Reporting requirements for defective products

Government notification

What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?

If producers or distributors become aware that any of their products present dangers to consumers, they must notify the General Secretariat immediately, without delay, and any other competent authority depending on the type of the product at issue, for the prevention of any danger and hazard to consumers.

The notification is made in a form provided by the competent authority and has to include information to identify the product, a complete description of the defect or the risk involved with the usage of the product, information to locate the product in the market, a description of the actions taken by the producer or distributor and actions that should be taken by consumers to prevent any further risk.

If the product has been marketed outside Greece as well, the procedure under the RAPEX notification system may be followed. The system allows the almost simultaneous transfer of information on dangerous products within the EU. Respective procedures apply especially to food and medicines.

The notified authorities may request additional information, the submission of relative documents or measures to be taken by the producer or distributor.

Notification criteria and time limits

What criteria apply for determining when a matter requires notification and what are the time limits for notification?

The safety of the product in question determines any notification needed (see question 1).

The following criteria are monitored from the point of view of risks to consumers’ safety and health protection (article 7, paragraph 3, Law No. 2251 implementing the GPSD), namely:

  • the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
  • the effect on other products, where it is reasonably foreseeable that it will be used with other products;
  • the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product; and
  • the categories of consumers at risk when using the product, in particular children and the elderly.

The producer may be informed about the danger of a product by any appropriate means. The producer may find out that the product is not safe because of his or her own inspections and tests or on the basis of initiatives from consumers, insurance companies, distributors or governmental bodies. In any case, it is necessary to notify the competent authority as soon as the producer establishes such risk.

Commission Decision 2004/905/EC sets out guidelines for the notification by producers and distributors of dangerous consumer products to the competent authorities of the member states (the Guidelines) in accordance with article 5, paragraph 3 of the GPSD.

The Guidelines (Annex, section 3) set out the notification criteria, which are as follows:

  • the product is understood to be intended for, or likely to be used by, consumers (article 2a of the GPSD);
  • article 5 of the GPSD applies (unless there are specific provisions established by other EU legislation);
  • the product is on the market;
  • the professional has evidence that the product is dangerous according to the GPSD, or that it does not satisfy the safety requirements of the relevant community sectoral legislation applicable to the product considered; and
  • the risks are such that the product may not remain on the market.

The Guidelines 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, in no case 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.

Competent authority

To which authority should notification be sent? Does this vary according to the product in question?

In general, notifications must be made to the competent authority as is stipulated in question 1. The authorities to which the notification should be made vary according to the product.

Further to the authorities mentioned in question 1, we examine below two important categories of products.

Food

For food products, the competent authority is the Hellenic Food Authority (EFET), established in 1999. EFET is supervised by the Ministry of Rural Development and Food.

EFET’s principal aims are to take all the necessary actions to ensure that food produced, distributed or marketed in Greece meets the standards of food safety and hygiene as described by the national and European legislation. EFET also acts as the national contact point of the European Union regarding the management of the Rapid Alert System for Food and Feed and for the Codex Alimentarius Commission (of the Food and Agriculture Organization of the United Nations and the World Health Organization) and it is the local point of the European Food Safety Authority.

Medicines

For medicines and sanitary products and equipment, EOF (see question 1) is the competent authority. EOF was established in 1983 and is supervised by the Ministry of Health. EOF’s mission is to ensure public health and safety with regard to the following products, marketed in Greece:

  • medicinal products for human and veterinary use;
  • medicated animal foods and food additives;
  • foodstuffs intended for particular nutritional uses and food supplements;
  • biocides;
  • medical devices; and
  • cosmetics.

Within the framework of its mission, EOF, in cooperation with the European Union, performs the following tasks:

  • evaluates and authorises new, safe and efficient health-related products;
  • monitors the post-marketing product’s quality, safety and efficiency;
  • monitors product manufacturing procedures, clinical studies and the marketing of products in order to ensure compliance with good manufacturing, laboratory and clinical practice, as well as with the existing legislation regarding the marketing, distribution, commercialisation and advertising of the products;
  • develops and promotes medical and pharmaceutical research; and
  • provides health scientists, competent authorities, and the general public with objective and useful information regarding medicines (for human or veterinary use) and other relevant products, in order to ensure their rational use and assess their cost-effectiveness.
Notification information

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

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

  • details of the authorities and resellers or distributors notified;
  • details of the producer and distributors;
  • details of the contact person regarding the notification;
  • details of the product, including the category of the product, product’s brand or trade name, product’s model, barcode or CN tariff, product’s country of origin and a photograph or description of the product;
  • description of the hazard and of the possible health or safety damages and conclusions of the risk estimation and evaluation carried out;
  • a record of accidents; and
  • details of corrective actions taken, including the type, the scope and the duration of actions and precautions taken and the identification of the responsible company.
Obligations to provide updates

What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?

Greek legislation does not expressly regulate the obligation to provide authorities with updated information on risks. However, the obligation falls within the general scope of safety regulations that stipulate that all products on the market must be safe and if a product becomes unsafe, the producer or distributor has to take all appropriate measures to meet all possible risks.

Taking into consideration that a notification to the authorities is made according to an initial assessment of the product’s hazard, the authorities will have to be kept informed of the results of any ongoing research in order to be updated and monitor the case.

Moreover, according to the provisions of Law No. 2251, the competent authority may request information from the producer or the distributor and can set a deadline, within which the information must be given to it.

Penalties

What are the penalties for failure to comply with reporting obligations?

See question 3.

Public disclosure

Is commercially sensitive information that has been notified to the authorities protected from public disclosure?

In general, information containing commercial or industrial secrets should not be disclosed to the public by the notified authorities.

The competent authorities should make available to the public information in relation to the notified product and the risk from its usage but they should prevent the disclosure of information containing commercial or industrial secrets, unless such disclosure is necessary to protect the public.

Moreover, any third party may request the issue of an order granting access to the files of the case kept by the competent authorities, including commercial or industrial secrets, from the public prosecutor. Such a request may be granted if the applicant proves a lawful interest for this.

Thus, notified commercially sensitive information is not always protected against public disclosure.

Use of information in prosecution

May information notified to the authorities be used in a criminal prosecution?

There is no specific provision in Greek legislation. In general, information obtained by the authorities may be used in criminal proceedings.