I

AT L INST. OF STANCI & TECH R IX

A111Q5 612012

NIST Special Publication 951

A Guide to EU Standards

and Conformity Assessment

Helen Delaney

Rene van de Zande

Co-Editors
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2 Some elements at Boulder, CO.
NIST Special Publication 951

A Guide to EU Standards

and Conformity Assessment

Helen Delaney

Rene van de Zande

Co-Editors

Global Standards Program

Office ofStandards Services

National Institute ofStandards and Technology

Gaithersburg, MD 20899-2100

Order No. 43 NANB9 12297

May 2000

U.S. Department of Commerce

William M. Daley, Secretary

Technology Administration

Dr. Cheryl L. Shavers, Under Secretary ofCommercefor Technology

National Institute of Standards and Technology

Raymond G. Kammer, Director
National Institute of Standards and Technology Special Publication 951

Natl. Inst. Stand. Technol. Spec. Publ. 951, 39 pages (May 2000)

CODEN: NSPUE2

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON: 2000

For sale by the Superintendent of Documents

U.S. Government Printing Office

Washington, DC 20402-9325
ABSTRACT

This guide is an easy-to-use introductory reference for industry and

government officials on the general principles and concepts behind the

European Union's (EU) " New Approach" laws and directives. It is designed

to help business and government officials understand the new laws, the EU'

standardization process, and the relationship between the European

Commission and the European standardization bodies in the European Union.

It also provides information on the EU' s approach to conformity assessment

and requirements for obtaining CE mark to gain access to the European

Market. The guide offers explanations of such concepts and requirements as

notified bodies, conformity assessment modules, supplier's declaration of

conformity, technical construction files, user manuals, authorized

representatives, and product liability in the European Union.

Key Words: CEN; CENELEC; conformity assessment; directives; ETSI; European

Union; modules; New Approach; notified bodies; product liability; standards

supplier's declaration of conformity; technical construction files; user

manuals

iii
J
Contents

Introduction to Europe: A Single Market 1

Harmonization: A New Approach to Lawmaking 1

Table 1 : New Approach Directives 2

Essential Health and Safety Requirements: An Example 3

Technical Harmonization: Conformity Assessment 4

Harmonization: The Global Approach 4

Conformity Assessment: The Module Decision 4

Modules 6

Table 2: Modules: Conformity Assessment Procedures in European

Legislation 8

Table 2 : Conformity Assessment Procedures in European Legislation

(Continued) 9

Technical Harmonization: Standardization 10

The European Standards Bodies: CEN, CENELEC, and ETSI 10

The Role of Standards in New Approach Directives 10

Harmonized Standards and the Presumption of Conformity 11

The Role of Standards in the Marketplace 11

European National Standards 12

National Standards (Mutual Recognition) 12

Table 3: European Standards Bodies: CEN National Members 13

Table 4: European Standards Bodies: CENELEC National Members 14

Table 5: European Standards Bodies: ETSI 15

Standardization in the EU and the United States: A Comparison 15

Similari ties 15

Differences 15

The Relationships 16

ISO 9000 16

Introduction to the Basic Principles of Compliance 17

CE Marking 17

Determining Which Directives Apply to the Product 17

Who Affixes the CE Mark 18

Placing on the Market 19

v
Self -Certification 20

Notified Bodies 20

Competent Bodies 21

Competent Authorities 21

Mutual Recognition Agreements 22

EC Type-Examination 22

Manufacturer 22

The Importer 2 3

Private Labeler 23

Authorized Representative 23

Technical File 24

Content of the Technical File 24

Risk Assessment 25

User's Manual 26

Language 26

Declaration of Conformity 26

Sample Declaration of Conformity 2 8

Language 2 9

Signature of Declaration of Conformity 29

Declaration of Incorporation 29

Sample Declaration of Incorporation 31

Product Liability 32

National Marks 33

Surveillance Authorities 34

vi
A Guide to EU Standards and Conformity Assessment

Introduction to Europe: A Single Market

Europe is a prize market, easier to access than ever before. Too many U.S. exporters,

especially small and medium sized enterprises, avoid it because the technical

requirements for entry seem too complicated, too difficult, or too expensive. U.S.

manufacturers who have successfully accessed the European market know that the time

to understand the European system is well worth the effort. The European Union alone is

filled with affluent consumers, approximately 370 million of them. But the European

market is a large area that comprises not only the 1 5 countries that presently make up the

European Union (Austria, Belgium, Denmark, Finland, France, Germany, Greece,

Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United

Kingdom), but also the three countries that complete the European Economic Area (EEA)

(Iceland, Liechtenstein, and Norway, i.e., EFTA countries except Switzerland.) In

addition, there are approximately 1 1 other Central and Eastern European countries, such

as the Czech Republic and Poland, which are candidates for future membership in the

European Union. These countries are rapidly adopting European Union laws, standards,

conformity assessment procedures, and the practice of CE marking.

For the exporter, therefore, Europe as a whole has become a market whose technical

requirements have been greatly simplified. Before the creation of the European Union,

each country imposed its own technical requirements. Different standards and

conformity assessment procedures forced exporters to target one or two countries only, or

to forego exporting to Europe altogether. The unification of 15 European countries into a European Union, and the consequent harmonization of laws, standards, and conformity

assessment procedures, changed all that.

Harmonization: A New Approach to Lawmaking

The formation of the single market in Europe, one in which there was a free flow of

goods, had as one of its objectives the elimination of barriers to trade between the

Member State countries. Differences between national laws, standards, and conformity

assessment procedures made trade between the countries difficult, contentious, and

expensive. In order to eliminate these barriers, a new legislative technique and strategy

was instituted. The new approach was designed to envelop, or "harmonize," the health,

safety, and environmental requirements of 15 Member States into one European-wide

legislative package. The result of this new approach to lawmaking, or "harmonization,"

was a new set of laws that emanated from the European Commission in Brussels,

Belgium, the capital of the European Union. They were called the New Approach

Directives. In every case, one law replaced fifteen. Member States were required to

adopt the new harmonized laws.

1
Regulating and harmonizing laws for every product with specific, highly technical

requirements for each proved to be an impossible task. The new, more practical

approach, the New Approach, was to govern families of products. Regulation of these

products took on a more generic format, and was limited to "Essential Health and Safety

Requirements." Today, because these laws have replaced old national laws, products

meeting these essential health and safety requirements can be placed on the market in any

country within the European Economic Area (EEA) Union and move freely throughout

all 18 countries. The families of New Approach products are listed below in Table 1.

