United States Department of Commerce

Technology Administration

National Institute of Standards and Technology

NAT L INST. OF STAND & TECH R.I.C.

.A 1110 M 7fl7bflfi

NISI

PUBLICATIONS

NIST Special Publication 891

Standards Setting in the European UnionStandards Organizations and Officials

in EU Standards Activities

Roger A. Rensberger and Rene van de Zande

***

* *

* *

* *

***

QC

100

U57

NO. 891

1995

TheW

COMMERCIAL

SERVICE I

United States ofAmerica I

Department ofCommerce

L

NIST Special Publication 891

Standards Setting in the European Union—

Standards Organization and Officials

in EU Standards Activities

Roger A. Rensberger

Standards Officer, USEU

Rene van de Zande

Commercial Specialist, USEU

September 1995

A joint publication of the U.S. Mission to the European Union, the Commercial Service, and the National Institute of Standards and

Technology, U.S. Department of Commerce.

The Honorable Stuart E. Eizenstat United States Representative to the European

Union

U.S. Department of Commerce

Ronald H. Brown, Secretary

Technology Administration

Mary L. Good, Under Secretary for Technology

National Institute of Standards and Technology

Arati Prabhakar, Director
National Institute of Standards

and Technology

Special Publication 891

Natl. Inst. Stand. Technol. Spec. Publ. 891

72 pages (Sept. 1995)

CODEN: NSPUE2

U.S. Government Printing Office

Washington: 1995

For sale by the Superintendent

of Documents

U.S. Government Printing Office

Washington, DC 20402
In April 1995, when European Commission Vice President

Sir Leon Brittan, Commissioner Martin Bangemann, and U.S.

Secretary of Commerce Ronald H. Brown jointly asked more than

1,400 U.S. and European businesses and associations how the

Commission and the U.S. Administration could improve and

deepen the transatlantic business relationship, the issue area

cited most often by far, was standards.

I am pleased that the Commercial Service at the U.S.

Mission to the European Union prepared a guide that will be an

important resource for U.S. manufacturers and exporters

seeking information on standards in the EU, on key EU

standards developing organizations and officials in the

Commission with standards responsibilities.

The purpose of the guide, "Standards Setting in the

European Union," is to bring U.S. industry closer to the EU

standards community to enhance trade between the European

Union and the United States. I hope that all its users find

it informative, and they should feel free to suggest

improvements or additions to our Commercial Service staff.

Ambassador Stuart E. Eizenstat

United States Representative to the European

Union

1
"Standardization, the best way of organizing

economic relations."

Florence Nicolas, Common Standards for

Enterprises

2
For most U.S. businesses in Europe today, tariffs,

quotas, even financing are not issues. Years of multilateral

trade negotiations have reduced most of the traditional

barriers to negligible levels. The key to competitiveness in

the European Union countries is the timely availability of

information. It is very appropriate to paraphrase the adage

and say that for Europe "Knowledge is Exports." This is

especially true in the field of standards, testing and

certification. With tariff barriers virtually gone, advance

warning and real insights into the issues of transparency of

standards development, ISO 9000, CE marking, environmental

management and ecolabelling are key to successful marketing

and reducing the cost of doing business.

This document is a real "Baedeker" to the standards and

regulatory community in Europe that directly affects doing

business and can be used to find just the right information to

avoid costly mistakes in a very complex and slippery field of

play.

Charles Ludolph, Director

Office of European Union and Regional Affairs

U.S. Department of Commerce

Chairman, U.S. interagency Working Group on EU

Standards and Regulatory Issues

3
ACKNOWLEDGMENTS

The authors thank Stephen C. Arlinghaus, Minister

Counselor, Margaret Keshishian, Commercial Attache, and Sylvia

Mohr, Commercial Assistant, Commercial Service, U.S. Mission

to the European Union (CS USEU) ; Charles Ludolph, Director,

Office of European Union and Regional Affairs and Lori Cooper,

Director, Trade Policy Division, Office of European Union and

Regional Affairs, International Trade Administration, U.S.

Department of Commerce; and JoAnne Overman, National Center

for Standards and Certification Information, NIST; for their

help in reviewing the guide: Standards Setting in the European

Union, Standards Organizat ions and Officials in EU Standards

Activities . Christopher Ginther, CS USEU, assisted in preparing the

guide to EU officials.

The cooperation of officials at the Commission of the

European Union and non-governmental organizations who have

provided information and reviewed their respective sections is

sincerely appreciated.

Brussels, Belgium 1995

4
ABSTRACT

Standards are a principal element of trade in general and

a vital focus of the European Union's Single Market Program.

The single market is one of the cornerstones of trade in the

EU. This is an area without internal frontiers in which the

free movement of goods, people, services and capital inside

the European Community is ensured. The free movement of goods

is covered by Articles 30 to 36 in the 1957 Treaty of Rome

that established the European Economic Community.

The EU is creating harmonized, European-wide standards in

key product sectors to replace the many thousands of differing

national standards in member countries. The guide Standards

Setting in the European Union, Standards Organizations and

Officials in EU Standards Activities is designed to help U.S.

manufacturers, exporters, government and private -sector

standards interests locate contact points for important

information on the development of standards and conformity

assessment issues.

The guide includes a brief history of the role of

standards in the European Union and the latest information on

the EU' s harmonization directives for implementing the "New

Approach" and the "Global Approach" for harmonizing technical

regulations and standards to reduce barriers to trade. The

harmonization of standards is expected to lead to expanded

trade within Europe as well as with other key markets,

including the United States.

The standards guide also contains information on the

three key European standards organizations that are mandated

by the EU Commission to draft European technical standards;

information on European testing and certification activities;

and a list of EU officials with standards-related

responsibilities. The appendices include a bibliography, an

extensive list of standards-related publications and

directories that are available from the National Institute of

Standards and Technology (NIST) ; sources for ordering U.S. and

European standards information in the United States and

Europe; and contact points for standards-related information

on the European Union in the United States.

5
CONTENTS

Acknowledgment s Abstract

Introduction

I Standards in the European Union

II European Union Harmonization Directives:

The New Approach and the Global Approach

III European Standards Organizations:

European Committee for Standardization

(CEN)

CEN National Members

European Committee for Electrotechnical

Standardization (CENELEC)

CENELEC Member National Committees

European Telecommunications Standards

Institute (ETSI)

IV Testing and Certification in the Single

European Market

:

European Organization for Testing and

Certification (EOTC)

V European Commission: Officials with Standard

Responsibilities

VI EU Member State Missions and Delegations to

the European Union

VII Other Country Missions and Delegations to

the European Union

VIII Non-Member International Standards

Organizations

:

International Organization for

Standardization (ISO)

International Electrotechnical

Commission (IEC)

Bibliography
Appendix A

Appendix B

Appendix C

Appendix D

New Approach Directives

Contacts in the United States for

Information on European Union

Standards and Standards-Related

Activities

Office of European Union and

Regional Affairs

National Center for Standards

and Certification Information

Delegation of the European

Commission

Publications from the NIST

Applications and Assistance

Program

Sources for U.S. and European

Standards

59

62

63

64

65

69

7
INTRODUCTION

The guide to Standards Setting in the European Union:

Standards Organizations and Officials in EU Standards

Activities provides information on the harmonization of

standards in the European Union for U.S. manufacturers,

exporters, government and private-sector officials and others

with standards interests. The publication is a joint effort

by the Commerce Department's Foreign Commercial Service at the

U.S. Mission to the European Union, Brussels, and the National

Institute of Standards and Technology, Gaithersburg, Md

.

Information in the directory was obtained from interviews

and documents provided by the EU Commission and major, key

standards developing organizations in the EU: the European

Committee on Standardization (CEN) , the European Committee for

Electrotechnical Standardization (CENELEC) and the European

Telecommunications Standards Institute (ETSI) . These three

organizations develop standards primarily to serve their

members, but when mandated by the EU Commission, they are

those competent to develop or adopt the harmonized standards

needed technically to achieve conformity to the EU "New

Approach" and "Global Approach" Directives.

The European Organization for Testing and Certification

is listed in view of its prominent role in carrying out the EU

Global Approach of 1989 to harmonize testing and certification

procedures in the Single European Market

.

Information also is included on the major organizations

that develop the international standards which are promoted or

adopted by EU standards organizations. These organizations

are the International Organization for Standardization (ISO)

and the International Electrotechnical Commission (IEC) . The

American National Standards Institute (ANSI) is the U.S.

member of ISO, and ANSI sponsors the U.S. National Committee

for the IEC.

The appendices include a list of EU New Approach

Directives, a compilation of standards-related publications

and information available from NIST, Gaithersburg, Md. , a list

of sources for ordering standards in the United States and

Europe, and contact points for obtaining standards-related

information on the European Union in the United States.

8
I Standards in the European Union

The European Economic Community (EEC) was created by the

signing of two Treaties of Rome in 1957 that added two new

communities to the European Coal and Steel Community

established by the Treaty of Paris in 1951: the European

Atomic Energy Community (EURATOM) and the EEC. Under a 1965

treaty, the communities were merged in 1967 into a single

entity, referred to as the European Community or European

Communities (EC)

.

After the Maastricht Treaty of 1991 was ratified in 1993

by all of the member nations, the European Community changed

its name to the European Union (EU) . The thrust of this

treaty is "to promote a harmonious and balanced development of

economic activities, sustainable and non- inflationary growth

respecting the environment, a high-degree of convergence of

economic performance, and to create an ever closer union among

the peoples of Europe, where decisions are taken as closely as

possible to the citizens."

The Union adopted provisions in its treaty to create EU

citizenship, establish a common foreign and security policy,

and set the goal of economic and monetary union, including a

central bank and single currency.

The EU member countries in 1985 approved a plan that

outlined 282 legislative proposals to create a "single market"

by the end of 1992 . This internal market is defined in the

treaty as an area without borders, where people, merchandise,

services and capital are free to circulate. The Single

European Act of 1987 committed government leaders to adhere to

the timetable and made passage of legislation easier.

At the end of 1993, 266 EU directives had been adopted by

the EU Council of Ministers, the supreme legislative body.

Over the course of years, the original 282 measures have been

changed often. They now amount to 2 71 because some became

obsolete and were abandoned or replaced, and still others were

consolidated. By the end of November 1994, the EU member

states had adopted 90 percent of the national measures

required to implement the internal market legislation.

The European Commission, a body of Commissioners from the

member states, will continue to monitor, enforce and assess

the implementation of the internal market during its second

phase. As the largest executive body of the EU, the

Commission serves as guardian of the Treaty and sees to it

that provisions of the Treaty and decisions of the

institutions are correctly applied.

9
The European Union is the largest trading partner of the

United States at more than $210 billion annually. U.S.

exports to the EU in 1994 amounted to approximately $102.8

billion and U.S. imports from the EU were approximately $110.8

billion

.

Standards that describe the quality and performance of

goods and services are critical in the development of the

global marketplace . They provide a framework and common

language for commerce and economic development worldwide.

Standards are a principal element of the European Union's

Single Market Program. The EU is creating harmonized,

European-wide standards in key product sectors to replace the

many thousands of differing national standards. The goal of

the EU legislative program is to free up the flow of goods,

services, capital and people throughout the EU by eliminating

differing national requirements among EU member states.

The European Union's Single Market is widely considered

to be an opportunity for U.S. business. The U.S. Department

of Commerce has made product standards, testing and

certification a top priority with the EU in recognition of

U.S. industry's concerns that the harmonization of several

thousand EU product standards could become EU-wide non-tariff

barriers to trade.

It is estimated that close to 50 percent, or $50 billion,

of U.S. exports to the EU are subject to harmonization

requirements for regulated products. The International Trade

Administration of the U.S. Department of Commerce recommends

that businesses be aware of the layers of business law that

coexist in the European Union as a result of new legislation

for the EU Single Market that was created in 1992. But for

the uninitiated, the EU can still be a little surprising. As

in the United States, not all products are "regulated" in the

sense that government intervenes to mandate how products are

designed. Many products enjoy free circulation throughout

Europe because governments have no requirements, and national

voluntary product standards are increasingly giving way to

European standards as the means for describing buyer

requirements throughout the EU.

For regulated products, the EU Commission has set out the

guidelines for harmonized European-wide standards in a number

of directives, commonly known as "New Approach Directives."

The harmonization of technical standards for regulated

products is centered on the health and safety aspects of these

products, and is intended to produce minimum safety and health

levels throughout the Union.

Not all product requirements are "harmonized" -- as

defined on an EU-wide basis. Non-harmonized products and

sectors still exist where member state regulations remain as

mandatory requirements. Gas connectors and analogue type

telecommunications terminal equipment are examples of products

10
that still require national approvals. However, most products

are harmonized.

The EU's Single Market successfully completed an 8-year

program to eliminate most of the EU's 15 member states'

technical barriers to trade by harmonizing the bulk of

technical requirements and preempting any member state

regulations for which an EU rule existed. For most regulated

products, such as gas appliances, electrical applications, and

telecommunications attachment equipment, the European Union

created harmonized requirements.

The EU's Single Market is well known for the "New

Approach" that includes harmonized directives, reference to

voluntary European-wide standards and the CE mark. This is

one of the key areas where the standards bodies described in

this guide are pivotal in describing the detailed performance

requirements for products. But in areas such as foods, drugs,

automobiles and airplanes, the EU has relied on the "Old

Approach." This is a form of harmonized legislation at the EU

level that preempts some aspects of local member state

authority, and describes detailed requirements in legislation

without reference to additional voluntary standards and does

not rely on any system of mark or marking.

