1 year Singe-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!

 


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

 

 


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.

 


Personalized nutrition as a medical device

From May 26 this year, the personalized nutrition space has been enriched with a new piece of legislation: the Regulation (EU) 2017/745 on medical devices (hereinafter: “MDR”). The MDR is, generally speaking, applicable to all personalized nutrition (software) products, including apps and algorithms, with a medical intended purpose. Since most personal nutrition services that are currently on the market are lifestyle related, they will not be affected by the MDR. This will however be different for services that offer dietary advice for the prevention, alleviation or treatment of a disease. This blogpost aims to provide an introduction to the new rules on personalized nutrition as a medical device.

What is the MDR?

The MDR comprises of a set of rules that governs the full medical devices supply chain from manufacturer to end user in order to ensure the safety and performance of medical devices. It applies to any apparatus, application, software or other article intended by the manufacturer to be used for a medical purpose. This includes, like under the old medical devices legislation, the diagnosis, prevention, monitoring, treatment or alleviation of a disease. Since the application of the MDR, also devices designed for the prediction or prognosis of a disease qualify as a medical device. Genetic testing kits for medical purposes and other medical devices to be used in vitro for the examination of specimens such as blood are covered by the MDR’s sister, Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (hereinafter: “IVDR”). The IVDR applies from May 26 next year.

When does the MDR apply to personalized nutrition software?

The essential question for the MDR’s applicability is thus whether the article or software concerned has a medical purpose or is merely lifestyle or well-being related. For example, an app that provides dietary advice based on the users’ preferences and potential health data is a lifestyle product. But if the same app claims to help address obesity or treat hypertension, then it can be linked to a disease and transforms into a medical device. 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 that a product is not a medical device, or is meant for lifestyle purposes only, does not constitute a reason 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. Disclaiming a medical intended purpose in the instructions for use but claiming such purpose in marketing materials will still result in a finding of a medical intended purpose. The MDR contains an explicit prohibition on statements that may mislead the end user about the intended purpose or ascribes functions or properties to the device that it does not have, which would be caught in its scope.

Another example of a medical device is the wearable being developed by the Australian start-up Nutromics, which assesses dietary biomarkers to provide dietary advice to minimize users’ risk for lifestyle-related chronic diseases. This device is designed to predict the user’s likelihood of developing a particular disease and to subsequently provide advice to prevent such disease, and will therefore be subject to the MDR when placed on the Union market. On the other hand and as clarified earlier by the European Commission in its borderline manual for medical devices, a home-kit that enables the user to ascertain their blood group in order to determine whether a specific diet should be followed falls outside the medical sphere (as defined in the (old) medical devices legislation). The sidenote should however be made that this decision was not related to following a specific diet for medical purposes.

It is also relevant to state that software may as well qualify partly as a medical device and partly as a non-medical device. Think for example of an app that provides the user with personalized nutritional advice as part of the treatment or alleviation of diabetes, and additionally facilitates online contact with fellow patients. While the software module(s) that provide information on the treatment or alleviation of the disease will be subject to the MDR, the software module that is responsible for the contact amongst patients has no medical purpose and will therefore not be subject to the MDR. The manufacturer of the device is responsible for identifying the boundaries and the interfaces of the medical device and non-medical device modules contained in the software. The Medical Device Coordination Group has pointed out in its guidance on qualification and classification of software (October 2019) that if the medical device modules are intended for use in combination with other modules of the software, the whole combination must be safe and must not impair the specified performances of the modules which are subject to the MDR. This means that also the non-medical devices module(s) may have to be covered in the technical documentation that supports the device’s compliance with the MDR and as further introduced below.

Way to market of personal nutrition software

All medical devices placed on the Union market must in principle have a CE (conformité européenne) marking as proof of compliance with the law. To apply the CE-mark, the manufacturer has to prepare technical documentation and carry out a conformity assessment procedure, including clinical evaluation. The specific procedure that must be followed depends on the risk class of the device. The MDR distinguishes the risk classes I, IIa, IIb and III (from low to high). The higher the risk class of the device, the more stringent requirements for clinical evaluation apply to demonstrate safety, performance and clinical benefits. It could ironically be stated that MDR stands for More Data Required: where an analysis of available clinical data from literature may have been sufficient in the past, the MDR more often requires own clinical investigations to support the device’s safety and performance.

