Dokumen Informasi Produk Kosmetik

Summary

This video explains the process of registering and notifying cosmetic products in Indonesia, highlighting key changes in regulations since 2011. It details the steps required for registering products, including creating an account, submitting documents for verification, and receiving certification within 14 days. The script outlines the necessary documents, such as product information, safety assessments, and labels, which must be prepared according to official guidelines. It also emphasizes the importance of compliance with Indonesian regulations for both domestic and imported cosmetics, and the role of proper documentation and claims to ensure product safety and quality in the market.

Takeaways

• 😀 The registration process for cosmetic products in Indonesia has shifted from registration to notification since January 2011.
• 😀 Cosmetic product notification is done by registering a business account online and submitting the required business documents for verification by Badan POM.
• 😀 A cosmetic product notification involves submitting product data and formula details through an online template, followed by payment.
• 😀 After submission, the result can be either an issued notification number, rejection due to non-compliance, or a confirmation process if further verification is needed.
• 😀 Before notifying a product, the applicant must prepare the Product Information Document (DEIP), which includes details on product quality, safety, and efficacy.
• 😀 The DEIP document consists of four sections: administrative data, ingredient safety data, product quality data, and safety & efficacy data.
• 😀 Section 1 of the DEIP includes administrative documents like certificates, contracts, and brand statements for both domestic and imported products.
• 😀 Section 2 of the DEIP focuses on the safety and quality of the ingredients, including specifications, certificates of analysis, and supplier safety data.
• 😀 Section 3 of the DEIP includes product formulation, manufacturing processes, stability testing, and analysis of microbial contamination and heavy metals.
• 😀 Section 4 of the DEIP includes a safety assessment report, adverse effect reports, claims about the product's efficacy, and product labeling requirements.
• 😀 Cosmetic product labels must include the product name, batch number, weight/volume, expiration date, ingredients list, and any required warnings or usage instructions.

Q & A

What is the main change in the cosmetic product registration process since January 2011?

Since January 2011, the process for registering cosmetic products has shifted from a registration system to a notification system. This means that companies no longer need to submit detailed product registration documents to Badan POM; instead, they need to submit a notification after registering their business account online.

How can a company submit a cosmetic product notification to Badan POM?

To submit a cosmetic product notification, a company first registers its business account online. Then, the company submits a notification for the cosmetic product online by filling out a provided template, which includes product data and formulas. After payment, Badan POM verifies the submission, which usually takes about 14 working days.

What is the DEIP and what does it include?

DEIP stands for 'Dokumen Informasi Produk', which is a document containing information about the quality, safety, and efficacy of a cosmetic product. It consists of four sections: administrative data, quality and safety of cosmetic ingredients, quality of the cosmetic product, and safety and efficacy of the cosmetic product.

What is included in the first section of the DEIP, the administrative data?

The first section of the DEIP contains administrative documents such as the business license, the Good Manufacturing Practice (GMP) certificate, and various statements related to the product's brand and production contracts. It also includes documents that verify the authority of foreign manufacturers or distributors when applicable.

What are the requirements for the second section of the DEIP, regarding the quality and safety of cosmetic ingredients?

The second section requires the specification of each ingredient in the cosmetic product, including safety data and certificates of analysis. For fragrance ingredients, the supplier's name and compliance with international fragrance guidelines must be provided.

What documents are needed in the third section of the DEIP, which pertains to the quality of the cosmetic product?

The third section includes the product's formula, a description of the manufacturing process, analysis certificates for the cosmetic product (including test results for microbial contamination and heavy metals), and stability testing data to determine the product's shelf life.

What is the role of the safety assessor in the DEIP process?

A safety assessor is a qualified individual responsible for evaluating the safety of cosmetic products based on their ingredients and exposure levels. They must provide a safety assessment report, which includes a review of the safety data for each ingredient, as well as calculations of the safety margin for both individual ingredients and the finished product.

What is the purpose of a cosmetic product's claim, and how should it be presented?

A cosmetic product claim is a statement about the product's benefits, safety, or other properties. Claims should be objective, scientifically substantiated, and not misleading. They must be supported by appropriate evidence, such as product testing reports or scientific literature.

What information must be included on cosmetic product labels?

Cosmetic product labels must include the product name, batch number, net weight or volume, notification number, country of origin, the applicant's name and address, usage instructions in Indonesian, expiration date, composition in descending order, any necessary warnings, and storage conditions.

What happens if a cosmetic product does not meet the requirements for notification?

If a cosmetic product does not meet the necessary requirements for notification, the notification will be rejected by Badan POM. In some cases, further confirmation may be required to resolve issues before the notification is approved.