New chemical substances environmental management practices
(January 19, 2010 People's Republic of China Ministry of environmental protection announced as of October 15, 2010, 7th) directory
Chapter I General provisions
Chapter II application for
Chapter III registration management
The fourth chapter tracking control
The fifth chapter legal liability
The sixth chapter supplementary articles
Chapter I General provisions
The first "purpose" in order to control environmental risks of new chemical substances to protect human health, and protection of the ecological environment, according to the State Department to set administrative administrative examination and approval items really necessary to be retained licensing decisions, as well as other relevant laws, administrative regulations, and these measures are formulated. Article "the scope" this regulation is applicable in the People's Republic of China Customs territory to engage in research, production, import and the processing of new substances environmental management activities.
Free trade zone and export processing zone of new chemical substances activities related to environmental management, these measures shall also apply.
Pharmaceuticals, agricultural chemicals, veterinary drugs, cosmetics, food, food additives, feed additives, such as management, relevant laws and regulations; however, as these products raw materials and intermediates of new environmentally sound management of chemicals-related activities governed by this approach.
Designed to be intentionally released by conventional use of goods with new chemical substances, in accordance with the management approach.
Article "sorting" according to chemical hazard identification and classification standards, of new chemical substances are divided into the general categories of new chemical substances, dangerous new chemical substances.
Risk of new chemical substances are persistent, bioaccumulative, ecological environment and human health hazard properties of chemical substances as a key environmental management of hazardous chemical substances.
New chemical substances mentioned in these measures refers to is not included in the list of existing chemical substances in China's chemicals.
The list of existing chemical substances in China by the Environmental Protection Department, adjusted and promulgated.
The fourth "basic system" country risk classification management of new substances, the implementation of registration and tracking system.
The fifth "registration certificate" new producers or importers of chemicals must be declared prior to production or import, receive a registration certificate for environmental management of new chemical substances (hereinafter "registration").
Without obtaining the registration of new chemical substances, and prohibit the production, import and processing.
Without a registration certificate or new chemical substances that are not filed declarations shall not be used for scientific research.
The sixth "encourages advanced technology" State support for new chemical risks, health risk assessment and the control of scientific research, promotion of advanced new chemical substance environmental risk control techniques to encourage environment-friendly alternative to chemical research, production, import and processing, encouraged the applicant to share new chemical substance registration data.
The seventh "keep secrets" staff engaged in environmental administration of new chemical substances shall be for the applicant to keep business secrets and technology secrets.
The eighth "public scrutiny" all units and individuals have the right to violate these rules of conduct to report, inform and bring charges against.
Chapter II application for
The Nineth "declaration type" Declaration of new chemical substances, divided into regular reporting, summary reporting, and research record declared.
The tenth "General reporting requirements" annual production or import of new chemical substances above 1 ton, to the Environmental Protection Department shall, before manufacture or import chemicals registration centre (hereinafter "the register") submitted a report of new chemical substances, handling routine reporting, however, meets the conditions for summary reporting, you can apply for summary reporting.
New chemical substances a report should include the following:
(A) general declarations of new chemical substances, and according to the classification of chemicals, warning labels and warnings safety norms of national standards, such as the classification, labelling and chemical safety data sheet;
(B) risk assessment reports, including reporting substances hazard assessment, exposure assessment and risk control measures, and risk assessment of environmental risks and health and so on; (C) physical and chemical properties, toxicological and eco-toxicological properties of test reports or information and testimonials about the test.
Eco-toxicological properties of test reports must be included in the territory of China by China for biological testing done in accordance with standard data. 11th "general declaration order of magnitude" general declarations follow the "number higher, test data requirements the higher the" principle.
The declarant shall, according to the Ministry of environmental protection to develop guidelines for the registration of new chemical substances, provide the test data or information.
Based on the number of new chemical substances, and regular reporting from low to high is divided into the following four levels:
(A) the level to more than 1 ton of annual production or import of less than 10 tons;
(B) secondary to annual production or imports more than 10 tons of less than 100 tons;
(C) three levels for annual production or import 100 tons or more of less than 1000 tons;
(D) the grade for more than 1000 tons annual production or import.
12th "summary report" annual production or import of new chemical substances of less than 1 ton, shall, before manufacturing or importing, go through the summary report to the registration centre.
Go through the summary report, the following documents shall be submitted:
(A) the summary return of new chemical substances;
(B) in China with the Chinese for eco-toxicological properties of bio-complete testing reports.
