China issues new regulations on genetically modified products

Asian Economic News, June 11, 2001

BEIJING, June 7 Kyodo

China has issued a new set of regulations governing the country's loosely controlled industry in genetically modified (GM) agricultural products, the official Xinhua News Agency reported Thursday.

The regulations, signed into law by China's State Council on May 23 but only announced publicly this week, upgrade Agriculture Ministry and Science Ministry ''management methods'' that have guided the country's treatment of GM products since 1986, industry analysts told Kyodo.

The new regulations will ''strengthen control over research and development, production, processing and trading of GM plants, animals and microbes,'' Xinhua said.

Like the old guidelines, the new regulations outline licensing and labeling requirements for the production and sale of GM materials.

But there are three major departures, according to Zhu Qinghua, China Regulatory Affairs Manager for U.S. biotechnology giant Monsanto.

On Firstly, the new regulations require that all data used to determine product safety be generated in China, while the old guidelines accepted data gathered abroad.

And the new regulations stipulate only four grades of product safety, ranging from ''safe'' through ''minimal risk'' and finally ''unsafe.'' This replaces the system of more detailed risk description prescribed in the old guidelines.

Thirdly, the waiting period for obtaining a product license has been lengthened from 90 days to 270.

''It is difficult to say what the effect on business will be,'' Zhu said in a telephone interview. ''It is really just a general framework. They are going to have to set clearer rules for implementation.''

Requirements on what product information is needed and how it is to be gathered will need to be determined at the ministerial level, Zhu said. The ministries will also need to set clearer rules for product registration, he added. ''Then we can say whether there has been a big improvement. We are looking forward to clear guidelines.''

The Chinese government has been keenly promoting GM products as part of its long-term strategy to feed the country's 1.3 billion people. It has not had to contend with the same level of public debate over questions of safety as in the United States, Japan and European countries.