Nothing left to hide? Status quo on Dutch bill permitting active disclosure of food safety inspection results
Posted: November 9, 2016 Filed under: Disclosure of information, Enforcement, Food | Tags: disclosure, enforcement, inspection, NVWA Comments Off on Nothing left to hide? Status quo on Dutch bill permitting active disclosure of food safety inspection results
Recently, an amendment to the Dutch Health Act (Gezondheidswet) was voted in Dutch Parliament, allowing the Dutch Food Safety Authority (Nederlandse Voedsel en Warenautoriteit or NVWA) to actively disclose its inspection results. The change in the Health Act equally applies to inspection results obtained by the Dutch Health Inspectorate (Inspectie Gezondheidszorg or IGZ) and therefore, it received broad interest from the pharmaceutical, medical devices, and the food industry and their legal practitioners. Three meetings on this topics were organised by respectively the Dutch association of Food Law (NVLR), the Dutch Pharmaceutical Law Association (VFenR) and by the Dutch organisation for food retail and management VMT. This post will put you up to speed on the actual changes to be applied to the Health Act, as well as on the expected consequences of their implementation for food business operators (FBOs).
Importance of inspection results
Inspection results are important for whom it concerns directly (inspected companies, as they provide answers to questions such as: is your organisation compliant? Will a fine be imposed? Inspection results are furthermore of interest to others, such as consumers, journalists and other companies, including competitors, for a number of reasons. These reasons include (but are not limited to) knowing where to supply from and what places to avoid, the possibility to check if your supplier’s manufacturing processes are up to standards and the option to stay informed on what challenges your competitor is meeting.
Active vs. passive disclosure
All administrative bodies disclose information, on their website, in social media, in leaflets, etc. Under the Dutch Act on Public Access to Government Information (Wet openbaarheid van bestuur or WOB) citizens have the right to file a request for information on administrative matters. The disclosure of such information on request of a person is called passive disclosure. Such disclosure does not take place publicly, but the information concerned will solely be provided to the person who filed the request, unless it is rejected based on the limited grounds specified in the WOB. Active disclosure on the other hand means that the information is disclosed by an administrative body prior to any request for information. Such information is publicly available after disclosure. In case of inspection results of the NVWA, these will most likely be published on the website this administrative body.
Rationale disclosure inspection results
The rationale for both passive and active disclosure of inspection results is threefold.
(i) Transparency. Without information on the inspection, one cannot assess the quality of the inspection or view the results of the inspection. This transparency is also present in other areas such as inspection results of the Inspectorate of Education and the Health Care Inspectorate.
(ii) Trust. By showing the results, the public can see what the NVWA is doing and therefore the public can build trust in the NVWA.
(iii) Increased compliance. Negative results of an inspection can lead to serious problems towards consumers or customers, such as liability claims from suppliers who expected to be supplied with products produced in compliance with the applicable quality standards and hygiene regulations). In this way active disclosure increases the pressure on FBOs to comply.
The current system
Opposed to other inspectorates in the Netherlands, the active disclosure by the NVWA is currently not provided for in a specific Act. So far, the mechanism laid down in the WOB has been used as the framework for disclosure of inspection results. Article 8 WOB enables the NVWA to actively disclose information, provided this is done is a clearly understandable way and offering interested parties in due time the opportunity to comment. As far as a request for information by any company or citizen is concerned, there are predefined grounds on which an administrative body cannot freely disclose information, being absolute and relative grounds. The absolute grounds are found to be of such importance that publication is interdicted, like confidential commercial information relating to the safety of the state or information containing personal data. The relative grounds relate for instance to privacy matters or to disproportional harm that could be created by publication. Such grounds have to be weighed against the interests of disclosure. In the current framework, the interested party can express a provisional opinion with respect to any intended publication by NVWA, which has to be dealt with before publication. This mechanism will disappear under the new system.
The new system
When the amendment of the Health Act will enter into force, the NVWA will not only have the option to actively disclose information, but will be obliged to do so. In the legal framework, the assessment of interests is already taken into account, which makes it unnecessary to do another assessment each time the NVWA decides to actively disclose information. In future, the option to express a provisional opinion by the NVWA will no longer be available. The only way to ensure that the information is not disclosed is starting summary proceedings before a civil court. If any interested party is doing so, NVWA will then be forced to suspend its decision to disclose information until the court decides on the matter. In case the NVWA will disclose the inspection report, the NVWA will provide the option for FBOs to provide a reaction to the inspection results, which will be disclosed together with the inspection results. In addition to the change applied to the Health Act, an underlying decree needs to specify more detailed rules on what information exactly needs to be published in what format. In the discussions on the amendment of the Health Act another amendment was added which ensures the underlying decree can only be amended with the approval of Dutch Parliament.
