China: New substance notification

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It has been more than three years since the revised version of the Measures on Environmental Administration of New Chemical Substances, MEP Order 7, came into force (GBB November 2010). Since then, many questions have been clarified as the regulatory regime has evolved. However, many issues remain to be resolved, and this creates problems and challenges for companies trying to meet the legislation’s requirements. In this article, I summarise the progress on implementation, clarify some issues and set out the remaining issues regarding new substance management in China.

Typical notifications

The number of typical notifications for new substances manufactured or imported in annual quantities of at least one tonne has increased significantly year on year. In the first year, 2011, there was only one batch and two typical notifications approved; in 2012, there were six batches and 55 notifications; and in 2013, the number rose to 11 batches and 73 notifications. This continuous increase indicates that the industry has responded actively to MEP Order No. 7. It also shows that the efficiency of MEP’s technical review has improved over the past three years.

Number of typical notifications

Once a typical notification of a new substance is approved, the new substance is categorised according to three categories based on its hazardous properties: general substances, hazardous substances and priority hazardous substances. Most registered new substances are either hazardous substances or priority hazardous substances. The results show that new substance notification is necessary and meaningful for the management of new substances placed on the Chinese market.

The types of notification are becoming more diverse. Whereas there were only two types of notification in 2011 and 2012, typical notification and joint notification, in 2013 we saw other types as well, such as serial notification, repeated notification and modified level notification.

The majority of notifiers, or “notification bodies”, are domestic manufacturers or importers of new substances. However, more and more manufacturers or traders outside China are assuming the role.

Simplified notification

In contrast to the increase in typical notifications, the number of simplified notifications, which are mainly for new polymers and substances produced in annual quantities below one tonne, is dropping, falling from 4,567 in 2011 to 3,402 in 2012, and 2,807 in 2013. We expect this number to continue to drop before reaching a steady level. The reason for the decrease is that there is an expiry date for new substance notification or exemption certificates issued before October 2010 for substances placed on Chinese market before 15 October 2010 and no expiry date for new substance notification certificates issued after 15 Oct 2010. When Order 7 came into force at the end of 2010, companies were required to re-notify their new substances when the old certificates expired in 2011 and 2012. When the re-notification process is over, companies will only need to notify new substances placed on the Chinese market after 15 October 2010, and the number of the new substances is quite stable.

Scientific research record notifications

The number of scientific research record notifications approved each year is quite stable, with 964 approved in 2011, 890 in 2012, and 899 in 2013. This indicates that there is no big increase in R&D activities involving new substances in China.

The guidance on new substance notification issued by the Ministry of Environmental Protection (MEP) is helpful. Yet it does not solve all problems. The MEPs Chemical Registration Centre has updated its FAQs on its websites and some issues have been clarified, particularly those relating to notification bodies and toxicokinetics studies.

Notification bodies

The regulation says that notification bodies must be direct exporters or importers when a new substance is imported into China, but either a manufacturer or trader based outside China can appoint a local agent. As an example, if a company in the US produces a new substance and sells it to a Japanese distributor who then directly exports the substance to China, the Japanese distributor or Chinese importer must notify the new substance, even if the US company has already notified the new substance and got a certificate. This is very different from the substance registration requirements of the EU REACH Regulation.

Toxicokinetics

Previously, registrants were generally required to submit testing data on the absorption part of a toxicokinetic study for level 2 notifications (for substances of ten to 100 tonnes) and complete a toxicokinetics study for level 3 or 4 notifications (for substances over 100 tonnes). Following an industry seminar on new substance notification, MEP-CRC published an FAQs document which clarifies that the data from non-testing methods can be accepted for level 2 notifications. Testing data is required for level 3 or 4 notifications.

Despite the progress made with new substance notification, many issues remain, creating challenges for companies. These include:

intermediates: it is widely believed in industry that the data requirements for intermediates should be less onerous than those for ordinary substances, due to their low exposure or low risks. In China, intermediates manufactured or imported in annual volumes above one tonne are treated as regular new substances, and are subject to typical notifications without any reduced data requirements. The chemical sector is hoping that one day they can be lowered through the revision of the guidance on new substance notification. Unfortunately, the authorities have not given any positive signs;

no direct communication with technical experts. In order to prevent a registrant bribing technical review experts, the list of experts in China is confidential and unavailable to the public and registrants. This has created communication barriers between registrants and technical review experts. Fortunately, this has attracted MEP’s attention, and an effective communication platform should be established soon;

registration of a new gas: there are few laboratories qualified to carry out the necessary studies for the notification of a new gas in China. Some of those that are qualified to do the tests are also reluctant to start the studies. The authorities are discussing this issue internally;

guidelines: some information in the guidance on new substance notification is vague. For example, there is a sentence that says terrestrial toxicity data can be waived if the adsorption of soil is low. However, there is no quantitative criterion to define “low”;

active substances: there is debate over whether an active substance manufactured or imported for pharmaceutical or pesticide use should require new substance notification if it is not listed in the Inventory of Existing Chemical Substances in China (IECSC). Article 2 of Order 7 says that “pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives and feed additives are subject to other laws or regulations. However, the raw materials or intermediates of above products are subject to the provision if they are new chemical substances.” But if an active substance is also treated as a raw material, notification will be required for the active substance, leading to double registrations with different authorities in China, and a big burden on the industry.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.