International quality standards for skin care products

I. The Latest International Quality Standards

1. IS0 22716:2007 (Cosmetics GMP)
   New guidelines in 2023: Emphasize the digital record traceability system and require the use of blockchain technology to ensure the transparency of the supply chain.
   Key points: Traceability of raw materials, microbial control of the production environment (the cleanliness needs to reach ISO 14644-1 Class 8 level).
2. EU Cosmetic Regulation (Ec 1223/2009)
   Revised in 2023: Added 26 prohibited ingredients (such as some nanomaterials), and it is mandatory to require SPF products to be labeled with both UVA/UVB marks.
   Safety report: It needs to include toxicological prediction data based on AI algorithms.
3. FDA 21 CFR Part 700 Series
   New clauses: Skin care products containing CBD ingredients need to submit clinical trial data, and the THC content must be lower than 0.3%.
4. China’s “Cosmetics Safety Technical Specification” (2021 Edition)
   Update: Added 41 prohibited ingredients (such as methylisothiazolinone), and requires that the efficacy claims need to be verified through human trials or in vitro reconstructed skin models.

1. Organic Certification
   ECOCERT COSMOS: In 2023, it requires that at least 95% of plant ingredients come from organic agriculture, and the use of PEG emulsifiers is prohibited.
   USDA Organic: Requires 100% natural preservatives (such as sodium benzoate is prohibited).
2. Cruelty-Free Certification
   Leaping Bunny: Since 2023, it has required that all links in the supply chain (including third-party raw material suppliers) sign ethical procurement agreements.
3. Halal Certification (Halal)
   New addition: Production equipment needs to pass the alcohol residue detection (limit value < 0.1%), and animal-derived collagen is prohibited.
4. China’s Non-special Record Filing
   It is necessary to submit the “Cosmetics Raw Material Safety Information Registration Form” with all ingredients and connect to the electronic traceability platform of the National Medical Products Administration.

1. Physical and Chemical Index Detection
   pH value: Use a digital pH meter (accuracy ±0.01), and it is necessary to simulate the actual use environment (such as testing the facial cleanser after dilution).
   Heavy metals: Detect arsenic, lead, cadmium, and mercury by ICP-MS method, and the detection limit is as low as 0.01 ppm (EU standard).
   Antiseptic Efficacy Test: According to USP <51>/EP 5.1.3, resistant strains (such as Pseudomonas aeruginosa) are newly added to the challenge strains.
2. Microbial Detection
   Rapid detection technologies:

• Use the PCR method to detect pathogenic bacteria (such as Staphylococcus aureus), and the result can be obtained within 4 hours.
• The ATP bioluminescence method is used for real-time monitoring of the production line, with a sensitivity of 1CFU/g.

3. Stability Test
   Accelerated test: Store at 40℃/75% RH for 3 months, simulating a shelf life of 24 months (ICH Q1A guideline).
   Freeze-thaw cycle: Alternate cycle 3 times between -20℃ and 40℃, and detect phase separation and degradation of active ingredients (such as vitamin C).
4. Safety and Efficacy Evaluation
   Patch test: According to ISO 10993-10, use a 3D epidermal model (such as EpiSkin) to replace animal testing.
   Determination of SPF value: Use the combination method of in vivo and in vitro (such as the COLIPA 2019 standard), and it is necessary to use a reference standard product with an SPF of 50+.

1. AQL Sampling (ANSI/ASQ Z1.4)
   Critical Defects (Critical): Accept 0 and reject 1 (AQL0.01), such as excessive microbial content.
   Minor Defects (Minor): AQL 2.5, such as misaligned labels.
2. Sensory Inspection
   Sensory inspection is the basic method for the quality inspection of skin care products, mainly including the inspection of appearance, color, aroma, and texture. Through sensory inspection, the quality and stability of the product can be preliminarily judged.
3. Packaging Integrity Test
   Use the vacuum decay method to detect the sealing performance of the hose (sensitivity 0.1 cc/min).
   Use a torque tester to ensure that the opening force of the bottle cap meets ergonomic requirements (0.6-2.2 N·m).
4. Functional Verification
   Emulsification system: Use a laser particle size analyzer to detect the particle size distribution (D90≤50um).
   Pump bottle spray volume test: The error rate of 3 consecutive presses is ≤5%.
5. Digital Traceability
   Attach a unique QR code to each batch, associated with production batch records, raw material COA, and transportation temperature and humidity data.

1. Dynamic Compliance Management: Subscribe to the Regulatory Watch service (such as ChemLinked) to track global regulatory updates.
2. Third-party Audit: Conduct surprise GMP inspections through a third-party audit institution every year.
3. Supply Chain Collaboration: Require raw material suppliers to provide REACH SVHC statements and carbon footprint reports.