All you wanted to know about organic food in the EU

EU_Organic_Logo_Colour_OuterLine_rgbThis contribution aims to provide you with a brief overview of the EU Organic legislation and recent developments. Being able to market products as ‘organic’ could be a plus for the food business operator (FBO) as the demand for sustainable production and organic food increases. This contribution focuses on the EU-system of organic certification of food products and will specifically look at the position of organic microalgae manufactured in the EU. Under the current legislative framework, these could not be marketed as such in the EU. This has changed since an interpretative note of the Commission of last summer. If you are an FBO interested in marketing organic microalgae, this for sure is of interest to you.

Organics Regulation – scope

First of all, what is ‘organic production’? According to recital 1 of the Organics Regulation organic production is: “(…) an overall system of farm management and food production that combines best environmental practices, a high level of biodiversity, the preservation of natural resources, the application of high animal welfare standards and a production method in line with the preference of certain consumers for products produced using natural substances and processes” (see also the definition in Article 2(a)).

What is covered by the Organics Regulation? Only agricultural plants, seaweed, livestock, aquaculture and animals are regulated under the Organics Regulation. For example, if an FBO wants to produce organic seaweed, all the processes have to be in compliance with the Organics Regulation. This approach is known as the ‘farm to fork approach’, which means every step in the production process throughout the supply chain has to comply with the Organics Regulation.

Organics Regulation – structure

The Organics Regulation has a layered structure. The following three layers of provisions can be found:

  1. General production rules (articles 1, 7 – 10), which apply to all forms of organic production.
  2. Production rules for different sectors (articles 11 – 21): general farm production rules and production rules for specific categories of products and production rules for processed feed and food.
  3. Detailed production rules (article 42).

If there are no production rules for the sector (layer 2), only the general production rules (layer 1) apply.

Organics certificate

Compliance with the Organics Regulation has to be demonstrated by obtaining certificates from a certification body. (See the following link for a list of competent certification bodies in different Member States). In the event a certification body audits the FBO marketing organic products and it encounters violations of the Organics Regulation, it can decide to block certain non-compliant batches of products pending an investigation. Depending on the outcome, the certification body can subsequently decide to withdraw the certificate. If the certificate is withdrawn, the FBO is no longer allowed to market the products as ‘organic’. In case of severe violations, the competent authority may impose a recall of the products. In the Netherlands, Skal Biocontrole is the designated Control Authority responsible for the inspection and certification of organic companies in the Netherlands, within the context of Regulations: (EC) Nr. 834/2007 (Organics Regulation), (EC) Nr. 889/2008 and (EC) Nr. 1235/2008 (import of organic products from third countries). Skal monitors the entire Dutch organic chain on behalf of the Dutch Ministry of Economic Affairs.

The EU organic logo

The EU logo is regulated in a separate Commission Regulation. The main objective of the European logo is to make organic products easier identifiable by the consumers. Furthermore it gives a visual identity to the organic farming sector and thus contributes to ensure overall coherence and a proper functioning of the internal market in this field. For practical information regarding the EU logo, see this link and this link.

Organic microalgae

Prior to July 2015, FBO’s could not obtain an organic certification for microalgae manufactured within the EU for the use in their food products. FBO’s from third countries (non-EU) could market their products in the EU based on either the import procedure as set out in Article 33 (2) (import from recognised third countries) or the import procedure laid down in Article 33 (3) of the Organics Regulation (import of products certified by recognised control bodies). The strange situation was created where ‘organic’ microalgae could only be imported into the EU and not be produced within the EU.

How come? All agricultural products were considered to fall within one of the different production rules for specific categories of products (layer 2) and microalgae for food production were not included. Furthermore, detailed EU production rules for microalgae were absent (layer 3). (Article 42 (2) Organics Regulation).

The Interpretative note of the European Commission (Directorate-General for Agriculture and Rural Development) of July 2015 opened up the possibility for companies in both EU Member States and third countries to produce microalgae, which can be marketed as ‘organic’ and carry the EU organic logo. Both the existing production rules for plants (Article 12 Organics Regulation) and seaweed (Article 13 Organics Regulation) could be suitable for microalgae.

‘Until an implementing act adopted on the basis of Article 38 (of Regulation 834/2007) has clarified the situation, operators producing organic micro algae (except for use as feed for aquaculture) have therefore to comply with the general production rules, which apply to all forms of organic production (“layer 1”) and with the production rules for the sector of plants or seaweed (“layer 2”).’

The use of microalgae as feed for aquaculture is not covered in the Interpretative note, as microalgae as feed are already subject to the detailed production rules. The rules for the collection and farming of seaweed apply according to Article 6a of Commission Regulation (EC) No 889/2008.

The interpretation opens up the possibility to certify microalgae to be used as food (or as an ingredient in food) as being organic. When an implementing act will be published and enter into force is still unknown. A proposal for a new Regulation repealing the Organics Regulation has been published. On 5 November 2015 a report from the Committee on Agriculture and Rural Development on the proposal was published, introducing 402 amendments. The current status of the proposal is available through this link.

Aside from enforcement by a national control authority in case of non-compliance with the Organics legislation, consumers and other interested parties often also have the possibility to lodge a complaint relating to advertising of organic products. However, advertising of (organic) products is a topic to be covered in another contribution on Food Health Legal. Stay tuned!


Weight loss claims – the proof in the pudding is in the eating

Vector illustration of changes in sizes choosing different dietSome food supplements claim to help the consumer to lose weight and achieve the ideal bodyweight by consuming the product. Sounds too good to be true? Then this post is of interest for you. Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to provide a scientific opinion on the conditions of use for health claims related to meal replacements for weight control. In fact, the NDA Panel previously evaluated the conditions of use for these types of claims in 2010. We take this re-evaluation as an opportunity to report on the legal framework for weight loss claims regarding foodstuffs.