The harmonized standards of the EU will be an important

condition of sale and, in some cases, a legal requirement in

Europe throughout the 1990 's and beyond. The standards will

reduce technical barriers to trade. Manufacturers will have

to meet only one European-wide standard, rather than making

costly changes to a product to meet 15 different national

standards. The harmonization of standards is expected to lead

to expanded trade within Europe as well as with other key

markets, including the United States. Information on

requirements for product testing is provided in the chapter on

"European Union Harmonization Directives: the New Approach

and the Global Approach."

Under the New Approach, the EU Commission mandates three

key, regional European standards organizations to draft

European technical standards. These organizations are the

European Committee for Standardization (CEN) , European

Committee for Electrotechnical Standardization (CENELEC) and

the European Telecommunications Standards Institute (ETSI)

.

Information on these organizations is in the chapter on

"European Standards Organizations."

CEN, CENELEC and ETSI not only draft standards for the

EU, they also develop standards to serve their European

national member organizations. In addition, the European

Organization for Technical Approvals (EOTA) provides technical

assessments of the fitness of construction products.

The EU Commission, CEN and CENELEC have stated their

intention to adopt and, wherever possible, implement the

international standards of the International Organization for

11
Standardization (ISO) and the International Electrotechnical

Commission (IEC) . The EU wants to avoid duplicating efforts

and use international standards to meet deadlines for EU

standards development. The Commission has stated that CEN and

CENELEC will develop their own standards only when

international standards do not exist and are unlikely to

emerge to meet EU needs

.

The adoption of existing international standards by CEN

and CENELEC is carried out under two agreements for technical

cooperation between the European standards organizations and

ISO and IEC. Under the Vienna Agreement of 1991, CEN and ISO

agreed on the general exchange of information, cooperation on

standards drafting between the two organizations, and the

adoption of existing international standards as European

standards

.

The Lugano Agreement of 1991 between CENELEC and IEC,

based on a 1989 formal collaboration on the exchange of

information, emphasizes prompt adoption and publication of

standards to meet the demands of industry. This agreement

also has some of the same objectives as the Vienna Agreement

between CEN and ISO.

The notion of "standstill" applies to European

standardization when no new standards work will be initiated

in the member states in areas where the EU Commission had

identified an EU directive and the European standards bodies

have begun developing EU-wide standards.

Under the new approach, CEN and CENELEC develop, in

general, EU-wide standards for both the regulated and

unregulated sectors . These standards are developed in various

technical committees. Standards for products not regulated by

the EU may still be developed at the national level; for

unregulated products, mutual recognition of national standards

applies

.

In 1989, the Commerce Department and the Commission

initiated a series of dialogues that increased the

transparency of the European standards -making process and U.S.

awareness of it. U.S. industry had argued that European

manufacturers had an advantage over producers in other

countries in obtaining information on standards development

activities in the EU through their state standards bodies,

which are members of CEN, CENELEC and ETSI

.

Both CEN and CENELEC took steps to make better

information available to everyone, for example, through the

"CEN/CENELEC/ETSI Bulletin." The total work program of the

standards organizations is transparent. If a U.S. company is

based in Europe and is a member of a European trade federation

or a national standards body, it may take an active role as

part of the national delegation or federation to these bodies.

It should also be noted that associate members of CEN, for

example the European Computer Manufacturers Federation, have

12
rights of participation in both policy-making and technical

committees

.

For U.S. business, representation to CEN and CENELEC can

be made by the American National Standards Institute (ANSI)

.

ANSI is the U.S. member body to ISO and sponsors the U.S.

National Committee for the IEC. U.S. parties may formally

request meetings with the chair of CEN and CENELEC technical

committees through ANSI. ISO and IEC may also nominate

representatives to sit in CEN and CENELEC committees when

there are working proceedings at both the European and ISO

level

.

Differences in testing and certification requirements in

other countries frequently pose obstacles to U.S. exports. To

help U.S. industry become more competitive, the U.S.

Department of Commerce's International Trade Administration is

conducting negotiations to conclude mutual recognition

agreements (MRAs) with the EU in areas where the U.S. private

sector has expressed interest

.

The National Institute of Standards and Technology

recently established the National Voluntary Conformity

Assessment System Evaluation (NVCASE) program to facilitate

the acceptance of U.S. products in international markets, such

as the European Union, based on U.S. government recognition of

the competence of qualifying U.S. conformity assessment

bodies

.

The NVCASE program may be applied to activities related

to laboratory testing, product certification or quality system

registration. NVCASE will evaluate and provide official

recognition to bodies in the United States that effectively

demonstrate that they satisfy established criteria and the

applicable regulatory requirements of other countries.

Acceptance by other governments of NVCASE recognition of a notified body will be subject to the terms of an MRA between

the United States and the other government

.

The European Union is also promoting the harmonization of

testing and certification requirements. The EU Commission

established the European Organization for Testing and

Certification (EOTC) in 1990 under a memorandum of

understanding (MOU) with CEN, CENELEC and the European Free

Trade Association (EFTA) countries.

EOTC was formally established in 1992 as an independent,

non-profit, international association. As mandated in the

MOU, EOTC is to provide: "The appropriate framework for the

non- regulatory sphere with regard to conformity assessment

issues, whilst operating in such a manner as to give technical

support to legislation of the Commission of the European

Communities and EFTA countries regarding conformity assessment

in the regulatory sphere." In 1992 the EFTA countries were

Austria, Finland, Iceland, Liechtenstein, Norway, Sweden and

Switzerland

.

13
Recent MRA negotiations between the EU Commission and the

United States, Canada, Australia and New Zealand have resulted

in an increase in third country representatives inquiring how

they may be more formally associated with EOTC . The U.S.

National Voluntary Laboratory Accreditation Program at NIST is

negotiating a multilateral agreement on testing with the

European Cooperation for Accreditation Laboratories (EAL) , a European member of EOTC.

14
II European Union Harmonization Directives:

The New Approach and the Global Approach

New Attitude to the Elimination of Trade Barriers

The single market is one of the cornerstones of the

European Union. This is a geographic area without internal

frontiers and where the free movement of goods, people,

services and capital inside the European community is ensured.

The free movement of goods is covered by Articles 3 0 to 3 6 in

the 1957 Treaty of Rome that established the European Economic

Community

.

Article 30 states:

Quantitative restrictions on imports and all measures

having equivalent effect shall, without prejudice to the

following provisions , be prohibited between the Member

States . Article 36 provides ground for exemption from the obligation

contained in Article 30:

The provisions of articles 3 0 to 34 shall not preclude

prohibitions or restrictions on imports, exports or goods

in transit justified on grounds of public morality,

public policy or public security; the protection of

health and life of humans, animals or plants; the

protection of national treasures possessing artistic

,

historic or archeological value; or the protection of

industrial and commercial property . Such prohibitions or

restrictions shall not, however, constitute a means of

arbitrary discrimination or a disguised restriction on

trade between Member States.

The justification by member states for national

regulations that created barriers to trade based on Article 36

has led to many legal cases before the European Court of

Justice. The "Cassis de Dijon" (Case 120/78, judgement of 20-

20-1979) , is well known for its far reaching implications of

the interpretation of Articles 30 to 36. The case involved an

attempt by Germany to restrict French currant liqueur from

entering its market.

The Court of Justice's decision stated:

a) products legally manufactured or marketed in one

country of the Community can in principle freely

15
circulate throughout the Community. Products

manufactured in third countries and legally put on the

market in one EU country, benefit from the same

principle; and

b) barriers to trade which result from differences

between national legislation can only be accepted if

there is an overriding health, safety or environmental

reason to prevent such trade circulation, and no

alternative exists that would create less barriers to

trade. Even then the regulations shall satisfy the

requirement that there shall be causal relationship

between the measure and its objective, and the regulation

shall be "proportional" to the objective pursued.

Where national regulations, accepted on the grounds of

the foregoing interpretation of Articles 30 to 36 give rise to

barriers to intra-community trade, the barriers can only be

eliminated by means of harmonization of the national

regulations or "technical harmonization." Even in the absence

of diverging national regulations, barriers to trade can exist

due to the adoption of technical specifications by public

authorities or independent standards bodies.

However, in order to overcome trade barriers, Article

100a of the Treaty of Rome states that if, after the adoption

of a harmonization measure by the Council acting by a qualified majority, a member state deems it necessary to apply

national provision on grounds of major needs referred to in

Article 36, or relating to protection of the environment or

the working environment, it shall notify the Commission of

these provisions. In turn, the Commission shall confirm the

provisions involved after having verified that they are not a means of arbitrary discrimination or a disguised restriction

on trade between member states. The Commission or any member

state may bring the matter directly before the Court of

Justice if it considers that another member state is making

improper use of the powers provided in Article 36.

In order to prevent the erection of new barriers to

trade, the EU adopted Directive 83/189/EEC on March 23, 1983

(amended by Directive 88/189/EEC and 94/10/EEC) , laying down

two information procedures, one for standards and the other

for technical regulations (mandatory standards) on industrial,

agriculture, pharmaceutical, cosmetic and food products.

The standards information procedure requires each

national standards body to inform the EU Commission and all

other member state standardization bodies of its proposed

draft standards or amendments to existing ones, except in the

case of a transposition of an international (ISO/IEC) or

European standard (EN) . Each national standards-developing

body publishes copies of its draft standards. In addition,

each national standards body may take an active or passive

role in the standardization work of another national standards

16
entity and is entitled to receive copies of drafts and learn

what action is taken on the comments to the drafts, if any.

The technical regulations information procedure also

obliges the member states to notify the EU Commission about

any draft regulation and subsequent amendments, unless the

regulation is an integral transposition of an international or

European standard, in which case a simple note on the

regulation is sufficient. This procedure gives the EU

Commission and other member states an opportunity to study the

proposed regulations and comment on their compliance with the

principles in Articles 30-36 of the Treaty.

Under this procedure, a member state is required to

refrain from adopting any draft technical regulation earlier

than 3 months after the date of receipt by the EU Commission

and the other member states. This procedure introduces the

concept of "standstill."

If the other member states or the EU Commission deliver

comments, the member state concerned may not adopt the draft

regulation before the end of the 3 -month standstill period.

Other procedures require a member state to postpone the

adoption of a draft by 4 months (draft in the form of a voluntary agreement) or six months (any other draft)

.

If the EU Commission wishes to propose or adopt a directive regulation or decision in the same area, or if the

draft concerns a subject already covered by an EU Commission

proposal, the member state concerned must suspend adoption of

the draft for 12 months. If the Council adopts a common

position during this period, the standstill period is extended

by 6 months for a total of 18 months.

In absence of one of these responses, member states can

adopt the draft legislation after the 3 -month standstill

period

.

Directive 83/189/EEC also marked the beginning of a new

attitude towards eliminating technical barriers to trade and

the important role of standards. This led to the adoption of

a resolution by the Council of the European Union, May 7,

1985, on "A New Approach to Technical Harmonization and

Standardization.

In addition to the 15 EU member states, the provisions of

the New Approach and the Global Approach also apply 'to

signatory states of the European Economic Area (EEA) , Iceland,

Liechtenstein and Norway. The EEA Agreement was initiated in

1993 by six out of the seven countries of the European Free

Trade Association (EFTA) . The nations were Austria, Finland,

Iceland, Liechtenstein, Norway and Sweden. Switzerland

rejected the EEA Agreement in a referendum because it feared

loss of its national identity. Austria, Finland and Sweden

joined the EU in 1995.

17
New Approach to Technical Harmonization

The goal of the European Union's standardization program

under the "New Approach" is to streamline technical

harmonization and the development of standards for certain

product groups. The program is called the "New Approach"

because it differs significantly from the way European

standards were drafted in the past. Under the "Old Approach,"

directives for the harmonization of standards by the member

states contained such a high degree of detail on the technical

specifications of products that it sometimes required 10 to 15

years to develop a standard. This harmonization process was

so time-consuming and tedious that it allowed the member

states to introduce national regulations and standards at a greater pace than the European Commission could handle, with

an ever- increasing backlog of harmonization work.

Under the New Approach, directives are limited to

essential safety or other performance requirements in the

general public interest. The technical details of how to meet

these requirements are left to manufacturers who self-certify

products, the three regional European standards organizations,

CEN, CENELEC, ETSI, and government appointed product

certification bodies. The EU Commission gives mandates to

these standards organizations to develop technical standards

that are consistent with the essential safety and performance

requirements of EU directives.

Products that meet the essential technical standards

outlined by CEN, CENELEC and ETSI are presumed to conform to

the requirements of EU directives and allowed to circulate

freely within the European Union. For many products, a

manufacturer can choose not to comply with the

CEN/CENELEC/ETSI standards, but then must demonstrate that the

product meets the essential safety and performance

requirements of the directives. As a result of the new

approach, a product manufactured in conformity with EU

legislation in one member state will be guaranteed automatic

access to the markets of all the other member states. U.S.

manufacturers who comply with health and safety requirements

in the New Approach Directives may affix the "CE Mark." The

mark signifies that a product meets essential conformity

assessment requirements and guarantees its legal access to all

of the markets in the member states of the European Union. A

discussion on the CE mark follows and a list of the adopted

New Approach Directives is in Appendix A.

