Food or medicinal product? New development in Dutch case law on EU harmonized provisions

Intro

Food businesses operators that make medical claims for their products in the Netherlands can be fined for doing so under food law. However, they also run the risk of being fined under the Dutch Medicines Act (in Dutch: “Geneesmiddelenwet”), in which case much higher fine amounts apply. The latter sometimes provokes surprise and outrage. Based on three recent rulings, we see a positive trend, which is explained below.

Drug definition

In principle, a medicinal product cannot be sold in the Netherlands without an authorization. Advertising a medicinal product that has not been authorized is prohibited as well. If a product is classified as such and sold without a license, the seller risks a hefty fine.

The legal definition of the term medicinal product and the corresponding authorization requirement can be found in the Dutch Medicines Act, which is based on the European Directive 2001/83/EC (the “Medicinal Product Directive”). The Medicinal Product Directive provides two criteria for the definition of a medicinal product: qualification by presentation and qualification by function. If a product meets one of these two criteria, it is classified as a medicinal product. The aforementioned criteria are further elaborated in case law.

Qualification by function

A product is a medicinal product by function (see the Hecht-Pharma judgment) if it can be administered to cure or prevent disease, diagnose or otherwise affect a person’s bodily functions. Of particular importance here are the composition and properties of the product, the method of use, the extent of distribution of the product, the consumers’ familiarity with the product and the health risks associated with its use.

Qualification by presentation

When applying the presentation criterion (see the Van Bennekom judgment), consideration is – unsurprisingly – given to whether a product should be regarded as a medicinal product on the basis of its presentation. It is not necessary that the product is expressly indicated or recommended as a medicinal product. The presentation criterion is already met if the manner of presentation gives the average consumer the impression that the product has a medicinal effect. The form in which the product is presented may give an indication for this, especially in the case of tablets, pills and capsules.

In particular the presentation criterion poses a risk to food companies. If they (unintentionally) make a medical claim in respect of their product, the presentation criterion may result in this product being classified (also) as a medicinal product by the Dutch Food and Consumer Product Safety Authority (“NVWA”). In that case, the NVWA may issue a fine under the Dutch Medicines Act. The starting point for such fine is €150,000, which is then differentiated based on the Policy rules of the Dutch Ministry of Health 2019. Even if the product also falls within the legal definition of food, the Dutch Medicines Act may apply simultaneously. The foregoing follows from the so-called hierarchy provision embodied in article 2.2 of the Medicinal Products Directive, which has been implemented into Dutch law as well. On the basis of this hierarchy principle, the Dutch Medicines Act is applicable if there is any doubt about the applicable product category. The result of this provision is that even a seller of coconut oil can receive a fine under the Dutch Medicines Act.

New trend in enforcement of medical claims?

Dutch case law gives numerous examples of products being classified as medicinal products by courts based on (solely) the presentation criterion. Recently, three court rulings have been rendered which give reason to assume that there is a new trend in case law. These are a ruling of the District Court of Oost-Brabant of March 25, 2022, and two (materially identical) rulings of the District Court of The Hague of June 28, 2022, regarding food supplements and follow-on milk, respectively.

The first case concerns the sale of dietary supplements, for which medical claims were made. The NVWA therefore classifies these supplements as medicinal products based on the presentation criterion and imposes two fines under the Dutch Medicines Act (both for sale and for advertising an unregistered medicinal product). The seller’s defense is that the Dutch Medicines Act should be interpreted in accordance with the Medicinal Product Directive and that it follows from there that the contested decision of the NVWA is based on an incorrect legal basis.

The court agreed with this argumentation, referring to the amendment of the Medicinal Product Directive of 2004. The court deduces from the preamble to the amendment that the Medicinal Product Directive does not apply if there is no doubt that a product clearly exclusively belongs to another product category, such as food or food supplements. The court ruled that this was indeed the case for the specific circumstances that were under discussion. The products clearly fall under the category of food supplements and therefore solely food law applies. The court confirms that the Dutch Medicines Act must, after all, be interpreted in accordance with the Medicinal Product Directive. The court therefore does not proceed testing the medical claims made against the presentation criterion based on drug legislation at all.

Clearly food-only

The above ruling raises the question when a product is “clearly exclusively” a food and what aspects of the product are important in this respect. Indications for this can be found in the two recent decisions of the District Court of The Hague regarding specific food products for toddlers, namely follow-on formula. In its assessment of whether the follow-on formula in question could be a medicinal product by presentation, the court determined that such qualification is not obvious with regard to products sold in supermarkets and drugstores. Another factor in this case was that the detailed information about the follow-on formula, on the basis of which the Dutch Ministry of Health (the counterparty in the cases at stake) believed it to be a medicinal product by presentation, could only be found on the seller’s website.

Conclusion

Based on the rulings discussed, we signal a trend that judges are halting the current practice of enforcement of prohibited medical claims for food products based on the Dutch Medicines Act. The discussed rulings make clear that (prohibited) health claims for food supplements and for other food products such as follow-on formula should be assessed on the basis of the Food Information for Consumers Regulation (the “FIC Regulation”), and not via the presentation criterion based on the Dutch Medicines Act. In our opinion this is justified, because since the FIC Regulation became applicable, food law is specifically set up to do so. We are very curious to see whether the trend initiated above will be followed by other courts. Although it follows from a ruling of the District Court of Zeeland-West-Brabant of 21 October, 2022, that this is not yet the case, we trust this will only be a matter of time.

The above does however not mean that food business operators would be allowed to make medical claims for their products. Also, the FIC Regulation contains a ban on medical claims for food products and the Nutrition and Health Claims Regulation sets forth a strict regime for authorized health claims. Having said that, fines following a violation of food legislation are far lower than fines based on the Dutch Medicines Act. On balance, food companies are therefore better off with fines based on food legislation.

This blogpost is written by Max Baltussen, Karin Verzijden and Jasmin Buijs.

The authors want to acknowledge Ebba Hoogenraad and Irene Verheijen for sharing the case law discussed here.

 

 

 

 


Nomenclature for cultivated meat across Europe

This blogpost covers the recent GFI report European messaging for cultivated meat (GFI Report) as recently presented during the International Scientific Conference on Cultivated Meat (ISCCM).The further aim is providing the relevant regulatory context. Market authorisation is often mentioned as the delaying factor for market access of cellular agriculture-based products. If you are interested to know how the names and narratives by which these products are designated fit into the EU regulatory framework, read on!

Accelerated developments in cultivated meat field

Developments in the field of cellular agriculture have been tremendous since the first market approval of Eat Just’s hybrid cultivated chicken product in Singapore at the end of 2020. To name just a few:

  • September 2021: Singapore Food Authority grants CMO Esco Aster a license to manufacture cultivated meat for commercial production. Meanwhile, several cultivated meat companies have concluded partnerships with Esco Aster for production purposes.
  • October 2021: US Dept. of Agriculture announces an award of USD 10 million to Tufts University to set up a National Institute for Cellular Agriculture;
  • October 2021: The Israeli Innovation Authority announces to invest an amount equalling USD 69 to establish four new public-private consortia, including one targeting cultivated meat;
  • November 2021: opening of Upside Food’s 53.000 square foot production facility for cultivated meat;
  • April 2022: The Dutch government agrees to invest through its National Growth Funds an amount of € 60 million to boost the formation of an ecosystem around cellular agriculture, representing the largest public funding in this field globally so far;
  • October 2022: Mosa Meat announces construction of its 77 square cultivated meat campus.
  • Upcoming event in November 2022: FAO Expert consultation in Singapore for gathering scientific advice on cell-based food products and food safety considerations.

For a comprehensive overview of the developments in the cultivated meat market, reference is made to GFI’s 2021 State of the Industry Report on Cultivated Meat and Seafood. This report also points out that investments in cultivated meat companies have grown from USD 420 million in 2020 to USD 1,8 billion in 2021. The sector clearly grows in interest and substance.

Market authorisation: where to start?

Quite a few of the cellular agriculture companies have their origin in the EU and in the UK. During the latest editions of KET Conference, the New Food Conference and the ISCCM, I witnessed however that most of them intend obtaining market approval in Singapore first, then in the United States of America and only afterwards in the European Union. Why is that? And it is justified based on the current EU regulatory framework?

EU: attractive but very diverse market

The European Union represents a market of more than 440 million consumers and thereby is a bigger market than for example the United States, counting currently over 330 million inhabitants. Based on this headcount alone it makes sense for each serious food business operator to consider the EU market for the launch of a new product. At the same time, the European Union consists of 27 Member States having their own cultural and culinary habits. This is exactly what is pointed out in the GFI Report. These varied backgrounds mostly require dedicated product communication. To a certain extent, some overlap in effective product communication in the four countries in which the research took place, was found as well.

