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.
On 5 and 6 May 2015, the Vitafoods Europe Conference took place in Geneva. For companies active in the ingredient business, this is the yearly meet up to share the latest ingredients insights, to present new products and to prepare actual or future deals. Axon Lawyers was asked to participate in the Conference Program, which this year was committed to three different steams, being “your business”, “your science” and “your product” respectively. Axon Lawyers presented two topics in the business stream, pertaining to EFSA Claims and Regulatory Issues and to Labelling. Below, some background with respect to these presentations will be provided and the actual presentations will be shared.
WRAP-UP OF NOVEL FOODS PRESENTATION
Rationale of Novel Food legislation for ingredient innovations
Karin Verzijden presented a topic on the status quo of Novel Foods (NF) in the EU under the new Regulation, in which she focused on the rationale of NF legislation for ingredient innovations. As reported earlier, a new NF Regulation was presented by the Commission in December 2013, which was heavily amended based on the input from EP Rapporteur Nicholson. In November 2014, the ENVI Committee accepted draft legislation including most of the Nicholson amendments. This text represents the current status quo of NF legislation and now awaits first reading in the European Parliament (EP). The EP approved text will constitute the final legal framework.
Developments in alternative proteins, meaning proteins derived from other than animal sources, was a key trend at Vitafoods, reported FoodIngredientsFirst. Amongst those sources for alternative proteins are algae, insects and duckweed inter alia. In the presentation made at Vitafoods, the importance to know the regulatory status of each of these sources of ingredients was explained (“Begin with the end in mind“). Ingredients that have been marketed as a source of food in the EU prior to 1997 to a significant extent are clearly outside the scope of the Novel Foods Regulation. As a consequence, they are not subject to pre-market authorization, at least not based on the NF requirements. If to the contrary, no valid case for a history of safe use can be made, then it is likely that a NF authorization will have to be obtained.
Regulatory status of algae
Such history of safe use was already established for various algae, like for instance specific types of the Chlorella and Laminaria algae. As a consequence, these ingredients can be used for food products without being subject to NF authorization, both under the current and future legal regime. The same does not apply to for instance the Rhodymenia palmata, regarding which so far only evidence on use as a food supplement is present. Such use can be of support to demonstrate the safety thereof, but as a single source will not be enough to market the product as a NF. For that purpose, it is likely that a NF authorization will have to be obtained.
Regulatory status of insects
Insects are well-known to be a rich source of proteins. Under the current NF legal framework, they are not considered to be Novel Foods, at least not explicitly so. This is likely to change under the new NF Regulation, as one of the new NF product categories reads “Food consisting of, isolated / produced from animals or their parts, including whole animals like insects, except where a history of safe use within the Union can be established”. As pointed out in one of our previous blogposts, this is contrary to the practice in some Members States, where the safety of various insects as a food ingredient has been established. Also, in practice, various insect based products are effectively marketed – examples can be found here and here. It will therefore be interesting to see if those products will be subject to enforcement measures of national health authorities. We believe that the longer those products have been marketed the more difficult this will be based on, amongst others, the principle of legal certainty.
Regulatory status of duckweed
Duckweed is reported to contain, depending on its cultivation procedure, 40 % proteins, whereas it grows much quicker than algae. Therefore this aquatic biomass could be an interesting source of alternative proteins too. Under the current legal framework, it would certainly be an option to investigate if any substantial equivalence to existing foods could be established. As a starting point, the protein RuBisCo, that occurs both in duckweed and in many green plants could be taken. If this is of no avail, it is interesting to know that under the future legal framework, the short cut authorization based on traditional foods from third countries might be available. Such will depend on the outcome of research into duckweed as a source of food in those countries, regarding which in such case a history of safe use for 25 years will have to be demonstrated.
WRAP-UP LABELLING PRESENTATION
Designing clearer labels for consumers
Since the entry into force of the Food Information to Consumers Regulation (“FIC Regulation”) on 13 December 2014, some experience has been gained with the new labelling rules applicable to all food products sold to end consumers. Sofie van der Meulen presented a topic on labelling, explaining the new requirements and how these are applied in practice.
The FIC Regulation aims to modernize, simplify and clarify the food-labelling scene by recasting the horizontal labelling provisions and merging them into one single Regulation. However, labelling is still not fully harmonised due to language requirements and room for national measures, for example on allergens and additional mandatory information to be stated on the label.
The provisions of the FIC Regulation are supposed to enable consumers to choose a healthy diet and they apply to food business operators (“FBO’s”) in all stages of the food chain who supply food to the final consumer. The FBO under whose name the food is marketed or the importer into the Union market is responsible for compliance. Since a lot of products are sold via the internet nowadays, the FIC Regulation explicitly applies to online sales of food products as well. Consumers’ have to receive particular information in a webshop prior to the purchase of the food product.
In general, food information shall not be misleading, must be accurate and shall not attribute pharmaceutical characteristics to food. The latter because the food would then be covered by the medicinal products Directive.
Article 9 of the FIC Regulation lists the mandatory particulars to be stated on all labels. Where should the information be stated? With regards to prepacked food, the information should be stated directly on the product or on a label attached thereto. The information should be easily visible and clearly legible. That’s is why detailed legibility requirements are laid down in the FIC Regulation. The minimum font size of the characters should be 1.2 mm or 0.9 mm if the packaging is smaller than 80 cm2. The language used on the label should be a language that is easy understandable in the Member State where the food product is marketed. In practice most FBO’s decide to use the official language of the Member State on their labels, or, as a very minimum, on their website.
