Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE laying down a procedure for the provision of information in the field of technical standards and regulations - (codified version)
Date: 1996-12-13
Institutions: European Commission
Subjects: codification of EU law, exchange of information, harmonisation of standards, technical regulations, technical standard

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  13.12.1996 
COM(96) 642  final 

96/ 0300 (COD) 

Proposal  for a 

EUROPEAN PARLIAMENT  AND  COUNCIL DIRECTIVE 

laying down a procedure for the provision of information in the field  of technical  standards 
and regulations 

(codified version) 

(presented  by the  Commission) 

EXPLANATORY  MEMORANDUM 

1. 

In  the  context  of  a  people's  Europe,  the  Commission  attaches  great  importance  to 
simplifying  and clarifying  Community law so as to make it clearer and more accessible 
to  the ordinary citizen, thus giving him new opportunities and the chance to make use 
of  the  specific rights it  gives him. 

This aim cannot be achieved so long as numerous provisions that have been  amended 
several  times, often  quite substantially,  remain scattered,  so that  they must be  sought 
partly  in  the  original  instrument  and partly  in later  amending  ones.  Considerable  re 
search  work,  comparing  many  different  instruments,  is  thus  needed  to  identify  the 
current  rules. 

For  this  reason  a  consolidation  of  rules  that  have  frequently  been  amended  is  also 
essential  if  Community  law  is to be clear  and  transparent 

2.  On  1 April  1987 the  Commission  therefore  decided  to  instruct  its  staff  that  all legis 
lative measures should  be consolidated  after  no more  than  ten amendments,  stressing 
that  this was a minimum requirement  and that departments  should endeavour  to con 
solidate  at  even  shorter  intervals  the  texts for which  they were  responsible,  to  ensure 
that  the  Community  rules were  clear  and  readily  understandable. 

3.  The  Conclusions  of  the  Presidency  of  the  Edinburgh  European  Council  (December 
1992)  confirmed  this, stressing  the  importance  of  legislative  consolidation  as it  offers 
certainty  as to  the  law applicable  to  a  given  matter  at  a given time. 

It  must  be  undertaken  in full  compliance with the  normal  Community  legislative pro 
cedure. 

Given  that no changes of substance  may be made  to the instruments  affected  by legis 
lative  consolidation,  Parliament,  the  Council  and  the  Commission  have  agreed,  by an 
interinstitutional  agreement  dated  20 December  1994, that  an  accelerated  procedure 
may be  used  for  the  fast-track  adoption  of codification  instruments. 

4.  The purpose  of this proposal (1) for consolidation  of  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 is to undertake  official  codification  of  this type. 
The  new  directive  will  supersede  the  various  directives  incorporated  in  it  (2);  their 
content  is  fully  preserved,  and  they  are  brought  together  with  only  such  formal 
amendments  as are  required  by the  codification  exercise  itself. 

5.  This consolidation  proposal was drawn up on the basis of a preliminary  consolidation. 
in all the official  languages, of Directive 83/189/EEC and the instruments amending it, 
carried  out  by the  Office  for  Official  Publications  of  the  European  Communities, by 
means  of  a  data-processing  system  referred  to  in  the  conclusions  of  the  European 
Council  meeting  at  Edinburgh.  Although  the  articles  have  been  given  new  numbers, 
the  former  number  is printed  alongside  in each case  for  the  reader's  convenience;  the 
correlation  between  the old  and  new numbers  is shown  in a table contained  in Annex 
IV  to  the  consolidated  Directive. 

(*)  Entered in the legislative programme for 1996. 
(2)  See Part A of Annex III. 

Proposal  for a 

EUROPEAN PARLIAMENT AND COUNCIL DDŒCTrVE -V.JEC 

of 

laying down a  procedure for the provision  of information  in the field  of technical stan 
dards and  regulations 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF 
THE EUROPEAN UNION, 

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; 

Having  regard  to  the  opinion  of  the  Economic  and  So 
cial  Committee (1); 

Acting  in  accordance  with  the  procedure  laid  down  in 
Article  189b of  the  Treaty  (2); 

1)  Whereas  Council  Directive  83/189/EEC  of  28  March 
1983  laying  down  a  procedure  for  the  provision  of  in 
formation  in  the  field  of  technical  standards  and  regula 
tions (3) has been  frequently  and  substantially  amended; 
whereas  for  reasons  of  clarity  and  rationality  the  said 
Directive  should  be  consolidated; 

