On 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.
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
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.
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.
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.
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.
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.
Algae 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.
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
Botanicals 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.
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.
Some food supplements claim to help the consumer to lose weight and achieve the ideal bodyweight by consuming the product. Sounds too good to be true? Then this post is of interest for you. Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to provide a scientific opinion on the conditions of use for health claims related to meal replacements for weight control. In fact, the NDA Panel previously evaluated the conditions of use for these types of claims in 2010. We take this re-evaluation as an opportunity to report on the legal framework for weight loss claims regarding foodstuffs.
Relevant legal framework
The relevant legal framework is constituted by both the Health Claim Regulation and the Energy Restricted Diets Directive. Article 12 of the Health Claim Regulation prohibits the use of claims making reference to the rate or amount of weight loss. According to article 13 of the Health Claim Regulation however, it is permitted to use health claims describing slimming or weight control or a reduction in the sense of hunger. It is also permitted to use claims describing an increase in the sense of satiety or the reduction of the available energy from the diet. For these claims to be allowed, they should be in line with the requirements of the Energy Restricted Diets Directive (containing both compositional and labeling requirements) and they should be included in the Community list of permitted claims. Furthermore, these claims should be based on generally accepted evidence and they should be well understood by the average consumer.
Various claims allowed regarding normal metabolism
The consumer could be helped in achieving weight reduction by consuming products that replace some of the daily need for energy or that reduce the craving for more food. In fact, maintaining a healthy metabolism (of either lipids or carbohydrates) could result in weight loss on the long term. There are quite a few authorized claims relating to a normal metabolism. For instance, the claim “Zinc contributes to normal carbohydrate metabolism” can be used if the product to which it relates contains zinc in a quantity of 1,5 mg/100 g or 0,75 ml/100 ml. Furthermore, the claim “Calcium contributes to normal energy-yielding metabolism” is allowed if it relates to a product contains at least 120 mg/100 g calcium or 60 ml/100 ml Calcium. As a final example, the claim “Choline contributes to normal lipid metabolism” can be used if the food product at stake contains at least 82,5 mg of choline per 100 g or 100 ml or per single portion of food.
One single authorized claim regarding weight loss
Until now only one single claim with respect to weight loss has been authorized. The claim reads “Glucomannan in the context of an energy restricted diet contributes to weight loss”. Glucomannan is extracted from a plant called “konjac”, having very diverse nicknames, such as devil’s tongue or snake palm. The claim regarding Glucomannan is targeted at overweight adults and may be used only for food products that contain 1 g of glucomannan per quantified portion. Furthermore, the consumers should be informed that the beneficial effect is obtained with a daily intake of 3 g of glucomannan in three doses of 1 g each, together with 1-2 glasses of water, before meals and in the context of an energy-restricted diet.
Two authorized claims for meal replacement
Next to the Glucomannan-claim, there are two claims available for foodstuffs replacing one respectively two meals a day. Both claims are identical and read “Meal replacement for weight control”. Where nutrition and health claims in general are linked to particular nutrients, this claim however is not. In order to achieve the claimed effect, one meal respectively two meals should be substituted with meal replacements daily. Furthermore, foodstuffs bearing this claim should comply with specifications laid down in Energy Restricted Diets Directive. This Directive sets minimum and maximum limits for nutritional values of foodstuffs that are consumed as a replacement for one or two meals a day. Furthermore, this Directive prescribes the content of replacement products, in terms of energy, proteins, dietary fiber, vitamins and minerals. The foods under the Energy Restricted Diets Directive are not to be confused with so-called medical foods. These foodstuffs also regulated in terms of content and labeling and they are also used to replace meals, however only upon prescription and not for the purposes of weight loss.
Re-evaluation of the weight loss claim
The reason for the re-evaluation of the claims regarding meal replacements for weight control is a bit of a technical story. We will try to do our best to explain this in clear and understandable terms. As of 20 July 2016, the Energy Restricted Diets Directive will be repealed by a new Functional Foods Regulation providing a common framework for all types of functional foods: infants foods, medical foods and total diet replacement for weight control. As a consequence, the Annex to the Energy Restricted Diets Directive containing detailed guidance on the composition of foods for energy restricted diets will no longer apply Instead, guidance will have to be taken from the applicable Annex to the Food Information for Consumers Regulation (Annex XIII, Part A to be exact) introducing the Nutrient Reference Values’ for vitamins and minerals. This will cause some changes (increases or decreases) in the micronutrient content of meal replacements to occur.
