Glossary · Regulatory
The technical file required under Article 11 of the EU Cosmetics Regulation 1223/2009, held by the Responsible Person for ten years after the last batch is placed on the market. It contains the product description, the CPSR, the manufacturing method and GMP statement, proof of claimed effects and animal testing data.
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Missing or out-of-date regulatory work is one of the most common reasons a product is held at the border or withdrawn after launch.
Guires CSL formulation, testing, clinical and regulatory teams work with PIF on client projects every week, from the first brief to the final product file.
EU CPSR guideRelated terms
The EU online portal where every cosmetic must be notified before it is placed on the market, under Article 13 of Regulation 1223/2009..
Read definition →The legal or natural person, established in the EU (or in Great Britain for the UK), who is responsible for making sure each cosmetic complies with the regulation, holds the PIF and notifies the product..
Read definition →The ratio between a toxicological point of departure, such as a NOAEL, and the systemic exposure from using the product.
Read definition →No Observed Adverse Effect Level: the highest dose in a study at which no adverse effect was seen.
Read definition →Regulations and standards are listed first, then peer-reviewed literature. Sources checked October 2026.
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