2)  Whereas  the  internal  market  comprises  an  area  without 
internal  frontiers  in which  the  free  movement  of goods, 
persons,  services  and  capital  is  ensured; whereas,  there 
fore,  the  prohibition  of  quantitative  restrictions  on  the 
movement  of  goods  and of  measures  having  an equival 
ent  effect  is one of the  basic principles of  the  Commun 
ity, 

3)  Whereas  in order  to promote  the  smooth  functioning  of 
the  internal  market,  as  much  transparency  as  possible 
should  be  ensured  as  regards  national  initiatives  for  the 
establishment  of  technical  standards  or  regulations; 

4)  Whereas  barriers  to  trade  resulting  from  technical  re 
gulations relating to products may be allowed only where 
they  are  necessary  in  order  to  meet  essential  require 
ments  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 
the 
technical  provisions;  whereas,  consequently, 
Member  States  which  are  required  to  facilitate  the 
achievement  of  its  task  pursuant  to  Article  5  of  the 
Treaty  must  notify  it  of  their  projects  in  the  field  of 
technical  regulations; 

() 
(3)  OJ  No  L  109, 26. 4.  1983, p. 8. Directive  as last  amended  by 
Commission Decision %/139/EC (OJ  No L 32, 10. 2.19%, p. 
31). 

88/182/EEC 
(adapted) 
83/189/EEC 
(adapted) 

94/10/EC 
(adapted) 

83/189/EEC 

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

7)  Whereas the aim of  the  internal  market  is to  create an 
environment  that is conducive to the 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 there 
fore  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 noti 
ced drafts and by means of the provisions relating to the 
confidentiality  of such  drafts; 

8)  Whereas  it  is  appropriate,  in  the  interests  of  legal  cer 
tainty,  that  Member  States  publicly  announce  that  a 
national 
in 
accordance with the formalities  laid  down  in this Direc 
tive; 

technical  regulation  has  been  adopted 

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

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

11)  Whereas 

other 

requirements, 

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

than 

12)  Whereas  it  is  necessary  to  specify  the  concept  of  a  de 
facto  technical  regulation;  whereas,  in  particular,  the 
provisions  by  which 
the  public  authority  refers  to 
technical specifications or other requirements, or encour 
ages the observance 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 re 
move or reduce any barriers which it might  create to the 
free  movement  of goods; 

14)  Whereas  the  Member  State  concerned  must  take  ac 
count of these amendments when formulating  the  defini 
tive text  of  the  measure  envisaged; 

83/189/EEC 

15. 

94/10/EC 
(adapted) 

16. 

(adapted) 

94/10/EC 

10. 

11. 

12. 

(adapted) 

83/189/EEC 

15)  Whereas  it  is  inherent  in  the  internal  market  that,  in 
particular where the principle of mutual recognition can 
not be implemented by the Member States, the Commis 
sion  adopts  or  proposes  the  adoption  of  binding Com 
munity  acts;  whereas  a  specific  temporary  standstill 
period  has been  established  in order to prevent the in 
troduction of binding Community acts by the Council or 
the Commission in the same field; 

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 prep 
aration  of  the proposal for a binding art of  the Council 
or  the  adoption  of  a  binding  act  of  the  Commission; 
whereas  the  time limits laid down in the Agreement of 
the representatives  of  the  Governments of  the Member 
States meeting within the  Council of  28 May  1969 pro 
viding for  standstill  and notification  to  the  Commission 
(l),  as amended by the Agreement of 5 March 1973 (2), 
have  proved  inadequate  in  the  cases  concerned  and 
should  accordingly be extended; 

17)  Whereas the procedure concerning the standstill arrange 
ment  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 Com 
mission  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; 

20)  Whereas it would  therefore  appear necessary  to inform 
the  Commission  of  draft  standards  under similar condi 
tions  to  those  which  apply  to  technical  regulations; 
whereas, pursuant to Article 213 of the Treaty, the Com 
mission  may, within  the  limits and  under the conditions 
laid down  by the  Council  in  accordance with the provi 
sions of the Treaty, collect any information and carry out 
any checks required for the performance of the tasks en 
trusted  to it; 

17. 

94/10/EC 
(adapted) 

83/189/EEC 
(adapted) 

18. 

94/10/EC 
(adapted) 

10. 

83/189/EEC 

11. 

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; 

12. 

