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COM (85) 0 19 
 
 
 
Vol. 1985/00 08 
  
 
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concernant l'ouverture au public des archives historiques de la Communauté économique 
européenne et de la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983, 
p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003 
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 
concerning the openi ng to the public of the historical archives of the European Econom ic 
Community and the European Atomic Energy Communit y (OJ L 43, 15.2.1983, p. 1), as 
amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243, 
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file have been declassified in conformity with Article 5 of the aforementioned regulation.  
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom  1. 
Februar 198 3 über die Freigabe der historischen Archive der Europäischen  
Wirtschaftsgemeinschaft und der Europäischen Atomgem einschaft (ABI. L 43 vom  15.2.1983,  
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COMMISSION OF THE EUROPEAN COMMUNITIES
CO M (85) 19 final
Brussels, 31 january 1985
Technical harmonization and standards: a new approach
(Communication from the Commission to the Council and to the
Europan Parliament)
COM(85) 19 final

COU Ij
SUM M AR Y A N D  CONCLUSIONS
I. Presentation of the approach: motivations and criteria
This new approach is presented on the basis of the finding that a revision  
is needed of the methods and procedures regarding technical harmonization in  
the Community to realise the objective of the completion of the Internal  
Market.
The new approach follows guidelines laid down by the European Parliament in 
its resolution of 16 October 1980 and conforms to those drawn up by the 
Council during its session on 16 July 1 9 8 4 .
II. Outline of a directive concerning the approximation of Member States'  
legislation for the elimination of technical barriers to trade using the  
"general reference to standards" approach
This outline of a directive concerning the approximation of Member States' 
legislation involves the development of a general approach which the 
Commission intends to apply/ according to the legislative requirements of 
sectors or groups of products as well as of categories of hazards, in 
drawing up proposals for directives based on Article 100 of the EEC Treaty.
The outline is not claimed to be a final legal text but it does provide in 
summary form a pattern for a directive on which the Commission could 
subsequently graft firm proposals. The text of this chapter therefore 
consists of a description of the contents of the directive and a paragraph 
by paragraph commentary.

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III. Priority sectors or areas to which the approach should initially be  
applied
The analysis of these sectors has been carried out in the light of the 
experience of over 15 years of activity in the field of technical barriers 
to trade. The choice of priority subjects takes into account both the need 
to make up for lost time and the opportunity to profit from what can be 
considered to be favourable conditions. As the word "priority" suggests, 
the choice of these areas does not imply the exclusion of other areas or 
sectors to which the approach could be applied in the future.
IV. Conclusions
The Commission envisages starting this work without delay in order to  
translate into concrete terms this new approach so that the Community may  
progress towards the realisation of the Internal Market for industrial  
products, progress which has to date been seriously hampered by the  
Community's burdensome decision-making procedures. The Commission awaits  
from the other Comunity institutions to which this communication is  
addressed, an unequivocal political commitment concerning the criteria and  
principles of this approach and criteria for the choice of priority areas  
to which the approach will be applied.

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Part One
Presentation of the approach: motivations and criteria
1. The discussion in the Council and the adoption of Council directive  
83/189/EEÇ on 28 March 1983 marked an awareness on the part of all parties  
concerned - the Commission, Member State administrations, standardization  
bodies, industry - of the need to begin an in-depth consideration of the  
criteria, principles and procedures which had, since 1969, guided work on  
the elimination of technical barriers to trade.
In 1969 the Council acting on a Commission proposal, adopted a series of  
resolutions which to a certain extent defined policy in this area both for  
the procedures and the work programmes. The procedures and work programmes  
were subsequently updated in 1973. However since this significant effort was  
made to produce a policy framework for Community activity on technical  
harmonization, no new consideration as a whole has ensued to check whether  
the chosen approach remained valid in all sectors and in the light of  
experience over the years.
2. This need to proceed to a revision of the policy was also made clear by the  
detailed factual findings which industry has repeatedly brought to the  
attention of the Commission.
While work on technical harmonization has doubtless ted to important results  
in certain areas (there are currently 177 Council directives, amended by 56  
Commission directives) it is necessary to point out that:
- in certain industrial sectors results remain almost negligible in the face of  
the multiplicity of technical rules and standards abounding in all countries;

