REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE THE OPERATION OF DIRECTIVE 98/34/EC IN 2009 AND 2010
Date: 2011-12-07
Institutions: European Commission
Subjects: European standard, exchange of information, legislation, single market, technical standard, trade restriction

EUROPEAN COMMISSION 

Brussels, 7.12.2011 
COM(2011) 853 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 IN 2009 AND 2010 

{SEC(2011) 1509 final} 

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TABLE OF CONTENTS 

REPORT  FROM  THE  COMMISSION  TO  THE  EUROPEAN  PARLIAMENT,  THE 
COUNCIL  AND  THE  EUROPEAN  ECONOMIC  AND  SOCIAL  COMMITTEE  –  THE 
OPERATION OF DIRECTIVE 98/34/EC IN 2009 AND 2010 

Executive summary .................................................................................................................... 3 

PART I: STANDARDISATION ............................................................................................... 3 

1. 

2. 

2.1. 

2.2. 

3. 

3.1. 

3.2. 

3.3. 

4. 

4.1. 

4.2. 

Introduction .................................................................................................................. 3 

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

Operation of the procedure in 2009 and 2010.............................................................. 4 

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

Mandates ...................................................................................................................... 4 

Operation of the mandating process in 2009 and 2010................................................ 4 

Trends in mandates ...................................................................................................... 4 

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

Formal objections......................................................................................................... 8 

Operation of the procedure in 2009 and 2010.............................................................. 8 

Conclusion.................................................................................................................... 8 

PART II: TECHNICAL REGULATIONS ................................................................................ 9 

1. 

1.1. 

1.2. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

2.6. 

Developments in 2009 and 2010.................................................................................. 9 

Use of the procedure within the context of “Better regulation”................................... 9 

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

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

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

Use of the urgency procedure .................................................................................... 13 

Follow-up to Commission reactions .......................................................................... 13 

Dialogue with the Member States .............................................................................. 13 

Infringements against the Directive ........................................................................... 14 

Conclusion.................................................................................................................. 14 

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EXECUTIVE SUMMARY 

This  report  analyses  the  application  in  2009  and  2010  of  the  procedures  laid  down  by 
Directive 98/34/EC1 for standardisation and technical regulations. It highlights the important 
contribution  of  standardisation  and  of  the  notification  procedure  for  technical  regulations  to 
the  functioning  of  the  single  market  and  to  the  implementation  of  the  Better  Regulation 
policy2.  

The standardisation part consists of the information procedure on standards, the Commission 
requests  to  the  European  Standards  Organisations  (ESOs)3  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,  in  turn  promoting  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  standardisers  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 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 as well as improving the regulatory framework. In this 
respect, 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  increased  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 to reduce the cost of accessing the regulations and applying them 
correctly. 

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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). 
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  and  Third 
strategic review of Better Regulation in the European Union, COM(2009) 15.  
CEN (European Committee for Standardisation), CENELEC (European Committee for Electrotechnical 
Standardisation) and ETSI (European Telecommunications Standards Institute). 

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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  (mandates4)  and  formal 
objections  against  standards  supporting  New  Approach  Directives.  It  provides  explained 
statistics for the period 2009-2010. 

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  the  Directive).  The 
notification system has been 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). 

2.1. 

Operation of the procedure in 2009 and 2010 

The  procedure  has  continued  to  operate  successfully  in  2009  and  2010.  From  the  reports 
provided  by  CEN  and  CENELEC  each  year,  it  is possible to see that the annual average of 
national measures has increased substantially in 2010. This increase is attributable mainly to 
ELOT5  who  passed  from  an  annual  average  number  of  notifications  of  1.25  for  the  period 
2006-2009 to 464 in 2010 and to UNI6 who in 2010 doubled its usual number of notifications. 
Annex 2 gives a breakdown of notifications by State.  

Excluding  the  atypical  number  of  notifications  made  by  ELOT  in  2010  and  comparing  the 
statistics of 2009-2010 with the previous period, the number of notification made by the EU-
15  countries  is  stable  at  around  1500  notifications  per  year  and  the  number  of  notifications 
from the EU-12 countries has dropped from 400 to 230 (see Annex 3). 

