UK Cosmetics Responsible Person and Notification Readiness

Article 4(1) says a cosmetic may not be placed on the market unless a responsible person established in the United Kingdom exists for it. A UK manufacturer of products made in the UK is that person.

Article 10(1) requires the responsible person to ensure, before placing on the market, that the product has had a safety assessment and that a cosmetic product safety report under Annex I exists. The assessment takes account of intended use and systemic exposure to individual ingredients, uses a weight-of-evidence approach and is kept up to date with new information after launch.

Article 11 requires a product information file once the product is placed on the market, kept for 10 years following the date on which the last batch was placed on the market. It contains a product description, the safety report, a description of the manufacturing method and a statement of compliance with good manufacturing practice, proof of claimed effects where justified, and data on any animal testing.

Article 13(1) requires the responsible person to submit electronically, before placing on the market: the product category and name, the responsible person's name, the address where the file is kept, an urgent contact person, details of nanomaterials where present, any CMR 1A or 1B substances by name and CAS or EC number, and the frame formulation. Article 13(2) requires the original labelling and, where reasonably legible, a photograph of the packaging.

Article 19 lists label particulars, including the responsible person's name and address, nominal content, date of minimum durability or period after opening, precautions, batch number, function and ingredients. A transitional point treats an EU-format address as meeting point (a) for seven years after IP completion day.