Guidelines for the EU rapid information system Safety Gate (formerly RAPEX)

SUMMARY OF:

Implementing Decision (EU) 2019/417 – guidelines for managing the European Union rapid information system ‘Safety Gate’

WHAT IS THE AIM OF THE DECISION?

The decision seeks in particular to clarify the notification criteria and update the terminology used, along with the scope of the system, integrating certain aspects of Regulation (EC) No 765/2008 on the market surveillance of harmonised products, repealed and replaced by Regulation (EU) 2019/1020 on market surveillance and compliance of products (see summary). In addition, it makes reference to new tools developed in recent years for the proper functioning of Safety Gate (such as the interface between Safety Gate and the Information and Communication System on Market Surveillance platform, set up under Regulation (EC) No 765/2008).
This implementing act sets out guidelines for the management of the European Union (EU) rapid information system Safety Gate. This system was originally set up by Directive 2001/95/EC, the general product safety directive (GPSD), which will be repealed and replaced by Regulation (EU) 2023/988 (see summary) from 13 December 2024.
Implementing Decision (EU) 2023/975 amends Implementing Decision (EU) 2019/417 and sets out, among other things, the respective roles and responsibilities of, and arrangements between, the European Commission and the EU Member States as joint controllers for processing data in the Safety Gate/RAPEX system in accordance with Regulation (EU) 2018/1725 (see summary) and Regulation (EU) 2016/679 (see summary).
Decision (EU) 2019/417 repeals Decision 2010/15/EU.

KEY POINTS

The decision, as amended by Decision (EU) 2023/975, comprises two annexes.

Annex I. Guidelines for the management of Safety Gate.
Annex II. Joint controllership of Safety Gate.

Annex I

Scope

These guidelines cover two sets of products:

products covered by the GPSD;
products covered by Regulation (EC) No 765/2008 on the accreditation and market surveillance of non-food products, which implies the inclusion of professional products and the extension of the risks to other risks than those for the health and safety of consumers, for example environmental risks.

The decision does not cover the following:

food and feed and other products covered by Regulation (EC) No 178/2002;
medicinal products covered by Directive 2001/83/EC on medicines for humans (see summary) and Regulation (EU) 2019/6 on veterinary medicines (see summary);
medical devices covered by Regulation (EU) 2017/745;
second-hand products, antiques or products to be repaired or reconditioned prior to use;
equipment used by professional service providers to supply a service.

Safety Gate

Safety Gate was originally set up for the rapid exchange of information between Member States and the Commission on products posing a serious risk to the health and safety of consumers. Its main features are that it:

prevents and restricts the supply of dangerous products;
monitors the effectiveness and consistency of market surveillance and enforcement activities;
identifies needs and provides a basis for action at the EU level;
ensures consistent enforcement of the EU product safety requirements.

Risk

Before a Member State’s authority decides to submit a Safety Gate notification, it assesses whether the product to be notified poses a risk to the health and safety of consumers, or, in the case of products covered by Regulation (EC) No 765/2008, a serious risk to the health, safety or security of the end users or to the environment, and thus whether the notification criteria are met.
Risk assessment guidelines and examples are included in an appendix to the decision.

Action notified through Safety Gate

Measures to prevent or restrict sales can be taken, in relation to products posing a risk, either voluntarily by manufacturers or distributors, or ordered by a Member State’s authority. Measures include, but are not limited to:

marking a product with warnings about risks;
making the marketing of a product subject to conditions;
warning consumers and end users of risks;
a temporary ban on the product’s supply or display;
a ban on the marketing of a product;
the withdrawal of a product from the market;
the recall of a product from consumers;
the destruction of a withdrawn or recalled product.

Notifications

Participation in Safety Gate is mandatory for Member States, which must notify the Commission where the following four criteria are met for a product.

The product falls under the scope of application of the GPSD or under the scope of application of Regulation (EC) No 765/2008.
It is subject to measures that prevent, restrict or impose specific conditions on its possible marketing or use.
It poses a risk to the health and safety of consumers, or, in the case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests of the end users.
It cannot be ruled out that the effect of the serious risk to the health and safety of consumers, or, in the case of products covered by Regulation (EC) No 765/2008, also to other relevant public interests of the end users, goes beyond the territory of the notifying Member State.

Additional rules for notifications covered by the decision include:

streamlining the processes for notification;
setting out the notification criteria;
defining the content of notifications;
establishing follow-up requirements for Member States;
describing how notifications and their follow-up are handled by the Commission;
setting deadlines for the various types of action taken under the notification mechanisms;
setting out the practical and technical arrangements needed at the Commission and national levels for the notification mechanisms to be employed effectively and efficiently.

Annex II: Joint controllership of Safety Gate

The Commission and Member States’ national authorities responsible for product safety (including market surveillance authorities monitoring the compliance of products with safety requirements and authorities in charge of external border controls) act as joint controllers for processing data in the Safety Gate system.

The Commission’s responsibilities as a joint controller of personal data include:
- processing information regarding measures taken against products posing serious risks, imported into or exported from the EU and the European Economic Area (EEA), for transmission to the Safety Gate contact points;
- processing information received from non-EU countries, international organisations, businesses or other rapid alert systems about products of EU and non-EU origin posing a risk, for transmission to the national authorities;
- ensuring compliance with the obligations and conditions of Regulation (EU) 2018/1725 regarding these activities.
National authorities’ responsibilities as joint controllers of personal data include:
- processing information pursuant to Directive 2001/95/EC and Regulation (EU) 2019/1020 in order to notify the Commission, other Member States and EEA / European Free Trade Association countries;
- processing information subsequent to their follow-up activities in relation to Safety Gate notifications in order to notify the Commission, other Member States and EEA / European Free Trade Association countries;
- ensuring compliance with the obligations and conditions of Regulation (EU) 2016/679 regarding these activities.
The annex also sets out detailed rules on:
- the categories of data subjects and personal data,
- providing information to data subjects,
- handling data subjects’ requests,
- security of processing,
- management of security incidents, including personal data breaches,
- localisation of personal data,
- recipients of data,
- recording of processing operations,
- duration of processing,
- liability for non-compliance,
- cooperation between joint controllers,
- settlement of disputes.

FROM WHEN DOES THE IMPLEMENTING DECISION APPLY?

Implementing Decision (EU) 2019/417 has applied since 12 November 2018.

The changes introduced by amending Implementing Decision (EU) 2023/975 have applied since 17 May 2023.

BACKGROUND

For more information, see:

The general product safety directive (European Commission)
General product safety regulation (European Commission)
Safety Gate (European Commission)
Safety Gate (the EU rapid alert system – non-food) (European Commission).

MAIN DOCUMENT

Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ L 73, 15.3.2019, pp. 121–187).

Successive amendments to Decision (EU) 2019/417 have been incorporated into the original text. This consolidated version is of documentary value only.