Brexit: what are the consequences for nutraceuticals?
Posted: June 30, 2016 Filed under: Authors, Food, Food Supplements, Health claims, Information, Nutrition claims Comments Off on Brexit: what are the consequences for nutraceuticals?
Shock and awe: they did it! A few days after the United Kingdom voted to leave the European Union, many sectors are investigating the consequences thereof for the services and products concerned. The more a sector has been regulated at an EU level, the more severe those consequences tend to be.
EU landscape of food law
If any sector has been highly regulated at an EU level, it is the food sector. The BSE crisis in the ’90-ies gave rise to the General Food Law Regulation in 2002, which has been the basis for a considerable corpus of rules relevant for the nutraceutical sector. These rules include the Food Supplements Directive (2002) as well as the Regulation on Fortified Foods and the Claims Regulation (both from 2006), as well as the Food Information to Consumers Regulation (2011) and the Regulation on Foods for Special Groups (2013) to name just a few.
What is going to happen next?
Although it is difficult to imagine that years of laws and case law can be cast by a vote, strictly speaking the European Regulations will cease to apply in the United Kingdom once it no longer forms a part of the EU. Also, there will no longer be an imperative to implement European Directives into English national law. Access for European nutraceuticals to the UK market and access for English nutraceuticals on the EU market will therefore depend on the instruments replacing the common European framework.
What are the options?
Firstly, the UK could reach and agreement similar to the one that the EU has with Norway or Iceland. In that case, the impact in the field of nutraceuticals would be fairly limited; the UK forming part of the European Economic Area and to a large extent be bound by EU legislation. Secondly, if the relationship would be shaped after the one between the EU and Switzerland, the implications could be more important, as EU food law would not be of general application in the UK. Thirdly, the gap between the current and future situation would be even greater if the relationship will be similar to the one that the EU has with the USA under the WTO, as for each specific sector specific agreements would need to be negotiated.
The trigger and the transition period
In order to move to the next stage, the UK will have to inform the Council of its decision to withdraw from the European Union, based on the famous article 50 of the Lisbon Treaty. So far, the UK seems to be divided on the question when this process has to be initiated. Some (Europeans) speculate that it may not be initiated at all. However, once the Council has received notice from the UK, an agreement setting out the arrangements for withdrawal should be negotiated within two years. During this transition period, the EU regulatory framework for nutraceuticals shall – in principle – remain in force. However, it can be expected that food business operators shall anticipate on the shift in the regulatory landscape. The UK may become less attractive to trade nutraceuticals due to the uncertainly what will be the applicable rules there.
Open ends… or not?
Based on the EU regulatory framework, nutraceuticals generally do not require prior market approval. This implies that English nutraceuticals could in principle still be marketed in the EU after the Brexit becoming effective. However, any English nutraceuticals marketed in the European Union will have to meet the EU requirements regarding the type of vitamins and minerals that may or may not be used in food supplements and fortified foods respectively. Furthermore, English nutraceuticals to be marketed in Europe may only use those nutrition and health claims that have been authorized at an EU level and that bear information on ingredients and nutrition facts in line with the Food Information to Consumers Regulation. The other way round is much less clear, meaning that it will remain an open question for quite some time with what rules European nutraceuticals to be marketed in the UK will have to comply . This will depend on the rules applicable to nutraceuticals in the UK replacing the EU regulatory framework. Summarizing it seems that trading UK nutraceuticals in the EU will not become “easier” from a UK perspective, whereas marketing European nutraceuticals in the UK will become less attractive because of the regulatory flaw.
Homework on IP licenses
For those food business operators distributing nutraceuticals under license in the licensed territory of the European Union, it is mandatory to clarify whether or not that territory still includes the EU after a Brexit becoming effective. This will not only depend on the wording of the agreement but also on the trademark backing the license. If this is for instance an EU trademark (former Community Trademark), this will no longer be valid in the UK in future. Moreover, if the validity of this EU mark was mainly based on genuine use in the UK, the validity of the entire trademark could be at stake because such use would no longer be of relevance for the continued existence of the mark.
