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).


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. These alternatives are similar to ‘traditional’ milk in terms of nutrients and sensory attributes. 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.


Insects as alternative source of animal protein for food and feed

insect-centre-imageDecember is the month of festivities and food. Could insects be part of this tradition in the long run? On 8 and 9 December last, the InsectCentre organized seminar on edible insects in Wageningen. The seminar brought together the insect rearing business of Europe, as well as investors and academics, to discuss opportunities and restrictions for insect rearing in Europe. The seminar covered insect autonomy, insect rearing, economics and legislation. For some background information on the opportunities of insect rearing in the Netherlands, see this document. The focus of this blog will be on the legislation regarding insects in food and feed as discussed in the seminar, combined with our sector knowledge by way of background.

Why the interest in insects?

Insects are extremely versatile and can be put to use in many ways. Insects are the most species rich class of organisms on earth, of which (approximately) 2.500 species are edible. In EFSA’s 2015 report on ‘Risk profile related to production and consumption of insects as food and feed’, 12 of the 2500 edible species are mentioned as having the biggest potential to be used in food and feed. In other parts of the world, insects are a staple food and some insects are even seen as a delicacy. The two most commonly commercially reared insects in the EU for feed applications are the larvae of the black soldier fly and for food applications the lesser mealworm (buffalo) seems to have the best potential. Many insects are pathogenic or too small in size to be commercially interesting to rear. However, during the past years, steady growth in the worldwide demand for alternative protein sources has lead to a renewed interest in insects as a potential source of food and feed. Insects can be viewed as mini short cycled livestock for producing protein. Insect protein is an interesting source of protein due to the quality of the insect protein as opposed to plant-derived protein. Animal protein (so also insect derived protein) has a superior amino acid content compared to plant-derived protein. With a growing world population, the demand for meat production and protein will only increase. Currently soya is imported into the EU for feed purposes. Insects might be a (partial) replacement for this soya in the future, and can even be produced in the EU instead of being imported.

Insects in food

Insects can be reared to produce food as a whole or processed as ingredients for food. As explained in one of our previous blogs, only in some Member States a number of insects are permitted to be used in food, meaning that no enforcement measures regarding such use is taking place. The previously mentioned EFSA report contains the assessment of the risks associated with insects used in food and feed. In short, the overall conclusion was that the safety of farmed insects for use in food and feed strongly depends on both the substrate and the processing of the insects. Further research is needed to be able to fully assess the safety of insects to be used in food and feed.

Current and future regulatory status of insects

Under the current Novel Food Regulation, whole insects are not explicitly regarded as Novel Foods. The rationale therefore is that the category of “food ingredients isolated from animals” are not considered to cover animals (insects) as a whole. However, this will change under the new Novel Food Regulation, entering into force on 1 January 2018, as of when insects will be considered Novel Foods. See our previous blog for further info on the contents of this regulation and the changes in respect of the current Regulation. Under the new Novel Foods regime, it remains to be seen how the competent authorities of the Member States will deal with FBO’s currently using insects in food.

Enforcement as of 1 January 2018

Even if EFSA concluded that additional information is required to assess the safety of insects in food in full, considerable experience has been gained already with the application of insects in food. As far as we are aware, no safety issues have been reported regarding these applications. As safety is the bottom line for enforcement, we take the view that enforcement measures without any safety incidents are not justified just like that. This in particularly applies with respect to products containing only a small percentage of insect derived protein. On the other hand we know that insect manufacturers are using the transition period until 1 January 2018 to compile a full Novel Food dossier based on the Guidelines that were made available in September this year. Taking into account that the new Novel Foods Regulation also contains a regime for data protection, they justify the investment involved to secure a competitive edge the field of alternative protein.

Insects in feed

Two restrictions currently hinder the growth of the insect sector for feed production. The first is a prohibition of certain types of animal protein in feed, commonly referred to as the ‘feed ban’, and secondly, the restrictions on certain types of feed for the insects.

