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Navigating Amazon’s New Compliance Guidelines for Skin-Lightening and Ophthalmic Products

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Amazon has recently updated its policies for skin-lightening and ophthalmic products, focusing on safety and compliance. Here’s a summary of key changes:

Affected Products

  1. Skin-Lightening Products: Includes bleaching creams, whiteners, skin brighteners, and fading creams, typically marketed to lighten skin tone or reduce spots.
  2. Ophthalmic Products: Includes over-the-counter eye solutions, drops, suspensions, gels, ointments, and creams.

What Testing is Required for Each Product Type?

Skin-lightening products must undergo the following lab tests:

Heavy Metals Testing: Amazon requires testing for mercury, lead, arsenic, and cadmium using AOAC methods 2011.19, 993.14, and 2015.01.

Microbiological Testing: Products must be tested for…

  • Total aerobic mesophilic microorganisms
  • E. coli
  • Pseudomonas aeruginosa
  • Staphylococcus aureus
  • Candida albicans
  • Burkholderia cepacia complex

Adulterant Testing: Amazon requires testing for specific banned chemicals, including…

  • Hydroquinone
  • Betamethasone dipropionate
  • Beclometasone 17-valerate
  • Clobetasol propionate
  • Clotrimazole
  • Halobetasol propionate
  • Fluocinonide
  • Fluocinolone acetonide

Ophthalmic products require:

  • Sterility Testing: Testing to verify that products are free from microbial contamination must be conducted by an ISO 17025-accredited lab.
  • Tamper-Evident Packaging Compliance: Packaging must meet FDA’s tamper-evident packaging standards under 21 CFR 211.132.

You Must Use an Amazon-Approved TIC

In addition, Amazon now mandates that all Testing, Inspection, and Certification (TIC) be performed by Amazon-approved TIC providers, such as Certified Laboratories. Only Amazon-approved TICs can verify your products against Amazon’s policies.

Ensuring Compliance

Certified Laboratories can help by offering testing for heavy metals, microbiological safety, sterility, and adulterants. As an Amazon-approved TIC and ISO 17025-accredited lab, we ensure your products meet all the necessary standards. Partner with Certified Laboratories to navigate Amazon’s compliance requirements and keep your products safely listed on the platform.


Disclaimer:

The above paid-for content was produced by and posted on behalf of the Sponsor. Content provided is generated solely by the Sponsor or its affiliates, and it is the Sponsor’s responsi­bility for the accuracy, completeness and validity of all information included. Global Cosmetic Industry takes steps to ensure that you will not confuse sponsored content with content produced by Global Cosmetic Industry and governed by its editorial policy.

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