Under the MDR, software as medical device is classified as class IIa when it is intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, or to monitor physiological processes. Translated to personal nutrition services, this would for instance include apps that track burned calories (monitoring of physiological processes) and that provide dietary advice as part of a treatment (therapeutic purposes). Risk increasing factors will however lead to a higher risk class than class IIa. While an app with which food products’ barcodes can be scanned to detect certain ingredients for allergen control purposes would normally be a class IIa device, it will be a class III device when food intake decisions based on the app may cause life-threatening allergic reactions when based on a false negative (safe to eat while it in fact is not safe).

All other software which is not specifically addressed but still has a medical intended purpose in scope of the definition of a medical device, is classed as class I. An example would be an app that provides nutritional support with a view to conception. The risk classification rules for software are new under the MDR, which means that existing medical devices software may be scaled in a higher risk class since 26 May 2021. This is relevant not only with regard to the conformity assessment procedure that must be followed, but also to the question who can perform the required assessment of legal compliance. Manufacturers of devices in a higher class than class I must always engage a so-called notified body in this regard, while class I devices can in principle be self-certified by the manufacturer. An exception exists however for class I devices that have a measurement function, for example by using the lidar of the user’s phone to measure the body as input for the functionality of the app, which also require the engagement of a notified body.

Take away for food businesses

When personal nutrition enters into the medical sphere, the MDR will come into play. This will impact first and foremost the manufacturers, importers and distributors of actual medical devices, including apps and algorithms. Having said that, food businesses that wish to market their food products through medical devices apps are advised to be aware of the implications thereof. This will help them to find a reliable partner and to ensure their interests are contractually protected.

A more elaborate version of this blogpost has been published at Qina in cooperation with Mariette Abrahams.


CBD as a food product: no drug, isn’t it? The interaction between food and opium legislation.

A number of legal developments in the field of cannabidiol (CBD) took place in the last few months of the previous year. For example, the European Court of Justice (ECJ) ruled in November that a member state cannot prohibit the marketing of CBD that was lawfully manufactured and marketed in another member state. Less than a month later, the United Nations Commission on Narcotic Drugs (CND) voted on six recommendations of the World Health Organization (WHO) regarding the reclassification of cannabis in the Single Convention on Narcotic Drugs (Single Convention). In practice, there appears to be confusion about the meaning of these developments for CBD as a food product. This confusion seems to arise from the interaction between food and opium legislation, both of which are applicable to this product. This article aims to provide clarity on these latest developments.

CBD is not a narcotic according to the ECJ
On 19 November 2020, the ECJ ruled, in summary, that the free movement of goods entails that when CBD is lawfully manufactured and marketed in one member state, it may, in principle, also be marketed in another member state. This is, however, different when Article 36 of the Treaty on the Functioning of the European Union (TFEU) justifies an exception to the free movement of goods, such as for the protection of health and life of humans. Yet, the trade restricting or prohibiting measure must in such a case be appropriate for securing the attainment of the objective pursued (the protection of health and life of humans) and must not go beyond what is necessary in order to attain it. To reach the aforementioned conclusion, the preliminary question had to be answered whether CBD falls within the scope of the free movement of goods. This principle does namely not apply to narcotics, which are prohibited throughout the Union (with the exception of strictly controlled trade for use for medical and scientific purposes). Based on the Single Convention and the Convention on Psychotropic Substances, the ECJ reasoned that CBD is subject the free movement of goods. Both conventions codify internationally applicable control measures to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes and to prevent them from entering illicit channels. The Convention on Psychotropic Substances regulates psychoactive substances, whether natural or synthetic, and natural products listed in the schedules to the Convention, including tetrahydrocannabinol (THC). CBD is not included. The Single Convention applies, inter alia, to cannabis (defined as “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated”). Although a literal interpretation of the above provision would lead to the conclusion that CBD (not obtained from the seeds and leaves of the cannabis plant) falls within the definition of cannabis, such an interpretation is not consistent with the purpose of the Single Convention, namely protecting the health and welfare of mankind. Indeed, according to the current state of scientific knowledge, CBD is not a psychoactive substance.

