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China Consults on Guidance on Environmental Management Registration of New Chemical Substances

China opened a public consultation on the new Guidance on Environmental Management Registration of New Chemical Substances. The draft Guidance provides implementation rules for MEE Order No. 12 with regard to registration scope, types and procedures, documents required, special rules on polymers, new usage management, registration certificate, etc. It is made clear that MEE Order No. 12 does not apply to pesticide technical materials, active pharmaceutical ingredients, wastes, etc.

Click here to register ChemLinked webinar on the Guidance. English translation is coming soon.

On August 17, 2020, the Chinese Ministry of Ecology and Environment (MEE) released a notice [1] on its official website, announcing to consult on the draft Guidance on Environmental Management Registration of New Chemical Substances. The public consultation is set to end on September 6.

Earlier on April 29 this year, the MEE published the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12 of 2020) [2]. The Measures will come into force on January 1, 2021 to replace the MEP Order No.7 [3] which has been in effect for a decade.

The MEE Order No. 12 produces an overhaul of the new chemical management framework in China, including management priorities, registration types and document requirements, post-registration management, etc. In order to guide businesses to apply for environmental management registration of new chemicals under the new Measures, the MEE revised the existing Guidance and published the draft one. Changes and adjustments are mainly made in the following three aspects.

Better-Clarified Definitions, Scope and Procedures

The draft Guidance makes it clear that the MEE Order No. 12 does not apply to pesticide technical materials, active pharmaceutical ingredients, waste water, waste gas and waste solids, so as to avoid regulatory duplication.

Any applicant who obtains a registration certification is the certificate holder. Thus, representatives will be no longer regarded as certificate holders, only performing the obligations of environmental management registration and post-registration management of new chemicals together with applicants.

Where products like pharmaceuticals, pesticides, veterinary drugs, cosmetics, etc. (substances enumerated in Article 2 of MEE Order No. 12) are classified as new chemicals and to be used for other industrial purposes, or chemicals subject to new usage management are to be used for industrial purposes other than the permitted ones, their manufacturers, importers or processors can be applicants.

It also provides the procedures, as well as document requirements, for the addition of chemical substances to the Inventory of Existing Chemical Substances in China (IECSC) [4]. According to the draft Guidance, chemicals which had been manufactured, sold, processed or imported in China before October 15, 2003 can be supplemented into the IECSC upon the given procedures.

Registration Types and Document Requirements

According to MEE Order No. 12, there are three types of registration of new chemical substances, namely regular registration, simplified registration and record notification. As the draft Guidance requires that all materials should be filled in and submitted through an online registration system, it is very likely that businesses no longer need to send paper materials to the authority.

Document requirements vary by registration type. See the table below for details.

Substance   info

Registration   type

Document   requirements

Manufactured/imported in quantities above   10 tonne per year

Regular registration

Regular registration application form, appendixes to the application form (legal person certificate or business license, representation contract or agreement, authorization letter, testing report or data, environmental risk assessment report, socio-economic benefit analysis report [for highly   hazardous new chemicals] , etc.)

Manufactured/imported in quantities of   1-10 tonne per year

Simplified registration

Simplified registration application form, appendixes to the application form (legal person certificate or business license, representation contract or agreement, authorization letter, testing report or data, conclusions on the persistence, bioaccumulation and toxicity of new chemicals and the basis for such conclusions, etc.)

Manufactured/imported in quantities below   1 tonne per year

Record notification

Notification form and appendixes to the application form (legal person certificate or business license, representation contract or agreement, authorization letter, etc.)

Polymers   containing less than 2% of a new chemical monomer/reactant or PLC

Notification form, appendixes to the   application form (legal person certificate or business license,   representation contract or agreement, authorization letter, etc.), list of monomers/reactants, plot of molecular weight distribution, mechanism of polymerization, materials illustrating that substances in question are not polymers which are subject to regular or simplified registration (the Guidance lists five circumstances under which PLCs are subject to regular or simplified registration), etc.

