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
Date: 1998-06-22
Institutions: Council of the European Union, European Parliament
Subjects: Cenelec, ETSI, EU Member State, European Committee for Standardisation, access to information, exchange of information, technical standard

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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

THE  EUROPEAN  PARLIAMENT  AND  THE  COUNCIL  OF
THE  EUROPEAN  UNION,

transparency  as  possible  should  be  ensured  as
regards national initiatives for the establishment of
technical  standards  or  regulations;

Having  regard  to  the  Treaty  establishing  the  European
Community,  and  in  particular  Articles  100a,  213  and  43
thereof,

Having  regard  to  the  proposal  from  the  Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting  in  accordance  with  the  procedure  laid  down  in
Article  189b  of  the  Treaty (3),

(1)  Whereas  Council  Directive  83/189/EEC  of  28
March  1983  laying  down  a  procedure  for  the
provision  of  information  in  the  field  of  technical
standards  and  regulations (4)  has  been  variously
and  substantially  amended;  whereas  for  reasons  of
clarity  and  rationality  the  said  Directive  should  be
consolidated;

internal 

frontiers 

(2)  Whereas  the  internal  market  comprises  an  area
without 
free
movement of goods, persons, services and capital is
ensured;  whereas,  therefore,  the  prohibition  of
quantitative restrictions on the movement of goods
and  of  measures  having  an  equivalent  effect  is  one
of  the  basic  principles  of  the  Community;

in  which 

the 

(4)  Whereas  barriers  to  trade  resulting  from  technical
regulations  relating  to  products  may  be  allowed
only  where  they  are  necessary  in  order  to  meet
essential requirements and have an objective in the
public  interest  of  which  they  constitute  the  main
guarantee;

(5)  Whereas it is essential for the Commission to have
the necessary information at its disposal before the
adoption  of 
technical  provisions;  whereas,
consequently, 
the  Member  States  which  are
required  to  facilitate  the  achievement  of  its  task
pursuant  to  Article  5  of  the  Treaty  must  notify  it
technical
of 
regulations;

their  projects 

field  of 

the 

in 

(6)  Whereas  all  the  Member  States  must  also  be
informed of the technical regulations contemplated
by  any  one  Member  State;

is 

to 

conducive 

environment 

(7)  Whereas the aim of the internal market is to create
the
that 
an 
competitiveness of undertakings; whereas increased
provision  of  information  is  one  way  of  helping
undertakings  to  make  more  of  the  advantages
inherent  in  this  market;  whereas  it  is  therefore
necessary  to  enable  economic  operators  to  give
their  assessment  of  the  impact  of  the  national
technical  regulations  proposed  by  other  Member
States,  by  providing  for  the  regular  publication  of
the  titles  of  notified  drafts  and  by  means  of  the
provisions  relating  to  the  confidentiality  of  such
drafts;

(3)  Whereas 

in  order 
functioning  of  the 

to  promote 
smooth
internal  market,  as  much

the 

(1)  OJ  C  78,  12.3.1997,  p.  4.
(2)  OJ  C  133,  28.4.1997,  p.  5.
(3)  Opinion  of  the  European  Parliament  of  17  September  1997
(OJ  C  304,  6.10.1997,  p.  79),  Council  Common  Position  of
23  February  1998  (OJ  C  110,  8.4.1998,  p.  1)  and  Decision
of  the  European  Parliament  of  30  April  1998  (OJ  C  152,
18.5.1998).  Decision  of  the  Council  of  28  May  1998.

(4)  OJ  L  109,  26.4.1983,  p.  8.  Directive  as  last  amended  by
Commission  Decision  96/139/EC  (OJ  L  32,  10.2.1996,  p.
31).

(8)  Whereas  it  is  appropriate,  in  the  interests  of  legal
certainty,  that  Member  States  publicly  announce
that  a  national  technical  regulation  has  been
adopted  in  accordance  with  the  formalities  laid
down  in  this  Directive;

(9)  Whereas,  as  far  as  technical  regulations  for
products  are  concerned,  the  measures  designed  to
ensure  the  proper  functioning  or  the  continued
include  greater
the  market 
development  of 
transparency  of  national 
intentions  and  a
broadening  of  the  criteria  and  conditions  for
assessing  the  potential  effect  of  the  proposed
regulations  on  the  market;

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(10)  Whereas  it  is  therefore  necessary  to  assess  all  the
requirements laid down in respect of a product and
to  take  account  of  developments 
in  national
practices  for  the  regulation  of  products;