Table 1: New Approach Directives

Directive Ref. Directive Subject

90/396/EEC A "TiTkT T A \TOT7C1 TJ T TTiXTTXT/^ /"^ A fTAT TO T7T TT7T O APPLIANCES BURNING GASEOUS FUELS

93/68/EEC CE MARKING DIRECTIVE (COUNCIL DIRECTIVE AMENDING

O I HER DIREC 1 IVES)

OA/1 A/" /T^ T"1 89/106/EEC CONSTRUCTION PRODUCTS

89/336/EEC ELECTROMAGNETIC COMPATIBILITY

96/5 7/EC ENERGY EFFICIENCY REQUIREMENTS FOR HOUSEHOLD

ELECIRIC RbrRIGERAlORS, rRLEZERS, AND COMBINA1IONS

TUT3D C/"\T7

1 rlbKbUr

94/9/bbC X7/~\T TTDA /fCXTT^ A "\TT\ DTD r\TCPTT\ /C CVCTT7A /TC TXT DATC\ITT A T T \7 bQUlrJVlbJN I AND PROIbCilVb SYSlbJVIS IN POIbJN IIALLY

CVDT bXrbUMVb OCT\ 7T7 AA TA/r/~\CTJT-r"Cr> TJC

1 JVlUorrlbKbo

CVPT f^CTVRQ "GTYD r^T\/TT TTCT?C nArLUiil V Jtio rUK L^IVIJL Uorlo

yo/4o/t!/L. TXTT'CT? MDTh T? AT3TT TTV CW TD A\TC PTTO/^PT-? ATVT TJTT/TP' CDCTnF> T? A TT UN 1 cKUrliKArJli^l 1 Y Ur 1 KAlNo-iiUKUrilAIN xliorl-or JdJdJJ KAIL,

SYSTEM

95/1 6/EC LIFTS (ELEVATORS)

73/23/bbC LOW VOL1AGE bQUIPMbNl

AO/T7 /T? 98/37/bC MACHlNbRY, SArbiY Or

OA /AO /CP yo/yo/bL MAKiJNb bOUlriVlblN 1 90/385/EEC MEDICAL DEVICES: ACTIVE IMPLANTABLE

93/42/EEC MEDICAL DEVICES: GENERAL

98/79/EC MEDICAL DEVICES: IN VITRO DIAGNOSTIC

90/384/EEC NON-AUTOMATIC WEIGHING INSTRUMENTS

94/62/EC PACKAGING AND PACKAGING WASTE

89/686/EEC PERSONAL PROTECTIVE EQUIPMENT

COM(93)322 PRECIOUS METALS (NOT FORMALLY PROPOSED)

97/23/EC PRESSURE EQUIPMENT

87/404/EEC PRESSURE VESSELS, SIMPLE

1999/5/EC RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL

EQUIPMENT AND THE MUTUAL RECOGNITION OF THEIR

CONFORMITY

94/25/EC RECREATIONAL CRAFT

88/378/EEC TOYS, SAFETY OF

Obviously, not all products are governed by New Approach Directives. There are

essentially three regulatory levels. Technical requirements differfor each ofthem. There

2
are the "old approach " regulations, which have technical specifications integrated into

the annexes. Some ofthese products are regulated on a product-by-product basis. The

New Approach Directives make references to harmonized standards. In the third level,

products are unregulated at the EU level, but the products may be regulated at the

national level and are governed by Member State laws. It must be remembered that the

European Union is the newest economic region in the industrialized world and as such, is

still a work in progress. This guide will cover only the products thatfall under the New

Approach Directives listed above.

Essential Health and Safety Requirements: An Example

Essential health and safety requirements are at the heart of the New Approach Directives.

They are mandatory, legally binding obligations, and they are enforced. Following is

one of the essential requirements taken directly from the Machinery Directive. It relates

to the starting function:

"Starting. It must be possible to start machinery only by voluntary actuation of a

control provided for the purpose. The same requirement applies when restarting

the machinery after a stoppage, whatever the cause, when effecting a significant

change in the operating conditions (e.g., speed, pressure, etc.), unless such

restarting or change in operating conditions is without risk to exposed persons.

This essential requirement does not apply to the restarting of the machinery or to

the change in operating conditions resulting from the normal sequence of an

automatic cycle.

Where machinery has several starting controls and the operators can therefore put

each other in danger, additional devices (e.g., enabling devices or selectors

allowing only one part of the starting mechanism to be actuated at any one time)

must be fitted to rule out such risks.

It must be possible for automated plant functioning in automatic mode to be

restarted easily after a stoppage once the safety conditions have been fulfilled."

The aim of most essential requirements is the elimination of risks of accident to the

extent possible. All manufacturers, domestic or foreign, are obliged to meet all the

essential requirements pertaining to their product. The law does not distinguish between

European manufacturers and manufacturers of other countries.

Conformity assessment in Europe, therefore, is the process by which compliance with

essential requirements is determined. This process can be carried out with or without the use of standards. This last principle is important to manufacturers of new or innovative

products for which standards do not yet exist, and ensures that standards annexed to New

Approach Directives (which are voluntary) do not become de jure obligatory.

3
Technical Harmonization: Conformity Assessment

Conformity assessment is defined by the International Organization for

Standardization/International Electrotechnical Commission Guide 2: 1996 as:

"any activity concerned with determining directly or indirectly that relevant

requirements are fulfilled."

Typical examples of conformity assessment activities are sampling, testing and

inspection, evaluation, verification and assurance of conformity (supplier's declaration),

certification, registration, accreditation, and approval as well as their combinations.

Conformity assessment may also be the process by which it is determined that a product's

design meets a specification or standard.

Conformity assessment may vary in levels of difficulty and complexity, depending on the

level of risk associated with the product. If a Harmonized Standard is used to meet an

essential requirement of a New Approach Directive, and if the risk of injury is low (See

Risk Assessment), no third party conformity assessment procedure is required. (This is

true regardless of the nationality of the manufacturer.) A manufacturer or supplier may

declare, after performing the necessary product evaluations (through a Declaration of

Conformity), that the product meets the essential requirements of a directive. As the risk

of injury increases, the level of complexity of the conformity assessment process (and the

cost) increases with it. The applicable directive will be the guide to the level of risk

involved and the methods of conformity assessment that may be employed.

Harmonization: The Global Approach

In Europe, the point of the New Approach Directives was to eliminate differences

between national laws, thereby eliminating barriers to trade between the Member States.

But differences in national standards and testing and certification procedures were the

root causes of barriers to trade, and it followed that a new, integrated scheme for

technical harmonization had to be implemented as well. The new scheme was embodied

in two Decisions: (1) the Module Decision, and (2) the regulation on CE Marking. The

policy was called the Global Approach. It incorporated conformity assessment

procedures directly into the New Approach Directives.

Conformity Assessment: The Module Decision

The Module Decision (90/683/EEC) set out the criteria and guidelines for conformity

assessment procedures to be used in the New Approach Directives. The General

Guidelines are as follows and are taken directly from the document as it appeared in the

Official Journal of the European Communities No. L 380/14, dated December 12, 1990:

4
the essential objective of a conformity assessment procedure is to enable the

public authorities to ensure that products placed on the market conform to the

requirements as expressed in the provisions of the directives, in particular with

regard to the health and safety of users and consumers;

conformity assessment can be subdivided into modules which relate to the design

phase of products and to their production phase;

as a general rule a product should be subject to both phases before being able to

be placed on the market if the results are positive;

there are a variety of modules which cover the two phases in a variety of ways.

