REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE THE OPERATION OF DIRECTIVE 98/34/EC FROM 2011 TO 2013
Date: 2015-07-17
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EU law - national law, European Committee for Standardisation, access to information, application of EU law, free movement of goods, single market, standardisation, trade restriction

EUROPEAN 
COMMISSION 

Brussels, 17.7.2015  
COM(2015) 338 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

THE OPERATION OF DIRECTIVE 98/34/EC FROM 2011 TO 2013 

{SWD(2015) 137 final} 

EN 

   EN 

 
 
 
 
  
 
Table of Contents 
Executive summary ................................................................................................................................. 3 

PART I: STANDARDISATION ..................................................................................................................... 4 

1. 

Introduction..................................................................................................................................... 4 

2. 

Information procedure.................................................................................................................... 4 

2.1.  Operation of the procedure from 2011 to 2012 ...................................................................... 4 

2.2. 

Conclusion................................................................................................................................ 4 

3.  Mandates......................................................................................................................................... 5 

3.1.  Operation of the mandating process 2011-2012 .................................................................... 5 

3.2. 

Trends in mandates ................................................................................................................. 5 

3.3. 

Conclusion................................................................................................................................ 6 

4. 

Formal objections............................................................................................................................ 6 

4.1.  Operation of the procedure from 2011 to 2012 ...................................................................... 7 

4.2. 

Conclusion................................................................................................................................ 7 

5.  New Legislative Framework ............................................................................................................ 7 

PART II: TECHNICAL REGULATIONS ......................................................................................................... 8 

1.  Developments 2011-2013 ............................................................................................................... 8 

1.1.  Use of the procedure within the context of “Better regulation” ............................................. 8 

1.2.  Use of the procedure to improve competitiveness .................................................................. 9 

1.3. 

Improvements in managing the 98/34 procedure ................................................................ 10 

2.  Application of the 98/34 procedure.............................................................................................. 10 

2.1. 

Effectiveness: general overview ............................................................................................ 10 

2.2.  Use of the urgency procedure ............................................................................................... 14 

2.3.  Notification of ‘fiscal or financial incentive measures’.......................................................... 14 

2.4. 

Follow-up to Commission reactions....................................................................................... 14 

2.5. 

Follow-up to the notification procedure................................................................................ 15 

2.6. 

Dialogue with the Member States......................................................................................... 15 

2.7. 

Requests for access to documents issued under Directive 98/34.......................................... 16 

2.8. 

Conclusion.............................................................................................................................. 16 

2 

 
EXECUTIVE SUMMARY 

This report analyses the application of the procedures laid down by Directive 98/34/EC1 from 
2011 to 2013 as regards technical regulations and for 2011 and 2012 as regards standards (the 
standardisation part of Directive 98/34/EC was repealed as of 1 January 2013 by Regulation 
(EU) No 1025/2012 on European standardisation2, in order to better address future challenges 
in  European  standardisation).  It  highlights  the  important  contribution  of  the  notification 
procedure  to  the  functioning  of  the  single  market  and  to  the  implementation  of  the  Better 
Regulation policy3.  

The standardisation part consists of the information procedure on standards, the Commission 
requests  to  the  European  Standards  Organisations  (ESOs)4  for  standardisation  work 
(mandates), and formal objections against standards. Each of these activities has proved to be 
an important element in the functioning of the single market. The information procedure has 
brought  transparency  to  standards  at  national  and  thus  also  European  level  and  has 
encouraged  National  Standards  Bodies  (NSBs)  to  continue  to  take  initiatives  at  European 
level,  which  in  turn  promotes  European  harmonisation.  Formal  objections  have  enabled 
Member  States  and  the  Commission  to  ensure  that  standards  meet  the  goals  of  regulation 
when  used  for  the  purposes  of  ‘New  Approach’  legislation.  Mandates  have  provided  the 
means by which the relationship between the Commission services and standardisation bodies 
is determined; the interface between the policy level and its technical expression. 

In the field of technical regulations, the notification to the Commission of national technical 
regulations  prior  to  their  adoption  has  again  proved  to  be  an  effective  instrument  of 
prevention of barriers to trade and of cooperation between the Commission and the Member 
States  and  among  the  Member  States  themselves.  The  notification  procedure  has  been  an 
important  tool  for  guiding  national  regulatory  activity  in  certain  emerging  sectors  and 
improving the quality of national technical regulations - in terms of transparency, readability 
and effectiveness - in non-harmonised or partly harmonised areas. The greater clarity in the 
legal  framework  of  the  Member  States  has  helped  economic  operators  reduce  the  cost  of 
accessing the regulations and applying them correctly. 

1 

2  

3 

4 

Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998,  laying  down  a 
procedure  for  the  provision  of  information  in  the  field  of  technical  standards  and  regulations  and  of 
rules on Information Society services (OJ L 204 of 21.07.1998), as amended by Directive 98/48/EC (OJ 
L 217 of 05.08.1998). 
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European  standardisation,  amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives 
94/9/EC,  94/25/EC,  95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC,  2007/23/EC,  2009/23/EC  and 
2009/105/EC  of  the  European  Parliament  and  of  the  Council  and  repealing  Council  Decision 
87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council, OJ L 316, 
14.11.2012, p. 12–33. 
Action  plan  for  improving  the  regulatory  environment,  COM(2002)  278  final.  See  also  Better 
Regulation  for  Growth  and  Jobs  in  the  European  Union,  COM(2005)  97  final;  Implementing  the 
Community  Lisbon  programme:  A  strategy  for  the  simplification  of  the  regulatory  environment, 
COM(2005) 535 final; A strategic view of Better Regulation in the European Union, COM(2006) 689; 
Second strategic review of Better Regulation in the European Union, COM(2008) 32, Third strategic 
review  of  Better  Regulation  in  the  European  Union,  COM(2009)  15  and  Smart  Regulation  in  the 
European Union; COM(2010)543.  
CEN (European Committee for Standardisation), CENELEC (European Committee for Electrotechnical 
Standardisation) and ETSI (European Telecommunications Standards Institute). 

