Amend­ment to Germany’s New Psycho­active Substances Act: Nation­wide regu­lations to combat the misuse of nitrous oxide and “knock-out” drugs

A. Introduction

On 2 July 2025, Germany’s federal cabinet adopted a bill to amend the New Psychoactive Substances Act (Neue-psychoaktive-Stoffe-Gesetz – NpSG). The proposal from the Federal Ministry of Health aims to address the increasing abuse of nitrous oxide (“laughing gas”), gamma-butyrolactone (“GBL”), and 1,4-butanediol (“BDO”). The bill will soon be introduced into the parliamentary process and then passed by the Bundestag. The amended New Psychoactive Substances Act is planned to come into force three months after its promulgation.

The bill has been in discussion for some time. The previous government identified a need for action in this area and, last year, planned to introduce a nationwide ban on the sale, purchase and possession of nitrous oxide as a narcotic in order to prevent the misuse of laughing gas as a recreational drug and of GBL and BDO. However, this plan was not implemented due to the early elections in February 2025. In the meantime, various local authorities have felt the need to issue municipal ordinances to prevent the sale and distribution of nitrous oxide. For example, the city of Dortmund in North Rhine-Westphalia introduced a local ban (see our Noerr Insight from 14 February 2025).

In the coalition agreement for the current legislative term, the CDU, CSU and SPD agreed to present a regulation on the distribution of nitrous oxide and GHB (gamma hydroxybutyrate)/GBL (Coalition agreement: Responsibility for Germany, page 112, line 3589). The government is now honouring this announcement.

B. Need for regulation: Misuse of nitrous oxide, GBL and BDO is a major health hazard

In Germany, nitrous oxide is used not only for commercial and medical purposes but is increasingly consumed as an intoxicant, particularly by teenagers and young adults. Its use has risen significantly in recent years. According to a study by Goethe University Frankfurt, in 2022, around 17% of respondents aged 15 to 18 had used nitrous oxide at least once, and 6% had used it within the last 30 days. In comparison, these figures were just 7% and 0.3%, respectively, in 2020. The misuse of nitrous oxide carries unpredictable and potentially serious health risks. Germany’s Federal Institute for Risk Assessment outlined these risks in a recent statement.

Legally, only the marketing and use of medical nitrous oxide, which as a medicinal product is regulated by the German Medicinal Products Act, are prohibited under its section 95(1)(1) and are subject to specific quality requirements starting from section 54. However, these regulations do not apply to technical nitrous oxide, which is frequently abused as an intoxicant and is not subject to comparable legal restrictions. Technical nitrous oxide is widely used as an industrial chemical and is therefore traded in large quantities. It is commonly found as a propellant in everyday products, such as cans of whipped cream.

The substances GBL and BDO, commonly known as “knockout drugs,” are not currently regulated by the German Narcotics Act (Betäubungsmittelgesetz – BtMG), the New Psychoactive Substances Act, or the German Medicinal Products Act. Their unrestricted availability is particularly problematic because, in addition to being misused for recreational purposes, they are often used to commit criminal offences such as sexual assault. GBL and BDO also have widespread industrial uses, especially as solvents, and are therefore traded in large quantities. They can be found in everyday products such as nail polish removers and façade cleaners.

C. Regulatory objective: Addressing misuse of nitrous oxide, GBL and BDO while allowing recognised uses

The proposed legislation seeks to amend the New Psychoactive Substances Act to more effectively regulate the misuse of nitrous oxide, GBL and BDO for intoxication purposes or to exploit their mind-altering effects, and to close existing legal loopholes in criminal law. It aims to address the serious health risks associated with the consumption of these substances and limit their ubiquitous availability. To protect children and young people, it will prohibit the sale and transfer of these substances to minors as well as purchase and possession by minors.

At the same time, the bill aims to take into consideration that these substances are essential bulk chemicals in industry and, as such, cannot easily be replaced. Therefore, only dosage forms, concentrations and distribution channels that are particularly susceptible to misuse should be subject to restrictions. For this reason, regulation is planned under the framework of the New Psychoactive Substances Act rather than the Narcotics Act. Placing these substances under the Narcotics Act would have far-reaching consequences, especially due to the authorisation requirements and extensive reporting obligations it imposes, which would significantly disrupt legitimate trade in these substances.