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even in the cases where directives have been adopted, they too often cover 
only certain aspects while other factors continue to obstruct the existence
of a true internal market;
the technological evolution is now too rapid for harmonization procedures and 
the decision making processes of the Council to hope to be even able to reach 
an objective which seems destined to become increasingly remote rather than
nearer to attainment;
these procedures have reached a degree of lengthiness1 which deprives of all
credibility policies based on guidelines which in certain respects have 
clearly been overtaken;
while the optional method of harmonization, which was generally followed, had 
the advantage of facilitating the seeking of compromise in the Council, it 
proved too often inadequate for the realisation of a true internal market the 
benefits of which need to apply to all sectors of the economy: industry, 
workers, user and consumers;
finally the root of most of these problems probably derives from a poor 
distribution of the respective roles between the public authorities on the 
one hand and the standardization bodies on the other. The authorities too 
often allocate to themselves competences in the area of detailed definition 
of technical specifications of products which belong more naturally to the 
standardization organizations.
Because of all these difficulties and because of the ensuing lack of 
Community legislative activity, the circulation of goods takes place on the 
basis of Article 30 of the EEC Treaty, as interpreted by the Court of
Justice.
It is now well known since the "Dassonvilie" decision (case 8/74), and even 
more so since the "Cassis de Dijon" decision (case 20/78) and the abundant 
jurisprudence which followed, that the application of national commercial 
regulations to imported products is to be' considered as a measure having 
equivalent effect to quantitative restrictions, except when the Member State 
in question can demonstrate that the measures are necessary in order to 
satisfy "imperative requirements" or can be justified by one of the
1 The 15 directives making up the "package" adopted by the Council on
17 September 1984 had an average age of 9 1/2 with a maximum of 12 years.

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derogations set out in Article 36. As the national courts and the European  
Court (Article 30 is directly applicable) decide on a case by case basis, the  
absence of Community legislation thus leaves to the judiciary the  
responsibility of deciding on questions which normally fall to the  
responsibility of the legislator. The ensuing uncertainty is highty  
detrimental to economic operators.
It thus became more and more necessary to make a selection of those standards  
which could create a right to the presumption of equivalence to the existing  
regulations within the Community vis à vis the safety objectives pursued and  
to organize the conditions in which this presumption can be reversed, as the  
jurisprudence in question leads in fact to a sort of presumption of  
equivalence.
3. At the Internal Market Council on 26 October 1983 the Commission had already  
stated that to a large extent the delays and difficulties encountered in the  
harmonization activities resulted from the procedure of harmonizing precise  
and detailed technical construction specifications in statutory texts rather  
than from an obligation of performance. There is only one sector, that of  
low voltage electrical equipment, for which the latter technique has been  
followed with success.
Basing itself on this conclusion, the Commission then envisaged a gradual  
move towards basing further legislative efforts on the formula of the Low  
Voltage directive, experience of which had proved favourable. Safety  
provisions would be established to which products would have to conform,  
while the task of defining technical characteristics of products would be  
left to European, and if necessary, national standards.
In the sectors for which this approach should be feasible the conditions for  
application of these guidelines should be:
- recognition by all member countries of the Community of the equivalence of  
objectives pursued by their technical regulations and standards concerning  
in particular the health and safety of their citizens;
- the existence of certification bodies and laboratories which ensure  
confidence between the authorities concerned;

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- the establishment of procedures ensuring that authorities in the Member  
States have efficient safeguards for the protection of the health and  
safety of their citizens.
4. The Council on 16 July 1984 set out general principles for a European  
standardization policy2.  This represented an important step in the process  
of consideration and revision which the Community has to pursue in order to  
definitively bring about the creation of the internal market for industrial  
products. The Council stated notably "that the objectives being pursued
by the Member States to protect the health and safety of their people as  
well as the consumer are equally valid in principle even if different  
techniques are used to achieve them." It recommended the "extension of the  
Community practice in matters of technical harmonization of entrusting the  
task of defining the technical characteristics of products to standards,  
preferably European but if necessary national, where the conditions  
necessary for this purpose, particularly as regards health protection and  
safety, are fulfilled."
5. The Commission has meanwhile pursued its work, assisted by a group of Senior  
Officials Responsible for Standardization Policy in the Member States, and  
in consultation with interests in industry and standardization circles. The  
most opportune approach has been to draw up an outline for a directive  
concerning the approximation of Member States' legislation for the  
elimination of technical barriers to trade using the "general reference to  
standards approach".
The following are the four fundamental principles on which the outline is  
based:
- legislative harmonization is limited to the adoption, by means of  
directives under Article 100 of the EEC Treaty, of the essential safety  
requirements (or other requirements in the general interest) with which  
products put on the market must conform, and which should therefore enjoy  
free circulation throughout the Community,
2By the term "standardization policy" is understood all activity, whether in  
the public or private sector, which relates to the definition of technical  
specifications of products and certification procedures.

