REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS On the functioning of the notification procedure under the WTO Agreement on Technical Barriers to Trade (TBT Agreement)
Date: 2012-06-29
Institutions: European Commission
Subjects: World Trade Organisation, administrative transparency, exchange of information, market access, small and medium-sized enterprises, technical barriers to trade, technical standard

EUROPEAN COMMISSION 

Brussels, 29.6.2012  
COM(2012) 354 final 

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

On the functioning of the notification procedure under the WTO Agreement on 
Technical Barriers to Trade (TBT Agreement) 

{SWD(2012) 189 final} 

EN 

   EN 

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

On the functioning of the notification procedure under the WTO Agreement on 
Technical Barriers to Trade (TBT Agreement) 

1. 

INTRODUCTION 

The  Agreement  on  Technical  Barriers  to  Trade  (the  TBT  Agreement1)  is  one  of  the  13 
multilateral  agreements  on  trade  in  goods  negotiated  during  the  Uruguay  Round.  It  entered 
into force in 1995 with the establishment of the World Trade Organisation (WTO). It obliges 
all WTO Members to notify technical regulations and conformity assessment procedures 
for  goods  at  a  draft  stage  to  the  World  Trade  Organisation  and  gives  the  other  WTO 
Members the possibility to comment on them. 

• 

• 

• 

• 

• 

The  procedure  is  a  concrete  way  of  helping  EU  businesses,  including  Small  and 
Medium-sized  Enterprises  (SMEs),  to  improve  their  access  to  third  countries' 
markets because: 

It  allows  unnecessary  technical  obstacles  to  international  trade  to  be  detected  and 
removed at source. 

It  helps  EU  and  Member  State  legislators  and  EU  economic  operators  to  get 
acquainted with new technical regulations and conformity assessment procedures of 
other WTO Members. 

It  enables  the  EU  to  promote  its  regulatory  approach  and  have  an  input  into  other 
WTO  Members’  regulations  during  the  dialogue,  which  takes  place  before  new 
regulations are adopted. 

It contributes to the convergence of rules and standards at international level.  

The  TBT  notification  procedure  is  therefore  an  important  element  of  the  EU’s  trade  and 
industrial  policy2  and  contributes  to  the  objectives  to  be  achieved  through  the  Europe  2020 
strategy3, in particular to smart, sustainable and inclusive growth. 

The  first  objective  of  this  report  is  to  draw  the  attention  of  the  European  institutions  and 
advisory bodies and of EU economic operators, including SMEs, to the opportunities the TBT 
notification  procedure  offers.  Its  second  objective  is  to  present  the  latest  trends  of  this 

1 
2 

3 

http://ec.europa.eu/enterprise/tbt/index.cfm?fuseaction=library.viewLibrary&section_id=1&dspLang=en 
European  Commission  Communication  Trade,  Growth  and  World  Affairs  —  Trade  Policy  as  a  Core 
Component  of 
the  EU’s  2020  Strategy  —  COM(2010)  612  final;  European  Commission 
Communication An Integrated Industrial Policy for the Globalisation Era: Putting Competitiveness and 
Sustainability at Centre Stage — COM(2010) 614 final. 
European  Commission  Communication  Europe  2020:  A  strategy  for  smart,  sustainable  and  inclusive 
growth — COM(2010) 2020 final.  

EN 

2 

   EN 

 
                                                 
instrument  by  compiling  an  overview  of  the  development  of  the  procedure  in  recent  years. 
Thirdly,  the  Commission  seizes  the  opportunity  this  report  gives  to  recommend  concrete 
action to bring about further improvements. To take advantage of the notification procedure 
for regulations of other WTO Members, it is crucial that the EU itself not only respects the 
obligations laid down in the TBT Agreement, but also actively contributes to improving the 
effectiveness of the procedure. It is important that the European Parliament, the Council and 
the Member States are aware of how the TBT notification procedure functions and cooperate 
with the Commission to achieve the objectives of compliance and enhanced transparency. 

2. 

PRESENTATION OF THE TBT NOTIFICATION PROCEDURE 

2.1. 

Obligations under the TBT Agreement 

The  TBT  Agreement  aims  to  make  international  trade  easier,  while  recognising  the  right  of 
WTO Members to adopt national technical regulations and conformity assessment procedures 
which  could  result  in  technical  barriers  to  trade  (due  to  adjustment  costs  as  a  result  of 
divergent  rules,  information  costs  etc.).  To  ensure  that  such  measures  do  not  create 
discriminatory  or  unnecessary  barriers  to  trade,  the  TBT  Agreement  contains  a  number  of 
substantive  and  procedural  conditions  which  WTO  Members  must  observe  when  devising 
technical regulations and conformity assessment procedures. 

These substantive and procedural conditions apply to all technical regulations and conformity 
assessment  procedures  related  to  trade  in  goods,  whether  industrial  or  agricultural.  Unlike 
standards, which are of a voluntary nature, technical regulations lay down mandatory product 
characteristics  and  their  related  processes  and  production  methods4.  Conformity  assessment 
procedures are used to determine whether the products meet these mandatory requirements. 

2.1.1.  The  substantive  conditions:  non-discrimination,  avoidance  of  unnecessary  barriers 

to trade, use of relevant international standards 

A  measure  that  falls  within  the  scope  of  the  TBT  Agreement  must  comply  with  the  non-
discrimination  principle.  The  non-discrimination  principle,  the  keystone  of  WTO  law,  is 
embodied in the General Agreement on Tariffs and Trade (GATT). It prohibits discrimination 
between imported and domestically produced goods (principle of national treatment, Article 
III  of  GATT)  and  amongst  imported  goods  (most-favoured-nation  principle,  Article  I  of 
GATT). In the same vein, Article 2.1 of the TBT Agreement requires WTO Members to grant 
products  originating  from  any  other  Member  treatment  that  is  no  less  favourable  than  that 
accorded  to  like  products  of  national  origin  and  to  like  products  originating  in  any  other 
country. 

