New Legislative Framework

Goods and services are traded freely within the European Union. To facilitate the exchange of products, requirements exist that apply everywhere.

The updated “New Approach” from 1985 that was complemented with the “New Legislative Framework” (NLF) in 2008 forms the regulatory framework for European product legislation. The EU legislation is limited to the essential requirements for products however. Harmonised standards provide the technical specifications.

The tasks of the New Legislative Framework include:

• To set the rules for conformity assessments, which check whether a product complies with the EU legislation and standards.
• To determine which organisations are allowed to carry out checks – and who checks the assessment bodies. So it also provides the framework for accreditation.
• To regulate market surveillance so that non-compliant products can be identified and withdrawn from the market if necessary.

With these instruments, the EU legislators strive to meet the obligation laid out in Article 114 (3) of the Treaty on the Functioning of the European Union (TFEU) of ensuring a high level of protection for the technical safety of products, production facilities and services.

Trust rather than control?

The fundamental idea of the New Legislative Framework is trust before control. The framework obliges manufacturers to ensure that products are safe. By affixing the CE marking on their products, they declare that these comply with the essential safety requirements of the relevant directives and regulations. Whether the products really are safe is mostly only reviewed during random sampling carried out as part of market surveillance after the products have been placed on the market. Therefore, a regulatory regime characterised by the principle of trust exists in Europe.

Only in the case of high-risk products does EU legislation prescribe more than a mere conformity assessment by manufacturers. An independent third party (a Notified Body such as the TÜV organisations) accompanies this process with extensive ex-ante assessment of the products.

Dare to test more!

Practice has shown that the New Legislative Framework has not yet been able to exploit its full potential as a legal framework. The annual market surveillance reports from the Rapid Exchange of Information System (RAPEX, now called Safety Gate) clearly show that far too many dangerous products are in circulation in the European single market. It is therefore questionable whether the conformity assessment procedures (modules) provided for the respective product groups to date can be considered suitable at all, or whether a more stringent regime with the increased involvement of Notified Bodies in the conformity assessment process would be more conducive to higher levels of conformity in the market. The TÜV Association is of the opinion that the liberal approach underlying the NLF must not lead European legislators to neglect their responsibility for technical product safety. The principle of self-declared conformity must be balanced with independent external controls by accredited assessment organisations. This will enhance trust among EU citizens in industry’s self-regulatory powers.

For the TÜV Association, product categories presenting a high risk of harm need external verification obligations as a regulatory element. As such, a closer look needs to be taken at IoT products in particular. The legislative regulatory framework must define clear and binding processes for third-party control so as to enable uniform, efficient controls throughout Europe. EU legislation should make greater use of the proven contribution of independent third-party testing to reduce the burden on market surveillance authorities.