CE Marking is currently required for many products sold in Europe, yet many U.S. exporters are still unsure or unaware of what affect this has on their business. In this article we will try to clarify the following:

  • How CE Marking affects exports to Europe.

  • Which U.S. exports require CE Marking.

  • How to select a notified body.

  • How to obtain CE Marking for exports.

    CE Marking - What's In It For You

    The good news - The most obvious benefit is that the CE Marking on your product will gain you access to the European Economic Area (EEA).

    If the European product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking is mandatory and therefore crucial to your success.

    There will be only one set of laws and regulations to comply with in designing and manufacturing your product for the entire European Union (EU) marketplace. The multiple and conflicting national restrictions on regulated products will be eliminated.

    Additional benefits may include your product being made safer for end-users and consumers as well as reduced damage claims and liability premiums.

    The not so good news - The new product directives may exceed the current national laws and regulations. These increased or new essential requirements may require a manufacturer to change their design or production processes to continue or enter into this market.

    You will incur costs in obtaining the product certification and any required testing. Also, the new directives and their implementation is confusing, undergoing constant change and subject to interpretation.

    What is CE Marking?

    The European Commission refers to the CE Marking of products as a "passport" which can allow a manufacturer to freely circulate their products within the European marketplace. The marking applies only to products regulated by the European Commissions health, safety and environmental protection legislation (product directives) but this is estimated to include more than 50% of the goods currently exported from the U.S. to Europe. All other consumer products are subject to the requirements of the General Product Safety Directive 92/59/EC, which does not require the CE-mark.

    The actual CE Marking is the letters "CE" which a manufacturer affixes to certain products for access to the European market (consisting of 18 countries and also referred to as the European Economic Area or EEA). The letters "CE' are an abbreviation of a French phrase "Conformite Europeene". The marking indicates that the manufacturer has conformed with all the obligations required by the legislation. Initially, the phrase was "CE Mark": however, "CE Marking" was legislated as its replacement in 1993.

    What Can A Notified Body Do For You?

    Most companies need a guide to take them through the CE Marking maze. There are many expert sources of information available to you (conferences, consultants, Department of Commerce, the Internet, hot lines, etc.) all of which are more than willing to sell or give you their best opinion as to whether you may self-certify or not.

    In case of third party certification the only opinion that matters is that of the agencies that certify products for the European Union. These agencies, independent and 'for profit' are called "notified bodies", there are a couple hundred of them and they are all located in Europe (some have satellites outside the EU that perform tests and submit results back to Europe for final approval).

    Notified bodies are authorized by European countries to serve as independent test labs and perform the steps called out by product directives, only in cases where self-certification is not possible. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union. Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.

    What To Look For In A Notified Body

    Once it is determined that you manufacture a product that is not subject to the self-certification route, the best way to proceed is to contact a notified body whose qualifications match up with your product, and whose credentials and affiliations match up with your and your target markets. After that there are a number of variables to consider.

  • Price - Obtain quotes from at least a few notified bodies; pricing can vary dramatically.

  • Service - Many notified bodies do not provide adequate service; usually due to peakload situations, lengthy European vacations and some simply disregard customer needs.

  • Consulting - Some notified bodies will (and some will not) offer advice in addition to testing to accelerate the process and simplify the process for you (such as a desk audit of your technical documentation prior to actual submission).

  • ISO 9000 and Product Certification - Very convenient and economical (when both are required) if a notified body can provide both services.

  • Documentation - Find a notified body that will accept documents in English. copyright 2007

  • Mutual Recognition - Look for a notified body that will accept ISO 9000 registration from a U.S. registrar to avoid duplicate costs; also, find a notified body that will consider using qualified U.S. based subcontractors for audits to reduce travel related expenses.

    If you can't find a Notified Body who will comply with the items listed above, keep looking, they do exist.

    Which Directives Are Most Likely To Apply?

    There are four directives which are quite inclusive. In addition, when more than one directive applies to a product, the product must comply with all applicable directives

    The Machinery directive
    became effective 1/95 and covers new and used machinery with moving parts (except manually operated machines).

    The Medical Device directive
    was effective 06/98. This directive requires an Authorized Representative be located in Europe.

    The Electromagnetic Compatibility
    directive was effective 1/96. This directive applies to most electronic equipment and concerns itself with electromagnetic emissions and immunity.

    The Low Voltage directive
    has been in place since 1973 and was amended 1/97. This directive applies to all electrical equipment designed for use with a voltage rating between 50 and 1000V AC and between 75 and 1500V DC. copyright 2007 by qnet

    Does Your Product Require CE Marking?

