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In order to further standardize the environmental management registration of new chemical substances in Shanghai, more scientifically and effectively assess and prevent the environmental risks of new chemical substances, protect the ecological environment, and protect public health. From June to September 2021, the Municipal Bureau of Ecology and Environment took the lead in organizing a special supervision and inspection of enterprises involving new chemical substances. This special inspection established a new model of joint law enforcement by the Law Enforcement Corps of Shanghai Municipal Bureau of Ecology and Environment, the Municipal Solidification Center, the District Brigade, and the Shanghai Municipal Institute of Chemical Industry, and through the linkage of the two levels in the urban area, it achieved global coverage, scientific and accurate law enforcement supervision and inspection of 98 enterprises involving new chemical substances. Typical cases of violations involving new chemical substances are hereby announced as follows.
01 A case of an enterprise producing new chemical substances without obtaining a registration certificate
According to the Measures for the Registration of the Environmental Management of New Chemical Substances, except for some specific new chemical substances and radioactive substances, the remaining chemical substances that are not listed in the List of Existing Chemical Substances in China shall be registered for the environmental management of new chemical substances.
In the special assessment and inspection of the new chemical substance tracking and control spot check, the law enforcement personnel of the corps found that compared with the "List of Existing Chemical Substances in China" updated on August 16, 2021, the raw material 3-aminoisoxazole (CAS number: 1750-42-1) used by an enterprise in Baoshan District in the production process and the two products produced by it were not listed in the "List of Existing Chemical Substances in China". According to the company's environmental management registration data for new chemical substances, the company only carried out a simple registration of its product 3-substitute-4-substitute cinnamaldehyde, and did not carry out routine registration, simple registration or filing of the raw material 3-aminoisoxazole and the other two products used. In view of the fact that the company's raw materials such as 3-aminoisoxazole have not obtained the relevant licenses of the drug regulatory authorities and do not belong to the scope of the exemption, the law enforcement corps of the Municipal Bureau of Ecology and Environment has filed a case for investigation on the grounds of producing new chemical substances without a registration certificate.
Case Implications
Enterprises and public institutions engaged in the research, production, import and processing of new chemical substances shall, as applicants, carry out routine registration, simplified registration and filing of new chemical substances that require registration procedures in accordance with the provisions of the Measures for the Registration of environmental management of new chemical substances, according to the amount of production, import or processing. Where new chemical substances are produced or imported without obtaining a registration certificate, or new chemical substances are processed and used without a registration certificate, the competent departments for ecology and environment at or above the districted municipal level shall order corrections and impose a fine of between 10,000 and 30,000 yuan;
02 A daily flavor and fragrance co., LTD. new chemical substances exceeded the registration amount of activities
On October 15, 2021, law enforcement officers of the Ecological environment law enforcement detachment of the Pudong New Area Urban Management Administrative Law Enforcement Bureau conducted an on-site inspection of a daily flavor and fragrance co., LTD. The company imports and uses the new chemical substance 3- (dialkyl substituted aromatic group) propionaldehyde, 3-(dialkyl substituted aromatic group) propionaldehyde as a fragrance component in the company's daily chemical products, and the company applied for the "Environmental Management Registration Certificate for New Chemical Substances" in June 2019, with a registration amount of 9.9 tons / year. Law enforcement officers inspected the company's 2020 Annual Report on New Chemical Substances and the import records of 3-(dialkyl substituted aromatic group) propionaldehyde, and found that the company's actual total imports of 3-(dialkyl substituted aromatic group) propionaldehyde in 2020 were 18.81 tons, exceeding the registered amount of 8.91 tons. The parties confirmed that due to the increase in demand for raw materials due to the expansion of the company's production capacity, the import and use of the new chemical substance 3-(dialkyl substituted aromatic group) propionaldehyde in 2020 exceeded the registered amount.
After preliminary examination, the parties' behavior of "not producing or importing new chemical substances in accordance with the provisions of the registration certificate" was suspected of violating the provisions of Item 2 of Article 49 of the Environmental Management Measures for New Chemical Substances (Decree No. 12 of the Ministry of Ecology and Environment). According to Item 2 of Article 49 of the Measures for the Registration of The Environmental Management of New Chemical Substances, the Pudong Detachment has filed a case for investigation and investigation on October 19, 2021, and the case is currently in the process of investigation and evidence collection.
Enterprises and public institutions engaged in the research, production, importation, and processing of new chemical substances shall produce, import or process and use new chemical substances in accordance with the provisions specified in the application registration certificate. Where new chemical substances are strictly controlled and used, must not exceed the amount or use of activities, standardize the implementation of environmental risk control measures and environmental management requirements, put an end to underreporting, underreporting, concealment of the amount of new chemical substances, and fail to produce, import or process the use of new chemical substances in accordance with the provisions of the new chemical substance registration certificate, the local ecological and environmental departments at or above the districted municipal level shall order corrections and impose a fine of between 10,000 and 30,000 yuan; Applications for environmental management registration of new chemical substances will not be accepted for one year.
03
A chemical technology company did not apply for the environmental management of new chemical substances to produce new chemical substances
On June 24, 2021, the law enforcement officers of the law enforcement brigade of the Jinshan District Ecological and Environmental Bureau found that there were 6 substances in the products developed and produced by the company (BOC-L-leucine, BOC-L proline, BOC-L proline methyl ester, N-BOC-L-tert-leucine, BOC sarcosine, BOC-L-dimethyl glutamate) in the inspection of a chemical technology co., LTD., which were not in the "List of Existing Chemical Substances in China" and belonged to new chemical substances. However, the company failed to provide environmental management registration or filing materials for new chemical substances in the relevant products. At the scene, law enforcement officers consulted the company's procurement records, product lists and production records of raw and auxiliary materials.
After investigation and inquiry, it was determined that the company was engaged in the production of 6 new chemical substances engaged in research and development and production of less than 1 ton, and did not handle the filing of the environmental management of new chemical substances, which violated the provisions of Article 4 of the Measures for the Registration of environmental management of new chemical substances. According to the first item of Article 49 of the Measures for the Environmental Management and Registration of New Chemical Substances, the Jinshan District Ecological and Environmental Bureau ordered the company to immediately correct the illegal acts, and at the same time, considering that the company had completed the environmental management record of the relevant new chemical substances on June 27, 2021 and did not cause harmful consequences, according to Article 33 of the Administrative Punishment Law of the People's Republic of China, the company's illegal acts were not administratively punished.
Enterprises and public institutions engaged in the research, production, import, and processing and use of new chemical substances, where the annual production or import volume of new chemical substances is less than 1 ton, shall handle the filing of environmental management of new chemical substances, and where new chemical substances are not produced or imported in accordance with the filing information, or where new chemical substances are processed and used without filing, the competent departments for ecology and environment at the districted municipal level or above shall order corrections within a time limit and impose a fine of between 10,000 and 30,000 yuan; Applications for environmental management registration of new chemical substances will not be accepted for one year.
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Contributed by: Municipal Environmental Law Enforcement Corps
Editor: Zhang Yujie