Novel food is a challenging subject for lawyers nowadays. In case your product constitutes a novel food, authorisation should be obtained before the product can be marketed in the EU. One digital application with the European Commission will suffice. A novel food is a foodstuff or ingredient that has not yet been sold as a foodstuff or ingredient in the EU before May 15, 1997.
The Novel Food Regulation (EU) no. 2015/2283 has entered into force on January 1, 2018. It contains an authorization procedure for food additives, food enzymes, food flavourings and sources of food flavourings used or intended for use in or on foodstuffs and novel foods. A novel food may not be brought onto the European market without prior authorisation. In order to find out whether a certain foodstuff or ingredient falls under the notion of novel food, one can consult the EU Novel Food Catalogue online.
What is the novel food legislation at the moment?
Per 1 January 2018, the new Regulation (EU) 2015/2283 on novel foods (the new Regulation) is applicable. It replaces Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 which were in force until 31 December 2017. The new Regulation improves conditions so that food businesses can easily bring new and innovative foods to the EU market, while maintaining a high level of food safety for European consumers. Article 4 of the novel food Regulation (EU) 2015/2283 requires food companies to verify if the food or food supplements they intend to place on the EU market falls within the scope of the novel food Regulation (EU) 2015/2283.
Application procedure for novel food
An application for market authorisation for a novel food may be submitted electronically with the European Commission. The European Food Safety Authority (EFSA) has drafted a guideline for the preparation and presentation of the application. The novel food application must include information related to the foodstuff, such as the description, the production process, the specific composition, the history and source of the foodstuff, the proposed method of consumption, and toxicological information. Based on the information, EFSA will perform a risk analysis and will assess whether the foodstuff will be considered safe or not. The conditions for approval vary. For example, EFSA assesses whether the foodstuff poses a risk to public health. The necessary time of the application procedure and costs involved are not clear. However, the rationale behind the new legislation on novel food is that the procedure for getting a foodstuff onto the market will be more efficient, given that the application can be done centrally with the European Commission.
Other requirements apart from status of novel food
Products should (also) comply e.g. with the regulations combined in the Food Improvement Agents Package (FIAP). This contains the Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings, the Regulation (EC) No 1332/2008 on food enzymes, the Regulation (EC) No 1333/2008 on food additives and the Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods.
Novel food example: CBD of cannabis in products
Cannabinoids like CBD are a novel food. Cannabinoids are considered to be the active ingredients in cannabis or hemp, including the most well-known active ingredients THC and CBD. The catalogue provides the following description of cannabinoids: “The hemp plant (Cannabis sativa L.) contains a number of cannabinoids and the most common ones are as follows: delta-9- tetrahydrocannabinol (Δ9-THC), its precursor in hemp, delta-9-tetrahydrocannabinolic acid A (Δ9- THCA-A), delta-9-tetrahydrocannabinolic acid B (Δ9-THCA-B), delta-8-tetrahydrocannabinol (Δ8- THC), cannabidiol (CBD), its precursor in hemp cannabidiolic acid (CBDA), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and delta-9-tetrahydrocannabivarin (Δ9-THCV). Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.”
Regarding Cannabis sativa L. the Novel Food Catalogue mentions: “In the European Union, 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 tetrahydrocannabinol (THC) content does not exceed 0.2 % (w/w). Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a history of consumption in the EU and therefore, are not novel. Other specific national legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities.”
At the moment an application for CBD is pending with the EU-commission filed by the Czech company Cannabis Pharma. The European Food Safety Authority (EFSA) will give an opinion on the application. Also an application is filed for synthetic CBD. In accordance with the requirements laid down in the Novel Food regulation the European Commission makes a summary of the application, the name and description of a novel food and scientific evidence demonstrating that the novel food does not pose a safety risk to human health. More on CBD products you can read here.
