Following California, Spain also declares CBD illegal to sell for human consumption until it will properly register the molecule as a food supplement… Other EU countries are considering their actions.
Is CBD illegal? EFSA (European Food Safety Authority), the European agency responsible for regulating all what has to do with food (among other things, food supplements) has issued a statement regarding the legality of CBD. According to EFSA, until the European Union regulates CBD, it is illegal to use it as a food supplement. Therefor, effective immediately, it is prohibited to distribute all food supplements containing CBD.
EFSA has informed all the member countries of the European Union through its corresponding agency in Spain, AECOSAN (Agency for Consumer Affairs, Food Safety and Nutrition), the immobilization of all the products qualified as FOOD SUPPLEMENTS containing CBD.
AECOSAN, through the Health Ministries of the different Autonomous Communities, has informed the companies in charge of their production or distribution that they are paralyzed until Europe regulates them.
In short, the affected companies in Spain should communicate the withdrawal of these products from all the businesses where their sale is offered as a food supplement. In this sense, EFSA bases its decision on the qualification of the CBD as “new food” without any regulation.
So, is CBD illegal? We must remember that CBD is a non-audited product, that is, it is NOT ILLEGAL, but effective immediately, it is also not legal to use as food supplement.
Until CBD is on the list, it is illegal to sell for human consumption, and, therefore, it is banned until the Spanish wake up from their siestas and put it on the list.
Let’s dive into CBD regulations, to understand the true meaning of this announcement, how big pharma companies are involved, if at all and is CBD illegal in Spain?.
The CBD molecule in crystalline form (99% purity) is first and foremost regarded in Spain and most legal hemp countries as a cosmetic product, “for external use only”. That is the default definition of use in majority member states of Europe.
“For external use only” (ie; cosmetic dermal creams and balms) is one of the labeling requirements needed on a CBD product to be registered legally and sold in Spain. It is illegal to sell it for human consumption, but only as a “technical product”. The meaning of that, be creative.
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 SPAIN, CBD has not yet been registered as a food supplement in the “authorized food supplement list” of the Spanish drugs and health products agency (AEMPS). It states the vitamins and minerals allowed for human consumption by SPANISH law, and CBD is not defined in Directive 2002/46 / EC of the European Parliament (transposed into Spanish law by Royal Decree 1487/2009 amending Royal Decree 130/2018).
By application of the principle of mutual acknowledgment, food supplements that contain ingredients other than the vitamins and minerals indicated in the authorized lists may be placed on the Spanish market only in the event that it is verified that the product in question may be placed on the market legally in another European Union Member State. It is not, however, permitted to apply said acknowledgment to products coming from countries that do not belong to the European Union.
Is CBD illegal? Only a few of the majority EU member states, recognize CBD as a nutritional food supplement
Only a few of the majority EU member states, recognize CBD as a nutritional food supplement,“for human consumption”. The Czech Republic was the first to regulate CBD as a food supplement, today also Germany, Holland,Italy and some others, all with their own local laws and regulation problems.
Until more regulations are put in place to ensure safety and Good Practices, CBD will have to wait patiently like any new food product on the market which needs verification of supply. Rest assured there will always be an area of legal maneuvering and description of products to secure free movement of goods from point A-to-B.
According to Miguel Torres, a lawyer and lecturer in International Private Law at the Law School of the University of Barcelona:
“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.”
It sounds very strange knowing that EPIDIOLEX®, a compound from GW Pharmaceuticals, was recently accepted the in the Spanish pharmacopoeia, a drug that is an extract from CBD. So why do we say that they have made it illegal? We say it because it has officially become a reality, possibly a decision influenced by strong lobby of big pharma companies with interest, unfortunately for many people.
On a personal note, this ruling is scandalous because it is a complete ethical nonsense!
On the one hand, the WHO made a recommendation strengthening the safety of CBD extracts, in December of last year and on the other hand they have prohibited its use as a food supplement.
Rest assured, there will always be a legal pathway of maneuvering and description to get products out there from point A-to-B.
A grossly misleading article which is really appalling journalism, distorting the facts in a sensationalist and completely inaccurate way.
The EFSA declared CBD isolate a ‘novel food’ in January so your idea that this ‘breaking news’ is ridiculous. CBD isolate may not be used in any product that is ingested and is only permitted in cosmetics, topicals and vape products.
This has NO IMPACT WHATSOEVER on the whole plant extracts containing CBD that represent the vast majority of the CBD market.
CBD isolate has never been a very popular product anyway. It is nowhere near as effective as whole plant extracts.~
I repeat, this is disgraceful, misleading reporting and if you have any ethical standards or concern for accuracy you should amend it immediately.
Hi Peter, read the fine print and open the links connected to this article. We are not saying CBD is banned forever only that EFSA has declared formally that CBD is NOT for human consumption (oils & crystals) UNTIL conformaty of testing and good practices are implimented for the safety of the public. Today nothing is regulated and “novel foods” if declared as such need regulation and validation of supply.
If you do not produce your supply in GMP standards you cannot supply the public. It’s logical , even if we dont like it., I am sorry.
You may explain it in the “fine print” but your headline and the overall thrust of your article is highly misleading. It’s not “oils and crystals” that have been determined as a novel food, it’s CBD isolate. Most oils are whole plant extracts which are not affected at all.
Neither is it anything to do with GMP certification. Getting a novel food authorised is far more complex.
At the Cannabis Trades Association we have been communicating this to members and through them to consumers since January in a responsible and accurate way. We liaise with the EFSA and the UK FSA on a regular basis. To repeat, most CBD products are entirely unaffected as they do not use isolate, they are whole plant extracts.
Nimm Terkel is the VP of sales for CBD-Testers with more than 10 years experience in the global and Israeli cannabis industry. He has accumulated vast knowledge, experience and understanding in regulations and market development of cannabis based products in the US, Israel and Europe.
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A grossly misleading article which is really appalling journalism, distorting the facts in a sensationalist and completely inaccurate way.
The EFSA declared CBD isolate a ‘novel food’ in January so your idea that this ‘breaking news’ is ridiculous. CBD isolate may not be used in any product that is ingested and is only permitted in cosmetics, topicals and vape products.
This has NO IMPACT WHATSOEVER on the whole plant extracts containing CBD that represent the vast majority of the CBD market.
CBD isolate has never been a very popular product anyway. It is nowhere near as effective as whole plant extracts.~
I repeat, this is disgraceful, misleading reporting and if you have any ethical standards or concern for accuracy you should amend it immediately.
Hi Peter, read the fine print and open the links connected to this article. We are not saying CBD is banned forever only that EFSA has declared formally that CBD is NOT for human consumption (oils & crystals) UNTIL conformaty of testing and good practices are implimented for the safety of the public. Today nothing is regulated and “novel foods” if declared as such need regulation and validation of supply.
If you do not produce your supply in GMP standards you cannot supply the public. It’s logical , even if we dont like it., I am sorry.
You may explain it in the “fine print” but your headline and the overall thrust of your article is highly misleading. It’s not “oils and crystals” that have been determined as a novel food, it’s CBD isolate. Most oils are whole plant extracts which are not affected at all.
Neither is it anything to do with GMP certification. Getting a novel food authorised is far more complex.
At the Cannabis Trades Association we have been communicating this to members and through them to consumers since January in a responsible and accurate way. We liaise with the EFSA and the UK FSA on a regular basis. To repeat, most CBD products are entirely unaffected as they do not use isolate, they are whole plant extracts.