~7~
- the task of drawing up the technical specifications needed for the 
production and placing o n  the market of products conforming to the  
essential requirements established by the directives, while taking into  
account the current state of technology, is entrusted to organizations 
competent in the standardization area,
- these technical specifications are not mandatory and maintain their status  
of voluntary standards,
- but at the sa m e  time national authorities are obliged to recognize that  
products manufactured in conformity with harmonized standards (or,  
provisionally, with national standards) are presum ed to conform to the  
"essential requirements" established by the directive. (This signifies  
that the producer has the choice of not manufacturing in conformity to the  
standards, but in this event, that he has an obligation to prove that his  
products conform to the essential requirements of the directive.)
In order that this system m a y  operate it is necessary:
- o n  the one hand that the standards offer a  guarantee of quality with  
regard to the "essential requirements" established by the directives,
- o n  the other hand that the public authorities keep intact their  
responsibility for the protection of safety (or other requirements  
envisaged) on their territory.
The quality of harmonized standards m ust be ensured by standardization  
mandates, conferred by the Commission, the execution of which m ust conform  
to the general guidelines which have been the subject of agreement between  
the Com m ission and the European standardization organizations. In so far as  
national standards are concerned their quality m ust be verified by a  
procedure at C om m unity level, and m anaged by the Commission, assisted by a  
Standing Committee com posed of officials from national administrations.
At the sa m e  time safeguard procedures m ust be provided for, under the  
m anagem ent of the Commission, advised by the s a m e  Committee, in order to  
allow the competent public authorities the possibility of contesting the  
conformity of a  product, the validity of a  certificate or the quality of a  
standard.

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In order to ensure the coherent operation of these new  directives the  
Commission envisages the creation of only one Standing Committee "general  
reference to standards" competent to assist the Commission in the management  
of a ll the directives of this type, instead of setting up a Committee for  
each directive. I t  would, moreover, be called upon to work in close liaison  
with the Standing Committee set up by directive 83/189/EEC (information  
procedure for technical standards and regulations).
6. In following this system of legislative harmonization in each area in which  
it  is feasible, the Commission intends to be able to halt the proliferation  
of excessively technically detailed product by product directives. The scope  
of directives according to the "general reference to standards" formula  
should encompass wide product categories and types of hazards.
The Community could on the one hand, therefore, complete the extremely  
complex undertaking of harmonizing technical legislation and on the other  
hand promote the development and application of European standards. These  
are essential conditions for the improvement of the competitivity of its  
industry.

-9 -
Part II
Outline for a directive on the harmonization of the Law s of the Member States  
in order to eliminate technical barriers to trade through the "general
reference to standards1 ' approach
This outline provides the principles and main elements which should make up the  
body of the directives.
A. JUSTIFICATIONS
Amongst the classical principles for the ju s tific a tio n  of the directive the  
following aspects should be underlined:
- Mem ber States have the responsibility of ensuring safety on their
te rrito ry  (in the home, at their place of work e tc .) of persons, domestic
animals and goods, or the respect of other essential requirements of collective
importance such as health, consumer or environment protection e tc ., with regard
(1)
to the hazards covered by the directive its e lf;
-  the national provisions ensuring such protection must be harmonized in  
order to ensure the free movement of goods, without lowering existing and  
ju s tifie d  levels of protection in the Mem ber States;
-  C E N  and C E N E LE C  (one or the other, or both according to the products  
covered by the directive) are the competent bodies to adopt European harmonized  
standards within the scope of this d irective, in accordance with the guidelines
which the Commission, a fter consultation of the Mem ber States, has signed with
.  .. (2)  these bodies
(1)
(2)For practical e d ito rial purposes the rest of this document refers only  
to safety.
For specific sectors of industrial a c tiv ity  other competent European bodies  
for the drawing up of technical specifications could be involved.