The directives shall set the range of possible choices which can be considered by

the Council to give the public authorities the high level of safety they seek, for a given product or product sector;

in setting the range of possible choices open to the manufacturer, the directives,

will take into consideration, in particular, such issues as the appropriateness of the

modules to the type of products, the nature of the risks involved, the economic

infrastructures of the given sector (e.g., existence or non-existence of third

parties), the types and importance of production, etc. The factors that have been

taken into account must be explicitly spelled out by the Commission in these

directives;

the directives will, in setting the range of possible modules for a given product or product sector, attempt to leave as wide a choice to the manufacturer as is

consistent with ensuring compliance with the requirements;

The directives will set out the criteria governing the conditions in which the

manufacturer shall choose the most appropriate modules for his production from

the modules laid down by the directives;

the directives should avoid imposing unnecessarily modules which would be too

onerous relative to the objectives of the directive concerned;

notified bodies should be encouraged to apply the modules without unnecessary

burden for the economic operators. The Commission, in cooperation with the

Member States, shall ensure that close cooperation is organized between the

notified bodies in order to ensure consistent technical application of the modules;

in order to protect the manufacturers, the technical documentation provided to

notified bodies has to be limited to that which is required solely for the purpose of

assessment of conformity. Legal protection of confidential information shall be

required;
(j) whenever directives provide the manufacturer with the possibility of using

modules based on quality assurance techniques, the manufacturer must also be

able to have recourse to a combination of modules not using quality assurance,

and vice versa, except where compliance with the requirements laid down by the

directives requires the exclusive application of a certain procedure;

(k) for the purposes of operating the modules, Member States shall notify on their

own responsibility bodies under their jurisdiction which they have chosen from

the technically competent bodies complying with the requirements of the

directives. This responsibility involves the obligation for the Member States to

ensure that the notified bodies permanently have the technical qualifications

required by the directives and that the latter keep their competent national

authorities informed of the performance of their tasks. Where a Member State

withdraws its notification of a body, it shall take appropriate steps to ensure that

the dossiers are processed by another notified body to ensure continuity;

(1) in addition, with regard to conformity assessment, the sub-contracting of work

shall be subject to certain conditions guaranteeing:

the competence of the establishment operating as sub-contractor, on

the basis of conformity with series EN 45000 standards, and the

capability of the Member State that has notified the sub-contracting

body to ensure effective monitoring of such compliance;

the ability of the body notified to exercise effective responsibility for

the work carried out under sub-contract;

(m) notified bodies which can prove their conformity with harmonized standards (EN

45000 series), by submitting an accreditation certificate or other documentary

evidence, shall be presumed to conform to the requirements of the directives.

Member States having notified bodies unable to prove their conformity with the

harmonized standards (EN 45000 series) may be requested to provide the

Commission with the appropriate supporting documents on the basis of which

notification was carried out;

(n) a list of Notified Bodies shall be published by the Commission in the Official

Journal ofthe European Communities and constantly updated."

Note: Lists ofNotified Bodies are published by the European Commission in the

"Official Journal ofthe European Communities. " A hard copy may be requestedfrom

Mrs. Janette AISTROPE, Tel: 011-322-299-9060, Fax: 011-322-296-0851, E-mail

Janette. Aistrope@cec.eu.int. At present, these lists are not available electronically.

Modules

Modules are how conformity assessment procedures used in New Approach Directives

are organized. Always found in an Annex to the Directives, the modules describe the

6
specific conformity assessment procedures to be applied to the products regulated by that

directive.

Modules vary in complexity. For example, Module A permits the manufacturer to

assume total responsibility for conformity assessment. If the product is manufactured to

Harmonized Standards, and if the risk is not unusually high (as in most machinery, for

example), the manufacturer may rely on internal manufacturing checks. He or she

compiles a Technical File, issues a Declaration of Conformity to the appropriate

directives, and if appropriate, standards, applies the CE marking, and places the product

on the market.

Modules for active implantable medical devices, on the other hand, could call for a type

examination of the product, plus a production quality assurance system that conforms to

the ISO 9002 (EN 29002) standard. Another choice for a medical device manufacturer

would be a complete quality assurance program that would conform to ISO 9001 (or EN

29001).

Where the risk is high and/or where Harmonized Standards are not used, the modules will

call for the involvement of a third party. In Europe, these third parties are designated by

authorities and are called Notified Bodies.

Each directive provides the module choices available, but there are no choices beyond the

modules specified.

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Technical Harmonization: Standardization

The harmonization of standards, like laws and conformity assessment procedures, has

greatly simplified technical regulation in Europe. Prior to harmonization, each country

developed its own standards through a national standards body. And, like differing and

conflicting laws and conformity assessment procedures, fifteen sets of standards were not

only costly, but also created technical barriers to trade between European countries. It became necessary to create a new, integrated, European system of standardization.

The European Standards Bodies: CEN, CENELEC, and ETSI

The new system provides for three standards bodies to create standards on a Europe-wide

level: (1) The European Committee for Standardization (CEN) in Brussels, Belgium; (2)

the European Committee for Electrotechnical Standardization (CENELEC) in Brussels,

Belgium; and (3) The European Telecommunications Standards Institute (ETSI), in

Sophia Antipolis, France. CENELEC activities are in the electrotechnical sector, while

ETSI specializes in telecommunications. All other sectors are covered by CEN.

CEN and CENELEC's principal members are national standards bodies (See Table 3 and

Table 4). ETSI's membership incorporates a wider range of interested parties (See Table

5). These three are the only recognized bodies from which a European Standard (EN) can

emanate. When the development of a European Standard begins in one of these

organizations, development of a national standard must stop. European Standards, like

European laws and European conformity assessment procedures, preempt national

(Member State) standards, and replace them.

The Role of Standards in New Approach Directives

The European Standards (ENs) that play a role in New Approach Directives are known as Harmonized Standards. Harmonized Standards are standards that support European

legislation. They (1) have been mandated by the European Commission, (2) have been

developed by the European Standards Bodies above, (3) address essential requirements of

New Approach Directives; and (4) notification of their development has been published

in the Official Journal ofthe European Communities.

For example, the following harmonized standards have met all the conditions above and

relate to certain Essential Health and Safety Requirements of the Safety of Machines

Directive (98/37/EC):

CEN EN Safety of machinery - Ergonomics requirements for the design of

894-1 displays and control actuators - Part 1 : General principles for human

interactions with displays and control actuators

CEN EN Safety of machinery - Ergonomics requirements for the design of

894-2 displays and control actuators - Part 2: Displays

10
Technically speaking, the use of a Harmonized Standard is voluntary. That is, a manufacturer can elect to use a Harmonized Standard (like the ones above), or elect to

use a non-Harmonized Standard (an American Standard, for example) to meet essential

requirements. When using a Harmonized Standard, however, the manufacturer is

presumed in conformity with the law. On the contrary, using a standard that is not a Harmonized Standard will impose additional responsibilities. The use of anything but a Harmonized Standard places a burden of proof upon the manufacturer that the product

meets essential requirements. This proof may be provided by the manufacturer's

Technical File, by the employment of a third party (consultant, testing house, etc.), or by

a combination of the two. (The directive will prescribe conformity assessment

procedures that are commensurate with the risk of injury associated with the product.)

Harmonized Standards and the Presumption of Conformity

Presumption of conformity is a legal concept surrounding Harmonized Standards that

denotes the relationship between the legislative and standardization processes. The

European Commission (the lawmaking body) and the European Standards Bodies

collaborate to produce Harmonized Standards. They enter into a contractual relationship,

with the Commission providing financial support when needed. The contract (or

mandate) stipulates that the standards body will produce a standard that will provide a

technical solution, or a technical interpretation, of an essential health and safety

requirement. When the standard is completed and the conditions of the Commission's

mandate are met, the Commission publishes the notice of its completion in the Official

Journal ofthe European Communities. Once the notice is published, the standard takes

on the presumption of conformity mantle. A manufacturer, therefore, using a Harmonized Standard in the design and/or production of the product, is presumed to be in

conformity with the essential requirements of the law.

The Role of Standards in the Marketplace

There is a vast body of European Standards (ENs) that is not mandated by the

Commission; and these standards are not necessarily directed toward essential

requirements. In theory, their use is voluntary, just as the use of harmonized standards is

voluntary. These standards may or may not address health or safety aspects of products.

They may define other characteristics, such as durability, appearance, quality levels, or even cultural preferences. They may be test methods, or measurement guides.

