Axon seminar Functional & Medical Foods

IE-Forum AXON Lawyers 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).

Ore_363832 The benefits of wine.

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 with your name, the names of colleagues you would like to register and contact information. Questions? Contact our office manager Marjon Kuijs at 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

IFT2014From 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.


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?

The role of national customs and self-regulatory bodiesVibovit-bis


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.


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

Spring!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

 1303_FB-COOLlabeling-Version-2As 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:

  1. Maintain origin labelling on a voluntary basis (status quo);
  2. Introduction of mandatory labelling on the basis of a) EU/non-EU indication, b) EU/specific third country indication;
  3. 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!

Prosek vs Prosecco

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 ( 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.

The Role of Razzies in EU Food Law

Golden RaspberriesRaspberry

One day before the distribution of the Academy Awards for excellence of cinematic achievements, the ceremony of Golden Raspberries or “Razzies” takes place. Razzies are awarded in recognition of the worst in film. Obviously, no producer, actor or actress is looking forward to receiving this “prize”. However, Razzy ceremonies continue to take place ever since 1980, so there seems to be no escape.

Razzies in Food Law

Since 2009, the Razzies have their peer in EU food law. Foodwatch, a European consumer protection organization active in Germany, France and the Netherlands, awards the so-called Golden Creampuff. This prize is granted for marketing strategies designed to “cleverly obscure the discrepancy between the alleged positive qualities of the products in question and their actual benefits.” For a number of years, this “prize” has been granted in Germany and the Netherlands under the names Goldener Windbeutel and Gouden Windei respectively.

Gouden Windei competition

On 3 October 2013, the Gouden Windei was awarded to the Dutch coffee company Douwe Egberts for a sweetener from its Natrena Stevia product line. Douwe Egbert’s product competed with four other products consisting of an energy drink, a cake, a salmon dinner product and a pear ice cream.The Natrena Stevia product line offers alternatives for sugar based on steviol glycosides that are extracted from the leaves of the Stevia plant. Douwe Egberts previously only marketed sweeteners based on Aspartame, but some consumers have a preference for the natural ingredient Stevia over the chemical compound Aspartame. You may recall that aspartame was regularly the object of public concern due to anecdotal reports of adverse effects. So far however, EFSA has concluded that it is safe to use this product as a food additive.

Natrena Stevia is the winner

Douwe Egberts’ winning product consisted of a small jar containing 70 grams of “Natrena Stevia crystal powder”. In total, 14.322 consumers had participated in the election of the Gouden Windei 2013, which election featured in total five products. 27 % of those consumers (3.866 persons) considered the Natrena Stevia sweetener to be the most misleading, as it only consists of 3 % Stevia. The other 97% of the product consists of Maltodoxtrine, which is a carbohydrate produced from potato or corn starch.

Applicable legal framework

The applicable legal framework, with which products such as Natrena Stevia have to comply, is in the first place constituted by the Food Information Regulation. This Regulation will replace the current labeling Directive 2000/13 on 13 December 2014. However, in order to ensure a smooth transition, many food operators tend to act in compliance with the Food Information Regulation as of today. According to article 22 of this Regulation, the indication of the quantity of an ingredient used in the manufacture or preparation of a food shall be required where the ingredient concerned is emphasised on the labelling in words, pictures or graphics. At a national level, similar provisions apply. The product Natrena Stevia features a list of ingredients indicating that this product contains 3 % Stevia. At this point, this products therefore seem to comply with the applicable legislation.

And what else?

In as far as food products do not comply with the applicable legal framework, consumer complaints can be justified and one could argue that organisations such as Foodwatch do a good job. However, it is all the more interesting to see that consumer complaints are also mobilised against products that in fact are in compliance. Reference is made to a case recently decided by the Dutch Advertising Code Authority that was previously discussed on this blog. Should it be concluded that the provisions laid down in the Food Information Regulation only provide a de minimis framework that does not pave the way for full consumer information? Or it is justified to expect from consumers of food products that they do some further research in addition to the information perceived at first glance?

