guichett - 31985Y0604(01) -

COUNCIL RESOLUTION of 7 May 1985 on a new approach to technical = harmonization=20 and standards (85/C 136/01)

THE COUNCIL,

in extension of its conclusions on standardization, approved on 16 = July 1984=20 (Annex I);

emphasizes the urgent need to resolve the present situation as = regards=20 technical barriers to trade and dispel the consequent uncertainty for = economic=20 operators;

emphasizes the importance and desirability of the new approach which = provides=20 for reference to standards - primarily European standards, but national = ones if=20 need be, as a transitional measure - for the purposes of defining the = technical=20 characteristics of products, an approach outlined by the Commission in = its=20 communication of 31 January 1985, which follows certain guidelines = adopted by=20 the European Parliament in its resolution of 16 October 1980 and forms = part of=20 the extension of the Council's conclusions of 16 July 1984;

aware that the new approach will have to be accompanied by a policy = on the=20 assessment of conformity, calls on the Commission to give this matter = priority=20 and to expedite all its work in this area;

approves the guidelines encapsulated in the list of principles and = main=20 elements to be embodied in the main part of the Directives (Annex II to = this=20 resolution);

calls on the Commission to submit suitable proposals as soon as = possible.=20

ANNEX I CONCLUSIONS ON STANDARDIZATION

Approved by the Council on 16 July 1984

The Council believes that standardization goes a long way towards = ensuring=20 that industrial products can be marketed freely and also towards = creating a=20 standard technical environment for undertakings in all countries, which = improves=20 competitiveness not only on the Community market but also on external = markets,=20 especially in new technology.

It recognizes that the objectives being pursued by the Member States = to=20 protect the safety and health of their people as well as the consumer = are=20 equally valid in principle, even if different techniques are used to = achieve=20 them.

Accordingly, the Council adopts the following principles for a = European=20 standardization policy: - agreement by the Member States to keep a = constant=20 check on the technical regulations which are applied - whether de jure = or de=20 facto - on their territory so as to withdraw those which are obsolete or = unnecessary;

- agreement by the Member States to ensure the mutual recognition of = the=20 results of tests and the establishment, where necessary, of harmonized = rules as=20 regards the operation of certification bodies;

- agreement to early Community consultation at an appropriate level, = in=20 accordance with the objectives of Directive 189/83/EEC where major = national=20 regulatory initiatives or procedures might have adverse repercussions on = the=20 operation of the internal market;

- extension of the Community practice in matters of technical = harmonization=20 of entrusting the task of defining the technical characteristics of = products to=20 standards, preferably European but if necessary national, where the = conditions=20 necessary for this purpose, particularly as regards health protection = and=20 safety, are fulfilled;

- a very rapid strengthening of the capacity to standardize, = preferably at=20 European level, with a view to facilitating on the one hand = harmonization of=20 legislation by the Community and on the other industrial development,=20 particularly in the field of new technologies, since this could in = specific=20 circumstances involve the Community in introducing new procedures to = improve the=20 drawing up of standards (e.g. standardization bureaus, ad hoc = committees). The=20 adoption of European standards would be submitted to the European=20 standardization bodies for approval.

In high technology sectors particularly, subjects should be = identified where=20 common specifications and standards will make for efficient exploitation = of the=20 Community dimension and the opening of public works and supply contracts = so that=20 the decisions required in this connection may be taken.

ANNEX II GUIDELINES FOR A NEW APPROACH TO TECHNICAL HARMONIZATION AND = STANDARDS

The following are the four fundamental principies on which the new = approach=20 is based: - legislative harmonization is limited to the adoption, by = means of=20 Directives based on Article 100 of the EEC Treaty, of the essential = safety=20 requirements (or other requirements in the general interest) with which = products=20 put on the market must conform, and which should therefore enjoy free = movement=20 throughout the Community,

- the task of drawing up the technical specifications needed for the=20 production and placing on the market of products conforming to the = essential=20 requirements established by the Directives, while taking into account = the=20 current stage of technology, is entrusted to organizations competent in = the=20 standardization area,

- these technical specifications are not mandatory and maintain their = status=20 of voluntary standards,

- but at the same time national authorities are obliged to recognize = that=20 products manufactured in conformity with harmonized standards (or,=20 provisionally, with national standards) are presumed to conform to the=20 "essential requirements" established by the Directive. (This signifies = that the=20 producer has the choice of not manufacturing in conformity with the = standards=20 but that in this event he has an obligation to prove that his products = conform=20 to the essential requirements of the Directive. )

In order that this system may operate it is necessary: - on the one = hand that=20 the standards offer a guarantee of quality with regard to the "essential = requirements" established by the Directives,

- on the other hand that the public authorities keep intact their=20 responsibility for the protection of safety (or other requirements = envisaged) on=20 their territory.