The use of a European standard in the European marketplace, however, has definite

advantages. Chief among them is recognition. A standard that does not emanate from

one of the European Standards Bodies is not always recognized by insurers, lending

institutions, retailers, developers, conformity assessment bodies, and consumers, and may

hinder acceptance of the product in the marketplace, particularly when a European

Standard already exists for the same product.

11
European National Standards

The harmonization, or the "Europeanization," of standards is an ongoing process. There

will be instances when no European Standard (EN) exists to cover essential requirements,

or no European Standard exists that is applicable to a product that is unique, or innovative, or a product whose technology is developing rapidly. In this case, a Member

State may inform the manufacturer of an existing national standard it considers relevant, or the use of a national standard may be permitted as a temporary solution to the proper

implementation of the essential requirements. However, a national standard, (one

produced by a European National Standards Body), like all other standards worldwide,

does not carry with it the presumption of conformity, and the burden of proof that the

product meets all the essential requirements still rests with the manufacturer.

National Standards (Mutual Recognition)

National standards may still govern products regulated at Member State level. The

harmonization of regulation is also an ongoing process, and some products that are unregulated at European level are still regulated by Member States. This means that

some national standards act as national technical regulations.

(If products are unregulated at the European level, the European Court of Justice has

decreed that Member States must recognize them in each other's territory (i.e.,

acceptance in one Member State means acceptance in all) unless there are proven health

or safety restrictions. This acceptance principle is known as mutual recognition. To this

date, however, products outside of the food sector have not enjoyed a liberal and free

exchange under the mutual recognition principle).

12
Table 3: European Standards Bodies: CEN National Members

CEN Web Site: http://www.cenorm.be

National Standards Body Country

ON Austria

http://www.on-norm.at

IBN/BIN Belgium

http://www.ibn.be

/-tn\ tt CSNI

http://www.csni.cz

Czech Republic

DS Denmark

http://www.ds.dk

SFS Finland

http://www.sfs.fi

AFNOR France

http ://www. amor, rr DIN

http://www.din.de

Germany

ELOT Greece

http://www.elot.gr

STRI Iceland

http ://www. stri .is NSAI Ireland

http://www.nsai.ie

T TV TT UNI

http : //www. unicei . it

T, 1 Italy

SEE Luxembourg

http://www.etat.lu/SbE

NNI "V T i 1 1 1 Netherlands

http : //www.nni.nl

NSF

http://www.standard.no/nsf

X T Norway

IPQ

http://www.ipq.pt

Portugal

AENOR Spain

http://www.aenor.es

SIS Sweden

http://www.sis.se

SNV Switzerland

http://www.snv.ch

BSI United Kingdom

http://www.bsi.org.uk

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Table 4: European Standards Bodies: CENELEC National Members

CENELEC Web Site: http://www.cenelec.be

National Standards Body Country

OVE Austria

http://www.ove.at

BEC/CEB Belgium

http ://www/bec-ceb/be

CSNI

http://.www/csni.cz

Czech Republic

DS Denmark

http://www.ds.dk

SESKO Finland

http : ://www. sesko . fi UTE France

http://www.ute-fr.com

DKE

http://www.dke.de

Germany

ELOT Greece

http://www.elot.gr

STRI Iceland

http://www.stri.is

ETCI Ireland

http://www.etci.ie

CEI

http : //www. ceiuni . it

Italy

SEE Luxembourg

http : //www. etat . lu/S EE

NEC Netherlands

http://www.nni.nl

NEK

http : //www. nek. no

Norway

IPQ Portugal

http://www.ipq.pt

AENOR

http://www.aenor.es

Spain

SEK Sweden

Http ://www. sekom. . se CES Switzerland

http : //www. sev. ch

BEC United Kingdom

Http://www.bsi. org.uk

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Table 5: European Standards Bodies: ETSI

ETSI Web Site: http://www.etsi.org

The European Telecommunications Standards Institute (ETSI) is composed of some 697

members from 50 countries, including the United States. They represent Administrations

(8.7%), network operators (17.75%), manufacturers (51.27%), service providers (18.48%), and

users (3.8%).

There are 552 full members from 35 countries, 62 observers from 18 countries (which category

has the largest U.S. concentration), and 83 associate members from 15 countries.

Standardization in the EU and the United States: A Comparison

Standardization, when used specifically to translate laws into technical solutions for

implementation, is tantamount to technical regulation. Standards developed by private

sector standards committees for this purpose, therefore, can have a profound effect on the

regulation of trade. A standard can determine, by defining and delineating technical

characteristics, what conditions will permit a product on the market. By excluding

characteristics, a standard can also prohibit a product from being placed on the market. In

non-regulated areas, standards can exert an equally powerful influence on the

marketplace. It is important, therefore, that wherever possible, manufacturers participate

in standards development where it impacts their targeted markets.

Similarities

The philosophy of standardization by committee and consensus is the same in the EU as

it is in the United States. Technical experts and others participate voluntarily, and

without compensation. The makeup of committees may be organized differently and

roles may vary, but they generally follow a pattern that includes input from producers,

users, government, and academia. On both sides, committees are fairly autonomous; and

both sides have processes for the creation of subcommittees, drafting of standards,

disseminating draft documents for comment, voting, and appeals. On both sides,

decisions are reached by consensus. And on both sides, standards organizations provide

management, administrative, and logistical support for standards activities. They also

provide for the editing, printing, publishing, sale, and distribution of standards

documents.

Differences

The differences between the United States and the EU are most notable in the way

standards activities are organized. In Europe, the structure of centralized national

standards bodies and centralized regional bodies (The European Standards Bodies)

contrasts sharply with the decentralized structure and the myriad of bodies that develop

15
standards in the United States. Organized by nation in Europe, standards activities are organized by sector in the United States.

Another striking difference between the two is policy regarding membership in standards

bodies. Membership in a national standards body in Europe requires that the member be

European or have a business interest or manufacturing presence in Europe (membership

in a national standards body is a prerequisite for participation in the European Standards

Bodies, except for ETSI, where participation is open to other nationals). In the United

States, in the large, full consensus standards developing bodies, membership is

unrestricted. Depending on the sector and global interest in the subject, therefore,

membership on a U.S. technical committee can be international in scope.

The Relationships

There is a relationship between U.S. standards activities and those in the EU. Two

organizations, the American National Standards Institute (ANSI) in the United States,

and the International Organization for Standardization (ISO) in Geneva, Switzerland, act as bridges to CEN, and ANSI, via the United States National Committee (USNC), and

the International Electrotechnical Commission (IEC) in Geneva, Switzerland, act as bridges to CENELEC.

The American National Standards Institute (ANSI) is the U.S. representative to the ISO.

It is also, via the USNC, the U.S. representative to the IEC. Each European national

standards body represents its country in the ISO and the IEC. The technical committees

of both the ISO and the IEC, therefore, are where technical experts from the EU countries

meet technical experts from the United States to develop international standards.

In addition, there are technical cooperation agreements between CEN and the ISO and

CENELEC and the IEC. These agreements more closely align their work. These

agreements are known as the Vienna (CEN/ISO) and Dresden (CENELEC/IEC)

Agreements. In certain areas (such as recreational craft), the standards recognized for use

in connection with European legislation are in effect the ISO standards.

It is also possible for U.S. interested parties to comment on draft CEN and CENELEC

standards through ANSI.