0)  OJ No C 76,17.6.1969, p. 9 
(2)  OJ No C 9,15. 3.1973, p. 3 

22)  Whereas systematic notification is actually necessary only 
in the case of new subjects for standardization and in so 
far  as the  treatment  of  these  subjects  at  national  level 
may gfve rise to differences  in national standards which 
are liable to  disturb the functioning  of  the market as a 
result;  whereas  any  subsequent  notification  or com 
munication 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; 

23)  Whereas the  Commission  must  nevertheless  be  able to 
request the communication of all or part of the national 
standardization programmes so that it can review the de 
velopment of  standardization  activity in particular econ 
omic sectors; 

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

openness, 

25)  Whereas the  functioning of standardization in the Com 
munity  must  be  based  on  fundamental  rights  for  the 
national standardization bodies, such as the possibility of 
obtaining  draft  standards,  being  informed  of  the action 
taken 
in  response  to  comments  submitted,  being 
associated with national  standardization  activities or re 
questing 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 standardization bodies observe these 
rights; 

26)  Whereas the provisions concerning the standstill arrange 
ments applicable to national standardization bodies when 
a  European standard  is in preparation must be brought 
into  line  with  the  relevant  provisions  adopted  by  the 
standardization  bodies  within  the  framework  of  the 
European standardization bodies; 

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

28)  Whereas  the  Standing  Committee  should  be  consulted 
on  the  draft  standardization  request  referred  to  in this 
Directive; 

29)  Whereas this Directive must not affect  the obligations of 
the  Member  States  concerning  the  deadlines  for trans 
position of the  Directives set out  in Annex III, Part B, 

HAVE ADOPTED THIS DIRECTIVE: 

94/10/EC 

7. 

(adapted) 

13. 

83/189/EEC 

88/182/EEC 
(adapted) 

Article 1 

83/189/EEC 

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

1. 

2. 

'product',  any industrially manufactured  product and 
any agricultural product, including fish products; 

95/1/EC, Euratom, ECSC 

94/10/EC -  Art  l(l)(b) 

'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 ap 
plicable  to  the  product  as  regards  the  name  under 
which the product is sold, terminology, symbols, test 
ing and test methods, packaging, marking or labelling 
and conformity  assessment procedures. 

The term 'technical  specification'  also covers produc 
tion methods and processes used in respect of agricul 
tural products  as  referred  to in Article 38  (1)  of  the 
Treaty, products intended for human and animal con 
sumption,  and  medicinal  products  as  defined  in  Ar 
ticle  1 of  Council  Directive  65/65/EEC (1), as well as 
production  methods  and  processes  relating  to  other 
products, where  these have an effect  on their charac 
teristics; 

3. 

'other  requirement',  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  condi 
tions  can  significantly  influence  the  composition  or 
nature  of  the  product  or  its marketing; 

4. 

'standard',  a technical specification  approved  by a rec 
ognized  standardization  body for  repeated  or continu 
ous application, compliance with which is not compul 
sory and  which  is one  of  the  following: 

— 

international  standard: a standard  adopted  by an 
international  standardization  organization  and 
made  available  to  the public, 

—  European  standard:  a  standard  adopted  by  a 
European  standardization  body  and  made  avail 
able  to  the  public, 

—  national  standard:  a  standard  adopted  by  a 
national standardization  body and made available 
to  the public; 

94/10/EC -  Art.  l(l)(c) 

5. 

'standards programme', a work programme of a recog 
nized  standardization  body  listing  the  subjects  on 
which  standardization  work  is being carried  out; 

94/10/EC -  Art.  l(l)(d) 

0)  OJNo22,9.2.1965,p.369/65.DirectiveaslastamendedbyDi-
rective 93/39/EEC (OJ No L 214, 24.8.1993, p. 22). 

JL 

'draft  standard',  document  containing  the  text of  the 
technical  specifications  concerning  a  given  subject, 
which is being considered for adoption in accordance 
with  the  national  standards  procedure,  as that docu 
ment stands  after  the preparatory work and as circu 
lated  for public comment or scrutiny; 

83/189/EEC -  94/10/EC -  Art  l(l)(e) 

7. 

8. 

9. 