UN Commission on Narcotic Drugs reclassifies cannabis
Shortly after the ECJ ruling regarding, among others, the Single Convention, the CND put six WHO recommendations to vote on 2 December 2020. This voting session would have taken place earlier, though had been postponed so that the voting countries had more time to study the matter and to determine their position. The WHO recommendations dealt with the reclassification, removal and addition of cannabis (substances) in the various schedules (Schedule I, II, III and IV) to the Single Convention. These four schedules represent four categories of narcotics and each category has its own rules. The substances in Schedule VI are controlled most strictly; they are considered dangerous without relevant medicinal applications. Schedule I concerns the second most strictly controlled category. The substances in this Schedule are subject to a level of control that prevents harm caused by their use while not hindering access and research and development for medical use. The lightest criteria apply to Schedule II and III. For example, Schedule II lists substances normally used for medicinal purposes and with a low risk of abuse.

Bedrocan (currently the sole supplier of medicinal cannabis to the Dutch government) has summarized these six WHO recommendations as follows:

  1. Extracts and tinctures are removed from Schedule I.
  2. THC (dronabinol) is added to Schedule I under the category Cannabis & Resin. Subsequently, THC is removed from Schedule II of the Convention on Psychotropic Substances.
  3. THC isomers are added to Schedule I under the category Cannabis & Resin. Subsequently, THC isomer is removed from the Convention on Psychotropic Substances.
  4. Pure CBD and CBD preparations with maximum 0.2 % THC are not included in the international conventions on controlling drugs.
  5. If they comply with certain criteria, pharmaceutical preparations that contain delta-9-THC should be added to Schedule III, recognizing the unlikelihood of abuse and for which a number of exemptions apply.
  6. Cannabis and cannabis resin are removed from Schedule IV, the category reserved for the most dangerous substances.

In the end, only the recommendation to remove cannabis from Schedule IV (i.e., recommendation 6) was approved, on the grounds that there are also positive aspects to cannabis. However, this does not mean that cannabis can now be freely traded. Cannabis is still included in Schedule I and is therefore in principle a prohibited substance. Having said that, research and product development for medical purposes is permitted if a country so desires. In the Netherlands, the Dutch Opium Act already allowed for this under certain conditions. The reclassification of cannabis is therefore more symbolic in nature than that it brings about practical changes.

The recommendation to explicitly exclude CBD from the scope of the Single Convention has thus been rejected. The industry considers this a missed opportunity to clarify the (legal) status of CBD with traces of THC. This rejection was on the other hand in line with the viewpoint of the European Commission, which advised its member states that sit on the CND (i.e. Belgium, Germany, France, Hungary, Italy, Croatia, the Netherlands, Austria, Poland, Spain, Czech Republic and Sweden) to vote against this recommendation since more research would be needed. For example, the European Commission takes the position that the proposed THC limit of 0.2 % is not sufficiently supported by scientific evidence. The WHO Expert Committee on Drug Dependence (ECDD) notes in this regard that medicines without psychoactive effects that are produced as preparations from the cannabis plant will contain traces of THC and provides the example of the CBD preparation Epidiolex as approved for the treatment of childhood-onset epilepsy, which contains no more than 0.15 % THC by weight. At the same time, WHO ECDD recognizes that it may be difficult for some countries to conduct chemical analyses of THC with an accuracy of 0.15%. Hence, it recommends the limit of 0.2 % THC. This limit is already known to food companies from the so-called Novel Food Catalogue of the European Commission, which recalls that in the EU, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the THC content does not exceed 0.2 % (w/w). This does, however, not necessarily mean that products derived from such cannabis varieties can be freely marketed as food.