(11)  Whereas 

than 

requirements,  other 

technical
specifications,  referring  to  the  life  cycle  of  a
product  after  it  has  been  placed on  the market are
liable  to  affect  the  free  movement  of  that  product
or  to  create  obstacles  to  the  proper  functioning  of
the  internal  market;

facto 

technical 

regulation;  whereas, 

(12)  Whereas  it  is  necessary  to  clarify  the  concept  of  a
de 
in
particular,  the  provisions  by  which  the  public
authority  refers  to  technical  specifications  or  other
requirements,  or 
the  observance
encourages 
thereof,  and  the  provisions  referring  to  products
with  which  the  public  authority  is  associated,  in
the public interest, have the effect of conferring on
such requirements or specifications a more binding
value  than  they  would  otherwise  have  by  virtue  of
their  private  origin;

(13)  Whereas  the  Commission  and  the  Member  States
must  also  be  allowed  sufficient  time  in  which  to
propose  amendments  to  a  contemplated  measure,
in order to remove or reduce any barriers which it
might  create  to  the  free  movement  of  goods;

(14)  Whereas  the  Member  State  concerned  must  take
account  of  these  amendments  when  formulating
the  definitive  text  of  the  measure  envisaged;

(15)  Whereas  it  is  inherent  in  the  internal  market  that,
in  particular  where 
the  principle  of  mutual
recognition cannot be implemented by the Member
States,  the  Commission  adopts  or  proposes  the
adoption  of  binding  Community  acts;  whereas  a
specific  temporary  standstill  period  has  been
established  in  order  to  prevent  the  introduction  of
national  measures 
the
from 
adoption  of  binding  Community  acts  by  the
Council  or  the  Commission  in  the  same  field;

compromising 

(16)  Whereas  the  Member  State  in  question  must,
pursuant  to  the  general  obligations  laid  down  in
Article 5 of the Treaty, defer implementation of the
contemplated  measure  for  a  period  sufficient  to
allow  either  a  joint  examination  of  the  proposed
amendments or the preparation of a proposal for a
binding  act  of  the  Council  or  the  adoption  of  a
binding  act  of  the  Commission;  whereas  the  time
limits 
the
representatives of the Governments of the Member

the  Agreement  of 

laid  down 

in 

States meeting within the Council of 28 May 1969
providing  for  standstill  and  notification  to  the
Commission (1), as amended by the Agreement of 5
March  1973 (2),  have  proved  inadequate  in  the
should  accordingly  be
cases  concerned  and 
extended;

(17)  Whereas  the  procedure  concerning  the  standstill
arrangement  and  notification  of  the  Commission
contained  in  the  abovementioned  agreement  of  28
May  1969  remains  applicable  to  products  subject
to  that  procedure  which  are  not  covered  by  this
Directive;

(18)  Whereas,  with  a  view  to  facilitating  the  adoption
of  Community  measures  by  the  Council,  Member
States  should  refrain  from  adopting  technical
regulations  once  the  Council  has  adopted  a
common  position  on  a  Commission  proposal
concerning  that  sector;

(19)  Whereas,  in  practice,  national  technical  standards
may have the same effects on the free movement of
goods  as  technical  regulations;

to 

those  which  apply 

(20)  Whereas  it  would  therefore  appear  necessary  to
inform  the  Commission  of  draft  standards  under
similar  conditions 
to
technical  regulations;  whereas,  pursuant  to  Article
213  of  the  Treaty,  the  Commission  may,  within
the  limits  and  under  the  conditions  laid  down  by
the  Council  in  accordance  with  the  provisions  of
the  Treaty,  collect  any  information  and  carry  out
any  checks  required  for  the  performance  of  the
tasks  entrusted  to  it;

(21)  Whereas it is also necessary for the Member States
and  the  standards  institutions  to  be  informed  of
standards  contemplated  by  standards  institutions
in  the  other  Member  States;

(22)  Whereas 

is 

systematic  notification 

actually
necessary  only  in  the  case  of  new  subjects  for
standardisation  and  in  so  far  as  the  treatment  of
these  subjects  at  national  level  may  give  rise  to
differences  in  national  standards  which  are  liable
to disturb the functioning of the market as a result;
whereas 
or
subsequent 
communication relating to the progress of national
activities  must  depend  on  the  interest  in  such
activities  expressed  by  those  to  whom  this  new
subject  has  already  been  communicated;

notification 

any 

(23)  Whereas the Commission must nevertheless be able
to  request  the  communication  of  all  or  part  of  the
national standardisation programmes so that it can
review  the  development  of  standardisation  activity
in  particular  economic  sectors;

(1)  OJ  C  76,  17.6.1969,  p.  9.
(2)  OJ  C  9,  15.3.1973,  p.  3.