Moreover,  technical  regulations  are  authorised  only  when  they  are  necessary  to  achieve  a 
legitimate objective. Similarly, conformity assessment procedures must not be more strict, or 
be  applied  more  strictly,  than  necessary  to  give  the  importing  WTO  Member  adequate 
confidence  that  products  conform  with  relevant  requirements.  A  non-exhaustive  list  of 
legitimate objectives can be found in Article 2.2 of the TBT Agreement, which includes the 
prevention  of  deceptive  practices,  the  protection  of  human  health  or  safety,  and  the 
environment.  Between  2008  and  2011,  the  protection  of  human  health  and  safety  was 

4 

The rules laid down in the TBT Agreement for standards will not be discussed in this report. 

EN 

3 

   EN 

 
                                                 
indicated  as  the  legitimate  objective  pursued  for  roughly  half  of  the  TBT  notifications5. 
Moreover,  this  "necessity"  requirement  means  that  a  balance  must  be  struck  between  the 
legitimate objective pursued  and the  risk  of  non-fulfilment,  in order to choose the approach 
which involves the least restriction on trade but is equally effective. To this end, the national 
legislator  can  draw  on  the  TBT  Agreement,  which  suggests  a  number  of  approaches  that 
facilitate  trade,  such  as  the  use  of  performance-based  technical  regulations,  and  the 
recognition  of  the  equivalence  of  technical  regulations  of other  WTO  Members  and  foreign 
conformity assessment results6. 

Relevant international standards must also be used when devising technical regulations or 
conformity assessment procedures. Several provisions of the TBT Agreement promote the use 
of  international  standards  as  a  way  of  fostering  the  harmonisation  of  technical  rules.  In 
particular, Article 2.4 states that, where relevant international standards exist, WTO Members 
‘shall use them … as a basis for their technical regulations’, except when such international 
standards would be ineffective or inappropriate for the fulfilment of the legitimate objectives 
pursued. A domestic technical regulation could, for example, go beyond what is required by 
the  relevant  international  standard  to  achieve  the  regulatory  objectives  of  a  WTO  Member 
related  to  climate  change  or  to  address  its  citizens’  legitimate  expectations  in  terms  of  an 
adequate  level  of  protection.  Similar  principles  are  laid  down  in  Article  5.4  for  conformity 
assessment procedures. 

2.1.2.  The formal condition: notification of draft legislation 

Pursuant to Articles 2.9 and 5.6 of the TBT Agreement, WTO Members are required to notify 
technical  regulations  and  conformity  assessment  procedures  when  the  following  two 
conditions are fulfilled: first, there is no relevant international standard or the draft measure is 
not ‘in accordance’ with the existing relevant international standard, and second, the proposed 
measure  may  have  a  significant  effect  on  the  trade  of  other  Members.  The  concept  of  a 
significant effect on the trade of other Members includes both import-enhancing and import-
reducing effects on the trade of other Members, as long as these are significant7. 

Notifications shall take place at an early appropriate stage, when amendments can still be 
introduced  and  comments  taken  into  account8.  The  notifying  Member  shall  allow 
reasonable  time  for  other  Members  to  make  comments  in  writing.  WTO  Members  have 
agreed  in  the  TBT  Committee  that  a  60  –  90  day  period  is  considered  a  reasonable  time. 
Developed  countries  are  encouraged  to  allow  more  than  60  days  for  comments9.  The 
comments shall be discussed on request and taken into account. This means that other WTO 
Members can be kept informed of the development of new or modified product requirements. 
The  notifications  the  WTO  Secretariat  receives  are  publicly  available10,  so  that  economic 
operators  also  have  the  possibility  to  be  alerted  and  to  get  acquainted  with  the  new 
requirements. 

5 

6 
7 
8 
9 
10 

The notifying authorities must indicate the objective and rationale of the measure under point 7 of the 
notification form accompanying the draft technical regulation or conformity assessment procedure. 
See Articles 2.8, 2.7 and 6.3 of the TBT Agreement. 
Recommendation of the TBT Committee: WTO document G/TBT/1/Rev.10, pt.7. 
Articles 2.9.2 and 5.6.2 of the TBT Agreement. 
Recommendation of the TBT Committee: WTO document G/TBT/1/Rev.10, pt.7. 
See  European  Commission  TBT  database:  http://ec.europa.eu/enterprise/tbt/  or  the  WTO  TBT 
Information Management System: http://tbtims.wto.org. 

EN 

4 

   EN 

 
                                                 
WTO Members  have the right to comment in writing on proposed technical regulations or 
conformity  assessment  procedures.  In  principle,  comments  should  refer  to  the  fact  that  the 
proposed regulations do not comply with the TBT Agreement. The comments should lead to a 
dialogue  with  the  notifying  WTO  Member.  The  right  to  comment  formally  under  this 
procedure  is  limited  to  WTO  Members  and  is  not  accorded  to  interested  parties,  such  as 
economic  operators.  Concerns  of  economic  operators  therefore  need  to  be  transmitted  by  a 
WTO  Member.  It  is  up  to  every  WTO  Member  to  organise  how  the  concerns  of  its  own 
economic operators are heard and taken into account. 

2.2. 

