The food market, and especially its dietary supplements segment, has been witnessing an increasing range of products with cannabidiol (CBD). CBD is a cannabinoid, a substance naturally made from hemp which may also be manufactured synthetically. Unlike the most famous hemp product, THC, cannabidiol is not a psychoactive substance and as such may potentially find its way into food. The present market for dietary supplements features numerous products based on CBD derived from fibre-type hemp, with CBD content reaching 5% or even 10%.

CBD used as food ingredient has even merited a dedicated communication from the Chief Sanitary Inspector (GIS) which was issued on 23 November 2018 in response to what GIS described as numerous questions on whether products based on CBD derived from fibre-type hemp may be marketed in Poland. The communication makes it clear that only fibre-type hemp (Cannabis Sativa L.) may be used in food production as it contains CBD but no THC (or only trace amounts of THC). The communication also offers important practical guidance as it requires those interested in marketing products based on fibre-type hemp to have valid results of product tests for THC content. This can have a serious impact on various food products, including mainly those whose intended placing on the market must be notified to GIS, such as dietary supplements.

Perhaps more importantly, though, according to the communication, the marketing of food products with CBD may be restricted by novel food regulations which require CBD to be authorised by the European Commission.

First of all, by law, dietary supplements are foods (foodstuffs).

The European Union has since 1997 used the term “novel foods” which may be defined (in simple terms, because the actual definition is very extended) as foods which did not exist in the EU market before 15 May 1997. With effect as of 1 January 2018, this matter is governed by Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods (“Novel Foods Regulation”). The Novel Foods Regulation requires in Article 6(2) that any novel food placed on the market must be first authorised by the European Commission (“Commission”) and added to the Union list established by the Commission Implementing Regulation 2017/2470.

How is CBD treated under the novel foods regulations? CBD is derived mainly from fibre-type hemp (Cannabis sativa L.). According to the Commission, certain foods obtained from this type of hemp have a history in the EU market going back to before 1997, therefore Cannabis sativa L., whether whole plants or their parts, should not generally be considered to be a novel food. At the same time, the Commission has held that extracts of Cannabis sativa L. in which CBD levels are higher than the CBD levels naturally existing in the source plant as well as derived products with cannabinoids meet the novel food definition.

According to the EU Novel Food Catalogue maintained by the Commission, cannabinoids as a class are currently treated as novel foods:

“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.”

This restriction fully applies to CBD, which is one of more than eighty different cannabinoids that have been identified in fibre-type hemp. But some products derived from the Cannabis sativa L. plant or plant parts such as seeds, seed oil, hemp seed flour, defatted hemp seed have a documented history of consumption in the EU before 15 May 1997. Accordingly, parts of Cannabis sativa L. plant or semi-finished products based on them are not subject to novel food restrictions provided they contain natural CBD levels. However, any other CBD, i.e. 1) CBD derived from fibre-type hemp with higher content than in the natural plant, 2) CBD derived from plants other than Cannabis sativa L., and 3) synthetic CBD, is treated as a novel food and as such requires authorisation (see above) to become part of any marketed food products.

Note that the Novel Food Catalogue offers only simplified and synthetic guidance on whether any foodstuff or ingredient requires Commission authorisation to be used for consumption. No novel foods may be marketed in the Union unless and until Commission approval is received and the Union list of novel foods is updated (unlike the Novel Food Catalogue, the list is in the form of a Regulation and as such a source of law).

