Indonesia released 6 drafts of new cosmetic regulations at the end of 2018 and implemented one of them in July 2019. The newly implemented regulation details contamination restriction requirements.
In December, 2018, Indonesia released 6 drafts of cosmetic regulations including : Limitations for Contamination in Cosmetics , Technical Requirements for Cosmetics Ingredients , Regulation for Supervision on Manufacture and Circulation of Cosmetics , Regulation for Cosmetics Side Effect Monitoring , Technical Requirements of Cosmetics , Criteria and Procedures for Filing and Notification of Cosmetics . Then on July 4, 2019, Limitations for Contamination in Cosmetics took effect. The main contents of these regulations are as follows.
1. Limitations for Contamination in Cosmetics
Indonesian Regulation on Requirements for Microorganisms, Impurity and Heavy Metals in Cosmetics came into effect on July 20, 2011, and were firstly revised in 2014. The second revised draft was issued on December 5, 2018, and became effective on July 4, 2019. Cosmetics that have completed notification and comply with the previous regulations shall be adjusted to comply with the current regulations by July 4, 2020.
The regulation clarifies the definition and scope of cosmetics contamination, including microbial, heavy metal and chemical contamination, restriction requirements for cosmetics contamination, administrative sanctions for violating enterprises, etc.
a) Limitation Standards on Microbial Contamination
|1. Cosmetics for children under 3 years old|
2. Cosmetics used around the eyes
3. Cosmetics used in the area contacting with mucous membranes
|Cosmetics except for:|
1. cosmetics for children under 3 years old
2. used around the eyes
3. used in the area contacting with mucous membranes
|Total plate count||≤ 5x102 colony/g or colony/mL||≤ 103 colony/g or colony/mL|
|Mold and Yeast||≤ 5x102 colony/g or colony/mL||≤ 103 colony/g or colony/mL|
|Pseudomonas aeruginosa||Negative per 0.1 g or 0.1 mL sample (test sample)||Negative per 0.1 g or 0.1 mL sample (test sample)|
|Staphylococcus aureus||Negative per 0.1g or 0.1 mL sample (test sample)||Negative per 0.1 g or 0.1 mL sample (test sample)|
|Candida albicans||Negative per 0.1 g or 0.1 mL sample (test sample)||Negative per 0.1 g or 0.1 mL sample (test sample)|
b) Limitation Standards on Heavy Metal Contamination
|Mercury (Hg)||≤ 1mg/kg or 1mg/L (1ppm)|
|Lead (Pb)||≤ 20 mg/kg or 20 mg/L|
|Arsenic (As)||≤ 5 mg/kg or 5 mg/L (5 ppm)|
|Cadmium (Cd)||≤ 5 mg/kg or 5 mg/L (5 ppm)|
c) Limitation Standards on Chemical Contamination
|1,4-Dioxane (*)||≤ 25 mg/kg or 25 mg/L|
Note: (*) refer to cosmetics containing ingredients made through ethoxylation processes such as Sodium Laureth Sulphate or Polyethylene Glycol.
2. Technical Requirements for Cosmetics Ingredients
This regulation is designed to prevent consumers from using unsafe or unqualified cosmetics, and therefore specifies the technical requirements for the ingredients used in cosmetics. The regulation clarifies the definition of cosmetic ingredients, restrictions and usage conditions of ingredients, permitted preservatives and sunscreens, prohibited and restricted ingredients, etc.
3. Regulation for Supervision on Manufacture and Circulation of Cosmetics
The regulation clarifies the definition of cosmetics manufacture, distribution, circulation, intermediate products, bulk products, storage places, distributors, agents, etc., the requirements for cosmetics in circulation, the qualifications of importers, etc.
4. Regulation for Cosmetics Side Effect Monitoring
The regulation clarifies the side effects monitoring mechanism for cosmetics in Indonesia, the scope of serious adverse reactions, the reporting methods, form templates for adverse reactions reporting, etc.
5. Technical Requirements of Cosmetics
The regulation clarifies the pre-market requirements for the manufacture, import or distribution of cosmetics, labeling, packaging, and claims requirements, etc.
6. Criteria and Procedures for Filing and Notification of Cosmetics
The regulation clarifies the qualifications for notification applicants, notification procedures, templates for applying for notification, cosmetic categories, etc.
Please contact at firstname.lastname@example.org if translations are needed. And ChemLinked will hold a free webinar about Indonesian Cosmetics Regulatory Compliance and Import Requirments on August, 21. Feel free to register if you are interested.
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