ISO 9000

The first quality management system standard was developed in Europe by the British

Standards Institution (BSI) in 1979. BSI took the activity into the ISO, and the result was

the ISO 9000 series of standards that are so well known and widely used throughout the

world today. When the European Commission adopted these standards as part of the

Global Approach, they became an integral and official part of the European conformity

assessment scheme. The European designation for this set of standards is EN 29000 (See

Modules). Two New Approach Directives (Active Implantable Medical Devices and the

Radio Equipment and Telecommunications Terminal Equipment and the Mutual

16
Recognition of their Conformity) designate a full quality management system (EN 46001

for Medical Devices and EN 29001 for RTTE) as a full route to CE marking. However,

a less comprehensive form of this standard may be used, along with other methods of

conformity assessment, to meet the essential requirements of this directive and other

directives as well.

Perhaps more importantly, ISO 9000 registration (or EN 29000 certification) is used

voluntarily but extensively in Europe as a condition of acceptance of a manufacturer's

product or as a means of recognition of the manufacturer's credibility. It is estimated

that, as of 1994, 78% of all ISO certificates worldwide were issued in Europe. The U.S.

exporter, therefore, should be aware not only of the use of EN 29000 in regulation, but of

its use in contractual arrangements with a European customer.

It is important to note that a manufacturer with a quality system in place (such as ISO

9000) should not automatically assume that his or her products are CE compliant

because ofthe quality system alone. The appropriate New Approach Directive(s) will

prescribe the correct andfull route to conformity assessment.

Introduction to the Basic Principles of Compliance

CE Marking

The CE mark is aptly called the passport to Europe for products. CE marking a product,

like carrying a passport when entering a foreign country, is not an option. It is required

by law if the product falls under one of the New Approach Directives. It is not a quality

mark, nor is it a mark for consumers. Intended for Member State authorities, it is the

visible sign to those authorities that your product is in compliance with the New

Approach Directives. All manufacturers, European, American, Japanese, or other, are required to affix the CE mark to products that are governed by New Approach Directives.

CE marking on a product indicates to all authorities that the product is in compliance

with the essential health and safety requirements of all directives that apply to the

product.

Determining Which Directives Apply to the Product

The first step to compliance is determining which directives apply to the product. A

product may be regulated by more than one directive. For example, machinery is

obviously regulated by the Machinery Directive (98/23/EC); but machinery that is

powered by electricity is also regulated by the Low Voltage Directive (73/23/EEC). The

LVD addresses the hazards associated with the electrical aspects of the machine.

Likewise, all electrical products are governed by the Electromagnetic Compatibility

Directive (89/336/EEC), which addresses the hazards associated with electromagnetic

interference. Most machinery is regulated by at least three New Approach Directives:

(1) Safety of Machinery, (2) Low Voltage, and (3) Electromagnetic Compatibility. But

there may be others that apply. If a machine contains a pressure vessel, for example, it

17
would also be regulated by the Simple Pressure Vessel Directive (87/404/EEC). The CE

marking affixed to a piece of machinery, therefore, would indicate to authorities that the

product has addressed all the risks associated with the product, whether or not those risks are defined in the Machinery Directive, the Low Voltage Directive, the EMC Directive, or any other directive that addresses a risk associated with the machine. Before affixing

the CE mark, therefore, the manufacturer must make sure the product complies with the

law by (1) determining which New Approach Directives govern the product, (2) applying

the appropriate standards, and (3) carrying out the appropriate method of conformity

assessment.

The CE mark does not disclose which directive(s) or standards apply to the product, nor

will it indicate the method of conformity assessment used to bring the product into

compliance. This information is provided by other accompanying documents, such as the

Declaration of Conformity.

Who Affixes the CE Mark

The Manufacturer or the Authorized Representative affixes the CE marking to the

product. It is not affixed by a Notified Body. The CE mark, consisting of the initials

"CE," and appearing as follows,

Figure 1. "CE" logo

must be affixed to the product, to its data plate or, where this is not possible, to its

packaging. Instructions for the graphic design are contained in Annexes to the

Directives and in Directive 93/68/EEC, known as the "CE Marking Directive." The CE

marking must be affixed visibly, legibly, and indelibly. Where special provisions do not

impose specific dimensions, the CE marking must have a height of at least 5 millimeters.

18
Figure 2: Actual layout for art work for the "CE " logo. NOTE: The grid is not actually

seen on the final art work. See Figure 1 above.

If the CE marking is affixed to a product inappropriately, the product may be prohibited

from being placed on the market or withdrawn from the market. Other marks may be

affixed to the product, provided they do not reduce the visibility or legibility of the CE

marking.

Placing on the Market

The European Commission's Guide to the Implementation ofDirective based on the New

Approach and Global Approach (Brussels, August 1999) defines "placing on the market"

as: "The initial action of making available on the Community market, for payment or free

of charge, a product covered by the directive, with a view to distribution and/or use in the

Community." This includes products that are manufactured within the European Union

and products imported from a country outside the European Union.

The following situations involving products are not considered "placing them on the

market:"

• Transfer of a product from a manufacturer in a country outside the European Union to

his Authorized Representative in the European Union for the purpose of ensuring

compliance;

• Importation of a product into the European Union for re-export outside the European

Union;

• Transfer of a product produced in the European Union to a country outside the

European Union;

• Exhibition of a product at trade fairs and exhibitions (where it must be clearly

indicated that the exhibited product is not in compliance);

• Transfer of a product to a manufacturer for further measures (for example,

assembling, packaging, processing or labeling); and

19
• Not (yet) granted release for free circulation by customs, or has been placed under

another customs procedure (for example, transit, warehousing or temporary

importation).

Self-Certification

Most products covered by New Approach Directives can be self-certified by the

manufacturer and do not require the intervention of a Notified Body. To self-certify, the

manufacturer must assess the conformity of products to the applicable directives, and to

the standards if applied.

The manufacturer may affix the CE marking to products or equipment (and prepare and

sign the Declaration of Conformity) as long as he or she can prove conformity to the

applicable requirements. Proof is provided in the Technical File that the manufacturer

must compile.

Certain (high risk) products may not be self-certified, but must be subjected to an EC

type-examination. This examination involves the inspection of a representative example

by a Notified Body.

Notified Bodies

Most products within the scope of European product legislation (New Approach

Directives) can be self-certified by the manufacturer and do not require the intervention

of a Notified Body.

There are products, however, which may not be self-certified, but must be subjected to an

EC type-examination. This examination involves the inspection of a representative

example by a Notified Body within the EEA.

Notified Bodies are independent testing houses, laboratories, or product certifiers

authorized by the EU Member States 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 and/or certification requirements set forth

in a directive. A Notified Body not only needs to be technically competent and capable of

carrying out the specified conformity assessment procedures, but it must also demonstrate

independence, impartiality, and integrity (The EN 45000 standard series addresses

criteria for accreditation, assessment, and operation of conformity assessment bodies, i.e.,

Notified Bodies).

Notified Bodies may carry out their activities in one or more Member States or in

countries outside the EEA. A Notified Body may also use a subcontractor to perform

part(s) of a conformity assessment procedure. Many U.S. testing houses, for example, act

as subcontractors to Notified Bodies. The Notified Body, however, is the ultimate

20
authority, is always responsible, and is the sole source of the certificate claiming

compliance.

Manufacturers, inside or outside of the EEA, may choose any Notified Body that has

been designated to carry out the conformity assessment procedure(s) specified in

applicable directive(s). Certificates issued by a Notified Body in one Member State must

be accepted throughout the EEA.

Lists ofNotified Bodies are published by the European Commission in the "Official

Journal ofthe European Communities. " A hard copy may be requestedfrom Mrs.

