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.

 


What Do Medical Devices Have To Do With Food?

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

Self-regulation of Marketing Food Products in the Netherlands

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

Clearance and monitoring services

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

Facts of the XL-S Medical Case

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

The Complaint

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

Complaint rebutted

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

Conclusion

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

 

 

 


Brexit: what are the consequences for nutraceuticals?

Mandatory Credit: Photo by Tolga Akmen/LNP/REX/Shutterstock (5738024r) Pro-EU campaigners protest against Britain leaving the European Union in Trafalgar Square London Stays anti-Brexit demonstration, Trafalgar Square, London, UK - 28 Jun 2016 The referendum was won by the leave campaign and caused Prime Minister David Cameron to resign on 23 June 2016.

Shock and awe: they did it! A few days after the United Kingdom voted to leave the European Union, many sectors are investigating the consequences thereof for the services and products concerned. The more a sector has been regulated at an EU level, the more severe those consequences tend to be.

EU landscape of food law

If any sector has been highly regulated at an EU level, it is the food sector. The BSE crisis in the ’90-ies gave rise to the General Food Law Regulation in 2002, which has been the basis for a considerable corpus of rules relevant for the nutraceutical sector. These rules include the Food Supplements Directive (2002) as well as the Regulation on Fortified Foods and the Claims Regulation (both from 2006), as well as the Food Information to Consumers Regulation (2011) and the Regulation on Foods for Special Groups (2013) to name just a few.

What is going to happen next?

Although it is difficult to imagine that years of laws and case law can be cast by a vote, strictly speaking the European Regulations will cease to apply in the United Kingdom once it no longer forms a part of the EU. Also, there will no longer be an imperative to implement European Directives into English national law. Access for European nutraceuticals to the UK market and access for English nutraceuticals on the EU market will therefore depend on the instruments replacing the common European framework.

What are the options?

Firstly, the UK could reach and agreement similar to the one that the EU has with Norway or Iceland. In that case, the impact in the field of nutraceuticals would be fairly limited; the UK forming part of the European Economic Area and to a large extent be bound by EU legislation. Secondly, if the relationship would be shaped after the one between the EU and Switzerland, the implications could be more important, as EU food law would not be of general application in the UK. Thirdly, the gap between the current and future situation would be even greater if the relationship will be similar to the one that the EU has with the USA under the WTO, as for each specific sector specific agreements would need to be negotiated.

The trigger and the transition period

In order to move to the next stage, the UK will have to inform the Council of its decision to withdraw from the European Union, based on the famous article 50 of the Lisbon Treaty. So far, the UK seems to be divided on the question when this process has to be initiated. Some (Europeans) speculate that it may not be initiated at all. However, once the Council has received notice from the UK, an agreement setting out the arrangements for withdrawal should be negotiated within two years. During this transition period, the EU regulatory framework for nutraceuticals shall – in principle – remain in force. However, it can be expected that food business operators shall anticipate on the shift in the regulatory landscape. The UK may become less attractive to trade nutraceuticals due to the uncertainly what will be the applicable rules there.

Open ends… or not?

Based on the EU regulatory framework, nutraceuticals generally do not require prior market approval. This implies that English nutraceuticals could in principle still be marketed in the EU after the Brexit becoming effective. However, any English nutraceuticals marketed in the European Union will have to meet the EU requirements regarding the type of vitamins and minerals that may or may not be used in food supplements and fortified foods respectively. Furthermore, English nutraceuticals to be marketed in Europe may only use those nutrition and health claims that have been authorized at an EU level and that bear information on ingredients and nutrition facts in line with the Food Information to Consumers Regulation. The other way round is much less clear, meaning that it will remain an open question for quite some time with what rules European nutraceuticals to be marketed in the UK will have to comply . This will depend on the rules applicable to nutraceuticals in the UK replacing the EU regulatory framework. Summarizing it seems that trading UK nutraceuticals in the EU will not become “easier” from a UK perspective, whereas marketing European nutraceuticals in the UK will become less attractive because of the regulatory flaw.

Homework on IP licenses

For those food business operators distributing nutraceuticals under license in the licensed territory of the European Union, it is mandatory to clarify whether or not that territory still includes the EU after a Brexit becoming effective. This will not only depend on the wording of the agreement but also on the trademark backing the license. If this is for instance an EU trademark (former Community Trademark), this will no longer be valid in the UK in future. Moreover, if the validity of this EU mark was mainly based on genuine use in the UK, the validity of the entire trademark could be at stake because such use would no longer be of relevance for the continued existence of the mark.

Conclusion

The majority of the British people do not seem to have done a favor to the nutraceuticals industry, to put it mildly. In order for English nutraceuticals to access the EU market, these products will have to meet the EU standards anyway. For European nutraceuticals to be marketed on the Brittish market however, it cannot yet be predicted to what rules they need to comply. It does not seem to be realistic that the UK will opt for the Norwegian model, as it deliberatly moved away from the EU and – presumably – from the EU regulatory framework. It is also hard to conceive that the UK, being such an important trade partner of the EU will put in the same position as the US under the WTO. Remains the Swiss model as a most likely option for the trade agreements to be negotiated between the EU and the UK, but the Swiss model currently also implies the free movement of persons, which is an issue for the UK. So this is not an easy one. Keep you posted.