The EU’s internal organisation with regard to the notification procedure 

Various parties must participate and cooperate with each other for the notification procedure 
to function properly and be useful and efficient. In the EU, the participation of the European 
institutions, the Member States and economic operators is of the utmost importance. A TBT 
website set up by the EU helps to coordinate the participation of all those involved. 

2.2.1.  The European Commission 

The TBT Agreement requires each WTO Member to set up a notification authority to ensure 
the implementation of the provisions concerning notification procedures, and to ensure that an 
enquiry  point  exists11.  The  enquiry  point  must  answer  all  reasonable  enquiries  from  other 
Members  and  interested  parties  on  technical  regulations  adopted  or  proposed  or  conformity 
assessment procedures and is also in charge of handling comments received from other WTO 
Members  on  notifications12.  In  the  EU,  these  obligations  are  fulfilled  by  one  unit  of  the 
European  Commission  in  the  Directorate-General  for  Enterprise  and  Industry,13  which  has 
been designated as the EU TBT Notification and Enquiry Point. 

The  role  of  the  EU  TBT  Notification  and  Enquiry  Point  is  twofold.  It  ensures  that  EU 
legislation,  to  be  adopted  either  by  the  European  Parliament  and  the  Council  or  by  the 
European Commission as an implementing measure, is notified at a draft stage to the WTO. It 
is also responsible for distributing other WTO Members’ notifications to all interested parties 
and ensures that comments are sent to the notifying WTO Member on the EU’s behalf when it 
appears that the measure in question could create market access problems for EU exporters. 
To  be  able  to  issue  comments  on  a  notification  of  another  WTO  Member,  the  EU  TBT 
Notification  and  Enquiry  Point  seeks  contributions  from  all  interested  parties,  i.e.  sectoral 
units of the European Commission, units of the Directorate-General for Trade, EU delegations 
in third countries, Member States and businesses in the EU. When editing comments from the 
EU  on  notifications  of  other  WTO  Members,  the  EU  TBT  Notification  and  Enquiry  Point 
ensures they are consistent with all the EU’s policies. 

2.2.2.  EU co-legislators: Parliament and Council 

The European Parliament and the Council also play an important role as they adopt legislation 
containing  technical  regulations  and  conformity  assessment  procedures  that  has  to  comply 
with the TBT Agreement. Given that the Agreement requires notification at a draft stage, the 
EU TBT Notification and Enquiry Point notifies the other WTO Members of EU legislation 
laying down product requirements that fall within the scope of the TBT Agreement, once the 

11 
12 
13 

Article 10 of the TBT Agreement. 
Recommendation of the TBT Committee: WTO document G/TBT/1/Rev.10, pt.7. 
Unit ENTR/C/3 ‘Notification of technical regulations’. 

EN 

5 

   EN 

 
                                                 
Commission has adopted its proposal for a Regulation, Directive or Decision of the European 
Parliament and the Council. The Commission analyses comments from other WTO Members 
and takes them into account in the legislative procedure. 

Both  Council  and  Parliament,  when  drafting  and  adopting  amendments  to  a  Commission 
proposal,  must  take  its  impact  on  international  trade  into  account.  Other  WTO  Members 
carefully  follow  the  legislative  discussions  and  often  comment  in  writing  or  in  TBT 
Committee  meetings  (which  take  place  three  times  a  year  in  the  WTO  in  Geneva)  on  the 
compatibility of proposed amendments with the TBT Agreement. 

2.2.3.  Member States 

Besides  the  EU  TBT  Notification  and  Enquiry  Point,  all  27  Member  States  have  their  own 
TBT notification authorities and enquiry points. Member States are responsible for assessing 
whether their proposed national technical regulations and conformity assessment procedures 
would have a significant impact on trade and, if they would, for notifying them directly to the 
WTO. Replies to comments from other WTO Members are, however, given by the EU TBT 
Notification  and  Enquiry  Point  (after  coordination  with  the  Member  State  concerned)  on 
behalf of the EU, since these replies are considered part of the common commercial policy, 
which  is  an  exclusive  EU  competence14.  Coordination  between  Member  States  and  the 
European Commission is ensured through the internal EU notification procedure laid down in 
Directive 98/34/EC15 and the Commission services meet every year with the representatives 
concerned from Member States to enhance such coordination. 

Member States also need to inform their public authorities and national economic operators of 
the obligations and opportunities related to the TBT notification procedure. The Commission 
regularly  receives  comments  on  other  WTO  Members’  notifications  from  Member  States. 
Some Member States have established efficient national mechanisms to get feedback directly 
from  national  industry,  including  smaller  business  federations  or  individual  companies.  The 
Commission uses this feedback to fight against potential technical barriers to trade. 

2.2.4.  Economic operators 

EU industry comments on other WTO Members’ notifications are of great importance to 
prevent the emergence of unnecessary obstacles to international trade. Several European 
industry  federations  located  in  Brussels  are  well  aware  of  the  means  offered  by  the  TBT 
Agreement and regularly send comments to Commission departments16. Some also contribute 
via  the  Market  Access  Advisory  Committee  that  has  been  set  up  in  the  context  of  the 
European Commission’s Market Access Strategy17. Other European economic operators send 
their comments to the EU delegation in the notifying WTO Member. 