Relevant legal framework

The relevant legal framework is constituted by both the Health Claim Regulation and the Energy Restricted Diets Directive. Article 12 of the Health Claim Regulation prohibits the use of claims making reference to the rate or amount of weight loss. According to article 13 of the Health Claim Regulation however, it is permitted to use health claims describing slimming or weight control or a reduction in the sense of hunger. It is also permitted to use claims describing an increase in the sense of satiety or the reduction of the available energy from the diet. For these claims to be allowed, they should be in line with the requirements of the Energy Restricted Diets Directive (containing both compositional and labeling requirements) and they should be included in the Community list of permitted claims. Furthermore, these claims should be based on generally accepted evidence and they should be well understood by the average consumer.

Various claims allowed regarding normal metabolism

The consumer could be helped in achieving weight reduction by consuming products that replace some of the daily need for energy or that reduce the craving for more food. In fact, maintaining a healthy metabolism (of either lipids or carbohydrates) could result in weight loss on the long term. There are quite a few authorized claims relating to a normal metabolism. For instance, the claim “Zinc contributes to normal carbohydrate metabolism” can be used if the product to which it relates contains zinc in a quantity of 1,5 mg/100 g or 0,75 ml/100 ml. Furthermore, the claim “Calcium contributes to normal energy-yielding metabolism” is allowed if it relates to a product contains at least 120 mg/100 g calcium or 60 ml/100 ml Calcium. As a final example, the claim “Choline contributes to normal lipid metabolism” can be used if the food product at stake contains at least 82,5 mg of choline per 100 g or 100 ml or per single portion of food.

One single authorized claim regarding weight loss

Until now only one single claim with respect to weight loss has been authorized. The claim reads “Glucomannan in the context of an energy restricted diet contributes to weight loss”. Glucomannan is extracted from a plant called “konjac”, having very diverse nicknames, such as devil’s tongue or snake palm. The claim regarding Glucomannan is targeted at overweight adults and may be used only for food products that contain 1 g of glucomannan per quantified portion. Furthermore, the consumers should be informed that the beneficial effect is obtained with a daily intake of 3 g of glucomannan in three doses of 1 g each, together with 1-2 glasses of water, before meals and in the context of an energy-restricted diet.

Two authorized claims for meal replacement

Next to the Glucomannan-claim, there are two claims available for foodstuffs replacing one respectively two meals a day. Both claims are identical and read “Meal replacement for weight control”. Where nutrition and health claims in general are linked to particular nutrients, this claim however is not. In order to achieve the claimed effect, one meal respectively two meals should be substituted with meal replacements daily. Furthermore, foodstuffs bearing this claim should comply with specifications laid down in Energy Restricted Diets Directive. This Directive sets minimum and maximum limits for nutritional values of foodstuffs that are consumed as a replacement for one or two meals a day. Furthermore, this Directive prescribes the content of replacement products, in terms of energy, proteins, dietary fiber, vitamins and minerals. The foods under the Energy Restricted Diets Directive are not to be confused with so-called medical foods. These foodstuffs also regulated in terms of content and labeling and they are also used to replace meals, however only upon prescription and not for the purposes of weight loss.

Re-evaluation of the weight loss claim

The reason for the re-evaluation of the claims regarding meal replacements for weight control  is a bit of a technical story. We will try to do our best to explain this in clear and understandable terms. As of 20 July 2016, the Energy Restricted Diets Directive will be repealed by a new Functional Foods Regulation providing a common framework for all types of functional foods: infants foods, medical foods and total diet replacement for weight control. As a consequence, the Annex to the Energy Restricted Diets Directive containing detailed guidance on the composition of foods for energy restricted diets will no longer apply Instead, guidance will have to be taken from the applicable Annex to the Food Information for Consumers Regulation (Annex XIII, Part A to be exact) introducing the Nutrient Reference Values’ for vitamins and minerals. This will cause some changes (increases or decreases) in the micronutrient content of meal replacements to occur.

Task of the NDA Panel

Under both the current and the future legal framework for meal replacements, the foodstuff has to contain specified quantities of certain vitamins and minerals to make sure that even when replacing meals as a whole, the consumer does not suffer a vitamin/mineral deficiency. Normally, the consumer is expected to loose weight on the basis that the replacement meal has a controlled energy content and a relatively high protein/low fat content. The NDA Panel was asked to give its scientific opinion about the substantiation of the health claim related to meal replacements under the new Functional Foods Regulation. The NDA Panel considered that the difference in micronutrient composition required under this new Regulation in respect to the Energy Restricted Diets Directive did not affect the scientific substantiation of said health claim, as previously assessed in 2010. As a consequence, the claim “contributes to weight loss” can still be used, provided of course that the conditions for use are met.

What more is allowed?

With respect to other ingredients and substances than Glucomannan, weight loss or similar claims have been made as well. As examples can be mentioned green tea extract and hyperproteins pasta. EFSA did assess more substances and the related claims and concluded that there was a lack of scientific evidence to substantiate such a claimed effect. Recently the claim; “fat-free yogurt and fermented milks with live yogurt cultures, with added vitamin d, and with no added sugars help to maintain lean body mass (muscle and bone) in the context of an energy-restricted diet” was not approved. In essence, products that carrying the claim, ‘contributes to weight loss’ which do not contain Glucomannan in the prescribed quantities and do not comply with the standards as set in the Energy Restricted Diets Directive, are not allowed on the European market. But with a little education of the consumer, explaining that a normal metabolism is actually at least as important as weight loss, plenty of other claims are available for healthy products. During the festive season, the emphasis may not be on the consumption of healthy products. But on a day-to-day basis, we strive for a healthy intake – or don’t we? That’s the point!