The exceptional number of notifications made by ELOT comes from a decision of the Greek 
Ministry of Public Works to change the status of around 460 technical specifications (public 
and  private)  on  National  Technical  Specifications.  As  a  consequence  ELOT  undertook  a 
major  project  to  redraft  the  existing  texts  into  the  proper  form  of  a  National  Technical 
Specification  and  check and update all references to European Standards. ELOT announced 
this action through the procedures of Directive 98/34/EC. 

The increase of UNI notifications in 2010 is mainly due to the improvement of UNI standard 
elaboration and publication processes. This upward trend allowed UNI to better manage the 
revision of national existing standards, which are also subject to the notification. As a matter 
of  fact,  in  2010  more  than  60%  of  UNI  notifications  were  revisions  of  Italian  existing 
standards.  

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5 
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Mandates are requests representing an invitation to ESOs that may be accepted under certain conditions. 
ELOT - Hellenic Organisation for Standardisation 
UNI - Ente Nazionale Italiano di Unificazione 

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The sectoral  breakdown (Annex 4) shows that the construction sector, in its broadest sense, 
dominates  the  national  notifications,  with  structures,  and  fire  protection  at  the  top.  Food 
products have also been a significant area. 

The  information  disseminated  under  the  procedure  continues  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. 

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Apart from the exceptional situation of 2010 the number of notifications has been decreasing 
since 2006. EU-12 countries have reduced the number of notifications during the period 2009-
2010 which could be interpreted as a sign of good integration in the system as more European 
standards  are  developed  compared  with  the  national  ones.  In  general  the  procedure  is  well 
applied  and  works  correctly.  The  break  of  tendency  in  2010  is  not  expected  to  continue  in 
2011 as it is linked to specific events. 

2.2. 

Conclusion 

information  procedure  still  plays  an 

The 
in  encouraging  national 
standardisation bodies to bring their initiatives to European level, thus encouraging the single 
market and European harmonisation. Notifications from new Member States are stable which 
can be considered as a good sign of their integration in the system. 

important  role 

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. 

3.1. 

Operation of the mandating process in 2009 and 2010 

In the reporting period, a total of 41 mandates were issued to the ESOs, with 4 amendment 
mandates.  The  ratio  of  amendments  is  similar  to  that  of  previous  years  (see  Annex  5).  The 
number  of  mandates  concerning  New  Approach  Directives  (9,  plus  the  4  amendments)  has 
fallen compared to the previous period.  

The  mandating  process  functions  well.  The  informal  consultation  carried  out  before  the 
documents  are  circulated  to  the  Committee  members  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. This brings greater transparency to the informal consultation. 

Database of mandates 

In order to increase transparency further, DG Enterprise and Industry of the Commission has 
developed a database of mandates. It contains the mandates with the numbering series M/xxx. 
This database was made accessible to the public through the internet in 2005 at: 

http://ec.europa.eu/enterprise/standards_policy/mandates/index.htm 

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

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European standards production 

The scope of Directive 98/34/EC and of this report is limited to mandates and does not cover 
the standards production process itself. Nevertheless, it is important to mention that the entire 
system relies on the capacity of the ESOs to produce standards of high quality, with a broad 
consensus and on time.  

Recently the European Commission has adopted the Standardisation package7 which consists 
of  a  legislation  proposal,  a  strategic  communication  and  an  impact  assessment.  One  of  the 
goals  is  to  modernize  the  European  standardisation  system  so  that  it  becomes  faster,  more 
efficient,  inclusive  and  open.  Despite  progress  made  by  the  ESOs  during  recent  years,  the 
Commission has set a goal to cut development time by 50% by 2020. As an example, in 2005 
the average time for drafting a standard was of 6.20 years for CEN, 3.45 years for CENELEC 
and only 1.08 years for ETSI. The situation in 2009 was 2.42 years for CEN, 2.34 years for 
CENELEC and 1.79 years for ETSI.  