Feed ban

The feed ban, was introduced as a reaction to the BSE crisis, and is laid down in the TSE Regulation. This ban prohibits the use of animal derived protein to be used in feed for farmed animals, unless an explicit exception is made. Insects could have a great potential in feeding farmed animals such as poultry and pigs and also for use in aquaculture. Currently the possibilities for feeding insects to farmed animals and aquaculture animals are limited. However, the European Commission published a draft amendment to the TSE Regulation to partially uplift the feed ban. The amendment will enable the use of certain insects for the production of  Processed Animal Protein (PAP) for the use in aquaculture. Discussions whether the use of PAP could be extended to poultry and pig farming are currently on going.

Food to feed the insects

In addition to the prohibition on the use of insect protein in feed, the materials that can be lawfully used to feed the insects are limited. From a circular economy point of view, the use of manure to rear insects could be attractive. In this way manure could be used to produce feed and the insects could transform the nitrate contained in the manure, that would otherwise contaminate the environment, into valuable nutrients for poultry. However, when rearing insects to produce feed, the insects are considered to be farmed animals (similar to cows or poultry). The Animal By-products Regulation prohibits the use of certain materials in feed for farmed animals, manure being one of them. The ideal situation for the insect rearing industry would be to be able to use all types of other waste stream for rearing insects. This is not possible. Currently only waste streams fit for human consumption and some waste streams of animal origin, such as milk and milk derived products, can be used as feed for insects.

Conclusion:

During the Wageningen seminar referred to in the introduction, the overall opinion of both the presenters and participants was that European legislation currently restricts commercial use of insects for both food and feed applications. On the one hand, the new Novel Foods Regulation will bring legal certainty on the Novel Food status of insects, on the other hand it will require FBO’s marketing insect based food products to obtain a Novel Food authorization. However, for feed there is light at the end of the tunnel. We conceive the exception for PAP of certain insects to be fed to aquaculture to be a first step in getting insects on the menu for poultry and other farmed animals as well. As always, we will keep you posted on developments regarding the use of insects in both food and feed.

The author has written this post together with her colleague Floris Kets, who attended the seminar organized by the Insects Centre.

 


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.


Nothing left to hide? Status quo on Dutch bill permitting active disclosure of food safety inspection results

nvwaRecently, an amendment to the Dutch Health Act (Gezondheidswet) was voted in Dutch Parliament, allowing the Dutch Food Safety Authority (Nederlandse Voedsel en Warenautoriteit or NVWA) to actively disclose its inspection results. The change in the Health Act equally applies to inspection results obtained by the Dutch Health Inspectorate (Inspectie Gezondheidszorg or IGZ) and therefore, it received broad interest from the pharmaceutical, medical devices, and the food industry and their legal practitioners. Three meetings on this topics were organised by respectively the Dutch association of Food Law (NVLR), the Dutch Pharmaceutical Law Association (VFenR) and by the Dutch organisation for food retail and management VMT. This post will put you up to speed on the actual changes to be applied to the Health Act, as well as on the expected consequences of their implementation for food business operators (FBOs).

Importance of inspection results

Inspection results are important for whom it concerns directly (inspected companies, as they provide answers to questions such as: is your organisation compliant? Will a fine be imposed? Inspection results are furthermore of interest to others, such as consumers, journalists and other companies, including competitors, for a number of reasons. These reasons include (but are not limited to) knowing where to supply from and what places to avoid, the possibility to check if your supplier’s manufacturing processes are up to standards and the option to stay informed on what challenges your competitor is meeting.

Active vs. passive disclosure

All administrative bodies disclose information, on their website, in social media, in leaflets, etc. Under the Dutch Act on Public Access to Government Information (Wet openbaarheid van bestuur or WOB) citizens have the right to file a request for information on administrative matters. The disclosure of such information on request of a person is called passive disclosure. Such disclosure does not take place publicly, but the information concerned will solely be provided to the person who filed the request, unless it is rejected based on the limited grounds specified in the WOB. Active disclosure on the other hand means that the information is disclosed by an administrative body prior to any request for information. Such information is publicly available after disclosure. In case of inspection results of the NVWA, these will most likely be published on the website this administrative body.

Rationale disclosure inspection results

The rationale for both passive and active disclosure of inspection results is threefold.

