The European Commission is conducting an evaluation of certain aspects of the New Legislative Framework, the legislative framework behind most of the EU CE marking directives. In this article, we discuss the purpose, scope and context of the evaluation.
The New Legislative Framework (hereinafter referred to as NLF) for EU product legislation consisted of Decision No 768/2008/EC and Regulation (EC) No 765/2008. It aimed to improve the internal market for goods and increase the quality of conformity assessment of products. Decision No. 768/2008/EC was a model for future Union product legislation. More than 20 legal texts have been aligned with the Decision today (1).
Since the adoption of the Decision, industry and products have undergone a digital and green transformation. The NLF ensures that products comply with applicable legislation at the time they are placed on the market. Products are becoming increasingly digital and are often updated or upgraded after they are put into service. They may also contain artificial intelligence that will lead to further changes to the product.
Evaluation New Legislative Framework
Manufacturing products is an ever-growing industry. The goals of promoting the circular economy and ensuring product safety must be adequately addressed. In today's economic reality and changing digital environment, there is a need to reassess whether the NLF is still fit for purpose. Moreover, it should be considered whether the conformity assessment procedures are still fit for this changing environment. These are the procedures that ensure that products placed on the Union market comply with the applicable legislation.
Where an independent third party (so-called "notified bodies") is involved in the conformity assessment procedure, the competence of such a body must be ensured. To this end, the NLF describes the accreditation of notified bodies as the preferred means of demonstrating the competence of such bodies; accreditation can thus play an important role, but its use is not mandatory in the EU (2).
Moreover, the recent COVID-19 crisis has challenged the resilience of Union product legislation based on the provisions of the NLF. Particularly in terms of whether it can adequately deal with a crisis. When certain products that played a role in combating COVID-19 (notably personal protective equipment and medical devices) became scarce, the rapid market entry of new products proved challenging. Specifically, it involved becoming familiar with the legislation and standards and completing the conformity assessment procedures.
Purpose and scope
Evaluation New Legislative Framework assesses its effectiveness, efficiency and relevance. It considers:
- technological development,
- coherence with similar initiatives and
- the overall EU added value.
The main objective is to provide an informed analysis of the current performance of the NLF. The exception is the provisions of Regulation (EC) No 765/2008 related to market surveillance. This has already been subject to an evaluation and review (3).
This review covers 27 EU Member States and 3 EFTA countries (Norway, Iceland and Liechtenstein) and the period from 2014 to 2020 (4) .
In particular, the review should focus on whether:
i) the NLF is appropriate to address how products may change during their lifetime, both to support the introduction of smartly connected or remanufactured products and to ensure safety;
ii) the conformity assessment procedures remain fit for purpose and ensure the safety and compliance with applicable requirements of products placed on the Union market;
iii) the rules for notified bodies are sufficiently robust to ensure the competence of those bodies;
iv) the accreditation system functions properly and ensures that the competence of notified bodies involved in conformity assessment procedures is sufficiently guaranteed;
v) the affixing of the CE marking and other product information on the product itself is still adequate;
vi) the lack of a crisis instrument for urgent situations makes the NLF less effective or efficient.
Consultation of citizens and stakeholders
The consultation strategy will aim to be as representative as possible of the different product sectors, types of stakeholders and Member States.
The following categories of stakeholders will be consulted:
- relevant Member State authorities (including market surveillance authorities and notifying authorities) and accreditation bodies,
- individual companies that are manufacturers, including SMEs and industry associations,
- other economic operators (such as distributors and importers),
- notified bodies,
- consumer organizations.
The following consultation activities will be conducted:
- public consultation to gather general evidence for the review. This will last for 16 weeks;
- targeted online survey to collect quantitative and qualitative data from different categories of stakeholders;
- interviews to gather information on the evaluation questions. Among others, on the different types of compliance and administrative costs and benefits. This is mainly in relation to the conformity assessment procedure.
- interviews to validate/test the evidence gathered and fill in the gaps so that there is a solid and credible basis to support the findings of the evaluation;
A validation workshop will be organized with key actors involved in the evaluation. The Commission will inform stakeholders about the start of the public consultation.
Data collection and methodology
The methodology for the evaluation includes.
- Desk research and literature review, including the previous evaluation for internal market legislation on industrial products (SWD(2014)23). Existing evaluations of specific product legislation based on the NLF are also included.
- REFIT review accompanying the proposal for a Regulation of the European Parliament and of the Council laying down rules and procedures (where relevant). This is for compliance and enforcement of Union harmonization legislation on products and annexes (SWD(2017)469).
The methodology for data analysis shall include at least:
- the analysis of the intervention logic,
- indicators to measure the direct and indirect effects of the NLF,
- triangulation of information,
- relevant statistics to support the analysis to identify the regulatory and administrative costs and benefits arising from the NLF. Data on the costs and benefits of the NLF will be collected through targeted surveys and interviews with stakeholders involved in the process;
- economic operators (manufacturers, importers, distributors),
- notified bodies involved in the conformity assessment procedure,
- market surveillance authorities,
- consumer organizations,
- case studies based on specific product categories, depending on the availability of data and the particularity of the product.
Evaluation New Legislative Framework
(2) EU product legislation is based on the fact that the manufacturer is responsible for the conformity of the product with the applicable legislation and must carry out the relevant conformity assessment procedure to demonstrate such conformity. Certain parts of the EU product legislation require that a third party conformity assessment body intervene in the conformity assessment procedure and perform certain tests on the product. Where this is the case, only the conformity assessment bodies designated for this purpose by the authorities of the Member States can perform the conformity assessment tasks required by that legislation. These are the so-called notified bodies. They must be notified to the Commission and the other Member States by public authorities in the Member State where these bodies are established. These notifying authorities are responsible for the competence and supervision of the notified bodies. In order to demonstrate their competence, notified bodies can provide an accreditation certificate issued by the national accreditation body, which declares that they are competent to perform the conformity assessment tasks specifically required by EU product legislation, according to Regulation (EC) No 765/2008.
(3) The market surveillance provisions of Regulation (EC) No 765/2008 were already the subject of a REFIT review (SWD(2017) 469 final). Since then, a new Regulation (EU) 2019/1020 will replace those provisions from July 2021.
(4) This review will build on and complement the SWD(2014)23 review (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A52014SC0023&qid=1604000100861) to Commission Communication COM(2014)25 on "A vision for the internal market for industrial products" (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A52014DC0025&qid=1603999880951).
Additional information: https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en