BAKGRUNN (fra kommisjonsforslaget)

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

Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection.

Streamlining reporting obligations and reducing administrative burden is therefore a priority. In this context, the present proposal aims to simplify initiatives included in headline ambition ‘An Economy that works for the people’, A ‘European Green deal’ and ‘Promoting our European way of life’ in the policy area of the Internal Market, Food safety and Health and impacting respectively the outdoor equipment and the radio equipment industry/sectors as well as sectors related to food treated with ionising radiation and on cross-border healthcare.

The proposal aims to rationalise reporting obligations by a combination of measures:

• for Directive 1999/2/EC on foods and food ingredients treated with ionising radiation, and for Directive 2000/14/EC on the noise emission of outdoor equipment, this proposal aims to remove reporting obligations that are not necessary;
• for Directive 2014/53/EU on radio equipment, this proposal aims to reduce the frequency of the reporting obligation of Member States; 
• for Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare, this proposal aims to reduce the frequency of the reporting obligation.

With regard to Directive 1999/2/EC, the reporting obligation concerns both Member States and the Commission. Article 7(3) of Directive 1999/2/EC provides that Member States report annually to the Commission the results of official controls they have carried-out in food irradiation facilities and on irradiated food placed on the market. Article 7(4) of that Directive provides that the Commission publishes in the Official Journal of the European Union a report based on the information provided every year by the national supervisory authorities.

These reporting obligations have become redundant, as annual reporting obligations for Member States’ competent authorities and the Commission are respectively also laid down in Articles 113 and 114 of Regulation (EU) 2017/625. Those obligations are sufficient to ensure enforcement and facilitate monitoring of the effectiveness of legislation. Therefore, the proposal provides for the deletion of the similar reporting obligations currently laid down in Article 7(3) and (4) of Directive 1999/2/EC.

With regard to Directive 2000/14/EC, those reporting requirements concern both companies and public authorities. Indeed, Article 16 of Directive 2000/14/EC provides that manufacturers, or their authorised representatives, shall send to both the authorities of Member States and to the Commission a copy of the EC declaration of conformity for equipment covered by that Directive. The Commission has then the obligation to collect the data and publish the relevant information periodically. According to recital 14 of Directive 2000/14/EC, one of the principal justifications for this reporting obligation was to provide for ‘a basis for informed consumer choice’. However, it appears that this reporting obligation creates an unnecessary administrative burden in this respect, since consumers are already informed of the noise emission level via the mandatory noise marking affixed on all the equipment covered by that Directive.

Consumers are also informed on the noise emission of the specific equipment via the instructions for use for machines which are under the scope of both Directive 2006/42/EC on machinery and its successor Regulation (EU) 2023/1230, as those pieces of legislation cover 55 of the 57 equipment categories that fall within the scope of Directive 2000/14/EC.

Consequently, it is proposed to delete Article 16 of Directive 2000/14/EC.

With regard to Directive 2011/24/EU the reporting obligation concerns the Commission. However, indirectly it also concerns Member States, as the Commission’s reporting relies largely on the Member States’ contributions on how the Directive is being applied at national level.

Article 20(1) of Directive 2011/24/EU provides that the Commission shall by 25 October 2015 and subsequently every 3 years thereafter, draw up a report on the operation of the Directive and submit it to the European Parliament and to the Council. The European Reference Networks established under Directive 2011/24/EU are to be evaluated every 5 years in accordance with Article 14(1) of Commission Implementing Decision setting out criteria for establishing and evaluating European Reference Networks.

The evaluation of the functioning and operations of all European Reference Networks is a key part of the content of the reports on the operation of Directive 2011/24/EU. Consequently, the current frequency of reporting is disproportionate and does not have added value in the absence of a parallel evaluation of the European Reference Networks. In addition to that, the current reporting period of 3 years is, in practice, insufficient for the Commission and Member States to address all follow-up actions expected. Furthermore, if the two processes (reporting on the operation of the Directive and evaluating the European Reference Networks) were aligned, synergies between the report and the evaluation could be ensured. Therefore, it is proposed to provide for the reporting on the operation of Directive 2011/24/EU to be carried out every 5 years.

With regard to Directive 2014/53/EU, the reporting obligation in question concerns Member States.

Indeed, Article 47(1) of Directive 2014/53/EU provides that Member States shall submit to the Commission, every two years, a report on the application of the Directive which is to contain a presentation of the market surveillance activities performed by the Member States and whether requirements of that Directive have been attained. The current frequency of that obligation does not match the reporting obligation from the Commission to the European Parliament and to the Council which takes place every five years.

In that spirit, it is proposed to reduce the frequency of the reporting obligation of Member States to every five years.