Conclusion
The majority of the British people do not seem to have done a favor to the nutraceuticals industry, to put it mildly. In order for English nutraceuticals to access the EU market, these products will have to meet the EU standards anyway. For European nutraceuticals to be marketed on the Brittish market however, it cannot yet be predicted to what rules they need to comply. It does not seem to be realistic that the UK will opt for the Norwegian model, as it deliberatly moved away from the EU and – presumably – from the EU regulatory framework. It is also hard to conceive that the UK, being such an important trade partner of the EU will put in the same position as the US under the WTO. Remains the Swiss model as a most likely option for the trade agreements to be negotiated between the EU and the UK, but the Swiss model currently also implies the free movement of persons, which is an issue for the UK. So this is not an easy one. Keep you posted.
Photo by Tolga Akmen/LNP/REX/Shutterstock (5738024r) Pro-EU campaigners protest against Britain leaving the European Union in Trafalgar Square – London Stays anti-Brexit demonstration, Trafalgar Square, London, UK – 28 Jun 2016. The referendum was won by the leave campaign and caused Prime Minister David Cameron to resign on 23 June 2016.
Who Does Not Want To Have A Healthy Breakfast?
Posted: August 10, 2015 Filed under: Authors, Enforcement, Food, Health claims, Information, Nutrition claims Comments Off on Who Does Not Want To Have A Healthy Breakfast?
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”.
Recommendations
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.
Latest and greatest from Vitafoods Europe
Posted: May 15, 2015 Filed under: Authors, Food, Information, novel food Comments Off on Latest and greatest from Vitafoods Europe
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.
Alternative proteins
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.
Scope
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.
Food information
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.
Allergens
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.
Conclusion
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!
Axon seminar Functional & Medical Foods
Posted: August 15, 2014 Filed under: event, Food, Food Supplements, Health claims, Information, novel food, Nutrition claims Comments Off on Axon seminar Functional & Medical Foods
On 24 September 2014 our firm organizes a seminar addressing the developments in Functional and Medical Foods. Where? Next door to our office in Pakhuis de Zwijger.
Functional foods
The Institute of Medicine has designated functional food as “any food or food ingredient that provides a health benefit beyond its nutritional benefit”. Functional foods comprise food supplements, probiotics and other foods having a beneficial effect on human health, which is often advertised by health or nutrition claims as using those claims in connection with this type of foods is very attractive from a marketing point of view.
Medical foods
Functional foods are just one step away from medical foods, catering for particular nutritional needs that regular foods do not supply. Contrary to functional foods, medical foods are highly regulated. Furthermore, both types of food are subject to specific legislation regarding health and nutrition claims as well as regarding food information to be provided to consumers.
The regulatory requirements for health and nutrition claims offer a chance and a challenge. Also, as of 13 December 2014, all food business operators have to comply with very strict, new information requirements on the basis of the Regulation on Food Information to Consumers. To what extent does this regulation help the final consumer to make healthy choices and how does this impact the entrepeneur? Our seminar will address these issues and provides practical guidance on solutions. Speakers are: Bernd Mussler (Innovation Project Manager at DSM), Ruud Albers (CEO at Nutrileads) and us (Karin Verzijden and Sofie van der Meulen).
A few spots left!
We still have a few spots left! Attendance is free and you are welcome to bring along your colleagues. More info? Check the invitation on our website. For registration, please send an e-mail to info@axonlawyers.com with your name, the names of colleagues you would like to register and contact information. Questions? Contact our office manager Marjon Kuijs at marjon.kuijs@axonlawyers.com or +31 (0) 88 650 6500.
Looking forward to see you there!
Missed our seminar? Download our slides!
The slides of our seminar on medical and functional foods can be found here and also via our SlideShare account.
Glimpse of IFT 2014
Posted: June 30, 2014 Filed under: Authors, Food, Health claims, Information, Nutrition claims Leave a comment »
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.
Functional foods
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.
Allergens
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.
Misleading Advertising of Food Supplements – or not?
Posted: April 18, 2014 Filed under: Food, Food Supplements, Health claims, Information, Nutrition claims, Uncategorized Leave a comment »The role of national customs and self-regulatory bodies
Introduction
Recently, the Rotterdam District Court decided a dispute between Omega Pharma and Procter & Gamble on allegedly misleading advertising of food supplements. The product in dispute was Vibovit, a multi vitamins product for mothers and young children marketed by Procter & Gamble (P&G) since January 2014. Although well-known for its consumer products such as detergents and toothbrushes, Procter & Gamble is a new player in the field of food supplements. Omega Pharma is a company focusing on OTC health and care products including food supplements, for instance Davitamon. It holds a market share of 61 % in volume and 65 % in value in this field. Omega Pharma clearly perceives Vibovit as a competing product for Davitamon. No doubt, clear scrutiny of the new competitor in the field of food supplements was the start of this case.