Janette AISTROPE, Tel: 01 1-322-299-9060, Fax: 01 1-322-296-0851, E-mailJanette.

Aistrope@cec.eu.int. At present, these lists are not available electronically.

Competent Bodies

The Electromagnetic Compatibility Directive (EMC) is unique in that, in addition to

Notified Bodies, it references Competent Bodies (accredited testing houses). According

to the EMC Directive, a Competent Body must be consulted when the manufacturer has

not used (all) applicable Harmonized Standards in the design or production of the

product. This manufacturer's Technical File will have to contain a technical report or

certificate obtained from a Competent Body. The role of the Competent Body, therefore,

is to assist the manufacturer in assessing and elucidating the compliance of his product

with the EMC Directive by issuing technical reports and certificates.

Notified Bodies, on the other hand, are specified within the EMC Directive to be

consulted only for an EC type approval for transmitting equipment.

Competent Authorities

Competent Authorities are Ministries of National Governments of EEA Member States

and are responsible for the supervision of the market and products already on the market.

21
Mutual Recognition Agreements

In December 1998, The European Union and the United States concluded Mutual

Recognition Agreements (MRAs) on conformity assessment. The U.S. - EU MRA is a

bilateral agreement between the United States and the European Union that establishes

procedures to facilitate transatlantic trade. The MRA recognizes that certain conformity

assessment bodies (CABs) in Europe can conduct - in accordance with U.S. regulatory

requirements - product approval type testing and quality system evaluations in a fashion

equivalent to those conducted by the FDA. Similarly, it recognizes that CABs in the

United States can conduct type testing and quality evaluations according to the EU

Medical Device Directive. The agreements cover several industrial sectors and are based

on acceptance by both Parties of test reports, certificates, and reports of inspections

issued by one another's conformity assessment bodies (CABs) and authorities.

MRAs include lists of conformity assessment bodies, inspection bodies, and

authorities, in both the EU and the United States. The full text of the U.S.- EU

MRA can be accessed at http://www.ustr.gov/agreements/mra/mral.pdf

EC Type-Examination

The EC type-examination is a procedure by which the Notified Body ascertains and

attests that a specimen representative of production meets the provisions of the directive

that applies to it. The manufacturer or his Authorized Representative established in the

European Union may make application to the Notified Body of his choice.

Manufacturer

The manufacturer is the person responsible for designing and manufacturing a product

covered by a New Approach Directive, and whose intention is to place it on the European

Union market. A manufacturer may contract out the design or production, may use

finished products, parts or components. In all cases, however, he or she is ultimately

responsible for the product and its compliance with the law.

The manufacturer is responsible for designing and manufacturing the product in

accordance with the essential requirements of all relevant directives and following the

conformity assessment procedures from the appropriate directives, such as compiling a Technical File, affixing the CE marking and drawing up of a Declaration of Conformity.

A manufacturer may be located inside or outside the European Union. Inside or out, he

or she can appoint an Authorized Representative (who must be located in the European

Union) to act on his or her behalf.

A person producing a new end product by assembling other existing products is also

considered a manufacturer, and acquires the responsibilities of a manufacturer. The

same is true of a person who changes the usage of a product, such as adding a new

function to a machine or changing an existing function. The law treats these "modified"

22
products as new products, and they are held to the same certification requirements as any

other new product.

The Importer

An importer is a person legally established within the European Union who places a product from a country outside the European Union on the European Union market.

Although the importer can provide the Surveillance Authority with the necessary

documentation or information regarding a product when the manufacturer is not

established in the European Union and the manufacturer has no Authorized

Representative, he or she may not wish to assume this responsibility. The decision is

declared in a contract between the importer and the manufacturer.

Private Labeler

In accordance with European product liability legislation, a person acting as the

manufacturer of the product, even if he or she is not the producer, is considered a manufacturer in the eyes of the law. This principle applies to the "private labeler." A

private labeler is one who does not manufacture the product, but places it on the market

under his or her private name or make. The "private labeler," therefore, as manufacturer,

is ultimately responsible for compliance with all requirements.

Authorized Representative

An Authorized Representative is the person appointed by the manufacturer and delegated

to act on his or her behalf in carrying out certain tasks required by a New Approach

Directive. This Authorized Representative must be established inside the European

Union and available to Member State Authorities. The manufacturer, however, is

ultimately responsible for the actions carried out by the Authorized Representative.

Manufacturers established outside the European Union are not necessarily required to

have an Authorized Representative in the European Union. There are exceptions,

however. Manufacturers who do not have a registered place of business in a Member

State and whose products are governed by the Directives for Medical Devices, Active

Implantable Devices and In-vitro Diagnostic Devices, must appoint an Authorized

Representative established within the European Union.

The delegation of tasks from the manufacturer to the authorized representative should be

arranged by contract.

Depending on the conformity assessment procedure and the directive, the following tasks

can be delegated to the Authorized Representative. He or she can:

• declare that the product complies with the requirements;

• affix the CE marking;

• draw up and sign the Declaration of Conformity; and

23
• keep the Declaration of Conformity available for national surveillance authorities.

Technical File

New Approach Directives contain more opportunities for self-declaration than mandated

third party involvement; but the right to self-declare compliance with the law means that a manufacturer must be responsible for completing all the procedures required by the law.

Most New Approach Directives allow the manufacturer to "self-declare" compliance with

Essential Health and Safety Requirements, but some directives require Notified Body

intervention (See Modules). For example, Annex IV of the Machinery Directive lists

types of machines that must be submitted to a Notified Body for evaluation. Whether or not the judgment of a Notified Body is required, the manufacturer is required to prepare a Technical File.

The Technical File is the written justification that all aspects of a product are safe. For

goods that must bear CE marking, this written justification must be prepared before the

product is placed on the market. The Technical File includes information that

demonstrates the technical basis for conformity of the product to the applicable

requirements of the directive.

The manufacturer must keep the Technical File for ten years after the last unit is placed

on the market, unless the directive provides for a different duration.

Any person placing a product on the market but not in possession of the Technical File

must, on request from national Surveillance Authorities, 1 ) state where the Technical File

is situated, and 2) produce the Technical File promptly. Most manufacturers already

possess 90% of the material necessary to compile a Technical File.

Content of the Technical File

The following main elements should be present in a Technical File:

• a general description of the product;

• design and production drawing and diagrams;

• detailed technical data for essential aspects of the product;

• a risk assessment;

• a list of standards and or solutions applied;

• reports of calculations and tests that have been carried out (calculations might include

a bearing, belt, or pulley based on a chart in a catalog);

• certificates and inspection reports;

• in the case of series production, internal conditions that have been observed to

safeguard compliance with the directive;

• a user's manual; and

• a Declaration of Conformity.

24
A Technical File may cover a range of product models or options. Similar but simpler

models may be considered within the scope of the most complex or most hazardous

combination evaluated.

A Technical File is proprietary in nature. It need not be given to one's customers or

competitors. The Technical File must be kept available for inspection or control by

national Surveillance Authorities who may ask to see all or parts of the Technical File.

Risk Assessment

Most New Approach Directives require a risk evaluation of the products they govern.

Assessing risks in the design phase of a product is an established practice. A good

designer examines all possible risks related to a design, and does everything possible to

remove them. A designer must be able to (legally) defend the safety aspects of his design

decisions for a period of at least ten years (five years for medical devices) after placing

the product on the European Union market. A systematic risk assessment on the one

hand, and good documentation of the design decisions concerning safety on the other, are

essential components of a viable legal defense. A systematic risk assessment also forms

the basis of self-certification and is the essence of the Technical File.

