The New Legislative Framework

Last reviewed: August 2026 · Legal status verified against EUR-Lex.

The New Legislative Framework (NLF) is the architecture on which nearly all EU product harmonisation law is built. It explains why the Low Voltage Directive, the PPE Regulation, and the Machinery Regulation all read the same way: essential requirements in the legal act, technical detail in harmonised standards, a menu of conformity assessment modules, defined obligations for each economic operator, and CE marking as the visible endpoint. Understanding the framework once makes every individual act easier to read.

The NLF was adopted in 2008 as a package of two horizontal instruments — Regulation (EC) No 765/2008 and Decision No 768/2008/EC — but its logic is older. It codified and refined two policy shifts of the 1980s: the New Approach of 1985 and the Global Approach of 1989.

Before 1985: the Old Approach

Early EU technical harmonisation wrote exhaustive product specifications directly into directives — dimensions, materials, test methods, all fixed in the legal text itself. This "Old Approach" produced detailed but slow-moving law: each technical change required a legislative amendment, negotiations took years per product category, and coverage remained patchy. Divergent national rules therefore continued to fragment the internal market, a problem the Court of Justice partially addressed through the mutual-recognition principle in Cassis de Dijon (1979), but which legislation still needed to solve for safety-critical products.

1985: the New Approach

The Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards changed the method. Under the New Approach:

• Legislation is limited to essential requirements — the health, safety, and other public-interest outcomes a product must achieve — written at a level of generality that does not need constant amendment.
• The technical detail of how to meet those requirements is left to harmonised standards drawn up by the European standardisation organisations (CEN, CENELEC, ETSI) under a mandate from the Commission.
• Standards remain voluntary: a manufacturer who applies a harmonised standard cited in the Official Journal benefits from a presumption of conformity with the requirements the standard covers, but may instead demonstrate conformity by any other adequate technical solution.
• Products meeting the requirements circulate freely: Member States may not impose additional national technical rules on matters the directive harmonises.

The Toy Safety Directive of 1988 and the Machinery Directive of 1989 were early products of this method, and it remains the core of every CE marking act today.

1989: the Global Approach

The New Approach settled what the law requires; the Global Approach — set out in the Council Resolution of 21 December 1989 on a global approach to certification and testing — settled how conformity is demonstrated. It established a toolbox of standardised conformity assessment procedures, later consolidated in Council Decision 93/465/EEC, which introduced the modules (A through H) and the general rules for affixing the CE mark. Instead of each directive inventing its own certification scheme, legislators would pick modules from a common menu, calibrated to the risk of the product category: from Module A (internal production control, no third party) up to Module H (full quality assurance overseen by a Notified Body).

2008: the New Legislative Framework

By the mid-2000s, two decades of practice had exposed weaknesses: uneven market surveillance between Member States, variable quality among conformity assessment bodies, unclear responsibilities in increasingly globalised supply chains, and drafting inconsistencies between directives. The NLF package of 9 July 2008 addressed these with two complementary instruments:

Regulation (EC) No 765/2008

Regulation 765/2008 is directly applicable law. It established:

• a single system of accreditation — each Member State designates one national accreditation body (co-ordinated through EA, the European co-operation for Accreditation) to attest the competence of conformity assessment bodies;
• the general principles of CE marking in Article 30: only the manufacturer or its authorised representative may affix the mark, the mark may only be affixed where legislation provides for it, and misleading marks are prohibited;
• the graphic form of the mark in Annex II;
• a framework for market surveillance and controls on products entering the EU — provisions since largely replaced by Regulation (EU) 2019/1020 (see market surveillance).

Decision No 768/2008/EC

Decision 768/2008/EC is different in kind: it imposes no obligations on manufacturers directly. It is a template addressed to the EU legislator — a set of reference provisions (the "R" articles of Annex I and the modules of Annex II) that future harmonisation acts should copy in whenever they regulate a subject the Decision covers. It standardises:

• definitions ("placing on the market", "making available", "manufacturer", "importer", "distributor", "recall", "withdrawal");
• the obligations of each economic operator, in parallel articles — see manufacturer, importer, and distributor obligations;
• the rule that an importer or distributor who markets a product under its own name, or modifies a product already placed on the market, assumes the manufacturer's obligations;
• the conformity assessment modules A–H and the model structure of the EU Declaration of Conformity;
• requirements for notifying authorities and Notified Bodies, and the safeguard-clause procedure for products presenting a risk.

The 2014 alignment package

Decision 768/2008/EC only takes effect as its provisions are written into sectoral law. The first large-scale exercise was the alignment package of February 2014, in which eight existing directives were recast to the NLF template, most applying from 20 April 2016:

• Low Voltage Directive 2014/35/EU
• EMC Directive 2014/30/EU
• ATEX Directive 2014/34/EU
• Lifts Directive 2014/33/EU
• Simple Pressure Vessels Directive 2014/29/EU
• Measuring Instruments Directive 2014/32/EU
• Non-Automatic Weighing Instruments Directive 2014/31/EU
• Civil Explosives Directive 2014/28/EU

The Radio Equipment Directive 2014/53/EU and the Pressure Equipment Directive 2014/68/EU were adopted in the same year on the same template. The essential requirements of these acts were carried over largely unchanged from their predecessors; what the recasts added were the standardised economic-operator obligations, traceability requirements, and Notified Body provisions of the NLF.

The framework as a system

The system deliberately trades pre-market state approval for manufacturer responsibility plus post-market enforcement. There is no general government licence to sell a CE-marked product; in exchange, the manufacturer carries full legal responsibility for the claim the mark embodies, and authorities may demand the evidence at any time — with the consequences described in penalties for non-compliance.

The NLF in current legislation

Acts adopted since 2008 continue to follow the template, even as they extend it:

• The Machinery Regulation (EU) 2023/1230 (applying from 20 January 2027) recasts the Machinery Directive as a regulation on the NLF pattern, adding provisions on digital instructions, software safety, and substantial modification.
• The Toy Safety Regulation (EU) 2025/2509, in force since 1 January 2026, replaces Directive 2009/48/EC with an NLF-structured regulation adding a digital product passport.
• The Battery Regulation (EU) 2023/1542 and the Ecodesign for Sustainable Products Regulation (EU) 2024/1781 reuse NLF operator roles and conformity assessment while extending requirements to sustainability, due diligence, and the digital product passport.
• The General Product Safety Regulation (EU) 2023/988, applicable since 13 December 2024, is not a CE marking act, but it imports NLF concepts — economic operator definitions, traceability, a responsible person in the EU — into the horizontal safety net for consumer products.
• The Construction Products Regulation (EU) 2024/3110, applying in phases from 8 January 2026, keeps its distinctive declaration-of-performance system but remains recognisably built from NLF components.

A visible trend is the shift from directives (requiring national transposition) to regulations (directly applicable), which removes transposition divergence between Member States while keeping the NLF structure intact.

Where to read the framework itself

The authoritative commentary on the whole system is the Commission's Blue Guide (2022 edition), which the Commission describes as a guide to implementing EU product rules and which authorities across the EEA use as their common reference. For how the framework applies to a specific product, start with does my product need CE marking? and the CE marking process.

Sources

• Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products — EUR-Lex.
• Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products — EUR-Lex.
• Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (OJ C 136, 4.6.1985) — EUR-Lex.
• Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures — EUR-Lex.
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products — EUR-Lex.
• Commission Notice — The "Blue Guide" on the implementation of EU product rules 2022 (OJ C 247, 29.6.2022, p. 1) — EUR-Lex.