China New Chemical Substance Notification Guidance: Comparative Analysis of Current Version and Pending Draft

Finished products

Finished products covered by other laws and regulations, including pharmaceuticals, pesticides, veterinary medicines, cosmetics, foodstuffs, food additives, feed and feed additives, radioactive materials, military products, explosives, tobacco are exempt

Fertilizer added into this exemption category

Naturally occurring substances

Naturally occurring substances, sub-category 4, the  biological substances, such as DNA, RNA, proteins etc. and other biological macromolecules are exempt 

Enzyme added into this exemption category; adding restriction on biological substances that those through chemical processing cannot be exempt

Articles

New chemical substances contained in articles intentionally released during normal use inapplicable to notification exemption

Inapplicable to notification exemption: All new chemical substances contained in articles with exposure to environment/human body during normal use, e.g. surface paint of articles

Scope of applicable territories

Within the boundary of the People's Republic of China; Bonded and Export Processing Zones

Free Trade Zone is also applicable, management of which is equivalent to Bonded and Export Processing Zones

Special case of Simplified notification

One case applicable: Manufactured at<1 t/a for export only

“Imported at<1 t/a for export only” also applicable

Qualification of domestic notifier

Business bodies registered in the People's Republic of China with legal personality

Business bodies registered in the People's Republic of China without legal personality is also qualified

Definition of holder of registration certificate

Domestic notifier is the holder of the registration certificate;

For foreign notifier, the local representative agent based in China is the holder of the registration certificate 

Notifier is the holder of registration certificate, regardless of domestic or foreign notifier

Qualification of local representative agent

8 items of requirements:

(1) Pass the annual industrial and commercial inspection

……

(3) Posses registered capital of over RMB 3,000,000

Delete requirements on annual industrial and commercial inspection and registered capital;

Enhance management of consultancy company as local representative agent, such as requirements for a comprehensive quality assurance system and professionals familiar with new chemical substances notification;

Add provisions specifying that local representative agents should keep secret the confidential business information or technology of foreign notifiers

Regular notification tonnage

Notify with specific tonnage amount

When applying for regular notification (except Band 4 where specific tonnage amount is still required), either specific tonnage amount or tonnage band can be accepted

Cancellation of registration certificate

cancellation of the registration certificate prior to the registered substances being included in the IECSC

Adding cancellation situation of simplified notification

Dossier compilation

Documents contained in dossier should be put in order

Adjustment of documents sequence

Simplified notification – Not approved

If notification application is rejected, applicant will be informed of the reasons in writing, no impact on future notification

If rejected, applicant not allowed to notify the same new chemical substance for the same notification type in the future; instead higher notification type should be applied for

Special case of simplified notification for polymers

Special case of simplified notification: polymers with low new chemical substance concentration of monomer which are≤2 % w/w or polymers of Low Concern (PLC)

Special case of simplified notification does not apply to (1)unstable or degradable polymers, or (2)water-absorbing polymers with Mn≥10,000;

One applicable situation added: If a polymer itself is not included in the IECSC, while its new chemical substance monomers/reactants present in ≥2% (w/w) concentration are all notified already, then this polymer can be notified under the special case of simplified notification.

Tonnage amount

Notified tonnage amount is specified on the certificate; Manufacturing or importing in volumes in excess of the notified tonnage requires modification and application to the SCC

Issuance of registration certificates without specific registration tonnage; no tonnage limit for manufacturing or importing of the new polymer after notification

Accredited testing institutes for data generation

For toxicology testing, institutes with credentials as specified in guidance

GLP labs approved by Ministry of Agriculture also applicable

Validity period of test report

Not specified

Test reports generated within the territory of China should be completed within the accreditation validity period of the testing institutes;

testing method used has been updated more than five years, the test report is unacceptable (only used as a reference for expert review committee reviews) and should be performed in accordance with the current standardized test method

