COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Disclaimer: This report commits only to the Commission's services involved in its preparation and does not prejudge the final form of any decision to be taken by the Commission. Accompanying the document Proposal for a Directive of the European Parliament and of the Council on the harmonisation of laws of the Member States to the making available on the market of radio equipment
Date: 2012-10-17
Institutions: European Commission
Subjects: Community certification, administrative formalities, electronic device, market supervision, marketing standard, quality standard, radio telecommunications, technical standard

EUROPEAN 
COMMISSION 

Brussels, 17.10.2012  
SWD(2012) 300 final 

COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 
Disclaimer: This report commits only to the Commission's services involved in its 
preparation and does not prejudge the final form of any decision to be taken by the 
Commission. 

Accompanying the document 

Proposal for a Directive of the European Parliament and of the Council on the 
harmonisation of laws of the Member States to the making available on the market of 
radio equipment 

{COM(2012) 584 final} 
{SWD(2012) 329 final} 

EN 

   EN 

 
 
 
 
  
 
COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 
Disclaimer: This report commits only to the Commission's services involved in its 
preparation and does not prejudge the final form of any decision to be taken by the 
Commission. 

Accompanying the document 

Proposal for a Directive of the European Parliament and of the Council on the 
harmonisation of laws of the Member States to the making available on the market of 
radio equipment 

Introduction  
This  Impact  Assessment  summary  report  addresses  a  possible  revision  of  the  R&TTE1 
Directive,  Directive  1999/5/EC  on  radio  equipment  and  telecommunications  terminal 
equipment2. The Directive covers an estimated €63 billion market (2007), inlcuding  inter alia 
mobile phones, mobile network transmitters and fixed telephones3. It harmonises at EU level 
regulatory requirements for the protection of health and safety, electromagnetic compatibility, 
and the avoidance of harmful interference.  

1. 

PROBLEM DEFINITION 

1.1. 

Low level of compliance 

A  low  level  of  compliance  with  the  requirements  of  the  Directive  has  been  observed. 
Available  evidence  from  EU  Market  Surveillance  Authorities  (MSAs)  show  values  ranging 
between 28% and 56% for compliance with the essential requirements, and even lower values 
for administrative compliance. 

Efficient enforcement by MSAs is strongly hindered by the limited traceability of products 
and  of  manufacturers.  When  a  valid  contact  point  cannot  be  found,  MSAs  are  obliged  to 
unfurl the distribution chain in order to contact the person responsible for placing the product 
in the EU market. 

Also,  the  Directive  is  often  ambiguous  and  unnecessarily  complex  (see  2.2  below),  and 
demands a relatively high effort from manufacturers to understand their obligations. 

1.2. 

Problems related to the legal provisions of the Directive 

The Directive is considered to be too complex and ambiguous. Some isses subject to different 
interpretations are: 

1 
2 
3 

R&TTE= Radio and telecommunications terminal equipment 
Directive 1999/5/EC OJ L 91, 7.4.1999, p. 10–28 
Non-radio telecommunications infrastructure such as switching systems is excluded from the scope of 
the R&TTE Directive  

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• 

• 

Whether the essential requirement in article 3.2 ('effective use of spectrum... so as to 
avoid  harmful  interference')  is  applicable  only  to  transmitters  or  also  to  the 
performance of reception by radio equipment 

Distinction  between  the  obligation  to  affix  the  'Alert  Sign'  on  products  subject  to 
restrictions  of  use  and  the  obligation  to  notify  the  placing  on  the  market  of 
equipment operating in non-harmonised bands 

These ambiguities and others lead to inconsistent application of the Directive and constitute a 
hindrance to the Internal Market. 

The Directive also includes many administrative provisions, and the value of some of them 
is  questionable,  e.g.  CE  marking,  Notified  Body number  and  Alert  Sign  must  be  affixed  on 
the equipment, on the package and on user instructions. 

1.2.1.  Problems with the scope of the R&TTE Directive 

It is unclear how to apply the Directive to some particular categories of equipment, such as 
equipment modifiable by software and installations made up of multiple components. 