The quality of harmonized standards must be ensured by = standardization=20 mandates, conferred by the Commission, the execution of which must = conform to=20 the general guidelines which have been the subject of agreement between = the=20 Commission and the European standardization organizations. In so far as = national=20 standards are concerned their quality must be verified by a procedure at = Community level managed by the Commission, assisted by a standing = committee=20 composed of officials from national administrations.

At the same time safeguard procedures must be provided for, under the = management of the Commission assisted by the same committee, in order to = allow=20 the competent public authorities the possibility of contesting the = conformity of=20 a product, the validity of a certificate or the quality of a standard. =

In following this system of legislative harmonization in each area in = which=20 it is feasible, the Commission intends to be able to halt the = proliferation of=20 excessively technical separate Directives for each product. The scope of = Directives according to the "general reference to standards" formula = should=20 encompass wide product categories and types of risk.

The Community could on the one hand, therefore, complete the = extremely=20 complex undertaking of harmonizing technical legislation and on the = other hand=20 promote the development and application of European standards. These are = essential conditions for the improvement of the competitiveness of its = industry.=20

OUTLINE OF THE PRINCIPLES AND MAIN ELEMENTS WHICH SHOULD MAKE UP THE = BODY OF=20 THE DIRECTIVES

A. JUSTIFICATIONS

Amongst the traditional principles justifying a Directive the = following=20 aspects should be emphasized: - Member States have the responsibility of = ensuring safety on their territory (in the home, at the workplace, etc.) = of=20 persons, domestic animals and goods, or the respect of other essential=20 protection requirements in the general interest such as health, consumer = or=20 environmental protection etc., with regard to the hazards covered by the = Directive itself (1);

- the national provisions ensuring such protection must be harmonized = in=20 order to ensure the free movement of goods, without lowering existing = and=20 justified levels of protection in the Member States;

- CEN and CENELEC (one or the other, or both according to the = products=20 covered by the Directive) are the competent bodies to adopt European = harmonized=20 standards within the scope of the Directive, in accordance with the = guidelines=20 which the Commission, after consultation of the Member States, has = signed with=20 these bodies (2). (1) For reasons of convenience and ease of drafting = the rest=20 of this document refers only to safety. (2) For specific sectors of = industrial=20 activity other competent European bodies for the drawing up of technical = specifications could be involved. 1. In this outline a general approach = is=20 developed which should be applied according to the needs for legislation = by=20 Directives based on Article 100 of the Treaty relating to sectors or = families of=20 products as well as types of hazard.

2. The object of the Directive will be specified in each sphere of=20 application according to the types of hazard (safety, health, = environmental,=20 consumer protection, etc.) and should the need arise to the = circumstances (in=20 the home, at the place of work, under road traffic conditions, during = leisure=20 activities, etc.).

3. Where appropriate, it should be stated that the Member States may = make=20 provision, in accordance with Community law, for national regulations = concerning=20 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=20 that it is carried into effect by the very adoption of the Directive = under=20 Article 100 of the Treaty, as the essential safety requirements = contained in it=20 are of such a nature as to ensure the pursuit of such an objective.

B. MAIN ELEMENTS I. Scope

Definition of the range of products covered, as well as the nature of = the=20 hazards it is intended to avert.

The scope should be defined in such a way that a consistent approach = to the=20 action is ensured, and that the proliferation of Directives on specific = products=20 is avoided. Moreover, it should be noted that the enacting terms of such = a=20 Directive do not preclude the possibility of several Directives being = adopted on=20 one and the same product according to the various types of hazard = associated=20 with that product (for example, mechanical safety of a machine on the = one hand=20 and pollution by that machine on the other hand).

