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1. Cosmetic Supplementary Testing Method
On July 7, 2023, NMPA released a new cosmetics supplementary testing method, BJH 202301 Determination of Tacrolimus and Pimecrolimus in Cosmetics, for the determination of the following two prohibited ingredients. 1
No. | Ingredient Name (CAS No.) | Detection Limit (ng) | Lower Quantitative Limit (ng) | Detection Concentration (mg/kg) | Minimum Quantitative Concentration (mg/kg) |
1 | Tacrolimus (104987-11-3) | 0.0004 | 0.001 | 0.01 | 0.025 |
2 | Pimecrolimus (137071-32-0) | 0.0004 | 0.001 | 0.01 | 0.025 |
These two ingredients are mainly used in the medical field but not allowed to be used in cosmetics. The new method is applicable for the determination of these two ingredients in cream, emulsion, and liquid (water, oil) cosmetics.
Introduction to Cosmetic Supplementary Testing Methods
Cosmetic supplementary testing methods are supplements to the conventional testing methods in the national cosmetic standards and technical specifications such as Safety and Technical Standards for Cosmetics 2015 (STSC 2015). They are established for products that may be adulterated or produced with prohibited cosmetic ingredients but lack corresponding testing methods. The application scope covers not only the testing of cosmetics produced after but before the release date of the methods.
Supplementary testing methods are an important weapon for regulators in cosmetics’ post-market supervision and administrative law enforcement, especially in the fight against illegal additions. Since the Working Rules for Management of Cosmetic Supplementary Testing Methods came into effect in July 2021, NMPA has issued eight supplementary testing methods, involving the determination of 28 prohibited ingredients, as shown below.
No. | Method Name | Prohibited Ingredients | Release Date |
1 | Benvitimod | September 2, 2021 | |
2 | BJH 202102 Determination of Five Components Including Bimatoprost in Cosmetics 4 | Bimatoprost, Tafluprost Ethyl Amide, Latanoprost, Travoprost, Tafluprost | September 13, 2021 |
3 | BJH 202201 Determination of Five Components Including Mupirocin in Cosmetics 5 | Mupirocin, Fusidic Acid, Timolol, Terbinafine, Erythromycin | July 28, 2022 |
4 | BJH 202202 Determination of Eight Components Including Elubiol in Cosmetics 6 | Elubiol, 5-Nitrobenzimidazole, 5-Chloro-1-methyl-4-nitroimidazole, Ornidazole, Tinidazole, Ipronidazole, Ronidazole, 1-(2-Hydroxyethyl)-2-Hydroxymethyl-5-Nitroimidazole | September 13, 2022 |
5 | BJH 202203 Determination of 16alpha-hydroxyprednisolone in Cosmetics 7 | 16alpha-hydroxyprednisolone | November 23, 2022 |
6 | BJH 202204 Determination of Five Components Including Tetrahydrozoline in Cosmetics 8 | Tetrahydrozoline, Naphazoline, Oxymetazoline, Antazoline, Xylometazoline | December 23, 2022 |
| 7 | BJH 202205 Determination of Dehydroandrographolide Succinate in Cosmetics 9 | Dehydroandrographolide Succinate | December 26, 2022 |
8 | BJH 202301 Determination of Tacrolimus and Pimecrolimus in Cosmetics 1 | Tacrolimus, Pimecrolimus | July 7, 2023 |
2. Three Testing Methods for Cosmetic Ingredients
NIFDC opened three testing methods for cosmetic ingredients for public consultation on July 12, 2023. 2 Any suggestions can be submitted via email to [email protected] before August 13, 2023. The details of the three testing methods are shown in the following table.
No. | Method Name | Testing Object | Testing Method | Applicable Scope | Drafting Purpose |
1 | Determination of Azelaic Acid and Potassium Azeloyl Diglycinate in Cosmetics (Draft for Comments) 2 | High performance liquid chromatography (HPLC) | This method is applicable to the determination of Azelaic Acid and Potassium Azeloyl Diglycinate in cream, emulsion, liquid, gel, powder, clay, and mask cosmetics. | This testing method was developed to provide methods for the screening, quantification and confirmation of Azelaic Acid and Potassium Azeloyl Diglycinate in cosmetics. | |
2 | Reactive Oxygen Species (ROS) Assay for Photoreactivity in Cosmetics (Draft for Comments) 2 | Chemical ingredients for cosmetics | Reactive oxygen species (ROS) assay for photoreactivity | This method is applicable to the evaluation of potential phototoxicity of chemical ingredients used in cosmetics. | In 2016, the In-vitro 3T3 Neutral Red Uptake (NRU) Phototoxicity Test Method for Chemicals Used in Cosmetics was included in STSC 2015 as a supplementary testing method. While this method can accurately identify most photostimulant chemicals, its ability to identify chemical substances in the photoallergen group is limited.
To address this, the Reactive Oxygen Species (ROS) Assay for Photoreactivity in Cosmetics was developed to predict the potential phototoxicity of chemical ingredients, complementing the existing phototoxicity testing method. With the in vitro ROS photoreactivity test method, the phototoxicity integration strategy can be enhanced and the in vitro alternative method system for cosmetics in China can be further improved. |
3 | Determination of Selenium Disulfide in Cosmetics (Draft for Comments) 2 | Selenium Disulfide | Hydride generation atomic fluorescence spectrometry (HG-AFS) | This method is applicable for the determination of selenium disulfide in anti-dandruff shampoo. | Currently, the standard for determining selenium disulfide in cosmetics in China is fluorescence spectrophotometry, as specified in Chapter 4.3.2 of STSC 2015. However, the pretreatment of this method is not effective in extracting selenium disulfide from cosmetics. As a result, when detecting anti-dandruff shampoos with the claim to contain selenium disulfide, the detected amount in some samples is significantly lower than the actual amount added to the product. Additionally, this method involves complex operational steps and is affected by numerous interference factors, which cannot meet the current testing needs of the industry. Thus, there is an urgent need for a more reasonable, efficient, and accurate detection method.
To address this, the Determination of Selenium Disulfide in Cosmetics has been developed, satisfactorily providing a more accurate detection approach and supporting the scientific supervision of cosmetics. |
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