19. 10. 89 Official Journal of the European Communities No C 267/3 
II 
(Preparatory Acts) 
COMMISSION 
A GLOBAL APPROACH TO CERTIFICATION AND TESTING 
Quality measures for industrial products (') 
COM(89) 209 final — SYN 208 
(Commission communication to the Council submitted by the Commission on 15 June 1989) 
(89/C 267/03) 
PREFACE 
The White Paper sets out to remove technical barriers to products on the basis of a 'new 
strategy' which combines harmonization with the mutual recognition of national regulations and 
standards. 
However, it was found from experience that the success of this strategy could not really be 
assured unless it was accompanied by a policy aimed at placing the conditions governing the 
assessment of conformity on an equal footing in all the Member States. In its resolution on a 
new approach to technical harmonization and standards the Council indicated that it was 
aware of this situation and invited the Commission to ensure that this new approach was 
accompanied by a policy on the assessment of conformity. The fact that a supplier has to send 
different certificates and marks with his products on each of the various markets does represent 
a technical barrier to trade and is a major factor in the fragmentation of these markets which is 
liable to persist in spite of the harmonization or the mutual recognition of regulations and 
standards. How can such a situation arise? 
Some examples help to illustrate the problem better. 
A manufacturer of special metal alloys is required to provide proof of certain chemical pro­
perties and certain mechanical performances of those alloys in order to be able to sell his 
products. This is a requirement which can be imposed on him either by regulations or under 
the terms of the contract he has signed with his client. If the regulations in question have been 
harmonized, there will be a directive (such as the directive on simple pressure vessels) which 
will not only specify what these properties and performances must be but will also state that 
each Member State must designate the body responsible for carrying out the tests and issuing 
the certificates. It will also have stipulated that Member States must recognize certificates 
issued in another Member State. 
However, in order for this mutual recognition to work, the technical credibility of the bodies 
must be comparable. A directive cannot therefore confine itself to stating this requirement; it 
must also lay down the conditions that the inspection bodies have to meet in order to be designated. 
Failing this, manufacturers in countries where the credibility of the designated bodies is low 
will continue to experience difficulties in exporting their products. 
Where, on the other hand, the requirement to provide a mark of conformity stems from 
national regulations which have not been harmonized — for example, in the case of the manu­
facture of industrial boilers, for which there is as yet no Community directive — the manu­
facturer falls in principle within the scope of Articles 30 to 36 of the Treaty, and when he has 
obtained certification for his alloys he expects to be able to sell them in the other Member 
States too. Assuming that in the other Member States the requirements governing the pro­
perties and performances of these alloys which are to be used in the manufacture of the boilers 
(') The proposal for the Commission Decision was published in OJ No C 231, 8. 9. 1989, p. 3. 
No C 267/4 Official Journal of the European Communities 19. 10. 89 
are equivalent, it will also be necessary for the authorities in these Member States to have full 
confidence in the technical credibility of the body that has carried out the tests and issued the 
certificates or marks of conformity. However, if the body in question does not have an interna­
tionally established reputation, or if its competence cannot be objectively established, the alloy 
manufacturer is unlikely to have the opportunity to benefit from the doctrine of mutual recog­
nition. 
Finally, there is the example where the alloy in question is to be used in the construction of a 
plant which is not covered either by national or by Community rules, but where the 
performances have to be guaranteed in the contract with the purchaser. The sensible purchaser 
will not have been content with including a clause in the contract requiring the attestation of 
conformity, but will also have specified which body was to issue that attestation. And, 
naturally, he will have chosen the body with which he is most familiar, which has a flawless 
technical reputation and with which he has been used to dealing for a long time. It should 
hardly be surprising that in most cases he will have chosen a body based in his own country 
(there being no rule in the Treaty requiring him to do otherwise). The manufacturer will then 
have to have his alloys certified afresh, unless there is a mutual recognition agreement between the 
body in his country and that chosen by his client. 
We can also imagine these situations arising when the various bodies are required to intervene 
in a different capacity, i.e. to certify not products but a firm's production processes. In such 
cases their task is to examine and approve a system of quality management (using quality 
assurance techniques) and to perform periodic checks in the plants of the certified firms. For 
example, in order to sell his products, a manufacturer of medical appliances must demonstrate 
that he has a quality control system that has been approved and is supervised by a third party. 
Unless the bodies carrying out these operations work on a common basis, applying the same 
standards and criteria, the manufacturer will be obliged to obtain certification on the different 
markets, according to the requirements of the countries concerned, which will either be laid 
down by law or be stipulated by the client. 
These multiple certifications of products and processes can entail very high costs which do not 
end with the initial costs; there are also the costs of the annual inspections which these bodies 
carry out as long as the manufacturer continues to use the marks and certificates that have 
been issued to him. 
It can therefore be concluded from these examples that despite the progress on the legal front 
it will be impossible to avoid barriers to trade altogether in the internal market until such time 
as the national structures and methods for conformity assessment — certification and 
inspection bodies and testing laboratories — are genuinely uniform and transparent (in other 
words until their competence and credibility can be objectively verified). 
Harmonization of conformity assessment structures is therefore the goal to aim for in order to 
create the conditions which are essential for engendering confidence and, hence, for the estab­
lishment of mutual recognition. 
This memorandum which the Commission is presenting to the Council describes the various 
instruments to be used in order to attain this goal, in particular those related to European 
standards, Community legislation and cooperation at European level between the national certifi­
cation, testing and inspection structures. 
Since the global approach set out in this paper is based on the most modern techniques 
(accreditation and quality assurance) already covered in international standards von modele 
(ISO-IEC), it not only enables the Community to secure the removal of technical barriers to 
trade but is also capable of becoming a major factor in the promotion of industrial quality and, 
hence, of the competitiveness of European firms, both on the internal market and beyond. 
19. 10. 89 Official Journal of the European Communities No C 267/5 
I. INTRODUCTION 
Regulation, standardization and the various structures 
for evaluating the conformity of products to the regu­
lations and standards together constitute some of the key 
elements in the organization of quality. That organ­
ization itself, which is the result of both legislative acts 
or regulations and consensual measures, has a profound 
influence on individual behaviour on a particular market 
and means that, in order to have access to that market, 
each manufacturer has to ensure that his products 
conform to the level of quality of which this organi­
zation is the expression. 
In order to be effective the work on completing the 
internal market must have as its goal the gradual estab­
lishment of a common market organization, with its own 
level of quality, by acting inter alia on three of its distin­
guishing features: regulations, standards and structures 
for the assessment of conformity. 
In its resolution of 7 May 1985 on a new approach to 
technical harmonization and standards, the Council laid 
the foundations for a policy geared to that objective. 
That resolution also states explicitly that this policy must 
be accompanied by a policy on the assessment of 
conformity and calls on the Commission to give this 
matter priority. 
The memorandum and draft proposal for a decision 
annexed to this communication are the response to that 
request. 
II. OBJECTIVES OF A GLOBAL APPROACH TO THE 
ASSESSMENT OF CONFORMITY 
In each national market the structures for conformity, 
inspection and testing meet specific needs expressed by 
the legislator and by the behaviour of buyers, users and 
consumers. Consequently, manufacturers must subject 
their products to a system of multiple checks according 
to the markets on which they intend to sell the products. 
Where these barriers to trade are the result of binding 
regulations, they must be removed 
— either, through directives based on Article 100a of 
the Treaty, by harmonizing these regulations and by 
requiring the authorities of each Member State to 
recognize proofs of conformity issued in other 
Member States; 
— or by applying the doctrine sanctioned by the Court 
with regard to the obligations arising out of Articles 
30 to 36 of the Treaty and under which a product 
lawfully produced and marketed in one Member 
State must, in principle, be admitted to the markets of 
the other Member States. Where, on the other hand, these obstacles are the result 
not of legal requirements but of the free play of market 
demand — i.e. there is no direct or indirect influence 
from the public authority — the means for the gradual 
removal must be sought on the one hand in the harmon­
ization of voluntary standards laying down criteria for 
the operation of national conformity structures and, on 
the other, in measures to promote agreements between 
these structures to bring them gradually towards the 
establishment of common systems of certification and 
testing. 
There is a danger, however, that action taken on these 
three levels — namely harmonization of regulations, 
mutual recognition of national regulations and the 
approximation of structures within a system of voluntary 
certification — might be ineffective in practice unless 
they solve the same problem and satisfy the same needs, 
that is to say the need to create the conditions which will 
enable confidence to grow and become fundamental to the 
operation of mutual recognition. 
The necessity for a global approach to certification, 
inspection and testing thus arises out of this basic need 
to create conditions that are conducive to confidence 
and, to that end, to bring the structures and procedures 
involved in these activities more closely into line. 
III. MEASURES NECESSARY FOR THE IMPLEMEN­
TATION OF THE GLOBAL APPROACH 
A start has already been made on some of the measures 
under this global approach since the resolution of 7 May 
1985 on the new approach and these must now be 
further developed and placed in the context of an overall 
policy. They relate to three different levels of action. 
A. Action on the basic structures 
The basic structures for the evaluation of conformity 
are the bodies responsible for certification and 
inspection of the testing laboratories, and the manu­
facturers' quality systems. The aim is to make these 
structures as homogeneous, transparent and credible 
as possible throughout the Community, since this 
is a precondition for the proper functioning 
of conformity assessment, both compulsory and 
voluntary. 
To this end the Commission took steps, as it had 
announced in its White Paper on completing the 
internal market ('), to encourage the drafting of 
technical guidelines setting out the criteria to be used 
when evaluating the competence of operators in the 
field of conformity assessment. 