With a view to promote earlier availability of mandated standards, the Commission is revising 
its internal procedures to make the mandating procedure faster and more transparent so that 
the  ESOs,  together  with  other  interested  parties,  can  better  anticipate  future  standardisation 
work. In order to encourage the ESOs to continue their efforts in improving their processes, 
the  Commission  is  negotiating  with  them  on  performance  indicators  like  "on  time 
development",  "inclusiveness"  and  "quality"  which  will  be  linked  to  the  future  financial 
support to be given by the Commission. The Commission will also carry out an independent 
review  of  the  standardization  system  to  assess  progress  against  strategic  objectives  and 
evaluate the performance of the current governance in the European standardisation system in 
2013 at the latest. 

3.2. 

Trends in mandates 

The  subject  matter  for  mandates  continues  to  broaden.  The  proportion  of  the  number  of 
mandates issued for the New Approach Directives is 31%, which shows a drop from the last 
reporting  period.  Mandates  in  other  policy  areas  continue  to  be  numerous,  in  particular 
consumer protection, environment and energy. 

Standards in support of legislation 

In the reporting period, mandates were issued in support of a broad spectrum of legislation. 
Some  examples  include:  legislation  on  construction  products,  ecodesign,  general  product 
safety or low voltage. The breadth of legislative areas shows the importance conferred on the 
model. 

The  number  of  mandates  supporting  European  policy  is  slightly  inferior  compared  to  the 
previous reporting period. The mobile phone charger or the electrical vehicle charger mandates 
are good examples of policy mandates to promote interoperability. 

The number of mandates supporting legislation outside the New Approach (see Annex 5) has 
significantly increased on average per year compared with the last period (from 35% to 54%) 
and  shows  that  this  co-regulatory  model  continues  to  be  adopted  across  a  broad  range  of 

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COM(2011) 311 final of 1.6.2011, COM(2011) 315 final of 1.6.2011, SEC(2011) 671 final of 1.6.2011 

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Commission  services.  Mandates  supporting  the  eco-design  Directive  have  been  the  major 
contributor to this increase. 

Up to nine mandates8 were issued during the period 2009–2010 in support of the eco-design 
Directive.  These  mandates  are  aimed  at  products  such  as  dishwashing  machines,  household 
refrigerating appliances, circulators and electric motors.  

No mandate for standardisation in the service sector has been issued for this period.  

This trend for the use of mandates in support of legislation outside the New Approach and in 
new areas of policy 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 2004 on the role of European standardisation in the 
framework of European policies and legislation9. 

3.3. 

Conclusion 

The process of mandating is well-established, but care must be taken to ensure it continues to 
operate smoothly. To this end, the informal consultation of the ESOs and all interested parties, 
in particular those European stakeholders representing the users of future standards, prior to 
the Committee consultation is essential and should continue. 

To improve transparency in the functioning of the Committee, the Commission services have 
from  2006  invited  the  European  standardisation  stakeholders,  ANEC,  ECOS,  ETUI-REHS 
and NORMAPME, to participate in its enlarged meeting. 

For  the  sake  of  transparency,  and  thanks  to  the  technological  advantages  that  will  be 
incorporated into the CIRCA10 system, the services of the Commission will in future consider 
the  possibility  of  organising  a  written  procedure  inspired  by  internet  forums.  The  objective 
will be to ensure that all committee members can read the observations of the other members, 
rendering this type of consultation similar to that held at the Committee meeting. 

The  process  of  mandating  has  proved  to  be  instrumental  in  enlarging  the  role  of 
standardisation  in  new  areas  of  EU  legislation  and  policy.  This  is  also  reflected  by  the  fact 
that a number of new EU legislative acts refer to the Directive. 

To enable wider and more effective use of mandates as a policy tool, the mandating process 
should be more responsive – the ESOs should respond earlier if requested European standards 
are  market  relevant,  if  they  accept  a  mandate  and  on  which  conditions  they  accept  it. 
Therefore,  future  modifications  to  the  mandating  process  should  make  sure  that  clear 
deadlines are set for replies of the ESOs so that the Commission services have time to develop 
alternative solutions if the ESOs are unable or unwilling to develop European standards.  

Vademecum on European standardisation 

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Mandates  M450  M451,  M458,  M459,  M462,  M469,  M470,  M476  and  M477  makes  reference  to  the 
Directive 2005/32/EC 
COM(2004) 674 final of 18.10.2004. 
CIRCA is a collaborative workspace with partners of the European Institutions. More information can 
be found in the following URL: http://circa.europa.eu/ 

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The procedure of handling mandates, formal objections against harmonised standards and the 
publication of the references of harmonised standards are all contained within the Vademecum 
on European standardisation, along with a number of other relevant documents. 

