Message 002
Communication from the Commission - TRIS/(2022) 02570
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2022/0514/LT
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
(MSG: 202202570.EN)
1. MSG 002 IND 2022 0514 LT EN 21-07-2022 LT NOTIF
2. LT
3A. Lietuvos standartizacijos departamentas
Algirdo g. 31, LT-03219 Vilnius
Tel. +370 (5) 270 9358
Elektroninis paštas: dir9834@lsd.lt
3B. Lietuvos Respublikos sveikatos apsaugos ministerija
Vilniaus g. 33, LT-01506 Vilnius
Tel. +370 5 266 1400
Elektroninis paštas: ministerija@sam.lt
Lietuvos Respublikos žemės ūkio ministerija
Gedimino pr. 19, LT-01103 Vilnius
Tel. +370 5 239 11 11
Elektroninis paštas: zum@zum.lt
4. 2022/0514/LT - C00A
5. Draft Order of the Minister of Health and the Minister of Agriculture of the Republic of Lithuania ‘On approving the list of maximum permitted levels of tetrahydrocannabinol in hemp grown for fibre products or categories intended for final consumption’ (hereinafter referred to as the ‘Draft Order’)
6. Food, feed materials, tobacco products including innovative tobacco products, electronic cigarettes and e-cigarette fillers (with and without nicotine), herbal products for smoking
7. -
8. The aim of the Draft Order is to establish, in accordance with Article 4(4) of the Republic of Lithuania Law on Hemp Grown for Fibre, maximum safe levels of tetrahydrocannabinol (hereinafter referred to as ‘THC’) in hemp grown for fibre products or categories thereof intended for final consumption, which do not endanger human and animal health.
9. Article 4(4) of the Republic of Lithuania Law on Hemp Grown for Fibre provides that the THC content in hemp grown for fibre products must not exceed the maximum level of 0.2%. Lower permissible THC levels may be established in respect of specific hemp grown for fibre products or categories thereof intended for final consumption and included on a list jointly adopted by the Minister of Health and the Minister of Agriculture of the Republic of Lithuania (hereinafter referred to as the ‘List’). Maximum THC levels in hemp grown for fibre products intended for final consumption that are included on the List shall be established taking into account the risk posed and the potential harmful effects on human or animal heath, and not exceeding maximum THC levels recommended by the European Food Safety Authority.
1. The Draft Order proposes the regulation of maximum THC levels in foodstuffs (proposing the establishment of maximum THC levels in foodstuffs lower than those laid down in Article 4(4) of the Law on Hemp Grown for Fibre).
In 2020, the European Commission prepared a comprehensive opinion on the Draft Law on Hemp Grown for Fibre, where it indicated that in the view of the European Food Safety Authority’s THC toxicity and impact assessment, foodstuffs containing 0.2% of THC pose a public health risk and therefore cannot be placed on the EU market. The European Food Safety Authority has determined acute toxicity at 1 µg THC per 1 kg of human body weight.
Taking the opinion of the European Food Safety Authority into account, the European Commission has prepared a draft regulation proposing maximum levels of THC in hemp seeds, their flour and other hemp seed products and hemp seed oil. The proposed levels of THC in these products range between 3 and 7 mg/kg. The procedure for the examination and adoption of the draft Regulation in question is currently underway in accordance with the procedures laid down by the EU.
In light of the provisions of the Law on Hemp Grown for Fibre, the opinions of the European Commission and of the European Food Safety Authority, and in order to protect public health, an inter-institutional working group (hereinafter referred to as ‘the working group’) was set up by Order No. V-2506 of the Minister of Health of 8 November 2021 ‘On setting up of an inter-institutional working group to determine the maximum permitted tetrahydrocannabinol levels in foodstuffs produced from hemp grown for fibre products’, involving representatives of the Ministry of Health, the Ministry of Agriculture, the State Food and Veterinary Service, the National Food and Veterinary Risk Assessment Institute, the Drug, Tobacco and Alcohol Control Department and the Centre for Health Education and Disease Prevention.
