Indonesia Implements Regulations for Cosmetics GMP and Adverse Reaction Monitoring

Guideline for Cosmetic Good Manufacturing Practice stipulates quality management system, personnel, building and facilities, equipment, etc. of cosmetics manufacturing. Monitoring cosmetics adverse reactions are activities that include monitoring, recording, data collection, reporting, evaluation, and follow-up of adverse reactions that arise due to the use of cosmetics...

On Sep 6^th, 2019, Indonesia implemented 2 cosmetic regulations, which are Guideline for Cosmetic Good Manufacturing Practice ^[1]and Regulation for Cosmetics Adverse Reaction Monitoring ^[2].

Guideline for Cosmetic Good Manufacturing Practice (CPKB Certificate)

The updated regulation revises the previous one which came into force in 2003 ^[3]. It stipulated the following aspects of cosmetics manufacturing:

1. Quality management system;
2. Personnel;
3. Buildings and facilities;
4. Equipment;
5. Sanitation and hygiene;
6. Production;
7. Quality control;
8. Documentation;
9. Internal audit;
10. Storage;
11. Production and testing contracts;
12. Handling of complaints and product recalls.

GMP certificate is valid for 5 years from the date of issuance.

Transitional measures:

GMP certification applications that have been submitted before Sep 6th, 2019, are still being processed based on the previous regulation
GMP certificates issued before Sep 6th, 2019, are still recognized and used as evidence that they have fulfilled and applied GMP for up to 5 years from the date of issuance

Regulation for Cosmetics Adverse Reaction Monitoring

The updated regulation revises the previous one which came into force in 2011 ^[4]. Monitoring cosmetics adverse reactions are activities that include monitoring, recording, data collection, reporting, evaluation, and follow-up of adverse reactions that arise due to the use of cosmetics.

Definitions of Serious and Non-serious Adverse Reaction

Serious adverse reactions are undesirable effects after normal use of cosmetics that cause death, are life-threatening, require hospitalization, or cause permanent disability.
Non-Serious adverse reactions are undesirable effects after the normal use of cosmetics which do not cause death, are not life-threatening, do not require hospitalization, or do not cause permanent disability.

Obligations of Owners of Notification Number

Owners of Notification Numbers that circulate cosmetics in Indonesia are required to monitor the adverse reactions and report the results to BPOM.

Serious adverse reactions which result in death and can be life threatening shall be reported no later than 7 days after the reaction is first known. Reporting documents shall be completed no later than 8 days after BPOM received the reporting.
Serious adverse reactions which require hospitalization or causes permanent disability shall be reported no later than 15 days after the reaction is first known.
Non-serious adverse reactions shall be reported periodically in January and July. However, if cosmetics contain the following 30 kinds of hair dyes, it is obligatory to report the results periodically in January, April, July and October.

No.	INCI Name
1	2-Methoxymethyl-p-Phenylenediamine 2-Methoxymethyl-p-Phenylenediamine Sulfate
2	Disperse Violet 1
3	Isatin
4	Dihydroxyindole
5	2-Methyl-1-Naphthol
6	Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate
7	HC Blue 16
8	2,3-Diaminodihydropyrazolo-pyrazolone Dimethosulfonate
9	Tetraaminopyrimidine Sulfate
10	Basic Orange 31
11	Basic Red 51
12	Picramic Acid and Sodium Picramate
13	1-Acetoxy-2-Methylnaphthalene
14	HC Red No 1
15	HC Blue No 17
16	5-Amino-6-Chloro-O-Cresol 5-Amino-6-Chloro-O-Cresol HCl
17	Basic Violet 2 (CI 42520)
18	1-Hydroxyethyl-4,5- Diamino Pyrazole Sulfate
19	Acid Black 1 (CI 20470)
20	p-Aminophenol
21	5-Amino-4-Chloro-o-Cresol HCl
22	HC Red No 3
23	Disperse Red 17
24	Acid Red 92 (CI 45410)
25	Disperse Blue 377 is a mixture of 3 dye ingredients: (1) 1,4-bis[(2-hydroxyethyl)amino]anthra-9,10-quinone (2) 1-[(2-hydroxyethyl)amino]-4-[(3-hydroxypropyl)amino]anthra- 9,10-quinone (3) 1,4-bis[(3- hydroxypropyl)amino]anthra-9,10-quinone
26	2,2'-Methylenebis-4-Aminophenol HCl
27	HC Blue No 15
28	2,6-Diaminopyridine
29	4-Formyl-1-Methylquinolinium-p-Toluenesulfonate
30	Acid Violet 43 (CI 60730)

The results of the monitoring of cosmetics adverse reactions shall be included in product information file.