No C 187/40 Official Journal of the European Communities 27. 7. 90 
Proposal for a Council Regulation (EEC) amending Regulation (EEC) No 1352/90 fixing rice prices 
for the 1990/91 marketing year 
COM(90) 246 final 
(Submitted by the Commission on 15 June 1990) 
(90/C 187/08) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, HAS ADOPTED THIS REGULATION: 
Having regard to the Treaty establishing the European 
Economic Community, 
Having regard to the Act of Accession of Spain and Portugal, 
and in particular Article 89 (2) thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Parliament, 
Whereas, pursuant to Articles 68 and 70 (1) of the Act of 
Accession of Spain and Portugal, Council Regulation (EEC) 
No 1352/90 (l) provides for an intervention price level in 
Spain which is different from that applying in the 
Community as constituted on 31 December 1985; 
Whereas, in view of the changes which have occurred since 
accession in the intervention mechanisms, from the 1990/91 
marketing year the intervention price for rice in Spain should 
be aligned with that applying in the Community as 
constituted on 31 December 1985, 
(») OJ No L 134, 28. 5. 1990, p. 17. Article 1 
Article 1 of Regulation (EEC) No 1352/90 is hereby 
replaced by the following: 
'Article 1 
For the 1990/91 marketing year, rice prices shall be as 
follows: 
(a) intervention price for paddy rice: ECU 314,19 per 
tonne; 
(b) target price for husked rice: ECU 546,88 per 
tonne.' 
Article 2 
This Regulation shall enter into force on the third day 
following its publication in the Official Journal of the 
European Communities. 
It shall apply from 1 September 1990. 
This Regulation shall be binding in its entirety and directly 
applicable in all Member States. 
Amended proposal for a Council Directive on the approximation of the laws of the Member States 
concerning telecommunications terminal equipment, including the mutual recognition of their 
conformity 
COM(90) 263 final — SYN 204 
(Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 20 June 1990) 
(90/C 187/09) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100A 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, Having regard to the opinion of the Economic and Social 
Committee, 
Whereas Council Directive 86/361/EEC (*) introduced the 
initial stage of the mutual recognition of type approval for 
telecommunications terminal equipment and in particular in 
OJNoL217, 5. 8. 1986, p. 21. 
27. 7. 90 Official Journal of the European Communities No C 187/41 
its Article 9 envisaged a further stage for full mutual 
recognition of type approval for terminal equipment; 
Whereas Council Decision 87/95/EEC (x) sets out the 
measures to be implemented for the promotion of 
standardization in Europe and the preparation and 
implementation of standards in the field of information 
technology and telecommunications; 
Whereas the Commission has issued a Green Paper on the 
development of the common market for telecommunications 
services and equipment (2) proposing to accelerate the 
introduction of the full mutual recognition of type approval 
as the measure vital for the development of a competitive 
Community-wide terminal market; 
Whereas the Council in its resolution of 30 June 1988 on the 
development of the common market for telecommunications 
services and equipment up to 1992 (3) considers as a major 
goal in the telecommunications policy the full mutual 
recognition of type approval for terminal equipment on the 
basis of the rapid development of common European 
conformity specifications; 
Whereas the terminal equipment sector is a vital part of the 
telecommunications industry which is one of the industrial 
mainstays of the Community economy; 
Whereas the Council resolution of 7 May 1985 (4), provides 
for a new approach to technical harmonization and 
standards; 
Whereas the field of application of the Directive must be 
based on a general definition of the term 'terminal equipment' 
so as to allow the technical development of products; 
Whereas Community law, in its present form, provides — 
notwithstanding one of the fundamental rules of the 
Community, namely the free movement of goods — that 
obstacles to movement within the Community, resulting 
from disparities in national legislation relating to the 
marketing of products must be accepted in so far as such 
requirements can be recognized as being necessary to satisfy 
imperative requirements; whereas, therefore, the 
harmonization of laws in this case must be limited only to 
those requirements necessary to satisfy the essential 
requirements relating to terminal equipment; whereas these 
requirements must replace the relevant national 
requirements because they are essential; 
Whereas the essential requirements must be satisfied in order 
to safeguard the general interest; whereas these requirements 
must be applied with discernment to take account of the state 
of the art at the time of manufacture and economic 
requirements; 
(!) OJNoL36, 7. 2. 1987, p. 31. 