Declaring the presence of any of the 14 listed allergenic ingredients has been a requirement since 2003. However, under the FIC Regulation the way they should be declared has changed. For prepacked foods allergens must be listed in the list of ingredients with a clear reference to the name of the allergen as listed in Annex II of the Regulation. Furthermore, the presence must be emphasized by using a different typeset that distinguishes them from the rest of the ingredients. This can be achieved by using a different font, style or background colour. The provision of allergen information for non-prepacked foods sold in, inter alia, cafes, canteens and restaurants are subject to national requirements. In the Netherlands this information can be provided orally, but for example in Ireland this information has to be provided in a written format.
Country of Origin Labelling
As of 1 April 2015 Country of Origin Labelling (‘COOL’) has been extended from beef to other unprocessed meats widely consumed in the EU. See this previous blogpost for more information on this particular extension. In the future, mandatory COOL could be further extended under the FIC Regulation and become applicable to other products such as milk and milk products and also to processed meats.
Nutrition declaration and the use of health and nutrition claims
Under the FIC Regulation, a nutrition declaration will become mandatory for most food products as from 13 December 2016. However, if health and nutrition claims are used, including a nutrition declaration on the label is already mandatory.
The nutrition declaration should state the energy value in calories and the amounts of fat, saturates, carbohydrates, sugars, protein and salt. This information should, as a main rule, be expressed per 100 g or 100 ml in order to enable the consumer to compare products and make a choice for a healthy diet. Exceptions apply to food supplements and mineral waters.
Consequences of non-compliance
Non-compliance could give rise to administrative sanctions such as administrative fines. Intended mislabelling could qualify as forgery under criminal law and be prosecuted. A Dutch meat trader was recently sentenced to 2.5 years in prison, as he was found guilty of forgery when horsemeat was not declared on the label of beef products. The Dutch Food Safety Authority currently focuses on misleading information on prepacked foods in 2015.
Both the topic of Novel Foods and Labelling is expected to evolve over time. For Novel Foods this is the case, since the legal framework has not yet been finalized. For labelling, this also applies, as the Commission still has to provide input on specific topics and also at national level, there is some room for manoeuvre. At Food Health Legal, we continue to follow and report these developments. Stay posted and do send us your comments!
Securing proteins from alternative sources than meat or fish is nowadays a topic in the centre of the debate. The Dutch Vegetarian Butcher has found a solution for this challenge by manufacturing and marketing meat-alikes. These are food products having the taste and bite of a meat product, but that are composed of non-meat ingredients such as soy. The trademark used for this type of products was at the basis of a recent decision of the Amsterdam District Court. However, this case contains some general learning for any food business operator caring about his trademark.
The Dutch Vegetarian Butcher was operating a butcher shop in The Hague and had concluded a collaboration agreement with a commercial partner to operate a similar shop in the centre of Amsterdam. The terms of the collaboration agreement stipulated, inter alia, that the Amsterdam based Vegetarian Butcher was allowed to use the Vegetarian Butcher trademark and trade name. In fact, the shop in Amsterdam was to operate as a flagship store of Vegetarian Butcher products in the Dutch capital. The contract therefore provided that the Amsterdam shop was only to a very limited extent allowed selling third party products.
Collaboration in practise
In practise, the collaboration between the parties did not work out as expected. During several test visits of the Vegetarian Butcher shop in Amsterdam, freezers turned out to be empty, the Vegetarian Butcher logo’s were used for products that had not been approved and an important number of third party products were offered for sale. After the parties failed to find an amicable solution for their dispute, the original Vegetarian Butcher had terminated the collaboration agreement, requesting that the Amsterdam based Vegetarian Butcher ceased the use of both the Vegetarian Butcher trademark and trade name. Furthermore, he requested assignment of the domain www.devegetarischeslageramsterdam.nl, being the Dutch equivalent for <vegetarian butcher in Amsterdam>. Finally, recovery of full legal costs (about € 25K) was requested on the basis of the Dutch legislation implementing the Enforcement Directive. In his counterclaim, the Amsterdam based Vegetarian Butcher disputed the termination of the contract and claimed a huge amount of damages (about € 250K), arguing that he could not recover his investments.
The case was dealt with by the Amsterdam District Court in summary proceedings, as the original Vegetarian Butcher had an urgent interest to put a term to the unauthorized use of his trademark. The Judge recognizes that this dispute boils down to a different interpretation of the collaboration agreement between the parties. In such situation, it is standard practise that the Court establishes what would be the most reasonable interpretation to be given to the agreement, taking into account all relevant circumstances of the case. As one of these circumstances, the Court states that the collaboration agreement was based on a Letter of Intent (LoI) drafted by the Amsterdam based Vegetarian Butcher. In this LoI, it was clearly stated that the original Vegetarian Butcher supplies should have an exclusivity position in the Amsterdam shop. Only in the situation that the original Vegetarian Butcher was not in the position to supply sufficient products to the Amsterdam shop, the latter was at liberty to sell third party vegetarian products, provided that the origin thereof was clearly indicated.
Contract based IP enforcement
Based on the above, the Court decided that the termination of the collaboration agreement was valid. As a consequence, the Amsterdam based Vegetarian Butcher was ordered to cease and desist from the further use of the Vegetarian Butcher trademark and trade name, explicitly including any such use on social media. Furthermore, the assignment of the domain www.devegetarischeslageramsterdam.nl was ordered. Legal costs were however only partially recovered, as the Amsterdam based Vegetarian Butcher had opposed the claim for full compensation of legal costs and these proceedings were not considered complicated. For such cases, the Dutch Courts rely on a nationally agreed (but not undisputed) schedule of fixed amounts. In the present case, only 25 % of the actual claimed legal costs were awarded as a result.
