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On November 17th, 2020, the Chinese Ministry of Ecology and Environment (MEE) published the Guidance on Environmental Management Registration of New Chemical Substances[1], along with tables used in registration of new chemical substances and instructions for filling them in.
The Guidance is a normative document dedicated to supporting the implementation of MEE Order No. 12 [3], which will replace MEP Order No. 7 next year. It details requirements laid out for the registration of new chemical substances, with an aim of providing facilitation for businesses involved and enabling more standardized and better-regulated practices in this regard.
Ms. Nelly Chen, a senior regulatory consultant from REACH24H elaborated on major highlights in the Guidance at CRAC-HCF 2020 [2], to help you get a better understanding of your obligations and ensure better regulatory compliance. (You can also access Ms. Ting Shen's presentation [in English language] on how to know your portfolio and start preparing now for MEE Order No. 12 via the link above.)
1. Scope of Exemption
The Guidance makes it clear that MEE Order No. 12 does not apply to pharmaceutics (including active pharmaceutical ingredients), veterinary drugs (including veterinary drug substances), pesticides (including pesticide technical materials), cosmetics, food, food additives, feeds, feed additives, fertilizers and radioactive substances.
The new scheme’s applicability to active pharmaceutical ingredients, veterinary drug substances and pesticide technical materials was a focus of heated discussions as the MEE solicited comments on the draft Guidance. Therefore, the clarified scope is a relief to those businesses involved, since substances which are used for the three purposes solely will not be subject to registration requirements under MEE Order No. 12.
2. Applicant and Representatives
Ms. Chen stressed that only the applicant can be the holder of registration certificate. This means that 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. Moreover, the Guidance eases qualification requirements for representatives by, for example, by removing the requirement concerning registered capital.
3. Types of Registration
According to MEE Order No. 12, there are three types of registration of new chemical substances, namely regular registration, simplified registration and record notification. It should be noted that there is no long exemption granted to substances manufactured or imported for R&D purpose in quantities of less than 0.1 ton per year. That is to say, no matter how much a new chemical substance is manufactured or imported, it will be subject to certain registration or notification obligations.
The table below shows differences between MEP Order No.7 and MEE Order No. 12 on registration types.
Substance type | MEP Order No.7 | MEE Order No. 12 |
Substances for R&D purpose, in quantities below 0.1t/yr | Scientific research record notification | No longer a separate registration type; subject to record notification |
Substances manufactured/imported in quantities below 1t/yr | Simplified notification (general case)
| Record notification |
1. Substances for R&D purpose, in quantities of 0.1-1 t/yr 2.Substances used only as intermediates or manufactured for the sole purpose of export, in quantities below 1 t/yr 3. PLC, or a polymer with low new chemical substance concentration of monomer < 2% (w/w) | Simplified notification (special case)
| Record notification (For any polymer which does not meet conditions for record notification or falls under any of the five circumstances where record notification does not apply, it is subject to regular or simplified registration requirements)
|
Substances for the purpose of Product and Process Orientated Research and Development (PPORD), in quantities below 10 tons for no more than two years | Simplified notification (special case)
| Simplified registration
|
Substances manufactured/imported in quantities of 1-10 t/yr | Regular notification (Level 1) | Simplified registration
|
Substances manufactured/imported in quantities above 10 t/yr | Regular notification (Level 2, 3 and 4)
| Regular registration |
Under MEP Order No. 7, several special forms of notification are specified under regular notification. In contrast, the 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 | 1. The quantity registered shall be the sum of quantities of each substance in a series 2. 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 | 1. The quantity registered shall be the sum of quantities submitted by each applicant 2. The withdrawal of a joint registration certificate requires the submission of withdrawal application by all joint applicants |
Ms. Chen noted that the requirement that “manufacturers or trade companies which will export new chemicals to China shall designate the same representative for joint registration”, which was provided in the draft, has been deleted from the Guidance. Therefore, as with MEP Order No. 7, MEE Order No. 12 allows different applicants in joint registration to choose representatives which meet qualification requirements at their own discretion.
4. Materials Required for Registration
According to Ms. Chen, the Guidance for MEE Order No. 12 requires that all materials should be filled in, submitted and supplemented through an online registration system, so businesses no longer need to send paper materials to the authority. Notably, in view of the need for confidential business information protection, third-party submission, which is allowed under MEP Order No. 7, will be retained: where a representative does not hold certain information about new chemical substances, it may entrust a third-party institution which knows the information to submit relevant materials in one go.
Document requirements vary by registration type. See the table below for details.
Substance type | Registration type | Materials required |
Manufactured/ imported in quantities above 10 tons per year
| Regular registration | 1. Regular registration application form 2. Appendixes to the application form: ü Legal person certificate or business license, representation contract or agreement, authorization letter ü Testing report or data ü Environmental risk assessment report ü Socio-economic benefit analysis report (for highly hazardous new chemicals) ü Materials stating the necessity of information protection (where one wishes to apply for protection of identification information of chemicals) ü Others |
Manufactured/ imported in quantities of 1-10 tons per year
| Simplified registration | 1. Simplified registration application form 2. Appendixes to the application form: ü Legal person certificate or business license, representation contract or agreement, authorization letter ü Testing report or data ü Conclusions on the persistence, bioaccumulation and toxicity of new chemicals and the basis for such conclusions ü Materials stating the necessity of information protection (where one wishes to apply for protection of identification information of chemicals) ü Others |
Manufactured/ imported in quantities below 1 ton per year
| Record notification | 1. Notification form 2. Appendixes to the application form: ü Legal person certificate or business license, representation contract or agreement, authorization letter ü Others |
Polymers containing less than 2% of a new chemical monomer/reactant or PLC | 1. Notification form 2. Appendixes to the application form ü Legal person certificate or business license, representation contract or agreement, authorization letter, etc. ü 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 ü Others |
5. Registration Procedures
The procedures for regular registration and simplified registration in comparison to record notification are different. See the pictures below.
Procedure for regular registration and simplified registration (above)
Procedure for record notification (above)
Notably, there is no approval or public scrutiny for record notification, which means that businesses can start relevant activities immediately after submitting application materials and receiving the receipt sent via the online registration system. The MEE will only conduct spot checks of the materials and release the results on a regular basis. Despite this, businesses still need to carefully prepare materials for record notification so as to avoid any punishment.
The biggest difference in the procedures for regular and simplified registration lies in technical review: for regular registration, the MEE will organize the Solid Waste and Chemicals Management Center (SCC) and the expert committee to carry out technical review, while for simplified registration, the SCC will carry out technical review by itself.
Click here to read Part II.
