Should hemp extracts and CBD Oil derived from hemp be considered novel food?
This article is based on the recent presentation given by the EIHA – published with kind permission from Lorenza Romanese (EIHA Managing Director)
You can read & download the full presentation here:
http://eiha.org/media/2019/03/19-03-12_PAFF_WG_EIHA_Final_small.pdf
Defining ‘novel food’
The EU defines novel food as food that was not consumed to a considerable degree by citizens of the EU prior to 1997, when the first regulation on novel food came into force. Novel food can be newly developed, innovative food, food produced using new technologies and production processes, and food traditionally eaten outside the EU. The regulation requires such foods be safe and be properly labeled so as not to mislead consumers, among other requirements. The upshot for food producers is a more burdensome marketplace as novel foods undergo stringent and costly authorization requirements.
Hemp flower products such as hempseed and hempseed oil (extract) are authorized novel foods under EU rules, exempt from registration due to demonstrated consumption in Member States prior to May 1997.
But the recent language changes to the Novel Food Catalogue state that “extracts of Cannabis sativa L. and derived products containing cannabinoids, including Cannabidiol (CBD), are considered novel foods as a history of consumption has not been demonstrated.”
EIHA’s evidence
During the March 12 session, however, EIHA rebutted that argument, for starters citing a Nova Institute survey (1997) ordered by the EU Commission in which 23 companies from across Europe reported a total of more than 255 tons of hemp-based foods as having been produced before 1997. Those products obviously contained CBD, the EIHA contends.
12 March 2019, WG PAFF Committee
Lorenza Romanese EIHA Managing Director
Daniel Kruse, Board Member Tony Reeves, Advisory Committee
What are hemp extracts? (focus on Cannabidiol)
Definition of hemp extracts: from latin “extrahere” = draw out, remove) means any method that uses a (solid, liquid or gaseous) extraction agent to remove one or several components from a substance mixture (of solid, liquid or gaseous substances)
Coffee > Coffee extract / tea > tea extract
Cannabidiol (CBD) is the most abundant cannabinoid naturally present in the industrial hemp plant and their extracts. It is non psychotropic, non-intoxicating, not addictive & very well tolerated by humans even in large doses
Hemp extracts are used in food/supplements for their health maintaining properties
How hemp extracts are made from hemp plant?
- Cold pressing: the most simple extract from hemp fruiting tops is hempseed oil
- Ethanol extraction: using alcohol to whole fruiting tops (infructescense) and leaves
- CO2 extraction: using Carbon Dioxide to whole fruiting tops (infructescences) and leaves
- Fat extraction: can easily be used for home-made preparations
The extract can be left raw or decarboxylated and added to consumer products without further processing.
Extracts are usually winterized in order to remove plant waxes
Extract can be further distilled/rectified in order to remove unwanted elements such as chlorophyll
Novel Food Catalogue last change:
On the 20th of January, 2019 MSs and COM agreed on a new wording for the Novel Food catalogue
In item Cannabis sativa L:
hemp seeds and their derivatives are not assessed as Novel Food
leaves and infructescence are left in a grey zone
Moreover, a new item “Cannabinoids” was introduced into Novel Food catalogue.
Hemp extracts are considered Novel Food
Conclusion: major confusion regarding interpretations and negative impact on the hemp sector (regarding investments, level playing field)
EIHA already demonstrated in October 2018
Food Business Operators in EU have been acting in GOOD FAITH based on guidance represented by the information provided in Novel Food Catalogue àinvestments.
Use of hemp leaves and infructescence have NOT BEEN discriminated in listing for item Cannabis sativa
Catalogue item Cannabidiol has provided a clear guidance: products with “natural“ levels of CBD have been considered “traditional“
Only traditional propagating practices are used for processing hemp infructescense
Such practices include pressing or solvent extraction
Presence of cannabinoids in human diet is also well documented across middle ages to the modern age. We will demonstrate it on 14 examples.
