The Harmonized Standards System (HAS)

Standards following the Harmonized Standards System (HAS) are called Harmonized Standards (hENs). They are technical standards developed by European standardization organizations to support the implementation of European Union (EU) legislation, particularly in the areas of product safety and free movement of goods within the European Single Market.

The concept of harmonized standards aims to eliminate technical barriers to trade and ensure that products conforming to harmonized standards are presumed to comply with the essential requirements of relevant EU directives and regulations. By complying with these harmonized standards, manufacturers can demonstrate that their products meet the necessary safety and performance requirements, facilitating market access throughout the EU. Harmonized standards are not mandatory, but they offer a presumption of conformity with EU legislation. What harmonized Standards are and how they are developed was explained in the European Commission and DKE Chair Secretary and Convenor Forum by representatives of the European Commission, the HAS Contractor, HAS Consultant and CCMC.

For the first time, the European Commission, Ernst & Young (EY), in the role of the HAS Contractor, HAS Consultants, CCMC, DKE, and over 80 German Technical Body Chairs, Secretaries and Convenors met on July 5^th, 2023, in Hanau, Germany at the European Commission & DKE Forum. The aim of this forum was an exchange between the standards developer and all other involved parties in the Harmonized Standards (HAS) system in order to answer open questions and improve the compliance status of the harmonized standards.

The morning session dealt with the HAS system itself, the interaction between the involved parties, roles and responsibilities in this system, and the drafting of harmonized standards in the international context. Those presentations were followed by a Q&A session.

The afternoon session was divided into two deep dive breakout sessions. In the first, the German experts exchanged on with the HAS Consultant and the European Commission Desk Officer on questions concerning the Low-Voltage Directive (LVD) and the respective mandated work. The other breakout session dealt with the Electromagnetic Compatibility Directive (EMCD). These two sectors are two one of the most relevant ones in the electrotechnical field since more than 1000 Standards are listed under these directives.

Federico Musso, team leader with the European Commission DG GROW Standards Policy, started with the background of the Harmonized Standards System. He highlighted the relevant legal basis, such as Art. 10 of the Regulation (EU) No 1025/2012 which states the preparation, adoption, and execution of the standardization requests. Another relevant article of this regulation is Art. 8 which states the Annual Union Work Programme (AUWP). In order to develop harmonized standards with the intention to be listed in the Official Journal of the European Union (OJEU), it is essential to apply the aforementioned articles. The standards must be mentioned in the AUWP and in the Standardization Request. Once the reference of the standard is listed in the OJEU, the use of the standard will provide presumption of conformity.

Daan Bijwaard, Manager at EY responsible for the EU Account, continued with the roles and responsibilities of the HAS System. The overall HAS project aims to improve the clarity, quality, consistency, and coherence of harmonized standards adopted by the European Standardization Organizations (ESOs) in response to the European Commission's standardization requests, as defined in Art. 10 Regulation on European standardization. The ultimate aim of EY’s project is to support the Commission in its efforts to reduce the number of non-cited hENs.

Key stakeholders of the HAS System includes the European Commission (DG GROW plus the sectorial Desk Officers), the three European Standards Organizations (ESO) with their technical committees, and the HAS Consultants, as well as the HAS Contractor which is EY. Currently, the HAS System covers 22 sectors, including EMC and LVD.

Since the new HAS contract had been signed in August 2022, the EY team has received over 850 assessment requests from the ESOs. Notably, over 60% of these requests have been thoroughly addressed and the corresponding reports sent back to the ESOs for further consideration. While a majority of the inquiries originate from a select few sectors, EMC and particularly LVD emerge as prominent contributors in terms of volume.

However, the proportion of assessment reports with ‘compliant’ outcomes remains is relatively low across sectors. Critical findings frequently leading to non-compliance in the EMC and LVD sectors includes questions with technical content or formalities such as undated or outdated normative references, and issues with Annex Z. In light of these observations the key aim of the HAS System project is to increase the compliance level .