3 

 
 
 
                                                            
PART I: STANDARDISATION 

1. 

INTRODUCTION 

This  section  describes  the  operation  of  the  standardisation  part  of  Directive  98/34/EC 
covering three main activities: the information procedure on standards, Commission requests 
to  the  European  Standards  Organisations  for  standardisation  work  (mandates5),  and  formal 
objections  against  standards  supporting  New  Approach  Directives.  It  provides  and  explains 
statistics  for  the  period  2011-2012,  as  the  standardisation  part  of  Directive  98/34/EC  was 
repealed  as  of  1  January  2013  by  Regulation  (EU)  No  1025/2012  on  European 
standardisation. 

2. 

INFORMATION PROCEDURE 

The  information  procedure  in  the  field  of  standards  is  designed  to  monitor  the  new 
standardisation activities introduced by the NSBs (as recognised under Directive 98/34/EC). 
The notification system was set up mainly to allow other bodies to comment, participate in the 
work or request an initiative to be taken at European level (see Annex 1). 

1.1. 

Operation of the procedure from 2011 to 2012 

The  procedure  continued  to  operate  successfully  from  2011  to  2012.  From  the  reports 
provided  by  CEN  and  CENELEC  each year, it is possible to see that the annual average of 
national measures remained relatively stable in 2011 and 2012. Annex 2 gives a breakdown of 
notifications by Member State. 

Comparing the statistics of 2011-2012 with the previous periods, the number of notifications 
made by the EU27 countries continued to be stable with between 1750 and 2000 notifications 
per year (not considering the exceptional situation in 2010). 

The sectoral breakdown (Annex 3) shows that the  construction sector, in its broadest sense, 
continues  to  dominate  the  national  notifications  in  CEN.  Food  products  and  petroleum 
products  have  also  been  a  significant  area  in  CEN.  In  CENELEC,  electrical  accessories, 
electric cables, and electrical installations in buildings have been significant subsectors both 
in 2011 and 2012. 

The  information  disseminated  under  the  procedure  continued  to  give  rise  to  requests  for 
further  information  by  the  Commission  services,  as  well  as  queries  regarding  the  standstill 
(Article 7) arising either from notifications or other sources. 

Apart  from  the  rather  exceptional  situation  of  2010  the  number  of  notifications  has  been 
relatively stable, or even decreasing since 2006. This applies also to the Member States which 
joined the EU in 2004 and 2007 and could be interpreted as a sign of good integration in the 
system as the standardisation activity appears to be moving from the national to the European 
level. In general the procedure is well applied and works correctly.  

1.2. 

Conclusion 

information  procedure  still  plays  an 

The 
in  encouraging  national 
standardisation  bodies  to  bring  their  initiatives  to  the  European  level,  thus  encouraging  the 

important  role 

5 

Mandates are requests representing an invitation to ESOs that may be accepted under certain conditions. 

4 

 
 
 
                                                            
single  market  and  European  harmonisation.  Notifications  from  EU  12  Member  States  are 
stable which can be considered as a good sign of their integration in the system.  

As  of  1  January  2013,  the  standardisation  part  of  Directive  98/34/EC  was  repealed  by 
Regulation (EU) No 1025/2012 on European standardisation in order to better address future 
challenges  in  European  standardisation.  This  relates  in  particular  to  the  increased 
development of standards for services, the evolution of standardisation deliverables other than 
formal  standards,  and  increased  requirements  on  the  inclusiveness  of  the  European 
standardisation  system.  Regulation  (EU)  No  1025/2012  however  maintains  a  similar 
information procedure operated under Directive 98/34/EC, even though with minor changes. 

3. 

MANDATES 

Standardisation  “mandates”  are  a  well-established  Commission  tool  to  obtain  technical 
specifications that support European legislation and/or policy. They are requests to the ESOs 
for  standardisation  work  and  provide  a  reference  framework  for  that  work  (see  Annex  1). 
They  are  indispensable  in  cases  where  standards  support  legislation,  for  example  in  the 
context of the 'New Approach' Directives. 

1.3. 

Operation of the mandating process 2011-2012 

In the reporting period, a total of 43 mandates were issued to the ESOs, with 8 amendment 
mandates.  The  ratio  of  amendments  is  relatively  higher  compared  to  that  of  previous  years 
(see Annex 4). Also the number of mandates concerning New Approach Directives (13, plus 
the 8 amendments) has increased compared to the previous period.  

The  mandating  process  functions  well.  The  informal  consultation  carried  out  before  the 
documents  are  circulated  to  the  members  of  the  Committee  on  Standards  and  Technical 
Regulations  means  that  a  mandate  normally  has  consensual  agreement  before  the  formal 
consultation starts. 

The  European  standardisation  stakeholders  –  ANEC  (European  association  for  the  co-
ordination  of  consumer  representation  in  standardisation),  ECOS  (European  Environmental 
Citizens Organisation for Standardisation), NORMAPME (European Office of Crafts, Trades 
and  Small  and  Medium-sized  Enterprises  for  Standardisation)  and  ETUI-REHS  (European 
Trade Union Institute – Research, Education, Health and Safety) were well-integrated into the 
process  during  the  reporting  period.  This  brings  greater  transparency  to  the  informal 
consultation. 

In order to increase transparency further, DG Internal Market, Industry, Entrepreneurship and 
SMEs maintains a database of mandates. It contains all mandates issued in the past with the 
numbering series M/xxx. This database is publicly accessible on the internet at: 

http://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.welcome 

The  practice  of  giving  a  follow-up  to  all  the  mandate  consultations  to  the  Committee  on 
Standards  and  Technical  Regulations  by  means  of  an  updated  list  has  continued  throughout 
the period. 