14 
15 

16 

17 

Article 207 of the Treaty on the Functioning of the European Union. 
Directive  98/34/EC  of  the  European  Parliament  and  the  Council  of  22  June  1998  laying  down  a 
procedure for the provision of information in the field of technical standards and regulations, OJ L 204, 
21.7.1998, p. 37. 
To raise awareness among economic operators, the Commission organised a large-scale conference on 
29  March  2007  in  Brussels.  150  people  attended  the  conference.  For  more  information  see: 
http://ec.europa.eu/enterprise/tbt/index.cfm?fuseaction=library.viewLibrary&section_id=175&dspLang
=en. 
European Commission Communication Global Europe: A stronger partnership to deliver market access 
for European exporters — COM(2007) 183 final. 

EN 

6 

   EN 

 
                                                 
The  Commission  coordinates  matters  internally  to  ensure  that  all  comments  reach  the  TBT 
Notification and Enquiry Point, which drafts official EU comments. Given the often relatively 
short  comment  period  of  60  –  90  days,  it  is  important  that  EU  economic  operators 
communicate  their  concerns  as  soon  as  possible  and  before  the  final  deadline  set  by  the 
notifying WTO Member18. 

2.2.5.  The EU TBT website 

In  order  to  provide  direct  access  to  notifications  and  facilitate  coordination  amongst  all 
involved, the EU TBT Notification and Enquiry Point set up its own public TBT website19 in 
2004. This website gives public access to the TBT database, which contains all notification 
forms, draft texts and comments the European Commission sent and received. 

The  website  provides  an  overview  of  each  TBT  notification:  the  notified  documents,  any 
translations  available,  and  the  comments  the  European  Commission  sent  and  received  are 
displayed on a single webpage for each notification. The display of all documents guarantees 
the  full  transparency  of  the  EU’s  action  under  the  TBT  Agreement.  In  addition,  economic 
operators and other interested parties can subscribe to an alert system of new notifications 
and  consult  a  monthly  review  of  the  EU  TBT  Enquiry  Notification  and  Enquiry  Point’s 
activity. 

The number of subscribers to the alert system shows that the use of the EU TBT website has 
been increasing since 2004. In 2011, 529 private or public entities were registered in the alert 
system (compared to 182 in 2005), and 15 000 searches were performed in the database. One 
third  of  subscribers  are  from  third  countries.  The  EU  TBT  Enquiry  Point  presented  its 
database on several occasions to the TBT Committee and has been approached by other WTO 
Members who want to develop their own websites. 

3. 

THE EU’S RESPONSE TO THE LATEST DEVELOPMENTS 

3.1. 

Adapting to an increasing number of TBT notifications 

The EU has always been proactive in monitoring third countries’ measures and is managing to 
cope with the increasing number of TBT notifications. The number of TBT notifications has 
been  growing  exponentially.  Whereas  fewer  than  400  draft  texts  were  notified  in  1995,  the 
year the TBT Agreement entered into force, this number has more than tripled since that time, 
reaching 1216 in 201120. In total, over the last 16 years, WTO Members have notified almost 
15 000  texts.  There  was  a  huge  increase  in  the  number  of  notifications  between  2004  and 
2009:  it  only  slightly  increased  over  the  first  ten  years  of  the  TBT  notification  procedure 
(from less than 400 in 1995 to 638 in 2004) before going, within six years, from 638 to almost 
1500 (see graph under point 1 of the Commission staff working document SWD(2012) 189). 

The first reason for this increase is the change in the number of WTO Members, from 128 in 
the beginning to 153 in 2011. There are some major players among the newcomers, such as 
China,  who  joined  in  2001,  Saudi  Arabia  (2005),  Vietnam  (2007)  and  Ukraine  (2008).  The 

18 

19 
20 

Ideally, the Commission should receive comments 3 weeks before the final deadline set by the notifying 
WTO member in the notification form. 
http://ec.europa.eu/enterprise/tbt/. 
The numbers presented in this report do not include the notification of addenda/corrigenda. 

EN 

7 

   EN 

 
                                                 
awareness campaigns organised by the WTO Secretariat and the national TBT Enquiry Points 
also made an impact. Moreover, both the WTO Secretariat and WTO Members have funded 
and  participated  in  technical  assistance  projects  in  the  TBT  field,  at  regional  and  national 
level.  The  intensified  regulatory  activity  of  WTO  Members  over  the  last  five  years  in 
emerging  sectors,  such  as  energy  efficiency  or  consumer  information,  is  another  important 
reason. Finally, the financial crisis, which has threatened national economies, could have led 
to increased regulatory activity. 

The  EU  has  been  closely  observing  and  monitoring  this  expanding  regulatory  framework. 
This  is  reflected  in  the  number  of  comments  from  the  EU  on  third  countries’  notifications, 
which is proportionate to the increase in TBT notifications. Thus, between 2004 and 2009, the 
number of comments from the EU almost doubled, from 47 to 91 per year. In 2011, the EU 
sent 102 comments, the highest number ever (see graph under point 1 of the Commission staff 
working  document  SWD(2012)  189).  It  is  also  actively  using  TBT  Committee  meetings  to 
supplement its written comments with oral statements and ask for follow-up to its comments. 
The  EU  is  one  of  the  most  active  members  in  the  TBT  Committee,  commenting  on  other 
WTO Members’ notifications that are likely to create unnecessary trade barriers. Depending 
on the notified draft, the EU may request withdrawal, modification, postponement, or it may 
seek  clarification.  There  are  numerous  examples  of  successful  cooperation  with  third 
countries that led to a favourable outcome for the EU and international trade. 

