EU: A recent meeting of tobacco policy experts at the European Commission focused on various issues related to tobacco products and the regulation of e-cigarettes. Among other things, member states discussed recent developments in vaporization-related diseases in the United States. One unspecified Member State – presumably Belgium – provided an update on a recent death on its territory that may have been related to the use of e-cigarettes (non-nicotine electronic e-fluids containing the CBD). In addition, several member states discussed the illegality of electronic liquids containing both nicotine and CBD, and broadly agreed that CBD “may give the impression that a product has health benefits”. They broadly agreed that the CBD “could give the impression that a product has health benefits”. They also stated that in their opinion there was a legal gap for CBD vaping products, as they are not covered by the EU Tobacco Products Directive (TPD).
EU: The number of food categories that could be used for exposure assessment of Δ9-THC (Δ9-tetrahydrocannabinol) has increased and member states should collect more data and submit them to the European Food Safety Authority (EFSA), the agency concluded in a new scientific report. In the report, EFSA presented the results of an evaluation of 588 samples of 13 different hemp and hemp-derived products. It found 12 different scenarios in which the consumption of a single food category – such as cereal bars, tea or beer – could lead to the so-called acute reference dose (ARfD) for Δ9-THC being exceeded. The ARfD of 1 μg per kg body weight for THC was established by EFSA in its 2015 scientific opinion on risks to human health related to the presence of THC in milk and other food of animal origin. The current report states: “Compared to the EFSA opinion published in 2015, there has been an increase in the number of samples as well as the number of food categories that could be used for the exposure assessment to Δ9-THC”. The Authority concludes that “Member States should be encouraged to collect and submit more data to EFSA (based on selective methods) on the occurrence of Δ9-THC in food and in particular animal origin, including dairy products, eggs and meat from animals fed on hemp and products derived from hemp. Consumption data on hemp products are needed to refine the exposure scenarios”.
Ireland: A third medicinal CBD oil has been approved for use under the Irish Medicinal Cannabis Access Programme (MCAP), which was approved last year and runs for five years. The Department of Health has stated that approval of a product “does not imply approval by the Minister of Health of the safety and quality of efficacy of the product for the prescribed condition”.
Italy: A legislative proposal entitled “Measures to support the hemp supply chain”, co-signed by MEPs from +Europe, the Five-Star Movement, the Democratic Party and Free and Equal, would amend the 2020 budget law by adding “products and preparations, which contain cannabidiol with a tetrahydrocannabinol content not exceeding 0,5 % for any use and are obtained from fresh and dried buds and oils’ shall be added among those which may be obtained from the cultivation and processing of industrial hemp and then sold A similar initiative failed in the Senate in December due to a last-minute intervention by the President of the Senate.
Italy: Multiple sclerosis patients in Sicily, who suffer from chronic and neuropathic pain or spasticity and for whom traditional medicine has not worked, can obtain a free prescription for medical cannabis from certain specialists, valid for up to six months. Similar provisions exist in other 16 regions. In Italy there are currently only two products available, Cannabis FM1 and Cannabis FM2, produced by the Military Pharmaceutical Chemical Factory in Florence. As their supply does not cover all domestic demand, the country imports mainly Dutch medical cannabis. Italy is expected to almost triple its domestic production in 2020.
Italy: According to Luca Marola, the founder of a local brand active in the cannabis light sector, the recently resubmitted amendment to the budgetary law to legalise hemp – commonly known as cannabis light – has little chance of being adopted. He says, however, that it is important to present a joint legislative proposal and “make everyone understand that we are talking about the industrial hemp flower, something much more similar to the artichoke or radicchio than cocaine or heroin”.
Italy: Fabrizio Galliati, president of Coldiretti Torino, the provincial association of direct growers of Torino, has reacted to the adoption of the long-awaited ministerial decree setting THC maximum levels for hemp foodstuffs. According to Galliati, the decree “in no way mentions the possibility of using other parts of the plant in addition to seeds and their derivatives, flour and oil, and therefore does not resolve the issue of using the inflorescence or different parts of the plant”. He also pleads for the adoption of “amendments to the law concerning the cultivation, processing and trade of cannabis for therapeutic purposes”.
Italy: The public prosecutor of Taranto in the region of Puglia has requested and obtained the dismissal of 56 people involved in the so-called “affari in fumo” prosecution of the Guardia di Finanza (an Italian law enforcement agency under the authority of the Minister of Economy and Finance), which resulted in the seizure of a ton of Cannabis sativa flowers and thousands of products in the province of Taranto and other Italian regions. The public prosecutor’s office said that the current legislation regulating the sale of hemp was “so confusing that it is impossible to tell if you are committing a crime, especially that of drug trafficking”.
Germany: The portal of the consumer advice centre has warned against food with CBD and reminded that in the opinion of the Federal Office of Consumer Protection and Food Safety (BVL) CBD is prohibited in food and food supplements. CBD products could contain “harmful amounts of THC” and the CBD itself could cause “drowsiness and dizziness” and lead to “insomnia, sleep disorders and inner restlessness”. In addition, “questions of dosage, safety and interactions have not yet been clarified”, products often contain “questionable hemp ingredients whose origin is unclear”, and labelling strategies with “pictures of hemp leaves and terms like ‘intoxicating’ or ‘high'” could lead to a “dangerous trivialisation of cannabis”.
Lithuania: The Parliamentary Committee for Rural Affairs has discussed draft law 3195, which would allow the processing of hemp containing 0.2% THC for the purpose of producing animal feed and cosmetics. Five members of the committee voted in favour of the bill, none against.
EU: The European Commission (EC) has published the position it expects from the member states regarding the World Health Organisation (WHO) cannabis planning recommendations. It recommends that the member states vote in favour of three of the six recommendations. Although the EC would support the deletion of cannabis and cannabis resin from Schedule 4 of the 1961 Single Convention on Narcotic Drugs, it would not recommend accepting proposed amendments concerning CBD preparations containing less than 0.2% THC. This would be due to the lack of scientific support for preparations containing predominantly CBD and because “the wording of the Recommendation does not exclude possible divergent interpretations regarding the way this limit is calculated”. The Authority also argued that “the differentiated treatment of cannabidiol compared to other cannabinoids is not justified and is not in line with the existing structure of the annexes to the Conventions”. The agenda of the March session of the United Nations Commission on Narcotic Drugs (CND) has not yet been finalised, but it is expected to include a decision on the recommendations.
Germany: Various consumer protection centres, including the Verbraucherzentrale Hessen and the Verbraucherzentrale Rheinland-Pfalz, have warned against the consumption of foods with CBDs – such as capsules, oil, chocolate, sweets or chewing gum – because of “undesirable side effects”, including sleep disturbances and restlessness. They claim that CBD products may contain “harmful” amounts of THC and particularly advise against their use in children and adolescents.
Poland: A company wishing to import synthetic CBD with a THC content of no more than 0.05% for the manufacture of cosmetic products must submit applications for authorisations to import and process psychotropic substances, according to the Main Pharmaceutical Inspectorate. The Inspectorate believes that THC and its variants constitute a Group II-P psychotropic substance – although the final product is THC-free (i.e. it may contain undetectable amounts) and the CBD is not used for the manufacture of pharmaceuticals.
UK: The Home Office issued its latest factsheet on the licensing of low THC cannabis (industrial hemp) on 15 January. The Ministry explicitly states that this licence does not allow a licence holder to grow hemp for the purpose of CBD extraction from leaves or flowers.
UK: The Department of Animal Feed, Foodborne Diseases, Allergies and Food Intolerances of the Food Standards Agency has stated that it maintains its original position on CBD for products intended for animals: “A marketing authorisation is required before these (CBD) products can be sold or supplied in the UK. She added that currently no CBD-based products have received veterinary marketing authorisation in the UK.