13th "summary report special circumstances" the production or import of new chemical substances the following special circumstances, should go through the summary report:
(A) as intermediates or for export only, the annual production or imports of less than 1 ton;
(B) for the purpose of scientific research, 0.1 ton annual production or import volume of not less than 1 tonne;
(C) new chemical substance content below the 2% polymers or low concern polymers;
(D) for the purpose of process and product research and development, production or imports less than 10 tonnes/year, and no more than two years.
Handle special case summary declarations shall submit a summary of new chemical substances application form and comply with appropriate supporting material.
14th "filing reporting requirements" any of the following circumstances, should be in the production or import of table to a registration centre for scientific research of new chemical substances, handle filing Declaration of scientific research:
(A) for the purpose of scientific research, of new chemical substances under 0.1 ton of annual production or import volume;
(B) in China with China for new chemical substances by biological eco-toxicological properties of test samples of tests and the import of new chemical substances.
15th "series of declarations, Joint Declaration, repeating the Declaration" for General reporting, any of the following circumstances, in accordance with the following provisions of declaration procedures:
(A) the same declarant on the molecular structure similar, uses the same or similar, test data, similar to a number of new chemicals that can put forward a series of new chemical substances declarations;
(B) two or more filers and declare the same new chemical substances and submit application materials may submit a joint declaration of new chemical substances; (C) the applicant has declared more than two of the same new chemical substances and agreed upon before the declarant with the consent of the applicant after applicant prior to use test data can be made double claims of new chemical substances.
Data testing method of cost-sharing, agreed to by the applicant itself.
16th "applicant eligibility" new chemical substances the applicant or his agent, shall be registered institutions in China.
Non-reporting of new chemical substances for the first time over the past three years for violation of regulations for environmental management of new chemical substances are bad records of administrative penalties.
17th "report" declared when people go through the formalities of new chemical substances, shall truthfully submit new chemical hazard and environmental risks for all known information.
The 18th article "access to environmental information" application materials submitted by the applicant relates to trade secrets or know-how require confidential and shall indicate in the application materials.
Information regarding harm to human health and environmental safety, confidentiality shall not be required.
When the applicant requested confidentiality of content available to the public, he shall notify the registration center.
19th "test body" provides test data for reporting purposes of new chemical substances tested institutions operating in, chemical testing institutions shall be announced for the Department of environmental protection, and accept the supervision and inspection of environmental protection.
Internally testing institution shall comply with the Environmental Protection Department issued guidelines for chemical test laboratory and chemicals testing-guidelines or chemical testing relevant national standards, eco-toxicological testing of new chemical substances.
New eco-toxicological properties of chemical substances in outside testing and provide test data of foreign testing agencies, must pass the test or the laboratory practice of the national authorities.
Chapter III registration management
20th "normal registration procedures" General registration of new chemical substances, according to the following procedures: (A) register after accepting the General Declaration, report submitted to the Ministry of environmental protection, of new chemical substances should be expert review Committee on chemicals management (hereafter "the Committee").
Jury made up of chemistry, chemical engineering, health, safety, environmental protection and other experts.
(B) the Commission shall, in accordance with the Environmental Protection Department has issued the new chemical hazard and risk assessment guidelines and norms, and chemical hazard identification and classification of relevant national standards, of new chemical substance identification and technical review of the following: 1.
Name and logo; 2.
The physico-chemical, human health and environmental hazard; 3.
Exposures and risks to human health and the environment; 4.
The adequacy of control measures for risks to human health and the environment.
Review Committee considers that existing materials are inadequate to the conclusions of the risk comprehensive evaluation of new chemical substances, notify the applicant in writing by the Registration Centre supplementary application materials. (C) the Review Committee shall file a new registration of chemical substances technical review comments submitted to the Department of environmental protection.
The registration of new chemical substances technical review comments include: 1.
Will be recognized as a general category, of new chemical substances hazardous and are focused on environmental management of hazardous chemical substances management category; 2.
Human health and environmental risk assessment opinions; 3.
Assessment of risk control measures appropriate conclusions; 4.
Whether or not to grant registration proposal.
(D) the Environmental Protection Department should review technical review comments on the registration of new chemical substances, identifying new chemical substance management categories, and depending on the circumstances, to make a decision: 1.
The appropriate risk control measures for the registration and issuance of registration certificate; 2.
Without the appropriate risk control measures, no registration, notify the applicant in writing and state the reasons.
The Environmental Protection Department before making a registration decision, registration of new chemical substances should be public.