To no surprise, the claim for damages made by the Amsterdam based Vegetarian Butcher was dismissed. In the first place because he was found wrong, but also because it is not possible to claim full damages in Dutch summary relief proceedings. In such proceedings, it is only possible to request an advance payment of damages, provided that the existence and scope of the damages are sufficiently plausible. This was denied in the present case, as the shop in Amsterdam was allowed to continue its business, however without the use of the name Vegetarian Butcher.
Lessons to be learnt?
What is the general learning to be drawn from this case? In the first place, it demonstrates the importance to draft clear contracts regarding the use of a trademark by a commercial partner. This is of importance for any type of partnership, including but not limited to licenses and franchise. If the commercial partner does not respect the contract in place, it is good to know that such can be efficiently enforced in preliminary relief proceedings in Holland. A hearing can be obtained at relatively short notice (between 2 days and 2 months, depending on the urgency) and a decision is rendered within 2 weeks at most. For the full recovery of legal cost however, it is of the essence that the work done is sufficiently specified and that is it clearly explained what makes one case stand out from a standard case, if any.
Further developments in Brussels took place since we last reported on the new Novel Foods Regulation. Draft legislation was approved in this respect by the ENVI Committee, awaiting the first reading of the European Parliament (EP). The current status quo was published in a Report dated 26 November 2014. Two particular subjects seized most public attention, notably the moratorium proposed on the use of nanomaterials in food and the compulsory labelling of cloned food products. These two items have been covered here and here inter alia and will be shortly touched upon below. Most of all however, this post will focus on the adjusted Novel Food definition. We consider this subject to be of the essence, whereas so far was not highlighted at all.
Moratorium nanomaterials and change to nano definition
The legislation takes as a starting point that food production processes involving nanotechnologies require specific risk assessment methods. These methods should have been assessed by EFSA prior to use. Furthermore, an adequate safety assessment on the basis of those methods should have shown that the foods at stake are safe for human consumption. The rationale of all this is the precautionary principle: emerging technologies in food production may have an impact on food safety. On top of that, the definition of nanomaterials was changed, introducing a 10 % nano-particles threshold for a food ingredient to qualify as “nano” instead of a 50 % threshold. This was in line with EFSA recommendations, but it may pose a serious problem to FBO’s currently marketing nano-foods. Using the 10 % threshold would imply that quite a few product currently marketed would, under the new Novel Foods Regulation, qualify as Novel Food whereas it currently does not. This will not benefit to legal certainty.
Compulsory labelling of cloned food products
During the long term discussions on the renewal of the Novel Food Regulation, it was decided that the subject of food from cloned animals would be left out. As a result, the Commission published two separate Directives on food from animal clones and on cloning on certain animal species for farming purposes respectively (the draft “Cloning Directives”) in December 2013. These two proposals have now been turned down by EP, as they did not address the food obtained from clones’s offspring. Until food from cloned animals will be covered by revamped Cloning Directives, cloned meat products have been brought within the scope of the Novel Food Regulation and they should be labeled as such.
Adjusted Novel Foods definition
Contrary to current legislation, the initial draft Novel Food Regulation contained an open product definition, where the listed categories of products merely served as examples. This was heavily criticised by rapporteur James Nicholson. Based on his consultations in the field, such open product definition according to him constituted a source of legal uncertainty. Instead, he suggested re-introducing the former product categories in an updated form in order to make this Resolution future-proof. In fact, this suggestion was followed, but somehow pushed to the extreme. The draft Novel Food definition currently also covers product categories that were never considered as Novel Foods before, such as insects and food obtained from cellular or tissue cultures.
10 categories of Novel Foods
The definition currently proposed for a Novel Food is a food that was not used for human consumption to a significant degree in the Union before 15 May 1997 and that falls under at least one of the ten following categories:
- Food with a new or intentionally modified primary molecular structure;
- Food consisting of, isolated / produced from microorganisms, fungi or algae;
- Food consisting of, isolated / produced from plants, except for plants having a history of safe food use within the Union;
- Food derived from cloned animals and / or their descendants;
- Food containing, consisting of, or obtained from cellular or tissue cultures;
- Food consisting of, isolated / produced from animals or their parts, including whole animals like insects, except where a history of safe use within the Union can be established;
- Food resulting from a new production process not used for food within the Union before 15 May 1997 affecting its nutritional value inter alia;
- Food containing nanoparticles;
- Vitamins and minerals (i) subject to the new production process referred to under (7) or (ii) containing nanoparticles referred to under (8) or (iii) for which a new source of starting material has been used;
- Food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use in other foods than food supplements.
What’s new actually?
Some of the categories mentioned above were already included in the 1997 Regulation, being those mentioned above under (1), (2), (3) and (7). Others were introduced in the initial Commission proposal for a new Novel Foods Regulation, notably those mentioned above under (8), (9) and (10). Truly new are therefore only the categories consisting of food derived from cloned animals (4), food obtained from cellular or tissue cultures (5) and food produced from whole animals such as insects and from animal parts (6). As explained above, the category consisting of food obtained from cloned animals is likely to be temporary. As soon as specific legislation covering this topic will be in place, such legislation will be applicable to cloned food products instead of the Novel Foods legislation. What are the consequences of the introduction the two other new categories? This will be discussed below.
Food obtained from cellular or tissue cultures are Novel Foods
As a good example of foods obtained from cellular cultures, the in-vitro burger engineered by Prof. Mark Post from the University of Maastricht (see picture from neontommy.com) can be mentioned. This burger was constructed on the basis of a tiny part of meat, using stem cell technology. For this purpose muscle cells harvested from a living cow were fed and nurtured, so that the single strand of cells multiplied to produce numerous new strands. In the end, 20.000 of those strands were assembled and put together in a hamburger. Obviously, the cell production used for this purpose will have to be increased for this technology to become a viable meat production method. However, now that the feasibility of this method in essence has been demonstrated, its application is not inconceivable. When in future, lab-burgers like the one from Maastricht will be marketed as food products, they will need to obtain pre-market authorization based on the current draft for the new Novel Food Regulation. This is understandable, as the use of this technique and starting material for food production is completely new and their safety needs to be established.