The  Commission  consulted  the  Committee  and  other  interested  parties  on  the  Vademecum 
prior to its publication. 

The Vademecum is published on the Europa website at: 

http://ec.europa.eu/enterprise/standards_policy/vademecum/index.htm 

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 is consulted (see Annex 1 for the details of 
the procedure). 

4.1. 

Operation of the procedure in 2009 and 2010 

The number of objections that have given rise to Commission Decisions during the reporting 
period  has  been  on  average  per  year  equivalent  to  the  last  period  with  a  total  of  7.  In  three 
cases, the Decision maintained the presumption of conformity; in four cases, the presumption 
of conformity was restricted or withdrawn (see Annex 6). 

4.2. 

Conclusion 

Although  the  process  from  receiving  the  objection  to  issuing  of  the  Decision  is  quite  time-
consuming, the procedure in general has worked adequately. 

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 at each meeting. 

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PART II: TECHNICAL REGULATIONS 

1. 

DEVELOPMENTS IN 2009 AND 2010 

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 7). It applies in a simplified manner 
to  the  EFTA  Member  States  which  are  signatories  to  the  Agreement  on  the  European 
Economic Area and to Switzerland and Turkey (see Annex 10). 

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  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 is an instrument for industrial policy 

1.1. 

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

In  its  Communication  "Better  regulation  for  growth  and  jobs  in  the  EU"11  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. 

11 

See supra, footnote 2. 

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In  the  framework  of  the  Commission’s  action  plan  to  simplify  and  improve  the  regulatory 
environment12,  Member  States  have  been  invited  to  submit  impact  studies  (or  their 
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 is to 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. 

1.2. 

Improvements in managing the 98/34 procedure  

The  Commission  continued  conducting  various  campaigns  during  2009-2010  to  increase 
transparency  and  dialogue  with  the  national  authorities.  The  operation  of  the  TRIS 
(“Technical Regulations Information System”) database has seen continuous improvement and 
the  new  version  TRIS  v2.0  has  been  launched  in  2010,  with  the  aim  of  reducing  the 
processing time of notifications and messages and allowing a direct connection between TRIS 
and national databases in Member States.  

The Commission ensures public access to the notified drafts, in the 23 official languages of 
the EU, and to the essential information on the conduct of the procedure through the website 
http://ec.europa.eu/enterprise/tris. A constant increase in the number of on-line consultations 
has  been  observed:  in  2009  and  2010  the  number  of  searches  rose  by  23.4%  to  reach 
approximately 192,000 searches in 2010 (see Annex 11). 

2. 

APPLICATION OF THE 98/34 PROCEDURE 

2.1. 

Effectiveness: general overview  

► Volume of notifications and sectors involved 

In  2009  and  2010,  the  total  number  of  notified  drafts  increased  in  comparison  with  the 
previous  period  (1,525  notifications  for  2009  and  2010  as  opposed  to  1,979  for  2006,  2007 
and 2008).  

12 

See supra, footnote 2. 

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The construction sector again saw the highest number of notifications over the reporting 
period. Many measures related to energy efficiency of buildings and labelling of construction 
and  decoration  products  regarding  their  volatile  pollutant  emissions.  Construction  was 
followed  by  agricultural  products  and  foodstuffs.  In  this  sector,  several  measures 
concerned  food  hygiene,  genetically  modified  organisms,  the  composition  and  labelling  of 
foodstuffs and beverages. Notifications increased significantly in the transport sector where 
many notifications related to traffic signals, vehicle safety, tractors and motor vehicle devices. 
Several  notifications  were  received  in  the  telecommunication  sector,  mainly  concerning 
radio  interfaces,  and  in  the  environment  sector  (eco-contribution  on  plastic  bags, 
management of waste batteries and accumulators and labelling of reusable drink packaging) 
(see Annexes 9.3). 

► 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, the Commission’s reactions were intended to warn 
Member  States  of  potential  obstacles  to  trade  which  could  be  created  by  unnecessary 
measures  disproportionate  to  the  objectives  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  harmonised  areas,  the  reactions  were  intended  to  ensure  that  national  measures  were 
necessary, justified and compatible with EU secondary legislation. 