Product communication vs. marketing

For clarity, there is a thin line between marketing and product communication, especially for pre-commercial companies that need to raise funds to get their product to the market. This was recognized by David Kay from Upside Foods in his ProVeg presentation, which you can watch here (starting at 26th minute). For the time being all cultivated meat companies, except perhaps East Just, are pre-commercial companies. Product communication means providing factual understandable information to the targeted public. Marketing means the direct or indirect recommendation of goods, services and/or concepts by on behalf of an advertiser, whether or not using third parties. The purpose of the GFI report is to develop positive, persuasive nomenclature and messaging for cultivated meat for each language and cultural context. In my view, the report thereby operates somewhere in the middle between product communication and marketing.

Rationale for common denominator

As recently acknowledged by the FAO, internationally harmonized terms to designate cultivated meat would be helpful to facilitate understanding worldwide:

“Cell-based food products are also referred to as “cultured” or “cultivated” followed by the name of the commodity, such as meat, chicken or fish while the process can also be called “cellular agriculture”. Given the various terminology in use for this technology, internationally harmonized terms for the food products and production processes would facilitate understanding at global level.”

Overlap in product communication

Back to the research performed by GFI. The very reason for the GFI Report is the current lack of consensus within the sector on the best nomenclatures and narratives to use. Negative framing of cultivated meat (which in some EU countries is already a reality) could prevent consumer acceptance of these products. GFI therefore tested which names and narratives worked well in each of France, Italy, Spain and Germany. Regarding the name, the GFI Report establishes that terms that loosely translate to “cultivated meat” are understood in all these countries and have a positive rather than a negative connotation. This comes down to “viande cultivée” / “carne coltivata” / “carne cultivada” / “kultiviertes Fleisch”. As to the accompanying narratives, overall findings are that communication on cultivated meat should not be too technical. For example, reference to “cells” and “bioreactors” should generally be avoided, whereas analogies construed with existing food practices, such as the brewing of beer, work well.

Particularities for France, Italy, Spain and Germany

The research however also showed diverging results in the countries involved, both as regards the familiarity and the appreciation of cultivated meat. In France for instance, the terms “cells” and “bioreactor” are considered too reminiscent of a laboratory and too far removed from the language of food. In Italy “bioreactor” is even considered reminiscent of nuclear energy. In Spain, the terms “cells” and “bioreactors” are considered too scientific. In Germany on the other hand, the reference to “cells” is interpreted in an entirely different way. In this country, stating that cultivated meat stems from animal cells is interpreted that it tastes like conventional meat. In view of the market potential, in France 33% of the respondents indicate they would buy this food, whereas in Germany, Italy and Spain, these percentages are 57%, 55% and 65% respectively.

Do we have any examples from practice?

In an interview broadcasted on French television BFM Business on 5 October 2022, Nicolas Morin-Forest (NMF) delivers a fairly inspiring message on the cultivated foie gras of Gourmey. Whereas the TV station consistently refers to “viande synthèse”, NMF speaks of “viande culture” and stresses this is not a plant-based product (“Ce n’est pas du végétal”). Instead, he states, Gourmey delivers real animal protein with the same quality as animal protein in terms of taste (“C’est de la vraie protéine animale avec toutes les qualités gustatives des proteines animales”). He also mentions that with this product, it is no longer necessary to conclude any compromises; it associates culinary delight with the so-called protein transition (“Plus de compromis: le plaisir est au centre de l’assiette; au centre aussi de la transition alimentaire”). He finally points out that France can play a fundamental role in this protein transition, specifically based on its culinary foodprint and gastronomic history (“La France a un rôle fondamentale à jouer par notre patrimoine culinaire, par notre histoire gastronomique”).

Why are names and narratives of relevance for market authorisation?

The four researched countries are all important EU Member States, both in terms of head count and political influence. Germany is very influential at EU level and has the largest population of any EU country. Spain is reported to have strong influence over EU policy as well and has the highest meat intake in the EU. Both France and Italy have significant influence over EU agricultural policy. However, these latter two are the countries where we have seen the most hostile approach to non-conventional meat. In France for instance, there is ongoing litigation before the Conseil d’Etat concerning the prohibition of meaty names for non-conventional and alternative meat products.

Legal basis EU authorisation procedure

The position taken by all four countries will be of relevance during the authorisation procedure of cultivated meat in the EU. Cultivated meat – if produced without genetic modification – is regulated under the EU Novel Food Regulation. Contrary to legislation in Singapore (of very recent date) and in the US (still to be further shaped), this Regulation has already been in place since 1997 and was updated in 2018. The system is ready to receive applications when the companies are ready, too. Extensive EFSA guidance on the preparation of a Novel Food application is available.

Dynamics at the PAFF Committee

After EFSA makes available its safety evaluation regarding an application for authorisation of a cultivated meat product, the European Commission submits a draft implementing act to the PAFF Committee. This committee consists of representatives of each Member State and subsequently provides by qualified majority (i) a positive opinion, (ii) a negative opinion or (iii) no opinion at all.  “Qualified majority” here means that 55% of the Member States vote in favour, representing at least 65 % of the EU population. The dynamics of this decision making procedure have been described in detail in the article Meat 3.0 – How Cultured Meat is Making its Way to the Market, which also provides for a flow chart at the end. In case of a negative opinion, one of the options is to escalate to the so-called Appeal Committee. In case of a negative opinion of the Appeal Committee, the EC shall not render an implementing act. In plain language: the application for authorisation of the cultivated meat product at stake will in such case be rejected.

Conclusion

Based on the above, It is quite easy to make the calculation that if for instance the representatives in the PAFF Committee from Germany (over 80 million inhabitants) or France (over 65 million inhabitants) do not vote in favour of an  application for authorisation of a cultivated meat product, it will be difficult to reach the 65% threshold. Agreement on the name of product, understanding of the technology behind it, as well as the various benefits it could bring is therefore expected to be key for the evaluation procedure by the PAFF Committee. When these products make it to the EU market, they will be subject to the applicable legislation on food information and marketing. Until that time, it is of the essence that comprehensive product information reaches the relevant stake holders. It follows from the GFI Report that chefs and dieticians are best placed to deliver this message. In turn, the cultivated meat companies are in the position to provide them with relevant information. I can only encourage them to do so, if only to expedite market access in the EU.

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Additional useful sources linked to this topic are ProVeg’s reports Communicating about cultured meat and The role of imagery in consumer perceptions of cultured meat (the latter targeting the UK specifically), each published in October 20222 and to be downloaded here.

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Foto credit: BioTech Foods

 

 


1 year Single-Use Plastics Directive: developments, bottlenecks and prospectives

Last summer, the European Single-Use Plastics (SUP) Directive became applicable. This Directive places restrictions on the use of single-use plastic food packaging (and other plastic products). Where do we stand 1 year after the SUP Directive’s date of application? How has this Directive been implemented in the Netherlands, what are the bottlenecks and what can we still expect?

The EU has set itself the goal of becoming a leader in the global fight against marine waste and pollution from plastic products. The SUP Directive contains several measures to help reaching this goal. These range from marking requirements on the presence of plastic and its negative impact on the environment (e.g. on to-go coffee cups) to a total ban for products for which more sustainable alternatives are already available (such as for plastic plates and cutlery). However, the scope of the SUP Directive is not crystal clear. For example, the definition of ‘single-use plastic product’ is interpreted differently in different countries.

Scope of the SUP Directive

All types of plastics
The SUP Directive defines plastic as a material consisting of a polymer as defined in the REACH Regulation (and which can function as a main structural component of final products – more about this requirement below). Additives or other substances may have been added to the polymer. Natural polymers that have not been chemically modified are not covered by the definition of plastic in the SUP Directive. While the Directive does not provide a further explanation of this concept, the European Commission’s Guidelines (“EC Guidelines” or “Guidelines”) provide further clarification. The aim of the Guidelines is to ensure a harmonized interpretation of the SUP Directive. According to these Guidelines, practically all types of plastics are covered by the SUP Directive, including so-called bio plastics. The Netherlands follows this interpretation in its Explanatory Memorandum to the Dutch SUP Regulation. What supported this approach by the Dutch government is its intention to prevent a shift from single-use plastic packaging to other types of disposable packaging that may also end up as litter and has a negative impact on the environment.

Even products with a small amount of plastic
Both products that consist wholly and partially of plastic can fall under the scope of the SUP Directive. The Directive does not refer to a certain minimum percentage of plastic that must be present. The EC Guidelines clarify that a qualitative assessment should be made, taking into account the objectives of the Directive. Thus, according to the EC Guidelines, otherwise non-plastic products fall under the definition of plastic as referred to in the SUP-Directive if a plastic layer or coating is applied to provide protection against water or fat. Think, for example, of paper- or cardboard-based cups for beverages. Such products often end up as litter. Continuing to allow these products without restrictions does not fit the transition to a circular economy, as part of which waste must be reduced and reuse encouraged. Having said that, non-plastic products seem to be excluded from the scope of the SUP Directive if these contain polymeric materials solely in the form of paints, inks and adhesives (recital 11 to the SUP Directive).