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1. in this outline a general approach is developed which should be applied  
according to the needs for legislation by Directives based on A rticle 100 of  
the Treaty relating to sectors or families of products as well as types of  
hazards.
2. The object of the Directive w ill be specified in each application according  
to the types of hazard (safety, health, environment, consumer protection,  
etc.) and should the need arise to the circumstances (in the home, at the  
place of work, under road tra ffic  conditions, during leisure a c tiv itie s ,  
e tc .).
3. Where appropriate, it  should be stated that the Mem ber States m ay m ake  
provision, in accordance with Community law, for national regulations  
concerning the conditions for use of products covered by the scope of the  
Directive.
4. Concerning the objective mentioned in the second principle, it  is obvious  
that it  is carried into effect by the very adoption of the directive under  
A rticle 100 of the Treaty, as the essential safety requirements contained in  
it  are of such a nature as to ensure the pursuit of such an objective.
B- M A IN  E L E M E N T S
I. Scope
Definition of the range of products covered, as well as the nature of the  
hazards it is intended to avert.
The scope should be drawn up in such a way that a coherent approach to the  
action is ensured, and that the proliferation of directives on specific  
products is avoided. Moreover, it  should be noted that the legal provisions of  
the directive under consideration do not preclude the possibility of several  
directives being adopted on one and the sam e product according to the various  
types of hazard associated with that product (for example, mechanical safety of  
a machine on the one hand and pollution by that machine on the other hand).
I I .  General clause for the placing on the market
The products covered by the directive m ay be placed on the market only if  they  
do not endanger safety of persons, domestic animals and goods when properly  
installed and maintained, and used in applications for which they were made.

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1. The directives would provide for to tal harmonization as a general rule.  
Consequently, any product placed on the market fa llin g  within the scope of  
the directive must be in conformity with the requirements of the directive.  
In certain specific conditions, optional harmonization for certain products  
m ay prove to be opportune. The outline d ire c tiv e , however, is drawn up with  
a view to to ta l harmonization.
Point I I  therefore represents a general clause setting out the  
responsibilities of the Mem ber States in relation to the placing of goods on  
the market.
2. In order to respect the general principle on which the outline directive is  
based, namely leaving to the professionals the choice of the m eans of  
attestation of conformity and which prohibits Mem ber States setting up any  
system of prior control to the placing on the market (except, of course, in  
cases where the prior control is required by specific directives for special  
sectors, as is moreover clearly provided for in Point V II I) , it  is obvious  
that the national authorities in order to acquit themselves of their  
responsibilities set out in this clause must be allowed to exercise control  
on the market by way of spot checks.
3. In certain cases, in particular with regard to the protection of workers and  
consumers, the conditions set out in this clause m ay be strengthened  
(foreseeable use).
I I I .  Essential safety requirements
Description of the safety requirements which are essential for the application  
of the general clause in Point I I  with which a ll products fa llin g  within the  
scope of the directive must conform.
1. The essential safety requirements which must be met in the case of products  
which can be put on the market shall be worded precisely enough in order to  
create, on transposition into national law, legally binding obligations  
which can be enforced. If  the basic requirements for safety are observed,
the general clause in Point I I  can be applied.
2. The amendments to these requirements can only be m ade by m eans of a Council  
directive pursuant to A rticle 100 of the Treaty.
IV. Free circulation clause
Obligation for the M em ber States to accept the free circulation of products  
which conform to the requirements of Point I I I  under the conditions set out in  
Point V.

