REGULATION & COMPLIANCE
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Figure 2 – Main chemical inventories in China
the public part of the IESCS , which most are , using CIRS ’ s APCISS ( www . apciss . cirs-group . com ). For access to the confidential part , it is necessary to submit an application to the MEE and pay a fee . For overseas enterprises , substances can be registered by its Chinese importer or an only representative ( OR ). The advantage of working with an OR is that your business mode in China is more flexible and you have the opportunity to develop a business relationship with any Chinese importers . The really fundamental difference between China REACH and EU REACH is that , in China , any company that directly introduces the substance to the market can carry out the registration . Where an agency agreement or contract is signed , it must include the following provisions : 1 . The agent and the applicant shall carry out the relevant obligations together , as well as bear the legal responsibilities
2 . The responsibilities and obligations when transferring the OR
3 . The validity period of the agency relationship There are different types of registration depending mainly on
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the tonnage . Record Filing applies for tonnages of < 1 tonne / year and polymers with new monomer and reactant concentrations of < 2 % or polymer of low concern ( PLCs ). There is no mandatory data requirement in Record Filing but polymers falling under the 2 % rules and PLCs need to provide supporting documents , including a list of the monomers and reactants , their molecular weight and distribution , and the reaction mechanism . It is also necessary to show that the polymer does not meet any of the five exclusion conditions : 1 . Cationic ( including polymers in the natural water environment ) 2 . Degraded or unstable 3 . Water absorbent polymers with
Mn of ≥10,000 Da 4 . Certain types of fluoropolymers 5 . Containing elements other than permitted elements There is no need for the authorities to approve substances under Record Filing before they are placed on the Chinese market , nor are there any testing requirements . Marketing can take place as soon as the application is made , a process which generally takes only one to two weeks to complete . However , the authorities will check the dossiers in the future
and may ask for supplementary information if required . Approval is required for Simplified Registration , which applies at 1-10 tonnes / year , and Regular Registration (> 10 tonnes / year ). Where there is no existing data , which is often the case for toxicological and ecotoxicological information , the testing and authority review processes take in general eight to 14 and 14-30 months respectively . It is also longer for persistent and bioaccumulative substances . There are two types of registration . Series Registration applies to multiple substances with very similar molecular structures that can be covered by a single dossier . Joint Registration takes place where more than one company that make the same substance can share the data workload . The dossier submitted must reflect the sum total of both companies ’ volumes of the substance . MEE Order No . 12 emphasised the definitions of highly hazardous substances , i . e . persistent , bioaccumulative and toxic ( PBT ), very persistent , very bioaccumulative ( vPvB ) and very toxic ( VT ) substances , and endocrine-disrupting chemicals ( EDCs ). Minimum data requirements apply to both Simplified and Regular Registration ( Figure 3 ) for such substances , including physicochemical , toxicological and ecotoxicological data . Testing reports are mandatory for these ; for other data , the authorities still prefer testing data to other sources , such as QSAR , read-across , systematic literature review , etc . To use them , it will be necessary to show why testing is unfeasible . MEE Order No . 12 brought in some new concepts that are worth highlighting . First , PB , PT and BT chemical substances and other highly hazardous chemical substances all need to need to have new-use environmental management implemented after being listed in the IECSC . In addition , where PB , PT and BT chemical substances are intended
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