MAINE INTERNATIONAL TRADE CENTER

presents . . .

Maine Exporter’s Guide

to the

European Union’s

CE Marking Requirements

Compiled July 27, 1999 by Will Smith, MITC Updated February 2007 by Faith Gillman, MITC

2

Table of Contents Page Section

3 What is the CE Marking?

3 What is the EU and its relationship to the CE Marking?

3 What legislation and body of standards governs the CE Marking process? Directives Standards 4 CENELEC Conformity 5 Types of Standards and Directives 5 What are the goals of CE Marking?

5 How does a manufacturer comply?

7 What is a Technical file and what information should it contain?

7 What is a Declaration of Conformity and what information should it contain?

7 How and when is a Notified Body selected?

8 How is the CE Marking affixed?

9 What are some non-compliance risks?

9 What should be known about product liability or victim's rights?

10 Where should a manufacturer go for assistance or information? CE Marking Services Sources of Information 12 UL International Compliance Service Additional Sources of Information 12 Appendix A: Status of EC Directives

13 Appendix B: In-Depth EC Directive Information

15 Appendix C: Sample Declaration of Conformity (EN 45014)

16 Appendix D: Products Covered Under CE Marking Directives

23 Appendix E: U.S Product Liability Implications

3

What is the CE Marking? The CE Marking, which stands for “Conformité Européenne,” is a label which must appear on a host of products sold in the member states of the European Union (EU). The mark can be thought of as a “passport” which allows manufacturers around the world to ship and sell industrial products freely within the internal market of the EU. The CE designation informs millions of European consumers that the manufacturer, no matter the location, has subjected the products to a variety of tests and that the products meet stringent health, safety and environmental regulations. However, the presence of a CE marking is not an indication of a product’s quality, nor will it guarantee sales. What is the EU and its relationship to the CE Marking? The European Union (EU) was established after WWII as a means of promoting the development and integration of the European economies decimated by the war. Modern efforts to integrate the economies of Europe date to 1951 with the creation of the European Coal and Steel Community, the first institution created under the EU umbrella. In 1958, the Treaty of Rome established the continent’s first customs union, a clear effort to eliminate trade barriers between countries and promote economic growth. In the 1980’s, EU members decided to eliminate all barriers to doing business and the idea of creating a single European international market was born. Since then, member states have worked to harmonize their business cultures, including tax laws and health, safety and environmental regulations. In 1994, the EU/EC and the European Free trade Association (EFTA) joined to create the European Economic Area (EEA), the largest economic region worldwide. Enter the CE Marking, an effort on the part of the EU to guarantee consumers that a host of products, manufactured throughout the world, meet the health, safety and environmental requirements of the member states. What legislation and body of standards governs the CE Marking process? Directives All EU legislation designed for the CE Marking effort is referred to as the “New Approach”. Under this system, EC Directives are created to ensure conformity to safety and quality standards throughout the EU and some members of the EFTA. Directives are legislative instruments intended to regulate a necessary level of safety throughout the EEA. Directives provide a framework for manufacturers working to meet requirements related to design, production and documentation. Each of the EEA countries is obligated to introduce these regulations into its existing national laws. Directives apply to almost all types of products, from toys, building materials or gas appliances to information technology equipment and sophisticated medical devices. Most of the legislation and procedures are now in place and the goal of “harmonization” is, for all practical purposes, complete. Numerous product safety, machinery and Electromagnetic Compatibility (EMC) standards have been published to support the directives’ essential requirements, which specify a minimum level of protection against injury to persons or damage to property. The essential requirements are general and do not identify specific design criteria. Although the standardization process is evolutionary, established procedures are meticulously maintained which cover all compliance aspects. The CE Marking is the manufacturer’s declaration that a product complies with all applicable directives. For most products sold in the EU, the use of the CE Marking and a Declaration of Conformity (see page__) are mandatory. Standards European Norm (EN) Standards define criteria for fulfilling the essential requirements. EN Standards are harmonized standards that contain technical specifications for the development and manufacturing of

4

products, and, therefore, provide a uniform approach to European conformity assessment. EN Standards are issued by the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC), or the European Telecommunications Standards Institute (ETSI). They are generally based on international standards. When European Standards (ENs) exist, their use is recommended to ensure conformity with the European Directives. In some cases non-EN Standards may be considered but must be justified. Use of non-European alternatives may be indefensible in court and could actually place the product and manufacturer in a position of non-conformity. Through harmonized European Standards, combined with a unified assessment process and acceptance by the participating countries, redundant testing and product submission to the individual member countries are eliminated. Product compliance requires an understanding of the goals of, and the methodology for achieving, compliance. The goals are explained in the directives. Technical rules, known as harmonized standards (ENs) provide ways to achieve the goals. Directives and standards should be considered together (with a focus on standards) for the product’s design and assessment criteria. The most important consideration is the protection of the consumer (user, operator, buyer, etc.), which in turn limits risks to the product manufacturer and supplier. CENELEC The EU and the EFTA countries utilize the European Committee for Electrotechnical Standardization (CENELEC) for developing electrotechnical standards. CENELEC cooperates closely with the International Electrotechnical Commission (IEC). In order to avoid duplication of efforts and to ensure as much consistency as possible between the international and European standards, IEC and CENELEC have entered into a coordination agreement. In principle, IEC holds the basic responsibility for the development of standards. These are being taken over by CENELEC in parallel coordination and published as European standards (ENs), perhaps with certain modifications. If CENELEC sees the need for a particular standard the IEC is required to develop the standard. If IEC is not able to fulfill the wishes of CENELEC within the time frame requested, CENELEC may develop the standard itself. In general, the IEC and CENELEC standards evolve to be identical or very similar in technical respects. A standard generated by IEC is subject to parallel voting as both an IEC and CENELEC standard. Thus, the CENELEC countries essentially determine acceptance of the standard for the purpose of compliance with EU directives. CENELEC standards are being endorsed as national standards of the member countries, usually without modifications. As national standards, they become legally binding. Conformity “Presumption of Conformity” is a phrase associated with products that comply with the relevant European harmonized standards. National enforcement authorities are obliged to recognize that equipment manufactured in conformity with the harmonized standards, published in the Official Journal of European Communities and transposed into national standards, are presumed to conform to the essential requirements of the directives. When a product is not in compliance with the appropriate ENs, a presumption of conformity does not exist. Directives detail why compliance is necessary and what may happen if the laws are ignored. But it is the ENs that provide guidelines for compliance (design and assessment). ENs are not mandatory, but the fulfillment of the essential requirements of the directives is. Types of standards and directives There are three primary areas in which ENs are concerned: 1) The Quality and Competence of the Bodies responsible for: • Accreditation • Testing • Certification

5

• Surveillance (i.e.: EN45000) 2) The Quality and Competence of Manufacturers (i.e.: ISO 9000) 3) The Quality, Safety and Reliability of Products (i.e.: EN/HD Product Standards) Of the product-related directives, there are three types: 1) Basic Directives apply to all manufacturers of products and address trade, enforcement, liability and other issues. It is important to understand the implication of these directives, especially concerning enforcement against product manufacturers. Some of the Basic Directives which apply to most products and suppliers are: • General Product Safety Directive – 92/59/EEC • Product Liability Directive – 85/374/EEC • Conformity Assessment Procedures and CE Marking Rules – 93/465/EEC • CE Marking Amendment – 93/68/EEC 2) Generic Directives address a specific range or group of products, such as products operating between certain voltage limits (LVD) or products that may generate RF emissions (EMC). These directives cover the “unregulated” sector of products. Typical unregulated products are information technology equipment (ITE), household appliances, etc. 3) Product-Specific Directives apply to “regulated” products, such as telecom and medical, as well as other products where extreme hazards exist, such as machinery listed in Annex IV of 98/37/EC. Involvement of an EU Notified Body (see page___) may be mandatory, but not in all cases. If the class or type of product is regulated by the directive, then a European Notified Body must assess it and issue a certificate prior to the CE Marking. It is necessary to refer to the relevant directive to see if involvement of an EU Notified Body is mandatory for the products in question. Product-specific directives take precedence over all other directives. What are the goals of CE Marking? With the exception of some high-risk products, most products can be self-assessed by the manufacturer to meet the Essential Requirements. While the CE Marking does permit a product’s access to the EU, it is only a declaration of the supplier’s own responsibility. The main goals of the CE Marking are to: • indicate a product’s conformity with the “essential requirements” of the directives • allow products to be “placed on the market” • ensure the “free movement of goods” • allow the “withdrawal of non-conforming products” by customs and enforcement authorities The CE Marking: • is not a mark or certification or approval issued by a third party • is not simply a marketing or promotional tool • is not a quality mark • is not for components (although there are some exceptions, the vast majority of components do not need

