European standardisation for 2021. An overview of relevant objectives and policies.

At the end of 2020, the European Commission (EC) released a Notice regarding the Annual Union Work Programme for European Standardisation for 2021 in accordance with article 8 of the European Standardisation Regulation.

As a prime concern, the 2021 programme targets the improvement of European standards on behalf of the twin transition to green neutrality and digital leadership, as well as the reinforcement of the revival and resilience of European industry.

Bearing in mind the mentioned priorities, the Commission’s Notice determines standards and standardisation deliverables that the EC aims to request for 2021. Specifically,  the Notice defines the concrete objectives and policy measures for these standards and deliverables. For instance:

  • Medical Devices: due to the COVID-19 circumstances, the improvement of standards tackling technological developments and market needs becomes decisive. In support of Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, the Commission demands the review of the current standards and the improvement of the new ones; with the aim of updating them to the state of the art, in order to guarantee users and patients the maximum level of safety;
  • Childcare articles: For the purpose of protecting children's safety and health, the Commission requests the development of standardisation regarding new safety requirements in the implementation of Directive 2001/95/EC on General Product Safety, regarding child products that are not classified as toys;
  • Batteries: in compliance with the PLAN/2018/531 Proposal for a Regulation of the European Parliament and of the Council on sustainability, collection and recycling requirements for batteries, the European Commission asks for improved standards, in order to ensure accurate technical specifications regarding the design and manufacture of electrochemical rechargeable batteries with internal storage.

The European standards for 2021 will guarantee that European services and commodities are globally competitive, while taking into consideration the most recent stages in the development of safety, health, security and environmental matters.


Leyre Carrasco Alonso – Regulatory Affairs Department


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References:

European Parliament and Council. (2001). Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. Eur-lex. Retrieved on 17/02/2021 from https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32001L0095

European Parliament and Council. (2012).  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 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.Eur-lex. Retrieved on 17/02/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32012R1025

European Parliament and the Council. (2017a). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Eur-lex. Retrieved on 17/02/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

European Parliament and the Council. (2017b). Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Eur-lex. Retrieved on 17/02/2021 from https://eur-lex.europa.eu/eli/reg/2017/746/oj

European Commission. (2020a). PLAN/2019/5391 Proposal for a Regulation of the European Parliament and of the Council on sustainability, collection and recycling requirements for batteries, repealing the Batteries Directive 2006/66/EC. EC. Retrieved on 17/02/2021 from https://ec.europa.eu/transparency/regdoc/rep/10102/2020/EN/SWD-2020-335-F1-EN-MAIN-PART-2.PDF

European Commission. (2020b). The annual Union work programme for European standardisation for 2021. Eur-lex. Retrieved on 17/02/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52020XC1218(01)&from=EN