In practice, there is (still) a lot of discussion about the question when a product is or is not a plastic product as referred to in the SUP Directive. Some EU Member States introduced a certain threshold value. As a result, paper and cardboard beverage cups and other food packaging that contain polymers in amounts below the maximum threshold do not fall under the SUP Directive in those Member States. The Netherlands purposely did not introduce such limit. Moreover, the Netherlands considers polymers applied as water or fat barriers to be a structural main component of food packaging. The reasoning behind this is that the packaging does not function for its intended use without such barrier. As a result of this approach, almost every material used for disposable food (incl. beverage) packaging falls within the scope of the Dutch SUP measures. As stated in the above-mentioned Explanatory Memorandum, this facilitates enforcement of the measures and makes them better fraud-proof.

Single-use vs. reuse
Once it has been determined that a product qualifies as a plastic product under the SUP Directive, it is relevant to determine whether the product is intended for single-use or reuse. Obviously, the SUP Directive only applies in case of the former. The mere fact that a product may be sold for multiple use cycles is insufficient to pass this test; relevant is whether reuse is included in the design of the product. For example, can the product be adequately cleaned without creating (food safety) hazards for the expected use? The possible reuse of packaging may be determined on the basis of the essential requirements in the Packaging and Packaging Waste Directive. Packaging being suitability for reuse can also be proven if part of a system that guarantees such reuse. Consider, for example, plastic beverage cups that, after use, are taken back by the dispensing location to be cleaned and then refilled. Whether a product is intended for one-time use must be considered on a case-by-case basis. The Dutch competent authority in the Netherlands, Human Environment and Transport Inspectorate (in Dutch: Inspectie Leefomgeving en Transport, or “ILT”), may issue additional guidelines for this purpose for the Dutch market.

Implementation in the Netherlands

In the Netherlands, the SUP Directive has been implemented through the SUP Decree (in Dutch: “Besluit kunststofproducten voor eenmalig gebruik“). This decree required amendments to the Packaging Management Decree 2014 (in Dutch: “Besluit beheer verpakkingen 2014”). The measures under the Decree are further detailed in the SUP Regulation (in Dutch: “Regeling kunststofproducten voor eenmalig gebruik”). The Dutch SUP Regulation gives substance to the freedom of policy granted to EU Member States under the EU SUP Directive. In concrete terms it sets rules for consumption reduction. For this purpose, different regimes will apply to consumption on-the-go on the one hand, and onsite use of disposables on the other hand. Extended producer responsibility, awareness raising measures (such as through national campaigns) and monitoring and reporting obligations are also covered by the Dutch SUP Regulation. The Regulation knows a phased implementation from January 1, 2023. The Dutch Ministry of Infrastructure and Water Management (in Dutch: Ministerie van Infrastructuur en Waterstaat, or “I&W”) keeps stakeholders informed of SUP-related developments in the Netherlands through online newsletters and webinars. A lot of information about the SUP Directive can also be obtained via the Netherlands Institute for Sustainable Packaging (in Dutch: “Kennisinstituut Duurzaam Verpakken”, or “KIDV”), such as a handy decision tree.

Practice in the Netherlands

The new rules have not gone unnoticed by consumers. Packaging for food on-the-go and other single-use plastic products now carry a marking that confronts the consumer with their use of such products. Several beverage dispensing locations have already taken a lead on the abovementioned Dutch SUP Regulation and have in place a deposit system for collection and reuse. The above examples show that various producers and importers have taken the necessary measures to act in accordance with the SUP Directive. At the same time, we notice that companies involved in the single-use plastics supply chain still have many questions. In our experience, most of these questions can be answered by carefully reading the detailed EC Guidelines. Since these Guidelines have an authoritative but no legal status, they may however leave the door open for alternative interpretations. So far, we are not aware of any relevant enforcement examples as a result of interpretation disputes. While these may emerge in the future, sufficient enforcement capacity will be a point of attention. Concerns for such are being expressed in Dutch politics, particularly in relation to the upcoming Dutch Single-Use Plastics Regulation. The ILT is currently assessing the required additional enforcement capacity.

Differences in Member States

Looking outside our own borders, we notice differences in the implementation of the SUP Directive among EU Member States. For example, some Member States such as Italy apply a threshold value for polymers in non-plastic products (10% by weight), while others don’t. Another example concerns an extended ban on single-use plastic products beyond the products banned under the SUP Directive, such as in France. Consumption reduction measures also vary from Member State to Member State, as shown by the report on reuse systems (in Dutch) commissioned by the Dutch Ministry of Infrastructure and Water Management. As a result of the above, companies that market their products in several Member States face challenges to ensure compliance in all markets in which they are active.

Conclusion

The SUP Directive became applicable over a year ago. The Directive provides for a phased implementation, which we see reflected in the Dutch SUP legislation. The implementation of the SUP-Directive is therefore still in full swing, both at home and abroad. Interpretation and implementation differences are not to be overlooked and companies are challenged to deal with this efficiently. Sharing best practices can be useful here, particularly when the phased implementation progresses and concrete enforcement actions start to take place. Feel free to reach out in case of any implementation issues you want to discuss.


The era of nudging: EU’s proposals for mandatory front-of-pack labeling

As part of the EU Farm to Fork Strategy for a sustainable food system under the Green Deal, the European Commission agrees that nudging is necessary to guide the consumer to healthier and more sustainable food choices. This has translated into two impact assessments for mandatory front-of-pack (FOP) labeling. Various EU Member States and individual food business operators are however not waiting for harmonized EU FOP labeling and adopted the nutri-score (guiding health choices) and/or eco-score (guiding sustainability choices). This blogpost shows how these initiatives fit into the current and upcoming legal framework.

 

Nutri-score

Nutri-score is a five-color nutrition label demonstrating the overall nutritional value of a food product front-of-pack. It allows consumers to compare various foods in a simple and fast way. The label is based on a scale of 5 color and letters, from a dark green “A” for the most healthy choice to a red “E” for the least healthy choice. Simply put, the algorithm behind nutri-score allocates positive points for favorable dietary components (fruits, vegetables, pulses nuts, fibers and proteins) and negative points for energy and unfavorable dietary components (saturated fatty acids, sugars and sodium). The total positive points are subsequently subtracted from the total negative points. The lower the score, the better the letter/color grade.

 

Fighting nutrition-related non-communicable diseases

The aim of nutri-score is to nudge the consumer into healthier food choices, and to stimulate the food industry to reformulate their recipes. This way, nutri-score should contribute substantially to a reduced burden of nutrition-related non-communicable diseases such as diabetes, cardiovascular diseases and some types of cancer.

 

Legal basis

From a legal perspective, nutri-score qualifies as voluntary food labeling in accordance with article 36 FIC Regulation. Food business operators that opt for using nutri-score are however obliged to use it for all foods they place on the market to avoid cherry picking. Moreover, a green “A” or “B” score additionally qualifies as a nutrition claim under the Claims Regulation. Since the claim is not listed in the annex to the Regulation, Member States adopting the nutri-score are subject to the notification procedure of article 23 of the Claims Regulation.

 

Algorithm changes

Countries that implemented nutri-score (France, Belgium, Luxembourg, Germany and Switzerland) or are willing to use it (Netherlands and Spain) join forces to ensure that nutri-score is in line with the national dietary guidelines. To coordinate such, the abovementioned countries established a Steering Committee and Scientific Committee in February 2021. The Steering Committee is composed of two representatives from national authorities in charge of the nutri-score implementation in each country; the Scientific Committee includes one or two independent experts nominated by each country involved. On March 7 last, the Scientific Committee published its interim report in which it proposes a methodology for modification of the nutri-score algorithm to handle problematic food categories (fats and oils, fish and seafood, whole grain products, salt, sugar, beverages, and dairy products). The Scientific Committee aims at providing a fully revised version of the nutri-score algorithm before the summer. The Steering Committee will have the final say in the recommendations proposed by the Scientific Committee and, where relevant, will elaborate a support document for food business operators to facilitate the appropriation of algorithm changes by the end of the year.

 

Developments at EU level

In the meantime, the European Commission held a public consultation to introduce standardized mandatory FOP nutrition labeling as part of the revision of the FIC Regulation within the EU’s Farm to Fork strategy. In its impact assessment, it listed five options:

  1. Baseline (“business as usual”) – it remains possible to voluntarily use a public or private, non-harmonized, FOP label.
  2. Nutrient- specific labels (numerical) – a harmonized FOP label such as the Italian Nutrinform Battery, providing numerical information on the content of macro nutrients and the energy value of a food, as well as the percentage of the daily refence intake that it makes up for.
  3. Nutrient-specific labels (color-coded) – a harmonized FOP label such as the UK Multiple Traffic Lights, which is similar to the numerical label but in addition uses colors to classify the content of nutrients as green, amber or red.
  4. Summary labels (endorsement logos) – a harmonized FOP label such as the Keyhole used in Sweden, which can be applied only to foods that comply with certain beneficial nutritional criteria.
  5. Summary labels (graded indicators) – a harmonized FOP label such as nutri-score, providing an appreciation of a product’s overall nutritional value through a graded indicator.