(2) COM(87) 290. 
(3) OJ No C 257, 4. 10. 1988, p. 1. 
(4) OJNo C 136,4. 6. 1985, p. 1. Whereas Council Directive 73 / 23 / EEC of 19 February 1973 
on the harmonization of the laws of the Member States 
relating to electrical equipment designed for use within 
certain voltage limits (5) and Council Directive 83/189/EEC 
of 28 March 1983 laying down a procedure for the provision 
of information in the field of technical standards and 
regulations (6), as amended by Directive 88/182/EEC (7), 
are applicable, inter alia, to the fields of telecommunications 
and information technology; 
Whereas Council Directive 89/336/EEC of 3 May 1989 on 
the approximation of the laws of Member States relating to 
electromagnetic compatibility (8) is applicable, inter alia, 
to the fields of telecommunications and information 
technology; 
Whereas in respect of the essential safety requirements and in 
order to help manufacturers to prove conformity to these 
essential requirements it is desirable to have standards 
harmonized at European level for the prevention of hazards 
arising out of the design and manufacture of terminal 
equipment and in order to allow checks of conformity to the 
essential requirements; whereas these standards harmonized 
at European level are drawn up by private-law bodies and 
must retain their non-binding status; whereas for this 
purpose the European Committee for Standardization 
(CEN) and the European Committee for Electrotechnical 
Standardization (Cenelec) are the bodies recognized as 
competent to adopt harmonized standards in accordance 
with the general guidelines for cooperation between the 
Commission and these two bodies signed on 13 November 
1984; whereas within the meaning of this Directive a 
harmonized standard is a technical specification (European 
standard or harmonization document) adopted by either or 
both of these bodies, on the basis of a remit from the 
Commission in accordance with the provisions of Directive 
83/189/EEC, and on the basis of the general guidelines 
referred to above; 
Whereas the formal adoption of the statutes of the European 
Telecommunications Standards Institue (ETSI) on 12 
February 1988 creates a new opportunity to produce 
harmonized standards in the telecommunications field; 
whereas after implementation by the Member States of the 
ETSI rules of procedures which depend on their authority it 
will be possible to introduce ETSI into the framework of 
European standardization as stipulated in Directive 
83/189/EEC; 
Whereas in respect of the essential requirements related to 
interworking with public telecommunications networks, it is 
in general not possible to comply with such requirements 
other than by the application of unique solutions; whereas 
such solutions shall therefore be mandatory; 
Whereas it is essential to ensure that notified bodies are of a 
high standard throughout the Community and meet 
(s) OJ No L 77, 26. 3. 1973, p. 29. 
(6) OJ No L 109, 26. 4. 1983, p. 8. 
(7) OJ No L 81, 26. 3. 1988, p. 75. 
(8) OJ No L 139, 23. 5. 1989, p. 19. 
No C 187/42 Official Journal of the European Communities 27. 7. 90 
minimum criteria of competence, impartiality and financial 
and other independence from clients; 
Whereas it is appropriate to set up a committee bringing 
together parties directly concerned with the implementation 
of this Directive, in particular the national bodies designated 
for certifying conformity, to assist the Commission in 
executing the tasks entrusted to it by this Directive; whereas 
representatives of the telecommunications organizations, 
users, consumers, manufacturers, service providers and the 
trade unions should have the right to be consulted; 
Whereas the Member States' responsibility for safety, health 
and the other aspects covered by the essential requirements 
on their territory must be recognized in a safeguard clause 
providing for adequate Community protection procedures; 
Whereas the addressees of any decision taken under this 
Directive must be informed of the reasons for such a decision 
and the means of appeal open to them; 
Whereas the measures aimed at the gradual establishment of 
the internal market must be adopted by 31 December 1992; 
whereas the internal market consists of an area without 
internal frontiers within which the free movement of goods, 
persons, services and capital is guaranteed, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Scope, placing on the market and free movement 
Article 1 
1. This Directive shall apply to terminal equipment. 
2. For the purposes of this Directive terminal equipment 
means equipment intended: 
(a) to be connected to the termination of a public 
telecommunications network by an electrically 
conductive system; 
and/or 
(b) to interwork with a public telecommunications 
network; 
and/or 
(c) to interwork via a public telecommunications 
network. 