 

Photo by Tolga Akmen/LNP/REX/Shutterstock (5738024r) Pro-EU campaigners protest against Britain leaving the European Union in Trafalgar Square – London Stays anti-Brexit demonstration, Trafalgar Square, London, UK – 28 Jun 2016. The referendum was won by the leave campaign and caused Prime Minister David Cameron to resign on 23 June 2016.

 

 

 

 

 


Vitafoods revisited

Screen Shot 2016-06-01 at 00.29.38This year marked the 20th anniversary of VitaFoods Europe. This is a global nutraceutical event, where the whole industry gathers to meet, talk, listen and do business. Axon Lawyers again participated in this event, which took place from 10 – 12 May in Geneva, by giving four presentations. Below, you will find a short wrap up of each of them as well as the slides belonging thereto.

B2C Communications in the functional food and nutraceutical sector

Each and any food business operator loves to communicate the benefits of its products, especially in the functional food and nutraceutical sector. However, a strict regulatory framework applies to such communication, which has been largely harmonized at EU level.

For instance, when using nutrition and health claims, one should make sure the authorized wording (or any permitted variation) is used, as well as that the conditions for use are met. Furthermore, one should know that regarding food for special medical purposes, the use of health claims is prohibited. It thereby does not make a difference whether the marketing is targeted at health care professionals or at consumers/patients. Finally, one should avoid making medical claims for food products, including functional foods.

The presentation shows that, based on the presentation of functional foods, it is not always easy to tell whether it is a food product or a medicinal product. Guidance is provided how to prevent a food product to qualify as medicinal products in order to prevent fines for unauthorized marketing of medicinal products.

Vitafoods B2C communication in the funtional food from Axon Lawyers

Marketing functional food to children within the EU

The marketing of functional food to children requires intimate knowledge of the applicable legal framework, both at an EU and at a national level. This presentation starts with a bird’s eye view on the topic, based on the recommendations of the WHO on the responsible marketing of foods and non-alcoholic beverages to children.

Subsequently the EU framework embodied in the Regulations on Health & Nutrition Claims, Food Information to Consumers and Food for Special Groups is discussed, where concrete examples of authorised claims for specific products are discussed.

Finally, it is explained that in various Member States, self-regulatory bodies such as the Advertising Code Committee in the Netherlands and the Advertising Standards Agency in the UK, play an important role in the evaluation of marketing campaigns of functional food products targeted at children. Again, concrete examples are provided by way of guidance.

Vitafoods marketing functional food to children from Axon Lawyers

New EU Clinical Trials Regulation

The aim of the new EU Clinical Trials Regulation (‘CTR’), which is applicable from 28 May 2016, is to ensure that Member States base their assessment of an application for authorisation on identical criteria throughout the EU. Furthermore, it aims to create an environment that is favourable for conducting clinical trials in the EU with the highest standards for patient safety.

The CTR applies to all clinical trials conducted in the European Union. It does not apply to non-interventional studies. The CTR covers investigations in relation to humans intended to:

  • discover or verify effects of one or more medicinal products;
  • identify any adverse reactions to one or more medicinal product;
  • study absorption, distribution, metabolism and excretion of one or more medicinal products to ascertain the safety or efficacy.

So, what is the relevance of the CTR for nutraceuticals, as only medicinal products are covered by the CTR? Although there is no legal definition of ‘nutraceutical’, the word was introduced in 1989 as a portmanteau of the words ‘nutrition’ and ‘pharmaceutical’. Thus, nutraceuticals blur the line between food and drugs and it is often difficult — by legal definition — to distinguish between nutrients, food additives, drugs and nutraceuticals. The presentation discusses relevant case law concerning the food/drug borderline and provides the highlights of the new CTR from that perspective.

Vitafoods eu clinical trials regulation from Axon Lawyers

Alternative sources of protein

Like last year, alternative proteins were all over Vitafoods. Reasons for the development of alternative sources of protein are easy to point out: health, sustainability and animal welfare. In October 2015, the WHO published a scientific report in which the following was concluded: ‘Consumption of processed meat increases colon cancer risk.’ In the Netherlands, the Dutch Health Council promotes a diet containing more plant based than animal derived proteins.

Eating less meat – and animal derived protein – is also better for the environment as the current production methods require too much natural resources. Last but not least, if meat consumption decreases this is positive for animal welfare. Not only because less animals are slaughtered, but the risk to outbreaks of diseases such as swine fever decreases. Therefore, today there are many alternatives to the consumption of meat.

