There is a lot of confusion and wrong information about the legality of CBD products in Europe. In this article, we will give you answers to all your questions. We will provide you with the whole story and timeline. It is a long article, but hang in there, we will cover everything you need to know.
Let's start by understanding the EU legislation for food products.
Definition of 'Novel Food' in EU
The first Novel Food regulation was introduced in 1997 by Regulation (EU) 258/97 to establish a food safety mechanism to control newly developed, synthetic or genetically produced food. An updated version of the regulation came into force on January 1st, 2018 (Regulation (EU) 2015/2283).
According to art. 3, 'novel food' is defined as: "any food that was not used for human consumption to a significant degree within the Union before May 15th 1997".
If a food is considered novel, it must be authorized by the EU Commission and undergo a pre-market safety assessment by the European Food Safety Authority (EFSA) before legally being marketed in the EU.
The Novel Food Catalogue serves as a non-legally binding orientation on whether a product (of animal and plant origin and other substances) will need authorization under the Novel Food Regulation. The Novel Food Catalogue reflects the opinion of the Member States.
Cannabis in the Novel Food regulation
Until the end of 2018, extracts of Cannabidiol were considered novel only if the levels of cannabidiol was "higher than the CBD levels in the source Cannabis sativa L.".
The Standing Committee already decided in December 1997, and the Commission confirmed at the beginning of 1998 literally: "it was decided that foods containing parts of the hemp plant do not fall under the scope of the regulations EC 258/97" and also "that hemp flowers ... are considered to be food ingredients" (e.g. used for the production of beer-like beverages)".
Hemp flowers and leaves being parts of the hemp plant were not considered to be Novel Food.
Then suddenly everything changed in January 1999
In late 2018, the authorities in Austria and France decided to change their classification on cannabis and started to put pressure on the EU to change their opinion.
In January 2019, Member States' representatives updated the Catalogue entries for "Cannabis sativa L." and "Cannabinoids". These updates are demonstrably incorrect based on logic and historical facts, as relevant industry associations have repeatedly explained to the Member States and the European Commission. However, this will take years to correct.
The new entry for "Cannabis sativa L." did not mention hemp leaves and flowers. From this alone, it is evident that the changes, which seem to be hastily written, concerning the entries in the Novel Food catalogue were not correct. Moreover, the traditionally produced hemp extracts were also missing, although extraction is considered a traditional food processing method.
In the new entry for "Cannabinoids", extracts with a naturally occurring level of cannabinoids were now excluded, although they were mentioned in the previous entry formulation. Such products were already on the market and consumed before 1997 to a significant degree.
European Industrial Hemp Association (EIHA) convince the EU to add hemp ingredients in the EU Cosmetic Database (CosIng)
In October 2019, our industry organization EIHA.org published its position on hemp ingredients in the EU Cosmetic Database (CosIng).
The proposal was suggested the following categories be added as new INCI entries in the CosIng Catalogue:
• CANNABIS SATIVA LEAF EXTRACT
• CANNABIS SATIVA LEAF/STEM EXTRACT
• CANNABIS SATIVA ROOT EXTRACT
Immediately after receiving the proposal from EIHA, the EU decided to implement the entries and thereby legalized the use of natural cannabinoids in cosmetics.
Implications of the Court of Justice of the European Union in French court case C-663/18 (Kanavape case)
In November 2020, the Court of Justice of the European Union in Luxembourg released press release no. 141/20 about the judgment in French court case C-663/18. We have written about the critical changes in this article.
The court case is about two French directors of a company that distributed CBD vape oil for electronic cigarettes in France. The CBD was produced in the Czech Republic from legal hemp plants and extracted from whole plant biomass, including cannabis leaves and flowers.
In the judgment, the court finds that EU law, particularly the provisions on the free movement of goods between EU member states (which with the present free-trade agreements include Norway and Switzerland), precludes national legislation such as that at issue.
The court observed that the provisions on the free movement of goods within the European Union (Articles 34 and 36 TFEU) are applicable since the CBD at issue in the main proceedings cannot be regarded as a 'narcotic drug'.