It is important to note that the "New Approach" deals

with large families of products- -machinery, gas appliances,

pressure equipment, toys, and construction products- -or

"horizontal" risks such as those addressed in the EU'

s

Electromagnetic Compatibility Directive, rather than being

product -based as under the old approach. Some products may be

governed by more than one directive because different risks

may be dealt with under separate directives. The manufacturer

18
is responsible for ensuring the product meets the requirements

for all applicable New Approach Directives.

EU directives are addressed to the member states, who

then must transpose them into national law. The directives

define a schedule for adopting and publishing national

provisions to implement each directive. Directives also

define when national provisions must be applied. New Approach

Directives also recognize a transitional period during which

existing national provisions and new legislation will coexist. In such cases, the manufacturer may choose to

following either of these series of conditions.

As noted, the "Old Approach" still remains in effect and

covers a range of products covering automobiles,

pharmaceuticals, foods, and aircraft. These products do not

require the CE mark.

CE Mark

The European Commission describes the CE mark as a "passport" that allows manufacturers to circulate industrial

products freely within the internal market of the EU. The

letters, "CE"--French for "Conformite Europeene," indicate

that the manufacturer has undergone all assessment procedures

required for the product . Although consumers may perceive the

CE mark as a quality mark, it is not . The CE mark addresses

itself primarily to the national enforcement authorities of

the member states, and its use simplifies the task of market

surveillance of regulated products.

Products covered by New Approach Directives must bear a CE mark before they can be sold in the EU. Details on the use

and affixing of the CE mark are spelled out in each of the New

Approach directives. In 1993, in an effort to harmonize CE

marking requirements across all of the New Approach

Directives, the EU published Council Directive 93/68/EEC and

Council Decision 93/465/EEC of July 22 1993 (OJ L 220, August

1993). Directive 93/68/EEC provides a consistent and

harmonized approach to affixing and using the CE mark, while

Decision 93/465/EEC lists the procedures for conformity

assessment that are to be used in certifying compliance with

the New Approach Directives.

The CE mark must be affixed to the product, to its data

plate or, where this is not possible or not warranted on

account of the nature of the product, to its packaging, if

any, and to the accompanying documents by the manufacturer,

the authorized representative in the community or, in

exceptional cases, by those responsible for placing the

product on the market. The CE mark must be affixed visibly,

legibly and indelibly. Where special provisions do not impose

specific dimensions, the CE mark must have a height of at

least 5 millimeters. Depending upon the directive, in some

cases the CE mark is followed by the identification number of

19
a notified body if such a body is involved in the production

control phase of the product

.

Currently, CE marking is only required under the New

Approach Directives. In cases where more than one directive

may apply (for example, machinery that is electrically

operated) , the CE mark can be affixed only if the product

complies with the appropriate provisions of all applicable

directives that have become mandatory. For instance,

electrically operated machinery sold in the EU in 1996 would

have to meet the requirements of the machinery and the

electromagnetic compatibility directives, under which CE

marking then will have become mandatory. Because the CE

marking does not become mandatory under a related directive

for low voltage until January 1, 1997, the CE mark on the

product would not necessarily reflect compliance with that

directive

.

Just looking at the CE mark will not tell surveillance

authorities to which directive a given product complies.

Rather, it is the declaration of conformity that contains the

details on the directives to which the product complies and

the standards that were relied upon in assuring compliance.

Declaration of Conformity

The CE mark is not intended to include detailed technical

information on the product, but there must be enough

information to enable the inspector to trace the product back

to the manufacturer or the authorized agent established in the

EU. This detailed information should appear not next to the

CE mark, but rather on the declaration (or certificate) of

conformity, which the manufacturer or authorized agent must be

able to provide at any time, along with the product's

technical file. New approach legislation provides for the

issue of a declaration of conformity by the manufacturer or

sometimes it requires a certificate of conformity by an

independent certification body.

Notified Bodies

Each New Approach Directive sets forth procedures to be

followed for assessing conformity with its essential

requirements. Generally, the method of compliance with the

New Approach Directive is voluntary. This means that the

manufacturer can choose how to comply with the conformity

assessment options available with each directive. Many new

approach directives require third-party certification before a manufacturer can affix a CE mark to a product; those thirdparties must be "Notified Bodies"

.

Notified bodies are independent testing houses or

laboratories authorized by their governments to perform the

conformity assessment tasks specified in directives. A

notified body is appointed by a member state and must have the

necessary qualifications to meet the testing requirements set

20
forth in a directive. The Commission and other member states

must be informed about the authorization. Notified bodies may

be private organizations or public entities. Manufacturers

may choose a notified body in any EU member state. Lists of

notified bodies are published by the European Commission in

the "Official Journal of the European Communities."

Global Approach to Certification and Testing

The European Commission complemented the new approach to

technical harmonization and standardization with a policy on

harmonized rules and procedures for conformity assessment,

"The Global Approach to Certification and Testing." Its

objectives are contained in a Council Resolution of December

12, 1989 (OJ C 267, 1989). This policy also aims to establish

conditions whereby mutual recognition agreements (MRAs) can be

implemented that will permit the recognition of test results

from a notified body by all of the member states or the

acceptance of test results between two governments, such as

between the United States and the European Union. The aim of

such agreements is to enhance market access on a reciprocal

basis by reducing the costs associated with demonstrating

product conformity to regulations, testing and certification.

The global approach can also be applied to conformity testing

of non-regulated products.

21
Ill European Standards Organizations:

NAME OF ORGANIZATION: European Committee for

Standardization (CEN)

Secretary General: Jacques Repussard

rue de Stassart 36

B-1050 Brussels, BELGIUM

Information and Communications Services:

Tel: (32 2) 519 6811

Fax: (32 2) 519 6819

Please note: CEN can be consulted for standards

information. See Chapter V for information on EU

legislation

.

Background: The European Committee for Standardization

(CEN), established in 1961, is a non-profit international

association. CEN is responsible for creating European

standards (ENs) in all areas except for electrotechnical

and telecommunications. Standards in these areas are the

responsibility of CENELEC and ETSI respectively. The aim

of CEN is to eliminate trade barriers resulting from

differing national technical standards to stimulate

industry and trade and promote safety, economy and

efficiency through the creation, harmonization and

promotion of European standards.

Role in the harmonization of standards in the European

Union: CEN is one of three officially recognized

European standards organizations that can write standards

for the Commission of the European Union under "New

Approach Directives" that are the basis for the

harmonization of standards in the EU' s single market

program as well as programs for research and development,

transport, public procurement and others. The other

recognized European standards developing organizations

are CENELEC and ETSI. CEN also develops standards to

serve its member organizations, trade, industry and

European society in general.

Standardization Activities: CEN develops voluntary

European Standards (EN) for mechanical engineering,

building and civil engineering, health technology,

information technology, biology and biotechnology,

quality, certification and testing, environment, health

and safety at the work place, gas and other energies,

22
transport and packaging, consumer goods, sports, leisure,

food, materials (iron and steel) , and chemistry.

CEN's administrative board concluded a technical

cooperation agreement in 1991 with the International

Organization for Standardization (ISO) that is aimed at.

securing the highest possible degree of identity between

European and international standards to avoid the

duplication of standardization work. Under the 1991

Vienna Agreement, CEN will work with its international

partner to harmonize European and international standards

to reduce technical barriers to trade within its sector.

ISO may appoint representatives to CEN technical

committees and vice versa.

Membership: The membership of CEN is made up of the

national standards bodies of the EU member states and the

EFTA countries. The member countries are Austria,

Belgium, Denmark, Finland, France, Germany, Greece,

Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,

Portugal, Spain, Sweden, Switzerland, and the United

Kingdom

CEN affiliate members are the national standards

organizations of Bulgaria, Cyprus, Czech Republic,

Estonia, Hungary, Lithuania, Poland, Romania, Slovenia,

and Turkey. The associate members are the European Trade

Union Technical Bureau for Health and Safety (TUTB) and

the European Construction Industry Federation (FIEC)

The 18 full members of CEN are obliged to issue the

adopted European standards as national standards without

modification and withdraw any conflicting national

standards. Affiliate members are encouraged to adopt ENs

as national standards but without the obligation to

withdraw their conflicting national standards. However,

affiliates are not allowed t'o modify an EN.

U.S. Access: CEN committees are not in general open to

bodies outside of Europe. U.S. parties may formally

request meetings with the chairs of CEN technical

committees through ANSI. ISO and IEC also may nominate

representatives to sit in CEN technical committees when

there are working proceedings at both the European and

ISO level.

Other Information: CEN normally issues its work as

European standards (ENs) , and it also issues

Harmonization Documents (HDs) , European Prestandards

(ENVs) and CEN reports (HDs) . CEN European standards are

prepared in English, French and German. They also are

translated into the national languages of CEN members as

they are issued as national standards by member

organizations

23
CEN' s technical publications may be purchased from its

member organizations and from some ISO members outside of

Europe such as ANSI in the United States. Draft European

standards (prENs) are available normally in English,

French and German at different stages of their

preparation and are available from CEN member

organizations as well as a number of ISO members outside

of Europe such as the American National Standards

Institute (ANSI) in the United States.

Copies of CEN Central Secretariat publications such as

catalogs and the English language 11 CEN/CENELEC/ETSI

Bulletin," which lists adopted standards and drafts, main

decisions of principal policy-making bodies, mandates

received and official citations, can be ordered from the

Distribution and Sales Unit, CEN- -Central Secretariat,

rue de Stassart 36, B-1050 Brussels, Tel: (32 2) 519

6811,

Fax: (32 2) 519 6819.

24
CEN National Members

Austria

Osterreichisches Normungsinst itut /Austrian Standards Institute

(ON)

Postfach 130

Heinestrasse 38

A- 1021 VIENNA

Tel: (43 1) 222 213 00

Fax: (43 1) 222 213 00 818

President: Dr. Karl Korinek

Managing Director: Dr. Ing. Gerhard Hartmann

Deputy Managing Director: Mr. Hans G. Stoklasek

Head PR and Communications: Dr. Johannes Stern

Tel: (43 1) 213 00 317

Fax: (43 1) 213 00 327

Belgium

Institut Beige de Normalisat ion/Belgisch

Instituut voor Normalisatie (IBN/BIN)

Avenue de la Brabanconne 2 9/ Brabanconnelaan 2 9

B-104 0 BRUXELLES/BRUSSEL

Tel: (32-2) 734 9205

Fax: (32-2) 733 4264

Head: Mr. P. M. Croon

Denmark

Dansk Standard (DS)

Baunegaardsve j 73

DK-2 900 HELLERUP

Tel: (45) 39 77 0101

Fax: (45) 39 77 0202

Managing Director: Mr. Jacob Erik Holmblad

Standardization and Head of Sales and Information Department

Mr. Mogens Winther

Section Manager Electrical Engineering: Mr. Jan Roed

Section Manager Healthcare: Mr. Lars Brogaard

Section Manager Information, Technology and Logistics: Mr.

Hans Jorn Reuss

Section Manager Building, and Civil Engineering: Mr. Jorgen

Riis- Jensen

Certification Manager: Mr. Egon Hansen

Finland

Suomen Standardisoimisliitto/Finnish Standards Association

(SFS)

PO Box 116 (Maistraatinportti 2)

FIN-00241 HELSINKI

Tel: (358 0) 149 9331

Fax: (358 0) 146 4925

Internet: given name.surname@sfs.fi

Managing Director: Kari Kaartama

Director Standardization: Raija Relander

25
Director Certification: Eeva Parviainen

Chief Marketing: Satu Simula

Head System Certification: Stefan Fagerstrom

Public Relations Officer: Jyrki Alanko

Library: Seija Koskimaa

Environmental Labelling Expert: Matti Jarvi

France

Association Francaise de Normalisation (AFNOR)

Tour Europe

F-92049 PARIS-LA DEFENSE Cedex 7

Tel: (33 1) 42 91 5555

Fax: (33 1) 42 91 5656

President: Mr. Henri Marte

General Manager: Mr. Bernard Vaucelle

Deputy: Mr. Alain Durand

Public Relations/Communication: Mrs. Ghyslaine Pertusot

Manager Internat . and European Affairs: Mrs. Florence Nicolas

Manager Personnel and Human Resources: Mr. Gabriel Bacq

Manager Finance and Logistics: Mr. Daniel Geronimi

Manager Quality and Strategic Marketing: Mrs. Claude Merle

Manager Standards/Normative Strategy: Mr. Etienne Dupont

Manager Certification: Mr. Jacques Beslin

Manager Products/Services/Consulting: Mr. Bruno Dusollier

Germany

Deutsches Institut fur Normung (DIN)

Burggraf enstrasse 6

D-10787 BERLIN

Tel: (49 30) 26 010

Fax: (49 30) 26 01 1231

President: Mr. Eberhard Mollmann

Vice President: Gottfried Kremer

Director: Dr. Ing. Sc . D Helmut Reihlen

Deputy Director: Mr. Klaus Gunther Krieg

Technical Director for International Cooperation:

Mr. Ernst-Peter Ziethen

Technical Director for Technical Coordination and Planning:

Mr. Peter Kiehl

DIN' s German Information Center for Technical Rules (DITR)