For cases (b) and (c) the system of connection to support the 
interworking may be wire, radio, optical, or other 
electromagnetic systems. 3. The intended purpose shall be declared by the 
manufacturer or supplier of the equipment. 
Article 2 
Member States shall take all necessary steps to ensure that 
terminal equipment may be placed on the market and put 
into service only if it complies with the requirements laid 
down in this Directive when it is properly installed and 
maintained and used for its intended purpose. 
Article 3 
Terminal equipment shall satisfy the following essential 
requirements, when they are relevant: 
(a) user safety in so far as this requirement is not covered by 
Directive 73/23/EEC; 
(b) safety of employees of public telecommunications 
network operators in so far as this requirement is not 
covered by Directive 73/23/EEC; 
(c) protection of the public telecommunications network 
from harm; 
(d) interworking of terminal equipment with network 
equipment for the purpose of establishing, modifying, 
charging for, and clearing real or virtual connections; 
(e) interworking of terminal equipment, in justified cases, 
as determined in accordance with the procedure laid 
down in Article 13. 
Article 4 
Member States shall not impede the placing on the market 
and the free circulation and use on their territory of terminal 
equipment which complies with the provisions of this 
Directive. 
Article S 
1. Member States shall presume compliance with the 
essential requirements referred to in Article 3 (a) and (b) in 
respect of terminal equipment which is in conformity with 
the national standards implementing the relevant 
harmonized standards the references of which have been 
published in the Official Journal of the European 
Communities. Member States shall publish the references of 
such national standards. 
2. The Commission, in accordance with the procedure 
laid down in Article 13, shall decide which harmonized 
standards, implementing the essential requirements referred 
to in Article 3 (c), (d) and (e) will be transformed in whole or 
in part into technical regulations compliance with which 
27. 7. 90 Official Journal of the European Communities No C 187/43 
shall be mandatory and the references of which shall be 
published in the Official Journal of the European 
Communities. 
Article 6 
Where a Member State or the Commission considers that the 
harmonized standards referred to in Article 5 do not entirely 
meet or exceed the essential requirements referred to in 
Article 3, the Commission or the Member State concerned 
shall bring the matter before the Committee referred to in 
Article 12, hereinafter referred to as 'the Committee', giving 
the reasons therefor. The Committee shall deliver an opinion 
wihout delay. 
In the light of the Committee's opinion and after consultation 
of the Standing Committee set up by Directive 83/189/ EEC, 
the Commission shall inform the Member States whether or 
not it is necessary to withdraw references to those standards 
and any related technical regulations from the Official 
Journal of the European Communities. 
Article 7 
1. Where a Member State finds that terminal equipment 
bearing the EC mark under the provisions laid down in 
chapter III does not comply with the relevant essential 
requirements when properly used in accordance with the 
purpose intended by the manufacturer, it shall take all 
appropriate measures to withdraw such products from the 
market or to prohibit or restrict their being placed on the 
market. 
The Member State concerned shall immediately inform the 
Commission of any such measure indicating the reasons for 
its decision, and in particular whether non-compliance is due 
to: 
(a) incorrect application of the harmonized standards 
referred to in Article 5; 
(b) shortcomings in the harmonized standards referred to in 
Article 5 themselves. 
2. The Commission shall enter into consultation with the 
parties concerned as soon as possible. Where, after such 
consultation, the Commission finds that any measure as 
referred to in paragraph 1 is justified it shall immediately so 
inform the Member State that took the action and the other 
Member States. Where the decision referred to in 
paragraph 1 is attributed to shortcomings in the harmonized 
standards, the Commission, after consulting the parties 
concerned, shall bring the matter before the Committee 
within two months if the Member State which has taken the 
measures intends to maintain them, and shall initiate the 
procedure referred to in Article 6. 
3. Where terminal equipment which does not comply 
with the relevant essential requirements bears the EC mark 
the competent Member State shall take appropriate action 
against whomsoever has affixed the mark and shall inform 
the Commission and the other Member States thereof. 4. The Commission shall keep the Member States 
informed of the progress and outcome of this procedure. 
