How to conduct new chemical notification in China in cost-effective way

Under the revised version (the Order No. 7) of the Provisions on Environmental Administration of New Chemical Substances in China that came into force on 15 Oct 2010, chemical substances that are not listed in Inventory of Existing Chemical Substances in China (IECSC) are regarded as new chemical substances and shall therefore be notified to Chinese authorities with certain minimum data sets depending on the tonnage level of the substance and types of notification. The Provisions were also somethimes known as ‘China REACH’ since it draws on many elements of EU REACH – particularly those concerning data requirements and risk assessment.  More than 2,000 notification certificates have been issued by the Ministry of Environmental Protection in China since the amended legislation entered into force.

The increasing volume and complexity of data that must be submitted to Chinese authorities has no doubt imposed great burdens on companies striving for compliance. Therefore the purpose of this article is to share some experience regarding cost analysis and how to conduct new chemical notification in a cost-effective way and also reduce the regulatory burdens of this law for the chemical industry.

The composition of notification costs

Normally the total cost for the notification of new chemicals in China consists of three parts:

    The above chart is for reference purposes only. It does not represent actual cost composition.

  • Administrative fee .Currently the MEP are not charging administrative fees from companies for chemical’s evaluation and registration. However, the company shall pay a small administrative fee if IECSC search is required. The administrative fee represents a very marginal part of total cost
  • Consulting fee.  For foreign companies planning to introduce new chemicals into China, they may appoint a competent local agent to prepare notification dossier. The consulting fee also represents a minor part of total costs.
  • Testing fee. The company must commission qualified laboratories to carry out necessary tests to meet the minimum data requirements under the legislation. This testing fee usually represents the major part of total costs, especially when it comes to typical notifications.

How to conduct the notification in cost-effective way

  • Choose appropriate notification type:
  • There are several types of notification under the Provisions. The notifying company is advised to determine the appropriate notification type, as the cost for different kinds of notification types varies greatly. The Provisions introduced three types of notification with low data requirements: scientific research record, specific simplified notification and general simplified notification.

    Scientific research record applies to new chemical substances used for scientific research with an annual quantity lower than 0.1 ton or if the sample is to be tested in laboratories in China;

    Specific simplified notification applies to new chemical substance used for product research & development (<10t/y), intermediates (1t/y), polymer with monomer content less than 2% as new chemical substance or low concern polymers. For both types of notification, the applicant only needs to submit existing data or information to Chinese authorities and thus no additional testing is required.

    The third type of notification is general simplified notification which applies to general new chemical substance below 1 ton per year. Under this type of notification, several eco-toxicological studies (ready biodegradability study, acute toxicity study on aquatic organisms, or acute toxicity study on terrestrial organisms) must be carried out in MEP-approved eco-toxicity laboratories in China. However, these are grade by grade studies and some studies can be waived accordingly. For instance, if the substance is proved to be ready-biodegradable, the acute eco-toxicity studies can be waived and the applicants can submit the notification materials with only Chinese ready-biodegradability study report.

    For typical notification of a new substance above 1t per year, it is wise for the applicant to acquire notification data by reasonable sources, formulate scientific testing strategies or utilize data share-sharing to save costs.

  • Acquire notification data by reasonable sources
  • The general principle for typical notification is "The greater the volume, the higher the data requirement". Physio-chemical, toxicological and eco-toxicological data and risk assessment report need to be submitted. There are minimum data requirements for different tonnage bands.

    In general, test reports are required by authorities. However, for data which can not be acquired by testing or if the testing is not practical, the applicant can rely on the following sources to acquire the data: i.e. published authoritative literature, authoritative database, and other non-testing methods such as QSAR, read-across and expert opinion, etc.

    Some mandatory Chinese eco-toxicological studies, testing reports generated in foreign laboratories may also be used for new chemical substance notification. According to the assessment standards, test reports from GLP accredited laboratories or laboratories authorized by local environmental authorities could also be accepted. They should complete the tests as per Chemical Test Guidelines (HJ/T153-2004) of China or follow better standards such as internationally renowned OECD methods and ISO standards

  • Formulate scientific testing strategy
  • For high level notifications, the applicants are recommended to conduct scientific data evaluation and formulate logical testing strategies. It is advised to adopt the principle of “primary studies at first and advanced studies afterwards” and set up grade by grade testing strategies. The first grade studies are usually basic physio-chemical and acute toxicity studies which are necessary to evaluate the intrinsic properties of the substance; the second grade studies are usually long-term studies and the necessity of whether these studies require to be carried out or not can depend on the results of first level studies. By following this strategy some unnecessary long-term and costly studies could be waived.

    For instance, if the applicant has firstly conducted skin corrosive study to show that the result is positive, the 28-day repeated oral toxicity study could be waived and hundreds of thousands RMB for testing can be saved.

  • Data Sharing
  • Currently there is no mechanism or platform set up by Chinese authorities for data and cost sharing, however data and cost sharing is encouraged by Chinese authorities to avoid repeated vertebrate testing, and also as an attempt to reduce the burdens of industry. The applicant can apply for the following special types of typical notification if the specific conditions are met:

    Serial notification;
    Serial notification refers to typical notification performed by applicants for two or more series of new chemical substances with similar molecular structures and similar test data for same or similar purposes. Based on principle, only one full set of toxicological and eco-toxicological data endpoints are required for the substances included in the serial notification, by which the applicants can avoid a lot of unnecessary testing for group substances.

    Joint notification;
    Joint notification refers to typical notification performed by two or more applicants by jointly submitting notification documents of the same new chemical substances. The applicants can share the data and cost for the same substance by joint notification.

    Repeated notification;
    Repeated notification refers to general notification performed by an applicant using test data in notification documents of former applicants. The applicant can therefore avoid duplicate testing and save the testing cost for the same substance.

Find our expert here

Mr Eric Xiong, New Substance Notification in China/Korea/Japan, CIRS China
11/F., Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533