Claims made by Omega Pharma
In a nutshell, Omega Pharma accuses P&G of committing misleading advertising and unfair commercial practises regarding its Vibofit product and also of violation of legislation on health claim, food supplements and labeling. More concretely, Omega Pharma inter alia opposed (1) the claim that Vibofit did not contain any preserving agents, whereas it appeared from the list of ingredients that the product contained potassium sorbate. (2) Furthermore, Omega Pharma complained that the packaging of Vibofit stated it contained only natural colouring agents, as it did not agree that the colouring agents titanium dioxide and carbon dioxide qualified as such. (3) Also, Omega Pharma considered the claim “+Omega 3” mentioned on the Vibofit packaging was made in violation of the Claims Regulation.
P&G’s preliminary defence
As a first preliminary defence, P&G had argued that Octapharma’s claim could not be received by the Civil Court, as Octapharma should have brought this claim before the Dutch self-regulatory body that advises on advertisements for health products (KOAG-KAG). This defence was rejected, as this self-regulatory body is only competent to hear disputes on health claims and not regarding any other claims in the field of food or advertising law. As a second preliminary defence, P&G had advanced that Omega Pharma’s claim actually related to unfair B2C commercial practices and that Omega Pharma could not invoke these rules (meaning their national implementation) against its competitor. This defence was also dismissed, as the Court considered that Omega Pharma was entiteld to invoke the rules on unfair commercial practises, being a lex specialis on the general law of the torts, against P&G.
(1) Evaluation of claim re. preserving agent potassium sorbate
Although the parties agree that potassium sorbate can be used as preserving agent, P&G argues this is not the case at hand. Instead, it uses this compound as a processing agent for the preparation of the yellow colour of the Vibofit gummies. As a result of the carry-over principle, a mimimum quantity of potassium sorbate is present in the final product. However, since this quantity is only 0,00005 %, which is 2.000 times too weak to be able to function as s preserving agent, the Court accepts this defence. As a consequence, the claim “free of preserving agents” is not considered misleading.
(2) Evaluation of claim re. colouring agents titanium dioxide and carbon dioxide
Omega pharma opposes the claims “100 % natural colouring agents” and “no artificial colouring agents”, as it considers that both titanium dioxide and carbon dioxide qualify as synthetic instead of natural colouring agents. Since the Food Additives Regulation does not make a distinction between natural and synthetic colouring agents, P&G relies on evidence from two national authorities to refute Omega Pharma’s claim. The first piece of evidence is a list of additives issued by the Dutch Food Safety Authority (Nederlandse Voedsel en Waren Autoriteit – NVWA) based on their qualification by the Dutch Nutrition Center (Voedingscentrum). This authority qualifies titanium dioxide (E171) and carbon dioxide (E172) as “natural”, as opposed to “synthetic” and “of natural origin, chemically processed”. The second piece of evidence is an NVWA fact sheet from which is follows that the colouring agents E171 and E172 are not considered synthetic. A consumer survey initiated by Omega Pharma investigating the misleading character of the claims used by P&G was considered not relevant, inter alia because it did not outweigh the opinion of the two Dutch national authorities and it was not considered completely neutral. As a consequence, P&G’s claims were not considered misleading.
(3) Evaluation of health claim +Omega 3
The notion + Omega 3 relates to the nutrition claim “source of Omega-3 fatty acids”. According the Health Claim Regulation, this claim is only allowed where the minimum quantities of 0,3 g ALA or 0,40 mg of the sum of EPA and DHA are met. One Vibofit gummy contains 2,5 mg Omega 3. As the packaging does not differ amongst ALA, EPA or DHA, it is not clear if the applicable standards are met. P&G however argues that it received prior approval from the self-regulatory body KOAG/KAG regarding its Omega 3-claims. Such approval has such authority that in those cases the Dutch Food Safety Authority usually does not apply any fines. In this particular case however, KOAG/KAG changed its policy after said prior approval was granted. According to the new policy, ingredients claims will only be allowed in as far as no existing health or nutrition claim is in place. Although P&G was not happy with this change, it nevertheless removed the Omega 3 claims from the Vibovit packaging and showed the galley proofs during the hearing. As a consequence, the Court considered that Omega Pharma no longer has sufficient interest re. its claim directed at Omega 3.