• 

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14 

15 

16 

Since  2009,  Member  States  have  notified  a  high  number  of  draft  technical 
regulations  in  the  field  of  construction.  These  drafts  concerned  all  types  of 
construction  products  (dangerous  substances,  wooden  materials,  fire  fighting 
equipments,  supporting  structures  made  from  concrete,  reinforced  concrete,  heat 
generators etc.), their properties (mechanical resistance and stability, fire resistance, 
insulating  properties,  etc.)  and  their  labelling  (in  particular,  labelling  on  volatile 
pollutant emissions). They were analysed principally under Directive 89/106/EEC13 
on construction products and the harmonised standards adopted in the context of this 
Directive as well as Directive 2002/91/EC14 on the energy performance of buildings, 
repealed by Directive 2010/31/EU15.  

In  particular,  the  Commission  issued  detailed  opinions  and  comments  concerning 
draft  technical  regulations  relating  to  the  labelling  of  construction  and  decoration 
products  regarding  their  volatile  pollutant  emissions.  The  notified  drafts  were 
examined  in  the  light  of  Directive  1999/45/EC16  relating  to  the  classification, 

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 
Directive  2002/91/EC  of  the  European  Parliament  and  of  the  Council  of  16  December  2002  on  the 
energy performance of buildings (OJ L 1, 4.1.2003, p. 65–71) 
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 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1–68)  

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packaging  and  labeling  of  dangerous  preparations  and  Regulation  (EC)  No 
1272/200817

 on classification, labelling and packaging of substances and mixtures. 

These drafts have prompted a number of reactions from several Member States who 
issued  detailed  opinions  raising  the  issue  of  compatibility  of  the  measures  notified 
with the principles of the free movement of goods in the internal market.  

Member  States  notified  several  drafts  on  genetically  modified  organisms  (GMOs). 
The notifications related in particular to the right to place GMOs on the market, to 
ban or restrict their cultivation and to their dispersal in the environment. They have 
been analysed in the light of Directive 2001/18/EC18 on the deliberate release into the 
environment of genetically modified organisms, Regulation (EC) No 1829/200319 on 
genetically  modified  food  and  feed  and  Regulation  (EC)  No  1830/200320  on  the 
traceability of food and feed products produced from genetically modified organisms 
and  amending  Directive  2001/18/EC,  and  Commission  Recommendation  on  Co-
existence measures (2010/C 200/01)21.  

In 2009 and 2010, Member States have notified drafts concerning food supplements, 
materials  intended  to  come  into  contact  with  foodstuffs  (containers,  packaging  and 
utensils manufactured from stainless steels, labelling of gold-plated, silver-plated and 
related  items),  mineral,  spring  and  drinking  water,  equipment  for  the  treatment  of 
water for human consumption, hygiene of foodstuff. Certain Member States notified 
draft regulations on the restriction or interdiction of the use of Bisphenol A in babies' 
bottles  and  materials  and  objects  which  are  designed  or  are  intended  to  come  into 
contact  with  food.  In  this  regard,  it  is  important  to  point  out  that  Directive 
2011/8/EU22  amending  Directive  2002/72/EC23  as  regards  the  restriction  of  use  of 
Bisphenol A in plastic infant feeding bottles has been adopted in January 2011 and 
provides for the prohibition from 1 March 2011 of the manufacture, and from 1 June 
2011  of  the  placing  on  the  market  and  importation  into  the  European  Union,  of 
plastic infant feeding bottles 

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1-1355) 
Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive 90/220/EEC - Commission Declaration (OJ L 106, 17.4.2001, p. 1-39) 
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1-23) 
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 
concerning the traceability and labelling of genetically modified organisms and the traceability of food 
and feed products produced from genetically modified organisms and amending Directive 2001/18/EC 
(OJ L 268, 18.10.2003, p. 24-28)  
Commission  Recommendation  of  13 July  2010  on  guidelines  for  the  development  of  national  co 
existence measures to avoid the unintended presence of GMOs in conventional and organic crops (OJ C 
200/1, 22.7.2010) 
Commission  Directive  2011/8/EU  of 28 January  2011  amending Directive  2002/72/EC  as  regards  the 
restriction of use of Bisphenol A in plastic infant feeding bottles (OJ L 26, 29.1.2011, p. 11-14) 
Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended 
to come into contact with foodstuffs (OJ L 220, 15.8.2002, p. 18-58)  