Public perception

One can wonder if the yearly Razzies constitute an isolated momentum or if they have some social or economic impact indeed. Based on the changes applied in the information provided currently provided with the Natrena Stevia product, this latest Razzy seem to have had repercussions indeed. Douwe Egberts added an explanatory note on its website regarding the limited quantity of Stevia contained in its product Natrena Stevia crystal powder. In free English translation this reeds Stevia crystal powder consist of the light filler maltodextrine (97%) and Stevia (steviol glycosides 3 %). Why so little Stevia? That is because Stevia is 300 times sweeter than sugar and in its pure form therefore is difficult to dose. The filler causes 1 small spoon of Natrena Stevia to be as sweet as a small spoon of sugar, but it contains far less calories (3kcal per tea spoon). Based on all of this, it can be concluded that public perception, in addition to all legal and other product requirements, also plays a role in EU Food Law. Hopefully for the benefit of our healthy appetite!


New Labelling Regulation: more COOL?

My Brittle Pony

Rumour has it that the European Commission will decide not to go for full country-of-origin labelling (‘COOL’) on all meat products in the European Union. According to the European Commission is planning to recommend only partial country-of-origin labelling for fresh meats. This is not in line with the request of MEPs and EU ministers who have explicitly asked to beef up the new Labelling Regulation with better meat origin labelling for both unprocessed and processed meats. Why does the Parliament pressure the Commission to impose origin-labels on processed meat?

The reason for the Parliament’s pressure: the horsemeat scandal

The horsemeat scandal has been making headline news over the last year. It was a scandal caused by fraudulent labelling. Horsemeat was present in beef products and the consumer was not informed about this. For a Dutch perspective on the horsemeat scandal, see this article (in Dutch).

To restore consumer confidence and to improve controls the Commission has launched an Action Plan. COOL is part of the Action Plan and the Parliament has been pushing the Commission to adopt mandatory origin labelling for both fresh meat and meat in processed food (meat as an ingredient). In April, and later in September 2013, MEP Glenis Willmott urged the Commission to put rules on country-of-origin in place on ‘country of origin’ labelling for meat in ready meals and in processed foods. This month Health Commissioner Tonio Borg received a letter from MEP Agnès Le Brun to further pressure the European Commission for better meat origin labelling. The MEPs main arguments are that the horsemeat scandal highlighted the need for honest food labelling and by using COOL producers would have a much better grip on their supply chain.

Could COOL ensure honest labelling and prevent fraud?

In March 2013 Commissioner Tonio Borg answered this question in an interview. According to Borg the horsemeat scandal should be seen for what it is: a fraud rather than a demonstration of a regulatory gap. COOL would not necessarily create another hurdle for fraudsters: “(…) one could be honest about the origin but fraudulent about the labelling on the ingredients.” If you want to see the video of the interview, click here. I agree with Borg. The horsemeat scandal was a case of intended mislabelling, COOL will not prevent it from happening again.

Country-of-origin: current EU legislation

The current Labelling Directive only requires the place of origin or provenance to be mentioned on the label where failure to give this information might mislead the consumer (article 3(8)). In the EU, the origin must always be labelled for olive oil, fish (unless it is canned or prepared), beef, fresh or frozen poultry of non-EU origin, wine, most fresh fruit and vegetables, honey and eggs. For all other foods, origin labelling is optional.

New Labelling Regulation

According to article 26 of the new Labelling Regulation, indication of the country of origin shall be mandatory where failure to indicate this might mislead the consumer and for meat listed in Annex XI (see below).

Annex XI

The following steps have to be taken by the European Commission from now:

Autumn 2013Adopt a Commission report on the possibility to extend mandatory origin labelling of all types of meat used as ingredient in foods and take any necessary follow up action.

December 2013 – Adopt implementing rules on the mandatory origin labelling of unprocessed meat of sheep, goat, pig and poultry, based on the new Labelling Regulation.

December 2013 – Adopt implementing rules to prevent misleading use of voluntary origin labelling in foods, based on the Regulation on Food information to consumers.

December 2014 – Adopt Commission reports, based on the new Labelling Regulation, on the possibility to extend mandatory origin labelling to:

  • other unprocessed meats not already covered by mandatory origin labelling rules, such as horse, rabbit, game meat etc.;
  • milk;
  • milk as an ingredient in dairy products;
  • single ingredient foods;
  • unprocessed foods;
  • ingredients that represent more than 50% of a food.

So far, no official report from the European Commission on the meat labelling subject has been released, but it is expected to be published soon. Anyway, you will see an update here as soon as the report is published.

More COOL?