II. General clause for placing on the market

The products covered by the Directive may be placed on the market = only if=20 they do not endanger the safety of persons, domestic animals or goods = when=20 properly installed and maintained and used for the purposes for which = they are=20 intended. 1. The Directives would provide for total harmonization as a = general=20 rule. Consequently, any product placed on the market falling within the = scope of=20 the Directive must be in conformity with the requirements of the = Directive. In=20 certain specific conditions, optional harmonization for certain products = may=20 prove to be opportune. The outline Directive, however, is drawn up with = a view=20 to total harmonization.

Appropriate solutions could be envisaged in order to take account of = the need=20 to support, in some Member States, a harmonious move towards the = introduction of=20 a system of binding regulations, in order in particular to ensure the=20 establishment of appropriate certification infrastructures.

Point II therefore represents a general clause setting out the=20 responsibilities of the Member States in relation to the placing of = goods on the=20 market.

2. In order to respect the general principle on which the outline = Directive=20 is based, which is to leave to the trade the choice of the means of = attestation=20 of conformity and thus to prohibit Member States from setting up any = system of=20 control prior to placing on the market (except, of course, in cases = where prior=20 control is required by specific Directives for special sectors, as is = moreover=20 clearly provided for in point VIII), it is obvious that the national = authorities=20 in order to acquit themselves of their responsibilities set out in this = clause=20 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=20 and consumers, the conditions set out in this clause may be strengthened = (foreseeable use).

III. Essential safety requirements

Description of the safety requirements which are essential for the=20 application of the general clause in point II with which all products = covered by=20 the Directive must conform. 1. The essential safety requirements which = must be=20 met in the case of products which can be put on the market shall be = worded=20 precisely enough in order to create, on transposition into national law, = legally=20 binding obligations which can be enforced. They should be so formulated = as to=20 enable the certification bodies straight away to certify products as = being in=20 conformity, having regard to those requirements in the absence of = standards. The=20 degree of detail of the wording will depend on the subject matter. If = the basic=20 requirements for safety are observed, the general clause in point II can = be=20 applied.

2. Amendments to these requirements can be made only by means of a = new=20 Council Directive under Article 100 of the Treaty.

IV. Free movement clause

Obligation on the Member States to accept, under the conditions = referred to=20 in point V, the free movement of products which conform to points II and = III. 1.=20 Free movement will be ensured in the case of products declared to = conform to the=20 protection requirements laid down in the Directive, without recourse as = a=20 general rule to prior verification of compliance with the requirements = set out=20 in point III, it being understood that note 2 of point II also applies = in this=20 case.

The interpretation to be given to this provision should not have the=20 consequence that third party certification is to be systematically = required by=20 the sectoral Directives.

2. The actual aim of the Directives in question is to cover all = essential=20 requirements, but in the exceptional case of cover proving incomplete, = it would=20 always be possible for a Member State to act under Article 36 of the = Treaty.=20

V. Means of proof of conformity and effects 1. Member States shall = presume to=20 be in conformity with points II and III products which are accompanied = by one of=20 the means of attestation described in point VIII declaring that they are = in=20 conformity with: (a) the harmonized standards adopted by the European=20 standardization body which is particularly competent within the scope of = this=20 Directive, when these standards are adopted in accordance with the = general=20 guidelines agreed between that body and the Commission and the = references of=20 which are published in the Official Journal of the European Communities = ; such=20 publication should, moreover, also be carried out by the Member States; =

(b) or as a transitional measure, and in so far as harmonized = standards do=20 not exist in the field covered by such standards, national standards = referred to=20 in paragraph 2.

2. Member States shall communicate to the Commission the text of = those=20 national standards which they consider to meet points II and III. The = Commission=20 shall forthwith forward this text to the other Member States. In = accordance with=20 the procedure laid down in paragraph 2 of Point VI, the Commission shall = notify=20 the Member States of the national standards which enjoy the presumption = of=20 conformity with points II and III.

Member States are required to publish the references of these = standards. The=20 Commission shall also ensure that they are published in the Official = Journal of=20 the European Communities.

