Baggrund og Problem
The affected EU-Regulation
Decision 768/2008, Regulation (EC)765/2008 and the Blue Guide containing the model provisions under NLF, the NLF principles and their interpretation as well as rules on accreditation. The Market Surveillance Regulation (EU) 2019/1020. Approximately 30 product legislations, existing legislations like the Toys Directive, Radio Equipment Directive or the Low Voltage Directive, and new ones like the Machinery Regulation and the Cyber Resilience Regulation.
The affected Danish regulation
All the above, whether Regulations or national laws transposing the above directives into national law.
Affected businesses
All businesses producing or using products covered by NLF legislation such as for example machinery, household appliances, electrical equipment, construction material, toys.
Reasoning behind the recommendation
When the model provisions of NLF and the NLF principles are not applied it becomes more difficult for businesses to comply with product requirements and for market surveillance authorities to control them. Furthermore, if challenges with the NLF principles and model provisions are dealt with in different ways in different new legislations or revisions the regulatory framework becomes more and more fragmented. This is due to the fact the same products must comply with multiple legislations at the same time. The Commission evaluation of NLF has documented its strengths, but also weaknesses that would benefit the Union if addressed (SWD (2022)364)).
For the NLF approach to work properly standards need to be available when the requirement becomes applicable and updated regularly to ensure they always represent the latest state of the art. The NLF standards are developed in line with the Standardisation Regulation (EU)1025/2012. Since the EC has changed its interpretation of the Standardisation Regulation, that process has been challenged by lack of flexibility and additional requirements delaying the delivery of standards.
Experts that participate in standardisation need assurance the standards they develop can be finalized and accepted by the EU-Commission. Otherwise, they prioritize to working on international standards they can apply globally. Lack of standards creates challenges to SME’s who might not have the necessary skills to show compliance without the standards. It is also challenging to market surveillance authorities who often also rely on the standards in their work. The EU-Commission has together with the European Standardisation Organization worked on solutions to the current challenges. To solve the issue, however, it is necessary to re-evaluate the new interpretation of the Standardisation Regulation the EU Commission is implementing to ensure the measures taken are appropriate and proportionate.
Expected consequences for industry and commerce
More difficult and expensive to stay compliant with existing and coming EU harmonization legislation. Need for especially SMV’s to apply 3rd party certification. A less ‘level playing field’ as market surveillance is scarce.
Economic consequences
Economic consequences will result from increased complexity in compliance work. It will require more and higher education of manpower for businesses and market surveillance to understand and apply the rules. In many cases especially SME’s will be forced to apply third party consultancy which will increase cost and decrease flexibility and speed to market.
Certain considerations
The EU Commission is expected to prepare initiatives for the next legislature on the topic. It might be in the form of a revision of Decision 768/2008 and/or Regulation (EC)765/2008, a revision of the Blue Guide and a revision of (EU)1025/2012, the Standardisation Regulation.
Current Danish efforts
Denmark has already been working on the topic under the Fit-4-Future-platform as author on a report as part of current Early representation of interest (Recommendation 82).
Denmark has been heavily engaged in the Standardisation Regulation and the challenges related to the delivery of standards. Denmark was instrumental in developing a non-paper 17 countries signed off to and is currently part of the High-Level Forum of Standardisation looking into the subject matter. The Standardisation Regulation was negotiated under the last Danish Presidency.
Anbefaling
We need horizontal responses to the current issues with NLF. Thus, the patchwork of solutions that is identified in different legislations need alignment. That could be done by updating the model provisions and principles og NLF that harmonized product legislation is based or updating the EU Commission guidance document (The Blue Guide). Furthermore, the legislators should reaffirm their commitment to the NLF framework and insist on an analysis of coming proposals by the EU Commission scrutiny board to ensure the model provisions and principles are taken on board when new legislation is proposed. This might imply a revision of Decision 768/2008.
The new interpretation of the Standardisation Regulation by the EU Commission needs to be reassessed to ensure the measures taken are appropriate and proportionate.
Regeringens svar
Regeringen tiltræder anbefalingen fra EU- og Regelforum. Regeringen vil arbejde for en ambitiøs revision af NLF, som skal sikre øget konsistens og horisontal tilpasning af lovgivningen hvor relevant, navnlig for at imødegå nye udfordringer i lyset af den grønne og digitale omstilling, modstandsdygtighed og at mitigere forhøjede risici forbundet med e-handel. Regeringen er ved forhandling af ny lovgivning opmærksom på, at undgå unødige byrder ved fravigelse af NLF, hvilket forudsætter synlighed herom samt grundige konsekvensanalyser. Regeringen arbejder fortsat for, at der i det eksisterende europæiske standardiseringssystem skabes mere robuste styringsprocesser, som balancerer behovet for politisk styring med en drivende rolle for industrien og samtidig styrker det europæiske engagement i den internationale standardiseringsorganisation.