(') Doc. COM (85) 310, 14. 6. 1985, paragraph 78. 
No C 267/6 Official Journal of the European Communities 19. 10. 89 
At present these guidelines (drawn from ISO 
documents) have been transposed into European 
standards (EN 29000 and EN 45000) and are 
therefore applicable in all Member States of the 
Community. The decision to give these guidelines the 
status of European standards rather than that of 
binding Council directives was dictated by the nature 
of the subject matter, which does not lend itself well 
(except in special cases such as pharmaceuticals, 
chemicals or pesticides where there is a close link 
with human health) to being imposed as such on the 
economic system. This is an area that requires fairly 
sophisticated expertise which all operators will 
eventually have to acquire, but which demand of 
them a considerable effort of adjustment and learning 
which cannot simply be imposed by law. 
Legislation, however, can serve as a powerful 
instrument to assist this development nevertheless by 
introducing a presumption of conformity with the 
provisions of the directives on conformity assessment 
for operators who can demonstrate that they are 
applying these standards (a practice that is a 
well-known part of the new approach); in other 
words for manufacturers who apply the standards 
governing the management of quality assurance (EN 
29000) and to certification bodies and accredited 
laboratories in accordance with the EN 45000 series 
standards. 
The Commission therefore calls on the Member 
States to promote the implementation of these 
standards both in their regulations and in private 
certification systems, and to introduce accreditation 
systems based on these standards. 
The Commission is also studying measures, including 
budgetary measures, to be envisaged for the devel­
opment of certification and testing structures in those 
Member States or specific sectors of industry where 
delays are liable to jeopardize the smooth functioning 
of Community regulations. 
B. Action on regulations 
The conformity assessment procedures in Community 
regulations must take account of the considerable 
progress made and the new mechanisms available 
(quality assurance, accreditation, standardized 
assessment criteria and so on). 
A global approach which involves drawing up a set of 
modules for the various operations is designed to 
allow the Community legislator to lay down the most 
appropriate procedures in the harmonizing directives, 
using what has already been done in the field of 
European and international standardization as a 
basis. The fundamental principles of the modular 
approach are as follows: 
— the directives must define the limits of the choice of 
procedures open to the manufacturer for ensuring 
compliance with the essential requirements; — the affixing of the CE mark on the products is the 
tangible sign of their conformity to Community 
rules. No other mark of conformity to 
Community rules is allowed to be used, although 
voluntary marks of conformity to standards are 
compatible with the CE mark. The Commission 
will be submitting a proposal for a directive on 
the use of the CE mark and will be examining 
carefully the case for a possible coexistence of the 
CE mark and national voluntary marks. 
— the bodies involved in the conformity assessment 
procedures are designated by the Member States and 
notified to the Commission and the other Member 
States in accordance with the common assessment 
criteria. The fact that these accredited bodies 
conform to European standards (EN 45000) gives 
rise to a presumption of conformity with those 
criteria. 
As far as non-harmonized national regulations are 
concerned, all the steps taken or advocated under 
point A above are intended to give full effect to the 
principle of mutual recognition; their aim is that the 
certification bodies and laboratories that are auth­
orized to attest that the products conform to national 
regulations should be designated or accredited 
according to objective criteria of transparency and 
competence and that the operation of such bodies 
should also satisfy the same criteria. In other words, 
their purpose is to ensure that the requirement of 
mutual recognition is applied in full without any 
possibility of this being contested by the national 
authorities. 
Similarly, it can be argued that the harmonization of 
conformity assessment procedures, as advocated by 
the modular approach, will inevitably exert an 
influence on the procedures laid down in 
non-harmonized national regulations. Moreover, 
Directive 83/189/EEC is the appropriate instrument 
for making sure that this is done in a systematic way. 
C. The need for a European infrastructure for certifi­
cation and testing 
The measures set out in point A above relate to the 
mechanisms which can help to generate the necessary 
confidence in the competence of operators in the 
field of conformity assessment. This confidence is 
essential if mutual recognition is to work. In areas 
which are not covered by the aims of Article 36 and 
which would be described as activities carried out 
privately on a contractual basis, mutual recognition 
cannot be imposed by law. Consequently, the efforts 
to remove barriers to trade that arise from the 
existence of national voluntary certification 
arrangements will have to be accompanied by 
incentives for cooperation between organizations and 
laboratories at European level — as was the case in 
19. 10. 89 Official Journal of the European Communities No C 267/7 
fact with standardization — with a view to the estab­
lishment of joint systems for certification and the 
recognition of test results. 
This has led to a call from several quarters for a 
flexible and non-bureaucratic structure, in Europe, to 
be set up under the aegis of the Commission within 
the existing European standardization infrastructure 
Comite europeen de normalisation/Comite europeen 
de normalisation electrotechnique (CEN/Cenelec). 
The Commission will also look into the possibility of 
a directive coordinating the statutes of these bodies, 
particularly as regards questions of liability and 
insurance which are likely to have a bearing on their 
cooperation agreements. 
IV. CONCLUSION 
This communication contains the main elements of the 
memorandum (set out in Annex 1) which elaborates on 
all the components of a European policy in the field of 
conformity assessment which, if carefully and properly 
assembled, will provide the Community with one of the 
basic essentials for progress towards an overall quality 
policy, indispensable to any industrial policy and 
inherent in the very concept of an internal market. 
The measures recommended can be summarized as 
follows: 
(a) The Council: 
— is to adopt the modules for the various phases of 
the conformity assessment procedures, which are 
to be used in the technical harmonization 
directives, and the criteria governing their use in 
those directives, 
— is to encourage the Member States to promote on 
a wide scale the use of standards EN 29000 and 
EN 45000 so as to harmonize to the greatest 
possible extent the criteria for the evaluation of 
quality systems and of certification, inspection 
and testing bodies, making use of the instrument 
of accreditation; 
(b) The Commission: 
— is to prepare, on the basis of the guidelines set 
out in the attached memorandum, a proposal for 
a directive on the use of the CE mark which it 
intends to put before the Council by the end of 
1989, 
— will give mandates to CEN/Cenelec to 
supplement the standards on the evaluation of the 
competence of operators in the area of 
conformity assessment (EN 29000 and EN 
45000), — is to continue its action in cooperation with the 
groups concerned with a view to expediting the 
completion of a suitable infrastructure for certifi­
cation and testing, within the organization of 
European standardization, 
— will take appropriate steps to strengthen the role 
of the Community bureau of reference (BCR) in 
the fields of standardization and cooperation 
between testing laboratories, 
— will examine the questions of liability and 
insurance and related problems associated with 
the different statutes which certification, 
inspection and testing bodies may have, with a 
view to drawing up, if appropriate, a proposal for 
a Directive, 
— is to seek to ensure that the Treaty rules on 
competition are observed by certification, 
inspection and testing bodies when they conclude 
recognition agreements or choose partners for 
such agreements or, more generally, exercise 
their normal activities, 
— shall seek to ensure that Member States observe 
the principle of mutual recognition both in the 
context of harmonized rules and in the context of 
national regulations, 
— shall study measures, including budgetary 
measures, to be envisaged for the development of 
the certification and testing structures where 
there are serious delays; 
(c) The Council and the Commission will work for the 
implementation of a coherent and open policy 
towards non-Community countries in the field of 
conformity assessment. Since the global approach is 
based to a large extent on what has already been 
achieved in international standardization, it provides 
the appropriate basis for the conclusion of mutual 
recognition agreements at international level. 
THE COMMISSION PROPOSES TO THE COUNCIL 
THAT IT: 
— approve the broad lines of the global approach to the 
assessment of conformity in respect of industrial 
products set out in its memorandum in the Annex to 
this communication (Annex I), 
— adopt the proposal for a decision concerning the 
modules for the various phases of the conformity 
assessment procedures which are intended to be used 
in the technical harmonization directives, and the 
criteria governing their use in those directives (Annex 
II). 
No C 267/8 Official Journal of the European Communities 19. 10. 89 
ANNEX 
COMMISSION MEMORANDUM ON A GLOBAL APPROACH TO CERTIFICATION AND 
TESTING 
Instruments of quality for industrial products 
CHAPTER I Page 
Introduction 10 
CHAPTER II 
The role and importance of testing, certification and inspection 11 
1. Basic concepts 11 
2. The private and public sectors 11 
3. The role of testing laboratories, certification and inspection bodies 12 
4. Product liability 12 
5. National practices 12 
6. Community legislative techniques 13 
CHAPTER III 
The objectives of a global approach 13 
CHAPTER IV 
The necessary measures to implement the global approach 15 
— Section One: building confidence through competence and transparency 15 
1. European standards 15 
2. Criteria to guarantee technical competence 16 
(a) The manufacturer 16 
(b) Testing laboratories, certification and inspection bodies 17 
(c) Good laboratory practice 17 
3. Transparency 18 
(a) Information procedures for technical specifications 18 
(b) Promolog — Certificat. 18 
(c) Transparency of conformity to technical competence criteria 18 
— Quality systems certification 18 
— Intercomparisons 19 
— Accreditation 19 
4. Community support for the development of certification and testing structures 20 
19. 10. 89 Official Journal of the European Communities No C 267/9 
— Section Two: new legislative techniques for conformity assessment 20 
1. Basic orientations 20 
2. Conditions for a coherent approach 20 
3. The modular approach 21 
4. The modules 21 
5. The notified bodies 23 
6. The CE mark 23 
— Section Three: impact of the global approach on the implementation of mutual recognition of national 
regulations 24 
— Section Four: the need for a new European organization for certification and testing 25 
CHAPTER V 
External aspects of the global approach 26 
1. Guiding principles 26 
2. Procedures 27 
(a) Products subject to legislation 27 
(b) Products not subject to legislation 27 
No C 267/10 Official Journal of the European Communities 19. 10. 89 
CHAPTER I 
INTRODUCTION 
The adoption by the Council of Directive 83/189/EEC on 28 March 1983 (') laying down a procedure for 
the provision of information in the field of standards and technical regulations constituted a watershed in 
terms of the Community's attitude towards the elimination of technical barriers to trade and led to the 
approval by the Council of its conclusions on standardization (2) on 16 July 1984 and its resolution of 
7 May 1985 (3) on a new approach to technical harmonization and standards. 
These three texts laid the foundation for a policy intended to make national activity in this area more 
transparent, to substantially reinforce European standardization and to streamline Community legislative 
techniques through greater recourse to European standards and the restriction of legislative texts to the 
'essential requirements' for the protection of the general interest, in particular health and safety or the 
protection of the consumer and of the environment. 