CBD as food product
With respect to cannabis extracts such as CBD, as well as its synthetic equivalent, no history of safe use has been demonstrated. As a result, these products qualify as novel foods and can only be placed on the EU market after approval by the European Commission. Several food companies such as the Swiss company Cibdol AG, Chanelle McCoy CBD LTD from Ireland and the Czech CBDepot, have already applied for the required novel food authorization. However, the assessment of the relevant dossiers has been paused, presumably because it was still unclear whether CBD qualified as a psychotropic substance and narcotic. Such a qualification would exclude use as a foodstuff. Thanks to the ECJ ruling, this has now been clarified, on the basis of which the European Commission will likely resume the evaluation of the various applications for CBD as a novel food.

CBD under the Dutch Opium Act
A potential approval of CBD as a novel food does, however, not automatically mean that CBD can be sold in the EU without any (legal) obstacles. The Novel Food Catalogue makes this reservation explicit by indicating that specific national legislation, other than food legislation, may restrict the placing on the market of a cannabis product as a food. In practice, it will in particular come down to opium legislation.

Although the ECJ clarified that CBD is not a narcotic, it did not specify how pure CBD must be to fall outside the scope of the Single Convention and to be freely traded. The respective rejected WHO recommendation referred to a THC content of up to 0.2 %. In the Netherlands is, however, only a contamination level of < 0.05 % allowed. This impurity can be caused by traces of THC, but also by the presence of other cannabinoids. Only pure CBD, i.e. with a purity level of > 99.95 %, falls outside the scope of the Dutch Opium Act. Having said that, there is another catch: although the Dutch Opium Act does not cover CBD, this Act is applicable to the cannabis plant (or its parts) from which the CBD is extracted. The production of (natural) CBD can therefore not take place in the Netherlands.

Conclusion
Recent developments in the field of CBD have clarified that CBD is not a narcotic and therefore does not fall under the Single Convention. Food businesses are nevertheless warned to not yet start celebrating. If they want to market CBD as a food, they will still have to go through the novel food procedure, or market a product in accordance with the terms of an already approved CBD product. The latter is possible insofar data protection does not prevent this. Besides this, the purity level of CBD is decisive to stay away from opium legislation. There is still no international agreement on what this level should be. Food businesses operating in different member states are therefore advised to seek local advice when marketing CBD in the EU.


Active disclosure of inspection results: how to prevent naming & shaming?

Since 1 September 2020, the Dutch Food Safety Authority (NVWA) has been given the power to publish  certain inspection results (including identification details of the inspected FBO) faster than before. Prior to that date, the legal basis for disclosure could primarily be found in article 8 of the Dutch Freedom of Information Act (in Dutch: Wet openbaarheid van bestuur). This act creates a duty for the administrative body concerned, for example the NVWA, to publicly provide information when this is in the interest of good and democratic governance. However, article 10 of the Freedom of Information Act requires an individual balancing of interests in order to avoid disproportionate disadvantage for the parties involved as a result of the publication. It also prohibits disclosure of certain sensitive information, such as company and manufacturing data that has been confidentially communicated to the government. This blog post explains what has changed since 1 September 2020, which FBOs are affected and what arguments they can use to prevent disclosure.

Additional basis of disclosure as of 1 September 2020
As of 1 September 2020, the NVWA is additionally bound by the Decree on the Disclosure of Supervision and Implementation Data under the Health and Youth Act (in Dutch: Besluit openbaarmaking toezicht- en uitvoeringsgegevens Gezondheidswet en Jeugdwet, hereinafter: Decree on Disclosure), as further elaborated in the Policy Rule on Active Disclosure of Inspection Data by the NVWA (in Dutch: Beleidsregel omtrent actieve openbaarmaking van inspectiegegevens door de NVWA, hereinafter: Policy Rule on Disclosure). This power of disclosure is based on article 44 of the Dutch Health Act (in Dutch: Gezondheidswet). Disclosure in accordance with the Decree on Disclosure does not require the balancing of interests: disclosure of information will simply take place when indicated in the relevant annex to the Decree on Disclosure. Companies that wish to prevent publication of information related to their business will therefore have to invoke factual criteria, such as that the information to be disclosed contains incorrect information or concerns information that is excluded from disclosure in Article 44(5) of the Health Act.

