Global Cosmetic Compliance
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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

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

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