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The CRC-MEP has updated on 23 Jan 2014 the FAQs concerning China new chemical substances notification (China NCSN, a.k.a China REACH). 37 most-frequently-asked questions (No.148-184) have been newly appended to the previous version.
Some controversies surrounding toxicokinetic testing, testing exemption conditions, etc. have been resolved in the FAQs, however much more questions are waiting to be answered when MEP publishes the revised China NCSN guidance document, which is the priority task in 2014.
As stipulated in the Guidance Document (2010), “for Band 2 of regular notification, if the 28 day repeated dose toxicity study show “significant irreversible damage”, or the “No Observed Adverse Effect Level” value is extremely low, the 90 day repeated dose toxicity study should be submitted. However, these two criteria turn out to be vague. Further interpretation was provided in Q163, clarifying that “irreversible damage” refers to damage failed to recover in the recovery phase, but the “significant irreversible damage” is still subject to the experts’ judgment. As for “No Observed Adverse Effect Level (NOAEL)”, concrete threshold values are given (see the table below).
Table 1. Threshold Value for NoAEL
Route of exposure | NOAEL threshold value |
Oral | 100 mg/kg |
Dermal | 200 mg/kg |
Inhalation (gas) | 0.25 ml/L |
Inhalation (vapor) | 1 mg/L |
Inhalation (dust/smoke/fog) | 0.2 mg/L |
It should be emphasized that as Q160 clarified, new chemical substances manufactured or imported above 100 tonne per year (Band 3/Band 4) can be exempt from 28 day repeated dose toxicity study if the testing report of 90 day repeated dose toxicity study was submitted.
Toxicokinetic testing has long been industry’s concern due to the high costs associated with animal testing and the extended duration. Official response to the newly added Q167 claims that for Band 2 regular notification, only relevant documents or expert statements concerning absorption kinetics are required, while for Band 3 and 4, a complete toxicokinetic study report should be provided.
Q182 and Q183 focus specifically on the submission of exposure information under different scenarios.
Case 1: For new chemical substances imported to use in China, the non-Chinese notifiers should provide brief information of the use process if the downstream users are undetermined.
Case 2: If the notifer is a domestic user, and the imported new chemical substance would be used to produce other substances, their manufacturing process flowchart, process instruction and chemical reaction equation should be provided. Point Sources of the three wastes (waste gas, waste water and industrial residue) should be marked in the process flowchart, with amounts, concentration or content of the new chemicals in the wastes and the material balance data.
Case 3: For a new chemical substance manufactured and used in China, in addition to its own manufacturing process flowchart, other exposure information required is the same of case 2 mentioned above.