CHAPTER II 
Conformity assessment 
Article 8 
1. According to the choice of the manufacturer or 
his authorized representative established within the 
Community, terminal equipment shall be subject to either 
EC type examination, as described in Annex 1, or to EC 
declaration of conformity, as described in Annex 4. 
2. An EC type examination as described in Annex 1 shall 
be accompanied by a declaration issued according to the EC 
declaration of conformity to type procedure as described in 
Annex 2 or 3. 
3. The records and correspondence relating to the 
procedures referred to in this Article shall be in an official 
language of the Member State where the said procedure will 
be carried out, or in a language acceptable to the notified 
body involved. 
Article 9 
1. Member States shall notify to the other Member States 
and the Commission the bodies which they have designated 
for carrying out tasks pertaining to the procedures referred to 
in Article 8, the specific tasks for which each body has been 
designated, and the identification codes of the designated 
bodies. 
The Commission shall publish the list of these notified bodies 
together with the tasks for which they have been designated, 
in the Official Journal of the European Communities and 
shall keep the list up to date. 
2. Member States shall apply the minimum criteria, set 
out in Annex 5, for the designation of bodies. Bodies that 
satisfy the criteria fixed by the relevant harmonized 
standards shall be presumed to satisfy the criteria set out in 
Annex 5. 
3. A Member State that has designated a body shall annul 
the designation if the body no longer meets the criteria for 
designation referred to in paragraph 2. It shall immediately 
inform the other Member States and the Commission 
accordingly and withdraw the notification. 
4. In order to facilitate the determination of conformity 
of terminal equipment with technical regulations and 
standards, the notified bodies shall recognize documentation 
issued by third country relevant bodies, when agreements 
between the Community and the third country concerned 
have been concluded on the basis of a mutually-satisfactory 
understanding. 
No C 187/44 Official Journal of the European Communities 27. 7. 90 
CHAPTER III 
EC mark of conformity and inscriptions 
Article 10 
1. The EC mark of conformity, which shall consist of the 
symbol 'CE' in conformity with the specimen in Annex 6, 
shall be affixed to terminal equipment in a clearly visible, 
easily legible and indelible form. It shall be followed by the 
last two digits of the year in which it was affixed. 
2. The affixing of marks which are likely to be confused 
with the EC mark of conformity shall be prohibited. 
3. Terminal equipment shall be identified by the 
manufacturer by means of type, batch, or serial numbers and 
the manufacturer's name. 
Article 11 
Where it is established that the EC mark has been affixed to 
terminal equipment which: 
— does not conform to an approved type, 
— conforms to an approved type which does not meet the 
essential requirements applicable to it, 
or, where the manufacturer has failed to fulfil his obligations 
under the relevant EC declaration of conformity, 
the notified body shall withdraw the EC type examination 
certificate as referred to in Annex 1, the EC quality system 
approval certificate, as referred to in Annex 3 or the EC 
design examination certificate as referred to in Annex 4, as 
relevant, notwithstanding any decisions taken pursuant to 
Article 7. 
CHAPTER IV 
Committee 
Article 12 
1. A Standing Committee for terminal equipment is 
hereby set up. The Committee shall be called the Approvals 
Committee for Telecommunications Equipment (ACTE). 
The Committee shall be composed of representatives 
appointed by the Member States. It shall be chaired by a 
representative of the Commission. Each Member State shall 
appoint two representatives. The representatives may be 
accompanied by experts. 
The Committee shall draw up its own rules of procedure. 
2. The Commission will periodically consult the 
representatives of the telecommunications organizations, the 
consumers, the manufacturers, the service providers and the 
trade unions and will inform the Committee on the outcome of such consultations, with a view to taking due account of 
this outcome. 
Article 13 
1. The representative of the Commission shall submit to 
the Committee established in Article 12, a draft of the 
measures to be taken as referred to in Article 5 (2). The 
Committee shall deliver its opinion on the draft within a time 
limit which the chairman may lay down according to the 
urgency of the matter. The opinion shall be delivered by the 
majority laid down in Article 148 (2) of the Treaty in the case 
of decisions which the Council is required to adopt on a 
proposal from the Commission. The votes of the 
representatives of the Member States within the Committee 
shall be weighted in the manner set out in that Article. The 
chairman shall not vote. 