Belgium: A CBD shop in the city of Antwerp was closed for 30 days because the permitted THC content of 0,2 % was exceeded. According to local media, the police said that users cannot visually see the difference between products that do not exceed the permitted THC content and those that do.
Finland: A number of products were seized because they do not have a novel food authorisation. The company Hamppumaa stated that it had complied with the order but was considering bringing an action against the Finnish Food Authority.
France: The French Professional Cannabis Union (SPC), which represents companies in the medical cannabis and wellness cannabis sector, has published an overview of its white paper on the CBD in France. The SPC argues that “the French demand for CBD products is exploding”, but that the law does not allow the processing and sale of hemp flowers, forcing companies to import products and use synthetic CBD. The white paper, once published, will “provide clear advice and proposals for a secure and fruitful development of the sector”.
Germany: The trial against the hemp specialist shop Hanfbar has been resumed at the Regional Court in Braunschweig. The operators of the store, Marcel Keine and Bardia Hatefi, are accused of drug trafficking and are facing several years in prison. The public prosecutor’s office called in two experts who gave as evidence that even a small amount of THC in the hemp teas sold by the defendants could lead to poisoning if the hemp flowers were smoked or baked in large quantities. The defense argues that hemp tea could not lead to such effects and that such products were sold by other retailers, including drugstores and health food stores. The trial will continue on 28 January.
Germany: The hemp tea (flowers and leaves) of a German retailer was recalled because of excessive THC content, according to the Portal der Bundesländer and the Federal Office for Consumer Protection and Food Safety (BVL).
Latvia: Amendments to the Law on Narcotics have come into force, which means that from 1 January 2020, the cultivation of hemp for industrial purposes, including CBD or the production of any other extract, will be allowed as long as the content of the plant does not exceed 0.2% THC.
Poland: The Supreme Sanitary Inspectorate has issued a public warning regarding CannabiGold Smart, a CBD food supplement containing a THC content of 299 mg per kg, based on tests carried out by the official food control authorities in Switzerland. The warning states that, according to the risk assessment of the Swiss authorities and on the basis of the risk assessment carried out by experts from the National Institute of Public Health, the product should be considered dangerous to public health. A representative of the company stated that they are clarifying the matter with the authorities as “the THC content in their product is 0.0299%, which is almost seven times lower than the standard (0.2% THC content) set by the Polish Medicines Act”.
EU: The Court of Justice of the European Union (CJEU) has ruled that a symbol referring to marijuana cannot be registered as an EU trademark. The plaintiff in this case is the Italian CBD and the hemp product chain Cannabis Store Amsterdam, which had tried to register a figurative sign consisting of ten cannabis leaves together with its company name as an EU trademark “for food and beverages and catering services”. The EU Intellectual Property Office (EUIPO) refused to register the mark on the grounds that it was “contrary to public policy”. The CJEU has now confirmed this decision, stating that although the Italian company did not sell a product with intoxicating effects, its logo, which included a cannabis leaf, “the media symbol for marijuana”, a reference to Amsterdam and the word ” shop”, deliberately gave such an impression. The CJEU’s decision is not yet final, but an appeal is only possible if the CJEU considers the case to be of fundamental importance.
France: The National Agency for the Safety of Medicines and Health Products (ANSM) has confirmed that the Mildeca Guidelines on the CBD also apply to CBD-infected cosmetic products. The ANSM says that the use of herbal-based cannabidiol, as it is made from an extract, tincture or resin of cannabis, is prohibited for the manufacture of cosmetic products with reference to Annex II of the EU Cosmetics Regulation. As regards the use of synthetic CBDs in cosmetic products, the ANSM confirms that this is allowed as long as such a synthetic CBD does not contain traces of THC.
Italy: According to local media, the President of the Senate, Elisabetta Casellati, has cancelled an amendment on hemp that was originally approved by the Senate’s Budget Committee. The amendment (91.0.2000/7) tabled by the five-star movement – which was to be considered together with the 2020 budget law – concerned the cultivation of Cannabis sativa L. Casellati said, however, it did not meet the requirements to be included in the budget law. The amendment would have amended Law 242/2016 to state that hemp and all its individual plant parts with a maximum THC content of 0.5% are not considered as narcotics and may be sold from January 2020. Furthermore, the amendment would have amended the Decree-Law of 26 October 1995 on excise duties by introducing an excise duty of €12 per 1000 kg for each percentage point CBD in hemp biomass. Overall, it would have clarified the legal grey area created by the Supreme Court ruling of 30 May, according to which products derived from hemp – regardless of the THC content of the product – are illegal, with the exception of products without psychotropic effects, without specifying how the latter condition is to be assessed. And it would allegedly have entailed more quality controls in all parts of the hemp production value chain. It is unclear whether the proposed amendment will be reintroduced in the future.
Spain: According to a spokesperson for the European Observatory on Cannabis Consumption and Cultivation (OECC), a proposal to regulate cannabis for therapeutic purposes has a real chance of progress under the next government. The proposal would create three forms of access to treatment: self-production, collective production and access to medicines. The aim is to protect individual rights and prevent them from having to go on the black market, said OECC spokesman Héctor Brotons at an event to present the proposal document, which took place in Barcelona on 11 December. Such a proposal could also affect the sale of CBDs in the country. Several parties have been receptive to the proposal, such as ERC, Citizens or PNV, Brotons also told the Spanish press.
BRITAIN: The National Pharmacy Association (NPA) said that non-medical CBD products need clear authoritative guidance and better content controls. Head of Advice and Support Services, Jasmine Shah, said: “It is up to each individual pharmacist to decide whether or not to stock a CBD product, but more research is needed into the safety and effectiveness of the product”. The Association for the Cannabinoid Industry announced that it welcomed the NPA’s call for improved CBD provisions and added that “the organisation and existing members have made a clear commitment to achieve novel food status through the Food Standards Agency (FSA). The association also stated that it has set a deadline of 20 December for the registration of novel foods.
Greece: The Hellenic Vaping Products Enterprises Association (SEEPA) – an association of vaping companies – has sent a memorandum to the Ministry of Health calling for immediate action on e-liquids containing cannabis products and asking for a legislative framework. The association carried out intensive research on the Greek market to determine whether these products were dangerous to health, in order to prevent consumers from being affected by lung diseases currently occurring in the USA – where, however, a large proportion of the e-liquids concerned contained THC. The association found that most e-liquids sold in cannabis shops in Greece contain CBD, according to Greek media reports.
Germany: Following a September ruling by the Administrative Court of Düsseldorf, the Administrative Court of Giessen in central Germany also upheld the ban on the sale of food and food supplements containing CBDs, dismissing a complaint by a Hessian CBD company that had been forced by local authorities to recall its products. The court referred to the EU regulation on novel foods and the guidelines of the Federal Office of Consumer Protection and Food Safety (BVL).
Norway:The Norwegian Medicines Agency (NOMA) stated that although it has argued that hemp products containing up to 0.2% THC should not be considered as narcotics, it is not sufficient to change the national framework for these products: “The Norwegian Ministry of Health will not change the regulations until the UN Commission on Narcotics is finalised” and added that this could be done in March 2020. When asked about their implementation strategy, the NOMA official said: “I do not believe that CBD products are sold in Norway. At the same time we do not believe that customs authorities consider it a priority to stop CBD products with very low THC content”.
EU: According to Lorenza Romanese, Managing Director of the European Industrial Hemp Association (EIHA), hemp flowers have been re-introduced into the EU CosIng – the European Commission’s database for cosmetic ingredients. The entry for cannabis leaf extract lists that it has softening and skin-caring functions.