D. What exactly will change?

The amendment of the New Psychoactive Substances Act involves a wide range of changes to standardise in law the goals set out in C. In detail:

Annex 2 listing individual substances added to the New Psychoactive Substances Act

The current annex to the New Psychoactive Substances Act only lists groups of substances. As a result, a substance or a preparation containing it must belong to one of these listed groups to fall within the definition of a “new psychoactive substance”. However, nitrous oxide, GBL and BDO cannot be classified under these groups due to their chemical structure and therefore are not currently covered by the Act. To close this regulatory loophole, the New Psychoactive Substances Act will be amended to include a new Annex 2, modelled on the Narcotics Act, which will serve as a positive list of individual substances that cannot be assigned to the substance groups in Annex 1 due to their chemical structure. The bill aims to include nitrous oxide, GBL and BDO in this new Annex 2, thereby making them subject to the provisions of the New Psychoactive Substances Act.

More exemptions from the scope of the New Psychoactive Substances Act

The bill specifically excludes medical devices and in-vitro diagnostics, including their accessories, from the scope of the draft New Psychoactive Substances Act. Both product groups may contain substances that are either classified within a substance group listed in Annex 1 or listed individually in Annex 2. These substances may also be necessary for the manufacture, use, development, testing or examination of such products. However, both medical devices and in-vitro diagnostics are essential for healthcare delivery.

Redefinition of “new psychoactive substance”

To extend the Act’s scope to cover nitrous oxide, GBL and BDO, it is also necessary to adapt the legal definition of “new psychoactive substance” in addition to creating Annex 2. For this purpose, section 2(1) of the New Psychoactive Substances Act will be amended. According to the bill, the legal definition of a new psychoactive substance will continue to include substances and their preparations that can be assigned to one of the substance groups listed in Annex 1 (such as designer drugs, research chemicals and legal highs) (section 2(1)(a) of the draft Act). In the future, it will also cover the individual substances listed in the new Annex 2 and their preparations, provided that the substance or preparation meets the criteria set out in column 2 of Annex 2 (section 2(1)(b) of the draft New Psychoactive Substances Act).

It should be noted that section 2(1)(b) of the draft New Psychoactive Substances Act specifically refers to column 2 of the Annex, where certain concentration thresholds are specified for these substances (e.g. 20%). Many of these psychoactive substances are legally sold in everyday products, such as nail polish remover containing GBL, which contain only low concentrations and cannot be used as intoxicants. Setting these concentration limits ensures that such products do not fall within the scope of the law. This approach aligns with the bill’s objectives outlined in section C: to prevent recreational use of these substances, without restricting their widely recognised legitimate uses.

At the same time, the draft takes into account the rapidly evolving nature of the narcotics market and the associated health risks. According to section 7 of the New Psychoactive Substances Act, the Federal Ministry of Health will be authorised to extend or amend Annex 2 by ordinance if this is necessary based on scientific evidence.

Administrative ban extended to substances in Annex 2; list of prohibited forms of handling greatly expanded

Finally, the bill proposes extending the administrative ban on handling new psychoactive substances under section 3(1) of the New Psychoactive Substances Act to include the substances listed in Annex 2 (i.e. nitrous oxide, GBL and BDO). It also significantly expands the list of prohibited activities. According to section 3(1)(1) of the draft Act, it will initially be prohibited to trade, place on the market, manufacture or transfer outside the scope of the Act, as well as to acquire, possess or administer to another person any substance listed in section 2(1)(a) or (b).

For nitrous oxide, it is important to note that section 3(1)(1) of the draft New Psychoactive Substances Act applies only to substances that meet the criteria specified in column 3 of Annex 2. According to Annex 2 column 3, nitrous oxide is considered a new psychoactive substance only if it is packaged in a container with a filling quantity of more than eight grams. This provision is to ensure that only nitrous oxide capsules containing more than eight grams are subject to the administrative ban on handling under section 3(1)(1) of the draft Act, as it is assumed that only capsules of this size or larger are typically used for personal recreational purposes.

Ban on sale by mail order and in vending machines

To prevent misuse for recreational purposes also in small quantities and to better protect children and teenagers from health risks, especially when these substances can be accessed quickly and anonymously, section 3(1)(2) of the draft New Psychoactive Substances Act provides that new psychoactive substances not meeting the criteria specified in Annex 2, column 3, may not be traded, placed on the market or acquired via mail order or self-service through vending machines within the scope of the Act. The term “mail order” also includes online retail.

