Our cannabis lawyers has been involved in the legal aspects of the changing Dutch market for Cannabis products. The Netherlands allows products that are high in cannabidiol (CBD) and low in THC (tetrahydrocannabinol). Cannabis in products in the Netherlands including drinks are allowed without exemption if:
- the amount of THC does not exceed 0.05%
- the product should not bear a medical claim
- the buyer should not be advising to take in more than 160 mg CBD per day.
- The use of THC extracted from a weed plant is not allowed in a product the Netherlands. Depending on the product it may be necessary to consult The Netherlands food and consumer product safety authority (NVWA).
What you need to know about the Dutch Act on Drugs (Opium Act)
- The distinction between hard and soft drugs markets is reflected in the Opium Act (Opiumwet). List I contains all substances considered hard drugs and List II substances considered soft drugs. Cannabis, hemp and hashish are on List II. List I contains hard drugs such as cocaine, ecstasy, LSD and opiates. The government regards List II as less harmful to consumers than List I and allows controlled sale of cannabis for recreational use in coffeeshops. In article 5 Opium Act, the competence to control and license Dutch coffeeshops is granted to municipalities. Under article 8 of the Opium Act, these exemptions may be granted for certain purposes. You may also be interested in: Dutch cannabis law and regulation.
Exemption under the Dutch Controlled Substances Act
- For products exceeding the abovementioned criteria you may apply for an exemption (ontheffing under the Opium Act) from the statutory prohibition of growing, dealing, selling of drugs including cannabis. An application for an exemption under the Dutch Opium Act should be filed with the Dutch Office of Medical Cannabis. Exemption under Section 8, paragraph 1 (a-c) of the Dutch Opium Act is only granted for the following purposes:
- public health
- animal health (with a distinction between exemptions for training sniffer dogs and other exemptions)
- academic or chemical analytical research
- training
- trade-related purposes.
- In general the Opium Act exemption “in the interest of public health or of the health” of animals fall under the general exemption for, for example, doctors, veterinary surgeons, pharmacists or institutions. Applications for dealing with Opium Act drugs which do not fall under this exemption, but are deemed to be in the interest of public health or that of the health of animals, may also be filed under this exemption. In that case, an exemption may be granted under this category. The Cannabis Bureau has issued several exemption for medical cannabis products, also for foreign applicants.
Dutch Policy Guidelines on Opium Act Exemptions
- Policy guidelines have been drawn up with a view to deciding applications for an Opium Act Exemption. They further develop the criteria mentioned in the Act which will be applied in the decision on an application for an exemption. They also indicate the restrictions and conditions which may be attached to an exemption. The fees which are associated with obtaining an exemption are also mentioned. An exemption may be granted which is subject to restrictions. The Cannabis Bureau may attach conditions to an exemption. Restrictions and conditions to an exemption will depend on the nature of the application and may differ in each case. Please do note that growers will be required to sell their entire harvest to BMC. Condition may be imposed on the exemption is that unnecessary hemp crops be destroyed Conditions to the exemption will cover the number and type of Opium Act drugs to which the exemption relates, the acts which may be performed under the exemption, the purpose for which the exemption has been applied for, adequate security measures regarding the Opium Act drugs present, proper records, cooperation with the Dutch Health Inspector in monitoring compliance with the exemption and other Dutch legislation.
Novel Food Catalogue and Cannabidiol(CBD)
- The Novel Food Catalogue van de EU (Regulation 2015/2283) is a non-binding catalogue.
- Extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel’. ‘While the Novel Food Catalogue is non-exhaustive and carries no legal power, it is frequently updated and amended with input from Member States, and is used as reference by authorities in EU countries to aid enforcement of Novel Food Regulations. It has been reported that the UK was one of a group of countries which requested an update to the catalogue, due to a previous lack of clarity of the status of CBD and other hemp-derived products. The change has been followed by news that the UK Food Standards Agency will now seek to have CBD food products removed from shelves while the current application to authorize its use is considered. Check: https://www.hanway.associates/news-opinion/eu-novel-foods-cbd
CBD needs to be approved for using in food in the Netherlands
- Regarding whole plant extracts, a “Grey Zone” will remain for some time. In regards to CBD, moving forward, companies operating in the “Grey Zone” may slowly be excluded from the whole EU market once particular products are banned. However at the moment CBD products are widely offered on the Dutch market and the Dutch Food Authority is not enforcing any ruels to stop sales. The new Novel Food Regulation is supposed help national regulators find and ban products that have no novel food authorization and/or are not extracted from varieties of hemp from the Common Catalogue of Varieties of Agricultural Plant Species. Howver, the Dutch authority has not doen anything sofar regarding CBD. A promised statement in 2019 was not issued.
Business integrity screening under Dutch BIBOB Act
- Extensive Business screening of the applicant will be part of the exemption procedure under the Dutch Substances Act.
- Our law firm assists clients with integrity screening procedures which occur also in other branches in the Netherlands. Exemption applicants may be subjected to a security screening, which will include a request to submit administrative and financial data through annual reports with explanations and a so-called Declaration concerning the conduct of the applicant or – in the case of legal entities – of the legal entities directors, managers, shareholders, financiers, etc.
Product file for Cannabis Products
- The applicant for a Dutch Cannabis Exemption should forward a quality file for the product. The product characteristics must be carefully recorded in the product file. The product file must include a description of what the growing conditions of the cannabis are (like intensity of light, temperature, dampness and fertilization), the specifications of the product grown under these conditions and how there can be monitoring that the product meets these specifications. The production process should prove the conditions for being able to develop a reproducible product or medicine. The selected grower must be able to demonstrate that he is able to deliver such a standardized product within a reasonable time.
- Policy guidelines have been drawn up with a view to deciding applications for an Opium Act Exemption. They further develop the criteria mentioned in the Act which will be applied in the decision on an application for an exemption. They also indicate the restrictions and conditions which may be attached to an exemption. The fees which are associated with obtaining an exemption are also mentioned. An exemption may be granted which is subject to restrictions. The Cannabis Bureau may attach conditions to an exemption. Restrictions and conditions to an exemption will depend on the nature of the application and may differ in each case. Please do note that growers will be required to sell their entire harvest to BMC. Condition may be imposed on the exemption is that unnecessary hemp crops be destroyed Conditions to the exemption will cover the number and type of Opium Act drugs to which the exemption relates, the acts which may be performed under the exemption, the purpose for which the exemption has been applied for, adequate security measures regarding the Opium Act drugs present, proper records, cooperation with the Dutch Health Inspector in monitoring compliance with the exemption and other Dutch legislation.
Advice from a Dutch Cannabis Lawyer
- Dutch legislation on cannabis has its peculiarities. Regulation is not well taken care of in all areas. Take for example the import or export exemption and the import and export of cannabis and cannabis resin. This exemption will be handled by a special inspector of the Health Care Inspectorate. The Cannabis Bureau may wish to enter into a contract that you may wish to be reviewed. Our lawyers are in touch with the authorities involved and can therefore deal with issues instantly.
- Please do not hesitate to discuss your cannabis product with one our lawyers.