随着药物研发日益艰难、临床周期拉长、法规门槛不断抬高，越来越多的制药公司和新兴电商品牌开始将目光转向保健品和化妆品。与此同时，消费者对预防性健康、日常保健和功能性产品的关注度也在持续上升。多年前我们就看到“超级食品”和保健成分的兴起，但今天的市场竞争已远非当年可比。

随着竞争加剧，许多公司为了让产品脱颖而出，开始将配方和定位做得越来越像“药”。

这正是法规风险开始浮现的地方。

一、先搞清楚你在做什么产品

产品开发的第一步，是想清楚你究竟在创造一个什么类别的产品。简单来说：

保健品，是由维生素、矿物质、氨基酸、传统成分或植物提取物制成的产品，用于补充日常膳食、支持身体功能。

化妆品，是主要用于清洁、美化、赋香、保护或改善皮肤、头发或身体外观的产品。

这些定义看起来不难，但真正的法规风险，往往来自产品如何被配方、如何被定位、如何被推向市场。

二、三个核心：配方、标签、宣称

很多情况下，产品的法规风险并非来自某一个成分，而是来自产品的整体呈现。

1. 配方

在设计配方时，企业需要理解每个成分在生理上的作用，以及组合后的配方是否真正支撑产品的预期用途。我们看到越来越多的公司，将多种植物提取物、维生素、传统草药、功能性食品成分和新型原料体系，糅合成极其复杂的配方，试图让产品看起来更有“功效”。

在某些情况下，整体配方可能已悄然滑向边界地带，甚至趋近于治疗性定位。新型剂型和递送系统（如脂质体技术）也可能因产品定位和宣称的需要，面临额外的法规考量。

2. 产品标签与定位

产品标签，应当与产品类别和消费者对产品的认知保持一致。需要仔细考量的方面包括：产品的预期用途、使用说明、剂量建议、目标消费人群，以及整体的市场营销呈现。有些时候，即便配方本身没有明显问题，产品的整体呈现和营销方向，也可能开始制造出一种“药”的印象。

3. 宣称

这是产品审评中最常见的问题之一：宣称超出了产品应有的类别范围。例如：

• 化妆品宣称能舒缓湿疹或牛皮癣

• 护发精华或保健品声称能刺激头发再生、逆转脱发

• 含咖啡因或草本兴奋剂的能量补充剂，声称能治疗慢性疲劳或改善倦怠症状

• 保健品声称能逆转骨关节炎、自然控制糖尿病或预防心血管疾病

• 产品虽定位为化妆品或保健品，却暗示具有疾病预防、治疗效果或医疗成效

许多企业认为，增加更多的营销宣称，能让产品在商业上显得更强。但过度或缺乏支撑的宣称，反而可能引发更多的法规关注。更可持续的做法，是聚焦在少数几条有充分支撑的宣称上，以公认参考文献、已发表文献或成熟的成分数据作为依据。

三、我们经常看到的误区

最常见的误区之一，是以为在别的国家能被接受的产品，在新加坡的法规框架下就能自动放行。

事实未必如此。

例如，某些在海外作为保健品销售的新兴保健成分或产品类别——如含有SARMs的补充剂、定位为认知增强的新型蘑菇提取物、促睾补充剂、CBD类保健产品、肽类美容补充剂——在新加坡可能需要更审慎的法规评估，取决于成分特性、剂量强度、预期用途和产品宣称。

还有一些产品，标签上虽然没有直接提及疾病，但整体的广告和营销物料却在强烈暗示治疗意图。例如：

• 祛痘精华宣称“临床验证祛痘治疗”

• 护发产品声称能“刺激头发再生”

• 能量补充剂声称能“支持身体压力恢复”

• 保健品暗示能控制糖尿病、关节炎、激素失调或其他疾病

就在这个环节，企业在无意中将自己的产品推入了边界地带，触发了额外的法规审查或分类争议。

四、进入市场前，先问自己几个关键问题

在进口或上市之前，企业应当认真思考：

• 配方在逻辑上是否支撑产品的预期用途？

• 宣称是否适度，且有科学支撑？

• 产品的整体呈现，是否在向药品靠拢？

• 新型成分或技术，在目标产品类别中是否可被接受？

• 相比其他市场，新加坡的法规是否会以不同的方式解读这个产品？

及早评估这些方面，能帮你避免后期不必要的配方重做、营销修改和注册延误。

五、为什么法规定位要趁早？

很多公司直到产品配方、品牌和营销概念全部敲定，才开始考虑法规要求。

但到了这个阶段，如果产品定位已经过于趋近治疗性，往往需要大幅调整。这种情况在以下产品中尤为常见：主打强效定位的产品、运用新型原料技术的产品、高浓度植物复方产品，以及试图打造更具“临床效果感”的药妆概念产品。

在实操层面，法规评估不应只看某个成分是否“可以用”，更要看产品的整体呈现、配方逻辑和预期宣称，是否始终与产品类别保持一致。这也是为什么在批量生产、包装定稿和营销铺开之前，尽早展开法规策略讨论如此重要。

