Commission Implementing Regulation (EU) 2024/2639 of 9 October 2024 laying down rules for the application of Regulation (EU) 2023/988 of the European Parliament and of the Council as regards the roles and tasks of the single national contact points of the Safety Gate Rapid Alert System

Type Implementing Regulation
Publication 2024-10-10
State In force
Text As published
Department European Commission, JUST
Source EUR-Lex
articles 3

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API
Image omitted; see official source Official Journal of the European Union EN L series
--- --- ---
2024/2639 10.10.2024

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC 1, and in particular Article 25(2), second subparagraph, thereof,

Whereas:

HAS ADOPTED THIS REGULATION:

Article 1

The roles and tasks of the single national contact points under Article 25(2) of Regulation (EU) 2023/988 (‘Safety Gate contact points’) shall be to:

Article 2

The Commission and the national authorities acting as joint controllers for processing data in the Safety Gate Rapid Alert System pursuant to Article 26 of Regulation (EU) 2016/679 and Article 28 of Regulation (EU) 2018/1725 shall have the roles and responsibilities set out in the Annex to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 13 December 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 9 October 2024.

For the Commission

The President

Ursula VON DER LEYEN

2

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, p. 121, ELI: http://data.europa.eu/eli/dec/2019/417/oj).

3

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, ELI: http://data.europa.eu/eli/dir/2001/95/oj).

4

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/679/oj).

5

Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj).

6

Not yet published in the Official Journal.

7

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, ELI: http://data.europa.eu/eli/reg/2019/1020/oj).

ANNEX

JOINT CONTROLLERSHIP OF THE SAFETY GATE RAPID ALERT SYSTEM

1. SUBJECT MATTER AND DESCRIPTION OF THE PROCESSING

The Safety Gate Rapid Alert System is a notification system operated by the Commission intended for the rapid exchange of information between national authorities of Member States, the three European Economic Area/European Free Trade Association (EEA/EFTA) states (Iceland, Liechtenstein and Norway) and the Commission on measures taken against dangerous products found on the Union and/or EEA/EFTA market.

The purpose of the Safety Gate Rapid Alert System is to allow the rapid exchange of information on corrective measures taken across the Union in relation to products that present a risk.

The information exchange concerns corrective measures taken in relation to dangerous consumer and professional products falling in the scope of Regulations (EU) 2023/988 or (EU) 2019/1020.

The Safety Gate Rapid Alert System covers both measures ordered by national authorities and measures taken voluntarily by economic operators.

2. SCOPE OF THE JOINT CONTROLLERSHIP

The Commission and national authorities shall act as joint controllers (‘Joint Controllers’) for processing data in the Safety Gate Rapid Alert System. ‘National authorities’ refers to all authorities acting on product safety in the Member States and/or the EFTA/EEA countries and participating in the EU network of Safety Gate contact points, including market surveillance authorities responsible for monitoring the compliance of products with safety requirements and authorities in charge of external border controls.

For the purposes of Article 26 of Regulation (EU) 2016/679 and Article 28 of Regulation (EU) 2018/1725, the following processing activities shall fall under the responsibility of the Commission as a Joint Controller of personal data:

When carrying out these activities, the Commission shall ensure compliance with the applicable obligations and conditions of Regulation (EU) 2018/1725.

The following processing activities shall fall under the responsibility of the national authorities, as Joint Controllers of personal data:

When carrying out these activities, the national authorities shall ensure compliance with the applicable obligations and conditions of Regulation (EU) 2016/679.

3. RESPONSIBILITIES, ROLES AND RELATIONSHIP OF THE JOINT CONTROLLERS TOWARDS DATA SUBJECTS

3.1.   Categories of data subjects and personal data

The Joint Controllers shall jointly process the following categories of personal data:

The following data may be processed:

These authors and validators include:

The following data may be processed:

3.2.   Provision of information to data subjects

The Commission shall provide the information referred to in Articles 15 and 16 and any communication under Articles 17 to 24 and 35 of Regulation (EU) 2018/1725 in a concise, transparent, intelligible and easily accessible form, using clear and plain language. The Commission shall also take appropriate measures to assist national authorities in providing any information referred to in Articles 13 and 14 and any communication under Articles 19 to 26 and 37 of Regulation (EU) 2016/679 in a concise, transparent, intelligible and easily accessible form, using clear and plain language concerning the following data:

Safety Gate Rapid Alert System users shall be informed about their rights through the Privacy Statement available in the Safety Gate Rapid Alert System.

