Contamination of toxins in cosmetics is a significant public health concern. Harmful substances can inadvertently or deliberately enter cosmetics during manufacturing, packaging, or storage, potentially causing adverse health effects. Regulatory authorities in Indonesia have taken significant step in defining the contamination limits in the cosmetics. This blog provides an understanding on the recent regulation passed on the contamination limits allowed in the cosmetics.
The Indonesian Food and Drug Authority, BPOM, regulates the safety and quality of cosmetics, including setting limits for contaminants to ensure that products are safe for human use.
Types of Contaminants identified by BPOM (NADFC)
Types of Contaminants are described in the Article 3 paragraph (1) of Presidential Regulation Number 80 of 2017
Microbiological Contaminants: Limits on the presence of bacteria, fungi, and other microorganisms in cosmetic products. This ensures that products do not cause infections or skin irritations.
Heavy Metals: Setting thresholds for heavy metals such as lead, mercury, arsenic, and cadmium, which are toxic and harmful to human health when present in excessive amounts.
Chemical Contaminants: Regulations on the presence of residual solvents, pesticides, or other chemical contaminants that may be introduced during manufacturing or packaging processes.
BPOM (NADFC) Regulation on Contamination Limits in Cosmetics
BPOM Regulation No. 16 of 2024 was passed on 6th September 2024 to address the limits of contamination in cosmetics. This regulation outlines permissible levels of contaminants in cosmetic products to ensure consumer safety. Contaminants in cosmetics can include harmful substances such as heavy metals, microbial pathogens, or chemical residues, which may pose risks to human health if they exceed certain thresholds.
The general requirements for contamination limits in cosmetics as per BPOM typically align with international standards like those from the WHO, ASEAN, and the European Union.
Highlights of BPOM (NADFC) Regulation on Contamination Limits in Cosmetics
Here are the general categories of contaminants and their typical limits according to BPOM:
Heavy Metals : BPOM has set maximum permissible limits for heavy metals to avoid toxicity from cosmetics:
Lead (Pb): ≤ 20 ppm
Mercury (Hg): ≤ 1 ppm (for products without intentional mercury use, as mercury is banned in cosmetics except for certain traditional medicinal uses)
Arsenic (As): ≤ 5 ppm
Cadmium (Cd): ≤ 5 ppm
These limits apply to trace amounts of metals that could enter cosmetics during production, often from impurities in raw materials.
Microbial Contaminants: BPOM sets specific guidelines to control microbial contamination, particularly for products prone to contamination (e.g., eye makeup, creams):
Total Plate Count: should not exceed 500 CFU/g or CFU/ml for products for children under the age 3, and 1,000 CFU/g or CFU/ml for products for other cosmetic products.
Pathogenic bacteria: Microbes such as Staphylococcus aureus, Pseudomonas aeruginosa, and Candida Albicans should be negative per 0.1g or 0.1ml of the sample.
Yeasts and molds: should not exceed 500 CFU/g or CFU/ml for products for children under the age 3, and 1,000 CFU/g or CFU/ml for products for other cosmetic products.
Preservatives and Chemical Contaminants: BPOM requires that cosmetics do not contain harmful chemicals beyond regulated limits, including:
1,4 Dioxane: should not exceed 10mg/kg or 10mg/l.
Acrylamide: should not exceed 0.1 mg/kg for non-rinse body care preparations and 0.5 mg/kg for other preparations.
Diethylene glycol: should not exceed 0.1%.
Transition Timelines for BPOM Regulation No. 16 of 2024
Article 9 and Article 10 of the Chapter IV of the agency regulations states,
BPOM Regulation Number 12 of 2019 concerning Contamination in Cosmetics (State Gazette of the Republic of Indonesia 2019 Number 738) is withdrawn and declared null and void.
The BPOM Regulation No. 16 of 2024 shall come into force after 12 months from the date of promulgation i.e., 3rd Sept 2024.
In conclusion, BPOM’s regulations on cosmetics contamination, particularly under Regulation Number 16 of 2024, play a critical role in ensuring the safety and quality of cosmetic products in Indonesia. By setting clear limits on contaminants such as heavy metals, microbes, and chemical preservatives, BPOM helps prevent exposure to harmful substances that could pose risks to consumer health.
The mandatory testing requirements—ranging from microbial testing to heavy metal analysis—ensure that manufacturers maintain strict quality controls throughout production and during a product's shelf life. Manufacturers must adhere to Good Manufacturing Practices (GMP), follow established testing protocols, and document their compliance with contamination limits. This regulatory framework aligns with international safety standards, enhancing consumer trust and promoting the availability of safe cosmetics on the market.
BPOM’s proactive approach to monitoring contamination in cosmetics is essential for safeguarding public health and supporting a robust cosmetics industry in Indonesia.
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