A Collection of Indonesian Cosmetic Regulatory Updates in July and August

Terms:

SKI (Surat Keterangan Impor) Post Border: An approval letter for the importation of quasi-drugs, cosmetics, health supplements, and processed food into the territory of Indonesia.

NIB (Nomor Induk Berusaha): Business identification number, a business actor's identity issued by the Online Singe Submission Agency after the business actor has registered.

Notification Approval: A form of approval for drug and food (including cosmetics) notification issued by the Head of the Agency for distribution in Indonesian territory.

On July 13, 2020, Indonesia implemented the amendments to Regulation for Supervision on the Entry of Drug and Food into the Territory of Indonesiaand Regulation for Supervision on the Entry of Drug and Food Ingredients into the Territory of Indonesia ^[1].

Following that, Indonesia released two drafts of amended cosmetic regulations, which are List of Forms and Types of Cosmetics Allowed for Production by Manufacturers with Class B Production Licenses and Regulation for Electronic Business Licensing Services Integration in Drug and Food Sector (Substances Related to Cosmetics) ^[2]. The main contents of these regulations are as follows.

1. Amendments to Regulation for Supervision on the Entry of Drug and Food into the Territory of Indonesia and Regulation for Supervision on the Entry of Drug and Food Ingredients into the Territory of Indonesia

SKI Post Border applicants’ obligations are specified.

1) Business actors importing cosmetic products and ingredients to Indonesia must have SKI Post Border no later than seven days from the issuance date of the approval for releasing the goods.

2) SKI Post Border applicant must submit a cosmetic ingredient distribution report every three months to the competent authority that handles the ingredients importation.

Document requirements for obtaining SKI Post Border and the applicant account are modified.

Types

Documents for Obtaining Applicant’s Username and Password (scans)

Documents for Obtaining SKI Post Border (electronic forms)

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/ingredients are stored

Note:

The applicant’s data can be changed as long as it is not related to the NIB.
If the data related to NIB changes, the applicant should re-apply for username and password.

Notification approval
Certificate of Analysis (COA) including product names, testing parameters, testing results, testing methods, batch number/production code, production date and/or expiration date, and manufacturer name (if the CoA issuer is not the manufacturer)
Invoice
Sampling/Laboratory testing (if necessary)
Other supporting documents required by the competent authority

Note:

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

Cosmetic Ingredients

Certificate of Analysis (COA) including ingredient names, testing parameters, testing results, testing methods, batch number/production code, production date and/or expiration date, and manufacturer name (if the CoA issuer is not the manufacturer)
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

Perfumes must also attach:

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

2. Draft List of Forms and Types of Cosmetics Allowed for Production by Manufacturers with Class B Production Licenses

Background

In Indonesia, all cosmetic manufacturers must obtain a production license before manufacturing cosmetics ^[3]. Production license is divided into two categories by cosmetic forms and types:

Class A Production License grants rights to manufacture all forms and types of cosmetics.
Class B Production License grants restricted rights confined to the manufacture of certain forms and types of cosmetics with low risks or are made with simple technologies. List of Forms and Types of Cosmetics Allowed for Production by Manufacturers with Class B Production Licenses regulates the prohibited and permitted cosmetic types manufactured by manufacturers with Class B Production Licenses.

Main Amendments

1) Several types of cosmetics prohibited from being manufactured by manufacturers with Class B Production Licenses are added. The prohibited cosmetic types include:

Cosmetics used for babies;
Cosmetics used around the eyes, oral cavity, or other mucous membranes;
Cosmetics containing functional ingredients such as anti-acne, skin whitening, sunscreen, chemical peeling, hair dying ingredients;
Cosmetics require complicated technologies such as aerosol and compact powders.

2) Several types of cosmetics that are permitted to be manufactured by manufacturers with class B production licenses are added.

Cosmetic Forms	Cosmetic Types
1. Liquids (liquid, viscous liquid, suspension)	Eau de toilette Eau de parfum Perfume Bath foam Hairdressing Hair creambath Day cream Night dream Moisturizer Makeup base Foundation Deodorant Other bath preparations (handwashing soap)
2. Half solid (cream, pomade)	Day cream Night cream Moisturizer Skin body and/or hand care Facial mask Peeling Hairstyling Hairdressing Hair conditioner Hair creambath Shampoo Facial cleanser Bath soap Deodorant
3. Semi-solid (gel)	Hairstyling Day cream Night cream Moisturizer Massage gel Skin, body, and/or hand care Hairdressing Facial cleanser Bath soap Other bath preparations (handwashing soap) Shampoo
4. Powder	Facial mask Cold powder Face powder
5. Solid	Deodorant Shampoo Hair and body wash Facial cleanser Other bath preparations (handwashing soap) Moisturizer
6. Solid (Sticky)	Moisturizer Deodorant

For the current full list of cosmetics permitted to be manufactured by manufacturers with Class B Production License, please refer to our Coslist.

3. Draft Regulation for Electronic Business Licensing of Drug and Food (Substances Related to Cosmetic Commodities)

This regulation serves as a guide for business actors obtaining licensing in the drug and food sectors. Business licensing related to cosmetics include notification approval and GMP certificate. The detailed application procedures, documents necessary, the time required, licensing renewal, licensing change, etc. are clarified.

Notification approval

Business actors who apply for notification approval must meet the following requirements.

Requirements	Cosmetics manufactured in Indonesia		Imported Cosmetics
Requirements	Independent production	Contract production	Imported Cosmetics
Equip a technical person in charge	√	√	√
Complete administrative data	√	√	√
Complete the qualitative and quantitative formula data for cosmetics	√	√	√
Provide supporting data on the safety of cosmetic ingredients/products (if necessary)	√	√	√
Provide supporting data for cosmetic claims (if necessary)	√	√	√
Provide product samples (if necessary)	√	√	√
Provide GMP certificate or GMP certificate application letter	√	√	√
Provide contract production agreement with the cosmetics industry which already has a GMP certificate		√
Provide a valid agency appointment letter			√
Provide contract production agreement between the notification applicant and the cosmetics industry outside Indonesia			√
Provide Certificate of Free Sale (CFS) for imported cosmetics originating from countries outside ASEAN			√

GMP certificate

Documents required for obtaining a GMP certificate are as follows:

Administrative documents	Application letter NIB Approval for building plans for the cosmetics industry
Technical documents	Documents on the application of the GMP quality system Approval letter for the use of the shared production facilities between cosmetics and medicine or traditional medicine