Required actions when companies disagree with disclosure
The publication of information as based on the Decree on Disclosure has consequences for the way affected companies can stand up to prevent disclosure and the speed with which they will need to object. Where the Freedom of Information Act offers affected companies the possibility to share their opinion (in Dutch: zienswijze) in reaction to the administrative body’s intention to disclose the information in question, this possibility does not exist under the Decree on Disclosure. If and when an affected company does not agree with disclosure on the basis of the latter decree, this company has two weeks to object to the respective administrative body’s intention of disclosure and needs to seek interim relief measures within this time frame in order to actually suspend the disclosure. In addition, under the Decree on Disclosure companies are provided the option to write a short response that will be published together with the information subject to disclosure. In this way, affected companies are given the opportunity to provide the outside world with a substantive (but very summary) response to the information to be made public. The Policy Rule on Disclosure in fact also grants this right of response to information disclosed by the NVWA under the Freedom of Information Act.

Relevant for all FBOs?
The aforementioned additional legal basis for disclosure by the NVWA applies for the time being to a limited number of supervisory areas only, namely the inspection results of the NVWA with regard to (i) fish auctions, (ii) the catering industry, and (iii) project-based studies into the safety of goods other than food and beverages. These areas may be expanded in the future, according to the explanatory notes to the Decree on Disclosure.

However, for companies with so-called borderline products that navigate between different regulatory regimes, it is relevant to know that Dutch Health and Youth Care Inspectorate (IGJ) has broader powers to actively disclose inspection results under the Decree on Disclosure. Since 1 February 2019, the IGJ has already been publishing information on the basis of this decree regarding, amongst other, compliance with the Dutch Medicines Act (in Dutch: Geneesmiddelenwet). This means that when the IGJ takes enforcement measures against a FBO handling food supplements or other foodstuffs that qualify as (unregistered) medicines, it may be obliged to make public the respective supervisory information. The same applies to enforcement under the Dutch Medical Devices Act (in Dutch: Wet op de medische hulpmiddelen) – think diet preparations – and the Opium Act (in Dutch: Opiumwet) – think CBD and other cannabis products.

An example: melatonin-containing foodstuff labeled as a medicine
An example of a FBO that was faced with disclosure in accordance with the Decree on Disclosure by the IGJ concerns a company involved in melatonin-containing products. The IGJ intended to publish an inspection report on these products, from which it would follow that the products in question qualify as medicines and that the FBO concerned would therefore illegally place them on the market (namely without the required licenses under the Medicines Act). The FBO at stake applied for a preliminary injunction suspending the publication decree. On 8 July 2020, the preliminary relief judge rendered a judgment in this case.

Possible factual criteria to prevent naming & shaming
Although disclosure under the Decree on Disclosure is obligatory and disclosure decisions thus do not require the balancing of interests, the above-mentioned melatonin case gives good insights into the factual criteria that can nevertheless be invoked to prevent disclosure. In this case, the respective FBO brought forward the following arguments.

The respective inspection report excluded from disclosure

Article 3.1(a) of Part II of the Annex to the Decree on Disclosure excludes certain supervisory information from disclosure, including the results of inspections and investigations established as a result of a notification by a third party. The FBO at stake (hereinafter: “Applicant’) takes the position that the present inspection report was initiated as a result of a notification or enforcement request by a competitor. This would mean that the respective inspection report must not be made public.

The preliminary relief judge cannot agree with this position in the present case and rules that the inspection report is clearly related to an earlier letter from the IGJ to the applicant in which it announced the intensification of supervision of melatonin-containing products. Moreover, the case file was silent on a notification or enforcement request by a competitor.

