oem cbdDecember 15, 2021
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.
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.
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.
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.
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.
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.
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).
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 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.
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.
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.
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.
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.
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.
Note: All of our CBD containing cosmetics are registered, approved and comply with all European regulatory requirements. Our CBD products are exclusively made from leaf extracts of approved hemp varieties and are available as white label, OEM, or private label products even in small quantities.
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