Food produced from insects are also Novel Foods
For numerous companies this may come as some surprise. Contrary to the use of cellular tissue for the production of food, the use of insects as food goes back to biblical times. Actually, in various European countries including the Netherlands and Belgium, insects are being offered for sale as food. For instance, Dutch supermarket chain JUMBO offers edible insects for sale as of October 2014. This has incentivised national authorities to investigate the safety of consumption of insects and to formulate basic requirements for rearing facilities. As a result, recommendations were made in the Netherlands that a specific number of insects, such as the mealworm beetle and the locust, should be considered as foods under the General Food Law Regulation (see our previous blogpost for more detailed information also covering other European countries). It should be observed that not all European countries are at the same page here. In Luxemburg for example, the marketing of edible insects, pending an EFSA opinion awaited for July this year, is prohibited.
We welcome that the open product definition for Novel Foods has been abandoned, as this increases legal certainty. It is questionable though to what extent it was wise to re-integrate food derived from cloned animals and / or their descendants into the Novel Food Regulation. During previous revision efforts of this Regulation, this topic was exactly the bottleneck why the revision could not be completed. Also, this does not serve as an incentive for the Commission to adjust its previous proposals for the Cloning Directives at short notice. We are more positive with respect to the introduction of the new category of Novel Foods relating to food produced from cellular cultures. This is exactly the type of high tech sustainable food, which in essence is a Novel Food. The same does not apply however with respect to insects. It is striking that up to and including the first Report by Rapporteur James Nicholson, whole animals such as insects never formed part of the Novel Food product definition. We are under the impression that they now landed therein by way of surprise. This is not consistent with current practise of various Member States and will pose a problem for many FBO’s actually marketing food produced from insects. Furthermore, there seems to be a substantial amount of evidence for safe consumption of insects, at least in the Netherlands. Therefore, instead of qualifying whole animals as insects instantly as Novel Foods, as an alternative for providing international industry standards, it could be considered to include a list of recommended edible insects into the Codex Alimentarius.
It is expected that the current draft legislation for the new Novel Foods Regulation will not be the final text. We expect active lobbies from FBO’s marketing nano-foods to oppose the adjusted definiton for nanomaterials. Likewise we expect, and we recommend, that FBO’s marketing insects or food from insects will oppose the fact that food made from whole animals like insects qualify as Novel Foods per se. The chances of success will depend, inter alia, on the expected EFSA report on certain risks of the production and consumption of insects. As of now however, there is already safety evidence which could be relied on pending the final text of the Novel Foods Regulation.
In one of our previous blog posts this year, we provided a summary of the Commission’s proposal for a new Regulation on Novel Foods. We reported that the proposal contained an open product definition and that it introduced a central authorisation procedure. We also pointed out that the new Regulation provided for a simplified authorisation procedure for traditional foods and for a data protection regime. Meanwhile, the European Parliament appointed James Nicholson as a Rapporteur. Mr. Nicholson consulted with local producers, industry experts and food business operators about the Commission’s proposal. As a result, a draft EP legislative Resolution is available, which is the subject of this blogpost.
The EP Rapporteur is a 69 years old Irish citizen, who belongs to the European Conservatives and Reformists Group. He shares his opinions on Novel Foods in the movie entitled Novel Foods: lucrative innovation or health hazard? Although it may seem ironic that a seasoned politician from a conservative party is heavily involved in the subject of Novel Foods, he did deliver a substantial job in less than a year. Can we qualify his suggestions for amendments of the Commission’s proposal as substantial enough? That’s questionable – let’s have a look.
3 area’s of concern
Mr. Nicholson indicates in his draft report of 6 October 2014 that he sees 3 area’s of concern in the Commission’s proposal, being:
(1) the definition of Novel Foods;
(2) the streamlining of the authorization process;
(3) robust data protection provisions.
Below, these concerns as well as their potential solution will be discussed.
1. Novel Foods definition
The basic product definition of Novel Foods, notably a food product / ingredient that has not been used for human consumption to a significant degree prior to 1997 within the EU, has not changed. However, the important difference in the new NF proposal is the removal of clearly defined categories of what constitutes a Novel Food. The categories listed in the Commission’s proposal are only examples and not an exhaustive list. After extensive consultation, the Rapporteur found that this open product definition is not satisfactory. It lacks legal certainty and fails to clarify the scope and definition of a Novel Food. As a solution, the Rapporteur suggests re-introducing the previous product categories in an updated form and to add a new product category related to foods for which a new source of starting material has been used. In this way, the new Novel Foods Regulation should be future-proof.
2. Streamlining of authorization process
The current authorisation process has been criticised for being too expensive and too lengthy. Processing a successful Novel Foods application takes in the average about three years (!) This of course did not stimulate food innovation and in particularly prevented SME’s from filing NF applications. It probably also explains why between 2000- 2013, only 70 NF applications have been authorized. Therefore, the move to a centralized authorization process can be welcomed. Making NF applications directly at a Commission level instead of at a national level first will most likely save time. The Rapporteur was concerned however that the Commssion’s proposals do not go far enough in reducing the time factor. He has therefore made amendments consisting of stating deadlines where there were not and shorting deadlines as initially proposed by the Commission. For instance, where the Commission proposal provides that an authorisation decision should be published within 9 months after a positive EFSA opinion, the Rapporteur considers such term could be shortened to 6 months.