CE Marking) How does a manufacturer comply? Depending upon the directive, a manufacturer may be able to self declare compliance to the directive's requirements or the manufacturer may need to involve a test firm to perform EMC testing. In other situations

6

the manufacturer may need to utilize an approved testing agency to test or evaluate the product or assess the manufacturer's quality system. The answers to what certification route is chosen are contained in the applicable directive. In virtually all instances, the manufacturer must develop a file that contains evidence that all applicable EHSRs in each applicable directive have been met. Depending upon the complexity of the product, the compliance process may involve considerable time in understanding the requirements and possibly making modifications to existing designs & equipment. If there is a non-compliance issue with a product, regulatory bodies in Europe blame the European counterpart of the U.S firm - the importer or distributor. The U.S. firm suffers due to a hold up or return of its product and the loss of sales/future business. The European company faces fines and possible imprisonment. Developing standards can be hard to track because they are not published anywhere. Information on upcoming Directives is more readily available. Once standards are decided upon, they are published in the Official Journal (OJ) of the European Union (EU). Companies need to monitor changes for any new equipment being shipped into the European market and may have to make changes to machinery installed before a particular standard changed. Most machinery manufacturing companies use self-certification methods for CE marking testing. Some categories of products, however, may not be self-certified and need to be checked by a notified or informed body. Details are outlined in directives. To avoid problems at customs the CE marking should be listed on the product, on the package and on shipping documents. Specific standards should be documented in paperwork. Companies who make products that are covered by specific safety standards may need more detailed information, including a technical file or declaration of conformity (see page ___). All of the standards apply to used and re-furbished equipment as well. The hazards of using the machine clearly spelled out in a technical file may be used against manufacturer in liability cases. For this reason, some companies may opt not to participate in a full written standard assessment of risks. The marking is a declaration of conformity and must follow after these actions: • reading of the appropriate directive in its entirety • a path has been chosen to conformity assessment as set out in the directive; depending on the class of

product, this may involve testing and a quality assurance system • the European Standards have been obtained if it has been chosen to base risk assessment and design

on standards, which is the preferred route • YOU (or your agent in the Union and/or EFTA area) declare your product to be in conformity with the

DIRECTIVE In order to legally affix CE marking to a product, all the following steps for each of the directives applying to the product and calling for CE marking must be completed: • Ensure product compliance with essential technical requirements. Refer to the applicable EN standards,

if existing. • Issue Declaration of Conformity (DOC). Normally manufacturers' self-certification based on compliance

with harmonized standards is acceptable. In only a few product categories such as high risk machinery (e.g., punch presses, saws, etc.) is third party certification required.

• Identify authorized representation. If the product is not manufactured in the EU/EEA, authorized representation located within the EU/EEA must be established. The EU/EEA based manufacturer or the authorized representative is responsible for the integrity of any related certification documents and for making available supporting information upon request.

• Technical documentation must be established as specified by individual directives. • As an alternative to affixing the CE marking to the product, the low voltage and EMC directives allow the

marking to be placed on the packaging or documentation accompanying the product.

7

What is a Technical file and what information should it contain? A technical file is required by the primary directives to document the conformity assessment and the product’s design. The technical file shall be compiled by the manufacturer or authorized representative and contain design documentation, manufacturing, test reports and operation information to show conformity as required by the directives. File Components: • Declaration of Conformity (and/or certificate for regulated products) • The name and address of the manufacturer and identification of the products • European agent’s name and address, if applicable • List of harmonized standards followed and/or the solutions adopted to satisfy the ERs • Description of the product (model, name, etc.…) • Operating instructions • Test report(s) • Design details, description of operation, components list, test rationale, circuits and diagrams – including

items necessary to understand the solutions adopted to satisfy the ERs • Technical Construction File (TCF) – This is a special technical file for regulated products, high-risk

machines (Annex IV machinery), and occasionally for EMC (large equipment, etc.), where the use of a Notified or Competent Body is mandatory.

What is a Declaration of Conformity and what information should it contain? A Declaration of Conformity is a written declaration containing directive specific information that the manufacturer can enclose in the packaging with each product shipped. The master copy must be kept available for reference by the relevant authorities for 10 years after the final production date. File Components: • Declaration of Conformity • Name and address of responsible person • Description of the apparatus • Numbers and titles of standards applied • Declaration that the product conforms with the protective requirements of the Directive • Signature of (or on behalf of) manufacturer or authorized representative • Date of issue See Appendix C for a sample Declaration of Conformity How and when is a Notified Body selected? With the exception of certain (e.g. safety related) products for which third party certification is required, self certification by the manufacturer or his authorized representative in the EU/EEA is accepted. Products are assumed to comply with the requirements of a directive if they are designed and tested to the respective harmonized standards applicable to the product as issued by the European Committee for Standardization (CEN) or for electrical products by the European Committee for Electrotechnical Standardization (CENELEC). This is the normal case for industrial control devices and automation products. If no standards are applicable, or if they have not or only partly been applied, compliance can be certified by a so called ''Competent Body''. A third way is to achieve a type-examination certificate by a so called ''Notified Body''. Notified/Competent Bodies are independent testing laboratories and/or certification bodies recognized in the EU to perform tests, audit quality systems and issue reports and certificates of conformity. Test reports and

8

certificates issued by Notified/Competent Bodies attest to a product or system’s conformity to the relevant standards/directives. These reports and certificates are the basis for mutual recognition of test results and build consumer confidence in a product’s conformity. Manufacturers should obtain certification from a Notified/Competent Body to show: • Proof of compliance with directives and essential requirements • Proof of compliance to meet customer demand • Evidence of compliance in case of challenges by the authorities Those who self-declare and do not use a Notified Body may face these problems: • CE Marking is absent or has been affixed unduly • Declaration of Conformity is incomplete or not in order • Technical File or documentation is incomplete • Inspection of product by national authority • EMC interference or non-compliance suspected • Safety deviation(s) noted by user, buyer or competitor • User is injured How is the CE Marking affixed? It is the responsibility of the manufacturer to meet the essential requirements of the applicable directives before affixing the CE Marking to the products. The CE Marking must be shown on the device or, if not possible, on its packaging. The CE Marking will not prevent national enforcement bodies from taking action against marked products for non-compliance. The CE conformity Marking shall consist of the initials “CE” in the following form: If the CE Marking is reduced or enlarged, the proportions given must be respected. The various components of the CE Marking must have substantially the same vertical dimension, which may not be less than 5 mm. In order to give manufacturers time to adapt their products to the new regulations, there exist ''transitional periods'' for EU directives during which the respective new directives may be applied, but also the old national standards of the country of installation are accepted. Refer to Figure 1. After the transitional period, compliance with EU directives becomes mandatory. Figure 1. Overview of the EU Directive Compliance Dates. Original Publication Date X

Implementation Date X Transitional Period* Mandatory Compliance X and CE Marking Date

*CE Marking optional here but only allowed if all steps are met for compliance with at least one directive.

