Dear Mr Grootewal,

You have asked me to give you legal advice on the truffles cultivated and traded by your company Fresh Mushrooms. It concerns the underground substrate, or sclerotium, of the Psilocybe mexlcana, a psychoactive mushroom. Your company professionally cultivates these truffles from decades of experience.

Your product falls under the category of food supplements according to European guidelines, It fully complies with the applicable safety standards. In addition, due to its special cultivation method, it contains a constant quantity of psilocybin of 1 to 2 milligrams per gram of fresh truffle. This makes this company-grown truffle highly suitable for the therapeutic application of microdosing naturally-grown psilocybin.

As mentioned on your company's website, such administration can naturally contribute to overall better mental and physical functioning and treat psychological problems such as depression, addictions and post-traumatic stress disorder.

Your question concerns the legal status of your product in the Netherlands.

The status of the psychoactive truffle internationally

The truffle grown by your company naturally contains a small but constant amount of psilocybin.

Psilocin and psilocybin are listed as banned substances on list I of the 1971 United Nations Psychotropic Substances Convention. This means that countries party to the convention, including the Netherlands and the United States, among others, have an obligation to criminalise these substances.' They cannot be freely traded except under specific conditions for scientific and/or medical purposes.

Of relevance to your question is that the Psychotropic Substances Convention, however, sought to ban only the listed psychoactive substances and not the various organisms in which these substances naturally occur, such as, for example, the psychoactive mushroom and its underground substrate, the truffle'. At the United Nations meeting on the convention, one delegate said, "that it is not worth attempting to impose controls on biological substances from which psychotropic substances could be obtained."

Psychotropic substances occur naturally in various living organisms, including plants, cacti, mushrooms, fish and nuts. The drafters of the treaty explicitly recognised that attempting to ban these organisms would involve the eradication and destruction of an unpredictable variety of plants, animals and other living organisms. The official commentary on the treaty is perfectly clear about the fact that this was never the intention. Organisms that naturally contain psychoactive substances and are not listed as such are not under the control of the convention. This includes the psychoactive mushroom. In the words of the commentary:

"Neither the crown, fruit, mescal button of the Peyote cactus nor the roots of the plant Mimosa Hostilis nor Psilocybe mushrooms themselves are included in Schedule I, but only their respective active principals Mescaline, DMT and Psilocybe (Psilocin, Psilotsin)

This implies that states party to the Psychotropic Substances Convention have no obligation to criminalise psychoactive mushrooms or truffles. However, they are obliged to ban the substances psilocybin and psilocin themselves and not allow them other than for medical and/or scientific purposes.

The convention also gives individual member states the freedom to impose stricter restrictions on the possession and trafficking of psychoactive substances, or organisms in which they naturally occur. This iS happened twice in the Netherlands.

The status of the psychoactive mushroom in the Netherlands

The United Nations' INCB, or International Narcotics Control Board, which monitors member states' compliance with the Psychotropic Substances Convention, wrote to Dutch authorities in 2001 about psychoactive mushrooms:

"As yon are aware, mushrooms containing the above substance are collected and abused for their hallucinogenic effects. As a matter of international law, no plants (natural material) containing psilocin and psilocybin are at present controlled under the Convention on Psychotropic Substances of 1971. Consequently, preparations made of these plants are not under international control and, therefore, not subject to any of the articles of the 1971 Convention."

The Dutch Supreme Court followed this interpretation of the convention and thus decided in 1998 and 2002 that organisms that naturally contain psychoactive substances, such as hallucinogenic mushrooms and truffles, were not punishable, as long as they were not themselves listed as such in the lists of the Dutch Opium Act.

At the same time, however, the Supreme Court took the liberty of placing a restriction on this. Natural products that are not listed in the lists of the Opium Act but contain naturally banned psychoactive substances are not prohibited.

However, this becomes different, according to the Dutch Supreme Court, the moment these natural products have undergone any kind of processing, including, for example, grinding, mixing or active drying. The actively dried or otherwise processed psychoactive mushroom became a banned product in the Netherlands with this court decision, but the fresh psychoactive mushroom was thus officially declared legal in the Netherlands.

This case law is still valid. But the legal status of fresh psychoactive mushrooms also came to an end in 2008. At that time, the Dutch legislator took advantage of the freedom given to it by the Psychotropic Substances Convention and reintroduced more far-reaching restrictions than the treaty mandated. On 1 December that year, a range of psychoactive mushrooms were placed on list II of the Opium Act.

This included the Psilocybe mexicana, whose underground substrate your company grows. The Psilocybe mexicana mushroom has thus been a banned product in the Netherlands since 2008.