Traditional cannabinoid-rich products
Evidence #1: ITALY
Inscriptions on the Tower of the Escape, Bologna
Constructed from 1220, the vault of the Canton de ‘Fiori carries the following Latin inscription:
“Panis Vita / Canabis Protectio / Vinum Laetitia”
“Bread is Life / Cannabis is Protection* / Wine is Joy”
*Protection = homeostasis
Evidence #2: ITALY
Use of aerial parts of the hemp plant within European perspective is CLEARLY demonstrated by two citations from [one of the oldest] cookbooks De Honesta Voluptate Et Valetudine, published in 1475 AD by Bartolommeo de Sacchi Platina
On Canabis.
To make cannabis yourself known as flax for thread. Use a mallet to crush clods collect after good harvest Taken as food in wine or cake. Add cannabis to nard oil an iron pot. Crush together over some heat until juice.
A health drink of cannabis nectar. Carefully treat food and divide for the stomach and the head. Finally remember everything in excess may be harmful or criminal.
Evidence #3: VATICAN
59 – On Ministrum de canapo
Boil flowers and leaves (canapo) in water.Once ready press them to mixture with bread crumbs and cooked onion. Slowly add the water in which canapo was boiled to the mixture and add saffron and spices.
Evidence #4: ITALY
Carlo Erba focused his studies between 1945 and 1958 on hemp extracts.
Doctor Erba quoted two methods of “cannabina” extracts commonly used at that time:
- British chemist, Smith
- French chemist, Decourtive
Erba after having analyzed these two methods, proposed the ether extraction as with ether there is no need for heating, no need to use metals and acids elements that could alter the hemp properties.
Moreover in his book, Doctor Erba mentioned the studies of Doctor Valerzi (from university of Naples) that studied hemp extracts with fat and honey (1887).
It is written that in July 1887, Valerzi went to Veneto region in Italy and harvested Sativa hemp. From the harvest Valerzi extracted distilled water, essential oil, tinctures alcohol, syrup, liquors, decortications and instilled.
Evidence #5: ITALY
Tortelli with hemp flowers
Take the hemp flowers without leaves and cook them with bacon. When the bacon is almost cooked add the flowers, finish cooking, chop everything, add grated cheese, as much as the mixture and with this filling, make the tortelli. (recipe dated 1884). Source: Frammento di un libro di cucina del Sec. XIV : edito nel di delle nozze Carducci-Gnaccarini”
Evidence #6: GERMANY
Germany – Monk Recipe for Hemp Soup
Regional Cuisines of Medieval Europe: A Book of Essays edited by Melitta Weiss Adamson
Six pounds = 2.7 kgs hemp. / 40 monks = 67g per person
RDI is 30g hemp seeds for western modern diet
Monks lived subsistence life. This indicates that 67g/pp included the green parts
Evidence #7.1: SWEDEN
The add specifically states: Hampfröextract: Extrakt-Cannabis och Maltos Cannabis
This ad confirms that hemp extract was used in the preparation of Maltos Cannabis nourishing food remedy.
In Sweden until the 1930s, the Red Cross sold the patent medicine Maltos-Cannabis, as a strengthening breakfast drink. Above mentioned advertisement in Aftonbladet 1894.
Evidence #7.2: SWEDEN
World Exhibition in Antwerp 1894 – official catalogue
Exhibition was held from 5 May to 5 November 1894 attracting 3 million visitors.
In category XIV –
Alimentaires , point 39:
Tekniska fabriken Roeda korset, Stockholm
Maltos Cannabis
Evidence #8: POLAND
During the famine suffered by both the inhabitants of Polish Siberian villages, as well as users of the north-eastern Polish borderland, ate different grasses. From these “edible” grasses, the inhabitants of the Widzew exchange osyt, and lituanizm v’iksva ‘sedge’, pokšyva ‘nettle’, hemp ‘hemp’, šn’itka
Evidence #9: POLAND
Kouopiew Rachunkach wymieniane bywają częstokroć, jako siemię konopne {semen canapi), w dni postne. Wiemy już że wybijano z nich olej, do kraszenia potraw służący w poscie alebardzo bye może iż siemienia owego używano juz wtedy do przyrządzania polewek, jadanych i dziś tu i owdzie u nas, szczególnie na wieczęrzę w wigilję Bożego Na Narodzenia, ale tego nie mówią nam “Rachunki” Konopie uprawiano w dobrach królewskich, atoli kupowano też siemię na targu.
