CE Marking and Exports to Europe

CE Marking and Exports to Europe

by Phil Gardiol

This document is available for download.

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?

First, the good news: - The most obvious benefit is that the CE Marking on your product will gain you access to the EEA (European Economic Area). If the new product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking will be 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 marketplace. The multiple and conflicting national restrictions on regulated products will be eliminated. Additional benefits may include your product being made safer for consumers as well as reduced damage claims and liability premiums.

Now, the not so good news: The new product directives may exceed the current national laws and regulations. These increased or new requirements may require that a manufacturer change their design or production processes to continue in, 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, constantly changing 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 European 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.

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 .

Note: 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 then 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.

However, the only opinion that matters is that of the agencies that certify products for the European Union. These agencies are called "Notified Bodies." There are a couple hundred of these agencies, 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. 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

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 from one notified body to the next.

Service - Many Notified Bodies do not provide adequate service; usually due to peak load situations and some simply disregard customer needs.

Consulting - Some Notified Bodies will offer advice in addition to testing to accelerate the process an simplify the process for you. This may include a desk audit of your technical documentation prior to actual submission. Some will not.

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.

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 need help in selecting the appropriate notified body, contact UNZ & CO. We are prepared to assist you.

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 January 1, 1995, and covers any machine with moving parts (except manually operated machines).

The Telecommunications Terminal Equipment directive became effective November 1, 1992. However, it was recently reported that the supporting technical standards under development now interpret computer and network hardware to fall under this directive.

The Electromagnetic Compatibility directive became effective January 1, 1996. 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. Recently added to it is a requirement for CE Marking which will be come effective January 1, 1997. This directive applies to all electrically operated products.

Does My Product Require CE Marking?

CE Marking is required if your customers are located in certain countries and if they purchase certain types of products from you.

Are your current or future customers in the following countries that make up the European Economic Area (EEA)?
Do you now, or will you in the future, ship to these EEA customers any of the following types of products?
- Toys
- Construction Products
- Simple Pressure Vessels
- Telecommunications
- Terminal Equipment
- Active Implantable Medical Devices
- Machinery
- Personal Protective Equipment
- Satellite Earth Station Equipment
- Electromagnetic Compatibility
- Gas Appliances
- Low Voltage
- Medical Devices
- Recreational Craft
- Lift Machinery
- Equipment & Protective Systems for
- Explosive Atmospheres
- Non-Automatic Weighing Instruments
- Cableways
- Pressure Equipment
- Appliances (other than gas)
- Child Safety Articles
- Fasteners
- Furniture Flammability
- In-Vitro Diagnostic Devices
- Marine Equipment
- Measuring Instruments
- Portable Fire Extinguishers
- Roading Requirements for Construction Machinery

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. A notified body would be the best resource for identifying the steps and alternatives that would apply to your specific product(s).

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(s) for your product. The directives often use a series of questions about the nature of your product to classify the level of risk and refers 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.
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 in the European Union for your product. The directives require that a manufacturer designate in Europe either a representative or a distributor to produce technical documentation in a timely fashion when called upon to do so.

For many products, 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 which includes a list the directives and standards that your product conforms to; product identification ; the manufacturer's name , address and signature. The CE Marking itself is not meant to provide details about the product to surveillance authorities. 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 color, 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.

Regulated Exports Versus Non-Regulated Exports

In the European market, regulated products are those which represent a potential threat to the general public and are identified by the regulated product directives. These directives (about 40 in total including proposed and adopted) are intended to assure that only products that conform to the safety requirements gain entry to the European market. Only those regulated products with a CE Marking can gain entry to the European market after the enforcement date for the product directive.

In the European market, non-regulated products are any products not identified by the product directives. These products do not require CE Marking but may need to comply with national standards of the country receiving the goods. Once a product enters one country, that same product gains entry to all member states of the EEA by means of mutual recognition.

Who Enforces The Requirement For CE Marking?

Each member state of the European Union is bound by the General Product Safety directive to adopt laws, 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 and prison term penalties. Most of the countries would prefer to monitor and educate manufacturers and distributors than initiate legal action.

In many cases this education is being provided to the manufacturer by their own customers. European Union legislation makes European importers liable for the products they import, including the machinery they provide to their employees for work. 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
1946

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.

1985 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 several 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.

About the Author. . . Phil Gardiol

Phil Gardiol is one of the founders of QNET, a consulting and training firm specializing in both quality and international business. Phil has 20+ years experience consulting and training and has several books published on ISO 9000. Since 1990, Mr. Gardiol has helped 100+ companies achieve registration and shown many registered companies how to minimize documentation.. Phil's ISO training materials are distributed by QNET to many educational institutions and training firms throughout the U.S. Phil also publishes the QNET TIMES a monthly newsletter on ISO 9000. Write:

Phil Gardiol
QNET
P.O. Box 527
19563 Lander Street
Elk River, MN 55330
Tel: (612) 441-0899
Fax: (612) 441-0898.