Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 1999/2/EC, 2000/14/EC, 2011/24/EU and 2014/53/EU as regards certain reporting requirements in the fields of food and food ingredients, outdoor noise, patients’ rights, and radio equipment
Date: 2023-10-17
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: disclosure of information, exchange of information, food safety, foodstuffs legislation, marketing standard, noise pollution, noise protection, patient's rights, radio equipment, standard

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   EUROPEAN COMMISSION  Brussels, 17.10.2023  COM(2023) 639 final 2023/0369 (COD)  Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 1999/2/EC, 2000/14/EC, 2011/24/EU and 2014/53/EU as regards certain reporting requirements in the fields of food and food ingredients, outdoor noise, patients’ rights, and radio equipment (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

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 
radiation2,  and  for  Directive  2000/14/EC  on  the  noise  emission  of  outdoor 
equipment3,  this  proposal  aims  to  remove  reporting  obligations  that  are  not 
necessary;  
for  Directive  2014/53/EU  on  radio  equipment4,  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 
healthcare5, 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 

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COM(2023)168. 
Directive  1999/2/EC  of  the  European  Parliament  and  of  the  Council  of  22  February  1999  on  the 
approximation  of  the  laws  of  the  Member  States  concerning  foods  and  food  ingredients  treated  with 
ionising radiation (OJ L 66, 13.3.1999, p. 16). 
Directive  2000/14/EC  of  the  European  Parliament  and  of  the  Council  of  8  May  2000  on  the 
approximation of the laws of the Member States relating to the noise emission in the  environment by 
equipment for use outdoors (OJ L 162, 3.7.2000, p. 1). 
Directive  2014/53/EU  of  the  European  Parliament  and  of  the  Council  of  16  April  2014  on  the 
harmonisation of the laws of the Member States relating to the making available on the market of radio 
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). 
Directive  2011/24/EU  of  the  European  Parliament  and  of  the  Council  of  9 March  2011  on  the 
application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 

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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) 2017/6256. 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/EC7 on 
machinery and its successor Regulation (EU) 2023/12308, 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 Networks9. 

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Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal health and welfare, plant health and plant protection products (OJ L 95, 7.4.2017, p. 1). 
Directive 2006/42/EC of the European Parliament and of the  Council of 17 May 2006 on machinery, 
and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24). 
Regulation  (EU)  2023/1230  of  the  European  Parliament  and  of  the  Council  of  14  June  2023  on 
machinery  and  repealing  Directive  2006/42/EC  of  the  European  Parliament  and  of  the  Council  and 
Council Directive 73/361/EEC (OJ L 165, 29.6.2023, p. 1).  
Commission  Implementing  Decision  2014/287/EU  of  10  March  2014  setting  out  criteria  for 
establishing  and  evaluating  European  Reference  Networks  and  their  Members  and  for  facilitating  the 
exchange  of  information  and  expertise  on  establishing  and  evaluating  such  Networks  (OJ  L  147, 
17.5.2014, p. 79). 

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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.  

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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. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

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  products10,  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. 

10 

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,  and  repealing  Council  Decision  93/465/EEC  (OJ  L  218, 
13.8.2008, p. 82). 

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• 

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(4),  points  (b)  and  (c), 
Commission  Implementing  Decision  2014/287/EU11  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. 

3. 

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N/A 

• 

N/A 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

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.  

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Commission  Implementing  Decision  2014/287/EU  of  10  March  2014  setting  out  criteria  for 
establishing  and  evaluating  European  Reference  Networks  and  their  Members  and  for  facilitating  the 
exchange  of  information  and  expertise  on  establishing  and  evaluating  such  Networks  (OJ  L  147, 
17.5.2014, p. 79). 

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• 

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.  

• 

N/A 

4. 

N/A 

5. 

• 

N/A 

• 

Fundamental rights 

BUDGETARY IMPLICATIONS 

OTHER ELEMENTS 

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(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 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  (4)  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.  

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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 

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2023/0369 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directives 1999/2/EC, 2000/14/EC, 2011/24/EU and 2014/53/EU as regards 
certain reporting requirements in the fields of food and food ingredients, outdoor noise, 
patients’ rights, and radio equipment 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee1, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

1 
2 
3 

4 

5 

Reporting  requirements  play  a  key  role  in  ensuring  proper  monitoring  and  correct 
enforcement of legislation. However, it is important to streamline those requirements, 
in order to ensure that they fulfil the purpose for which they were intended and to limit 
the administrative burden. 