It should be noted that, the Guidance does not grant any exemption to substances manufactured or imported for R&D purpose in quantities of less than 0.1 tonne per year. That is to say, no matter how much a new chemical substance is manufactured or imported, it has to be subject to certain registration or notification obligations.

Under MEP Order No. 7, several special forms of notification are specified under regular notification. In contrast, the draft Guidance provides two special forms of registration, which are available in both regular and simplified registration. See the table below for details.

Special   form of registration

Definition

Requirements

Serial registration

Registration of multiple new chemical substances of similar molecular structure, identical or similar uses, and similar testing data, which are submitted as a series by the same applicant

l  The quantity registered shall be the sum of quantities of each substance in a series

l  Number of new chemicals in each series≤6

Joint registration

Registration of the same new chemical substance by two or more applicants at the same time

l  The quantity registered shall be the sum of quantities submitted by each applicant

l  Manufacturers or trade companies which are to export new chemicals to China shall designate the same representative

l  The withdrawal of a joint registration certificate requires the submission of withdrawal application by all joint applicants

Registration Procedures

According to the draft Guidance, both regular and simplified registration contain six steps, namely preparation of application, submission of application materials, formal examination and approval, technical review, public scrutiny and registration decision-making, and release of results. The procedure of record notification consists of five steps, including preparation of application, submission of application materials, application for notification, spot check of compliance, and release of results

Notably, there is no approval or public scrutiny for record notification, which means that businesses can start relevant activities immediately after submitting application materials. The MEE will only conduct spot checks of the materials and release the results on a regular basis.

More Explicit Criteria of Technical Review and Determination of Certain Substances

The draft Guidance lists circumstances under which an applicant can fail the technical review process, including: where the applicant conceals relevant information or provides false materials; where errors are identified in the name or identification information of new chemical substances; where testing reports and documents do not meet relevant requirements or are of poor quality; etc.

Meanwhile, with relevant standards and technical specifications at home and abroad as the benchmark, the Guidance specifies the criteria for determining persistence, bioaccumulation and toxicity or any equivalent environmental or health hazard in a chemical substance. In particular, where the existing data is not sufficient in the determination process, a screening rule is established based on the data requirements for registration application: where the existence of persistence, bioaccumulation or toxicity cannot be ruled out, it should be deemed that the substance in question has such properties, unless the applicant voluntarily submits additional data.

Improved Data Requirements for Registration Application

The draft Guidance details the requirements concerning the categorized and stratified submission of data. Specifically, data are divided into two categories, namely minimum required data and other data. In the case of regular registration or simplified registration, an applicant shall submit at least the minimum required data; where the minimum required data is not sufficient to support environmental risk assessment in regular registration, other data shall be submitted with regard to exposure pathways. The minimum required data include basic data and specially required data, with the latter applying to only chemicals which are persistent and bioaccumulative.

The requirements on testing and non-testing data are better clarified as well. The minimum required data should be derived from testing reports. It is preferable that other data come from testing reports; where tests cannot be conducted in reality, other data can be derived from non-testing data as well. The draft Guidance also proposes requirements for evaluation of the validity of testing reports which are issued using testing methods that are not currently in effect, as well as conditions for data from predictive modelling.

The draft Guidance also sets forth requirements concerning assessment and analysis reports. It requires that the environmental risk assessment be conducted on a quantitative basis, and provides specific rules concerning hazard assessment, exposure assessment, environmental risk characterization, etc. For the socio-economic benefit analysis reports, there shall be adequate evidence for whether new chemicals are relatively or significantly advantageous, compared with chemicals which are already in use, in terms of their impacts on human health or the environment and socio-economic benefits.

Additionally, the requirements on documents illustrating the necessity to apply for information protection are made more clear and detailed. For the identification information of new chemicals without any hazard class, businesses are allowed to apply for the extension of information protection.

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