PREFACE

Directive 2001/95/EC (“the General Product Safety Directive“), as adapted to the Agreement on the European Economic Area (“the EEA Agreement”) by Protocol 1 thereto, entered into force in the EFTA States on 1 March 2004. (1) In the EU, the General Product Safety Directive has been repealed and replaced by Regulation (EU) 2023/988 on general product safety (“the General Product Safety Regulation”) with effect from 13 December 2024, see Article 50(1) of the Regulation. However, by September 2025, the General Product Safety Regulation has not been incorporated into the EEA Agreement. Accordingly, the General Product Safety Directive currently remains applicable in the EFTA States.

In accordance with Article 11(1), third subparagraph, of the General Product Safety Directive, and point 8 of its Annex II, the European Commission (“the Commission”) is to prepare and regularly update guidelines concerning the management of the Community Rapid Information System (“RAPEX”). However, with the General Product Safety Regulation, the name RAPEX was changed to “Safety Gate Rapid Alert System” (“Safety Gate”). Given that Safety Gate is now the official name of this alert system, it is appropriate to use it in these Guidelines, even though the General Product Safety Regulation has not yet entered into force in the EEA. (2)

By Decision 2004/418/EC of 29 April 2004, the Commission adopted, for the first time, Guidelines to supplement Directive 2001/95/EC for the management of RAPEX and for notifications presented in accordance with Article 11 of that Directive. Decision 2004/418/EC was repealed by Decision 2010/15/EU of 16 December 2009. By its Implementing Decision (EU) 2019/417 (3) of 8 November 2018 (“Decision (EU) 2019/417”) the Commission adopted new Guidelines (“the Commission Guidelines”) and thereby repealed Decision 2010/15/EU. By its Implementing Decision (EU) 2023/975 (4) of 15 May 2023 (“Decision (EU) 2023/975”), the Commission amended Decision (EU) 2019/417 and thereby the Guidelines applicable to EU Member States. As of September 2025, Implementing Decision (EU) 2023/975 is no longer in force. In the EU, it has been replaced by Commission Delegated Regulation (EU) 2024/3173. (5)

The currently applicable Guidelines by the EFTA Surveillance Authority (“the Authority”) were adopted by Decision No 447/14/COL of 5 November 2014. (6) Those are replaced by the present Guidelines. They will remain applicable in the EFTA States when the General Product Safety Regulation enters into force in the EEA Agreement, and until they are amended by the Authority or replaced by EEA relevant Commission Delegated Regulations under the General Product Safety Regulation.

These Guidelines are addressed to the national authorities in the EFTA States designated as contact points in the Safety Gate network and in charge of the notification procedure under Article 11 of the General Product Safety Directive. The Authority is to use the present Guidelines as the reference document in operating Safety Gate and the Article 11 notification procedure under the General Product Safety Directive.

PART I

SCOPE AND ADDRESSEES OF THE GUIDELINES

1.    Overview, scope, objectives and update

1.1.   Overview - scope

Under Article 11 of the General Product Safety Directive, the EFTA States are to inform the Authority of measures taken which restrict the placing on the market of products — or require their withdrawal or recall — to the extent that such information is not required by Article 12 of the Directive or any other specific EEA legislation.

Article 22 of Regulation (EC) No 765/2008 (7) provides that, where an EFTA State takes or intends to take a measure that prevents, restricts or imposes specific conditions on the marketing and use of products posing a serious risk to the health, safety and other relevant public interests of the end-users, it must immediately notify such a measure to the Authority using Safety Gate.

Article 23 of Regulation (EC) No 765/2008 provides that the EFTA States must make available to the Authority the information at their disposal, and not already provided under Article 22, on products presenting a (less than serious) risk.

Article 20 of Regulation (EU) 2019/1020 (8) provides that when a market surveillance authority takes or intends to take a measure where products that present a serious risk are withdrawn or recalled or their placing on the market is prohibited, it shall immediately notify the Authority thereof using Safety Gate.