The author is grateful to Floris Kets, intern at Axon Lawyers at the time of drafting this blog.

 

 


Novel Foods – the final verdict?

Amsterdam Westerpark. Foodfestival De Rollende keukens. Bij deze bus kan men snacks kopen die gemaakt zijn van insecten, zoals gefrituurde sprinkhanen op een stokje of meelworm loepia'sThe heat was on today in the European Parliament (EP).  The reason for that was that the new Novel Foods Regulation was put to vote in a plenary session. In the debate prior to the vote, the opinions centred between concerns about food safety and the free circulation of goods. In this post, you will be updated about the outcome of the vote. In short, the adoption of the new Novel Foods Regulation will have important consequences for Food Business Operators (FBO’s). In an earlier post, we already reported about streamlined authorisation procedures. Today, we will mainly focus on the type of products covered by this legislation. Insects are in for a start. In a 10 minutes read, you will learn what are the consequences thereof – and more.

Shaping the new Novel Foods Regulation

Today (28 October 2015), the EP adopted the latest proposal for a Regulation on Novel Foods [insert final text]. As reported in one of our previous posts, the European Commission published an initial proposal for this Regulation in December 2013. EP Rapporteur Nicholson heavily criticised this draft, mainly for its open product definition and for the lack of streamlining the authorisation procedure. As a result, an EP legislative proposal became available, in which the Rapporteur formulated a number of improvements. Most of them were included into the draft legislation approved by the ENVI committee by the end of November 2014, which further developed into the text voted today. This adopted proposal will enter info force after publication in the OJ. However, a transition period of 24 months after such publication has been provided before its actual application.

So what are Novel Foods finally?

In the initial Commission proposal, the various product categories had not been exhaustively defined. Although such a system could present the advantage of flexibility, in fact FBO’s resisted against the legal uncertainty this would create. As a result, the approved draft by the ENVI Committee identified 10 categories of Novel Foods. Some of these have again been heavily debated, like for instance insects – however without success. The Regulation voted today in the EP defines the following products as Novel Foods:

  1. food with a new or intentionally modified molecular structure;
  2. food consisting of or isolated / produced from microorganisms, fungi or algae;
  3. food consisting of or isolated / produced from material of mineral origin;
  4. food consisting of or isolated / produced from plants or their parts, except when the food has a history of safe food use in the Union and one out of two alternative conditions are met;
  5. foods consisting of or isolated / produced from animals or their parts, except where these animals were obtained from traditional breeding practises and the food from those animals has a history of safe food use;
  6. food consisting of or isolated / produced from cell or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
  7. food resulting from a production process not used within the Union before 15 May 1997, giving rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesired substances;
  8. food consisting of engineered nanomaterials;
  9. vitamins, minerals and other substances, where a new production process has been applied or where they contain engineered nanomaterials;
  10. food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use other than in food supplements.

 What’s in? – Most striking changes

Contrary to the ENVI proposal, the current text of the Regulation no longer mentions food derived from cloned animals or their descendants as a separate product category. However, it becomes clear from the recitals in the new Novel Foods Regulation that no change is intended here. Until specific legislation on food from animal clones enters into force, such food is covered by category nr. 5 of this Regulation, as food from animals obtained by non-traditional breeding practises. Another textual change relates to category nr. 8. Whereas the ENVI draft still specified the highly debated 10 % threshold for a food ingredient to qualify as nano (instead of the 50 % threshold proposed by the Commission), no such threshold is contained in the current text. Although this is no doubt a compromise solution, it is expected it shall give rise to new discussions. A real change with respect to the ENVI proposal relates to product category nr. 3, covering food of mineral origin. For now,  the background of this change remains unclear. Finally, insects are still covered by category nr. 4. Today, many food products consisting of or containing insects are marketed in various Member States. It is therefore important to establish what will be the consequences of considering insects as Novel Foods. In order to answer that question, the provisions laying down the transition regime are of interest. Furthermore, by way of background, a number of safety evaluations of insects as food are briefly discussed.

Evaluation of insects as food by certain Member States

In one of our previous blogs relating to the marketing of insects as food products, we reported that due to the lack of clarity regarding the status of insects (Novel Foods or not?), some Member States issued their own guidance. In Belgium for instance, the placing on the market of 10 particular insects species as food product is tolerated, provided that specific food law requirements are met. In the Netherlands, the Dutch Food Safety Authority and the Health Minister ordered a safety report with respect to three types of insects currently marketed as food in the Netherlands. These are the mealworm beetle, the lesser mealworm beetle and the locust, regarding which the heat-treated and non-heat treated consumption was evaluated in terms of chemical, microbiological and parasitological risks. Based on the outcome, it was recommended to consider these insects as “regular” foods (in the sense of the General Food Law Regulation) and not as Novel Foods.

Evaluation of insects as food and feed by EFSA

On 8 October 2015, EFSA published its Risk profile related to production and consumption of insects as food and feed ordered by the Commission. In fact, EFSA was requested to assess the micro-biological, chemical and environmental risks posed by the use of insects in food relative to the risks posed by the use of other protein sources in food. EFSA found that for the evaluation of micro-biological and chemical risks, the production method, the substrate used, the stage of harvest, the specific insect species and the method of further processing are of relevance. It established however that with respect to any of these topics, fairly limited data are available. It therefore strongly recommends further research for better assessment of microbiological and chemical risks from insects as food, including studies on the occurrence of hazards when using particular substrates, like food waste and manure.

