Placing Novel Foods on the market?

Cocoa juice, argan oil, chia seeds and noni juice: these are all well-known examples of novel foods that were not on the market for human consumption (at least not to a relevant extent) within the European Union before 15 May 1997. The Netherlands Food and Consumer Product Safety Authority (NVWA) has published the Novel Foods Handbook as a guideline for businesses in order to comply with the legal obligations concerning the marketing of a novel food (hereinafter: the 'Handbook'). The Handbook covers the definition of a novel food, the European and Dutch regulations on novel foods, the authorisation procedure for novel foods and the intervention policy of the NVWA. Ferah Taptik Salman briefly discusses the contents of the Handbook as well as the (legal) obligations applicable to businesses.

Regulatory framework

The two most important European regulations for novel foods are Regulation (EU) 2015/2283 containing the basic rules for placing novel foods on the market in the EU and Implementing Regulation (EU) 2017/2470 containing the Union list of authorised novel foods. In addition, there are various European documents[1] that a company can use to determine whether or not its product is a novel food. In the Netherlands, the European rules have been implemented via the Novel Food and Genetically Modified Foods (Commodities Act) Decree. This Decree regulates two topics: (1) prohibition: it is prohibited to market a novel food in the Netherlands if it is not on the Union list or if it does not comply with the conditions and specification set out in that list (Art. 2); and (2) designation of competent authority: operators may consult the Minister of Health, Welfare and Sport to ask whether a food does or does not fall under Regulation (EU) 2015/2283 after they have studied all available information. The Minister shall take a decision on this (art. 3).

What falls within the definition of novel foods?

Novel foods are foods, ingredients or foods with an ingredient which were not used for human consumption within the European Union before 15 May 1997. Article 3 (2) of Regulation (EU) No. 2015/2283 contains an extensive definition of "novel food" with 10 categories of food that may fall under it. Article 2(2) states that Regulation (EU) 2015/2283 does not apply to the following products, which means that these products do not fall under the novel foods regulation: genetically modified foods (except if a genetically modified ingredient is used at the start of the production process which does not end up in the final ingredient or product), food enzymes, food flavourings and extraction solvents.

According to the NVWA, a company that wants to sell a novel food, a novel ingredient or a food with a novel ingredient within the EU has the responsibility to find out for itself whether the product in question qualifies as a novel food and therefore falls under the regulations for novel foods. In practice, at least the following companies have to deal with this: 

• an importer of non-standard ingredients, food supplements or herbal preparations from third countries (e.g. a moss that grows high in the Andes and not in Europe or a plant that only grows in Asia);
• a company selling non-standard ingredients or products for supplements;
• a company wanting to sell an ingredient that is already consumed in food supplements, but not yet in food. This is a broadening of the application which potentially increases exposure;
• a company that chemically processes an existing ingredient in such a way (e.g. extraction) that the product is significantly modified and is no longer comparable to the original foodstuff;
• a company that processes a product in such a way (e.g. concentration) that the new product has no history of use and requires a safety evaluation (e.g. because the product contains more contaminants);
• A company that wants to develop an innovative ingredient or foodstuff itself.

Step-by-step plan: is my product a novel food?

The NVWA has included in the Handbook a step-by-step plan for the above-mentioned companies to check whether their product falls under the regulations for novel foods:

1. Is your product exempt from the European Novel Food Regulation in Article 2 of Regulation (EU) 2015/2283, for example because it is an additive or a flavouring? 
   • Yes, then your product does not fall under the European Novel Food Regulation and your product must comply with the product-specific regulation.
   • No, then your product may be a novel food. Go to step 2. 2.
2. Is your product included in the Union list of authorised novel foods (Regulation (EU) 2017/2470)?
   • Yes, then your product is an (authorised) novel food. You may only market the product if you comply with the conditions and specification for the product included in the Union list.
   • No, then your product may still be an (unauthorised) novel food. You need to investigate this further. Go to step 3. 3.
3. Has your product been used for human consumption to a significant degree within the EU before 15 May 1997?
   • Yes, then your product is not a novel food. On request you must be able to demonstrate this to the NVWA.
   • No, then your product may still be an (unauthorised) novel food. You need to investigate this further. Go to step 4. 4.
4. Is your product included in the European Novel Food Catalogue?
   • Yes, your product is listed in the Catalogue; then you can see whether your product is considered a novel food or not.
     • a. Is your product a novel food according to the Catalogue? Then it is only authorised in the EU after the authorisation procedure has been completed with a positive result (see chapter 6 of this Handbook);
     • b. Is your product not a novel food according to the Catalogue? Then the regulations for novel foods do not apply, but you must comply with the European and national regulations for foodstuffs.
   • No, your product is not listed in the Catalogue, then your product may still be a (non-authorised) novel food. If, after studying all the information, you still have doubts about the status of your product, you can prepare a technical file for consultation with a Member State where you intend to place the product on the market for the first time. On the basis of the file, the Member State will assess whether the product is a novel food or not. Go to step 5. 5.
5. Is the outcome of the consultation that your product is a novel food?

In addition, the NVWA points to the use of four documents to determine whether or not a product is a novel food, accompanied with explanatory notes: (1) Union list of authorised novel foods; (2) European Information and Guidance document on human consumption to a significant decision; (3) European Novel Food Catalogue and (4) Website with results of consultation requests.

The company could also consider submitting a formal request for consultation, including an accompanying technical file, to the Member State where it intends to market the new product for the first time. In the Netherlands, the Minister of Health, Welfare and Sport is formally responsible for the consultation process. In practice, a request for consultation in the Netherlands must be sent by e-mail to the Novel Foods Agency (BNV, novelfoods@cbg-meb.nl). This Bureau falls under the Medicines Evaluation Board (CBG), which advises the Minister of Health, Welfare and Sport. Please note: the request for consultation is only intended to determine whether the product in question is a novel food; the next step is to authorise the novel food in question on the market.