(i) Transparency. Without information on the inspection, one cannot assess the quality of the inspection or view the results of the inspection. This transparency is also present in other areas such as inspection results of the Inspectorate of Education and the Health Care Inspectorate.

(ii) Trust. By showing the results, the public can see what the NVWA is doing and therefore the public can build trust in the NVWA.

(iii) Increased compliance. Negative results of an inspection can lead to serious problems towards consumers or customers, such as liability claims from suppliers who expected to be supplied with products produced in compliance with the applicable quality standards and hygiene regulations). In this way active disclosure increases the pressure on FBOs to comply.

The current system

Opposed to other inspectorates in the Netherlands, the active disclosure by the NVWA is currently not provided for in a specific Act. So far, the mechanism laid down in the WOB has been used as the framework for disclosure of inspection results. Article 8 WOB enables the NVWA to actively disclose information, provided this is done is a clearly understandable way and offering interested parties in due time the opportunity to comment. As far as a request for information by any company or citizen is concerned, there are predefined grounds on which an administrative body cannot freely disclose information, being absolute and relative grounds. The absolute grounds are found to be of such importance that publication is interdicted, like confidential commercial information relating to the safety of the state or information containing personal data. The relative grounds relate for instance to privacy matters or to disproportional harm that could be created by publication. Such grounds have to be weighed against the interests of disclosure. In the current framework, the interested party can express a provisional opinion with respect to any intended publication by NVWA, which has to be dealt with before publication. This mechanism will disappear under the new system.

The new system

When the amendment of the Health Act will enter into force, the NVWA will not only have the option to actively disclose information, but will be obliged to do so. In the legal framework, the assessment of interests is already taken into account, which makes it unnecessary to do another assessment each time the NVWA decides to actively disclose information. In future, the option to express a provisional opinion by the NVWA will no longer be available. The only way to ensure that the information is not disclosed is starting summary proceedings before a civil court. If any interested party is doing so, NVWA will then be forced to suspend its decision to disclose information until the court decides on the matter. In case the NVWA will disclose the inspection report, the NVWA will provide the option for FBOs to provide a reaction to the inspection results, which will be disclosed together with the inspection results. In addition to the change applied to the Health Act, an underlying decree needs to specify more detailed rules on what information exactly needs to be published in what format. In the discussions on the amendment of the Health Act another amendment was added which ensures the underlying decree can only be amended with the approval of Dutch Parliament.

Current status of the amendment

On the 11th of October the House of Representatives of the Netherlands (Tweede Kamer) accepted the proposed changes to the Health Act and amended some parts. The Dutch Senate (Eerste Kamer) accepted the amendments without making any additional amendments on the 1th of November. However, the change of the Health Act has not yet entered into force and it is currently still unclear when the exact date of entry into force will be. Guestimates are hinting at June 2017, however the Ministry of Health Welfare and Sport is still working on the underlying decree on what information has to be published and in what format. There is a fair chance the amendment will only enter into force simultaneously with this underlying decree. In such case the entry into force of the changes to the Health Act will most likely be later than the guestimate mentioned above.

Situation in other EU countries and NVWA pilot

Other EU Member States already have a system of active disclosure of inspection results for restaurants in using a system of easily understandable designations or colours (Denmark and Ireland for instance). In those countries, the outcome of the inspection is presented at the entrance of the inspected restaurant, in order to give the public an overview of the level of compliance at first glance. For instance, a green colour or a happy face means that the restaurant is compliant and colours closer to red or a less happy face mean the place was less compliant. In the Netherlands, the NVWA launched a pilot for disclosure of inspection results for lunchrooms, which were disclosed via an app. This app subsequently displayed the results on a map. The map showed the lunchrooms in four different colours, depending on the level of compliance. The idea was to provide a quick overview of the lunchrooms and the level of compliance. However, the reaction of the minister of Health, Welfare and Sport to this format was negative due to interpretation issues, particularly interpretation of the colours. There are also lists of inspected products instead of inspected FBOs. The experience gained therewith and during the pilot will have to be evaluated in order to choose an acceptable form for the disclosure of over 200.000 inspections done each year in the Netherlands by the NVWA.