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18 

19 

20 

21 

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23 

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• 

• 

• 

In the Information Society services sector numerous were the notifications on radio 
interfaces;  others  concerned,  inter  alia,  on-line  gambling,  pricing  of  digital  books, 
electronic  tax  registers,  EPoS  systems  (Electronic  Point  of  Sale)  and  electronic 
signature devices, interoperability of information systems.  

In  the  environment  sector  the  Commission  examined  in  particular  draft  regulations 
on  the  labelling  of  drink  packaging,  labelling  of  batteries,  labelling  of  plastic  bags 
and PVC packaging. These notifications have been analysed in the light of Directive 
94/62/EC24  on  packaging  and  packaging  waste  and  Directive  2006/66/EC25  on 
batteries and accumulators and waste batteries and accumulators.  

The  procedure  has  also  allowed  intervention  in  the  sectors  where  harmonisation 
was  envisaged  at  European  Union  level  and  has  prevented  Member  States  from 
introducing divergent national measures, as in the case of the promotion of electricity 
production  from  liquid  biomass,  the  compulsory  mention  of  the  origin  of  foodstuff 
on  labelling,  the  importation  and  transit  of  seal-based  products,  the  approval 
standards for test bench equipment for roller brakes for vehicles with a total mass in 
excess of 3.5 tonnes, labeling and presentation of foodstuff, quality of table grapes, 
recycling of spent lead acid batteries and accumulators, the production of fermented 
alcoholic  beverages  other  than  beer  and  wine,  and  combustion  plants  and  remote 
heating power stations.  

► Reactions 

The  Commission  issued  detailed  opinions  in  relation  to  105  notifications,  which  represents 
7% of the total number of drafts notified by the 27 Member States over the reporting period. 
This  figure  shows  a  fall  in  the  number  of  detailed  opinions  issued  by  the  Commission 
compared to the previous reporting period, suggesting that the Member States are legislating 
increasingly  with  the  European  Union  legislation  and  principles  in  mind  and  taking  into 
account  the  requirements  of  an  effectively  functioning  internal  market.  For  their  part,  the 
Member  States  issued  130  detailed  opinions.  Of  the  616  observations  issued  during  the 
reporting  period,  262  were  made  by  the  Commission  and  354  by  the  Member  States  (see 
Annexes 9.4 and 9.6). 

In 11 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, so as not to compromise 
European Union harmonisation work underway in the area (see Annexes 9.5). 

In  addition,  the  Commission  drew  the  attention  of  the  Member  States  to  the  need  to  ensure 
compatibility  with  the  rules  of  the  Agreement  on  Technical  Barriers  to  Trade  when  the 
measures concerned were also notified to the World Trade Organisation.  

24 

25 

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) 
Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries 
and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC (OJ L 266, 
26.9.2006, p. 1-14) 

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2.2. 

Use of the urgency procedure 

Out of a total of 1525 notifications, the Member States made 52 requests to apply the urgency 
procedure  to  notified  drafts.  The  Commission  confirmed  its  strict  interpretation  of  the 
exceptional  conditions  required,  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 given was based on purely economic grounds or stemmed from 
an attempt to make up for national administrative delay. The urgency procedure was deemed 
justified  in  29  cases,  mainly  concerning  psychotropic  substances,  control  of  narcotics, 
pollutants,  games  of  chance,  security  bags  and  the  private  security  sector  (transport  of 
dangerous goods, weapons, safes, alarms, money and valuable items) (see Annex 9.7). 

2.3. 

Follow-up to Commission reactions 

In  2009-2010,  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 89.5% 
over  the  period).  This  percentage  is  the  main  indicator  used  to  assess  Member  States’ 
commitment to meeting their obligations under the procedure. The Commission observes that 
the number of satisfactory responses was not high (an average of 32.5% over the period) (see 
Annex 9.8). 

2.4. 

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.  

