A Collection of Indonesian Cosmetic Regulatory Updates in October and November

Terms:

SKI (Surat Keterangan Impor) Post Border: An approval letter for importing quasi-drugs, cosmetics, health supplements, and processed food into the territory of Indonesia.
NIB (Nomor Induk Berusaha): Business identification number, issued by the Online Single Submission Agency after the business actor registered.
BPOM: Competent authority for drugs (including cosmetics) and food in Indonesia.
Notification Approval: A form of approval for drugs (including cosmetics) and food notification issued in Indonesian territory by the Head of BPOM.

From October to November 2021, Indonesia issued a notice and three draft regulations. ChemLinked summarized the main amendments related to cosmetics as follows.

Release Date	Regulation/Notice	Status
Oct. 29, 2021	Notice on Allowing Cosmetics Packaged by Different Companies to Apply for One Notification Number ¹	Effective on Oct. 29, 2021
Oct. 22, 2021	Amendment to Application of 2D Barcode in the Control of Drugs and Food ²	Draft
Nov. 12, 2021	Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia ³	Draft
Nov. 12, 2021	Regulation for Supervision on the Entry of Drugs and Food Ingredients into the Territory of Indonesia ⁴	Draft

1. Cosmetics Packaged by Different Companies are Allowed to Apply for One Notification Number

In view of the impact of COVID-19 and for the convenience of companies, Indonesia issued a notice on Oct. 29, 2021, allowing the same cosmetics packaged by different packaging companies in Indonesia (a maximum of three) to apply for one notification number. The packaging scope is limited to primary and secondary packaging.

The notification applicant shall meet the following requirements:

1) Have a GMP certificate;

2) Have packaging cooperation contracts with each packaging company. The contract should be legalized by a notary and contains at least:

Names of contracting parties;
Cosmetic’s product name;
The validity period of the cooperation contract.

The notification applicant shall also ensure:

The technical requirements of cosmetics packaged by different packaging companies are consistent with self-produced cosmetics;
The packaging companies have implemented GMP;
The labeling is in accordance with Technical Requirements for Cosmetic Labeling.

2. Labeling Requirements for 2D Barcode to be Amended

On Dec. 7, 2018, Indonesia implemented Application of 2D Barcode in the Control of Drugs and Food, stipulating that 2D barcode shall be labeled on cosmetics packaging. On Oct. 22, 2021, Indonesia released a draft amendment to Application of 2D Barcode in the Control of Drugs and Food for public consultation. The main amendments related to cosmetics are marked in red below:

1. For cosmetics, 2D barcode can be printed or affixed to the packaging as a sticker with an ink color different from the base color.

Whether 2D barcode is printed or affixed, it is necessary to ensure that it will not easily come off or separate from the packaging and will not be easily faded or damaged.

2. Business actors are required to include 2D barcode on the packaging in a rectangular shape with a size of at least 0.6 x 0.6 cm.

3. Business actors are required to include the words “BPOM RI” on 2D barcode issued by BPOM on cosmetic packaging.

3. Application Documents of SKI Post Border to be Amended

On Nov. 12, 2021, Indonesia BPOM released the draft of Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia and draft of Regulation for Supervision on the Entry of Drugs and Food Ingredients into the Territory of Indonesia for public consultation.

The two drafts stipulate the entry requirements for imported drugs, food, and ingredients (including cosmetics). Imported cosmetic products and ingredients are required to obtain SKI Post Border prior to entering Indonesia. Drugs, food, and ingredients that are not stated in SKI Post Border are prohibited from importing into Indonesia.

The main amendments related to cosmetics in the drafts are as follows:

1) Modify the requirement for the remaining shelf life of imported cosmetic products, from the current one-third to two-thirds of the shelf life. Cosmetics imported into Indonesia must at least have two-thirds of the original shelf life;

2) Modify the application documents of SKI Post Border. Newly required documents include the original identity card of the person in charge, and photos of the front and back view of the company's warehouse and office;

Types

Documents for Obtaining Applicant’s Username and Password

Documents for Obtaining SKI Post Border

Cosmetic Products

Original signed and stamped application letter
Original stamped statement of the person in charge
Original NIB
Original import power of attorney
HS code list of commodities to be imported
Warehouse address where the products are stored
Original Identity Card of the person in charge
Photos of the front and back view of the company's warehouse and office

Notification approval
Certificate of Analysis (COA) including product names, testing parameters, testing results, testing methods, batch number/production code, production date, expiration date, and manufacturer’s name and address
Invoice
Sampling/Laboratory testing (if necessary)
Other supporting documents required by the competent authority

Notes:

The product name, packaging, and packing size listed on the invoice must correspond to those listed on the notification approval.

Cosmetic Ingredients

Original signed and stamped application letter
Original stamped statement of the person in charge
Original NIB
Original import power of attorney
HS code list of commodities to be imported
Warehouse address where the ingredients are stored
Original Identity Card of the person in charge
Photos of the front and back view of the company's warehouse and office

Certificate of Analysis (COA) including ingredient names, testing parameters, testing results, testing methods, batch number/production code, production date, and expiration date, manufacturer’s name and address
Safety data sheets and/or ingredient specification
Statement of use purpose and distribution purpose
Invoice
Sampling/Laboratory testing (if necessary)
Other supporting documents required by the competent authority

Fragrance must also attach:

A statement letter issued by the ingredient manufacturer claiming the fragrance is made in accordance with International Fragrance Association (IFRA) guidelines
Report on the distribution of previously imported fragrance

3) Delete the lists of drugs, food, and ingredients restricted from entering Indonesia. Drugs, food, and ingredients (including cosmetics) restricted from entering Indonesia will be determined separately by the head of BPOM.