六、TRC如何提供支持

TRC为企业面向新加坡市场的保健品、化妆品及边界产品，提供早期法规评估服务。

支持范围包括：产品分类评估、配方与成分审阅、宣称与标签评估、边界风险识别，以及在进口或递交申请前，就市场定位给出合规指引。

很多情况下，一次早期的法规审阅，就足以在大量时间和资源被投入上市活动之前，识别出潜在问题。

如果你正在评估一款新的保健品、化妆品或功能性保健产品是否适合进入新加坡市场，欢迎联系TRC进行初步探讨。

With increasing challenges surrounding drug development, long clinical timelines and rising regulatory barriers, many pharmaceutical companies and emerging e-commerce brands are beginning to expand into health supplements and cosmetics.

At the same time, consumers are becoming increasingly focused on preventive health, wellness and functional products that support daily wellbeing. We started seeing this trend years ago with the rise of “superfoods” and wellness-focused ingredients, but the market today has become much more competitive.

As competition increases, many companies are now trying to formulate and position their products to look increasingly “drug-like” in order to stand out in the market.

This is where regulatory concerns may start to arise.

Understanding the Intended Product Category

One of the first steps during product development is understanding what type of product you are actually trying to create.

Simply:

Health Supplements

Health supplements are products made from vitamins, minerals, amino acids, traditional ingredients or botanical extracts intended to supplement the diet and support healthy body functions.

Cosmetics

Cosmetics are products intended primarily for cleansing, beautifying, perfuming, protecting or improving the appearance of the skin, hair or body.

While these definitions may appear straightforward, the actual regulatory concerns often arise from how the product is formulated, positioned and marketed.

The Three Core Areas: Formulation, Label and Claims

In many situations, the regulatory risk of a product does not come from a single ingredient alone, but from the overall presentation of the product.

1.Formulation

When designing a formulation, companies should understand how the individual ingredients work physiologically and whether the combined blend supports the intended purpose of the product.

We increasingly observe companies combining:

• multiple botanical extracts,
• vitamins,
• traditional herbal ingredients,
• functional food extracts,
• and novel ingredient systems

into highly complex blends designed to appear more “efficacious”.

In some situations, the overall formulation may begin moving closer towards a borderline or therapeutic positioning.

Novel dosage forms and delivery systems such as liposomal technologies may also require additional consideration depending on the product positioning and intended claims.

2.Product Label and Positioning

The product label should align with the intended product category and consumer understanding of the product.

Areas that should be considered include:

• intended purpose of the product,
• directions for use,
• dosage recommendations,
• target consumers,
• and overall marketing presentation.

In some situations, even where the formulation itself appears acceptable, the overall presentation and marketing direction may begin creating a therapeutic impression.

3. Claims

One of the most common issues observed during product review is the use of claims that extend beyond the intended product category.

Examples may include:

• cosmetics claiming to relieve eczema or psoriasis,
• hair serums or supplements claiming to stimulate hair regrowth or reverse hair loss,
• energy supplements containing caffeine or herbal stimulants claiming to treat chronic fatigue or improve burnout symptoms,
• supplements claiming to reverse osteoarthritis, control diabetes naturally, or prevent cardiovascular disease,
• or products implying disease prevention, therapeutic benefit, or medical treatment outcomes despite being positioned as cosmetics or health supplements.

In many situations, companies assume that adding more marketing claims makes the product appear stronger commercially. However, excessive or unsupported claims may instead increase regulatory concerns.

A more sustainable approach is to focus on a smaller number of well-supported claims supported by recognised references, published literature or established ingredient data.

Common Misconceptions We Commonly Observe

One of the more common misconceptions is assuming that a product accepted in another country will automatically be acceptable under Singapore’s regulatory framework.

This may not always be the case.

For example, certain novel wellness ingredients or emerging product categories marketed overseas — such as SARMs-containing supplements, novel mushroom extracts positioned for cognitive enhancement, testosterone-boosting supplements, CBD-type wellness products, or peptide-based beauty supplements — may require closer regulatory consideration in Singapore depending on:

• ingredient profile,
• dosage strength,
• intended purpose, and
• product claims.

Similarly, some products may technically avoid directly mentioning diseases on the label, while the overall advertising and marketing materials strongly imply therapeutic intent.

Examples may include:

• acne serums marketed as “clinically proven acne treatment”,
• hair products claiming to “stimulate hair regrowth”,
• energy supplements claiming to “support body stress recovery ”,
• or supplements implying management of diabetes, arthritis, hormonal imbalance, or other medical conditions.

This is where companies may unintentionally move their product into a borderline category and trigger additional regulatory scrutiny or classification concerns.

Key Questions to Consider Before Market Entry

Before importing or launching a product, companies should consider:

• Does the formulation logically support the intended product purpose?
• Are the claims proportionate and scientifically supportable?
• Does the overall product presentation resemble a therapeutic product?
• Are novel ingredients or technologies acceptable within the intended category?
• Could the product potentially be interpreted differently under Singapore regulations compared to other markets?