The Council resolution of 7 May 1985 clearly states 'that the new approach will have to be accompanied 
by a policy on the assessment of conformity' and calls on the Commission to give this matter priority. 
Testing and certification issues in past Community legislation have almost exclusively been restricted to the 
determination of common technical specifications for products, as these were the main object of the 
national regulations which had to be harmonized in order to eliminate barriers to trade. 
In many Member States, however, as in many other countries in the world, there is a growing move 
towards ensuring the level of safety of a product by means of measures to improve and to control the 
quality of the product itself as well as the quality and competence of the suppliers, the testing laboratories, 
and the certification and inspection bodies. Under this approach, measures designed to ensure the product's 
safety and quality can be taken at a number of different stages in its development and can relate to the 
product itself, to the manufacturing process or to the controls applied to either. 
That is why the Council called on the Commission to draw up a policy not simply restricted to certifi­
cation, i.e. the action of certifying the conformity of a product or service to a given specification, but 
enlarged to include conformity assessment, which covers a much wider field, involving testing (and cali­
bration), quality systems, certification and accreditation. Moreover, the national systems for ensuring the 
safety of products put on the market are in some instances extremely divergent, ranging from full 
confidence in the manufacturer (manufacturer's declaration) to reliance on inspection at the place of instal­
lation or during the use of products. (In the foodstuffs area the distinction between pre-market and market 
controls is not made as the systems of control cover both). 
This memorandum is a response to these broader terms of reference and attempts to bring together all the 
different elements which, when carefully and properly assembled, will give the Community as a whole a 
comprehensive quality policy which is an indispensable part of any industrial policy and fundamental to the 
very concept of an Internal Market. 
To begin with it is necessary to circumscribe the notion of quality. For ISO (8402 — 1986) quality is 'the 
totality of features and characteristics of a product or service that bear on its ability to satisfy stated or 
implied needs'. Over and above the commercial connotations of quality which are expressed in terms of 
excellence, it is clear that the ISO definition is a generally acceptable one, both for the private and 
legislated sectors. Using this definition as a basis, quality organization relates to the elements and 
instruments to be developed in order to ascertain and control identification, transparency and observance 
of these properties and characteristics, thus ensuring fairness of transactions and an informed choice by the 
consumer, in accordance with the binding rules and voluntary standards applied. 
(') OJ No L 109, 26. 4. 1983, p. 8. 
O OJ No C 136, 4. 6. 1985, p. 2. 
(3) OJ No C 136, 4. 6. 1985, p. 1. 
19. 10. 89 Official Journal of the European Communities No C 267/11 
Consequently, under Community legislation, quality is associated with the essential requirements, inasmuch 
as quality can only be equal to or higher than the level of these essential requirements in the Community 
since any product failing to satisfy them is, by definition, prohibited. Outside the field of legislation where 
there is no need to legislate since the products do not present any dangers, it is clear that the concept of 
quality remains linked to the ability of the product to meet the needs of users and consumers, in other 
words, the needs of the market. 
The purpose of this memorandum is to establish a doctrine on the assessment of the conformity of 
products to the requirements set down in legislation or other technical specifications. In this sense it is just 
one basic component of a quality policy which must also include others. 
CHAPTER II 
THE ROLE AND IMPORTANCE OF TESTING, CERTIFICATION AND INSPECTION 
1. Basic concepts 
Just as the process of testing is an integral part of product design and development, and continuous 
surveillance and testing are an essential part of ongoing production so as to ensure conformity with the 
original design, prototype or model representative of the projected series. 
Metrology and calibration provide the basic language for the measurement which is fundamental to 
testing, while quality systems, certification and inspection procedures provide the final demonstration of 
quality, i.e. quality in the sense of conformity to product requirements. 
All of these elements can be found either in private systems (i.e. used for commercial reasons) or in 
systems imposed by public authorities for the purpose of ensuring a proper level of safety. 
These activities are carried out at varying stages: 
— before production, in the course of the development of a prototype or model, 
— during production, either as surveillance of the products or as surveillance of the production 
processes, 
— after the manufacturing process but before the marketing of the product, 
— after the initial marketing of the product. This can include spot checks on the market and inspection 
after installation and during use of given types of products. 
The procedures may be undertaken either by competent and properly equipped manufacturers them­
selves, or by specialist third parties, i.e. testing laboratories and certification bodies. These laboratories 
and bodies can, in turn, be evaluated as to their technical competence by a third party (accreditation 
body) and hence be accredited, as can in-house testing laboratories which are separate from production 
or commercial divisions of a company. Increasingly industry is using quality systems (with the object of 
ensuring that products conform to a model or to a technical specification) and where these are certified 
by a third party the credibility of that manufacturer is enhanced in so far as quality and product safety 
no longer solely depend on product certification for verification. The competitiveness of his industrial 
production is improved and the costs associated with lack of quality (rejects, recalls, customer guar­
antees, etc.) are reduced. 
2. The private and public sectors 
Companies are now voluntarily investing, substantially, in quality systems and other in-house techniques 
because they improve efficiency, cut costs, and establish a reputation for reliability. Alternatively a 
company may entrust systematic or sample product testing to an independent body (third party). In 
either case the concern is for quality and cost saving — and the decision as to the appropriate technique 
to apply is a voluntary one. 
No C 267/12 Official Journal of the European Communities 19. 10. 89 
Mandatory testing, certification and inspection are generally imposed by public authorities in order to 
ensure that certain public interests such as health, safety, consumers or the environment are effectively 
protected. 
Testing, certification and inspection however, are not always based solely on such considerations; they 
can also be an integral part of a national industrial policy intended to promote goods both nationally 
and internationally. The reasoning behind such policies is that the reputation of certain certification 
marks represents a strong commercial advantage in international trade. 
Nevertheless, it should be underlined that the proportion of products which come under mandatory 
systems in the Member States remains small compared to the total quantity of products on the market. 
3. The role of testing laboratories, certification and inspection bodies 
There is an important role in ensuring conformity, building confidence and protecting public interests. 
The competence and quality of such bodies varies, as does their distribution among Member States. It 
has been estimated that there are over 10 000 testing laboratories and 1 000 certification bodies in 
Europe of varying capacity, legal status and reputation. In the less industrially developed regions of the 
Community, the presence of competent bodies is small. If they are to become an essential part of the 
structure of the internal market, the Community will have to see to it that this gap is filled. 
4. Product liability 
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and 
administrative provisions of the Member States concerning product liability (') makes manufacturers 
liable for damage caused by defective products. This Directive clears the manufacturer of his liability if 
he proves 'that the defect is due to compliance of the product with mandatory regulations issued by the 
public authorities' i.e. when he has no discretion whatsoever as to how to proceed. In most cases 
Community technical regulations do not affect such liability because they leave the manufacturer a 
choice as to the specification to be applied. Under the new approach directives the economic operator is 
not obliged to follow the European standards referred to in the directives. He also has some choice as 
to the methods for demonstrating conformity to the Directive. Testing, certification and inspection may 
diminish the risks and hence the likelihood of damages (which in turn reduces the insurance cost), but 
do not affect the liability of the manufacturer. 
This Directive therefore puts responsibility on the supplier to produce safe products, through the 
pressure which the costs liability places on him after an accident due to a defective product. 
Testing, certification and inspection activities place the emphasis on preventing as far as possible the 
putting on the market of unsafe products and thus avoiding damage being caused. These two elements 
can therefore be seen as complementary in ensuring an adequate level of safety, whether the testing, 
certification and inspection activities are mandatory or voluntary. 
Community safety policy therefore places responsibilities on the manufacturer through product liability 
(within the limits set out in Directive 85/374/EEC) and in the form of the obligation imposed by the 
technical legislator to take certain preventive measures. 
5. National practices 
Certain Member States in some industrial sectors rely on the manufacturer to ensure conformity to 
mandatory safety requirements, whilst others require third party intervention. The choice of mechanisms 
to be applied and the procedures for applying them vary from Member State to Member State and from 
sector to sector as does the use of voluntary or mandatory certification. This variation is due to the 
(') OJ No L 210, 7. 8. 1985, p. 29. 
19. 10. 89 Official Journal of the European Communities No C 267/13 
relative importance attached to the manufacturers, to the strength or weakness of national testing, certi­
fication and inspection infrastructures, to national political traditions in respect of the role of legislation, 
and, before 1985, to different national attitudes towards product liability. It is an expression of 
divergence between the Member States not as to the results to be obtained but rather as to the tech­
niques which should be used in order to reach the desired end. 