3. Robust data protection regime
The proposal for the new NF Regulation moves from a personal to a generic authorisation system. This mechanism is aligned to the health claims system, according to which authorized claims can be used by anyone, provided that the conditions of use are met. However, applicants for NF authorisations usually make substantial investments. Under a system of generic authorisations, it is all the more important that those investments are protected, at least for a minimum period of time. The Commission therefore introduced protection for newly developed scientific evidence during a period of five years from the authorization date of the NF application. Although the Rapporteur welcomes this concept, the is concerned that it will restrict the useful contribution of scientific research to the food industry. He therefore proposes that once the conditions for data protection are met, such protection should also be granted if the data at stake are published in a scientific journal.
Amongst the measures proposed for the area’s of concern, the one relating to the NF product definition certainly is the best. One can argue about the exact phrasing of the proposed product categories, but taking leave of the open product definition provides the required clarity for entrepreneurs whether or not their product qualifies as a Novel Food. If this is an open end at the beginning of the authorization process, why would one even bother to start it? As for the suggestions made to further streamline the authorization process, these can be considered merely symbolic. Instead of shortening a deadline here and introducing another one there, the most important issue has not been addressed. Under the new NF proposal, the Commission shall take into account the view of the Member States regarding NF applications it received “where applicable”. The text seems to suggest that this will not be a standard procedure, but this is not clear. One can imagine that at this point, this may easily absorb a lot of time. Also, no fixed time frames for Member States to comment the NF application has been set. Finally, the system of data protection seems promising, but experience regarding a similar system contained in the Health Claim Regulation has shown that its effect is limited. If third parties for instance produce the same data as the protected data based on independent research, nothing will prevent them from using those data. Taking this into account, it is completely unclear how data protection can be enforced regarding data that have been published in scientific reviews, as suggested by the Rapporteur.
Should this all be considered as “too little, too late”? No – that would be a sombre conclusion. Provided that the suggestions of the Rapporteur regarding the NF product definition are followed and some more substantial reductions in time in the authorization procedure are achieved, the new proposal is a real improvement. This will all the more be the case, once a corpus of generic authorizations will have been published. In that case, manufacturers and importers of Novel Foods will no longer have to undergo an authorization process at all regarding authorized products. But that will be some dishes away from the present menu.
For some background information on Novel Foods and practical examples, reference is made to the Slides “Novel Foods, sexy or burdensome products“, used for a presenation at the Food Valley Expo on 23 October 2014.
The use of nutrition and health claims is gaining wider application in the food industry. At the same time companies in the horticultural sector focus their marketing more and more at end users of their products. On the basis of this development, the Dutch Kenniscentrum Plantenstoffen (knowledge institute for plant compounds) initiated an investigation whether and how the vegetable chain can benefit from the use of nutrition claims. This information is relevant for breeders, growers, retailers, processors and consumers of vegetables.
The so-called claim legislation (EC Regulation1924/2006 and EC Regulation 116/2010) is applicable to all food and distinguishes between nutrition and health claims. These and the central concept of foodstuff have been defined as follows.
• Foodstuff: any substance or product, whether processed or unprocessed, intended to be consumed by humans. This includes, of course, vegetables.
• Claim: any non obligatory indication that states or implies that a food has particular characteristics, including graphics representations and symbols.
• Nutrition claim means any claim that the impression that a food has particular beneficial nutritional properties with regard to energy, and / or nutrients (“What is in the product?“)
• Health claim means any claim that the impression that there is a relationship between a food and health (“What does the product do?”).
Importance of claims for the horticultural sector: targeted breeding and communication
The Kenniscentrum Plantenstoffen chose to focus its investigation of the importance of nutrition claims for the horticultural sector. The use of health claims generally requires further research and evidence than is required for the use of nutrition claims. The importance of claims for the horticultural sector is twofold. Not only offer claims the opportunity to provide detailed information about specific nutrients in a product. Also the possibility of the use of a nutrition claim can offer an incentive for product improvement. When it is known which claims are relevant in connection with which vegetables and what conditions must be satisfied, is it possible to adjust the marketing and / or the breeding activiteis accordingly. For this purpose two documents were produced.
(1) List of permitted nutrition claims
(2) List of permitted vitamins and minerals associated with specific nutrition claims
List of permitted nutrition claims
|Selected nutrition claim||Condition for use||Relevant crops|
|High fibre||Product should contain at least 6 g fibre per 100g or 3 g fibre per 00 kcal.||Cauliflower, broccoli, cabbage, beans, Romaine lettuce and celery|
List of permitted vitamins and minerals
A special group of nutrition claims are the claims that read “source of [name of vitamin / mineral]” and “rich in [name of vitamin / mineral]”, which may be used solely in conjunction with permitted vitamins and minerals. The applicable legislation (currently EC Directive 90/496 and as per December 13, 2014 EC Regulation 1169/2011) identifies 27 permitted vitamins and minerals. 16 of them have been identified as potentially interesting in connection with plants and flowers. Subsequently, it has been established which claim can be used in connection with which vegetable, both per 100g and per portion. An example is as follows.
|Selected vitamine||Nutrition claim: “high on [selected vitamin]|
|Per 100 g||Per portion|
|Vitamine A||Carrots (raw and cooked), Cantaloupe melon, spinach, kale, chard, celery and chili||Carrots (raw and cooked), Cantaloupe melon, spinach, kale, chard, celery and chili|
In order to make a selection of crops in the list of nutrition claims, the following actions were taken per ingredient: (i) identification of crops rich in fiber (in particular example stated above) in two independent sources, (ii) selection of relevant Dutch horticultural crops, (iii) identification of the quantity of fiber per 100 g and per portion on the basis of two independent sources, and (iv) selection of crops on the basis of the so-called reference intake. For the selection of crops on the list of vitamins and minerals, an identical selection process was applied.
