Request a Demo
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.) Click here to read Part I of this article.
--------------------------------------------------------------------------------------------------------------------
6. Special Provisions on Polymers
The Guidance stipulates more detailed and reasonable rules concerning polymers. Major adjustments include:
Ø Determination of PLCs
The Guidance clarifies the criterion for determining polymers of low concern (PLCs) as number-average molecular weight (Mn). Moreover, changes are made to the scope of functional groups of high concern or high reactivity which, under MEE Order No. 12, include “cyano (except those nonconjugated), acrylate, aziridine, isocyanate (except for blocked isocyanates), thio-isocyanate, vinyl sulfone, alkoxy silane (methyl or ethyl), amine, helicene amine, halogenosilane, hydrazine, α/β-lactone, methacrylate, etc.”
Ø Definition of polyester polymers
The Guidance defines polyester polymers as polymers “whose main chain is the monomers bonded by ester bonds or whose main chain exhibits the characteristics of ester bonds”.
Ø Five circumstances where polymers are subject to simplified or regular registration
The table below lists 5 types of circumstances where polymers are subject to simplified or regular registration under MEE Order No. 12.
Description | |
1 | Cationic polymers (such as polymers covalently bonded with phosphanium ion, sulfanium ion, ammonium ion, etc.), or polymers expected to become cationic polymers in natural water environment (such as polymers containing amidogen and isocyanate, etc.). |
2 | Degradable or unstable polymers, including easily degraded, decomposed, depolymerized polymers, and polymers decomposed after production or uses |
3 | Water-absorbing polymers with a number-average molecular weight ≥10,000 daltons. |
4 | Fluoropolymers containing perfluoroalkylsulfonic acid groups, perfluoroalkylcarboxylic acid groups or fluorotelomer structural fragments in the structure; fluoropolymers containing perfluoroalkyl structural fragments covalently bonded to carbon or sulfur atoms in polymer molecules. |
5 | Polymers containing elements other than the permitted elements in the Guidance, in addition to impurities. |
The circumstances are largely derived from the regulatory practices of other countries or regions with regard to polymers, raising the bar for businesses to apply for record notification of polymers and requiring a deeper understanding of polymer properties.
Ms. Chen stated that some changes are also seen in the requirements for simplified and regular registration of polymers. Under the current Guidance, there is no need to submit an environmental risk assessment report for regular notification of polymers and toxicology and ecotoxicology data can be exempted if four specific conditions are met. However, according to the newly introduced Guidance, it is necessary to submit toxicology and ecotoxicology data and an environmental risk assessment report if a polymer fails to meet any of the three conditions. (the condition of “whether the polymer in question is a PLC” is deleted).
7. Qualification Requirements of Laboratories
The Guidance provides more explicit requirements for both domestic and overseas institutions engaged in relevant testing, as shown in the table below.
Laboratory type | Testing type | Qualification requirements under MEE Order No. 12 |
Domestic laboratories | Testing of physicochemical properties | China Inspection Body and Laboratory Mandatory Approval (CMA) |
Toxicological testing | 1. CMA 2. Any of the following institution: ² an institution that has passed the accreditation certification of non-clinical research quality management practices by National Medical Products Administration (NMPA). ² a chemical toxicity identification institution that has passed the quality assessment of the Chinese Center For Disease Control And Prevention (CDC) ² a pesticide registration testing entity announced by the Ministry of Agriculture and Rural Affairs (MARA) ² an institution that has passed good laboratory practices evaluation by the Certification and Accreditation Administration of the People’s Republic of China (CNCA) | |
Ecotoxicological testing | 1. CMA 2. Good laboratory practices (GLP) 3. Accept supervision and random inspection of the testing situations and conditions by the MEE | |
Overseas laboratories | Testing of physicochemical properties | Meet the management requirements of the competent authority in the country where they are located or the internationally recognized GLP requirements |
Toxicological testing | GLP | |
Ecotoxicological testing | GLP |
8. Information Protection
According to Ms. Chen, information protection is of particular concern to businesses. According to the new Guidance, where applicants of simplified or regular registration wishes to apply for identification information protection of chemical substances, they need to submit materials illustrating the necessity of such information protection.
The validity period of identification information protection such as chemical substance names shall not exceed 5 years from the date of first-time registration or record notification. In terms of substances for which registration certificates have been obtained under MEP Order No. 7 and substances which have been included in the Inventory of Existing Chemicals Substances in China (or IECSC) before MEE Order No.12 comes into force and already subject to identification information protection, the validity of information protection shall expire no later than December 31st, 2025.