In  its  Communication  on  ‘Long-term  competitiveness  of  the  EU:  looking  beyond 
2030’2,  the  Commission  has  committed  to  rationalise  and  simplify  reporting 
requirements,  with  the  ultimate  aim  to  reduce  such  burdens  by  25%,  without 
undermining the related policy objectives. 
Directive  1999/2/EC  of  the  European  Parliament  and  of  the  Council3,  Directive 
2000/14/EC of the European Parliament and of the Council4, Directive 2011/24/EU of 
the  European  Parliament  and  Council5  and  Directive  2014/53/EU  of  the  European 

OJ C […], […], p. […]. 
COM(2023)168. 
Directive  1999/2/EC  of  the  European  Parliament  and  of  the  Council  of  22  February  1999  on  the 
approximation  of  the  laws  of  the  Member  States  concerning  foods  and  food  ingredients  treated  with 
ionising radiation (OJ L 66, 13.3.1999, p. 16). 
Directive  2000/14/EC  of  the  European  Parliament  and  of  the  Council  of  8  May  2000  on  the 
approximation of the laws of the Member States relating to the noise emission in the environment by 
equipment for use outdoors (OJ L 162, 3.7.2000, p. 1). 
Directive  2011/24/EU  of  the  European  Parliament  and  of  the  Council  of  9  March  2011  on  the 
application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 

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Parliament  and  of  the  Council6  contain  a  number  of  reporting  requirements  in  the 
fields  of  food  and  food  ingredients,  outdoor  noise,  patients’  rights,  and  radio 
equipment.  

In accordance with Article 7(3) of Directive 1999/2/EC, Member States are to report 
annually to the Commission the results of official checks that they have carried out in 
ionising  irradiation  facilities  and  checks  carried  out  at  the  product  marketing  stage. 
Article 7(4) of Directive 1999/2/EC provides that the Commission is to publish in the 
Official  Journal  of  the  European  Union  a  report  based  on  the  information  provided 
every year by Member States. Articles 113 and 114 of Regulation (EU) 2017/625 of 
the European Parliament and of the Council7 provide that that each Member State is to 
submit to the Commission, by 31 August every year, a report setting out the outcome 
of  official  controls  performed  in  the  previous  year  under  its  multi-annual  national 
control  plan  (‘MANCP’).  The  MANCP  covers,  inter  alia,  the  scope  of  Directive 
1999/2/EC.  In  addition,  Article  114  of  Regulation  (EU)  2017/625  provides  that  the 
Commission  is  to  make  available  every  year  to  the  public  an  annual  report  on  the 
operation of official controls in Member States taking into account the annual reports 
submitted by Member States in accordance with Article 113 of that Regulation. Since 
the annual reporting obligations laid down in Articles 113 and 114 of Regulation (EU) 
2017/625 already ensure enforcement and monitoring of legislation on irradiated foods 
and  food  ingredients,  the  similar  annual  reporting  obligation  currently  laid  down  in 
Directive  1999/2/EC  should  be  deleted  in  order  to  reduce  administrative  burden  for 
competent authorities and the Commission. 

In  accordance  with  Article  16  of  Directive  2000/14/EC,  manufacturers,  or  their 
authorised representatives, are to send a copy of the EC declaration of conformity for 
equipment  for use outdoors falling  within the scope of that  Directive to  the Member 
States’ authorities and to the Commission. The Commission is to collect the data and 
publish relevant information periodically.  

Consumers  can  find  the  relevant  information  regarding  the  noise  emissions  of 
equipment covered by Directive 2000/14/EC directly on the equipment, as Article 4(1) 
of that Directive provides for a mandatory noise marking on the equipment. Therefore, 
the  obligations  on  Member  States  and  the  Commission  laid  down  in  Article  16  of 
Directive  2000/14/EC  to  provide  documentation  and  to  collect  and  publish  data  are 
superfluous  and  should,  in  the  interest  of  rationality  and  in  order  to  limit  the 
administrative burden of companies and of authorities, be deleted.   

In accordance with Article 20(1), point (a), of Directive 2000/14/EC, the Commission 
is to submit to the European Parliament and to the Council a review of the noise data 
collected in accordance with Article 16 of that Directive. Since such noise data will no 
longer be collected, that obligation should also be deleted. 