The discussions particularly concerned the development of the new TRIS database, the quality 
of the translation of the notified texts, the fiscal measures intended to deal with the economic 
and financial crisis to be notified under Directive 98/34/EC, the question of the confidentiality 
of certain notified drafts, the links between Regulation (EC) No 764/200826 of the European 
Parliament  and  of  the  Council  of  9  July  2008  laying  down  procedures  relating  to  the 
application  of  certain  national  technical  rules  to  products  lawfully  marketed  in  another 
Member State and Directive 98/34/EC. 

The guidelines relating respectively to the blockage foreseen in Article 9, paragraphs 3 and 4 
and to the urgency procedure laid down in Article 9, paragraph 7, of Directive 98/34/EC were 
presented by the Commission.  

Moreover, the Commission made a presentation of the new TRIS v2.0 database, of the "one-
stop-shop" (single entry point for notifications by EU Member States – including when they 
are  obliged  to  notify  documents  according  to  other  EU  acts)  and  of  the  guide  for  the 
application of the Treaty provisions governing the free movement of goods. 

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.  

26 

Regulation  (EC)  No  764/2008  of  the  European  Parliament  and  of  the  Council  of  9 July  2008  laying 
down  procedures  relating  to  the  application  of  certain  national  technical  rules  to  products  lawfully 
marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, p. 21-
29) 

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During a seminar held in November 2008 on the occasion of the 25th anniversary of Directive 
98/34/EC,  proposals  and  suggestions  on  the  functioning  of  the  notification  procedure  were 
formulated by Member States and by economic operators. Inspired by those requests, it was 
decided, on the initiative of the Commission, to set up a Working Group on the functioning of 
Directive 98/34/EC.  

This Working Group examines how the notification procedure worked so far and if and how 
its  functioning  could  be  improved  through  administrative  adjustments  or,  if  necessary, 
through the introduction of changes to the Directive currently in force.  

The  group  comprises  representatives  of  twelve  Member  States  (the  98/34  Contact  Points  of 
Austria,  the  Czech  Republic,  Denmark,  France,  Germany,  Malta,  the  Netherlands,  Poland, 
Portugal,  Romania,  Slovakia  and  the  United  Kingdom)  and  is  chaired  by  the  Commission's 
service responsible for the management of the 98/34 notification procedure. 

The first meeting of the Working Group was held on 12 April 2010 and discussed problems 
relating, on the one hand, to the three months standstill period of notified draft regulations and 
its  possible  reduction  and,  on  the  other  hand,  to  the  consequences  of  the  case-law  of  the 
European  Court  of  Justice  "CIA  Security  and  Unilever"  (unenforceability  of  non  notified 
regulations) with regard to national texts which comply in substance with EU law, but which 
were  adopted  without  being  notified  under  the  98/34/EC  procedure,  or  which  were  adopted 
during the standstill period, or which were substantially modified during the standstill period. 

During the second meeting, held on 29 June 2010 the Working Group dealt with the extension 
of  the  initial  standstill  period  by  three  more  months  (one  month  for  Information  Society 
services) only when the Commission (and not other Member States) issues a detailed opinion. 
It also discussed the possibility of providing for a minimum standstill period to be observed 
for fiscal, financial and urgent measures, in order to allow time for their proper examination. 

The third meeting took place on 27 October 2010 and focused on the issue of public access to 
documents  exchanged  in  the  framework  of  the  98/34/EC  procedure  and  the  development  of 
the "one-stop-shop" function of Directive 98/34/EC. 

2.5. 

Infringements against the Directive 

The number of infringement proceedings (Article 258 of the TFUE) brought against Member 
States  for  breach  of  obligations  under  the  Directive  remained  low  during  the  period  in 
question: three in 2009 and seven in 2010. 

2.6. 

Conclusion 

During  2009  and  2010,  the  utility  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  ensured  that  national 
regulatory activities have been carried out without creating technical barriers to trade and that 
European  Union  harmonisation  has  occurred  only  where  really  needed,  in  strict  compliance 
with  the  subsidiarity  principle.  The  fact  that  the  number  of  infringement  proceedings 
remained low during the reporting period shows that Directive 98/34/EC is an important tool 
for ensuring the correct application of European Union legislation.  

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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 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).  

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