When a substance registered is listed into IECSC, the identification information of the substance shall be disclosed if it is not subject to information protection or the information protection has expired. Notably, the draft guidance states that applicants are not allowed to apply for information protection extension for “chemicals with any environmental or health hazard class”, while the official version narrows the scope to “highly hazardous chemical substances, or chemical substances with relatively high potential environmental risk or health risk, and the extension of disclosure may case huge impact on environment and public health”.
9. Data Requirements
The Guidance divides data into two categories, namely minimum required data and other data. In the case of regular registration or simplified registration, an applicant may usually submit only 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/or bioaccumulative.
In the minimum required data, basic data should be derived from testing reports, and specially required data should come mainly from testing reports. It is preferable that other data come from testing reports. Where tests cannot be conducted in reality, the data submitted can be derived from non-testing data as well. The Guidance increases items for which computational toxicological data can be submitted as a supplement to screening testing data.
Unlike the draft, the official Guidance further details requirements concerning specially required data based on substance properties, by explicitly differentiating data required for substances which are persistent and bioaccumulative and for substances which are persistent or bioaccumulative. In this way, the data requirements for those with persistence or bioaccumulation are eased.
In the case of simplified registration, applicants need to submit basic data (physicochemical properties, persistence, bioaccumulation and acute aquatic toxicity); if the substance to the registered is persistent and/or bioaccumulative, applicants shall also submit specially required data for chronic aquatic toxicity. Toxicological data is not required for simplified registration.
10. Risk Assessment Report
According to the Guidance, where the hazard assessment result shows that the substance question has no environmental or health hazard classes, and does not have persistence or bioaccumulation, and the registration volume is less than 100 tons per year, no subsequent environmental risk assessment is required.
The requirements concerning environmental risk assessment, health risk assessment and assessment of chemicals throughout their lifecycle in China are made more stringent and explicit in the Guidance. For instance, it requires that environmental and health risk assessment be carried out in a quantitative manner, and provides guidance for the construction of exposure scenarios in the consumer use and waste disposal of substances. It is also worth noting that a risk assessment report is generally required for the regular registration of a polymer.
The MEE is working on finalizing the guidelines for risk assessment, etc., and expects to release them soon. A new exposure assessment tool called CET will be published later as well.
11. Socio-economic benefit analysis report
The Guidance offers detailed instructions for preparing a socio-economic benefit analysis report, a new requirement laid out in MEE Order No. 12.
When applying for regular registration and new usage environmental management registration of highly hazardous chemical substances, applicants shall also submit a socio-economic benefit analysis report, including an explanation on whether the new chemical substance in question has equivalent or evident advantages in performance or environmental friendliness, etc. compared with chemical substances which are already used in its application, so as to clarify the necessity of applying for its activity.
The report can be prepared referring to relevant internationally accepted technical documents, such as those published by European Chemical Agency (ECHA).
12. Listing into IECSC
Based on MEE Order No. 12, the Guidance sets out requirements and procedures for listing different types of substances into IECSC. It specifies the information which should be made public for any substance registered, including identification, permitted uses (for those subject to new usage environmental management), environmental management requirements, etc.
Meanwhile, for the first time, the Guidance states that for chemical substances that had been manufactured, sold, used in processing or imported within China before October 15th, 2003, the manufacturers, importers, processors, users, relevant industry associations, and other relevant entities may apply for supplementing them into IECSC by submitting application forms and relevant materials via the online registration system.
13. Follow-up Management
Follow-up management after registration will be a priority under the new scheme, with more concrete and stringent requirements laid out in the Guidance.
Ø Information transmission
The Guidance requires manufacturers, importers and processors transmit information such as No. of registration certificate, hazards and risk management measures to direct downstream users (including distributors and processers), and request them to continue the transmission level by level until the final processors get to know the information.
Ø Post-registration activity report
MEE Order No. 12 lifts the requirements for submission of every-time activity report and five-year activity report, requires businesses to submit only an annual report and a first-time activity report. Under the new scheme, however, the first-time activity report is required for both simplified registration and regular registration applicants, and the annual report is only required for substances for which the submission of an annual report is specified as an environmental management requirement in the Regular Registration Certificate.
Ø Information disclosure
According to the Guidance, manufacturers, processors and users of new chemical substances subject to regular registration shall publish the implementation of environmental risk control measures and environmental management requirements via their official websites or other means accessible to the public after the first-time activity, and update the information in a timely manner.
The new scheme will take effect on January 1st, 2021. Our recommendation is that businesses gain a comprehensive and profound understanding of their compliance obligations and step up preparedness in all aspects. We encourage you to consult with our regulatory editors and consultants should you have any questions or comments regarding MEE Order No. 12 and its Guidance.