Step-by-step plan: (European) authorisation procedure for novel foods

If a product is a novel food and it is not on the Union list of authorised novel foods, it can only be marketed in the EU after the European authorisation procedure has been completed with a positive result. The NVWA has included in the Handbook a step-by-step plan for the authorisation procedure for the above-mentioned companies, with explanatory notes. Below is a short overview.

1. Prepare an application file that complies with the requirements set out in Implementing Regulation (EU) 2017/2469 with administrative and scientific requirements for applications for authorisation. Also use the 2016 EFSA Guidance and the 2018 EFSA Guidance.
2. Submit the application to the European Commission via its website (via the so-called e-Service system) using the User's Guide provided.
3. The Commission shall share the application directly with Member States.
4. The Commission shall prepare a summary of the application and publish it on its website.
5. The Commission shall assess whether the application is valid and contains all the mandatory information.
6. The Commission shall send the application to EFSA with a request for a safety assessment within one month from the verification of its validity.
7. Within 30 working days, EFSA shall inform the Commission whether the application fulfils all legal requirements.
8. EFSA shall draft its safety assessment within 9 months from the receipt of the application. This period may be extended if EFSA requests additional information from the applicant.
9. EFSA shall send its opinion on the safety assessment to the Commission, the Member States and the applicant.
10. Within 7 months of the EFSA opinion, the Commission must submit a draft implementing act to the (European) Standing Committee on Plants, Animals, Food and Feed for the authorisation or rejection of the novel food.

For traditional foods from third countries that have a history of safe food use and that are new to the EU, there is a notification procedure. Then this product may be marketed in the EU if it can be demonstrated that the product concerned has been consumed safely for more than 25 years in at least one country outside the EU and if there are no safety concerns from the European Member States or EFSA. If there are safety concerns, an authorisation procedure, including a safety assessment by EFSA, still has to be carried out.

Enforcement by the NVWA       

Novel foods may thus only be sold in the Netherlands if they have been authorised in the EU and comply with the European basic requirements for placing novel foods on the market in Regulation (EU) 2015/2283 and the EU regulations based on it. They must be included in the so-called Union list of novel foods in Regulation (EU) 2017/2470 and comply with the conditions and specifications in this Union list. The NVWA enforces the European regulations for novel foods in the Netherlands. In its Handbook, the NVWA states that the choice for enforcement is based on a risk assessment for the health of consumers, also taking into account the risk of deception.

For this purpose, NVWA uses the General Intervention Policy. This intervention policy describes the method or working method by which the NVWA determines the intervention to be applied, linked to the seriousness of the violations and to the risks associated with the process and/or the product with which the company or person concerned is involved. NVWA believes that when assessing a violation and determining the appropriate intervention, the following should be taken into account: the possible consequences of the violation, the circumstances under which the violation was committed, the behavior of the violator, the history and the principles of subsidiarity and proportionality. The intervention policy for novel foods is contained in the Specific Intervention Policy on Food Composition. This policy describes within the framework of the general intervention policy the classification and interventions for the assessment of specific infringements of the legislation.

The basic principle for the enforcement of the Commodities Act and the regulations based on it is that violations are dealt with under administrative law. This means that these violations are usually enforced by means of an administrative fine and not through criminal law. There are some exceptions. A violation of the Commodities Act cannot be dealt with by an administrative fine: (i) if a higher fine can be imposed for that violation under the Economic Offences Act than the amount of the envisaged administrative fine; (ii) if the deliberate or reckless violation results in an immediate danger to human health or safety; or (iii) if the administrative fine envisaged for the violation is substantially exceeded by the economic benefit gained from the violation (Article 32a, third paragraph, Commodities Act).

Applied to novel foods, the NVWA states in its Handbook that if an authorised novel food does not comply with the conditions or specification included in the Union list, a written warning will be issued and the company will have to correct the violation. If novel foods are traded that are not included in the Union list, an administrative fine will, in principle, be imposed. A novel food that is not on the Union list is considered by the NVWA, on the basis of Regulation (EU) 2015/2283, to be potentially harmful because it has not undergone a risk assessment. In such a case the operator has to stop the marketing of such a product. If there are indications that a novel food is an immediate danger or harmful to human health, the (food business) operator must withdraw this product from the market and warn the public.

It should be noted that the NVWA explicitly emphasizes that a (food business) operator cannot approach the NVWA with individual questions about rules and obligations relating to novel foods. The NVWA does not judge whether a product qualifies as a novel food or not. A company must substantiate this itself and contact a specialist in food legislation for questions about the regulations for novel foods.

Impact for (food) businesses

Pursuant to the NVWA Handbook, the placing on the market of novel foods entails various obligations for companies. These include qualifying the product in question as a novel food, complying with various laws and regulations at European and national level, and having to go through a European authorisation procedure. If a company does not comply with the aforementioned legislation and regulations, this may have considerable (financial) consequences for the company. For the above reasons, it is therefore advisable to seek (legal) advice in good time, if necessary, before placing the product in question on the market within the EU.

About Ploum's International Trade, Customs and Food Safety & Product Compliance team

The specialists of our International Trade, Customs and Food Safety & Product Compliance team will be happy to advise you on the laws and regulations as well as the legal steps required when importing, selling or developing novel foods. Thanks to our many years of experience in the food (safety) and commodities practice, we can serve you quickly and effectively. If you have any questions on this topic or on other issues regarding International Trade, Customs or Food Safety law, please contact one of our team members or contact Marijn van Tuijl directly (m.vantuijl@ploum.nl).