Information Inquiries: Tel: (49) 30 2601 2600

Euro-Info-Center: Tel: (49) 30 2601 2505

Greece

Hellenic Organization for Standardization (ELOT)

Acharnon Street 313

GR-111 45 ATHENS

Tel: (30 1) 2015 025

Fax: (30 1) 2020 776

President: Prof. G. Varoufakis

Tel: (30 1) 2234 966

Managing Director: N. Malagardis

Tel: (30 1) 2234 966

Promotion and Information: V.A. Filopoulos, Manager

Tel: (30 1) 2013 778

26
Standardization: D. Agapalidis, Manager

Tel: (30 1) 2019 891

Electrotechnical Standardization: Dr. P. Theofanopoulos

,

Manager

Tel: (30 1) 2029 367

Testing Laboratories: K. Ionas, Manager

Tel: (30 1) 5247 117

Directive. 83/189/EEC and GATT : E. Melagrakis, Manager

Tel: (30 1) 2019 890

Iceland

The Icelandic Council for Standardization (STRI)

Technological Institute of Iceland

Keldnaholt

IS -112 REYKJAVIK

Tel: (354) 587 7000

Fax (354) 587 7409

Internet: stri@iti.is

Chairman: Mr. T. Karlsson

Secretary: Mr. J. Thorsteinsson

Ireland

National Standards Authority of Ireland (NSAI)

Glasnevin

Ireland DUBLIN 9

Tel: (353 1) 837 0101

Fax: (353 1) 836 9821

Head: Mr. E. Paterson

Italy

Ente Nazionale Italiano di Unificazione (UNI)

Via Battistotti Sassi, lib

1-20133 MILANO

Tel: (39 2) 70 02 41

Fax: (39 2) 70 10 6106

Head: Dr. E. Martinotti

Luxembourg

Inspection du Travail et des Mines (ITM)

Boite postale 27

26, rue Ste Zithe

L-2 010 LUXEMBOURG

Tel: (35 2) 478 6154

Fax: (35 2) 49 1447

Head: Mr. P. Weber

ITM's main role is to ensure the implementation of all

legislative aspects related to the working conditions and

contracts, health and safety at the workplace, etc. Due to

the size of the country and owing to some industrial reasons,

Luxembourg does not develop National Standards. For the

implementation of European Standards, the procedure is

executed by ITM.

27
The Netherlands

Nederlands Normalisatie- Instituut (NNI)

Postbus 5059

Kalf jeslaan 2

NL 2600 GB DELFT

Tel: (31 15) 690 255

Fax: (31 15) 690 130

Head: Mr. C. De Visser

Portugal

Instituto Portugues da Qualidade (IPQ)

Rua Jose Estevao, no. 83-A

P-1199 LISBON Codex

Tel: (351 1) 52 3978

Fax: (351 1) 353 0033

Head: Mr. C. dos Santos

Norway

Norges Standardiseringsforbund (NSF)

Postboks 7020

Homansbyen

N-0306 OSLO

Tel: (47 22) 46 6094

Fax: (47 22) 46 4457

Managing Director: Ivar Jachwitz

Technical Director: Liv Solhjell

Support /Services : Odd Bjornstad, Assistant Director

Assistant Director Information: Sidsel Aarnaes Arbo

Assistant Director Standards: Anne Kristof f ersen

Assistant Director Marketing: Frederik Hilsen

Assistant Director Certification: Kirsten Svindahl

Spain

Asociacion Espanola de Normalizacion y Cert if icacion (AENOR)

Calle Fernandez de la Hoz, 52

E-28010 MADRID

Tel: (34 1) 310 4851

Fax: (34 1) 310 4976

Head: Mr. R. Naz Pajares

Sweden

Standardiseringskommissionen I Sverige (SIS)

PO Box 3 2 95

Tegnergatan 11

S-103 6 6 STOCKHOLM

Tel: (46 8) 613 5200

Fax: (46 8) 411 7035

Director: Dr. L. Wallin

Head Technical Department: Mr. Anders Skold

Head Certification Department: Mr. Ivar Paljak

Head PR and Communications: Ms. Jannecke Schulman

Tel. (46 8) 613 5227

Fax (46 8) 10 8464

28
Switzerland

Schweizerische Normen-Vereinigung (SNV)

Muhlebachstrasse 54

CH-8 0 08 ZURICH

Tel: (41 1) 254 5454

Fax: (41 1) 254 5474

Director: Dr. H.C. Zurrer

Information/Communication Manager: Mr. Heinz Kull

United Kingdom

British Standards Institution (BSD

2, Park Street

UK LONDON W1A 2BS

Tel: (44 71) 629 9000

Fax: (44 71) 629 0506

Head: Sir Neville Purvis

29
Affiliate Members

Bulgaria

Committee for Standardization and Metrology

21, rue de 6 Septembre

BG-1000 SOFIA

Head: Mr. Y. Yordanov

Tel: (359) 2 85 91

Fax: (359) 2 80 1402

Czech Republic

Czech Office for Standards, Measurement, and Testing

Vaclavske Namesti 19

113 4 7 PRAGUE 1

Tel: (42 2) 242 247 34

Fax: (42 2) 242 247 26

President: Mr. Michal Tosovsky

Tel: (42 2) 242 166 88

Fax: (42 2) 242 282 90

Department of International Relations

Vice President: Mrs. Vaclava Horakova

Tel: (42 2) 236 57 06

Fax: (42 2) 242 297 54

Department of State Testing

Director: Mr. Vojtech Petrik

Tel: (42 2) 248 109 39

Fax: (42 2) 248 109 64

Department of Metrology

Director: Mr. Jiri Kraus

Tel: (42 2) 248 109 39

Fax (42 2) 248 109 64

Cyprus

Cyprus Organization for Standards and Control of Quality (CYS)

Ministry of Commerce and Industry

CY-NICOSIA

Tel: (357 2) 30 3441/(357 2) 36 6185

Fax: (357 2) 36 6120

Chairman: Dr. G. Christodoulides

Director: Dr. I.G. Karis

Secretary: Mrs. Katherina Photiadou

Hungary

Hungarian Office for Standardization (MSZH)

25 Ulloi Ut

H-1450 BUDAPEST 9PF 24

Tel: (36 1) 118 3011

Fax: (36 1) 118 5125

Head: Mr. G. Ponyai

Lithuania

Lietuvos Standart izaci j os/Luthianian Standardization Office

(LST)

A. Jaksto g. 1/25

30
2600 VILNIUS

Tel: (370 2) 226 962

Fax: (370 2) 226 252

Director: Mr. Brunonas Sickus

Tel: (370 2) 226 962

Deputy Director: Mr. Stasys Brencius

Tel: (370 2) 224 944

Poland

Polski Komitet Normalizac j i/Polish Committee for

Standardization (PKNMIJ)

PO Box 10

PL-00-950 WARSAW

Tel: (48 2) 620 5434

Fax: (48 2) 620 5434

President: Mr. Marian Lukaszewicz

Tel: (48 2) 620 29 16

Fax: (48 2) 620 07 41

Vice-President: Mr. Andrzje Kocznorowski

Tel: (48 2) 620 6621

Fax: (48 2) 620 0741

Secretary: Mr. Krzysztof Trzcinski

Tel: (48 2) 620 2914

Fax: (48 2) 620 0741

Foreign Relations: Mr. Zygmunt Niechoda, Director

Tel/Fax: (48 2) 620 5434

Information and Documentation: Mrs. Jadwiga Bochinska,

Director

Tel/Fax: (48 2) 247 122

Romania

Institutul Roman de Standardizare

13, rue Jean-Louis Calderon

RO-702 01 BUCAREST 2

Director General: Mihail Ciocodeica

Tel: (401) 611 40 43

Fax: (401) 312 08 23

Division of Standardization

Director: Mircea Petcu

Tel: (401) 615 58 70

Fax: (401) 210 08 33

Division of Certification, Accreditation, Notification of

bodies, Quality

Director: Claudiu Stefanescu

Tel: (401) 222 38 50

Fax: (401) 210 08 33

Division of Services, Consulting, Communication, International

Relations (ISO, CEN, CENELEC, ETSI . IEC, TERMNET)

Director: Daniela Moga

Tel: (401) 615 58 70

Fax: (401) 312 47 44

Division of Human resources, Finances, Accounting, Logistics,

Marketing

Director: Clementina Enciu

Tel: (401) 615 58 70

Fax: (401) 312 47 44

31
Division of the Secretariat of the National Center for

Training, Consultancy and Management in Quality Assurance

Director: Gabriela Anghelescu

Tel: (401) 222 38 60

Fax: (401) 210 08 33

Slovakia

Slovak Office of Standards, Metrology and Testing (UNMS)

Stef anovicova 3

814 3 9 BRATISLAVA

Tel: (42 7) 491 085

Fax: (42 7) 491 050

President: Mr. Lubomir Sutek

Tel: (42 7) 491 085

Standards: Mrs. Kvetoslava Steinlova, Director

Tel: (42 7) 493 521

International Relations: Mr. Andrej Svatik, Director

Tel: (42 7) 494 728

Slovenia

Standards and Metrology Institute (SMIS)

Ministry of Science and Technology

Kotnikova 6

SI-61000 LJUBLJANA

Tel: (386 61) 131 23 22

Fax: (386 61) 314 882

Internet: ic@usm . mzt . si

Director: Mr. Bogdan Topic

Admin, and Legal Advice: Mr. Vitomir Fister, Assistant

Director

Standardization: Mr. Tone Pogacnik, Assistant Director

Metrology: Mr. Vasja Hrovat , Director

Accreditation: Mr. Bogdan Topic, Director

Type Approval Road Veh.: Mr. Miha Luckmann, Assistant

Director

Information Center: Mr. Dusan Zuzic, Advisor to the Director

Turkey

Turkish Standards Institution (TSE)

Necatibey Cad 112

TR- 0 610 0 ANKARA BAKANLIKAR

Tel: (90 4) 417 83 30

Fax: (90 4) 425 43 99

Head: Mr. M.Y. Ariyoruk

32
Associate Members

European Trade Union Technical Bureau for Health and Safety

( TUTB

)

Blvd. Emile Jacqmain 155

B-1210 BRUSSELS

BELGIUM

Tel: (32 2) 224 0560

Fax: (32 2) 224 0561

President: Mr. Fritz Verzetnitsch

Vice President: Mr Emilio Gabaglio

Director: Mr. Marc Sapir

Standards Research Officer: Mr. Jean- Jacques Gueant

Standards Research Officer: Mr. Vicente Verde Peleato

Information Officer: Ms. Janine Delahaut

Tel: (32 2) 224 0552

European Construction Industry Federation (FIEC)

avenue Louise 6 6

B-1050 BRUSSELS

BELGIUM

Tel: (32 2) 514 5535

Fax: (32 2) 511 0276

President: Dr. Ing Thomas Rogge

Director General: Mr. Ulrich Paetzold

Technical Affairs: Mr. John Goodall

33
NAME OF THE ORGANIZATION: European Committee for

Electrotechnical Standardization (CENELEC)

Secretary General: Stephen Marriott

rue de Stassart 35

B-1050 Brussels, BELGIUM

Standards Information:

Tel: (32 2) 519 6871

Fax: (32 2) 519 6919

Please note: CENELEC can be consulted for standards

information. See Chapter V for information on EU

legislation

.

Background: CENELEC is a non-profit making international

association established in 1972. The aim of CENELEC is

to produce a single set of harmonized electrotechnical

standards in Europe including those that support EU

directives

.

Role in the harmonization of standards in the European

Union: CENELEC is one of three officially recognized

European standards organizations that write standards for

the Commission of the European Union under the "New

Approach Directive" that is the guide for the

harmonization of standards in the EU' s single market

program. The other organizations appointed by the

Commission are CEN and ETSI

.

Standardization Activities: CENELEC develops standards

for the whole field of electrotechnical and electronic

engineering where no International Electrotechnical

Commission (IEC) standards are available. CENELEC works

very closely with the Geneva-based IEC at the

international level and transposes IEC documents with or

without modification. CENELEC is linked to the IEC by

the Lugano Agreement that was ratified by CENELEC

s

General Assembly in 1991. Under the agreement, CENELEC

and IEC have agreed to exchange information aimed at

harmonizing European and international standardization.

In turn, some CENELEC standards have been adopted by the

IEC.

Membership: The member countries of CENELEC are Austria,

Belgium, Denmark, Finland, France, Germany, Greece,

Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,

Portugal, Spain, Sweden, Switzerland, and the United

Kingdom. CENELEC has affilate members from Poland,

Romania, Slovakia and Slovenia.

34
U.S. Access: CENELEC committees are not open in general

to bodies outside of Europe. U.S. parties may formally

request meetings with the chairs of CENELEC technical

committees through the American National Standards

Institute (ANSI) . ISO and IEC also may nominate

representatives to sit in CENELEC committees when there

are working proceedings at both the European and ISO

level

Other Information: CENELEC standards may be purchased

from CENELEC members within their countries. The

official versions of the standards are available in

English, French and German, and in the relevant national

languages of the member states. CENELEC standards also

are available through IEC members outside of Europe such

as the American National Standards Institute (ANSI) in

the United States.

Information on CENELEC s activities, catalogs, and annual

report are available from the CENELEC Central

Secretariat, rue de Stassart 35, B-1050 Brussels, Tel:

(32 2) 519 68 71, Fax: (32 2) 519 69 19.