The 21st "easy registration procedure" simple registration of new chemical substances, according to the following procedures:
(A) register after accepting the simple declaration, it shall submit a written statement of opinion, submitted to the Ministry of environmental protection.
Eco-toxicological properties of test reports are submitted as required, Review Committee should declare material in assessing the technical and technical review comments, and submitted to the Ministry of environmental protection.
(B) the Department of environmental protection to meet the requirements, registration, issuing registration certificates; do not meet the requirements, registration, notify the applicant in writing and state the reasons.
22nd "filing registration program" record of scientific research of new chemical substances, according to the following procedures:
(A) register after receipt of filing Declaration of scientific research shall be monthly summaries submitted to the Ministry of environmental protection;
(B) the Environmental Protection Department in the announcement on the Government Web site on a regular basis.
23rd "registration" shall be announced on a Government Web site of the Department of environmental protection approve the registration of new chemical substance name, type of applicant, Declaration and registration of new chemical substances management information such as the categories.
The 24th "processing time" central registry shall accept General within 5 working days from the date of the Declaration, new chemical substance report submitted to the Review Committee; acceptance within 5 working days from the date on which the summary declaration, written comments submitted to the Department of environmental protection. General registration of specialists in the field may not exceed 60 days, expert review of a simple registration time not later than 30th.
Supplementary application materials that registers the notification, the applicant time needed to supplement materials without expert review. Department of environmental protection shall receive registration centre or a new Chemical Review Committee reported within 15 working days from the date of the registration document, make a decision on whether to register.
Not available within 15 working days to make a decision, approved by the head of the Department of environmental protection, can be extended by 10 working days.
The 25th "registration certificate" registration certificate shall set forth the following major items:
(A) the name of the applicant or his agent;
(B) the names of new chemical substances;
(C) the registered purpose;
(D) the registered level and quantity;
(E) new chemical substance management category.
General Declaration of registration certificate shall set forth the risk control measures and administrative requirements.
26th article "new features and the" holder of the registration certificate are registered new chemical substance found when there is a new hazard characteristics shall immediately submit to the registration centres of the chemical hazard new information.
Register should be allowed to register new chemical hazard information, submitted to the Review Committee for the technical review.
According to the Review Committee's technical review comments of the Department of environmental protection, to take the following measures:
(A) through an increase in risk control measures to control the risk, registration certificate updating appropriate risk control measures, and ensure the registration certificate holder added risk control measures;
(B) without adequate measures to control the risk, to withdraw the registration of new chemical substances, and make an announcement.
The 27th "new declaration" has not been included in the list of existing chemical substances in China, and has allowed the registration of new chemical substances, any of the following circumstances, registration certificate holder shall declare the procedure as provided herein:
(A) increasing the order of registration;
(B) change the registered uses of key environmental management of hazardous chemical substances.
Has been included in the list of existing chemical substances in China, and allowed to register focuses on environmental management of hazardous chemical substances, registration purposes, can also be used by the processing of the registration of new chemical substances, again declared.
28th "information sharing", Ministry of environmental protection should have been allowed to register for the dangerous classes of new chemical substances (including focus on environmental management of hazardous chemical substances) for information, inform the relevant management departments.
The fourth chapter tracking control
Article 29th "loop reviews precondition" the Environmental Protection Department shall, of new chemical substances registered, would approve production or processing using the conditions of the new document of the construction project environmental impact assessment of chemical substances.
Article 30th "Messaging" General Declaration the registration certificate holder should be specified in the technical manual on chemical safety hazard of new chemical substances, and pass processing using the following information:
(A) the risk control measures specified in the registration certificate;
(B) the chemical safety data sheet;
(B) according to the classification of chemicals, warning labels and warning instructions safety rules for classification;
(D) any other relevant information.
The 31st "General risk control measure" General Declaration of the holder of the registration certificate and the corresponding processing users, shall be registered in accordance with the provisions of the certificate, to take one or more of the following risk control measures:
(A) risk and protective education of new chemical substances;
(B) increased exposure to new chemicals in the individual protection of personnel;
(C) the set closed, isolation, security, and features warning signs;
(D) improvement of production, of new chemical substances used to reduce releases and environmental exposure;
(E) improvement of pollution prevention technology in order to reduce environmental emissions;
(Vi) develop contingency plans and response measures;
(VII) other risk control measures.