1.4. 

Trends in mandates 

In the reporting period, mandates were issued in support of a broad spectrum of legislation. 
The most significant areas include legislation on construction products, ecodesign, consumer 
protection,  and  environmental  protection.  The  breadth  of  legislative  areas  shows  the 
importance conferred on the model. 

5 

 
The subject matter for mandates continues to broaden. At the same time, mandates issued for 
the New Approach Directives are still very important, and their number has actually increased 
compared  to  the  previous  reporting  periods.  Mandates  in  other  policy  areas  continue  to  be 
numerous, in particular consumer protection and the environment. 

The number of mandates supporting legislation outside the New Approach (see Annex 4) has 
remained  relatively  high  compared  with  the  last  period  and  shows  that  this  co-regulatory 
model  continues  to  be  adopted  across  a  broad  range  of  EU  policies.  Mandates  supporting 
Directive 2009/125/EC (the Ecodesign Directive) have been a major contributor in this field. 

Six  mandates6  were  issued  during  the  period  2011–2012  in  support  of  the  Ecodesign 
Directive. These  mandates are aimed at products such as household dishwashers,  lamps, air 
conditioners, pumps or fans.  

This trend for the use of mandates in support of legislation outside the New Approach and in 
new areas reflects the situation that European standardisation is increasingly used in support 
of  the  better  regulation  policy.  This  has  been  recognised  in,  and  indeed  encouraged  by,  the 
Commission  Communication  of  2011  'A  strategic  vision  for  European  standards:  Moving 
forward to enhance and accelerate the sustainable growth of the European economy by 2020'7. 

The number of mandates supporting European policy continued to drop and is for the second 
consecutive  time  slightly  inferior  compared  to  the  previous  reporting  period.  Nevertheless, 
amongst the five policy mandates are some key initiatives to promote interoperability such as 
the mandate on smart grids or the mandate on the space industry. 

No mandate for standardisation in the service sector was issued during this period.  

1.5. 

Conclusion 

The process of mandating is well-established and is today governed by Regulation (EU) No 
1025/2012.  The  informal  consultation  of  the  ESOs  and  all  interested  parties  (in  particular 
those  European  stakeholders  representing  the  users  of  future  standards)  prior  to  the 
consultation of the Committee on Standards and Technical Regulations is essential. 

To  improve  transparency  in  the  functioning  of  the  Committee  on  Standards  and  Technical 
Regulations,  the  Commission  services  continued  in  the  reporting  period  in  the  practice 
introduced in 2006 to invite the European standardisation stakeholders ANEC, ECOS, ETUI-
REHS and NORMAPME, to participate in its enlarged meeting. 

The  process  of  mandating  has  proved  to  be  instrumental  in  enlarging  the  role  of 
standardisation in new areas of EU legislation and policy.  

4. 

FORMAL OBJECTIONS 

The  New  Approach  directives  contain  safeguards  for  cases  where  a  harmonised  standard 
cannot enable products to meet the essential requirements of the directives concerned. When 
such cases occur, the Member States or the Commission may introduce a formal objection to 
the standard in question on which the Committee on Standards and Technical Regulations is 
consulted (see Annex 1 for the details of the procedure). 

6 
7 

Mandates M481, M485, M488, M495, M498 and M500 make reference to the Directive 2005/32/EC 
COM(2011) 311 final of 01.06.2011. 

6 

 
 
                                                            
1.6. 

Operation of the procedure from 2011 to 2012 

Compared  to  previous  years,  the  number  of  objections  that  have  given  rise  to  Commission 
Decisions has slightly decreased during the reporting period. Only one Decision was adopted 
by the Commission which restricted the presumption of conformity. This Decision however 
concerned two formal objections against an identical harmonised standard (see Annex 5).  

1.7. 

Conclusion 

The procedure in general has worked adequately. Compared to the previous reporting period, 
the process from receiving the objection to issuing the Decision was shortened significantly in 
2011 and 2012. 

In  a  similar  way  to  the  mandates,  and  for  the  sake  of  transparency,  the  Commission  makes 
decisions on formal objections public in a consolidated way, and makes an updated table of 
the actions in relation to the formal objections available to the Committee on Standards and 
Technical Regulations at each meeting. 

5. 

NEW LEGISLATIVE FRAMEWORK 

As  of  1  January  2013,  the  standardisation  part  of  Directive  98/34/EC  was  repealed  by 
Regulation  (EU)  No  1025/2012  on  European  standardisation  which  introduced  significant 
changes  with  respect  to  the  information  procedure,  mandating  procedure  and  formal 
objections.  

A specific report on the implementation of the Regulation (EU) No 1025/2012 for the period 
from  2013  to  2015  will  be  presented  to  the  European  Parliament  and  to  the  Council  in 
accordance with Article 24(3) of the Regulation.  

7 

 
PART II: TECHNICAL REGULATIONS 

1. 

DEVELOPMENTS 2011-2013 

The  notification  procedure  for  national  technical  regulations  (the  procedure)  allows  the 
Commission  and  the  Member  States  of  the  EU  to  examine  preventively  the  technical 
regulations  Member  States  intend  to  introduce  for  products  (industrial,  agricultural  and 
fishery) and for Information Society services (see Annex 6). It applies in a simplified manner 
to the European Free Trade Association (EFTA) Member States which are signatories to the 
Agreement  on  the  European  Economic  Area  (EEA)  and  to  Switzerland  and  Turkey  (see 
Annex 9). 

The major benefits of the procedure 

•  It allows new barriers to the internal market to be detected before they have any negative 

effects, thus avoiding long and costly infringement proceedings.  

