Once the filing of new cosmetic raw materials is completed, can they be sold and used in China?
The answer is not necessarily.
If the new raw materials are new chemical substances, new chemical substance compliance is also required, used illegally will be fined by the Ministry of Ecology and Environment, and in serious cases will be included in the loss of trust and penalized.
Therefore, in order to avoid risks and ensure the safe use of new raw materials, it is also necessary to pay attention to new chemical substance compliance.
1. What are new chemical substances?
According to Article 3, Chapter 1 of the “Measures for Registration of New Chemical Substances for Environmental Management” (hereinafter referred to as the “Measures”), new chemical substances are those that are not listed in the “Inventory of Existing Chemical Substances in China” (IECSC).
There is no absolute correlation between new chemical substances and new cosmetic raw materials, i.e. cosmetic raw materials already used in China (listed in the Inventory of Used Cosmetic Raw Materials (IECIC)) may be available chemical substances (listed in the IECSE), or they may be new chemical substances.
According to the “Guidelines for Registration of New Chemical Substances for Environmental Management” (the main guidance document for the implementation of the Measures, hereinafter referred to as the “Guidelines”), raw materials or intermediates used for the production of cosmetic products, which are new chemical substances, are applicable to the Measures.
Therefore, for cosmetic raw materials belonging to new chemical substances, even if they have been listed in the IECIC or have completed the registration of new cosmetic raw materials for the record, enterprises are still required to carry out the registration of environmental management of new chemical substances and obtain the corresponding registration certificate in accordance with the provisions of the Measures before producing in China or importing into China.
2.How to determine whether a substance is a new chemical?
Inclusion in the IECSC is the only criterion for determining whether a substance is a new chemical substance. The current version of IECSC was issued by the former Ministry of Environmental Protection in 2013, and 21 supplemental announcements have been issued so far.
Search Methods:
Directory search:
Enterprises should search both the 2013 version of the directory and the previous additions, which is inconvenient and easy to miss.
Official system search:
The Ministry of Ecology and Environment has set up an online search on the government service hall, and enterprises need to open an account in the government service hall and log in after inputting the verification code to make a search, which is also inconvenient.
3.What is exempted from registration of new chemical substances?
Which cosmetic raw materials are exempted from registration of new chemical substances?
Exemption conditions
If a certain proportion of the cosmetic raw materials are natural substances, such as plant extracts and animal tissues, and they meet the following four processing methods, they are exempted from the Measures and are exempted from the registration of new chemical substances for environmental management.
- Unprocessed or only processed or treated by physical ways such as manual, mechanical, gravity, dissolution in water, flotation in water, heating and dewatering;
- Extracted from air in various ways;
- Natural polymers that have not been chemically processed;
- Living substances, such as RNA, DNA, proteins and other biomolecules, whose chemical structure has not been altered by chemical processing.
There are fewer exemptions that apply to natural substances, distillation, alcohol extraction and supercritical extraction are not exempted extraction processes.
4.Who can apply for registration of new chemical substances
According to the Guidelines, applicants for registration of new chemical substances for environmental management shall be domestic manufacturers or importers, and overseas manufacturers or traders who intend to export new chemical substances to China ( It is required to have an enterprise or institution with relevant qualifications in China as an agent).
As cosmetic raw materials manufacturers, trading companies and cosmetic manufacturers, before producing or importing cosmetic raw materials into China, you need to register or file new raw materials in accordance with the “Regulations on the Supervision and Administration of Cosmetics”, and you also need to determine whether you need to carry out the registration of new chemical substances for environmental management in accordance with the “Registration of New Chemical Substances for Environmental Management”.
