Two questions first...
1. Do you often ask yourself why certain technical standards do not make it into the Official Journal of the EU and why you cannot make use of the presumption of conformity as a result? There is a lot of speculation about the reasons in professional circles, but one is never shown the result of the HAS assessment.
2. Are you aware of your rights of access to European Parliament, Council and Commission documents? This right is given, among other things, by Regulation (EC) No. 1049/2001.
For market access to the European Union, harmonized European standards (hENs) are to be drawn up as a matter of preference, which, when cited in the Official Journal, give rise to a presumption of conformity. The application of an hEN gives rise to a presumption of conformity with an essential requirement of a directive (or regulation).
We have many technical standards at hand that were created and published by the European standardization organizations (CEN, CENELEC, ETSI) at the request of the EU Commission (standardization request). Unfortunately, these standards rarely make it through the HAS assessment and are therefore not published in the Official Journal.
It would be very helpful to the people using the standards if the results of the HAS assessment were publicly available. Perhaps the standard is technically capable of addressing the basic requirements of the EU regulations, but fails due to formalities.
During our regular discussions with market surveillance authorities, we have noticed what I would call "gazetteerism". We usually recommend the application of the latest technical standard, as this most closely reflects the state of the art. It is annoying when enforcement requires conformity with the older, gazette-listed version.
We have requested the inspection!
With the introductory words "On the basis of Regulations 1049/2001 and 1367/2006, I would ask you to send me documents containing the following information", our request to inspect the completed evaluation forms of the HAS consultants was granted by the European Commission - Internal Market, Industry, Entrepreneurship and SMEs(GROW-E3@ec.europa.eu).
The completed assessment forms for the EMC Directive and the Low Voltage Directive of the case-related technical standard prEN IEC 62752:2023 can be viewed publicly at FragDenStaat (in German).
Note: FragDenStaat is a useful platform for communicating with authorities. We have decided to make the communication with the EU Commission public and have also benefited from the text templates and the contact details provided. The request could just as well be made directly to the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs.
The evaluation form guides the evaluator through 26 questions. For example, it asks whether the terminology and scope of the standard are consistent with the EU regulation in question (see 1.2.1 and 1.2.3). It is also asked whether the technical standard inappropriately repeats requirements from the EU regulation (1.2.16).
The HAS assessment sheet for the Low Voltage Directive is negative in 7 out of 26 points. For example, the wording 'unless otherwise agreed between manufacturer and user' may not be included in the standard due to the neutrality requirement. The intended performance (e.g. safety) must be guaranteed by the product design and the product characteristics (see 1.2.18). By being aware of this specific weakness, it is possible to remedy it when applying the standard.
It is more difficult to counteract the misguided reproducibility requirement. In 1.2.17 it is criticized that the manufacturer is given a choice of different requirements in the standard.
Perhaps even the people working on the technical committees that draw up the standards are not aware of the assessment practice. How could they, when they first have to apply for the completed forms? We have requested the inspection on February 14, 2025. The EU Commission missed the deadline four times. We sent two reminders. With success! On May 6, 2025, we received the documents we had hoped for.
Next, we will ask whether we can also view the existing risk assessment (1.2.20). This document could be of great benefit to the manufacturer in order to comply with the obligation to carry out an "appropriate risk analysis and assessment".
We will keep you informed and will be happy to provide you with further details.
Author's note
This article has been machine translated into English.
DEFINITIONS AND ABBREVIATIONS
A HAS (Harmonized Standards Assessment) is an assessment procedure for harmonized standards (hEN) carried out by the European Commission. The aim is to determine whether a standard meets the requirements for publication in the Official Journal of the European Union (OJEU). HAS consultants check whether the standard complies with the underlying standardization request (mandate).
Regulation (EC) No 1049/2001 of the European Parliament and of the Council regulates public access to documents of the EU institutions. It defines the conditions under which citizens of the European Union can inspect documents of the European Parliament, the Council and the Commission.
Regulation (EC) No 1367/2006 implements the so-called Aarhus Convention* within the institutions and bodies of the European Community (now the European Union). The aim of this regulation is to ensure that citizens and organizations have access to environmental information, are involved in environmental decision-making procedures and have legal access to justice in environmental matters.
*The Århus Convention is a treaty under international law that was signed in 1998 in the Danish city of Århus. It strengthens the rights of the public in environmental matters and is based on three pillars: Access to environmental information, public participation in decision-making and access to justice in environmental matters. The European Union and its member states have committed themselves to implementing these principles.
