Definition
What is the ISO 22716 standard?
The ISO 22716 standard defines the Good Manufacturing Practices (GMP) for cosmetic products. Published in 2007, it is the global benchmark for cosmetic GMP and is referenced by the EU Cosmetics Regulation (1223/2009) and increasingly by FDA cosmetic guidance under MoCRA (Modernization of Cosmetics Regulation Act).
The standard covers personnel, premises, equipment, raw materials and packaging, production, finished products, quality control laboratory, treatment of out-of-specification products, waste, subcontracting, deviations, complaints, recalls, change control, internal audits, and documentation.
ISO 22716 is the de facto GMP standard for cosmetic manufacturing worldwide. In the EU, it is the recognised GMP standard under Article 8 of Regulation 1223/2009. In the US, under MoCRA, FDA is developing GMP regulations expected to align closely with ISO 22716.
Who is ISO 22716 for?
The standard targets cosmetic product manufacturers: skincare, haircare, makeup, fragrance, oral care, and personal care product manufacturers. It also applies to contract manufacturers and packaging operations for cosmetics.
Why get certified?
ISO 22716 certification is required for marketing cosmetics in the EU (under Regulation 1223/2009), positions the manufacturer for FDA MoCRA compliance in the US, conditions access to international cosmetic retailers, and structures cosmetic quality and consumer safety.
Avg. timeline
6 to 12 months