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Free movement w ill be ensured in the case of products declared to conform to  
the protection requirements laid dow n in the directive, without as a general  
rule, preventive verification of compliance with the requirements set out in  
Point I I I ,  it  being understood that the note 2 of Point I I  also applies in this  
case.
The interpretation to be given to this provision should not have the  
consequence that third party c ertificatio n  is to be used systematically.
V. Means of proof of conformity
1. M em ber States shall presume to be in conformity with the requirements of  
Point I I I ,  products which are accompanied by one of the m eans of attestation  
described in Point V III declaring that they are in conformity with:
(a) the harmonized standards adopted by the European standards body which is  
particularly competent within the scope of this d irective, when these 
standards are adopted in accordance with the guidelines agreed between that  
body and the Commission and the references of which are published in the  
OJEC; such publication is moreover also carried out by the Mem ber States^
(b) or as a transitional measure, and insofar as harmonised standards do not  
exist in the fie ld  covered by such standards, national standards referred  
to in paragraph 2.
2. M em ber States shall communicate to the Commission and to the other M em ber  
States the text of those national standards which they consider to meet the  
provisions of Point I I I .  In accordance with the procedure laid dow n in para. 2  
of Point V I, the Commission shall notify the Mem ber States of the national  
standards which enjoy the presumption of conformity with the requirements of  
Point I I I .
The Mem ber States are required to have the references of these standards  
published. The Commission w ill see to it  that they are also published in the  
OJEC.
3. M em ber States shall accept that the products for which the manufacturer has  
not applied any standard (because of absence of a standard as laid dow n in  
paras. 1a) and b) above or for other exceptional reasons), are considered to be

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in conformity with the provisions of Point I I I ,  w hen their conformity is  
demonstrated by one of the m eans of attestation set out in Point V III paragraph  
1a) and b).
1. Only those m eans of attestation provided for in Point V III necessarily carry  
presumption of conformity.
2. The presumption of conformity is constituted by the fact that the conformity  
of a product to harmonized or national standards is declared by one of the  
m eans of attestation set out in Point V III. W hen the product is not in  
conformity with a standard, because the standards do not e xist, or because  
the manufacturer, for example in cases of innovation, prefers to apply other  
manufacturing c rite ria  of his choice, conformity to the requirements of  
Point I I I  is declared by the m eans of an attestation delivered by an  
independent body.
3. In cases under Point V  § 1  and § 3 M em ber States w ill therefore have the  
rig h t, for the presumption to operate, to request at any time one of the  
m eans of attestation set out in Point V III.
4. The drafting and adoption of the harmonized standards mentioned in para. 1a)  
by the C E N  and CENELEC, these bodies being generally considered to be the  
"European standards bodies which are particularly competent", and the  
obligation relating to transposition into national standards, are governed  
by these two bodies' internal rules and th e ir regulations relating to  
standards work. The internal rules of C E N  and C E N E LE C  are in the process of  
being harmonized.
However, it  is not impossible that the harmonized standards referred to in  
para. 1  be prepared outside C E N  and C E N E LE C  by other bodies which m ay assume  
these functions in particular areas; in such cases adoption of the  
harmonized standards shall be submitted for approval by CEN/CENELEC. In any  
case, the drafting and introduction of the harmonized standards referred to  
in Point V  must be subject to the guidelines agreed between the Commission  
and these organizations. The guidelines deal in particular with the  
following principles and conditions:
-  the availab ility of suitable staff and technical infrastructure at the  
standards body which the Commission mandates to proceed with  
standardization;
-  the association of public authorities and interested circles (in  
particular manufacturers, users, consumers, unions);
-  the adoption of harmonized standards and their transposition into national  
standards or, at least, the annulment of diverging national standards under  
conditions approved by the Commission set out in a mandate for  
standardization, after consultation with the M em ber States.