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(24)  Whereas  the  European  standardisation  system
must  be  organised  by  and 
the  parties
concerned,  on  a  basis  of  coherence,  transparency,
openness,  consensus, 
independence  of  special
interests,  efficiency  and  decision-making  based  on
national  representation;

for 

(25)  Whereas  the  functioning  of  standardisation  in  the
Community  must  be  based  on  fundamental  rights
for the national standardisation bodies, such as the
possibility  of  obtaining  draft  standards,  being
informed  of  the  action  taken  in  response  to
submitted,  being  associated  with
comments 
national standardisation activities or requesting the
preparation  of  European  standards  in  place  of
national  standards;  whereas  it  is  for  the  Member
States  to  take  the  appropriate  measures  in  their
power  to  ensure  that  their  standardisation  bodies
observe  these  rights;

2. 

‘technical  specification’,  a  specification  contained  in
a  document  which  lays  down  the  characteristics
required  of  a  product  such  as  levels  of  quality,
performance,  safety  or  dimensions,  including  the
requirements  applicable  to  the  product  as  regards
the  name  under  which 
is  sold,
terminology,  symbols,  testing  and  test  methods,
packaging,  marking  or  labelling  and  conformity
assessment  procedures.

the  product 

term 

The 
‘technical  specification’  also  covers
production methods and processes used in respect of
agricultural  products  as  referred  to  Article  38(1)  of
the Treaty, products intended for human and animal
consumption,  and  medicinal  products  as  defined  in
Article  1  of  Directive  65/65/EEC (1),  as  well  as
production  methods  and  processes  relating  to  other
products,  where  these  have  an  effect  on  their
characteristics;

(26)  Whereas  the  provisions  concerning  the  standstill
national
applicable 
arrangements 
standardisation  bodies  when  a  European  standard
is  in  preparation  must  be  brought  into  line  with
the 
the
standardisation  bodies  within  the  framework  of
the  European  standardisation  bodies;

provisions 

adopted 

relevant 

by 

to 

(27)  Whereas  it  is  necessary  to  set  up  a  Standing
the  members  of  which  will  be
Committee, 
appointed  by  the  Member  States  with  the  task  of
helping  the  Commission  to  examine  draft  national
standards  and  cooperating  in  its  efforts  to  lessen
any  adverse  effects  thereof  on  the  free  movement
of  goods;

3. 

‘other  requirements’,  a  requirement,  other  than  a
technical specification, imposed on a product for the
purpose  of  protecting,  in  particular,  consumers  or
the environment, and which affects its life cycle after
it has been placed on the market, such as conditions
of  use,  recycling,  reuse  or  disposal,  where  such
the
conditions 
composition  or  nature  of  the  product  or 
its
marketing;

significantly 

influence 

can 

4. 

‘standard’,  a  technical  specification  approved  by  a
recognised  standardisation  body  for  repeated  or
continuous  application,  with  which  compliance  is
not  compulsory  and  which  is  one  of  the  following:

(28)  Whereas 

the  Standing  Committee  should  be
consulted  on  the  draft  standardisation  requests
referred  to  in  this  Directive;

—  international standard: a standard adopted by an
international  standardisation  organisation  and
made  available  to  the  public,

(29)  Whereas 

this  Directive  must  not  affect 

the
obligations  of  the  Member  States  concerning  the
deadlines for transposition of the Directives set out
in  Annex  III,  Part  B,

HAVE  ADOPTED  THIS  DIRECTIVE:

Article  1

For  the  purposes  of  this  Directive,  the  following
meanings shall apply:

1. 

‘product’,  any  industrially  manufactured  product
and  any  agricultural  product, 
fish
products;

including 

—  European  standard:  a  standard  adopted  by  a
standardisation  body  and  made

European 
available  to  the  public,

—  national  standard:  a  standard  adopted  by  a
and  made
standardisation  body 

national 
available  to  the  public;

5. 

‘standards  programme’,  a  work  programme  of  a
recognised  standardisation  body  listing  the  subjects
on  which  standardisation  work  is  being  carried
out;

(1)  Council  Directive  65/65/EEC  of  26  January  1965  on  the
approximation of provisions laid down by law, regulation or
administrative  action  relating  to  medicinal  products  (OJ  22,
9.2.1965,  p.  369/65),  Directive  as  last  amended  by  Directive
93/39/EEC  (OJ  L  214,  24.8.1993,  p.  22).

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6. 

‘draft standard’, document containing the text of the
technical  specifications  concerning  a  given  subject,
which 
in
accordance  with  the  national  standards  procedure,
as  that  document  stands  after  the  preparatory  work
and  as  circulated  for  public  comment  or  scrutiny;

is  being  considered 

for  adoption 

7. 

‘European  standardisation  body’,  a  body  referred  to
in  Annex  I;

8. 

‘national  standardisation  body’,  a  body  referred  to
in  Annex  II;

9. 

the 

including 

requirements, 

‘technical  regulation’,  technical  specifications  and
other 
relevant
administrative provisions, the observance of which is
compulsory,  de  jure  or  de  facto,  in  the  case  of
marketing or use in a Member State or a major part
thereof, as well as laws, regulations or administrative
provisions  of  Member  States,  except  those  provided
for  in  Article  10,  prohibiting  the  manufacture,
importation,  marketing  or  use  of  a  product.