Having examined regulatory practices in other EU countries and in line with the precautionary principle, as well as taking the potential risks to human health into account, in the Draft Order the working group decided to propose the levels of THC within the range of 0.02 to 7.5 mg for the following food categories: hemp grown for fibre seed oil; ground hemp seeds, hemp seeds partially defatted and other products produced or processed from hemp seeds; food supplements (excluding food supplements intended for use by infants, children under 18, pregnant and lactating women); non-alcoholic drinks; other foodstuffs (e.g., baked bread and cake, flour confectionery, breakfast cereals), except hemp grown for fibre tea (dried).
It is proposed that food intended for infants and young children and food supplements intended for use by infants, children under 18, pregnant and lactating women should not contain THC. In order to protect the health of the most vulnerable group, infants and young children, EU law requires the lowest maximum levels to be achieved through the strict selection of raw materials for the production of food for infants and young children.
Taking information from the Drug, Tobacco and Alcohol Control Department into account, that the use of THC in combination with ethyl alcohol can cause human health and life-threatening side effects, the working group proposes zero allowable THC levels in alcoholic beverages.
The provisions of the legislation of the Republic of Lithuania governing the maximum levels of THC in foodstuffs will have to be reviewed and aligned with the provisions of the Regulation on maximum THC levels in grown for fibre seeds and derived products, which are directly applicable in all EU member states, once the regulation is adopted.
2. The Draft Order proposes to regulate the maximum levels of THC in feed materials (proposing setting maximum levels of THC in feed materials lower than those laid down in Article 4(4) of the Law on Hemp Grown for Fibre).
Taking into account the evaluations of the European Food Safety Authority, the proposed maximum levels of THC in feed materials proposed in the Draft Order are safe and do not pose any risk to human and animal health. It should be noted that such maximum levels of THC in feed materials are discussed at the meetings of the European Commission taskforce on undesirable substances in animal feed.
The proposed maximum levels of THC in feed materials are calculated taking into account the fact that the THC acute reference dose (ArfD) is 1 µg/kg of body weight; milk intake in children (standard weight 12 kg) is 125 g/kg/day and 30 g/kg/day in adults (standard weight 70 kg). Account shall also be taken of the proportion of hemp grown for fibre feed in cow feed daily rations, the transfer of THC from feed to milk constituting 0.15% and the milk yield (30–40 l/day).
3. The Draft Order proposes a regulation of maximum THC levels in tobacco products (including innovative tobacco products) and products related to tobacco products (electronic cigarettes and their fillers, herbal products for smoking) (it is proposed to set maximum levels of THC in tobacco products and products related thereto, including herbal products for smoking, lower than those laid down in Article 4(4) of the Law on Hemp Grown for Fibre).
Article 7(6) of Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (hereinafter referred to as the ‘Directive 2014/40/EU’) provides that Member States shall prohibit the placing on the market of tobacco products containing the following additives: vitamins or other additives that create the impression that a tobacco product has a health benefit or presents reduced health risks; (b) caffeine or taurine or other additives and stimulant compounds that are associated with energy and vitality. Article 20(3)(c) of Directive 2014/40/EU provides that the nicotine-containing liquid must not contain additives listed in Article 7(6). According to the Drug, Tobacco and Alcohol Control Department, taking into account the provisions of Directive 2014/40/EU and the provisions of Article 41(3)(1) and (2) and 92(4)(1) and (2) of the Law of the Republic of Lithuania on Control of Tobacco, Tobacco Products and Related Products (hereinafter referred to as the ‘Law on Tobacco Control’) transposing them, and the fact that THC has a stimulating and psychoactive effect, the placing on the market of tobacco products, electronic cigarettes and their fillers containing THC would be in conflict with the abovementioned provisions of Directive 2014/40/EU and the Law on Tobacco Control. In order to protect public health, paying particular attention to the potential risks to the health of young people, it is proposed to introduce a similar regulation of THC levels for herbal products for smoking in line with the precautionary principle.