The  Directive  does  not  allow  to  require  equipment  to  interoperate  with  accessories,  such  a 
chargers.  In  the  absence  of  voluntary  industry  agreements,  lack  of  interoperability  is  an 
inconvenience for users and creates unnecessary waste4.  
Receivers (e.g. GPS or Galileo receivers) are generally included in the Directive. Sound and 
TV  broadcast  receivers,  and  also  intentional  radiators  non-capable  of  communication  (e.g. 
wireless  chargers)  are  excluded  from  the  Directive,  and  fall  under  the  EMC  Directive5. 
Different legal requirements for similar equipment create legal uncertainty. 

1.3. 

Regulatory barriers to market entry of innovative radio equipment 

Market  access  for  new  radio  technologies  requires  compliance  with  the  R&TTE  Directive, 
two issues are relevant here: 

• 

• 

Excessive  delays  in  the  development  of  harmonised  standards  (up  to  several  years) 
and in the publication of references in the OJEU6 (up to 1 year) 

Difficulties  in  obtaining  opinions  from  notified  bodies  (NBs)  in  the  absence  of 
approved rules for the use of spectrum.  

Other  issues  affecting  market  access  of  innovations  fall  outside  the  scope  of  the  R&TTE 
Directive,  and  include  the  lack  of  harmonisation  of  spectrum  in  the  EU,  and  the  relatively 
long, complex and uncertain process for the re-allocation of spectrum use. 

1.4.  Who is affected. 

•  Users  of  R&TTE  equipment,  public  services  and  citizens  in  general  exposed  to 

non-compliant equipment. 

4 
5 
6 

http://ec.europa.eu/enterprise/sectors/rtte/chargers/index_en.htm  
Electromagnetic Compatibility Directive, Directive 2004/108/EC 
Official Journal of the European Union 

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•  Manufacturers  affected  by  distortion  of  competition  by  non-compliant  products, 
by the complexity and ambiguity of the Directive, and by difficulties in bringing 
innovations to the market  

•  Market  Surveillance  Authorities  affected  by  difficulties  in  efficiently  enforcing 

the Directive and by legal uncertainty  

2. 

ANALYSIS OF SUBSIDIARITY 

The Single Market is an area of ‘shared competence’ according to article 4 of the Treaty on 
the  Functioning  of  the  European  Union  (TFEU).  The  revised  Directive  shall  be  based  on 
TFEU articles 26 (Internal Market) and 114 (Approximation of Laws). Action at EU level is 
necessary in order to adapt, clarify or simplify provisions which are the keystone of the Single 
Market  in  this  area.  This  cannot  be  done  by  Member  States  on  their  own.  A  possible  new 
obligation  to  register  at  EU  level  manufacturer  and/or  product  (options  A2,  A3,  A4)  would 
affect  the  the  whole  EU  market,  its  advantages  with  respect  to  similar  measures  at  national 
level are clear. Option C2 affects spectrum regulation, an area largely within the competence 
of Member States, this is discussed below. For the other options considered, the EU right to 
act and the value-added of action at EU level can be considered uncontroversial.  

3. 

OBJECTIVES 

The  review  of  the  R&TTE  Directive  aims  to  ensure  better  implementation  of  the  essential 
requirements  in  the  Directive.  It  must  preserve  and  improve  the  Single  Market,  avoid 
unnecessary  costs  and  burden,  in  particular  for  SMEs,  and  support  innovation.  Specific  and 
operational objectives are the following: 

A 

To achieve improved enforcement and compliance with the Directive: 

•  To reinforce the obligations of economic operators, and to improve the legal tools 

available to MSAs in particular regarding traceability of products  

To  make  available  a  sound  legal  basis  for  the  implementation  of  the  essential 

B 
requirements: 

•  To  clarify,  simplify  or  suppress  a  number  of  provisions  and  administrative 

obligations; to improve the coherence with other EU legislation.  

•  To facilitate the application of the Directive some specific technologies; to enable 

harmonisation of interfaces between equipment and accessories 

•  To include within the scope of the Directive all equipment for which avoidance of 

harmful interference is relevant  

To  remove  regulatory  barriers  for  access  to  the  market  of  innovative  radio 

C 
equipment: 

•  To simplify regulatory decision-making and reduce associated delays 

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4. 

POLICY OPTIONS 

4.1. 

Options addressing objective A 

-Option A0 is the status quo.  

