The RAPEX system in the year 2019: an overview
The new guidelines for the "Rapid Exchange of Information" (RAPEX) system include some important clarifications.
In light of the adoption of updated guidelines for the "Rapid Exchange of Information" system at the end of 2018, the key aspects of the "new" RAPEX system will be summarized below.
With regard to the scope of the RAPEX system, the new guidelines expressly clarify that they do not apply only to consumer or "migrated" products. Products which are subject to EU harmonizing legislation require notification in RAPEX regardless of whether they are intended for consumers or for commercial users.
Notification in the RAPEX system is mandatory for authorities if the following criteria are met:
- the product is a consumer or migrated product or is subject to EU harmonizing legislation;
- voluntary or compulsory preventive and restrictive measures have been taken with regard to the product;
- the product poses a serious risk to health and safety or, if the product is subject to EU harmonizing legislation, to other relevant public interests; and
- the possibility cannot be ruled out that the impact of the risk will extend beyond the sovereign territory of the relevant member state.
In addition, notification regarding consumer or migrated products is mandatory for authorities if
- the product is subject to preventive and restrictive measures;
- the measures do not have to be notified under any other system; and
- the product poses a less than serious risk whose effects may extend beyond the sovereign territory of the member state; or
- the product poses a serious risk whose effects are merely local.
RAPEX notification is expressly recommended to the authorities if a less than serious risk exists and
- voluntary measures have been taken with regard to a consumer or migrated product; or
- voluntary or compulsory measures have been taken with regard to a product which is subject to EU harmonizing legislation.
In the interests of ensuring a coherent notification system, the EU Commission considers the most pragmatic solution to be for the RAPEX system to contain all measures taken with regard to hazardous products, regardless of whether a serious or less than serious risk exists.
The previous risk assessment remains in effect. With regard to products which are subject to EU harmonizing legislation, the guidelines also make reference to the "EU general risk assessment methodology." Essentially, this methodology is comparable to the "RAPEX methodology," except that it includes risks to other relevant public interests which must be heeded with regard to those products.
The clarifications of the guidelines demonstrate that the Commission would rather have "too many" than "too few" RAPEX notifications from the authorities, something which is especially apparent from the fact that it recommends notifications for products with less than serious risk.
Although the RAPEX guidelines are generally directed towards public authorities, as before, manufacturers and importers should nevertheless take the guidelines into account when assessing potential risks and should build up expertise accordingly. A valid and solid risk assessment is essential to ensure compliance with notification requirements if any measures are taken in connection with risky products, and its importance is heightened given the direction which the new guidelines take.
The EU Commission's "risk assessment guidelines" tool
Safety Gate (formerly the RAPEX website for external communication)
"Business Gateway" for notification of measures taken to the competent authorities