In  accordance  with  Article  20(1)  of  Directive  2011/24/EU,  the  Commission  is  to 
submit to the European Parliament and to the Council a report on the operation of that 
Directive  every  three  years.  That  report  heavily  draws  on  the  reporting  and 

Directive  2014/53/EU  of  the  European  Parliament  and  of  the  Council  of  16  April  2014  on  the 
harmonisation of the laws of the Member States relating to the making available on the market of radio 
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). 
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal health and welfare, plant health and plant protection products (OJ L 95, 7.4.2017, p. 1). 

(4) 

(5) 

(6) 

(7) 

(8) 

6 

7 

EN 

9 

  EN 

 
(9) 

contributions  of  national  competent  authorities.  The  European  Reference  Networks 
established under Directive 2011/24/EU are to be evaluated every five years as set out 
in  Article  14(1)  of  Commission  Implementing  Decision  2014/287/EU8.  In  order  to 
align  the  reporting  and  evaluation  requirements  and  to  reduce  the  administrative 
burden  for  the  Commission  and  for  the  Member  States  that  are  requested  to  provide 
information  on  the  implementation  of  Directive  2011/24/EU,  the  frequency  of  the 
reporting by the Commission should be changed to every five years. Considering that 
the  most  recent  report  on  the  operation  of  Directive  2011/24/EU  was  published  in 
2022, the next report should be published in 2027. 

In  accordance  with  Article  47(1)  of  Directive  2014/53/EU,  Member  States  are  to 
submit to the Commission regular reports on the application of that Directive at least 
every two years. The frequency of that mandatory reporting is higher than necessary. 
In the interest of rationality and in order to limit the administrative burden of Member 
States, the frequency of the mandatory reporting by Member States should be changed 
to every five years, so that it corresponds to the Commission’s obligation under Article 
47(2) of Directive 2014/53/EU to report to the European Parliament and to the Council 
on  the  operation  of  that  Directive.  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. 

(10)  Directives 1999/2/EC, 2000/14/EC, 2011/24/EU and 2014/53/EU should therefore be 

amended accordingly,  

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 
Amendments to Directive 1999/2/EC 

Article 7 of Directive 1999/2/EC is amended as follows: 

(1) 

paragraph 3 is replaced by the following: 

‘3.  Each  Member  State  shall  forward  to  the  Commission  the  names,  addresses  and 
reference numbers of the irradiation facilities which it has approved, the text of the 
approval document, and any decision suspending or withdrawing approval.’; 

(2) 

paragraph 4 is replaced by the following: 

‘4. On the basis of the data supplied in accordance with paragraph 3, the Commission 
shall  publish  in  the  Official  Journal  of  the  European  Union  the  details  of  the 
facilities as well as any changes in their status.’. 

Article 2 
Amendments to Directive 2000/14/EC 

Directive 2000/14/EC is amended as follows:  

8 

Commission  Implementing  Decision  2014/287/EU  of  10  March  2014  setting  out  criteria  for 
establishing  and  evaluating  European  Reference  Networks  and  their  Members  and  for  facilitating  the 
exchange  of  information  and  expertise  on  establishing  and  evaluating  such  Networks  (OJ  L  147, 
17.5.2014, p. 79). 

EN 

10 

  EN 

 
 
(1) 

(2) 

Article 16 is deleted;  

in Article 20(1), point (a) is deleted.   

Article 3 
Amendment to Directive 2011/24/EU 

In Article 20 of Directive 2011/24/EU, paragraph 1 is replaced by the following: 

‘1.  The  Commission  shall  by  25  October  2027  and  subsequently  every  five  years 
thereafter,  draw  up  a  report  on  the  operation  of  this  Directive  and  submit  it  to  the 
European Parliament and to the Council.’. 

Article 4 
Amendment to Directive 2014/53/EU 

In Article 47(1) of Directive 2014/53/EU, the first sentence is replaced by the following: 

‘Member  States  shall  submit  to  the  Commission  reports  on  the  application  of  this 
Directive by 12 December 2027, covering the period since 13 June 2023, and every 
five years thereafter.’.  

Article 5 
Transposition 

1. 

Member States shall adopt and publish, by [Note to PO: insert exact date – […] 12 
months after entry into force of this Directive] at the latest, the laws, regulations and 
administrative  provisions  necessary  to  comply  with  Article  2,  point  (1),  of  this 
Directive.  They  shall  forthwith  communicate  to  the  Commission  the  text  of  those 
provisions. 

They  shall  apply  those  provisions  from  [Note  to  PO:  insert  exact  date  –  […]  12 
months and one day after entry into force of this Directive]. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

Article 6 
Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

EN 

11 

  EN 

Article 7 
Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

EN 

12 

  EN