Omnibus IV Simplification Package Common Specifications
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1 September 2025
Background
On 21 May 2025, the European Commission published its new Single Market Strategy In addition to addressing barriers within the Single Market, the strategy outlines current challenges facing the European standardisation system Notably, the system struggles to meet both the evolving demands of the market and the EU’s political objectives. This is particularly evident with regard to the timely provision of harmonised European standards (hEN), which negatively affects the functioning of the internal market. To address these shortcomings, the Commission is implementing the revision of the Standardisation Regulation (EU) No 1025/2012 and the systematic application of Common Specifications through the Omnibus IV package Common Specifications, adopted via implementing acts, are intended to serve as an alternative to hEN in cases where these are unavailable, delayed or insufficient to demonstrate compliance with EU legislation.
German industry welcomes the uniform and horizontal regulation of this instrument. At the same time, we emphasise that Common Specifications should only be used as an alternative to harmonised standards in well-justified exceptional cases. Furthermore, we wish to highlight that key questions remain unresolved regarding the framework conditions and rules governing their development, application, and withdrawal. Below, we present our proposals and positions on this matter for further consideration.
Reaffirming the Role of the European Standardisation System
The European standardisation system is a cornerstone of the internal market and a key driver of the European Union’s international competitiveness. It is fundamentally based on the provision of harmonised European standards (hEN) under the regulatory framework of the New Legislative Framework (NLF) This model ensures a clear separation between essential requirements set out in legal acts (e.g. product safety) and their technical implementation through requirements described in standards. Accordingly, hENs serve as the primary instrument for presumption of conformity within the framework of EU legislation. They are developed by standardisation experts through a transparent, consensus-based process and reflect both the state of the art and market relevance The integration of technical and market-related expertise into the implementation of EU legislation enables practical regulation and creates competitive advantages for the European industry.
We appreciate the European Commission’s intention to support industry with timely technical guidance, in light of concerns surrounding the availability of hENs. However, we believe that the root causes of delays in developing hENs, such as the HAS assessment and the time required for publication of the reference in the Official Journal of the European Union (OJEU), must be addressed as a matter of priority Furthermore, we do not see sufficient consideration of the negative impacts of a comprehensive introduction of the Common Specifications instrument on the competitiveness of the European economy
On the one hand, we have concerns about the availability of adequate expertise, which is essential for the development of technical guidelines for the implementation of legal protection objectives Such state-of-the-art technical know-how resides primarily within the standardisation bodies and is limited within the European Commission or other mandated entities. A lack of expertise and involvement of qualified experts in drafting Common Specifications may result in inappropriate or technically unfeasible requirements, thereby hindering the free movement of goods within the EU. Additionally, developing Common Specifications outside the established standardisation system risks creating parallel structures that consume already scarce resources and further intensify the shortage of technical experts
On the other hand, the broad adoption of Common Specifications could introduce technical barriers to trade at the global level. Because unlike hENs, Common Specifications are not aligned with international standardisation within the framework of ISO and IEC. The competitiveness of the European economy depends heavily on the access to global markets. Internationally harmonised technical requirements reduce trade barriers and facilitate market access. Any divergence from internationally agreed technical solutions risks market fragmentation and competitive disadvantages for European companies in global trade.
We therefore advocate investing the available resources in optimising and accelerating the existing European standardisation system, rather than establishing new structures that are disconnected from industrial practice. Harmonised standards must remain the primary instrument for presumption of conformity under EU legislation. The use of Common Specifications should not serve as an alternative to the legal framework of the NLF and the European standardisation system but should only be considered in narrowly defined and well-justified exceptional cases.
Defining Framework Conditions for the Use of Common Specifications
The use of Common Specifications should be governed by a horizontal regulatory approach and permitted only in narrowly defined and well-justified exceptional cases, such as:
▪ hENs are not available because the European Standardisation Organisations (ESOs) have not accepted the Standardisation Request (SReq), or
▪ there are significant delays in the development of hENs and an extension of the deadline is not possible, or
▪ the requirements of the legal act are not or not sufficiently covered by the requirements of the hEN
In such cases, the European Commission must provide transparency and justification by explaining why:
▪ the SReq was not accepted by the ESOs.
▪ the development of a harmonised standard will not be completed in time, by making the ESOs' report (e.g. the Annual Work Programme) on this matter publicly available.
▪ the technical requirements of the hEN do not meet or sufficiently cover the requirements of the legal act in question.
