4 minute read
COS-GMP
By Robert Low, Lead Management System Specialist
Section 13 of COS-GMP is the standard’s largest section, and it covers ground ISO 22716 simply does not address — product design and development, labelling, and the legality of marketing claims. This is one of the clearest examples of COS-GMP genuinely expanding beyond its source standard rather than just restructuring it.
This post is part of a series working through COS-GMP section by section. This is the final substantive section before the series summary.
A documented procedure needs to govern product design and development, with every finished product following the controlled process. A design brief needs to record, at minimum, the intended region of sale, applicable legislation, customer input requirements, controls, verification methods, and outputs.
Raw materials need assessing for suitability, legal compliance, and fraud vulnerability — covering compositional legislation, additive regulation limits, compounded ingredient permissibility, market-specific prohibited ingredients (particularly botanicals), active ingredient limits, irradiation status, genetically modified status, and patent compliance. The recipe itself needs detailed formulation records with any modifications justified and traceable. Manufacturing methodology needs documenting with specific instructions on raw material additions, mixing times, temperatures, and required equipment.
Stability testing needs confirming product integrity across its intended shelf life, with results reviewed periodically. Compatibility testing needs confirming no adverse reaction between ingredients and packaging. Preservative efficacy needs verifying through microbiological testing, with critical preservation controls built into the method of manufacture itself.
Release requires compliance with EU Regulation 1223/2009, including a Cosmetic Product Safety Report from a qualified safety assessor, registration with the applicable authority such as the Cosmetic Product Notification Portal, and a final documented approval process before market release.
This sub-section is extensive. Full ingredient disclosure needs using INCI nomenclature, with allergenic substances clearly highlighted. A legally responsible person needs designating, with their contact details stated on the label. A unique batch coding system needs implementing for full traceability. Shelf life needs determining through stability testing, with a Period After Opening symbol included where applicable. Best before dates need clear indication where required. The product’s intended function and safe use instructions need stating clearly. Net measurements need declaring per legal metrology requirements. Necessary safety warnings need including based on product classification. Cruelty-free and organic claims both need certification and documented evidence. Dermatological claims need supporting with clinical testing and maintained reports. Recycling information needs providing for packaging components.
Claims need checking to ensure they are not misleading and comply with ingredient, allergen, and other relevant regulation. Ingredient calculations need to comply with legislation using EU-accepted standardisation methods. Active component calculations need to correctly account for moisture, assay, and concentration levels. The dose of product relative to any intended claim needs supporting by genuine scientific evidence.
The most common gap is treating design and development documentation as a one-time activity completed before launch, rather than maintaining it as a living record that gets updated whenever a formulation, supplier, or claim changes after launch.
The second common gap is claims substantiation — particularly dermatological and cruelty-free claims — where the underlying certification or test evidence exists but is not clearly linked to the specific claim being made on a specific product’s label.
Design and development records connect to document control given the extensive formulation, testing, and approval history this section requires. Raw material assessments connect back to supplier approval, since fraud vulnerability and compositional compliance both depend heavily on supplier-provided data being reliable.
This post is part of the Cornerstone COS-GMP series. See the full series summary with links to all 11 sections.
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