Transition regime

How to deal with insects as food products that are currently marketed? The new Novel Food Regulation provides first of all that these products do not have to be withdrawn from the market. However, for the continued marketing of such food products a request for authorisation should be filed within 24 months after the date of application of the new Novel Food Regulation. This would come down to the following.

  • Entry into force of new Novel Foods Regulation: 1 January 2016 (assumption)
  • Date of application of new Novel Foods Regulation: 1 January 2018
  • Ultimate date for filing authorisation for continued marketing of insects as food: 1 January 2020.

This means that roughly speaking 4 years from now, FBO’s offering insects as food should still obtain a Novel Food authorisation. Assuming that these products have been marketed since the end of 2014 (see for instance the news on the launch of the insect burger sold by Dutch grocery chain JUMBO), this would mean that they were on the market 5 years before. If no safety concern ever arose so far, it would not be unreasonable to request an exemption from this obligation. At any rate, such FBO’s should know that prior to the indicated date of 1 January 2020, they can most likely successfully rebut any enforcement measures by local food safety authorities.

Conclusion

The adoption of the new Novel Foods Regulation has been a process with quite a few hick-ups and some surprising results. Whereas food from cloned animals for a long time had been the cause of delay, it is surprising to see that this Novel Food category nevertheless ended up within the scope of the new Novel Foods Regulation. As to products providing alternative protein, such as insects, we understand that the safety aspects from rearing to consumption should be carefully assessed. However, we note that EFSA does not have any immediate safety concerns per se. Furthermore, it should be stressed that the notion of “safety” in EU food law has only been negatively defined. That is, food is safe as long as it is was not found unsafe. Therefore, we consider that alternative protein products that were marketed for a number of years without any problems reported should not be subject to further barriers. Anyhow, FBO’s should be aware of their rights of continued marketing of such products, at least for four more years to come.

Want to know more about this subject? Do join the Axon Seminar on Alternative Proteins: invitation seminar.

Image: Amsterdam Westerpark, food festival “The Rolling Kitchens“, serving snacks made out of insects, such as fried grasshoppers on a stick or mealworm spring rolls.

 

 


The medicinal effect of …. Coca Cola

Coca-ColaRecent research from the Erasmus medical centre (Netherlands, Rotterdam) suggests that certain medicines might be taken up better by patients when administered with Coca Cola instead of water. In short, the researchers where looking for a way of helping patients who received the medicine erlotinib (Tarceva). The medicine is used to treat lung cancer patients and it is orally administered. Most of the cancer patients also use stomach protection medicines against the side effects of cancer medication. These protection medicines however lower the pH in the stomach and therefore the uptake of erlotinib in the bloodstream was not optimal. Taking the medicine with Coca Cola (which creates a temporary more acid environment in the stomach) gave spectacular results: the levels of uptake in the blood were in the average 40 % and sometimes even 100 % higher. Could Coca Cola therefore be considered to be a medicine?

Food or medicine?

 At first sight, this question may seem to be somewhat far-fetched, but in this context it is interesting to know that Coca Cola was invented by a pharmacist. Furthermore, the question whether a product qualifies as a food or as a medicine is not highly theoretical. In fact, there is an important body of EU case law since the 80-ies that deals with exactly this question. This is all the more relevant, as the qualification of a food product as a medicinal product can have drastic consequences for market access. This blogpost will discuss a number of those cases, including vitamin preparations and garlic pills, and address the status of Coca Cola against that background.

Criteria of medicinal products and of food products

According to the Medicinal Products Directive, a medicinal product is:

(a) “any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”

According to the General Food Law Regulation, a food means “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”

Are vitamin preparations medicinal products?

In order to answer this question, the national authorities should properly assess the pharmacological properties (the “function of the product”) and the presentation of the product. In the Van Bennekom case (C-227/82), relating to a Dutch national trading highly concentrated vitamin preparations in the form of tablets, pills and capsules, the European Court of Justice (“EU Court”) elaborately dealt with the presentation criterion. This was also one of the first cases where the EU Court provided a dividing line to be drawn between medicinal products and food products. In short, the EU Court ruled that the form given to the product (pills, capsules) can serve as strong evidence of the intention of the manufacturer or seller to market a medicinal product, but is not conclusive in its own right. However, the concept of presentation with respect to borderline products must be broadly conceived in order to protect consumers. Therefore, a product can qualify as medicinal product if any well-informed consumer, based on the presentation of the product, gains the impression this is actually a medicinal product.

Do Member States differ on the qualification of borderline products?

Yes, they sometimes do. This was clearly demonstrated in the Delattre case (C-369/88). In this case, products that were sold in Belgium as supplements and cosmetics qualified as medicinal products in France. The EU Court ruled that the products were presented as having positive effects on certain body functions, like the functioning of the gastro intestinal tract or liver and therefore, they were covered by the Medicial Products Directive. The French authorities could qualify the products as medicinal products, even if in Belgium these products qualified as foods and cosmetics. The national authorities and courts will have to judge on a case-by-case basis if a product is either a food or a medicinal product. If the product can be qualified as food and or cosmetic and as a medicinal product, the product is considered a medicinal product and not both.

Are Garlic pills medicinal products?

The so-called Garlic case (C-319/05) related to food supplements that were presented in a capsule form. The German authorities qualified these supplements as a medicine, but the EU Court did not agree. Although the supplements had a capsule form, the EU Court ruled that this form is not exclusive to medicinal products. Moreover, the supplements did not contain any mention that they aimed to prevent or treat a certain disease. Furthermore, although the beneficial effect from the active ingredient allicin was recognized, this effect did not transcend the normal metabolism of garlic. Therefore, the food supplements were not considered to be medicinal products, neither by presentation, nor by function.

Qualification of Coca Cola as a medicinal product?

