Toelichting bij COM(2023)639 - Wijziging van de Richtlijnen 1999/2/EG, 2000/14/EG, 2011/24/EU en 2014/53/EU wat betreft bepaalde rapportagevereisten op het gebied van voedsel en voedselingrediënten, geluidsemissies buitenshuis, patiëntenrechten en radioapparatuur - Hoofdinhoud
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| dossier | COM(2023)639 - Wijziging van de Richtlijnen 1999/2/EG, 2000/14/EG, 2011/24/EU en 2014/53/EU wat betreft bepaalde rapportagevereisten op het ... |
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| bron | COM(2023)639  |
| datum | 17-10-2023 |
•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 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 2 , and for Directive 2000/14/EC on the noise emission of outdoor equipment 3 , this proposal aims to remove reporting obligations that are not necessary;
–for Directive 2014/53/EU on radio equipment 4 , 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 5 , 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 i 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 6 . 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 i 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 7 on machinery and its successor Regulation (EU) 2023/1230 8 , 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 9 .
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.
•Consistency with existing policy provisions in the policy area
The proposal is part of a first package of measures to rationalise reporting requirements. This is a step in a continuous process looking comprehensively at existing reporting requirements, with a view to assessing their continued relevance and to making them more efficient.
The rationalisation introduced by these measures will not affect the achievement of the objectives in the policy area, for the following reasons.
With regard to Directives 1999/2/EC and 2000/14/EC, the reporting requirements that are proposed to be removed from the respective Directives do not to provide any longer any added value to the Union and to the functioning of the single market.
The obligation to report on the operation of Directive 2011/24/EU will be maintained, but the reporting frequency would be aligned with the periodical evaluation of the European Reference Networks, which is key in the implementation of Directive 2011/24/EU.
With regard to Directive 2014/53/EU, this proposal aims at reducing the frequency of the reporting obligation of Member States, so that it corresponds to the frequency of the reporting obligation of the Commission to the European Parliament and to the Council.
•Consistency with other Union policies
Under the Regulatory Fitness and Performance Programme (REFIT), the Commission ensures that its legislation is fit for purpose, targeted to the needs of stakeholders and minimizes burdens while achieving its objectives. This proposal is therefore part of the REFIT programme, reducing reporting burdens arising from the Union legislation.
While certain reporting requirements are essential, they need to be as efficient as possible, avoiding overlaps, removing unnecessary burden and using as much as possible digital and interoperable solutions.
The current proposals rationalise reporting requirements thus making the achievement of the objectives of legislations more efficient and less burdensome for companies and public authorities.
Inhoudsopgave
•Legal basis
The proposal is based on Article 114 of the Treaty on the Functioning of the European Union, in line with the original legal bases for the adoption of the sectoral frameworks, which this proposal aims to amend. These sectoral frameworks are Directive 1999/2/EC on foods and food ingredients treated with ionising radiation, Directive 2000/14/EC relating to the noise emission of equipment for use outdoors, Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare and Directive 2014/53/EU on radio equipment.
Directive 1999/2/EC on foods and food ingredients treated with ionising radiation aims at the smooth operation of the internal market by reducing differences between national laws related to the treatment of foodstuffs by ionising radiation. It sets out the conditions for manufacturing, marketing, importing and compulsory labelling of foods treated with ionising radiation, a process used to reduce the number of pathogenic micro-organisms in food and to increase its shelf life.
The Union sectoral frameworks laid down by Directives 2000/14/EC and 2014/53/EU, are so-called “product harmonisation legislation”. Both Directives lay down harmonised rules regarding the design, manufacture, conformity assessment and placing on the market of products. Essentially, these sectoral frameworks introduce for each respective sector/product category the essential safety requirements which the products should meet and the procedures how to assess the compliance with these requirements.
Another common feature of these frameworks is that they are more or less closely aligned to the general principles laid down in Decision No 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products 10 , which lays down reference provisions for the drawing up of Union legislation harmonising the conditions for the marketing of products.
Directive 2011/24/EU on patients’ rights in cross-border healthcare is the first piece of Union legislation in the area of healthcare services. It complements the more widely used Regulation on social security coordination by codifying Court of Justice jurisprudence and laying down more detailed and systemic rules to give patients the freedom to choose healthcare in another Member State and to be reimbursed (partially) for the medical costs. Furthermore, Directive 2011/24/EU, amongst others, provides that the Commission shall support Member States in the development of European Reference Networks for rare diseases.
All the above-mentioned pieces of legislation affected by this proposal contain provisions of a similar type, which impose obligations that have become unnecessary with time. Amending the mentioned Directives in the proposed manner will result in the rationalisation of reporting obligations in all of the affected legal frameworks.
•Subsidiarity (for non-exclusive competence)
The reporting requirements concerned are imposed by Union law and can therefore only be amended at Union level. Member States, companies and the Commission will be benefiting from the rationalisation of reporting requirements that is the subject of this proposal.
•Proportionality
The rationalisation of reporting requirements simplifies the legal framework by introducing minimum changes to existing requirements that do not affect the substance of the wider policy objective. The proposal is therefore limited to those changes that are necessary to ensure efficient reporting without changing any of the substantial elements of the legislation concerned.
