A cosmetic Product Information Document (PID) is data related to the quality, safety, and benefits of cosmetics that serves as a guide for the cosmetic industry, cosmetic importers, and individual/business entities that will conduct notifications. The Product Information Document (PID) guideline is also a guide for the Indonesian FDA (BPOM) in conducting inspections/audits.
This PID is mandatory and must exist for every cosmetic preparation. If you do not have a PID, the cosmetic industry or the cosmetic marketing authorization holder will be sanctioned by BPOM, and the marketing authorization can be revoked. Because of the importance of this PID, every marketing authorization holder must be able to compile a PID. You can download an example of a PID template below to make it easier to compile. The template example has been adjusted to the latest rules of BPOM (Indonesian FDA), Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2023 (Regulation Number 17 of 2023).
Cosmetics are products that are used to care for and beautify the skin, hair, nails, lips, and other body parts. Cosmetics can also function to change the appearance, eliminate body odor, or protect the skin from sunlight. However, not all cosmetics are safe and of good quality to use. Therefore, there are regulations that govern the requirements and supervision of cosmetics in Indonesia.
One of the regulations related to cosmetics is the Regulation of the Head of the Food and Drug Supervisory Agency Number 17 of 2023 concerning Cosmetic Product Information Documents issued in August 2023. This regulation replaces the old regulation, namely the Regulation of the Head of the Food and Drug Supervisory Agency Number 12 of 2019.
This regulation regulates the data that must be prepared by cosmetic business actors before notifying cosmetic products to the Food and Drug Supervisory Agency (BPOM). Notification is a notice to BPOM that the cosmetic product has met the requirements of safety, usefulness, quality, labeling, and claims.
Obligations of the Marketing Authorization Holder
PID must exist and be prepared by the cosmetic marketing authorization holder, because it is mandatory in the regulation, and it is audited. Even though it is not a mandatory requirement for registration. So the marketing authorization holder can register new products in parallel and compile PID.
Here is the translation to English, with some grammar corrections:
“What are the Parts of the Product Information Document?
The Product Information Document consists of four parts, namely:
Part I: Administrative Document
Part II: Quality and Safety Data of Cosmetic Ingredients
Part III: Cosmetic Quality Data
Part IV: Cosmetic Safety and Benefit Data
Part I: Administrative Document
This section contains administrative data related to the identity of the cosmetic business actors, cosmetic products, and safety assessors. The administrative data that must be attached are examples like this:
- Notification application letter
- Absolute responsibility statement letter
- Statement of compliance with safety, benefit, quality, labeling, and claim requirements
- Statement of compliance with fragrance ingredient requirements
- Statement of compliance with sunscreen ingredient requirements
- Statement of compliance with preservative ingredient requirements
- Statement of compliance with coloring ingredient requirements
- Statement of compliance with Indonesian natural ingredient requirements
- Appointment letter of safety assessor
- Safety assessor competency certificate
- Agency appointment letter (for imported products)
- GMP certificate (for imported products)
Here is the translation to English, with some grammar corrections:
“Part II: Quality and Safety Data of Cosmetic Ingredients
This section contains data related to the quality and safety of cosmetic ingredients used in the product formulation. The data that must be presented include:
List of cosmetic ingredient compositions along with the concentration of each ingredient
Specifications of each cosmetic ingredient along with the analysis method
Name and code number of the fragrance for the fragrance ingredient along with the supplier’s address
Statement of compliance with IFRA (International Fragrance Association) guidelines for fragrance ingredients (for BPOM regulation no 23 of 2023 it is not mandatory, but if it is equipped with IFRA it is allowed)
Safety data of each cosmetic ingredient based on supplier data, published scientific data, or empirical data specifically for Indonesian natural ingredients
Statement of compliance with the list of ingredients that are permitted to be used in cosmetics with restrictions and usage requirements
Part III: Cosmetic Quality Data
This section contains data related to the quality of cosmetic products resulting from the production process. The data that must be presented include:
- Cosmetic product specifications along with the analysis method
- Cosmetic product production method
- Cosmetic product stability data
- Cosmetic product compatibility data with packaging
- Cosmetic product analysis method validation data
Here is the translation to English, with some grammar corrections:
Part IV: Cosmetic Safety and Benefit Data
This section contains data related to the safety and benefits of cosmetic products for users. The data that must be presented include:
Cosmetic product safety assessment report made by the safety assessor
Clinical trial data of cosmetic products (if any)
Cosmetic product effectiveness data (if any)
Cosmetic product label
Cosmetic product claims along with supporting evidence
That is a brief explanation of the Cosmetic Product Information Document. Hopefully it will be useful for those of you who want to know more about the requirements and supervision of cosmetics in Indonesia.
Cosmetic Safety Assessment
This is often asked, whether the cosmetic safety assessor must have experience and certification? the answer is yes
Is there a certified safety assessor training in Indonesia? Yes, there is, I know there is 1 in Indonesia
If the cosmetic product is made by a foreign factory, we are only as agents, then who makes the safety assessment or PID? the one responsible for the PID is the marketing authorization holder (agent in Indonesia, can be made by the factory or the agent itself). Meanwhile, the cosmetic safety assessment is attached to the product, so the one who makes the safety assessment should be from the foreign factory.
Here is the translation to English, with some grammar corrections:
“Download an Example of a Product Information Document
I learned to make this PID is difficult, I have to read the BPOM Regulation no 17 of 2023 repeatedly. The format of each requested section is also not generally available on the internet, so I have to make it myself based on experience.
“You can download and own this PIF template for 100 US dollar paid via paypal.”
Here is the translation to English, with some grammar corrections:
You can contact me via whatsapp/phone at +6285643416332 or email [email protected].
