In Indonesia the so-called negative list approach is employed for chemicals control. Hazardous and toxic chemicals are regulated by making lists of specified hazardous chemicals to be controlled. Indonesia does not have a risk-based chemical control approach to regulated chemicals based on assessment results of their hazards and exposure as is employed in for example EU-REACH. However, the Indonesia government is working to improve the current method of chemical control. Indonesian government published the Chemical Substance Bill that aims to regulate from import/export, production, transportation, usage to disposal in 2012. As of 2018 the Bill has not been promulgated but is still under consideration.
Sep-15-2023
On August 24, 2023, the Indonesian Food and Drug Supervisory Agency (BPOM; Badan Pengawas Obat Dan Makanan Republik Indonesia) published a new amendment on the technical requirements for cosmetics.
The Indonesian government has issued regulations to protect the public from using cosmetic ingredients that do not meet safety, efficacy, and quality requirements. These regulations include Regulation Number 21 of 2020, Regulation Number 22 of 2020, and Regulation Number 24 of 2022. The regulations also require adjustments to ingredients permitted in cosmetics to reflect international technical requirements and scientific and technological advancements.
In August 2023, the government decided to require a Decree from the head of the Food and Drug Supervisory Agency regarding changes in permitted ingredients in cosmetics. The draft was open for comments till 8 September 2023.
Changes made in the updated version of cosmetics technical requirements
Appendix |
Chemical name |
Concentration/ Amendment |
Appendix I List of Ingredients Permitted for Use in Cosmetics with Restrictions and Requirements for Use |
Salicylic acid |
|
Methyl-N-methylanthranilate
|
|
|
Appendix II List of Permitted Coloring Ingredients in Cosmetics Pigment white |
Titanium dioxide |
|
Appendix III List of Preservatives Allowed in Cosmetics
|
Methenamine 3-chloroallylochloride |
|
Salicylic acid and its salts |
|
|
Sodium hydroxymethyl amino Acetate |
|
|
Appendix IV List of Sunscreen Ingredients Permitted for Use in Cosmetics
|
Titanium dioxide |
|
The authority updated Companies with a Cosmetic notification number before the Head of this Agency's Decree came into force, ensuring they adhered to the provisions.
Sep-12-2023
On 2 August 2023, the Indonesian Agency for Drug and Food Control (BPOM) published the revised guidelines on the information required for the cosmetics Product Information Document (DIP). The guidelines were under public consultation for nine months from 31 October 2022 till August 2023.
The Guidelines, which are divided into six chapters, sixteen articles, and an annex, are intended to aid cosmetic firms in creating and collecting DIPs and to offer direction to BPOM representatives during DIP evaluations. The DIP guidelines aim to protect the public from health risks associated with the distribution of cosmetics that do not meet safety, efficacy, and quality standards, particularly for the Agency for Drug and Food Control. The updated version replaces the 2017 Regulation of the Head of the Food and Drug Supervisory Agency Number 14 of 2017 regarding the requirements for cosmetic product information sheets.
A DIP as referred to in Article 3 of the guidelines consists of:
Part I: Administrative documents
Part II: Data on quality and safety of cosmetics ingredients
Part III: Cosmetic Quality Data
Part IV: Data on the safety and benefits of cosmetics
Article 5 calls for a DIP that is updated with changes to safety, usefulness, and quality data and is available in either Indonesian or English. All modifications must be recorded and integrated into the DIP. The DIP must be retained for at least a year after the final cosmetics manufacturing or import, whether it is electronic or non-electronic.
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