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Outlook for raw material management of cosmetics in 2020
Release time:
2020-02-26 17:17
020 is an important year for China's cosmetics laws and regulations. After five years of revision, the new version of the Regulations on Supervision and Administration of Cosmetics was promulgated on January 3, 2020. The implementation of the Regulations will definitely bring many changes to China's cosmetics industry, which will have a significant impact on many aspects, from management concept to division of responsibilities to operation mode. One of the biggest highlights of the newly revised "Regulations" is the management of cosmetic raw materials, which the industry has been looking forward to for a long time.
History will turn a new page. At this time of transition between the old and the new, let us review the past of the management of cosmetic raw materials in our country, and look forward to and look forward to the future.
Management of new raw materials for cosmetics
In 1989, the "Cosmetics Hygiene Supervision Regulations" was promulgated, marking the beginning of the construction of China's cosmetics regulations.
The "Regulations" give a clear definition of new raw materials for cosmetics, and pointed out that "the use of new raw materials for cosmetics to produce cosmetics must be approved by the health administration department of the State Council". However, in the following 20 years, the "approval" requirements for new raw materials have not been strictly implemented, and administrative licensing also focuses on the review of final products.
After the State Food and Drug Administration SFDA took over the management of cosmetics in 2008, the management of raw materials has entered a new stage.
At the end of 2009, SFDA issued the "Regulations on the Acceptance of Cosmetics Administrative License Application", which clearly included the use of new cosmetics raw materials into the scope of administrative license approval, and made specific provisions on the requirements of application materials.
The promulgation of the "Regulations" has received widespread attention from the industry. Everyone believes that the approval of their own unique raw materials will improve the competitiveness and innovation capabilities of enterprises. In the first few years, the enthusiasm of enterprises to declare new raw materials is very high.
In the first year after the implementation of the regulations, 20 new raw materials were declared, and the number of new declarations in each of the following years reached about 50. The progress of the declaration and review of new raw materials is not smooth, far below the expectations of the industry. The attitude of the review Secondary specialized school is relatively conservative, and the requirements for details are too detailed and too high, resulting in rare results.
Catalog of used raw materials for cosmetics
In 1989, China gave a definition of new raw materials for cosmetics, but it was not controlled in practice. After the declaration and review of new raw materials was started in 2009, how to judge "new raw materials" was put on the agenda.
There are different voices in the industry on whether to establish a "positive list": one voice suggests that the status quo should be maintained and the list should not be established, and the other voice thinks that it is necessary to establish a list so that there is a unified yardstick in the evaluation and supervision.
After many discussions, it was finally decided to establish a catalogue of used raw materials in China.
The "Catalogue of Used Cosmetic Ingredients" was established for about 4 years, during which there were some problems and twists and turns. Finally, with the joint efforts of the industry, the "Catalogue of Used Cosmetic Ingredients" was officially released in December 2015.
There are 8783 entries in the catalogue, some of which are listed by category and some are named after extracts. The promulgation of the "Catalogue" provides a basis for judging whether it is a "new raw material" in the declaration of products and raw materials. In a certain historical period, its role is indispensable.
But the catalog itself has some shortcomings:
First of all, the safety of raw materials has not been evaluated;
Secondly, the quality of raw materials, purity, impurities, processes, etc. are not defined, the extraction process, solvent, enrichment degree, active substance content, etc. of plant raw materials are not distinguished, and the differences between raw materials under the same entry may be considerable;
Furthermore, there are no statistics on the concentration of raw materials used, the number of products already on the market and the range of usage in the industry. It cannot be guaranteed that all raw materials in the list have products on the market. Strictly speaking, it is a list of raw materials with a history of registration or filing.
The catalogue was originally planned to have a dynamic update mechanism, but no new raw materials have been approved in the past four years, so no new raw materials have been added. At the same time, the correction of errors and the refinement of category raw materials are all in the process, so the catalogue has not been updated since its release in 2015.
Provisions on raw materials in the technical regulations of cosmetics
The first systematic technical regulation of China's cosmetics industry, "Cosmetic Hygiene Standard", was produced in 2002 and promulgated by the former Ministry of Health.
For the first time, the list of prohibited substances, the list of restricted substances and the list of permitted substances in cosmetics (including the list of colorants, hair dyes, preservatives and sunscreens) were promulgated. When each list was first drawn up, it was mainly based on the EU Cosmetics Regulation (The Cosmetic Directive76/768/EEC,March 2000).
