China: Regulatory Updates April–June 2020
China REACH: MEE Order 12 to replace MEP Order 7
On 29th of April 2020, China’s Ministry of Ecology and the Environment (MEE) published the final version of the MEE Order 12 “Measures for the Environmental Management of New Chemical Substances” which will replace the current MEP Order 7 (often referred to as “China REACH”). MEE Order 12 is due to repeal and replace MEP Order 7 on the 1st of January 2021.
Following Order 12, the Transitional Measures for Order 12 was published on the 3rd of June 2020. MEE Order 12 and the Transitional Measures contain the following key updates:
New definitions and obligations
MEE Order 12 includes new definitions e.g. “Highly hazardous chemicals” and corresponding obligations (e.g. annual reporting).
New registration/notification types:
Record notification for substances (<1t/y) and PLCs or polymers new monomers <2% w/w;
Simplified registration for substances 1-10t/y;
Regular registration: for substances ≥10 t/y.
CBI Protection
CBI protection for substances currently in the IECSC will be abolished by 31 December 2025. For new substances added to the inventory of existing chemicals in China (IECSC) the maximum time available for CBI protection will be 5 years.
New Post-registration obligations (including “New use management” and risk control measures)
Annual reporting will only be necessary for substances that have undergone Regular registration and that have the annual reporting requirement stated in the registration certificate.New timelines
Due to the new registration types, the administrative timelines are different from MEP Order 7. The new deadline for the “First Activity Report” has been increased from 30 to 60 days after the first time importing/manufacturing.Data requirements
For Record notification, applicants need only to submit known risk/hazard data. For Simplified registration, applicants must provide physicochemical properties and persistent, bioaccumulative and toxic (PBT) properties. For Regular registration, the data requirements will depend on the hazardous properties of the substance and exposure scenarios. A new guidance document is expected soon which will elaborate on the data requirements.Transitional measures
Substances notified under Order 12 with use restrictions or that have been designated as ‘Priority Environmental Management and Hazardous’ will be under the ‘New Use Management’ under Order 12.
After the enactment of Order 12, the post-notification requirements for Order 7 notified substances are stipulated in the transitional measure.
IECSC supplement
On 6th May, MEE published the announcement that 156 chemicals substances have been newly added to the IECSC (Inventory of Existing Chemical Substances in China). These substances will be regarded as existing substances from 6th May.
Source: IECSC supplement
NRCC launched the online Hazchem Management Platform.
National Registration Centre for Chemicals (NRCC) published the online Hazchem Management Platform and the key information published on the platform are the following:
● Hazchem information (e.g. China GHS classification, the registrants of the hazardous chemicals);
● Online emergency service and emergency hotline 0532-83889191;
● China Hazchem Regulations.
MEE published “Technical guidelines for eco-environmental health risk assessment”
On 18th March, MEE published the “Technical guidelines for eco-environmental health risk assessment (General principles)”. According to the MEP Order 7 and MEE order 12, an Environmental Risk Assessment Report is required for new substance notification/registration. These guidelines will be an important reference point to facilitate the Environmental Risk Assessment.
Source: Technical guidelines for eco-environmental health risk assessment
MIIT published Draft Monitored Chemical Substance List
On 20th March, the Ministry of Industry and Information Technology (MIIT) published a list of monitored chemical substances under the management of the Regulations on Administration of Monitored Chemicals. The regulation aims at fulfilling the requirements of the 24th Conference of the States Parties - Prohibition of Chemical Weapons.
Standardization Administration published several new GB standards on disinfectant products
On 9th April, China Standardization Administration published the following National Standards (GB) for disinfectant product regulation. These GB standards will be implemented from 1st Nov 2020.
● GB 38850-2020 List of materials and restricted substances in disinfectants
● GB 27948-2020 General requirements for air disinfectants
● GB 27949-2020 General requirements for disinfectants of medical instruments
● GB 27950-2020 General requirements for hand disinfectants
● GB 27952-2020 General requirements for ordinary object surface disinfectants
● GB 27953-2020 General requirements on disinfectants for infectious focus
● GB 27954-2020 General requirements for disinfectants of mucous membranes
● GB 27955-2020 General requirements for low-temperature hydrogen peroxide gas plasma sterilisation devices
● GB 28235-2020 Safety and Hygienic Standard for Ultraviolet Air Sterilizer
● GB 28232-2020 Hygienic requirements for Ozone disinfector
● GB 28233-2020 Hygienic requirements for Sodium hypochlorite generator
In addition, GB 38850-2020 “List of Materials and Restricted Substances in Disinfectants” contains:
● The Active Substance positive list;
● Inert Ingredient positive list;
● Banned active substances; and Restricted Substances.
Disinfectant products containing active ingredients or inert ingredients that are not listed on the positive lists are regarded as new disinfectant products. The standard also clarified the difference between disinfectant products and drugs.
Active substance positive list: The national standard GB 38850-2020 contains an active substance positive list including: 82 chemical substances; 1 metal ion and 2 biological substances. Each of the substances has a corresponding approved scope of use, including the following:
● A: Indoor air disinfection
● C: Pollutant treatment
● D: Drinking water disinfection
● E: General surface and environment disinfection
● #E: General surface disinfection
● H: Human use disinfection
● K: For ventilation system and air conditioning systems
● M: Medical device disinfection
● S: Swimming pool disinfection
● W: Medical Sewage disinfection
Inert ingredient positive list: According to GB 38850-2020, the definition of a disinfectant inert ingredient is that in the disinfectant formula, it has auxiliary functions of anti-corrosion, skin care, stability, pH adjustment, flavouring and colouring. There are 115 substances (and CAS Numbers) in the inert ingredients positive list and each substance has a corresponding approved scope of use.
Banned substances:
● Medicines and raw materials in the Chinese Pharmacopoeia 2015, human medicinal vaccines, serums or mycins and their products (except lysozyme and staphylococcus enzyme).
● Disinfectants for the human body must not contain prohibited substances (except iodine) listed in the "Cosmetics Safety Technical Specifications" (2015 edition).
● Sodium hypochlorite raw materials cannot be the Level B material in GB/T 19106
● Peroxyacetic acid raw materials cannot be the Level III material in GB/T 19104
● Disinfectants with trichlorohydroxydiphenyl ether raw material, the content of Dioxin should obey the concentration limit in Chinese Pharmacopoeia 2015.
● Sodium dichloroisocyanurate for emergency water treatment cannot be Level II material in GB/T 3779.
● Disinfectant raw materials used for disinfecting human bodies, medical devices, and drinking water shall not use industrial-grade raw materials (should obey the requirement of Chinese Pharmacopoeia 2015)
● Raw material for drinking water should also follow GB 5749 and NHC Code for sanitary safety evaluation of drinking water disinfection 2005.
● Chlorine dioxide solution for human, food, drinking water and medical devices cannot be Level II solution in GB/T 20783.
Restricted substances
The following are detailed requirements:
● Skin disinfectants: Glucose chlorhexidine, Chlorhexidine acetate should be no more than 45%; 2,4,4'-Trichloro-2'-hydroxydiphenyl Ether should be no more than 20%; Benzbronam, Benzalkonium chloride should be no more than 5%.
● Mucosa disinfectants: Glucose chlorhexidine, Chlorhexidine acetate should be no more than 5%; 2,4,4'-Trichloro-2'-hydroxydiphenyl Ether should be no more than 3.5%; Benzbronam, Benzalkonium chloride should be no more than 2%.