The harmonized FOP nutrition label as listed under 2 – 5 above could be either voluntary or mandatory, which is still subject to debate. The impact assessment also mentions the possibility of having a policy mix rather than using one preferred option. Next to the outcome of the public consultation, the European Commission will take into account the comprehensive review on FOP nutrition labeling schemes by the Joint Research Centre (2020) on EFSA’s recent scientific advise on nutrient profiling. A legislative proposal is expected in Q4 2022.

 

Eco-score

Eco-score can be seen as the equivalent of nutri-score in the field of sustainability. Just like nutri-score, eco-score is a French initiative. It shows the consumer the environmental impact of a food, using the same presentation as nutri-score in terms of colors and letters. The food’s environmental impact is measured in two steps. First, the environmental footprint is calculated using the Product Environmental Footprint (PEF) method, which is based on a Life Cycle Assessment (LCA). The PEF method takes into account 16 different impact categories, such as ozone depletion, land use and climate change. This eventually translates into a score between 0 and 100. Thereafter, bonus points can be added up or minus points can be deduced from this score. These extra points (positive or negative) are based on 4 additional criteria: (1) food production methods as measured through attributed third-party sustainability credentials such as organic certification, fairtrade or MSC, (2) recyclability of the packaging, (3) the provenance of ingredients, and (4) the stay-away from biodiversity-related issues such as overfishing and deforestation. The LCA takes place at product category level; the allocated bonus and minus points are related to the individual product.

 

Legal basis: currently no specific rules  

There is not yet a legal framework specifically dedicated to environmental claims, let alone a legal definition thereof. Environmental claims are currently enforced based on general rules, guidelines and self-regulation within the legal framework of unfair commercial practices and misleading advertisements, as discussed in our earlier blogpost. Interestingly, these different sources produce different definitions of environmental claims. The definition thereof in the Dutch Code for Environmental Advertising is for example very broad and includes the eco-score as a claim related to the environmental factors connected with the product. It is however questionable whether an eco-score “C”, “D” or “E” would fall under the definition of a ‘green claim’ under the EC Guidance on the Unfair Commercial Practices Directive. This latter guidance namely refers to a positive environmental impact (which products with lower scores have not) or a lower damaging impact on the environment than competing products. Since the eco-score algorithm is largely based on product categories rather than individual products, it is not necessarily suitable for comparisons between competing products such as for example different fruit juices. Assuming that eco-score does qualify as an environmental claim, the following question is whether it is in conformity with the applicable rules. These rules are however not black and white and leave room for interpretation, especially since the number of enforcement cases is still rather low.

 

Future situation: EU harmonization of eco-score?

The ambiguity illustrated above may be over with in the near future, since the European Commission is working towards the harmonized use of a sustainability label under its Farm to Fork Strategy and the transition towards a sustainable food system. In its impact assessment, it lists the following options:

  1. Baseline (“business as usual”) – No specific new actions, though existing initiatives on environmental claims will be continued, such as the upcoming legislation on the substantiating of environmental footprint claims by use of the PEF or OEF (organizational environmental footprint) method.
  2. Voluntary approaches – No legislative initiatives but guidance and private initiatives such as codes of conducts.
  3. Reinforcing existing legislation – Development of sustainability labeling provisions related to more than one sustainability component (such as environmental and social sustainability) through existing sector-specific legislation (for example fisheries marketing standards).
  4. Voluntary EU sustainability label – Development of a voluntary harmonized sustainability label, either applicable to all foods or to foods that meet a certain sustainability standard only.
  5. Mandatory EU sustainability label – Development of a mandatory harmonized sustainability label, either for all foods placed on the EU market or mandatory for EU produced foods and voluntary for imported foods.

A legislative proposal is expected in Q4 2023. Until July 21 of this year, it is possible to contribute through the public consultation.

 

Meanwhile in the Member States….

Member States seem not to be waiting for the legislative proposals of the European Commission. Instead, various Member States launched national initiatives on FOP sustainability labels and join forces to ensure that such labels will be implemented in a similar way throughout the EU. Taking the Netherlands as an example, the Ministry of Agriculture, Nature and Food Quality aims to implement a voluntary sustainability label for foods in the Netherlands by 2025. This goal forms part of the National Climate Agreement. Together with the food sector and other stakeholders, the Ministry is currently investigating how such a label for the Dutch market could look like. LCA’s based on the PEF-method are taken as a starting point for further development.

 

Conclusion

FOP labeling is a topic of conversation. Various initiatives on both national and European level are taking place simultaneously, in the hope that they will once come together as an EU harmonized label. We see different food businesses reacting to this situation differently. Where some opt for awaiting formal decisions at national level and instructions by the government, others are pioneering and experimenting with FOP labeling within the currently existing legal framework. Examples include the nutri-score pilot by Iglo and the full-fledged use of eco-score by Colruyt Group in Belgium. What about you? Are you a game changer or a laggerd?

Together with Lisa Gray from Iglo and Veerle Poppe from Colruyt Group, Jasmin Buijs presented this topic at the VMT Food Law Event on June 7 last.


This will change (soon): an update on environmental claims legal & policy framework

Many companies wonder what kind of environmental claim they can make for their product or packaging. Although there is no specific legal framework for this (yet), environmental claims fall under the general prohibition on misleading practices. Thanks to various developments at the European level, the legal framework for environmental claims is shaping up.  Below is an update of the latest developments.

 

New guidance on the Unfair Commercial Practices Regulation

At the end of last year, the European Commission published an update of its guidance on the Unfair Commercial Practices Directive (“Revised Guidance”). The guidance provides amongst others an interpretation of the general prohibition on misleading practices in the aforementioned directive. Although the guidance has no legal status, it concerns an authoritative document. Judges and regulators such as the Netherlands Authority for Consumers and Markets (ACM) regularly refer to it. With regard to environmental claims, the Revised Guidance continues the line as set forth in its previous version from 2016. At certain points the text has been more detailed and more extensive examples are provided. However, the Revised Guidance also highlights a number of new points. The most striking additions are as follows.

 

Use of logos and labels

Environmental claims must be presented in a clear, specific, accurate and unambiguous manner. Simply placing a logo on a packaging will generally be insufficient to meet the above requirements since the average consumer cannot be expected to be familiar with the meaning thereof. This is not surprising considering that there are more than 100 sustainability logos in the EU. To prevent misleading practices, the Revised Guidance prescribes informing the consumer on the meaning of the logo, whether certification is done by a third party or not, and where further information can be found. These requirements are not absolutely new since they can also be found in the Guidelines sustainability claims issued by the ACM and the Code for Environmental Advertising by the Dutch self-regulatory organization of advertising (of which an update is expected this year). What is more is that the Revised Guidance sets forth additional requirements in case private instead of public quality marks are being used. The European Commission therefore seems to hint at a preference for public quality marks (e.g. EU Ecolabel, the Nordic Ecolabel ‘the Swan’ or the German ‘Blue Angel’) over private quality marks and to aim at a reduction of the total number of such marks. In this context, the ACM calls upon companies to use existing quality marks instead of developing their own.

 

Use asterisk for reference to additional information

It follows from the above that environmental claims (including logos) sometimes need further explanation to be well understood by the consumer. This is especially the case for general terms such as “sustainable” and “good for the environment”. A clarifying text should be placed as close as possible to the general claim, preferably right next to it. Another place may be chosen if there is no room for this, such as on the back of the packaging on which the claim is presented. An asterisk can be used to make the connection between the main claim and the additional information. A similar suggestion is made in the ACM Guidelines sustainability claims. The Revised Guidance states that when there is no room to specify the environmental claim, the claim should in principle be omitted.

 

Sharing information with competent authorities, but not with consumers

Environmental claims should be based on evidence that can be verified by the competent authorities. Authorities requesting such evidence are expected to take into account confidential information of the company making the environmental claim (such as certain input data for an LCA). The Revised Guidance emphasizes that the Unfair Commercial Practices Directive does not contain an obligation to provide such evidence to consumers (upon request). The ACM however takes a different position on this matter in its Guidelines sustainability claims, referring to the Guidelines for Making and Assessing Environmental Claims (2000) of the European Commission. The ACM advises placing evidence that substantiates the claim on a website and referring to it on (the packaging of) the product concerned. It also states that consumers should be provided with more information about the evidence concerned upon request. This raises the question how to deal with confidential information. A practical solution is to remove confidential information (provided this does not render the information concerned practically illegible), or to make a summary of the evidence for the claim available as a ‘consumer version’.

 

Completed public consultation on bio-plastics

Bio-plastics are a hot topic these days. These include ‘bio-based’, ‘biodegradable’ and ‘compostable’ plastics. Where bio-degradable plastics degrade and eventually dissolve due to changes in their chemical structure, the idea behind compostability is that a soil improver remains after the composting process. In contrast, bio-based plastics are plastics made from components derived from natural materials (as opposed to fossil-based materials). Bio-based plastics are not necessarily biodegradable or compostable. The EU is investigating the following policy areas with regard to bio-plastics.

