Cosmetic Market Compliance File (US and EU)
One compliance file for a cosmetic sold in the US and the EU: the responsible person in each market, the EU safety report and US safety substantiation, GMP evidence, US facility registration and product listing, EU notification, the EU product information file, and adverse event reporting under both regimes with their different clocks.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A single file that shows a cosmetic meets the responsible-person obligations of both the US Modernization of Cosmetics Regulation Act of 2022 and the EU Cosmetics Regulation. The two regimes ask for similar things in different forms — safety evidence, GMP, registration or notification, and adverse event reporting — so one file, kept current, avoids two diverging records of the same product.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
Under MoCRA, as described on FDA’s MoCRA page, the responsible person reports serious adverse events within 15 business days, lists products and updates listings annually, and keeps safety substantiation records, while facilities register and renew every two years; FDA has records-access and mandatory-recall authority, and is required to issue GMP regulations. Regulation (EC) No 1223/2009 requires a responsible person (Article 4), GMP with a presumption of conformity from harmonised standards (Article 8), a safety assessment and report (Article 10), a product information file kept for ten years (Article 11), notification (Article 13) and reporting of serious undesirable effects without delay (Article 23). The file structure is SPEQ practitioner synthesis.
WHERE NEXT
- FILL IT INHow to Place a Cosmetic on the US and EU Markets →The procedure this template records, one step at a time.
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