Two Harmonized Standards have been developed to assist the manufacturer in the risk

assessment of Machinery (EN 1050) and Medical Devices (EN 1441).

Some manufacturers approach risk assessment by using a design standard. Conformity to a standard, however, does not necessarily mean that the manufacturer will escape liability

for a faulty design. Conformity to a standard may only provide a rebuttable presumption

of conformity with the safety requirements of the directive. The strongest defense against

liability is the combination of the use of standards where reasonable, and a documented

design review that shows how the manufacturer effectively minimized risk.

A good example is found in Annex I of the Machinery Directive titled "Essential Health

and Safety Requirements Relating to the Design and Construction of Machinery." This

Annex provides both a description of a safety-conscious design approach, and a list of

desirable safety characteristics. The principles elucidated are sound principles that, when

followed, will substantially support a legally defensible design. The list of safety

characteristics is a reasonably thorough list that facilitates the critical design review

process. This design review is often referred to as a Risk Assessment. By using the

contents of Annex I, a manufacturer is more likely to prepare a complete Risk

Assessment.

The self-declaring manufacturer is required to list the Essential Health and Safety

Characteristics of the Machinery Directive (these are contained in Annex I), and describe

the measures taken to minimize the hazards that are described therein. Basically, this

aspect of the directive describes an obligation to engage in a critical design review,

focused on product safety, with the results documented in writing. This is the step that

25
many manufacturers have not undertaken, prior to exporting to the European Union. The

precise form of this exercise is left to the discretion of the manufacturer, and may be in

the form of a Failure Modes and Effects Analysis, or a HAZOP (Hazard of Operations)

analysis, or some other form that serves to direct the safety related aspects of designing a safe machine, and teaching people how to use it safely.

Some manufacturers are reluctant to prepare written design reviews. They reason that

such reviews could be used against them in a product liability lawsuit. Not recognizing

or effectively dealing with a hazard, however, is not a winning argument. A more

powerful defense is available when the manufacturer can show awareness of hazards, and

can also show how risks to the user were minimized through the thoughtful application of

design, guarding, and instructions.

In all cases, the directive should be looked to for direction. For example, Annex I of the

Machinery Directive contains specific detailed technical requirements that are to be

followed in conducting a risk assessment.

User's Manual

A user's manual is an essential safety requirement. A user's manual must contain all the

information required for the correct and safe use of a product, including:

• information concerning risks;

• identification and discouragement of hazardous applications;

• instructions on how the product must be put to safe use;

• identification of those authorized to perform certain actions; and

• identification of appropriate safety precautions that have to be taken.

Language

The user's manual must be written in one official language of the European Union

(English is one of the official languages) and/or in the language of the country where the

product will be used. Because its proper use is critical to the safety of the user, a prudent

manufacturer will make sure that a competent technical translator translates the user's

manual. Applying drawings and pictograms is widely accepted in the European Union

and is cost effective from a translation point of view.

Declaration of Conformity

After performing a critical design review, making changes to the product design that will

minimize risks of harm, and compiling the Technical File, the manufacturer may affix the

CE marking and prepare a Declaration of Conformity.

New Approach Directives require the issuance of a Declaration of Conformity by the

manufacturer or his Authorized Representative. A Declaration of Conformity is a document informing Surveillance Authorities that the product meets the essential

26
requirements of the applicable directives, or that the product has been issued an EC typeexamination certificate, and meets the essential requirements of the applicable directives.

Although the Declaration of Conformity is only required to be made available (by the

manufacturer or his authorized representative) upon request by national surveillance

authorities, it is better to include the Declaration with each shipment.

The Declaration of Conformity must contain:

• the product (name, type or model number, lot, batch or serial number);

• the name and address of the manufacturer or his Authorized Representative;

• the name and identification number of the Notified Body if required by the directive;

• standards or other normative documents applied to verify compliance with the

directive(s). Declaration should also include reference to other directives if

applicable;

• the date of issue; and

• the signature and title.

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Sample Declaration of Conformity

[PRINTED ON ORIGINAL COMPANY LETTERHEAD]

Sample Declaration of Conformity

Product Identification

Product name : Brand : Cat. Number : Batch/Serial Nr.

Manufacturer

Name

Address : Country : Representative:

Authorized Representative/Distributor in Europe

Name : Address :

Country :

Means of Conformity

declares that the product listed is in conformity with the essential

requirements and provisions of Council Directive and conforms to

standards

Signature

Place and date

Signature :

Name : (Name, Title, and Signature of Authorized Person)

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The Declaration of Conformity must be kept for at least ten years from the last date of

manufacture of the product, unless the directive provides for a different duration. For

example, the Directives for Medical Devices and Active Implantable Medical Devices

require that the Declaration of Conformity be kept for five years.

Directives for Machinery, Equipment for Use in Potentially Explosive Atmospheres,

Recreational Craft, and Lifts require that the Declaration of Conformity accompany each

product. It is highly recommended that a Declaration of Conformity be included with

shipments of products that fall under other directives as well, although it is not necessary

to include it with each product.

Language

The Declaration of Conformity must be in one of the official languages of the European

Union (English is one of the official languages). For products that must be accompanied

by a Declaration of Conformity (i.e., products covered by Directives for Machinery,

Potentially Explosive Atmospheres, Recreational Craft, and Lifts), the Declaration of

Conformity must be in the language of the country of use. It is recommended that the

Declaration of Conformity that is required by directives other than the ones listed above

also be in the language of the country where the product or equipment will be used.

Signature of Declaration of Conformity

The Declaration of Conformity must be signed by a person who is authorized to bind the

company, as the Declaration is, in essence, a statement by the company. The person who

signs should be one who has responsibility for determining that the design of the product

is reasonably safe and has authority to direct changes to the design. It is not necessary for

the signatory to be domiciled in the European Union.

The person who will be placing his signature on the Declaration of Conformity must act

in good faith: i.e., he must be informed that anything stated on the document is believed

to be correct. Everything stated on the Declaration is stated in good faith and can be

backed up by a solid Technical File.

Declaration of Incorporation

Annex II of the Machinery Directive lists the information that must appear in the

Declaration of Conformity. It is the only directive that also calls for more than one type

of Declaration. Machines that operate standing alone are covered by a Declaration of

Conformity as described in Part A of Annex II. But, where the maker of a larger machine

integrates or incorporates a subassembly, the manufacturer of the subassembly is required

to issue a Declaration of Incorporation (Part B of Annex II).

The general principle behind a Declaration of Incorporation is that the manufacturer of a subassembly cannot be required to foresee all the ways the subassembly may be

29
incorporated, and, more importantly, may not be able to provide all the safety aspects of

the larger machine.

The Declaration of Incorporation includes a statement that protects the subassembly

manufacturer, and transfers the responsibility for safe incorporation to the builder of the

larger system. Annex II part B contains suggested language for this statement by the

manufacturer of the subassembly: "This machinery may not be put into service until the

machinery into which it is to be incorporated has been declared in conformity with the

provisions of the Directive."

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Sample Declaration of Incorporation

[PRINTED ON ORIGINAL COMPANY LETTERHEAD]

Sample Declaration of Incorporation

Product Identification

Product name : Brand : Cat. Number : Batch/Serial Nr.

Manufacturer

Name : Address : Country : Representative:

Authorized Representative/Distributor in Europe

Name : Address :

Country :

Means of Conformity

declares that the product listed is in conformity with the essential

requirements and provisions of Council Directive and conforms to

standards

The equipment above must not be put into service until the machinery into which it is to

be incorporated has been declared in conformity with the provisions of the Directive.

