Regulasi Kosmetika

Summary

This video lesson provides an in-depth discussion of cosmetic regulations in Indonesia, focusing on key laws, such as the Minister of Health Regulation No. 11/76 and the guidelines for cosmetic production and circulation. It covers the definition of cosmetics, production permits, notification procedures, and the technical requirements for cosmetics in circulation, including safety, quality, labeling, and claims. The lesson also emphasizes the ethical standards for cosmetic advertising and promotion. This comprehensive guide aims to ensure that cosmetics are produced and marketed safely and effectively in accordance with Indonesian regulations.

Takeaways

• 😀 Cosmetics are regulated under various laws in Indonesia, including the Regulation of the Minister of Health and the Decree of the Head of the POM Agency.
• 😀 According to the Regulation of the Minister of Health, cosmetics are materials or preparations used externally on the human body, such as the skin, hair, nails, and mucosa, to clean, perfume, change appearance, or protect the body.
• 😀 Cosmetic production permits in Indonesia are divided into two groups: Group A (can produce all types of cosmetics) and Group B (can only produce certain types using simple technology).
• 😀 Group A cosmetic industries must have a pharmacist in charge, production facilities, laboratories, and must follow Good Cosmetic Production Methods (CPKB).
• 😀 Group B cosmetic industries need pharmaceutical technical personnel, simple production facilities, and must adhere to hygiene, sanitation, and documentation standards.
• 😀 Cosmetics in circulation must be registered or notified by the POM Agency and meet safety, quality, and benefit standards.
• 😀 Cosmetics must have safety and technical requirements that ensure quality and meet government regulations for materials and production methods.
• 😀 Cosmetic labels must provide clear and truthful information, including name, benefits, ingredients, usage instructions, manufacturer details, and expiration date.
• 😀 Cosmetics should not make false medical claims, such as advertising anti-acne properties, and must provide scientific evidence to support any claims made.
• 😀 The notification procedure for cosmetics involves filling out an online form on the BPOM website, making payment, and receiving a product ID and notification number, with a process lasting up to 14 working days.
• 😀 Cosmetic promotion and advertising must be truthful, ethical, and not misleading, and cannot suggest that the cosmetic has medicinal properties or use health workers in demonstrations.

Q & A

What are the main regulations governing cosmetics in Indonesia?

Cosmetics in Indonesia are regulated by several key regulations, including the Regulation of the Minister of Health Number 11 of 2010 concerning cosmetic production permits, Decree of the Head of the POM Agency Number HK 0054 3870 of 2003 for good cosmetics manufacturing guidelines, and the Regulation of the Minister of Health Number 11 76 of 2010 concerning cosmetic notifications.

How are cosmetics defined according to Indonesian regulations?

Cosmetics are defined as materials or preparations used externally on the human body, including the epidermis, hair, nails, external genital organs, teeth, and mucosa, with the purpose of cleaning, perfuming, altering appearance, or improving body odor or protecting and maintaining the body in good condition.

What are the different types of cosmetic production permits in Indonesia?

There are two main types of cosmetic production permits in Indonesia: Group A, which allows the production of all types of cosmetics, and Group B, which only permits the production of certain types and preparations using simpler technology.

What are the requirements for obtaining a Group A cosmetic production permit?

To obtain a Group A cosmetic production permit, the industry must have a pharmacist as the person in charge, production facilities that meet the requirements for the intended products, the ability to produce all forms and types of cosmetic preparations, laboratory facilities, and must implement good cosmetic production practices (CPKB).

What are the specific requirements for Group B cosmetic production permits?

For Group B, the requirements include having at least pharmaceutical technical personnel in charge, production facilities with simple technology, and the prohibition of producing certain products like baby cosmetics with antiseptics, anti-dandruff agents, skin lighteners, and sunscreens.

What are the safety and quality requirements for cosmetics in circulation?

Cosmetics in circulation must meet several safety, quality, and benefit standards, as per government regulations. They must be registered or notified to the BPOM (Indonesian Food and Drug Authority), comply with technical requirements, and be produced by facilities that implement CPKB for Group A or basic hygiene and documentation for Group B.

What does the technical requirement for cosmetics include?

The technical requirements for cosmetics include safety, quality, labeling, and claims requirements. These must comply with the Indonesian cosmetic code or ASEAN cosmetic directive and ensure that products are safe for use.

What must be included on a cosmetic product's label according to Indonesian regulations?

A cosmetic product's label must include the product's name, its benefits or uses, instructions for use, composition, country of manufacture, full name and address of the applicant, size or net weight, expiration date, notification number, and any necessary warnings or additional information.

What are the rules regarding claims made by cosmetic products in Indonesia?

Cosmetic claims must be based on the ingredients used, supported by scientifically acceptable test data, and must not be misleading. Claims must not suggest that the cosmetic has medicinal properties, such as claiming to be an anti-acne drug, which is prohibited.

What is the process for notifying a cosmetic product to the BPOM?

To notify a cosmetic product, the applicant must fill out an online notification form via the BPOM website, make a payment, and submit the form. BPOM will verify the submission, and if everything is in order, the applicant will receive a notification number. The entire process takes approximately 24 working days, and the notification is valid for three years.