35
CENELEC Member National Committees

Austria

Osterreichisches Elektrotechnisches Komitee (OEK)

beim Osterreichischen Verband fur Electro

Eschenbachgasse 9

A- 10 10 VIENNA

Tel: (43 1) 587 6373

Fax: (43 1) 56 7408

President: Dipl.-Ing. Helmut Hainitz

Gen. Sec.: Dipl.-Ing. Dr. H. Starker

Exec. Sec.: Mr. P. Rausch

Belgium

Comite Electrotechnique Beige (CEB)

Belgisch Elektrotechnisch Comite

(BEC)

Avenue Fr . Van Kalken 9

B-1070 BRUSSELS

Tel: (32 2) 556 0110

Fax: (32 2) 556 0120

President: M.R. Laurent

Administrateur delegue

NOVA Electro International

Overhamlaan 44

B-3 70 0 TONGEREN

Tel: (32 12) 23 2986

Fax: (32 12) 26 2056

Secretary-General: M.J. Papier

Denmark

Dansk Standard (DS) / (Danish Standards Association)

Electrotechnical Sector

Baunegaardsve j 73

DK-2 900 HELLERUP

Tel: (45) 39 77 0101

Fax: (45) 39 77 0202

Pres.: Mr. Niels W. Holm

Managing Director: Mr. Jacob Erik Holmblad

Standardization and Head of Sales and Information Department

Mr. Mogens Winther

Section Manager Electrical Engineering: Mr. Jan Roed

Section Manager Healthcare: Mr. Lars Brogaard

Section Manager Information, Technology and Logistics: Mr.

Hans Jorn Reuss

Section Manager Building, and Civil Engineering: Mr. Jorgen

Riis -Jensen

Certification Manager: Mr. Egon Hansen

Finland

Finnish Electrotechnical Standards Association (SESKO)

36
Sarkiniementie 3

PO Box 134

FIN-00211 HELSINKI

Tel: (358 0) 696 391

Fax: (358 0) 677 059

President: Mr. Kalervo Rudanko

Vice President: Mr. Otso Kuusisto

Director: Mr. Tuomo Ilomaki

Information and Documentation Officer: Mrs. Pirkko

Taavitsaien

France

Union Technique de 1 ' Electricite (UTE)

Location Address

Immeuble Lavoisier

4, place des Vosges

La Defense 5-COURBEVOIE

Mailing Address

UTE-Cedex 64

F-92052 PARIS-LA DEFENSE

Tel: (33 1) 46 91 1111

President: M.P.R. Sallebert

Director-General: M.J. Benoist

UTE, Approval Department, Tel: (33 1) 47 89 4587

UTE, All Services, Tel: (33 1) 47 89 4775

UTE, Standardization Department, Tel: (33 1) 46 91 1265

Germany

Deutsche Elektrotechnische Kommission im DIN und VDE (DKE)

Stresemannallee 15

D- 605 9 6 FRANKFURT/MAIN

Tel: (49) 69 630 80

Fax: (49) 69 631 2925

President: Mr. Gunter G. Seip

Direktor, Siemens AG

AS I 3 GWR

Siemenstrasse 10

D- 93 0 55 REGENSBURG

Tel: (49) 941 790 2252

Fax: (49) 941 790 2700

Teletex: 2627-9418128=Sie IBJR

Secretary: Dipl.-Ing. K. Orth

Greece

Hellenic Organization for Standardization (ELOT)

Acharnon Street 313

GR-111 4 5 ATHENS

Tel: (30 1) 2015 025

Fax: (30 1) 2020 776

President: Prof. G. Varoufakis

Tel: (30 1) 2234 966

Managing Director: N. Malagardis

Tel: (30 1) 2234 966

Promotion and Information: V.A. Filopoulos, Manager

Tel: (30 1) 2013 778

Standardization: D. Agapalidis, Manager

37
Tel: (30 1) 2019 891

Electrotechnical Standardization: Dr. P. Theof anopoulos

,

Manager

Tel: (30 1) 2029 367

Testing Laboratories: K. Ionas, Manager

Tel: (30 1) 5247 117

Dir: 83/189/EEC and GATT : E. Melagrakis, Manager

Tel: (30 1) 2019 890

Iceland

The Icelandic Council for Standardization (STRI)

Technological Institute of Iceland

Keldnaholt

IS- 112 REYKJAVIK

Tel: (354) 587 7000

Fax: (354) 587 7409

Internet: stri@iti.is

Chairman: Mr. T. Karlsson

Secretary: Mr. J. Thorsteinsson

Ireland

Electro-Technical Council of Ireland (ETCI)

ESB Office

Parnell Avenue

Harold' s Cross

Ireland DUBLIN 12

Tel: (353 1) 454 5819/454 5820

Fax: (353 1) 454 5821

Chairman: Mr. S. Elmore

Personal Assistant: Ms. Lucie Quesnel-Brady

Admin.: Mr. J. P. Sheehan

Ballymun Road

Tel: (353 1) 837 6773

Fax: (353 1) 836 9821

Head Secretary: Mr. D. 0' Regan

Luxembourg

Service de l'energie de l'Etat

34, avenue de la Porte-Neuve

L-22 2 7 LUXEMBOURG

Tel: (352) 46 9746-1

Fax: (352) 22 2507

Postal Address:

c/o Service de l'Energie de l'Etat

BP 10

L-2 010 LUXEMBOURG

Director: M. Jean-Paul Hoffmann

The Netherlands

Nederlands Elektrotechnisch Comite (NEC)

Kalfjeslaan 2

Postbus 5059

NL-2 6 00 GB DELFT

Tel: (31 15) 690 255

Fax: (31 15) 690 130

38
President: Mr. E. Ribberink,

Vice President, Euro Affairs

Holec Systems and Components BV

PO Box 2 3

NL-75 5 0 AA HENGELO

Tel: (31 74) 46 4880

Fax: (31 74) 46 42208

Vice-Presidents

Prof. Ir. J.L. de Kroes

Mr. C. Ch. Smit

Director: Mr. T.D. Roodbergen

Tel: (31 15) 690 208

Fax: (31 15) 690 242

Norway

Norsk Elektroteknisk Komite (NEK)

Harbitzalleen 2A, SkY yen

Postboks 280

N-0212 OSLO 2

Tel: (47 22) 52 6950

Fax: (47 22) 52 6961

Telegrams NORWELCOM

Pres.: Mr. Knut Herstad

Tel: (47 7) 59 7200

Fax: (47 7) 59 7250

Director: Mr. B.I. Odegard

Portugal

Instituto Portugues da Qualidade (IPQ)

Rua Jose Estevao, no. 83 -A

P-1199 LISBON Codex

Tel: (351 1) 52 3978

Telex: (404) 13042 QUALIT P

Fax: (351 1) 353 0033

Pres.: Mr. Candido dos Santos

Spain

Asociacion Espanola de Normalizacion y Certif icacion (AENOR)

Comite Electrotecnico Espanol

Calle Fernandez de la Hoz 52

E-28010 MADRID

Tel: (34 1) 310 4851

Fax: (34 1) 310 4976

Chairman: Mr. I Tornos

IBERDROLA

Calle Claudio Coello 53

E-28010 MADRID

Tel: (34 1) 577 6565

Fax: (34 1) 577 0848

General Director: Mr. R. Naz

Secretary: Mr. V. Ruiz de Valbuena

Sweden

Svenska Elektriska Kommissionen (SEK)

Kistagangen 19

39
Box 1284

S- 164 2 8 KISTA STOCKHOLM

Tel: (46 8) 750 7820

Fax: (46 8) 751 8470

Chairman: Mr. M. Setterwall

Sveriges Elektroindustriforening

Box 5501

S- 11485 STOCKHOLM

Tel: (46 8) 783 8164

Fax: (46 8) 663 6323

Vice Presidents:

Mr. G. Sandqvist

Mr . J . Nou

Managing Director and Secretary of the Swedish Committee

IEC and CENELEC committees: Mr. Hans Erik Rundqvist

Switzerland

Swiss Electrotechnical Committee (CES)

Luppmenstrasse 1

CH-83 2 0 FEHRALTORF

Tel: (41 1) 956 1170

Fax: (41 1) 956 1190

President: Dr. Ing. Paul W. Kleiner

AWK Engineering AG

Leutschenbachstrasse 45

CH-8050 ZURICH

Tel: (41 1) 305 9511

Fax: (41 1) 305 9519

Secretary-General: Mr. R.E. Spaar

United Kingdom

British Electrotechnical Committee (BEC)

British Standards Institution (BSD

2, Park Street

UK LONDON W1A 2BS

Tel: (44 71) 629 9000

Fax: (44 71) 629 0506

Chairman: Mr. Norman J. A. Holland

Consultant: Standards & Directives

Pinehaven, 94 Hiltingbury Road

Chandler's Ford, Hampshire S05 1NZ

Tel: (44 0703) 27 0605

Fax: (44 0703) 27 0605

Secretary: Mr. I. Campbell

40
Affiliate Members

Poland

Polski Komitet Normalizac j i/Polish Committee for

Standardization (PKNMiJ)

PO Box 10

PL-00-950 WARSAW

Tel: (48 2) 620 50434

Fax: (48 2) 620 5434

President: Mr. Marian Lukaszewicz

Tel: (48 2) 620 2916

Fax: (48 2) 620 0741

Vice-President: Mr. Andrzje Kocznorowski

Tel: (48 2) 620 6621

Fax: (48 2) 620 0741

Secretary: Mr. Krzysztof Trzcinski

Tel: (48 2) 620 2914

Fax: (48 2) 620 0741

Foreign Relations: Mr. Zygmunt Niechoda, Director

Tel/Fax: (48 2) 620 5434

Information and Documentation: Mrs. Jadwiga Bochinska,

Director

Tel/Fax: (48 2) 247 122

Romania

Institutul Roman de Standardizare

13, rue Jean-Louis Calderon

RO-70201 BUCAREST 2

Director General : Mihail Ciocodeica

Tel: (401) 611 4043

Fax: (401) 312 0823

Division of Standardization

Director: Mircea Petcu

Tel: (401) 615 5870

Fax: (401) 210 0833

Division of Certification, Accreditation, Notification of

bodies, Quality

Director: Claudiu Stefanescu

Tel: (401) 222 3850

Fax: (401) 210 0833

Division of Services, Consulting, Communication, International

Relations (ISO, CEN, CENELEC, ETSI . IEC, TERMNET)

Director: Daniela Moga

Tel: (401) 615 5870

Fax: (401) 312 4744

Division of Human resources, Finances, Accounting, Logistics,

Marketing

Director: Clementina Enciu

Tel: (401) 615 5870

Fax: (401) 312 4744

41
Division of the Secretariat of the National Center for

Training, Consultancy and Management in Quality Assurance

Director: Gabriela Anghelescu

Tel: (401) 222 3860

Fax: (401) 210 0833

Slovakia

Slovak Electrotechnical Committee (SEV) /Slovak Office of

Standards, Metrology and Testing (UNMS)

Stefanovicova 3

814 3 9 BRATISLAVA

Tel: (42) 7 491 085

Fax: (42) 7 491 050

President: Mr. Vladimir Adamec

Tel: (42) 7 496 847

Slovenia

Standards and Metrology Institute (SMIS)

Ministry of Science and Technology

Kotnikova 6

SI -61000 LJUBLJANA

SMIS is an affiliate of CEN, CENELEC and a member of ETSI

Director: Mr. Bogdan Topic

Admin, and Legal Advice: Mr. Vitomir Fister, Assistant

Director

Standardization: Mr. Tone Pogacnik, Assistant Director

Metrology: Mr. Vasja Hrovat , Director

Accreditation: Mr. Bogdan Topic, Director

Type Approval Road Veh.: Mr. Miha Luckmann, Assistant

Director

Information Center: Mr. Dusan Zuzic, Advisor to the Director

Tel: (386) 61 131 2322

Fax: (386) 61 314 882

Internet ic@usm.mzt . si

42
NAME OF THE ORGANIZATION: European Telecommunications

Standards Institute (ETSI)

Director: Karl Heinz Rosenbrock

650 route des Lucioles

F-06921 Sophia Antipolis CEDEX

FRANCE

Standards Information:

Tel: (33) 92 94 4200

Fax: (33) 93 65 4716

Please note: ETSI can be consulted for standards

information. See Chapter V for information on EU

legislation

Background: ETSI is a non-profit organization whose

mission is to determine and produce telecommunications

standards for improving communications between the member

countries of the European Union. It was established in

March of 1988 to assume the standards writing activities

of the European Conference of Postal and

Telecommunications Administration (CEPT) to prepare for

the European unified market. ETSI represents one of the

largest international technical associations in the field

of telecommunications and brings together an impressive

array of expertise, all working together towards the

ultimate goal of a universal information network.

Role in the harmonization of standards in the European

Union: ETSI is one of three officially recognized

European standards organizations that write standards for

the Commission of the European Union under the "New

Approach Directive" that is the guide for the

harmonization of standards in the EU' s single market

program. The other organizations are the European

Committee for Standardization (CEN) and the European

Committee for Electrotechnical Standardization (CENELEC)

Standardization Activities: ETSI standards are produced

under voluntary work programs and costed work programs.

