Date: 2023-12-01Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2023/2669 of 27 November 2023 amending Implementing Decision (EU) 2022/2191 as regards harmonised standards for wireless communication devices used next to the ear or in close proximity to the human body
**Executive Summary:**
This Commission Implementing Decision (EU) 2023/2669 amends Implementing Decision (EU) 2022/2191 regarding harmonized standards for wireless communication devices used near the ear or body. It updates the references to harmonized standards EN 50360:2017 and EN 50566:2017 to include amendments A1:2023. Point 1 of the Annex, regarding deletions, applies from 1 June 2025. The decision enters into force on the day of its publication.
**Key Points / Main Content:**
* **Amendment of Implementing Decision (EU) 2022/2191:**
* Annex I to Implementing Decision (EU) 2022/2191 is amended.
* **Deletion of References:**
* Rows 1 and 4 of Annex I to Implementing Decision (EU) 2022/2191 are deleted from 1 June 2025. These rows contain references to harmonised standards EN 50360:2017 and EN 50566:2017.
* **Insertion of New References:**
* The following rows are inserted into Annex I:
* EN 50360:2017/A1:2023 for wireless devices used next to the ear (300 MHz - 6 GHz).
* EN 50566:2017/A1:2023 for handheld and body-mounted devices in close proximity to the human body (30 MHz - 6 GHz).
* **Compliance and Presumption of Conformity:**
* The updated harmonized standards EN 50360:2017/A1:2023 and EN 50566:2017/A1:2023 satisfy essential requirements of Directive 2014/53/EU.
**Impact Analysis:**
**Manufacturers of Radio Equipment:**
* *Impact:* Need to ensure radio equipment complies with the updated harmonized standards EN 50360:2017/A1:2023 and EN 50566:2017/A1:2023 to maintain presumption of conformity with Directive 2014/53/EU.
* *Action Required:* Adapt radio equipment to comply with the amended standards.
**Member States:**
* *Impact:* Must recognize the updated harmonized standards for presumption of conformity.
* *Action Required:* Apply the changes to their national regulations and market surveillance activities.
**European Committee for Electrotechnical Standardisation (CENELEC):**
* *Impact:* Acknowledgment of the assessment of the updated harmonized standards.
* *Action Required:* No specific action is stated, but CENELEC has already drafted the amended standards based on a commission request.
Key Entities Referenced
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining the scope of the EU's powers and the procedures for its institutions to make decisions.
Regulation EU No 1025/2012: Regulation of the European Parliament and of the Council on European standardisation, amending Council Directives and repealing Council Decision.
Directive 2014/53/EU: Directive of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC.
European Committee for Electrotechnical Standardisation (Cenelec): A European standards organization responsible for standardization in the electrotechnical engineering field.
European Telecommunications Standards Institute (ETSI): A European standards organization that produces telecommunications standards.
Commission Implementing Decision EU 2022/2191: Commission Implementing Decision on the harmonised standards for radio equipment drafted in support of Directive 2014/53/EU of the European Parliament and of the Council.
EN 50360:2017A1:2023: Amending harmonised standard for wireless communication devices used next to the ear
Official Journal EN
of the European Union L series
2023/2669 1.12.2023
COMMISSION IMPLEMENTING DECISION (EU) 2023/2669
of 27 November 2023
amending Implementing Decision (EU) 2022/2191 as regards harmonised standards for wireless
communication devices used next to the ear or in close proximity to the human body
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament
and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European
Parliament and of the Council(1), and in particular Article 10(6) thereof,
Whereas:
(1) In accordance with Article 16 of Directive 2014/53/EU of the European Parliament and of the Council(2), radio
equipment which is in conformity with harmonised standards or parts thereof, the references of which have been
published in the Official Journal of the European Union, is to be presumed to be in conformity with the essential
requirements set out in Article 3 of that Directive where they are covered by those standards or parts thereof.
(2) By Commission Implementing Decision C(2015) 5376(3), the Commission made a request to the European
Committee for Electrotechnical Standardisation (Cenelec) and the European Telecommunications Standards Institute
(ETSI) for the drafting and the revision of harmonised standards for radio equipment in support of
Directive 2014/53/EU (‘the request’).