Current status of the amendment
On the 11th of October the House of Representatives of the Netherlands (Tweede Kamer) accepted the proposed changes to the Health Act and amended some parts. The Dutch Senate (Eerste Kamer) accepted the amendments without making any additional amendments on the 1th of November. However, the change of the Health Act has not yet entered into force and it is currently still unclear when the exact date of entry into force will be. Guestimates are hinting at June 2017, however the Ministry of Health Welfare and Sport is still working on the underlying decree on what information has to be published and in what format. There is a fair chance the amendment will only enter into force simultaneously with this underlying decree. In such case the entry into force of the changes to the Health Act will most likely be later than the guestimate mentioned above.
Situation in other EU countries and NVWA pilot
Other EU Member States already have a system of active disclosure of inspection results for restaurants in using a system of easily understandable designations or colours (Denmark and Ireland for instance). In those countries, the outcome of the inspection is presented at the entrance of the inspected restaurant, in order to give the public an overview of the level of compliance at first glance. For instance, a green colour or a happy face means that the restaurant is compliant and colours closer to red or a less happy face mean the place was less compliant. In the Netherlands, the NVWA launched a pilot for disclosure of inspection results for lunchrooms, which were disclosed via an app. This app subsequently displayed the results on a map. The map showed the lunchrooms in four different colours, depending on the level of compliance. The idea was to provide a quick overview of the lunchrooms and the level of compliance. However, the reaction of the minister of Health, Welfare and Sport to this format was negative due to interpretation issues, particularly interpretation of the colours. There are also lists of inspected products instead of inspected FBOs. The experience gained therewith and during the pilot will have to be evaluated in order to choose an acceptable form for the disclosure of over 200.000 inspections done each year in the Netherlands by the NVWA.
Criticism
The proposed changes to the Health Act have been much criticised. The active disclosure of the inspection results together with the imposed sanctions can be viewed as punitive sanction in addition to the sanction itself imposed based on the findings during the inspection. In the explanatory notes on the amendment of the Health Act, the government explains that active disclosure should not be perceived as a punitive sanction and therefore not a criminal charge in the sense of Art. 6 ECHR. In case the disclosure will be viewed as a punitive sanction, article 6 ECHR will be applicable, meaning the procedural safeguards embodied in this article will apply. Basically, the government states that the disclosure does not aim at punishing the inspected party, and therefore is not an additional sanction. However, the arguments provided by the government in the explanatory notes are not very convincing. Assuming the disclosure will lead to more transparency, consumers and customers will be aware of the non-compliance due to the disclosure. This disclosure can in turn decrease the trust in the non-compliant producer, which could mean a decline in sales or even liability claims from consumers or customers. It is not the fines imposed by the NVWA, but the disclosure of the inspection results, which leads to these (potential) damages of the producer, whom will not have had the chance to remedy the situation before it is out in the open. This is all the more important, as so far there is no evidence that such public disclosure indeed will lead to an increased level of compliance. Moreover, this situation does not seem to be in line with competition law, which constitutes the regular level playing field of any FBO, just like it is for manufacturers of medical devices or medicinal products. Therefore, competition law elements should in our opinion be an aspect of the legislation concerning disclosure. In the explanatory notes to the amendment, this aspect has not even been mentioned.
Conclusion
As a result of a change applied to the Dutch Health Act, the first steps towards active disclosure of inspection results from the NVWA have been initiated. The actual implementation thereof depends on the underlying decree, which is still under construction. This is why is not clear as of when the legal basis for active disclosure of NVWA inspection results will be operational. As of this moment however, FBOs will be subject to increased enforcement measures, without the effect thereof being necessarily positive. We will keep an eye out for you and report on any relevant development in this field, as they are likely to have an important impact for each FBO.
The author thanks Floris Kets for his contribution to this post.
