APPENDIX V
A. SCOPE
Only regulatory requirements imposed by health authorities are considered in this document. The requirements are applicable to Phase 1 of the harmonized scheme only.
B. IMPORT REQUIREMENTS
1. Registration of registrants or companies/persons responsible for placing the product in the market
This will facilitate investigation and follow up by regulatory authorities in the event of product problems. Registration of registrant or company/person responsible for placing the product in the market should be based on the requirements of individual countries.
2. Product Registration
Only countries which wish to register cosmetic products will be involved. The requirements in the approved Technical Document on Product Registration procedures should be followed.
3. Product Labelling
To ensure informed choice by consumers, to facilitate the work of healthcare professionals and to allow effective control by the regulatory authorities, cosmetic products in the market should conform with designated labeling requirements. The requirements in the approved Technical Document on Product Labelling requirements should be followed.
4. Compliance With Allowed, Prohibited and Restricted Ingredient Lists
To ensure that only safe ingredients are used in cosmetic products sold in ASEAN countries, lists of cosmetic ingredients and prohibited substances must be laid down for the cosmetic industries in ASEAN. The requirements in the approved Technical Document on Common Ingredient Listings should be followed.
5. Record Keeping By Registrant or Company/Person Responsible for Placing the Product in the Markets
The registrant or company/person responsible for placing the product in the market must keep records of the primary distribution of their products, for the purpose of product recall according to the respective country’s procedures.
C. IMPORTATION FOR DIRECT RE-EXPORTATION OUT OF ASEAN
Importation for direct re-export of cosmetic products can be exempted from cosmetic product import requirements as they will not impact the safety of local consumers, but the registrant or company / person responsible for placing the product in the market should maintain proper records and documents. These records should be open to inspection by the authorities at any time when required.
“Import for direct re-export” refers to importation by an ASEAN trader of cosmetic products which are subsequently exported out of ASEAN by the same ASEAN trader. The cosmetic products involved do not enter into the ASEAN market.
D. EXPORT REQUIREMENTS
Requirements for the export of cosmetic products will be based on the requirements of individual countries, if any. If the products meant for the export market are also sold locally and hence comply with the relevant regulatory requirements, free sale certificates may be issued by the health authorities upon request. The list of health authorities in ASEAN member countries issuing Certificate of Free Sale can be complied later by ACCSQ CPWG and distributed to all ASEAN member countries.
E. SUMMARY
In summary, cosmetic products will be allowed for importation provided they comply with local registration and licensing requirements, labeling requirements and requirements on restriction of ingredients. The registrant or company / person responsible for placing the product in the market will be required to maintain records of primary distribution for the purpose of product recall. Requirements for the export of cosmetic products will be based on the requirements of individual countries, if any.