Regulatory Compliance

Everybody wants ‘globally compliant’ formulas and labeling.  This is not always possible.  With Product Integrity Laboratory’s experience, they can explain the limitations so that the clients understand what they can and cannot do.  We also make every effort to suggest changes to the product or labeling to get around the regulatory problems without compromising the product.

International distribution for cosmetics, fragrances and personal care industry is growing, and we advise that our clients should probably plan for some amount of international distribution.  Depending on the country, different criteria are required, from “notifying” Health Canada to much more involved steps for distribution in the EU. PIL can develop formulas and labeling to make satisfying those requirements easier when the time comes.

Product Integrity Laboratory can contact the FDA with technical and regulatory questions without disclosing the identity of our clients.  This can be of significant help in a problem situation when your company may not want to call attention to itself or to its contract manufacturer.

• Cosmetics
• OTC Drugs
• Label Copy Review

° Regulatory Compliance

° Claim Substantiation

• Ingredient List Preparation
• International product informational packages:

° EU

° Canada

° Other

•  Arrange safety toxicity testing
• Arrange Safety assessments

Memberships in the Society of Cosmetic Chemists (SCC), Independent Cosmetic Manufacturers and Distributors (ICMAD), and American Chemical Society (ACS) help keep us abreast of changes in technical and regulatory matters. From possible changes in legislation to how the FDA regulates cosmetics to controversial issues with California’s Prop 65, Green Chemistry, Safe Cosmetics and others, to Health Canada’s ‘Hot List’ of ingredients, PIL is on top of this to help navigate clients through this often confusing landscape.