Enforcement measures regarding borderline products
Posted: October 14, 2016 Filed under: Authors, Enforcement, Food Supplements Comments Off on Enforcement measures regarding borderline products
Photo Peter Hilz / HH
As observed in an earlier post, the boundaries between food products and medicinal products are sometimes blurred. However, the qualification of a product as either one or the other may have huge regulatory consequences. In recent litigation in several Dutch Courts the Hecht-Pharma decision from the EU Court of Justice (ECJ) was applied. This series of cases is of interest for food business operators, as it provides a clear message regarding enforcement measures directed against borderline products. The national health authorities should strike a fair balance between the free movement of goods and the optimal protection of public health. Whereas enforcement policies re. borderline products constituting a threat to public health may be justified, this does not entail that each and every food product containing a substance with a physiological effect automatically qualifies as a medicinal product by function.
Red Rice
The facts of the case Hecht-Pharma related to a food supplement with fermented rice that Hecht-Pharma had been marketing in Germany under the name “Red Rice”. The recommendations for use read “as food supplement, 1 capsule, 1 – 3 times a day”. The German authorities had qualified this product as a medicinal product by function, but Hecht-Pharma did not agree. It argued that having regard to the recommended dose, the product at stake could not exert a pharmacological action.
Medicinal product by function
In its request for a preliminary ruling, the Federal Administrative Court aimed to clarify if, after a change of the Medicinal Products Directive, criteria previously developed to establish if a product qualified as a medicinal product by function, still applied. Qualification as a product as a medicinal product by function implies that it is aimed at a change in physiological functions by exerting a pharmacological, immunological or metabolic action. The ECJ confirmed in its Hecht-Pharma decision that previously developed criteria were still in place. As a result, the national authorities must decide on a case-by-case basis, taking into account all the characteristics of the product at stake, in particular its composition and pharmacological properties, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail when they decide if a product qualifies as a medicinal product by function. Clearly, a product cannot be regarded as such, when it is incapable of appreciably restoring, correcting or modifying physiological functions in human beings.
Melatonin-based products
The Dutch Court cases related to melatonin-based products, marketed by a number of companies represented by the Dutch foods supplements association NPN (Natuur- en Gezondheidsproducten Nederland). During the period between 2011 and 2014, The Dutch Health Inspectorate (IGZ) and the Dutch Food Safety Authority (NVWA) on the one hand and NPN on the other hand, corresponded on the topic of melatonin-based products. The Dutch authorities thereby took the view that they considered products containing 0,3 mg melatonin or more to be a medicinal product by function. They based their view on literature studies, from which it would follow that a single oral dose of 0,3 mg melatonin produced a pharmacological effect on humans. In view of their public role of safeguarding public health, the authorities intended to launch enforcement measures regarding products containing more than 0,3 mg melatonin, unless the manufacturer at stake had applied for an authorization to market these products as medicinal products.
Enforcement measures and subsequent summary proceedings
Early 2015, IGZ sent a letter to all Dutch manufacturers of melatonin-based products informing that they would require a market authorization for continued marketing of products containing 0.3 mg melatonin or more. Each such manufacturer should inform the authorities prior to 15 March 2015 for which melatonin-based products it would or it had already applied for such authorization, failing which enforcement measures could follow. NGN subsequently initiated summary relief proceedings, claiming inter alia that IGZ should refrain from enforcement measures, unless it had demonstrated with respect to each and every melatonin-based product that it qualified as a medicinal product according to applicable legal criteria as validated in case law. In these proceedings, NPN claimed that IGZ had not sufficiently demonstrated, based on scientific evidence, that products containing 0,3 mg melatonin or more could change physiological functions in the human body, for instance by a pharmacological effect. Furthermore NGN argued that IGZ had neglected to apply the criteria developed in Hecht-Pharma, according to which IGZ should have established with respect to each melatonin-based product that it qualified as a medicinal product, thereby taking into account all relevant circumstances. According to NPN, these products were food supplements, not medicinal products.
Evaluation by the Court in summary proceedings
Based on a very broad interpretation of the definition of medicinal product, as contained in article 1.2 of the Medicinal Products Directive, NGN’s claim was dismissed. According to the Court, assessment of each individual product could be done by the Dutch Medicines Evaluation Board or by EMA, upon filing of an application for marketing authorization. It was not necessary for IGZ to proceed to this evaluation at an earlier stage, as the chances that any deviations from the general conclusion would be found, were considered very small. The Court did consider however that IGZ’s communication and application of enforcement measures had not been unambiguous. Even if the manufacturers of the melatonin-based products followed the request to indicate by 15 March 2015 for which products they filed an application for marketing authorization, it would not be clear by when they would know if IGZ – pending such application – would refrain from enforcement measures. This created uncertainty in the market and was considered unlawful vis-à-vis NGN. The Court therefore ordered IGZ to set a term after 15 March 2015 during which the products for which a market authorization had been requested would be tolerated.