Conclusion
From the correspondence exchanged between the parties and reproduced in the judgement, it appears that P&G did not simply dismiss Omega Pharma’s claim but had meticulously prepared this case. Where it estimated that its claims would not hold, it had decided to move and to do so quickly. This is of course a very strategic approach, which quite often is successful to avoid litigation. However Omega Pharma simply decided to go after its new competitor. What is most striking in this case from an EU perspective, is the role of national authorities and national customs formulated by self-regulatory bodies. The prior approval from KOAG/KAG with respect to an ingredients claim for the food supplement Vibovit carried an enormous weight in the present dispute. Also, interpretations of national authorities of European food additives standards proved to be a decisive factor in this case. Therefore, when preparing a case of misleading advertising involving labelling and health and nutrition claims, carefully consider where to initiate it in view of those local customs.
Spring College on EU Food Law
Posted: March 7, 2014 Filed under: Food, Health claims, Information, Uncategorized Leave a comment »
After a succesful Autumn College last year September, this 2 days event on EU Food Law is repeated under the name Spring College. The event will take place on 27 and 28 March in Brussels and offers a unique opportunity to receive a profound insight and practical understanding of the complex legal and regulatory framework on EU Food Law. By means of a interactive and informal approach, this intensive two days training provides crucial knowledge on the legal and regulatory requirements, technical standards and relevant case law regarding two specific food law subjects.
Focusing on Health and Nutrition Claims and Food Information as the subjects which are nowadays at the core of the food industry, the Spring College provides fundamental theoretical and practical knowledge thanks to a number of highly topical presentations and ample opportunity for Q&A. Following the “learning by doing” approach, each day will be concluded by a case study, where the participants will split up in small groups to actively discuss and present their solutions. This will allow for a practical understanding and the application of the issues discussed.
The lecturers are seasoned food professionals stemming from the industry, private practise and consultancy. For the case studies, “tag teams” of two lecturers, providing insights from both the private practise and industry perspective, will be operative. All lecturers will stay for an entire day, so that they will also be available for taking questions outside the slots assigned to them.
Looking forward to see you there!
COOL update
Posted: January 7, 2014 Filed under: designation of origin, Food, Information | Tags: horsemeat, labelling, meat, processed meat Leave a comment » 
As announced in the post of October 30, 2013, the European Commission was expected to table a report concerning mandatory country of origin labelling (COOL) for meat used as an ingredient. In December 2013 this report was published. The report weighs the need for the consumers to be informed, the feasibility of introducing mandatory COOL and provides a cost/benefit analysis including the impact on the single market and international trade. On the basis of the debate following this report, the Commission will consider what, if any, appropriate next step should be taken. Tabling a legislative proposal concerning COOL for processed meats is a possible outcome. What was in the report?
Brief description of EU supply chain of processed meats and traceability
The EU meat processing industry represents more than 13.000 companies (Food Business Operators, FBOs) being mainly SME’s (90%). Products range from relatively simple meat preparations, e.g. fresh meat with spices, to sophisticated multi-ingredient foods. SME’s tend to change their suppliers more times a year to guarantee an adequate level of raw material at an affordable price. When the FBO process meat into (multi-ingredient) foods, these are then further sold to retailers/catering/butchers. Because of the variety of suppliers the FBOs of (multi-ingredient) foods use and the relatively small quantities they order, the FBOs do not have enough bargaining power to impose origin requirements to their suppliers. The supply chain of processed meats is quite complex and lengthy. The more complex the cutting and processing stages and the more advanced level of processing, the more complex traceability becomes. The existing EU traceability systems are not adequate to pass on origin information because the legislation is primarily based on the need to ensure food safety. Information to consumers is becoming more important, but food safety is still the core of EU food law. (see Article 18 of Regulation 178/2002 and Commission Implementing Regulation 931/2011 on the traceability requirements for food of animal origin). Because of the structure of the supply chain, the absence of a significant B2B interest in origin information and the inadequacy of the current traceability systems, the implementation of transmission of origin information to the consumer will be challenging.
Consumer interest in COOL
Despite challenging implementation, no less than 90% of consumers demand COOL for processed meat, but price and quality of meat are considered more important factors affecting consumer choice. Consumers would specifically like to know the country where meat was produced. The high percentage of consumers that want COOL could partly be caused by the horsemeat scandal, given the fact that the survey for the report took place in the midst of this scandal. According to the report, the consumer wants to be informed about the origin of meat, but does not want to pay for the additional costs that would be incurred in providing that information.