There are 11 technical committees and approximately 60

technical subcommittees and more than 140 working groups

and rapporteur groups. These committees deal with

standards for public and private telecommunications

systems and equipment, local area networks, and other

electronics equipment for government and consumers. By

relating its work to developments on the global scene,

ETSI also is helping to work towards establishing

telecommunications standards worldwide.

43
ETSI has produced more than 4,000 voluntary standards

since it was established. Many of these have been

adopted by the Commission of the European Union as the

technical basis for directives and regulations.

Membership: ETSI is an open forum that brings together

373 full members, 14 associate members and 71 observers

from 30 European countries. ETSI members are from EU

member national telecommunications administrations,

manufacturers, public network operators, users and

counsellors, and firms established within ETSI member

states, albeit of foreign origin, are also ETSI members

ETSI members are currently from Austria, Belgium,

Bulgaria, Croatia, Cyprus, Czech Republic, Denmark,

Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Romania, Russia, Slovak Republic,

Slovenia, Spain, Sweden, Switzerland, Turkey, and the

United Kingdom. Australia and Israel are associate

members

.

U.S. Access: ETSI has granted the United States and U.

companies observer status.

Other Information: ETSI Standards are available in

English, and global dissemination of its standards has

been one of ETSI's top priorities. At the European

level, ETSI has reached agreement with the national

standards organizations of the European Standards

Committee (CEN) and the European Electrotechnical

Standards Committee (CENELEC) for the sale and

distribution of documents. For information on ETSI

standards, contact the ETSI Secretariat, 650 route des

Lucioles, F-06921 Sophia Antipolis CEDEX, FRANCE, Tel:

(33) 92 94 42 00, Fax: (33) 93 65 47 16.

44
IV Testing and Certification in the Single European Market

NAME OF THE ORGANIZATION: European Organization for

Testing and Certification (EOTC)

Secretary General: David H. Stanger

Egmont House

rue d' Egmont st raat 15

B-1050 Brussels, BELGIUM

Information

Tel: (32 2) 502 4141

Fax: (32 2) 502 4239

Background: The European Organization for Testing and

Certification (EOTC) was established in 1990 under a memorandum of understanding (MOU) signed by the

Commission of the European Union, the European Free Trade

Association (EFTA) , the European Committee for

Standardization (CEN) and the European Committee for

Electrotechnical Standardization (CENELEC) to serve as

the focal point in Europe for all issues relating to

conformity assessment

EOTC, as mandated by the MOU, is to provide the

appropriate framework for the non-regulatory sphere with

regard to conformity assessment issues, while operating

in such a manner as to give technical support to

legislation of the Commission of the European Communities

and the EFTA countries regarding conformity assessment in

the regulatory sphere

EOTC is a non-profit organization which attained legal

status under Belgian law in April 1993. EOTC operates

under a General Assembly composed of an increasing number

of representatives of all relevant interests from both

the public and private sectors.

Role in Conformity Assessment: The role of EOTC as the

focal point for conformity assessment in Europe is being

achieved by actively encouraging the formation of

Sectorial Committees through which it gives recognition

to Agreement Groups composed of calibration or testing

laboratories or certification bodies that operate in

accordance with the internal regulations and relevant

guidelines established by EOTC over the past 4 years.

Members: EOTC has 32 members, including 16

representatives of national conformity assessment

communities and 16 European organizations. Each national

member has documented rules of operation that demonstrate

it is open to representation from all parties concerned

with conformity assessment at the national level, notably

45
manufacturers, suppliers, users and consumers, conformity

assessment practitioners, and public authorities. The

national members are Austria, Belgium, Denmark, Finland,

France, Germany, Greece, Ireland, Italy, Netherlands,

Norway, Portugal, Spain, Sweden, Switzerland, and the

United Kingdom.

Other Information: EOTC disseminates information on

European testing and certification activities. It also

coordinates pre-standardization work to complement or

service EU Commission program. The EOTC Secretariat

recently took over the management of the Testing,

Inspection, Calibration, Certification and Quality

Assurance database (TICQA Project) that was launched by

Directorate General -- I I I , Industrial Affairs of the

European Commission in 1991. The database is an

inventory of more than 10,000 entities, public and

private, working in the areas of testing, inspection,

calibration, certification and quality assurance in each

member state of the European Union.

The TICQA Database is being updated and will be made

public by the end of 1995 to those who have an interest

in doing business in the single market. EOTC also is

involved in the Conformance Testing Services Program to

provide funding for suitable projects. EOTC has signed a

Five-Year Framework Contract (1995-99 with the European

Commission and the European Free Trade Association

(EFTA)

.

46
V The European Commission:

Officials with Standards Responsibilities

Please note: European Commission Officials can be

consulted for information on EU legislation. For

standards information see Chapter III.

The European Commission is the executive body of the European

Union which has, generally speaking, four main tasks: 1) to

carry out the detailed implementation of decisions reached by

the Council of Ministers; to exercise its powers of decision;

to act as guardian of the EU treaties by investigating treaty

breaches and by summoning offenders before the European Court

of Justice; and to serve as the sole initiator of EU policies

by making policy proposals to the Council of Ministers. In

this chapter the names are listed of staff members responsible

for standards related activities within the European

Commission

Directorate General (DG)

Postal Address:

rue de la Loi 200

1049 Brussels

Directorate A -

Director: N/A

III: Industrial Affairs

Industrial Policy

Advisors

Peter Lennon Tel: (32 2) 295 1226

Fax: (32 2) 296 9852

Piero Squartini Tel: (32 2) 295 1486

Fax: (32 2) 296 9852

1. Industrial Relations and International Technologies

Jean Michel Corre Tel: (32 2) 295 8822/296 5738

Fax: (32 2) 296 6026

Industrial Cooperation

Petro Paolo Merolla Tel: (32 2) 295 7756/296 32 30

Fax: (32 2) 296 9853

Competitiveness and Industrial Policy

Jean-Francois Marchipont Tel: (32 2) 295 7965/295 7928

Fax: (32 2) 296 3028

Industrial Aspects of Structural Assistance (PEDIP)

N/A

Info Technologies and Telecoms Equipment

Michel Catinet Tel: (32 2) 296 9529

47
Fax: (32 2) 296 8867

Directorate B

Regulatory Policies and Standards for Telematic Networks

Evangelos Vardakas Tel: (32 2) 295 0296/295 0245

Fax: (32 2) 296 2893

1. Technical Legislation

David White Tel: (32 2) 295 5724/296 2877

Fax: (32 2) 296 0851

2. Standardization

Michel Audoux Tel: (32 2) 296 9539/296 9540

Fax: (32 2) 296 9500

3. Quality Policy, Certification, and Conformity Marking

Jacques McMillan Tel: (32 2) 295 2475

Fax: (32 2) 295 3877

4. Industrial Problems related to Environmental Regulations

Jaqcues Soenens Tel: (32 2) 295 1267/295 7716

Fax: (32 2) 296 0916

5. Networks and European Telematic Systems

Emile Peeters Tel: (32 2) 299 2246/299 22 47

Fax: (32 2) 299 0286

Directorate C - Industrial Affairs I

Pedro Ortun Silvan Tel: (32 2) 296 0391/295 2084

Fax: (32 2) 295 6515

Advisor

Reginald Spence Tel: (32 2) 295 5831

Fax: (32 2) 295 6515

1. Steel, Internal Market and Sectdral Structures

Giacomo Giacomello Tel: (32 2) 295 1268/295 1279

Fax: (32 2) 295 9800

2. Steel, External Measures

Jacobus Aarts Tel: (32 2) 295 4492/ 295 2267

Fax: (32 2) 295 6515

3 . Raw and Advanced Materials

Vicente Leoz Arguelles Tel: (32 2) 295 1225/295 2511

Fax: (32 2) 295 6515

4. Chemicals, Plastics, Rubber

Gyorgy von O'Svath Tel: (32 2) 295 7074/295 2258

Fax: (32 2) 295 6515

Directorate D - Industrial Affairs III

48
Paul Weissenberg Tel: (32 2) 296 3358/295 3363

Fax: (32 2) 296 1125

1. Mechanical and Electrotechnical Engineering

Luis Montoya Moron Tel: (32 2) 296 2592/295 4242

Fax: (32 2) 296 6273

2. Pressure and Medical Devices, Metrology

Joseph Putzeys Tel: (32 2) 295 5956/295 1890

Fax: (32 2) 296 1125

3 . Construction

Karlheinz Zachmann Tel: (32 2) 295 4816/ 295 5718

Fax: (32 2) 296 1065

4. Industry of Means of Transportation

Abraao Carvalho Tel: (32 2) 295 7397/295 7048

Fax: (32 2) 295 6851

Directorate E - Industrial Affairs III

Guy Crauser Tel: (32 2) 295 5572/295 3049

Fax: (32 2) 296 1027

1. Foodstuffs Legislation

Egon Gaerner Tel: (32 2) 295 3126/295 4661

Fax: (32 2) 295 1735

2. Food-Processing Ind. , Biotechnology

Kirtikumar Mehta Tel: (32 2) 295 7389/295 2871

Fax: (32 2) 296 6265

3. Pharmaceuticals

N/A

4. Textiles and Clothing, Leather & Shoes, Furniture

Fabrizio Barbaso Tel: (32 2) 2295 6739/295 3940

Fax: (32 2) 296 1027

5. Automobiles and other Road Transport

Richard Wright Tel: (32 2) 295 3397/295 6499

Fax: (32 2) 296 9930

6. Public Electronics

Galway Johnson Tel: (32

Fax: (32

Directorate F - RTD Actions:

George Metakides Tel: (32

Fax: (32

2) 296 2342

2) 296 1027

Information Technologies

2) 296 8067/296 8076

2) 296 8363

Principal Advisor

Attilio Stajano Tel: (32 2)

Fax: (32 2)

General Aspects & Coordination

296 8067/296 8076

296 8363

of Info. Technologies Programs

49
Claude Ouannes Tel: (32 2) 296 8048/296 8044

Fax: (32 2) 296 8597

1. Coordination and Execution of Information Technology

Programs

Bernard Libertalis Tel: (32 2) 296 8952/296 8953

Fax: (32 2) 296 8597

2. Basic Research & Scientific Relations in the Info. Tech.

Field

Simon Bensasson Tel: (32 2) 296 8066

Fax: (32 2) 296 8390

3. Micro-Electronics

Horst Forster Tel: (32 2) 296 8057/296 8061

Fax: (32 2) 296 1692

4. Logistics & Advanced Treatment of Information

David Edward Talbot Tel: (32 2) 296 8103/296 8102

Fax: (32 2) 296 8364

5. Informatics Distributed at High Performance

Thierry Van Der Pijl Tel: (32 2) 296 8405/296 8105

Fax: (32 2) 296 1692

6. Multimedia Systems & Application of Micro Processors

Rosalie Zobel Tel: (32 2) 296 8168/296 8144

Fax: (32 2) 296 8387

7 . Industry Technology

Patricia MacConaill Tel: (32 2) 296 8127/296 8121

Fax: (32 2) 296 8365

Library/Documentation Center

Roger Prosperpio Tel: (32 2) 295 4930

Fax: (32 2) 296 8597

Directorate General- -V: Employment, Industrial Relations &

Social Affairs

Directorate F - Health and Safety

William Hunter Tel: (352) 43 013 27 19/2708

Fax: (352) 43 013 45 11

Directorate General - -XII : Science, Research, and Development

Directorate C - R & TD Actions:

Industrial Technologies and Materials

Arturo Garcia Arroyo Tel: (32 2) 295 0013/296 1985

Fax: (32 2) 295 8046

Joint Research Centre

Institute for Reference Materials and Measurements

50
Steenweg op Retie

B-2240 Geel

Belgium

Tel: (32 14) 57 1211

Fax: (32 14) 58 4273

Director: Werner Muller

Institutes of the Joint Research Centre

Institute for Advanced Materials

Westerduinweg 3 , Postbus 2

NL-1775 ZG Petten

The Netherlands

Tel: (31 22) 46 5656

Fax: (31 22) 46 1002

Director

also : 1-21020 Ispra (VA)

Italy

Tel: (39 322) 78 9111

(39 322) 78 9889

Fax: (39 322) 78 90 01

Director: (N/A)

Environment Institute

1-21020 Ispra (VA)

Italy

Tel: (39 322) 78 9111

(39 322) 78 9889

Fax: (39 322) 78 90 01

Director: Bruno Versino (acting)

Institute for Safety Technology

1-21020 Ispra (VA)