Despite the care applied to the selection of crops included in the list of nutrition claims, this selection is of course not set in stone. The reason is that the amount of nutrients (such as vitamins and minerals) is dependent on the specific cultivar per crop. Furthermore, growing conditions such as sun, soil, water and temperature affects the amount of nutrients present in crops. Finally, in the literature consulted regarding nutrients (including vitamins and minerals) intra-and intercontinental differences were found in the same crops. In addition, differences may exist within the same crop per portion: the weight of one tomato does not necessarily equal any other tomato.
Despite the above qualifications, the lists of authorized nutrion claims and vitamins & minerals can be considered as a good indication for which nutrition claims could be used in combination with which vegetable. These lists will be published shortly at this website and they can serve as a new perspective for the Dutch horticultural sector for their marketing and communication of their crops. With respect to vitamins and minerals are also a large number of health claims is available. The Kenniscentrum Plantenstoffen will look into this in the near future.
Health and nutrition claims targeted at food and medical products
For further information on the use of health claims targeted at different products, reference is made to our previous post on this blog. The slides of our seminar on medical and functional foods can be found here.
From 21 – 24 June, the yearly conference of the International Food Technologists (IFT) took place in New Orleans, Louisiana. During this conference, over 16.000 food science and technology professionals discussed the most recent product, ingredient and technology developments, as well as the potential business impact and regulatory framework. Below, you will find a selection of topics discussed. It will also be commented how these impact food business operators in the EU.
So far, no proper legal definition exists of functional foods. Since 1984 however, the Institute of Medicine has designated as functional food “any food or food ingredient that provides a health benefit beyond its nutritional benefit”, which I consider a clear working title. In the functional food market, functional beverages are the fastest-growing sector. In the IFT-session “The evoluation of functional beverages” advances in ingredients were discussed, such as new vitamin forms, dietary fibers and certain omega-3 fatty acids. Also, trends towards more natural forms of coloration were discussed, for instance from lycopene and beta-carotene, which also increase antioxidant properties. Obviously, using health claims in connection with these functional foods is very attractive from a marketing point of view. However, this remains a strictly regulated area in the USA, where different rules apply to “classical” health claims, structure function claims and qualified health claims. As discussed in our posts of 8 May 2014 and 2 November 2013, this is not any different in the EU.
Health benefits of prebiotics
In IFT-session Presenters Detail Gut Health Research some of the latest research was shared on the ways in which prebiotics affect the gut microbiota. Prebiotics are substances that are selectively fermented by gut microbes, thereby delivering health benefits to the host. It was reported that during the last 20 years, research has shown that prebiotic ingredients stimulate the growth of beneficial gut bacteria. Furthermore, evidence has been obtained suggesting that diet can contribute health benefits by changing the composition of the gut microbiota. It was pointed out during this presentation, however, that regulatory bodies like the EFSA have refused to permit health claims for prebiotics. Although this may be true in general, it is not entirely correct for lactulose, regarding which EFSA’s NDA panel acknowledged the beneficial effect consisting of a reduction of transit time.
From the session Allergens-Free Food Formulation, it became obvious that allergies (being defined as an abnormal response to a food triggered by the body’s immune system) constitute a prominent item on the agenda of food business operators for the years to come. Currently, millions of people have food allergies and that total is growing. Presenters during this session referred to the statistics from the Centers for Disease Control, according to which food allergies among children surged by 50% between 1997 and 2011. In order to respond appropriately, food manufacturers not only have to formule allergen-free foods, but also create an allergen-free manufacturing environment. Also, all of this should be effectively reflected in the product information, in order to meet the applicable labeling requirements. As reported already in our post of 17 September 2013, with the entry into force of the Food Information Regulation by the end of this year, specific measures apply regarding 14 named allergens, both for pre-packed and non pre-packed food.
Product qualification: food or pharmaceutical?
In the session Food Clinical Trials and IND-applications, it was explained when clinical studies for foods would require the filing of an Investigational New Drug (IND) application. This question was answered based on a recent guidance document (Guidance for Clinical Investigators) issued by 3 organisations involved in the evaluation of drugs, biologicals and food and of course on the basis of the criteria contained in the Federal Food, Drug & Cosmetic Act (FFD&C Act). It was explained that if the intent of the clinical study is to investigate a physiological effect of the food on the structure or function of the body beyond the provision of taste, aroma, or nutritive value, then the study will require the filing of an IND application. Furthermore, guidance can be found in FFD&C Act, according to which a food qualifies as a drug if it is intended for use in diagnosis, cure, mitigation, treatment or prevention of disease and if it is intended to affect the structure or any function of the body inter alia. In the EU, we regularly see legal decisions dealing with similar qualification issues based the European Drug Directive. Clearly, this is a topic in the centre of interest on both sides of the Atlantic. It is therefore expected that US guidance on this topic may be of interest for its European counterparts as well.
Further topics @ IFT and subsequent updates @ FHL
Other topics discussed at IFT were overweight and obesity, perception of food in media and GMO’s in the food industry. At FoodHealthLegal, we continue to follow all these topics, and in particular their legal and regulatory implications, with interest and we will provide you with further updates shortly. Please feel free also to join Axon’s life sciences seminar on medical and functional food, which will be held on 24 September 2014.