Since then, according to the main problems in China's supervision and with reference to the changes in the laws and regulations of major countries/regions in the world, it has been revised three times in 2005, 2007 and 2015 respectively.
The basic principle in the revision is to strictly require the basic absorption of prohibited items, stricter restrictions or permitted items added to other national laws and regulations, while the newly approved permitted raw materials in other national laws and regulations are carefully absorbed.
Management of Prohibited Substances
In the interpretation of "prohibited substances", our country has gone through some detours.
In the past, many consumers, even some law enforcers, mistakenly understood "prohibited use" as "must not contain"; in the history of the "heavy metal lipstick" incident, due to the detection of trace heavy metals in lipstick, the business activities and brand reputation of enterprises were still fresh in the memory of colleagues in the industry.
The 2015 edition of the Code introduces the concept of "technically inevitable trace substances" for the first time, which is an example of applying the theory of safety risk assessment to the construction of laws and regulations, and is a great progress in the construction of laws and regulations in China.
The establishment of the list of prohibited raw materials in the Cosmetic Safety Technical Specification refers to the laws and regulations of the European Union and the world's major economies, and also adds some parts with Chinese characteristics. For example, the list of prohibited plant (dynamic) components of cosmetics is based on the extensive understanding of traditional Chinese medicine and natural substances, which is unique to China.
whitening active raw materials
In 1989, the "Regulations" defined freckle removal as special-purpose cosmetics. Since then, relevant regulations have defined whitening products in a broad sense as special-purpose cosmetics.
Some Asian countries/regions such as Japan, South Korea, Taiwan, etc. also classify whitening products as efficacy cosmetics or pharmaceutical products, and the corresponding whitening active ingredients are managed in a positive list (including public and confidential) manner. China's management of whitening agents has not yet adopted positive list management, if a raw material has been used in China, it is only necessary to provide the raw material whitening efficacy research report or published literature and other information.
After the "cuckoo alcohol" incident of Japan's Kanebo Company, China's Food and Drug Administration intends to standardize the management of whitening ingredients. In 2015, the China Insurance Office conducted a survey on China's declared whitening cosmetics and extremely effective raw materials, and organized experts to discuss the management ideas of whitening raw materials.
As of 2015, there are more than 100 kinds of single active ingredients in the declared whitening products, and the number of compound active ingredients is more. Based on the current status of China's whitening product registration management, there is no requirement to provide the final product whitening efficacy test proof, claiming that the efficacy and concentration range of whitening ingredients are difficult to determine.
The revision of the "Regulations" is about to be completed, in which whitening agents and hair dyes, colorants, preservatives and sunscreens are classified as high-risk raw materials, and a registration management system is implemented. At present, the other four types of raw materials have been managed according to the positive list. Whether whitening active ingredients are also managed according to the list, how to generate the basic list, and how to view the past review conclusions are all aspects that need to be decided.
Considering the complexity and diversity of the mechanism of freckle and whitening products, many products are designed with multi-active components, multi-mechanism and multi-way synergy to achieve the desired effect. Under the premise of ensuring safety, it should be a more reasonable management method to make a comprehensive evaluation of the efficacy of the main active ingredient and the final product.
Prospect of Cosmetic Raw Material Management
In the revision of the regulations, the change of the concept and method of the management of cosmetic raw materials is one of the highlights of the regulations. Mainly include the following aspects:
Introduced a classification management system
According to the risk of raw materials, raw materials are divided into high-risk raw materials and ordinary raw materials, and different management methods are implemented. Administrative licensing management is implemented only for high-risk raw materials, while informative filing management is implemented for other low-risk ordinary raw materials. The introduction of the raw material classification management system fully embodies the scientific management concept based on risk, which is consistent with the international practice. It is a specific measure to promote the streamlining of administration and decentralization, the combination of decentralization, the optimization of services, and the continuous improvement of government efficiency. The system is responsible for the quality and safety of raw materials for low-risk raw materials by enterprises, which will greatly enhance the sense of responsibility and participation of enterprises, it is beneficial to enhance the enthusiasm of research and development of new raw materials and improve the quality and safety of new raw materials.
The management mode of "monitoring period" has been introduced
The Regulations will set a three-year monitoring period for newly registered or filed raw materials. This management model not only protects the interests of innovative companies and encourages their investment in research and development, but also ensures that the safety risks of new raw materials are within a controllable range, killing two birds with one stone.
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Copyright: New Anrun (Beijing) Consulting Co., Ltd.