The Council of Ministers in its conclusions of 16 July 1984 recognized 'that the objectives being 
pursued by the Member States to protect the safety and health of their people as well as the consumer 
are equally valid in principle, even if different techniques are used to achieve them.' 
In the past, the impossibility of accepting this divergence of practice and, more importantly, the 
difficulty of demonstrating that different testing, certification and inspection techniques could lead to a 
level of safety acceptable in legal and political terms, even though the technical results may not be 
identical, have hampered the development of Community legislation. 
6. Community legislative techniques 
Almost all EEC Directives adopted to date, apart from new approach Directives and the 'Low Voltage 
Directive' ('), provide for the operation of the mutual recognition of certificates on the basis of a single 
assessment technique for a given product and on certificates being issued by or under the direct respon­
sibility of public authorities. Certification and the mutual recognition thereof were considered to be 
within the purview of public administration. Directives did not, therefore, lay much emphasis on the 
technical competence of the bodies involved. 
The Council resolution of 7 May 1985 on the new approach to technical harmonization made a clear 
distinction between the function of the essential requirements (mandatory) and that of standards 
(voluntary), underlining the notion that a product manufactured in conformity with harmonized 
standards is presumed to conform to the essential requirements established by a directive. This 
distinction is particularly important in the present context, in that one of its consequences is to leave the 
manufacturer a degree of flexibility in demonstrating conformity to the directive. If he follows the 
harmonized standards he may use a simplified procedure, whereas if he manufactures directly to the 
essential requirements, for whatever reason, third party intervention is required to ensure conformity 
with the directive. 
Thus the Council resolution itself introduces the approach whereby there may be different ways of 
evaluating the conformity of a product to Community technical legislation. However, this is only a first 
step in addressing to the necessities of the Internal Market in this sphere of activity. 
CHAPTER III 
OBJECTIVES OF A GLOBAL APPROACH 
The activity of assessing the conformity or products to the technical specifications which define their level 
of quality is a response to a need expressed either 
— by mandatory regulations, or 
— by the market. 
In the first case, the proofs of conformity are laid down by the public authority which requires the manu­
facturer — for reasons which may bear on the protection of health, safety, the environment, etc — to 
adduce those proofs before the products are placed on the market. 
In the second case they are required by the purchasers when concluding commercial transactions, and are 
therefore contractual in nature. 
In both cases — regardless of whether they are mandatory or voluntary — the various types of proof of 
conformity (marks, certificates, test reports, etc) must be provided by suppliers wishing to sell their goods 
on a particular market. 
(') Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to 
electrical equipment designed for use within certain voltage limits (OJ No L 77, 26. 3. 1973, p. 29). 
No C 267/14 Official Journal of the European Communities 19. 10. 89 
Given the liability aspects, which can be an extremely important factor in the assessment of conformity, it is 
natural that the person demanding the proof of conformity (be it the public authority or the purchaser) 
should at the same time demand the soundest possible guarantees of competence and credibility, both in 
technical terms and in terms of professional ethics, from those adducing that proof. 
The result of this is that in each national market the structures for conformity, inspection and testing meet 
the specific needs expressed by the legislator and by the behaviour of buyers, users and consumers. Conse­
quently, manufacturers must subject their products to a multitude of controls depending on the markets on 
which they intend to sell them. 
Where these barriers to trade are the result of mandatory regulations, they must be removed 
— either by means of directives based on Article 100a of the Treaty, through the harmonization of these 
regulations and through the requirement on the authorities of each Member State to recognize proofs 
of conformity issued in other Member States, 
— or by applying the doctrine sanctioned by the Court with regard to the obligations arising out of 
Articles 30 to 36 of the Treaty and under which a product lawfully produced and marketed in one 
Member State must, in principle, be admitted to the markets of the other Member States. 
Where, on the other hand, these obstacles are the result not of legal requirements but of the free play of 
market demand — i.e. there is no direct or indirect influence from the public authority — the means for 
their gradual removal must be sought, on the one hand, in the harmonization of voluntary standards laying 
down operating criteria for the national conformity structures and, on the other hand, in measures to 
promote agreements between these structures to bring them gradually towards the establishment of 
common systems of certification and testing. 
There is a danger, however, that action taken on these three levels — namely harmonization of regu­
lations, mutual recognition of national regulations and the approximation of structures within a system of 
voluntary certification — might be ineffective in practice unless they solve the same problem and satisfy the 
same needs, that is to say the need to create the conditions to enable confidence to grow and become funda­
mental to the operation of mutual recognition. 
The necessity for a global approach to certification, inspection and testing thus arises out of this vital need 
to create conditions conducive to confidence and, to that end, to bring the structures and procedures 
involved in these activities, more closely into line. 
The next chapter sets out the various measures, some of which have already been initiated since the 
resolution of 7 May 1985 on the new approach and which now need to be further encouraged, developed 
and, in particular, placed within the context of a comprehensive policy. It comprises four sections dealing 
respectively with: 
— action to be taken on basic structures (the operation of which is instrumental in determining the results 
of both mandatory and voluntary certification) in order to make them as homogeneous, transparent 
and credible as possible throughout the Community, 
— the measures necessary to facilitate mutual recognition under the procedures for assessment of 
conformity laid down in the harmonizing directives based on Article 100a of the EEC Treaty, 
— the impact of these actions on the implementation of the Court's case-law concerning mutual recog­
nition of national regulations, 
— initiatives to be promoted to assist cooperation between national certification and testing structures. 
19. 10. 89 Official Journal of the European Communities No C 267/15 
CHAPTER IV 
THE NECESSARY MEASURES TO IMPLEMENT THE GLOBAL APPROACH 
Section One: 
BUILDING CONFIDENCE THROUGH COMPETENCE AND TRANSPARENCY 
Paragraph 3 of Article 100a of the Single European Act sets out the principle that, with respect to 
industrial products, health and safety legislation as well as the protection of the environment and the 
consumer shall be based on a high level of protection. This can be achieved amongst other means by 
ensuring a high level of quality of the products themselves, through appropriate European standardization 
and the promotion of the use of quality management systems by manufacturers. Improvements in the 
competence, capacity and quality of the testing laboratories and of the certification and inspection bodies 
will also contribute. But confidence in the new systems will only be developed if the systems not only work 
properly but are seen to work properly. Thus transparency and competence are both equally essential in 
order to generate confidence. 
Transparency and competence of quality structures are also a necessary condition for the success of a 
Community industrial policy as a whole, since testing, certification and inspection constitute the foun­
dations of any industrial activity. The development of a Community market in these areas will reduce 
unnecessary costs both for economic operators and for the public authorities by limiting the number of 
certifications, tests and multiple inspections. It will also lead to an improvement in the competitiveness of 
European products both on the Community market and on world markets. It must be recognized, 
however, that the reduction of testing, certification and repetitive inspection for many products will no 
doubt be offset by additional voluntary demand for these services as manufacturers and consumers attach 
greater importance to quality. This is seen as a particularly important factor in maintaining or even 
enhancing the competitive position on the world markets of an industry established in countries with high 
costs. Consumers and users will find themselves faced with fewer administrative costs passed on in the price 
of the products and will have a greater choice of products, on a more resilient and innovative market, in 
which the safety considerations will have been catered for effectively but without artificial or arbitrary 
constraints. 
1. European standards 
The Community policy for the reinforcement of European standardization was formally initiated in 
1983 with the adoption of Directive 83/189/EEC laying down inter alia a procedure for the provision 
of information on national standardization programmes and draft standards and the mechanism by 
which the Commission, after consulting the Standards and Technical Regulations Committee, can give 
mandates to the European standardizing bodies to draw up European standards for Community 
purposes and in particular to ensure compliance with the essential requirements. The effect of such 
standardization orders is to impose a formal standstill on all national work covered by the European 
mandate. 
To date, several standardization programmes have been or are being drawn up under this system. In 
particular in areas covered by new approach activities (such as toys, pressure vessels, construction 
products, machines, personal protection equipment) and by the Community policy in information tech­
nology and telecommunications. Most of this standardization work relates to product specifications. 
European standardization also has an important role to play in heiping to open up procurement 
contracts which traditionally impose national technical specifications on suppliers. The Community has 
already amended the existing directives on public procurement to require reference to European 
standards where they exist, and the Commission has recently transmitted to the Council proposals which 
adopt the same approach in respect of the hitherto excluded sectors (water, energy supply, transport and 
telecommunications). These proposals will require the adoption of a great number of European 
standards, and work is underway to prepare new mandates for the European standards bodies to draw 
up appropriate standardization programmes. 
European standardization activities are also expanding and will have to expand still further in order to 
reduce divergencies between national standardization in those areas which do not come under EEC 
regulations. 
No C 267/16 Official Journal of the European Communities 19. 10. 89 
It must also be emphasized that European standardization will be easier in future in so far as it is no 
longer necessary to impose a single European technical solution in a European standard except, 
possibly, where questions of interoperability and compatibility are involved. In view of the separation in 
the new approach between the level of safety to be obtained and the means by which it can be obtained, 
European standards can recognize the technical validity of a number of technical solutions as long as 
they are capable of giving the desired result: conformity to the essential requirements. Thus a greater 
degree of flexibility can be introduced into European standardization. 
More emphasis will, however, have to be given to drawing up common test methods and to addressing 
testing and conformity assessment issues in order to reinforce the effectiveness of product standards. 