(3) On the basis of the request, Cenelec amended harmonised standards EN 50360:2017 for wireless communication
devices used next to the ear, and EN 50566:2017 for wireless communication devices used in close proximity to the
human body, the references of which are published in the Official Journal of the European Union by Commission
Implementing Decision (EU) 2022/2191(4). This resulted in the adoption of amending harmonised standards
EN 50360:2017/A1:2023 and EN 50566:2017/A1:2023.
(4) The Commission, together with Cenelec, has assessed whether those harmonised standards comply with the request.
(5) Harmonised standards EN 50360:2017, as amended by EN 50360:2017/A1:2023, and EN 50566:2017, as
amended by EN 50566:2017/A1:2023, satisfy the essential requirements which they aim to cover and which are set
out in Article 3 of Directive 2014/53/EU. It is therefore appropriate to publish the references of those standards in
the Official Journal of the European Union.
(1) OJ L 316, 14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj.
(2) Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the
Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153,
22.5.2014, p. 62, ELI: http://data.europa.eu/eli/dir/2014/53/oj).
(3) Commission Implementing Decision C(2015) 5376 final of 4 August 2015 on a standardisation request to the European Committee
for Electrotechnical Standardisation and to the European Telecommunications Standards Institute as regards radio equipment in
support of Directive 2014/53/EU of the European Parliament and of the Council.
(4) Commission Implementing Decision (EU) 2022/2191 of 8 November 2022 on the harmonised standards for radio equipment drafted
in support of Directive 2014/53/EU of the European Parliament and of the Council (OJ L 289, 10.11.2022, p. 7, ELI: http://data.
europa.eu/eli/dec_impl/2022/2191/oj).
ELI: http://data.europa.eu/eli/dec_impl/2023/2669/oj 1/3EN
OJ L, 1.12.2023
(6) Annex I to Implementing Decision (EU) 2022/2191 provides the references of harmonised standards conferring a
presumption of conformity with Directive 2014/53/EU. In order to ensure that the references of harmonised
standards drafted in support of Directive 2014/53/EU are listed in one act, the references of harmonised standards
EN 50360:2017, as amended by EN 50360:2017/A1:2023, and EN 50566:2017, as amended by
EN 50566:2017/A1:2023, should be included in that Annex.
(7) It is necessary to withdraw from the Official Journal of the European Union the references of harmonised standards
EN 50360:2017 and EN 50566:2017, given that they have been amended. It is therefore appropriate to delete
those references from Annex I to Implementing Decision (EU) 2022/2191.
(8) Implementing Decision (EU) 2022/2191 should therefore be amended accordingly.
(9) In order to allow manufacturers sufficient time to adapt their radio equipment that is covered by harmonised
standard EN 50360:2017 or EN 50566:2017, it is necessary to defer the withdrawal of the references of those
harmonised standards.
(10) Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential
requirements set out in Union harmonisation legislation from the date of publication of the reference of such
standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its
publication,
HAS ADOPTED THIS DECISION:
Article 1
Annex I to Implementing Decision (EU) 2022/2191 is amended in accordance with the Annex to this Decision.
Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
Point (1) of the Annex shall apply from 1 June 2025.
Done at Brussels, 27 November 2023.
For the Commission
The President
Ursula VON DER LEYEN
2/3 ELI: http://data.europa.eu/eli/dec_impl/2023/2669/ojEN
OJ L, 1.12.2023
ANNEX
Annex I to Implementing Decision (EU) 2022/2191 is amended as follows:
(1) rows 1 and 4 are deleted;
(2) the following rows are inserted in sequential order:
‘1a EN 50360:2017
Product standard to demonstrate the compliance of wireless communication devices, with the basic
restrictions and exposure limit values related to human exposure to electromagnetic fields in the
frequency range from 300 MHz to 6 GHz: devices used next to the ear
EN 50360:2017/A1:2023’;
‘4a. EN 50566:2017
Product standard to demonstrate the compliance of wireless communication devices with the basic
restrictions and exposure limit values related to human exposure to electromagnetic fields in the
frequency range from 30 MHz to 6 GHz: hand-held and body mounted devices in close proximity to the
human body
EN 50566:2017/A1:2023’.
ELI: http://data.europa.eu/eli/dec_impl/2023/2669/oj 3/3