Since November 2020, the ECJ ruling has changed the legal landscape for CBD products throughout the EU Member States in the last couple of months. Following the verdict, most local authorities have changed their legal stance on CBD products, which clearly defines that CBD extracted from the entire hemp plant (including leaves and flowers) should not be classified as a drug.
All bans of cannabis entries in cosmetics removed in February 2021
Since the ECJ ruling in November 2020, EIHA has asked for an update in the CosIng Database and have requested to lift the bans on Cannabis Sativa L. (restriction under II/306) and to integrate more INCI (International nomenclature of cosmetic ingredients) entries into the database.
More specifically, EIHA had asked the EU to remove all bans related to cannabis entries in the CosIng Database by considering that the ECJ's ruling explicitly refers to the whole cannabis plant approach (paragraph 76 of the Judgement). Furthermore, they have suggested that the EU add a new entry into the CosIng database called "CANNABIDIOL".
In February 2021, the EU has accepted this change and implemented CBD into the CosIng Database. You can see the brand-new entry for Cannabidiol following this link. Please notice that it is called "CANNABIDIOL - DERIVED FROM EXTRACT OR TINCTURE OR RESIN OF CANNABIS.
Furthermore, CBD has been added with the following functions: Anti-Sebum, Antioxidant, Skin Conditioning and Skin Protecting. These functions may now be marketed without giving CBD cosmetics products any medical effects.
The new classification also means that cannabis leaf extracts from naturally derived CBD are allowed in cosmetic products in the EU.
CBG (Cannabigerol) allowed in cosmetics in May 2021
The EU Commission has added CBG (Cannabigerol) to the CosIng database in May 2021. This means that CBG is now allowed to be used in cosmetics without any restriction. You can see the entry here.
Formula Swiss products are registered in the European Union and in The United Kingdom
All our CBD products - including CBD oils - are also registered as cosmetics in The European Union in the Cosmetic Products Notification Portal (CPNP). Consequently, we are one of the very few European cannabis companies that are not selling our CBD oils as food but as cosmetics, thus not violating The EU Novel Food Catalogue.
All EU Member States have direct access to the confidential information we have submitted into CPNP.
To claim cosmetic product status and register in EU is not enough
For each of our cosmetics products, we have a very detailed Product Information File (PIF), which we are by law not allowed to produce ourselves. It has to be produced by a third-party agency specialising in this area.
As part of the PIF documentation, we have also conducted mandatory skin testing on 50 test persons in independent laboratories in Germany and documented that our products are safe and do not cause any side effects when applied to the skin.
We are not aware of any other cannabis company in Europe that have completed the full registration and provided the extensive documentation incl. skin testing on 50 people per product.
Our EU Responsible Person is Publishing & Management ApS, Raadmandsgade 55, 2200 Copenhagen N in Denmark (company registration number 27290752).
We are also compliant in the UK with Formula Swiss UK Ltd.
We have established Formula Swiss UK Ltd. as a subsidiary in North Yorkshire and have duly notified the Office for Product Safety and Standards (OPSS) about all our cosmetic CBD products available to Great Britain consumers.
All our product information is available for the British authorities in the Cosmetic Product Notification Portal or 'SCNP', a similar system as the European Union's CPNP system.
For more information, please do not hesitate to contact us.
Conclusion
The classification of cannabis as a new food or drink to humans since 1997 is wrong. Still, we have to respect the classification until the European cannabis associations change it in the years to come.
The Novel Food catalogue is not a law but a non-binding classification. However, all EU Member States - as well as Norway and Switzerland - treat it as law without implementing local varieties based on the EU catalogue.
The result is that anyone promoting CBD products as food, drinks or oral consumption are breaking the law, according to the local authorities.
Claiming that a CBD product is for cosmetic usage is also not enough. The producer or first importer into the European Union must register the product in the EU database, provide a detailed Product Information File, and conduct mandatory skin testing on people in third-party laboratories. The full registration is a lengthy and costly process, so it is not surprising that very few companies in Europe - Formula Swiss included - has gone through the whole process for all their cosmetic products.
Even if a product is correctly classified as cosmetics in the EU database, the authorities can choose to declassify the product if it is being described or promoted as having any features, advantages or benefits that are not listed in the CosIng database. As such, a CBD oil tincture may not have dosage recommendations, nor may it have any kind of health or medical claims.
