How to Place a Cosmetic on the US and EU Markets

Both the US and the EU now place the main legal obligations for a cosmetic on one named party — the responsible person — and both expect safety evidence, product registration or notification, adverse event reporting and GMP. The details differ: who the responsible person is, what the safety file contains, how and when events are reported. This sequence builds one compliance file that serves both.

1. 1

   Name the responsible person in each market

   In the US it is the manufacturer, packer or distributor whose name appears on the label. In the EU it must be a legal or natural person established in the EU: the EU manufacturer, the importer for an imported product, or a person designated by written mandate. A distributor that sells under its own name becomes the responsible person.

2. 2

   Build the safety case

   For the EU, have a qualified safety assessor prepare the cosmetic product safety report under Annex I before the product is placed on the market. For the US, keep records that adequately substantiate safety; no specific tests are required and animal testing is not a requirement, but the data must come from scientifically robust methods. One well-built EU safety report usually covers most of the US substantiation.

3. 3

   Manufacture under GMP

   Manufacture to ISO 22716, which gives a presumption of conformity with the EU GMP requirement in Article 8. For the US, MoCRA requires FDA to issue GMP regulations; until they are final, ISO 22716 is the practical reference. Record the manufacturing method and a GMP statement for the product information file.

4. 4

   Register, list and notify

   In the US, make sure each manufacturing or processing facility is registered and renewed every two years, and list each product with its ingredients, updating annually. In the EU, notify the product electronically to the Commission before placing it on the market, then notify the original labelling.

5. 5

   Assemble the product information file

   For the EU, keep the file — product description, safety report, manufacturing method and GMP statement, proof of claimed effects, animal-testing data — at the address on the label and accessible to the competent authority, for ten years after the last batch is placed on the market.

6. 6

   Set up adverse event handling

   Route every complaint through one intake. In the US, report serious adverse events to FDA within 15 business days with a copy of the label, and follow-up information received within a year within a further 15 business days. In the EU, notify serious undesirable effects without delay to the competent authority of the Member State where they occurred.