•  It  allows  the  detection  of  protectionist  measures  which  might  be  drawn  up  by  Member 

States under exceptional circumstances, such as an economic and financial crisis. 

•  It  allows  Member  States  to  ascertain  the  degree  of  compatibility  of  notified  drafts  with 

European Union legislation.  

•  It  allows  an  effective  dialogue  between  Members  States  and  the  Commission  when 

assessing notified drafts.  

•  It is a benchmarking tool allowing Member States to draw on the ideas of their partners in 

order to solve common problems regarding technical regulations.  

•  It  allows  economic  operators,  including  small  and  medium-sized  enterprises  (SMEs),  to 
make  their  voices  heard  and  to  adapt  their  activities  in  good  time  to  future  technical 
regulations. This right of scrutiny is used extensively by economic operators, helping the 
Commission and national authorities to detect any barriers to trade. 

•  It contributes to the application of the subsidiarity principle. 

•  It  is  a  regulatory  instrument  which  can  be  used  to  identify  areas  where  harmonisation  is 

necessary. 

•  It  helps  to  improve  the  quality  of  national  and  EU  regulations  in  line  with  the  "Better 

regulation" approach. 

•  It  contributes  to  improving  competitiveness  of  enterprises  in  the  context  of  industrial 

policy.  

Use of the procedure within the context of “Better regulation”  

1.8. 
In its Communication "Better regulation for growth and jobs in the EU"8 the Commission has 
highlighted  that  the  preventive  control  mechanism  established  by  Directive  98/34/EC  is 
crucial for improving national regulations on products and Information Society services. 

In  the  framework  of  the  Commission’s  action  plan  to  simplify  and  improve  the  regulatory 
environment9,  Member  States  have  been  invited  to  submit  impact  studies  (or  their 

8 
9 

See supra, footnote 3. 
See supra, footnote 3. 

8 

 
 
 
                                                            
conclusions) together with notified drafts, where such studies have been carried out internally. 
The analysis of these impact studies encourages the Member States to reflect in advance on 
the most appropriate instrument to be used, and allows the Commission to check the necessity 
and proportionality of the measures proposed.  

The  cooperation  between  the  Commission  and  the  Member  States  within  the  context  of  the 
98/34/EC notification procedure helps to improve the clarity and consistency of the notified 
draft national legislations. This cooperation will be intensified with a view to ensuring a clear 
and legible regulatory framework for economic operators while guaranteeing a high level of 
protection for public health, consumers and the environment. 

The national authorities are encouraged to consider the following aspects in particular: 

•  the  wording  of  drafts:  clarity,  consistency,  transparency  and  legal  certainty  in  the 

application of the texts; 

•  the possibility of accessing all regulations in a given sector through the publication both on 

paper and on-line of consolidated versions of the texts; 

•  the  identification  and  avoidance  of  procedures  imposing  unnecessarily  complex  and 
onerous  administrative  burdens  on  economic  operators,  particularly  when  placing  a 
product on the market. 

1.9. 

Use of the procedure to improve competitiveness 

In the framework of the EU 2020 strategy, a new approach of the industrial policy based on 
competitiveness analysis of legislation has been proposed. 

In this context, in the latest update of the Communication on Industrial Policy of 10 October 
2012 - Communication of the Commission to the European Parliament, to the Council, to 
the  European  Social  and  Economic  Committee  and  to  the  Committee  of  the  Regions  -  A 
stronger  European  industry  at  the  service  of  economic  growth  and  re-launch  -  COM 
(2012)582 final – the Commission underlined that: 

“Governance  and  regulatory  obstacles  to  the  Internal  Market  also  arise  from  policy  areas 
that  are  regulated  by  Member  States,  for  example  technical  rules,  refusals  to  apply  mutual 
recognition  and  mismatches  between  the  27  different  sets  of  taxation  rules.  An  upstream 
analysis  of  draft  technical  rules  can  prevent  the  emergence  of  regulatory  obstacles.  This  is 
precisely  the  objective  of  the  98/34  notification  procedure,  which  requires  draft  legislation 
containing technical rules on products and information society services to be communicated 
to  the  Commission  before  they  are  adopted.  The  preventive  nature  of  this  procedure  has 
avoided a large number of contraventions of free movement of goods rules. This notification 
procedure  can  also  be  used,  however,  to  improve  national  legislation  in  line  with  "Better 
Regulation"  principles  and  through  benchmarking.  Its  potential  can  be  further  exploited  by 
recommending  that  Member  States  use  competitiveness  proofing  in  the  context  of  national 
impact assessments.”. 

The  Communication  of  the  Commission  on  industrial  policy  makes  an  explicit  reference  to 
Directive  98/34/EC  which,  beside  to  its  role  as  an  instrument  for  prevention  of  obstacles to 
intra-EU  trade  has  the  task  to  encourage  Member  States  to  proceed  to  a  competitiveness 
analysis of national legislation. 

This  approach  was  endorsed  by  the  Committee  on  Industry,  Research  and  Energy  of  the 
European  Parliament  in  its  Report  of  18  December  2013  on  reindustrialising  Europe  to 
promote  competitiveness  and  sustainability  ((2013/2006(INI))  where  it  encouraged  further 
exploitation  of  the  potential  of  the  98/34  notification  procedure  and  suggested  that  the 
9 

 
Member  States  introduce  competitiveness  proofing  in  impact  assessments  conducted  at  the 
drafting stages of national legislative processes, in the wider framework of the ‘Single Market 
Test’ called for in Parliament’s resolution of 7 February 2013 with recommendations to the 
Commission on the governance of the Single Market. 

In this context, Member States, as of March 2014, have been invited to prepare on a regular 
basis  a  competitiveness  analysis  of  the  national  legislation  notified  under  the  scope  of  the 
procedure established by Directive 98/34/EC. 

1.10. 

