REGULATORY AND SAFETY INFORMATION REQUIREMENTS for ALL SUPPLIERS OF FINISHED GOOD FORMULATIONS
The objective of the following guideline is to mitigate Amway’s global regulatory compliance risk for all finished goods and the raw materials contained in their formulations. This guideline provides our suppliers with Amway’s expectations for technical documentation for raw materials and finished goods formulas.
Documentation Required for All Finished Products
ü Manufacturing process described in brief
ü Certificate of Analysis per Access Business Group product specification parameters
ü Chemical, physical and microbiological specifications of the product including test procedures
ü MSDS for finished product
ü Storage Recommendations/Restrictions, if available
ü Product Stability Data and methods, if available
ü Signed Report of the Efficacy Assessment of the product for all claims made on product, if available
ü Adverse Event Reports on the product, if available
Information Required for the Finished Formula
Ø Please provide Base formula or Ingredient listing/Qualitative formula as soon as available so review can begin
Ø Please provide final Quantitative formulas as shading progresses; include on the formula sheet(s):
ü Trade names and supplier names
ü INCI names and CAS numbers (or alternate identification) for all components and subcomponents of each ingredient if they're not 100% pure, including carry-overs, impurities and excipients. Include % of subcomponents
ü Function for each ingredient
ü Origin (animal/synthetic/biotech/plant/mineral) If animal, type of animal, if plant, part of plant and potential pesticide contamination assessment
GMP Documentation
ü A statement by the manufacturer that the product was manufactured according to the GMP Guidelines by any ACC approved equivalent organization, for example ASEAN, CTFA, Colipa or ISO
ü Manufacturers of products classified as drugs in U.S and Canada must meet all U.S. and Canadian Drug GMP requirements. They must be able to supply a current audit report from inspections conducted by a Qualified Regulatory Authority. They must agree to be listed on the Amway Canadian Drug Establishment License and registered with the U.S. FDA.
Product Registration
ü Additional documentation as requested for registration of the product. Necessary documents may require government authentication, for example a Certificate of
Free Sale
REGULATORY AND SAFETY INFORMATION REQUIREMENTS for ALL SUPPLIERS OF FINISHED GOOD FORMULATIONS
Evaluation of the Safety of the Product (if available)
ü Studies documenting good tolerance when product is used
· Human Repeated Insult Patch Test (Skin Allergy)
· Use Test with repeated applications (4 weeks)
· Other Studies, including in vitro eye irritation
ü Safety assessment of the final product including basis of safety for each raw material by INCI used in this product (regulatory citation, calculation of margins of safety, description for basis of contaminants, safety support, etc.) and evaluation of any toxic contaminates including margin of safety calculations
ü Safety statement prepared and signed by person making the product assessment
ü Qualification of the person responsible for the safety evaluation, including full CV with Education and Professional Experience
Documentation Required for All Raw Materials
The driver of the requirements for the following documentation is the European Cosmetic Directive. For any and all raw material in a given product, the supplier will be expected to provide the following:
ü Technical Data Sheet or Specifications of raw materials, including purity and microbiology requirements
ü Material Safety Data Sheet. A European Safety Data Sheet with Risk Phrases is preferred
ü Certification of compliance to EU/ASEAN restriction list criteria, color purity, color batch certification for USA, etc. as requested. Annexed materials should be identified. See detailed listing below.
ü Specify method of analysis of restricted materials, including Annex materials
ü A CAS Number and INCI Name for each ingredient in the raw material
ü
Information Required for Raw Materials where applicable
ü Identify contaminants of toxicological significance and state amounts Level of contaminates must only to be present at technically unavoidable (i.e. lowest achievable) levels to not pose safety concern to the consumer, as specified by EU
ü Particle size information including nanoparticle identification and size distribution
Test graphs or charts preferred with mean and range of particle size. Identification of any percentage below 100nm is required.
ü Support for botanical materials: flow chart, manufacturing process, pesticide statement, analysis of pesticides report
ü Eye area use ingredients and botanicals require eye data, lip area use requires data for ingestion
ü Fragrance should be in compliance with the current IFRA guidelines. Certificate of compliance is required
ü Unusual or uncommon ingredients will require safety support, which typically is a complete toxicological portfolio
ü General statement for products with glitter/shimmer effects: Use of glitter-like effect pigments in eye area products should be limited to specific particle size and shapes that would be expected to pass a safety in use study. Glitter-like materials used in eye area products should be less than 0.006 inches (150 microns) and should not have any sharp or irregular edges. Products with a 0.004 inch Hex shape glitter (100 microns) and with the small square shape have passed eye area testing. We internally size and photograph all glitter-like pigments used in eye area products prior to approval and outside clinical testing