The Drug, Tobacco and Alcohol Control Department has assessed information on lung diseases and deaths caused by the use of e-cigarettes containing THC officially published by the Centres for Disease Control and Prevention of the United States (CDC), the US Food and Drug Administration (FDA), the Canadian Public Health Agency and the Belgian Federal Public Service for Health, Food Safety and the Environment. Based on the CDC data of February 2020, 2 807 residents of the United States were hospitalised as a result of the use of e-cigarettes with THC in liquid, and 69 people died of lung lesions caused by the use of e-cigarettes. The CDC points out that as many as 82% of the 2 022 hospitalised persons used THC-containing products, while 33% used exclusively THC-containing products. Having assessed the statistics collected on lung lesions and deaths caused by the use of e-cigarettes, the CDC, together with the FDA, recommends that e-cigarettes containing THC in liquid should not be used and stresses that the use of such e-cigarettes may lead to severe lung damage and other negative health consequences caused by long-term consumption.
According to the Canadian Public Health Agency, by 14 August 2020,
it received 20 reports of pulmonary diseases caused by the use of electronic cigarettes. 5 afflicted persons had been exclusively consuming THC containing products, 3 persons had been consuming products containing nicotine, THC and other substances. Although there were no recorded deaths from e-cigarettes containing THC in liquid, Canada’s Public Health Agency has urged residents to stop using such products.
According to data provided by the Belgian Federal Public Service for Health, Food Safety and the Environment, an 18-year-old resident in Brussels died in November 2019 due to complications of lung diseases caused by the use of e-cigarettes in which CBD was detected in liquid.
It is important to note that the Drug, Tobacco and Alcohol Control Department notes worrying trends in Lithuania related to growing interest in grown for fibre products containing the psychotropic substance THC. This interest has particularly increased with the adoption of the Law on Hemp Grown for Fibre, which allows hemp grown for fibre products with a THC content below the 0.2 % threshold to be placed on the market. According to the Drug, Tobacco and Alcohol Control Department, allowing the placing on the market of e-cigarettes containing THC in liquids of up to 0.2 percent could significantly increase the attractiveness and consumption of e-cigarettes containing THC, especially among young people and minors, as well as the possibility of similar negative effects on health to those faced by the public in the United States. According to the Drug, Tobacco and Alcohol Control Department, it is necessary to responsibly evaluate the information provided by the CDC on the adverse effects on human health caused by the use of e-cigarettes containing THC in liquid. At the same time, it is important to note that there is currently a lack of research-based information on the effects on human health of herbal products for smoking containing THC; thus, the precautionary principle must be respected in the absence of sufficient data on the risks and potential harmful effects on human health of herbal products containing THC for smoking.
Also, it is important to note that the World Health Organisation has issued a recommendation [1]to prohibit the addition of pharmacologically active substances such as cannabis and tetrahydrocannabinol (in jurisdictions where they are legal), other than nicotine in electronic nicotine delivery systems, to electronic nicotine delivery systems and electronic non-nicotine delivery systems. The same applies to tobacco products and tobacco-related products.
In light of the above provisions of Directive 2014/40/EU and the Law on Tobacco Control, and following an assessment of the WHO recommendation, information on lung diseases and deaths caused by the use of e-cigarettes containing THC officially published by the Centres for Disease Control and Prevention of the United States (CDC), the US Food and Drug Administration (FDA), the Canadian Public Health Agency and the Belgian Federal Public Service for Health, Food Safety and the Environment, it is proposed to set an absolute zero limit for THC in tobacco products (including innovative tobacco products), in nicotine-free or nicotine-free liquids in e-cigarettes and in herbal products for smoking, providing a reference to a footnote on the limit of quantitative and qualitative determination.
[1] https://www.who.int/publications/i/item/9789240022720 (p. 313)
10. References to the basic texts: The Draft Order is attached as an annex
11. No
12. -
13. No
14. No
15. Given the purpose of this draft legislation and its regulatory nature, no negative impact is expected.
16. TBT aspect
Yes
SPS aspect
No. The draft is neither a sanitary nor phytosanitary measure
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Europos Komisijos
Direktyvos (ES) 2015/1535 Kontaktinis taškas
Faksas: +32 229 98043
el. pašto adresas: grow-dir2015-1535-central@ec.europa.eu