Dangerous new chemical substances (including focus on environmental management of hazardous chemical substances) holder of the registration certificate, as well as processing users shall abide by the regulations on the safety management of dangerous chemicals, such as the current legal and administrative regulations relevant provisions.
The 32nd "focus on risk control measures," focused on environmental management of hazardous chemical substances registered card holders and processing consumer, should also take the following risk control measures: (A) during processing in the production or use, should be monitored or estimates focus on environmental management of hazardous chemical substances released into the environment.
Do not have monitoring capabilities, you can delegate and city-level recognized by the Environmental Protection Department of the Environmental Protection Department monitors agencies or monitoring the social inspection body.
(B) at the time of transfer, shall, in accordance with the relevant regulations, equipped with the appropriate equipment, to take appropriate measures to prevent sudden emergencies focus on environmental management of hazardous chemical substances in the environment, and prompt emergency treatment when an emergency occurs.
(C) environmental management of hazardous chemical substances in the emphasis was abandoned, in accordance with the relevant disposal hazardous waste disposal regulations.
Article 33rd "banning the transfer of" General Declaration the registration certificate holder shall not be allowed to transfer the registration of new chemical substances to processing users incapable of taking risk control measures.
Article 34th "development management" scientific research activities, and technology of new chemical substances and products of research and development activities, should be in a specialized facility, under the guidance of professionals, in strict accordance with the relevant regulations. For scientific research or for the purpose of process and product research and development, production or import of new chemical substances, it should be kept, and shall not be used for other purposes.
To be destroyed, should be carried out in accordance with the regulations on hazardous waste disposal.
35th "activity report" General Declaration the registration certificate holder should be in production for the first time in the 30th, or first-time imports which have been processed using transfer in the 30th, submit to a registration center of new substances activity report form for the first time.
Focus on environmental management of hazardous chemical substances registered card holders should also be at each transfer to different users focus on environmental management of hazardous chemical substances within 30th of, to report to the registration centre flows of new chemical substances information.
Article 36th "annual reports" holder of the registration certificate of a simple declaration, should be before February 1 of each year, report to the registration centre in the previous year are allowed to the actual registration of new substances produced or imported.
Dangerous new chemical substances (including focus on environmental management of hazardous chemical substances) holder of the registration certificate shall be before February 1 of each year, report to the registration centre in the previous year are registered new chemical substances the following:
(A) the actual production or import conditions;
(B) implementation of risk control measures;
(C) environment exposure and releases;
(D) the actual situation of the environmental and human health effects;
(V) other information relevant to environmental risks.
Focused on environmental management of hazardous chemical substances registered holder, you should report to the registration centre at this year's registration of new substances production or import plan, as well as the readiness of the risk control measures have been implemented.
37th "data retention" registration certificate holder should be a new chemical materials and related data such as actual production and import activities more than ten years.
Article 38th of "regulatory notice" Department of environmental protection received register submitted to the first report on the activities of the new chemical substances list or the flow of information within the 30th of new chemical substances shall be made to the dangerous classes of new chemical substances (including focus on environmental management of hazardous chemical substances) producers, provincial Department of environmental protection processing users send notification of new chemicals regulation.
Provincial environmental protection Department is responsible for monitoring notifications sent to that chemical producers, processed using local municipal or County Environmental Protection Department.
Regulatory notice includes: names, of new chemical substances management category, registrations specified risk control measures and administrative requirements, as well as supervision and inspection points.
The 39th "supervision" departments responsible for the supervision and management of the local environment protection should be based on the new chemicals regulatory notification requirements, according to the Ministry of environmental protection to develop new chemical regulatory inspection specification, of new chemical substance production, processing, use the activity monitor to check.
Found manufacturing or processing activities using the new chemical substances, causes or is likely to cause immediate or cumulative environmental pollution hazard, shall order the producers, processing to take immediate steps to eliminate hazards or risks, and report the situation step by step to the Environmental Protection Department.
Ministry of environmental protection, according to the report, required registration certificate holders allowed to register new possible new chemical hazard information, and in accordance with this approach on new chemical substances the new hazard reporting and handling requirements to deal with.
The 40th "deregistration" registration certificate holder under the production, import or stop production and import activities, may apply to the registration centres in cancellation, explain the situation, and return the registration certificate.
Department of environmental protection identified in the preceding paragraph does not produce effects, import or no environmental hazards, log out, and the announcement of the cancellation of the registration of new chemical substances information.
41st "included in the list of existing chemical substances program" General class of new chemical substances from the holder of the registration certificate for the first time or the expiration of five years from the date of import activities, announcement by the Environmental Protection Department for inclusion in the list of existing chemical substances in China.