Many current European product standards are posing problems for testing laboratories, certification and 
inspection bodies alike, because they have been drawn up for the purposes of the manufacturing 
processes and techniques and not specifically for that of facilitating demonstration of conformity. 
The Commission has already recognized this problem and is proposing to modify its framework 
contracts with CEN and Cenelec in order to take it on board. These considerations will be incorporated 
into future standardization mandates. The need for greater interaction between the preparation of 
standards and testing, certification and inspection must also be kept in mind in the context of the 
establishment of the European Organization for Testing and Certification referred to below, as proper 
input into standards activities will also help to ensure that European standards become more compre­
hensive and effective. 
2. Criteria to guarantee technical competence 
(a) The manufacturer 
Besides using European standardization as a means of improving the quality and acceptability of 
products, it is necessary to enhance confidence in the ability of the manufacturer to supply quality 
products. This confidence cannot he simply imposed either upon public authorities or consumers; it 
depends primarily upon the attitude of the manufacturer himself, i.e. it must be earned! 
The international and, recently, the European standardization bodies have drawn up appropriate 
instruments to assist the manufacturer who wishes to obtain a consistent product quality through the 
proper management of his quality systems. They are enshrined in the EN 29000 series of standards 
on quality assurance techniques (the common CEN and Cenelec implementation of the ISO 9000 
series), which contain the general rules relating to quality assurance models and the general rules 
applicable to the different industrial sectors. 
Quality assurance techniques should play an important role in developing quality consciousness in 
the Community, but can also contribute towards conformity assessment in both the voluntary and 
the mandatory areas. Although these techniques cannot be made mandatory as such because each 
specification is linked to the characteristics of the production unit, they may be presented as a 
complement to the more conventional method of product certification. 
Quality assurance techniques are an integral part of the design and operation of a production unit. 
As an investment in modern management techniques, quality assurance can play an important role in 
reducing the number of non-quality products, hence reducing the nurner of rejects at the end of the 
production line. This leads to a better quality image for the manufacturer and his products and to a 
reduction of his costs (rejects, controls by third parties etc). 
In the face of world competition, in particular from countries such as Japan and the United States 
where quality has become an integral part of the production process in certain important mass 
production sectors, the recourse to quality assurance techniques must be one of the main objectives 
of a Community industrial policy. By providing for the possibility of using quality assurance in the 
demonstration of conformity either to an approved model or to standards, as an alternative to more 
conventional product certification based only on product testing. Community legislation will be 
encouraging investment in quality on the part of the manufacturer an will allow him to reduce the 
costs incurred by product certification. In the past, the obligation to use certification has led manu­
facturers, on occasion, to reduce internal production controls to a bare minimum, thus placing the 
burden of finding rejects on the third party. Such a situation is economically second-best. 
19. 10. 89 Official Journal of the European Communities No C 267/17 
Promoting voluntary use of quality assurance techniques not only makes economic, industrial and 
commercial sense; it also helps to ensure that the products placed on the market are safe. 
CEN and Cenelec should therefore consider the framing of a standardization programme, drawing 
on the practical experience of economic operators in the implementation of these standards. 
(b) Testing laboratories, certification and inspection bodies 
Experience of the implementation of Community directives under the old approach, the restrictions 
placed on the free movement of goods by national legislation and attempts at cooperation 
agreements between bodies and laboratories in the field of voluntary certification have highlighted 
one of the main problems, namely the lack of adequate information concerning the operation and 
competence of these bodies as well as the lack of means for demonstrating their competence. 
Such uncertainty can only be avoided if appropriate criteria are used for evaluating these bodies on 
the grounds of technical competence and independence and applied throughout the Community. 
Criteria have been developed over recent years in international fora such as ISO, IEC and ILAC 
(International Laboratory Accreditation Conferences), and in November 1987 CEN and Cenelec 
were mandated by the Commission to adopt a set of criteria, developed by Commission working 
groups, as European standards before the end of 1988. 
These documents are at present being processed as the EN 45000 series of European standards for 
the operation and evaluation of testing laboratories and certification bodies undertaking product 
certification, quality system assessment and so on. Once they have been formally adopted as 
European standards, they will be accepted in all the Member States and this acceptance will ensure 
their implementation (since any diverging national standard must be withdrawn), without there 
being any need to provide for mandatory across-the-board application, which would be contrary to 
the philosophy of the new approach. Conformance to these standards will help to reinforce the 
position of Community producers wishing to export to other Community countries, especially when 
the test reports and certificates concerned are based on harmonized European standards. 
The more these criteria are used, both in Community and in national legislation, the more 
confidence is likely to develop. This will encourage the private sector to use the self-same criteria 
when operating outisde mandatory systems so as to reinforce the credibility of their activities and 
thus reduce the possibility of disputes. Member States should commit themselves to promoting the 
use of the EN 45000 series as widely as possible. 
It has to be pointed out that the EN 45000 series is incomplete since it does not yet cover all 
conformity assessment activities. It will be necessary, in particular, to establish criteria for the 
inspection bodies and for the bodies responsible for accrediting the certification and inspection 
bodies. Standardization mandates to this end will be issued shortly to CEN/Cenelec. 
Lastly, the implementation of these standards and the operation of the existing mutual recognition 
agreement between bodies clearly shows that it will also be necessary to look into the issues of 
liability and insurance, as well as related questions concerning the various types of status such 
bodies may have. 
(c) Good Laboratory Practice (GLP) 
Good laboratory practice guidelines (GLP) follow the same logic as the EN 45000 series of 
standards, i.e. they define a level of performance for laboratories. GLP guidelines have been 
developed for specific use in the field of chemicals (not only chemicals but also pharmaceuticals, 
food additives etc. . . .) and first originated in the OECD. They were adopted by the Council in 
Directives 87/18/EEC and 87/19/EEC of 18. 12. 1986 (l) for testing of chemical products, 
pesticides and pharmaceuticals. 
These mandatory provisions represent a departure from the general philosophy of the new 
approach, which is based on the principle that standards are voluntary. It is explained by the special 
features inherent in this sector with regard to the protection of human health and by the fact that 
the regulations in this area are largely based on the old approach. 
(') OJ No L 15, 17. 1. 1987, p. 29 and p. 31. 
No C 267/18 Official Journal of the European Communities 19. 10. 89 
Within the Community, the principles of GLP should be seen as a particular sectoral application of 
criteria governing the operation of laboratories, and their future evolution should be examined in 
this context rather than in isolation. There is a move at international level towards a review of the 
OECD GLP guidelines in order to separate those criteria which can be considered as being general 
(and which are therefore covered by the EN 45000) from those which relate specifically to chemical 
analysis testing laboratories. The object of such a move is to show that all testing laboratories 
conform to the same basic criteria, with specific supplementary requirements being drawn up for 
particular industrial sectors (such as GLP for chemicals). 
3. Transparency 
Technical competence and transparency must be taken together if mutual confidence is to be achieved. 
Transparency means access to information as well as openness of operation. 
(a) Information procedures for technical specifications 
Directive 83/189/EEC established two information procedures which ensure transparency as to 
national activities in the field of draft standards (operating between the national members of CEN 
and Cenelec) and in the field of draft technical regulations (operating between the Member States 
and the Commission). Both procedures concern not only product specifications but also product-
related issues such as testing, certification and inspection requirements. 
Information on draft standards is fed into the integrated Standardization Information System 
database (ISIS) in CEN and Cenelec, which is accessible to member standards bodies for further 
distribution to interested parties. Discussions are underway between the Commission and the 
European standards organizations to promote more direct and wider access to the information by 
European Industry. 
(b) Promolog-Certificat 
The above information will be complemented by the end of 1990 by the Certificat database which 
the Commission is developing with AFNOR (Association francaise de normalisation) and CEN and 
which will contain information on all certification systems and procedures in Europe, both 
mandatory and voluntary, including the relevant technical specifications and the bodies and labora­
tories involved. Thus, in spite of the lack of harmonization, the economic operator will have the 
means of knowing what is expected of him and how he can go about placing his product on his 
targeted market. 
It is intended that Certificat be merged with the integrated standardization information system 
(ISIS) at a later stage, and may also be expanded to contain a directory of testing laboratories in 
Europe. 
(c) Transparency of conformity to technical competence criteria 
Greater confidence will be generated if this competence and quality are transparent, i.e. can be 
demonstrated. 
— Certification of manufacturers' quality systems 
The manufacturer has always had the possibility of asking a third party to test or certify his 
products. However, there is a growing awareness on the part of manufacturers of the value of 
quality assurance techniques and, at the same time, of the need to be able to demonstrate to 
purchasers that these techniques have been properly applied. Consequently, private certification 
of quality systems have developed in many parts of the Community. 
Such a development should be encouraged, all the more so as the standards used by all these 
systems are mainly based on the abovementioned ISO 9000 series of standards which has been 
recently adopted at European level as the EN 29000 series. There is thus a common standard 
throughout Europe on which third party certification of quality assurance can rely. 
The development of private certification systems based on the same European standards will be a 
step towards reducing the multiplicity of separate and different audits which manufacturers are 
often required by their various buyers to undergo. This should not only encourage large and 
small firms to make more systematic use of quality systems, but also reduce considerably the 
costs of such systems, especially for small and medium-sized enterprises which are often 
sub-contractors for bigger firms. 
19. 10. 89 Official Journal of the European Communities No C 267/19 
The more the various national certification systems in this area are made coherent and 
compatible, the easier it will be to ensure mutual recognition and acceptance of certificates and 
the more accessible and acceptable quality systems will become throughout the Community. 