2. The Commission shall adopt the measures envisaged 
if they are in accordance with the opinion of the 
Committee. 
3. If the measures envisaged are not in accordance with 
the opinion of the Committee, or if no opinion is delivered, 
the Commission shall, without delay, submit to the Council a 
proposal relating to the measures to be taken. The Council 
shall act by qualified majority. If, within three months of the 
proposal being submitted to it, the Council has not acted, the 
proposed measures shall be adopted by the Commission. 
CHAPTER V 
Final and transitional provisions 
Article 14 
1. Where, for a given terminal equipment, harmonized 
standards as referred to in Article 5 do not exist, national 
conformity specifications shall be applicable. These national 
conformity specifications shall not impose requirements 
beyond those strictly necessary to respect the essential 
requirements set out in Article 3. 
The right to place on the market terminal equipment, which 
has received national type approval on the basis of national 
conformity specifications, may be limited to the territory 
of the Member State where the national conformity 
specification applies except if it complies with a national 
specification of another Member State and is intended for 
re-sale or for use in this Member State. 
2. A national authority shall recognize, for the purpose of 
national type approval, a certificate of conformity to its own 
national conformity specification, accompanied by the 
appropriate test reports, which has been issued by an notified 
27. 7. 90 Official Journal of the European Communities No C 187/45 
body of another Member State and shall not impose a 
requirement for any repetition of tests. 
A national authority shall recognize, for the purpose of 
national type approval, a certificate of conformity based on 
the national conformity specifications of another Member 
State provided that these conformity specifications are 
equivalent to those used in the Member State of the 
authority. 
Article 14a 
The Commission shall draw up a report every two years on 
the implementation of this Directive, including progress on 
drawing up the relevant harmonized standards and on 
transforming them into mandatory technical regulations, as 
well as any problems that have arisen in the course of 
implementation. The report will also outline the activities of 
the Committee established in Article 12, and assess progress 
in achieving an open competitive market for terminal 
equipment at Community level consistent with the essential 
requirements in Article 3. Article 15 
Directive 86/361/EEC is hereby repealed with effect from 
(1 January 1992) (1). 
Article 16 
1. Member States shall introduce the measures necessary 
to comply with this Directive referred not later than 
(1 January 1992) C1). They shall forthwith inform the 
Commission thereof. 
The provisions adopted pursuant to the first subparagraph 
shall make express reference to this Directive. 
2. Member States shall inform the Commission of the 
provisions of national law which they adopt in the field 
governed by this Directive. 
Article 17 
This Directive is addressed to the Member States. 
(J) To be adapted at the date of adoption of the Directive. 
ANNEX 1 
EC TYPE EXAMINATION 
The EC type examination is that part of the procedure by which a notified body ascertains and attests that 
terminal equipment,representative of the production envisaged and hereinafter called the 'type', conforms 
to the essential requirements that apply to it. 
The application for EC type examination shall be lodged by the manufacturer or his authorized 
representative established within the Community with one of the notified bodies designated to carry out EC 
type examination. 
The application shall include: 
— the name and address of the manufacturer and, if the application is lodged by the authorized 
representative, his name and address in addition, 
— a written declaration that the application has not been lodged with any other notified body, 
— the technical documentation, as described in paragraph 3. 
The applicant shall place the type, in the required quantity, at the disposal of the notified body. 
The technical documentation shall enable understanding of the design, manufacture and operation of the 
product, so far as is relevant for assessment of conformity of the product with the essential requirements 
that apply to it. 
The documentation shall contain so far as relevant for assessment: 
— a general description of the type, 
— conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, 
etc., 
— descriptions and explanations necessary for the understanding of said drawings and schemes and the 
operation of the product, 
No C 187/46 Official Journal of the European Communities 27. 7. 90 
— a list of the standards referred to in Article 5, applied in full or in part, declarations of conformity to the 
standards referred to in Article 5(1) where such standards have been applied, and descriptions of the 
solutions adopted to meet the essential requirements where the standards referred to in Article 5(1) 
have not been applied, 
— results of design calculations made, examinations carried out, etc., 
— test reports. 
