In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore what constitutes a product as “Made in Singapore,” the  pathway  to achieve this , and the certifications available from Singapore Customs , Singapore Manufacturing Federation, as well as the Singapore International Chamber of Commerce, that can facilitate export.

What is Considered a “Made in Singapore” Product?

A “Made in Singapore” product refers to goods that are substantially manufactured or processed within Singapore, in line with regulatory criteria established by local authorities. To earn this designation, a significant portion of the production costs—including labor and materials—must be incurred locally, ensuring considerable local value addition. Furthermore, products must comply with Singapore’s safety, health, and environmental standards to meet quality expectations.

It’s essential to note that if a product is manufactured outside of Singapore and only undergoes labeling or assembly here, it may be labeled as “Packed in Singapore” or “Secondary assembled by ABC Pte Ltd in Singapore.” However, it cannot be marketed as “Made in Singapore,” as this designation necessitates significant manufacturing or processing within the country.

Importance of Free Sale Certificate (FSC) and Certificate of Origin (COO)

When exporting goods, obtaining a Free Sale Certificate (FSC) and a Certificate of Origin (COO) can significantly streamline the process and enhance market acceptance in your destination country.

• Free Sale Certificate (FSC): Issued by Singapore Customs, the FSC confirms that the products are sold locally in Singapore and are compliant with local regulations. It serves as a testament to the product’s quality and safety, making it easier for foreign authorities to accept the product without extensive scrutiny.
• Certificate of Origin (COO): This document attests to the origin of the goods and is essential for international trade. Many countries require proof of origin to determine applicable tariffs and compliance with trade agreements. There are two types of COOs:
  • Ordinary COO (Non-Preferential): Identifies the origin of the good but does not allow overseas buyers to claim preferential tariff treatment, as it is not issued under any Free Trade Agreement.
  • Preferential COO: Enables your buyer to benefit from lower or no customs duty when exporting under a Free Trade Agreement or Schemes of Preferences.

Steps to Brand Your Complementary Health Products or Cosmetics as “Made in Singapore”

1. Set Up a Manufacturing Facility: Establish a manufacturing facility that adheres to Good Manufacturing Practice (GMP) requirements to produce your product, or partner with a licensed contract manufacturing facility that specializes in complementary health products. Ensure that your facility is registered with relevant authorities to facilitate inspections and audits.
2. Ensure Regulatory Compliance: Comply with the relevant regulatory controls for your type of health product. Prepare comprehensive documentation to establish the quality, safety, and efficacy of your product. This documentation should include:
   • Product specifications
   • Safety data sheets
   • Clinical studies (if applicable)
   • Quality assurance protocols

Seek the appropriate approvals before marketing and distributing it locally. This may involve obtaining licenses to import and distribute if necessary.

3. Obtain Necessary Certifications: Once you receive approval from the regulatory authority, you can apply for a Free Sale Certificate from Singapore Customs or a Certificate of Origin from the Singapore Manufacturing Federation and the Singapore International Chamber of Commerce to facilitate exportation, depending on the domestic procedures of your destination country.
   • Free Sale Certificate: To apply for the FSC, submit your application along with supporting documents that demonstrate your product’s compliance with local regulations. The certificate will detail the product’s description, registration numbers, and the local regulatory authority’s confirmation.
   • Certificate of Origin: To obtain a COO, you will need to provide documentation that supports the origin of your goods. This may include:
     • Invoices
     • Shipping documents
     • Manufacturing process details

COs are issued by the Singapore International Chamber of Commerce and the Singapore Manufacturing Federation. Ensure that you are familiar with the requirements of the importing country to facilitate a smooth export process.

For further information, please refer to the following resources:

• Certificate of Origin
• Singapore Customs FAQs

We hope this information proves useful to you. Be sure to check out our other related blogs that may interest you:

• 3 Facts to Know When Importing Cosmetics into Singapore
• Addressing Regulatory Challenges in the Cosmetics and Personal Care Industry in Singapore
• Navigating Nutraceutical Regulations Within the ASEAN Region
• Key Things to Note When Importing Health Supplements into Singapore

 

In today’s fast-paced society, maintaining a healthy diet has never been more relevant. Nutraceuticals, or health supplements, are becoming increasingly popular for their role in maintaining overall health and supplementing nutrients lacking in our daily diets. These products are typically derived from natural and organic sources, catering to growing interests in areas such as immunity, joint support, sports nutrition, and heart health. Additionally, immunity boosters, cholesterol-lowering agents, fish oil, skin and hair-strengthening supplements, collagen supplements and fat-burning supplements are some of the highest-selling products in the market. 

