Greece introduces new regulations: smoke-free electric heating products and nicotine products must be notified before being launched

background

On March 3, 2026, the Greek Ministry of Health officially issued a Ministerial Order with the number Δ 2 β/Gamma. 871. οικ. 7623 in the Official Gazette of the Greek Republic (Issue 2, No. 1106), authorizing manufacturers and importers of smokeless electric heating products and nicotine products under Article 27 of Law No. 5216 of 2025 to notify and file with the Greek National Public Health Organization (EODY) before their products are launched. Products that are not notified within the deadline will be considered violations.

1、 New Product Definition

1. Smoke free electric heating products

Refers to industrial products that do not contain tobacco and produce aerosols for inhalation through heating (rather than combustion). This product exists in solid form and contains any of the following matrices: nicotine, a mixture of nicotine and other substances, or other substances without nicotine.

2. Nicotine products

Refers to products that do not contain tobacco but contain any amount of nicotine alkaloids and can be consumed in any way. This type of product includes but is not limited to: products that exist in solid form (such as nicotine bags), are intended for oral ingestion (rather than inhalation), do not require heating or combustion processes, and contain nicotine matrix or a mixture of nicotine and other substances. Excluding products used for medical or pharmaceutical purposes.

2、 Materials required for reporting

Applicants are required to submit the following categories of information to EODY (specific formats and reporting requirements can be obtained by contacting us):

Category main content

Applicant Information: Enterprise Name, Tax ID, Address, Contact Information, etc

Product information: Product name, model, launch/removal date, packaging specifications, etc

Ingredient list sorted by content (including CAS number, formula dosage, etc.)

Nicotine specific information includes nicotine content, type, source, and available pharmacokinetic data

Additional information (by product type) Smoke free electric heating products: size, weight, emission data (such as particle size distribution);

Nicotine products: pH value, free base ratio, dynamic pH curve, etc

3、 Notification time requirements

Before the launch of a new product: a notification must be completed at least 6 months in advance, and the compliance of the product must be reviewed by EODY

When there is a change in ingredients: the notification must be resubmitted according to the same procedure

When an adverse event occurs: EODY must be notified immediately

4、 Classification of reporting obligation subjects:

The manufacturer is established within the European Union and bears the responsibility

The manufacturer is located outside the EU and the importer is located within the EU → The importer bears the responsibility

Both the manufacturer and importer are located outside the European Union → Both parties jointly bear the responsibility

5、 Effective Date and Transition Period

Event Date/Deadline

The regulation officially comes into effect on March 3, 2026 (the date of publication in the government gazette)

The transition period for products already on the market shall be within 6 months from the effective date (i.e. before September 3, 2026)

At least 6 months prior to the launch of new product notifications

Special reminder: For products that were already in circulation in the Greek market before the implementation of this regulation, operators must complete a supplementary notification before September 3, 2026. Failure to do so will be considered a violation.

If you have any questions about the new regulations in Greece, please feel free to contact us at any time. We will continue to provide you with the latest regulatory information and high-quality testing and certification services.