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Belgium plans to revise the Royal Decree on the Manufacturing and Sale of Electronic Cigarettes to supplement the instructions and requirements for zero nicotine electronic cigarettes

Author.

LCS

Source:

Post time:

2023-11-17

In November 2023, Belgium notified the European Commission of a revised draft Royal Decree (Notification No. 2023/0631/BE) to amend the Royal Decree of 28 October 2016 on the manufacturing and marketing of electronic cigarettes, On the basis of the Royal Revised Decree 7 NOVEMBER 2022- Royal decrease amending the Royal decrease of 28 October 2016 related to the manufacturing and marketing of electronic cigarettes, some requirements for instructions and zero nicotine e-cigarettes have been added.
1. The volume requirements for zero nicotine e-cigarettes are consistent with those for nicotine containing e-cigarettes: the volume of specialized supplementary containers should not exceed 10ml, and the volume of disposable e-cigarettes or cartridges should not exceed 2ml.
The toxicity requirements for zero nicotine e-cigarettes are consistent with those for nicotine containing e-cigarettes: whether heated or not, they do not pose a risk to human health.
3. The packaging of zero nicotine e-cigarettes must be accompanied by the following warning language (English, French, German, format requirements consistent with the requirements for nicotine containing e-cigarettes):
This product harms your health It use is not recommended for non-smokers
Ce produit nuit à votre sant é Son utilization par les non fumeurs n'est pas command é e
Dies produkt sch ä digt Ihre Gesundheit Es wird nicht f ü r den Gebrauch durch Nichtraucher empfohlen
However, according to the Royal Revised Order 7 NOVEMBER 2022, some information on packaging and instructions must be in Dutch, French, and German, so this warning should also be accompanied by a Dutch version.
4. The manual must include information on how to quit smoking. (It should be noted that the Royal Amendment Act 7 NOVEMBER 2022 also requires the number of the Anti Poison Center to be included in the instruction manual.).
The screenshot of the revised draft law notified is as follows:

 

Notification link: https://technical-regulation-information-system.ec.europa.eu/en/notification/25090
Royal Detail of 28 October 2016 on the manufacturing and marketing of electronic cities: http://www.ejustice.just.fgov.be/eli/arrete/2016/10/28/2016024250/moniteur
7 NOVEMBER 2022- Royal decrease amending the Royal decrease of 28 October 2016 related to the manufacturing and marketing of electronic: https://www.ejustice.just.fgov.be/eli/arrete/2022/11/07/2022034085/moniteur
Background:
The Technical Regulation Information System (TRIS) is a technical regulation information system established in accordance with the directive DIRECTIVE (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and rules on Information Society services. (EU) 2015/1535 stipulates that member states have an obligation to inform the European Commission of their intention to introduce draft technical regulations for products (industrial, agricultural, and fishery) and information society services before national laws are passed. Its purpose is to ensure that these technical regulations comply with EU laws and internal market principles, and to prevent them from creating trade barriers in the internal market. Member States will notify the European Commission of their legislative projects on products and information society services, and the Commission will analyze these projects based on EU legislation. Member States participate equally with the Committee in this process and express their opinions on the draft notification.
The main benefits of this program are:
a. Allow for the emergence of new trade barriers before any negative impact on the internal market occurs;
b. Allow the identification of trade protectionism measures;
c. Allow member states to determine the degree of compatibility between the notification draft and EU laws;
d. Allow effective dialogue between member states and the committee when evaluating the draft notification;
e. Allow economic operators to voice their voices and adjust their activities in a timely manner to adapt to future technical regulations. This review power is widely used by economic operators to help committees and national authorities detect any trade barriers;
f. Allow the identification of coordination needs at the EU level.
A notification usually has a stand still period, which is the period during which the member state concerned cannot pass the draft technical regulation being notified. The validity period of the notification of the draft technical regulation is three months, which can be extended based on the feedback type issued by the committee or other member states. During the three-month stagnation period, the Commission and other member states reviewed the notified draft technical regulations to determine whether they comply with EU law and the principle of free movement of goods and services. The extended standstill period allows for dialogue with notified member states or prevents them from passing legislative drafts while coordinating work at the EU level.
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