Laboratory Test Request

Amazon.com Germany Hair Skin and Nails VItamins Testing

Project Description

EUROPE LABORATORY
MULTIPLE TESTS
Europe Laboratory needed for Amazon.com Germany certification testing of Hair Skin and Nails VItamins according to the food supplements category;

One of the common forms of documentation Amazon requests from brands is a Certificate of Analysis (or COA). COAs are the standard quality assurance certification in the industry, and they confirm that a product meets the following FDA regulations:

21 CFR 101.36 - Nutritional Labeling of Dietary Supplements
21 CFR 111 - Current Good Manufacturing Practice (cGMP) in manufacturing, packaging, labeling, or holding operations for dietary supplements
21 CFR 117 - Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk Based Preventive Controls (HARPC) for Human Food
Until recently, the COA approval process was pretty straightforward. Then in December 2020, Amazon announced that every vitamin and supplement distributor on the platform would be required to get their products reapproved by February 2021 in order to continue selling.

As part of the reapproval process, brands would still need to submit a COA, but that COA could only come from an ISO/IEC 17025 accredited third-party or in-house laboratory. That caveat eliminated many manufacturers' ability to produce COAs themselves and threw thousands of sellers across the platform for a loop.

Amazon is currently accepting any one of the following certifications from brands for reapproval to sell on the platform:

1. A finished product Certificate of Analysis (COA) issued by an ISO/IEC 17025 accredited lab (in-house or third-party). The valid ISO certificate showing name of accreditation body and accreditation number must also be submitted.

2. A finished product Certificate of Analysis (COA) issued by an in-house laboratory that is compliant with current good manufacturing practices (cGMP) per 21 CFR 111 and 117. A valid GMP certificate of the manufacturing facility must also be submitted. Amazon accepts GMP certificates from the following third-party programs: NSF (NSF/ANSI 173 Section 8), GRMA (GRMA 455-2), UL GMP, USP GMP, Eurofins, SAI Global, SGS, Intertek, TGA, and SSCI.

3. Evidence of Product/ASIN enrollment or participation in one of the following third-party quality certification programs: NSF/ANSI 173 Product Certification, NSF Certified for SportĀ®, BSCG Certified Drug FreeĀ®, Informed-Choice/Informed-Sport Program, USP Dietary Supplement Verification Program, UL Brand Certification Program.

Another thing that Amazon has changed is the timeline requirements for a COA to be approved. It used to be required that COAs were six months old or newer, then it went to nine months, and most recently it's 12 months.
Thank you

Project Information

Number:22-00569

Industry:Dietary Supplements and Nutraceuticals

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