Recently, the General Court has decided a dispute concerning a health claim on water, explaining the concept of a disease risk reduction claim as defined by art. 14 (1) of the Health Claim Regulation. More specifically, the Court has clarified that indicating a ‘risk factor’ is mandatory in order to acquire authorisation for such claim. According to the grapevine, this was a test case for the working of the EU food and advertising rules, which has been much criticised. Anticipating the EU elections, EU criticism is not rare to find. Below you will read however, how this case has contributed to clarification of the notion of a disease risk reduction claim.
Cause of the case
The case was initiated by two German individuals, Moritz Hagenmeyer and Andreas Hahn (“the Claimants”), both food law academics, who submitted an application for authorisation of a health claim via the German Federal Office for Consumer Protection and Food Safety. The claim at stake was ‘Regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance‘. Although the claim seems uncontroversial, EFSA delivered a negative opinion. According to EFSA, the application did not provide a ‘risk factor’ for a human disease that would significantly be reduced by the consumption of water. The Commission followed EFSA’s advice and issued Regulation 1170/2011 refusing the claim applied for. In line with EFSA, the Commission held that the proposed risk factors are measures of water depletion and thus are measures of the disease. Accordingly, as a risk factor in the development of a disease is not shown to be reduced, the claim does not comply with the requirements of the Health Claim Regulation and cannot be authorized.
Continuing their experiment, the Claimants requested the Court to annul the part of Regulation 1170/2011 that refused the authorisation of their claim. To support their action, nine pleas of law were provided. In response, the European Commission pleaded for inadmissibility of the claim, and alternatively for its lacking justification. The Court however, decided to address the matter on admissibility in final judgment, forcing the Commission to take position on the reasons of justification of the claim. In its defence the Commission enjoyed the support of the Council of the European Union, as the application for intervention was admitted. The majority of the pleas brought before the Court regarded the procedural aspects of the claim authorisation procedure. The material dispute, however, focussed on the risk factor and whether this factor was dispensable.
Broad interpretation of “disease risk reduction claim”?
With their first plea, the Claimants argued that according to the Health Claim Regulation, it is not mandatory to provide for a risk factor in the application for a disease risk reduction claim. In support, they relied, inter alia, on previous case law from the European Court of Justice on health claims. In the first place, they argued that it follows from Green Swan, C-299/12 that in order to qualify as a disease risk reduction claim, such claim does not have to state that the consumption of a particular food significantly reduces the development of a certain disease. In the second place, they deduced from Deutsches Weintor, C-544/10 that the link between the consumption of a particular food and the effect on health, should be interpreted broadly. Even if the Court seems to acknowledge this concept, the Court disagreed, explaining that the concept of a disease risk reduction claim is defined by art. 2 (2)(6) of the Health Claim Regulation, and should be interpreted in this context. Therefore, there can be no distinction between the risk factor of art. 2(2)(6) and the term ‘disease risk’ in art. 14 (1). An indication of one, or multiple risk factors in the development of a human disease is, therefore mandatory for the authorisation of a disease risk reduction claim.
In rejection of the subsequent pleas, the Court emphasized the importance of the risk factor as component of the disease risk reduction claim. Without an indication for a disease or a risk factor for a disease, the Commission cannot judge the beneficial physiological effect that is required by the Regulation for the claim to be permitted. The Court further explained that it is sufficient when the application implies a risk factor instead of a providing a specific indication (see consideration 92 of the decision) thereof. However “water loss in tissues” or “reduced water content in tissues” indicated by the Claimant when requested for clarification could not be interpreted as the required risk factors. The Court, following the reasoning of the Commission and the EFSA advice decided that these alleged risk factors should be considered as a measures of dehydration rather than risk factors for developing such disease.
Although the claim chosen for this experiment may give rise to hilarity and the length of proceedings to process it may criticised, this case further tightens up the body of case law around disease risk reduction claims. That is a welcome development. As a general rule, health claims should contribute to properly inform the consumer about the characteristics of food and they should not be misleading. Now imagine the situation that this claim had been authorised and was subsequently used by many food business operators for mineral waters. That would be stating the obvious and not really add to any specific consumer information. After all, the Commission did not deny that scientific evidence had shown the link between dehydration and decrease of performance (see consideration 81 of the decision). It simply clarified the requirements for a disease risk reduction claim and more specifically, the mandatory ‘risk factor’. Those requirements prevented stating the obvious in this case. Cheers!
The author is grateful to Lisanne van Kouterik, intern at Axon Lawyers, for her valuable contribution to this post.
Novel Foods (NF) are all foods that were not used for human consumption to a significant degree within the EU prior to 1997. One of the most well known examples is BECEL, a margarine containing plant sterols with a cholesterol lowering activity. So far, Novel Foods were covered by Regulations 258/97 and 1852/2001, but obtaining market access for a novel food within this regulatory framework could easily take three years. Therefore, between 2008 and 2011, a new proposal for the NF Regulation was discussed. This proposal has never been adopted by Union legislator, due to a number of bottlenecks including food produced from cloned animals. On 18 December 2013, the Commission has published a new proposal for a NF Regulation, which is the subject of this blog post. One of the aims is to shorten the authorisation procedure to 18 months. How? Continue reading.
Food from cloned animals no longer covered
In order to find a solution for the sensible issue of food from cloned animals, the current proposal for the NF Regulation simply no longer covers such food. Instead, two separate proposals have been prepared: (1) a Directive on the cloning of animals of various species kept and reproduced for farming purposes and (2) a Directive on the placing on the market of food from animal clones. These two proposals will – at least temporarily – ban the use of the cloning technique in the EU for farm animals and the imports of these animal clones. The marketing of food from animal clones, such as milk or meat, will also be prohibited. Cloning will however not be prohibited for purposes of research or conservation of rare breeds and endangered species. Furthermore, cloning will be allowed for the production of pharmaceuticals and medical devices, where the use of this technique can be justified.