Standards and specifications for a strong Europe

In 2022 the European Commission has published its European Standardization Strategy.

This strategy is intended to make the European standardization system agile, efficient and future-proof. In this way, the EU Commission wants to strengthen European industry in global competition and bring innovations to market more quickly. In addition, the aim is to ensure that European and international standards are in line with the strategic interests and values of the EU.

Frédéric Mlanao, Account Manager for the Harmonized Standards Compliance at CCMC, continued with the drafting of hENs in the international context. He highlighted three key points:

1. Starting the harmonization process and the development of the European elements, such as Annex Z, as early as possible
2. Providing feedback to the HAS Consultant’s comments
3. Communicating with the HAS Consultant and taking the opportunity to request a meeting with the HAS Consultant

Then he continued with correct use of normative references and highlighted the importance of dated, active and published normative references. Normative references are common reasons for lack of compliance, therefore, he recommends using the checklist for hENs and also align closely with the internal regulations part 3 (IR3). Which can be found on CENELEC BOSS.

Citation of hENs in OJEU

The last speaker of the morning session was Aarre Viljanen from the European Commission. He gave an overview of the process of the citation of hENs in the OJEU and linked the relevant articles of the Regulation (EU) No 1025/2012 to the OJEU and the presumption of conformity.

The afternoon session was followed by two breakout sessions, Low Voltage Directive (LVD) and the Electromagnetic Compatibility Directive (EMCD)

One of the LVD HAS Consultants, John Cotman, was present and led, together with the European Commission Desk Officer, Alexis Basiaux, the LVD Breakout session. John Cotman summarized this breakout session in the end and pointed out that one challenge addressed the Risk Assessment. Even though there is the CENELEC Guide 32 Guidelines for Safety Related Risk Assessment and Risk Reduction for Low Voltage Equipment, it does not tell which risks apply and this seems to be a challenge in some of the technical body’s when drafting hENs. Another challenge seems to be the normative references and the requirements set by the European Commission. Some normative references may be used in the international context but are not allowed in the European context such as UL standards. Last but not least it was mentioned that, if an IEC standards does not fulfill all the European requirements, the text needs to be modified on European level. However, this is not the preferred way by the stakeholders.

Ronald Storrs, the EMCD HAS Consultant, led this breakout session together with the Legal Officer, Nikos Michailidis. During the discussion three main points have been discussed. First, a general agreement that the HAS Assessment should be requested as early as possible. The second that experts all over the world prefer to have one standard, meaning the same IEC standard should apply in Europe without modifications, which is the case with most harmonized standards. However, if requirements in IEC standards deviate from European requirements, the European standard needs to be modified, to become a harmonized standard. After all, the harmonized standard is supposed to specify the legal basis. The last key point were alternative test methods. There is an ongoing discussion and a lot of concerns raised by the experts. However, Mr. Storrs summarized that alternative test methods for EMC are acceptable, provided they give equivalent results.

The recently concluded EC & DKE Forum stands as a pivotal and fruitful event in bolstering the European standardization system. The gathering provided a platform for open dialogue, serving as an avenue for standards developers to articulate their challenges to the European Commission. Simultaneously, the European Commission seized the opportunity to elucidate the rationale behind its methodologies and approaches. While complete consensus may not always be reached, the significance of mutual comprehension within a multifaceted system, underpinned by the presumption of conformity, remains paramount.

Underscoring the vigor of the European standardization system, the speaker emphasized its robustness. From his perspective, this system stands as the epitome of strength due to its capacity to confer legal recognition upon international standards. All participants are aligned in their belief that these exchanges hold profound importance and should become more frequent occurrences.

For more internationally relevant information about DKE, check out our LinkedIn channel:

• get into the depths of international, standardization-related topics;
• consolidate and expand your knowledge with new formats and interesting technical information;
• network with colleagues and experts from all over the world;
• stay informed about important news and events as usual.