The Commission has not given a clear position on COOL yet, but if the rumours are true, the Commission is set to propose COOL for fresh pork, poultry and lamb. Compared to the current legislation, this results in more COOL because the requirements are being rolled out from beef to other meats, which will have an impact on the meat industry. But not totally COOL as the Parliament wants to see it. At this point it looks like COOL for processed meat will be rejected, which probably will be substantiated through an impact assessment. COOL for processed meat is likely to turn out to be too costly for the industry, and the consumer might not want to pay the price for origin information. Of course this is still speculative. Stay tuned for the update!


How to advertise healthy berries without cherrypicking?

Healthy PeopleHow do you communicate the main characteristics of your product to the public? First of all by its name of course – fair enough. At second glance, the list of ingredients comes into play. Pretty simple, isn’it? Beware however that Regulation 1169/2011 on the provision of food information to consumers (“the Regulation”) provides detailed rules for these two items – and more. And that you need to act in compliance by 13 December 2014, both regarding your product labels and regarding the information provided on your company’s website. If you are of the opinion that you can use a little help from this perspective, this post may be useful to you.

Name of the food

If there is a name prescribed by law for a food product, this must be used, e.g. “herring”. In the absence of such legal name, the customary or a descriptive name shall be used. This is a description of the food, and if necessary of its use, which is sufficiently clear to enable consumers to know its true nature and distinguish it from other products with which it might be confused, e.g. “cookie with Brazil nuts”.

Name in Member State of production equals name in Member State of marketing

In general, the name of the food in the Member State of production will be the same as the name in the Member State where the food is marketed, unless such does not enable the consumer to know the true nature of the food. For example, the name “vegetable samosa” may need to be qualified by “a pastry parcel with spicy vegetable filling”.

Other particulars to be communicated

Furthermore, the name of the food shall include or be accompanied by the particulars as to the physical condition of the food or the specific treatment which it has undergone in all cases where omission of such information could mislead the consumer, e.g. “freeze-dried” or “quick-frozen”. Also, in the case of foods in which a component or ingredient that consumers expect to be normally used or naturally present has been substituted, the labeling shall bear a clear indication of the component/ingredient that has been used for the partial of whole substitution. This should be done in close proximity to the name of the product and in a font size that is not much smaller than the name of the product. Finally, meat and fishery products giving the impression to be made of a whole piece of meat or fish, but actually consist of different pieces combined with other ingredients, shall bear the indication “formed meat/fish”. Bon appetit!

List of ingredients and legibility requirements

The list of ingredient shall include all ingredients of the food, named by their specific name, in descending order of weight, as recorded at the time of their use in the manufacture of the food. Only ingredients constituting less than 2 % of the finished product may be listed in a different order after the other ingredients. Futhermore, ingredients which belong to certain categories, e.g. “mixtures of flour obtained from two or more cereal species”, may be designated by the name of that category rather than by the specific name. As far as information present on the product label is concerned, this shall be printed on the package or on the label in such a way as to ensure clear legibility. Therefore, the x-height of het characters used shall in principle be equal to or greater than 1,2 mm.

Both product label and website information should be complete

Even if your product labels comply with all of the above, you may still be subject to a complaint regarding misleading information if your website information is not complete. In a recent decision of the Dutch Advertising Code Committee, a complaint regarding the product “Healthy People’s blueberry and raspberry juice” was discussed. According to this complaint, both the packaging and the company website provided misleading information regarding this product. The claim regarding the packaging was aimed at the fact that it only displayed blueberries and raspberries, whereas in reality, the juice consisted of 10 % blueberry and 4 % raspberry. From the list of ingredients, it appeared that other ingredients were apple, white raisin and aronia. The claim regarding the website was directed against the fact that blueberry and raspberry were the only ingredients mentioned.

Characteristic taste of the product

As a defence, Healthy People argued regarding both the packaging and its website that it was a deliberate choice to insist on the characteristic taste of the product rather than on side-issues.  Besides, the consumer was considered smart enough to understand that a juice consisting of only blueberries and raspberries would be too sour and too expensive (the average price of a liter blueberries being EUR 15). Healthy People so far had not received any consumer complaints and it therefore had not realised there was some issue here.

Average consumer

The Advertising Code Committee considered that the packaging was in line with applicable legislation. Allegedly, the average consumer would understand that the product does not only consist of blueberries and raspberries. Instead, such consumer understands that these ingredients are, amongst others, part of the product. Such could be deduced from the list of ingredients that the average consumer can be expected to consult regarding a high end fruit drink. Now that the website did not contain such list of ingredients, this was considered unclear. In the absence of full information a consumer could decide to buy this product, whereas he would not have done so otherwise. The limited information provided on the website was therefore considered misleading.