Yet, the absence of unified regulations in certain aspects, such as labelling, might complicate product marketing across ASEAN countries and limit consumer access. In this article, we will delve into the complexities of complying with multiple local protocols while highlighting the importance of product safety and market entry.

• Harmonised Standards

In 2004, the ASEAN Economic Community established the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) to unify technical requirements for nutraceutical or health supplements and traditional medicines across the region. The group developed ten core annexes or technical requirements essential to harmonisation efforts. However, these have yet to be fully implemented as they require the ratification document to be signed by ASEAN trade ministers.

ASEAN Harmonised Technical Guidelines and Standards for Health Supplements

• Annex I– ASEAN Guiding Principles for Inclusion Into or Exclusion From the Negative List of Substances for Health Supplements
• Annex II– ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements
• Annex III – ASEAN Guidelines on Limits of Contaminants for Health Supplements
• Annex IV – ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements
• Annex V – ASEAN Guidelines on Stability and Shelf-Life of Health Supplements
• Annex VI – ASEAN Guiding Principles on Safety Substantiation of Health Supplements
• Annex VII – ASEAN Guidelines on Claims and Claims Substantiation for Health Supplements
• Annex VIII – ASEAN Guideline on Good Manufacturing Practice for Health Supplements
• Annex IX – ASEAN Guidelines on Labelling Requirements for Health Supplements
• Annex X – ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements

Despite this, countries like Singapore, Malaysia, Brunei, Thailand, and Myanmar have begun adopting these standards, especially for the inclusion or exclusion of substances on the negative list. Though yet to be ratified, they provide a uniform framework, simplifying approvals and facilitating market entry. Adherence ensures products meet safety and quality criteria, which is crucial for consumer confidence and market success.

• Registration Process

Registering a nutraceutical product in the ASEAN region usually involves several steps, which can vary slightly from country to country. Typically, this includes submitting detailed product information, safety data, and efficacy studies to the relevant regulatory authority. Despite these variations, all countries stress the importance of thorough documentation and adherence to local regulations. Understanding these steps enables companies to plan effectively and prevent delays in the registration of pharmaceutical products and dietary supplements.

• Labelling Requirements

Among the many regulations to follow, labelling stands out as one of the most crucial aspects. Mandatory information often includes the product name, the name and strength of the active ingredients, usage instructions, and any necessary warnings. Labels must be clear, accurate, and in the appropriate languages used in the countries where the product will be sold. Adhering to these guidelines when introducing nutraceuticals into the ASEAN region makes sure that consumers receive the necessary information for safe and effective product use.

For detailed labelling requirements, refer to the ASEAN guidelines on labelling requirements.

• Permissible Ingredients

Furthermore, each ASEAN country maintains a list of approved ingredients for nutraceutical products, aligned with ASEAN guidelines that determine which substances are permitted or restricted. These lists often impose restrictions on certain substances for safety and efficacy reasons. Companies must stay informed about these lists and verify that their products comply with regulatory standards by avoiding prohibited ingredients. This vigilance not only helps minimise regulatory risks but also certifies that the products are safe for consumers.

Read more: ASEAN Guiding Principles for Inclusion Into or Exclusion from the Negative List of Substances for Health Supplements.

• Market Access Challenges

Gaining market access in the ASEAN region involves navigating diverse regulatory requirements and addressing local market conditions, which can pose significant challenges. Companies often encounter hurdles such as varying approval timelines, different documentation requirements, and cultural nuances affecting product acceptance. Overcoming these challenges requires strategic approaches such as conducting thorough market research, collaborating with local regulatory specialists, and remaining flexible to adapt to evolving procedures and market dynamics.

Navigating nutraceutical regulations in the ASEAN region requires a thorough understanding of the factors listed above. With the right insights and the support of regulatory affairs services, you can ensure compliance and successfully enter the ASEAN market. If you need guidance, consider reaching out to The Reg Consultants in Singapore. Our team offers comprehensive services to help you achieve regulatory compliance.

Contact us today to explore how we can support your market entry into the ASEAN region.