— Intercomparisons 
Testing laboratories and certification bodies can demonstrate their competence and efficiency by 
taking part in 'Round Robin' tests (the same product is tested, in turn, by all the participating 
bodies and the results compared), or in proficiency testing programmes (i.e. by means of interla-
boratory test comparisons). Such techniques are important today and will no doubt be used even 
more in the future in mutual recognition agreements. The Commission's Community bureau of 
reference (BCR) has been carrying out a programme of work in this area for a number of years 
which should be expanded beyond scientific circles into the industrial arena. A reinforced BCR 
programme in this area, more directly designed to reflect current industrial priorities than 
hitherto, would have the objectives of helping to develop transparency, to improve the quality of 
the laboratories and to prepare testing material for input into the European standardization 
process. 
— Accreditation 
Accreditation entails laboratories, certification and inspection bodies being assessed and audited 
at regular intervals as to their technical competence against published technical criteria by a third 
party. As a third party assessment technique, it is therefore an important instrument for the 
generation and maintenance of confidence in these bodies, just as certification is for products. 
The EN 45000 series of standards includes the technical criteria for the operation and 
assessment of testing laboratories as well as those to which the accreditation bodies for testing 
laboratories themselves should conform. They also include the criteria for certification bodies. 
In the field of testing laboratories there are already eight accreditation networks in the 
Community either in operation or in development phase at the national level (but not operated 
by the public authorities). This development should be extended to the rest of the Community 
and cooperation between the various national networks reinforced and stimulated, a process 
which will be helped by the adoption and implementation of the EN 45000 series of standards. 
Mutual recognition agreements between national networks, based on the EN 45000 series, stan­
dardized test methods and the inclusion of interlaboratory test comparisons and proficiency 
testing for the implementation of these agreements in conjunction with mutual audits, appears to 
be the next logical step towards promoting greater competence and quality in testing and certifi­
cation in the Community. It is the Commission's belief that creating a 'network of the national 
networks' would be the most efficient means of achieving the necessary degree of trust between 
them. A more formal structure at Community level may be necessary, in the future, to oversee 
the mutual recognition agreements in order to ensure consistency between the agreements and to 
cement the bonds created by them. However, in view of the proposals concerning an overall 
European Infrastructure for testing and certification, (see below), the Commission does not feel 
that it is appropriate to encourage the setting up of a Community accreditation body which 
would unnecessarily lengthen the chain of responsibility and add unnecessary administrative and 
bureaucratic burdens without providing additional confidence. 
In the field of certification and inspection bodies accreditation techniques should be more widely 
applied. At present only three national accreditation systems for such bodies exist in the 
Community (Netherlands, Portugal and the United Kingdom). The extension of accreditation to 
this area would help mutual recognition, facilitate the drawing up of Community legislation, and 
reduce the need for more arbitrary national designation, which can have the effect of discrimi­
nating against national bodies which can demonstrate their competence. As is mentioned in 
Section Two of this chapter, the Commission has every intention of encouraging more 
systematic recourse to the technique of accreditation by inviting Member States, wherever 
possible and appropriate, to notify for the purposes of EEC legislation only those bodies which 
are accredited to EN 45000 or those which can demonstrate by any other means that they 
conform to these standards (e.g. by providing documentary evidence). 
No C 267/20 Official Journal of the European Communities 19. 10. 89 
4. Community support for the development of certification and testing structures 
Delays in the development of infrastructures for certification and testing, inspection, accreditation and 
quality management in certain sectors of industry or in certain countries may seriously hamper the 
implementation of this policy of harmonizing structures and procedures. In particular this may prove a 
real obstacle to the putting into effect of certain Community directives. 
The Commission is studying measures, including budgetary measures, which might help to make up the 
delays in the development of these infrastructures. 
Section Two: 
NEW LEGISLATIVE TECHNIQUES FOR CONFORMITY ASSESSMENT 
1. Basic orientations 
The previous chapters have dealt with basic instruments applicable to both the voluntary and the regu­
latory areas, whether national or Community. Their development, taken in conjunction with the 
growing experience in the drawing up of new approach directives should allow such directives to be 
more effective in protecting collective interests whilst avoiding undue bureaucracy. 
The Council resolution of 7 May 1985 showed the way by accepting that there could be more than one 
means of proof of conformity to a directive. It provided for presumption of conformity to a directive on 
the basis of a European harmonized standard, or, during a transitional period, of national standards 
which had been submitted and recognized as equivalent under a Community control procedure. When 
the manufacturer complies with these standards, the directives are there to allow him to make use of 
simplified certification mechanisms. 
When the product does not conform to a standard, however, either because the standards do not exist 
or because the manufacturer, for example in the case of innovation, prefers to apply other manufac­
turing criteria of his own choice, the assessment of conformity to the essential requirements must involve 
a third party, either by certification or by third party testing. 
The resolution therefore introduced the fundamentally new principle that directives should as far as 
possible leave it to the manufacturers themselves to choose one of two methods for assessing 
conformity. 
The Council resolution recognized, however, that it had not provided all the anwers on conformity 
assessment and that the new approach needed to be accompanied by a comprehensive policy on such 
issues. 
2. Conditions for a coherent approach 
In view of the considerable progress made towards the development of conformity assessment 
procedures and techniques in the private sector, a coherent approach can now be put forward on their 
use in future legislation at Community level ('modular approach'). 
Taking as a starting point that the objective is to ensure the protection of the general interest, the 
Council resolution of 7 May 1985 laid down the general principle that there may be different technical 
means of achieving similar, if not 'identical', results. In other words the Community legislator may, 
when laying down in a directive the essential requirements to be met, decide that different conformity 
assessment mechanisms will afford an adequate guarantee that this requirement wll be met and that the 
economic operators may, within the conditions set out in the directive, choose the most appropriate 
from among those mechanisms-. Such an approach entails redefining conformity assessment in such a 
manner as to allow the legislator to evaluate the consequences of each of the mechanisms so that the 
system can be applied with flexibility and various mechanisms are capable of giving an acceptable result. 
In future, therefore, Community legislation should, as a general rule, avoid fixing only one conformity 
assessment procedure for a given product. It should confine itself to laying down the essential 
requirements to be met and to determining the different means for assessing conformity and the 
conditions in which these can apply. 
The modular approach thus provides a means of spreading the burden of conformity assessment more 
flexibly over the entire production process, adapting it to the needs of each individual operation. This 
should in particular enable the legislator to obtain the desired level of safety without having 
unnecessarily to burden the economic operators, and especially the small and medium-sized businesses, 
with excessively onerous conformity assessment procedures. 
19. 10. 89 Official Journal of the European Communities No C 267/21 
It is clear that this objective is the first parameter which must be taken into consideration in the choice 
of conformity assessment procedures. However, other parameters must also be taken into consideration, 
such as: 
— appropriateness of the methods to the types of risk and to the sensitivity of consumers and users to the 
risk which a product or group of products may present. For instance, sterile products may require 
different solutions from those reserved for simple pressure vessels, 
— appropriateness of the methods to the infrastructure of the sector of activity — for example, it might be 
inappropriate to choose third party intervention on products in an area where appropriate bodies do 
not exist, 
— appropriateness of the procedures to the characteristics of the products themselves— for example, some 
products using advanced technology lend themselves less well to tests on the finished product (cf. 
data-processing equipment or sterile products). In such cases, one can apply methods based on the 
application of quality assurance on production, 
— appropriateness of the procedures to the rate of production of a product— for example, it is not neces­
sarily practicable to impose assessment methods adapted to mass production when a large proportion 
of the production is based on small series. Nor is it practicable to provide for verification of indi­
vidual units when the product is mass-produced. 
3. The modular approach 
The modular approach subdivides conformity assessment procedures into a number of operations 
(modules) which differ according to: 
— the stage of development of the product, (e.g. design, prototype, full production), 
— the type of assessment involved (e.g. documentary checks, type-testing, quality assurance, inspection, 
etc.), 
— who carries out the assessment (the manufacturer or various third parties). 
These separate operations or 'modules' can be combined to form a complete procedure. In one directive 
several alternative modules can be applied to the same function provided that a degree of equivalence 
between their results is obtained, (i.e. they all ensure that the product meets a given technical specifi­
cation or affords a given level of safety). 
Such a modular approach allows the procedures to be more easily evaluated in relation to both the 
burden on the manufacturer and the desired end result, and therefore facilitates the choice of the appro­
priate modules for a particular sector or product to be incorporated in the directive. 
Conformity assessment procedures normally come into play at two levels in the manufacturing process: 
the design stage and the production stage. The procedures have therefore been subdivided into modules 
addressing each of these two levels. However, some modules which only relate to the production stage 
may be applied on their own without the intervention of a module at the design stage (although it seems 
that this is exception). Some modules, on the other hand, automatically cover both the design and 
production phases and so constitute full procedures in their own right. 
4. The modules 
A detailed description of the modules, guidelines for their use and a summary table are attached in 
annex. 
The functions of each of the modules are summarized below: 
— Module A: EC declaration of conformity 
This module covers both the design and production phases. The manufacturer declares that the 
products concerned satisfy the requirements of the directive. He establishes technical documentation 
explaining the design, manufacture and operation of the product as well as the assessment of 
conformity with the directive. This technical documentation is available to the public authorities for 
inspection for a specified period of time. The manufacturer affixes the CE mark to the products and 
draws up a written declaration of conformity. 