Task of the NDA Panel
Under both the current and the future legal framework for meal replacements, the foodstuff has to contain specified quantities of certain vitamins and minerals to make sure that even when replacing meals as a whole, the consumer does not suffer a vitamin/mineral deficiency. Normally, the consumer is expected to loose weight on the basis that the replacement meal has a controlled energy content and a relatively high protein/low fat content. The NDA Panel was asked to give its scientific opinion about the substantiation of the health claim related to meal replacements under the new Functional Foods Regulation. The NDA Panel considered that the difference in micronutrient composition required under this new Regulation in respect to the Energy Restricted Diets Directive did not affect the scientific substantiation of said health claim, as previously assessed in 2010. As a consequence, the claim “contributes to weight loss” can still be used, provided of course that the conditions for use are met.
What more is allowed?
With respect to other ingredients and substances than Glucomannan, weight loss or similar claims have been made as well. As examples can be mentioned green tea extract and hyperproteins pasta. EFSA did assess more substances and the related claims and concluded that there was a lack of scientific evidence to substantiate such a claimed effect. Recently the claim; “fat-free yogurt and fermented milks with live yogurt cultures, with added vitamin d, and with no added sugars help to maintain lean body mass (muscle and bone) in the context of an energy-restricted diet” was not approved. In essence, products that carrying the claim, ‘contributes to weight loss’ which do not contain Glucomannan in the prescribed quantities and do not comply with the standards as set in the Energy Restricted Diets Directive, are not allowed on the European market. But with a little education of the consumer, explaining that a normal metabolism is actually at least as important as weight loss, plenty of other claims are available for healthy products. During the festive season, the emphasis may not be on the consumption of healthy products. But on a day-to-day basis, we strive for a healthy intake – or don’t we? That’s the point!
The author is grateful to Floris Kets, intern at Axon Lawyers at the time of drafting this blog.
The heat was on today in the European Parliament (EP). The reason for that was that the new Novel Foods Regulation was put to vote in a plenary session. In the debate prior to the vote, the opinions centred between concerns about food safety and the free circulation of goods. In this post, you will be updated about the outcome of the vote. In short, the adoption of the new Novel Foods Regulation will have important consequences for Food Business Operators (FBO’s). In an earlier post, we already reported about streamlined authorisation procedures. Today, we will mainly focus on the type of products covered by this legislation. Insects are in for a start. In a 10 minutes read, you will learn what are the consequences thereof – and more.
Shaping the new Novel Foods Regulation
Today (28 October 2015), the EP adopted the latest proposal for a Regulation on Novel Foods [insert final text]. As reported in one of our previous posts, the European Commission published an initial proposal for this Regulation in December 2013. EP Rapporteur Nicholson heavily criticised this draft, mainly for its open product definition and for the lack of streamlining the authorisation procedure. As a result, an EP legislative proposal became available, in which the Rapporteur formulated a number of improvements. Most of them were included into the draft legislation approved by the ENVI committee by the end of November 2014, which further developed into the text voted today. This adopted proposal will enter info force after publication in the OJ. However, a transition period of 24 months after such publication has been provided before its actual application.
So what are Novel Foods finally?
In the initial Commission proposal, the various product categories had not been exhaustively defined. Although such a system could present the advantage of flexibility, in fact FBO’s resisted against the legal uncertainty this would create. As a result, the approved draft by the ENVI Committee identified 10 categories of Novel Foods. Some of these have again been heavily debated, like for instance insects – however without success. The Regulation voted today in the EP defines the following products as Novel Foods:
- food with a new or intentionally modified molecular structure;
- food consisting of or isolated / produced from microorganisms, fungi or algae;
- food consisting of or isolated / produced from material of mineral origin;
- food consisting of or isolated / produced from plants or their parts, except when the food has a history of safe food use in the Union and one out of two alternative conditions are met;
- foods consisting of or isolated / produced from animals or their parts, except where these animals were obtained from traditional breeding practises and the food from those animals has a history of safe food use;
- food consisting of or isolated / produced from cell or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
- food resulting from a production process not used within the Union before 15 May 1997, giving rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesired substances;
- food consisting of engineered nanomaterials;
- vitamins, minerals and other substances, where a new production process has been applied or where they contain engineered nanomaterials;
- food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use other than in food supplements.