4. The notified body shall, 
4.1. examine the technical documentation, verify that the type has been manufactured in conformity with the 
technical documentation and identify the elements which have been designed in accordance with the 
relevant provisions of the standards referred to in Article 5 (1), as well as the elements which have been 
designed without applying the relevant provisions of those standards; 
4.2. perform or have performed the appropriate examinations and necessary tests to check whether, where the 
standards referred to in Article 5(1) have not been applied, the solutions adopted by the manufacturer meet 
the essential requirements of the Directive referred to in Article 3 (a) and (b); 
4.3. perform or have performed the appropriate examinations and necessary tests to check that the type 
complies with the relevant harmonized standards referred to in Article 5 (2). 
5. Where the type conforms to the applicable essential requirements the notified body shall issue an EC type 
examination certificate to the applicant. The certificate shall contain the name and address of the 
manufacturer, conclusions of the examination, conditions for its validity and the necessary data for 
identification of the approved type. 
Relevant parts of technical documentation shall be annexed to the certificate and kept by the notified 
body. 
6. The applicant shall keep the notified body that has issued the EC type examination certificate informed of 
any modification to the approved type. 
Modifications to the approved type must receive additional approval from the notified body that issued the 
EC type examination certificate where such changes may affect the conformity with the essential 
requirements or the prescribed conditions for use of the product. This additional approval is given in the 
form of an addition to the original EC type examination certificate. 
7. Each notified body shall publish periodically the relevant information concerning: 
— the applications for EC type examination received, 
— the EC type examination certificates and additions issued, 
— the EC type examination certificates and additions refused, 
— the EC type examination certificates and additions withdrawn. 
8. The other notified bodies may receive copies of the EC type examination certificates and / or their additions 
and any annexes. 
ANNEX 2 
EC DECLARATION OF CONFORMITY TO TYPE 
1. This declaration of conformity is that part of the procedure whereby the manufacturer ensures and declares 
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. The manufacturer shall affix the EC mark to 
each product and draw up a written declaration of conformity. 
2. The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure 
compliance of the manufactured products with the type as described in the EC type examination certificate and 
with the requirements of the Directive that apply to them. 
27. 7. 90 Official Journal of the European Communities No C 187/47 
3. A notified body chosen by the manufacturer shall carry out or have carried out product checks at random 
intervals. An adequate sample of the final products, taken on site by the notified body, shall be examined and 
appropriate tests as set out in the relevant standard(s) referred to in Article 5, shall be carried out to check the 
conformity of the production output with the the relevant requirements of the Directive. In those cases where 
one or more of the products checked do not conform the notified body shall take appropriate measures. 
ANNEX 3 
EC DECLARATION OF CONFORMITY TO TYPE (PRODUCTION QUALITY ASSURANCE) 
1. This declaration of conformity is that part of the procedure whereby a manufacturer who satisfies the 
obligations of paragraph 2 ensures and declares 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. The manufacturer shall affix the EC mark to each product and shall draw up a written 
declaration of conformity. 
2. The manufacturer shall operate an approved quality system for production, final product inspection and 
testing as specified in paragraph 3 and shall be subject to EC surveillance as specified in paragraph 4. 
3. Quality system 
3.1. The manufacturer shall lodge an application for assessment of his quality system with one of the notified 
bodies designated to carry out quality system approval. 
The application shall include: 
— all relevant information for the product category envisaged, 
— the quality system's documentation, 
— an undertaking to carry out the obligations arising from the quality system as approved, 
— an undertaking to maintain the quality system as approved to ensure its continuing suitability and 
effectiveness, 
— if applicable, the technical documentation of the approved type and a copy of the EC type examination 
certificate. 
3.2. The quality system shall ensure compliance of the products with the type as described in the EC type 
examination certificate and with the requirements of the Directive that apply to them. 
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a 
systematic and orderly manner in the form of written policies, procedures and instructions. This quality 
system documentation shall ensure a common understanding of the quality programmes, plans, manuals 
and records. 
It shall contain in particular an adequate description of: 
— the quality objectives and the organizational structure, responsibilities and powers of the management 
with regard to product quality, 
— the manufacturing, quality control and quality assurance techniques, processes and systematic actions 
that will be used, 
— the examinations and tests that will be carried out before, during and after manufacture and the 
frequency with which they will be carried out, 
— the means to monitor the achievement of the required product quality and the effective operation of the 
quality system. 