Note that when CE marking is applied during the transitional periods, if the product does not yet meet all applicable directives (i.e., one or more have later mandatory compliance dates), the accompanying

9

documentation must indicate which directives are met. As an example, this could be the case for a control product covered by the EMC and Low Voltage Directive. Beginning 1 Jan 96 this product would have to comply with the EMC directive but need not comply with the new low voltage standards (EN 60947) until 1 Jan 97. Previously installed products are not affected unless there is a problem reported with the installation. See Appendix A for Mandatory CE Marking Dates for each directive What are some non-compliance risks? A complaint about a product from a dissatisfied customer or competitor to the enforcement authority could bring harsh penalties. Most damaging of all to the business and reputation of a company, its product may be subjected to suspension and prohibition notices and banned from all EU member states. A single CE Marking should be used in order to facilitate controls on the Community market by inspectors and to clarify the obligations of economic operators [manufacturer or supplier]. The aim of the CE Marking is to symbolize the conformity of a product and to indicate that the economic operator has undergone all the evaluation procedures laid down by Community law in respect of his product. Where a Member State authority establishes that a CE Marking has been affixed unduly, the manufacturer/agent shall be obliged to make the product comply as regards to the provisions concerning the CE Marking and to end the infringement under conditions imposed by the Member State. Where non- compliance continues the Member State must take all appropriate measures to restrict or prohibit the placing of the product in question on the market or to ensure its withdrawal from the market. Enforcement will be at the national level via three methods:* • Policing of incoming goods at EU/EEA border crossings by member countries' national officials • Market surveillance by regulatory authorities of the member countries of the EU/EEA • Investigation by authorities following complaints of suspected non-compliance *Some aspects of enforcement may change prior to directive compliance dates as procedures evolve. What should be known about product liability or victim's rights? In 1985, the Product Liability Directive was issued changing the old focus of negligence to that of strict liability on the manufacturer’s or supplier’s part, thereby shifting the onus to better protect the consumer and placing a greater burden on the product supplier. Strict liability means that, in the case of a claim, the producer of a defective product can no longer exonerate themselves by proving no fault. Even a defense of due diligence may no longer protect the producer from liability. The due diligence defense still has some importance although it may be more difficult to prove. Since the negligence (no fault) defense no longer exists, the notions of defectiveness, state-of-the-art and consumer expectations are of new importance. Quality control, documentation and warnings also gain increased significance. With respect to safety/EMC conformity, producers are expected to document their quality system procedures and have a duty to warn consumers of hazards. Strict liability applies to producers or suppliers of any end product, raw material or component as well as to the quasi producers, meaning anyone who presents themselves as a producer by affixing their name, trademark and other distinguishing feature on the product. Losses in the area of consumer goods are more likely; however, producers of industrial products will encounter more actions resulting from worker compensation. Component producers may also face claims caused by the defective product components of third-party manufacturers. Placing the CE Marking on a product informs users, competitors and authorities that the producer is aware of the laws, standards and consequences when a product becomes suspect. See Appendix E for a more detailed look at US product liability in the E

10

Where should a manufacturer go for assistance or information? CE Marking Services CE Marking Services are capable of doing all of the following tasks for a company:

• Determine applicable EC Directives, harmonized standards and essential requirements • Provide technical guidance in applicability and interpretation of standards • Determine alternatives when published standards are not applicable or not used to verify product

compliance to the essential requirements • Provide testing and design support • Create and assess technical files • Issue certificates and test reports that have a legal basis in Europe

Local CE Marking resources include: Weinstein Associates Address: 8 Lincoln Street, Brunswick, ME 04011 Tel/Fax: (207) 725-2111 / (207) 725-1181 Email: walaw@gwi.net Contact: Dianne M. Shvanda Retliff Testing Associates Address: 101 New Boston Road, Goffstown, NH, 03045 Tel/Fax: (603) 497-4600 / (603) 497-5281 Email: nhsales@retliff.com Contact: Rob Bournival NTS Corporation Address: Acton, Boston, Boxborough – Massachusetts Tel: 1-800-270-2516 Website: www.ntscorp.com TUV America Address: 5 Cherry Hill Dr., Danvers, MA 01923 Tel/Fax: 1-800-TUV-0123 or (978) 739-7000/ (978) 762-7637 Contact: Kate Barrett E-mail: kbarretttuvam.com

Maine Manufacturing Extension Partnership Address: 87 Winthrop Street, Augusta, ME 04330 Tel/Fax: (207) 282-0058 Email: robertd@mainemep.org Contact: Bob Doiron Sources of information: Office for Official Publications of the European Communities Address: 2, Rue Mercier L-2985 Luxembourg, Luxembourg, Europe Tel: (352) 2929-1 Email: opoce-info-info@cec.eu.int Website: http://publications.europa.eu/index_en.html The Office for Official Publications of the European Communities can provide access to the entire collection of publications and directives issued by the European Union. Delegation of the European Commission 2300 M Street, N.W. Washington, D.C. 20037-1434 Tel: (202) 862-9500

11

Fax: (202) 429-1766 Library of the European Commission Delegation: (202) 862-9539 or fax enquiries to (202) 429-1766 www.eurunion.org/ Office of European Union and Regional Affairs U.S. Department of Commerce 14th and Constitution Avenue, N.W., Room 3036 Washington, D.C. 20230 For information on CE Marking or to obtain an information package on a specific CE directive, contact Bob Straetz at the Office of EU Affairs (202) 842-4496. 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 Western 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 marking 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 trade 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. National Center for Standards and Certification Information (NCSCI) National Institute of Standards and Technology 100 Bureau Drive Gaithersburg, MD 20899-2160 Tel: (301) 975-4040 Fax: (301) 926-1559 Email: ncsci@nist.gov www.nist.gov/ncsci 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 database containing EU standards (CEN, CENELEC and ETSI) and directives. The Center also subscribes to the Official Journal of the European Communities and maintains various EU-related 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 trade-related technical standards, regulations and conformity assessment procedures.

12

UL International Compliance Service New York Division/Customer Service 1285 Walt Whitman Rd., Melville, NY 11747-3081 Telephone: 1-877-ULHELPS (854-3577) Fax: (631) 439-6464 Email: CustomerExperienceCenter@us.ul.com UL's CE Marking Assistance Program UL can assist companies in identifying applicable European Directives and standards for their products, and help companies apply them. UL's CE Marking Assistance Program includes a summary of all critical elements contained in applicable Directives and/or the complete text of Directives; descriptions of the methods of conformity and required documentation; and a list of applicable EN Standards that can be used to demonstrate compliance to the Directive. In addition, UL offers a range of versatile programs to meet most European conformity assessment needs, from customized workshops to testing. Companies can register for any of UL’s compliance seminars, or obtain more information by accessing UL's web site at http://www.ul.com/international/seminars.html Additional sources of information • Commission offices of the European Community • Delegates of the Commission • National manufacturer's trade associations • National standards bodies * • Local chambers of commerce * • Technical journals, publications and seminars • Manufacturers' publications * These organizations would be able to give the most concrete information regarding certain product categories or problem areas. Appendix A: Status of EC Directives (for current updates see http://publications.europa.eu/index_en.html) Directive: Date for Mandatory CE Marking

Active implantable medical devices (90/385/EEC) 1/1995ATEX equipment (94/9/EEC) 6/2003Boilers (92/42/EEC) 1/1988Construction products (89/106/EC) 4/1998Electromagnetic Compatibility EMC (89/336/EEC) 1/1996Energy efficiency of household appliances uncertainExplosives (93/15/EEC) 1/2003Gas appliances (90/396/EEC) 1/1996General pressure equipment (97/23/EC) 5/2002Low-voltage electrical safety (73/23/EEC)* 1/1997Machines (89/392/EEC) 1/1995Medical devices (93/42/EEC) 6/1998Non-automatic weighing machines (90/384/EEC) 1/1993Passenger lifts (95/16/EEC) 7/1999Personal protective equipment (89/686/EEC) 7/1995Recreation craft (94/25/EEC) 6/1998Simple pressure vessels (87/404/EEC) 7/1992Telecommunications terminal equipment (91/263/EEC) 11/1992Toys (88/378/EEC) 1/1990*(for products operating at 50-1,000 VAC or 75-1,500 VDC)

