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Internal Market, Industry, Entrepreneurship and SMEs

New legislative framework

Adopted in 2008, the new legislative framework aims to improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU market. It is a package of measures that aim to improve market surveillance and boost the quality of conformity assessments. It also clarifies the use of CE marking and creates a toolbox of measures for use in product legislation.

What does the new legislative framework provide?

The package reinforces the application and enforcement of internal market legislation. It:

  • improves market surveillance rules to better protect both consumers and professionals from unsafe products, including those imported from outside the EU. In particular, this applies to procedures for products which can pose danger to health or the environment;
  • sets clear and transparent rules for the accreditation of conformity assessment bodies;
  • boosts the quality of and confidence in the conformity assessment of products through stronger and clearer rules on the requirements for the notification of conformity assessment bodies;
  • clarifies the meaning of CE marking and enhances its credibility;
  • establishes a common legal framework for industrial products in the form of a toolbox of measures for use in future legislation. This includes definitions of terms commonly used in product legislation, and procedures to allow future sectorial legislation to become more consistent and easier to implement.

The new legislative framework consists of

  • Regulation (EC) 765/2008 setting out the requirements for accreditation and the market surveillance of products
  • Decision 768/2008 on a common framework for the marketing of products, which includes reference provisions to incorporate in product legislation revisions. In effect, it is a template for future product harmonisation legislation
  • Regulation (EU) 2019/1020 on market surveillance and compliance of products

Evaluation

The European Commission has published the evaluation of the New Legislative Framework (NLF) for industrial products in the EU, which aims to improve the internal market for goods by strengthening market surveillance and boosting the quality of conformity assessment. Since the adoption of the New Legislative Framework in 2008, industry and products have transformed radically, in particular due to the ongoing digital and green transitions.

The main purpose of the evaluation is to look into the performance of the New Legislative Framework, to assess its effectiveness, efficiency and relevance, as well as its coherence with similar initiatives.

Almost 200 stakeholders replied to the Commission’s targeted consultation and 125 stakeholders participated in the public consultation. Based on all these replies and additional research, the evaluation concludes that the New Legislative Framework has been effective and efficient in achieving its objectives by ensuring coherence among different pieces of product legislation. The EU added value of the New Legislative Framework is also highly appreciated by stakeholders.

The evaluation also found that the regulatory toolbox set out in the New Legislative Framework, has reduced divergences in EU product legislation and helped stakeholders be familiar with the rules.

Conversely, the evaluation identified the relevance of certain elements of the New Legislative Framework as its main weakness. It concludes that, for the New Legislative Framework to respond to the current and future needs of product legislation and preserve its relevance, it would be useful for the Commission to explore if an update is needed to

  • uphold its role as a general framework, taking into account the challenges of digitalisation and complex value chains
  • facilitate remanufacturing and high-quality recycling of products
  • introduce a digital product passport
  • introduce digital CE marking

Alignment of product legislation

A main objective of the Commission is to bring product harmonisation legislation and related non-legislative acts in line with the reference provisions of Decision 768/2008/EC. The following directives, regulations and delegated act are now aligned with, or based on, these reference provisions:

  1. Toy Safety - Directive 2009/48/EU
  2. Transportable pressure equipment - Directive 2010/35/EU
  3. Restriction of Hazardous Substances in Electrical and Electronic Equipment - Directive 2011/65/EU
  4. Construction products - Regulation (EU) No 305/2011
  5. Pyrotechnic Articles - Directive 2013/29/EU
  6. Recreational craft and personal watercraft - Directive 2013/53/EU
  7. Civil Explosives - Directive 2014/28/EU
  8. Simple Pressure Vessels - Directive 2014/29/EU
  9. Electromagnetic Compatibility - Directive 2014/30/EU
  10. Non-automatic Weighing Instruments - Directive 2014/31/EU
  11. Measuring Instruments - Directive 2014/32/EU
  12. Lifts - Directive 2014/33/EU
  13. ATEX - Directive 2014/34/EU
  14. Radio equipment - Directive 2014/53/EU
  15. Low Voltage - Directive 2014/35/EU
  16. Pressure equipment - Directive 2014/68/EU
  17. Marine Equipment - Directive 2014/90/EU
  18. Cableway installations - Regulation (EU) 2016/424
  19. Personal protective equipment - Regulation (EU) 2016/425
  20. Gas appliances - Regulation (EU) 2016/426
  21. Medical devices - Regulation (EU) 2017/745
  22. In vitro diagnostic medical devices - Regulation (EU) 2017/746
  23. EU fertilising products – Regulation (EU) 2019/1009
  24. Drones - Commission Delegated Regulation (EU) 2019/945 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems
  25. Batteries - Regulation (EU) 2023/1542