After helping our client obtain a new gaseous chemical substance notification certificate Level IV, CNCIC Compliance Team support our client to obtain a general notification certificate for new gaseous substance once again.
At present, most of the notified new chemical substances exist in liquid or solid form accepted by MEE-SCC. Gaseous substances are very difficult to store, transport and test. Taking into account the particularity of the gaseous substances, we used various resources in the first time, and designed 3 sets of test plans for the gasous chemical notification after thorough and detailed analysis, in the case that the conventional notification solutions cannot be covered, and finally all the tests required for the general notification level 1 were completed within 7 months, and help the client obtained the notification certificate successfully.
For the notification of gaseous new chemicals, we would like to share the following 3 points:
1. Scientifically Set Up Test Items Based on Chemical Properties
Taking into account the physical properties, in combination with the notified use, the acute inhalation test was selected as the acute data end point; for the ecotoxicological test, the test of algae, daphnia and fish was set according to the water solubility data of the notified substance. Due to the spillage of the gas, the concentration of the test substance in the reaction system cannot meet the test validity requirement, and the gas is not suitable for the activated sludge test. In terms of adsorption and desorption property, the test method was scientifically selected, and logKoc was determined by OECD TG121 instead of OECD TG106 method.
2. Data Waiving and Exemption
Based on the specificity of the notified gas and the limitations of the test equipment, according to the exemption conditions, the data exemption is used to save the test cost. For example, skin irritation and skin sensitization test are exempted; combined with the AMES test results, the use and exposure of notified chemicals, the mutagenicity data for higher notification level that should be submitted are exempted.
3. Scientific and Reasonable Risk Assessment
Based on the data obtained, the notified gas has certain health and environmental hazards. when the risk assessment report was prepared the notified chemical production, process and use conditions was fully considered, its process and waste disposal methods was refined, as well as the exposure was fully considered, finally appropriate risk control measures were to be implemented. The risk of reporting material risks is controllable.
Up to now, the CNCIC regulatory team has completed the submission of more than 200 regular filing files, including more than 50 special-purpose substances of easily decomposable substances, gaseous substances, corrosive/irritating substances, UVCB, and four-level regular declarations. He has accumulated rich experience in the declaration of new chemical substances.