Against the above background, could Coca Cola possibly be qualified as a medicinal product? For sure, it will not qualify as such by presentation. The product is sold in a bottle or as a can in quantities that exceed by far the average medicinal product. It is not recommended for care or cure, but to refresh at most. The qualification by function is a different story, as it does present some positive effects on certain body functions. The Erasmus research has demonstrated that taking the medicine erlotinib (Tarceva) together with a glass of Coca Cola will temporarily lower the pH in the stomach, back to the acidity levels prior to taking any stomach protection. In essence the Coca Cola restores a body function. A regular soft drink does not have this effect and one could therefore argue that Coca Cola does have a medicinal function. The pharmacological properties of Coca Cola as such are not substantial, although the effect in combination with the medicine can be. The boundaries between food and medicinal products are not set in stone but keep on moving.

The author thanks Floris Kets, trainee at Axon Lawyers, who had the great idea for this post.

 

 


180 fold higher fines in Dutch Commodities Act

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On 11 September 2015 new legislation amending the current Commodities Act (in Dutch: Warenwet), partly entered into force. Under the new legislation the maximum administrative fine to be imposed on Food Business Operators (hereinafter: ‘FBO’s’) by the Dutch Food Safety Authority (NVWA) is increased dramatically compared to the prior maximum fine. The Dutch legislator has clearly increased existing fines to make them stronger and more effective to increase compliance with food safety regulations. The NVWA has more teeth, but will it bite?

The rationale behind the increased fines

A reason to increase the maximum fines can also be found in the battle against food fraud in general. Until recently the NVWA could impose a fine on an FBO on the basis of Article 32 of the Commodities Act. The maximum fine was set at € 4.500. According to its latest annual report, the NVWA imposed 2808 fines on FBO’s in 2014. The average amount of a fine was € 1.206,– and the total amount of imposed fines was € 3.413.893,–. Considering the costs of compliance with hygiene and administration standards, these penalties are merely peanuts for the average FBO and do not have the desired effect of contributing to compliant behavior as is confirmed by the statement further down in this post.

Fines linked to system under Dutch Penal Code

Fines in other areas such as data protection law are also subject to revision and they will both increase and expand (meaning an increased number of provisions will be subject to potential fines in case of non-compliance and those fines tend to increase as well). With a political climate both in the EU and in the Netherlands that leans towards stronger enforcement instruments, it was just a matter of time before the fines under the Commodities Act would be increased. The Dutch legislator seems to try to harmonize the several fines in different legal acts by referring to the categories of fines specified in the Dutch Penal Code. These categories are linked to the severity of the violation. The first category is the lowest and the sixth category the highest. The maximum fines are now set at the maximum of the sixth category: € 810.000,– (or 10% of the annual turnover). This means a 180 fold higher maximum fine!

In relation to the increase of administrative fines politician Sjoera Dikkers (Dutch Labour Party – PVDA) stated: “it is clear that a fine of 4.500,– is cheaper for practically every company, then acting in compliance with hygiene practices in the Netherlands. For a fine of 81.000,– this can be similar for big companies, depending on the nature of the infringement. That is why we would like to further increase the maximum penalty to the sixth category. This is the only way to scare companies enough to make sure they comply with hygiene requirements.

The exact amount of the fine will have to be proportionate and therefore depend on factors such as the number of employees, the degree of culpability, the severity of the violation and/or the turnover of an FBO. The NVWA has to assess all individual circumstances in order to establish the amount of the fine.

Final thoughts

Although relatively low fines indeed might give rise to profit for FBO’s from non-compliance and fraudulent behavior, drastically increasing the fines could have a downside for both the NVWA and the FBO’s. Imposing higher fines requires more effort and expertise from the NVWA. For fines that exceed the amount of € 340,– additional procedural requirements, similar to criminal law, have to be met by the NVWA. For FBO’s a high fine could indeed have a significant impact and even potentially mean bankruptcy. As we have seen in Dutch cases relating to the horsemeat crisis, the NVWA can impose the execution of a recall that can lead to bankruptcy. We will keep you informed on how this potential powerful enforcement instrument of high fines in the hands of the NVWA is handled in practice and dealt with in court. Hopefully, this will serve FBO’s in establishing what should be done to avoid or annul the decision of the NVWA to impose such fines, which is a part of our active practice.

The author is grateful to Floris Kets, trainee at Axon Lawyers, for his valuable contribution to this post.

 

 


Who Does Not Want To Have A Healthy Breakfast?

Crude health blackThe 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.

  1. 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.
  2. 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.
  3. 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.
  4. When using general, non-specific claims, use the specific, authorized claim in the same field of vision.
  5. When in doubt, or if you simply need a sparring partner, consult an expert.

 


Latest and greatest from Vitafoods Europe

Vitafoods EuropeOn 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.

 

Novel foods for Vitafoods from Axon Lawyers

 

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.

 

Vitafoods Europe 2015: Clearer labels for consumers from Axon Lawyers

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!


New legislation: COOL for unprocessed meats

hh-16665591In a previous post from January last year I wrote about country of origin labelling (COOL). I mentioned that the Commission was expected to adopt implementing rules on mandatory COOL for unprocessed meat of sheep, goat, pig and poultry, based on the Food Information to Consumers Regulation. A nice infographic about the new EU food labelling rules can be found here.

And now there is ‘COOL’ news: rules on origin labelling for meat apply from 1 April 2015. Which rules? The Commission adopted Regulation 1337/2013 on the indication of the country of origin or place of provenance for fresh chilled and frozen meat of swine, sheep, goats and poultry.

