Regulatory Updates for Cosmetic Distributors: Key Changes in the Second Amendment to Permenkes 14/2021

The cosmetic distribution industry in Indonesia is undergoing regulatory changes with the introduction of Minister of Health Regulation Number 17 of 2024, also known as the Second Amendment to Permenkes 14/2021.

This amendment, which came into force on November 14, 2024, brings key updates for Major Cosmetic Distributors (PBK), particularly in business licensing, facility standards, and distribution channels.

Understanding these changes is essential for businesses to remain compliant and take advantage of new opportunities.

Key Takeaways

1. The Second Amendment to Permenkes 14/2021 came into effect on November 14, 2024 and introduces new regulatory adjustments for Major Cosmetic Distributors (PBK).
2. Businesses with existing licenses must comply with the new regulations by November 14, 2025.
3. Cosmetic distributors are now categorized based on whether they hold a cosmetic notification or operate under a manufacturer’s appointment.
4. Facility standards now require scheduled cleaning programs and written cleaning procedures.
5. The amendment allows wholesale distribution of cosmetics through e-commerce platforms, expanding market opportunities.

Business Licensing Process in the Second Amendment

The amendment does not alter ongoing licensing processes under Permenkes 14/2021, but it introduces compliance requirements for existing businesses.

1. Licensing for New Businesses and Renewals

• The issuance process for business licenses already in progress will continue without changes.
• New applicants must comply with the updated facility and distribution standards.

2. Adjustments for Existing Businesses

• Businesses with licenses under Permenkes 14/2021 must align with the new regulations by November 14, 2025.
• Non-compliance may lead to penalties or operational restrictions.

Navigating business licensing requirements in the health sector can be complex, particularly with ongoing regulatory changes. Permitindo provides expert assistance in securing business licenses, ensuring compliance with the latest regulations, and helping businesses meet operational standards.

Updated Standards for Major Cosmetic Distributors (PBK)

One of the key regulatory updates in the Second Amendment is the classification of cosmetic distributors into two categories:

1. Distributors with Cosmetic Notification

These distributors contract licensed cosmetic manufacturers to produce products under their brand.

2. Distributors Without Notification

These distributors do not produce their products but are appointed by manufacturers or importers through an agreement to handle distribution and marketing.

Additionally, cosmetic industries that distribute their products (KBLI 20232, including toothpaste manufacturers) are now exempt from the requirement to obtain a PBK business standard certificate.

Updated Facility Standards for Cosmetic Distributors

The Second Amendment retains the fundamental requirements from Permenkes 14/2021 while adding new obligations for facility management.

1. Retained Facility Requirements

• Facilities must be protected from adverse weather conditions.
• Adequate lighting and proper equipment must be available.
• Workspaces must be clean, free from dust, and waste-free.

2. New Facility Obligations

• Businesses must establish written procedures for cleaning activities.
• A scheduled cleaning program must be implemented.
• Proper documentation of all cleaning activities must be maintained.

These additional standards ensure that cosmetic storage and distribution facilities meet high hygiene and safety standards, aligning with global cosmetic industry best practices.

Wholesale Distribution Through E-Commerce

A significant update in the Second Amendment is the authorization for PBK to distribute cosmetics through e-commerce platforms.

Previously, Permenkes 14/2021 did not include e-commerce as a recognized distribution channel. This update opens new opportunities for businesses to:

With the right guidance, businesses can avoid unnecessary delays and focus on successfully expanding their operations in Indonesia’s growing horticultural sector.

• Expand their market reach beyond traditional retail distribution.
• Streamline supply chains by selling directly to businesses or bulk buyers online.
• Adapt to digital transformation trends in the beauty and cosmetics industry.

This shift aligns with Indonesia’s growing digital economy, allowing distributors to compete more effectively in an increasingly e-commerce-driven market.

Conclusion

The Second Amendment to Permenkes 14/2021 introduces critical changes for cosmetic distributors, including updated facility standards, licensing adjustments, and expanded e-commerce opportunities. With a transition period until November 14, 2025, businesses have time to ensure compliance.

Ensuring compliance with evolving regulations is essential for business continuity. If you need assistance with securing business licenses or navigating regulatory updates, fill in the form below to get expert guidance.