What is it called?
The New Legislative Framework (also known as the "NLF"), is a package of legislation first adopted in 2008 that consists of: (1) Regulation (EC) 765/2008, which sets out the requirements for accreditation and the market surveillance of products; (2) Decision 768/2008, which sets out a framework of requirements for selling products under a number of key regimes (essentially, a template for legislation for many CE marked products); and, finally, (3) Regulation (EU) 2019/1020 on market surveillance and the compliance of products, which applied in full from July last year (you can read more about this in our Productwise blog here).
What is it about?
The NLF harmonises and reinforces the application of EU products legislation by establishing:
- a common legal framework for products that come within scope of 23 directives and regulations aligned with the NLF - such as the Toy Safety Directive, the Radio Equipment Directive, the Restriction of Hazardous Substances ("RoHS") Directive and the Medical Device Regulation (you can find a full list here);
- principles governing CE marking and how accreditation and notification of conformity assessment bodies works; and
- a set of rules for the market surveillance and enforcement of conformity of products sold on the EU market.
Who and what does it apply to?
The NLF applies to manufacturers, authorised representatives, importers and distributors of products covered by the 23 pieces of legislation aligned with or based on the reference provisions in Decision 768/2008. In addition, under Regulation 2019/1020, fulfilment service providers may have certain responsibilities in relation to the products they handle.
The NLF is also relevant to market surveillance authorities, customs authorities and conformity assessment bodies. In short, it is applicable to a very wide range of products stakeholders.
Why does it matter?
The NLF is important to understanding how a large number of products can be sold lawfully in the EU. It grew out of a desire to introduce greater coherence and consistency in the EU's so-called "New Approach" to product regulation, which set out essential requirements for products sold in the EU. In many ways, it has simplified the regulatory framework by creating a toolbox that can be used by legislators to ensure a consistent approach to definitions, requirements and obligations across a broad range of products.
As the NLF nearly 15 years old, there are now questions about whether it remains fit for purpose and the European Commission is currently reviewing the NLF to consider whether it's satisfactory in a digital and circular economy. The Commission is focussing on the effect of changes to products after launch as a result of software updates and upgrades, AI and machine learning and refurbishment and repairs. A public consultation is open until 7 March 2022, so products stakeholders are encouraged to share their feedback.
Where can I find it?
You can read more about the NLF on the European Commission page, here.
You can find the Regulations and Decision here:
- Regulation (EC) 765/2008: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0765&locale=en
- Regulation (EU) 2019/1020: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32019R1020
- Decision 768/2008: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768&locale=en
Is there any guidance?
The Blue Guide contains guidance on the NLF at Section 1.2 (see here). Note that the Blue Guide is also under review - more to come on that topic on Productwise soon.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.