An important pillar of the New Legislative Framework (NLF) is the principle of voluntary application of harmonized standards (hEN) in the context of the conformity assessment procedure in order to demonstrate compliance with the essential requirements prescribed by law (e.g. RoHS, EMC, electrical safety). When applying or partially applying the hENs, the manufacturer may presume that the essential requirements of the respective harmonization legislation covered by the hENs are met. However, the prerequisite is that these hENs have been published in the Official Journal of the European Union. This is where things get complicated, as the hENs have to pass the so-called "HAS Assessment" on their way to the Official Journal. This is carried out on the basis of Art. 10 (5) Standardization Regulation 1025/2012.
A note at this point: Article 7 of the new Product Safety Regulation 2023/988 (GPSR for short) refers to "European standards". According to the Standardization Regulation (Art. 2 para. 1 letter b)), a European standard is defined as follows
"a standard adopted by a European standardization organization".
The difference to a harmonized standard is that European standards are developed by the standardization organizations CEN, CENELEC as well as ETSI without a mandate (mandate) from the Commission. In the context of the GPSR, the Standardization Regulation was amended here and Art. 10 (7) was added, in which European standards for the GPSR are also to be published in the EU Official Journal (not yet done).
When drafting new or revised internal market regulations, the Commission has granted itself authorization for a new instrument that has not yet been adequately recognized by the broad user community: the so-called "common specifications".
For example, Article 20(3) of the new Machinery Regulation 2023/1230 states that
"The Commission may adopt implementing acts to lay down common specifications covering the technical requirements providing a means of meeting the essential health and safety requirements set out in Annex III for products falling within the scope of this Regulation.
Those implementing acts shall be adopted only if the following conditions are met:
(a) the Commission has requested, in accordance with Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardization organisations to develop harmonized standards for the essential health and safety requirements set out in Annex III; and
(i) the request has not been accepted; or
(ii) the harmonized standards documents that are the subject of that request are not drafted within the time limit set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
(ii) the harmonized standards documents do not comply with the mandate; and
(b) no reference to harmonized standards covering the relevant essential health and safety requirements set out in Annex III has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period of time.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).
The conditions under which implementing acts are drawn up and published are sufficiently described in KANBrief 2/23 (see link below) and are not described in more detail here.
These common specifications are intended to be a further instrument alongside the harmonized standards and thus also serve to support the harmonization of product requirements. In addition to the Machinery Regulation, the Cyber Resilience Act 2024/2847 and the new AI Regulation 2024/1689 also recognize this instrument of common specifications.
The Medical Devices Regulation 2017/745 and the IVDR 2017/746 also use this term. However, these are based on explicit requirements in this legislation. There were no specific standardization mandates for CEN and CENELEC in this regard, as the legal texts generally envisaged an independent development of these common specifications by the Commission (see MDCG 2021-5 Rev. 1 "Guidance on standardization for medical devices", link inserted below).
In principle, common specifications are to be applied as an "exceptional fall-back solution" (in the German version "außergewöhnliche Ausweichlösung"). The implementing acts may therefore only be adopted if, for example, certain conditions are met in accordance with the Machinery Regulation (see above).
The problem is that the above-mentioned individual acts do not contain any concrete indications as to how the Commission intends to draw up the specific, technically demanding common specifications and how the necessary expertise is to be ensured.
It would therefore make sense to adopt a single horizontal legal act on the procedures for drawing up, adopting and publishing such common specifications.
The Commission for Occupational Health and Safety and Standardization (KAN) has published a position paper on this subject that is well worth reading (see link below). In the European standardization strategy from 2022, the Commission stated that it was working towards a horizontal approach. However, there are currently no public drafts or other information available. It therefore remains to be seen how things will progress at this point.
If you would like to discuss this topic, please do not hesitate to contact us.
Author
Dipl.-Ing. (FH) Michael Loerzer
Regulatory Affairs Specialist
DEFINITIONS AND ABBREVIATIONS
CEN: French for Comité Européen de Normalisation / the European Committee for Standardization
ETSI: European Telecommunications Standards Institute
One of the three EU standards organizations (ESO)
IEC: International Electrotechnical Commission
ISO: International Organization for Standardization
OJEU: Official Journal EU
CENELEC: European Committee for Electrotechnical Standardization