Improvements in managing the 98/34 procedure 

The  Commission  continued  conducting  various  campaigns  during  2011-2013  to  increase 
transparency  and  dialogue  with  the  national  authorities.  The  TRIS  (Technical  Regulations 
Information System) database has seen continuous improvement. 

the 

revamping  of 

The  Commission  worked  on 
the  TRIS  public  website, 
(http://ec.europa.eu/growth/tools-databases/tris/en/), to explain the 98/34 procedure in a more 
accessible way and to reach a wider audience, especially SMEs. The website ensures public 
access  to  the  notified  drafts,  in  the  23  official  languages  of  the  EU,  and  to  essential 
information  regarding  the  procedure.  A  constant  increase  in  the  number  of  on-line 
consultations has been observed: from 2011 to 2013 the number of searches rose by 10% to 
reach  approximately  212,000  searches  in  2013  (see  Annex  10).  More  than  4300  economic 
operators subscribed to the TRIS mailing list, which is a rise of 25% since 2010. 

In 2012-2013, the Commission also produced a video on the 98/34 procedure. The message 
was to explain in a simple and attractive way the functioning of the procedure and its benefits 
for enterprises, to encourage active participation by enterprises, especially SMEs, and explain 
how  they  can  make  best  use  of  the  existing  tools  (websites,  databases,  alert  systems).  This 
video  was  published  on  11  September  2013  and  is  accessible  using  the  following  link  - 
http://www.youtube.com/watch?v=ziuAklsNKdI.  It  has  been  promoted  on  social  networks 
and was viewed 2675 times by stakeholders since its publication. 

2. 

APPLICATION OF THE 98/34 PROCEDURE 

1.11.  Effectiveness: general overview  

► Volume of notifications and sectors involved 

From 2011 to 2013, the Commission received 2114 notifications (675 in 2011, 734 in 2012 
and 705 in 2013). 

Like in the previous reporting period, the construction sector saw the highest number of 
notifications  over  the  reporting  period.  Many  measures  related  to  energy  efficiency  of 
buildings  and  concrete  structures,  road  pavements  and  constituent  materials,  fire  safety  of 
buildings.  Construction  was  again  followed  by  agricultural  products,  foodstuffs  and 
beverages.  In  this  sector,  several  measures  concerned  food  hygiene,  the  composition  and 
labelling  of  foodstuffs  and  beverages,  food  packaging,  minimum  price  for  alcoholic 
beverages,  composition  and  marketing  of  alcoholic  and  non-alcoholic  beverages. 
Notifications 
(radio  equipment  and 
telecommunications  terminal  equipment,  radio  interfaces,  hardware  and  software  for  the 
collection, management and use of data gathered by electronic mechanisms installed on board 
vehicles  (black  box))  and  in  the  environment  sector  (packaging  and  packaging  waste, 
recyclable products, processing of biodegradable waste) (see Annex 8.3). 

telecommunications  sector 

increased 

the 

in 

10 

 
 
► Issues examined 

In the non-harmonised areas, subject to compliance with Articles 34-36 (free movement of 
goods) and 49 and 56 (right of establishment and freedom to provide services) of the Treaty 
on  the  Functioning  of  the  European  Union  (TFEU),  the  Commission’s  reactions  were 
intended  to  draw  Member  States’  attention  to  potential  obstacles  to  trade  which  could  be 
created  by  an  unnecessary  measure  disproportionate  to  the  objective  pursued.  Thus  the 
Commission  ensured  compliance  with  these  principles  and  in  addition  continued  to  invite 
Member States to insert mutual recognition clauses into each draft technical regulation falling 
outside the harmonised area.  

In the harmonised areas, the reactions were intended to ensure that national measures were 
necessary, justified and compatible with EU secondary legislation. 

• 

  In 2011, 2012 and 2013 Member States notified 512 draft technical regulations in the 
field of construction. These drafts concerned all types of construction products, inter 
alia,  bridge  structures  and  concrete  road  structures,  pitched  roof  coverings  for 
buildings,  fire-fighting  and  rescue  equipment,  thermal  insulation,  synthetic  fill 
materials,  concrete  structures,  electrical  installations  on  and  in  concrete  structures, 
metallic materials in contact with drinking water.  

In particular, the Commission examined draft technical regulations setting additional 
technical  requirements  or  tests  for  construction  products  impeding  the  free 
movement of products labelled with the CE mark. The notified drafts were examined 
principally  under  Directive  89/106/EEC  on  construction  products10  and  Regulation 
(EU)  No  305/2011  laying  down  harmonised  conditions  for  the  marketing  of 
construction products and repealing Council Directive 89/106/EEC11.  

The Commission also examined draft legislation prohibiting the installation of fossil 
oil  furnaces  and  natural  gas  furnaces  in  new  buildings  except  when  oil  and  gas 
furnaces  use  only  renewable  energy.  The  notified  draft  was  examined  under 
Directive  2009/142/EC  on  gas  appliances  (GAD)12  and  Directive  92/42/EEC  on 
efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels13. 

Technical regulations relating to energy efficiency of buildings were assessed under 
Directive  2012/27/EU  on  energy  efficiency14,  Directive  2010/31/EU  on  the  energy 

10  

11  

12  

13  

14  

Council  Directive  89/106/EEC  of  21  December  1988  on  the  approximation  of  laws,  regulations  and 
administrative provisions of the Member States relating to construction products, OJ L 40, 11.2.1989, p. 
12–26. 
Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying 
down  harmonised  conditions  for  the  marketing  of  construction  products  and  repealing  Council 
Directive 89/106/EEC, OJ L 88, 4.4.2011, p. 5–43. 
Directive 2009/142/EC of the European Parliament and of the Council of 30 November 2009 relating to 
appliances burning gaseous fuels, OJ L 330, 16.12.2009, p. 10–27. 
Council  Directive  92/42/EEC  of  21  May  1992  on  efficiency  requirements  for  new  hot-water  boilers 
fired with liquid or gaseous fuels, OJ L 167, 22.6.1992, p. 17–28. 
Directive  2012/27/EU  of  the  European  Parliament  and  of  the  Council  of  25  October  2012  on  energy 
efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 
2006/32/EC, OJ L 315, 14.11.2012, p. 1–56. 