EU: The EIHA has expressed concern about the lack of regulation, quality standards and quality controls for e-liquids. It is calling for additional “rules on ingredients and labelling” for products manufactured in Europe, including CBD fluids, to protect EU consumers from inferior substances – similar to the vitamin E acetate that industry news reports is behind the US vaping crisis. The EIHA is currently working to update its vaping advice.
Germany: Interest groups have accused the police of using disproportionate force against the owners of the hemp shop Cannameleon in Würzburg, Lower Franconia, when they searched it and confiscated hemp and CBD products such as a hemp tea with allegedly up to 0.3% THC. This is not the first time that such charges have been brought against the Bavarian police. The owner claimed that CBD products containing up to 0.2% THC on a hemp basis were legal – although he stated that the shop sold up to 0.3% THC. However, some authorities apply a zero-THC tolerance policy for all consumer goods, while others believe that CBD products as a whole category are not covered by any of the legal exemptions provided for – making the sale illegal.
Italy: Nine senators from Cinquestelle (five-star party) introduced an excise tax on hemp production and marketing from 2020 in an amendment to the Legge di bilancio 2020. The amendment would have to be passed before the end of the year. If the Senate’s budget committee were to approve, e-commerce companies that also sell hemp-based products, including CBD e-fluids, would have to comply with this new legislation.
Italy: The Agriculture Commission of the House of Representatives adopted a joint resolution (based on resolutions 7-00292 Benedetti, 7-00298 Cenni and 7-00314 Gagnarli) on the agricultural use of products derived from Cannabis sativa. In view of the judgment of the Court of Cassation at the end of May and the regulatory uncertainty regarding hemp-based products, the Commission has asked the government to do so:
– to regulate the sale of dried, chopped or pelleted biomass from the whole plant or its parts with a THC content of no more than 0.2% to suppliers in the pharmaceutical, food, cosmetics and processing industries.
– To set maximum THC levels in foodstuffs by ministerial decree.
– To define the customs codes for each category of hemp products.
– Consideration of the approval of the proposal
1) to increase the THC content in industrial hemp in the EU from 0.2 to 0.3% and 2) to change the classification of cannabinoids as novel foods to allow the use of hemp flowers in finished products.
– Consider the allocation of specific funds for the hemp sector in the 2020 budget law.
The underlying proposals have been criticised by some industry stakeholders as they restrict the sale of hemp flowers for extraction purposes only. It remains to be seen when and how the government will implement the Commission’s recommendations.
BRITAIN: Liberal Democrats intend to reform access to medicinal cannabis through a regulated market, according to their manifesto published before next month’s general election. The party promises to introduce restrictions on the potency of cannabis, channelling sales through licensed outlets restricted to adults over 18 years of age. Neither recreational use nor CBD status was addressed.
Czech Republic: the Ministry of Health has introduced a draft law amending the narcotics laws that would allow legal persons to obtain licences for the cultivation of medical cannabis. Until now, this has only been awarded to the winner of the tendering procedure, which is carried out annually by the State Institute for Drug Control. The aim of the reform is to increase the number of growers and, ultimately, the availability of medical cannabis, while reducing its price. Improvements within the legal medical cannabis regime may have an impact on the highly developed retail market for CBD products in the country.
Estonia: The Riigikogu’s Social Affairs Committee discussed an appeal for legalisation of cannabis on Tuesday, but said consumption and health care costs would increase and no further steps towards legalisation are expected, local press reports said. Allowing cannabis varieties with high THC content would also help the CBD’s processing industry and the sale of flowers.
Germany: “CBD hemp flower extract” and “CBD crystals” are allegedly considered as unauthorised novel foods when sold nationally or used as food ingredients in Germany. According to media reports, a recently published ruling by the Düsseldorf Administrative Court on 27 September confirms this position of the German government. The website of the Federal Office of Consumer Protection and Food Safety (BVL) states that the CBD is considered a medicinal product or novel food and as such may no longer be used as an ingredient in foods and food supplements without proper authorisation since the publication of information earlier this year.
UK: The United Kingdom’s National Institute for Health and Care Excellence (NICE) has recommended GW Pharmaceuticals’ Epidyolex for the treatment of Dravet Syndrome and Lennox-Gastaut Syndrome after initially advising against it for reasons of cost-effectiveness and uncertainty about its long-term efficacy. However, NICE reversed its decision after the European Medicines Agency granted marketing authorisation in September. The company is now reportedly negotiating with regulators in other EU countries, including Italy, France, Spain and Germany, “to ensure reimbursement before the expected launch of the drug in these countries”.
Local law enforcement authorities in Bavaria – in cooperation with food control authorities – have carried out searches in three hemp shops in the cities of Coburg, Bamberg and Erfurt. They confiscated products and searched the homes of shop owners suspected of violating narcotics and drug laws by selling hemp flowers and finished products containing CBD. In Germany, pure CBD is considered a drug. CBD isolate that is not sold as a medicinal product could be considered a medicinal product by the authorities if it is proven to have pharmacological effects.
According to local media, Cannamigo – a hemp shop in Sonthofen, Bavaria – was searched by local authorities who confiscated tea made from hemp leaves. According to reports, no other CBD products were sold in the shop due to the complex legal situation in Germany.
Germany: The lawsuit against the hemp specialist shop Hanfbar will be continued, as the court still has to examine additional claims of the defence counsel. The verdict against the shop’s operators, Marcel Keine and Bardia Hatefi, who are accused of drug trafficking, is therefore adjourned. Defense counsel argued that the hemp tea sold in the shop could not lead to poisoning, and Keine also pointed out that such products were sold by other retailers, including drugstores and health food stores. According to the German Federal Institute for Drugs and Medical Devices (BfArM), “products such as tea, tobacco substitutes or bags made only from dried and chopped hemp plants may not be sold to the end consumer […] as misuse for poisoning purposes cannot be ruled out”. The trial will continue on 23 October.
Lithuania: The Ministry of Economy and Innovation expects an investment of between 15 and 150 million euros from a total of six foreign investors interested in expanding their businesses in Lithuania, following the adoption of Laws 429 and 3195, which, according to local media, seek to legalise hemp processing.
Slovakia: Cannabidiol will not be removed from the deletion list in Slovakia following the full adoption of a new draft law with the amendments tabled by Member of Parliament Jozef Valocky. The Health Committee of the National Council first approved Valocky’s amendments and the National Council then adopted them at second and third reading, both on 16 October. The amendment deleted the deletion of the clause on the deletion of cannabidiol from the proposal to amend the current Narcotics Law which has now been adopted. Surprisingly, the new law removes the resin of EU-certified industrial hemp from the narcotics law. Martin Poliacik, the MP who has already tabled several legislative proposals to remove the CBD from the list of psychotropic substances, said he would do “everything possible” to ensure that the new government (next elections on or before March 2020) “will take remedial action”.
EU: Cannabis products are becoming more diverse in Europe and require more detailed information – at national and European level – on the exact ingredients to better monitor their health effects, according to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) in its speech at the 2019 European Health Forum.
Slovakia: In Slovakia, CBD has come a step closer to removing trade barriers after the Constitutional Law Committee of the National Council recommended the adoption of a draft law to this effect by the Slovak Ministry of Health. The Health Committee discussed the proposal on 9 October, but its opinion has not yet been published. However, local media report that the committee unanimously adopted a proposal to delete the current proposal to remove cannabidiol. The proposal was tabled by Jozef Valocky, Member of Parliament from the ruling Socialist Smer Party. Parliament can still choose to approve the proposal in its original form without accepting the additional amendments.