In the presentation some alternative protein products, such as products containing algae, mushrooms or insects are discussed in the light of the new Novel Foods Regulation as food products may be qualified as “novel” and therefore require authorization under the EU Novel Foods Regulation.

Vitafoods – Alternative Sources of Protein from Axon Lawyers

 

 


How about claims for botanicals?

VitaminesperpostBotanicals are preparations made from plants, algae or fungi that are applied for uses in cosmetics, pharmaceuticals and food supplements. These products have become widely available in the EU and can be bought OTC in pharmacies, supermarkets, drug stores and via the Internet. As to foods supplements, typically these products are labelled as “natural foods” and they come along with various claims regarding potential health benefits. The authorization of health claims for botanicals is still pending in the EU, meaning that they have been neither authorized nor rejected. A recent case from the appeal body of the Dutch Advertising Code Committee perfectly demonstrates the room for manoeuvre for this type of claims.

Green coffee extract

The Dutch online store www.vitaminesperpost.nl offered for sale the product “Green Coffee Plus Extra Strong”, consisting of a green coffee extract, to which was added an extract from green tea and artichoke. The product was a food supplement advertised as being a powerful formula for fat burning, based on its high contents of chlorogenic acid. The Dutch Advertising Code Committee received a complaint regarding this product, as its allegedly beneficial properties could not be substantiated. Complainant had consulted the Natural Medicines Comprehensive Database regarding all 3 ingredients, but did not find any support for the claim regarding fat burning. Complainant considered the claim misleading and therefore unfair.

Authorized use of “claims on hold”                                                                                     

The Dutch branch organization for marketing health products (KOAG/KAG) currently permits the use of health claims for botanicals under certain conditions. The advertiser should be able to produce the EFSA ID number under which the claim is on hold, as well as the conditions of use and the recommended quantity per day of the ingredient at stake. Furthermore, when the use of such claim is disputed, the advertiser using it should be able to substantiate it. In the case at hand, the FBO selling Green Coffee Plus Extra Strong deduced from EFSA’s on hold claims database that it was permitted to associate at least green tea and artichoke with weight control and / or digestion.

Substantiation of claims made

In first instance, the Advertising Code Committee recognized the claim “stimulates fat burning” as a health claim, whereas it was not immediately obvious to which of the three ingredients this claim was linked. Due to the applicable transition regime with respect to the “on hold” claims for botanicals, it did not consider this claim to be in violation of the Health Claim Regulation. The Dutch Advertising Code Committee insisted however that the advertiser of the product Green Coffee Extra Strong substantiates its claim regarding fat burning. The plausibility of the claim made does not automatically follow from the fact that certain ingredients are placed on EFSA’s on hold database. As the advertiser did not succeed to provide the required evidence, his advertisement was considered incorrect. On the basis of this incorrect information, consumers might be inclined to buy the product, which is why the advertising was also considered misleading and therefore unfair.

From green coffee to green tea

On appeal, it became clear that the advertiser was aware that it was not allowed to make any health claims for green coffee. It had therefore added to its product a green tea extract for the minimum conditions of use to obtain the claimed effect. The advertiser clarified that the claim for fat burning was specifically linked to green tea. The Appeal body established that for green tea, a number of claims were on hold in connection with “weight management” and “fat metabolism”. It furthermore established that for such claims to be lawfully used under the transition regime captured by article 28.5 of the Health Claims Regulation, the following conditions should be met:

  • the claims should not be misleading (article 3 Claims Regulation);
  • the claims must be based on generally accepted scientific evidence (article 6 Claims Regulation); and
  • the claims should be in compliance with national legislation.

Anticipating authorization procedure

When an advertiser uses an “on hold” claim and without reservation claims a particular effect, it in fact anticipates the outcome of the authorization procedure pertaining thereto. In such situations, said advertiser should be able to substantiate the claim when disputed. The rationale thereof is that the Health Claims Regulation aims to maintain a high level of consumer protection (article 1 Health Claims Regulation) and in general advertisers should be able to substantiate their claims (article 17 Health Claims Regulation). Once again, it was established that the advertiser was not able to do so and therefore its use of the claim regarding fat burning was considered misleading. The fact that he was also using the disclaimer that Green Coffee Extra Strong was not a miracle product and that it should be used as in support of a healthy diet and sufficient physical exercise, could not change this conclusion.

Negative EFSA opinion

Moreover, it appeared that EFSA had published a negative opinion stating that there was no relationship of cause and effect between the consumption of green tea and green coffee and fat burning. Basically, this was the end of the story, as EFSA had declared that substantiation of claim with respect to fat burning in relation to green coffee and/or green tea could simply not be delivered.

Conclusion

Under the current regulatory framework, it is not allowed to use health claims for botanicals, provided that the conditional character of such claims is clearly communicated. Before using any such claim, it is furthermore recommended to check if it is not covered by a negative EFSA opinion. Finally, when the claim made is being disputed, the advertiser should be able to substantiate it.

 

 

 

 

 


Timmers Promotions