Using an extract of hemp species in food
Certain hemp plant varieties included in the catalogue ‘Common Catalogue of Varieties of Agricultural Plant Species’ have a THC percentage below 0,2%, and are therefore permitted in agriculture. In the Netherlands the allowed maximum percentage of THC in consumer products that does not trigger law enforcement, is 0,05%. Foodstuff that originates from these specific plant species are not considered as novel food. Therefore it is necessary that the hemp extract originates from a permitted plant species. The catalogue can be consulted via this link. One should select ‘A – 85 – Hemp – Cannabis sativa – under ‘species’. All registered plant species can then be consulted. It is also possible to consult which species of varieties permitted per country.
National laws on novel food
National laws in the EU may still prohibit product with certain ingredients, even though they are not considered as novel food. EU countries may have rules on penalties applicable to infringements of the provision of the Novel Food Regulation. Food producers should therefore asses national laws in the EU on food requirements. In the Netherlands the Dutch Authority NVWA investigates substances in food supplements and herb products. The Dutch NVWA authority also has investigative powers. It may request digital or physical information, documents etc. CBD for example is a substance from cannabis is not allowed or exempted in the Netherlands and no active enforcement takes place at the moment while a lot of CBD products already are available in the Netherlands.
Netherlands food supplement regulation
Producers should comply with the the Dutch Act on Food Supplements (Warenwetbesluit voedingssupplementen). The Dutch food supplement act refers to the various EU-directives on food such as Directive 2002/46/EG that is implemented in the act. The act allows food supplements on the market without prior authorization from the Dutch Authority if the supplements contain the allowed ingredients stipulated in Directive 2002/46/EG. For food supplements that are allowed in another EU Member state one can request for an exemption in the Netherlands. A health claim for a food supplement is allowed if it’s not misleading for the consumer and in compliance with Directive 1924/2006.
Dutch Food Authority on novel food
The Dutch food authority acknowledges on it’s website the prohibition to market novel food without EC permission. In case of non-compliance with the requirements on novel foods and the Nvwa policy rules ‘Specific food composition intervention policy’ that the marketing of a non-authorized novel food constitutes as a Class B violation. If it is unclear if is a substance is a novel food then the Nvwa makes it own assessment if it concerns a novel food. The protection of public health and the importance of uniform safety checks play an important role in this regard. This violation is subject to an administrative fine, the amount of which depends on the specific circumstances of the matter.
Law enforcement of Novel food rules in the Netherlands
In the Netherlands the Dutch Food and Consumer Product Safety Authority (NVWA) is the supervisory authority with regard to the compliance to Dutch food law and regulation, with the aim of safeguarding the human health. The NVWA has various enforcement instruments to its disposal. You may wish to seek legal advice in case the Dutch Authority takes actions towards your company. Depending on the seriousness of the violation, it can take corrective and sanctioning measures, including fines, penalties and seizure of products.
The NVWA has made a distinction between certain violations and infringements of Dutch food legislation. Class A and B violations are categorized as the most serious violations,amongst others violations that have major consequences for human safety and/or health, that cause a risk of social unrest, and that have an effect on the system or authority of the NVWA. The offenders of Class A and B violations in the Netherlands are among other opportunistic, calculating and/or deliberately risk-taking offenders. The violations of Class C are less serious than the violations of Class A and B, and include actions that are so undesirable that recurrence must be avoided. Class D violations are of a minor violations but are risky in the event of continuation or recurrence.
Administrative measures by Dutch Authority on novel food
Administrative (not criminal) law enforcement by the Dutch Authority (Nvwa) may be a warning, but can also include a administrative seizure, the imposition of a product recall, the application of a mark of rejection, the shutdown of production and the obligation to withdraw from the market. The sanctioning powers of the Dutch Authority include the imposition of administrative fines or an administrative penalty. These measures may be challenged in administrative court procedings in the Netherlands.The NVWA can also file an official report with the Public Prosecution service in case of a criminal offense, which can be followed by criminal proceedings.