Italy: The police chief of the province of Macerata has ordered the closure of four CBD shops. The four shops have had their licence withdrawn under Article 100 of the TULPS (Testo unico delle leggi di pubblica sicurezza). Three of the four shops had already been the subject of police action in the past. Quaestor Antonio Pignataro said that the shops were still in breach of the ruling by the Court of Cassation earlier this year that cannabis products were illegal except those “without psychotropic effect”.
Lithuania: The Legal Committee has said that a bill to legalise the processing of hemp fibres – Bill No. 429 – should be merged with another bill – Bill 3195 – which allows the processing of hemp products that may contain up to 0.2% THC. The committee’s conclusion also stated that it had unanimously decided to support the bill, noting that the definition of “hemp grown for fibre” should be amended to specify which parts of the hemp plant can be used.
France: François-Michel Lambert, Member of the National Assembly, has put a parliamentary question to Justice Minister Nicole Belloubet concerning a decision of the Bordeaux Criminal Court which found a tobacconist who marketed CBD products not guilty of drug offences. “This decision, which has not been appealed, will set a precedent and is a first for the sale of CBD flowers,” Lambert said. “It ends the prosecution of shops selling products made from cannabis, whereas the CBD is neither a doping nor a psychotropic drug and does not pose a health hazard. France lags far behind in this respect, while most European countries allow the CBD and even promote its trade”. He asks what the government thinks about the CBD and what measures can be taken to remove the legal ambiguities regarding CBD shops.
Germany: The lawsuit against the hemp shop Hanfbar, whose branches in Cologne and Braunschweig were searched in the summer, has been resumed according to media reports. During the hearing it was reported that the THC content of the confiscated products was between 0.07% and 0.65% and that the proceeds from the sale amounted to about 50,000 Euro. It is expected that the court will rule on the case before October 17. The next day of the trial is scheduled for October 10, when experts are expected to provide information on how the consumption of the confiscated hemp tea can lead to poisoning. The defendants had previously announced that they would appeal to the Federal High Court to challenge the constitutionality of the narcotics laws.
Netherlands: The Inspectorate for Health and Youth Care has confirmed that a legislative amendment is planned to exclude CBD products from the scope of the Narcotics Act, while edible products must comply with the EU Novel Foods Directives. Currently, finished products infused with CBD on a plant basis fall under the Opium Act, but are tolerated on the Dutch market under various conditions, as explained in the regulatory report.
Northern Macedonia: The government has adopted a proposal to amend the Narcotics Law. According to the government’s announcement, cultivation is to be permitted with the approval of the Ministry of Health. Companies that produce cannabis for medical purposes will be obliged to pay 10% of their sales proceeds to the state budget, which will help finance a newly created independent agency to control the cultivation and extraction of cannabis.
UNITED KINGDOM: A Kenyan-based business selling aromatherapy products claims its PayPal account has been frozen because it sells CBD-infected bath bombs. Local media report that PayPal has not currently allowed the use of the platform to sell CBD-containing products, an eBay spokesperson said: “Products containing CBD oil are banned on eBay because there is no way to determine how much THC, which is a controlled substance, is contained in the product. The owner of the store, BonneBomb, pointed out that PayPal still works with the larger retailers Holland & Barrett, who also sell CBD products.
France: A tobacconist in the small village of Landiras in south-western France has been found not guilty by a court in Bordeaux of possession or trafficking in narcotic drugs. Police confiscated CBD-E liquids, herbal tea and hemp buds from the shop.
Finland: Valvira, the Finnish E-cigarette Regulatory Authority, has announced that the Finnish Medicines Agency considers CBD to be a medicine and therefore it may not be used in consumer or tobacco products, including e-cigarettes.
Italy: The initiative by five-star MEP Matteo Mantero to regulate cannabis for recreational and therapeutic use, including low THC varieties, was officially presented in the Italian Senate.
Italy: The Court of Cassation has ruled that the police in the province of Forli-Cesena acted lawfully in seizing “light cannabis” from shops that were searched in December 2018. The court dismissed an appeal against the judgment of the Forli district court that the sale of CBD flowers was illegal. Fifteen people were charged after the raids, during which 73 kg of flowers with a total value of around 75,000 euros were confiscated.
Luxembourg: From 1 December, all CBD vaping products containing less than 0.3% THC will be taxed with 17% VAT, the same rate as tobacco products or cigarettes in Luxembourg, according to press reports. This rate is paid by the final consumer. Mixtures of infusion plants, which are presented and packaged as such, with a high proportion of hemp leaves, will be exempt from tax at source.
San Marino: The Parliament of San Marino last week adopted a public petition calling for regulation of the use of cannabis for recreational purposes, the Italian press reports. If the initiative is adopted, it will become legal to grow, process and sell cannabis and cannabis derivatives in the microstate, which is completely surrounded by northern central Italy.
France: Police in Nîmes raided a CBD shop and confiscated CBD products that might contain traces of THC for investigation, according to local press. It is unclear whether a 0.2% concentration would be considered outside the scope of the drug laws, as interpretation by local authorities and courts remains inconsistent.
Italy: Five-star Senator Matteo Mantero has submitted an official request for a bill he submitted in June to amend the regulation of industrial hemp, which is to be declared ‘urgent’ and given special priority. His bill would extend the scope of Law 242/2016 and explicitly include hemp flowers for food purposes and distillates of essential oils, labelling requirements, etc.
Germany: The trial against the hemp shop Hanfbar, whose branches in Cologne and Braunschweig were searched during the summer, has been opened. The defense attorney told the court in Braunschweig that small traders would be prosecuted, but not “big traders with sales in the millions”. The most controversial confiscated product, hemp tea, had also been sold in reform houses and large drugstores. The hearing will continue on September 27, when further details on the THC content of the confiscated products are expected.
Italy: With a new government coalition between the Five Star Movement (M5S) and the Centre Left Democratic Party (PD), there are new hopes for the legalisation of cannabis, according to local media reports. Three proposals are said to have been tabled by the M5S, including a bill on “cannabis light” tabled by Senator Matteo Mantero, who said: “The first test to see if the political will is there is an amendment to the law on industrial hemp. Following the recent ruling of the Court of Cassation, we need to better regulate the exploitation of leaves, flowers, oil and resin. We have asked that the legislature should decide between September and October on the priority of this proposal’. Mantero added: “In my opinion, the first step is to amend the law on industrial hemp, which provided for the resumption of the cultivation of industrial hemp. It has achieved excellent results, creating 9000-10,000 jobs and a turnover of several tens of millions of euros, mainly for the sale of flowers, extracts and derivatives”. Five-star Senator Cinquestelle told the news magazine Dire: “Both the Democratic Party and the M5S have different visions of decriminalisation and legalisation. I see it as very complicated to achieve a positive vote. But it is not impossible. It used to be impossible when the League was in the majority”.
In Switzerland: National Councillor Heinz Siegenthaler of the Conservative Democratic Party has reaffirmed his support for the hemp industry in the run-up to the parliamentary elections in October, according to press reports. He said: “It is a plant that has many functions. It enables the production of substances, it is edible, it has medicinal virtues and finally it has recreational effects like wine. As the first council member of his party to table a motion to decriminalise cannabis, he added: “It is the task of the Federal Council to present a new legal basis for the cultivation, trade and consumption of cannabis containing THC, based on the legal provisions for strong alcohol. More than 200,000 people regularly consume cannabis products. The current legislation indirectly encourages drug trafficking and unnecessarily monopolizes the financial and human resources of law enforcement agencies without any concrete effect”.
Germany: The German government said that it would not take any measures to clarify the legal position of the CBD and that the public prosecutor’s office had “sufficient powers” to carry out prosecution tasks, responding to questions from the FDP. Even when asked what prompted the change of the CBD entry in the Novel Food Catalogue in January 2019, the German government only gave the standard line that there was no evidence of isolated cannabinoid use prior to 1997. The German Hemp Association (DHV) criticized the federal government – it called their answers “evasive” and said that with their response to the amendment of the Novel Food Catalogue they had avoided the question of full-spectrum extracts with naturally occurring cannabinoids.
