MEP Revised the Data Requirements under Guidance Documents for New Chemical Substance Notification in China

Updated on 8 September 2017

The Guidance Documents for New Chemical Substance Notification in China (hereinafter referred to as Guidance Documents), as an important supporting document under the Provisions on the Environmental Administration of New Chemical Substance (MEP Order No. 7, hereinafter referred to as the Provisions), played an important role for criterion and the direction of applying notification of new substances for enterprises. However, some new problems occurred a few years after the implementation of the Provisions. To solve the problems, Ministry of Environmental Protection (hereinafter referred to as MEP) began to revise the Guidance Documents in 2014. In the following three years, MEP has released drafts for public comments for many times and formed the final opinion for revision. Recently, MEP released the announcement for revising the data requirements of the Guidance Documents which is to be implemented on October 15, 2017. This article will give a detailed interpretation on the data requirements and the exemption conditions of the Guidance Documents after revision as well as its influence on enterprises and enterprises’ coping strategies. 

On 31 August 2017, MEP released an Announcement on the amendments of the data requirements under the Guidance Documents for New Chemical Substance Notification in China (the 42nd Announcement in 2017). According to the requirements of the Guidance Documents, in order to make the data requirements more scientific and normative, MEP revised the minimum requirements of toxicological data and eco-toxicological data as well as the exemption conditions of physic-chemical data, toxicology testing data and eco-toxicology testing data. The Announcement will be put into force on October 15, 2017. When the original Guidance Documents is inconsistent with the Announcement, the Announcement shall prevail.

The release of this Announcement indicates that MEP finally completed the revision to the Guidance Documents. After detailed comparison and analysis, the new chemical substance notification experts from CIRS found that the revision of the Guidance Documents by MEP is based on the requirements of curbing the power bureaucrats and reining in government spending and the principle of easing enterprises’ burdens, simplifying the testing data requirements of new chemical environment management and notification. Compared with the current data requirements, the amended data requirements are more scientific and reasonable, conform to the requirements of new chemical substance management and reduce the cost of testing data greatly which apparently ease enterprises’ notification burdens.

Table 1 and Table 2 below are analysis from CIRS by comparing the data requirements and exemption conditions under the revised Guidance Documents with the current one for solving enterprises’ problems in new chemical substance notification:

Table 1 Amendments to the Minimum Data Requirements

Tonnage (ton/year)

Data endpoint

Current requirements

Requirements after revision

1-10

Acute oral, dermal and inhalation toxicity

The acute oral, dermal and inhalation toxicity shall be submitted;

Only the data for one of the three exposure ways is required based on the purpose of notification.

AMES and in vitro chromosome aberration

Submit at the same time

Only the result of AMES testing should be submitted; when the result is positive and the substance will be widespread used, then data for the higher tonnage level (10-100 tonnes/ year) is required.

Repeated dose 28-day toxicity study

Shall be submitted.

Deleted

10-100

AMES, in vitro chromosome aberration and in vivo chromosome aberration

Submit at the same time

Results of AMES and in vitro chromosome aberration testing should be submitted at first; based on the results of the above two tests, the other tests (such as in vitro gene mutation testing, in vivo gene mutation testing and in vivo chromosome aberration testing) will be carried out or not.

Repeated dose 90-day toxicity study

Required when severely damages were observed in the repeated dose 28-day toxicity study  

Deleted

Reproduction/ Development screening test

Shall be submitted

Could be replaced by the extended one-generation reproduction toxicity data.

Toxic kinetics

Submit relevant information of absorption of toxic kinedtcs.

Evaluate based on the existing information.

14 days extended toxicity study in fish

Shall be submitted

Deleted

100-1000

AMES, in vitro chromosome aberration and in vivo chromosome aberration

Submit at the same time

Same as the requirements for the 10-100 tonnage level

Two-generation reproduction toxicity

Shall be submitted

Could be replaced by the extended one-generation reproduction toxicity data

Toxic kinetics

Submit complete toxic kinetics data

Same as the requirements for the 10-100 tonnage level

1000+

AMES, in vitro chromosome aberration and in vivo chromosome aberration

Submit at the same time

Same as the requirements for the 10-100 tonnage level

Two-generation reproduction toxicity

Should be submitted

Could be replaced by the extended one-generation reproduction toxicity data

Toxic kinetics

Submit complete toxic kinetics data

Same as the requirements for the 10-100 tonnage level

Carcinogenicity

Shall be submitted

Whether to submit the testing data or the evaluation report is based on the mutagenicity classification and the possibility of exposure.

Chronic toxicity test in fish

Data for one of the following three tests is required: Fish, Early-life Stage Toxicity Test, Fish, Short-term Toxicity Test on Embryo and sac-fry Stages and Fish, Juvenile Growth Test

Only the result of fish juvenile growth test should be submitted

Earthworm reproduction test

Not required

Require submission when it is classified as terrestrial organism acute toxicity

From the revised data requirements, it can be discovered that the requirements of toxicology and that of REACH are similar like the data for one of the three exposure ways is required for the acute toxicity, the requirements of mutagenicity experiment, repeated dose 28-day and 90-day toxicity study and toxic kinetics, which objectively reduce the cost and the amount of data required for the notification of enterprises.