 

Sustainability of natural materials vs. fossil resources

Plastics based on natural materials are often advertised as being more sustainable than fossil-based plastics. The question is, however, whether such natural materials offer real environmental benefits beyond a reduction in the use of fossil resources. To measure those benefits, the environmental impact of the full life cycle of such materials needs to be considered. This includes amongst other things the origin of the raw materials used. The use of arable land to grow natural materials for bio-plastics while this land could have been used for food is for example not necessarily ‘sustainable’.

 

Effective biodegradability and its role in a circular economy

As far as biodegradability is concerned, it is being investigated whether and how plastics with this property fit into a circular economy. After all, there is little ‘circular’ about products that ‘dissolve’ in nature; reuse and recycling may offer better alternatives. It may at the same time be useful for certain product groups if they break down under specific conditions. An example of this could be agricultural film, which is not always removed completely after harvest and which is not easy to recycle after use due to contamination with soil. Similar questions arise with regard to compostable plastics. At best they break down into water and CO2, and therefore cannot contribute to soil improvement. Biodegradation of so-called compostable plastics could however also be useful for certain product groups. Think for example of compostable coffee and tea bags, which create a co-benefit when their use results into more coffee and tea being disposed in the green bin and subsequently composted.

 

Misleading practices

The prevention of misleading practices is also on the agenda. The European Commission recognizes that there is currently much confusion among consumers about bio-plastics. Stricter rules for the use of this and similar terms can prevent greenwashing. Moreover, it must be prevented that consumers interpret a biodegradability claim as a license to litter packaging with this characteristic.

From 18 January to 15 March 2022, a public consultation took place at European level concerning the policy framework currently being under construction. Publication of the policy framework is planned for this summer.

 

European policy framework PEF and OEF

Environmental footprint claims, just like other environmental claims, need to be supported by evidence. There is however no harmonized method for substantiating such claims. Having said that, EU standard methods for the ecological footprint of products (PEF) or organizations (OEF) do exist since 2013. These methods focus on the measurement of the environmental performance of a product or organization over its entire life cycle using 16 environmental impact categories, including climate change, ozone depletion and water use. The European Commission is currently exploring the possibilities of putting more emphasis on the use of the abovementioned methods for the substantiation of environmental claims. The outcome of this study was planned for the first quarter of this year, but is still pending.

 

Ecodesign

There is even more happening in the field of sustainability in Brussels. On 30 March of this year, the European Commission adopted a proposal for a revised directive establishing rules for sustainable products (“Revised Ecodesign Directive”). Sustainable products will become the norm, with reusability, recyclability and energy efficiency being key concepts.

 

Food products are excluded from this European proposal on sustainable products. It is also unlikely that the Revised Ecodesign Directive will set specific rules for packaging materials meant for food contact. The rules to be established for packaging materials will namely be introduced via product-oriented requirements for products that do fall under the Revised Ecodesign Directive.  This initiative nevertheless does mark a spot on the European sustainability horizon, which will also determine the direction for sustainability rules on packaging materials for foodstuffs.

 

Conclusion

Environmental claims are a topic of attention at national and European level. Food and food packaging businesses that make or wish to make environmental claims are therefore advised to keep an eye on current developments. Stay tuned!

 


Dairy under attack … and strikes back!

How to strike the right balance between freedom of speech and preventing unfair advertising targeting the dairy industry? This is the object of a Q4 2021 decision of the Appeal Board of the Dutch Advertising Code Committee, consisting of an advertising campaign on bus shelters in the Netherlands and a website campaign. If you are interested to know how broad the scope of “advertising” is and how a rather aggressive campaign was evaluated, continue reading. This post will be limited to the bus shelter campaign only since that already demonstrates the operation of the applicable legal framework.

Bus shelter campaign attacking dairy industry

The bus shelter campaign showed several very explicit pictures demonstrating the misery life of young calves. Under the title “Do you need help quitting?” information was provided on the consequences of the dairy industry for these calves. The text on the various posters in the bus shelters stated the question “Do you need help quitting?”, followed by the following texts:

  • Poster 1: “ “Dairy causes serious animal suffering. Calves are taken away from their mothers immediately after birth.”
  • Poster 2: “Dairy is deadly. On a yearly basis, 1.5 million calves are slaughtered for dairy”.
  • Poster 3: “Milk destroys more than you like. Calves are being fed artificial milk because the cow’s milk ended up in your cappuccino.”

The wording used above appeals to two well-known anti-smoking and anti-alcohol campaigns in the Netherlands, notably “quit smoking” and “alcohol destroys more than you like (your marriage for example).” The driver behind the anti-diary campaign is the Dutch organisation Animal & Law (“Dier & Recht”) that claims to be voice of the animals. This campaign was opposed by the Dutch dairy organization DairyNL (“ZuivelNL”), that aims to strengthen the Dutch dairy chain in a way that respects the environment and society. DairyNL considered this campaign misleading and therefore unfair.

Scope of the Dutch Advertising Code

The Netherlands knows a system of a self-regulation for advertising, embodied in the Dutch Advertising Code. Companies and other organisations can choose to submit to this system and the outcome (so-called recommendations) of cases based on complaints by whoever considers an advertisement misleading has a high degree of compliance (97 % in 2020). Animal & Law argued that their campaign was out of scope, as it did not envisage selling any products or services. Instead, it alleged to be a non-profit organisation that by public campaigns aims to improve the (legal) position of animals. Alternatively, it argued that if their campaign was captured by the scope of the Dutch Advertising Code, it would benefit from the principle of freedom of expression, as protected by the European Convention on Human Rights. Animal & Law overlooked however that the Dutch Advertising Code also captures ideas that are systematically recommended by an advertiser. The anti-dairy campaign by Animal & Law was found to meet this test. The Advertising Code Committee (“Reclame Code Commissie”) subsequently assessed for each bus shelter poster whether the information constituted misleading advertising.

Test for misleading advertising

The test applied is as follows: Advertising is unfair if it contravenes with standards of professional conduct and if it substantially disrupts or may disrupt the economic behaviour of the average consumer. One could consider this is exactly what Animal & Law was after and for a good cause. Under the Dutch Advertising Code however, aggressive advertising is at any rate considered unfair. Furthermore, all advertising containing incorrect or ambiguous information regarding specific aspects of the product at stake is considered misleading, if such information entices or may entice the average consumer to take a transaction decision (including refraining therefrom) that such consumer otherwise would not have made.

Poster 1

Just below the text “Do you need help quitting?” a milk carton is shown depicting a young calf being led away in a wheelbarrow followed by the text “Dairy causes serious animal suffering. Calves are taken away from their mothers immediately after birth.” All of this is depicted within a black framework, just like the health warning on a box of cigarettes. DairyNL argued, amongst other things, that according to the Netherlands Nutrition Centre, the consumption of dairy fits into a healthy diet, whereas the reference to quitting creates the impression dairy is very bad for human health. During the hearing, Animal & Law acknowledged that it is incorrect to state in general that dairy is not healthy. The Advertising Code Committee therefore considered the information re the quitting provided on poster 1 to be ambiguous and thus misleading. This results in unfair advertising.

Poster 2

This poster shows the same setting as poster 1, namely a milk carton depicting an earmarked calf surrounded by a black framework. According to DairyNL, in this context the text “Dairy is deadly. On a yearly basis, 1.5 million calves are slaughtered for dairy” can only be understood as a health warning. Furthermore, the absolute claim on the number of slaughtered calves creates the impression that this slaughter can only be attributed to the dairy industry, whereas it also serves meat production. Animal & Law had responded that calves are merely a by-product of dairy. It had used the warning that “dairy is deadly” to awaken the conscience of consumer. Obviously, the consumer understands the calf is going to die, not the consumer. The Advertising Code Committee considered this warning to be misleading, for the same reason as mentioned above. This part of the advertising was therefore considered unfair. The complaint regarding the slaughter was strikingly not addressed. I deduce therefrom that at any rate it was not concurred with.

Poster 3

On this poster, a calf is shown behind the bars of its small cage. DairyNL argued the setting of this poster (identical as described above) and the text “Milk destroys more than you like” links milk to two health hazard products, i.e. cigarettes and alcohol. DairyNL also argued that the claim “Calves are being fed artificial milk because the cow’s milk ended up in your cappuccino” creates the impression calves only drink artificial milk. Animal & Law refuted this complaint by explaining the claim does not state that calves only drink artificial milk. Animal & Law did not deny calves are being fed colostrum right after birth. However, this only takes 2 days, whereas the natural weaning period of calves amounts to 6 – 12 months. Here the Advertising Code Committee did not consider DairyNL’s  claim founded, as DairyNL did not dispute that after a few days, the calves are being fed artificial milk instead of cow’s milk.

