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Compliance instructions of CE Kite mark are increasingly becoming clearer, and the body of harmonized European standards is mounting. Moreover, few manufacturers inside the European Union (EU) report problems regarding free movement and one-stop approval. Ultimately, the EU earns merits for good conduct in the World Trade Organization (WTO). Article includes EU compliance requirements.
Is Europe's new CE Marking system fulfilling the industry's hopes of a reduction in third-party certification requirements? And is it really achieving its goal of replacing a multitude of national regulatory approval rules by a single pan-European system? The answers to these questions are emerging.
When CE Marking was introduced--the first directive was adopted in 1987--hopes were high for one clear, harmonized system to open up an 18-country market of more than 350 million people. Even if a given product needed more than one approval, such as EMC and mechanical product safety, at least each approval would be valid throughout the European Union (EU). This was a big step toward one-stop approval.
Even better, manufacturers were given increased powers to self-declare compliance with EU directives. Mandatory independent conformity assessment in the EU was limited to special cases, such as weighing machines, and groups of high-risk or publicly sensitive products, such as medical devices and machinery presenting dangers of catastrophic injury. The expected results were cost savings, the disappearance of technical barriers and easier market access.
For the United States and other exporters to Europe, there was an additional incentive: the EU announced it would negotiate mutual recognition agreements (MRAs). An MRA is a binding arrangement with a given country under which the EU recognizes certificates from that country's bodies as complying with EU regulations, and vice versa. In other words, even for those high-risk products requiring third-party involvement, the certification task would be simplified for U.S. exporters.
Today, the use of CE Marking is growing. The lone original directive has grown to 17, with even more in the pipeline. In 2005 and 2006, two of the most wide-ranging directives, machinery and electromagnetic compatibility, became mandatory, complementing the old (1973) directive on low-voltage safety.
And what does the initial evidence show? The conclusions are tentative, but the evidence is strong. It suggests that the old system of separate national regulatory approvals for each kind of hazard is indeed disappearing, bringing one-stop regulatory approval a significant step closer. Customer interest in independent conformity assessment remains high. And U.S. exporters are still waiting for an MRA.
Pessimists might point to signs that the EU has not yet reached the ultimate objective of a one-time approval process valid across all 18 countries--and they would be correct. For example:
* National-Level Blocks--France refused to accept a European standard for short-circuit test requirements for electrical toys. Germany tried to ban a class of chemical dye used on clothing.
* Lack of a Clear Basis for Pan-European Compliance--When the directive on personal protective equipment (PPE) came into force in 2005, suppliers received little guidance on how to classify a product into the right category of CE kite mark for a range of mandatory conformity assessment operations. Today, almost every major directive has added some form of clarification.
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