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Detailed information on the registration and filing of new raw materials for cosmetics!
Release time:
2020-09-27 09:33
The "Specification for Registration and Filing of New Cosmetic Ingredients" (Draft for Comments) (hereinafter referred to as the "Specification") issued in August 2020 provides clear guidance on the specific materials required to be submitted for the registration and filing of new cosmetic ingredients.
Under the specification, in principle, the information required for filing/registration of new cosmetic raw materials is consistent, and the requirements for toxicological safety evaluation data are different according to the efficacy and use history of new raw materials, which are mainly divided into the following nine categories:
1. intended for anti-corrosion, sunscreen, coloring, hair dyeing, whitening, anti-hair loss, acne, anti-wrinkle, anti-dandruff, antiperspirant function of the new raw materials
2. intended to be used for anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, hair loss prevention, acne removal, anti-wrinkle, anti-dandruff and anti-perspirant functions, sufficient evidence can be provided to prove that the raw material has been used safely in cosmetics listed abroad for more than three years.
3. can provide sufficient evidence that the material has a history of safe consumption of new cosmetic raw materials (need to use the same site)
4. chemically synthesized polymers consisting of one or more structural units, linked by covalent bonds, with an average molecular weight of more than 1000 daltons and a molecular weight of less than 1000 daltons. The content of oligomers is less than 10%, and the structure and properties are stable (except for raw materials with high biological activity)
5., the international authoritative safety evaluation agency has concluded that the use of new raw materials in cosmetics is safe.
6. nano raw materials
7. raw materials of oligopeptides, polypeptides and proteins derived from biotechnology
The 8. is intended to be used for anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening, anti-hair loss, acne, anti-wrinkle, anti-dandruff, antiperspirant function of raw materials
List of Requirements for Registration and Filing Materials of New Raw Materials for Cosmetics
Category | 1 | II | 3 | 4 | Five | Six | Seven | Eight |
Acute oral/percutaneous test | + | + | - | - | - | + | + | + |
Skin and acute eye irritation/corrosion test | + | + | + | + | - | + | + | + |
skin allergy test | + | + | + | - | - | + | + | + |
skin phototoxicity test | + | + | + | + | - | + | + | + |
skin photoallergy test | + | + | + | - | - | + | + | + |
mutagenic test | + | + | - | - | - | + | + | + |
Repeated dose oral/transdermal toxicity test | + | - | - | - | - | + | + | + |
teratogenic test | - | - | - | - | - | + | + | + |
chronic toxicity/carcinogenicity combination test | - | - | - | - | - | + | + | + |
Toxicant Metabolism and Kinetics Test | - | - | - | - | - | + | + | + |
inhalation toxicity test | - | - | - | - | - | ± | ± | ± |
skin absorption or transdermal absorption test | - | - | - | - | - | + | + | + |
Immunogenicity/Toxicity Tests | - | - | - | - | - | - | + | - |
"" This test data is required
"-" No need to provide this test data
"±" shall be submitted according to the actual situation
To sum up and based on the specification requirements, the following points should be paid attention to in submitting toxicological test data in the registration and filing of new cosmetic raw materials:
1, about the efficacy of raw materials
The application of registration or filing management of new raw materials and the corresponding toxicological test data requirements are mainly based on the efficacy of the raw materials to judge, in the specification clearly requires that the raw materials to be filed must submit a commitment that the raw materials do not have anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening functions, and put forward different functional raw materials. Therefore, determining the feedstock function claims to be a top priority.
It should be noted that in the "Code for Registration and Filing of New Cosmetic Raw Materials (Draft for Comments)", the 9. filing commitment filing person shall promise when filing new raw materials: according to the existing relevant literature or research data, the new cosmetic raw materials filed do not have the functions of anti-corrosion, sun protection, coloring, hair dyeing, freckle removing and whitening. If the new raw materials have anti-corrosion, sun protection, coloring, hair dyeing, freckle whitening functions, the registrant/filer should first register the new raw materials and then apply for the record ". "14. toxicological safety evaluation review...... intended for anti-corrosion, sunscreen, coloring, hair dyeing, whitening, anti-hair loss, acne, anti-wrinkle, anti-dandruff, antiperspirant function of the new raw materials". The functional definition of new raw materials for cosmetics in the specification includes "existing relevant literature or research data" and "proposed efficacy" two sources, which still need to be confirmed after the issuance of official documents, and we will continue to pay attention to it.
2. About raw materials of biological origin
In the specification, specific requirements are put forward for the materials required to be submitted for new raw materials from biotechnology. It is considered that some oligopeptides, polypeptides and the like may have the biological activity of drugs (such as growth factors), which is beyond the scope of cosmetic raw materials. Therefore, more toxicology tests are required for oligopeptides, polypeptides and protein raw materials from biotechnology, with a test period of 2 years or more.
3. About nano raw materials
Based on the small particle size of nano-raw materials, can pass through the biofilm barrier, trace can enter the blood, and may cause cell DNA damage and apoptosis and other characteristics, the standard of nano-raw materials toxicological safety assessment requirements are higher than the general raw materials, toxicological test cycle is expected to be 2 years or more.
[1]
Including light irritation and light allergy, raw materials with ultraviolet absorption characteristics need to do this test
[2]
This test is required for raw materials with ultraviolet absorption characteristics.
[3]
Include at least one gene mutation test and one chromosome aberration test
[4]
If the raw material is used in cosmetics with a high possibility of oral intake, a repeated dose oral toxicity test should be provided.
[5]
Plant materials with a single component purity of less than 80% are not required to submit to this test.
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