Examples of achievements under the TBT procedure: 

Withdrawal:  The  Colombian  draft  regulation  on  alcoholic  beverages21 
labelling 
requirements  that  were  too  strict  and  would  have  entailed  significant  costs  for  economic  operators. 
Following  the  interventions  of  the  EU  in  TBT  Committee  meetings  and  its  written  comments,  the 
Colombian authorities withdrew the regulation. 

imposed 

Modification: The Brazilian notification on conformity assessment for the safety of toys22 proposed a 
burdensome  and  discriminatory  conformity  assessment  procedure.  At  the  request  of  the  EU  and 
several  other  trade  partners,  Brazil  modified  its  regulation  in  2010  by  easing  up  on  its  conformity 
assessment procedure for imported toys. 

Postponement: The Indian notification on tyres for automotive vehicles was first notified in 200623. 
Further to written comments from the EU and its numerous interventions in TBT Committee meetings, 
the adoption of the draft was postponed. An amended version was notified in 201024.  

Clarification:  With  regard  to  the  Chinese  notification  on  supervision  and  administration  of  the 
inspection  and  quarantine  of  imports  of  solid  waste,  China  clarified  that  importers  who  were 
accredited according to certain European standards would also qualify for the required registration25. 

3.2. 

Responding to the active participation of more WTO Members 

The EU has also been adapting to the emergence of new players in  the  TBT  procedure  and 
their  critical  views  on  its  regulatory  choices.  The  significant  increase  in  the  number  of 
notifications over recent years is not only to be ascribed to big countries but also to smaller 

21 
22 
23 
24 
25 

G/TBT/N/COL/120. 
G/TBT/N/BRA/259, 313 and 339. 
G/TBT/N/IND/20. 
G/TBT/N/IND/40. 
G/TBT/N/CHN/649. 

EN 

8 

   EN 

 
                                                 
global  players  such  as  Saudi  Arabia,  Qatar  and  Bahrain.  The  active  participation  of 
developing  countries,  such  as  Uganda,  which  notified  the  highest  number  of  texts  in  2010, 
confirmed this trend. 

More WTO Members have been actively participating in the procedure, increasingly notifying 
and also commenting on notifications. Other WTO members often comment on texts notified 
by the EU. In 2011, the EU TBT Enquiry Point received 25 comments from third countries, in 
particular  from  China,  New  Zealand,  Japan  and  the  U.S.A.  (see  graph  under  point  2  of  the 
Commission staff working document SWD(2012) 189). In the TBT Committee, among WTO 
Members, the EU received the most comments in recent years. Indeed, the EU, being a huge 
export market, with 500 million potential consumers, and often at the forefront of regulatory 
developments,  fostering  a  high  level  of  consumer  protection  and  pursuing  an  ambitious 
environmental policy, is closely monitored by numerous trading partners. 

The  EU  replies  to  all  comments  received  by  explaining  its  legislation,  defending  it  or 
amending  it  when  necessary.  The  replies  are  given  in  writing  to  written  comments  the  EU 
TBT Notification and Enquiry Point receives under the notification procedure or orally during 
TBT Committee meetings in reply to statements other WTO Members make. The European 
Commission  answers  each  WTO  Member’s  written  comments  individually  on  the  EU’s 
behalf.  Most  of  the  issues  raised  regarding  EU  legislation  since  1995  have  related  to  the 
agricultural sector, the registration of chemicals, animal welfare and ecodesign/labelling. 

Examples of the EU’s responsiveness: 

Modification: A 2002 Commission Regulation on wine sector products26 was modified several times 
following its notification and comments from third countries. When a new Commission Regulation on 
wine  products  was  notified  in  200827,  11  provisions  of  the  draft  were  amended  to  take  into  account 
written comments from 4 different WTO Members. 

Taking the concerns of other parties into account: In addition to written comments, the EU replied 
to  concerns  expressed  orally  in  TBT  Committee  meetings.  Third  countries’  concerns  regarding 
REACH28 have therefore been taken into account in the guidance documents that aim to facilitate the 
implementation of this Regulation. 

Clarification: In 2010, several WTO Members expressed their concerns in the TBT Committee that 
the European accreditation framework set up by Regulation (EC) No 765/200829 could undermine the 
ability  of  non-EU  conformity  assessment  bodies  to  perform  tasks  in  the  regulated  area.  The  EU 
clarified  that  the  new  rules  had  been  developed  for  internal  market  purposes  only  and  that  the 
possibilities of accepting or recognising the results of foreign conformity assessments were unaffected 
by the new Regulation. 

3.3. 

Facing the challenge of transparency 

In  line  with  the  overall  trend,  the  EU  has  also  significantly  increased  the  number  of  its 
notifications per year. Over the last ten years, the number has more than tripled, from 17 to 
63. In 2008, the number of EU notifications doubled compared to the previous year (see graph 
under point 2 of the Commission staff working document SWD(2012) 189). The number of 

26 
27 
28 
29 

G/TBT/N/EEC/15. 
G/TBT/N/EEC/264. 
G/TBT/N/EEC/52. 
G/TBT/N/EEC/152. 

EN 

9 

   EN 

 
                                                 
Member States’ notifications has fluctuated since 1995, but stabilised over the last 3 years at 
54 notifications per year (see graph under point 3 of the Commission staff working document 
SWD(2012) 189). However, compared to the number of Member States’ notifications under 
the internal notification procedure30, the number remains low. 

Regarding  the  comment  period  of  60  –  90  days  granted  to  other  WTO  Members  before  the 
notified  legislation  is  adopted,  statistics  show  that,  in  practice,  the  allocated  time  for 
comments has varied between 58 and 61 days over the last 5 years, compared to 46 days in 
199731. Regarding EU notifications, the average number of days given for comments in 2011 
was  65  (see  graph  under  point  4  of 
the  Commission  staff  working  document 
SWD(2012) 189). This progress has given WTO Members more opportunities to analyse the 
technical regulations of third countries and has helped improve the TBT procedure. However, 
as  underlined  in  the  last  WTO  Trade  Policy  Review  on  the  EU,  the  length  of  the  comment 
period related to the notifications of EU Member States could be further increased32. 

