Cosmetic Compliance
Intelligence & Solutions
Guidelines for Safety Assessment of Cosmetic Product
Local Title:
Annex I, part 6 GUIDELINE FOR SAFETY ASSESSMENT OF COSMETIC PRODUCTS
Country/Region:
Malaysia
Competent Authority:
National Pharmaceutical Regulatory Agency
Type:
Regulation
Status:
In force
Release Date:
2022-07-19
Implementation Date:
2022-08-01
Document
Language Source Title Access
EN
Official Annex I, Part 6 Guideline for Safety Assessment of Cosmetic Products
Summary

The purpose of this Guideline is to help the Cosmetic Industry in assessing the safety of the product as well as the Regulators in auditing the data contained in the Product Information File (PIF). This guideline serves to highlight some of the important considerations in the safety assessment of cosmetic product in line with Article 8 d) of the ASEAN Cosmetics Directive 1 which requires an “assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure”.

This safety assessment is to be performed by a qualified professional defined as the “Safety Assessor”.

Main Content

  1. Objective

  2. General Approach

  3. Ingredients

  4. Safety Evaluation of Finished Products

  5. Safety Claims

  6. Responsibility of the Safety Assessor

  7. Raw Material Supplier Responsibilities

  8. Manufacturer Responsibilities

  9. Distributor Responsibilities

  10. Regulator Responsibilities

  11. References

History
2022-07-19
Guidelines for Safety Assessment of Cosmetic Product
In force
Release Date: 2022-07-19
Implementation Date : 2022-08-01
2017-02-01
Invalid
Release Date: 2017-02-01
Implementation Date : 2017-02-01
Noteworthy Information