11 

 
 
                                                            
performance of buildings15 and Directive 2009/125/EC establishing a framework for 
the setting of ecodesign requirements for energy-related products16. 

• 

In the foodstuffs and agricultural sectors, from 2011 to 2013 Member States notified 
393 draft technical regulations. These drafts concerned, inter alia, materials coming 
into  contact  with  foodstuff,  energy  drinks,  trans  fats  in  food  products,  wine  and 
spirits, labelling of foodstuff, in particular nutritional declarations, quality marks, the 
well-being of fur animals and the marketing of fur products. 

Certain  Member  States  notified  draft  regulations  imposing  restrictions  on  or 
prohibition of food packaging containing bisphenol A and in particular packaging for 
foods  intended  for  children  between  0  and  3  years,  as  well  as  concerning  health 
warning to be affixed to packaging containing bisphenol A. These notifications have 
been  examined  under  the  Treaty  provisions  on  the  free  movement  of  goods  and 
Regulation  (EC)  No  1935/2004  concerning  materials  and  articles  intended  to  come 
into contact with food.17  

During the relevant period the Commission examined many notifications concerning 
the hygiene of foodstuffs and issued detailed opinions and comments on the basis of 
Regulations  (EC)  No  852/2004  on  the  hygiene  of  foodstuffs18,  (EC)  No  853/2004 
laying down specific hygiene rules for food of animal origin19 and (EC) No 854/2004 
laying  down  specific  rules  for  the  organisation  of  official  controls  on  products  of 
animal origin intended for human consumption20. 

Other notifications concerned the labelling of foodstuff and the Commission assessed 
their  compatibility  with  Directive  2000/13/EC  on  the  approximation  of  the  laws  of 
the  Member  States  relating  to  the  labelling,  presentation  and  advertising  of 
foodstuffs21 and Regulation (EU) No 1169/2011 on the provision of food information 
to consumers.22 

• 

  In  the  Information  Society  services  sector  there  were  99  notifications.  Numerous 
notifications  were  in  the  area  of  gambling,  while  others  concerned,  inter  alia, 

15  

16  

17  

18  

19  

20  

21  

22  

Directive 2010/31/EU  of  the European Parliament  and of  the  Council  of 19  May 2010 on  the  energy 
performance of buildings, OJ L 153, 18.6.2010, p. 13–35. 
Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing 
a  framework  for  the  setting  of  ecodesign  requirements  for  energy-related  products,  OJ  L  285, 
31.10.2009, p. 10–35. 
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC, OJ L 338, 13.11.2004, p. 4–17. 
Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the 
hygiene of foodstuffs, OJ L 139, 30.4.2004, p. 1–54. 
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying 
down specific hygiene rules for food of animal origin, OJ L 139, 30.4.2004, p. 55–205. 
Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying 
down specific rules for the organisation of official controls on products of animal origin intended for 
human consumption, OJ L 139, 30.4.2004, p. 206–320. 
Directive  2000/13/EC  of  the  European  Parliament  and  of  the  Council  of  20  March  2000  on  the 
approximation of the laws of the Member States relating to the labelling, presentation and advertising of 
foodstuffs, OJ L 109, 6.5.2000, p. 29–42. 
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 
the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) 
No  1925/2006  of  the  European  Parliament  and  of  the  Council,  and  repealing  Commission  Directive 
87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC 
of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC) No 608/2004, OJ L 304, 22.11.2011, p. 18–63. 

12 

 
 
 
 
                                                            
copyright  in  the  digital  environment,  on  demand  audio-visual  media  services, 
electronic commerce, electronic signature and other trust services. 

• 

• 

• 

  Since 2011, Member States have notified a series of technical regulations concerning 
measuring  instruments.  These  drafts  concerned  various  types  of  measuring  devices 
such  as  gas,  electricity  and  heat  meters,  taximeters  or  prism  refractometers  and 
provided  for  specific  requirements  which  these  instruments  have  to  fulfil.  The 
notifications on gas, electricity and heat meters and taximeters were mainly analysed 
under  Directive  2004/22/EC  on  measuring  instruments23.  The  novelty  consisted  of 
projects  of  new  smart  metering  systems,  also  falling  under  Directive  2004/22/EC, 
which are quite complex due to the needs of the combination of engineering with IT 
and communication, data privacy and security aspects. 

  In  the  chemicals  sector  the  Commission  received  76  notifications.  Some  of  them 
regarded the annual declaration of nanoparticle substances as well as draft legislation 
banning  the  import  and  sale  of  products  containing  certain  phthalates  intended  for 
indoor  use  or  which  may  come  into  contact  with  skin  or  mucous  membranes.  The 
notified  drafts  were  mainly  examined  under  Regulation  (EC)  No  1907/2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH)24.  

  In  the  environment  sector  the  Commission  examined  141  draft  regulations.  Some 
notified drafts established conditions for the use of environmental claims on plastic 
objects  and  packaging  while  others  prohibited  the  marketing  of  non-biodegradable 
shopping  bags.  These  notifications  have  been  mainly  analysed  in  the  light  of 
Directive 94/62/EC on packaging and packaging waste25. 