What’s in? – Most striking changes
Contrary to the ENVI proposal, the current text of the Regulation no longer mentions food derived from cloned animals or their descendants as a separate product category. However, it becomes clear from the recitals in the new Novel Foods Regulation that no change is intended here. Until specific legislation on food from animal clones enters into force, such food is covered by category nr. 5 of this Regulation, as food from animals obtained by non-traditional breeding practises. Another textual change relates to category nr. 8. Whereas the ENVI draft still specified the highly debated 10 % threshold for a food ingredient to qualify as nano (instead of the 50 % threshold proposed by the Commission), no such threshold is contained in the current text. Although this is no doubt a compromise solution, it is expected it shall give rise to new discussions. A real change with respect to the ENVI proposal relates to product category nr. 3, covering food of mineral origin. For now, the background of this change remains unclear. Finally, insects are still covered by category nr. 4. Today, many food products consisting of or containing insects are marketed in various Member States. It is therefore important to establish what will be the consequences of considering insects as Novel Foods. In order to answer that question, the provisions laying down the transition regime are of interest. Furthermore, by way of background, a number of safety evaluations of insects as food are briefly discussed.
Evaluation of insects as food by certain Member States
In one of our previous blogs relating to the marketing of insects as food products, we reported that due to the lack of clarity regarding the status of insects (Novel Foods or not?), some Member States issued their own guidance. In Belgium for instance, the placing on the market of 10 particular insects species as food product is tolerated, provided that specific food law requirements are met. In the Netherlands, the Dutch Food Safety Authority and the Health Minister ordered a safety report with respect to three types of insects currently marketed as food in the Netherlands. These are the mealworm beetle, the lesser mealworm beetle and the locust, regarding which the heat-treated and non-heat treated consumption was evaluated in terms of chemical, microbiological and parasitological risks. Based on the outcome, it was recommended to consider these insects as “regular” foods (in the sense of the General Food Law Regulation) and not as Novel Foods.
Evaluation of insects as food and feed by EFSA
On 8 October 2015, EFSA published its Risk profile related to production and consumption of insects as food and feed ordered by the Commission. In fact, EFSA was requested to assess the micro-biological, chemical and environmental risks posed by the use of insects in food relative to the risks posed by the use of other protein sources in food. EFSA found that for the evaluation of micro-biological and chemical risks, the production method, the substrate used, the stage of harvest, the specific insect species and the method of further processing are of relevance. It established however that with respect to any of these topics, fairly limited data are available. It therefore strongly recommends further research for better assessment of microbiological and chemical risks from insects as food, including studies on the occurrence of hazards when using particular substrates, like food waste and manure.
How to deal with insects as food products that are currently marketed? The new Novel Food Regulation provides first of all that these products do not have to be withdrawn from the market. However, for the continued marketing of such food products a request for authorisation should be filed within 24 months after the date of application of the new Novel Food Regulation. This would come down to the following.
- Entry into force of new Novel Foods Regulation: 1 January 2016 (assumption)
- Date of application of new Novel Foods Regulation: 1 January 2018
- Ultimate date for filing authorisation for continued marketing of insects as food: 1 January 2020.
This means that roughly speaking 4 years from now, FBO’s offering insects as food should still obtain a Novel Food authorisation. Assuming that these products have been marketed since the end of 2014 (see for instance the news on the launch of the insect burger sold by Dutch grocery chain JUMBO), this would mean that they were on the market 5 years before. If no safety concern ever arose so far, it would not be unreasonable to request an exemption from this obligation. At any rate, such FBO’s should know that prior to the indicated date of 1 January 2020, they can most likely successfully rebut any enforcement measures by local food safety authorities.
The adoption of the new Novel Foods Regulation has been a process with quite a few hick-ups and some surprising results. Whereas food from cloned animals for a long time had been the cause of delay, it is surprising to see that this Novel Food category nevertheless ended up within the scope of the new Novel Foods Regulation. As to products providing alternative protein, such as insects, we understand that the safety aspects from rearing to consumption should be carefully assessed. However, we note that EFSA does not have any immediate safety concerns per se. Furthermore, it should be stressed that the notion of “safety” in EU food law has only been negatively defined. That is, food is safe as long as it is was not found unsafe. Therefore, we consider that alternative protein products that were marketed for a number of years without any problems reported should not be subject to further barriers. Anyhow, FBO’s should be aware of their rights of continued marketing of such products, at least for four more years to come.
Want to know more about this subject? Do join the Axon Seminar on Alternative Proteins: invitation seminar.
Image: Amsterdam Westerpark, food festival “The Rolling Kitchens“, serving snacks made out of insects, such as fried grasshoppers on a stick or mealworm spring rolls.