Ban on supply and transfer to minors and on acquisition and possession by minors

In addition, sections 3(1)(3) and (4) of the draft New Psychoactive Substances Act introduce comprehensive bans on the supply to, transfer to, and acquisition and possession of these substances by persons under 18, regardless of the method of distribution. These bans are intended to complement the prohibitions on mail-order and vending machine sales, helping to reduce the overall availability of these substances. The aim is to protect health and safeguard children and young people, and to prevent minors from using alternative distribution channels to bypass age restrictions.

Exemption from prohibitions for substances requiring costly extraction

However, the prohibitions in section 3(1)(2) to (4) of the draft New Psychoactive Substances Act are not intended to apply without exception. The existing exceptions in section 3(2)(1) and (2) of the Act will be fully retained. In addition, section 3(2)(3) of the draft Act will introduce a new exception to the bans in section 3(1)(2) to (4). This exception applies if the activities subject to the administrative ban involve handling the substance in a manner that would require disproportionate effort to extract the new psychoactive substance.

The key consideration is whether the substance is present in a form (such as in a particular container or preparation) that requires disproportionately high effort to extract. This applies, for example, to products in which the psychoactive substance is firmly integrated and only present in small amounts, such as nitrous oxide used as a propellant in containers for producing foam. In these cases, misuse is virtually impossible, so a blanket ban would be excessive, especially since such products are commonly used in everyday life. However, the situation is different for forms that are easily accessible, such as whipped cream dispensers, where nitrous oxide cartridges can be removed and the gas extracted with minimal effort.

The bill does not affect the existing exemptions under section 3(2)(1) and (2) of the New Psychoactive Substances Act. This means that the recognised industrial, commercial or scientific use of nitrous oxide, GBL and BDO remains permitted regardless of their concentration or filling quantity, since they are not intended for consumption or for achieving a psychoactive effect. The exemption in section 3(2)(1) of the Act should be interpreted broadly, and applies to all activities listed in section 3(1), including acquisition and possession.

Clarification of the criminal provisions

Apart from minor clarifications for the sake of clarity, the bill does not introduce any changes to the existing criminal provisions. The criminal provisions in section 4(1) of the New Psychoactive Substances Act correspond to the prohibitions in section 3(1)(1) and (2) of the draft Act. Consistent with the current approach of the Act, not every violation of the administrative prohibitions in section 3(1) automatically constitutes a criminal offense. The criminal provisions in section 4 are more narrowly defined and do not cover violations of the prohibitions in section 3(1)(3) and (4) of the draft Act. Criminal liability is limited to specific actions such as trafficking, placing on the market, administering to others (section 4(1)(1)), or manufacturing and importing for the purpose of placing on the market (section 4(1)(2)). Therefore, violations such as supplying or transferring a new psychoactive substance listed in section 2(1)(b) to minors for direct consumption (section 3(1)(3)), or acquisition or possession of such a substance by minors (section 3(1)(4)), are not subject to criminal penalties.

E. Relationship to the municipal regulatory ordinances

In light of the planned comprehensive new federal legislation, questions inevitably arise concerning the relationship between these federal regulations and existing ordinances issued by the municipal authorities that prohibit the sale, supply and distribution of nitrous oxide to minors. Since the end of 2024, numerous municipalities have responded to the delay in amending the New Psychoactive Substances Act in the previous legislative period by issuing their own regulatory ordinances imposing broad bans on the sale, supply and transfer of nitrous oxide to minors.

First, it is necessary to determine whether these ordinances were lawfully issued. This involves not only questions of legislative authority (see our Noerr Insight of 14 February 2025), but also substantive constitutional considerations.

It should be noted that the bans established by these regulations, along with the associated fines, affect a sensitive area in terms of fundamental rights. It is therefore possible that the materiality threshold emphasised by the Federal Constitutional Court (Bundesverfassungsgericht – BVerfG) has been exceeded. According to the Court’s doctrine of materiality, which has been honed in established case law, the legislature must enact a formal law to legitimise state action in fundamental areas and make all essential decisions itself (see, for example, Federal Constitutional Court decision of 28 October 1975, 2 BvR 883/73, 2 BvR 379/74, 2 BvR 497/74, 2 BvR 526/74). This means that essential regulatory decisions cannot be delegated to the executive branch; rather, parliament must take them itself. If this requirement is not met, the relevant administrative regulations would be invalid from the outset, as only the parliamentary legislature is authorised to enact such provisions.