The preliminary relief judge additionally states that it agrees with the IGJ’s viewpoint that the inspection report does not concern a penalty report (the report was drafted within the context of supervision and only indicates that Applicant will be informed about the to be imposed enforcement measure by separate notice). The fact that Applicant had earlier received a written warning for violation of the Medicines Act has no influence on this. The inspection report is therefore neither excluded from publication pursuant to article 3.1(a)(ii) of Part II of the Annex to the Decree on Disclosure, which makes an exception for “results of inspections and investigations that form the basis of decisions to impose an administrative fine”.

Disclosure in violation of the goal of the Health Law: outdated scientific foundation conclusions IGJ

The purpose of disclosure under the Health Act, in the wording of article 44(1) of that act, is to promote compliance with the regulations, to provide the public with insight into the way in which supervision and implementation of the Decree on Disclosure is carried out and into the results of those operations. Pursuant to Article 44a(9) of the Health Act, information should not be made public where this is or may violate aforementioned purpose of disclosure. Applicant takes the position that publication of the present inspection report does not contribute to improved protection of the public or to better information about the effects of melatonin, as a result of which the report should not be disclosed. More specifically, the applicant complains that the report (i) contains obvious errors and inaccuracies, (ii) gives the impression that it concerns a penalty decision, and (iii) is based on an incorrectly used framework to determine whether the qualification of a medicine is met.

The preliminary relief judge first of all notes that the fact that Applicant does not agree with the conclusions of the inspection report does not mean that the report therefore contains obvious inaccuracies. The preliminary relief judge further summarizes Applicant’s position as follows: (i) the IGJ wrongly took a daily dosage of 0.3 mg melatonin to determine the borderline between foodstuff and medicines; (ii) in doing so, the IGJ did not demonstrate that products with a daily dose of 0.3 mg melatonin actually acts as a medicine; (iii) moreover, the product reviews refer to outdated scientific publications (a more recent study by one of the authors thereof as well as more recent EFSA reports have not been included in the inspection report), whereas the current state of scientific knowledge must be taken into account according to established case-law. For these reasons, the preliminary relief judge agreed with Applicant that the IGJ has not made it sufficiently clear that from a daily dose of melatonin of 0.3 mg or more a ‘significant and beneficial effect on various physiological functions of the body’ occurs scientifically – according to the current state of scientific knowledge – and that products with a daily dose of melatonin of 0.3 mg or more act as a medicine”. Having said that, the preliminary relief judge did not accept Applicant’s statement that disclosure is contrary to the purpose of disclosure under the Health Act. Instead, the preliminary relief judge sought to comply with the so-called principles of sounds administration (in Dutch: algemene beginselen van behoorlijk bestuur) and ruled that the disclosure decision was not diligently prepared and insufficiently substantiated.

Incorrect facts

Applicant claims that the inspection report contains various inaccuracies, including the incorrect information that Applicant would produce melatonin itself. Applicant had already raised these inaccuracies in her response to the draft version of the report, but this had not resulted into adjustments in the final, to be published version of the report. The preliminary relief judge ruled on this matter that the IGJ should further investigate Applicant’s concerns and should amend the report where relevant. After all, the content of the report must be correct and diligently compiled. The mere fact that Applicant was given the opportunity to respond to the draft version of the report and that the IGJ responded to this in its decision to disclose the report does not mean that this requirement is met.

Violation of article 8 ECHR: disclosure has a major impact on Applicant’s image

Applicant claims that the planned disclosure will have a major impact on Applicant’s image and that of the natural person involved in the company. This is in violation of article 8 of the European Convention on Human Rights (ECHR) concerning the right to respect for private and family life. The Explanatory Memorandum to the Amendment to the Health and the Youth Care Act (in Dutch: Memorie van Toelichting op de Wijziging van de Gezondheidswet en de Wet op de Jeugdzorg) deals with this in detail. It emphasizes that the disclosure of inspection data does normally not constitute an interference with private life, because the data normally relates to legal persons and not to natural persons. The aforementioned Explanatory Memorandum therefore concludes that article 8 ECHR does not preclude disclosure on the grounds of the Health Act. Nevertheless, the court has at all times the competence to review a disclosure decision in the light of that article, in which case it will in fact have to balance the interests involved. In the present case, preliminary relief judge sees however no reason to assume a violation of article 8 ECHR.