Ireland: CBD can be used in cosmetic products – be it from a cannabis extract or synthetically derived, the Health Products Regulatory Authority’s Compliance Department confirmed to CBD-Intel. End products may not contain traces of THC and must meet all other requirements of the primary legislation on cosmetics, Regulation (EC) 1223/2009.
Sweden: The Administrative Court in Uppsala rejected the appeals of five different CBD companies against the marketing ban issued by the Swedish Medicines Agency. This means that manufacturers are still prohibited from selling these products. Although the sales ban remains in place, there is disagreement as to whether CBD oils should be regarded as medicines. The Court said that the Swedish Medicines Agency had not proved that they were “functional medicinal products”, but in all cases the complainants had made medical claims when placing the products on the market, which therefore required pre-marketing authorisation.
Germany: In a hemp shop near Nuremberg in Bavaria, police confiscated products – including chocolate, pesto, oils, e-liquids, teas, chewing gum and shower gel – during a raid. According to local media, the Nuremberg-Fürth district court considers CBD products to be prescription drugs.
Italy: Eleven shops selling hemp products in Padua, northern Italy, which have been investigated by local authorities, have not been charged with drug offences, according to reports in the local press. Tests showed that the products contained less than 0.5% THC, a concentration low enough not to be classified as narcotic, according to the local prosecutor.
Slovakia: The government has approved a proposal by the Ministry of Health to repeal the CBD. Slovakia is the only EU Member State that still lists CBD as a psychotropic substance. Earlier proposals to remove the CBD had failed in parliament. If the government proposal is passed in three parliamentary debates in the National Council, industrially produced hemp resin will also be exempted from the narcotics law. However, the processing of cannabis (not industrial hemp) into fibres and seeds and the production of extracts and tinctures from cannabis would still be subject to ministerial approval.
Croatia: The Social Democratic Party plans to put forward a proposal to legalise the recreational use of cannabis and the cultivation, processing and trade of industrial hemp. The draft law will be the subject of a public debate, after which the final draft will be submitted to parliament for discussion.
Italy: A new proposal to regulate the sale of “Cannabis light” (CBD hemp products) in Italy has been tabled by the centre-left party Più Europa (+Europe). It defines the varieties of hemp that can be legally grown and processed, and states that they can also be marketed in the country. It specifies that products such as fresh and dried flowers, resins, oils, smoke/ inhalation products and other non-medical and non-food uses, for which a specific discipline is already provided, would all be legal.
Spain: According to the Minister of Health, María Luisa Carcedo, the legalisation of cannabis for medical or recreational use is not part of the government’s plan at the moment. The opening of a social debate to re-evaluate control measures has been included in the election manifesto of her socialist party. However, Carcedo believes that the usefulness of cannabis as a drug is questionable and that there are too many myths surrounding it. The current increase in cannabis use among young people is also worrying. The current socialist government is currently negotiating with the far left Podemos party to form a coalition. Podemos supports the legalisation of cannabis and may launch an initiative to this end.
Jersey: The self-governing dependency of Great Britain has decided to allow the cultivation of hemp flowers for CBD production. In Great Britain, the flowers still have to be disposed of after harvesting, which means that CBD can legally only be produced from fibres.
Switzerland: The Swiss Federal Supreme Court has upheld the decision of a lower court that convicted a hemp farmer for exceeding the permissible THC levels in his crop. The farmer had appealed against the decision, arguing that there was not enough legal certainty about how THC is measured and controlled. He said that the amount of tetrahydrocannabinol should not be added to the value of tetrahydrocannabinoleic acid (THC-carboxylic acid) because THC-carboxylic acid is only converted into a psychoactive substance by adding an external influence – for example by heating. The court decided that the narcotics ordinance clearly states that hemp plants with an average total THC content of at least 1% are considered narcotics.
Germany: A raid has been carried out in a hemp shop in Cologne, North Rhine-Westphalia, according to local media. In contrast to earlier police raids in the Braunschweig branch of the same shop, this time the raid reportedly involved not only CBD flowers – the sale of which as a final product is illegal in Germany – but also hemp teas, cosmetics, CBD chocolate and hemp seeds.
Belgium: A circular from the Federal Medicines Agency states that the use of raw materials such as cannabidiol containing traces of THC is acceptable for medicines prepared in a pharmacy for an individual patient on the basis of a prescription. Traces should be limited to a maximum of 1 microgram of Δ9-THC per kilogram body weight per day, as indicated in the European Food Safety Authority’s information on THC in food. The circular also states that pharmacists are currently not allowed to use cannabidiol for the manufacture of food supplements due to the novel food status of the CBD, which means that the sale of food supplements based on the CBD is currently prohibited.
Germany: The German Hemp Association (DHV) has published the answers of various German authorities to its inquiries. The Federal Ministry of Food and Agriculture refused to comment on the German government’s position on the CBD classification of novel foods, but said there was still no evidence of their use in the EU before 1997. The Interstate Working Party on Consumer Protection (LAV), which focuses on food and consumer durables, wine and cosmetics (ALB), said that there were no working groups on CBD-infected consumer goods at federal or state level, but agreed with the Federal Office of Consumer Protection and Food Safety (BVL) that the CBD was a Novel Food. She added that controls of CBD and hemp products are not mandatory and controls are carried out randomly or on a case-by-case basis. Transitional periods for shopkeepers were neither existing nor planned.
Germany: Only the parts of the hemp plant and the products derived from these parts that are not considered narcotics or drugs may be marketed as food (essentially the parts with minimal cannabinoids), while further investigation would be necessary to determine whether such products are covered by the Novel Food Regulations, the Federal Government said. It added that it has no reliable information on the use of hemp in food and cosmetics and that the Federal Agency for Agriculture and Food (BLE) randomly tests hemp varieties for their THC content, although farmers do not incur any costs. The government’s answers to parliamentary questions also discuss the area under hemp cultivation, the price of hemp seeds, the competitive advantage for German farmers and further research on the use of industrial hemp.
Germany: In July, Germany registered three CBD pet food products from different EU member states with the RASFF portal because they contain the “unauthorised feed additive cannabidiol (CBD)”.
Netherlands/Germany: The Netherlands will increase the amount of medicinal cannabis exported to Germany from 1500 kg to 2500k g. This is stated in a letter from the Minister of Health Care, Bruno Bruins, to the lower chamber of the Dutch parliament. Exact quantities are to be determined by the Bureau for Medical Cannabis, and deliveries are to be made gradually throughout the year. The demand for medical cannabis in Germany has grown progressively; the German CBD wellness market (the largest in Europe after the United Kingdom) has been shaken by recent enforcement actions against CBD oils and edibles.
France: The rules restricting CBD production in France would also prevent the country from benefiting from the opportunities that a medical cannabis sector would offer, says MEP François André of La Republique En Marche. He said that the inability to use flowers under French law – as opposed to European law – prevented the creation of a sector and made importation the only possible course of action. André asked the Minister of Agriculture and Food to what extent the government intends to support the development of a medical marijuana sector and whether it would support the use of hemp flowers for the extraction and purification of cannabinoids in certified laboratories.
Italy: According to Secretary of State Armando Bartolazzi, the Ministry of Health will not take measures to stop the sale of cannabis products to consumers. He said that any measure based on the production of consumer goods (for example the enforcement of an adequate THC content in hemp flowers) would be “superfluous and even contradictory” after the Supreme Court of Cassation recently ruled that cannabis products are illegal, with the exception of products “without psychotropic effect”, he said in response to a member of the conservative party “Fratelli d’Italia”. However, a regulatory intervention by parliament cannot be ruled out, as the government is already considering some directives and specific bills that could lead to a change in the regulatory framework. Meanwhile, he added, hemp seed food products containing traces of THC, which will be defined by a government decree to be adopted soon, remain legal.