Background and scope

As from 1 April 2015 no packaged unprocessed meat product from abovementioned animals may be lawfully placed on the market in the European Union without a label indicating where the animal was reared and slaughtered. An exception applies to meat that was lawfully placed on the Union market before 1 April 2015. This may be sold until the stocks are exhausted, provided of course that the best before date/use by is not exceeded.

The European COOL rules do not apply to processed meats. In December 2013 the European Commission published a report concerning mandatory country of origin labelling (COOL) for meat as an ingredient. 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. Read this post if you want to recall the discussion on the December 2013 report. Click here for the response (in Dutch) from the Dutch Food Industry Federation (FNLI) on the resolution and here for an article on this topic on the website of EurActiv. Until now, COOL has not been extended to processed meats, however this may change. In this resolution from February 2015, the European Parliament urges the Commission to follow up its report with legislative proposals making the indication of the origin of meat in processed foods mandatory. It is expected that this will ensure greater transparency throughout the food chain and it will rebuild consumer confidence in the wake of the 2013 horsemeat scandal, and other food fraud cases. This seems contrary to the outcome of the report in terms of feasibility as COOL for processed meats means higher costs for the industry and an increased administrative burden.

Now let’s have a look at the new rules. What is meant with ‘country of origin’ and what information should be placed on the label? Continue reading to find out!

Labelling rules

The core provision of the new Regulation is Article 5, which lays down the COOL rules for the meats covered by the Regulation. Either the indication (i) ‘origin’, (ii) ‘reared in’ + ‘slaughtered in’, or (iii) a list of different indications should be placed on the label according to Article 5.

What is meant with ‘country of origin’ for meat products?

Recital 3 of Regulation 1337/2013 refers to the concept as set out in Articles 23 to 26 of Council Regulation 2913/92 (Customs Code). For meat products the country of origin means the country in which the animal was born, reared and slaughtered. Only in this situation the following indication may be placed on the label as far as the food business operator is able to prove the correctness of the statement to the competent authority:

  • ‘Origin: (name of Member State or third country)’

But what if the meat comes from animals, which were born, reared and slaughtered in different countries? In that case in indication of the country (Member State or third country) where the animal was reared and the country where the animal was slaughtered have to be specified on the label.

‘Reared in’

Article 5 of the Regulation gives specific criteria to determine the correct indication for the country where the animal is ‘reared in’ related to the rearing period of the animal in a country. If the specified rearing period is not attained in any country the label must show one of the following indications:

  • ‘Reared in: several Member States’
  • ‘Reared in: several non-EU countries’
  • ‘Reared in: several EU and non-EU countries’
  • ‘Reared in: (list of Member States or third countries where the animal was reared)’

The last option may only be used if the FBO is able to prove this to the competent authority.

‘Slaughtered in’

The Member State or third country in which the slaughter of the animal took place has to be indicated as follows:

  • ‘Slaughtered in: (name of the Member State or third country)’

If pieces of meat, of the same or different species, are packed together and correspond to different labelling indications, the label has to indicate the list of relevant countries for each species (see Article 5(3)).

Furthermore, the batch code identifying the meat supplied to the consumer or mass caterer should be placed on the label.

A little extraFullSizeRender: COOL in the U.S.

If you are a FBO operating both in the EU and the US you might be interested in COOL in the U.S. Like Europe, the U.S. COOL statute defines multiple origins for muscle cuts of meat, depending on where the animal was born, raised and slaughtered. This is pretty much in line with Europe, which defines “born, reared and slaughtered” as the origins that must be placed on the label. Do you want to learn more about COOL in the US and how the new EU rules are perceived in the U.S.? Here is an article.

The United States Department of Agriculture (USDA) Agricultural Marketing Service has published a practical COOL labelling guide for the industry with specific examples of appropriate COOL language for the U.S. market. You can find it here.

Cool with COOL?

What is the potential impact of the new rules on your business? With an increased complexity of the label this is likely to increase the costs for compliance. Consumers will receive extra information, but will they see this as an improvement? With regards to food safety, the Regulation prescribes the use of an identification and registration system to ensure traceability (Article 3). The system has to particularly record the arrival at and the departure of animals, carcasses or cuts from the establishment of the FBO. Also a correlation between arrivals and departures has to be ensured. Aside the mislabelling issue, the horsemeat scandal clearly showed that the current traceability systems are not adequate in case of incidents. More detailed rules on traceability are aimed to contribute to food safety and protection of food safety is also an important interest for the food industry. Compliance is serious business as non-compliance can lead to administrative sanctions. Furthermore, fraudulent labelling constitutes a criminal offence and an offender can be prosecuted under criminal law. This is what happened to Dutch meat trader Selten. Last week he has been sentenced to 2.5 years in prison. According to the court he is guilty of forgery. He has sold horsemeat as beef. Click here for the newsitem (in Dutch).


The Vegetarian Butcher – or how to protect the goodwill vested in your trademark

Secvegetarian-butcheruring proteins from alternative sources than meat or fish is nowadays a topic in the centre of the debate. The Dutch Vegetarian Butcher has found a solution for this challenge by manufacturing and marketing meat-alikes. These are food products having the taste and bite of a meat product, but that are composed of non-meat ingredients such as soy. The trademark used for this type of products was at the basis of a recent decision of the Amsterdam District Court. However, this case contains some general learning for any food business operator caring about his trademark.

Outline Partnership

The Dutch Vegetarian Butcher was operating a butcher shop in The Hague and had concluded a collaboration agreement with a commercial partner to operate a similar shop in the centre of Amsterdam. The terms of the collaboration agreement stipulated, inter alia, that the Amsterdam based Vegetarian Butcher was allowed to use the Vegetarian Butcher trademark and trade name. In fact, the shop in Amsterdam was to operate as a flagship store of Vegetarian Butcher products in the Dutch capital. The contract therefore provided that the Amsterdam shop was only to a very limited extent allowed selling third party products.