The status of the psychoactive truffle in the Netherlands

However, this does not apply to the truffle, or underground substrate, of this Psilocybe mexicana. This is because the Opium Act explicitly bans only the psychoactive mushrooms placed on its List II in 2008 and not the sclerotium or truffle from which they can grow. This means that fresh truffles from banned psychoactive mushrooms have remained legally marketable in the Netherlands. They do not fall under the prohibited substances added to the Dutch Opium Act in 2008.

In criminal law, the so-called principle of legality applies, according to which no act is punishable except by virtue of a prior explicit criminalisation.

It follows from this principle that a particular offence cannot be interpreted extensively by the court. Now that it is generally scientifically accepted, that the truffle, the sclerotium, is not a mushroom, the said principle of legality implies that the truffle does not fall under the prohibitions of the Opium Act, newly introduced in 2008. The latter has also been recognised twice, in 2009 and 2011, by the Dutch health minister to the House of Representatives. It is an explanation consistent with the 1971 Psychotropic Substances Convention, as indicated above.

It means for you that Psilocybe Mexicana truffle can be freely produced, traded and exported in the Netherlands. It can also be freely provided to third parties in therapeutic sessions. It is a legal product in the Netherlands, as long as it has not undergone any active processing'.

This legal status of the psychoactive truffle in the Netherlands has allowed your company Fresh Mushrooms to build up years of experience in growing high-quality psychoactive truffles, also suitable for the therapeutic application of microdosing.

The export of the psychoactive truffle to other countries

The Psilocybe mexicana truffle can be freely exported from the Netherlands. But in the country where the product is imported, the status of this product will have to be checked again. The legal status of the product may differ per country.

The product does not fall under the control of the Psychotropic Substances Convention, as described above, and this means that the member states have no obligation to criminalise it. However, the Member States are free to ban this product in their national legislation. This does not alter the fact that the export of the product from the Netherlands takes place legally.

We are currently seeing many developments around the medical and therapeutic use of psilocybin and psilocin, both in the Netherlands and abroad. Governments are becoming increasingly aware of their positive obligation to safeguard the health of their citizens. Criticism of many modern drugs, such as anti-depressants, is swelling and there is a growing awareness that natural products used for centuries could provide a good alternative to these. It is a good development that more and more scientific research is being conducted into this.

The state of Oregon in the United States serves as an important and interesting example in this regard. In November 2020, the people there voted in favour of a new law that aims to regulate, through licensing, the production and dispensing of psilocybin for therapeutic and medicinal treatments. I do not rule out that this development in Oregon will be followed more widely in the near future.

The Psilocybe mexicana truffle cultivated by Fresh Mushrooms seems eminently suitable for such novel medicinal and therapeutic applications.

Hoping to have informed you to your satisfaction with this,

Ms A. G. van der Plas

Bakker, Schut and Van der Plas - Amsterdam law firm

Mutual recognition of goods

This page has been translated verbatim from the website:

https://single-market-economy.ec.europa.eu/single-market/goods/free-movement-sectors/mutual-recognition-goods_en

 The principle of mutual recognition guarantees market access for goods that are not, or only partially, covered by EU harmonisation legislation. It guarantees that any good lawfully sold in one EU country can also be sold in another. This is possible even if the good does not fully comply with the other country's technical regulations (although there may be exceptions when public safety, health or environmental concerns are involved).

What the European Commission is doing

Technical rules developed at national level can create unnecessary obstacles to intra-EU trade. The Commission aims to:

• guarantee the free movement of goods
• ensuring that EU countries accept goods lawfully marketed in another EU country unless very specific conditions are met (these conditions relate to the protection of public safety, health or the environment)

The principle of mutual recognition should not be confused with mutual recognition agreements that facilitate access to markets between the EU and non-EU countries.

How does the principle work?

The principle derives from Articles 34-36 of the Treaty on the Functioning of the European Union and is further defined in Regulation (EU) 2019/515 on mutual recognition of goods lawfully marketed in another country. Regulation 2019/515 applies from 19 April 2020 and replaces Regulation (EC) No 764/2008. This regulation defines the rights and obligations regarding the principle of mutual recognition for competent authorities and companies when selling goods in another EU country.

It describes how mutual recognition should be applied in individual cases. It includes:

• a clearly defined assessment procedure to be followed by competent authorities when assessing goods
• mandatory elements to be included in an administrative decision restricting or refusing market access
• a voluntary 'declaration of mutual recognition', which companies can use to demonstrate that their products have been lawfully marketed in another EU country (practical advice on the mutual recognition declaration is available)
• A user-friendly dispute resolution procedure, based on SOLVIT, which includes the possibility of an assessment by the Commission on the compatibility of a decision to restrict or deny market access with EU law
• enhanced administrative cooperation to improve the application of the principle of mutual recognition, for example through the Information and Communication System for Market Surveillance (ICSMS)
• more information for businesses through strengthened 'product contact points' (see below) and the 'single digital gateway'

The Commission's opinions

The Commission issued its first advice adopted under the Mutual Recognition of Goods Regulation.

