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CBD LEGISLATION AND REGULATION IN EU
In recent years, the demand for cannabidiol (CBD), a phytocannabinoid from the Cannabis Sativa L plant, has increased significantly. Rezultatŭt e razprostranenie na produkti s „CBD maslo“, kakto e dobre izvestno, za koito se tvŭrdi, che sŭdŭrzhat kanabidiol. Skoroshna statiya obache ustanovi, che nyakoi ot tezi produkti sa izmamni i dori ne sŭdŭrzhat CBD. Informatsiyata idva ot doklad na Amerikanskata administratsiya po khranite i lekarstvata (FDA), koĭto analizira nyakolko produkta i zaklyuchava, che te ne sŭdŭrzhat sleda ot CBD. Sŭshto taka se tvŭrdi, che nyakoi produkti sa napraveni ot ostatŭtsi ot rasteniya kanabis, prednaznacheni za promishlena upotreba. Mostrar más 508 / 5.000 Resultados de traducción star_border The result is a proliferation of "CBD oil" products, as they are commonly known, that claim to contain cannabidiol. However, a recent article found that some of these products are fraudulent and don't even contain CBD. The information comes from a report by the US Food and Drug Administration (FDA), which analyzed several products and concluded that they contained no trace of CBD. It is also alleged that some products are made from the remains of cannabis plants intended for industrial use.
These problems are due to the lack of legal definition of cannabis products that lead to interpretations that are not consistent with the legal situation.
In this context, CBD-containing products are marketed as dietary supplements. However, according to Spanish law, dietary supplements can only contain vitamins or minerals, not plants.
In some countries, plants can be considered dietary supplements and the Spanish authorities cannot oppose the marketing of medicines in the EU as a dietary supplement. In this regard, in its ruling of March 5, 2009 in case C-88/07 (Commission of the European Communities against the Kingdom of Spain), the Court of Justice legally regulated the free movement of goods and products in other Member States . Dietary supplements or dietary products are purposefully manufactured or marketed.
CBD is a substance obtained by extracting from cannabis flowers. It can also be obtained from other parts of the plant, but the flowers contain the bigest amount. 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, as the production of CBD requires cannabis flowers, it is important to note that cannabis flowers themselves are classified as “narcotics” and are subject to administrative control. Whatever its medical benefit, cannabis cannot be called traditional medicine.
Royal Legislative Decree 1/2015 of 24 July 2015, which approves the consolidated text of the Law on the Guarantees and Rational Use of Medicines and Medical Devices, refers to a list of plants whose sale to the public is restricted or prohibited. Although the list has not yet been published, it seems clear that it will contain cannabis, as it was already on the list of ministerial decrees from 2004, which was overturned by a decision of the Supreme Court (National audience).
The International Narcotics Control Board recalls that Article 28 (2) of the 1961 Agreement on the Exemption of Industrial Cannabis Cultivations applies only to seeds and fibers and not to extracts. For cannabinoids contained in the plant and intended for medicinal purposes, the same cultivation controls as for opium should be used.
It follows from the interpretation of the 1961 Narcotic Drugs Convention that the extraction of 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 CBD ) and not THC (a controlled substance). The underlying question is whether both substances can be extracted by extraction. In Spain, the cultivation of cannabis, regardless of the percentage of THC intended for the production of flowers for the extraction of cannabinoids, requires prior approval from the Spanish Agency for Medicines and Health Products (AEMPS). The legal marketing of products with CBD in Spain is about to become a reality; All that is missing is the participation of the pharmaceutical industry in the marketing of the products. After completing the testing phase, the problem is to find companies that have the necessary machinery and are approved by the Ministry of Health.
There are currently a number of products manufactured in other EU countries that benefit from the principle of free movement of goods. The EU member states that regulate cannabis as dietary supplements are Germany, the United Kingdom, Belgium, the Netherlands, Italy, and the Czech Republic.