    CE Marking is required if your customers are in located in certain countries and if they purchase certain types of products from you.
    1. Are your current or future customers in the following countries?
    European Union (EU) member states - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxemburg, the Netherlands, Portugal, Spain, Sweden and United Kingdom.

    European Free Trade Association (EFTA) members - Iceland, Liechtenstein and Norway.

    2. Do you now, or will you in the future, ship to these customers the following types of products?

    · Toys
    · Construction Products
    · Pressure Vessels
    · Telecommunications
    · Medical Devices
    · Machinery
    · Personal Protective Equipment
    · Satellite Station Equipment
    · Gas Appliances
    · Pressure Equipment
    · Appliances (other than gas)
    · Non-automatic weighing instruments
    · Recreational Craft
    · Lift Machinery
    · Equipment and Protective systems for explosive atmospheres
    · Non-Automatic Weighing equipment
    · Measuring Instruments
    · In-Vitro Diagnostic Medical Devices
    · Marine Equipment
    · Electrical products

    How Do You Acquire CE Marking?

    There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.

  • Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.

  • Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).

  • Choose the conformity assessment procedure from the options called out by the directive for your product.
    The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

    Options for products with minimal risk include self certification where the manufacturer prepares a declaration of conformity and affixes the CE Marking to their own product.

    Options for products with greater risks can require tests, audits or additional certificates from a notified body.

  • Select the applicable product standards and test methods for your product and select an independent lab If the product testing is to be done externally.
  • Establish an authorized representative for regulatory affairs in the European Union for your product. Some directives require that a manufacturer designate in Europe a representative to produce technical documentation in a timely fashion when called upon to do so.

    The directives require for many products that a technical file be prepared by the manufacturer. The technical file holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.

  • Prepare a declaration of conformity that includes a list of the directives and standards that your product conforms to; product identification, the manufacturer's name, address and signature.
    The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.
  • Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging and material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.

  • Who's Going To Enforce The Requirement For CE Marking?

    Each member state of the European Union is bound to adopt into their National Law, regulations and administrative provisions to ensure that products placed on the market are safe. Each country has its own way of handling enforcement.

    Many have added staff specifically to conduct spot checks against implemented directives and respond to complaints. Countries have also set in place a combination of return-to-origin procedures, financial penalties, criminal prosecution, etc.
    European Union legislation makes European importers liable for the products they import, including the machinery they provide to their employees for work under the PUWER Directive. U.S. exporters are finding that no matter how interested a prospective European customer may be in their product, they will not risk importing non-conforming products when accidents will generate legal action against them.

    What's Europe Trying To Pull With This CE Marking?

    Since the signing of the Treaty of Rome in 1946, the European community has continued to pursue the plans for economic development laid out in that document.

    "The community shall adopt measures with the aim of progressively establishing the internal market ... The internal market shall comprise an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured"

    - The Treaty of Rome, article 8a

    CE Marking is just one measure that the European Union has adopted to establish a single market and foster economic development for the member states. Listed below are some key events leading up to the free movement of goods throughout Europe:

    1975 The European Court of Justice via "the rule of reason" permits European Union (then called European Community) members to set national rules so long as trade between member states is not restricted. However, product restrictions were permitted for health, safety or environmental reasons.
    1979 The European Court of Justice upholds "mutual recognition" permitting products manufactured (or imported) by a member state which do not present a health, safety or environmental threat, to travel freely among other states.
    1983 The European Council requests the European Commission to propose revised legislation for health, safety and environmental product restrictions.
    The European Council approves "New Approach" legislation, eliminating national regulations that restrict trade and establishing community-wide standards, testing and certification procedures.

    1992 The Vice President of the Commission of Brussels along with ministers from the EU and the EFTA sign an agreement organizing the free movement of goods, persons, services and capital within the European Economic Area (EEA).

    What's New About the New Approach?

    The implementation of the New Approach policy resulted in the changes outlined below:

    Product Directive Content - directives will be limited to the "essential requirements" or performance levels to which the product must conform.

    Previously, the directives included detailed technical specifications which took forever to prepare since it involved the wrong level of bureaucracy and expertise.

    Harmonized Standards - the technical specifications required of products to comply with the directive will be established by European standards agencies (CEN, CENELEC, ETSI and EOTA).

    Compliance Procedures - the directives are linked to a series of compliance modules based on 4 factors including the nature of risk involved. There is a concerted effort to provide a range of choices to the manufacturer.

    CE Marking - common rules established for the affixing of the CE Marking to products.

    Written by Yvonne Halpaus and Phil Gardiol
    Copyright © 2007 All Rights Reserved

    PO Box 527
    Elk River, MN 55330
    Telephone: 763.441.0899 -  Fax: 763.441.0898
    E-Mail: QNET@CE-Mark.com

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