13

Appendix B: In-Depth EC Directive Information Please visit http://publications.europa.eu/index_en.html for new directives/updates Low-Voltage Directive (LVD) 73/23/EEC This directive relates to electrical product safety. It applies to products with 50 to 1,000 VAC or 75-1500 VDC Input. Products may include computers, information technology equipment, household products, power tools, laboratory equipment, test and measurement equipment and power supplies. Components must comply with the applicable directives, but in most cases should not be CE Marked. The Low-Voltage Directive has been in effect since 1973. The Low-Voltage Directive 73/23/EEC was amended by 93/68/EEC with the adding of the CE Marking. EMC Directive 89/336/EEC This directive sets the requirements for the control of emissions and immunity. It covers all electrical and electronic products, in particular household appliances, data-processing equipment, information technology equipment, telecommunications equipment and machinery. Some products, such as automotive and medical devices, are required to meet the EMC requirements of product-specific directives. In these cases, the EMC requirements specified in each directive take precedence over those stated in the EMC Directive. Machinery Directive 98/37/EC This directive applies to both machinery and specific safety components (such as light curtains, two-hand controls, etc.). Safety components shall not bear the CE Marking but need a declaration. Machinery is defined as:

• an assembly of linked parts or components (at least one of which moves with the appropriate actuators, controls and power circuits) joined for a specific application, in particular for the processing, treatment, moving or packaging of material;

• an assembly of machines that, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;

• interchangeable equipment modifying the function of a machine that is supplied for the purpose of being assembled with a machine (or a series of different machines or with a tractor) by the operators themselves insofar as this equipment is not a spare part or tool.

Medical Device Directive (MDD) 93/42/EEC This directive applies to many medical products. According to the MDD, Article 1.2a, a definition of a medical device is: “any instrument, apparatus, appliance, material or other article, whether used alone or in combination (including the software necessary for its proper application intended by the manufacturer), to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease; • diagnosis, monitoring, treatment, alleviation of or compensation for any injury or handicap; • investigation, replacement or modification of the anatomy or of a physiological process; • control of conception;

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means…” Active Implantable Medical Device Directive (AIMD) 90/385/EEC This directive applies to products according to Article 2.C AIMDD, which are defined as: 'active implantable medical device' means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure...’ Demonstrating compliance with the Medical Directives in order to affix the CE Marking may require the services of a Notified Body for part or all of the following operations:

14

• Type testing • Examination of the design • Assessment of the manufacturer’s Quality Management System (compliance with EN 46000

standards) • Evaluation of the clinical data

Products must meet the essential requirements of the directives, which include product safety, EMC, biocompatibility and others, as well as effectiveness and functionality. Pressure Equipment Directive (PED) 97/23/EC This directive applies to the design, manufacturing and conformity evaluation process of Pressure Equipment, as well as Pressure Equipment Assemblies. The maximum allowable design pressure must be greater than 0.5 bar. Covered under the general term “Pressure Equipment” are pressure vessels, steam boilers, exchangers, tubing (pipe) and pressure accessories, as well as devices under pressure. Also included are all parts and products that are attached to pressurized parts (i.e., flanges, nozzles, lifting parts, fast-connectors, etc.) According to Article 20, the PED will not be applicable before November 29, 1999. From then on, each European member state has the responsibility to implement and adopt the PED into national law. This transition must be completed by May 29, 2002. Until May 29, 2002, manufacturers and the final users of pressure equipment can decide if the product shall meet the PED-requirements or the national pressure vessel code requirements of the country, where the product will be put into service (e.g. German Pressure Vessel Code). Telecom Terminal Equipment Directive 91/263/EEC This directive sets the essential requirements for telecommunication terminal equipment intended for connection to a public telecommunications network. Besides the requirements of the LVD and EMC directives, provisions are made to protect the public telecommunications network for the purpose of establishing, modifying, charging for, holding and clearing real or virtual connection. To harmonize the requirements of different categories of equipment, Common Technical Regulations (CTRs) are published in the Official Journal. The basis of these CTRs is the Technical Basis for Regulation (TBR), which is published by ETSI and sets the technical requirements for the different types of telecommunication terminal equipment. Approved equipment can be labeled with the CE0000X Marking. Appliances Burning Gaseous Fuels Directive 90/396/EEC This directive outlines the essential requirements that an appliance must meet when it is placed on the market. The directive applies to:

• appliances burning gaseous fuels and used for cooking, heating, hot water production, refrigeration, lighting and washing, hereinafter referred to as "appliances"; burners using air under pressure and heating units fitted with such burners are treated as appliances;

• safety and control devices and subassemblies other than burners using air under pressure and heating units fitted with such burners, hereinafter referred to as "equipment".

The directive does not indicate how the essential requirements must be met, allowing flexibility to manufacturers regarding the solutions they adopt. The annexes to the directive give details of the essential requirements, procedures for attestation of conformity, use of the "CE mark" etc.

If a Member State finds that, under normal conditions of use, an appliance fitted with a CE marking poses a risk to the safety of persons, domestic animals or property, it shall take all the steps necessary to have the appliance withdrawn or to prohibit or restrict the placing on the market of such an appliance.

15

Appendix C: Sample Declaration of Conformity (EN 45014)

DECLARATION OF CONFORMITY

We ...................................................................................................... (suppliers name)

............................................................................................................

(address)

declare under our sole responsibility that the product

............................................................................................................. (name, type or model, lot, batch or serial number, possibly

sources and numbers of items)

to which this declaration relates is in conformity with the following standard(s) or other normative document(s)

.............................................................................................................

(title and/or number and date of issue of the standard(s) or other normative document(s))

(if applicable) following the provisions of .............. Directive

............................................ ......................................... (Place and date of issue) (name and signature or

equivalent marking of authorized person)

16

Appendix D: Products Covered Under CE Marking Directives Please visit http://publications.europa.eu/index_en.html for updates and new directives 90/396/EEC Appliances burning gaseous fuels Central heating boilers using gaseous fuels Dedicated liquefied petroleum gas appliances Domestic gas-fired water heaters Gas burners using fans Gas cooking appliances Gas-fired air heaters Gas-fired sorption, domestic gas-fired washing and drying appliances Independent gas-fired space heaters

Large kitchen appliances using gaseous fuels Non-domestic gas-fired overhead radiant heaters Rubber and plastics hoses and hose assemblies Safety and control devices for gas-burners and gas-burning appliances Sealing materials and lubricants for gas appliances and gas equipment Test gases, test pressures and categories of appliances

00/9/EC Cableway installations designed to carry persons Chains, ropes, webbing, slings and accessories – Safety Safety requirements for passenger transportation by rope 89/106/EEC Construction products Acoustic properties of building products and of buildings Acoustics Adhesives Aggregates Automatic fire detection systems Cast iron pipes, fittings and their joints Cement and building limes Ceramic tiles Chimneys Concrete (performance, production, placing and compliance criteria) Concrete reinforcing and prestressing steels Copper and copper alloys Doors, windows, shutters, building hardware and curtain walling Durability of wood and derived materials Elastomeric seals for joints in pipework and pipelines Fire safety in buildings Fire service equipment Fixed firefighting systems Flanges and their joints Flexible sheets for waterproofing Foundry technology Free-standing industrial chimneys Geotextiles and geotextile-related products Glass in building Gypsum and gypsum based products Heat exchangers Lighting columns and spigots Masonry Natural stones Non metallic materials Paints and varnishes Paving units and kerbs

