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Declaration of new chemical substances, declaration of hazardous chemicals......
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Business Scope
One-stop chemical compliance service
The Ministry of Ecology and Environment of China issued Ministry Order No. 12 in April 2020, the "New Chemical Substances Environmental Management Registration Measures", which will be officially implemented on January 1, 2021. The Measures are applicable to the environmental management registration of the research, production, import, processing and use of new chemical substances in China. It stipulates that before an enterprise produces or imports new chemical substances in China, it must register new chemical substances for chemical substances that are not listed in the "China Existing Chemical Substances List" (I. e. IECSC). After receiving the new chemical substance environmental management registration certificate, the production or import of new chemical substances can be carried out.
Regulations on the Safety Management of Hazardous Chemicals (Order No. 591 of the State Council)
Article 3 The term "dangerous chemicals" as mentioned in these Regulations refers to highly toxic chemicals and other chemicals that are toxic, corrosive, explosive, burning, combustion-supporting and harmful to the human body, facilities and the environment.
Article 78 under any of the following circumstances, the supervision and administration department of production safety shall order it to make corrections and may impose a fine of not more than 50000 yuan; if it refuses to make corrections, it shall be fined not less than 50000 yuan but not more than 100000 yuan; if the circumstances are serious, it shall be ordered to suspend production or business for rectification:
(12) A hazardous chemical production enterprise or import enterprise does not go through the registration of hazardous chemicals, or discovers that the hazardous chemicals it produces or imports have new hazardous characteristics and does not go through the procedures for changing the registration of hazardous chemicals.
According to the Regulations on the Supervision and Administration of Cosmetics (State Order No. 727), the natural or artificial raw materials used in cosmetics for the first time in my country are new raw materials for cosmetics. The registered and filed new raw materials for cosmetics are still used before they are included in the catalog of used cosmetic raw materials. New raw materials for cosmetics are managed.
It should be noted that only when the expected use method, use part and use purpose of the raw materials meet the relevant attributes of cosmetics, can they apply for registration or record according to the new raw materials of cosmetics.
GMP Compliance and Certification
Provide a package of services from system establishment, improvement, audit, simulation inspection to official certification inspection.
Includes:
1) China GMP Certification
GMP certification of domestic enterprises
NMPA on-site inspection of overseas enterprises
New chemical substances and existing chemical substances in Taiwan are regulated by the "Measures for the Registration of Information on New Chemical Substances and Existing Chemical Substances" under the "Measures for the Administration of Toxic Chemical Substances" (TCSCA, referred to as the Toxic Control Law). The measures have been officially implemented on December 11, 2014, and the centralized management department is the "Environmental Protection Agency" (EPA). At the same time, new chemical substances in Taiwan are regulated by the "Administrative Measures for the Registration of New Chemical Substances" under the "Occupational Safety and Health Measures" (OSHA, referred to as the Occupational Safety Law). The measures have been formally implemented on January 1, 2015. The management department is the "Ministry of Labor" (MOL).
Quality management system (Quality Management system, QMS) refers to the quality of command and control of the organization's management system. A QMS is an organization's approach to ensuring that the quality of its products or services meets the expectations and needs of its customers. The main goal of QMS is to ensure the consistency and reliability of the product or service, as well as to maximize the satisfaction of customer expectations and needs.
COMPANY
New Anrun Consulting Creates Value for Customers
New Anrun (Beijing) Consulting Co., Ltd. focuses on chemical regulatory compliance consulting services. With its profound professional technical strength and multi-resource advantages, it is committed to providing chemical regulatory consulting and environmental protection regulatory response services for pharmaceutical and chemical enterprises, consumer goods manufacturers and large multinational companies.
Established in
Cooperation Customers World Top 500 Enterprises
Our advantage
One-stop chemical compliance service
01
Diversification
Focus on chemical regulatory compliance consulting services, with its deep professional technical strength and multi-resource advantages.
02
Scale
Has successfully provided chemical regulatory consulting services to more than ten Fortune 500 companies.
03
Specialization
Committed to pharmaceutical, chemical enterprises, consumer goods production enterprises, large multinational companies to provide chemical regulations consulting and environmental protection regulations to respond to services.
04
Compliance
New Anrun Consulting has become a leading consulting agency for chemical regulations and environmental regulations in China, with customers in more than 30 regions in more than 10 countries.
News
One-stop chemical compliance service
Key Illustration of Railway Transportation Regulations for Consumer Lithium Battery Cargo
Recently, the Ministry of Industry and Information Technology of the National Railway Administration China National Railway Group Co., Ltd. announced the guidance on the railway transportation of consumer lithium battery goods. For details, please refer to our public article. Official
I recommend: For pre-registration projects with large tonnage and short grace period, or small tonnage pre-registration projects that are clearly registered in the future, it is recommended to choose joint registration and join the joint registration IT system agreement this time. For pre-registration projects that are clearly not registered in the future, it is recommended to choose subsequent registration. May I ask you
Cancellation of GMP certification means stricter supervision of drug production?
The cumbersome process of GMP and GSP certification has made many pharmaceutical manufacturers and distribution companies feel the strict supervision of the pharmaceutical industry. On September 25, 2019, the State Food and Drug Administration issued a notice on the study, publicity and implementation of the the People's Republic of China Drug Administration Law., It is clearly proposed to strengthen dynamic supervision and cancel the drug production quality management practice (GMP) certification and the drug business quality management practice (GSP) certification.
Dry goods! Common technical questions and answers on new raw materials for cosmetics
On July 8, 2024, the Chinese Academy of Inspection issued a (I) of common technical questions and answers on new raw materials for cosmetics and a (II) of common technical questions and answers on new raw materials for cosmetics.
Announcement No. 153 of the State Drug Administration on December 4, 2023, "Medical Device Business Quality Management Regulations" will come into force on July 1, 2024. The Announcement of the former State Food and Drug Administration on the Implementation of Medical Device Business Quality Management Standards (No. 58 of 2014) shall be abolished at the same time.
Interpretation! Historical evidence for the safe use of new cosmetic raw materials in China
On May 31, 2024, the Central People's Procuratorate issued a notice on publicly soliciting opinions on the "Guidelines for the Study and Determination of the Safe Use of New Cosmetic Raw Materials (Trial) (Draft for Solicitation of Comments)" (hereinafter referred to as the "Draft for Solicitation of Comments"). On the basis of the "Regulations on the Administration of Registration and Filing Materials of New Cosmetics Raw Materials" (hereinafter referred to as the "Regulations"), the draft for comments further clarifies the details of the relevant data requirements for the safe use of new raw materials. The following is a summary of the contents of the regulations and a sharing of our views for your reference.