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V I. Managem ent of the lists of standards
1. Where a Mem ber State or the Commission has reason to believe that  
harmonized standards or drafts thereof do not fu lly  satisfy the requirements of  
Point I I I ,  the Commission shall bring this to the attention of the Committee  
(Point X) setting out the reasons. The Committee shall give an opinion as a  
matter of urgency.
The Commission may, on the basis of the Committee's opinion, notify the M em ber  
States of the necessity of withdrawing the standard from the publication  
referred to in Point V  1a. It  w ill inform the European standards body concerned  
and, if  necessary, give it  a new  or revised mandate.
2. O n  receipt of the communication referred to in Point V  2, the Commission  
w ill consult the Committee. After the Committee has given its  opinion, the  
Commission may, within a certain period, notify the Member States that the  
national standard in question should enjoy presumption of conformity and have  
its  references appear in a national publication.
I f  the Commission considers that a national standard does not f u l f i l the  
conditions for presumption of conformity to the safety requirements, it  may,  
after consulting the Committee, notify the Mem ber States that the standard in  
question should no longer enjoy presumption of conformity, and thus be withdrawn  
from the publications referred to in Point V  § 2.
A s indicated above (see notes to Point V  § 2) the Mem ber States have the power  
to decide which of th e ir national standards m ay be considered to be in  
conformity with the provisions of Point I I I  and thus be subject to the  
Commission confirmation procedure.
V II. Safeguard clause
1. Where a Mem ber State finds that a product does not conform to the  
provisions of Point I I I ,  it  shall take a ll appropriate measures to prohibit the  
placing on the market of the product in question or impede its  free movement  
even if  it  is accompanied by one of the m eans of attestation referred to in  
Point V III.

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Wit h  i n a given period of time, and only when the product in question is  
accompanied by one of the m eans of attestation provided for in Point V III, the  
M em ber State shall inform the Commission of such a measure. I t  w ill indicate  
the reasons for its  decision and in particular whether the non-conformity  
results from:
a) the non-respect of the provisions of Point I I I  (when the product does not  
conform to any standard);
b) incorrect application of the standards referred to in Point V;
c) a shortcoming in the standards themselves.
2. Within a given period of time, the Commission shall submit the cases under
b) and c) above to the Committee. Where the Commission, a fter consultation of  
the Committee, finds that the action is ju s tifie d  it  sh all, also within a given  
period of time, give confirmation to that effect to the Mem ber State in  
question and inform the other Mem ber States that they are also obliged to  
prevent the product in question from being placed on the market.
3. Where the non-conformity of the product to the requirements of Point I I I  
results from a shortcoming in the harmonized standards or in the national  
standards, the consequences are those set out in Point VI;
4. Where the non-conforming product is accompanied by a m eans of attestation  
issued by an independent body or by the manufacturer, the competent M em ber  
State shall take the appropriate measures against the author of the attestation  
and informs the Commission and the other Mem ber States.
5. The Commission shall ensure that a ll Mem ber States are kept informed of the  
progress and of the outcome of this procedure.
1. This Point describes the consequences when recourse by a Mem ber State to the  
safeguard clause appears to be ju s tifie d . It  does not give any indication  
on the consequences when recourse does not appear to be ju s tifie d  after the  
expiry of the Community examination procedure, because in such cases the  
general rules of the Treaty apply.
2. In a ll cases, referral to the Committee does not necessarily imply a  
procedure for the formulation of an opinion. In m any cases, as the  
experience of the "Low Voltage Directive" shows, problems can be solved by  
b ila te ra l contacts between the Commission and the Member State which has had  
recourse to the safeguard clause.

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V III. M eans of attestation of conformity
1. The m eans of attestation referred to in Point V  which the professionals m ay  
use are:
(a) certificates and marks of conformity issued by a third party
(b) results of tests carried out by a third party
(c) manufacturer's declaration of conformity
(d) other m eans of attestation which could possibly be determined in the  
di rective.
2. The choice of the professionals between these different m eans m ay be  
lim ited, or even suppressed, according to the nature of the products and  
hazards covered by the directive.
3. National bodies authorized to issue marks or certificates of conformity  
shall be notified by each Mem ber State to the Commission and to the other  
M em ber States.
1. The appropriate m eans of attestation w ill be established and expanded in the  
specific directives taking into account the special requirements of their  
scope.
2. The bodies referred to in para. 3 must carry out th eir duties according to  
recognized international practices and principles and especially in  
accordance with ISO Guides. The responsibility for the control of the  
operation of these bodies lies with the Mem ber States. Questions concerning 
the carrying out of tests and certific atio n  m ay be put before the Committee  
set up under Point IX.
3. With regard to the manufacturer's declaration of conformity, the national  
authorities have the right to ask the manufacturer or the importer to  
communicate the data relating to the tests carried out concerning safety  
etc. when they have good grounds to believe that a product does not offer  
the degree of safety required in a ll respects. Refusal on the part of the  
manufacturer or the importer to communicate these data constitutes  
sufficient reason to doubt the presumption of conformity.
4. Another of the m eans covered by para. 1d) could consist for example in the  
manufacturer's declaration of conformity coupled with a system of production  
surveillance.
5. The determination of a lim itative lis t of m eans of attestation only concerns  
the system of presumption of conformity but cannot have the effect of  
restricting the possibility for a professional to prove by any m eans at his  
disposal within the framework of a dispute or court proceedings, the  
conformity of the product with the requirements of Point I I I .