De  facto  technical  regulations  include:

requirements  or 

—  laws,  regulations  or  administrative  provisions  of
a  Member  State  which  refer  either  to  technical
specifications  or  other 
to
professional  codes  or  codes  of  practice  which  in
turn  refer  to  technical  specifications  or  other
requirements  and  compliance  with  which  confers
a presumption of conformity with the obligations
imposed  by  the  aforementioned  laws,  regulations
or  administrative  provisions,

—  voluntary agreements to which a public authority
is  a  contracting  party  and  which  provide,  in  the
public  interest,  for  compliance  with  technical
specifications  or  other  requirements,  excluding
public  procurement  tender  specifications,

—  technical  specifications  or  other  requirements
which  are  linked  to  fiscal  or  financial  measures
the  consumption  of  products  by
affecting 
encouraging  compliance  with  such 
technical
specifications  or  other  requirements;  technical
specifications  or  other  requirements  linked  to
national  social-security  systems  are  not  included.

This  comprises  technical  regulations  imposed  by  the
authorities  designated  by  the  Member  States  and
appearing  on  a 
list  to  be  drawn  up  by  the
Commission  before  1  July  1995,  in  the  framework
of  the  Committee  referred  to  in  Article  5.

The same procedure shall be used for amending this
list;

10.  ‘draft  technical  regulation’,  the  text  of  a  technical
specification  or  other 
including
administrative provisions formulated with the aim of
enacting  it  or  of  ultimately  having  it  enacted  as  a
technical  regulation,  the  text  being  at  a  stage  of
preparation  at  which  substantial  amendments  can
still  be  made.

requirement, 

This Directive shall not apply to those measures Member
States  consider  necessary  under  the  Treaty  for  the
protection  of  persons, 
in  particular  workers,  when
products  are  used,  provided  that  such  measures  do  not
affect  the  products.

Article  2

1. The  Commission  and  the  standardisation  bodies
referred  to  in  Annexes  I  and  II  shall  be  informed  of  the
new  subjects  for  which  the  national  bodies  referred  to  in
Annex  II  have  decided,  by  including  them  in  their
standards  programme,  to  prepare  or  amend  a  standard,
unless  it  is  an  identical  or  equivalent  transposition  of  an
international  or  European  standard.

2. The  information  referred  to  in  paragraph  1  shall
indicate,  in  particular,  whether  the  standard  concerned:

—  will  transpose  an 
being  the  equivalent,

international  standard  without

—  will  be  a  new  national  standard,  or

—  will  amend  a  national  standard.

After  consulting  the  Committee  referred  to  in  Article  5,
the  Commission  may  draw  up  rules  for  the  consolidated
presentation  of  this  information  and  a  plan  and  criteria
governing the presentation of this information in order to
facilitate  its  evaluation.

3. The  Commission  may  ask  for  all  or  part  of  the
standards  programmes  to  be  communicated  to  it.

It  shall  make  this  information  available  to  the  Member
States  in  a  form  which  allows  the  different  programmes
to  be  assessed  and  compared.

4. Where  appropriate,  the  Commission  shall  amend
Annex  II  on  the  basis  of  communications  from  the
Member  States.

5. The  Council  shall  decide,  on  the  basis  of  a  proposal
from  the  Commission,  on  any  amendment  to  Annex  I.

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Article  3

The  standardisation  bodies  referred  to  in  Annexes  I  and
II,  and  the  Commission,  shall  be  sent  all  draft  standards
on  request;  they  shall  be  kept  informed  by  the  body
concerned  of  the  action  taken  on  any  comments  they
have  made  relating  to  drafts.

Article  4

1. Member States shall take all necessary steps to ensure
that  their  standardisation  bodies:

—  communicate information in accordance with Articles

2  and  3,

—  publish  the  draft  standards  in  such  a  way  that
from  parties

comments  may  also  be  obtained 
established  in  other  Member  States,

—  grant  the  other  bodies  referred  to  in  Annex  II  the
right  to  be  involved  passively  or  actively  (by  sending
an  observer)  in  the  planned  activities,

—  do not object to a subject for standardisation in their
work programme being discussed at European level in
accordance with the rules laid down by the European
standardisation bodies and undertake no action which
may  prejudice  a  decision  in  this  regard.

2. Member States shall refrain in particular from any act
of recognition, approval or use by reference to a national
standard  adopted  in  breach  of  Articles  2  and  3  and  of
paragraph  1  of  this  Article.

Article  5

A  Standing  Committee  shall  be  set  up  consisting  of
representatives appointed by the Member States who may
call on the assistance of experts or advisers; its chairman
shall  be  a  representative  of  the  Commission.