In certain specific cases, directives may require the EC declaration of conformity to be accompanied 
by the obligation for a test or series of tests to be carried out on one or several specific aspects of a 
product, either by the manufacturer in the presence of a third party, or directly by the third party. 
Directives may also provide for random product checks to be carried out by or under the responsi­
bility of a notified body. In such cases the directives set out the general rules for the carrying out of 
the checks. 
No C 267/22 Official Journal of the European Communities 19. 10. 89 
— Module B: EC type examination 
This module only relates to the design phase and must be accompanied by a 'production module'. A 
notified body ascertains and attests that a product specimen, representative of the production 
envisaged meets the provisions of the Directive which apply to it. It will examine the technical docu­
mentation and perform or have performed those tests only which are necessary to demonstrate 
conformity to the provisions of the directive. 
These tests should be restricted, by the notified body, to what is absolutely necessary for demon­
strating conformity. In order to ensure a consistent interpretation of what is necessary, the European 
organization for Testing and Certification or, in its absence, the Commission will establish close 
links between the notified bodies. The notified body shall issue an EC type examination certificate. 
The CE mark is not affixed during this phase. 
— Module C: EC declaration of conformity to type 
This module relates to the production phase only and cannot be carried out alone: It must follow 
the issuance of an EC type examination certificate. The manufacturer satisfies himself that the 
products concerned are in conformity with the type as described in the EC type examination 
certificate and meet the requirements of the directive that apply to them, and makes a declaration to 
that effect. The manufacturer affixes the CE mark to the products and draws up a written 
declaration of conformity. 
Directives may provide for random product checks to be carried out by or under the responsibility 
of a notified body. In such cases the directives set out the general rules for carrying out the checks. 
— Module D: EC declaration of conformity to type (production quality assurance) 
This module relates to the production phase only and cannot be carried out alone: it must follow the 
issuance of an EC type examination certificate. The manufacturer satisfies himself that the products 
concerned are in conformity with the type as described in the EC type examination certificate and 
satisfy the requirements of the directive that apply to them and makes a declaration to that effect. 
He operates an approved quality system for manufacturing, final production inspection and testing 
(such as described in EN 29002) and is subject to EC surveillance. He affixes the CE mark to the 
products and draws up a written declaration of conformity. The CE mark is accompanied by the 
identification symbol of the notified body which carries out the EC surveillance. 
— Module E: EC declaration of conformity (product quality assurance) 
This module relates to the production phase only. It is normally carried out in conjunction with an 
EC type examination, but may, in special cases, be carried out alone. The manufacturer satisfies 
himself that the type as described in the EC type examination certificate or with the essential 
requirements (when EC type examination is not required under the directive) that apply to them and 
makes a declaration to that effect. He operates an approved quality system for final product 
inspection and testing (such as described in EN 29003) under which all products are individually 
examined and appropriately tested. He is subject to EC surveillance and affixes the CE mark to the 
products and draws up a written declaration of conformity. The CE mark is accompanied by the 
identification symbol of the notified body which carries out the EC surveillance. 
— Module F: EC verification 
This module relates to the production phase only. It is normally carried out in conjunction with an 
EC type examination, the notified body checks and attests that the products are in conformity with 
the technical documentation (when EC type examination is not required under the directive) or with 
the type as described in the EC type examination certificate and, in both cases, that the products 
satisfy the requirements of the directive that apply to them. The manufacturer may choose (within 
the limits set by the directive) statistical verification provided he takes all the necessary measures to 
ensure that the manufacturing process guarantees homogenity of production as well as conformity to 
the technical documentation or to the type as described in the EC type examination. 
The notified body or the manufacturer, according to the provisions of the directive, affixes the CE 
mark to the products and draws up a written certificate of conformity. The CE mark is accompanied 
by the identification symbol of the notified body. 
19. 10. 89 Official Journal of the European Communities No C 267/23 
— Module G: EC unit verification 
This module relates to both the design and production phases. It is normally used for unit 
production or production in small series. The notified body checks and attests that individual 
products are in conformity with the requirements of the directive that apply to it. The notified body 
affixes the CE mark to the products and draws up a written certificate of conformity. The CE mark 
is accompanied by the identification symbol of the notified body. 
— Module H: EC declaration of conformity (Full Quality Assurance) 
This module relates to both the design and production phases. The manufacturer ensures and 
declares that the products concerned satisfy the requirements of the directive that apply to them. He 
operates an approved quality system for design, manufacture and final product inspection and testing 
(such as described in EN 29001). The directive may, in certain cases, require the manufacturer to 
request a notified body to examine and approve the conformity of the design to the requirements of 
the directive. He is subject to EC surveillance and affixes the CE mark to the products and draws up 
a written declaration of conformity. The CE mark is accompanied by the identification symbol of 
the notified body which carries out the EC surveillance. 
5. The notified bodies 
The idea underlying the new approach is that it is desirable to limit direct involvement by the public 
administrations to that which is absolutely necessary to ensure compliance with the essential 
requirements (as is made clear in the general clause concerning placing on the market which appears in 
all the directives). This principle is fully consistent with the fact that the authorities are still required to 
be responsible for surveillance of the market and of the use of the products. 
The various modules provide for the involvement of bodies at different levels (type-examination, 
product surveillance, approval of quality assurance, verification). The purpose of the directives is to 
define the general criteria which these bodies must satisfy in order to be deemed competent. It is the 
task of each Member State to designate them and notify them to the Commission and to the other 
Member States. Where the notified bodies can demonstrate that they satisfy the criteria laid down in the 
European standards (EN 45000 series); for example, the fact that they are accredited means that they 
are presumed to comply with the criteria laid down in the directive. 
If they are unable to demonstrate that they meet the criteria, it is then up to the Member States to 
provide the Commission with equivalent proof. 
This approach makes it possible to distinguish between the act of designation and the act of recognition 
of competence, the first being the acknowledged power of the authorities to choose and the second 
ensuring that this choice is objective and transparent. 
6. The CE mark 
The present situation concerning the affixing to products of Community marks in directives is unsatis­
factory and confusing. Community directives have provided for a number of different Community 
marks over the years, which do not always have the same significance. Such confusion is not conducive 
to an organized market. 
With the preparation of the first directives under the new approach provision was made for a single 
Community mark and it should therefore be adopted for all future comprehensive Community legis­
lation. It should have the following shape in all language versions: 
Application of the CE mark should be determined by the following criteria: 
— The mark should be reserved exclusively to indicate, for control purposes, conformity to directives 
which are comprehensive in nature and therefore replace completely all national legislation relating 
to its scope, 
— The mark should signify or indicate that the product and/or the manufacturer comply with the 
essential requirements and that the manufacturer (importer) or third party has carried out the 
relevant conformity assessment operations so that the product may be placed on the market without 
restriction, 
— The mark should be affixed on the product, but specific directives may allow the CE mark to be 
affixed on the packaging or the accompanying documentation, 
No C 267/24 Official Journal of the European Communities 19. 10. 89 
— The mark, should relate to all the essential requirements which concern a given product. If the 
product is covered by several directives, the affixing of the mark will signify conformity to all the 
directives involved. The person responsible for affixing the mark must ensure that all the directives 
have been complied with. (These two requirements considerably reduce the problems of overlapping 
between directives), 
— The mark should not indicate the directives and/or standards to which a product conforms. The test 
reports and certificates should contain such information (in an appendix, where appropriate), 
— The CE mark should not signify conformity to a particular conformity assessment procedure, even 
though it has to be affixed at the production phase of the assessment procedure only and not at the 
design phase, 
— Although the CE mark will not indicate that a particular procedure has been followed, it is advisable 
that when a third party is involved in one of the modules of the production phase of a conformity 
assessment procedure, that the third party should affix its stamp/mark/seal next to the CE mark to 
so indicate, 
— The mark should also be accompanied by the last two digits of the year in which it is affixed, 
— Since the CE mark is a sign of conformity to legislation, the national marks of conformity to 
European or national standards therefore remain compatible. These national marks of conformity to 
standards cannot, however, indicate conformity to Community legislation, 
— The CE mark is therefore the only mark which can indicate conformity to the comprehensive 
Community directives which replace all national regulations on the subject. This means that the CE 
mark replaces all national marks indicating conformity to national regulations, which are no longer 
allowed (such as the GS mark in Germany), 
The Commission intends to propose a directive to the Council which will set down the conditions 
governing the use and protection of the mark and which will clear up some of the confusion which has 
crept into recent legislation of this issue. 
It will also closely monitor market developments in connection with the coexistence of the CE mark and 
voluntary national marks which eventually would lose their reason to exist if they did not provide a 
further element of quality in addition to that provided by Community legislation. 
Section Three: 
THE IMPACT OF A GLOBAL APPROACH ON THE IMPLEMENTATION OF MUTUAL 
RECOGNITION OF NATIONAL REGULATIONS 
In its judgment in the 'Cassis de Dijon' case the Court of Justice held that any product lawfully produced 
and marketed in a Member State must, in principle, be admitted to the market of every other Member 
State. 
The significance of the words 'in principle', as emphasized by the Commission in its communication on the 
subject published in the Official Journal of the European Communities No C 256 of 3 October 1980, p. 2, 
comes from the fact that the Court accepts no exceptions to this rule, except under very strict conditions. 
Barriers to products originating in other Member States are only admissible if they are necessary to satisfy 
mandatory requirements, serve a purpose in the general interest and are essential for the purpose to be 
attained. 