Pigments and extenders Plastics Plastics piping systems and ducting systems Precast concrete products Prefabricated reinforced components of autoclaved aerated concrete Railway applications Refractory products and materials Resilient and textile floor coverings Road equipment Road materials Roof covering products for discontinuous laying and products for wall cladding Round and sawn timber Sanitary appliances Steel - Mechanical testing Steel wires Steels - Definition and classification Steels for heat treatment, alloy steels and free- cutting steels Structural bearings Structural Eurocodes Structural steel sections and hot rolled steel bars for engineering use Structural steels - Grades and qualities Surface coated flat products - Qualities, dimensions, tolerances and specific tests Surfaces for sports areas Suspended ceilings Thermal insulating materials and products Thermal performance of buildings and building components Timber structures Transportable gas cylinders Unfired pressure vessels Ventilation for buildings

17

Waste water engineering Water supply Welding Wind turbine systems

Wire-rod - Qualities, dimensions, tolerances and specific tests Wood-based panels

Directive 89/336/EEC - Electromagnetic compatibility Aeronautical,cf,terrestrial,maritime,satellite Alarm systems ANALOGUE Antenna, aerial AUDIO Automatic controls for household use Broadband (inc. B-ISDN) Broadcast point to multipoint message transfer - see "multipoint" Broadcasting, TV, audio Cable networks for television signals, sound signals and interactive services CB;Citizens Band (radio) Circuit breakers and similar devices for household and similar applications Commercially available amateur radio equipment Construction equipment and building material machines - Safety CT2;Cordless Telephone - 2nd generation DATA DCS;(extension of GSM) DECT;Digital European Cordless Telecommunications Detection and measurement of combustible gases DIGITAL DRRS;Digital Radio Relay System EARTH STATION;(satellite) Electrical equipment in medical practice Electrical installations for lighting and beaconing of aerodromes Electroacoustics Electroheating equipment Electromagnetic Compatibility (EMC) Electrotechnical equipment for surface transport systems EMC;Electro-Magnetic Compatibility EMERGENCY;Including maritime/terrestrial search & rescue EMISSION;Of unwanted signals, radiated/conducted (EMC) Equipment for electrical energy measurement and load control ERMES;European Radio MEssaging System FM;Frequency Modulation GMDSS;Global Maritime Distress and Safety System GSM;Global System for Mobile communications High-voltage switchgear and controlgear HIPERLAN;HIgh PErformance Radio Local Area Networks (LAN)

Home and Building Electronic Systems (HBES) Industrial Trucks - Safety LAN;Local Area Network LBRDC;Low Bit Rate Data Communications LMSS;Land Mobile Satellite Services Low frequency phenomena Low-voltage switchgear and controlgear assemblies Low-voltage switchgear and controlgear including dimensional standardization Luminaires and associated equipment Mains communicating systems Management Maritime navigation and radiocommunication equipment and systems MARITIME;(Cf terrestrial, satellite, aeronautical) Measurement uncertainties MES;Mobile Earth Station (satellite) METHODOLOGY MMSS;Maritime Mobile Satellite Service MOBILE;(telecommunications in general) MSS;Mobile Satellite Service MULTIMODE;Optical fibre; terminal equipment NAVTEX;Navigation telegraph NETWORK PAGING Passenger, goods and service lifts Photoelectronic controls for road lighting PMR;Private Mobile Radio POINT-TO-POINT Power electronics POWER SUPPLY Power system control and associated communications Power transformers PRIVATE;(network) RADAR RADIO Radio frequency interference RADIO MIC;Wireless microphone Railways - Electrical and electronic applications RECEIVER;(radio, etc) Relays RO;Receive Only Road traffic signal systems Rotating machinery S-PCN;Satellite - Personal Communications Network (Cf PCN) SATELLITE;(Cf terrestrial, aeronautical, maritime) SDH;Synchronous Digital Hierarchy

18

SERVICE SHORT RANGE;(radio) Solar photovoltaic energy systems SPEECH SPREAD SPECTRUM;(radio transmission) SRD;Short Range Device (radio) Static measuring relays STM;Synchronous Transport Module Switches for appliances Switches for household and similar fixed electrical installations SWITCHING SYSTEM TELEPHONY

TESTING TETRA;Trans European Trunked RAdio system Tractors and machinery for agriculture and forestry TRANSMISSION TRANSMITTER;(radio) UIC;Union Internationale des Chemins de fer VHF;Very High Frequency (band) VIDEO VSAT;Very Small Aperture Terminal (satellite earth station) Welding - Electric arc welding equipment Wind turbine systems

Directive 94/9/EC - Equipment and protective systems in potentially explosive atmospheres Apparatus type of protection "n" Centrifuges - Safety requirements Continuous handling equipment and systems - Safety Detection and measurement of combustible gases Detection and measurement of combustible gases Electrical apparatus for explosive atmospheres: General requirements Electrical apparatus for explosive atmospheres: General requirements Electrostatic painting and finishing equipment Electrostatic painting and finishing equipment Encapsulation "m" Equipments for making and shaping of metals - Safety requirements Fans - Safety Flameproof enclosures "d" Increased safety "e" Industrial thermoprocessing - Safety

Internal combustion engines Intrinsically safe apparatus and systems "i" Packaging machines - Safety Potentially explosive atmospheres - Explosion prevention and protection Pressurization and other techniques Printing and paper machinery - Safety Pumps Refrigerating systems, safety and environmental requirements Rubber and plastics machines - Safety Safety of machinery Surface treatment equipment - Safety Textile machinery and machinery for dry-cleaning and industrial laundry Tractors and machinery for agriculture and forestry Woodworking machines - Safety

93/15/EEC Explosives for civil uses Explosives for civil uses 95/16/EC Lifts Chains, ropes, webbing, slings and accessories - Safety Lifting platforms Passenger, goods and service lifts Directive 73/23/EEC - Low voltage equipment Alarm systems Appliance couplers Audio, video and multimedia subsystems and equipment Audio, video and similar electronic equipment Automatic controls for household use Cable management

Cable networks for television signals, sound signals and interactive services Cables - Electric cables Circuit breakers and similar devices for household and similar applications Connecting devices Degrees of protection by enclosures Electrical accessories

19

Electrical installations of buildings: Protection against thermal effects Electroacoustics Electroheating equipment Electrotechnical aspects of telecommunication equipment Equipment and tools for live working Equipment for electrical energy measurement and load control Fire hazard testing Fuses - Low voltage fuses Fuses - Miniature fuses Gas detectors Hand-held and transportable electric motor operated tools Hearing aids and audiometers High frequency EM radiation Home and Building Electronic Systems (HBES) Household and similar electrical appliances Industrial electroheating equipment Industrial plugs and socket-outlets Insulation coordination for low-voltage equipment Isolating and safety isolating transformers Lamps Low-voltage surge protective devices Low-voltage switchgear and controlgear assemblies Low-voltage switchgear and controlgear including dimensional standardization

Luminaires and associated equipment Machinery: electrotechnical aspects Mains communicating systems Man-machine interface Measuring equipment for electrical and electromagnetic quantities Measuring relays and protection equipment Measuring, control, and laboratory equipment Operation of electrical installations Optical radiation safety and laser equipment Photoelectronic controls for road lighting Power capacitors Power electronics Radio data System (RDS) Relays Rotating machinery Safety and energy efficiency of information technology equipment Secondary cells and batteries Solar photovoltaic energy systems Switches and sensors Switches for appliances Switches for household and similar fixed electrical installations Transmitting equipment for radiocommunication Welding - Electric arc welding equipment Welding - Electric resistance welding Wind turbine systems