Decision reversed on appeal in summary proceedings
On appeal, the discussion was focused on the correct application of Hecht-Pharma. Contrary to the Court in first instance, the Appeal Court held that a public health authority announcing enforcement measures should at that very moment motivate why a product containing > 0,3 mg melatonin qualifies as a medicinal product. A different approach could create unjust market restrictions, for instance regarding products that upon application were not considered medicinal products. Moreover, the requirement to file a market authorization for each and any melatonin-based product containing > 0,3 mg melatonin is not just a formality, but would oblige manufacturers of this type of products to make an important investment in time and resources. Taking into account there were no acute health issues for the continued marketing of melatonin-based products, at least not for those containing a maximum up to 5 mg melatonin, the Appeal Court ordered that public health authorities should apply all criteria developed in Hecht-Pharma when considering enforcement measures against borderline products.
Confirmation in proceedings on the merits
This summer, the District Court of The Hague confirmed in a decision on the merits the appeal decision in summary proceedings discussed above. In short, this Court held that the unconditional qualification of a group of products as medicinal products, without any individual evaluation taking place, was not in line with EU case law. The Court in particular referred to paragraph 68 of the conclusion of the Advocate General. The Advocate General stated, inter alia, that the insidious extension of the scope of the Medicinal Product Directive by including products that do not belong there, would harm the free movement of goods. Therefore, until an individual assessment of a borderline product based on the Hecht-Pharma criteria has taken place, the public health authorities are not allowed to take any enforcement measures. No appeal was filed by IGZ against the present decision of The Hague District Court, but we were informed that where necessary, IGZ will proceed to enforcement in individual cases.
Take home
If and when your company receives a warning letter from IGZ announcing enforcement measures because of its borderline status, please bear in mind the following. Before considering any change in the product like the lowering of its active substance or even its withdrawal from the market, the public authorities should have unconditionally qualified the product at stake as a medicinal product. If and when this situation is not clear, make sure to obtain professional advice to properly deal with the health authorities.
All you wanted to know about organic food in the EU
Posted: January 26, 2016 Filed under: Enforcement, Food, organic Comments Off on All you wanted to know about organic food in the EU
This 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:
- General production rules (articles 1, 7 – 10), which apply to all forms of organic production.
- 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.
- 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!
Novel Foods – the final verdict?
Posted: October 28, 2015 Filed under: Authors, Enforcement, Food, novel food Comments Off on Novel Foods – the final verdict?
The heat was on today in the European Parliament (EP). The reason for that was that the new Novel Foods Regulation was put to vote in a plenary session. In the debate prior to the vote, the opinions centred between concerns about food safety and the free circulation of goods. In this post, you will be updated about the outcome of the vote. In short, the adoption of the new Novel Foods Regulation will have important consequences for Food Business Operators (FBO’s). In an earlier post, we already reported about streamlined authorisation procedures. Today, we will mainly focus on the type of products covered by this legislation. Insects are in for a start. In a 10 minutes read, you will learn what are the consequences thereof – and more.
Shaping the new Novel Foods Regulation
Today (28 October 2015), the EP adopted the latest proposal for a Regulation on Novel Foods [insert final text]. As reported in one of our previous posts, the European Commission published an initial proposal for this Regulation in December 2013. EP Rapporteur Nicholson heavily criticised this draft, mainly for its open product definition and for the lack of streamlining the authorisation procedure. As a result, an EP legislative proposal became available, in which the Rapporteur formulated a number of improvements. Most of them were included into the draft legislation approved by the ENVI committee by the end of November 2014, which further developed into the text voted today. This adopted proposal will enter info force after publication in the OJ. However, a transition period of 24 months after such publication has been provided before its actual application.
So what are Novel Foods finally?
