Singapore’s cosmetics market is vibrant and dynamic, reflecting a high demand for cosmetics and offering opportunities for businesses looking to introduce their beauty products. Before diving into this dynamic market, understanding the cosmetic registration process is crucial.

This article helps you understand the steps and requirements to register your cosmetic products in Singapore.

Here are the Top 5 Reasons Why Singapore is an Ideal Market for Your Cosmetic Products

Singapore is a prime market for cosmetic products due to its unique blend of economic prosperity and cultural diversity.

• Economic prosperity: Singapore’s strong economy with high disposable incomes creates a favorable environment for cosmetic sales.
• Cultural diversity: The multicultural society allows cosmetic brands to cater to various skin tones, preferences, and beauty rituals, fostering inclusivity.
• Innovation embraces: Singaporeans’ openness to innovation and technological advancement creates a receptive market for cutting-edge cosmetic products.
• Strategic location: Situated in Southeast Asia, Singapore is a gateway to the broader regional market, facilitating expansion for cosmetic businesses.
• Expansion opportunities: Successful entry into the Singaporean cosmetic market can open doors to neighboring countries, tapping into the growing regional demand for beauty products.

Important insights before market entry

• Before entering the Singapore cosmetics market, crucial insights are essential for a successful venture. Understanding the regulatory landscape governed by the Health Sciences Authority (HSA) is paramount. 
• Rigorous preparation, including the creation of a comprehensive Product Information File (PIF) and adherence to Good Manufacturing Practice (GMP), sets the foundation for a seamless entry.
• Recognizing the significance of accurate labeling, claims alignment, and safety assessments are key components for market approval. 
• These insights empower businesses to navigate the complexities and position their cosmetic products for success in Singapore.

Determining product eligibility (what is a cosmetic and what are exclusions)

Definition of Cosmetics

According to HSA guidelines, cosmetics encompass a diverse array of products, including skincare, haircare, makeup, and various other items. These guidelines define the category, highlighting its broad scope within the realm of personal care and beauty products.

Exclusions

Recognizing exemptions, such as soap and oral care products, can simplify the registration process by identifying items that may not necessitate registration.

Regulatory requirements   

Regulatory authority -HSA (Health Science Authority)

In Singapore, the Health Sciences Authority (HSA) oversees the regulation of cosmetics. Familiarize yourself with HSA’s role in ensuring the safety and quality of cosmetic products

Local regulation – Association of Southeast Asian Nations (ASEAN)

Cosmetic products supplied in Singapore must comply with the requirements under the Health Products Act and its Health Products Regulations(2007) (Cosmetic Products – ASEAN Cosmetic Directive)

The Regulations are in line with the ASEAN Cosmetic Directive (ACD), which adopts similar regulatory principles and requirements as the European Union (EU) regulations on cosmetic products.

Good manufacturing practice certificate

In Singapore, cosmetic manufacturers don’t need a license, but they can apply for a voluntary Good Manufacturing Practice (GMP) certificate to ease product export. HSA conducts a GMP audit based on ASEAN Cosmetic Directive recommendations, and the certificate is granted upon compliance with GMP standards.

Cosmetic Product Information File (PIF)

PIF is vital for cosmetic product registration, encompassing details like composition, safety assessments, and labeling. This mandatory document is essential for placing cosmetics in ASEAN and European markets, maintained by the responsible person, and presented during audits.

What should be contained in PIF?

• Description of the cosmetic product
• Cosmetic Product Safety Report (CPSR)
• Description of the method of manufacturing and a statement on compliance with Good Manufacturing Practices (GMP)
• Proof of the claimed effect of the cosmetic product
• Product label                                                                                        
• Data on any animal testing performed  

If you are interested in the drug registration and approval process in Singapore, click here for more information.

Registration process

• In Singapore, there are two distinct processes for cosmetics – notification and registration.
• Notification is a simple step where companies inform the Health Sciences Authority (HSA) before putting their cosmetics on the market. Basic product details, including ingredients and labeling, are shared to ensure compliance with regulations.
• Registration is a more in-depth process requiring thorough data and scientific information submission to the HSA. Typically needed for higher-risk products, like those with specific active ingredients or claims.
• The decision between notification and registration is based on the product’s characteristics and potential risks. Companies should evaluate requirements carefully to choose the appropriate regulatory pathway for their specific product.

