Message 002
Communication from the Commission - TRIS/(2022) 01882
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2022/0365/NL
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
(MSG: 202201882.EN)
1. MSG 002 IND 2022 0365 NL EN 25-05-2022 NL NOTIF
2. NL
3A. Ministerie van Financiën, Dienst Douane Noord, CDIU
3B. Ministerie van Volksgezondheid, Welzijn en Sport
Directie Wetgeving en Juridische Zaken
4. 2022/0365/NL - X00M
5. Amendment of the Opium Act Decree and List II, belonging to the Opium Act, in relation to the inclusion of nitrous oxide (laughing gas) on this list
6. Nitrous oxide (laughing gas)
7. -
8. With this amendment to the Opium Act Decree, nitrous oxide is placed on List II of the Opium Act. As a result, it is prohibited to prepare, process, sell, deliver, supply, transport, be in possession or manufacture laughing gas or take it in or out of the territory of the Netherlands. The actual applications of nitrous oxide remain authorised without prejudice. The actual application of nitrous oxide includes use in veterinary medicine as an anaesthetic and short-acting painkiller or as a medical aid, in technical industries as syngas and oxidising gas, and in the hospitality and food industry for sprayed food such as whipped cream.
The objective of the ban is to reduce the wide availability of nitrous oxide for recreational use, thereby limiting the supply of nitrous oxide for recreational use while ensuring availability for actual applications.
A prohibition to market, use or consume a product as contained in this proposal (Article 3 of the Opium Act relating to the List II of the Opium Act) is considered a technical regulation within the meaning of Directive 2015/1535.
9. Nitrous oxide has various actual applications in healthcare, food and gastronomic sectors and in technical industries. In addition to these original applications, nitrous oxide is also used more and more frequently and in larger quantities as a recreational drug. The national centre for information and advice on intoxications (‘Nationaal Vergiftigingen Informatie Centrum’) (hereinafter: NVIC) reported a sharp increase in registered reports in 2019 in the number of health complaints following recreational use of nitrous oxide. The increase in the number of reports to the NVIC in spring 2019 prompted the Secretary of State for Health, Welfare and Sport to ask the CAM for a risk assessment of nitrous oxide.
The risk assessment was carried out by the Risk Assessment Committee and showed that nitrous oxide is a substance with substantial risks to (public) health and society. For example, the report of the Risk Assessment Committee shows that it cannot be excluded that serious neurological damage may occur even after single use in the case of a person suffering from a functional vitamin B12 deficiency. A B12 deficiency is usually unknown in humans. Nitrous oxide is widely used in various sections of the population, including vulnerable groups, such as young and/or inexperienced users. The Risk Assessment Commission also mentions in particular that the wide and easy availability and accessibility of nitrous oxides clearly contributes to the problem and poses a risk to public health. The Risk Assessment Committee recognises the local issues experienced, such as nuisance. Based on this risk profile, the Risk Assessment Commission recommends the recreational use of nitrous oxide as a drug is discouraged and the high availability of nitrous oxide as a recreational drug is reduced. With this decision, the government responds to the recommendation to reduce the wide availability of nitrous oxide as a recreational drug.
The inclusion of nitrous oxides on List II and the requirements for excluded use are justified by the importance of protecting public health. The aim of the proposed measures is to reduce the number of incidents related to or involving nitrous oxide (potentially irreparable neurological damage but also traffic incidents, for example) and reduce damage to (public) health and society.
The requirements are proportionate, because nitrous oxide is used as a recreational drug in addition to the original applications and this can lead to health damage and damage to society. The protection of public health is so important that the inclusion of these requirements is justified. A balanced approach has been chosen so that the measure does not go beyond what is necessary. In fact, the actual applications of nitrous oxide are excluded in the general meaning of Article 3 of the Opium Act. In order to avoid a disproportionate burden, a notification obligation, licensing system and exemption system for carrying out operations with nitrous oxide intended for technical purposes or as a food additive have not been introduced. However, manufacturers and (intermediate) traders of medical nitrous oxide and laughing gas as a medical aid will have to apply for an exemption under Articles 6 and 8 of the Opium Act, in line with other Opium Act drugs which are also medical products. This exemption system is seen as proportionate because it is a very small group that is largely already bound by a licensing system under the Medicinal Products Law. Manufacturers and traders of medicines are already used to working with the exemption system from the Opium Act. Applying for or amending an exemption is a limited additional burden for them. In addition, in most cases, manufacturers of nitrous oxides will produce both nitrous gas intended for use as a medicinal product and nitrous gas intended for use as a medical aid, thereby minimising the additional burden for this small group. Finally, the measures are applied without discrimination.
10. Restriction of the trade or use of a substance, preparation or chemical product
Numbers or titles of basic texts: Opium Act and Opium Act Decree
11. Yes
12. The use of nitrous oxide as a recreational drug poses a danger to health and society and therefore forms the basis for listing nitrous oxide on List II of the Opium Act (Ow).
There is no safe limit of use that can simply be determined and limited use can also lead to serious health damage. The most common effects that occur during or shortly after nitrous use are dizziness, confusion, and headaches. With intensive use (even once) a vitamin B12 deficiency may develop, which may cause neurological problems and blood diseases. Excessive use is known to lead to serious (neurological) health risks, including paralysis symptoms. The National Drug Monitor (NDM) shows that nitrous oxide is mainly used among different groups of young people and young adults. Use increased in recent years among school children and MBO/HBO students (measured until 2019) and there are indications of an increase in (problematic) use within certain groups of young people. Recent reports show that neurologists and addiction physicians, among others, find that the risks and harmfulness seem more and more significant than initially thought. The growing knowledge in this field supports the seriousness of the risks and harmfulness of the use of nitrous oxide as a recreational drug and the need to treat this measure with urgency so that the ban can enter into force as soon as possible. In view of previous health risks, the Lower House has also requested that the ban enter into force as soon as possible.
13. No
14. No
15. In the explanatory note in paragraph 7 (Implications for the regulatory burden).
16. TBT aspect
NO – The draft does not have a major impact on international trade.
SPS aspect
No, the draft is neither a sanitary nor a phytosanitary measure
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European Commission
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu
