Cannabis sativa L. and Its Extracts: Regulation of Cannabidiol in the European Union and United Kingdom

Abstract

The lawful sale of Cannabis sativa L. and its extracts including Cannabidiol is not harmonized under European Union law. Such products have in the most part been classified as novel foods and thus illegal for sale in Europe without prior authorization. The regulation of such substances not only spans EU and Member State food laws but also international conventions on illicit drug and psychoactive substances. An understanding of the laws governing the sale of these compounds can help business and academia better understand the challenges consumers may face in selecting products lawfully placed on the market, whilst identifying the unique challenges imposed from the marketing of Cannabis-based foods.

Keywords:

• Cannabidiol
• Cannabis sativa
• European Union
• food law
• United Kingdom

Disclosure statement

No potential conflict of interest was reported by the authors. I provide consultancy work to companies that manufacture hemp and hemp extracts for the European food market.

Notes

1 Article 2(g) of Regulation (EC) No 178/2002 (GFL) of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, p. 1–24.

2 Misuse of Drugs Act 1971. SI 1971/c.38. 2.

3 Ibid.

4 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311, 28.11.2001, p. 67–128.

5 Human Medicines Regulation 2012. SI 2012/1916.

6 A guide to what is a medicinal product. MHRA Guidance Note 8. March 2016. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/759581/012__GN8_-_final_2018_combined_doc_Oct.pdf.

7 Judgment of Supperstone J, The Queen on the application of Blue Bio Pharmaceuticals Ltd & Anor v The Secretary of State for Health & Health Food Manufacturers' Association, [2014] EWHC 1679 (Admin).

8 HLH Warenvertriebs GmbH (para 30‎), [2005] ECR I-5141.

9 Court of Appeal in R. (on the application of Blue Bio Pharmaceuticals Ltd) v Secretary of State for Health, [2016] EWCA Civ 554. See para 69.

10 Commission v Germany (Re Garlic Preparations in Capsule Form) [2008] 1 CMLR 36 and Chemische Fabrik Kreussler & Co GmbH v Sunstar Deutschland GmbH [2012] ECR 1-000.

11 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. OJ L 327, 11.12.2015, p. 1–22.

12 The Novel Foods (England) Regulations 2018. SI 2018/154.

13 Article 3(2)(iv) of NFR.

14 Article 3(2)(a)(vii) of NFR.

15 https://ec.europa.eu/food/safety/novel_food/catalogue_en.

16 VG Düsseldorf, decision of 27.09.2019 - 16 L 2333/19. https://openjur.de/u/2184420.html.

17 Judgment of the Court (Second Chamber) of 15 January 2009. M-K Europa GmbH & Co. KG v Stadt Regensburg. Reference for a preliminary ruling: Bayerischer Verwaltungsgerichtshof—Germany. Reference for a preliminary ruling—Regulation (EC) No 258/97—Article 1(1) to (3)—Novel foods and novel food ingredients. Case C-383/07.

18 Section 2(2) of Psychoactive Substances Act 2016. SI 2016/c.2.

19 Commission Regulation No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. OJ L 364 20.12.2006, p. 5.

20 Food Safety Act 1990. SI 1990/c.16 (Section 7).

21 Case C-157/14, Neptune Distribution v. Minister for Economic Affairs and Finance, para. 82, Case C-192/01, Commission v. Denmark, para. 52.

22 Case C-111/16, Fidenato, para. 44 & 50.

23 Case C-127/02, Waddenzee, para. 51; Case T-229/04, Sweden v. Commission, para. 170.

Additional information

Notes on contributors

Mark J. Tallon

Dr. Tallon is the Managing Partner of the food law consultancy Legal Foods Ltd. He is regarded as an expert in European food law and has over 20 years of experience within the food industry. He holds higher degrees in European law, Food law and a holds a doctorate in nutritional biochemistry. He is a chartered scientist, biologist and registered nutritionist with over 200 published articles in trade and peer reviewed journals covering sports nutrition, functional foods and the impact of European food law regulations.

He is past chair of the Food Law group of the Institute of Food Science and Technology (IFST) and vice-chair of European Specialist Sports Nutrition Alliance (ESSNA). He holds fellowships with the Royal Society of Medicine, Royal Society of Biology, Institute of Food Science and Technology, and is editorial board member of the Journal of the International Society of Sports Nutrition.