Table 2 Amendments to the Exemption Condition and its Analysis

End point

Requirements of current guidance

Requirements after adjustment

Autoignition temperature

Nonflammable liquid in the atmosphere;

Add the explanation of “E.g. flash point > 200”;

Melting point <160, or the solid only with the self-heating when  test temperature was up to 400 in preliminary testing;

Melting point ≤160, or the solid without self-heating when  test temperature was up to 400 in preliminary testing;;

Oxidability

Impossible to generate exothermic reaction with inflammable substance;

Add the explanation of “E.g. substance based on chemical structure (such as organism without oxygen or halogen atom, or these elements are not chemical bonding with nitrogen or oxygen, or the inorganics without oxygen or halogen atom);

For solid, if its oxidability showed clearly in preliminary trail, the full trail is not demanded;

Deleted

Skin corrosion/ irritation

Acute dermal toxicity is highly toxic;

Acute dermal toxicity category 1;

Eye irritation

Moderate skin irritation toxicity (and above); skin corrosion

Skin irritation category 2 (and above) or skin corrosion;

Mutagenicity

——

Add “If the in vivo genotoxicity test has already been tested, the in vitro genotoxicity test with same end point can be exempted”.

Acute inhalation/ Repeated dose inhalation toxicity for 28 days

The vapour pressure of substance <10-2Pa in 20;

The vapour pressure of liquid <10-1Pa in 20;

——

Explain the size of inhalable particles in particle size distribution is grain diameter10μm;

Acute dermal toxicity/Acute inhalation/ Repeated dose dermal toxicity for 28 days

——

Add “skin corrosion”;

Repeated dose oral toxicity for 28 days

——

Add reliable “Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test”;

Repeated dose toxicity for 90 days

——

Add “the result of repeated dose toxicity test for 28 days with same tested animal and exposure route indicates the toxic effect is observed or “No-observed-adverse-effect level

(NOAEL) is low and give the guideline values;

——

Add “cancerogenic substance category 1 or category 2”;

Chronic toxicity

- NOAEL of repeated dose toxicity is high;

- Not classified as Specific target organ toxicity (repeated)

- NOAEL of repeated dose toxicity is high (e.g. NOAEL of 90-day systemic toxicity≥300mg/kg), but except the situation that some toxic effect caused by the specific molecular structure  is hard to be detected in 90-day repeated dose toxicity test and the substance have potential of hazard which cannot be detected by 90-day repeated dose toxicity test;

- Available toxic kinetics data could illustrate the chronic toxicity of substance;

- Combined Chronic Toxicity/ Carcinogenicity study

carcinogenicity

Germ cell mutagenicity or reproductive toxicity (regard as of germ cell Mutagenicity, carcinogenicity and reproductive/ developmental toxicity);

- Substance is classified as germ cell mutagenicity Category 1A or 1B;

- Completed the Combined Chronic Toxicity/Carcinogenicity Study.

Daphnia and fish acute toxicity

Has long-term toxicity test data with the same test species;

Has long-term toxicity test data with the same species (contains available acute toxicity data);

Terrestrial organism toxicity

Low soil absorption;

Low soil absorption, logKoc<1.5

Activated sludge respiration inhibition

Information indicates that microorganism toxicity cannot be generated, e.g. extreme low water solubility;

Information indicates that microorganism toxicity cannot be generated, e.g. the result of soil microorganisms- nitrogen/ carbon transformation test is non-toxic.

Absorption/ Desorption

Substance and its degradation products decompose rapidly;

Substance and its degradation products decompose rapidly, e.g. hydrolysis half-life <12h;      

From the two tables above, it can be seen that the revised data exemption conditions mainly refer to the exemption requirements under REACH. In order to properly manage the risks of new chemical substances, MEP quantifies the parameter for exemption and adds the exemption conditions. Besides, MEP also removes unnecessary tests, which not only becomes easier to understand but also can reduce the test costs. Additionally, in accordance with the amended data requirements, enterprises are able to avoid some animal tests which saves the testing resources and is more consistent with the “3R” principles required by the Guidance.   

As the amended data requirements will soon take effect. CIRS warmly reminds that when applying for new chemical substance notification in China, enterprises should take into consideration of the data requirements, the exemption conditions, test cycle and the time of submitting notification to make sure that they can smoothly complete notification and carry out manufacturing or importing activities.

Besides, CIRS will hold the 3rd Summit Meeting on Chemical Regulations in Asia Pacific on 20 & 21 September 2017 at Hangzhou. Experts from China Solid Waste and Chemicals Management Center under MEP will speak at the 3rd Summit Meeting on Chemical Regulations in Asia Pacific and share the amendments to the Guidance Documents and the changes of the new chemical substance notification policies in China.

If you have any questions about the new substance notification in China and the revision of data requirements under the Guidance Documents, please contact us at service@cirs-reach.com.

Further Information

MEP Announcement on the Amendments of Data Requirements under Guidance Documents for New Chemical Substance Notification in China

China New Chemical Substance Notification