The  Committee  shall  draw  up 
procedure.

its  own  rules  of

3. The  Committee  shall  express  its  opinion  on  the
communications and proposals referred to in paragraph 2
and  may  in  this  connection  propose,  in  particular,  that
the  Commission:

—  request  the  European  standards  institutions  to  draw
up  a  European  standard  within  a  given  time  limit,

—  ensure  where  necessary,  in  order  to  avoid  the  risk  of
barriers  to  trade,  that  initially  the  Member  States
concerned  decide  amongst  themselves  on  appropriate
measures,

—  take  all  appropriate  measures,

—  identify  the  areas  where  harmonisation  appears
necessary,  and,  should  the  case  arise,  undertake
appropriate  harmonisation  in  a  given  sector.

4. The  Committee  must  be 
Commission:

consulted  by 

the

(a)  before any amendment is made to the lists in Annexes

I  and  II  (Article  2(1));

(b) when  drawing  up  the  rules  for  the  consolidated
presentation  of  information  and  the  plan  and  criteria
for the presentation of standards programmes (Article
2(2));

(c)  when  deciding  on  the  actual  system  whereby  the
exchange of information provided for in this Directive
is  to  be  effected  and  on  any  change  to  it;

(d) when reviewing the operation of the system set up by

this  Directive;

(e)  on  the  requests  to  the  standards  institutions  referred

to  in  the  first  indent  of  paragraph  3.

5. The Committee may be consulted by the Commission
on  any  preliminary  draft  technical  regulation  received  by
the  latter.

Article  6

6. Any  question  regarding  the  implementation  of  this
Directive  may  be  submitted  to  the  Committee  at  the
request  of  its  chairman  or  of  a  Member  State.

1. The  Committee  shall  meet  at  least  twice  a  year  with
the  representatives  of  the  standards  institutions  referred
to  in  Annexes  I  and  II.

7. The  proceedings  of 
information  to  be  submitted  to  it  shall  be  confidential.

the  Committee  and 

the

2. The  Commission  shall  submit  to  the  Committee  a
report  on  the  implementation  and  application  of  the
procedures  set  out  in  this  Directive,  and  shall  present
proposals  aimed  at  eliminating  existing  or  foreseeable
barriers  to  trade.

However,  the  Committee  and  the  national  authorities
may,  provided  that  the  necessary  precautions  are  taken,
consult,  for  an  expert  opinion,  natural  or  legal  persons,
including  persons  in  the  private  sector.

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Article  7

1. Member  States  shall  take  all  appropriate  measures  to
ensure  that,  during  the  preparation  of  a  European
standard  referred  to  in  the  first  indent  of  Article  6(3)  or
after  its  approval,  their  standardisation  bodies  do  not
take any action which  could  prejudice  the  harmonisation
intended  and,  in  particular,  that  they  do  not  publish  in
the  field  in  question  a  new  or  revised  national  standard
which is not completely in line with an existing European
standard.

product  concerned  and 
to  known  and  available
substitutes,  where  such  information  may  be  available,
and  communicate  the  anticipated  effects  of  the  measure
on  public  health  and  the  protection  of  the  consumer  and
the  environment,  together  with  an  analysis  of  the  risk
carried out as appropriate in accordance with the general
principles  for  the  risk  evaluation  of  chemical  substances
as  referred  to  in  Article  10(4)  of  Regulation  (EEC)  No
793/93 (1)  in  the  case  of  an  existing  substance  or  in
Article  3(2)  of  Directive  67/548/EEC (2),  in  the  case  of  a
new  substance.

2. Paragraph 1 shall not apply to the work of standards
institutions  undertaken  at  the  request  of  the  public
authorities  to  draw  up  technical  specifications  or  a
standard for specific products for the purpose of enacting
a  technical  regulation  for  such  products.

The  Commission  shall  immediately  notify  the  other
Member  States  of  the  draft  and  all  documents  which
have been forwarded to it; it may also refer this draft, for
an opinion, to the Committee referred to in Article 5 and,
where  appropriate,  to  the  committee  responsible  for  the
field  in  question.

Member States shall communicate all requests of the kind
referred  to 
in  the  preceding  subparagraph  to  the
Commission  as  draft  technical  regulations,  in  accordance
with  Article  8(1),  and  shall  state  the  grounds  for  their
enactment.

Article  8

to  Article  10,  Member  States 

1. Subject 
shall
immediately  communicate  to  the  Commission  any  draft
technical  regulation,  except  where  it  merely  transposes
the full text of an international or European standard, in
which  case  information  regarding  the  relevant  standard
shall  suffice;  they  shall  also  let  the  Commission  have  a
statement  of  the  grounds  which  make  the  enactment  of
such  a  technical  regulation  necessary,  where  these  have
not  already  been  made  clear  in  the  draft.