Criticism

The proposed changes to the Health Act have been much criticised. The active disclosure of the inspection results together with the imposed sanctions can be viewed as punitive sanction in addition to the sanction itself imposed based on the findings during the inspection. In the explanatory notes on the amendment of the Health Act, the government explains that active disclosure should not be perceived as a punitive sanction and therefore not a criminal charge in the sense of Art. 6 ECHR. In case the disclosure will be viewed as a punitive sanction, article 6 ECHR will be applicable, meaning the procedural safeguards embodied in this article will apply. Basically, the government states that the disclosure does not aim at punishing the inspected party, and therefore is not an additional sanction. However, the arguments provided by the government in the explanatory notes are not very convincing. Assuming the disclosure will lead to more transparency, consumers and customers will be aware of the non-compliance due to the disclosure. This disclosure can in turn decrease the trust in the non-compliant producer, which could mean a decline in sales or even liability claims from consumers or customers. It is not the fines imposed by the NVWA, but the disclosure of the inspection results, which leads to these (potential) damages of the producer, whom will not have had the chance to remedy the situation before it is out in the open. This is all the more important, as so far there is no evidence that such public disclosure indeed will lead to an increased level of compliance. Moreover, this situation does not seem to be in line with competition law, which constitutes the regular level playing field of any FBO, just like it is for manufacturers of medical devices or medicinal products. Therefore, competition law elements should in our opinion be an aspect of the legislation concerning disclosure. In the explanatory notes to the amendment, this aspect has not even been mentioned.

Conclusion

As a result of a change applied to the Dutch Health Act, the first steps towards active disclosure of inspection results from the NVWA have been initiated. The actual implementation thereof depends on the underlying decree, which is still under construction. This is why is not clear as of when the legal basis for active disclosure of NVWA inspection results will be operational. As of this moment however, FBOs will be subject to increased enforcement measures, without the effect thereof being necessarily positive. We will keep an eye out for you and report on any relevant development in this field, as they are likely to have an important impact for each FBO.

The author thanks Floris Kets for his contribution to this post.


Enforcement measures regarding borderline products

Nederland, Leiden, 18 maart 2015, Gaper in Centrum van Leiden. Drogist winkelstraat Leiden, Gaper, gapers vanaf de 17e eeuw als uithangteken voor een drogist gebruikt. De nar als gaper verwijst naar de kwakzalver die op jaarmarkten en kermissen zijn diensten aanbood. In gezelschap van zijn knecht (een nar in rare uitdossing) kon hij indruk maken en was hij verzekerd van klanten. Een andere gaper die veel voorkomt is de zieke zelf, soms met pil op de tong. medicijnen drogist apotheek pillen beeld pil patient patienten slikken apotheker medicijn zelfmedicatie medicatie farmaceutische farmacie geneesmiddelen zorgpremie gezondheidszorg Foto; Peter Hilz / HH

Photo Peter Hilz / HH

As observed in an earlier post, the boundaries between food products and medicinal products are sometimes blurred. However, the qualification of a product as either one or the other may have huge regulatory consequences. In recent litigation in several Dutch Courts the Hecht-Pharma decision from the EU Court of Justice (ECJ) was applied. This series of cases is of interest for food business operators, as it provides a clear message regarding enforcement measures directed against borderline products. The national health authorities should strike a fair balance between the free movement of goods and the optimal protection of public health. Whereas enforcement policies re. borderline products constituting a threat to public health may be justified, this does not entail that each and every food product containing a substance with a physiological effect automatically qualifies as a medicinal product by function.

Red Rice

The facts of the case Hecht-Pharma related to a food supplement with fermented rice that Hecht-Pharma had been marketing in Germany under the name “Red Rice”. The recommendations for use read “as food supplement, 1 capsule, 1 – 3 times a day”. The German authorities had qualified this product as a medicinal product by function, but Hecht-Pharma did not agree. It argued that having regard to the recommended dose, the product at stake could not exert a pharmacological action.