In the initial Commission proposal, the various product categories had not been exhaustively defined. Although such a system could present the advantage of flexibility, in fact FBO’s resisted against the legal uncertainty this would create. As a result, the approved draft by the ENVI Committee identified 10 categories of Novel Foods. Some of these have again been heavily debated, like for instance insects – however without success. The Regulation voted today in the EP defines the following products as Novel Foods:
- food with a new or intentionally modified molecular structure;
- food consisting of or isolated / produced from microorganisms, fungi or algae;
- food consisting of or isolated / produced from material of mineral origin;
- food consisting of or isolated / produced from plants or their parts, except when the food has a history of safe food use in the Union and one out of two alternative conditions are met;
- foods consisting of or isolated / produced from animals or their parts, except where these animals were obtained from traditional breeding practises and the food from those animals has a history of safe food use;
- food consisting of or isolated / produced from cell or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
- food resulting from a production process not used within the Union before 15 May 1997, giving rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesired substances;
- food consisting of engineered nanomaterials;
- vitamins, minerals and other substances, where a new production process has been applied or where they contain engineered nanomaterials;
- food used exclusively in food supplements within the Union before 15 May 1997, where it is intended for use other than in food supplements.
What’s in? – Most striking changes
Contrary to the ENVI proposal, the current text of the Regulation no longer mentions food derived from cloned animals or their descendants as a separate product category. However, it becomes clear from the recitals in the new Novel Foods Regulation that no change is intended here. Until specific legislation on food from animal clones enters into force, such food is covered by category nr. 5 of this Regulation, as food from animals obtained by non-traditional breeding practises. Another textual change relates to category nr. 8. Whereas the ENVI draft still specified the highly debated 10 % threshold for a food ingredient to qualify as nano (instead of the 50 % threshold proposed by the Commission), no such threshold is contained in the current text. Although this is no doubt a compromise solution, it is expected it shall give rise to new discussions. A real change with respect to the ENVI proposal relates to product category nr. 3, covering food of mineral origin. For now, the background of this change remains unclear. Finally, insects are still covered by category nr. 4. Today, many food products consisting of or containing insects are marketed in various Member States. It is therefore important to establish what will be the consequences of considering insects as Novel Foods. In order to answer that question, the provisions laying down the transition regime are of interest. Furthermore, by way of background, a number of safety evaluations of insects as food are briefly discussed.
Evaluation of insects as food by certain Member States
In one of our previous blogs relating to the marketing of insects as food products, we reported that due to the lack of clarity regarding the status of insects (Novel Foods or not?), some Member States issued their own guidance. In Belgium for instance, the placing on the market of 10 particular insects species as food product is tolerated, provided that specific food law requirements are met. In the Netherlands, the Dutch Food Safety Authority and the Health Minister ordered a safety report with respect to three types of insects currently marketed as food in the Netherlands. These are the mealworm beetle, the lesser mealworm beetle and the locust, regarding which the heat-treated and non-heat treated consumption was evaluated in terms of chemical, microbiological and parasitological risks. Based on the outcome, it was recommended to consider these insects as “regular” foods (in the sense of the General Food Law Regulation) and not as Novel Foods.
Evaluation of insects as food and feed by EFSA
On 8 October 2015, EFSA published its Risk profile related to production and consumption of insects as food and feed ordered by the Commission. In fact, EFSA was requested to assess the micro-biological, chemical and environmental risks posed by the use of insects in food relative to the risks posed by the use of other protein sources in food. EFSA found that for the evaluation of micro-biological and chemical risks, the production method, the substrate used, the stage of harvest, the specific insect species and the method of further processing are of relevance. It established however that with respect to any of these topics, fairly limited data are available. It therefore strongly recommends further research for better assessment of microbiological and chemical risks from insects as food, including studies on the occurrence of hazards when using particular substrates, like food waste and manure.
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.
180 fold higher fines in Dutch Commodities Act
Posted: September 14, 2015 Filed under: Enforcement, Food | Tags: Commodities Act, enforcement, fines, NVWA, Warenwet Comments Off on 180 fold higher fines in Dutch Commodities Act
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?
Posted: August 10, 2015 Filed under: Authors, Enforcement, Food, Health claims, Information, Nutrition claims Comments Off on Who Does Not Want To Have A Healthy Breakfast?
The Netherlands Food and Consumer Product Safety Authority (NVWA) has been pretty active this Summer. Following up on previous enforcement reports on nutrition claims, it recently published such enforcement report re. both nutrition and health claims for breakfast cereals. As this report relates to legislation that has been harmonized at an EU-wide level and it provides detailed enforcement information, this is an interesting read – not only for the Netherlands.