Where  appropriate,  and  unless  it  has  already  been  sent
with  a  prior  communication,  Member  States  shall
simultaneously  communicate  the  text  of  the  basic
legislative  or  regulatory  provisions  principally  and
directly  concerned,  should  knowledge  of  such  text  be
necessary  to  assess  the  implications  of  the  draft  technical
regulation.

Member  States  shall  communicate  the  draft  again  under
the  above  conditions  if  they  make  changes  to  the  draft
that  have  the  effect  of  significantly  altering  its  scope,
shortening 
for
implementation, adding specifications or requirements, or
making  the  latter  more  restrictive.

timetable  originally  envisaged 

the 

Where, 
limit  the
in  particular,  the  draft  seeks  to 
marketing or use of a chemical substance, preparation or
product  on  grounds  of  public  health  or  of  the  protection
of  consumers  or  the  environment,  Member  States  shall
also  forward  either  a  summary  or  the  references  of  all
relevant  data  relating  to  the  substance,  preparation  or

With  respect  to  the  technical  specifications  or  other
requirements  referred  to  in  the  second  subparagraph  of
Article  1(9),  third  indent,  the  detailed  comments  or
opinions  of  the  Commission  or  the  Member  States  may
concern  only  the  aspect  which  may  hinder  trade  and  not
the  fiscal  or  financial  aspect  of  the  measure.

2. The  Commission  and  the  Member  States  may  make
comments  to  the  Member  State  which  has  forwarded  a
draft  technical  regulation;  that  Member  State  shall  take
such  comments  into  account  as  far  as  possible  in  the
subsequent  preparation  of  the  technical  regulation.

3. Member  States  shall  communicate  the  definitive  text
of  a  technical  regulation  to  the  Commission  without
delay.

4.
Information  supplied  under  this  Article  shall  not  be
confidential except at the express request of the notifying
Member  State.  Any  such  request  shall  be  supported  by
reasons.

In  cases  of  this  kind,  if  necessary  precautions  are  taken,
the  Committee  referred  to  in  Article  5  and  the  national
authorities may seek expert advice from physical or legal
persons  in  the  private  sector.

(1)  Council  Regulation  (EEC)  No  793/93  of  23  March  1993  on
the evaluation and control of the risks of existing substances
(OJ  L  84,  5.4.1993,  p.  1).

(2)  Council  Directive  67/548/EEC  of  27  June  1967  on  the
approximation  of  the  laws,  regulations  and  administrative
provisions  relating  to  the  classification,  packaging  and
labelling  of  dangerous  substances  (OJ  L  196,  16.8.1967,
p.  1).  Directive,  as  amended  by  Directive  92/32/EEC,  (OJ
L  154,  5.6.1992,  p.  1).

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5. When  draft  technical  regulations  form  part  of
measures  which  are  required  to  be  communicated  to  the
Commission at the draft stage under another Community
act,  Member  States  may  make  a  communication  within
the  meaning  of  paragraph  1  under  that  other  act,
provided  that  they  formally 
indicate  that  the  said
communication  also  constitutes  a  communication  for  the
purposes  of  this  Directive.

receipt by the Commission of the communication referred
to  in  Article  8(1)  if,  within  the  three  months  following
that  date,  the  Commission  announces  its  finding  that  the
draft  technical  regulation  concerns  a  matter  which  is
covered  by  a  proposal  for  a  directive,  regulation  or
decision  presented  to  the  Council  in  accordance  with
Article  189  of  the  Treaty.

The  absence  of  a  reaction  from  the  Commission  under
this  Directive  to  a  draft  technical  regulation  shall  not
prejudice any decision which might be taken under other
Community  acts.

Article  9

1. Member States shall postpone the adoption of a draft
technical  regulation  for  three  months  from  the  date  of
receipt by the Commission of the communication referred
to  in  Article  8(1).

2. Member  States  shall  postpone:

—  for  four  months  the  adoption  of  a  draft  technical
regulation  in  the  form  of  a  voluntary  agreement
within  the  meaning  of  Article  1(9),  second  indent,

—  without  prejudice  to  paragraphs  3,  4  and  5,  for  six
months  the  adoption  of  any  other  draft  technical
regulation,

from  the  date  of  receipt  by  the  Commission  of  the
communication  referred 
the
to 
Commission  or  another  Member  State  delivers  a  detailed
opinion,  within  three  months  of  that  date,  to  the  effect
that  the  measure  envisaged  may  create  obstacles  to  the
free  movement  of  goods  within  the  internal  market.

in  Article  8(1) 

if 

The  Member  State  concerned  shall  report  to  the
Commission  on  the  action  it  proposes  to  take  on  such
detailed  opinions.  The  Commission  shall  comment  on
this  reaction.