Article 16 of the General Product Safety Directive provides an obligation for the EFTA States and the Authority to make available to the public information relating to risks to consumer health and safety posed by products. It would therefore be opportune that all information on measures adopted relating to products posing a risk, insofar as product safety is at stake, are contained in the system intended for this purpose, namely Safety Gate. The EFTA States are therefore encouraged to provide Safety Gate with the measures adopted against products posing a risk and entering into the scope of application of the General Product Safety Directive or Regulation (EC) No 765/2008. The information can be provided directly in Safety Gate. In case the information has to be notified in another information system according to Regulation (EC) No 765/2008, (9) the EFTA State can generate a Safety Gate notification from within the information system.

Whereas the General Product Safety Directive applies only to products posing a risk to the health and safety of consumers, Regulation (EC) No 765/2008 also applies to professional products covered by EU harmonisation legislation (such as certain medical devices and marine equipment). It also covers a broader scope of risk, in addition to those related to the health and safety of consumers, such as security and environmental risks. Therefore, a risk can concern not only consumers but also, where Regulation (EC) No 765/2008 applies, other “end-users”.

The Risk Assessment Guidelines of Appendix 6 in Part III of the Commission Guidelines are an integral part of the Commission Guidelines. They enable determining the level of risk of a product and therefore help to identify the measures to be adopted.

The Risk Assessment Guidelines refer to the level of risk as well as to the possible injuries caused by a single product. The risk assessment for a single product must be accompanied by sound risk management. For example, the risk level for a defective household electrical appliance posing a risk of fire may be only ”low”, meaning that the probability of a single appliance causing a fatal fire during the lifetime of the appliance is less than one in a million. Nevertheless, if millions of the defective appliances have been placed on the market, it is almost inevitable that fatal fires will occur if appropriate measures are not taken.

1.2.   Objectives

In addition to the objectives set out by the Commission Guidelines, the objectives of these Guidelines are to:

(a)	ensure that the Commission Guidelines are applied uniformly, also in the EFTA States

(b)	describe the handling of notifications and follow-up notifications by the contact points of the EFTA States and the Authority, taking into consideration the adaptations that follow from Protocol 1 to the EEA Agreement

1.3.   Update

These Guidelines will be regularly updated by the Authority in accordance with updates adopted by the Commission on the basis of experience and new developments in the product safety area and in accordance with the advisory procedure.

2.    Addressees of the Guidelines

These Guidelines are addressed to the authorities of the EFTA States acting on product safety and participating in the Safety Gate network, including market surveillance authorities responsible for monitoring the compliance of products with safety requirements and authorities in charge of external border controls.

The Authority shall use these Guidelines as a reference for managing, in cooperation with the Commission, Safety Gate and the notification procedures referred to above.

PART II

APPLICATION OF THE GUIDELINES IN RELATION TO THE SAFETY GATE RAPID ALERT SYSTEM

3.    Tasks and role of national Safety Gate Contact Points of EFTA States

3.1.   General

The tasks and role of the national Safety Gate Contact Points of the EFTA States are equivalent to the tasks and role of the national Safety Gate Contact points of the EU Member States.

Their role and tasks are outlined in the Commission Guidelines.

3.2.   National validation tasks – EFTA States

The national validation process is the responsibility of the national Safety Gate Contact Points of the EFTA States.

During the validation process the national Safety Gate Contact Points of the EFTA States are to notify the Authority Safety Gate Contact Point that a notification or a follow up notification is pending, by sending an e-mail to the Authority Safety Gate Contact Point’s functional mailbox: safetygate@eftasurv.int. The Authority, via the Authority Safety Gate Contact Point, is the competent body to review notifications and reactions from the EFTA States pursuant to Articles 11(2)-12(2) of the General Product Safety Directive, in accordance with the adaptations that follow from Protocol 1 to the EEA Agreement.