Medicinal product by function

In its request for a preliminary ruling, the Federal Administrative Court aimed to clarify if, after a change of the Medicinal Products Directive, criteria previously developed to establish if a product qualified as a medicinal product by function, still applied. Qualification as a product as a medicinal product by function implies that it is aimed at a change in physiological functions by exerting a pharmacological, immunological or metabolic action. The ECJ confirmed in its Hecht-Pharma decision that previously developed criteria were still in place. As a result, the national authorities must decide on a case-by-case basis, taking into account all the characteristics of the product at stake, in particular its composition and pharmacological properties, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail when they decide if a product qualifies as a medicinal product by function. Clearly, a product cannot be regarded as such, when it is incapable of appreciably restoring, correcting or modifying physiological functions in human beings.

Melatonin-based products

The Dutch Court cases related to melatonin-based products, marketed by a number of companies represented by the Dutch foods supplements association NPN (Natuur- en Gezondheidsproducten Nederland). During the period between 2011 and 2014, The Dutch Health Inspectorate (IGZ) and the Dutch Food Safety Authority (NVWA) on the one hand and NPN on the other hand, corresponded on the topic of melatonin-based products. The Dutch authorities thereby took the view that they considered products containing 0,3 mg melatonin or more to be a medicinal product by function. They based their view on literature studies, from which it would follow that a single oral dose of 0,3 mg melatonin produced a pharmacological effect on humans. In view of their public role of safeguarding public health, the authorities intended to launch enforcement measures regarding products containing more than 0,3 mg melatonin, unless the manufacturer at stake had applied for an authorization to market these products as medicinal products.

Enforcement measures and subsequent summary proceedings

Early 2015, IGZ sent a letter to all Dutch manufacturers of melatonin-based products informing that they would require a market authorization for continued marketing of products containing 0.3 mg melatonin or more. Each such manufacturer should inform the authorities prior to 15 March 2015 for which melatonin-based products it would or it had already applied for such authorization, failing which enforcement measures could follow. NGN subsequently initiated summary relief proceedings, claiming inter alia that IGZ should refrain from enforcement measures, unless it had demonstrated with respect to each and every melatonin-based product that it qualified as a medicinal product according to applicable legal criteria as validated in case law. In these proceedings, NPN claimed that IGZ had not sufficiently demonstrated, based on scientific evidence, that products containing 0,3 mg melatonin or more could change physiological functions in the human body, for instance by a pharmacological effect. Furthermore NGN argued that IGZ had neglected to apply the criteria developed in Hecht-Pharma, according to which IGZ should have established with respect to each melatonin-based product that it qualified as a medicinal product, thereby taking into account all relevant circumstances. According to NPN, these products were food supplements, not medicinal products.

Evaluation by the Court in summary proceedings

Based on a very broad interpretation of the definition of medicinal product, as contained in article 1.2 of the Medicinal Products Directive, NGN’s claim was dismissed. According to the Court, assessment of each individual product could be done by the Dutch Medicines Evaluation Board or by EMA, upon filing of an application for marketing authorization. It was not necessary for IGZ to proceed to this evaluation at an earlier stage, as the chances that any deviations from the general conclusion would be found, were considered very small. The Court did consider however that IGZ’s communication and application of enforcement measures had not been unambiguous. Even if the manufacturers of the melatonin-based products followed the request to indicate by 15 March 2015 for which products they filed an application for marketing authorization, it would not be clear by when they would know if IGZ – pending such application – would refrain from enforcement measures. This created uncertainty in the market and was considered unlawful vis-à-vis NGN. The Court therefore ordered IGZ to set a term after 15 March 2015 during which the products for which a market authorization had been requested would be tolerated.

Decision reversed on appeal in summary proceedings 

On appeal, the discussion was focused on the correct application of Hecht-Pharma. Contrary to the Court in first instance, the Appeal Court held that a public health authority announcing enforcement measures should at that very moment motivate why a product containing > 0,3 mg melatonin qualifies as a medicinal product. A different approach could create unjust market restrictions, for instance regarding products that upon application were not considered medicinal products. Moreover, the requirement to file a market authorization for each and any melatonin-based product containing > 0,3 mg melatonin is not just a formality, but would oblige manufacturers of this type of products to make an important investment in time and resources. Taking into account there were no acute health issues for the continued marketing of melatonin-based products, at least not for those containing a maximum up to 5 mg melatonin, the Appeal Court ordered that public health authorities should apply all criteria developed in Hecht-Pharma when considering enforcement measures against borderline products.