3. Member States shall accept that the products for which the = manufacturer=20 has not applied any standard (because of absence of a standard as laid = down in=20 paragraphs 1 (a) and (b) above or for other exceptional reasons, are = considered=20 to be in conformity with points II and III, when their conformity is=20 demonstrated by one of the means of attestation set out in point VIII, = paragraph=20 1 (a) and (b). 1. Only those means of attestation provided for in point = VIII=20 necessarily carry presumption of conformity.

2. The presumption of conformity is constituted by the fact that the=20 conformity of a product to harmonized or national standards is declared = by one=20 of the means of attestation set out in point VIII. When the product is = not in=20 conformity with a standard, because the standards do not exist or = because the=20 manufacturer, for example in cases of innovation, prefers to apply other = manufacturing criteria of his choice, conformity to points II and III is = declared by the means of an attestation delivered by an independent = body.

3. In cases under point V, paragraphs 1 and 3, Member States will = therefore=20 have the right, for the presumption to operate, to request at any time = one of=20 the means of attestation set out in point VIII.

4. The drafting and adoption of the harmonized standards mentioned in = paragraph 1 (a) by the CEN and CENELEC, these bodies being generally = considered=20 to be the "European standards bodies which are particularly competent", = and the=20 obligation relating to transposition into national standards are = governed by=20 these two bodies" internal rules and their regulations relating to = standards=20 work. The internal rules of CEN and CENELEC are in the process of being=20 harmonized.

However, it is not ruled out that the harmonized standards referred = to in=20 paragraph 1 (a) will be prepared outside CEN and CENELEC by other bodies = which=20 may assume these functions in particular areas ; in such cases adoption = of the=20 harmonized standards shall be submitted for approval by CEN/CENELEC. In = any=20 case, the drafting and introduction of the harmonized standards referred = to in=20 point V must be subject to the guidelines agreed between the Commission = and=20 these organizations. The guidelines deal in particular with the = following=20 principles and conditions: - the availability of suitable staff and = technical=20 infrastructure at the standards body which the Commission mandates to = proceed=20 with standardization;

- the association of public authorities and interested circles (in = particular=20 manufacturers, users, consumers, unions);

- the adoption of harmonized standards and their transposition into = national=20 standards or, at least, the annulment of diverging national standards = under=20 conditions approved by the Commission when drawing up a frame of = reference for=20 standardization after consultation with the Member States.

5. In the selection of national standards, due consideration will be = given to=20 any practical difficulties arising from that selection.

National standards are selected only on a transitional basis. = Accordingly,=20 when a selection decision is made, the relevant European bodies will in=20 principle be sent instructions to draft and adopt the corresponding = European=20 standards within a given period of time and under the conditions stated = above.=20

VI. Management of the list of standards 1. Where a Member State or = the=20 Commission considers that harmonized standards or drafts thereof do not = fully=20 satisfy points II and III, the Commission or the Member State shall = bring this=20 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 shall, in the light of the committee's opinion, notify = the=20 Member States of the necessity of withdrawing or not withdrawing the = standard=20 from the publication referred to in point V, paragraph 1 (a). It shall = inform=20 the European standards body concerned and, if necessary, give it a new = or=20 revised mandate.

2. On receipt of the communication referred to in point V, paragraph = 2, the=20 Commission shall consult the committee. After the committee has given = its=20 opinion, the Commission shall, within a given period, notify the Member = States=20 whether the national standard in question should or should not enjoy = presumption=20 of conformity and, if so, be subject to national publication of its = references.=20

If the Commission or a Member State considers that a national = standard no=20 longer fulfils the conditions for presumption of conformity to the = safety=20 requirements, the Commission shall consult the committee. In the light = of the=20 opinion of the committee, it shall notify the Member States whether or = not the=20 standard in question should continue to enjoy presumption of conformity = and in=20 the latter case be withdrawn from the publications referred to in point = V,=20 paragraph 2.

As indicated above (see notes to point V, paragraph 2) the Member = States have=20 the power to decide which of their national standards may be considered = to be in=20 conformity with points II and III and thus be subject to the Commission=20 confirmation procedure.

VII. Safeguard clause 1. Where a Member State finds that a product = might=20 compromise the safety of individuals, domestic animals or property, it = shall=20 take all appropriate measures to withdraw or prohibit the placing on the = market=20 of the product in question or to restrict its free movement even if it = is=20 accompanied by one of the means of attestation referred to in point = VIII.