Progress  made  on  transparency  is  proportionate  to  the  steps  WTO  Members  have  taken  to 
raise awareness of the TBT procedure. Internal coordination to ensure that all legislation that 
falls  within  the  scope  of  the  TBT  Agreement  is  notified  at  an  appropriate  stage  has  to  be 
carefully  monitored  on  a  day-to-day  basis  and  national  administrative  bodies  must  be 
informed regarding such legislation. The European Commission has been particularly active 
in this field, by regularly organising seminars for its departments and for EU Member States. 
The  EU  TBT  Notification  and  Enquiry  Point  organised  three  seminars  for  Commission 
departments between 2008 and 2011. 

4. 

MULTILATERAL  DISCUSSIONS  ON  TRANSPARENCY  IN  THE  TBT  NOTIFICATION 
PROCEDURE 

4.1. 

Remaining difficulties 

The TBT Committee has issued and fine-tuned detailed recommendations on transparency33 
which  improved  the  implementation  of  the  notification  procedure  when  followed  by  WTO 
Members34.  However,  some  WTO  Members  still  do  not  respect  the  basic  obligations  of 
the  TBT  notification  procedure,  such  as  simple  notification  or  notification  at  draft  stage. 
This is often due to a lack of coordination within national administrative bodies to ensure that 
the notification authority is aware of the development of legislation that needs to be notified, 
or due to the inability of the notification authority to impose the notification obligation on the 
administrative body in charge of the proposed legislation. Some WTO Members do not notify 

30 

31 

32 

33 
34 

Directive  98/34/EC  of  the  European  Parliament  and  the  Council  of  22  June  1998  laying  down  a 
procedure for the provision of information in the field of technical standards and regulations, OJ L 24, 
21.7.1998, p. 37. 
Sixteenth annual review of the implementation and operation of the TBT Agreement: WTO document 
G/TBT/29, p. 6. 
‘Trade  Policy  Review:  European  Union’,  WTO  Secretariat  Report,  2011,  p.  46:  ‘For  approximately 
17 % of individual Member State notifications, the comment period, or the period between the date on 
which  a  notification  was  published  and  its  date  of  adoption,  was  less  than  60  days’  (period  covered: 
Oct. 2008–Jan. 2011). 
WTO document G/TBT/1/Rev.10. 
E.g.  a  60  –  90  day  comment  period,  replies  to  be  given  in  one  of  the  three  official  languages  of  the 
WTO,  direct  access  to  the  notified  text  through  the  notification  format,  sharing  of  unofficial 
translations, communication of adopted and published texts etc. 

EN 

10 

   EN 

 
                                                 
legislation  adopted  by  the  legislative  powers  (such  as  the  parliament),  as  coordination 
between the notification authority and the legislative power is more difficult to negotiate. 

Moreover,  not  all  WTO  Members  use  the  opportunity  to  comment  on  proposed  technical 
regulations and conformity assessment procedures. Many Members have difficulty following 
notifications  or  bringing  together  the  technical  expertise  needed  to  analyse  certain 
notifications. Similarly, not all enquiry points of WTO Members are fully operational. Some 
rarely reply, others simply report that they have informed the competent authorities about the 
query, often no answer is provided despite repeated reminders. This significantly hinders the 
outcome of the procedure and renders it less efficient. 

There  are  still  some  grey  areas  regarding  the  scope  of  the  TBT  Agreement  and  the 
notification obligation.  While  two  recent  WTO  panel  rulings35  should  help  to  further define 
the scope of the Agreement, uncertainties remain, especially with regard to requirements for 
non-product-related  production  methods  (which  do  not  have  any  influence  on  the  technical 
characteristics  of  the  final  product)  and  with  regard  to  voluntary  labelling  linked  to  certain 
requirements without imposing exclusive labelling. 

Analysis of the notified texts in the relatively short comment period of 60 days, especially 
when the draft text has to be translated, remains a major challenge for WTO Members and for 
economic operators. The budget for translation is still too limited. It is extremely important 
to  raise  awareness  among  economic  operators  of  the  procedure  and  the  possibility  of 
sending  comments  to  the  authorities  of  WTO  Members.  This  is  particularly  true  for 
federations or national companies, especially SMEs, which have limited in-house resources to 
analyse proposed regulations and react in due time. 

Finally, the TBT Committee should not become a forum that simply reports the concerns 
of  industry.  It  should  provide  an  opportunity  for  public  authorities  to  exchange  views  on 
proposed technical regulations and conformity assessment procedures on the basis of all the 
related policy aspects. 

4.2. 

Regular Discussions in TBT Committee meetings and Triennial Reviews 

The  regular  meetings  of  the  TBT  Committee  and,  in  particular,  the  review  on  the 
operation  and  implementation  of  the  TBT  Agreement,  which  is  carried  out  according  to 
Article  15.4  of  the  TBT  Agreement  every  three  years,  are  occasions  to  discuss  and  clarify 
some of the difficulties and challenges related to the notification procedure. The Commission 
regularly  uses  these  Triennial  Reviews  to  suggest  ways  of  improving  transparency  in  the 
notification procedure. The EU actively participates in all discussions regarding the Triennial 
Review and contributed a paper on transparency36 to the Fifth Triennial Review37 concluded 
in November 2009. 