Three scenarios
The report is accompanied by a Commission Staff Working Document, which underpins the report. Further, an external study commissioned by DG SANCO by the Food Chain Evaluation Consortium (FCEC) has been undertaken. Results van be found here and here. The report describes three different scenarios:
- Maintain origin labelling on a voluntary basis (status quo);
- Introduction of mandatory labelling on the basis of a) EU/non-EU indication, b) EU/specific third country indication;
- Introduction of mandatory labelling indicating the specific EU Member State or specific third country.
For scenarios 2 and 3, different modalities of processed meats have been studied for the three main categories of the products concerned in an increasing order of processing. Scenario 2 is less informative than scenario 3, as scenario 3 provides more specific origin information. Please see below for a table concerning scenarios 2 and 3.
The scenarios examined
Scenario 1 would not raise any additional operational challenges but it would not provide a fully satisfactory solution to the consumer demand for origin information. In this respect scenario 2 and 3 would both be more desirable. However, scenario 2 would result in an increase in operating costs for FBOs up to 25% and may result in market segmentation and changes in international trade flows. It would also increase the burden on public authorities with 10-30%. Under scenario 3 the increased burden on public authorities is expected to be even higher along with an increase of 8-12% of the total production costs.
Table: Advantages and disadvantages of origin modalities under scenarios 2 and 3.
| Modalities under 2nd and 3rd scenario | Advantages | Disadvantages | |
| Category I: Meat preparations/mechanically separated meat | Country where ingredient was wholly obtained or country of last substantial transformation (Customs Code) | – Provides meaningful information to the consumer;- Trimmings and fat could be used as ingredients, where origin is determined as the country of the last substantial transformation. | – Additional traceability systems;- Implementation could be challenging if multiple origins are involved;- Trimmings and fat are not likely to be used as ingredients in cases, where origin is determined as the place of minimum rearing prior to slaughter, given the challenges in storage/traceability. |
| Place of minimum rearing prior to slaughter + place of slaughter | – Places more emphasis on the provenance of the raw material where the ingredient was not wholly obtained in one country. | – Additional traceability systems;- Implementation could be challenging if multiple origins are involved;- Trimmings and fat are not likely to be used as ingredients, given the challenges in storage/traceability. | |
| Category II: Meat products | Country where ingredient was wholly obtained or country of last substantial transformation (Customs Code) | – Places more emphasis on the place of processing where the country of last substantial transformation applies;- Technically feasible for FBOs;- More practical, if multiple origins are involved;- Trimmings and fat could be used as ingredients. | – Provides no information on the provenance of the raw material where the country of last substantial transformation applies. |
| Place of minimum rearing prior to slaughter + place of slaughter | – Places more emphasis on the provenance of the raw material where the ingredient was not wholly obtained in one country. | – Provides no information on the place of processing;- Additional traceability systems;- Particularly challenging where multiple origins are involved;- Trimmings and fat are not likely to be used as ingredients, given the challenges in storage/traceability. | |
| Category III: Multi-ingredient foods with meat used as an ingredient | Country where ingredient was wholly obtained or country of last substantial transformation (Customs Code) | – Places more emphasis on the place of processing where the country of last substantial transformation applies;- Trimmings and fat could be used as ingredients. | – Provides no information on the provenance of the raw material where the country of last substantial transformation applies;- Additional traceability systems;- Particularly challenging where multiple origins are involved. |
| Place of minimum rearing prior to slaughter + place of slaughter | – Places more emphasis on the provenance of the raw material where the ingredient was not wholly obtained in one country. | – Provides no information on the place of processing;- Additional traceability systems;- Particularly challenging where multiple origins would be involved;- Trimmings and fat are not likely to be used as ingredients, given the challenges in storage/traceability. | |
Final thoughts and more upcoming changes
The overall conclusion of the report is that consumer interest in COOL is strong, but this is not reflected in the willingness pay for the extra costs for FBOs and an additional administrative burden. Further, as set out in my previous post on this subject, COOL would not prevent fraud like the horsemeat scandal from happening again at all. While being informed about the origin of the meat, the consumer still risks receiving misleading information concerning the ingredient(s) itself. However, the horsemeat scandal did show that the current traceability systems are not adequate in case of incidents. In the aftermath of the horsemeat scandal, the debate concerning COOL might therefore give rise to changes to the traceability systems. More specifically, the discussion between the Commission, the Council and the Parliament concerning COOL may result in legislative changes that have an impact on your business. Aside the report discussed in this post, the Commission is also expected to adopt implementing rules on mandatory COOL for unprocessed meat of sheep, goat, pig and poultry, based on the New Labelling Regulation. Get informed and subscribe to updates from FoodHealthLegal (see section above ‘Tweets” on the right side of your screen) in order to stay posted!