The  98/34  procedure  has  also  allowed  the  Commission  to  intervene  in  sectors  where 
harmonisation was envisaged or under way at European Union level and thus has prevented 
Member  States  from  introducing  divergent  national  measures.  Pursuant  to  Articles  9(3)  and 
9(4)  of  Directive  98/34/EC,  the  Commission  has  blocked  the  adoption  of  notified  draft 
legislation  for  twelve  months  from  the  date  of  notification  in  the  fields  of:  type-approval 
requirements  for  masses  and  dimensions  of  motor  vehicles  and  their  trailers;  marketing  and 
use  of  explosives  precursors;  the  indication  of  the  origin  of  olive  oil  on  the  label  and  the 
methods for such indication; compounds terms for spirit drinks; electronic identification and 
trust  services  for  electronic  transactions;  fertilisers  allowed  in  organic  production.  Through 
this  type  of  intervention,  not  only  has  the  Commission  avoided  the  fragmentation  of  the 
market  in  areas  where  harmonisation  was  envisaged  or  under  way,  but  it  has  also  granted 
greater certainty and stability in the legal framework of Member States and of the European 
Union  to  the  benefit  of  economic  operators  and  of  the  competitiveness  of  European 
enterprises. 

► Reactions 

23  

24  

25  

Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring 
instruments, OJ L 135, 30.4.2004, p. 1–80. 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, OJ L 396, 30.12.2006, p. 1–849. 
European  Parliament  and  Council  Directive  94/62/EC  of  20  December  1994  on  packaging  and 
packaging waste, OJ L 365, 31.12.1994, p. 10–23. 
13 

 
                                                            
The  Commission  issued  detailed  opinions  in  relation  to  208  notifications,  which  represents 
9.8% of the total number of drafts notified by the Member States over the reporting period. 
This  figure  shows  a  29.2%  increase  in  the  number  of  detailed  opinions  issued  by  the 
Commission compared to the previous three years. For their part, the Member States issued 
205  detailed  opinions.  Of  the  910  comments  issued  during  the  reporting  period,  425  were 
made by the Commission and 485 by the Member States (see Annexes 8.4 and 8.6). 

In 12 cases, the Commission invited the Member States concerned to postpone the adoption of 
the notified regulations for one year from the date of their receipt because there was European 
Union harmonisation work under way in the area (see Annex 8.5). 

1.12.  Use of the urgency procedure 

Out of a total of 2114 notifications, the Member States made 87 requests to apply the urgency 
procedure  to  notified  drafts.  The  Commission  confirmed  its  strict  interpretation  of  the 
exceptional  conditions  required  by  Directive  98/34/EC,  namely  serious  and  unforeseeable 
circumstances relating in particular to the protection of health and safety. As a result, use of 
the urgency procedure was refused where the justification was not sufficiently established or 
was  based  on  purely  economic  grounds  or  national  administrative  delay  as  well  as  in  cases 
where  no  unforeseeable  circumstances  were  demonstrated.  The  urgency  procedure  was 
deemed  justified  in  56  cases,  in  particular  concerning  psychotropic  substances,  control  of 
narcotics,  radioactive  waste,  infection  of  bees,  poisonings  caused  by  methanol  intoxication, 
explosive precursors, protection of cash transports, prohibition of products that are harmful to 
health, prohibition of the possession and use of fireworks not intended for private individuals. 
(see Annex 8.7). 

1.13.  Notification of ‘fiscal or financial incentive measures’ 

According  to  Directive  98/34,  Member  States  have  to  notify  fiscal  and  financial  incentives, 
i.e.  technical  regulations  which  are  linked  to  fiscal  or  financial  measures  affecting  the 
consumption  of  products  or  services  by  encouraging  compliance  with  such  technical 
regulations. The specificity of such technical regulations is that the standstill period does not 
apply. 

During  the  period  2011-2013  Member  States  notified  112  draft  regulations  as  ‘fiscal  or 
financial measures’. The Commission observes that often national legislation is misclassified 
as  ‘fiscal  or  financial  measure’ in  the  meaning  of  Directive  98/34/EC  when  it  contains  any 
fiscal or financial measures but not the incentive to comply with such technical regulations. In 
order to help Member States to correctly classify these technical regulations the Commission 
drafted Guidelines on the definition and notification of 'fiscal or financial measures' for the 
purposes of Directive 98/34/EC. 

1.14. 

 Follow-up to Commission reactions 

From 2011 to 2013, the ratio between the number of responses given by Member States and 
the  volume  of  detailed  opinions  issued  by  the  Commission  was  satisfactory  (an  average  of 
86%  over  the  period).  This  percentage  is  the  main  indicator  used  to  assess  Member  States’ 
commitment  to  meeting  their  obligations  under  the  procedure.  The  number  of  completely 
satisfactory  responses  was  higher  in  comparison  with  the  previous  reporting  period  (an 
average of 48.4% over the period 2011-2013 in comparison with 32.5% over the period 2009-
2010) (see Annex 8.8), showing an increased compliance of Members States with the internal 
market  legal  framework  following  the  Commission's  reaction.  The  effect  of  Commission's 
reactions was even more remarkable in the case of notified draft technical regulations which 
were  withdrawn  following  the  delivery  of  a  detailed  opinion  (24  cases  for  the  reporting 
period). For other notified draft technical regulations the dialogue is still on-going. 

14 

 
1.15.  Follow-up to the notification procedure  

For all other cases where the potential breaches of the EU internal market law have not been 
entirely cleared within the framework of the 98/34/EC procedure, the Commission conducted 
further  investigations  which  in  some  cases,  eventually  led,  to  EU  Pilots  or  to  infringement 
proceedings  (Article  258  of  the  TFEU)  on  subjects  such  as  quality  and  transparency  of  the 
supply  chain  for  virgin  olive  oils,  taxation  of  food  products  with  high  sugar,  salt,  and/or 
caffeine content, environmental protection product charges, traditional food production, wine 
and  spirits,  banning  of  products  intended  for  indoor  use  which  contain  certain  types  of 
phthalates, products made of leather, hide and fur, minimum content of fruit juice that must be 
contained in non-alcoholic fruit-based beverages and plastic bags.  

