Hand Sanitizer / Hand Gel can be exported to EU market according to Cosmetics Regulation (EC) No 1223/2009 or Biocides Product Regulation (EU) 528/2012. The ingredient of Hand Sanitiser probably is ethanol or ethyl alcohol which is still under review by European Chemicals Agency (ECHA) under Biocides Product Regulation (EU) 528/2012.
So we observed the Hand Gel /Hand Sanitizer Manufacturer / Trader preferred to follow Cosmetics Regulation (EC) No 1223/2009 In the market,
What is Cosmetics Regulation (EC) No 1223/2009
The regulation requires manufacturers of cosmetics to prepare a product safety report prior to placing a product on the market and notify their products via the EU Cosmetic Products Notification Portal (CPNP). Manufacturers which plan to place finished cosmetics on EU market must appoint a legal or natural person within the EU to undertake compliance obligations.
7 Steps Guide - how to apply for EU Market
- Classify the Product whether meet EU Cosmetic Product Definition or not
- Prepare Product Information File (PIF)
- Arrange Testing of Product
- Conduct Safety Assessment by Professional
- Review the Claims & Labelling
- Make a Cosmetic Product Notification Portal (CPNP) Notification
- Assign EU Responsible Person for the product
4 Steps Guide - how to apply for US Market
- Register DUNS Number for Manufacturer
- NDC labeler code Register with FDA
- Check Label Compliance
- Submit Label for Drug List
Remark : Active Drug Ingredients should be in OTC Monograph.
Manufacturing process must comply with cGMP requirements