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred 
to in paragraph 3.2. It shall presume conformity with these requirements in respect of quality systems that 
implement the relevant harmonized standard. 
The assessment team shall have at least one member experienced as an assessor in the product technology 
concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises. 
No C 187/48 Official Journal of the European Communities 27. 7. 90 
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the 
examination and the reasoned assessment decision. Where the notified body decides to approve the quality 
system it shall issue an EC quality system approval certificate. 
3.4. The manufacturer or his authorized representative shall keep the notified body that has approved the 
quality system informed of any intended modification to the quality system. 
The notified body shall evaluate the modifications proposed and decide whether the amended quality 
system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is 
required. 
It shall notify its decision to the manufacturer. The notification shall contain the conclusions of the 
examination and the reasoned assessment decision. 
4. EC surveillance 
4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out 
of the approved quality system. 
4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of 
manufacture, inspection, testing and storage and shall provide it with all necessary information, in 
particular: 
— the quality system documentation, 
— the quality records, such as inspection reports and test data, calibration data, qualification reports of 
the personnel concerned, etc. 
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and 
applies the quality system and shall provide an audit report to the manufacturer. 
4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits full or 
reduced audits may be carried out by the notified body. The notified body shall provide a visit report and, if 
applicable, an audit report to the manufacturer. 
5. Each notified body shall publish periodically the relevant information concerning the EC quality system 
approval certificates issued and withdrawn. 
ANNEX 4 
EC DECLARATION OF CONFORMITY (FULL QUALITY ASSURANCE) 
1. This declaration of conformity is the procedure whereby the manufacturer who satisfies the obligations of 
paragraph 2 ensures and declares that the products concerned satisfy the requirements of the Directive that 
apply to them. The manufacturer shall affix the EC mark to each product and draw up a written 
declaration of conformity. 
2. The manufacturer shall operate an approved quality system for design, manufacture and final product 
inspection and testing as specified in paragraph 3 and shall be subject to EC surveillance as specified in 
paragraph 4. 
3. Quality system 
3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified 
body. 
The application shall include: 
— all relevant information for the product category envisaged, 
— the quality system's documentation, 
— an undertaking to carry out the obligations arising from the quality system as approved, 
— an undertaking to maintain the quality system as approved to ensure its continuing suitability and 
effectiveness. 
27. 7. 90 Official Journal of the European Communities No C 187/49 
3.2. The quality system shall ensure compliance of the products with the requirements of the Directive that 
apply to them. 
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a 
systematic and orderly manner in the form of written policies, procedures and instructions. This quality 
system documentation shall ensure a common understanding of the quality policies and procedures such as 
quality programmes, plans, manuals and records. 
It shall contain in particular an adequate description of: 
— the quality objects and the organizational structure, responsibilities and powers of the management 
with regard to design and product quality, 
— the technical design specifications including harmonized standards and technical regulations laid down 
in Article 5, 
— the design control and design verification techniques, processes and systematic actions that will be used 
when designing the products pertaining to the product category covered, 
— the corresponding manufacturing, quality control and quality assurance techniques, processes and 
systematic actions that will be used, 
— the examination and tests that will be carried out before, during, and after manufacture, and the 
frequency with which they will be carried out, 
— the means by which it is ensured that the test and examination facilities respect the requirements for 
notified bodies designated for testing, 
— the means to monitor the achievement of the required design and product quality and the effective 
operation of the quality system. 
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred 
to in paragraph 3.2. It shall presume compliance with these requirements in respect of quality systems that 
implement the relevant harmonized standard (i.e. EN 29001). 
The assessment team shall have at least one member experienced as an assessor in the product technology 
concerned. The evaluation procedure shall include an assessment visit to the manufacturer's premises. 
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the 
examination and the reasoned assessment decision. 
3.4. The manufacturer or his authorized representative shall keep the notified body that has approved the 
quality system informed of any intended updating of the quality system. 
The notified body shall evaluate the modifications proposed and decide whether the amended quality 
system will still satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is 
required. 
It shall notify its decision to the manufacturer. The notification shall contain the conclusion of the 
examination and the reasoned assessment decision. 