'European  standardization  body',  a  body  referred  to 
in Annex I; 

94/10/EC -  Art  l(l)(f) 

'national  standardization  body', a body referred  to in 
Annex II; 

94/10/EC -  Art  l(l)(g) 

'technical  regulation',  technical  specifications  and 
other requirements, including the relevant administra 
tive  provisions,  the  observance  of  which  is  compul 
sory, 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  Ar 
ticle  10,  prohibiting  the  manufacture,  importation, 
marketing  or  use of  a  product 

De facto  technical  regulations  include: 

— 

laws, regulations or administrative provisions of a 
Member  State  which  refer  either  to  technical 
specifications  or  other  requirements  or  to  pro 
fessional  codes or codes of practice which in turn 
refer  to technical  specifications  or other  require 
ments  and compliance with which confers  a pre 
sumption  of  conformity  with  the  obligations  im 
posed 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 
affecting  the consumption of products by encour 
aging  compliance  with  such  technical  specifica 
tions  or  other  requirements;  technical  specifica 
tions  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  ap 
pearing  on  a  list  to  be  drawn  up  by the  Commission 
before  1 July  1995, in  the  framework  of  the  Commit 
tee  referred  to  in  Article  5. 

The  same  procedure  shall  be  used  for  amending  this 
list; 

94/10/EC -  Art  l(l)(g) 

10. 

'draft  technical  regulation',  the  text  of  a  technical 
specification  or other requirement, including adminis 
trative provisions formulated  with the aim of enacting 
it or  of  ultimately having it enacted  as a technical re 
gulation,  the  text  being  at  a  stage  of  preparation  at 
which  substantial  amendments  can still be  made. 

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

Article  2 

94/10/EC -  Art  1(2) 

1.  The  Commission  and  the  standardization  bodies  re 
ferred  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 pro 
gramme,  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 indi 
cate,  in particular,  whether  the  standard  concerned: 

—  will transpose  an  international standard without being 

the  equivalent 

—  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  stan 
dards  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. 

Article  3 

94/10/EC -  Art. 1(3) 

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

Article  4 

94/10/EC -  Art  1(4) 

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

—  communicate  information  in accordance with Articles 

2 and 3, 

—  publish  the  draft  standards  in  such  a way  that com 
ments  may also be  obtained  from  parties  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 standardization  in their 
work programme being discussed at European level in 
accordance with the rules laid down by the European 
standardization  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 

83/189/EEC 

A Standing Committee  shall  be  set  up consisting of  repre 
sentatives  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  its  own  rules of  procedure. 

Article  6 

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

(adapted) 

2.  The  Commission  shall  submit  to  the  Committee  a re 
port  on  the  implementation  and  application  of  the  pro 
cedures  set  out  in  this  Directive,  and  shall  present  propo 
sals aimed  at eliminating existing or foreseeable  barriers to 
trade. 

3.  The  Committee  shall  express  its  opinion  on  the  com 
munications  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 con 
cerned  decide  amongst  themselves  on  appropriate 
measures, 

10 

— 

take  all  appropriate  measures, 

83/189/EEC 

— 

identify 
the  areas  where  harmonization  appears 
necessary,  and,  should  the  case  arise,  undertake  ap 
propriate  harmonization  in a given  sector. 

88/182/EEC -  Art  1(4) 

4.  The  Committee  must  be  consulted  by  the  Commis 
sion: 

83/189/EEC 
(adapted) 

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

nexes I  and II  (Article  2 (1)); 

(b)  when  drawing  up  the  rules  for  the  codified  presenta 
tion  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  ex 
change 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 

(adapted) 

this  Directive; 

(e)  on  the  requests  to  the  standards  institutions  referred 

88/182/EEC -  Art  1(5) 

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. 

83/189/EEC 

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

7.  The  proceedings  of  the  Committee  and  the  informa 
tion  to  be  submitted  to  it  shall  be  confidential. 

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. 

Article 7 

1.  Member  States  shall  take  all appropriate  measures  to 
ensure  that  during  the  preparation  of  a  European  stan 
dard  referred  to in the first indent of Article  6 (3) or  after 
its  approval,  their  standardization  bodies  do  not  take  any 
action  which  could  prejudice  the  harmonization  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. 

94/10/EC -  Art  1(5) 

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

83/189/EEC 

11 

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

83/189/EEC 

94/10/EC -  Art  l(6)(a) 

Article 8 

1.  Subject to Article 10, Member States shall immediate 
ly communicate to the Commission any draft technical re 
gulation, except where it merely transposes the full text of 
an  international  or  European  standard, in which  case in 
formation  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 re 
gulation  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 simulta 
neously  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 
the  timetable  originally  envisaged  for  implementation,  ad 
ding  specifications  or  requirements,  or  making  the  latter 
more  restrictive. 

