(fra kommisjonsforslaget)

Reasons for and objectives of the proposal

In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’ 1 , the Commission stressed the importance of a regulatory system that ensures objectives are reached at minimum costs. To that end, it committed to a dedicated effort to rationalise and simplify reporting requirements and administrative burdens, with the ultimate aim of reducing such requirements by 25% without undermining the related policy objectives.

Reporting requirements play a key role in ensuring the correct enforcement and proper monitoring of legislation. The costs of reporting are overall largely offset by the benefits they bring, in particular as regards monitoring and ensuring compliance with key policy measures. However, reporting requirements can also impose a disproportionate burden on stakeholders, particularly SMEs and micro-companies. The accumulation of these requirements over time can result in redundant, duplicate or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The Commission promotes the ‘digital by default’ principle in its Digital Strategy/Better regulation to support digital transformations, facilitating digital-ready policies that take into account the fast-evolving world of digitalisation and technology, and are digital, interoperable, future-proof and agile by default. 2  

The Communication ‘A Competitiveness Compass for the EU’ 3 highlights that digitalisation goes hand in hand with simplification to reduce reporting burdens. The Communication emphasises that reporting should move to digital formats based on standardised data. However, where digital procedures exist today, aspects such as fragmented IT ecosystems, and inefficient data exchanges all make it burdensome for businesses to interact with public authorities digitally.

The upcoming European Business Wallets initiative will address these challenges by establishing digital identity for all economic operators and by providing the framework for interoperable Business Wallets sharing verified data and credentials, enabling seamless digital interactions between economic operators and public administrations across the Union. This way, the European Business Wallets will build on the already existing digital solutions designed to simplify everyday activities for European economic operators, such as the Single Digital Gateway, the Once Only Technical System (‘OOTS’), the Digital Product Passport (‘DPP’), eInvoice, thus building a cohesive ecosystem of digital solutions that will maximise synergies and foster greater economic integration and innovation throughout Europe

However, there are still various pieces of EU legislation that provide for the use of paper format.

Removing references to paper format would also force public authorities to rethink the ways they process submissions or reporting by companies. Streamlining such submissions and reporting by promoting digital-by-default would create new incentives to invest in data collection and processing with eGovernment solutions that could pave the way to a document-free Single Market based on interoperable structured data and the once-only principle.

While the New Legislative Framework (‘NLF’) does not impose a particular format for the instructions for use accompanying the products, practice has shown that most market surveillances authorities expect those instructions to be in paper format and therefore impose this format on manufacturers.

The Blue Guide 4  provides detailed explanations on EU product rules.

Taking into account that in 2024, no less than 94% of EU households had access to internet 5 , the paper format of instructions for use accompanying products under the scope of the Directives is outdated and not aligned with current technologies, consumer habits or green objectives.

Consequently, manufacturers should be able to choose a digital format for instructions for use. Where manufacturers choose to provide instructions for use in digital format, the safety information (including any parts of the instructions for use deemed imperative for safety) should still be provided in paper format to protect the safety of consumers. Moreover, end-users should be able to obtain a paper copy of the instructions upon request – at the time of purchase and for a certain period of time after purchase.

Streamlining reporting obligations, reducing administrative burdens and promoting digitalisation are priorities. In this context, the present proposal aims to simplify initiatives included in the headline ambition ‘A new plan for Europe’s sustainable prosperity and competitiveness’ in the policy area of the Internal Market, Food safety and Health impacting a multitude of sectors.

Moreover, the Communication ‘A Competitiveness Compass for the EU’ identified the need to seek for alternative options to give businesses legal certainty regarding compliance with EU rules in situations where harmonised standards do not exist, are not available, are not sufficient, or there is an urgent need. Several existing legislative acts already contain an alternative option to provide businesses with legal predictability and prove compliance with EU law, to cater for such situations. The present proposal’s objective is to align the alternative option in legislative acts which do not provide for any alternative option to harmonised standards. The alternative option is to be implemented in a uniform manner as regards definition, legal effect, the conditions under which that alternative option may be adopted and adoption procedure. The initiative on common specifications is fully in line with the need referred to above and aims to simplify the life of businesses that have to comply with one or more product-specific health and safety requirements, as enshrined in sectoral regulations that make use of harmonised standards.

The proposal aims to rationalise and digitalise economic operators’ obligations for Directive 2000/14/EC on the noise emission in the environment by equipment for use outdoors, 6 Directive 2010/35/EU on transportable pressure equipment, 7 Directive 2011/65/EU on restriction of hazardous substances in electrical and electronic equipment, 8 Directive 2013/53/EU on recreational craft and personal watercraft, 9 Directive 2014/29/EU on simple pressure vessels, 10 Directive 2014/30/EU on electromagnetic compatibility, 11 Directive 2014/31/EU on non-automatic weighing instruments, 12 Directive 2014/32/EU on measuring instruments, 13 Directive 2014/33/EU on lifts and safety components for lifts, 14 Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres, 15 Directive 2014/35/EU on electrical equipment designed for use within certain voltage limits, 16 Directive 2014/53/EU on radio equipment, 17 Directive 2014/68/EU on pressure equipment 18 and Directive 2014/90/EU on marine equipment 19 by a combination of measures.

Additionally, the proposal will align the existing fall-back option to harmonised standards uniformly in Directive 2011/65/EU on restriction of hazardous substances in electrical and electronical equipment, Directive 2013/53/EU on recreational craft and personal watercraft, Directive 2014/29/EU on simple pressure vessels, Directive 2014/30/EU on electromagnetic compatibility, Directive 2014/31/EU on non-automatic weighing instruments, Directive 2014/32/EU on measuring instruments, Directive 2014/33/EU on lifts, Directive 2014/34/EU on ATEX, Directive 2014/35/EU on low voltage, Directive 2014/53/EU on radio equipment, and Directive 2014/68/EU on pressure equipment.

To avoid inconsistencies and an additional burden on manufacturers and to create an overall coherence between harmonised product laws under the NLF, it is necessary to introduce a provision that allows for the use of the DPP’s data carrier when such DPP is made mandatory by another piece of legislation that covers the same product.