4. EC surveillance 
4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out 
of the approved quality system. 
4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of design, 
manufacture, inspection and testing, and storage, and shall provide it with all necessary information, in 
particular: 
— the quality system documentation, 
— the quality records as foreseen by the design part of the quality system, such as results of analyses, 
calculations, tests, etc., 
— the quality records as foreseen by the manufacturing part of the quality system, such as inspection 
reports and test data, calibration data, qualification reports of the personnel concerned, etc. 
4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and 
applies the quality system and shall provide an audit report to the manufacturer. 
4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits full or 
reduced audits may be carried out by the notified body. The notified body shall provide a visit report and, if 
applicable, an audit report to the manufacturer. 
No C 187/50 Official Journal of the European Communities 27. 7. 90 
5. Each notified body shall publish periodically the relevant information concerning the quality system 
approvals issued and withdrawn. 
6. Design examination 
6.1. The manufacturer shall lodge an application for examination of the design with a notified body. 
6.2. The application shall enable understanding of the design, manufacture and operation of the product, and 
shall enable assessment of conformity with the relevant requirements of the Directive. 
It shall include: 
— the technical design specifications, including harmonized standards and technical regulations laid 
down in Article 5 that have been applied, 
— the necessary supporting evidence for their adequacy. This supporting evidence shall include the results 
of tests carried out by an in-house notified body designated for testing or on behalf of the manufacturer 
by a notified body designated for testing. 
6.3. The notified body shall examine the application and where the design meets the provisions of the Directive 
that apply to it shall issue an EC design examination certificate to the applicant. The certificate shall 
contain the conclusions of the examination, conditions for its validity, the necessary data for identification 
of the approved design and, if relevant, a description of the product's functioning. 
6.4. The applicant shall keep the notified body that has issued the EC design examination certificate informed of 
any modification to the approved design. Modifications to the approved design must receive additional 
approval from the notified body that issued the EC examination certificate where such changes may affect 
the conformity with the essential requirements of the Directive or the prescribed conditions for use of the 
product. This additional approval is given in the form of an addition to the original EC design examination 
certificate. 
6.5. The notified bodies shall publish periodically the relevant information concerning: 
— the applications for EC design examination received, 
— the EC design examination certificates and additions issued, 
— the EC design examination certificates and additions reissued, 
— the EC design examination certificates and additions refused, 
— the EC design approvals and additional approvals withdrawn. 
ANNEX 5 
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN APPOINTING 
NOTIFIED BODIES 
1. The notified body, its director and staff responsible for carrying out the tasks for which the notified body has 
been designated shall not be a designer, manufacturer, supplier or installer of terminal equipment, nor the 
authorized representative of any of such parties. They shall not become directly involved in the design, 
construction, marketing or maintenance of terminal equipment, nor represent the parties engaged in these 
activities. This does not preclude the possibility of exchanges of technical information between the 
manufacturer and the notified body. 
2. The notified body and its staff must carry out the tasks for which the notified body has been designated with the 
highest degree of professional integrity and technical competence and must be free from all pressures and 
inducements, particularly financial, which might influence their judgement or the results of any tests or 
inspection, especially from persons or groups of persons with an interest in such results. 
3. The notified body must have at its disposal the necessary staff and facilities to enable it to perform properly the 
administrative and technical work associated with the tasks for which it has been designated. 
27. 7. 90 Official Journal of the European Communities No C 187/51 
4. The staff responsible for tests or inspections must have: 
— sound technical and professional training, 
— satisfactory knowledge of the requirements of the tests or inspections they carry out and adequate 
experience of such tests or inspections, 
— the ability to draw up the certificates, records and reports required to authenticate the performance of the 
test or inspections. 
5. The impartiality of test and inspection staff must be guaranteed. Their remuneration must not depend on the 
number of tests or inspections carried out nor on the results of such tests or inspections. 
6. The notified body must take out liability insurance unless its liability is assumed by the State in accordance with 
national law, or the Member State itself is directly responsible. 
7. The staff of the notified body is bound to observe professional secrecy with regard to all information gained in 
carrying out its tasks (except vis-a-vis the competent administrative authorities of the State in which its 
activities are carried out) under this Directive or any provision of national law giving effect to it. 
ANNEX 6