Collaboration in practise

In practise, the collaboration between the parties did not work out as expected. During several test visits of the Vegetarian Butcher shop in Amsterdam, freezers turned out to be empty, the Vegetarian Butcher logo’s were used for products that had not been approved and an important number of third party products were offered for sale. After the parties failed to find an amicable solution for their dispute, the original Vegetarian Butcher had terminated the collaboration agreement, requesting that the Amsterdam based Vegetarian Butcher ceased the use of both the Vegetarian Butcher trademark and trade name. Furthermore, he requested assignment of the domain www.devegetarischeslageramsterdam.nl, being the Dutch equivalent for <vegetarian butcher in Amsterdam>. Finally, recovery of full legal costs (about € 25K) was requested on the basis of the Dutch legislation implementing the Enforcement Directive. In his counterclaim, the Amsterdam based Vegetarian Butcher disputed the termination of the contract and claimed a huge amount of damages (about € 250K), arguing that he could not recover his investments.

In Court

The case was dealt with by the Amsterdam District Court in summary proceedings, as the original Vegetarian Butcher had an urgent interest to put a term to the unauthorized use of his trademark. The Judge recognizes that this dispute boils down to a different interpretation of the collaboration agreement between the parties. In such situation, it is standard practise that the Court establishes what would be the most reasonable interpretation to be given to the agreement, taking into account all relevant circumstances of the case. As one of these circumstances, the Court states that the collaboration agreement was based on a Letter of Intent (LoI) drafted by the Amsterdam based Vegetarian Butcher. In this LoI, it was clearly stated that the original Vegetarian Butcher supplies should have an exclusivity position in the Amsterdam shop. Only in the situation that the original Vegetarian Butcher was not in the position to supply sufficient products to the Amsterdam shop, the latter was at liberty to sell third party vegetarian products, provided that the origin thereof was clearly indicated.

Contract based IP enforcement

Based on the above, the Court decided that the termination of the collaboration agreement was valid. As a consequence, the Amsterdam based Vegetarian Butcher was ordered to cease and desist from the further use of the Vegetarian Butcher trademark and trade name, explicitly including any such use on social media. Furthermore, the assignment of the domain www.devegetarischeslageramsterdam.nl was ordered. Legal costs were however only partially recovered, as the Amsterdam based Vegetarian Butcher had opposed the claim for full compensation of legal costs and these proceedings were not considered complicated. For such cases, the Dutch Courts rely on a nationally agreed (but not undisputed) schedule of fixed amounts. In the present case, only 25 % of the actual claimed legal costs were awarded as a result.

Counterclaim dismissed

To no surprise, the claim for damages made by the Amsterdam based Vegetarian Butcher was dismissed. In the first place because he was found wrong, but also because it is not possible to claim full damages in Dutch summary relief proceedings. In such proceedings, it is only possible to request an advance payment of damages, provided that the existence and scope of the damages are sufficiently plausible. This was denied in the present case, as the shop in Amsterdam was allowed to continue its business, however without the use of the name Vegetarian Butcher.

Lessons to be learnt?

What is the general learning to be drawn from this case? In the first place, it demonstrates the importance to draft clear contracts regarding the use of a trademark by a commercial partner. This is of importance for any type of partnership, including but not limited to licenses and franchise. If the commercial partner does not respect the contract in place, it is good to know that such can be efficiently enforced in preliminary relief proceedings in Holland. A hearing can be obtained at relatively short notice (between 2 days and 2 months, depending on the urgency) and a decision is rendered within 2 weeks at most. For the full recovery of legal cost however, it is of the essence that the work done is sufficiently specified and that is it clearly explained what makes one case stand out from a standard case, if any.


Novel Foods continued – draft legislation voted by ENVI Committee

in-vitro burgerFurther developments in Brussels took place since we last reported on the new Novel Foods Regulation. Draft legislation was approved in this respect by the ENVI Committee, awaiting the first reading of the European Parliament (EP). The current status quo was published in a Report dated 26 November 2014. Two particular subjects seized most public attention, notably the moratorium proposed on the use of nanomaterials in food and the compulsory labelling of cloned food products. These two items have been covered here and here inter alia and will be shortly touched upon below. Most of all however, this post will focus on the adjusted Novel Food definition. We consider this subject to be of the essence, whereas so far was not highlighted at all.

Moratorium nanomaterials and change to nano definition

The legislation takes as a starting point that food production processes involving nanotechnologies require specific risk assessment methods. These methods should  have been assessed by EFSA prior to use. Furthermore, an adequate safety assessment on the basis of those methods should have shown that the foods at stake are safe for human consumption. The rationale of all this is the precautionary principle: emerging technologies in food production may have an impact on food safety. On top of that, the definition of nanomaterials was changed, introducing a 10 % nano-particles threshold for a food ingredient to qualify as “nano” instead of a 50 % threshold. This was in line with EFSA recommendations, but it may pose a serious problem to FBO’s currently marketing nano-foods. Using the 10 % threshold would imply that quite a few product currently marketed would, under the new Novel Foods Regulation, qualify as Novel Food whereas it currently does not. This will not benefit to legal certainty.

Compulsory labelling of cloned food products

During the long term discussions on the renewal of the Novel Food Regulation, it was decided that the subject of food from cloned animals would be left out. As a result, the Commission published two separate Directives on food from animal clones and on cloning on certain animal species for farming purposes respectively (the draft “Cloning Directives”) in December 2013. These two proposals have now been turned down by EP, as they did not address the food obtained from clones’s offspring. Until food from cloned animals will be covered by revamped Cloning Directives, cloned meat products have been brought within the scope of the Novel Food Regulation and they should be labeled as such.