-Option A1 is an alignment with the New Legislative Framework (NLF) for the marketing of 
goods 

-Option A2 includes Option A1 plus the obligation for manufacturers to register in a central 
EU  registration  system  their  contact  data.  A  unique  company  registration  number  shall  be 
affixed on all products placed on the EU market 

-Option  A3  includes  Option  A1  plus  the  obligation  for  the  manufacturer  to  register  in  a 
central EU registration system each new product type and upload part of the technical file. A 
product specific registration number shall be affixed on each corresponding product 

-Option  A4  includes  Option  A1  plus  the  possibility  for  the  Commission,  on  the  basis  of 
delegated  powers,  to  introduce  product  registration  as  in  option  A3  for  some  specific 
categories of equipment where a high level of compliance has not been achieved 

4.2. 

Options addressing objective B 

-Option B0 is the status quo  
-Option  B1  includes  the  alignment  of  definitions  and  obligations  in  the  Directive  with  the 
NLF for the Internal Market for goods, the clarification of currently problematic provisions on 
the basis of the current ‘Guide for the implementation of the Directive’, and the simplification 
of some administrative obligations  
-Option  B2  includes  option  B1,  plus  the  introduction  of  additional  provisions  to  deal  with 
some  specific  technologies,  a  new  requirement  for  interoperability  with  accessories,  and  an 
extension of scope to all radio transmitters and receivers 

-Option  B3 includes option  B1, the  introduction of additional provisions to deal with some 
specific technologies, a restriction of the scope of the Directive to radio transmitters, and an 
empowerment to the Commission to facilitate the application of the Directive and to address 
interoperability with accessories  

4.3. 

Options addressing objective C 

-Option C0 is no new EU action.  

-Option  C1  includes  non-legislative  measures:  to  set  up  a  single  EU  point  of  request  for 
experimental  licences  for  use  of  radio  equipment;  an  action  plan  to  improve  cooperation 
between regulators, notified bodies and standardisation bodies; and an information campaign 
towards companies and SMEs on the regulatory framework of radio equipment 
-Option C2 includes option C1 and two legal changes: the creation of a special category of 
notified  bodies  focussing  on  the  more  innovative  radio  equipment;  and  the  setting  up  of  a 
central  EU  body  empowered  to  allow  the  placing  in  the  market  and  the  use  of  a  limited 
amount of radio equipment within well-defined geographical areas and periods of time 

5. 

ASSESSMENT OF IMPACTS 

All  options  are  assessed  in  terms  of  effectiveness  in  achieving  the  objectives.  Accrued 
compliance is expected to bring in positive social impacts, i.e. improved protection of health 

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and safety and better operation of equipment for the benefit of consumers, business and public 
services.  

Economic  impacts  relate  to  the  functioning  of  the  internal  market,  the  efficient  use  of 
spectrum and the administrative costs induced by the Directive, and some innovation aspects. 
No significant specific impact on SMEs has been identified. 

5.1. 

Options  addressing  objective  A:  To  achieve  improved  enforcement  and 
compliance with the Directive 

Some  50%  of  Member  States  and  most  economic  operators7  expect  a  high  impact  of  the 
alignment to the NLF (Option 1) on compliance in the R&TTE area.  

Most MSAs consider that the additional effect on enforcement efficiency and on compliance 
of  Option  A2  should  be  positive  but  limited.  Option  A3  brings  in  an  additional  tool  for 
enforcement,  providing  quick  access  to  the  technical  file  of  registered  products,  online 
availability of product-specific contact data and therefore a reduction of delay enforcement. 
One  MSA  estimated  an  overall  gain  of  up  to  10-15%  in  time/resources  allocated  to  market 
surveillance and an improvement in reaction time of several weeks. While focussing only on 
problematic product categories, Option A4 should have a similar impact on effectiveness as 
option A3. 

Negative  impact  of  Option  A3  on  administrative  burden  is  perceived  as  much  more 
significant than for the other options. 32% respondents to the 2010 consultation (but only 12% 
of SMEs) assess the impact as significant against only 10% for the NLF alignment. It seems 
that the current obligation to establish a technical file prior to the placing of a product on the 
market  is  often  not  complied  with.  Should  it  be  the  case,  additional  burden  arising  from 
collecting, formatting and uploading this information would be very limited. For Option A4 
additional  administrative  costs  would  be  limited  to  those  product  categories  subject  to 
registration. 