Subject matter, scope and definitions
General criteria for the NF definition remain unchanged: they should be safe and not mislead the consumer. The definition of NF is however considerably changed, now that food from cloned animals is no longer included. Futhermore, only one out of four previous NF categories is maintained, namely food to which a new production process is applied. 3 new categories are introduced, being
(i) food containing of or consisting of engineered nano materials;
(ii) vitamins and minerals to which a new production process has been applied or consisting of or containing engineered nano materials; and
(iii) food used exclusively in food supplements prior to 1997, where it is intended to be used in foods other than food supplements.
It should be observed that it is unclear if this list of categories is of an exhaustive enumeration. Also, the introduction of nanomaterials may have huge implications for manufacturers of medical or baby foods. Those foods, although regulated by Regulation 609/2013 inter alia, could be covered by the NF definition, for instance when there was a significant change in the production process or particle size.
Three major changes
The new proposal for the NF Regulation aims to simplify and streamline the regulatory process, while it continues to ensure food safety. More concretely, three major changes are being proposed.
(1) There will be one centralized procedure for NF assessment and authorisation, aimed at the reduction of the authorization procedure from 3 years in average to 18 months.
(2) Introduction of simplified and more proportionate procedure for placing on the market of traditional foods from third countries.
(3) Introduction of a data protection regime covering newly developed scientific evidence and proprietary data during a maximum period of 5 years.
Ad (1) Central authorisation procedure
NF will continue to require pre-market authorisation. Currently, such authorisation is applied for at a national level. The Commission subsequently circulates initial national assessments to all Member States (MS). If these do not raise any reasoned safety objections, the NF can be marketed. However, in the majority of the 68 NF authorisations granted between 2000 and 2013, such objections were raised and an EFSA safety opinion was obtained. The current NF regulation does not set a time frame therefore and quite often, the 60 days term for the MS to provide their opinion is not enforced. This explains why authorisation procedures can last up to 6 years. Under the new NF Regulation, an application for a NF authorisation should be directly made to the Commission. Where the Commission requests a safety opinion, EFSA shall adopt such opinion within 9 months from the date of receipt of a valid application. Subsequently, the Commission shall publish a draft authorisation decision within 9 months from the date of publication of the EFSA opinion. The system of individual authorisations will be replaced by a system of generic authorisations and the “simplified procedure” based on substantial equivalence will cease to exist. Authorised NF will be included into a so-called Union list.
Ad (2) Simplified authorisation of traditional foods
The new NF Regulation introduces a simplified and more proportionate procedure for placing on the market traditional foods from third countries, provided that a history of safe use can be demonstrated. This should be confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a large part of the population of a third country. An applicant who intends to place on the EU-market a traditional food for a third country shall notify that intention to the Commission. When the Commission does not receive any reasoned safety objections within 4 months, the food applied for can be marketed in the EU. In case of any objections, the applicant can file a new application taking into account said objections, which the Commission forwards to EFSA. EFSA shall subsequently adopt, within 6 months from the date of a valid application, its safety opinion. Finally, the Commission shall publish a draft authorisation decision within 3 months from the date of publication of the EFSA opinion.
Ad (3) Data protection
On request of the applicant, data protection is available for newly developed scientific evidence or scientific data supporting the application. This measure was introduced in order to support innovation in the EU-food industry. A similar mechanism is also contained in the Health Claim Regulation for so-called “new function” claims under article 13.5. Under both Regulations, data protection implies that data covered may not be used for the benefit of a subsequent application during 5 years, in the case of a NF to be calculated from the inclusion of the NF in the Union list. Such individual authorisation should however not prevent other applicants from filing applications on the basis of their independently generated scientific data, which may be identical with or similar to the protected data.
Transitional measures, monitoring and timelines
NF that were authorized prior to the entry into force of the new NF Regulation, will be included in the Union list too. As a consequence, a food that was legally placed on the market prior to the application of the new NF Regulation may be further marketed. However, it is mandatory for those foods to undergo the authorisation procedure laid down in the new NF Regulation. Likewise, when a NF is authorized and included in the Union list, the Commission may introduce post-market requirements to monitor the use of the authorized NF, so to ensure that the food is within safe limits as established by EFSA. The new NF Regulation expected to enter into force in 2016 at the earliest, when the Council and the Parliament will have adopted their positions on this topic as well.
Over time many food business operators started to doubt if a new proposal for the NF Regulation would be published at all. The mere fact that this finally happened can be called a positive fact. Also, this proposal contains various positive elements, such as more defined timelines within the authorization procedure for EFSA. However, it should be noted that authorisation delays could still easily increase. For instance, if EFSA requests additional information from the applicant, the authorisation for sure will not make it within 18 months. Furthermore, the authorisation of traditional foods from third countries will take, as a very minimum, 13 months if an EFSA opinion is requested. In line with the number of times an EFSA opinion is requested for NF, it is not unrealistic to expect this will happen most of the times. The procedure provided is therefore not necessarily “simplified” in view of a food that in other parts of the world is considered safe. Also, the proposal still does not contain at all a fixed term in which the MS should provide their reasoned objections, if applicable. At any rate, many items covered by the NF Regulation are still open, since the NF definition does not seem to be of an exhaustive nature. Furthermore, the Commission has received implementing powers to (i) decide whether a particular food falls within the NF definition, (ii) design a procedure to collect information on human consumption of particular foods prior to 1997 and (iii) update the Union list. Finally, legal uncertainty is bound to arise regarding already authorized NF, as they will have to undergo the authorization procedure again under the new NF Regulation.
Image from Clinton Smith Design Consultants