Adjusted Novel Foods definition

Contrary to current legislation, the initial draft Novel Food Regulation contained an open product definition, where the listed categories of products merely served as examples. This was heavily criticised by rapporteur James Nicholson. Based on his consultations in the field, such open product definition according to him constituted a source of legal uncertainty. Instead, he suggested re-introducing the former product categories in an updated form in order to make this Resolution future-proof. In fact, this suggestion was followed, but somehow pushed to the extreme. The draft Novel Food definition currently also covers product categories that were never considered as Novel Foods before, such as insects and food obtained from cellular or tissue cultures.

10 categories of Novel Foods

The definition currently proposed for a Novel Food is a food that was not used for human consumption to a significant degree in the Union before 15 May 1997 and that falls under at least one of the ten following categories:

  1. Food with a new or intentionally modified primary molecular structure;
  2. Food consisting of, isolated / produced from microorganisms, fungi or algae;
  3. Food consisting of, isolated / produced from plants, except for plants having a history of safe food use within the Union;
  4. Food derived from cloned animals and / or their descendants;
  5. Food containing, consisting of, or obtained from cellular or tissue cultures;
  6. 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;
  7. Food resulting from a new production process not used for food within the Union before 15 May 1997 affecting its nutritional value inter alia;
  8. Food containing nanoparticles;
  9. Vitamins and minerals (i) subject to the new production process referred to under (7) or (ii) containing nanoparticles referred to under (8) or (iii) for which a new source of starting material has been used;
  10. Food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use in other foods than food supplements.

What’s new actually?

Some of the categories mentioned above were already included in the 1997 Regulation, being those mentioned above under (1), (2), (3) and (7). Others were introduced in the initial Commission proposal for a new Novel Foods Regulation, notably those mentioned above under (8), (9) and (10). Truly new are therefore only the categories consisting of food derived from cloned animals (4), food obtained from cellular or tissue cultures (5) and food produced from whole animals such as insects and from animal parts (6). As explained above, the category consisting of food obtained from cloned animals is likely to be temporary. As soon as specific legislation covering this topic will be in place, such legislation will be applicable to cloned food products instead of the Novel Foods legislation. What are the consequences of the introduction the two other new categories? This will be discussed below.

Food obtained from cellular or tissue cultures are Novel Foods

As a good example of foods obtained from cellular cultures, the in-vitro burger engineered by Prof. Mark Post from the University of Maastricht (see picture from neontommy.com) can be mentioned. This burger was constructed on the basis of a tiny part of meat, using stem cell technology. For this purpose muscle cells harvested from a living cow were fed and nurtured, so that the single strand of cells multiplied to produce numerous new strands. In the end, 20.000 of those strands were assembled and put together in a hamburger. Obviously, the cell production used for this purpose will have to be increased for this technology to become a viable meat production method. However, now that the feasibility of this method in essence has been demonstrated, its application is not inconceivable. When in future, lab-burgers like the one from Maastricht will be marketed as food products, they will need to obtain pre-market authorization based on the current draft for the new Novel Food Regulation. This is understandable, as the use of this technique and starting material for food production is completely new and their safety needs to be established.

Food produced from insects are also Novel Foods

For numerous companies this may come as some surprise. Contrary to the use of cellular tissue for the production of food, the use of insects as food goes back to biblical times. Actually, in various European countries including the Netherlands and Belgium, insects are being offered for sale as food. For instance, Dutch supermarket chain JUMBO offers edible insects for sale as of October 2014. This has incentivised national authorities to investigate the safety of consumption of insects and to formulate basic requirements for rearing facilities. As a result, recommendations were made in the Netherlands that a specific number of insects, such as the mealworm beetle and the locust, should be considered as foods under the General Food Law Regulation (see our previous blogpost for more detailed information also covering other European countries). It should be observed that not all European countries are at the same page here. In Luxemburg for example, the marketing of edible insects, pending an EFSA opinion awaited for July this year, is prohibited.

Discussion

We welcome that the open product definition for Novel Foods has been abandoned, as this increases legal certainty. It is questionable though to what extent it was wise to re-integrate food derived from cloned animals and / or their descendants into the Novel Food Regulation. During previous revision efforts of this Regulation, this topic was exactly the bottleneck why the revision could not be completed. Also, this does not serve as an incentive for the Commission to adjust its previous proposals for the Cloning Directives at short notice. We are more positive with respect to the introduction of the new category of Novel Foods relating to food produced from cellular cultures. This is exactly the type of high tech sustainable food, which in essence is a Novel Food. The same does not apply however with respect to insects. It is striking that up to and including the first Report by Rapporteur James Nicholson, whole animals such as insects never formed part of the Novel Food product definition. We are under the impression that they now landed therein by way of surprise. This is not consistent with current practise of various Member States and will pose a problem for many FBO’s actually marketing food produced from insects. Furthermore, there seems to be a substantial amount of evidence for safe consumption of insects, at least in the Netherlands. Therefore, instead of qualifying whole animals as insects instantly as Novel Foods, as an alternative for providing international industry standards, it could be considered to include a list of recommended edible insects into the Codex Alimentarius.

Conclusion

It is expected that the current draft legislation for the new Novel Foods Regulation will not be the final text. We expect active lobbies from FBO’s marketing nano-foods to oppose the adjusted definiton for nanomaterials. Likewise we expect, and we recommend, that FBO’s marketing insects or food from insects will oppose the fact that food made from whole animals like insects qualify as Novel Foods per se. The chances of success will depend, inter alia, on the expected EFSA report on certain risks of the production and consumption of insects. As of now however, there is already safety evidence which could be relied on pending the final text of the Novel Foods Regulation.

 

 


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