Signature

Place and date :

Signature :

Name : (Name, Title, and Signature of Authorized Person)

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Product Liability

New Approach Directives do not always provide guidance on how to implement, nor do

they provide interpretations of the law. Legal critiques of design(s) are conducted in

hindsight at trials, where the issue may be whether or not the manufacturer was negligent,

and whether or not the designer produced a reasonably safe design. When these are the

issues, a national European court will inquire as to how the manufacturer of the product

applied (or didn't apply) good safety engineering practices.

A review of the law will show that some designs are deemed "not reasonably safe," and

that some manufacturers have judgments rendered against them for failing to exercise

reasonable engineering practices. The legal obligation to use good engineering practices

in safety matters is not embedded in directives, but exists independently of them.

This does not make design decisions straightforward for the manufacturer, but it does

place the manufacturer in a unique position. A manufacturer, or more precisely the

designer, is the only one who can evaluate and change the design of a product before it is

put on the market. It follows, then, that in the event of a breach of safety, the

manufacturer and/or the designer will be the responsible parties required to defend the

design decisions related to the product.

The legal concept of product liability is the same in the European Union as it is in the

United States, although the scale of award in the United States is considerably higher.

Any product manufactured or imported into the European Union which causes damage to

individuals or property is covered by the Product Liability Directive (85/374/EEC). This

directive provides the right of civil action for product liability to all citizens of the

European Union.

The Product Liability Directive covers all moving parts, electricity, raw materials, and

components for final products, and holds the manufacturer liable for all damages. If the

manufacturer cannot be identified, each supplier of the product becomes liable.

Certain directives require that critical design review processes be documented in writing.

In addition, a manufacturer should not consider making a product "safer" for one market

than for another.

Manufacturers that place products on the European Union market should reach

contractual agreements with customers that include liability issues. In addition to the

sales contract, liability aspects should be covered in the Declaration of Conformity, the

Technical File, and the User's Manual.

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The General Product Safety Directive (92/59/EC) describes the obligations to a manufacturer when no other directive or regulation applies (for example, a wind-powered

artistic mobile that is not a machine or a toy). According to this directive (and according

to well-established United States law) a manufacturer is expected to consider and deal

with the risks involved in the intended use and foreseeable misuse of its products. The

scope of this directive includes packaging and instructions. This is not a "CE Marking"

directive, and in fact the General Product Safety Directive expressly says that the CE

mark is not to be affixed to products that are covered by the directive.

National Marks

New Approach Directives requiring CE marking were intended to replace national law

product requirements and multiple national safety markings.

Market forces, however, may still continue to drive manufacturers to use national

markings in addition to CE marking. In addition, manufacturers may encounter national

testing houses that promote their own "marks" to be used in addition to CE marking.

Member States may not maintain or introduce new markings that will denote compliance

with requirements of the New Approach Directives. The CE marking is the only marking

which implies conformity of a product to New Approach Directives. A product may

bear other markings provided they do not reduce the visibility or legibility or create

confusion with respect to CE marking.

Surveillance Authorities

Member State Authorities, appointed for the purpose of market surveillance, are responsible for the enforcement of the New Approach Directives. The purpose of market

surveillance is to ensure that the provisions of the directives are complied with

throughout the European Union.

These public authorities can be the Department of Health, Department of Industry,

Department of Labor, or other established inspection authorities of a Member State.

In case of an incident or random check, the surveillance authority may require access to

the manufacturer's Declaration of Conformity and Technical File. The manufacturer, his

authorized representative or importer, must be able to provide the Technical File within

seven to ten days as of the date of request by the surveillance authority. If the product is

found to be non-compliant, corrective action will depend on and be appropriate to the

level of non-compliance.

The surveillance authority will hold the person responsible for affixing the CE marking to a non-compliant product accountable. Others who are responsible for the noncompliance of the product will be held accountable as well. Penalties, which may include

imprisonment, are determined by National law.

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Surveillance authorities monitor products placed on the market as follows. They will:

• visit commercial, industrial and storage premises on a regular basis;

• visit work places and other premises where products are put into service and used;

• organize random checks;

• take samples of products and subject them to examination and testing; and

• require all necessary information.

34
Technical Publications

Periodical

Journal of Research of the National Institute of Standards and Technology—Reports NIST research

and development in those disciplines of the physical and engineering sciences in which the Institute is

active. These include physics, chemistry, engineering, mathematics, and computer sciences. Papers cover a broad range of subjects, with major emphasis on measurement methodology and the basic technology

underlying standardization. Also included from time to time are survey articles on topics closely related to the Institute's technical and scientific programs. Issued six times a year.

Nonperiodicals

Monographs—Major contributions to the technical literature on various subjects related to the

Institute's scientific and technical activities. Handbooks—Recommended codes of engineering and industrial practice (including safety codes) developed in cooperation with interested industries, professional organizations, and regulatory bodies.

Special Publications—Include proceedings of conferences sponsored by NIST, NIST annual reports, and

other special publications appropriate to this grouping such as wall charts, pocket cards, and bibliographies.

National Standard Reference Data Series—Provides quantitative data on the physical and chemical

properties of materials, compiled from the world's literature and critically evaluated. Developed under a worldwide program coordinated by NIST under the authority of the National Standard Data Act (Public

Law 90-396). NOTE: The Journal of Physical and Chemical Reference Data (JPCRD) is published

bimonthly for NIST by the American Chemical Society (ACS) and the American Institute of Physics (AIP).

Subscriptions, reprints, and supplements are available from ACS, 1155 Sixteenth St., NW, Washington, DC

20056.

Building Science Series—Disseminates technical information developed at the Institute on building

materials, components, systems, and whole structures. The series presents research results, test methods, and

performance criteria related to the structural and environmental functions and the durability and safety

characteristics of building elements and systems.

Technical Notes—Studies or reports which are complete in themselves but restrictive in their treatment of

a subject. Analogous to monographs but not so comprehensive in scope or definitive in treatment of the

subject area. Often serve as a vehicle for final reports of work performed at NIST under the sponsorship of

other government agencies.

Voluntary Product Standards—Developed under procedures published by the Department of Commerce

in Part 10, Title 15, of the Code of Federal Regulations. The standards establish nationally recognized

requirements for products, and provide all concerned interests with a basis for common understanding of

the characteristics of the products. NIST administers this program in support of the efforts of private-sector

standardizing organizations.

Order the following NIST publications—FIPS and NISTIRs—from the National Technical Information

Service, Springfield, VA 22161.

Federal Information Processing Standards Publications (FIPS PUB)—Publications in this series

collectively constitute the Federal Information Processing Standards Register. The Register serves as the

official source of information in the Federal Government regarding standards issued by NIST pursuant to the Federal Property and Administrative Services Act of 1949 as amended, Publio Law 89-306 (79 Stat.

1 127), and as implemented by Executive Order 1 1717 (38 FR 12315, dated May 11, 1973) and Part 6 of

Title 15 CFR (Code of Federal Regulations).

NIST Interagency or Internal Reports (NISTIR)—The series includes interim or final reports on work

performed by NIST for outside sponsors (both government and nongovernment). In general, initial distribution is handled by the sponsor; public distribution is handled by sales through the National Technical

Information Service, Springfield, VA 22161, in hard copy, electronic media, or microfiche form. NISTIR's may also report results of NIST projects of transitory or limited interest, including those that will be

published subsequently in more comprehensive form.