Although the above shows that the preliminary relief judge in the respective melatonin case does not agree with all arguments put forward by Applicant, the request for suspension of publication of the contested inspection report was nevertheless granted thanks to factual criteria that were sufficiently substantiated. In particular the (implicit) argument that the conclusions in the inspection report lack a sufficient factual basis affects the essence of the information to be disclosed.

Conclusion
Rapid action is required to prevent active disclosure of inspection results under the Decree on Disclosure as these will usually be published after two weeks. This is not only relevant for FBOs active in the supervisory areas of the NVWA as designated in the Decree on Disclosure, but also for FBOs that operate at the interface of legal regimes under the supervision of the IGJ. To suspend disclosure, interim relief proceedings will have to be instituted as the Decree on Disclosure no longer provides for the possibility of submitting an opinion prior to publication. Moreover, affected companies cannot invoke the argument of suffering a disproportionate disadvantage as a result of the publication. Publication on the basis of the Decree on Disclosure is namely not subject to an individual balancing of interests (apart from an assessment on the basis of article 8 ECHR, insofar relevant). Although the arguments that companies can bring forward to prevent publication are therefore more limited than in the case of disclosure under the Freedom of Information Act, this does not mean that companies cannot successfully object an intention of disclosure. The melatonin case mentioned above is an example of this: conclusions that are not based on most recent science may not be published without adequate justification. Also, facts that are alleged to be incorrect should be further investigated before disclosure.


Towards 100 % recyclable or re-usable plastic food packaging in 10 years

What would food be without packaging? And what does packaging mostly consist of? Of course: plastic! To date, only few other materials have proved as reliable for food packaging as plastic. At the same time, we know that plastic has many disadvantages for the environment. Read this blogpost to be informed on the most important initiatives of the food sector and on the legal tools of the European Commission in this field.

The visionary number of 2030
By 2030, all plastic packaging in the EU will be recyclable or re-usable. In other words, all plastic packaging will then be collected and transformed into new packaging materials, or can be used as such more once. This goal follows, amongst others, from the European Strategy for Plastics. It is a worthy endeavor, and for some it is not even ambiguous enough. The signatories of the Plastics Pact aim to achieve this result as early as 2025. Nestlé has also announced its ambition to make 100% of its packaging recyclable or re-usable by 2025. Since this year, Lipton bottles sold in the Netherlands are already made from 100% recycled plastic. The so-called European Single-use plastics Directive (Directive 2019/904) will soon be introduced to further promote recycling of plastics as one of the measures against disposable plastics. In the Netherlands, this Directive will be implemented by means of a General Administrative Order (in Dutch: Algemene Maatregel van Bestuur, or “AMvB”) before the Directive’s date of application on 3 July 2021. In this regard, an internet consultation will be launched this month to invite citizens, companies and institutions to make suggestions to improve the quality and feasibility of the current proposal.

Recycled materials and articles
The encouragement to use recycled materials and articles in the EU for environmental reasons was already expressed in recital 24 of the European framework legislation on food contact materials (Regulation 1935/2004). However, food safety and consumer protection should not be neglected. Therefore, food packaging materials, including recycled plastics, should not endanger human health and not adversely affect the composition of foods or their sensory properties in an unacceptable way. The above-mentioned framework legislation leaves room for detailed rules on specific materials, and priority has been given to rules on recycled plastics. Their use has been increasing for a long time. Indeed, today’s sustainability initiatives cannot be imagined without the recycling of plastic food packaging. Moreover, diverging national legislation on this topic as a consequence of no harmonization at EU level would be highly undesirable.