998/37/EC Machinery Safety Acoustics Advanced Manufacturing Technologies Aircraft ground support equipment Atomizing oil burners and their components - Function - Safety - Testing Centrifuges - Safety requirements Chains, ropes, webbing, slings and accessories - Safety Compressors - Safety Construction equipment and building material machines - Safety Continuous handling equipment and systems - Safety Conveyor belts Cranes - Safety Electroheating equipment Equipment for destruction of information carriers Equipments for making and shaping of metals - Safety requirements Ergonomics Eye protective equipment Fairground and amusement park machinery and structures - Safety Fans - Safety Fire service equipment

Food processing machinery - Safety and hygiene specifications Foundry machinery Hand-held and transportable electric motor operated tools Hand-held, non-electric power tools - Safety Household and similar electrical appliances Industrial automation system Industrial thermoprocessing - Safety Industrial Trucks - Safety Internal combustion engines Lasers and laser related equipment Leather and imitation leather goods and footwear manufacturing machinery Lifting platforms Light and lighting Machine tools - Safety Machinery: electrotechnical aspects Machines for underground mines - Safety Mechanical vibration and shock Packaging machines - Safety Passenger, goods and service lifts Portable grinding machines - Mechanical safety Power-operated warehouse equipment Printing and paper machinery - Safety

20

Pumps Railway applications Refrigerating systems, safety and environmental requirements Rubber and plastics machines - Safety Safety of machinery Sewing machines Surface treatment equipment - Safety Tannery machinery - Safety

Textile machinery and machinery for dry-cleaning and industrial laundry Tractors and machinery for agriculture and forestry Waste management - Containers and their technical equipment Wind turbine systems Woodworking machines - Safety

90/385/EEC Medical devices: Active implantable Active implantable medical devices - CEN Active Implantable Medical Devices - CENELEC Biocompatibility of medical and dental materials and devices Clinical investigation of medical devices Electrical equipment in medical practice Medical alarms and signals Quality systems - Particular requirements for the EN ISO 9000 series - CEN Quality sytems - Particular requirements for the EN ISO 9000 series - CENELEC Risk Analysis Sterilization of medical devices Sterilizers for medical purposes Symbols, information - nomenclature for regulatory data exchange Transportable gas cylinders Directive 93/42/EEC - Medical devices: General Biocompatibility of medical and dental materials and devices Chemical disinfectants and antiseptics Dentistry Electrical equipment in medical practice Electroacoustics Hearing aids and audiometers Lasers and laser related equipment Medical alarms and signals Medical devices utilizing tissues Non-active medical devices Non-active surgical implants Ophthalmic optics Optical radiation safety and laser equipment

Quality systems - Particular requirements for the EN ISO 9000 series - CEN Quality sytems - Particular requirements for the EN ISO 9000 series - CENELEC Rescue systems Respiratory and anaesthetic equipment Risk Analysis Sterilization of medical devices Sterilizers for medical purposes Symbols, information - nomenclature for regulatory data exchange Technical aids for disabled persons Transportable gas cylinders

Directive 98/79/EC - Medical devices: In vitro diagnostic In vitro diagnostic medical devices Directive 92/42/EEC – New hot-water boilers fired with liquid or gaseous fluids (efficiency requirements) Boilers using gaseous fuels Boilers using oil and solid fuels Directive 90/384/EEC - Non-automatic weighing instruments Measuring Instruments Non automatic weighing instruments (Dormant)

Directive 94/62/EC - Packaging and packaging waste Packaging Directive 89/686/EEC - Personal protective equipment Acoustics Equipment and tools for live working Ergonomics Eye protective equipment Foot and leg protectors Head protection Hearing protectors

Protection against falls from height including working belts Protective clothing including hand and arm protection and lifejackets Respiratory protective devices Sports, playground and other recreational equipment

Directive COM(93)322final - Precious metals Precious metals - Applications in jewelery and associated products Directive 97/23/EC - Pressure equipment Aluminium and aluminium alloys Copper and copper alloys Cryogenic vessels Flanges and their joints Flat products for cold working Gas pressure regulators for use in gas transmission and distribution GRP tanks and vessels Industrial piping and pipelines Industrial valves Liquefied petroleum gas equipment and accessories Manual means of fire fighting equipment Non-destructive testing Plastics piping systems and ducting systems Refrigerating systems, safety and environmental requirements

Shell and water tube boilers Steel castings Steel forgings Steel tubes and fittings for steel tubes Steels for heat treatment, alloy steels and free- cutting steels Steels for pressure purposes - Qualities Structural steels - Grades and qualities Threaded and non-threaded mechanical fasteners and accessories Unfired pressure vessels Utensils in contact with food Welding Wire-rod - Qualities, dimensions, tolerances and specific tests

Directive 99/5/EC - Radio and telecommunications terminal equipment BROADCASTING Broadcasting, TV, audio DECT Digital Enhanced Cordless Telecommunications DRRS Digital Radio Relay System EMC Electro-Magnetic Compatibility FWA Fixed Wireless Access (cf RLL, WLL, FRA) GMDSS Global Maritime Distress and Safety System GSM Global System for Mobile communications HIPERLAN High Performance Radio Local Area Networks (LAN) IMT-2000 International Mobile Telecommunications 2000 (ITU project) PMR Private Mobile Radio RADIO- SATELLITE (Cf terrestrial, aeronautical, maritime) SHORT RANGE (radio) TERMINAL (as opposed to NETWORK) TETRA Terrestrial Trunked Radio system Directive 94/25/EC - Recreational craft Electrical Installations of ships and of mobile and fixed offshore units Shipbuilding and maritime structures

22

Directive 87/404/EEC - Simple pressure vessels Aluminum and aluminum alloys Non-destructive testing Threaded and non-threaded mechanical fasteners and accessories Unfired pressure vessels Welding Directive 88/378/EEC – Toy safety Household and similar electrical appliances Isolating and safety isolating transformers Safety of toys Directive 98/13/EC - Telecommunications terminal and satellite earth station equipment

3.1 KHZ ACCESS AERONATICAL AMATEUR ANALOGUE ANTENNA ATS_MP FILE AUDIO BASIC BROADBAND BROADCAST BSS CB CCBS CDMA DATA DCS DECT DIGITAL DISKETTE EARTH STATION EMC EMERGENCY EMISSION ERMES FM FSS GENERIC GMDSS GSM HIPERLAN INTERFACE ISDN LAN LBRDC

LEASED LINE LEO LMES LMSS MANAGEMENT MARITIME MEASUREMENT UNCERTAINTY MES METHOLOGY MMSS MOBILE MSS MULTIMODE MULTIPOINT NAVTEX NETWORK ONP PACKET MODE PAGING PAP PDN PMR POINT TO POINT POWER SUPPLY PRIMARY PRIVATE PSPDN PSTN RADAR RADIO RADIO MIC RATE RECEIVER REGULATION

RLL RO S-PCN SATELLITE SDH SERVICE SHORT RANGE SNG SPREAD SPECTRUM SRD STAGE 2 STM SUPPLEMENTARY SERVICE SWITCHING SYSTEM TDMA TELEPHONY TELESERVICE TERMINAL TES TESTING TETRA TFTS TRANSMISSION TRANSMITTER TV VHF VIDEO VOICE VSAT X.21 X.25

