novel food

EU MOVES TO REGULATE HEMP DERIVED PRODUCTS by Joris Geelen

A proposed decree in Italy with maximum levels for tetrahydrocannabinol (THC) in food (2018/546/I) is the latest EU regulatory attempt to bring hemp and hemp derived products under a closer scrutiny, in the face of increasing demand for these products. 

In particular, the following maximum THC limits are laid down:  

  • Oil obtained from hemp seeds: 5.0 ppm;

  • Seeds of hemp, flour obtained from hemp seeds: 2.0 ppm;

  • Supplements containing foods derived from cannabis: 2.0 ppm.

Just a few months ago Italy authorized hemp oil and seeds with the publication of the new decree on botanicals.

 EU PERSPECTIVE

As it is the case with all plant extracts the regulation of hemp and hemp derived products follows a national approach in the EU[1], where a tenuous regulatory patchwork for hemp extracts and cannabidiol (CBD) exists:

  • Belgium: even though Cannabis sativa is on the list of prohibited plants, an exception is granted if analysis show that THC levels are below 10 ppm for hemp oil, 5 ppm for seeds and flour, and 0.2 ppm for other foods and drinks[2] Belgian authorities have published a document with questions and answers about the use of Cannabis in food supplements[3];

  • Romania: the seeds and oil are expressly authorized, and no limits are laid down;

  • Denmark: a maximum of 10 ppm of THC for oil, 5 ppm for seed and flour, 0.5 ppm for beer, tea, bread and other foodstuffs is laid down;[4]

  • Germany: the Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV, now BfR), sets as a guideline the following limits: 5 ppm for edible oils, 0.15 ppm for all other foods and 0.005 ppm for non-alcoholic and alcoholic beverages.

Role of the Novel Food Regulation

At EU level, the novel food catalogue expressly states that Regulation 2015/2283 on novel foods is not applicable to most food ingredients from Cannabis sativa. However, for CBD, the said catalogue states that extracts of Cannabis sativa in which CBD levels are higher than the levels in the source would be considered novel.

Thus, cold pressed oil and non-purified extracts obtained through traditional methods are not considered novel. However, further concentration or the use of new production methods (e.g. supercritical CO2 extraction) run the risk to trigger the application of the Novel Food Regulation when no history of consumption before 1997 can be established. In such cases, a novel food approval would be required[5].

 Use in cosmetics

Cannabis as defined by the Single Convention on Narcotic Drugs is considered to be a narcotic. This means cannabis extracts are prohibited in cosmetic products, except for extracts of the leaves and seeds if they are not accompanied by the flowering or fruit-bearing buds.

CBD is therefore permitted as an ingredient of cosmetic products, unless it is prepared by extraction from the flowering or fruiting tops.

Recent international developments

The legalization of ‘medical marijuana’ in the US, Canada and in some EU countries have sparked a renewed interest in its non-psychoactive cousin “hemp”, mainly because of the presence of CBD.

 The World Health Organization has officially recommended on December 14, 2017, that CBD should not be internationally scheduled as a controlled substance. Moreover, CBD is no longer mentioned on the list of prohibited substances in competition sports of the World Anti-Doping Agency (WADA).

Over the last few years the hemp food sector has grown considerably and has reached a volume of €40 million in Europe and a global volume of €200 million. In the US, the CBD market is expected to become a billion-dollar industry by 2020.

Vegetarians like hemp for its high protein content, with all essential amino acids, vitamins, minerals and fiber. Its oil has an ideal fatty acid profile. The seeds are also gluten-free and can be fed to animals. Concentrations of CBD in hemp range from 1.5 to 3% by weight and it contains only low amounts of THC. Among several other physiological effects, evidence shows that CBD can act as an immunomodulator, it can help to improve sleep and elevate mood.


[1]         Except for Ephedra species, the use of which is prohibited EU-wide (Cf. Annex III of Regulation 1925/2006).

[2]        These levels derive from the risk assessment by the Food Standards Australia New Zealand (FSANZ).

[3] Cfr. https://www.health.belgium.be/fr/FAQ_cannabis_en_tant_que_ou_dans_les_denrees_alimentaires

[4]        Cf. EFFL, 2018, ISSN (Print) 1862–2720· ISSN (Online) 2190–8214, available at:  https://effl.lexxion.eu/data/article/13003/pdf/effl_2018_04-011.pdf.

[5]        In 2016 a Czech firm submitted a dossier for a novel food authorization of a highly purified CBD extract to the Czech authorities, which was later sent to EFSA (EFSA-Q-2018-00512). It is still under consideration and it remains unclear when it could be approved.

Novel food approval for hen egg white lysozyme hydrolysate by Joris Geelen

The European commission has authorized the use of hen egg white lysozyme hydrolysate in food supplements on the EU market. 

Lysozyme is a polypeptide with 129 amino acids that occurs naturally in chicken eggs has a significant history of consumption within the EU and it is also authorized as an additive (E1105). 

According to the assessment report of Ireland the novel food ingredient is produced by the hydrolysis of commercially available hen egg white lysozyme with a food grade protease (subtilisin). The difference with lysozyme is that it comprises a distinct set of peptides of varying amino acid length (primarily of di- and tri-peptides), many of which are rich in tryptophan.  

Hen egg white lysozyme hydrolysate complying with the specifications may be placed on the market in the EU as a novel food ingredient to be used in food supplements at a maximum daily dose of 1000 mg per day. 

The designation of the novel food on the labelling of food supplements containing it shall be “Hen egg white lysozyme hydrolysate”.

Novel food approval for a Japanese fermented soybean extract by Sebastian MELCHOR

Japan Bio Science Laboratory has obtained a novel food authorization to place on the EU market a fermented soybean extract which contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-GMO soybeans with a selected strain of Bacillus subtilis var. natto.

Natto is traditionally consumed in Japan and is rich in manganese, iron, Vitamin K and other nutrients.

The new novel food ingredient can be used in food supplements in capsule, tablet or powder form intended for the adult population, excluding pregnant and lactating women.

The maximum daily dose is 100 mg fermented soybean extract

The designation of the authorized fermented soybean extract is fermented soybean extract’.

 

Commission Implementing Decision (EU) 2017/115 of 20 January 2017 authorising the placing on the market of fermented soybean extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 165), C/2017/0165 (OJ L 18, 24.1.2017, p. 50–52).