National authorities shall take appropriate measures to provide any information referred to in Articles 13 and 14 and any communication under Articles 19 to 26 and 37 of Regulation (EU) 2016/679 in a concise, transparent, intelligible and easily accessible form, using clear and plain language concerning the following data:

The information shall be provided in writing, including electronically.

National authorities shall use the model for a privacy statement provided by the Commission when complying with their obligations concerning data subjects.

3.3.   Handling of data subjects’ requests

The data subjects may exercise their rights under Regulation (EU) 2018/1725 and Regulation (EU) 2016/679, respectively against the Commission or against national authorities acting as Joint Controllers.

The Joint Controllers shall handle the requests of data subjects in accordance with the procedure established by the Joint Controllers for this purpose. The detailed procedure for the exercise of data subjects’ rights is explained in the privacy statement.

The Joint Controllers shall cooperate and, when so requested, provide each other with swift and efficient assistance in handling any data subject requests.

Should one Joint Controller receive a data subject request, which does not fall under its responsibility, that Joint Controller shall forward the request promptly, and at the latest within seven calendar days of its receipt, to the Joint Controller actually responsible for that request. The responsible Joint Controller shall send an acknowledgment of receipt to the data subject within three calendar days after reception of the forwarded request, while at the same time informing thereof the Joint Controller, which received the request in the first place.

In response to a data subject request for access to personal data, no Joint Controller shall disclose or otherwise make available any personal data processed jointly without first consulting the other Joint Controller.

4. OTHER RESPONSIBILITIES AND ROLES OF JOINT CONTROLLERS

4.1.   Security of processing

Each Joint Controller shall implement appropriate technical and organisational measures to:

Each Joint Controller shall implement appropriate technical and organisational measures to ensure the security of processing pursuant to Article 33 of Regulation (EU) 2018/1725 and Article 32 of Regulation (EU) 2016/679, respectively.

The Joint Controllers shall provide a swift and efficient assistance to each other in case of security incidents, including personal data breaches.

4.2.   Management of security incidents, including personal data breaches

The Joint Controllers shall handle security incidents, including personal data breaches, in accordance with their internal procedures and applicable legislation.

The Joint Controllers shall in particular provide each other with swift and efficient assistance as required to facilitate the identification and handling of any security incidents, including personal data breaches, linked to the joint processing operation.

The Joint Controllers shall notify each other of the following:

Each Joint Controller shall be responsible for handling all security incidents, including personal data breaches, that occur as a result of an infringement of that Joint Controller’s obligations under this Implementing Regulation, Regulation (EU) 2018/1725 and Regulation (EU) 2016/679, respectively.

The Joint Controllers shall document security incidents (including personal data breaches) and notify each other without undue delay and at the latest within 48 hours after becoming aware of a security incident (including a personal data breach).

The Joint Controller responsible for a personal data breach shall document that personal data breach and notify it to the European Data Protection Supervisor or the competent national supervisory authority. It shall do so without undue delay and, where feasible, no later than 72 hours after having become aware of the personal data breach, unless the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons. The Joint Controller responsible shall inform the other Joint Controller of such notification.

The Joint Controller responsible for the personal data breach shall communicate that personal data breach to the data subjects concerned if the personal data breach is likely to result in a high risk to the rights and freedoms of natural persons. The Joint Controller responsible shall inform the other Joint Controller of such communication.

4.3.   Localisation of personal data

Personal data collected for the purpose of the notification process through the Safety Gate Rapid Alert System shall be stored and collected in the Safety Gate Rapid Alert System to ensure that the access to the application is limited only to clearly identified persons and thus that data stored in the application are well protected.

Personal data collected for the purpose of the processing operation shall only be processed within the territory of the EU/EEA and shall not leave that territory, unless they are in compliance with Articles 45, 46 or 49 of Regulation (EU) 2016/679 or with Articles 47, 48 or 50 of Regulation (EU) 2018/1725.