23

Appendix E: U.S Product Liability Implications and EU New Approach Safety Directives and Related EN Safety Standards Published by SIMCOM International March 1995 Introduction While mention has been made of the product liability implications of EU safety directives and related EN safety standards in previous issues of The Complete European Trade Digest(TM), these observations have been touched upon in relation to other topics such as records management and documentation, product design, warnings and instructions, post-sale obligations, component parts, etc. This article will focus specifically upon the future interplay between European safety standards and litigation in non European forums such as the United States. Historical Antecedents to EU Safety Standards In 1975 the European Court of Justice (ECJ) established the rule of reason which stated that EU member states had the freedom to develop national rules provided that they didn't hinder trade between EU member states, with the exception that member states could restrict the entry of products for health, safety or environmental reasons. An early application of the rule of reason came in the Casis de Dijon decision in 1979. In that case a French company attempted to introduce its casis (currant liquor) into Germany which was rejected by the German government because it didn't satisfy national distilling laws. The court rejected this restriction and noted that the French casis presented no health or safety hazard to German consumers. Therefore, the casis could enter Germany or any other EU member state under the principle of mutual recognition. As a consequence of this decision, any product which does not present a health, safety or environmental threat can move freely between EU member states under the principle of mutual recognition. Similarly, any imported product which presents no health, safety or environmental threat to the receiving EU member state can travel freely among the fifteen EU member states under the principle of mutual recognition. The Casis de Dijon decision presented the European Union (European Community at that time) with an interesting dilemma in the early 1980's. On one hand the Court had developed the principle of mutual recognition which allowed products to move freely between member states, but on the other hand the Court recognized that existing European Community Treaty Law allowed member states to restrict the entry of products for health, safety or environmental reasons. It was this second issue which caught the attention of the European Council (heads of government/heads of state) in 1983 and prompted a request for new legislation from the European Commission. In 1985, the EC Commission submitted a white paper, Completing the Internal Market: White Paper from the European Commission to the European Council, which was approved by the Council. The white paper contained approximately 300 pieces of legislation (later reduced to 286) which pledged to eliminate fiscal, technical and physical barriers by: --Replacing national standards with EC-wide standards --Eliminating national regulations that restrict trade (i.e., health, safety and environmental restrictions) --Agreeing on EC-wide testing and certification procedures Because of the scope of the white paper and the Commission's program to replace national safety standards with Community-wide safety standards, a new approach was adopted for standards development. Previously, EC-wide safety standards for products such as pharmaceuticals or chemicals were governed by product directives that were self-contained. Defined product characteristics were detailed and binding. Everything a company needed to know was contained within the body of the directive.

24

In contrast to this old approach (which the EU continues to use), the commission adopted a new strategy for its Community-wide safety standards. This strategy, known as the "new approach" identified a basic framework, outlined the alternative conformity assessment (compliance) procedures, set forth the directive's Essential Safety Requirements (which identify what must be done) and turned the standards writing program (how it is to be done) over to European regional standards organizations, CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization). These two organizations represent 18 of the 19 EU and EFTA (European Free Trade Association) nations. The only country missing is Liechtenstein. To this group two new standards organizations have been added --ETSI (European Telecommunications Satellite Institute) and EOTA (European Organization for Technical Approvals). The former deals with telecommunications standards and the latter deals primarily with construction products. Finally, under the "new approach" structure, when a company has complied with the requirements of a new approach directive, it must construct a Technical File which describes what standards were used to achieve compliance, issue a Declaration of Conformity and affix a CE Marking. Only CE marked products can be sold legally once a new approach directive becomes mandatory. Liability and the Machinery Directive / A Case Study While this article will review the liability implications of several EU new approach directives, such as Electromagnetic Compatibility (EMC), Toy Safety, Personal Protective Equipment, Medical Devices, Simple Pressure Vessels, etc., the Machinery Directive, which became mandatory on January 1, 1995, offers a good example of the liability implications of the new European safety standards. When the standards program for the Machinery Directive was first transmitted to the European Committee for Standardization, CEN identified 36 technical committees from CEN and one from CENELEC to undertake the standards writing program. Over time, the number of committees has increased to 40 and the total number of standards involved has increased to over 650. The effort is ongoing and the number of standards will continue to increase. The CEN effort on behalf of the EU Machinery Directive is the most comprehensive and systematic approach ever undertaken, drafting safety standards covering several thousands of different kinds of machines. The types of questions posed by CEN to its governing body and technical committees to guide this effort are set forth below: In order to keep standardization rational, priorities must be laid down. In this connection, it is necessary to answer a series of questions: --Are European standards demanded from legislative bodies or other interested groups? --Does there exist a need for a standard to support other safety standards? --Do dangers exist which cause significant hazards for the safety and health of persons? --Does such a large number of corresponding machines or equipment exist, or will this exist in the foreseeable future, to justify drawing up a standard? --Do national standards exist, with specific requirements, either directly or through cross-reference to other documents, which can represent barriers to trade for the European internal market? --Do technically recognized national or international standards already exist or are other standards already available which would allow one to expect positive or quick results? Where possible, CEN attempts to work with the International Organization for Standardization (ISO) in Geneva to create parallel committees that can work simultaneously with CEN to jointly develop a CEN and ISO standard. Through this mechanism, the European standards writing process invites international participation in creating new safety standards.

25

Under the Machinery Directive, a basic hierarchy was developed to guide the standards writing process: • Type A Standards - Fundamental Safety Standards that apply to all machines, including basic

concepts and principles of safety integration applicable to all machinery • Type B-1 Standards - Group Safety Standards that apply to a particular aspect of safety such as

safety distances and surface temperatures • Type B-2 Standards - Group Safety Standards that apply to specific safety-related devices such as

guards, interlocks, pressure sensitive bars and mats • Type C Standards - Machine Specific Standards which include safety requirements for a specific

category of machines or group of machines, e.g., pumps, food processing machines, packaging machines, textile machines, rubber and plastics machines, etc.

The starting point of the machinery safety standards program was the creation of Technical Committee CEN/TC 114 on Safety of Machinery. Their first task was to develop two fundamental European standards (EN 291-1 & EN 292-2) which set forth "the basic concepts, general principles and methodology for the design of safe machinery." It is interesting to note that the work to develop these two standards dealing with the basic principles of safety integration was carried out in parallel with the drafting of the Machinery Directive. To this group could be added the preliminary standard prEN 1050, Safety of Machinery - Risk Assessment. At the very least, these three standards provide a basic safety step for the manufacture of any machine for the European Union. In almost every instance, however, additional standards would be added dealing with other safety concerns and issues such as ergonomics, vibration or acoustics. In many instances it will be necessary to comply with machine-specific Type C Standards. Basic Premise The basic premise of the CEN program is to identify dangers which cause significant hazards for the safety and health of persons and to reduce those hazards by design, guards and warnings, and instructions. This is done by following the basic safety hierarchy of first designing out hazards, guarding against those hazards that can't be designed out and warning against those hazards that cannot be designed out or guarded against. Each of the safety standards represents a minimum hurdle that must be overcome to affix a CE Marking and sell machinery in the European Union. While a company can reach for higher safety standards in the design and manufacture of machinery, they must satisfy the minimum requirements for EN standards that affect their machinery. State of the Art This vast EU safety standards effort puts in place new standards where few previously existed. It, in effect, sets the global "state of the art" for machinery safety. While a few machine safety standards exist at the ISO or IEC (International Electro-technical Commission) level, or have been adopted by ANSI (American National Standards Institute), ASME (American Society for Mechanical Engineers) or U.S. industry trade associations, for the most part these new EN standards will meet, exceed and in most cases create safety standards where none previously existed. Further, these CEN standards have been created by technical committees comprised of European representatives of machinery manufacturers, member state regulatory personnel (e.g., BSI, DIN, AFNOR, etc.), testing laboratory representatives, academic engineering faculty and in some cases, consumer group representatives. To bring the issue closer to home, consider a pre-Machinery Directive product liability lawsuit in an American courtroom. In addition to the facts of the case and the determination of negligence, the plaintiff and defendant often will point to the prevailing safety manufacturing standards in a particular industry and the "state of the art" in that industry. Where it is apparent that the state of the art is economically obtainable and this level was achieved by the defendant company in designing its machine, the company's attention to safety and its concern for prevailing safety standards will enhance its defense before a jury. If it is clear that the state of the art was obtainable and little or no effort was made to

