– 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?
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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.