Prošek vs. Prosecco – cheers!
Posted: November 13, 2013 Filed under: designation of origin, Food, geographical indication, Information | Tags: designation of origin, DO, geographical indication, GI, prosecco, Prošek, protection Leave a comment »
Italy vs. Croatia
What’s in a name? With Croatia’s accession to the European Union as of 1 July 2013 the beloved Croatian wine called Prošek is not allowed to be marketed under the name ‘Prošek’ anymore. How come? The Italian wines marketed under the name ‘Prosecco’ enjoy the rights granted by the protection of Designation of Origin since 17 July 2009. Meanwhile, the Croatian Prošek wine, even though it has been produced since hundreds of years ago, enjoys no such protection or protection as a “geographical indication” protection, due to the failure of the Croatian national authorities to protect this name.
Legal background
EC Regulation No. 1234/2007 (Single CMO Regulation) lays down the rules on the protection of “designation of origin” (DO) and “geographical indication” (GI) of wines marketed within the EU, independent whether they originate from an EU Member State or a third country. The DO or GI protection of wines originating from third countries (as Croatia was before joining the EU) is possible without going through the entire procedure set out in the Single CMO Regulation, provided that such protection is initially granted on national level (Article 118d). Croatian Prošek was not protected on national level and therefore could not obtain protection on EU level anymore.
No focus on protection of the names of local products
In order to convince the EU for its membership in the Union, Croatia had to solve several issues. Clearly, during that period there was no focus on protection of products, such as Prošek, on EU level. In fact, besides the Prošek wine, many other Croatian products (http://www.croatiaweek.com/no-croatian-products-with-european-protection/) lack protection on EU level. This might be the result of a weak IP protection policy, which maybe characterizes not only Croatia but also other western Balkan countries that aspire EU membership such as Albania, Bosnia and Herzegovina, Kosovo, Montenegro, Serbia and The Former Yugoslav Republic of Macedonia. This case should serve as a lesson to those countries so that they ensure that their products are properly protected before their eventual entry into the EU. See also this article.
Back to the bottles
Coming back to the Processo and Prošek dispute, why is it forbidden to use the name Prošek for Croatian sweet wine since 1 July 2013? Italian Prosecco producers claimed that the name Prošek is too similar to their already protected name. The name Prošek might therefore confuse those consumers who intend to buy Prosecco but end up buying Prošek. Such claims were followed by the threats of the Italian Prosecco wine producers about complaining to the EU authorities in case the Croatian wine producers would continue to market their wines under the name Prošek.
Confusion indeed?
One could argue that the first paragraph of article 118j of the Single CMO Regulation allows the registration of a name that is wholly or partially homonymous with that of a name already registered. However, this argument will not be successful as the local and traditional usage and the risk of confusion are decisive factors in determining a permissible registration. The traditional usage of the name Prošek and this wine`s qualities and differences when compared to Prosecco may be found here, here and here. Looking at the differences between the sweet Croatian Prošek and the sparkling Italian Prosecco, I couldn’t help but wonder how a consumer would confuse a bottle of Prošek with a bottle of Prosecco.
Conclusion: take up that challenge!
The Croatian authorities gave the impression that they gave up trying to protect the name Prošek, without fighting for it. The threat of being sued for marketing the Croatian wine under the name Prošek does not necessarily mean that the European court would decide in disfavor of Croatia. The Court of Justice has to decide whether or not the names Prosecco and Prošek may co-exist (as in the similar case with the Hungarian “Tokaj” and the Italian “Tocai” (See joined cases C-23/07 and C-24/07, ‘Confcooperative Friuli Venezia Giulia and Others’).
The author is grateful to Arber Gjunkshi, paralegal at Axon Lawyers, for his valuable contribution to this post.