Italy: The Customs and Monopolies Authority has published a statement confirming that the Supreme Court of Cassation, in its decision 30475, has given a decisive interpretation that the sale of leaves, flowers, oil and resin to consumers – regardless of the variety of hemp and traces of THC – does not fall within the scope of Law 242/2016 and therefore constitutes a criminal offence under Presidential Decree 309/1990 on narcotics. An exception is made if the derivatives are in practice deprived of “doping effects”. This will be decided by the judiciary on a case-by-case basis.
Spain: The full regulation of cannabis and its by-products, including the CBD, is the only solution to the wasted resources that are wasted by a “failed” cannabis control policy, according to the left-wing Podemos party in response to the presentation of the latest report on the National Drug Control Plan. The report highlights that 80% of drug law offences are related to cannabis – for example, because the sale of hemp flowers is illegal. Podemos is the fourth largest party in Spain and is currently negotiating with the leading Social Democratic Party (PSOE) to form a new Spanish government.
Luxembourg: Some of the 34 shops involved in previously reported police investigations say they were forced to sell large quantities of CBD products worth between 15,000 and 20,000 euros. A member of the industry told local media that “the whole deal is pretty vague” and said that several emails sent to the Luxembourg Ministry of Health to find out about regulations and the legality of the products to see if they could be sold had not been answered.
UK: Norman Lamb, a Liberal Democrat MEP and former Minister of Health, spoke on the purchase and use of cannabis oil for recreational purposes ahead of an important meeting on a BBC documentary on the legalisation of the drug in Canada. Lamb visited Canada with Labour MEP David Lammy and Conservative MEP Jonathan Djanogly for the programme to learn about the effects of cannabis in Canada, where recreational use of the drug is legal. As part of the documentary for the BBC Radio 1 newsbeat, he bought and tasted cannabis oil and flushed the rest down the toilet before returning to the UK. The cannabis oil Lamb tasted contained THC in addition to the CBD found in legal oils from the UK, local media reported.
Belgium: According to the local press, a number of towns in the province of West Flanders plan to develop regulations to control and restrict the distribution of CBD shops in the region. Koksijde, De Panne and Nieuwpoort are planning to ban CBD shops and to open them near schools, amusement parks and other places frequented by minors. They will also consider limiting the total number of shops in a given area and plan to conduct background checks on shop owners based on the fact that selling CBD products makes it difficult to tackle drug problems.
France: Member of the National Assembly François-Michel Lambert has presented a draft law that would create a state monopoly on the production and sale of cannabis. The draft in its current version does not mention the CBD, although it sets a ceiling on THC concentration and restricts sales to state tobacco dealers. It is unclear what effect this would have on the sale of CBD consumer products, which may currently contain no traces of THC, while a pending appeal by the French Supreme Court in Case C-663/18 to the Court of Justice of the European Union is being decided.
France: The Council for Economic Analysis (Conseil d’analyse Économique), which informs government decisions on economic matters, has published a paper entitled “Cannabis: how to regain control? It recommends the strictly regulated legalisation of cannabis in a similar way to the draft law presented by Lambert, in order to limit access to cannabis for young adults, create jobs and increase tax revenues.
Latvia: A letter to the Latvian President claims that Parliament has restricted the cultivation of hemp for industrial purposes by adopting amendments to the law on the legal circulation of narcotic and psychotropic substances and medicines. The letter, signed by MP Andrejs Klementjevs, states that the cultivation of industrial hemp must be limited to the production of fibres and seeds, as such an interpretation is “explicitly mentioned by the UN Drugs Control Council”. However, the Ministry of Agriculture has submitted a proposal for a second reading to delete the reference to the purpose of cultivation, as the amendments adopted do not comply with the 1961 UN Convention on Narcotic Drugs, which Latvia has ratified.
Germany: The Health Committee of the German Bundestag, after discussing several legislative proposals, has passed the Federal Government’s draft bill “For more safety in the supply of medicines” (GSAV). According to the new law, the prices for medical cannabis – including CBD isolate and preparations containing CBD – are to be reduced. Once cannabis treatment is approved, it will also become easier to obtain a prescription for a new strain or product. The respective proposals of the Left Party and the Greens to improve patients’ access to medical cannabis by abolishing the current pre-approval requirements of health insurance companies were rejected.
Germany: The European Industrial Hemp Association (EIHA) has criticised the guidelines of the Federal Institute for Risk Assessment (BfR) on THC concentrations in food containing hemp from the year 2000. According to the EIHA, the limit values for THC in food are much stricter than for other harmful substances such as alcohol or nicotine, and the BfR’s risk assessment “does not meet scientific standards and urgently needs to be revised” to allow “competitive opportunities for the German hemp industry”. The EIHA refers to a study of the nova-Institut on the evaluation of the BfR guidelines, which emphasises the “systematic unequal treatment” of THC compared to other similarly effective substances and points out the “objectively wrong results” obtained by carrying out the risk assessment on sick people, who tend to react more strongly to THC than healthy people.
Luxembourg: The police, in cooperation with the Customs and Excise authorities and the public prosecutor’s office, investigated 34 CBD shops in Luxembourg, press reports. Random samples of CBD products were taken to determine whether they comply with the applicable legislation.
Portugal: Portuguese hemp growers have stated that they “will abandon the 2019 growing season because of continuing confusion between two governmental authorities over licensing”.
UK: The Church of England announced this week that it would lift a long-standing ban on medical cannabis to consider investment in the industry, according to press reports. It is believed that it will also include the possibility of investment in the hemp/CBD sector. The church has long banned investments in “sin industries”, although it considers pharmaceuticals acceptable.
EU: The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) has published its European Drugs Report 2019: Trends and Developments, which examines the EU’s ‘drug supply and market, prevalence and trends in drug use, and drug-related harm and responses’. It focuses mainly on cannabis as a drug and discusses in more detail the increasing trend in synthetic cannabinoids. With regard to the booming market for CBD products, the report notes that the divergent views of national regulators on the legality of CBD-E liquids, flowers, oils and creams “raise problems for regulation at both EU and national level”, while the lack of an established testing standard for CBD products causes problems at the consumer level.
EU: The German Federal Office of Consumer Protection and Food Safety (BVL) reports that three EU Member States (Hungary, Ireland and Spain) have sent notifications of food products with CBD as unauthorised novel food ingredient to the portal of the EU’s Rapid Alert System for Food and Feed (RASFF).
Since 2017, the number of CBD shops in Italy has increased steadily. In 2018 alone, more than 300 such “Cannabis Light” stores opened nationwide and were pleased with growing customer numbers. After the rapid growth, the end of cannabidiol is now threatening after less than three years. Italy’s Supreme Court of Cassation ruled on Thursday that the sale of any part of the cannabis plant, including oil, leaves and resin, is illegal. Only the licensed cultivation of cannabis for medical purposes remains legal. The industry in Italy is accordingly shocked.
The Italian Minister of the Interior, Matteo Salvini, was delighted with the verdict. He had already announced this at an election meeting at the beginning of May:
“From today on I will go to war on Cannabis street by street, shop by shop, neighbour by neighbour, city by city, street by street”.
The controversial politician had sworn to close all CBD shops, because “drug consumption must be fought with all means”. However, Salvini has little interest in the fact that the sale and consumption of CBD and other cannabinoid products has very little to do with the consumption of “drugs”. He bases his argumentation on a ruling by the Supreme Health Council in Italy (CSS) last year. In it, the CSS stated that the dangerousness of CBD could not be excluded.