 

Procedure for marketing authorisation of novel foods and updating the Union list

Under Article 7 of the Novel Foods Regulation (all Articles below are from the Novel Foods Regulation unless otherwise stated), a novel food will be authorised by the Commission and included in the Union list only if: (a) the food does not, on the basis of the scientific evidence available, pose a safety risk to human health; (b) the food’s intended use does not mislead the consumer, especially when the food is intended to replace another food and there is a significant change in the nutritional value; and (c) where the food is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

  1. The procedure commences on Commission’s initiative or on application made to the Commission (Article 10(1)).
  2. Where the Commission requests an opinion, it forwards the application to the European Food Safety Authority (“Authority”) not later than one month after having verified its validity (Article 11(1)).
  3. The Authority adopts its opinion generally within nine months from receipt of the application (Article 11(1)), but may extend this period.
  4. Within seven months from the date of publication of the Authority’s opinion, the Commission submits to the Standing Committee on Plants, Animals, Food and Feed (“Committee”) a draft implementing act authorising the placing of the novel food on the market within the Union and updating the Union list (Article 12(1)).
  5. If the Committee’s opinion issued on examination is approving, the Commission adopts the implementing act and thus issues its authorisation in accordance with the examination procedure (Article 12(1))
  6. If the Committee’s opinion is disapproving, the Commission does not adopt the draft implementing act (Article 5(3) of Regulation 182/2011).
  7. Once the implementing act becomes effective, the foodstuff with CBD may be marketed.

 

Commission’s power to extend time periods

In exceptional circumstances, the Commission may extend the time periods mentioned in points 2, 3 and 4 if this is reasonable in the circumstances (Article 22).

 

Authority’s power to extend time periods

In duly justified cases, where the Authority needs to request additional information from the applicant, the nine-month period for adopting an opinion may be extended by another nine months (Article 11(4)). The Commission may object to the extension within eight working days of being informed of the need for one.

An average time needed to complete the novel food authorisation procedure is about 18 months.

 

CBD marketing authorisation procedures

Cannabis Pharma of Teplice (Czech Republic) has filed for novel food authorisation for (-)-trans-cannabidiol (CBD) to be used in dietary supplements for adults, with daily consumption of up to 130 mg or 1.86 mg/kg body weight. The authorisation procedure continues and the applicant is currently waiting for an opinion of the Authority regarding the safety of extracts of Cannabis sativa L. and derived products containing cannabinoids. The Authority’s opinion was supposed to be issued in spring 2019.

 

Notification of novel foods placed on EU market

With respect to any novel food in the form of:

  • infant formulas or foodstuffs for particular nutritional uses which do not belong to the classes specified in Article 24(2)(1)-(3) of the Food Safety Act;
  • dietary supplements; or
  • foodstuffs to which are added vitamins, minerals or the substances mentioned in Parts B or C of Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods;

the first-time placing of such novel food in the market in the Republic of Poland requires a notification to Chief Sanitary Inspector (Article 29(1) of the Food Safety Act).

Failure to notify may attract a penalty. Under Article 100(1)(3) of the Food Safety Act, whoever places relevant foodstuff in the market for the first time without notifying GIS shall be punishable by a fine of between PLN 20.00 and PLN 5,000.00.

 

SUMMARY

In accordance with a communication issued by Chief Sanitary Inspector on 23 November 2018 in relation to cannabidiol (CBD), the novel foods regulations prohibit the marketing of foods which include Cannabis sativa L. extracts “containing CBD (or other cannabinoids) in amounts which exceed the levels existing naturally in the plant, or derived from other plants, or obtained synthetically”. Only an implementing act issued by the Commission to authorise the marketing of extracts of Cannabis sativa L. and derived products containing CBD will permit each business in the EU to legally market foods (including dietary supplements) with CBD contents.

 

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Check what we refer to:

  • Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC)
  • Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)
  • Communication of Chief Sanitary Inspector on cannabidiol (CBD), 23 November 2018, Warsaw
  • the Food and Nutrition Safety Act of 5 July 2018 (Journal of Laws of 2018, item 1541; “Food Safety Act”)
  • The Drug Addition (Combating) Act of 10 May 2018 (Journal of Laws of 2018, item 1030)
  • Siudem P., Wawer I., Paradowska K., Konopie i kannabinoidy. Farmacja współczesna 2015; 8: 1-8