE); the European association representing the interests of manufactures and traders of tea and herbal infusions as well as extracts thereof in the EU. THIE’s Compendium, which should be read in combination with THIE’s inventory list (also non-exhaustive), contains numerous herbs and aqueous extracts thereof, which are used in the EU. Other herbs might not be considered Novel Foods, as long as the FBO can prove a history of safe use in the EU prior to 1997. For instance, the history of safe use of Goji berries has been successfully substantiated.

Traditional foodstuffs from third countries  

In previous blogs we already pointed to a new procedure to receive a Novel Food authorization as of 1 January 2018, relating to ‘traditional foods from third countries’. EFSA published a guidance document for FBOs wishing to bring traditional foods to the EU market, enabling them to use data from third counties instead of European data for the substantiation of the safety of the foodstuff. The procedure is a simplified procedure to obtain a Novel Food authorization for a foodstuff, which has been consumed in a third country for at least a period of 25 years. For sure, this is not an easy one, but we have high hopes that such data can be established for TCM being used in Asia. In the affirmative, the FBO can use these data to substantiate the safety of the product and receive a Novel Foods authorization via a 4 months short track procedure, enabling the FBO to market the foodstuff at stake in the EU.

Health claims for herbal products

The EU Claims Regulation provides the legal framework for health and nutrition claims to be used on foodstuffs. In previous blogs we elaborated how such claims can be used for botanicals, being herbs and extracts thereof. So far, no authorized claims for botanicals are available, but their use is nevertheless possible under certain circumstances. In sum, an on-hold claim can be used when the FBO clearly states the conditional character thereof (by stating the number of such on hold claim on this claims spreadsheet. Upon dispute, the FBO should furthermore be able to substantiate that the compound in the final product can have the claimed effect when consumed in reasonable amounts. TCM can take advantage of this current practice, thereby communicating the healing effect thereof, which basically comes down to a contribution to general health. It should be carefully checked though, if the claim for the herbal remedy at stake has not been rejected, as happened to four claims regarding caffeine. 

Conclusion 

EU market introduction of TCM could take place in various ways, depending on the qualification of the product at stake. Qualification as a regular foodstuff certainly ensures the quickest way to market, as no prior market approval is required. This will be different if the product qualifies as a Novel Food. However, as of 1 January 2018, a fast track authorization procedure will be available for traditional foods from third countries, from which TCM might benefit as well. TCM could furthermore use so-called botanical claims, in order to communicate the healing effects thereof. When the TCM qualifies as a medicinal product, the good news is that for traditional herbal medicinal products, a simplified registration procedure is available under the EU Medicinal Product Directive, provided that certain criteria are met. Registration takes place via the national competent authorities in each Member State, which in the Netherlands is the Medicines Evaluation Board (CBG).


Timmers Promotions