Less than 50 % fully compliant
Actually, the report publishes data on the review of claims regarding 126 different breakfast cereals marketed under 24 different brands. These data were compiled during the period between March – October 2014. From this review, It appeared that less than half of those products were fully compliant with the Claims Regulation. The NVWA considers it of the essence that Food Business Operators (FBO’s) offering for sale breakfast cereals fully comply with the Claims Regulation to enable consumers to make informed choices.
Nutrition and health claim framework
Since the entry into force of the Claims Regulation on 1 July 2007, only authorized claims can be used for food products. A claim is a message or representation in any form, that is not mandatory under EU law or national legislation and that states, suggests or implies that a food has certain characteristics. A nutrition claim is a claim that states or implies that a food has particular beneficial nutritional properties in terms of energy and/or nutrients. A health claim is a claim that states or implies there is a relationship between food and health. Amongst the health claims, a distinction is made between general claims, disease risk reduction (DRR) claims and claims relating to the health and development of children. In 2012, the Commission published a list of 222 authorized general claims that is dynamic and has currently evolved into 229 claims. Furthermore, there are currently 14 authorized DRR claims and 11 children’s claims. For both nutrition and health claims, strict conditions of use are applicable. For instance, in order to claim that a product is high in proteins, at least 12 % of the energy delivered by the product should be provided by proteins.
Method of enforcement
Contrary to previous claims enforcement reports that only related to nutrition claims, the NVWA this time also took into account health claims. More concretely, it report relates to pre-packed breakfast cereals that were offered for sale in the Netherlands at both retail and wholesale level. If the products at stake were advertised at websites as well, such information was also subject to enforcement. The products at stake consisted of granola, corn flakes, puffed rice grains, oatmeal and wheat meal, some of them supplemented by nuts, sugar, dried fruits or chocolate. The information reviewed was the name of the product and the nutrition labelling, in as far as related to nutrition and health claims. A warning letter was sent to those FBO’s whose products were not compliant, except when an unauthorized claim was used. In those cases, a fine was imposed under the suspensive condition of full compliance within a grace period. When I contacted the NVWA to know the average amount of such fine, I was informed that my query would be answered within 6 weeks. Apparently, the Summer scheme is still on at NVWA – too bad. But an update will be provided at FoodHealthLegal when more information is available.
Outcome of enforcement
As mentioned above, out of the 126 products that were reviewed, over half of them did not fully comply with the Claims Regulation, mostly because the claims used were pretty vague. Although it is permitted to use a variation on an authorized claim, the essence thereof should be the same as an authorized claim. An example of a claim that was sanctioned by the NVWA is “The cereals present in this product are the basis for a healthy and nutritious breakfast. It contains nutrients that are indispensable for the human body and that are quickly absorbed by the body.” Another reason why products were not compliant was that non-existent nutrition claims were used, such as “does not contain cholesterol” or “ contains many nutrients”. Furthermore, sometimes nutrition claims were made, whereas the strict conditions of use were not met. Although this is not visible from the product label, such is a violation of the Claims Regulation as well. Finally, on many products, the link between a specific nutrient and the health claim used on the labelling was missing. Instead, pretty general, non-specific, claims were made that can be quickly taken in by the consumer, but also easily be misunderstood. Therefore, such general, non-specific claims are only allowed if accompanied by a specific, authorized, health claim. For example, the claim “Crisply granola of brand X forms part of a healthy and nutritious breakfast” cannot be used alone, but it can be used jointly with an authorized claim for iron, like “Iron contributes to normal energy-yielding metabolism”.
Recommendations
The fact that the NVWA nowadays actively enforces health and nutrition claims shows that it considers B2C communication on food product to be an integral part of food safety. From our practise I know changing the packaging of your food products is a lot of hassle, so better get it right as from the start. Here are a few tips to help you along.
- At all times, it should be avoided to made a medical claim with respect to food products. Medical claims are claims directed at the prevention or treatment of a disease. Their use, if allowed at all, is strictly reserved for pharmaceuticals.
- If you consider the authorized claims are not persuasive or sexy enough, choose one of the variations published by the self regulatory body KOAG-KAG.