Two  of  the  infringement  proceedings  brought  against  Member  States  during  the  reporting 
period were grounded on the breach of obligations under Directive 98/34/EC.  

1.16.  Dialogue with the Member States  

The  regular  meetings  of  the  Committee  on  Standards  and  Technical  Regulations  allowed 
views  to  be  exchanged  on  points  of  general  interest  and  also  on  specific  aspects  of  the 
procedure.  

As  regards  technical  regulations,  the  discussions  particularly  concerned  the  role  of 
notifications  for  national  competitiveness  issues  and  competitiveness  proofing;  access  to 
documents of the Commission under Regulation (EC) No 1049/2001 regarding public access 
to  European  Parliament,  Council  and  Commission  documents26;  the  obligation  for  Member 
States to communicate to the Commission the final text of a notified technical regulation; and 
the  legal  consequences  of  the  delivery  of  a  detailed  opinion  under  Article  9(2)  of  Directive 
98/34/EC. 

The  Commission  made  presentations  concerning  Regulation  (EU)  No  1169/2011  on  the 
provision  of  food  information  to  consumers;  the  review  of  Regulation  (EC)  No  1907/2006 
(REACH);  the  Product  Safety  and  Market  Surveillance  Package;  the  evaluation  report  of 
Directive  2006/123/EC  on  services  in  the  internal  market27;  the  state  of  play  of  the  internal 
market  in  the  construction  sector;  issues  related  to  technical  regulations  in  the  area  of 
renewable  energy  sources;  notifications  about  metrology  and  notifications  in  the  railway 
sector,  in  particular  notification  obligations    in  the  framework  of  Directive  2004/49/EC  on 
safety on the Community's railways28  and Directive 2008/57/EC on the interoperability of the 
rail system within the Community29.  

Guidelines on the definition and notification of 'fiscal or financial measures' for the purposes 
of  Directive  98/34/EC,  and  guidelines  on  the  “One-stop-shop  for  the  98/34  notification 
procedure and for the notification procedures laid down in specific EU rules” were presented 
by the Commission.  

26  

27  

28  

29  

Regulation  (EC)  No  1049/2001  of  the  European  Parliament  and  of  the  Council  of  30  May  2001 
regarding  public  access  to  European  Parliament,  Council  and  Commission  documents,  OJ  L  145, 
31.5.2001, p. 43-48. 
Directive  2006/123/EC  of  the  European  Parliament  and  of  the  Council  of  12  December  2006  on 
services in the internal market, OJ L 376, 27.12.2006, p. 36–68. 
Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the 
Community's  railways  and  amending  Council  Directive  95/18/EC  on  the  licensing  of  railway 
undertakings  and  Directive  2001/14/EC  on  the  allocation  of  railway  infrastructure  capacity  and  the 
levying of charges for the use of railway infrastructure and safety certification, OJ L 164, 30.4.2004, p. 
44–113. 
Directive  2008/57/EC  of  the  European  Parliament  and  of  the  Council  of  17  June  2008  on  the 
interoperability of the rail system within the Community, OJ L 191, 18.7.2008, p. 1–45. 

15 

 
                                                            
Seminars  were  also  held  in  several  Member  States,  allowing  direct  dialogue  between  the 
Commission  and  the  national  authorities  involved  in  the  procedure  and  helping  the  latter  to 
become familiar with the highly technical elements of the procedure.  

1.17.  Requests for access to documents issued under Directive 98/34 

From 2011 to 2013 the Commission received 272 requests for access to documents issued in 
the  framework  of  the  98/34  procedure.  The  major  part  of  them  concerned  detailed  opinions 
and  comments  delivered  by  the  Commission.  In  167  of  the  cases,  access  to  the  requested 
documents was given. In the other cases, access to documents was refused while the dialogue 
with the Member States, aimed at removing the potential obstacle to trade, was ongoing. 

1.18.  Conclusion 

During  the  period  2011-2013,  the  usefulness  of  the  procedure  has  again  been  confirmed  in 
terms of effectiveness, transparency and administrative cooperation.  

The preventive and networking approach of the 98/34 procedure has substantially reduced the 
risk  of  national  regulatory  activities  being  carried  out  in  a  way  that  would  create  technical 
barriers  to  the  free  movement  of  goods  within  the  internal  market.  The  high  number  of 
detailed opinions and comments issued during the reporting period demonstrates that there is 
still a risk of fragmentation of the internal market for goods. On average 86% of the detailed 
opinions issued by the Commission during the period were replied to by the Member States 
concerned and dialogues followed to remove any incompatibility with EU law and ensure the 
free movement of goods within the internal market, thus avoiding infringement procedures.   

The 98/34 procedure has also confirmed its usefulness in providing the possibility to identify 
areas where harmonisation at EU level might be an option. 

When applying Directive 98/34/EC the Commission remains vigilant regarding the principle 
of better regulation and the need to sustain a favourable environment for the competitiveness 
of  the  European  economy.  Notified  drafts  continue  to  be  available  electronically,  free  of 
charge  and  in  all  the  official  languages  of  the  EU,  thus  providing  the  opportunity  for 
economic operators and other stakeholders to comment on them.  

Efforts  will  continue  in  order  to  ensure  a  clear  legal  framework  for  economic  operators 
aiming at enhancing the competitiveness of European enterprises in the EU and abroad, taking 
into account the links between the 98/34 procedure and that established by the Agreement on 
Technical  Barriers  to  Trade  (TBT)  in  the  context  of  the  World  Trade  Organisation 
(WTO).Further  promotion  of  the  Directive  and  its  stronger  implementation  together  with  a 
stronger link with follow-up policy and legislative actions are crucial in order to fully achieve 
its objectives. 

16