Confirmation in proceedings on the merits

This summer, the District Court of The Hague confirmed in a decision on the merits the appeal decision in summary proceedings discussed above. In short, this Court held that the unconditional qualification of a group of products as medicinal products, without any individual evaluation taking place, was not in line with EU case law. The Court in particular referred to paragraph 68 of the conclusion of the Advocate General. The Advocate General stated, inter alia, that the insidious extension of the scope of the Medicinal Product Directive by including products that do not belong there, would harm the free movement of goods. Therefore, until an individual assessment of a borderline product based on the Hecht-Pharma criteria has taken place, the public health authorities are not allowed to take any enforcement measures. No appeal was filed by IGZ against the present decision of The Hague District Court, but we were informed that where necessary, IGZ will proceed to enforcement in individual cases.

Take home

If and when your company receives a warning letter from IGZ announcing enforcement measures because of its borderline status, please bear in mind the following. Before considering any change in the product like the lowering of its active substance or even its withdrawal from the market, the public authorities should have unconditionally qualified the product at stake as a medicinal product. If and when this situation is not clear, make sure to obtain professional advice to properly deal with the health authorities.

 

 

 

 

 

 


Organic certification of food grade micro algae – wishful thinking or soon reality?

161003-essentials-sports-shotjeAlgae are in the spotlight as a sustainable source of protein, fibres and fatty acids. A form of sustainability is found in organic production. Besides sustainable, consumers perceive organic products as healthy and safe. Therefore producers of microalgae would like to use the organic logo. We previously reported on this topic in an earlier post this year. This post reports what is new in the regulatory framework. It furthermore elaborates on the legal and practical obstacles that algae producers currently encounter with respect to the use of the organic logo, as regulated here, and it explores potential solutions.

Various species of algae

The term “algae” covers both macro- and microalgae. Macroalgae – popularly called seaweed – can be seen with the naked eye. Examples include nori (sushi sheets), sea lettuce and kelp. Microalgae are single-celled organisms up to 50 micrometres in size, and thus not or hardly visible to the naked eye. There are many different species of microalgae, of which Chlorella and Spirulina are the best known. Both species have a history of safe use as application in food for human consumption. This means that the Novel Food legislation does not preclude the use of these algae in foodstuffs.

Organic certification


For a general description of the content of the EU Organic Regulation, we refer to our previous post. In essence, it comprises an overall system from farm to fork for the production of foodstuffs including micro and macroalgae. Furthermore, it provides for the possibility that so-called compliant products imported into the EU from recognized countries may be marketed as organic when certain conditions are met. The bottleneck so far was that the EU Organic Regulation did not provide for specific rules for the production of microalgae. This situation was partly remedied by the so-called Interpretative Note that the Commission published in July 2015. This document accepted the application of private standards recognized or accepted by the Member States, provided that they did not impose additional measures upon products originating from other Member States. Furthermore, it was established that until the moment that detailed production rules for micro algae would be determined, the production of microalgae must comply with the rules applicable to the production of either plants or seaweed. As a consequence, there was no consensus about the exact production standards for organic labelling of microalgae produced in Europe. At the same time it was – and is – possible for organically produced microalgae in third countries to be imported as such in the EU. Because of this situation European microalgae products are one-nil down.

Further regulations


In April this year, the Commission adopted a new Regulation changing the executive provisions of the EU Organic Regulation. In this 2016 Regulation, the Commission stipulates that to date no detailed production rules have been defined for microalgae used as food. Because of this it is still unclear what production rules govern the cultivation of microalgae. Therefore it should be clarified that detailed production rules that apply to the production of seaweed also apply to the production of microalgae for use as foodstuff. This clarification has been obtained by extending the production rules for seaweed applicable to feed, based on an amendment of the executive provisions of the EU Organic Regulation, also to food. The 2016 Regulation will enter into force on May 7, 2017.