Test method

Domestic testing institutes: Guidelines for the Testing of Chemicals, 2004 ver. (1st version)

Updated to adopt Guidelines for the Testing of Chemicals, 2013 ver. (2nd version)

Chinese test organism

Organisms cultivated and bred in China that comply with the requirements for the designated tests, including Gobiocypris rarus (Rare minnow), Xiphophorus helleri (Sword-tail fish) , Brachydanio rerio or Danio rerio (Zebra Fish), activated sludge

Local organisms cultivated and bred in China that comply with the requirements for the designated tests, including Gobiocypris rarus (Rare minnow), activated sludge within Chinese territory

Spectrum

Not specified

For organic substance, should provide at least two of the three the following spectrographic data, including infrared, nuclear magnetic resonance (NMR), mass spectrometry; For chiral material, optical confirmation information should be provided where possible

Minimum acute toxicity data for Band 1 regular notification

acute toxicity by oral, dermal and inhalation routes, skin/eye irritation and skin sensitization

Acute toxicity by oral route, skin/eye irritation and skin sensitization required; acute toxicity by dermal and inhalation routes can be optional according to the corresponding exposure route and physic-chemical properties

Data requirements of mutagenicity

Mutagenicity:

For Band 1: A bacterial reverse mutation test and an in vitro mammalian chromosome aberration test should be submitted. In some cases, an in vitro gene mutation test in mammalian cells may be provided instead. This is for cases where the substance has shown significant toxicity effects on the bacteria and thus the bacterial reverse mutation test is not scientifically applicable or the substance has been demonstrated (or is assumed) to adversely affect DNA duplication in mammalian cells.

For Bands 2 to 4: An in vivo mammalian bone-marrow chromosome aberration test or mammalian erythrocyte micronucleus test should be submitted. If the toxicokinetic study indicates that the substance cannot be absorbed or exposed to a target tissue (marrow), resulting in the in vivo test being difficult to perform, other related testing data should be provided.

More flexible combination of mutagenicity tests will be adopted to fully appreciate the mutagenic properties of a substance

Data requirements of carcinogenicity

Minimum requirement for Band 4 regular notification, except the substance is known to be germ-cell mutagenic or reproductively toxic

More exemption conditions are introduced. Mutagenicity conclusion will be used to determine whether carcinogenicity data should be submitted. Mechanism of carcinogenicity assessment will be introduced to demonstrate whether the notified substance is carcinogenic.

Chronic toxicity

Waiver criteria:

-The repeated dose NOAEL is high;

-The classification of the Specific Target Organ Toxicity (repeated dose) for the substance is ‘unclassified’

Delete the original waiver criteria of chronic toxicity, only those having combined chronic toxicity and carcinogenicity study can be exempt, which means it almost a default testing item for band 4 regular notification without exemption

Fish, Prolonged toxicity testing (14-day study)

a minimum data requirement for Band 2 regular notification

Delete the fish prolonged toxicity test (14-day) of Band 2 regular notification

Earthworm reproduction test

Not required

Add long-term toxicity test on terrestrial organism (earthworm) to eco-toxicological data requirement of Band 4 regular notification, required to submit when terrestrial acute toxicity test results in hazard classification

Toxicokinetics

For Band 2: A study of the absorption kinetics and other relevant information should be submitted.

For Band 3 to 4: A complete toxicokinetic study and other relevant information should be provided.

For Band 2: toxicokinetic relevant information should be provided.

For Band 3 to 4: if applicable to health hazard classification, A complete toxicokinetic study report should be provided; if inapplicable, toxicokinetic relevant information should be provided.

