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FAQ Vol. 25 | Regulatory Insights from Indonesia’s BPOM on Cosmetic Ingredient Use

In this issue, ChemLinked summarizes the official responses published by Indonesia’s Food and Drug Supervisory Agency (BPOM) to questions raised by cosmetic companies. The focus is on cosmetic ingredients, including regulatory requirements for ingredient use and labeling.
1. Can food-grade ingredients be used in cosmetic products?

Yes, food-grade ingredients can be used in cosmetics as long as they comply with BPOM No. 17 of 2022 concerning Amendments to Regulation No. 23 of 2019 concerning Technical Requirements for Cosmetic Ingredients and BPOM Regulation No. 31 of 2020 concerning Amendments to Regulation No. 25 of 2019 concerning Guidelines for Cosmetic Good Manufacturing Practice. The ingredients must meet the technical and safety criteria specified in these regulations.

2. Can stem cells derived from human umbilical cords be used as cosmetic ingredients?

No. According to Attachment V (No. 1187) of BPOM Regulation concerning Technical Requirements for Cosmetic Ingredients, cells, tissues, or products derived from humans are prohibited for use in cosmetics.

3. Are cosmetic ingredients in the form of perfume used in soap required to have an International Fragrance Association (IFRA) certificate when applying for an SKI (Import Certificate)?

Yes. In accordance with Article 16(b) of BPOM Regulation concerning the Supervision on the Entry of Drug and Food Ingredients, perfume-type cosmetic ingredients must be accompanied by an IFRA certificate when applying for an SKI through the e-BPOM system.

4. Is methanol allowed in cosmetic products?

Methanol is listed as a restricted ingredient in Appendix V of BPOM Regulation concerning Technical Requirements for Cosmetic Ingredients. It is only permitted as a denaturant for ethanol and isopropyl alcohol, with a maximum concentration of 5%, calculated based on the content of ethanol and isopropyl alcohol.

5. How should the composition be listed on cosmetic labels?

According to BPOM Regulation concerning Technical Requirements for Cosmetic Ingredients, ingredients must be listed in descending order of concentration, except for ingredients with concentrations below 1%, which may be listed out of order.

6. Is it mandatory for imported cosmetics to declare the exact quantitative formula, or can ingredient ranges be used?

As per BPOM Regulation concerning Guidelines for Product Information File, the quantitative formula must include the name and exact concentration (%) of each ingredient, totaling 100%. Ingredient names must be written in INCI format or follow internationally accepted nomenclature.

7. Can the formula of a notified cosmetic product be changed?

No. A formula change requires re-notification. Modifications cannot be made under the existing notification.

8. Is hydroquinone allowed in whitening cosmetic products?

No. Hydroquinone is not permitted in cosmetic products intended for skin whitening. According to BPOM Regulation concerning Technical Requirements for Cosmetic Ingredients, hydroquinone and its derivatives are only allowed in artificial nail preparations at a concentration not exceeding 0.02%, and only for professional use while avoiding skin contact.

9. Is retinoic acid permitted in cosmetic products

No. Retinoic acid is classified as a drug and must be prescribed by a doctor for skin care. It is not permitted in cosmetic products, including facial whiteners.

10. Does BPOM test dermatologist-formulated creams for mercury or hydroquinone?

No. BPOM does not test doctor-prescribed creams. However, mercury is strictly prohibited in skincare cosmetics and must not be present in any cosmetic formulation.

11. Can cosmetics contain ingredients derived from pigs? What are the requirements?

Cosmetics are not explicitly prohibited from containing pig-derived ingredients. However, in line with Indonesia’s Halal Product Assurance Law (Law No. 33 of 2014), cosmetics distributed in Indonesia are required to be halal-certified as of the enforcement date. If pig-derived ingredients are used, they must be clearly disclosed on the label, as per the Consumer Protection Law, which requires accurate and honest disclosure of product content and origin.

12. What are the regulations regarding the use of Triclosan in cosmetics?

As outlined in BPOM Regulation concerning Technical Requirements for Cosmetic Ingredients, Triclosan may serve as both a restricted ingredient and a preservative, and is only allowed in specific cosmetic products with strict concentration limits:

1) Maximum concentration of 0.3%, permitted for the following product types:

Toothpaste, hand soaps, body soaps/shower gels, deodorant (non-spray), face powder and blemish concealers, nail preparations (for cleaning nails prior to artificial nail application), shampoo, hair conditioner, and facial cleansers.

2) Maximum concentration of 0.2% is allowed only for mouthwash formulations.

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