As follows from the decision discussed above, it is not sufficient that the labeling is in compliance with the applicable food information legislation, the same applies to the information provided at your company’s website. As of December 2014, many detailed food information rules will apply under the Regulation. However, despite the aim for harmonization at an EU level, there is still room for interpretation. This for instance applies to name of the product in connection with the wording “where omission of such information could mislead the consumer”. It does not come as a surprise that the interpretation of such wording may vary from country to country. Obtaining local advice for the launch of a new product therefore continues to be a sound plan. Also, do not overlook the annexes attached to the Regulation. They are 15 and full of strict requirements, for instance the one to state “formed meat” on your product. Although not so sexy, when applicable, you will not be able to get around it!


Food Information on Allergens: no escape!

allergens4Your company wants to provide bullet proof information on the food products it offers for sale in view of the upcoming changes in food legislation? This post may be helpful to you, as it highlights the issue of allergens and substances causing intolerances addressed by Regulation 1169/2011 on the provision of food information to consumers (“the Regulation”). You may recall that the rules laid down in the Regulation apply to food business operators at all stages in the food chain, where their activities concern the provision of food information to consumers. The new rules will in principle enter info force on 13 December 2014. However, in order to avoid time constraints by the end of 2014, a large number companies aim acting in compliance as soon as possible. What should be taken into account?

The issue of allergergies/intolerances

As allergies and/or intolerances seem to occur more frequently nowadays, the Regulation aims to ensure that full information is provided to allow the consumer to make an informed choice. The EU here clearly follows the example of the US, where FDA requirements on labeling allergens information already is in place. The Regulation stipulates to this respect that any ingredient or processing aid causing allergies or intolerances used in the manufacture or preparation of the food and still present in the finished product shall be indicated in the list of ingredients.

How to list allergens/substances causing intolerances?

This should be done in descending order or weight, as recorded at the time of their use in the manufacture of the food, where the allergens should be emphasised by using a typeset that clearly distinguishes it from the rest of the ingredients, by means of font, style or background colour. If the product does not contain a list of ingredients, then it should mention as a minimum: ”contains….” followed by the allergens. For the time being, 14 types of allergens have been distinguished, but the Commission is at liberty to extend the current list on the basis of a delegated act.

Allergens obligations also for non-prepacked food

Whereas EU food legislation used to apply only to prepacked food, it is striking to note that the obligation to provide information on allergens/substances causing intolerances also applies to non-prepacked food. More precisely, such obligation exists for foods that are offered for sale to the final consumer or to mass caterers without prepackaging, or where foods are packed on the sales premises at the consumer’s request or prepacked for direct sale. So do not be surprised to find a warning at the cheese corner of your Albert Heyn grocery stating that the products sold contain lactose, beind one of the allergens defined under the Regulation.

Stricter national requirements/means of providing information

More particulars, such as the quantity of the allergens or its country of origin, may need to be mentioned too, but only if such has been declared mandatory under national law. The sensitive area of allergens allows Member States to formulate stricter requirements as well (albeit within the Regulation’s framework). However, they are also at liberty to adopt national measures  concerning the means through which the information on allergens are to be made available.

How to handle non prepacked food requirements?

It can only be hoped for the Member States adopting national measures on the means of providing information in this area, adopt a practical approach. Although providing information “upon request” is not to be considered as a “means of providing information”, national measures may stipulate that detailed allergen/intolerance information may be given upon request of a consumer. However, such information should be provided in a conspicuous place and in such a way that it is easily visible and clearly legible. This is a practice that restaurants and cafes will need to get used to.


Allergies and substances causing intolerances are in the centre of interest. Many companies whom previously did not have to deal with information on allergies will find that the Regulation also applies to their business. In addition to getting acquinted with and stay posted on the EU allergens requirements, it is important to keep an eye on national legislation in this area. Member States are at liberty to formulate stricter national requirements here. Therefore, despite the aim of harmonization that the Regulation aims to achieve, obtaining local advice for the launch of a new product continues to be a sound plan. Also, stay tune to FoodHealthLegal, as we will provide you with information on requirements for the name of your product and other labeling requirements shortly.

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