Within a given period of time, and only when the product in question = is=20 accompanied by one of the means of attestation provided for in point = VIII, the=20 Member State shall inform the Commission of such a measure. It will = indicate the=20 reasons for its decision and in particular whether the non-conformity = results=20 from: (a) non-compliance with points II and III (when the product does = not=20 conform to any standard);

(b) incorrect application of the standards referred to in point V; =

2. The Commission shall consult the Member States concerned as soon = as=20 possible. If the Member State which has taken measures intends to = maintain them,=20 the Commission shall refer the matter to the committee within a = specified=20 period. Where the Commission, after consultation of the committee, finds = that=20 the action is justified it shall, also within a given period of time, = inform the=20 Member State in question and point out to the other Member States that = (all else=20 being equal) they are also obliged to prevent the product in question = from being=20 placed on the market.

3. Where failure of the product to comply with points II and III = results from=20 a shortcoming in the harmonized standards or in the national standards, = the=20 consequences shall be those set out in point VI.

4. Where the non-conforming product is accompanied by a means of = attestation=20 issued by an independent body or by the manufacturer, the competent = Member State=20 shall take the appropriate measures against the author of the = attestation and=20 inform the Commission and the other Member States.

5. The Commission shall ensure that all Member States are kept = informed of=20 the progress and of the outcome of this procedure.

This point describes the consequences when recourse by a Member State = to the=20 safeguard clause appears to be justified. It does not give any = indication on the=20 consequences when recourse does not appear to be justified after expiry = of the=20 Community examination procedure, because in such cases the general rules = of the=20 Treaty apply.

VIII. Means of attestation of conformity 1. The means of attestation = referred=20 to in point V which the trade may use are: (a) certificates and marks of = conformity issued by a third party;

(b) results of tests carried out by a third party;

(c) declaration of conformity issued by the manufacturer or his agent = based=20 in the Community. This may be coupled with the requirement for a = surveillance=20 system;

(d) other means of attestation which could possibly be determined in = the=20 Directive.

2. The choice by trade and industry between these different means may = be=20 limited, or even removed, according to the nature of the products and = hazards=20 covered by the Directive.

3. National bodies authorized to issue marks or certificates of = conformity=20 shall be notified by each Member State to the Commission and to the = other Member=20 States. 1. The appropriate means of attestation will be established and = expanded=20 in the specific Directives taking into account the special requirements = of their=20 scope. It must be borne in mind that the certification bodies designated = by the=20 Member States for cases (a) and (b) will have to intervene in particular = in the=20 absence of standards and where the manufacturer does not observe = standards (see=20 point V, paragraph 3).

2. The bodies referred to in paragraph 3 must carry out their duties=20 according to recognized international practices and principles and = especially in=20 accordance with ISO Guides. The responsibility for the control of the = operation=20 of these bodies lies with the Member States. Questions concerning the = carrying=20 out of tests and certification may be put before the committee set up = under=20 point IX.

3. With regard to the manufacturer's declaration of conformity, the = national=20 authorities have the right to ask the manufacturer or the importer to=20 communicate the data relating to the tests carried out concerning safety = etc.,=20 when they have good grounds for believing that a product does not offer = the=20 degree of safety required in all respects. Refusal on the part of the=20 manufacturer or the importer to communicate these data constitutes = sufficient=20 reason to doubt the presumption of conformity.

4. The determination of a limitative list of means of attestation = only=20 concerns the system of presumption of conformity but cannot have the = effect of=20 restricting the possibility for a member of the trade to prove, by any = means he=20 sees fit within the framework of a dispute or court proceedings, the = conformity=20 of the product with points II and III.

IX. Standing committee

A standing committee shall be set up chaired by a representative of = the=20 Commission and consisting of representatives appointed by the Member = States who=20 may avail themselves of the help of experts or advisers.

The committee shall be convened by its chairman either on his own = initiative=20 or at the request of a Member State.

The committee shall draw up its own rules of procedure.

X. Tasks and operation of the committee 1. The committee shall carry = out the=20 tasks entrusted to it by virtue of the foregoing points.