Conclusion

So what is the result of all this and what can we learn from this advertising decision? If the campaign of Animal & Law was mainly after shock and awe, it certainly succeeded. The pictures of the calves shown in the context of health warnings for cigarettes did not miss their effect. Potentially, a number of consumers became aware of certain facts it did not realise before. But will these consumers say a definite no to dairy? That’s the question, as the campaign may also have a counterproductive effect. Personally, I expect the chances of a seductive dairy alternative much higher for inducing consumers to eat no more (or just less) dairy. The learning from this decision is that even if the freedom of expression is a major public good, it also has its limits. No purpose justifies providing incorrect or ambiguous information. This learning applies equally to those outlining the pro’s of dairy alternatives, but certainly also to those emphasizing the con’s of dairy.


Making an environmental claim on a product? Stay away from these 7 sins of greenwashing

Food packaging materials (and other products) are more and more often advertised as environmentally friendly, compostable, recyclable, or otherwise sustainable. In general, this is a positive development: it helps consumers to make (more) sustainable choices. But there is also a danger lurking, namely greenwashing. Greenwashing occurs when a product (including packaging) is being advertised as more sustainable than it actually is. In such cases, the consumer is not helped by the information conveyed and in fact the opposite is true: the consumer is misled. This blogpost explains what environmental claims are, the applicable legal framework, and, most importantly, how to prevent greenwashing.

 

Definition of environmental claims

There is no legal definition of environmental claims. However, the term is described in the European Commission guidance on unfair commercial practices legislation and by Dutch self-regulation. In short, environmental claims refer to the practice of suggesting in commercial communications that a product or service has a positive or no impact on the environment or causes less damage to the environment than other products or services (for example by text, images or the use of color). The Dutch Code for Environmental Advertising clarifies that environmental claims may concern the entire life cycle of a product, from production to waste processing.

Environmental claims, also known as ‘green claims’, are not the same as sustainability claims. Both the Dutch Advertising Code Committee (in Dutch: Reclame Code Commissie, or ‘RCC’) and the Netherlands Authority for Consumers and Markets (in Dutch: Autoriteit Consument & Markt, or ‘ACM’) specified that ‘sustainability claim’ is an umbrella term including claims referring to environmental aspects, animal welfare and/or labor conditions.

 

Legal framework

Since there is no legal definition of environmental claims, it comes as no surprise that there is no specific legal framework either. At least not yet, because the regulation of environmental claims is a topic of debate under the European Green Deal. Having said that, at present companies making environmental claims are free to decide how to substantiate such claim. As a result of this, environmental claims are not comparable, more difficult to verify and not always reliable.

The fact that there is no specific legal framework does however not mean that no rules apply to environmental claims. Such claims must namely comply with general rules, guidelines and self-regulation on misleading advertisements. This includes first and foremost the Dutch Unfair Commercial Practices Act (in Dutch: Wet oneerlijke handelspraktijken), which prohibits misleading advertisements and which is supervised by the ACM. What the Dutch Unfair Commercial Practices Act means for environmental claims is explained in the above-mentioned guidelines of the European Commission. Furthermore, the ACM launched the Guidelines Sustainability Claims early this year, which document provides general tools to make clear, correct and relevant sustainability claims (and so environmental claims). With regard to food packaging materials in particular, the EU Framework Regulation on Food Contact Materials states that the labeling, advertising and presentation of a material or article must not mislead the consumer. Last but not least, there are several ISO standards that help meet the legal requirements for environmental claims. For example, ISO 14021:2016 contains requirements for so-called self-declared environmental claims, which are made without independent third-party certification. Based on this ISO standard, the European Commission developed a guideline to help formulating environmental claims and evaluating existing environmental claims.

 

The 7 sins of greenwashing

Environmental claims, unlike for example health claims for foods, are not part of a closed system with an exhaustive list of claims that can be made. On the one hand, this means that advertisers have more room to make such claims. At the same time, it means that there is more ambiguity about what is and is not allowed. The key question “What may and may not be claimed?” requires an individual assessment. What is clear, however, is that the following seven sins of greenwashing are absolute no-gos.

 

  1. Hidden trade-offs

Describing the product as ‘sustainable’ or ‘environmentally friendly’ on the basis of only a limited number of properties without considering the environmental impact of the total life cycle of the product. For example, if a new production process saves water while it increases the total footprint of the product in question, then a claim on the water saving is not justified.

 

  1. No evidence

Making environmental claims without providing easily accessible evidence that supports the claim. If a package is for instance being advertised as ‘CO2 neutral’, inform the consumer where the outcome of the underlying life cycle assessment (LCA) and/or other relevant test reports are explained in a way that is understandable to the consumer (e.g. on your company’s website).

 

  1. Vague language

Using terms that are too broad and/or too general to understand the correct meaning thereof. The more general a claim is, the higher the burden of proof is to substantiate the claim. Make environmental claims therefore as specific as possible.

 

  1. Use of false labels

Using designations and symbols that falsely give the impression that the claim has been externally verified. It is therefore preferred to make use of an existing quality mark rather than inventing your own designation or symbol. This also helps the consumer not to get lost in the jungle of quality marks.

 

  1. Irrelevant claims

Claiming something about the product that is technically true, but which is not important when looking at distinctions in terms of environmental performance. For example, glass is factually speaking BPA-free, but such a claim would be misleading since this substance never occurs in glass.

 

  1. Smaller evil

Claiming to be more sustainable than other products within the same category, while the sustainability of these types of products in general is in question. Consider, for example, an environmental claim on cigarette packaging. This is not done.

 

  1. Untruths

Claiming something about the product while it is not (entirely) true. Is the packaging for example recyclable or compostable? Substantiate this claim with a validated test before communicating this to the consumer.

 

Practical tips

Companies wishing to make environmental claims on food packaging materials (or other products or services) are advised to take into account the following tips. First, put yourself in the shoes of the consumer. Can there be confusion about the environmental benefit being claimed? If so, adjust the claim accordingly. Secondly, be honest. Make sure the environmental claim does not give the impression that the packaging is more sustainable than it actually is. Finally, support your claim with evidence. This could be done by having the packaging material and its environmental impact independently assessed. The results of such assessment should subsequently be expressed on the packaging in a way that the consumer can understand, or, if there is no room for this, on a website. In the latter case, don’t forget to make a reference to that website on the packaging!

A Dutch version of this blogpost has been published at VMT.

Authors: Jasmin Buijs, attorney-at-law at Axon Lawyers & Agnieszka van Batavia, Packaging Sustainability and Regulatory Advisor at The LCA Centre

 

 


Clean labelling – smart product innovation or tricky business?

Over the last ten years, the trend of clean labelling in consumer food products has gained ever more ground. Clean labelling consists of replacing E numbers such as citric acid (E 330) and beetroot (E 162) by their natural counterparts, such as plant extracts. There is nothing wrong with E numbers per se. The use thereof is subject to specific purity criteria and their safety has been evaluated and approved. Consumers however tend to less appreciate E numbers as not being ‘natural’. This is not an unambiguous notion, as shown by this blogpost. Designing food products based on these consumer preferences can however become a tricky business, which was shown by a letter of the Dutch Ministry of Health, Welfare and Sport of 16 June this year as sent to the Dutch food industry associations. Even if this letter dates back to this Summer, it recently gained again traction on social media. We therefore consider it helpful to highlight the strict measures announced therein.

Fact-finding mission FVO in 2015

Some background information may be useful. In 2015, the Dutch Food Safety Authority NVWA received a visit from the Food and Veterinary office of the European Commission in the framework of a fact-finding mission. During this visit, non-authorised use of food additives in meat preparations was established that had not been detected by the Dutch authorities during official controls. After this visit, the NVWA announced the Action program on EU Food Additives (see paragraph 1.2 of this recent decision of the highest Dutch administrative law Appeal Court for further context). The Dutch Food Safety authority was thus confronted with its lack of oversight, which it clearly wanted to compensate.

NVWA published Additives Handbook in 2019

In June 2019, the NVWA published its Additives Handbook, which was updated in September 2020.  The Additives Handbook also contains a chapter on clean labelling. In this chapter it is stated that the use of plant extracts in consumer food products, that are merely applied for their technological function, should be regarded as unauthorized use of additives. An example is beetroot extract containing high levels of nitrate that can be converted into nitrite for use in meat preparations. The converted nitrite is identical to the additive nitrite, except that it does not necessarily meet the additives purity criteria. The PAFF Committee also considers that such cases represent targeted use of food additives, because the plant extracts at stake are merely used for their technological function, such as preservative, antioxidant or colorant. This use of plant extracts should therefore meet all applicable criteria to food additives, including being authorized as such. To easily verify which additives can be used in which foods and under which conditions, the NVWA also recently launched an interactive tool on its website.