Where, in particular, the draft  seeks to limit the 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 re 
lating  to  the  substance,  preparation  or  product  concerned 
and  to  known  and  available  substitutes,  where  such  in 
formation  may  be  available,  and  communicate  the  antici 
pated  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  evalu 
ation  of  chemical  substances  as  referred  to  in  Article  10 
(4) of  Council  Regulation  (EEC) No 793/93 (l)  in the case 
of  an  existing  substance  or  in  Article  3  (2)  of  Directive 
67/548/EEC (/), as amended  by Directive 92/32/EEC (3); in 
the  case of  a new substance. 

immediately  notify 

the  other 
The  Commission  shall 
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. 

C1)  OJNoL84,5.4.1993,p.l. 
(2)  OJ No L196,16.8.1967, p. 1. 
(3)  OJ No L 154,5. 6.1992, p. 1. 

12 

With  respect  to  the  technical  specifications  or  other  re 
quirements  referred  to  in the  second subparagaph  of Ar 
ticle  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. 

94/10/EC -  Art  l(6)(a) 

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. 

83/189/EEC 

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

94/10/EC -  Art  l(6)(b) 

Information  supplied  under  this  Article  shall  not  be 
4. 
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  Commission  and the national  authorities may seek ex 
pert  advice  from  physical  or  legal  persons  in  the  private 
sector. 

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  paragaraph  1  under  that  other  act,  provided 
that  they  formally  indicate  that  the  said  communication 
also  constitutes  a  communication  for  the  purposes  of  this 
Directive. 

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. 

94/10/EC -  Art  l(6)(c) 

Article  9 

94/10/EC -  Art  1(7) 

1.  Member  States shall postpone  the  adoption  of a  draft 
technical  regulation  for  three  months  from  the  date  of re 
ceipt  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  re 
gulation  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  re 
gulation, 

from  the  date  of  receipt  by  the  Commission  of  the  com 
munication  referred  to  in  Article  8  (1)  if  the  Commission 
or  another  Member  State delivers a detailed opinion, with 
in  three  months  of  that  date,  to  the  effect  that  the  mea 
sure  envisaged  may create  obstacles  to the  free  movement 
of  goods within  the  internal  market 

13 

94/10/EC -  Art  1(7) 

The Member State concerned shall report to the Commis 
sion  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. 

4.  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  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. 

5. 
If  the  Council  adopts  a common  position  during the 
standstill  period  referred  to  in  paragraphs  3  and  4,  that 
period  shall,  subject  to  Article  9  (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 bind 
ing 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 un 
foreseeable  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 pre 
pare  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  Com 
mission. 

Article  10 

94/10/EC -  Art. 1(8) 

1.  Articles  8 and  9 shall  not  apply  to those  laws, regula 
tions  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; 

14 

— 

fulfil the obligations arising out of international agree 
ments which result in the adoption of common techni 
cal specifications  in the Community; 

—  make use of safeguard clauses provided for in binding 

94/10/EC -  Art  1(8) 

Community acts; 

—  apply  Article  8 
92/59/EEC(1); 

(1)  of  Council  Directive 

—  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 
administrative provisions of the Member States prohibiting 
manufacture  insofar as they do not impede the free move 
ment 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 in 
dent. 

Article 11 

94/10/EC -  Art 1(9) 

The Commission shall report every two years to the Euro 
pean Parliament, the Council and the Economic and Social 
Committee on the results of  the application  of  this Direc 
tive.  Lists of  standardization  work  entrusted  to  the Euro 
pean standardization organizations pursuant to this'Direc-
tive, as well as statistics on the notifications received, shall 
be published  on  an annual  basis  in the Official Journal  of 
the European  Communities. 

Article 12 

94/10/EC -  Art. 1(10) 

When Member States adopt  a technical  regulation, it shall 
contain  a reference  to this Directive  or shall  be accompa 
nied by such reference on the occasion of its official  publi 
cation. 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 
A are hereby repealed without prejudice to the obligations 
of  the  Member States  concerning  the  deadlines for trans 
position  of  the  said  Directives,  set  out  in Annex  III, Part 
B. 

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. 

(*>  OJ No L 228,11.8.1992, p. 24. 

15 

Article  14 

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

Article  15 

This Directive is addressed to the Member States. 