Verification of “unlikely to cross biological membranes”

Not specified

Provide testing report on biological membrane permeability; if not, specify the reason and provide non-test data

Self-igniting substance

Only density testing data is required

Density testing data is required; toxicological and eco-toxicological tests are exempted while data from QSAR, read-across or the literature etc. shall be submitted

Classification criteria

Safety rules for classification, precautionary statements of chemicals (GB 2006 series)

Replaced by Rules for classification and labeling of chemicals (GB 30000 series)

Staff/organization for RA report compilation

Not specified

Enhance management of compiling organization and persons for compilation of risk assessment report: professional background, work experience, relevant training received; signature of person for compilation; contract documents for entrusting of RA compilation; qualification documents of compiling organization, etc.

Risk assessment of serial substances

Not specified

Supplement the contents on risk assessment report of serial substances: data sharing principles for serial substances; requirements for hazard identification assessment, tec.

Identification of PBT/vPvB

Not specified

Identification of PBT/vPvB substances: GB/T 24782

Exposure assessment

Abstract description

Specify the contents required in exposure scenario description; exposure assessment factor scoring modified

Format of RA report

Unpublished

Format of risk assessment report attached as Annex 1

Notified use information

Specified in notification application form according to actual situation without standard rules for uniform description

Use Code List of Chemicals attached as Annex 2 (60 categories)

Post-notification report

Format of each-activity report is not provided

Redesign and add three report form as Annex:

• Annex 3. Each-activity report of new chemical substances

• Annex 4. Annual report of new chemical substances

• Annex 5. Five-year actual activity report of notified new chemical substances

Each-activity report of new chemical substances

Regardless of tonnage, new hazardous substances of priority environmental concern are required to report the transfer information to the authority within 30 days each time of when these substances are transferred to different downstream users in the supply chain.

Low volume exemption for substances transferred in quantities below 10 kg per time offered

Means of application

Holder of registration certificate shall submit application

If the holder of registration certificate is a foreign entity, the modification application shall be submitted by the certificate holder and its local representative agent jointly

Means of approval

If the modification is approved, the original registration certificate should be exchanged for a new one

Modification receipt will be issued by SCC-MEP, the certificate holders don’t need to be submitted to exchange for a new registration certificate

General

Hazardous

Hazardous of priority environmental concern

Uses

No need to apply modification

No need to apply modification

Application→Re-compilation and re-submission of risk assessment report; Modification receipt issued If the modification is approved, instead of the exchange for a new registration certificate

Re-notification, exchange for a new registration certificate

Activity type

(Manufacture/importation)

No need to apply modification

Manufacture changed to importation: Application→Modification receipt issued if approved, instead of the exchange for a new registration certificate

Importation changed to manufacture: Application→Re-compilation and re-submission of risk assessment report; Modification receipt issued if approved, instead of the exchange for a new registration certificate

Identification information

(Chemical name/ CAS No.)

Application→Modification receipt issued if approved, instead of the exchange for a new registration certificate

Name of Holder of registration certificate/local representative agent (resulting from company merge or acquisition of assets, etc.)

Application→Modification receipt issued if approved, instead of the exchange for a new registration certificate

Appointment of local representative agent

Application→Modification receipt issued if approved, instead of the exchange for a new registration certificate

Tonnage (within the notified tonnage band)

* applicable to those notified with specific tonnage amount rather than those notified with tonnage band

Application→Modification receipt issued if approved, instead of the exchange for a new registration certificate

Band 1: Application→Modification receipt issued if approved, instead of the exchange for a new registration certificate

Band 2-4: Application→Re-compilation and re-submission of risk assessment report; Modification receipt issued if approved, instead of the exchange for a new registration certificate

Tonnage decrease (Band 1-4): Application→Modification receipt issued if approved, instead of the exchange for a new registration certificate

Tonnage (exceeding the notified tonnage band

Re-notification, exchange for a new registration certificate

Content - Public consultation & final announcement of regular notification

Registered substance name (generic name if applied for CBI protection), notifier’s name, notification type, environmental management category of the substance

For hazardous new chemical substances of priority environmental concern, the hazard classification of should be issued for public reference as well 

Website for public consultation of regular notification

MEP website

SCC website