In Italy’s current government coalition, this is likely to become another controversial issue. The “five-star movement” involved in the government is even in favour of a complete legalisation of cannabis in general. So it can only be hoped that the last word has not yet been spoken on CBD. However, the current state of affairs means the end for CBD in Italy for the time being.
Bulgaria grants approval for various CBD products
Many EU member states are still discussing fiercely whether CBD products fall under the Novel Food Regulation or not. Other countries even believe that CBD products fall under the Narcotics Law.
The Ministry of Agriculture, Forestry and Food and the Food Safety Authority in Bulgaria have now officially approved various CBD products from Kannaway. Kannaway is a subsidiary of the US cannabis company Medical Marijuana. These products are known for their exceptionally high price and low concentration of active ingredients.
This certifies that the CBD products comply with the requirements of food legislation in Bulgaria. The same applies to the regulations of the European Food Safety Union. This means that the products are also officially approved for export to other countries.
However, all other member states are currently reluctant to issue official approvals. Many EU countries also do not want to confirm the legal conformity of CBD products. This makes the first official approval of CBD products in Bulgaria under consideration of the Novel Food Regulation really an absolute speciality and great news. According to the European Industrial Hemp Association (EIHA), hemp and its products are traditional foods. As a consequence, free sale in Bulgaria is also allowed.
Furthermore, it is said that Bulgaria wants to allow further products in the future, so that other manufacturers can bring their products to the market without any problems. The European Hemp Association is therefore also receiving official confirmation of its definition of hemp and hemp products. It is of course desirable that other countries now follow the example of Bulgaria.
According to the Ministry of Health in Luxembourg, a working group is currently analysing questions and taking the first steps towards preparation. This also includes “very close contact” with colleagues in the Netherlands and Canada, the government announced. At the end of May, Health Minister Etienne Schneider would fly to Canada “to get a first-hand impression”.
In the future, every adult in Luxembourg will be allowed to grow, buy, own and consume cannabis for personal use. All under strict conditions, of course, which still have to be determined. The Grand Duchy hopes that this will dry up the illegal market with its associated procurement criminality plus less health risks for consumers – by ensuring better quality of the substance. The revenues from “the national production and sales chain under state control” are to flow into addiction prevention.
The recent threats by Italian Interior Minister Matteo Salvini against CBD companies have been described by political insiders as empty.
Salvini does not have the authority to actively close CBD sellers – although his ministry has issued guidelines calling on the local authorities who do so to intensify and strengthen controls on retailers.
Similarly, his threat to overthrow the government – Salvini is also chairman of the political party Le Lega (Northern League), one of the main members of the governing coalition – was dampened as several authorities said that cannabis was simply not on the agenda.
The Federal Public Finance Service (FPS Finance) said the sale of CBD flowers was legal. They can also be sold by tobacco dealers and are taxed under the same name as “other smoking tobaccos”.
This means a duty of 31.5% of the retail selling price plus €48.3083 per kg fee plus 21% VAT.
This clarification is only a department note – i.e. the change is not yet final.
– Introduction to hemp (cannabis) and medicinal qualities
– Hemp-based ingredients in cosmetic & personal care products
– Applications in topical & skincare products
– Issues when using hemp-based ingredients
– Future outlook: what can we expect to see in this area?
If you want to book a seat in the audience, please contact
These limits apply exclusively to commercial cultivation and processing. These products can NOT be sold to an end customer.
There is not only the risk that users could be tested positive for THC in a drug test and even lose their drivinglicense or their job in case of doubt – as a dealer you violate applicable laws.
In some EU countries ( UK, IT, DE, FR… ) the zero tolerance policy on controlled substances is already in place and the other countries will follow, as no country will voluntarily raise the THC acceptance threshold again.
Zero tolerance means a non-detectability by the authorities. And this value is < = 0.0005%.
Any dealer who sells CBD products containing more than 0.0005% THC is liable to prosecution. And this is not an administrative offence, but a trade in narcotics.
Please bear this in mind when choosing your supplier.
“The EIHA (European Hemp Association) wishes to reaffirm its position on hemp extracts. Until the presentation of the EIHA, the limit line of the naturally occurring CBD content was not defined as a percentage of the CBD. The EIHA can confirm that the natural concentration of cannabidiol in hemp biomass commercially grown in the EU is between 1-5% on a dry weight basis.
We should note that indoor hemp varieties may contain much higher levels of naturally present CBD. Although we accept that the Novel Food Catalogue is not legally binding and serves only as a guide for food business operators (FBOs) and regulators, this should be seen as a standard position for all Member States.
FBOs can expect products with a natural concentration of cannabidiol to be placed on the market and thus comply with European directives. European guidelines on “high levels of consumption”, which also play an important role in distinguishing between traditional and novel foods, were already published in 2012 and any food placed on the market should comply with them.
The raw materials used by us ( so-called hemp dry matter ) originate from licensed cultivation areas of the EU and demonstrably contain up to 16.5% naturally present CBD supported by official analyses of state institutions.
Therefore, the new EU directive would only apply to products containing more than 16.5% CBD. All products in lower doses are therefore considered to conform to EU guidelines.
In addition (this is very important for distributors of CBD products) the final product must not contain more than 0.0005% THC. Otherwise this could be punished as a violation of the BTMG.
The country’s health ministry written to the Commission setting out its plans to regulate the amount of THC which can legally be in products derived from hemp and low-THC cannabis.
The ministry told the EC it intended to limit THC content to 2 mg per kg (0.0002%) for hemp seeds, hemp seed flour, and food supplements derived from hemp seed.
However, hemp seed oils can contain up to 5 mg/kg (0.0005%).
Valeo CBD oils and capsules have always fallen below the 0.0005% detection limit and can therefore be traded in Italy without any problems even after this regulation comes into force.
The result has been a proliferation of “CBD oil” preparations, as they are generally known, which claim to contain cannabidiol. However, a recent article denounced several of these products as being fraudulent and not even containing CBD. The information was taken from a report by the US Food and Drug Administration (FDA), which analysed a number of products and concluded that they contained no trace whatsoever of CBD. It is also claimed that some products are manufactured with waste from cannabis plants intended for industrial use.
These problems stem from a lack of legal definition of cannabis-derived products, giving rise to interpretations that do not match the legal position.
In this context, products containing CBD are marketed as food supplements. However, under Spanish law, food supplements can only include vitamins or minerals, not plants.
In some countries, plants can be classified as food supplements and the Spanish authorities cannot oppose the marketing of products made with medicinal plants in the EU as food supplements. In this regard, the Court of Justice handed down a categorical ruling in its judgement of 5 March, 2009 on Case C‑88/07 (Commission of the European Communities v Kingdom of Spain) on the free movement of goods and products classified as medicinal products and products lawfully produced or marketed as food supplements or dietary products in other Member States.
CBD is a substance obtained through extraction from cannabis flowers. It can also be extracted from other parts of the plant, but the flowers contain the highest proportion. CBD is not a psychotropic substance and is therefore not covered by the 1971 Vienna Convention on Psychotropic Substances, unlike tetrahydrocannabinol (THC), which is also found in cannabis flowers.
However, given that CBD production requires cannabis flowers, it is important to note that the cannabis flowers themselves are classed as “narcotic” and are subject to administrative control. Whatever its medicinal utility, cannabis cannot be said to be a traditional medicine.
Royal Legislative Decree 1/2015, of 24 July 2015, approving the consolidated text of the act on guarantees and rational use of medicine and health products refers to a list of plants whose sale to the public will be restricted or prohibited. Although the list has not yet been made public, it seems clear that it will include cannabis, since it was already on the list included in the Ministerial Order of 2004, overturned by a sentence from the Spanish High Court (Audiencia Nacional).