Recent research from the Erasmus medical centre (Netherlands, Rotterdam) suggests that certain medicines might be taken up better by patients when administered with Coca Cola instead of water. In short, the researchers where looking for a way of helping patients who received the medicine erlotinib (Tarceva). The medicine is used to treat lung cancer patients and it is orally administered. Most of the cancer patients also use stomach protection medicines against the side effects of cancer medication. These protection medicines however lower the pH in the stomach and therefore the uptake of erlotinib in the bloodstream was not optimal. Taking the medicine with Coca Cola (which creates a temporary more acid environment in the stomach) gave spectacular results: the levels of uptake in the blood were in the average 40 % and sometimes even 100 % higher. Could Coca Cola therefore be considered to be a medicine?
Food or medicine?
At first sight, this question may seem to be somewhat far-fetched, but in this context it is interesting to know that Coca Cola was invented by a pharmacist. Furthermore, the question whether a product qualifies as a food or as a medicine is not highly theoretical. In fact, there is an important body of EU case law since the 80-ies that deals with exactly this question. This is all the more relevant, as the qualification of a food product as a medicinal product can have drastic consequences for market access. This blogpost will discuss a number of those cases, including vitamin preparations and garlic pills, and address the status of Coca Cola against that background.
Criteria of medicinal products and of food products
According to the Medicinal Products Directive, a medicinal product is:
(a) “any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
According to the General Food Law Regulation, a food means “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”
Are vitamin preparations medicinal products?
In order to answer this question, the national authorities should properly assess the pharmacological properties (the “function of the product”) and the presentation of the product. In the Van Bennekom case (C-227/82), relating to a Dutch national trading highly concentrated vitamin preparations in the form of tablets, pills and capsules, the European Court of Justice (“EU Court”) elaborately dealt with the presentation criterion. This was also one of the first cases where the EU Court provided a dividing line to be drawn between medicinal products and food products. In short, the EU Court ruled that the form given to the product (pills, capsules) can serve as strong evidence of the intention of the manufacturer or seller to market a medicinal product, but is not conclusive in its own right. However, the concept of presentation with respect to borderline products must be broadly conceived in order to protect consumers. Therefore, a product can qualify as medicinal product if any well-informed consumer, based on the presentation of the product, gains the impression this is actually a medicinal product.
Do Member States differ on the qualification of borderline products?
Yes, they sometimes do. This was clearly demonstrated in the Delattre case (C-369/88). In this case, products that were sold in Belgium as supplements and cosmetics qualified as medicinal products in France. The EU Court ruled that the products were presented as having positive effects on certain body functions, like the functioning of the gastro intestinal tract or liver and therefore, they were covered by the Medicial Products Directive. The French authorities could qualify the products as medicinal products, even if in Belgium these products qualified as foods and cosmetics. The national authorities and courts will have to judge on a case-by-case basis if a product is either a food or a medicinal product. If the product can be qualified as food and or cosmetic and as a medicinal product, the product is considered a medicinal product and not both.
Are Garlic pills medicinal products?
The so-called Garlic case (C-319/05) related to food supplements that were presented in a capsule form. The German authorities qualified these supplements as a medicine, but the EU Court did not agree. Although the supplements had a capsule form, the EU Court ruled that this form is not exclusive to medicinal products. Moreover, the supplements did not contain any mention that they aimed to prevent or treat a certain disease. Furthermore, although the beneficial effect from the active ingredient allicin was recognized, this effect did not transcend the normal metabolism of garlic. Therefore, the food supplements were not considered to be medicinal products, neither by presentation, nor by function.
Qualification of Coca Cola as a medicinal product?
Against the above background, could Coca Cola possibly be qualified as a medicinal product? For sure, it will not qualify as such by presentation. The product is sold in a bottle or as a can in quantities that exceed by far the average medicinal product. It is not recommended for care or cure, but to refresh at most. The qualification by function is a different story, as it does present some positive effects on certain body functions. The Erasmus research has demonstrated that taking the medicine erlotinib (Tarceva) together with a glass of Coca Cola will temporarily lower the pH in the stomach, back to the acidity levels prior to taking any stomach protection. In essence the Coca Cola restores a body function. A regular soft drink does not have this effect and one could therefore argue that Coca Cola does have a medicinal function. The pharmacological properties of Coca Cola as such are not substantial, although the effect in combination with the medicine can be. The boundaries between food and medicinal products are not set in stone but keep on moving.
The author thanks Floris Kets, trainee at Axon Lawyers, who had the great idea for this post.
The Netherlands Food and Consumer Product Safety Authority (NVWA) has been pretty active this Summer. Following up on previous enforcement reports on nutrition claims, it recently published such enforcement report re. both nutrition and health claims for breakfast cereals. As this report relates to legislation that has been harmonized at an EU-wide level and it provides detailed enforcement information, this is an interesting read – not only for the Netherlands.
