ニュースセンター
MEPSCC finally issued the revised <Guideline for New Chemical Substance Notification> (draft for comments) on June 25th, 2015 on its website www.mepscc.cn/tabid/75/InfoID/915/frtid/40/Default.aspx. Comments shall feedback to MEPSCC by July 31st to guidance@mepscc.cn.
MEPSCC is also planning a presentation in the afternoon of July 9th at MEPSCC’s office. Participants shall register on line via http://apply.mepscc.cn/znxd/.
Changes to the current Guideline:
In general, notification formality is simplified, while data requirement is enhanced.
Details are as below,
1 Exempted substances: enzyme (without treatment by chemical process) and fertilizer are included in the exemption list. While the exemption condition for Articles are stricter: articles are not exempted if the contained new chemical substance (NCS) can expose to environment and/or human body for example during usage, e.g. surface coating of articles.
2 Notification Agent (OR)
2 main changes: overseas registrant is now the Certificate Holder, the OR takes the liability if the overseas registrant cannot or will not carry out the liabilities; no capital requirement to the OR anymore.
3 Registration hierarchy
It clarifies that from low to high hierarchy of the registration is Scientific Record Notification --> Simplified Notification --> Typical Notification. A higher hierarchy registration certificate will automatically abolish the lower hierarchy registration certificate.
4 Notification formality
4.1 Notification dossier can be signed by Legal Representative, responsible person or by delegated person.
4.2 No need to send the hardcopy of notification documents to MEPSCC.
5 Simplified Registration
Export only: it clarifies that if a NCS is imported to China with quantity < 1 ton/year, then all exported from China, then the NCS can make simplified registration of For Export Only.
6 Polymer.
6.1 If a monomer of a polymer is not in IECSC but already registered by Typical Registration, then simplified registration for the polymer can be applied.
6.2 If a polymer is easily to degrade, decompose, depolymerize, or if the polymer decomposes after production or usage, the polymer cannot apply for simplified registration.
6.3 Water Absorbing Polymer with Mn> 10,000 D cannot apply for simplified registration either.
7 Typical Registration
Registrant can make level registration --- it is optional to register a concrete quantity (e.g. 200 ton/year) or to register a level (e.g. 100~100 ton/year).
8 Tests
8.1 If test method is revised, test reports by old test method are not valid anymore after 5 years.
8.2 More complex requirements for mutagenic tests based on test results of AMES test, in vitro test, etc.
For Level 1 (1~10 ton), acute oral test is mandatory, acute dermal and inhalation toxic test should be provided based on the substance’s physic-chemical properties and main exposure routes;
For Mutagenic tests:
For Level 1, if any result of AMES and in vitro chromosome aberration (or in vitro micronucleus test) is positive and the substance has risk of far-ranging exposures (e.g. the substance will be used in numerous places), then mutagenic test for upper level should be provided.
From Level 2 (>10 ton), test data should be provided based on test results of Level 1,
a) If all test results are negative, then in vitro gene mutation test shall be performed. If in vitro gene mutation test result is positive, then in vivo gene mutation test (e.g. unscheduled DNS synthesis test with mammalian liver cells in vivo or transgenic rodent somatic mutation test, etc.) shall be also performed.
b) if AMES result is negative while in vitro chromosome aberration result is positive, then in vitro gene mutation test and in vivo chromosome aberration test shall be performed (e.g. mammalian erythrocyte micronucleus test, mammalian bone marrow chromosome aberration test, etc); If in vitro gene mutation test result is positive, then in vivo gene mutation test shall be performed.
c). if AMES result is positive while in vitro chromosome aberration result is negative, then in vivo gene mutation test shall be performed.
d). if test results of Level 1 are all positive, then in vivo gene chromosome aberration test and in vivo chromosome aberration test shall be performed.
For carcinogenicity test: if the substance has far-ranging and dispersive usages or the possibilities of frequent, long-term exposure to human body, and have category 2 classification of germ cell mutagenicity or evidence in repeated exposure test shows the substance can induce hyperplasia and/or precancerous lesion, then carcinogenicity test shall be performed.
For Level 4 (>1000 ton), chronic toxicity test of at least one exposure route shall be provided (the current valid Guideline excepts chronic toxicity test if NOAEL of repeated 90d test is very high, or if the substance is not classified under STOT-RE).
8.3 From level 3 typical registration, full toxicokinetics study shall be performed if the NCS has any GHS classification.
8.4 Tests shall be performed to the NCS itself (to mixture of the NCS is not accepted anymore).
9 NCS Risk Assessment Report
More detailed and stricter requirements for the assessment report.
10 Registration Certificate
10.1 Usage change: If registered usage is changed, for hazardous NCS (typical registration), a new risk assessment report shall be prepared to MEPSCC for evaluation by Expert Panel for approval; for simplified registration, no change formality is needed, but the change shall be indicated in Annual Report.
PS: The draft Guideline also provides a Usage Code table.
10.2 Activity change: for typical registration if activity is changed from import to manufacture, then a new Risk Assessment report shall be prepared to MEPSCC for evaluation by Expert Panel for approval.
10.3 Change of OR: An application can be submitted to MEPSCC for change of OR.
10.4 Change of registered quantity: for level 2~4 typical registration, a new risk assessment report shall be prepared to MEPSCC for evaluation by Expert Panel for approval.
For all the change above, no new Registration Certificate will be issued. MEPSCC will issue a change receipt acknowledge to the registrant.
11 Activities Reports
Data requirement for annual report and each activity report of critically hazardous NCS are simplified: information on import customs and on customer is not needed anymore.
Background:
China issued 3 Guidelines in the past 12 years. <Guideline for New Chemical Substance Notification> (Trial) was issued in December 2003, <Guideline for New Chemical Substance Notification> (1st edition) was issued in October 2004, and with revision of the Regulation, <Guideline for New Chemical Substance Notification> was revised and re-issued in September 2010. Randis staff were actively and deeply involved in revision of all the Guidelines.
With more than 12 years knowledge and solid experience on China New Chemical Substance management, Randis provide professional and dependable service for new chemical substance registration to China, with language ability on English and Japanese.
Should you have any need or enquiry, please feel free to contact us.
Randis ChemWise (Shanghai) Co., Ltd.
Unit 505, KeChuang Building, #350 Xianxia Road, Shanghai, 200336 P.R.China
Email: frankwang@randis.cn
Tel.: +86-21-62757818
Skype: randischemwise