No. 003 and 004 new cosmetic raw materials have been made public

Release time:

2021-08-26 18:02

After the landing of the new regulations announced by the State Drug Administration, the filing of products and raw materials has also been updated. On June 28, 2021, the official website of the State Drug Administration officially announced the filing information of two new raw materials for domestic cosmetics, the 20210001 of the original preparation of the national makeup: N-acetyl neuraminic acid and the 20210002 of the original preparation of the national makeup: lauroyl alanine.

Nearly two months after the birth of "001" and "002", the cosmetics industry once again ushered in new raw materials. On August 24, 2021, the official website of the State Food and Drug Administration officially announced the filing information of "003" beta-alanyl hydroxyprolyl diaminobutyric acid benzylamine and "004" snow lotus culture two new raw materials for domestic cosmetics.

In the 10 years from 2009 to 2019, only 4 new cosmetic ingredients were approved in China. In other words, after the implementation of the regulations on the Supervision and Administration of Cosmetics, the amount of new raw materials approved in two months is equivalent to that in the past 10 years.

Prior to this, the China Institute for Food and Drug Control announced 37 new cosmetic raw materials that have accepted and have not yet made an administrative licensing decision, among which 001 N-acetylneuraminic acid and 002 lauroyl alanine are listed. However, 003 and 004, which passed the filing this time, did not appear on this list. This also means that there are more than 37 new raw materials being approved by the China Food and Drug Control Institute.

It is worth noting that up to now, the four new raw materials that have passed the record are all domestic raw materials. Among the 37 new raw materials announced above, the declared foreign-funded enterprises account for half of the country. However, the four new cosmetics raw materials that have passed the record are all from local companies, and the industry is very pleased.

β-alanyl hydroxyprolyl diaminobutyric acid benzylamine is a chemical raw material. It is white crystalline powder or block with slightly acidic smell. It is used for skin protectant. It can be used for cleaning products, water emulsion, facial mask and various facial base cream. The maximum allowable concentration is 1% when used in cosmetics.

Saussurea involucrata culture is a biotechnology raw material, composed of total flavonoids, 1,5-dicaffeoylquinic acid, chlorogenic acid, syringin, etc., in purple-gray powder, slightly fragrant gas, the main use is antioxidants, can be widely used in all kinds of cosmetics, the maximum allowable concentration is 4%.

The newly approved Saussurea involucrata culture and β-alanyl hydroxyprolyl diaminobutyric acid benzylamine are marked with the words "monitoring period" in the column of the status of the two new raw materials.

According to the regulations on the Supervision and Administration of Cosmetics, after the successful filing of new raw materials, they will also be monitored for a period of three years, starting from the date of successful filing or registration of finished cosmetics using approved new raw materials. Based on the advantages of raw materials, the three-year monitoring period for the development of real skin care products is also a risk period.

In accordance with the requirements of the Regulations on the Supervision and Administration of Cosmetics, after the registered and filed new cosmetic raw materials are put into use, if there are safety problems within 3 years, the registration will be canceled or the filing will be canceled; if there are no safety problems within 3 years, they will be included in the used The catalog of cosmetic raw materials.

The filer shall report the use and safety of the new raw materials to the drug regulatory department every year until the expiration of 3 years. When the new raw materials may have safety risks, it shall immediately take measures to control the risks and submit the safety risk control report of the new raw materials for cosmetics. If it is not carried out as required, a fine of 50000-200000 yuan will be imposed, and if the circumstances are serious, the registration or filing will be canceled.

According to the regulations on the Supervision and Administration of Cosmetics, those who use new cosmetic raw materials that are still under safety monitoring will still use the new cosmetic raw materials to produce cosmetics after the new raw materials have been deregistered or the record has been canceled, and a fine will be imposed. If the circumstances are serious, they will be ordered to suspend production and business, cancel the record or revoke the license, and those who constitute a crime will be investigated for criminal responsibility according to law.

The industry generally believes that the source of innovation in the cosmetics industry lies in raw materials. However, raw materials have always been a major shortcoming in China, which largely restricts the development and breakthrough of the industry. Encourage and support enterprises to use modern science and technology to research and develop new raw materials for cosmetics. This is an important background for the "Regulations on the Supervision and Administration of Cosmetics" to "untie" new raw materials and open the filing system.

As early as 2018, national leaders said that "scientific and technological research must abandon illusions and rely on themselves" and "some major core technologies must rely on themselves to overcome difficulties", which is also applicable in the cosmetics industry. Only by attaching importance to scientific research and independent research and development of raw materials, can we not be controlled by others in the development and production of cosmetics.

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