The Authority Safety Gate Contact Point is to respond to the notification sent by the national Safety Gate Contact Point within 24 hours of the receipt of a notification, if it is received on a working day within working hours.  (10) If neither a response nor a proposal for amendment of a notification or a follow-up notification is received within the aforementioned timeframe, the notification may be validated and sent to the European Commission via Safety Gate, by the national Safety Gate Contact Point.

In cases of urgency, the national Safety Gate Contact Points of the EFTA States are to make direct contact with the Authority Safety Gate Contact Point as quickly as possible to ensure that the Authority has no objections to the notification or reaction being uploaded onto the Safety Gate system, prior to validation and sending to the Commission.

The national Safety Gate Contact Points of the EFTA States shall not under any circumstances validate and send a notification or reaction to the Commission without having duly notified the Authority Safety Gate Contact Point thereof and checked that it has no concerns regarding the notification or reaction, according to the previous paragraphs.

4.    Additional commitments

Every effort will be made to ensure the smooth and efficient management of the Safety Gate system by the Authority and the EFTA States’ Contact Points.

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(*1)  As corrected by College Decision 037/26/COL.

(1)  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4). The Act has been incorporated into the EEA Agreement at point 3h of Chapter XIX of Annex II to the Agreement.

(2)  According to Recital 68 of the General Product Safety Regulation, “It is opportune to change the abbreviated name from RAPEX to Safety Gate for greater clarity and better outreach to consumers”. The new name is used throughout the Regulation, notably in Chapter VI “SAFETY GATE RAPID ALERT SYSTEM AND SAFETY BUSINESS GATEWAY”. The name Safety Gate has also replaced the name Rapex on the Commission’s public webpage for product safety: https://ec.europa.eu/safety-gate/#/screen/pages/productSafetyLegislation.

(3)  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, 15.03.2019, p.121).

(4)  Commission Implementing Decision (EU) 2023/975 of 15 May 2023 amending Commission Implementing Decision (EU) 2019/417 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC of the European Parliament and of the Council on general product safety and its notification system (OJ L 132, 17.5.2023, p. 77).

(5)  Commission Delegated Regulation (EU) 2024/3173 of 27 August 2024 supplementing Regulation (EU) 2023/988 of the European Parliament and of the Council with regard to rules on access to and operation of the Safety Gate Rapid Alert System, information to be entered in that System, notification requirements and the criteria for assessment of the level of risk, (OJ L, 2024/3173, 13.12.2024).

(6)  Doc No 724664.

(7)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 2018, 13.08.2008, p. 30). The Act has been incorporated in the EEA Agreement at point 3b of Chapter XIX of Annex II to the Agreement. Articles 22 and 23 of Regulation (EC) No 765/2008 have been repealed by Article 39(1)(4) of Regulation (EU) 2019/1020. However, the latter Regulation has not yet been incorporated in the EEA Agreement, cf. footnote 8.

(8)  Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). The Act was incorporated in the EEA Agreement at point 9 of Chapter XVII, points 3b and 3v of Chapter XIX and point 1 of Chapter XXI of Annex II to the Agreement, by Decision 317/2023 of the EEA Joint Committee of 8 December 2023, which is currently, by September 2025, pending constitutional requirements and has therefore not yet entered into force in the EEA Agreement.

(9)  The Information and Communication System on Market Surveillance (‘ICSMS’). This platform is aimed at facilitating communication between market surveillance bodies in the EU and in EFTA countries on non-compliant products.

(10)  The term “working days” is to be understood as Monday through Friday except for those days published in the Official Journal of the European Union as the Authority’s public holidays, whereas the term “working hours” is to be understood as the time between 0700 and 1630 UTC+1. If the notification is received by the Authority Safety Gate Contact Point at a point in time which is not on a working day within working hours, for example on a public holiday, on a Saturday or Sunday, or on a Friday at 1700 GMT+1, the 24 hours response deadline for the Authority Safety Gate Contact Point will be counted from the next working hour on the next working day, following the actual receipt of the notification.