Practical problems


Are thus all obstacles removed to organic certification of microalgae produced in the EU? Unfortunately not, because microalgae cannot be compared with seaweed just like that; as seaweed is a macroalgae. Although there are similarities between growing micro and macro algae, the harvest thereof is different. As to the similarities: both macro and micro algae need dissolved minerals and CO2 to grow since they do not break down manure automatically. Therefore, fertilizer and manure derivative products are usually added to the water in order to make the minerals contained in the fertilizers bioavailable to the algae. However, the addition of fertilizer or manure derivative products to an algae culture results into the harmful organisms present therein, such as toxins and heavy metals, to mix with the algae. Products made from algae to which manure or manure derivatives solutions are added, may therefore constitute a very high food safety risk. As to the differences between macro and micro algae: in the harvest of seaweed only the macro algae are harvested. The organisms and bacteria present in the water remain there and the product can be cleaned from harmful substances. However, this is not possible with the harvest of microalgae because of their small diameter. As a result, the bacteria, fungi and other organisms present in the culture are harvested as well and partly end up in the final product. The food safety of such products is questionable.

Risks of open cultivation systems


The vast majority of micro-algae are being cultivated in open ponds. These systems are afflicted by external influences. For that reason, a pond is continuously contaminated with undefined organisms such as bacteria, fungi, aquatic insects, toxins and even faeces. A method to inhibit this unwanted growth is the use of high concentrations of iodine. Algae products from such systems often contain very high concentrations of iodine and they therefore constitute a potential health risk. Nevertheless, third countries other than recognized countries do certify these products as being organic. As a matter of fact, they are marketed outside the system of similar products and recognized countries. This forms a troublesome form of competition for micro algae produced in the EU.

Advantages of closed systems


In closed systems, there are hardly any external influences. In these systems, the entire process of cultivation up to and including harvest can be closely monitored. In the unfortunate situation that any contamination occurs, this can promptly be detected and appropriately responded to. This way of cultivation of algae excludes the risk of unwanted organisms in the final product. However, in order to be able to grow algae under these conditions, the minerals required for the start of growth of the algae have to be added in a different way than in the open nature. Production of microalgae in closed systems therefore usually takes place by the addition of dissolved minerals.

Addition of minerals hinders organic certification


In organic production only a limited number of permitted minerals can be used. When an algae producer uses minerals that are not on the list of permitted substances, he cannot certify his products as being organically grown for the time being. From that perspective, it is important to mention that for some minerals, such as nitrogen and phosphate, there are no suitable natural alternatives or sources available. Mineral salts extracted from mines for instance are not considered safe for use in food. Therefore, currently isolated variants, of which the food safety is guaranteed, are used. Even if an algae producer could apply for admission of these minerals on the list, this has a downside. Normally, these minerals form an integral part of a specific production process containing proprietary information that cannot be disclosed by an algae producer just like that. When filing a request for authorization of minerals in organic production, the probability is low that confidential elements of the relevant production processes remain confidential in such an application.

Possible solutions


We see two possible solutions to the problems identified above. Firstly, we expect that when the confidentiality of so-called proprietary data in an application for authorization of certain minerals in organic production could be ascertained for a minimum period, this would give a big boost to the organic cultivation of microalgae. Such regimes also exist for dossiers to be filed for the authorization of Novel Foods and of health claims, so this is not uncommon in food law. Secondly, a so-called grace period for substances currently used in closed culture systems could provide a solution. This grace period would need to apply until there is an acceptable functional alternative available for the envisaged substances in terms of quality, quantity and price. In both cases, of course, food safety is paramount. This means that the added minerals should be proven to be food-safe. Application of the proposed solutions would enable EU producers of microalgae the opportunity to use the EU organic logo for food-safe algae products. This would be a win-win for consumers and producers.

This post is based on a Dutch article that was co-written by the Dutch algae manufacturer Nutress, belonging to the Phycom group. It was published in the September 2016 issue of VMT, a Dutch magazine for the food business. The picture was kindly provided by Nutress, who owns the copyright thereof.

 


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