Here we will discuss the registration process.

Preparation

Gather comprehensive information about the cosmetic product, including its formulation, ingredients, and intended use.

Appointment of a Local Responsible Person (LRP)

Appoint a local individual or entity as the LRP, who will act as the point of contact between the company and the Health Sciences Authority (HSA) if you are a foreigner

Submission of Application

Utilizing the HSA’s online platform, PRISM, prepare and submit the registration application.

To submit a cosmetic application to the Health Sciences Authority (HSA) in Singapore, log in to the PRISM system on the HSA website using the following link. 

Documentation

Provide necessary documents, including product information, manufacturing details, safety assessment, and evidence of Good Manufacturing Practice (GMP).

Compliance verification

 Ensure compliance with regulatory requirements, including labeling, claims, and restrictions on certain ingredients.

Labeling requirements

Every cosmetic product must have labeling in English that is easily readable. The label should be visible on the product at the point of sale. If the container’s size, shape, or nature doesn’t allow for all required information, alternatives like leaflets, pamphlets, hang tags, display panels, or shrink wrap are permitted. However, the cosmetic product name and manufacturer’s batch number must be on the container or immediate package.

Ingredient restrictions

The ASEAN Cosmetic Directive includes technical documents about cosmetic regulations for all products in the ASEAN market. One document is a detailed list of ingredients, indicating whether an ingredient is allowed or not. 

There are five ingredient annexes.

1. Annex II – Prohibited ingredients: Lists ingredients not allowed in cosmetic products, except for “unavoidable traces in Good Manufacturing Practice.”
2. Annex III – Restricted substances: Specify ingredients with limits and conditions; exceeding these is not permitted in cosmetic products.
3. Annex IV – Permitted coloring ingredients: Contains approved coloring ingredients (excluding hair colors) with specified conditions for use.
4. Annex VI – Permitted preservatives: Lists allowed preservatives in cosmetics, detailing usage limits, conditions, and necessary warnings.
5. Annex VII – Permitted UV filters: Identifies allowed UV filters in cosmetic sunscreen products, including limits, conditions, and required warnings.

Claims

Product claims: Claim whether a word, sentence, paragraph, or implication in cosmetics cannot state alleviation, treatment, cure, or prevention of diseases or symptoms. Guidelines assist in classifying a product as either cosmetic or therapeutic.

Advertising claims: Cosmetic ads must be legal, decent, honest, and truthful. They cannot falsely suggest characteristics or functions through marketing elements like text, names, trademarks, pictures, or signs.

Payment of fees

Pay the required registration fees to the HSA. The amount varies depending on factors such as product type and risk level.

Product	Annual fee
Single higher-risk product	$26
The first three variants of higher-risk product	$26 per variant
A fourth and subsequent variant of the higher-risk product	$6 per variant
Single lower-risk product	$11
The first three variants of lower-risk product	$11 per variant
A fourth and subsequent variant of the lower-risk product	$6 per variant

Review by HSA

HSA will review the application, assessing the safety, quality, and efficacy of your cosmetic product.

Approval and registration

Upon successful review and compliance verification, HSA issues approval and registers the cosmetic product.

Post-Market Surveillance

Adhere to post-market surveillance requirements, reporting any adverse events or changes to the product.

To report adverse events during cosmetic product registration in Singapore, promptly notify the Health Sciences Authority (HSA) with details.

For label updates, submit revised labels to HSA. Ensure accurate and timely communication for a smooth registration process. 

Conclusion 

Registering cosmetic products in Singapore requires careful evaluation of notification or registration options, following labeling and ingredient limitations, and adhering to advertising and claims regulations.

Understanding these aspects and following the prescribed procedures, businesses can successfully introduce their cosmetic products to the dynamic Singaporean market, ensuring safety and regulatory compliance throughout the journey. 

This comprehensive guide aims to simplify the intricate steps for a seamless registration experience.

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