- Make sure you have data supporting the nutrition facts of your food product, as the burden of proof lies with the FBO when receiving a request pertaining thereto from the NVWA.
- When using general, non-specific claims, use the specific, authorized claim in the same field of vision.
- When in doubt, or if you simply need a sparring partner, consult an expert.
The Vegetarian Butcher – or how to protect the goodwill vested in your trademark
Posted: March 5, 2015 Filed under: Authors, Enforcement, Food Comments Off on The Vegetarian Butcher – or how to protect the goodwill vested in your trademarkSec
uring 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.
Untraceable = unsafe?
Posted: February 22, 2014 Filed under: Enforcement, Food | Tags: enforcement, horsemeat, recall, safety Leave a comment »
Dutch slaughterhouse Van Hattem suffering severe blow
This week the Trade and Industry Appeals Tribunal, (in Dutch: College van Beroep voor het bedrijfsleven) rendered its judgment (interim injunction) in the lawsuit that was filed by slaughterhouse annex meat processing company Van Hattem Vlees B.V. against an administrative enforcement decision from the State Secretary for Economic Affairs.
Recall large amount of meat
In her decision, the State Secretary imposed an administrative order to recall all meat produced or processed by Van Hattem between 1 January 2012 and 23 January 2014 (approximately 28.000 tons of meat). The request to suspend the order to execute the recall was rejected by the Court. Why? First of all, horsemeat was detected by the Netherlands Food and Consumer Product Safety Authority (NVWA) in a lot of meat that was solely labelled as beef. This is a matter of fraudulent labelling and not of food safety (see also my other articles concerning labelling and the horsemeat scandal here and here). As the investigation continued, Van Hattem failed to clarify the origin and destination of several slaughtered horses. Read below how this is relevant for to the safety of the meat.
Horse passport
Horses in the EU require a passport for identification according to Regulation 504/2008. The slaughterhouse has to check whether a horse is indicated for slaughter in its passport. If so, an official veterinarian has to perform an inspection of the live horse. Without a passport and inspection the horsemeat can be declared unfit for human consumption. Also, information in the passport such as drug use, can result in disapproval of the intended slaughter for human consumption as residues of veterinary drugs can pose a health risk for humans.
The risk of dark horses
Van Hattem was not able to fully trace the processed meat and the company’s administration showed an unclear discrepancy between the amounts of received meat and the amounts that left the company. More horses were slaughtered than were inspected and approved for slaughter. The processing of (now) unidentifiable “dark” horses poses the risk that horsemeat unfit for human consumption ends up in food products for consumers, putting consumer health in jeopardy. The placing on the market of unsafe food is illegal according to Article 14 of Regulation 178/2002 (The General Food Law).
Was the meat in the case of Van Hattem indeed unsafe? Even though there was no evidence of unsafe food, the risk of unsafe food was sufficiently substantiated to consider the meat unsafe. Thereby an order to execute a recall was triggered based on Articles 17, 18 and 19 of the General Food Law (Article 14 is not mentioned by the Court). The Court does not place its bets on a dark horse. The Court ruled that although the order to execute a recall has a far-reaching impact on the business of Van Hattem, the order is proportionate given the circumstances.
Comparable decision re. Selten
In the ruling re. Van Hattem, the Court explained the relation between the specific circumstances and the risk of unsafe food. In a comparable judgment resulting in a recall of horsemeat, no such risk was pertinent per se. The case related to meat processing company Willy Selten B.V. The rationale for seizure in that case pertained to the facts that horsemeat was detected, which was not declared on the label and Selten’s business records could not be used to trace and identify the meat. The requested interim injuctions by this company were rejected twice (see here and here). But was there any indication that processed meat that was placed on the market was unsafe? In fact, there were not. The reasoning of the Court basically came down to stating that because the meat was untraceable, the meat was unsafe. The Court further added that it was almost certain that the veterinary drug phenylbutazone was present in one of the seized lots. But the presence of this drug poses no food safety issues according this joint statement from the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA). See also this press release from the European Commission concerning phenylbutazone. In it’s conclusion, the Court in the Selten case referred to Article 14(6) of the General Food Law which reads as follows:
‘Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.’
As set out above, in this case there was no indication of unsafe food, therefore the imposed order should have been lifted. It seems a tall order to base the order on Article 14 General Food Law as the requirement of unsafe food has not been fulfilled. In my opinion, the correct reasoning in this matter would have been as follows:
Untraceable = ?