Italy

Tel: (39 322) 78 9111

(39 322) 78 9889

Fax: (39 322) 78 9001

Director: Helmut Holtbecker

51
VI EU Member State Missions and Delegations to

the European Union, Brussels, Belgium

Austria

Industrial/Products: Alfred Komaz, Tel: (32 2) 741 21 51

Environment: George Rebernig, Tel: (32 2) 741 21 96

Belgium

Industry: Francois De Vleeschouwer , Tel: (32 2) 233 21 63

Standards: Chris Vanden Bilcke, Tel: (32 2) 233 21 11

Fax: (32 2) 231 10 75

Denmark

Industry: Leif Thomassen, Tel: (32 2) 233 08 22

Environment: Jeff Huntington/ Kim Christiansen,

Tel: (32 2) 233 08 22

Finland

Industry: Pakka Lindroos, Tel: (32 2) 287 84 11

Environment: Satu Nurmi , Tel: (32 2) 287 84 46

Tuiga Talsi, Tel: (32 2) 287 84 77

France

Industry: Jean-Francois Corallo/Henry Breuil,

Tel: (32 2) 229 84 04

Environment: Mme Laurence Auer, Tel: (32 2) 229 82 74

Germany

Industry: Hartwig Burghart , Tel: (32 2) 238 18 55

Environment: F. Petermann, Tel: (32 2) 238 18 58

Greece

Industry: Zachary Mavroukas, Tel: (32 2) 739 56 80

Environment: Athena Mourmouri, Tel: (32 2) 73 9 56 79

Fax: (32 2) 735 59 79, or (32 2) 739 56 71

Ireland

Industry: Paul Farrell, Tel: (32 2) 218 06 05, ext 242,

Fax: (32 2) 218 46 19

Environment: Mary O'Donoghue, Tel: (32 2) 218 06 05, ext 242,

Fax: (32 2) 219 43 36

Italy

Industry: Corrado Buresti, Tel: (32 2) 220 04 86

Fax: (32 2) 219 34 49

Environment: Clara-Maria Bisegna, Tel: (32 2) 220 04 96

Fax: (32 2) 220 04 94

52
Luxembourg

Industry: Jean-Marc Hoscheit

Environment : Jean Graff

Tel: (32 2) 735 20 60

Fax: (32 2) 736 14 29

Netherlands

Industry: Walter van Ditmars, Tel: (32 2) 679 15 16

Fax: (32 2) 679 17 92

Environment: Robert Milders, Tel: (32 2) 679 15 19

Fax: (32 2) 679 17 93

Portugal

Industry: Sergio de Fonseca, Tel: (32 2) 211 12 24

Environment: Jose' Carvalho, Tel: (32 2) 211 12 89

Fax: (32 2) 218 15 42 or (32 2) 218 14 59

Spain

Industry: Miguel Perez-Zarco, Tel: (32 2) 509 86 97

Environment: Carlos Emeno-Sanz, Tel: (32 2) 509 86 96

Fax: (32 2) 511 10 23

Sweden

Industry: Lennart Lindeborg, Tel: (32 2) 289 56 77

Environment: Suzanne Frigren, Tel: (32 2) 289 56 75

United Kingdom

Industry: Tom Davy, Tel: (32 2) 287 82 95

Adam Jackson, Tel: (32 2) 287 82 78

Environment: James Humphries, Tel: (32 2) 287 82 01

Fax: (32 2) 287 83 98

53
VII Other Country Missions and Delegations to the

European Union, Brussels, Belgium

Iceland

Industry: Harald Aspelund, Tel: (32 2) 219 90 90

Environment: Johann Benediktsson, Tel: (32 2) 219 90 90

Norway

Industry: Andreas Mortensen, Tel: (32 2) 234 11 65

Environment: Kiell Glomnes, Tel: (32 2) 234 11 48

Switzerland

Industry: Alois Ochsner

Environment: Michael Ambuhl

Tel: (32 2) 286 13 11

Fax: (32 2) 289 56 00

United States Mission to the European Union

4 0 Blvd. du Regent

B-1000 Brussels, Belgium

Tel: (32 2) 508 27 46

Fax: (32 2) 513 12 28

CS USEU PERSONNEL

Stephen C. Arlinghaus

Minister Counselor

Tel: (32 2) 508-2747

Gill Huyghe

Secretary

Tel: (32 2) 508-2746

Margaret A. Keshishian

Commercial Attache

Tel: (32 2) 508-2755

Helen Davis Delaney

Standards Officer

Tel: (32 2) 508-2674

Rene van de Zande

Commercial Specialist

Tel: (32 2) 508-2676

Eric Fleury

Commercial Specialist (Fisheries)

Tel: (32 2) 508-2769

Sylvia Mohr

Commercial Assistant

Tel: (32 2) 508-2675

Carol Proven

EC Tender Reporter

Tel. (32 2) 508-2677

54
VIII Non-Member International Standards Organizations

International Organization for Standardization (ISO)

rue de Varembe 1

CH-1202 Geneva

Switzerland

Tel: (41 22) 749 01 11

Fax: (41 22) 733 34 30

ISO/IEC Information Center:

Tel: (41 22) 749 02 22

ISO is a non-governmental international organization

established in 1947. It is made up of national standards

organizations of 90 countries (71 members and 19

corresponding members) . The main function of ISO and its

member bodies is to provide a forum for the standards

making process, to approve standards by a set of

procedures that ensure their validation and to publish

them. This effort is aimed at facilitating the

international exchange of goods and services and to

develop cooperation in the sphere of intellectual,

scientific, technological, and economic activity.

Membership: Participation is restricted to official

representatives of members. There is only one member per

country. The American National Standards Institute

(ANSI) is the official U.S. member of ISO.

Other Information: ISO has published more than 7,500

international standards drafted by approximately 2,600

technical committees. The standards are available in

English. The scope of these standards cover all fields

except electrical and electronics engineering that are

the responsibility of the International Electrotechnical

Commission (IEC)

The ISO Information Network (ISONET) coordinates and

systematizes the exchange of information on standards and

standards -type documents by linking the information

centers of ISO members and the information center of the

General Secretariat. As the U.S. member of ISONET, the

National Institute of Standards and Technology has access

to information through the other ISONET members and the

ISO information center in Geneva, Switzerland.

55
International Electrotechnical Commission (IEC)

rue de Varembe 3

CH-1211 Geneva

Switzerland

Tel: (41 22) 34 01 50

Fax: (41 22) 33 38 43

ISO/IEC Information Center:

Tel: (41 22) 749 02 22

Founded in 1906, IEC develops technical standards in the

electrical and electronic engineering fields to promote

international understanding. IEC standards are developed

and promoted with the national committees from more than

50 countries. IEC and ISO form together the world's

largest non-governmental system for voluntary industrial

and technical collaboration at the international level.

Membership: The American National Standards Institute

(ANSI) provides support to the U.S. National Committee

for the IEC.

Other Information: IEC standards are available in

English and French from IEC distributors such as the IEC

National Committees.

56
BIBLIOGRAPHY

o The Creation of an Internal Market for Industrial Goods

in Europe through Technical Harmonization,

Standardization, Certification and Mutual Recognition , Egide Jongen, European Commission DG III, January 1991.

o "The European Community Single Market and U.S. Trade

Relations," Business America , International Trade

Administration, U.S. Department of Commerce, March 8,

1993 .

o EC Testing and Certification Procedures Under the

International Market Program , International Trade

Administration, U.S. Department of Commerce, April 1993.

o Business Guide to EU Initiatives , EU Committee of the

American Chamber in Commerce, Winter/Spring 1994.

o EC Information Handbook, 1994/95 , The EC Committee of the

American Chamber of Commerce in Belgium, April 1994.

o Product Standards Under the Internal Market Program , International Trade Administration, U.S. Department of

Commerce, March 1994.

o European Technical Legislation and Standardization. A

Guide for Foreign Businessmen , European Commission 1994.

o Guide to the Implementation of Community Harmonization

Directives Based on the New Approach and the Global

Approach , First Version, European Commission 1994.

57
o EOTC Directory , Subscriber Update, January 1995.

o US-EC Facts and Figures , U.S. Mission to the European

Union, 1995, Brussels, Belgium.

o Common Standards for Enterprises , Florence Nicolas with

the Cooperation of Jacques Repussard, 1995, Office for

Official Publications of the European Communities, L-2985

Luxembourg

.

o Compliance Manual for Trade, The European Union Machinery

Directive , James W. Kolka and Bruce Mcintosh, Simeon,

Inc., 1995.

58
Appendix A

New Approach Directives

The Official Jour. Pub, column refers to the date the

adopted legislation was published in the Commission's Official

Journal. The Adopt . Date column indicates date of adoption by

the Council. The Entry Date column refers to the date by

which the Member States of the European Union are supposed to

have implemented the legislation (and thus is "in force")

The Trans . End (Transitional Period) column refers to the date

until which CE Marking is optional for manufacturers.

The following "New Approach Directives" have been adopted:

1) Low Voltage - concerns electrical equipment designed for use within

certain voltage limits

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

73/23/EEC OJ L 77 of 26.3.1973, p. 29 19.2.1973 18.8.1974 NA

2) Simple Pressure Vessels - first is Council Directive of 25.06.87 on the

harmonization of the laws of the Member States relating to simple pressure

vessels; second is Council Directive of 17.09.90 amending Directive

87/404/CEE on the harmonization of the laws of the Member States relating

to simple pressure vessels.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

87/404/EEC OJ L 220 of 8.8.1987, p. 48 25.6.1987 1.7.1990 1.7.1992

90/488/EEC OJ L 270 of 2.10.1990, p. 25 17.9.1990 1.7.1991 NA

3) Safety of Toys - Council Directive of 03.05.88 on the approximation of

the laws of the Member States concerning the safety of toys

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

87/378/EEC OJ L 187 of 16.7.1988, p. 1 3.5.1988 1.1.1990 NA

4) Construction Products - Council directive of 21.12.88 on the

approximation of laws, regulations and administrative provisions of the

Member States relating to construction projects.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

89/106/EEC OJ L 40 of 11.2.1989, p. 12 21.12.1988 27.6.1991 not fixed

5) Electromagnetic Compatibility (EMC) - first is Council Directive of

03.05.89 on the approximation of the laws of the Member States relating to

electromagnetic compatibility; second is Council Directive of 28.04.92

59
amending Directive 89/336/CEE on the approximation of the laws of the

Member States relating to electromagnetic compatibility.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

89/336/EEC OJ L 139 of 23.5.1989, p. 19 3.5.1989 1.1.1992 31.12.1995

92/31/EEC OJ L 126 of 12.2.1992, p. 11 12.7.1992 12.11.1992 NA

6) Safety of Machines - first is Council Directive of 14.06.89 on the

approximation of the laws of the Member States relating to machinery;

second is Council Directive of 20.06.91 amending Directive 89/392/CEE on

the approximation of the laws of the Member States relating to machinery;

third is Council Directive of 14.06. 93 amending Directive of 14 . 06 . 93

amending Directive 83/392/EEC on the approximation of the laws of the

Member States relating to machinery.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

89/392/EEC OJ L 183 of 29.6.1989, p. 9 14.6.1989 31.12.1992 31.12.1994

91/368/EEC OJ L 198 of 22.7.1991, p. 16 20.6.1991 1.1.1993 NA

93/44/EEC OJ L 175 of 19.7.1993, p. 12 14.6.1993 1.1.1995 31.12.1996

7) Personal Protection Equipment - Council Directive of 21.12.89 on the

approximation of the laws of the Member States relating to personal

protective equipment.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

89/686/EEC OJ L 399 of 30.12.1989, p. 18 21.12.1989 1.7.1992 30.6.1995

93/95/EEC OJ L 276 of 9.11.1993, p. 11 29.10.1993 29.1.1994 NA

8) Non-automatic Weighing Machines - Council Directive of 2 0.06.90 on the

harmonization of the laws of the Member States relating to non-automatic

weighing machines

.

Reference Official Jour. Pub. Adopt. Date Entry Date Trans End

90/384/EEC OJ L 189 of 20.7.1990, p.l 20.6.1990 1.1.1993 1.1.2003

9) Active Implantable Medical Devices - Council Directive of 20.06.90 on

the approximation of the laws of the Member States relating to active

implantable medical devices.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

90/385/EEC OJ L 189 of 20.7.1990, p. 17 20.6.1990 1.1.1993 31.12.1994

10) Appliances Burning Gaseous Fuels - Council Directive of 29.06.90 on the

approximation of the laws of Member States relating to appliances burning

gaseous fuels.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

90/396/EEC OJ L 196 of 26.6.1990, p. 15 29.6.1990 1.1.1992 31.12.1995

11) Telecommunications Terminal Equipment - Council Directive of 29.04.91

on the approximation of the laws of the Member States concerning

Telecommunication equipment, including the mutual recognition of their

60
conformity; second is Council Directive 29.10.93 supplementing Directive

91/263/CEE in respect to satellite earth station equipment.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

91/263/EEC OJ L 128 of 23.5.1991, p.l 29.4.1991 6.11.1992 NA

93/97/EE OJ L 290 of 24.11.1993, p.l 29.10.1993 1.5.1995 NA

12) New hot-water boilers fired with liquid or gaseous fuels - Council

Directive of 21.05.92 on efficiency requirements for new hot-water boilers

fired with liquid or gaseous fuels.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

92/42/EEC OJ L 167 of 22.6.1992, p. 17 21.5.1992 1.1.1994 31.12.1997

13) Explosives for Civil Uses - Council Directive of 5.4.93 on the

harmonization of the provisions relating to the placing on the market and

supervision of explosives for civil uses. Reference Official Jour. Pub. Adopt. Date Entry Date Trans End

93/15/EEC OJ L 121 of 15.5.1993, p. 20 5.4.1993 1.1.1995 31.12.2002

14) Medical Devices - Council Directive of 14.06.93 concerning medical

devices

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

93/42/EEC OJ L 169 of 12.7.1993, p.l 14.6.1993 1.1.1995 13.6.1998

15) Rules for the affixing and use of the CE conformity marking - Council

Directive of 22.07.93 amending Directives: 87/404/EEC - simple pressure

vessels, 88/378/EEC - safety of toys, 89/106/EEC - construction products,

89/336/EEC - electromagnetic compatibility, 83/392/EEC - machinery

889/686/EEC - personal protective equipment, 90/384/EEC - non-automatic

weighing instruments, 90/385/EEC - active implantable medicinal devices,

90/396/EEC - appliances burning gaseous fuels, 91/263/EEC - telecommunications terminal equipment, 92/42/EEC - new-hot-water boilers

fired with liquid or gaseous fuels, 73/23/EEC - electrical equipment

designed for use within certain voltage limits, 93/68/EEC.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

93/68/EEC OJ L 220 of 30.8.1993, p.l 22.7.1993 1.1.1995 NA

16) Equipment for Explosive Atmospheres - Council Directive of 23.03.94 on

the approximation of the laws of the Member States concerning equipment and

protective systems intended for use in potentially explosive atmospheres.