Less than 50 % fully compliant
Actually, the report publishes data on the review of claims regarding 126 different breakfast cereals marketed under 24 different brands. These data were compiled during the period between March – October 2014. From this review, It appeared that less than half of those products were fully compliant with the Claims Regulation. The NVWA considers it of the essence that Food Business Operators (FBO’s) offering for sale breakfast cereals fully comply with the Claims Regulation to enable consumers to make informed choices.
Nutrition and health claim framework
Since the entry into force of the Claims Regulation on 1 July 2007, only authorized claims can be used for food products. A claim is a message or representation in any form, that is not mandatory under EU law or national legislation and that states, suggests or implies that a food has certain characteristics. A nutrition claim is a claim that states or implies that a food has particular beneficial nutritional properties in terms of energy and/or nutrients. A health claim is a claim that states or implies there is a relationship between food and health. Amongst the health claims, a distinction is made between general claims, disease risk reduction (DRR) claims and claims relating to the health and development of children. In 2012, the Commission published a list of 222 authorized general claims that is dynamic and has currently evolved into 229 claims. Furthermore, there are currently 14 authorized DRR claims and 11 children’s claims. For both nutrition and health claims, strict conditions of use are applicable. For instance, in order to claim that a product is high in proteins, at least 12 % of the energy delivered by the product should be provided by proteins.
Method of enforcement
Contrary to previous claims enforcement reports that only related to nutrition claims, the NVWA this time also took into account health claims. More concretely, it report relates to pre-packed breakfast cereals that were offered for sale in the Netherlands at both retail and wholesale level. If the products at stake were advertised at websites as well, such information was also subject to enforcement. The products at stake consisted of granola, corn flakes, puffed rice grains, oatmeal and wheat meal, some of them supplemented by nuts, sugar, dried fruits or chocolate. The information reviewed was the name of the product and the nutrition labelling, in as far as related to nutrition and health claims. A warning letter was sent to those FBO’s whose products were not compliant, except when an unauthorized claim was used. In those cases, a fine was imposed under the suspensive condition of full compliance within a grace period. When I contacted the NVWA to know the average amount of such fine, I was informed that my query would be answered within 6 weeks. Apparently, the Summer scheme is still on at NVWA – too bad. But an update will be provided at FoodHealthLegal when more information is available.
Outcome of enforcement
As mentioned above, out of the 126 products that were reviewed, over half of them did not fully comply with the Claims Regulation, mostly because the claims used were pretty vague. Although it is permitted to use a variation on an authorized claim, the essence thereof should be the same as an authorized claim. An example of a claim that was sanctioned by the NVWA is “The cereals present in this product are the basis for a healthy and nutritious breakfast. It contains nutrients that are indispensable for the human body and that are quickly absorbed by the body.” Another reason why products were not compliant was that non-existent nutrition claims were used, such as “does not contain cholesterol” or “ contains many nutrients”. Furthermore, sometimes nutrition claims were made, whereas the strict conditions of use were not met. Although this is not visible from the product label, such is a violation of the Claims Regulation as well. Finally, on many products, the link between a specific nutrient and the health claim used on the labelling was missing. Instead, pretty general, non-specific, claims were made that can be quickly taken in by the consumer, but also easily be misunderstood. Therefore, such general, non-specific claims are only allowed if accompanied by a specific, authorized, health claim. For example, the claim “Crisply granola of brand X forms part of a healthy and nutritious breakfast” cannot be used alone, but it can be used jointly with an authorized claim for iron, like “Iron contributes to normal energy-yielding metabolism”.
The fact that the NVWA nowadays actively enforces health and nutrition claims shows that it considers B2C communication on food product to be an integral part of food safety. From our practise I know changing the packaging of your food products is a lot of hassle, so better get it right as from the start. Here are a few tips to help you along.
- At all times, it should be avoided to made a medical claim with respect to food products. Medical claims are claims directed at the prevention or treatment of a disease. Their use, if allowed at all, is strictly reserved for pharmaceuticals.
- If you consider the authorized claims are not persuasive or sexy enough, choose one of the variations published by the self regulatory body KOAG-KAG.
- Make sure you have data supporting the nutrition facts of your food product, as the burden of proof lies with the FBO when receiving a request pertaining thereto from the NVWA.
- When using general, non-specific claims, use the specific, authorized claim in the same field of vision.
- When in doubt, or if you simply need a sparring partner, consult an expert.