For the European 
Parliament 

The  President 

For the Council 

The President 

16 

ANNEX I 

94/10/EC -  Art 1(11) 

European standardization  bodies 

ŒN 

European  Committee  for  Standardization 

CENELEC 

European  Committee  for Electrotechnical  Standardization 

ETSI 

European  Telecommunications  Standards Institute 

17 

ANNEX II 

%/139/EC -  Art 1 

NATIONAL STANDARDIZATION BODIES 

BELGIUM 

IBN/BIN 
Institut  belge de normalisation 
Belgisch  Instituut  voor  Normalisatie 
CEB/BEC 
Comité  électrotechnique  belge 
Belgisch Hektrotechnisch  Comité 

DENMARK 

DS 
Dansk  Standard 

NTA 

Telestyrelsen, National  Telecom Agency 

GERMANY 

DIN 

Deutsches  Institut  fur  Normung  e. V. 

DKE 
Deutsche  Elektrotechnische  Kommission im DIN und 

VDE 

GREECE 

EAOT 

5. 

6. 

8. 

EXXnyixôç Ogyaviouô; Tunoreoinori; 

SPAIN 

AENOR 

Asodaaôn  Espanola de Normalizaaôn y Ccrtificadôn 

FRANCE 

AFNOR 
Assodation  française  de  normalisation 
UTE 
Union  technique de l'électricité — Bureau  de norma 
lisation  auprès  de  l'AFNOR 
IRELAND 
NSAI 
National  Standards  Authority of  Ireland 
ETCI 
Electrotechnical  Coundl  of  Ireland 
ITALY 

UNI (!) 
Ente  nazionale  italiano  di  unificazione 

CEIO) 
Comitato  elettrotecnico  italiano 

(1 )  UNI and CEI, in coopération with the Istituto superiore delle 
Poste  e  Telecomunicazioni  and  the  ministère deu'Industria, 
have allocated  the work within ETSI  to CONCIX  Comitato 
nazionale  di  coordinamento  per  lc  tecnologie  delTinforma-
zione. 

18 

9.  LUXEMBOURG 

96/139/EC -  Art 1 

ITM 
Inspection du travail et  des mines 

SEE 

Service de l'énergie  de l'État 

10. NETHERLANDS 

NNI 
Nederlands  Normalisatie-instituut 
NEC 

Nederlands  Hektrotechnisch Comité 

11.  AUSTRIA 

ON 
Ôsterreichisches  Normungsinstitut 
OVE 
Ôsterreichischer  Verband fur  Elektrotechnik 

11  PORTUGAL 

IPQ 

Instituto  Português da Qualidade 

13.  UNITED  KINGDOM 

BSI 
British Standards Institution 
BEC 

British Electrotechnical  Committee 

14.  FINLAND 

SFS 
Suomen Standardisoimisliitto SFS ry 
Finlands Standardiseringsfôrbund  SFS rf 
THK/TFC 
Telehallintokeskus 
Telefôrvaltningscentralen 
SESKO 
Suomen  Sâhkôteknillinen  Standardisoimisyhdistys 
SESKO ry 
Finlands  Elektrotekniska  Standardiseringsfôrening 
SESKO rf 

15.  SWEDEN 

SIS 
Standardiseringen  i  Sverige 

SEK 
Svenska  elektriska kommissionen 

ITS 
Informationstekniska  standardiseringen 

19 

ANNEX 111 

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 Dedsion 92/400/EEC 

European Parliament and Council Directive 
94/10/EC 

Commission Decision 96/139/EC 

20 

Part B 

List of deadlines  for transposition  into national law 
(referred  to by Article  13) 

Directive 

Deadline for transposition 

83/189/EEC (OJ No L109,26.4.1983, p. 8) 
88/182/EEC (OJ No L 81,26.3.1988, p. 75) 
94/10/EC (OJ No L100,19.4.1994, p. 30) 

31 March 1984 
1 January 1989 
1 Jury 1995 

21 

ANNEX IV 

CORRELATION TABLE 

Directive 83/189/EEC 

This Directive 

Artide  1 
Artide  2 
Article  3 
Artide  4 
Article 5 
Article 6 
Article 7 
Article 8 
Article 9 
Artide  10 
Article  11 
Article  12 

Annex I 
Annex II 

Article  1 
Article  2 
Artide  3 
Artide  4 
Artide  5 
Artide  6 
Artide  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 

22 

ISSN 0254-1475 

COM(96) 642 final 

DOCUMENTS 

EN 

06 

Catalogue number  :  CB-CO-96-645-EN-C 

ISBN  92-78-13053-2 

Office  for Official  Publications of the European Communities 

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