How to get [CE Mark] for Hand Sanitizer

August 16, 2021

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

  1. Classify the Product whether meet EU Cosmetic Product Definition or not
  2. Prepare Product Information File (PIF)
  3. Arrange Testing of Product 
  4. Conduct Safety Assessment by Professional
  5. Review the Claims & Labelling
  6. Make a Cosmetic Product Notification Portal (CPNP) Notification
  7. Assign EU Responsible Person for the product

4 Steps Guide – how to apply for US Market

  1. Register DUNS Number for Manufacturer
  2. NDC labeler code Register with FDA
  3. Check Label Compliance
  4. Submit Label for Drug List

Remark : Active Drug Ingredients should be in OTC Monograph.
Manufacturing process must comply with cGMP requirements

If you need further information about Cosmetics Regulation or FDA Registration, please leave contact information / call 2366 4622 for enquiry.


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