PRESS RELEASE
Number HM.01.1.2.10.24.79 Date October 25, 2024
BPOM Sets Changes to Contamination Limits in Cosmetics
Jakarta – Tuesday (3/9/2024), BPOM set BPOM Regulation (PerBPOM) Number 16 of 2024 concerning Contamination Limits in Cosmetics. This regulation replaces PerBPOM Number 12 of 2019 concerning Contamination in Cosmetics. The regulation regarding contamination limits in cosmetics in the previous regulation is no longer in accordance with legal requirements and developments in science and technology in the cosmetics sector, so it needs to be replaced.
This regulatory update is in accordance with the agreement in ASEAN, namely that the level of 1,4-dioxane contamination is reduced from 25 parts per million (ppm) to 10 ppm. on contamination in cosmetics is clearly stated in the attachment to this PerBPOM which can be accessed via www.jdih.pom.go.id.
The reduction in contamination levels has taken into account various studies and discussions up to the Southeast Asian level that were carried out in order to provide protection to consumers. The chemical 1,4-dioxane is carcinogenic. This material is a chemical contaminant in cosmetics that cannot be avoided but can be limited and its levels monitored.
Before being enacted, this PerBPOM had gone through a public consultation on November 10, 2023. Then a harmonization discussion was carried out on July 25, 2024 by the Ministry of Law and Human Rights and was declared to have been completed, and met the requirements to be submitted for Presidential approval through the Cabinet Secretariat. On September 17, 2024, this PerBPOM received approval from the President.
Thus, this PerBPOM has officially come into effect and the cosmetics industry is required to comply with policies regarding requirements for microbial contamination limits, heavy metal contamination, and/or chemical contamination. The commitment of business actors in fulfilling this new regulation aims to ensure that cosmetic products before and during circulation have met safety and quality requirements.
Contamination is something that enters Cosmetics unintentionally and cannot be avoided, originating from the processing, storage, and/or carried over from raw materials. The presence of microbial, heavy metal, and chemical contamination can be harmful to human health. Therefore, testing must be carried out in an accredited laboratory or an internal laboratory owned by the cosmetic industry certified by Good Cosmetic Manufacturing Practices (CPKB). Testing must use a validated or verified analysis method.
Business actors are also required to document the test results in cosmetic product information documents. For business actors who violate, they will be subject to administrative sanctions in the form of written warnings, a temporary ban on distributing cosmetics for a maximum of 1 year, withdrawal of cosmetics from circulation, destruction of products, temporary cessation of production activities, and/or import of cosmetics for a maximum of 1 year, revocation of notification numbers, and temporary closure of online access to submit notification applications for a maximum of 1 year. BPOM is committed to continuing to ensure the safety, efficacy/benefits, and quality of cosmetic products in Indonesia. Regulatory innovation continues to be carried out in accordance with developments in science and technology. For this reason, BPOM invites all business actors to collaborate in complying with this regulation in order to protect the public from cosmetics that do not meet safety and quality requirements that pose a risk to health and increase the competitiveness of cosmetic products.
Source:
BPOM Press Release. (2024, October 25). BPOM Sets Changes to Contamination Limits in Cosmetics.
https:// www.pom.go.id siaran pers bpom tetapkan perubahan batas cemaran dalam kosmetik