Basic documents and KAN position papers

Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence
(Artificial Intelligence Act – AI Act) aims to provide legal certainty in technical
innovation fields and to protect health, safety and fundamental rights. Although so
far only parts of the AI Act’s requirements are applicable, the European Commission
published a proposal for a regulation to simplify the implementation of the rules on
artificial intelligence, the Digital Omnibus on AI, in November 2025.

Regulation (EU) No 1025/2012 forms the central framework for the development of European standards. These standards play a crucial role in the harmonisation of products, services and processes within Europe. They thus contribute decisively to the functioning of the Single Market and to strengthening the European Union’s competitiveness. The principle of clear demarcation between legislative responsibility and technical standardisation has proved to be a reliable basis for the European regulatory system.

The New Legislative Framework (NLF) is an element essential for the success of the European Single Market. Since its introduction, it has proved to be a viable legal framework for product safety and the role of standardisation in Europe. KAN therefore calls for the core of the proven NLF system to be retained, and the NLF only adapted to new challenges, such as the digital transformation. As stated in the 2022 evaluation of the NLF, it is of undeniable importance for the creation of coherence within the EU legal framework for products. From KAN’s perspective, it is therefore important to ensure that the system remains coherent and practicable in the future.

As part of its Omnibus IV package, the European Commission proposes to introduce the instrument of common specifications into numerous other items of Single Market legislation. Common specifications are European implementing acts that are intended to serve as an exceptional fallback solution for the European Commission in cases where standardisation mandates have been issued but the European standardisation organisations fail to develop harmonised standards, fail to deliver them on time, or present standards that are inadequate.

KAN welcomes the European Commission’s study for surveying up-to-date anthropometric data. The data concerned is particularly relevant to occupational safety and health. Products and workplaces can be safe and competitive only if the anthropometric data against which they are designed correspond to the body measurements of the current population.

Regulation (EU) No 1025/2012 forms the central framework for the development of European standards. These standards contribute significantly to the harmonisation of products, services and processes within Europe. They thus make a decisive contribution to the success of the Single Market and to strengthening the EU’s competitiveness.

Agriculture is undergoing a process of change. New technologies such as highly automated, driverless mobile machinery are increasingly being used in farming. OSH experts view equipment of this kind as potentially beneficial to safety and health.

This paper is addressed to standards committees that develop documents of relevance to occupational safety and health and artificial intelligence (AI). It formulates key points that should be implemented in standards relevant to AI.

Common specifications are European implementing acts that are intended to ensure that the public interest, such as the protection of health and safety, is nevertheless satisfied in the case of non-existent or inadequate harmonized standards. They are technical specifications that aim to harmonize product requirements in the same way as standards.

KAN has published this position paper on this instrument.

The essential principles of standardization apply only in part to standardization documents such as DIN SPECs, VDE SPECs, VDE rules of application, CWAs and IWAs. The Commission for Occupational Health and Safety and Standardization (KAN) therefore considers such documents inherently unsuitable for governing occupational safety and health issues.

Standards are an important element in prevention activity for safe and healthy workplaces. Elaborated at European and increasingly also at international level, they set out technical requirements for products and define measurement methods for emissions such as noise, vibration, radiation, and harmful substances. At the same time, standards increasingly impact upon non-technical areas such as the harmonization of management systems, services, health care, and qualification. Against this background, the signatories have agreed upon a set of joint positions on their standardization policy.

Since its foundation in 1994, KAN has established itself as a permanent fixture in occupational health and safety, adjusting its range of tasks to reflect developments in standardisation and regulation and refining its working methods whenever necessary. This document provides a concise overview of KAN's development, reflects the shared understanding of its members and communicates a coherent image of KAN to the public.

The non-visual effects of artificial lighting are a topic with a bearing upon the safety and health of workers at work. If standardization activity in this area is planned, the German government's policy document concerning the role of standardization in the safety and health of workers at work requires consideration first to be given to what extent such standardization is permissible.

The act is a regulation pursuant to Article 16 and Article 114 of the Treaty on the Functioning of the European Union (TFEU). Article 16 TFEU concerns the right to protection of personal data. Article 114 TFEU governs implementation of the Single Market. In derogation from the practice of the New Legislative Framework to date, the proposal combines the elimination of barriers to trade with obligations directly addressed to users (in particular Article 29 of the proposal) and far-reaching fundamental right concerns. KAN's position is that a number of issues must therefore be clarified (for example by the European Commission) before the regulation is ratified.

Policy paper on the role of standards in the health and safety of workers at work

Published in November 2016, the process description underpins the policy paper on the role of standardisation in the health and safety of workers at work published in 2015. The process description expands on the policy paper with regard to new and ongoing standardisation projects relating to occupational health and safety. It describes the role of the various stakeholders and the procedures, and supports the goal of ensuring that the expertise of all occupational health and safety stakeholders is incorporated into KAN's position in an appropriate and timely manner.

The safety of products in the health sector - from hospital beds to heart-lung machines – is assured by standards. Increasingly however, and to some extent with the support of the European Commission, standardization is addressing not only products but also services in the health sector, ranging from nursing to the electronic processing of patients' data.

The Commission for Occupational Health and Safety and Standardization (KAN) is taking a critical interest in this development as it could result in established, proven social security systems (especially those concerning health and safety) colliding with undesired parallel systems – to workers' detriment.

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of October 2012 on 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

CEN Guide 15

Guidance document for the development of Service standards

CEN/CENELEC Guide 17

Guidance for writing standards taking into account micro, small and medium-sized enterprises (SMEs) needs

CEN-Guide 14

Common policy guidance for addressing standardisation

on qualification of professions and personnel

This Memorandum reflects the views of European occupational safety and health experts active in

standardisation, testing, certification and related research. It deals with possible improvements to the preparation and use of standards in support of New Approach directives which make reference to standards as one means of providing a presumption of conformity to the relevant Essential Health and Safety Requirements (EHSRs) of these directives. The final version of the Memorandum has been accepted by the EUROSHNET Steering Committee. The Steering Committee recommends that it be used as a basis for further political action at national, European and international level.

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

Single Market and product safety

Safety and health of workers at work

European Standardization is mandated to contribute to the competitiveness of Europe and to support the European economy in international trade. Manufacturers and importers of machinery (who have to construct or distribute their machinery in accordance with the EC Machinery Directive) as well as standards bodies developing product standards found that there is a certain lack of easily applicable generic standards in the field of ergonomics. As a result, specifications concerning ergonomic aspects are sometimes regulated several times in different standards and not necessarily in the same way. A clear structure for ergonomics standards and their contents will help to prevent possible uncertainties for the users. The present guide is intended to effectively support the core activities of the ergonomics standards committees in this sense.

Agreement on Technical Barriers to Trade