The Triennial Reviews are not only important with regard to issues related to the notification 
procedure, but also with regard to other systemic issues related to the TBT Agreement: good 
regulatory  practice,  conformity  assessment  procedures,  standards,  technical  assistance 
and  the  operation  of  the  TBT  Committee.  The  TBT  Committee  has  therefore  become  an 

35 

36 
37 

United States — Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products 
(DS381) and United States — Certain Country of Origin Labelling Requirements (DS 384, DS 386). 
WTO document G/TBT/W/309. 
WTO document G/TBT/26. 

EN 

11 

   EN 

 
                                                 
important forum in which WTO Members can discuss issues related to the international trade 
of  goods  and  policy  approaches.  The  Commission  regularly  uses  this  Committee  to  present 
EU policy approaches to other WTO Members and promote regulatory convergence through 
the  use  of  good  regulatory  practice  in  the  development  of  technical  regulations  and 
conformity assessment procedures. 

The  Commission  also  provides  overviews  of  the  EU’s  and  Member  States’  technical 
assistance  programmes  for  developing  countries  that  include  aid  on  TBT  matters38.  At  the 
June  2011  TBT  Committee  meeting,  Sweden  presented  its  mentoring  programme, 
implemented  from  2008  to  2011,  to  support  the  setting  up  and  functioning  of  the  TBT 
Notification  and  Enquiry  Points  of  7  Sub-Saharan  African  countries39.  Apart  from  its 
technical assistance programmes, the EU TBT Notification and Enquiry Point received, at the 
request  of  certain  WTO  Members,  visits  from  other  WTO  Members  who  wanted  to  know 
more  about  how  it  is  organised  and  how  it  functions40.  TBT  experts  from  the  European 
Commission have also participated in technical assistance seminars organised by the WTO in 
different regions of the world. 

5. 

CONCLUSIONS AND THE WAY FORWARD 

The  TBT  notification  procedure  is  a  powerful  means  of  finding  out  about  regulatory 
developments related to goods in third countries. When WTO Members comply with the 
notification obligation, this allows other WTO Members to get acquainted with new technical 
regulations and conformity assessment procedures and provides a concrete way of reacting to 
technical barriers to trade. At the same time, the procedure allows general tendencies in other 
WTO  Members  or  in  one  particular  WTO  Member  to  become  widely  known  and  therefore 
provides important information for the EU’s trade and industrial policy. 

In  order  to  take  full  advantage  of  it,  it  is  of  course  crucial  that  the  EU  itself  respects  the 
principles  and  complies  with  the  obligations  laid  down  in  the  TBT  Agreement.  If  the  EU 
does not play by the rules, it cannot ask others to do so. EU and Member State legislation 
must therefore follow the principles of the TBT Agreement and be notified according to the 
rules, with maximum transparency. 

Submitting proposed legislation to screening by other WTO Members can also be very useful. 
Comments  from  other  Members  can  help  identify  problems  that  have  not  been  noticed  or 
aspects that have not been taken into account when drafting legislation41. 

The  procedure  also  gives  regulators  around  the  world  the  opportunity  to  compare  policy 
approaches  and  to  reflect  on  reasons  for  legislating  differently.  The  TBT  notification 
procedure thus serves as a benchmarking instrument and can contribute to a certain degree 
of  convergence  at  international  level,  where  appropriate.  It  also  helps  the  EU  make  its 
regulatory  decisions  known  and  promote  them.  These  decisions  are  based  on  thorough 
evidence-based analysis, extensive consultation with stakeholders and comprehensive impact 

38 
39 
40 

41 

WTO document G/TBT/W/303. 
Burundi, Ethiopia, Kenya, Rwanda, Tanzania, Uganda and Zambia. 
Visits from an Indian delegation in 2007, from an official from the Chinese TBT Enquiry Point in 2009 
and from a Tunisian delegation in 2011. 
Despite the analysis and impact assessment, including the assessment of consequences on international 
trade, that the Commission regularly carries out before proposing legislation. 

EN 

12 

   EN 

 
                                                 
assessment.  Furthermore,  it  gives  the  EU  an  opportunity  to  explain  the  reasons  for  its 
decisions to other countries. 

At  present,  the  Commission,  Member  States  and  economic  operators  use  the  procedure 
efficiently. Nevertheless, the Commission sees room for improvement and intends therefore to 
take the following actions: 

Action 1: Further awareness-raising to trigger comments from EU economic operators, 
including SMEs 

The Commission will continue to inform Commission departments, economic operators and 
Member States of the advantages of the procedure, including the option of sending comments 
directly to the Commission. In particular, the Commission will continue to organise seminars 
and  conferences  with  Member  States  and  economic  operators,  including  SMEs,  and  to 
encourage Member States to raise awareness among national economic operators. 

In the context of implementation of the Commission Communication supporting the economic 
activities of SMEs outside the EU42, the Commission will also continue to explore what more 
can  be  done  to  help  SMEs  participate  more  actively  in  the  notification  procedure.  The 
Commission will ensure that the future multilingual online portal43, providing information on 
foreign markets that is relevant for businesses and an overview of available support activities 
related to markets outside the EU, will include a link to the TBT database44. The Commission 
also intends to improve its TBT website in 2012 to make it more user-friendly for economic 
operators, including SMEs. 

