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What are the regulatory requirements for traceability?
A central pillar of the cosmetic regulatory framework in most countries is compliance with Cosmetics Good Manufacturing Practices (GMP) ISO 22716. For example, in the EU compliance with Regulation (EC) No 1223/2009 requires adherence to GMP and stipulates i). maintenance of complete and accurate documentation (para. 17) and ii). change control (para. 15). Paragraphs 6.4.4 and 188.8.131.52 set out requirements for documenting all batches of raw materials used to manufacture your product, as well as information on each supplier. Complying with ISO 22716 therefore extends responsibility above and beyond the regulatory requirements for maintaining up-to-date product information files (PIFs), resulting in complex and time-consuming administration for companies that have no effective system for managing these tasks.