Kouopiew “Accounts” are often mentioned as hemp (semen canapi), on fast days. We already know that oil was thrown out of them, but it can be used to prepare the soups, eaten here and now here and there with us, especially for the evening on Christmas Eve, but they do not tell us “Bills” of Hemp were grown in royal estates, but at the market were also bought.
Chmiel A.2015. Kuchnia I Rzeczpospolitej. ZNUV, 45(7):11. Translation:
However, the greatest admiration must be aroused by the number and variety of used vegetables and garden plants (Vegetables). Among them the most popular were: red beets, onions, horseradish, garlic, grysz, later unused, kucmorek (kucmorka) eaten in a great post, peas, cabbage, hemp, cumin, dill, poppy, carrot, cucumbers, parsley, turnip, radish, cress, lentils. The above set indicates that Polish medieval cuisine was exceptionally well stocked with vegetables and vegetables, and their use was quite common (Peszke 1904, No. 9, pp. 133-134).
Evidence #10: POLAND
https://alchetron.com/Siemieniotka 6.03.2019
Siemieniotka is a Silesian soup made of hemp seed, often eaten at the traditional Christmas Eve meal
Stryber R. 2007. Polish Holiday Cookery. Hipocrene Books. INC, Nowy Jork: 44.
Evidence #11: GERMANY
The Nova Institute was commissioned by the Hanfgesellschaft to undertake a survey on the request of EU Commission to obtain data on volume of hemp products sold prior to May 1997.
Out of 40 companies contacted, 23 companies from Europe, including Germany, Austria, the Netherlands and the UK responded:
Hempseeds – ca 200 tonnes
Hempseed oil – ca 33,000 litres
Hemp ready made products (snacks, flour, muesli, bread, bakery & pasta) – ca 55 tonnes
Drinks with hemp flowers/leaves – ca 115,000 litres
Snacks with hemp flowers – ca 2 tonnes
The letter also states “unfortunately several large hemp companies did not participate in the survey because they did not want to share their data, especially from the drinks sector.”
Evidence #12: GERMANY
The letter of European Commission, dated 03.02.1998, to Mr Kreutner (Öko-Handels GmbH, Austria) stated “that hemp flowers used for the production of beer-like beverages are considered to be food ingredients and not additives since they are used in the same manner as hop flowers.“
Important, paragraph 2:
“Secondly it was decided that foods containing parts of the hemp plant do not fall under the scope of the Regulation (EC) 258/97.”
NOTA BENE: Hemp flowers (EU) are not Cannabis in the meaning of the UN SC, otherwise contradiction to definition of food in Reg. (EC) 178/2002, Art. 2 (g).
Evidence #13: GERMANY
Letter of the European Commission to Mr Dupetit, dated 03.03.1998, saying the Standing Committee on Food agreed on 18.12.1997 that foods which contain parts of the hemp plant do not fall under Regulation (EC) No. 258/97 …… on Novel Food and Novel Food Ingredients.”
Evidence #14: SLOVAKIA
Official use of hemp leaves for making teas can also be demonstrated on a case of Slovak Republic:
SLOVAKIA – DECREE 09/2015 Z.z. of Ministry of Agriculture and Rural Development of Slovak Republic, of December 4, 2015, on spices, table salt, dehydrated food, soup preparations and on aromas contains item konopa siata – Cannabis sativa L. – leaf, seed in Annex III, Table 1:
LIST OF PLANTS AND THEIR PARTS SUITABLE FOR PRODUCTION OF TEAS without recommending any restrictions on the amount [of herb] used.