Experience has shown that it can sometimes be very difficult to demonstrate that a requirement is neither 
necessary nor in the general interest, nor essential when, say, the protection of health and safety is at issue. 
This difficulty is even more evident when, in addition to securing recognition of the equivalence of 
national regulations, it is a matter of establishing the credibility of proofs of conformity to those regu­
lations or, rather, the credibility of those providing those proofs ('). 
(') In its judgment of 17 December 1981 in the 'Biologische Producten' case, the Court stressed that the national public 
authorities are not entitled unnecessarily to require tests to be carried out that have already been performed in another 
Member State. The need to repeat tests therefore appears to imply lack of confidence in the person or body 
performing them. 
19. 10. 89 Official Journal of the European Communities No C 267/25 
The object of all the measures undertaken and advocated in Section One of this chapter is to ensure the 
full implementation of the principle of mutual recognition; they seek to create a situation where the certifi­
cation bodies and laboratories that are authorized to attest the conformity of products to national regu­
lations are designated or accredited according to objective criteria of transparency and competence and 
where the operation of such bodies also meets these criteria. Thus, the aim is to make mandatory mutual 
recognition fully applicable, with no possibility of this being disputed by the national authorities. 
Similarly, the harmonization of conformity assessment procedures as advocated under the modular 
approach will inevitably have an influence on the procedures laid down in non-harmonized national regu­
lations. Directive 83/189 is the appropriate instrument to ensure that this is done in a systematic way. 
Section Four: 
THE NEED FOR A NEW EUROPEAN ORGANIZATION FOR CERTIFICATION AND TESTING 
The measures set out in Section One of this chapter are to do with the mechanisms that can serve to 
generate the necessary confidence in the competence of operators in the field of conformity assessment. 
That confidence is essential in order for mutual recognition to work. In areas which are not covered by the 
provisions of Article 36 and which involve private activities carried out on a contractual basis, mutual 
recognition cannot be imposed by legislation. Consequently, the only way to eliminate certification systems 
is through cooperation at European level between bodies and laboratories — as has been done in the case 
of standardization activity — in order to establish common systems for certification and the recognition of 
test results. 
A need was therefore felt in various quarters for a flexible and nonbureaucratic structure in Europe which 
would draw the various elements together and constitute a focal point for all interested parties. 
Such an infrastructure must be able to provide information, experience, and a framework within which 
appropriate structures and agreements for the different industrial sectors can be negotiated. It should also 
provide a coherent environment capable of reassuring consumers, users and public authorities that the 
requisite levels of quality and safety are being met. 
Apart from a few isolated sectoral agreements, such as the CCA, CECC and HAR within Cenelec and two 
Cencer Systems within CEN, there is at present an institutional vacuum at European level in the testing, 
certification and inspection field, which is in sharp contrast to the situation in respect of standardization. 
The Community's immediate task is to ensure that this vacuum is filled. 
In line with the separation of responsibilities between the private and public sectors required by the new 
approach, this task should be assigned to the private sector rather than to the public authorities, political 
control of the national and Community authorities must not be affected. 
In January 1988 the Commission services published a consultative document on the future organization in 
this field, in order to gather reactions to the basic conditions which they considered were indispensable to 
the launching of such a project. 
On this basis the Commission decided to organize a large-scale Symposium in Brussels in June 1988 on the 
theme of organizing testing and certification for Europe, which brought together some 800 participants. 
The Symposium conclusions confirmed the need for such an infrastructure if the achievement of the 
internal Market is to have any real significance for the free movement of goods within the Community. 
Such an infrastructure would also provide the common technical basis that is indispensable for the nego­
tiation of mutual recognition agreements with non-Community partners. 
The existence of such an infrastructure could also play an important role in facilitating the administration 
of EEC legislation, by providing a common technical basis for future directives for the regulated sectors. 
No C 267/26 Official Journal of the European Communities 19. 10. 89 
In accordance with the broad guidelines agreed in consultation with the representatives of national 
governments and confirmed by the Symposium conclusions, the Commission asked CEN/Cenelec to 
establish the necessary contacts with all the interested parties, in order to draw up a list of priority areas 
where sectoral work should be started, to make proposals on how the sectoral committees could be 
organized, and to reflect on appropriate ways in which the coordinating structure could be supported by 
CEN/Cenelec. 
Since the Symposium in June 1988, work has gone on within CEN/Cenelec to devise appropriate answers 
to these questions. This has led to the formulation of a proposal for a more general restructuring of testing, 
certification and inspection activities at European level round the present CEN/Cenelec structure, whilst 
ensuring a certain degree of autonomy for these activities from the conventional standardizing activities of 
these organizations. 
The Commission considers that it has a responsibility in this matter for properly discharging the super­
visory functions conferred on it by the Treaty in respect of any activity liable to have a bearing on the 
completion of the internal Market. 
CHAPTER V 
EXTERNAL ASPECTS OF THE GLOBAL APPROACH 
The adoption by the Community of the global approach, which provides clear and objective means of 
assessing the competence and responsibilities of testing, certification and inspection bodies, should 
considerably facilitate the relations between the Community and its international partners in this area. The 
strengthening of confidence through the structures to be established within the Community will in turn 
generate greater confidence in dealings with the non-Community countries, either through the relevant 
international organizations or on a bilateral basis. 
1. Guiding principles 
The starting point for the Community is, of course, its commitments in GATT (General agreements on 
tariff and trade) under the Agreement on Technical Barriers to Trade. The Community will continue to 
grant non-discriminatory access to its conformity assessment procedures to products originating in third 
countries. Under Community law any product, including one originating in a third country, which has 
been lawfully marketed in one Member State will be able to circulate freely within the Community as a 
whole. The reinforcement of mutual confidence resulting from the adoption of the global approach will 
enable this free movement to operate more effectively for products subject to conformity assessment 
procedures, for both third country and Community goods. 
As regards recognition by the Community of non-Community declarations, tests, reports, certificates or 
marks of conformity, the GATT Agreement on Technical Barriers to Trade does not lay down binding 
obligations, although its Article 5.2 requires parties 'where possible' to accept such declarations, tests 
and certificates from other parties, subject to bilateral negotiations to ensure 'a mutually satisfactory 
understanding'. The Community is prepared, in accordance with this undertaking, to conclude 
agreements for mutual recognition of tests, reports, certificates and marks provided that the following 
conditions are met: 
— The technical competence of the non-Community partner is adequate: The Community will be 
concerned to ensure that tests or inspections carried out by a non-Community body will offer the 
same guarantees as those located within the Community. This would normally require the use of 
common evaluation criteria (EN 45000 series) based on international standards, and would be 
further facilitated by the use of common standards or technical regulations for the products 
concerned. It would also be necessary to ensure that both sides offered equivalent safeguards with 
regard to the continued technical competence of their testing, certification and inspection bodies, 
— The mutual benefits flowing from the agreement are equivalent and guaranteed in an identical 
manner. The Community will wish to be satisfied that the practical results of any agreement, in 
terms of ease of access to the market, are the same for both sides; for instance, it would be difficult 
to accept that one party to the agreement did not reduce its administrative requirements in respect of 
conformity assessment for placing products on the market as a result of the agreements, 
— The agreement is limited to the testing, certification and inspection activity of designated bodies. 
Since these arrangements are based upon confidence in particular bodies, their scope needs to be 
carefully defined. They cannot be automatically extended to include third parties by further 
agreements on mutual recognition without the consent of the parties to the original agreement, 
19. 10. 89 Official Journal of the European Communities No C 267/27 
2. Procedures 
The parties involved in the negotiation of mutual recognition agreements and the procedure for such 
negotiations will differ according to whether the products concerned are subject to government regu­
lation or not. 
(a) Products subject to legislation 
International agreements between governments on the mutual recognition of test reports or 
certificates, although they seek to ensure that the public policy objectives of technical legislation are 
achieved, are primarily intended to promote international trade, and therefore are a matter of 
common commercial policy under Article 113 of the Treaty. The negotiation and conclusion of such 
agreements with third countries for products subject to lawfully enforced conformity assessment 
systems is therefore the responsibility of the Community. 
Moreover, the obligation for Member States under Community law to accept products, including 
third country products, lawfully marketed in another Member State means that the conditions of 
access to an integrated Community market cannot be determined by agreements with third countries 
concluded by individual Member States. In this context, the technical bodies within the new 
European Organization for Testing and Certification will need increasingly with time, to draw up 
common codes of practice or rules for conformity assessment. 
It follows that mutual recognition agreements for products subject either to Community or national 
technical regulations will be negotiated by the Commission on behalf of the Community, advised by 
representatives of the Member States in the normal way. (Negotiations of this kind are due to be 
opened shortly for example, in respect of the mutual recognition of good laboratory practice verifi­
cation between the Community and OECD member countries). In the case of products not subject 
to Community legislation, any Member State wishing to benefit from a mutual recognition 
agreement must inform the Commission which will then obtain negotiating directives from the 
Council for a Community-level agreement with the third country concerned. The Commission 
recognizes that this activity will represent a considerable additional demand on its resources and 
intends to explore with the Member States ways in which national technical expertise can be made 
available to the Community for these negotiations. 
(b) Products not subject to legislation 
Where, in the absence of legislation, testing, certification or inspection bodies outside the 
Community wish to participate in voluntary mutual recognition agreements under the global 
approach, they should be permitted to do so provided that they fulfil the same conditions of 
competence as their counterparts in the Community. The participants in the Community agreements 
can satisfy themselves that this is the case, and establish their own rules for the extension of the 
agreements.