Action  2:  Support  the  right  of  economic  operators  to  obtain  information  about 
applicable market access requirements from TBT Enquiry Points 

The  TBT  Agreement  obliges  WTO  Members  to  set  up  a  TBT  Enquiry  Point  to  answer  all 
reasonable  enquiries  from  other  Members  and  interested  parties  on  technical  regulations 
adopted  or  proposed,  conformity  assessment  procedures  and  standards45.  This  opens  up  a 
direct  communication  channel  for  economic  operators  with  the  authorities  of  other  WTO 
Members, from whom they can obtain information about market access requirements linked 
to  technical  regulations,  conformity  assessment  procedures  and  standards.  Such  a  direct 
communication channel can be of interest with regard to specific issues, when other sources 
of information, such as the EU’s market access database46 or the websites of third countries, 
do not contain enough information. The Commission therefore intends to advertise the TBT 
Enquiry Points on the revamped TBT website. Depending on the human resources available, 
the Commission will also consider giving support to European economic operators who need 
information,  for  example  if  the  enquiries  they  send  to  the  enquiry  points  of  other  WTO 
Members are not answered. 

42 

43 

44 
45 
46 

European Commission Communication Small Business, Big World — A new partnership to help SMEs 
seize global opportunities, COM(2011) 702 final. 
See  point  4.2.2  of  the  European  Commission  Communication  Small  Business,  Big  World  —  A  new 
partnership to help SMEs seize global opportunities. 
http://ec.europa.eu/enterprise/tbt/. 
See Article 10 of the TBT Agreement. 
http://madb.europa.eu/. 

EN 

13 

   EN 

 
                                                 
Action 3: Further coordination with other important instruments of the EU’s trade and 
industrial policy 

The Commission will continue to use the TBT notification procedure as part of its trade and 
industrial  policy  and  will  try  to  create  more  synergies  between  the  different  aspects  of  the 
policy.  The  Market  Access  Teams  in  EU  delegations  in  third  countries  can,  for  example, 
provide valuable support if they have the resources to monitor TBT notifications, to create a 
network  to  collect  comments  from  EU  businesses  in  third  countries,  to  establish  links  with 
Commission  departments  based  in  Brussels  and  to  follow  up  with  competent  authorities  in 
third  countries.  Where  possible,  the  Commission  will  continue  to  use  existing  or  new 
regulatory dialogues and trade agreement negotiations to address systemic or specific barriers 
to  trade  that  have  been  identified  through  the  TBT  notification  procedure.  The  Commission 
will  also  continue  to  promote  full  compliance  with  the  notification  obligation,  and  with 
relevant recommendations of  the TBT Committee, through negotiations  on TBT  chapters in 
free trade agreements, including provisions on transparency. 

Action  4:  Further  support  for  the  functioning  of  the  TBT  notification  procedure  at 
multilateral and bilateral levels 

The  Commission  will  continue  to  develop  and  improve  the  functioning  of  the  procedure  by 
actively  participating  in  TBT  Committee  meetings.  It  intends  to  submit  another  paper  on 
transparency in the notification procedure in the context of the Sixth Triennial Review, due in 
November  2012.  The  Commission  will  also  consider  how  developing  countries  could  be 
further  supported  in  order  that  they  can  more  effectively  participate  in  the  notification 
procedure. This could  include enhanced assistance of  TBT  Notification and Enquiry Points, 
especially those of the EU’s neighbouring countries. 

The Commission will consider encouraging the WTO Secretariat to further develop its TBT 
Information  Management  System47  to  be  an  efficient  tool  for  all  WTO  Members,  enabling 
quicker publication of notifications and allowing Members to easily obtain all the necessary 
information on notifications and better participate in the procedure. 

Action 5: Maximum adherence to the notification rules 

The  Commission  is  committed  to  ensuring  that  Commission  proposals,  as  well  as 
implementing legislation adopted by the Commission, comply with the TBT Agreement and 
that  they  are  notified  at  a  draft  stage,  with  a  60  –  90  day  comment  period  for  other  WTO 
Members.  It  will  also  ensure  that  comments  from  other  WTO  Members  are  discussed  and 
taken into account before legislation is finalised. It is important that sufficient time is foreseen 
in the adoption process to enable compliance with the notification obligation. 

Action 6: Further efforts to improve transparency in the ordinary legislative procedure 

As  regards  proposals  to  the  European  Parliament  and  the  Council  containing  technical 
regulations  and  conformity  assessment  procedures,  the  Commission  has  started  to  inform 
WTO  Members  of  significant  changes  introduced  in  the  legislative  procedure,  when  these 
proposals  have  triggered  the  interest  of  other  WTO  Members  and  when  the  ordinary 

47 

http://tbtims.wto.org/web/pages/search/notification/Search.aspx. 

EN 

14 

   EN 

 
                                                 
procedure so allowed48. To improve transparency, a comment period could be reopened that 
would  allow  other  WTO  Members  to  comment  on  the  changes  introduced  in  the  ordinary 
procedure  and  to  send  the  comments  received  to  the  co-legislators.  The  Commission  will 
investigate this possibility on a case-by-case basis. 

Action 7: More coordination with Member States 

For a coherent, efficient trade policy, and to get the most out of the procedure, the EU must 
act in concert. Member States must fully comply with the obligations of the TBT Agreement 
and  support  the  EU  policy  of  transparency  in  the  notification  procedure  by  effectively 
coordinating  their  action.  The  Commission  will  continue  to  inform  Member  States  of 
important aspects of the procedure and the latest developments. It calls on Member States to 
ensure coordination on their side too. 

48 

In these cases, the EU TBT Notification and Enquiry Point informed the other WTO members through 
an  addendum  to  the  original  notifications  about  the  positions  taken  by  the  Council  or  the  European 
Parliament without, however, opening a new comment period on the changes introduced. 

EN 

15 

   EN