September 2002: Volume 44, Number 9
China -- A Changing Landscape for Manufacturers and Certifiers
by Tom Bruursema
China is a market that has the attention of many manufacturers across a broad front of industries, including that for drinking water treatment units (DWTU).
The interest is twofold. First, China is well recognized as a leading country in the manufacture and export of goods. Last year, China was the sixth leading exporter of merchandise at $266 billion. Second, China has a population of over 1.2 billion people, making it the sixth largest importer of goods at $244 billion. When compared to 2000, China was the only country to see growth in both imports and exports. In addition, an estimated 38.6 percent of the rural population and 75 percent of the largest cities have unsafe water, with an estimated annual impact on human health of $3.9 billion. In short, you quickly realize the potential of this market.
Historically, China has been a complicated market relative to import/export regulations and procedures. This has certainly been true of DWTUs. A recent development, however, will have increasing benefits to manufacturers in simplifying this process. After 15 years of negotiations, the World Trade Organization (WTO) accepted China as a new member country last November. As a condition of membership, China agreed to undertake a series of steps, including the following -- provide non-discriminatory treatment to all WTO member countries; eliminate dual pricing practices and differences in treatment for goods produced for sale in China and those produced for export, and eliminate certain price controls that afford protection to domestic industries.
In this year’s first quarter, resulting from China’s WTO accession, a series of regulatory changes were adopted. Several government bodies were reorganized, and several others were created. These changes impact both certification organizations and product manufacturers.
A newly created agency, the Certification and Accreditation Administration, is responsible for all product certification organizations and systems registrars (those offering registration to ISO 9000 and other ISO standards). Of greater significance to product manufacturers, and a benefit to certifiers, is the expected reduction in the issuance of false certificates through the oversight of this new administration. False certificates and standard marking have been significant problems in China. Similar to the American National Standards Institute (ANSI), the recognized accrediting body in the United States for third-party product certifiers, the administration will closely monitor activities and post details on the accreditation of all certifiers.
Another newly formed agency will have its impact on product manufacturers. The China Quality Certification Centre (CQC) is now responsible for issuance of certificates and the China Compulsory Certification Mark. Effective May 1, 2002, the first series of product categories was required to apply through the CQC for approval. While this first series of product categories doesn’t include performance certifications of DWTUs, it does address many electrical devices including electrical certification for home appliances. The new process of certification applies to both products marketed domestically as well as imported. Beginning May 1, 2003, only products recognized by CQC as certified will be allowed for importation or sale in China. For a more complete listing of affected products and a brief overview of the new regulations, visit CQC’s website (see: www.cqc.com.cn).
Water quality in China is governed by the Sanitary Standards for Drinking Water, promulgated last June. These standards are further divided into seven categories. All of these are published in a single document and comprise 393 pages of text. Unfortunately, this is only available in Chinese at the present time.
The seven categories are as follows:
1. Sanitary Standards for Drinking Water Quality;
2. Standard for Hygienic Safety Evaluation of Equipment and Protective Materials in Drinking Water;
3. Standard for Hygienic Safety Evaluation of Chemicals Used in Drinking Water Treatment;
4. Sanitary Standards for Hygienic Safety and Function Evaluation on Treatment Devices of Drinking Water;
5. Sanitary Standard for Drinking Water Plants;
6. Sanitary Standard for Enterprises and Related Hygienic Safety Products for Drinking Water, and
7. Standard Examination for Methods of Drinking Water.
DWTUs are assessed against the requirements of items 2 and 4 above. Item 1 establishes the general parameters and criteria of individual contaminants, much like the U.S. Environmental Protection Agency (USEPA) Primary Drinking Water Regulations. These same criteria form the basis of acceptance for all subsequent testing, similar to the ANSI/NSF DWTU standards relying upon USEPA, Health Canada, and other regulations to establish pass/fail levels.
Item 2 specifies the requirements for all materials in contact with drinking water. Similar to Standard 61, materials are tested individually. In the case of DWTUs, both the individual materials and the complete system are tested. All material testing is conducted with a single 24-hour exposure. A series of chemical parameters are established similar to those of the ANSI/NSF standards. In addition and consistent with their general sanitary standard for drinking water, there are requirements for microorganisms. The extraction water cannot contain more than 100 total bacteria per milliliter (ml) and no more than three E. coli/ml.
Finally, Item 4 addresses the performance claims of the DWTU. The basic criteria are as follows:
1. Product water must conform to the requirements of the sanitary standard;
2. The device must attain the claimed purification efficiency at the specified flow rate and stated capacity, and
3. Multi-function treatment devices are evaluated for all functions.
The evaluation procedure differs across three product categories including general devices, mineralizers and reverse osmosis (RO) devices. By definition, common devices and RO units are for the removal of harmless substances from the drinking water to improve quality, according to the standard, while the mineralizer standard is for those devices that enhance the mineral content of the drinking water. Each type of device has its individual function test, i.e., performance evaluation for stated claims. There are no structural requirements for these devices.
Process of certification
The Ministry of Health (MOH) is ultimately responsible for the approval of many hygiene-related products including DWTUs. The process differs slightly for imported products vs. those manufactured locally. For importers, all evaluations are performed at one of the national testing laboratories. These aren’t directly under the ministry, but rather are housed in the newly formed China Centers for Disease Control (CCDC). The most prominent laboratory used for evaluating imported products is the Institute for Environmental and Health Related Product Safety in Beijing. The institute conducts the applicable testing, according to the Sanitary Standards, and provides the completed test reports to the MOH.
In the case of locally manufactured goods, testing is first performed in the applicable provincial laboratory where the manufacturing plant is located. This information then feeds into the national approval process for those goods planned for national sale in China.
The MOH reviews product certification requests through a committee structure that meets once every quarter. The test reports and products are evaluated at that time. If approved, a license to manufacture and distribute is issued.
There’s a significant amount of change under way in China, and with this change is a fair amount of confusion It will take some time for the new and reorganized agencies to fully implement their individual responsibilities and new processes. It’s likely this transition will result in further changes, particularly over the next few years as the full requirements of the WTO are addressed. These changes, while creating additional burden on the manufacturers and certifiers, don’t outweigh the tremendous benefits this market has to offer. The changes also represent a significant step forward when compared to the multi-level requirements of local, provincial and federal agencies of just a few years ago.
Perhaps the greatest challenge that remains is the language differences. Those who don’t speak Chinese will find it impossible to seek acceptance in this vast country. Consultants are available, and many organizations have hired bilingual employees to assist with communication barriers.
About the author
Tom Bruursema, general manager of the Drinking Water Treatment Unit Program, is a 17-year veteran of NSF International. NSF has established working relationships with the Chinese Ministry of Health, provincial and national institutes of product testing, and other organizations that offer assistance in the process of product certification there. He can be reached at (800) 673-6275, (734) 769-0109 (fax) or email: email@example.com