Criminal prosecution
In the judgment re. Van Hattem, the Court mentions that the instrument of an order to execute recall has a far-reaching impact on the business of the company involved. In the case re. Selten, the company went bankrupt. Therefore, the instrument of recall should only be used if food safety is at stake. Especially in the case re. Selten, I have the impression that the administrative instrument of a recall is abused to punish the offenders and that the emotion and demand for action of consumers played a role here (I wonder if consumers would have responded differently if it were not horse but chicken that was mixed with beef, but that’s quite a different story). But the Court did have an escape. Without evidence of unsafe food, fraudulent labelling still constitutes a criminal offence and the offenders can be prosecuted for forgery under criminal law.
Developments
The supply chain of processed meats is complex and lengthy. 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. The horsemeat scandal clearly showed this. The debate concerning COOL might therefore give rise to changes to the traceability systems and the proposed new Regulation on Official Controls aims to strengthen the enforcement of health and safety standards. Further, supermarkets in the Netherlands have announced to tighten the required certification for all suppliers. At end of this month the Global Food Safety Initiative will launch the module “Food Fraud”. The Dutch food industry federation (FNLI) welcomes this initiative and urges its members to add this module in their food safety system.
Smarter rules for safer food: draft regulation on official controls
Posted: July 8, 2013 Filed under: Enforcement, Food | Tags: animal health, food, food safety, official controls, plant health Leave a comment »
On the 6th May 2013, the European Commission adopted a proposal for a draft regulation on official controls and other official activities performed which aims to strengthen the enforcement of health and safety standards across the “agri-food chain”.
This is an important Regulation, which will have an impact on every food business, producer, operator and Competent Authority in the EU.
Currently, the legislative framework for the organization of official controls is established through Regulation (EC) No. 882/2004. The new proposal aims to put in place a more robust, transparent and sustainable regulatory framework that is better “fit for purpose” which will repeal Regulation (EC) No 882/2004.
The proposal is part of a ‘landmark package’ which also includes major reviews to modernise, simplify and strengthen animal health, plant health and plant reproductive material legislation. The current body of EU legislation covering the food chain consists of almost 70 pieces of legislation. The package of reform will cut this down to 5 pieces of legislation. For official controls this is achieved by integrating the current applicable rules in specific areas currently governed by separate sets of rules (e.g. controls on residues of veterinary medicinal products in live animals and animal products, and plant health controls) into the framework of the new official controls Regulation.
Watch this video for the statement of Tonio Borg, Member of the EC in charge of Health and Consumer Policy, concerning this major reform.
An overview of legislation that will be repealed or amended through the proposed Regulation can be found through this link (see page 2). More information can be found here, here and here.
Some highlights
- Broadened scope to include the whole agri-food chain. The new areas included are plant health, plant reproductive material and animal by products;
- The current system of mandatory fees to finance the effective implementation of these controls within a sustainable system along the whole chain will be extended to other sectors within the chain which are currently not charged; Micro-enterprises will be exempted from such fees, but not from controls, in order not to affect their competitiveness;
- Member States will also be asked to fully integrate anti-fraud checks into their national control plans and to ensure that financial penalties applicable to violations must at least offset the economic advantage sought through the violation;
- Provisions to enhance transparency in relation to how competent authorities carry out official controls. This includes a requirement to publish more timely and regular information on the types of controls and their outcome and to establish “rating schemes” whereby consumers can consult data on the performance of retailers restaurants and other businesses;
- The creation of a common framework for carrying out border import controls on animals and goods entering the EU;
- Provisions allowing the Commission to adopt detailed rules across a range of areas of official controls via delegated and Implementing Acts;
- Rules to facilitate official controls for on-line sales. These facilitate competent authorities to order samples on line for official testing without having to identify themselves. The Regulation also specifically gives competent authorities the option of closing internet sites where non compliances have been identified relating to activities of the site.
Entry into force
Approximately in 2016. It depends on when both European Parliament and Council have approved the final text of a legislative proposal. More information about the legislative procedures? Click here for general information and here for a PDF-file concerning the ‘Ordinary legislative procedure’.
Next step?
This letter was sent to the European Parliament and the Council. They will consider the Commission’s package of measures and adopt their positions. When more details of the legislative planning or other news regarding this proposal are published, you will read it here!