•Choice of the instrument
Directives 2000/14/EC and 2014/53/EU are both harmonised products legislations under the Single Market rules. Together with Directives 1999/2/EC and 2011/24/EU, these pieces of legislation contain redundant or ineffective reporting obligations. Therefore, in the interest of efficiency, a joint proposal for the rationalisation of the reporting obligation in the form of the present omnibus proposal appears to be the most suitable solution.
Having regard to Directive 2011/24/EU, in particular Article 12 i, points (b) and (c), Commission Implementing Decision 2014/287/EU 11 setting out criteria for establishing and evaluating European Reference Networks was adopted. Both instruments provide for periodic reporting and evaluations to be prepared by the Commission.
Therefore, considering that the results of the evaluation of the European Reference Networks are relevant for the measurement of the Directive operation, in the interest of creating synergies between the reports and to reduce the administrative burden for the Commission and Member States, the alignment of the reporting period for the rationalisation of the reporting obligations as part of this omnibus proposal is considered appropriate and efficient.
•Ex-post evaluations/fitness checks of existing legislation
•Stakeholder consultations
•Collection and use of expertise
The proposed rationalisation measures have been identified following a process of internal scrutiny of existing reporting obligations and based on the experience from implementation of the related legislation. Since this is a step in the process of continuous assessment of reporting requirements arising from Union legislation, the scrutiny of such burden and of its impact on stakeholders will continue.
•Impact assessment
The proposal concerns limited and targeted changes of legislation in view of rationalising reporting requirements. They are based on experience from implementing legislation. The changes do not have significant impact on the policy, but only ensure a more efficient and effective implementation. Their targeted nature and the lack of relevant policy options make an impact assessment not necessary.
• Regulatory fitness and simplification
This is a REFIT proposal, aiming to simplify legislation and cut burdens for stakeholders.
•Fundamental rights
N/A
•Implementation plans and monitoring, evaluation and reporting arrangements
•Explanatory documents (for directives)
Considering the scope of the proposal, it is not justified or proportional to require explanatory documents.
•Detailed explanation of the specific provisions of the proposal
With regard to Directive 1999/2/EC:
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 i 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 are redundant, as annual reporting obligations on official controls and other official activities performed to ensure the application of food and feed law and applicable to Member States’ competent authorities and the Commission are also laid down in Articles 113 and 114 of Regulation (EU) 2017/625. The latter obligations are sufficient to ensure enforcement and facilitate monitoring of the effectiveness of the Union legislation on food irradiation. Therefore, the proposal provides for the deletion of the reporting obligations currently laid down in Article 7(3) and i of Directive 1999/2/EC regarding the results of official controls carried out in food irradiation facilities or on irradiated food placed on the market.
With regard to Directive 2000/14/EC:
Article 16 of the Directive provides for an obligation for manufacturers, or their authorised representatives, to send a copy of the EC declaration of conformity of their products to both Member States and to the Commission. The Commission has the subsequent obligation to collect the data received and to publish the relevant information periodically.
As indicated in the evaluation of the Directive that reporting obligation seems ineffective since in accordance with Article 4(1) of the Directive, the manufacturers have the obligation to affix a noise marking on the equipment covered by that Directive. This noise marking is deemed to be sufficient to provide information with regard to the noise level of equipment to consumers.
In that spirit, it appears to be appropriate to delete Article 16, as there is no need for this reporting obligation anymore.
As Article 20 of that Directive mentions Article 16, it is therefore appropriate to amend that Article accordingly.
With regard to Directive 2011/24/EU:
Article 20(1) of Directive 2011/24/EU provides that the Commission shall by 25 October 2015 and subsequently every three years thereafter, draw up a report on the operation of the Directive and submit it to the European Parliament and to the Council. The last report on the operation of the Directive was published on 12 May 2022. According to the current rules, the next report of the Directive is to be ready by 2025.
The European Reference Networks established under Directive 2011/24/EU are evaluated every 5 years as provided in Article 14(1) of Implementing Decision 2014/287/EU. As the European Reference Networks were established in 2017, the Commission is evaluating the European Reference Networks for the first time in 2022-2023 and the next evaluation of the European Reference Networks would, in accordance with Article 14(1) of Implementing Decision 2014/287/EU, occur in 2027.
By aligning these two processes (reporting on the operation of the Directive and evaluating the European Reference Networks), synergies could be ensured. Therefore, the proposal will provide for the reporting on the operation of Directive 2011/24/EU to be carried out every five years, from 2027 onwards.
With regard to Directive 2014/53/EU:
Article 47(1) of the Directive provides for an obligation for Member States to report every two years to the Commission.
The report is to contain a presentation of the market surveillance activities performed by Member States and provide information on whether and to what extent compliance with the requirements of that Directive has been attained.
The frequency of that reporting obligation appears to be higher than necessary. In accordance with Article 47(2) of the Directive, the Commission has to report to the European Parliament and to the Council every five years. The proposal aims to modify the frequency of the reporting obligation for Member States to every five years. In such way, the information provided by Member States can be used by the Commission as a reference draft for the report to the European Parliament and to the Council.
This will also provide the Commission with the information necessary for the assessment it is to carry out when adopting delegated acts under Article 5(2) of Directive 2014/53/EU specifying which categories of radio equipment are concerned by the registration requirement and allow the Commission to use the information from Member States’ reports more efficiently