Dangerous new chemical substances (including focus on environmental management of hazardous chemical substances) holder of the registration certificate shall be the first production or importation activity for five years from the date of six months ago, actual activities report to the registration centre.
Organization Review Committee experts on the practical activities of the Department of environmental protection reported retrospectively to assess, based on the assessment results the dangerous classes of new chemical substances (including focus on environmental management of hazardous chemical substances) notice included in the list of existing chemical substances in China.
Easy registration and registered new chemical substances for scientific research are not included in the list of existing chemical substances in China.
The 42nd article "Troubleshooting on a regular basis", Ministry of environmental protection every five years to organize a screening of new chemical substances.
On October 15, 2003 in the People's Republic of China territory of chemicals produced or imported, the Environmental Protection Department for inclusion in the list of existing chemical substances in China.
Without registration certificates produced, imported or processed using the new chemicals, the Environmental Protection Department will be punished according to law.
The fifth chapter legal liability
The 43rd article "false claims" breach of these rules, in the reporting process to hide the information or provides false materials, by the Department of environmental protection ordered corrective action and notice its violation, recorded their record penalty of between 10,000 yuan and 30,000 yuan have been registered, and revocation of their registration.
The 44th "punishment of environmental protection matters" breach of these rules, any of the following acts, by the Department of environmental protection ordered corrective action and fines of between 10,000 Yuan:
(A) not submitted in time, new environmental risks of chemical substances are registered to update information;
(B) is not required to submit a new chemical substance activity report for the first time tables or new chemical substances flow of information;
(C) is not required to submit previous year new chemical substance produced or imported;
(D) the report is not submitted in accordance with provisions of the actual activities.
Article 45th "punishment" in violation of this regulation, any of the following acts, by the departments responsible for the supervision and management of the local environment protection ordered corrective action and fines of between 10,000 yuan and 30,000 yuan, and reported to the Department of environmental protection notice irregularities, recorded their record:
(A) refuse or hinder environmental protection authorities of supervision and inspection or accept supervision and inspection to deception;
(B) without a registration certificate or not stipulated in the registration certificate manufacturing or import of new chemical substances;
(C) processing of use without obtaining the registration of new chemical substances;
(D) did not take risk control measures as stipulated in the registration certificate;
(E) the transfer of the registration of new chemical substances to processing users incapable of taking risk control measures.
Article 46th "punishment II" breach of these rules, any of the following acts, by the departments responsible for the supervision and management of the local environment protection ordered corrective action and fines of between 10,000 yuan and 30,000 Yuan:
(A) is not required to pass the risk control of the processing of information;
(B) is not required to save the new chemical materials and related data such as actual production and import activities;
(Iii) based on scientific research as well as technology and product research and development for the purpose of production or import of new chemical substances used for other purposes or not complying with the provisions of the management.
47th "reviewer punishment in violation of the" Review Committee experts in the assessment of new chemical substances in fraud or negligence, causing serious misrepresentation of the results by the Environmental Protection Department to cancel the selected expert qualification, and make an announcement.
48th "test organization offence" provides test data for new chemical substances declared test institutions in new chemical substances tested during forging, tampering with data or if there are other falsifications by the Environmental Protection Department from the test list, and make an announcement.
The 49th "abuses of punishment" in violation of this regulation, staff engaged in environmental administration of new chemical substance abuse or neglect their duties, shall be subject to punishment constitutes a crime, criminal responsibility shall be investigated according to law.
The sixth chapter supplementary articles
50th article of "term" of this approach, the following terms mean:
(A) the General class of new chemical substances refers to harmful characteristics have not been found or less harmful than chemical hazard identification, classification standard rating of new chemical substances;
(B) the dangerous classes of new chemical substances, is a physico-chemical, human health or environmental hazard, and meet or exceed the chemical hazard identification and classification standard rating of new chemical substances.
The 51st "document format" means the following instruments format, developed by the Department of environmental protection:
(A) general declarations of new chemical substances;
(B) the summary return of new chemical substances;
(C) the table of scientific research of new chemical substances;
(D) environmental management registration of new chemical substances;
(E) new chemical substance activity report form for the first time;
(Vi) regulatory notifications of new chemical substances.
52nd "effective date" these measures come into force on October 15, 2010. On September 12, 2003 issued by the State environmental protection administration of the new chemicals regulation repealed simultaneously.
