Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (“the General Product Safety Directive”, “the Act”),(1)

| Official Journal of the European Union | EN L series ---|---|--- * * * | 2026/1040 | 7.5.2026 ---|---|--- EFTA SURVEILLANCE AUTHORITY DECISION No 146/25/COL of 9 September 2025 adopting Guidelines for the Safety Gate Rapid Alert System as established under Directive 2001/95/EC on general product safety [2026/1040] THE EFTA SURVEILLANCE AUTHORITY, Having regard to the Act referred to at point 3h of Chapter XIX of Annex II to the Agreement on the European Economic Area (“The EEA Agreement”) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (“the General Product Safety Directive”, “the Act”), (1) As adapted to the EEA Agreement by Protocol 1 thereto, and in particular to Article 11(1), third subparagraph of the Act, and point 8 of Annex II thereto, The College Member with special responsibility for product safety has been empowered, on behalf of the Authority and under its responsibility, to (1) submit draft Guidelines to the EFTA Committee on Technical Regulations, Standards, Testing and Certification (“the EFTA Committee”) (2) and to (2) adopt such guidelines after having consulted the EFTA Committee on the matter, (3) Whereas: In the EU, the General Product Safety Directive has been repealed and replaced by Regulation (EU) 2023/988 on general product safety (“the General Product Safety Regulation”) with effect from 13 December 2024. By September 2025, the General Product Safety Regulation has not been incorporated into the EEA Agreement. Accordingly, the General Product Safety Directive remains applicable in the EFTA States. In accordance with Article 11(1), third subparagraph of the General Product Safety Directive, and point 8 Annex II thereto, 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 revised Guidelines, even though the General Product Safety Regulation has not yet entered into force in the EEA. By its Implementing Decision (EU) 2023/975 (4) of 15 May 2023 (“Decision (EU) 2023/975”), the Commission amended its previous Decision 2019/417 and thereby the Guidelines currently applicable to the 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) According to Article 5(2)(d) of the Agreement between the EFTA States on the Establishment of a Surveillance Authority and a Court of Justice (“Surveillance and Court Agreement”), the EFTA Surveillance Authority (“the Authority”) shall carry out the functions which, through the application of Protocol 1 to the EEA Agreement, follow from the acts referred to in the Annexes to that Agreement, as specified in Protocol 1 to the Surveillance and Court Agreement. Furthermore, pursuant to Article 1(2) of Protocol 1 to the Surveillance and Court Agreement, the Authority shall carry out certain functions corresponding to the functions of the Commission. The Authority adopted the RAPEX Guidelines that are currently applicable to the EFTA States by Decision No 447/14/COL of 5 November 2014. (6) Against the background of the Commission having adopted revised Guidelines by its Decision (EU) 2023/975, the Authority now considers it necessary to adopt revised Guidelines to ensure that the Commission’s Guidelines are uniformly applied, also within the EFTA States, while taking into account the necessary adaptations that follow from Protocol 1 to the EEA Agreement. The College Member with special responsibility for product safety has been empowered, on behalf of the Authority and under its responsibility, to adopt such measures, if the draft measures to be adopted are, as in the present case, in accordance with the opinion of the relevant EFTA Committee. By letter of 25 September 2024, the Authority invited the EFTA Committee to deliver its opinion on the draft Guidelines. (7) The EFTA Committee agreed with the draft revised Guidelines, only suggesting that the name “RAPEX” be replaced by “Safety Gate”. That suggestion has been incorporated in the annexed Guidelines. HAS ADOPTED THIS DECISION: 1. | After having consulted the EFTA Committee on Technical Regulations, Standards, Testing and Certification on the matter, the Authority hereby adopts amended Guidelines to supplement the Act referred to at point 3h of Chapter XIX of Annex II to the Agreement on the European Economic Area for the management of the Safety Gate Rapid Alert System established under Article 11(1) of the Act. ---|--- 2. | The Decision, including the amended Guidelines set out in the Annex, shall be published in the EEA Section of, and the EEA Supplement to, the Official Journal of the European Union. ---|--- 3. | The Decision is authentic in the English language. ---|--- 4. | This Decision is addressed to the EFTA States. ---|--- Done at Brussels, 9 September 2025. For the EFTA Surveillance Authority, acting under Delegation Decision 198/10/COL, Árni Páll ÁRNASON Responsible College Member Melpo-Menie JOSÉPHIDÈS Countersigning as Director, Legal and Executive Affairs * * * (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 was incorporated into the EEA Agreement by Joint Committee Decision No 9/2003, which entered into force on 1 March 2004. While the Act has been amended by subsequent legislation, the amendments do not affect the provisions material to the present Decision. (2) The EFTA Committee on Technical Regulations, Standards, Testing and Certification, as designated by Decision No 4/2012/SC of the Standing Committee of the EFTA States of 26 October 2012. (3) See Decision No 124/24/COL to seek the Opinion of the EFTA Committee. (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) Doc No 1499315. * * * ELI: http://data.europa.eu/eli/dec/2026/1040/oj ISSN 1977-0677 (electronic edition) * * *