According to Article 40 of Regulation (EU) 2023/988, the Commission may provide third countries or international organisations with selected information from the Safety Gate Rapid Alert System and receive relevant information on the safety of products and on preventive, restrictive and corrective measures taken by those third countries or international organisations. Any information exchange under Article 40 of Regulation (EU) 2023/988 shall, to the extent it involves personal data, be carried out in accordance with Union data protection rules.

4.4.   Recipients of personal data

Access to personal data shall only be granted to authorised staff and contractors of the Commission and national authorities for the purposes of administering and operating the Safety Gate Rapid Alert System. This access shall be subject to identity and password requirements as follows:

The persons who shall have access to the collected personal data are:

The persons who shall have access to all collected personal data and who shall have the possibility to modify them upon request are:

A list of all Safety Gate contact points, containing their contact details (surname, name, name of authority, address of authority, phone, email) shall be available on the Safety Gate Portal 10. User management at national level shall be controlled by the Safety Gate contact points through the Safety Gate Rapid Alert System.

All users shall have access to the content of notifications with an ‘EC validated’ status. Only national Safety Gate Rapid Alert System users shall have access to the draft of their notifications (before submission to EC). Commission staff and authorised persons shall have access to notifications with an ‘EC submitted’ status.

Each Joint Controller shall inform all other Joint Controllers about any transfer of personal data to the recipients in third countries or international organisations.

5. SPECIFIC RESPONSIBILITIES OF JOINT CONTROLLERS

The Commission shall ensure and be responsible for:

The national authorities shall ensure and be responsible for:

6. DURATION OF PROCESSING

Joint Controllers shall not retain or process personal data longer than necessary to carry out the agreed purposes and obligations as set out in this Regulation, i.e. for the time necessary to fulfil the purpose of collection or further processing. In particular:

Legitimate requests from data subjects to have their data blocked, adjusted or erased shall be complied with by the Commission within one month from receipt of the request.

7. LIABILITY FOR NON-COMPLIANCE

The Commission shall be liable for non-compliance in accordance with Chapter VIII of Regulation (EU) 2018/1725.

The EU Member States’ authorities shall be liable for non-compliance in accordance with Chapter VIII of Regulation (EU) 2016/679.

8. COOPERATION BETWEEN JOINT CONTROLLERS

Each Joint Controller, when so requested, shall provide a swift and efficient assistance to the other Joint Controllers in execution of this Regulation, while complying with all applicable requirements of Regulations (EU) 2018/1725 and (EU) 2016/679, respectively, and other applicable data protection rules.

9. SETTLEMENT OF DISPUTES

The Joint Controllers shall endeavour to settle amicably any dispute arising out or relating to the interpretation or application of this Regulation.

If at any time a question, dispute or difference arises between the Joint Controllers, in relation to or in connection with this Regulation, the Joint Controllers shall use every endeavour to resolve it by a process of consultation.

The preference is that all disputes are settled at the operational level as they arise, and that they are settled by the contact points referred to in point 10 of this Annex and listed on the Safety Gate Portal.

The purpose of the consultation shall be to review and agree so far as it is practicable the action taken to solve the problem. The Joint Controllers shall negotiate with each other in good faith to that end. Each Joint Controller shall respond to a request for amicable settlement within seven working days following the reception of such request. The period to reach an amicable settlement shall be 30 working days from the date of reception of the request.

If the dispute cannot be settled amicably, each Joint Controller may refer to mediation or/and judicial proceedings in the following manner:

10. CONTACT POINTS FOR COOPERATION BETWEEN THE JOINT CONTROLLERS

Each Joint Controller nominates a single point of contact, who other Joint Controllers shall contact in case of queries, complaints and provision of information within the scope of this Regulation.

A detailed list of all contact points nominated by the Commission and the national authorities, containing their contact details (surname, name, name of authority, address of authority, phone, fax, email), shall be available on the Safety Gate Portal.

8

This field may refer to the physical person representing the manufacturers or authorised representatives. Member States are however asked to avoid entering any personal data and favour non-personal contact details like generic email addresses.

9

Commission Decision (EU, Euratom) 2017/46 of 10 January 2017 on the security of communication and information systems in the European Commission (OJ L 6, 11.1.2017, p. 40, ELI: http://data.europa.eu/eli/dec/2017/46/oj).

ELI: http://data.europa.eu/eli/reg_impl/2024/2639/oj

ISSN 1977-0677 (electronic edition)

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.