3. Member States shall postpone the adoption of a draft
technical  regulation  for  12  months  from  the  date  of
receipt by the Commission of the communication referred
to  in  Article  8(1)  if,  within  the  three  months  following
that  date,  the  Commission  announces  its  intention  to
propose  or  adopt  a  directive,  regulation  or  decision  on
the  matter  in  accordance  with  Article  189  of  the  Treaty.

5.
If  the  Council  adopts  a  common  position  during  the
standstill  period  referred  to  in  paragraphs  3  and  4,  that
period  shall,  subject  to  paragraph  6,  be  extended  to  18
months.

6. The  obligations  referred  to  in  paragraphs  3,  4  and  5
shall lapse:

—  when  the  Commission  informs  the  Member  States
that  it  no  longer  intends  to  propose  or  adopt  a
binding  Community  act,

—  when  the  Commission  informs  the  Member  States  of

the  withdrawal  of  its  draft  or  proposal,

—  when  the  Commission  or  the  Council  has  adopted  a

binding  Community  act.

7. Paragraphs  1  to  5  shall  not  apply  in  those  cases
where,  for  urgent  reasons,  occasioned  by  serious  and
unforeseeable  circumstances  relating  to  the  protection  of
public  health  or  safety,  the  protection  of  animals  or  the
preservation  of  plants,  a  Member  State  is  obliged  to
prepare technical regulations in a very short space of time
in  order  to  enact  and  introduce  them  immediately
without  any  consultations  being  possible.  The  Member
State  shall  give,  in  the  communication  referred  to  in
Article  8,  the  reasons  which  warrant  the  urgency  of  the
measures  taken.  The  Commission  shall  give  its  views  on
the  communication  as  soon  as  possible.  It  shall  take
appropriate  action  in  cases  where  improper  use  is  made
of this procedure. The European Parliament shall be kept
informed  by  the  Commission.

Article  10

1. Articles  8  and  9  shall  not  apply  to  those  laws,
regulations  and  administrative  provisions  of  the  Member
States  or  voluntary  agreements  by  means  of  which
Member  States:

—  comply with binding Community acts which result in

the  adoption  of  technical  specifications,

—  fulfil  the  obligations  arising  out  of  international
agreements  which  result  in  the  adoption  of  common
technical  specifications  in  the  Community,

4. Member States shall postpone the adoption of a draft
technical  regulation  for  12  months  from  the  date  of

—  make use of safeguard clauses provided for in binding

Community  acts,

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21.7.98

—  apply  Article  8(1)  of  Directive  92/59/EEC (1),

Article  12

—  restrict themselves to implementing a judgment of the
Court  of  Justice  of  the  European  Communities,

—  restrict themselves to amending a technical regulation
within the meaning of Article 1(9) of this Directive, in
accordance  with  a  Commission  request,  with  a  view
to  removing  an  obstacle  to  trade.

2. Article  9  shall  not  apply  to  the  laws,  regulations  and
the  Member  States
administrative  provisions  of 
prohibiting  manufacture  insofar  as  they  do  not  impede
the  free  movement  of  products.

3. Article  9(3)  to  (6)  shall  not  apply  to  the  voluntary
agreements  referred  to  in  Article  1(9),  second  indent.

4. Article 9 shall not apply to the technical specifications
or  other  requirements  referred  to  in  Article  1(9),  third
indent.

When  Member  States  adopt  a  technical  regulation,  it
shall  contain  a  reference  to  this  Directive  or  shall  be
accompanied  by  such  reference  on  the  occasion  of  its
official  publication.  The  methods  of  making  such
reference  shall  be  laid  down  by  Member  States.

Article  13

1. The Directives and Decisions listed in Annex III, Part
the
A  are  hereby  repealed  without  prejudice 
the
obligations  of 
deadlines  for  transposition  of  the  said  Directives,  set  out
in  Annex  III,  Part  B.

to 
the  Member  States  concerning 

2. References  to  the  repealed  directives  and  decisions
shall be construed as references to this Directive and shall
be read in accordance with the correlation table set out in
Annex  IV.

Article  14

This  Directive  shall  enter  into  force  on  the  20th  day
following that of its publication in the Official Journal of
the  European  Communities.

Article  11

Article  15

This  Directive  is  addressed  to  the  Member  States.

The  Commission  shall  report  every  two  years  to  the
European Parliament, the Council and the Economic and
Social Committee on the results of the application of this
Directive.  Lists  of  standardisation  work  entrusted  to  the
European  standardisation  organisations  pursuant  to  this
Directive,  as  well  as  statistics  on  the  notifications
received,  shall  be  published  on  an  annual  basis  in  the
Official  Journal  of  the  European  Communities.

Done  at  Luxembourg,  22  June  1998.