The main points of the opinion are that:

• Regulation (EU) 2019/515 on mutual recognition of goods is directly applicable
• authorities must take the necessary measures to remedy a deficiency in the application of a legal act that is binding and directly applicable in its entirety, using the existing remedies available in the national administrative procedure
• remedying the authority's failure to apply Regulation (EU) 2019/515 should not impose an additional burden on the operator
• the competent authority should always verify, and if necessary, apply Regulation (EU) 2019/515 before or when it decides that non-harmonised goods are not in conformity with national technical rules, whether or not the economic operator invokes the application of Regulation (EU) 2019/515
• administrative decisions must include the reasons for the decision as well as the elements listed in the regulation
• competent authorities must notify other EU countries and the Commission of their administrative decision via ICSMS within 20 working days from the day of the decision 

The Commission adopted its second opinion adopted under Article 8 of the Mutual Recognition of Goods Regulation.

The main points of the opinion are that:

• in case the competent national authority considers that documents and information necessary for the assessment of the goods in relation to the national technical rules are missing, it should invite the economic operator and give him at least 15 working days to submit the requested documents and information
• remedying the authority's failure to apply Regulation (EU) 2019/515 should not impose an additional burden on the operator
• administrative decisions must include the reasons for the decision as well as the elements listed in the Regulation
• competent authorities must notify other EU countries and the Commission of their administrative decision via ICSMS within 20 working days from the day of the decision

The Commission adopted its third, fourth and fifth opinion adopted under the Mutual Recognition of Goods Regulation.

 The three opinions, which are similar, point out that national administrative decisions refusing sales authorisation for non-harmonised goods lawfully marketed in another EU country should:

• set out the reasons in a manner that is sufficiently detailed and reasoned (Article 5(10) of the Regulation)
• contain the technical or scientific evidence considered (Article 5(11)(c) of the Regulation)
• include evidence that the decision is appropriate and proportionate (Article 5(11)(e) of the Regulation)

The three decisions in question, first, do not sufficiently state the technical or scientific evidence considered by the competent national authority and, second, do not contain sufficient evidence that they are appropriate and proportionate.

The Commission adopted its sixth opinion adopted under Article 8 of the Mutual Recognition of Goods Regulation.

The main points of the opinion are that:

• the principle of mutual recognition of goods does not apply to goods originating in and imported directly from third countries
• the Regulation does not apply where the goods come from and are imported directly from a third country and have not yet been released for free circulation, since they are not goods to which Article 34 TFEU applies, whereas Article 1(2) of the Regulation provides that it applies only to goods to which Article 34 TFEU applies
• the national administrative decision in question did not infringe the Regulation, since that Regulation does not apply in this case

Product contact points

Product contact points have been set up in each EU country to provide free advice on the Mutual Recognition Regulation within 15 working days.

Guidance on Regulation (EU) 2019/515 on mutual recognition

This guideline explains various aspects of the regulation, including the declaration of mutual recognition for companies and the assessment of goods by national authorities. It also provides practical information on support services provided by SOLVIT centres and product contact points.

Training on mutual recognition

In January 2021, the Commission organised two types of training sessions on mutual recognition:

• 'Train the trainers' - for experts from EU, EEA and EFTA states and Turkey who will deliver training on mutual recognition in their respective countries and languages. The course material is available in all official EU languages.
• 'Training on mutual recognition and ICSMS' - aimed at competent authorities applying the principle of mutual recognition in their daily work. As these authorities report their decisions to deny or restrict market access through ICSMS, we also demonstrated the use of the new mutual recognition module in ICSMS. The course material is available in all official EU languages.

A short summary of the regulation on mutual recognition for companies is also available in all official EU languages.

Guidance documents for Regulation 764/2008

The following guidance documents were available for withdrawal Regulation 764/2008:

• The relationship between the regulation 764/2008 and Directive 98/34/EC on the provision of information in the field of technical standards and regulations
• The concept of 'lawfully marketed' in the regulation 764/2008
• The application of the regulation 764/2008 to articles of precious metals
• The relationship between the regulation 764/2008 and Directive 2001/95/EC on general product safety
• The application of the regulation 764/2008 to food supplements
• The application of the regulation 764/2008 to narcotic drugs and psychotropic substances
• The application of the regulation 764/2008 to prior authorisation procedures
• The application of the regulation 764/2008 to weapons and firearms
• The application of the regulation 764/2008 to fertilisers and growing media
• The application of the regulation 764/2008 to non-CE-marked construction products

Contact

grow-mutual-recognition@ec.europa.eu