The International Narcotics Control Board recalls that Article 28.2 of the 1961 Convention exempting cannabis crops intended for industrial purposes applies only to seeds and fibres and not to extracts. In the case of any cannabinoids contained in the plant and intended for medicinal purposes, the same controls on cultivation need to be applied as for opium.
According to the interpretation of the 1961 Convention on Narcotic Drugs, it is clear that extraction from cannabis flowers –regardless of their THC content or whether they are male or female– is subject to control, even if the purpose of the procedure is to obtain CBD (an uncontrolled substance) and not THC (a controlled substance). The underlying question is whether extraction can be used to obtain both substances.
In Spain, the cultivation of cannabis, regardless of THC percentage, intended for the production of flowers for extraction of any cannabinoid requires prior authorisation from the Spanish drugs and health products agency (AEMPS).
The AEMPS is aware of recent developments in the therapeutic use of cannabis, with the European Medicines Agency approving a number of applications for developing medicines with CBD for treating rare diseases, such as Dravet’s syndrome, perinatal asphyxia and glioma. Arising out of this approval, pharmaceutical companies can benefit from EU incentives for medicine development, such as reduced costs and protection from competition once the medicine has been marketed.
The AEMPS has therefore authorised a number of companies in Spain to grow cannabis for research purposes and to produce derivatives from cannabis extraction. One such firm has been authorised by the AEMPS to undertake an experimental project for “Production of flowers and leaves for the extraction of cannabinoids”. The AEMPS lists a series of prerequisites for cultivation: inter alia, the company may only send the products to other AEMPS-authorised organisations and its inspection department must be able to perform controls on the plants when so required.
Legal marketing of products with CBD in Spain is close to becoming a reality; all that is lacking is the involvement of the pharmaceutical industry in marketing of the products. On completion of the experimentation phase, the problem is to find companies that have the necessary machinery and are authorised by the Health Ministry.
For the time being, there are a number of products manufactured in other EU countries which benefit from the principle of free movement of goods. The EU member states that regulate cannabis as a food supplement are Germany, the United Kingdom, Belgium, Netherlands, Italy, and the Czech Republic.
Products manufactured in Spain do not have the necessary government authorisation and therefore cannot be sold openly on the market; instead they circulate in closed circuits or over the Internet. Given that they do not contain any controlled psychotropic substance, buyers are not breaking any law. However, these products do not offer even the most minimal guarantees with regard to their exact composition, meaning that users do not know what exactly they are and what real effects they may have.
Products manufactured by Valeo Laboratories are registered in Germany as dietary supplements and can therefore be marketed under the ValeoCare label in Europe without any problems and therefore of course in Spain.
Extraction / manufacture
No specific rules have been developed regarding extraction and manufacture of CBD. However, the OGYEI paper on CBD makes an inference about the use of hemp seeds for CBD extraction. We are quite sceptical as to what this means in practice since CBD extraction from hemp seeds is not very efficient, and all relevant the authorities avoid providing any interpretation. When it comes to topical products, Cosmetic Regulation No. EC 1223/2009 prohibits the use of cannabis flowers and fruiting tops from which the resin has not been extracted.
Import / export
As CBD is not under specific government control, its import and export should not entail any special requirements.
Pure CBD isolate / flowers
Flowers may not be used for CBD extraction for use in cosmetics (Regulation (EC) No. 1223/2009) or food products (Regulation (EC) No. 178/2002). However, it is not clear to what extent this is enforced. Hungarian national regulation does not provide any information on this issue.
According to the OGYEI CBD paper, THC content in finished product should be limited to:
10 mg/kg (0.001%) in hemp seed oil in food supplements
0.2 mg/kg (0.00002%) in other hemp seed derivatives in food supplements
up to 5-10 ppm (0.0005% – 0.001%) in cosmetics
There are no provisions limiting THC in e-liquid, however in our view they should be THC-free.
CBD food supplements are allowed on the Hungarian market. There is no regulation of CBD origin, so based solely on the OGYEI CBD paper we can infer that CBD can be extracted only from hemp seeds. The paper does not specifically ban extraction of CBD from other parts of the plant, but it does say that only hemp seeds can be used in the manufacture of food supplements. We believe the process of CBD extraction for use in food supplements would be considered to be manufacturing and therefore prohibited.
Maximum level of CBD in the final product is also unregulated; however, it seems the authorities consider that naturally occurring CBD in hemp seed can reach a maximum of 25mg/kg (0.0025%). Any concentration above this would be considered enriched, and therefore come the under category of novel food.
All dietary supplements, including those with CBD, must be registered with OGYEI before they are placed on the market. If the product has been available on the EEA (European Economic Area) market, the manufacturer or importer should note where the initial registration was made and submit the information initially provided to OGYEI. These details can be submitted in either Hungarian or English.
In addition, a data sheet – available in the Dietary Supplement Act, Annex 4 – should be submitted. The data sheet requires the following data to be disclosed:
Company information – name, contact information
Country of production, manufacturer name and contact information, markets where the product is available
When the product was placed on the Hungarian and EEA market
Composition, presented in descending order
Sensory attributes (colour, taste, fragrance, shape etc)
Label (to attach)
If imported, importer’s declaration if marketed in the country of production
Instructions for use
Name, production/expiry date.
The authority may request additional information. The manufacturer or importer should try to describe the components as accurately as possible and indicate the origin of CBD – where it was extracted from.
OGYEI confirms that hemp foods with “a higher amount” of CBD fall under Regulation 2015/2283 on novel food. However, the paper does not specify what is considered to be “a higher amount”. Referring to “hemp association data”, it says that naturally occurring CBD in hemp seed oil can reach a maximum of 25 mg/kg and everything above this content is considered enriched and cannot be legally marketed as food. This is a very low CBD content, which in practice means that all edibles with more than 0.0025% CBD have to obtain novel food authorisation before they are placed on the market.
In 2018, the European Commission requested information from EU member states about the use of other hemp parts (leaves, flowers, extracts of different plant parts etc) prior to 15th May 1997. If it is proven that food from other hemp parts was legally placed on the market, the list of novel foods will be updated.
All cosmetic products placed on the EU market must comply with the Cosmetic Regulation No. EC 1223/2009, which prohibits the use of cannabis flowers and fruiting tops from which the resin has not been extracted.
The ban is a consequence of the Single convention on narcotic drugs, Annex II no. 306, according to which cannabis is defined as the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted.
The EU CosIng – Inventory of Ingredients lists cannabidiol under restricted substances, referring to the same schedule, which is why it is possible that CBD extracted from flowers and fruiting tops cannot be commercialised in Hungary.
All cosmetic products must be registered online free-of-charge through the EC Cosmetic Products Notification Portal (CPNP). The act of registration does not mean that the product is compliant or safe. There is no need for a separate national registration of the product.
The OGYEI paper states that safe content of THC from hemp seed in cosmetics is less than 5-10 ppm.
The Cosmetics Act gives OGYEI authority over cosmetic products on the market, while enforcement is carried out by the district office for public health and consumer protection authority.
According to the TNRSG (Tobacco and Nonsmoker Protection Act), vegetable smoking products are subject to the statutory reporting and labelling obligations. Before a product is placed on the market or the composition of a product changes, all ingredients must be reported to the BMASGK.
It is imperative to comply with the THC value regulated in the Narcotic Drugs Act, which must not exceed the limit of 0.3% (the substance that is prohibited under the Narcotic Drugs Act and has the intoxicating known effect). In the context of tobacco law, this value must also be interpreted as meaning that the THC content is only considered to be lower if the THC content does not exceed 0.3% even after conversion of THCa into THC in the course of the combustion process.