EIHA position on hemp extracts
- Leaves and flowers of industrial hemp plants are non NF -->regulated like food and food supplements (rules and labelling)
- Extracts, with traditional extraction technologies, from hemp plants legally growing in EU are not NF
- Naturally occurred cannabinoids in the whole plant extracts are not NF
- For consumer safety EIHA proposes a maximum daily intake of 160 mg (for an average adult) for food or\and food supplements
- Genetic modified plants and synthetic material are NF
Further reflections
- Hemp flower products such as hempseed and its extract – hempseed oil – are traditional food exempt from authorization as Novel foods due to demonstrated consumption in Member States prior to May 1997.
- Naturally incidental to the long history of consumption of the hempseed is a sticky resin, on the outside of the seed shell —> cannabinoids are found inside this resin
- Cannabinoids are found on seeds and other part of the plants (which are not NF) as residues and are therefore consumed without authorisation.
- In the process of pressing, the hempseed oil can get contaminated with other elements of infructescence of the plant that contain cannbinoids, resulting in cannabinoids presence in hempseed oil
- In the past, up until the beginning of the 20th century, when the mechanical threshers were introduced, any seeds – be it wheat grain or hemp seed – were obtained in the process of manual threshing with flails. The inevitable presence of such combination from which the oil was pressed results in inflated levels of cannabinoids in the hempseed oil.
- In the pre-industrial era hempseed oil obtained in this way was the primary source of plant oil in human diet, hence cannabinoids have been consumed in larger amounts than today and have a long history of consumption prior to 1997
- The parts making up the whole are inseparable from the whole; if the whole is exempt then so are the parts.
Further reflections
- It must also be considered that hemp and hops are the same plant family of Cannabaceae, which includes about 170 species grouped in about 11 genera, including Cannabis (hemp, marijuana), Humulus (hops) and Celtis (hackberries). (https://en.wikipedia.org/wiki/Cannabaceae)
One will surely not question that hops, its flowers, leaves and whole tops are used as food, ingredients and extracts.
- As long as the product
- has no added Cannabidiol isolate or synthetics, and is less than 2.000 ppm THC and recommended intake to fulfill the guidance values re THC, and
- is from an approved Hemp cultivar or non-Cannabis source…
…then it must be considered a traditional product, not Novel Food needing pre-marketing authorization
Implications if MSs enforce the NF Catalogue
- End of the internal market creating a vacuum which will be filled by the ‘grey market’ (54% of consumers are willing to buy CBDs it even if they are illegal)
- Loss of jobs in production, processing and sales
- Loss of market control represents significant potential consumer risk as they access
products which do not comply with any safety, labeling or compliance standards.
- Loss of competitiveness for EU enterprises (vs Canada, the US, China and Switzerland)à no equal level playing field for all actors
- Discrepancy on the labelling —> impossible for consumers to compare products
- All the environmental benefits of cultivating hemp (e.g. CO2 absorption) will be outside of Europe (not in line with CAP orientations)
Benefits for MS
- CBD helps maintain homeostasis; which in turn supports better health for all = improved productivity and reduced public health service costs
- Facilitating the growth of the CBD industry will create new jobs at a range of skill levels and deliver increasing tax revenues (VAT and income tax)
- Hemp extracts represent an additional income for farmers
- Enabling farmers to utilise the entire hemp plant including the leaves will encourage much more cultivation of this key crop with numerous additional benefits including carbon sequestration, enhanced biodiversity, land reclamation and phyto remediation.
- Safe and clear framework which will guarantee an even playing field for all actors in the hemp sector (SMEs vs big companies)
For further information: Lorenza Romanese EIHA Managing Director lorenza.romanese@eiha.org
Download the full presentation here:
http://eiha.org/media/2019/03/19-03-12_PAFF_WG_EIHA_Final_small.pdf
