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National governments are finding it increasingly hard to enforce CE mark wiki regulations which block one-stop, pan-European approval. A landmark court case in late 2005 in telecommunications condemned the French government for imposing its own independent certification rules.
Indeed, the courts are becoming a last resort. Procedures now exist for amicable review of attempts to deviate from harmonized approval, and most are settled long before court action becomes necessary. The EU has a complaints procedure that enables suppliers to force a review when one-stop approval is denied.
Compliance instructions are becoming clearer. In the PPE case quoted here, detailed guidelines were issued in February 2006. In another complex area, the marking of passive components for low-voltage electrical safety, guidelines are being developed.
The body of harmonized EN standards is growing. The total number of standards officially recognized so far is approaching 1,000, and far more are in the works. One estimate from the British government puts the figure at less than 2% of all suppliers. The proportion of shipments affected would be even lower.
The EU earns high marks for good conduct in the World Trade Organization (WTO). After a full year of operation under the new WTO Technical Barriers to Trade code, which includes a prohibition on discriminatory certification requirements, only one complaint has been lodged against the EU. Against the background of these successes, there is no question that one-stop regulatory certification for Europe is here to stay. The progress applies both to products eligible for self-declaration and to those requiring third-party approval. Where temporary problems remain, the past successes will lead regulators to fight even harder to solve them.
Although the EU hopes to complete its first MRAs with third countries during 1996, the latest indications suggest that the United States is not likely to be on the list. Explanations of the problems in the still-confidential political negotiations vary, with the EU blaming U.S. rigidity and perhaps vice versa. Meanwhile, U.S. exporters have no option but to continue to use European test houses for mandatory certification needs.
The steady progress of one-stop approval in the EU has revealed a paradox. The EU's directives rely heavily on self-declaration of compliance by suppliers, and yet there appears to be increasing interest in third-party certification. The reasons can be deduced from the evidence, which includes:
* The European Consumers Association (BEUC), which groups all national consumers associations in the EU, repeatedly stresses that strong consumer protection must include recognized third-party conformity assessment schemes. The BEUC regards the self-declaration options of CE Marking as a bare regulatory minimum.
* Suppliers are going to third-party test houses. Even if self-declaration is officially available for most products except large industrial machinery, suppliers are still flooding test houses with orders. Why? Self-declaration includes specified requirements for test reports. One major European test house estimates that the minimum investment cost for the associated test equipment can often approach $500,000. Only the largest manufacturers can afford this.
* Third-party certifiers are responding by strengthening the policing of their activity. There is a strong movement toward harmonized accreditation rules for certification bodies beyond the minimum required by EU regulations for CE mark wiki.
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