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IX. Standing Committee
A  Standing Committee shall be set up chaired by a representative of the  
Commission and consisting of representatives appointed by the M em ber States w ho  
m ay avail themselves of the help of experts or advisers.
The Committee shall be convoked by its  Chairman either on his ow n in itia tiv e  or  
at the request of a M em ber State.
The Committee shall draw up its  ow n rules of procedure.
X. Tasks and operation of the Committee
1. The Committee shall be consulted by the Commission on harmonized and  
national standards in accordance with Points V  and V I.
2. The Committee shall have submitted to it  a ll cases arising out of the  
measures adopted by the Mem ber States under Point V II 1b) and c) and shall be  
consulted by the Commission on the outcome to be given to such cases.
3. The Committee m ay be consulted on a ll questions arising out of Point V III.
4. Any question regarding the implementation of this directive m ay be submitted  
to the Committee.
The tasks of the Committee are concerned with the implementation of the  
directive. The object of the consultation of the Committee prior to the  
publication of the references of the national standards is more to provide for  
a forum for the discussion of the objections which the Commission or a Mem ber  
State m ay formulate, than to carry out a systematic examination of the entire  
contents of the standards.

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Part III
Priority areas or sectors in which this approach could in itia lly  be applied
1. The need to find a new  approach to the harmonization of technical  
regulations, based on "general reference to standards" and following the lines  
described e a rlie r, is the outcome of a number of conditions (outlined in the  
fir s t part of this Communication) backed up by the experience already acquired  
by the Community. Consequently it  is a general principle, th e .v a lid ity  of which  
w ill have to be assessed in practical terms in the various areas in which it  
w ill be applied.
The Council took a sim ilar view in its  "Conclusions" of 16 July 1984 when it  
confirmed the general need for an extension of the "general reference to  
standards" practice, but only provided the necessary conditions were fu lfille d ,
1 . e. as regards the obligation on public authorities to protect the health and  
safety of th eir citizens.
2. Before the p rio rity  areas in which this approach should in itia lly  be  
applied can be chosen, it  is therefore necessary to establish a number of  
selection c rite ria  to be taken into consideration, c rite ria  which cannot be  
taken separately:
(a) Since the approach calls for the "essential requirements" to be harmonized  
and m ade mandatory by directives under A rticle 100 of the Treaty, the  
"general reference to standards" approach w ill be appropriate only where it  
is genuinely possible to distinguish between "essential requirements" and  
"manufacturing specifications”. In other words, in a lt areas in which the  
essential requirements in the public interest are such that a large number  
of manufacturing specifications have to be included i f  the public  
authorities are to keep intact th e ir responsibility for protection of their

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citizens,the conditions for the "general reference to standards" approach  
are not fu lfille d  as this approach would have li t t le  sense. In the light of  
this statement areas involving safety protection certainly appear to have  
p rio rity  over those involving health protection (which applies to the scope  
of Directive 83/189).
(b) I f  "general reference to standards" is to be possible, the area concerned  
must be covered by, or capable of being covered by, standardization. Areas  
which are inherently ill-s u ite d  to standardization work are certainly the  
areas referred to in (a) above where the need for regulations is fe lt  
unanimously throughout the Community. In other areas there is a  
standardization capacity or potential and in the la tte r case the Community  
should encourage it  in close cooperation with both the industry concerned  
and the European standards bodies, whilst ensuring that the interests of  
consumers are taken into account.
(c) The progress of technical harmonization work in the Community under the 
general programme established by the Council resolutions of 1969 and 1973  
varies greatly from one industrial sector to another. In the manufacturing  
industry (which appears at fir s t sight to best meet the abovementioned  
c rite ria ) most of the directives adopted concern three areas: motor  
vehicles, metrology and e le c tric a l equipment.
The new  approach w ill therefore have to take this state of a ffairs  into  
account and concentrate mainly on other areas in which there is a lack of  
Community a c tiv itie s  (e.g. m any engineering products and building  
materials) without calling into question regulations that are already well  
advanced (for example those referring to motor vehicles). The case of  
e le c tric a l equipment is d iffe re n t: this is the only area to have been