If the municipal regulations do not violate the principle of materiality, they will remain valid at least until the new draft of the New Psychoactive Substances Act comes into force. However, once the federal law is enacted, it will take precedence in the event of any conflict, by virtue of the principle of the primacy of law. Regulatory ordinances issued by local authorities must not contravene higher-ranking federal legislation. Therefore, if a municipal ordinance conflicts with the New Psychoactive Substances Act (assuming that Act has been properly adopted, promulgated and entered into force), the ordinance is null and void. However, it has not been finally settled whether an authority can simply disregard a regulatory ordinance that has been declared null and void.

Many of the regulatory ordinances issued by municipalities are limited in duration, often to a few years. In addition, each federal state typically sets a maximum validity period for such ordinances. For example, in North Rhine-Westphalia, regulatory ordinances may not exceed a maximum period of 20 years, as stipulated in sentences 2 and 3 of section 32(1) of the German Regulatory Authorities Act (Ordnungsbehördengesetz).

F. Summary and outlook: What should affected companies prepare for?

The federal government intends to give priority to introducing the bill into the parliamentary process. To expedite proceedings, the government has declared the bill to be particularly urgent within the meaning of sentence 4 of Article 76(2) of the German Basic Law (Grundgesetz – GG). This allows the bill to be forwarded to the Bundestag just three weeks after it has been submitted to the Bundesrat. Additionally, this bill is classified as an objection bill, which means it does not require approval from the Bundesrat. An objection from the Bundesrat is considered unlikely due to broad cross-party support for regulation. Even if the Bundesrat were to object, the Bundestag can override this objection in accordance with Article 77(4) of the Basic Law, allowing the bill to be passed regardless.

Complex regulatory system

If the draft New Psychoactive Substances Act comes into force, affected businesses and stakeholders will face increased compliance work, as they will need to meet the new requirements set out in the draft New Psychoactive Substances Act within an already complex regulatory framework. This will raise numerous legal questions for companies in specific cases, with potentially significant consequences for how the requirements are interpreted and fulfilled.

Companies should consider at the manufacturing stage whether their products fall under the scope of the New Psychoactive Substances Act or qualify for an exemption. If the products are subject to the Act, companies must also determine whether the design of the product, in accordance with Annex 2, columns 2 and 3, triggers any of the specified bans. For GBL and BDO, these substances are subject to the bans in section 3(1) of the draft Act if the product is classified as a new psychoactive substance under section 2(1) and the Act is applicable. In the case of nitrous oxide, it is possible to avoid the ban in section 3(1)(1) by limiting the filling quantity to a maximum of eight grams, as specified in Annex 2, column 3. However, even in this case, the other restrictions under section 3(1)(2) to (4) would still apply.

A key issue for affected companies is whether an exception to these prohibitions applies under section 3(2) of the draft New Psychoactive Substances Act, particularly whether a recognised use exists. This determination must be made on a strict case-by-case basis and carries significant risks if the assessment is incorrect. In particular, violations may lead to criminal prosecution under the offences outlined in section 4(1) of the draft Act.

Mail order and online retail

Companies in the mail-order and online retail sectors, as well as operators of self-service vending machines, should carefully assess whether they are trading in substances subject to the ban in section 3(1)(2) of the draft New Psychoactive Substances Act.

If this is the case, trading activities should be halted or adjusted immediately to comply with the requirements of section 3 of the draft New Psychoactive Substances Act. According to section 4(1) of the draft Act, violating the trade ban under section 3(1)(2) constitutes a criminal offence and is punishable by a custodial sentence of up to three years or a fine; even an attempt to commit the offence is punishable. In cases of commercial offences, section 4(3) allows for a custodial sentence of up to ten years.

In this context as well, it is crucial to determine whether an exception to these bans applies under section 3(2) of the draft New Psychoactive Substances Act – particularly whether a recognised use exists.

Control obligations

With regard to the bans on supplying, transferring and selling to minors in section 3(1)(3) of the draft New Psychoactive Substances Act, all sales outlets (such as drugstores, supermarkets, grocery stores and kiosks) are subject to strict inspection and control requirements. If there is any doubt about a customer’s age, it is mandatory to request identification to verify that the customer is of legal age.

Draft New Psychoactive Substances Act will come into force three months after promulgation

The bill provides that the amended New Psychoactive Substances Act will come into force three months after its promulgation. This transitional period is intended to give dispensing outlets, in particular, sufficient time to implement the necessary organisational and technical changes to comply with the bans on mail-order and vending machine sales. The same transitional period applies to the introduction of age verification checks.

Affected companies should therefore familiarise themselves with the complex requirements of the draft New Psychoactive Substances Act well in advance and prepare to make any necessary changes.