Health Ministry’s letter of 6 June 2021

This Summer’s letter of the Dutch Ministry of Health, Welfare and Sport (in consultation with the NVWA) is even more concrete. It announces active enforcement regarding the unauthorised use of additives, as set out above, which it also considers as misleading information for consumers. As an additional example, the letter also states the use of microcultures, that are mainly used because of their preservative function. Enforcement measures can be avoided when four cumulative conditions have been met:

  1. an application for the clean label ingredient at stake as an authorised additive has been filed to the European Commission, who has confirmed the application is complete;
  2. the application was done before 1 January 2022;
  3. the clean label ingredient at stake has been used in food products since 16 June 2021 or before;
  4. the declaration of the clean label ingredient at stake includes its technological function.

Consequences of the Health Ministry’s letter

The letter of the Dutch Ministry of Health, Welfare and Sport in fact introduces a (very short) transition regime for food business operators using plant extracts and other ‘clean label ingredients’ mainly for their technological function in food products sold to consumers. These companies have two options. The first one is to make the investment for an application regarding an authorised additive in due course and revising their product labels as set out above (i.e. specification of the technical function of the clean label ingredient). This is for sure a costly and lengthy option, so it may be worthwhile to make such application on an industry level, as authorisations are generic. This is however only a viable option when the clean label ingredient was already used in food products for its technological function on or prior to 16 June of this year. The second option is to reformulate their product by using the ‘conventional’ additives and mentioning the appropriate E numbers on their product labels. In case neither option is retained, it follows from the NVWA’s food information intervention policy that a written warning can be triggered, followed up by a fine if the warning does not result in compliance. If and when any such warning is received, it should of course be meticulously studied if the correct legal basis was cited and if indeed a warning logically follows therefrom. If not, an administrative complaint before the NVWA can be lodged in first instance and an administrative appeal in second instance. We expect to see a lot of these in the near future if clean label enforcement will be as tight as announced in the letter of 16 June of this year.

 

 

 


The regulatory framework of personalised nutrition

On 7 October 2021, Food Valley NL published its personalised nutrition position paper. With no less than 53 stakeholders, this paper was written to create a business definition of ‘personalised nutrition’ and to give insights into profitable business models. Axon Lawyers, together with Alie de Boer and Sabrina Röttger-Wirtz from Maastricht University, contributed to this paper a chapter summarizing the three main legal challenges related to personalised nutrition: (1) processing of personalised data, (2) the borderline between certain regulated products and (3) nutrition and health claims. Alie de Boer and Sabrina Röttger-Wirtz wrote earlier about the applicable legal framework to personalised nutrition (see here). In this blogpost, we present an extended version of our contribution to the Food Valley personalised nutrition position paper.

Processing of personal data
The essence of personalised nutrition is that it targets individuals, including their phenotypic and/or genotype information, their specific lifestyle and/or their dietary requirements. In order to do so, any supplier of personalised nutrition will have to process personal data, more in particular data concerning health. Under EU standards, personal data is defined as any information related to an identified or an identifiable person (art. 4.1 General Data Protection Regulation, or “GDPR”). While anonymised data does not fall under this definition, the bar for considering data to be anonymised is set very high. Health data are data relating to the physical or mental health of a person, including the provision of health care services, revealing information about his or her health status (art. 4.15 GDPR). Genetic data may also be relevant in the context of personalised nutrition, which are data relating to the inherited or acquired genetic characteristics of a person which give unique information about the physiology or the health of that person (art. 4.13 GDPR). For clarity, the “processing” of personal data includes but is not limited to each of the following actions with respect to such data: collection / storage / structuring / adaptation / consultation / transmission / destruction (art. 4.2 GDPR).

For any supplier of personalised nutrition products and/or solutions, it is of the essence to only process personal data based on a valid legal basis, such as consent (art. 6 GDPR). “Consent” is defined as any freely given, specific, informed and unambiguous indication of a data subject’s agreement with the processing of his/her personal data based on a statement or clear affirmative action (art. 4.11 GDPR). The use of consent as a legal basis for the processing of personal data is further detailed in Guidelines 05/2020 by the European Data Protection Board.

Even in case of a valid legal basis, the processing of health, genetic and other sensitive data remains however prohibited unless specific conditions have been met (article 9 GDPR). This is for instance the case when the data subject has given its specific consent for processing for a specific purpose (art. 9.2 (a) GDPR), or when processing is necessary for scientific purposes (art. 9.2 (j) GDPR).

Suppliers of personalised nutrition products and / or solutions should be able to demonstrate with respect to the personal data of each individual they are processing that the conditions of article 6 and 9 GDPR have been met. This could be done for example by documentation of written consent forms. Other grounds for processing than consent as provided for in article 6 and 9 GDPR may be used as well, although this is not very obvious in a commercial context.

Borderline products
By definition, any product that is intended for human consumption or which can be expected to be ingested – whether it is processed or not – is considered to be a food product. Due to the effects that products have or due to the nature of presenting their effects, it can become unclear how a particular product should be classified, i.e. whether it falls under the definition of a medicinal product, a medical device, or under other sectorial legislation. In the case of these ‘borderline products’, the decision on a product’s classification must be taken on a case-by-case basis. In the case of personalised nutrition products, the way in which their effect on health is communicated (for example through claims, further described in paragraph iii) is decisive for the qualification of the product being offered. For example, such a product could qualify as a medicinal product either by way of presentation or by function. A medicinal product is understood to be any substance or combination of substances presented for treating or preventing a disease in human beings (art. 1.2 Medicinal Products Directive). A product qualifies as a medicinal product by presentation if consumers are entitled to expect it to have a medicinal effect (even without a genuine therapeutic or medicinal effect – see Van Bennekom case (1983) of the European Court of Justice (“ECJ”)). A product is a medicinal product by function if it is capable of exerting a pharmacological action (see ECJ Hecht-Pharma case (2009)). Thus, food products that are customised to the nutritional needs of a specific individual and are claimed to treat, cure or alleviate the symptoms of a disease may be classified as medicinal products rather than as foods.

Personalised nutrition products or solutions, or certain components thereof, could also qualify as a medical device (e.g. a personalised nutrition app) or an in vitro medical device (e.g. a genetic testing kit). Unlike medicinal products that tend to improve physical functions by creating a pharmacologic, immunologic or a metabolic effect, medical devices do not achieve their principal intended action by these means (but they may be assisted in their function by such means). Medical devices are any device, software or other article intended by the manufacturer to be used for specific medical purposes, such as the diagnosis, prevention, monitoring or treatment of a disease (art. 2 Medical Devices Regulation or “MDR”).

The essential question for the MDR’s applicability is therefore whether the product concerned has a medical purpose or is merely lifestyle or well-being related. For example, an app that provides dietary advice even when based on potential health data is a lifestyle product, but transforms into a medical device where it claims to help address or treat a medical condition like obesity or hypertension. While the intention of the manufacturer of the device is leading for the application of the MDR, it should be noted that only a statement from the manufacturer that a product is not a medical device, or is meant for lifestyle purposes only, is insufficient to escape from this regulation. The intended purpose is inferred from every document and statement that expresses the intended purpose, including advertising and marketing material. See also our earlier blogpost on personalised nutrition as a medical device.

How a personalised nutrition product or solution is qualified determines the applicable regulatory framework and significantly changes the legal requirements. Entrepreneurs should be open to a thorough product qualification analysis before market entry. This does not per se hinder the development of personalised nutrition, but unawareness of the regulatory borderlines can be a pitfall.

Nutrition & health claims
Even if personalised nutrition qualifies as a food product as opposed to medicinal product or medical device, this does not mean that just any health benefit can be claimed on such a product. In fact, there is a pretty strict legal framework that applies here, not only to mandatory food information, but also to voluntary food information. As to the latter, we refer to the framework on health & nutrition claims.

Any statement that describes, suggests or implies that a food product either has certain beneficial nutritional characteristics (nutrition claim) or that its consumption will result in certain health benefits (health claim) is regulated within the EU (Regulation (EC) No 1924/2006). Only pre-authorised claims which are considered substantiated by scientific evidence, based on an assessment by the European Food Safety Authority (EFSA), can be used on foods. Health claims can exclusively be used to address health benefits of foods, and no suggestions or implications can be made that consuming a food may result in treating, curing or alleviating symptoms of a disease (Regulation (EC) No 1924/2006). Only when health benefits are supported by pre-authorised claims and the product meets the conditions of use for this claim, health benefits of personalised nutrition products can be put forward. At the same time, food business operators may consider submitting authorisation requests for new health claims on personalised nutrition products. Currently, it is however uncertain whether referring to genetic predispositions in claims would be considered making a medicinal claim or a health claim (Ballke & Meisterernst, 2014; Röttger-Wirtz & de Boer, 2021). Also, it is unknown whether health claims, currently mainly targeting the general population, could be directed to specific target groups who would benefit from these personalised or tailored products (Röttger-Wirtz & de Boer, 2021).