These and other impacts are summarised in the table below: 

Table 1. Summary table comparing options addressing objective D 

Effectiveness  in 
achieving 
objective A 

0 

+/++ 
Moderate to 
significant 

Option A0 

Option A1 

Option A2 

+/++ 

Limited impact on 
top of A1 

Option A3 

+++ 
Additional 

Cost and efficiency  Coherence 

0 

0 

- 
Increase of 
administrative 
requirements, in 
particular for importers 
and distributors 
-/+ 
Perceived as a small 
increase of burden by 
manufacturers 
Limited improvement in 
the efficiency of MSAs 
--/++ 
Perceived as a significant 

+++ 
NLF improves 
coherence with New 
Approach legislation 

+++/- 
Idem NLF / 
Slight depart from 
New Approach 
legislation 

+++/-- 
Idem NLF /  

7 

In  the  course  of  the  2010  public  consultation  71%  of  respondents  (MSAs  were  excluded  in  this 
question) expected from the NLF alignment a medium to strong impact on compliance  

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Option A4 

instrument for 
effective 
enforcement of 
obligations and 
education of 
companies 

++ 
Additional 
instrument only for 
problematic 
categories 

increase of burden by 
manufacturers 
Improves efficiency of 
MSAs 
Estimated 300000€ 
investment 
-/+++ 
Smaller increase in 
burden for industry than 
Option A3 
Higher overall efficiency 
than Option A3 

Departs from New 
Approach legislation 

+++/- 
Idem NLF / 
Departs from New 
Approach legislation 
in justified cases 

5.2. 

Options  addressing  objective  B:  To  make  available  a  sound  legal  basis  for  the 
implementation of the essential requirements 

Table 2. Summary table comparing options addressing objective B 

Option B0 

Option B1 

Option B2 

Option B3 

Effectiveness in 
achieving 
objective B 
0 

++ 
-Significant 
clarification  

++/- 
-Clarifies application 
of the Directive to 
specific technologies 
-A general requirement 
for interoperability 
with accessories may 
be inapplicable  
-Improves legal 
certainty - all receivers 
under the R&TTED 
-Improves protection of 
spectrum - all 
intentional radiators 
under the R&TTE D 
+++ 
-Commission powers 
allow to react to future 
technology/ market/ 
legal issues  
-Improves legal 
certainty: all receivers 
and fixed terminals 
under the EMCD 
-Improves protection of 
spectrum: all 
intentional radiators 
under the R&TTE 

Side effects 

Cost and 
efficiency 

Coherence 

0 

0 

0 

+ 
-Improved 
compliance 
(objective A) 

++ 
Some reduction 
of administrative 
requirements 

++ 
-Improves 
coherence with 
other EU 
legislation  

+/- 
-More efficiency in 
the use of spectrum 
through regulatory 
requirements for 
receivers 
-A general 
requirement for 
interoperability 
with accessories 
may deter 
innovation 

-- 
-Additional cost 
due to general 
interoperability 
obligation 
-Some additional 
cost for broadcast 
receivers and 
non-
communicating 
intentional 
radiators  

- 

-Performance of 
receivers left to 
voluntary standards 
-Essential 
requirements in 
article 3.3 not 
applied to pure 
receivers, e.g. 
Galileo receivers 

+/- 
-Some additional 
cost non-
communicating 
intentional 
radiators  
-Some reduction 
of cost for 
receive-only 
equipment and 
fixed terminals 

++ 
-Improves 
coherence with 
other EU 
legislation on 
competition  

-Implementing 
powers facilitate 
consistent 
application of the 
Directive across the 
EU 

5.3. 

Options addressing objective C: to remove regulatory barriers to innovation in 
radio equipment 

Option C1 is expected to improve awareness of regulation among companies, to facilitate the 
role  of  notified  bodies  in  assessing  innovative  products,  and  to  achieve  some  reduction  of 
delays to accommodate novel products within the regulatory framework. 

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The central EU body in Option C2 would reduce time-to-market for innovative products, up 
to  1-2  years  in  some  cases.  Industry  is  reluctant  to  invest  on  the  basis  of  temporary 
authorisations. The central EU body would need to be staffed, 10 persons full-time is a lower 
estimate8. Its powers raise subsidiarity issues with regard to national competences in this area. 