Reference Official Jour. Pub. Adopt . Date Entry Date Trans End

OJ L 100,1994 1.03.1996 30.06.2002

61
Appendix B

Contacts in the United States for Information on European

Union Standards and Standards-Related Activities

Office of European Union and Regional Affairs

U.S. Department of Commerce

14th and Constitution Avenue, N.W. , Room 3036

Washington, D.C. 20230

Tel: (202) 482-5276

Fax: (202) 482-2155

The Office of European Union and Regional Affairs

(OEURA) , part of the U.S. Department of Commerce's

International Trade Administration, works to ensure that U.S.

exporters maintain access to the West European market and to

improve market access wherever possible. In carrying out this

mission, OEURA develops policy, participates in negotiations , and provides information to U.S. businesses regarding

legislative, regulatory and policy matters in Western Europe

which might have an impact on U.S. exports to that region.

U.S. exporters have indicated that an important

determinant of market access in Western Europe is access to

timely information on European product standards, testing and

certification requirements. Consequently, a significant

portion of business counseling by OEURA staff involves

providing the latest information on CE mark requirements, the

New Approach directives and related standards, product

certification under the "old approach, " as well as other EU

legislation and regulation. OEURA also serves as coordinator

of the U.S. government effort to be tested and certified in

the United States to European requirements, and vice versa.

OEURA staff members provide copies of directives,

information on the availability of standards, lists of

notified bodies, and interpretive guides, as well as

information on tariffs, value added and other taxation

requirements, and trade and economic data analysis. In

addition to these general information services, OEURA also

assists U.S. companies in overcoming specific tarde barriers

encountered in exporting to Europe, by serving as a link to

contacts and resources in the EU and, where necessary,

engaging in consultations or negotiations with EU officials.

62
National Center for Standards and Certification Information

(NCSCI)

National Institute of Standards and Technology

Bldg. 411, Room A163

Gaithersburg, MD 20899

(301) 975-4040

Fax: (301) 926-1559

e-mail: overman@micf.nist.gov

The Center, part of the Office of Standards Services, National

Institute of Standards and Technology, serves as a referral

service and focal point for standards-related information in

the United States. NCSCI staff respond to inquiries

concerning U.S., foreign, and international standards,

technical regulations and conformity assessment procedures.

There is no charge for the services.

The Center maintains an extensive reference collection of

standards, specifications, test methods, codes and recommended

practices as well as indexes, directories and other resource

material. NCSCI has a comprehensive standards bibliographic

CD-ROM database containing EU standards (CEN, CENELEC and

ETSI) and directives. Copies of these documents are available

on CD-ROM for review only (NCSCI does not provide copies of

standards) . The Center also subscribes to the Official

Journal of the European Communities and maintains various EUrelated publications.

NCSCI serves as the U.S. inquiry point in response to

obligations resulting from the World Trade Organization (WTO)

Agreement on Technical Barriers to Trade (TBT Agreement), the

North American Free Trade Agreement (NAFTA) , and the ISO

Information Network (ISONET) . The Center, with other national

inquiry points, form networks - for WTO and ISO - that

regularly exchange standards-related -information . These

networks also provide NCSCI with access to foreign traderelated technical standards, regulations and conformity

assessment procedures

Two hotlines are maintained by NCSCI to provide the latest

information on proposed foreign technical regulations notified

under the TBT Agreement (GATT Hotline - (301) 975-4041) and

draft CEN and CENELEC standards (EC Hotline - (301) 921-4164)

The recorded messages are updated weekly and are available 24

hours a day, 7 days a week.

An annual report and newsletter concerning NCSCI ' s TBT

Agreement activities are published and are available upon

request

63
Delegation of the European Commission

2300 M Street, N.W.

Washington, D.C. 20037-1434

Tel: (202) 862-9500

Fax: (202) 429-1766

Information

:

Tel: (202) 862-9539

64
Appendix C

PUBLICATIONS

Applications and Assistance Program

Office of Standards Services

National Institute of Standards and Technology

Gaithersburg, MD 20899

o The ABC's of Standards -Related Activities in the United

States (NBSIR 87-3576)

This report is an introduction to voluntary standardization,

product certification and laboratory accreditation for readers

not fully familiar with these topics. It stresses some of the

more important aspects of these fields; furnishes the reader

with both historical and current information on these topics;

describes the importance and impact of the development and use

of standards; and serves as background for using available

documents and services.

Order as PB 87-224309 from NTIS.

o The ABC'S of Certification Activities in the United States

(NBSIR 88-3821)

This report, a sequel to NBSIR 87-3576, The ABC'S of

Standards-Related Activities in the United States , provides an

introduction to certification for readers not entirely

familiar with this topic. It highlights some of the more

important aspects of this field, furnishes the reader with

information necessary to make informed purchases, and serves

as background for using available documents and services.

Order as PB 88-239793 from NTIS.

o Laboratory Accreditation in the United States (NISTIR 4576)

This report, a sequel to NBSIR 87-3576 The ABC'S of

Standards-Related Activities in the United States and NBSIR

88-3821 The ABC'S of Certification Activities in the United

States , is designed to provide information on laboratory

accreditation to readers who are new to this field. It

discusses some of the more significant facets of this topic,

provides information necessary to make informed decisions on

the selection and use of laboratories, and serves as

background for using other available documents and services.

Order as PB 91-194495 from NTIS.

65
o Questions and Answers on Quality, the ISO 9000 Standard

Series, Quality System Registration, and Related Issues

(NISTIR 4721)

This report provides information on the development, content

and application of the ISO 9000 standards to readers who are

unfamiliar with these aspects of the standards. It attempts

to answer some of the most commonly asked questions on

quality; quality systems; the content, application and

revision of the ISO 9000 standards; quality system

approval/registration; European Community requirements for

quality system approval/registration; and sources for

additional help.

Order as PB 93-152080/AS from NTIS.

o More Questions and Answers on the ISO 9000 Standard Series and

Related Issues (NISTIR 5122)

This report, a sequel to NISTIR 4721, provides additional

information on the ISO 9000 standards and related issues to

readers unfamiliar with some of the new developments in this

area. It attempts to answer additional questions on ISO 9000

standards related issues which NIST has received since the

publication of NISTIR 4721. It also identifies sources for

further help in this area.

Order as PB 93-140689 from NTIS.

o Directory of International and Regional Organizat ions

Conducting Standards-Related Activities (NIST SP 767)

This directory contains information on 338 international and

regional organizations which conduct standardization,

certification, laboratory accreditation, or other

standards-related activities. It describes their work in these

areas, as well as the scope of each organization, national

affiliations of members, U.S. participants, restrictions on

membership, and the availability of any standards in English.

Order as PB 89-221147 from NTIS or order as Cat. #SP767 from

Global Engineering Documents.

o Directory of European Regional Standards-Related Organizations

(NIST SP 795)

This directory identifies more than 150 European regional

organizations - both governmental and private - that engage in

standards development, certification, laboratory accreditation

and other standards-related activities, such as quality

assurance. Entries describe the type and purpose of each

organization; acronyms; national affiliations of members; the

nature of the standards-related activity; and other related

information

.

Order as PB 91-107599 from NTIS or order as Cat. #0258-3 from

Global Engineering Documents.

66
o Standards Activities of Organizat ions" in the United States

(NIST SP 806)

The directory identifies and describes activities of over

750 U.S. public and private sector organizations which

develop, publish, and revise standards; participate in this

process; or identify standards and make them available through

information centers or distribution channels. NIST SP 806, a revision of NBS SP 681, covers activities related to both

mandatory and voluntary U.S. standards. SP 806 also contains a

subject index and related listings that cover acronyms and

initials, defunct bodies and organizations with name changes.

Order as PB 91-177774 from NTIS or order as Cat. #SP806 from

Global Engineering Documents.

o Directory of Private Sector Product Certification Programs

(NIST SP 774)

This directory presents information from 132 private sector

organizations in the United States which engage in product

certification activities. Entries describe the type and

purpose of each organization, the nature of the activity,

product certified, standards used, certification requirements,

availability and cost of services, and other relevant details.

Order as PB 90-161712 from NTIS.

o Directory of Federal Government Certification Programs

(NBS SP 739)

This directory presents information on U.S. Government

certification programs for products and services. Entries

describe the scope and nature of each certification program,

testing and inspection practices, standards used, methods of

identification and enforcement, reciprocal recognition or

acceptance of certification, and other relevant details.

Order as PB 88-201512 from NTIS.

o Directory of Federal Government Laboratory Accreditation/

Designation Programs (NIST SP 808)

This directory provides updated information on 31 federal

government laboratory accreditation and similar type programs

conducted by the federal government. These programs, which

include some type of assessment regarding laboratory

capability, designate sets of laboratories or other entities

to conduct testing to assist federal agencies in carrying out

their responsibilities. The directory also lists 13 other

federal agency programs of possible interest, including

programs involving very limited laboratory assessment and

programs still under development.

Order as PB 91-167379 from NTIS.

o Directory of State and Local Government Laboratory

Accreditation/ Designation Programs (NIST SP 815)

This directory provides updated information on 21 state and

11 local government laboratory accreditation and similar type

programs. These programs, which include some type of

assessment regarding laboratory capability, designate private

sector laboratories or other entities to conduct testing to

assist state and local government agencies in carrying out

their responsibilities. Entries describe the scope and nature

of each program, laboratory assessment criteria and procedures

67
used in the program, products and fields of testing covered,

program authority, and other relevant details.

Order as PB 92-108968 from NTIS.

o Directory of Professional/Trade Organization LaboratoryAccredit at ion /Designation Programs (NIST SP 831)

This directory is a guide to laboratory accreditation and

similar types of programs conducted by professional and trade

organizations. These programs accredit or designate

laboratories or other entities to assist private sector

professional societies, trade associations, related

certification bodies, their membership, as well as government

agencies, in carrying out their responsibilities. This

accreditation or designation is based on an assessment of the

capability of the laboratory to conduct the testing. However,

the nature of the assessment varies considerably by

organization and program.

Order as PB 92-181940 from NTIS.

To order publications contact;

National Technical Information Service (NTIS)

52 85 Port Royal Road

Springfield, Virginia 22161, USA

Telephone: (703) 487-4650

Orders Only: (800) 553-6847

Fax: (703) 321-8547

Global Engineering Documents

15 Inverness Way East

Englewood, CO 80112-5704

Telephone: (800) 854-7179

(303) 792-2181

Fax: (303) 792-2192

68
Appendix D

Sources for U.S. and European Standards

The following U.S. organizations can provide copies of European

standards

Organization Information

American National Standards Institute (ANSI)

(the U.S. member body for ISO and IEC)

Standards

11 West 42nd Street, 13th Floor

New York, New York 1003 6, USA

Telephone: (212) 642-4900

Fax: (212) 302-1286 (Orders Only)

(212) 398-0023

Internet : http : / /www . ansi . org/home . html

Global Engineering Documents

(and Global Information Centers)

15 Inverness Way East

Englewood, Colorado

Telephone

Fax

(800)

(303)

(202)

(202)

(303)

80112-5704, USA

854-7179

792-2181

492-2860 (Washington, DC)

331-0960

792-2192

ANSI and ANSI approved

U.S. Industry

International (ISO and

IEC) and Foreign

Standards and Draft

ISO, CENELEC and

CEN Standards

U.S. Industry Standards

Federal (FED) , Military

(MIL) and Department

of Defense (DOD)

Specifications and

Standards /Handbooks

International /Foreign/

European Standards

and Documents

Historical standards

Standards Sales Group (SSG)

2 0 025 Highway 18

Apple Valley, California 92307

Telephone: (619) 946-0500

Fax: (619) 946-2999

2639, USA

International and

Foreign Standards,

Publications and Other

Reference Materials

Select U.S. and

Foreign Regulatory

Compliance Information

Translation Services

Document Center

1504 Industrial Way, Unit 9

Regulations

94 0 02, USA

Telephone: (415) 591-7600

Fax: (415) 591-7617

Internet : http : / /www . doccenter . com/

doccenter and e-mail: doc@netcom.com

U.S. Industry Standards

U.S. Federal

Belmont, California

DOD/MIL/ FEDERAL

standards/

specifications

EC/ International/

standards and

documents

Note: The National Center for Standards and Certification

Information, National Institute of Standards and Technology can

provide additional sources for obtaining standards in the United

States (see Appendix B)

69