What is harmonised
Ingredient restrictions, permitted UV filters, labelling requirements and product information expectations follow the Directive across all member states. Zinc oxide is permitted as a UV filter under the common annexes, which means a formula acceptable in one member state is generally acceptable in another on technical grounds.
What is not
Notification procedure is handled nationally. Some member states require notification before the product is placed on the market; others operate a post-market system where notification follows. Fees, timelines, language requirements for labelling, and the identity of the local responsible entity all vary.
Indonesia in particular applies additional halal certification requirements for cosmetics, which is a separate track from the ACD notification and can be the longest item on the critical path for that market.
What we provide
The technical file: composition, method of manufacture, safety data, particle specification where the material is nano-scale, and evidence of the manufacturing standards applied. The national notification is filed by the local entity or agent in each country.
National procedures change. Verify current requirements with a local regulatory agent in each target market before planning a launch date.