This and other impacts are summarised in the table below: 

Table 3. Summary table comparing options addressing objective C 

Option C0 

Option C1 

Option C2 

Effectiveness in 
achieving 
objective C 
0 

+ 
-Incremental 
improvement of 
regulatory delays in 
access to the market 
+/++ 
-Improves 
credibility of 
opinions of 
‘special’ NBs 

-Important 
reduction of 
regulatory delays in 
access to the market 
-Temporary 
authorisation not 
attractive for 
investment 

Side effects 

Cost and 
efficiency 

Coherence 

0 

0 

0 

-- 
-Special category of 
NBs may distort 
competition among 
NBs 

-Difficulties in 
reversing temporary 
authorisations 

+ 
-Improves 
coherence of the 
current institutional 
arrangement 
-- 

-Double regime for 
authorisations 

-Raises subsidiarity 
issues 

+ 
-Incremental 
efficiency 
improvements 

-- 
Important costs: 
-Operation of new 
accreditation of a 
special category of 
NBs 
-Set up of a new 
competence centre 
-High expenses for 
withdrawal of 
previously 
authorised 
equipment  

6. 

COMPARISON OF OPTIONS. PREFERRED OPTION. 

Option  A1  should  increase  compliance  with  limited  increases  in  administrative  cost. 
Manufacturer registration as per Option A2 provides only limited value-added. Full product 
registration  as  per  Option  A3  is  a  powerful  additional  instrument  for  improving  the 
effectiveness  of  market  surveillance,  but  is  perceived  by  industry  as  a  significant  additional 
burden. Option A4 provides a flexible and proportional approach: to perform the alignment 
with  the  NLF,  and  to  introduce  product  registration  as  required  by  compliance  in  some 
specific product categories. Option A4 is therefore the preferred option addressing objective 
A. 

Option  B1  achieves  clarification,  simplification,  reduction  of  burden  and  improvement  of 
coherence.  Option  B2  further  clarifies  and  improves  the  legal  basis  in  dealing  with  some 
specific  technologies,  intentional  radiators  and  receivers.  Requirements  on  performance  of 
reception  bring  in  increase  efficiency  in  the  use  of  spectrum,  but  entail  additional  costs. 
Option  B3  allows  to  clarify  the  application  of  the  Directive  to  current  and  future  specific 
cases, sets clear criteria for its scope in relation to the EMCD, and reduces or avoids costs, 
leaving. Option B3 is therefore the preferred option addressing objective B. 

8 

For reference, ECO, the Secretariat of CEPT, employs a staff of 14 people including 7 experts 

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Option  C1  provides  incremental  improvements  in  time-to-market  and  efficiency  gains  for 
economic operators, regulators and other entities. Option C2 provides shorter time–to-market 
but involves non-negligible additional costs, as well as some institutional drawbacks. Option 
C1 is therefore the preferred option addressing objective C. 

Overall,  this  package  of  preferred  options  is  expected  to  increase  compliance,  to  bring 
increased legal  certainty, a smoother  and  more  consistent  application  of  the  Directive  and  a 
more  comprehensive  prevention  of  harmful  interference,  with  limited  additional  burden  for 
market operators. Beyond the synergies between Options A4 and B3 explained in chapter 7 no 
other  interaction  effects  are  expected  between  the  three  elements  of  the  preferred  option. 
Therefore, an additional in-depth assessment of the package is not considered necessary. 

At the end of the impact assessment, there was no indication that the selected options might 
result in a disproportionate burden for SME. Consequently, there is no element showing the 
need  for  SME  specific  measures  in  order  to  ensure  compliance  with  the  proportionality 
principle. 

7. 

MONITORING AND EVALUATION 

The  following  table  summarises  the  core  indicators  of  progress  towards  meeting  the 
objectives for the revision of the Directive: 

Table 4. Core indicators of progress 

Indicator 

Approach 

Compliance 

Compliance ratios 

Administrative 
simplification 
legal adaptations 

and 

Induced  administrative  cost 
and  burden,  number  of 
provisions  in  the  Directive 
perceived as unclear  

Periodic 
Member States 

reports 

from 

Regular 
stakeholders  

exchange  with 

Regulatory  barriers 
to innovation 

Perceived 
simplicity 
introducing innovations 

of 

Regular 
stakeholders 

exchange  with 

In  accordance  with  the  proposal,  Member  States  would  have  an  obligation  to  send  to  the 
Commission  biannual  reports  on  the  application  of  the  Directive,  providing  information  on 
levels of compliance with the Directive.  

The Commission plans to regularly review the operation of this Directive and report thereon 
to the European Parliament and to the Council every five years.  

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