2. Furthermore, any question regarding the implementation of a = Directive may=20 be submitted to the committee.

The tasks of the committee shall be concerned with the implementation = of the=20 Directive. The object of the consultation of the Committee prior to the=20 publication of the references of the national standards is more to = provide for a=20 forum for the discussion of the objections which the Commission or a = Member=20 State may formulate, than to carry out a systematic examination of the = entire=20 contents of the standards.

Criteria for choosing the priority areas in which this approach could = initially be applied

1. The need to find a new approach to the harmonization of technical=20 regulations, based on "general reference to standards" and following the = lines=20 described earlier, is the outcome of a number of conditions (outlined in = the=20 first part of this communication) backed up by the experience already = acquired=20 by the Community. Consequently it is a general principle, the validity = of which=20 will have to be assessed in practical terms in the various areas in = which it=20 will be applied.

The Council took a similar view in its "Conclusions" of 16 July 1984 = when it=20 confirmed the general need for an extension of the "general reference to = standards" practice, but only provided the necessary conditions were = fulfilled,=20 i.e. as regards the obligation on public authorities to protect the = health and=20 safety of their citizens.

2. Before the priority areas in which this approach should initially = be=20 applied can be chosen, it is therefore necessary to establish a number = of=20 selection criteria to be taken into consideration, criteria which cannot = be=20 taken separately. (a) Since the approach calls for the "essential = requirements"=20 to be harmonized and made mandatory by Directives based on Article 100 = of the=20 Treaty, the "general reference to standards" approach will be = appropriate only=20 where it is genuinely possible to distinguish between "essential = requirements"=20 and "manufacturing specifications". In other words, in all areas in = which the=20 essential requirements in the public interest are such that a large = number of=20 manufacturing specifications have to be included if the public = authorities are=20 to keep intact their responsibility for protection of their citizens, = the=20 conditions for the "general reference to standards" approach are not = fulfilled=20 as this approach would have little sense. In the light of this statement = areas=20 involving safety protection certainly appear to have priority over those = involving health protection (which applies to the scope of Directive = 83/189).=20

(b) If "general reference to standards" is to be possible, the area = concerned=20 must be covered by, or be capable of being covered by, standardization. = Areas=20 which are inherently ill suited to standardization work are certainly = the areas=20 referred to in (a) above where the need for regulations is felt = unanimously=20 throughout the Community. In other areas there is a standardization = capacity or=20 potential and in the latter case the Community should encourage it in = close=20 cooperation with both the industry concerned and the European standards = bodies,=20 whilst ensuring that the interests of consumers are taken into account. =

(c) The progress of technical harmonization work in the Community = under the=20 general programme established by the Council resolutions of 1969 and = 1973 varies=20 greatly from one industrial sector to another. In manufacturing industry = (which=20 appears at first sight better to fulfil the abovementioned criteria) = most of the=20 Directives adopted concern three areas : motor vehicles, metrology and=20 electrical equipment.

The new approach will therefore have to take this state of affairs = into=20 account and concentrate mainly on other areas in which there is a lack = of=20 Community activities (e.g. many engineering products and building = materials)=20 without calling into question regulations that are already well advanced = (for=20 example those referring to motor vehicles). The case of electrical = equipment is=20 different : this is the only area to have been tackled by a Directive of = the=20 "general reference to standards" type and should certainly be included = in the=20 priority areas for all such products not yet covered, in view of the = extremely=20 important part played in this area by international and European=20 standardization.

(d) One of the main purposes of the new approach is to make it = possible to=20 settle at a stroke, with the adoption of a single Directive, all the = problems=20 concerning regulations for a very large number of products, without the = need for=20 frequent amendments or adaptations to that Directive. Consequently in = the=20 selected areas there should be a wide range of products sufficiently = homogeneous=20 to allow common "essential requirements" to be defined. This general = criterion=20 is, however, based mainly on practical and labour-saving considerations. = There=20 is nothing to prevent a single type of product, in certain cases, from = being=20 covered by the "general reference to standards" formula if all the=20 abovementioned criteria are met.

(e) Finally, mention should be made of one criterion that the = Commission, in=20 agreement with industry, has always regarded as essential. There must be = grounds=20 for considering that the existence of different regulations does in = practice=20 genuinely impede the free movement of goods. In some cases, however, = even if=20 these grounds are not obvious, a Directive may appear necessary to = protect an=20 essential public interest uniformly throughout the Community.