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tack led by a directive of the "general reference to standards" type and  
should certainly be included in the priority areas for alt such products  
not yet covered, in view of the extremely important part played in this  
area by international and European standardization.
(d) O n e  of the main purposes of the n ew  approach is to m ake it possible to  
settle at one stroke, with the adoption of a single directive, a ll the  
problems concerning regulations for a very large num ber of products ,
2without the need for frequent am endm ents or adaptations to that directive .  
Consequently in the selected areas there should be a  wide range of products  
sufficiently hom ogeneous to allow c o m m o n  "essential requirements" to be  
defined. This general criterion is, however, based mainly o n  practical and  
labour-saving considerations. There is nothing to prevent a  single type of  
product, in certain cases, from being covered by the "general reference to  
standards" formula if a ll the abovementioned criteria are met.
(e) Finally mention should be m ad e of one criterion that the Commission, in  
agreement with industry, has always regarded as essential. There m ust be  
grounds for considering that the existence of different regulations does in  
practice genuinely impede the free m ovem ent of goods. In so m e cases,  
however, even if  these grounds are not obvious, a  directive m a y  appear  
necessary to protect an essential public interest uniformly throughout the  
Community. Whereas technical manufacturing specifications are bound to  
becom e obsolete as technological progress is made.
1The "Low  voltage" Directive 73/23/EEC defining the essential safety
requirements for electrical products and referrering to C E N E L E C  standards is  
currently based o n  around one hundred E N  and H D. If  the Community had had to  
follow the approach adopted in the "motor vehicles" framework directive, for  
example, it would probably have needed about one hundred directives under  
Article 100!
2e c  ?  mam features of the "essential requirements" that have to be  
is the fact that they remain valid for long periods.

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3. It  is the Commission's intention to in itia te  the procedures leading to the  
submission of practical proposals and it  w ill start on the necessary work at  
the earliest opportunity, selecting the following areas^:
(a) Mechanical engineering
This work w ill have to find solutions for areas in which harmonization has  
already been started (pressure vessels, gas appliances, construction plant,  
liftin g  appliances) and areas in which there are no directives such as  
machine tools and other types of machines.
(b) Building materials
O ne specific area appears to merit p rio rity: the fir e  resistance of  
building materials and components.
(c) Electrical appliances
Tw o areas should be chosen: active and passive protection against  
disturbances by conduction and radiation, the essential requirements for  
which apply to an ever-increasing market for industrial products,  
especially in information technology, and electromedical equipment, only  
covered to a very limited extent by the recent Council Directive  
84/539/EEC, which should be subjected to a thorough study.
4. The choice of of these three areas does not m ean that in the near future  
further work m ay not appear necessary to meet other requirements (e.g.  
labelling for the information of consumers) or to cover other areas.
The Commission considers that a ll these a c tiv itie s  should be carried out with  
s tric t attention to p rio ritie s  and c rite ria  but also in a great s p irit of  
pragmatism as it  is in the light of experience and the successes achieved that  
the procedure w ill be streamlined and sim plified.
3Not necessarily in order of p rio rity .

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The Commission requests that the European Parliament and the Council approve  
the orientations set out in this Communication, especially on the following  
points :
- the urgency of putting right the present situation in the fie ld  of technical  
barriers to trade and of clearing the uncertainty for the economic operators  
which stem from that situation;
-  the new  approach consisting in asking general references to standards;
-  the four fundamental principles on which the outline directive is based (c f.  
especially Part I ,  paragraph 5);
-  the selection c rite ria  which have to be taken into consideration in order to  
determine those fields in which the new  approach should be applied as a  
p rio rity  (c f. especially Part I I I ,  paragraph 2).