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Enforcement of product safety laws

Who enforces the product safety laws in your jurisdiction? If there are multiple regulators, how do their activities intersect and to what extent do they cooperate?

The General Secretariat of Commerce and Consumer Protection of the Ministry of Development and Investments is the central competent authority for product safety (the General Secretariat). Various other authorities exist depending on the products in question. 

For industrial products, the main authority is the General Secretariat of Industry of the Ministry of Development and Investments (the Industry Secretariat). 

Regarding sectoral authorities and indicatively, for food products, the competent authority is the Hellenic Food Authority (EFET) supervised by the Ministry of Rural Development and Food. For medicines, sanitary products and equipment, the competent authority is National Organisation for Medicines (EOF) supervised by the Ministry of Health. 

Product safety regulators are allowed to cooperate with other non-product safety regulators in the general frame of cooperation between public administrative bodies, provided that such cooperation serves a specified legitimate cause and the case falls within their scope of competence. Greek regulators may also cooperate with analogous international regulators within the framework of existing international legislation (eg, the EU Rapid Alert System for dangerous consumer products (RAPEX).

What enforcement actions are available to the regulatory authorities? What penalties may they impose for non-compliance with product safety laws?

Authorities may request that the producer, the distributor or any supplier take specific preventive or corrective actions. They may also define the time frame within which these actions should be accomplished. If the obliged party fails to satisfy these requests, the competent authority may impose fines.

Products that present or may present serious dangers to the safety and health of consumers when used in conditions that are normal or predictable may be revoked or withdrawn, as a precaution, by the competent authority. The procedure, the terms and conditions for the revocation, the withdrawal or the disposal of the product, the destruction of the product and any other relevant topic are regulated by a decision of the Minister of Development and Investments or by a joint decision of him or her and by any other competent minister.

Government authorities may also publish warnings or other information to users or suppliers, and even organise a product recall where a producer or other responsible party has not already done so. There are no rules whereby the same authorities may issue informal information or notices outside the established regulatory scheme. Further, Greek authorities’ websites do not provide a facility for the public to post remarks or reports of incidents. 

However, the European Commission’s ‘Business Gateway to report dangerous products to the member state authorities’ (formerly known as the GPSD Business Application) allows the producers or distributors of the notified product or their authorised representatives to submit notifications under the GPSD. It also allows Greek and other EU competent national authorities to use the information provided to submit a RAPEX notification if all criteria for this are met.

RAPEX is the EU Rapid Alert System for unsafe consumer products (with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms) established under article 12 of the GPSD. RAPEX allows a quick exchange of information on measures such as repatriation or product recalls, whether carried out by national authorities or by voluntary action of manufacturers and distributors (more at https://joinup.ec.europa.eu/collection/rapex and https://ec.europa.eu/safety-gate/#/screen/home). Further, the EU Commission has issued guidelines for the management of RAPEX by its Implementing Decision (EU) 2019/417 of 8 November 2018.

Regarding penalties, according to article 13(a) of Law No. 2251 (as amended by Law No. 4933/2022) and subject to the stipulations of the Criminal Code and the Rules Regulating the Market of Products and the Provision of Services (Law No. 4177/2013), the following sanctions may be imposed by a decision of the competent organ of the Ministry of Development and Investments, acting either ex officio or after a complaint filed, namely:

For the imposition of the above penalties, certain criteria are indicatively listed. This includes any sanctions imposed on the same infringer for the same breach in other EU member states regarding transboundary cases, if relevant information is available under the Regulation (EU) 2017/2394 ‘on cooperation between national authorities responsible for the enforcement of consumer protection laws’, in force as of 17 January 2020.          

Moreover, when the Greek authorities are to impose penalties under article 21 of same above Regulation 2017/2394 for ‘widespread infringements’ or ‘widespread infringements with a Union dimension’, the maximum fine may be up to 4 per cent of the infringer’s annual turnover in the relevant EU member state and, in case there is no information on such turnover, the fine may reach €5 million.

By the latest amendment of 2022 an additional sanction of a temporary closure of the infringer’s business for a period ranging from three months to one year, that could also be imposed in certain conditions, was abolished. 

Further, a special set of sanctions may be imposed on infringers that do not provide requested documents, or that do not respond to consumers’ complaints per the provided proceedings.

Last, a summary of any decision imposing a fine that exceeds €50,000 (or not, if it is imposed for a repeated infringement) is publicised by any appropriate means and it is uploaded at the website of the Ministry of Development and Investments within five working days from its issue.

What is the typical process for enforcement actions and what procedures are involved? What rules govern enforcement actions?

Communications with the regulators are in writing. However, informal oral contacts often take place as a more efficient and prompt procedure, especially in urgent cases, including clarifications and unofficial guidance on the discussed actions. The authorities have extensive powers to take any measure considered appropriate in the circumstances to protect the health and security of the public.

How prevalent is enforcement action under the product safety laws? Have there been any notable recent examples of enforcement actions?

Enforcement action under the product safety laws must be considered as having a limited effect and practice, whereas there have not been any recent notable examples thereof.

What mechanisms are available to companies to challenge the imposition of enforcement actions?

The administrative decisions imposing sanctions on infringers must be served on the party affected thereby. A quasi-judicial proceeding before the Minister of Development and Investments against those decisions is provided for, within an exclusive period of 30 days as of the above service whereas the minister must issue his or her decision within an additional exclusive period of 60 days. Eventually, the minister’s decision may be judicially challenged within a period of 60 days of his or her decision being served on the interested party.

What are the time limits for notification?

The Guidelines (Annex, section 4.3) provide that the notification shall be made without delay and specify the deadline for making notifications in terms of days. Accordingly, in cases of serious risk, companies are required to inform the authorities without delay, no later than three days after obtaining information and in any other case within 10 days.

There are only minimal differences in the preconditions and time framework for notification for various specific product categories.

What form should notification take? What product information and other data should be provided in the notification to the competent authority?

The notification is made in a form required by each competent authority and what matters are the contents of the same. 

In accordance with the provisions of the Guidelines (Annex, section 5), the notification must include at least the following:

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