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New chemical activities are not declared and punished? How to deal with it, look here!
Release time:
2019-11-21 17:07
A few days ago, the Ministry of Ecology and Environment of the People's Republic of China announced on its official website the penalties for the production of new chemical substances without a registration certificate. Some customers have asked us whether the inspection by the Ministry of Environment is increasing and what impact it will have on the enterprise.
From the revised version of Decree No. 7 and the revised version of the regulations on environmental risk assessment and control of chemical substances, we can see that the supervision of the production and use of new chemical substances by government departments will become more and more strict in the future. The "non-compliance" of new chemical substances will seriously affect the reputation of the enterprise once it is investigated and dealt.
We can learn from the revised draft of the New Chemical Substances Environmental Management Measures issued on July 11, 2019. The Ministry of Ecology and Environment has refined and improved Article 45 [Local Penalties] of the Measures. The penalties will be more specific. At the same time, for illegal acts, in addition to being ordered to correct by the local ecological and environmental authorities at or above the municipal level divided into districts, a fine of 10,000 yuan to 30,000 yuan will be imposed, it will also announce its violations, include them in the record of environmental violations, and report the punishment to the competent department of ecological environment under the State Council.
The revised draft also further clarifies the matters of supervision and random inspection. The competent department of ecological environment under the State Council and the competent department of ecological environment at or above the municipal level with districts shall conduct supervision and random inspection on the activities of new chemical substances, focusing on whether the registration of new chemical substances is handled as required Or the authenticity of the registration and filing items, the items recorded in the registration certificate, and the implementation of other relevant provisions of these Measures.
In addition, it is worth noting that Article 34 [(I) of Corporate Legal Liability] of the Regulations on Environmental Risk Assessment and Control of Chemical Substances (Draft for Comment) issued in January this year clearly stipulates that new chemical substances should be reported but not reported. Penalties, namely: "A fine of 500,000 to 1 million yuan; If serious consequences are caused, a fine of 500,000 to 20,000 yuan shall be imposed; If a crime is constituted, criminal responsibility shall be investigated in accordance with the law".
The environmental management of new chemical substances in our country started in 2003. There is no EU reach and Japan's chemical review law for a long time. Previously, the supervision of government departments was relatively weak, and many companies did not do this work with a fluke mentality, or did not know this law at all. However, with the strengthening attention of the competent authorities, the management work is bound to become more stringent, and enterprises should correctly understand the importance and necessity of doing a good job in the compliance of new chemical substances.
Then the editor will introduce to you what is the declaration of new chemical substances and how to declare new chemical substances.
The current Environmental Management Measures for New Chemical Substances was issued by the Ministry of Environmental Protection of China in January 2010 and formally implemented on October 15, 2010. It stipulates that before enterprises produce or import new chemical substances into China, they must declare new chemical substances that are not listed in the list of existing chemical substances in China (IECSC) in accordance with the measures for environmental management of new chemical substances, and the production or import of new chemical substances can only be carried out after receiving the environmental management registration certificate of new chemical substances.
Subject of declaration:
Domestic production enterprises/import enterprises to declare directly;
An overseas enterprise exporting to China must entrust a domestic agent when making a declaration.
Note: Exporters from Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan are overseas filers.
Declaration process:
1. Confirm whether the substance is within the scope of the new substance declaration
This step is mainly to check whether the substance is exempt and whether it is in the List of Existing Substances in China, which is divided into open and confidential libraries. The public library can be found on the internet, and the editor has already found it for everyone. you can download it directly from the download center of this website. The inquiry of the confidential library needs to be entrusted to the Ministry of Environmental Protection.
2. Confirmation of declaration type:
According to the annual declaration volume and the purpose of manufacturing, import and export, the types of declaration are divided into the following types.
Scientific Research Filing Declaration
Import of samples of new chemical substances for ecotoxicological testing in China using Chinese test organisms with an annual production or import volume of <0.1 tons for scientific research purposes
Simple declaration
Basic situation: annual production or import of new chemical substances <1 ton
Special cases: Used as an intermediate or for export only, annual production or import <1 ton
For the purpose of scientific research, 0.1 tons ≤ annual production or import <1 ton
Polymers with less than 2% monomer content of new chemicals or low-interest polymers (unlimited tonnage)
For the purpose of process and product research and development, the annual production or import volume is less than 10 tons and does not exceed two years.
regular declaration
Annual production or import of new chemical substances ≥ 1 ton
According to the different tonnage of the declared substance, it is divided into 1-10, 10-100, 100-1000 and 1000 (tons/year) four declaration levels.
3. Data gap analysis
According to the different types of new chemical substances, the requirements for data are also different. The experiments based on the "Measures" include physical and chemical tests, toxicity tests and ecotoxicology tests. According to the type of declaration, information on the production, testing, use, etc. of new substances is collected and evaluated. Determine which data meets the review requirements, which data does not meet the reporting requirements and needs to be corrected, and which data are missing and need to be retested.
According to the physical and chemical properties and toxicity data of the new substance, the test scheme is formulated. And start collecting the information required for the application materials and risk assessment reports.
4. Experiment
This step is based on the results of the previous step to determine what experiments need to be done, and then select the laboratory, contact the laboratory, arrange the experiment. This step requires regular tracking of the progress and circumstances of the experiment.
5. Preparation of application materials
After obtaining all experimental data, the risk assessment report shall be compiled. After the preparation of all test reports and wind assessment reports, the reporting company shall sign and seal them and submit them to the registration center of the Ministry of Environmental Protection.
6. Follow-up correction and final approval
After the materials are submitted, the expert review may give requirements for supplementing and revising the application materials, so it is necessary to track the progress of the review status of the materials and give timely feedback until the new substance declaration is approved.
If you have any questions about new chemicals, please contact Xinanrun Consulting:
Contact: Mr. Wang
Contact information: 400-660-1329/18918216701
Micro signal: wgdeng1981
Electronic E-mail: nar@china-reach.net
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