26

achieve that level of safety, the company's defense will be compromised. Either way, the issue of state of the art will be difficult to ignore. Consider a different case. A company is defending itself in a product liability lawsuit in a US courtroom and the company's defense attorney discovers that the company also manufactures and sells the same product in Europe. Worse yet, the defense attorney discovers that some additional safety precautions taken in Europe were not taken in the United States. For example, suppose that the product is an electric saw that has a safety guard in Europe but no comparable safety guard in the United States. Quite clearly, the discovery by the plaintiff's attorney that the company manufactures the same product to a higher safety standard outside the U.S. than it does inside the U.S. will compromise its legal defense and likely lead to punitive damages in addition to conventional damages. U.S. Companies Manufacturing Machines for the U.S. and EU Companies manufacturing machinery for export to the European Union clearly will have to manufacture to the same level of safety for the U.S. market. Using a lower safety standard for the U.S. would create an immediate problem for a company who knew of, and manufactured to, a higher safety standard in order to obtain a CE Marking and to enter the EU marketplace. Likewise, European companies should not expect to manufacture to higher safety standards and affix CE Markings to machines in Europe but sell a less safe machine in the U.S. A company that did this would have known of higher safety standards, but deliberately choose to meet lower standards because the U.S. has no CE marking requirement for its market. In either case, companies manufacturing to two different safety standards should expect to suffer product liability losses in the country where lower safety standards are used. Obviously, such companies knew of higher safety standards and were capable of manufacturing to those standards. Also, any U.S. or EU company placing CE Markings on machinery for the U.S. or EU markets but manufacturing to lower standards in countries such as Canada, Australia, Japan or various developing countries should not be surprised if they experience difficulty in product liability lawsuits. The notion that a company can manufacture products to higher safety standards, but chooses to manufacture to lower safety standards because it is possible should be prepared for hostile reception in those countries as well as a court perception of cultural arrogance by the manufacturer. To deal with the new requirements for the Machinery Directive, several U.S. companies have chosen to identify those machines they wish to CE Marking and manufacture all of their selected machines to European standards. In several instances these companies are stamping CE Markings on their packaging as well as on their machines and enclosing an EC Declaration of Conformity with each machine. In addition to declaring to their customers that they are meeting the world's highest safety standards, these companies are using the CE Marking as a global marketing strategy. Finally, several U.S. companies have decided to make European safety requirements the minimum safety standards for all of their new products. As a consequence, all new products will automatically have a Machinery Directive Technical File, a Declaration of Conformity and a CE Marking for the global marketplace. U.S. Companies Manufacturing for the U.S. Domestic Market While U.S. domestic machinery manufacturers generally have ignored the EU Machinery Directive unless they have been preparing to enter the EU Market, that strategy may not be an option in a few years. In fact, it may not be an option today. As the various European safety standards being developed under the Machinery Directive achieve formal EN (European Norm) status they will become the state of the art for a number of machines in the

27

American marketplace. As observed in the previous section, several U.S. companies that are globally competitive have elected to pursue Machinery Directive compliance, with European standards, create Technical Files, issue Declarations of Conformity and CE Marking all of their new products and several existing products for all markets including the U.S.. By this act alone, EN safety standards will become state of the art in the U.S. marketplace. In addition, several EN safety standards are new and unique, suggesting that it is possible to achieve a higher level of safety in a whole range of areas, from portable hand tools, to ergonomics, to vibration, to safety controls, to acoustics, to electrosensitive machinery. Not only do these new standards represent an achievable state of the art, but the standards have been developed with the collective energies of quasi-governmental European standards organizations and their technical committees comprised of practitioners: manufacturers (safety engineers, design engineers, production engineers), testing laboratory personnel, member state safety regulatory personnel, academic engineering faculty, and in some instances, consumer advocacy representatives. These practitioners constitute some of the most credible problem solving specialists ever assembled to develop machine product safety standards. Further, the early draft standards are circulated in draft form for comments by CEN and coordinated with ISO and IEC for international input. Following this step they become EN safety standards. In short, it will be extremely difficult, if not impossible, for U.S. domestic manufacturers to ignore these new European safety directives and their related EN safety standards. Whether these standards are adopted by a company's competitors and enter the marketplace through that route or whether these standards become state of the art for several thousands of kinds of machines, they will enter U.S. courtrooms in product liability lawsuits. Finally, it should be noted that at least one U.S. product liability lawsuit in late 1994 found European machine safety standards cited by the attorneys. In that instance, the defendant company had been preparing for CE Marking and consequently had incorporated European safety standards into the machine in question. As a consequence, the company was able to defend itself. As the various EN standards become state of the art, the entry of European safety standards as state of the art will increase in U.S. courtrooms. U.S. Product Liability Insurance and EU Safety Standards The existence of EU new approach safety directives and EN standards raises a potential good news and bad news situation with regard to insurance. The good news is that each new approach directive usually has a risk assessment standard such as the Machinery Directive's prEN 1050 or the Medical Devices Directive's prEN 1441. This means that a path has been provided along with examples for conducting a systematic risk assessment and hazard analysis for each product. Neither standard is put forth as definitive and each instructs companies that only the company can create the kind of diagnostic risk assessment appropriate to their products. The existence of a path replete with risk assessment steps and examples, however, is more than previously existed in many industries. It means that systematic risk assessment is achievable. In addition, for insurance companies it means that for CE marked products a risk assessment and hazard analysis has been conducted, the most up-to-date European safety standards have been incorporated into product design and production, a Technical File has been created and an EC Declaration of Conformity has been issued. It will be much easier to have confidence when writing a product liability insurance policy for such a company. The bad news is that insurance companies are learning that the identification of the Essential Health and Safety Requirements and European safety standards under a safety directive such as the EU Machinery Directive means that there is a better and safer way to build a mousetrap. Insuring U.S. companies that have not examined these new European safety standards and the new emerging state of the art over the next several years will mean that these insurance companies will be facing greater risks in their insurance

28

policies. In time, insurance company decisions about whether and at what rate they will insure American companies that choose to ignore these new safety standards could pivot on this issue. An example might help to amplify this point. Increasingly, American companies are facing an increasing number of lawsuits for repetitive motion injuries. The existence of European machine safety standards dealing with the following conditions could affect a repetitive motion lawsuit: • Basic machine risk assessment • Basic principles of safe design • Ergonomic principles dealing with human physical performance with machines • Measurement and testing of machinery for hand-arm vibration • Whole body vibration • Mechanical vibration and shock The application of these principles to specific machines such as portable power tools or portable food processing machinery will be extremely difficult for insurance companies to ignore when writing liability insurance policies. These EN standards will require close attention. Conclusion Quite clearly, the creation of new European safety standards will have a major impact upon manufacturers preparing to enter the European Union, other countries and the United States. Further, the liability implications for global manufacturers as well as US domestic manufacturers will be significant and difficult to ignore. To a certain extent, EU conformity assessment approaches which utilize requirements such as the Technical File and Declaration of Conformity may find their way into the American marketplace. Finally, it is apparent that European safety directives and technical standards may find their way into U.S. product liability insurance policies. Resources Miller, Jerry "The CE Mark" Northeast Export, March/April 1998. "List of references to harmonised standards" (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html). Product Safety Zone "Introduction to CE Marking" (http://web.meganet.net/eszlari/introduction_to_ce_marking.htm). SIMCOM International "CE Marking Overview Manual" (http://www.esimcom.com/aak2_0_1_2/simcom_about/ab3_IQ_cemark_overv.asp). TUV Rheinland of North America, Inc. “CE Marking"

(http://www.us.tuv.com/product_testing/ce_marking/index.html). Underwriter's Laboratories, Inc. "On the MARK" (http://www.ul.com/about/otm/). U.S. Department of Commerce: Globus and NTDB "Standards Setting in the European Union"

(http://www.stat-usa.gov/). New Approach Standardization in the Internal Market: (http://www.newapproach.org) Web Portal on CE Marking and Regulatory Affairs: http://www.cemarking.net