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Forum highlights advantages of EU regulatory system for electrical equipment

Taipei, 28 March – The European Chamber of Commerce Taiwan (ECCT) today called upon the Taiwan government to bring Taiwan's regulations governing electrical engineering and equipment in line with the best international standards and practices. The call comes following an intensive two-day "EU-Taiwan high voltage electrical equipment management forum" held from 25-26 March in Taipei. The forum was jointly organized by the ECCT together with the European Economic and Trade Office (EETO), the Ministry of Economic Affairs' (MoEA) Bureau of Foreign Trade (BoFT) and Bureau of Energy (BoE). It was co-organised by the Taiwan Research Institute and the European Business and Regulatory Cooperation programme (EBRC, a service project funded and supervised by the European Commission and implemented by the ECCT).

The forum provided a rare opportunity for open communication between EU and Taiwan regulatory authorities and industry experts. The forum brought together three industry experts from the International Electrotechnical Commission (IEC) and senior government officials from the European Commission, The Netherlands and Germany to discuss regulations governing electrical equipment. By bringing in foremost technical experts from the IEC to Taiwan, the organizers' main objective was to give a comprehensive briefing and share the best international standards and practices with the Taiwan government and industry players in order to assist them to put in place a system in Taiwan that is line with the best international standards and practices. It also established communication channels for further exchanges in the future.

The forum focused on aspects of Taiwan's regulations which are not in line with international standards and practices, particularly guidelines for Directive 401 on the Indoor Wiring Standard. The BoE first officially announced the guidelines on 1 January 2012 and amendments to the guidelines on 25 December 2012. The guidelines set out provisions for the inspection and accreditation of high voltage electrical facilities (of over 600 volts). The regulation requires BoE certification of laboratories, factories of origin and type test reports, with the aim of verifying the quality and safety of products. The amended version of the guidelines provides a two-year grace period to allow companies to obtain BoE certifications for their products. The amended guidelines, while an improvement on the original guidelines are nevertheless not in line with European practices. For example, Taiwan requires factories to obtain IEC/ISO 17025 certification for production facilities, although internationally, this is the standard for test and lab facilities and not for production facilities. The international standard for production facilities is ISO 9001 and Taiwan regulations furthermore require that factories with ISO 9001 certification are also required to be inspected by the BoE upon renewal of their certification within three years.

Through the forum, the effectiveness and efficiency of the European regulatory system was comprehensively demonstrated. Experts and government officials clearly showed how the European authorities and industry players cooperate to ensure the highest possible level of safety of electrical equipment.

At the conclusion of the forum, delegates urged the Taiwan authorities to follow the European practice related to electrical equipment and thereby harmonise Taiwan's regulations with the best international standards and practices.

A major difference between the EU and Taiwan system is the recognition in the EU that IEC 17025 is the standard to ensure the competency of laboratories. It does not guarantee the safety of the products. Manufacturers need to do type tests to ensure that their products are safe. The best place to do type tests is in 17025-certified labs. Once the type test is done, production is done in a factory, after which routine tests on products are done to ensure compliance with the type test. Labs have 17025 certification but factories have ISO 9001 certification and this quality standard ensures they are producing according to standard. Factories are inspected every year to ensure compliance. The European system works well and a produces high level of safety.

The EU obliges manufacturers to ensure that products are totally safe and must at all times be able to prove to authorities that the products are safe by maintaining and being able to provide the relevant technical documentation. While the EU encourages the use of international standards, ISO/IEC 17025 only sets general requirements for the competence of testing and calibration laboratories, while ISO/IEC 9001 refers to quality management. They do not directly cover the safety of products. The EU does not require testing or third party certification in government-recognised laboratories. The government's role is to police the market and the EU achieves a very high safety record.

The forum highlighted the fact that there are no new players in the high voltage industry. They are all established players with long and reputable track records in terms of technical know-how and dealing with safety. Moreover, their customers have similar track records and reputations. All stakeholders are acutely aware of the need for safety and the costs and dangers of failure. The main customers will only buy from reputable players and the manufacturers know that the consequences of supplying unsafe products are severe. Providing unsafe products would result in them having to pay significant damages, and much more importantly for them, would damage their reputations. This is a crucial factor. None of the major players would risk damaging their reputations and therefore future business prospects by supplying unsafe products. 17025 only ensures that labs act properly. Routine testing covered by 9001 is sufficient to ensure safety and compliance. The obligation for accreditation based on ISO/IEC 17025 is only useful for test laboratories that perform testing for third parties. Using ISO/IEC 17025 does not prevent manufacturers from producing non-compliant products.

In Germany only products that meet IEC and ISO standards are allowed in the market and the market surveillance system is also very strong. Manufacturers can be liable to pay large damages for faulty products so they do not dare to introduce unsafe products in the market. Technological innovation happens very quickly and much faster than the government can keep up with. If regulations are too specific, they can become outdated as better technologies are developed. The German government recognizes that the regulatory system should not stifle innovation and therefore only requires that industry players are able to prove that their products are safe, if requested.

The Netherlands' experiences and evaluation of accidents and incidents show that there is no relation between the application of ISO/IEC 17025 and preventing those events.

Delegates also discussed the benefits of the post market surveillance system adopted in the EU. They noted that post market surveillance is a much more efficient use of government resources than pre-market approval as long as enough inspectors are employed. They also emphasized that high voltage products are usually custom-made and complex. Not every inspector will understand all the technical requirements for every new product. It is therefore important to trust established players. The job of inspectors in the EU is to check to make sure all the tests have been done properly and that the products passed the tests. The practice in the EU is not to get involved in the operations of producers because this actually hampers innovation. Panelists from the EU therefore recommended that Taiwan adopt a post market system.

In the final panel discussion of the forum, panelists concluded that the European system has a comprehensive array of tests and procedures to ensure that electrical equipment is safe. In addition, a robust market surveillance system ensures that producers comply with their quality and safety commitments. The same level of assurance could be achieved in Taiwan if it adopted the European system. For this reason panelists recommended that Taiwan authorities withdraw the use of ISO/IEC 17025 in Directive 401 as part of the obligation to manufacturers because it does not contribute to preventing incidents and accidents. Delegates also welcomed further exchanges to resolve any remaining technical obstacles caused by a lack of understanding of product design. In order to avoid doubling testing and the misunderstanding of type test reports, Directive 401 reviewing committee members and Taiwanese testing lab experts were invited to communicate with IEC experts and manufactures to achieve a comprehensive understanding of product designs. In addition, members of the ECCT's Electrical Engineering and Equipment committee offered to set up video conferences to enable direct communication between Taiwan regulators and IEC experts or manufacturers to discuss technical issues at any time in the future.