Conclusion
Overall, personalised nutrition is subject to extensive regulation under existing EU legislation. In a birds-eye view of legal frameworks applicable globally, data protection, product qualification and the regulation of voluntary food information comprise similar concepts although the detailed rules differ. For example, globally, health claims are allowed to be used in different jurisdictions. Whereas pre-market authorisation is required – in different forms – in some jurisdictions including the EU as well as Australia/New Zealand, this is not necessarily the case for other jurisdictions such as Japan and the United States of America (de Boer & Bast, 2015; Dominguez Diaz et al, 2020). Awareness of the different regulatory frameworks is key before market entry.

Authors: Karin Verzijden, Jasmin Buijs, Alie de Boer & Sabrina Röttger-Wirtz

References

  1. SH Adams, JC Anthony, R Carvajal, L Chae, CSH Khoo, ME Latulippe, NV Matusheski, HL McClung, M Rozga, CH Schmid, S Wopereis, W Yan (2020). Perspective: Guiding Principles for the Implementation of Personalized Nutrition Approaches That Benefit Health and Function. Advances in Nutrition 11(1), 25–34.
  2. C Ballke, A Meisterernst (2012). Nutrigenomics – A New Trend from a Legal Perspective. European Food & Feed Law Review 7(1), 14-21.
  3. A de Boer, A Bast (2015). International nutrition and health claims legislation. Food Policy 55, 61-70.
  4. L Domínguez Díaz, V Fernández-Ruiz, M Cámera (2020). An international regulatory review of food health-related claims in functional food products labeling. Journal of Functional Foods 68, 103896.
  5. European Data Protection Board (2020), Guidelines 05/2020 on consent under Regulation 2016/679.
  6. JM Ordovas, LR Ferguson, ES Tai, JC Mathers (2018). Personalised nutrition and health. BMJ 2018; 361:bmj.k2173.
  7. S Röttger-Wirtz, A de Boer (2021). Personalised Nutrition: the EU’s fragmented legal landscape and the overlooked implications of EU food law. European Journal of Risk Regulation 12(1), 212-235.

 

 


SUP Directive: Restrictions on plastic food packaging (and other plastic products)

Last month, the European Single Use Plastics (SUP) Directive came into force. The purpose of this Directive is to reduce plastic litter, especially in the sea. Think for example of styrofoam hamburger trays or disposable plastic salad boxes for a meal on the go. The SUP Directive is part of the European action plan towards a circular economy (part of the Green Deal), to which re-use and recycling of products is central. The SUP Directive includes a phased introduction of various measures, with the goal of all plastic packaging being reusable or easily recyclable by 2030.

Scope SUP Directive
The SUP Directive primarily covers single-use plastic products. This includes packaging and other products that are partially made of plastic, such as cardboard boxes with a plastic coating. Plastics are materials consisting of a polymer, to which additives may have been added. Natural polymers that occur naturally in the environment are excluded from the definition of ‘plastic’. Bio-based and biodegradable plastics (based on natural polymers that have been chemically modified) are instead covered under the Directive. Single-use refers to the situation in which the product is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-sued for the same purpose for which it was conceived. What exactly constitutes a single-use plastic product is further clarified in a guideline issued by the European Commission. Among other things, the composition and potential washability and repairability of the product play a role in this.

In addition to single-use plastic products, the SUP Directive also pays attention to products made of oxo-degradable plastics and fishing gear. Fishing gear is namely responsible for a large percentage of the plastics in marine litter. Oxo-degradable plastics are addressed by the Directive because these plastics have a negative impact on the environment and do not fit within a circular economy. This is because oxo-degradable plastics fragment into tiny particles, which then disappear in the environment.

Restrictions on placing on the market
Since 3 July 2021, the date of application of the SUP Directive, it has been prohibited to market products made of oxo-degradable plastics and the plastic products listed in Part B of the Annex to the SUP Directive. This includes plates, beverage stirrers, certain food containers as well as cups and containers for beverages made of expanded polystyrene (a type of styrofoam), sticks to be attached to and to support balloons, including the mechanisms of such sticks (unless for professional applications) and cotton bud sticks and straws (unless they qualify as medical devices).

The trade ban applies to the above-mentioned packaging and other plastic products placed on the market from 3 July 2021. The term ‘placing on the market’ refers to a product being supplied for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge, for the first time. Plastic products that have already become part of the supply chain in a given Member State before the trade ban entered into force, for example because a food business operator purchased such from its supplier prior to the aforementioned date, may therefore continue to be used in that Member State even after the trade ban has become applicable. However, the foregoing does not apply to products that were placed on the market in a certain Member State before 3 July 2021, and that are further distributed in another Member State after that date (in the context of a commercial activity). Thus, if a Dutch food company has in stock food packaging covered by the trade ban that it purchased from its supplier prior to 3 July 2021, it can continue using this packaging for food products to be marketed in the Netherlands. However, the Dutch food company can no longer use this packaging for its food products destined for the Spanish market. Although this seems to go against the internal market principles of the EU, the SUP Directive explicitly refers to placing on the market of a Member State (and not on the EU market).

Disposal instructions for beverage cups
Conspicuous, clearly legible and indelible marking on plastic products should, since 3 July 2021, ensure that consumers are aware of how to dispose of these and are aware of the negative impact of littering or other improper means of waste disposal on the environment. The European Commission has established marking specifications for this purpose. These markings may be affixed by means of stickers in case of products placed on the market before 4 July 2022. Thereafter, the markings must be printed on the product itself, or on its packaging. The text of the marking must be in the official language(s) of the Member State(s) where the product is marketed. Where the product is marketed in several Member States, it will usually be necessary to include the text of the markings in several languages. Based on Part D of the Annex to the SUP Directive, the above marking requirements apply to beverage cups and several non-food related plastic products.

Other litter-reducing measures
The SUP Directive includes many other rules, such as that caps and lids must remain attached to plastic beverage containers during their entire intended use stage (as of 3 July 2024). In addition, beverage bottles must contain at least 25% recycled plastic from 2025, and at least 30% recycled plastic from 2030. However, the above measures only apply to beverage containers and bottles of up to 3 liters. Furthermore, glass and metal beverage bottles with caps and lids made from plastic are exempt from the above rules, as well as such beverage bottles for food for special medical purposes.

In addition, the SUP Directive calls on Member States to take awareness raising measures to prevent and reduce litter, to ensure the separate collection for recycling, to take the necessary measures to achieve consumption reduction, and to establish extended producer responsibility schemes. The latter means, in short, that ‘the polluter pays’ and that the producer or importer thus pays the cost of cleaning up litter. The Annex to the SUP Directive indicates the plastic products to which the above measures apply.

Measures differ between Member States
Although the SUP Directive was adopted at European level, this does not mean that measures to prevent litter and stimulate a circular economy will be the same in all Member States. To achieve reduction in the consumption of single-use plastics, a Member State may for instance set national targets, take measures to ensure that re-usable alternatives are made available at the point of sale to the final consumer, or ensure that single-use plastic food and beverage containers are no longer provided free of charge to the final consumer. Next to the above-mentioned examples, there are many other possibilities that Member States may exploit.

In the Netherlands, the SUP Directive is implemented in the Single-use Plastic Products Decree (in Dutch: Besluit kunststofproducten voor eenmalig gebruik) and in the Packaging Management Decree 2014 (in Dutch: Besluit beheer verpakkingen 2014). To achieve reduction in the consumption of single-use plastics, the Netherlands is keeping open the possibility of no longer providing food packaging and beverage cups (as defined in article 15d of the Packaging Management Decree 2014) free of charge to the final consumer, having available a re-usable alternative to the final consumer at the point of sale and/or prohibiting the provision of the above-mentioned products to the final consumer at certain locations or occasions. Such measures will apply as per 1 January 2023.

Companies operating in several Member States would do well to become familiar with the national measures relevant to them. For plastic products listed in Part E of the Annex to the SUP Directive (including certain single-use food and beverage containers), the Directive even explicitly requires producers that sell such products in a Member State other than where they are established to appoint an authorized representative in the Member State of sale. The authorized representative is responsible for ensuring that the producer’s obligations in the Member State of sale are met.

Alternatives
Although the SUP Directive appears to be a set of restrictions, it is also meant to encourage the production and use of sustainable alternatives to single-use plastic products. For example, food companies that depend on packaging for the shelf life and quality of their products, or to convey information to consumers, may want to explore their options to switch to reusable packaging, to set up collection and recycling systems, or to use other materials such as paper and cardboard (without plastic coating). Of course, such sustainable initiatives should not come at the expense of food hygiene and food safety.  

Conclusion
Plastic products are increasingly being restricted to protect the environment and human health. Food companies using packaging consisting wholly or partly of plastic are advised to check whether the packaging they use is covered by the SUP Directive, what measures apply to it and whether alternatives are available. It should also be borne in mind here that measures under the SUP Directive are introduced gradually and may differ per EU Member State. For entrepreneurs who operate intra-Community, the correct implementation of the new rules will require the necessary efforts. But who does not want to move towards a more liveable world and a sustainable production chain? The reduction of plastic could make a valuable contribution to that purpose.

 


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