For  the  European  Parliament

For  the  Council

The  President

The  President

J. M.  GIL-ROBLES

J.  CUNNINGHAM

(1)  Council  Directive  92/59/EEC  of  29  June  1992  on  general

product  safety  (OJ  L  228,  11.8.1992,  p.  24).

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ANNEX  I

EUROPEAN  STANDARDISATION  BODIES

CEN

European  Committee  for  Standardisation

Cenelec

European  Committee  for  Electrotechnical  Standardisation

ETSI

European  Telecommunications  Standards  Institute

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ANNEX  II

NATIONAL  STANDARDISATION  BODIES

1.  BELGIUM

IBN/BIN
Institut  belge  de  normalisation
Belgisch  Instituut  voor  Normalisatie

CEB/BEC
Comite´ e´lectrotechnique  belge
Belgisch  Elektrotechnisch  Comite´

2.  DENMARK

DS
Dansk  Standard

NTA
Telestyrelsen,  National  Telecom  Agency

3.  GERMANY

DIN
Deutsches  Institut  für  Normung  e.V.

DKE
Deutsche  Elektrotechnische  Kommission  im  DIN  und  VDE

4.  GREECE

ΕΛˆΤ
ΕλληνØκ(cid:222)ς  ˆργÆνØ(cid:243)µ(cid:222)ς  Τυ(cid:240)(cid:239)(cid:240)(cid:239)(cid:221)η(cid:243)ης

5.  SPAIN

AENOR
Asociación  Española  de  Normalización  y  Certificación

6.  FRANCE

AFNOR
Association  française  de  normalisation

UTE
Union  technique  de  l’e´lectricite´ —  Bureau  de  normalisation  aupre`s  de  l’AFNOR

7. 

IRELAND

NSAI
National  Standards  Authority  of  Ireland

ETCI
Electrotechnical  Council  of  Ireland

8. 

ITALY

UNI (1)
Ente  nazionale  italiano  di  unificazione

CEI (1)
Comitato  elettrotecnico  italiano

(1)  UNI  and  CEI,  in  cooperation  with  the  Istituto  superiore  delle  Poste  e  telecommunicazioni  and  the  ministero
dell’Industria,  have  allocated  the  work  within  ETSI  to  CONCIT,  Comitato  nazionale  di  coordinamento  per  le
tecnologie dell’informazione.

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9.  LUXEMBOURG

ITM

Inspection  du  travail  et  des  mines

SEE

Service  de  l’e´nergie  de  l’État

10.  NETHERLANDS

NNI

Nederlands  Normalisatie-instituut

NEC

Nederlands  Elektrotechnisch  Comite´

11.  AUSTRIA

ON

Österreichisches  Normungsinstitut

ÖVE

Österreichischer  Verband  für  Elektrotechnik

12.  PORTUGAL

IPQ

Instituto  Portugueˆs  da  Qualidade

13.  UNITED  KINGDOM

BSI

British  Standards  Institution

BEC

British  Electrotechnical  Committee

14.  FINLAND

SFS

Suomen  Standardisoimisliitto  SFS  ry

Finlands  Standardiseringsförbund  SFS  rf

THK/TFC

Telehallintokeskus

Teleförvaltningscentralen

SESKO

Suomen  Sähköteknillinen  Standardisoimisyhdistys  SESKO  ry

Finlands  Elektrotekniska  Standardiseringsförening  SESKO  rf

15.  SWEDEN

SIS

Standardiseringen i Sverige

SEK

Svenska  elektriska  kommissionen

ITS

Informationstekniska  standardiseringen

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ANNEX  III

PART  A

Repealed  Directives  and  Decisions

(referred  to  by  Article  13)

Directive  83/189/EEC  and  its  following  amendments

Council  Directive  88/182/EEC

Commission  Decision  90/230/EEC

Commission  Decision  92/400/EEC

Directive  94/10/EC  of  the  European  Parliament  and  Council

Commission  Decision  96/139/EC

PART  B

List  of  deadlines  for  transposition  into  national  law

(referred  to  in  Article  13)

Directive

Deadline  for  transposition

83/189/EEC  (OJ  L  109,  26.4.1983,  p.  8)

88/182/EEC  (OJ  L  81,  26.3.1988,  p.  75)

94/10/EC  (OJ  L  100,  19.4.1994,  p.  30)

31.3.1984

1.1.1989

1.7.1995

ANNEX  IV

CORRELATION  TABLE

Directive  83/189/EEC

This Directive

Article  1

Article  2

Article  3

Article  4

Article  5

Article  6

Article  7

Article  8

Article  9

Article  10

Article  11

Article  12

—

—

—

Annex  I

Annex  II

—

—

Article  1

Article  2

Article  3

Article  4

Article  5

Article  6

Article  7

Article  8

Article  9

Article  10

Article  11

Article  12

Article  13

Article  14

Article  15

Annex  I

Annex  II

Annex  III

Annex  IV