In summary, the process of developing technical requirements for the implementation of EU legal acts must, without exception, always begin with a SReq addressed to the officially recognised European Standardisation Organisations Only if one of the exceptional cases outlined above applies, resulting in the unavailability of a hEN, should the development of Common Specifications be considered as a fallback option. This should already be defined in the SReq, along with clear criteria for the development, review, and potential withdrawal of such alternative specifications. We strongly reject any approach that would allow a Standardisation Request to be directly oriented towards the development of Common Specifications. The same applies to the development of Common Specifications without a prior SReq.
Ensuring a Transparent Development Process for Common Specifications
Many questions regarding the implementation of Common Specifications, particularly the development process, remain unanswered and must be clarified by the European Commission in a legally binding manner. To prevent fragmentation and inconsistency in the standards and regulations, the use of Common Specifications, which are equally technically demanding, should be guided by the same criteria applied to the development, evaluation, and publication of harmonised European standards (hENs).
The development process must be transparent and inclusive Given the significant economic impact of technical specifications, it is essential to ensure that the necessary technical expertise and market understanding are incorporated throughout the process. It is both logical and beneficial for technical solutions to be developed by those who will ultimately apply them in practice, thereby ensuring the quality, market relevance, and practicality of the resulting requirements. The composition of committees responsible for drafting Common Specifications should be defined in the Standardisation Request, including a description of the qualifications and degree of impact of the authorities, organisations, and experts involved. If Common Specifications are developed without the involvement of practical and technical expertise, this may result in requirements that are less applicable in practice and detrimental to competitiveness.
Limiting the Use of Common Specifications
The introduction of Common Specifications as a fallback option in EU legislation must not result in the establishment of a permanent parallel structure alongside the established standardisation system. It is therefore essential to define clear framework conditions governing the validity and withdrawal of Common Specifications
Their validity begins with the publication of the corresponding implementing act by the European Commission. However, this is conditional upon the absence of an equivalent hEN, either because no reference has yet been listed in the OJEU, or because no completed hEN has been submitted to the Commission for listing.
As soon as the reference of an equivalent hEN is listed in the OJEU, the corresponding Common Specification must be withdrawn. To ensure a smooth transition, an appropriate transition period should be defined in the SReq, during which the Common Specification may continue to justify the presumption of conformity with the essential requirements.
Preserving the Integrity of the European Standardisation System
Although German industry welcomes the regulation of the concept of Common Specifications, we highlight numerous unresolved issues regarding the uniform and horizontal regulation of their justification, development, application, and withdrawal, as well as the risk of serious misalignments. We therefore invite the Commission to reconsider its current approach to common specifications. The harmonised European standardisation system has long served as a cornerstone of Europe's competitiveness, innovative capacity and regulatory coherence. Its inclusive and consensus-based structure, bringing together industry, civil society and public authorities, neutrally moderated and organised by standardisation organisations, has produced trustworthy and high-quality standards that strengthen both the internal market and Europe's global role in setting international standards.
While we recognise the Commission's legitimate interest in ensuring the timely implementation of EU legislation, we are concerned that the introduction of Common Specifications as a standard solution or parallel path could undermine the strengths of the established system. Introduction without clearly defined conditions and safeguards could lead to fragmentation, reduced stakeholder participation and a weakening of Europe's strategic role in global competition
We firmly believe that Common Specifications must remain a fallback option, used only in sufficiently justified cases where, despite a clear regulatory need, the market fails to deliver a harmonised standard within a reasonable timeframe. Even in such cases, their development must respect the fundamental principles of inclusiveness, transparency and stakeholder participation, as enshrined in the European standardisation approach and reflected in the work of CEN, CENELEC and ETSI.
Strengthening and optimising the harmonised standardisation process itself, including improvements to the HAS system and better coordination between stakeholders, must remain a priority. This balanced approach best serves Europe's long-term strategic interests and preserves the integrity, legitimacy and global credibility of the European standardisation system.
About the BDI
The BDI represents the interests of German industry to political decision-makers. In doing so, it supports companies in global competition. It has an extensive network in Germany and Europe, in all important markets and in international organisations. The BDI provides political support for international market development. It also offers information and economic policy advice on all industry-related topics. The BDI is the umbrella organisation for German industry and industry-related service providers. It represents 39 industry associations and more than 100,000 companies with around eight million employees. Membership is voluntary. Fifteen regional offices represent the interests of industry at the regional level.
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Editorial Team
Helena Weizel
Senior Manager, Environment, Technology and Sustainability
T: +49 30 2028-1589
h.weizel@bdi.eu
BDI document number: D2143