Specific legislation
Specific rules on recycled plastic materials and articles intended to come into contact with foods can be found in Regulation 282/2008. Such rules are important because plastic packaging waste can be contaminated by residues from previous use, but also by contaminants from misuse and from non-authorized substances. In order to ensure that possible contamination is removed and that recycled plastics therefore do not adversely affect human health and foodstuffs with which they come into contact, an appropriate sorting and recycling process is essential. It should be noted that Regulation 282/2008 refers to mechanical recycling, which does not involve any significant change in the chemical structure of the plastic material. This process is less suitable for composites and multilayered plastics, which means that not all plastics are eligible for recycling under Regulation 282/2008.

Authorization procedure plastic recycling processes in a nutshell
Before a recycling process can be applied to plastics to create food packaging, the process must be approved by the European Commission. Such authorizations are process specific. This means that authorizations cover a specific recycling process used in a specific company by applying specific technologies and process parameters. Authorization holders are of course free to license out the authorized recycling process to other companies. Applications for the approval of recycling processes shall be submitted to the competent authority at Member State level. The European Commission published a list of contact points for competent authorities. In the Netherlands, applications can be submitted to the Ministry of Health, Welfare and Sport (in Dutch: Ministerie van Volksgezondheid, Welzijn en Sport, or “VWS”) and the National Institute for Public Health and the Environment (in Dutch, Rijksinstituut voor Volksgezondheid en Milieu, or “RIVM”).

As part of the application, a technical dossier is to be provided. This dossier will subsequently be subject to a safety assessment by EFSA, followed by a scientific opinion. In fact, here we very much see the parallel with the safety evaluations EFSA performs regarding for instance Novel Foods and additives. Topics to be covered to evaluate the safety of a particular recycling process include input characterization, description of the recycling process, determination of the decontamination efficiency of the recycling process, output characterization, and intended application in contact with food. For example, the dossier must demonstrate that and how it is ensured that the input material does not contain any chemical substances that could survive the recycling process and migrate to our foods in irresponsible quantities. In order to evaluate potential migration, detailed information on the type of food(s) intended to come into contact with the final product shall be provided. This will also include information on time, temperature and contact surface. Another important aspect concerns single or repeated use of the final product. All of this data serves to exclude possible health hazards and unacceptable influences on foods due to migration of substances. Further details can be found in the guidelines published by EFSA.

After receipt of a valid dossier, EFSA has, in principle, six months to evaluate the dossier. Thereafter, it is up to the European Commission to take an authorization decision. In doing so, it will take into account EFSA’s scientific advice. The final authorization may be subject to conditions and/or restrictions, such as with regard to the plastic input, the recycling process and/or the field of application of the recycled plastic. Authorized recycling processes are listed in a Community register established by the European Commission.

100% Recyclable
Many companies like to inform consumers that the food packaging they use is made from recycled plastics. However, it is essential that consumers are not misled about, for example, the actual content of recycled plastics used. Companies are therefore advised to follow ISO 14021 on environmental labels and declarations, or equivalent rules. In addition, the Dutch Advertising Code Committee (in Dutch: Reclame Code Commissie, or “RCC”) also explains what is possible and what is not, such as regarding packaging made of recycled plastics being environmentally friendly or friendlier. Environmental claims, i.e. advertisements in which implicit or explicit reference is made to environmental aspects associated with the production, distribution, consumption or waste processing of goods or services, must be verifiable. For instance, communicating that an article is “good for nature” because of the material used is perceived as misleading when this statement cannot be checked. It is no problem to use environmental symbols, as long as there is no confusion about the symbol’s origin and meaning. Examples of this include the Mobius Loop accompanied by the percentage of recycled material used in or near the symbol, as well as Lipton’s variation thereof.

Conclusion
While food business operators shall normally not be involved in the recycling of packaging themselves, they are advised to closely follow developments in this regard. Packaging namely plays an essential role in protecting foodstuffs and in providing information about the food it contains. Food business operators will therefore benefit from being aware of sustainable packaging possibilities. Moreover, food business operators can strengthen their legal position by being familiar with the legal requirements of the parties they cooperate with as well as with their own responsibilities set out by law. An example of the latter concerns making verifiable and non-misleading environmental claims, which is not always as easily done as said.


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