Early assessment of these areas can help reduce unnecessary reformulation work, marketing revisions and regulatory delays later in the process.

Why Early Regulatory Positioning Matters

In many situations, companies only begin considering regulatory requirements after the product formulation, branding and marketing concepts have already been finalized.

However, by that stage, significant changes may already be required if the product positioning begins leaning too closely towards therapeutic territory.

This is particularly common in products developed around:

• aggressive efficacy positioning,
• novel ingredient technologies,
• highly concentrated botanical blends,
• or “cosmeceutical”-style concepts designed to appear more clinically effective.

In practice, regulatory assessment should not only focus on whether an ingredient is “allowed” individually, but also whether the overall product presentation, formulation rationale and intended claims remain consistent with the intended product category.

This is one of the reasons why early regulatory strategy discussions are important before large-scale manufacturing, packaging finalisation or marketing rollout begins.

How TRC Can Support

TRC supports companies with early-stage regulatory assessment for health supplements, cosmetics and borderline products intended for the Singapore market.

Support may include:

• product classification assessment,
• formulation and ingredient review,
• claims and label evaluation,
• identification of borderline regulatory risks,
• and guidance on appropriate market positioning before importation or submission activities.

In many situations, an early regulatory review is often sufficient to identify potential issues before significant time and resources are invested into product launch activities.

If your company is currently evaluating a new supplement, cosmetic or functional wellness product for the Singapore market, feel free to contact TRC for an initial discussion.

Key Takeaways

• A compliant Product Information File (PIF) is mandatory for all cosmetic product notifications in Singapore.
• The PIF demonstrates safety, quality, and compliance with Health Sciences Authority (HSA) and ASEAN Cosmetic Directive (ACD) requirements.
• Common pitfalls include unsubstantiated claims, use of banned ingredients, and incomplete safety assessments.
• The Reg Consultants (TRC) supports cosmetic companies  by reviewing and maintaining  PIFs to meet ACD requirements and avoid enforcement issues with HSA.

Why PIF Compliance Matters in Singapore’s Cosmetic Industry

Cosmetic product notification isn’t just a simple formality.  The Product Information File (PIF) is a comprehensive safety dossier that establishes your product safety and quality standards. Without a compliant PIF, your brand risks import refusals, product seizures, market withdrawals, or unannounced audits — all of which can severely affect timelines and reputation.

Recent HSA recalls of cosmetic products containing undeclared restricted substances underscore the importance of having a fully compliant PIF. Working with a regulatory affairs consultant ensures your PIF is robust before market entry.

What is a PIF and Who Needs It?

The PIF is mandatory for every cosmetic product notification in Singapore. It must be kept readily accessible, whether physically or digitally, for inspection at any time by the HSA. For overseas brands, this responsibility is usually handled by a local cosmetic notification holder r or appointed partner.The product owner is reposnible to provide the local appointed holder with PIF and need to take proactive steps to ensure that a compliant PIF is in place before their products enter the Singapore market.

Key Components of a Compliant PIF

A compliant Product Information File (PIF) is a complete dossier that demonstrates your product meets Singapore’s cosmetic regulations and ASEAN Cosmetic Directive (ACD) standards. Core elements include:

a) The qualitative and quantitative composition of the product, in case of perfume compositions, the name and code number of the composition and the identity of the supplier;
b) Specifications of the raw materials and finished product;
c) The method of manufacture complying with the good manufacturing practice as laid down in the ASEAN Guidelines
d) Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure;
e) Existing data on undesirable effects on human health resulting from use of the cosmetic product; and
f) Supporting data for claimed benefits of cosmetic products should be made available; to justify the nature of its effect;

They should be organized into Part I(Administrative documents and Product Summary ), Part II (Quality data of raw materials), Part III (Quality data of Finished Product) and Part IV( Safety and Efficacy Data) as per a dossier.

Together, these components form the backbone of cosmetic compliance, supporting a smooth HSA notification and protecting your brand from enforcement actions.

Common Pitfalls We See

Recurring issues that delay approval or trigger enforcement include:

• Unsubstantiated product claims: Terms like “whitening” and “anti-ageing” require supporting evidence such as clinical trial summaries, published data, or in vitro studies. 
• Use of banned or restricted ingredients: Outdated formulations or poor ingredient verification often result in the accidental inclusion of substances restricted under the ACD. This not only causes rejection but can raise red flags for future submissions.
• Incomplete or weak stability and shelf-life data: HSA expects evidence to demonstrate that a product maintains its safety and quality until its expiry. Submitting generic data or failing to provide in-market product samples can delay approval.
• Safety assessments from unqualified assessors: A cosmetic safety dossier must be signed off by a qualified safety assessor recognised under EU/ASEAN standards. Using assessors without the proper credentials may undermine the validity of your PIF.
• Inconsistent or non-compliant labelling: Issues such as missing mandatory warnings, incorrect font sizes, or formatting errors are frequently overlooked but can trigger corrective action or product recalls.
• PIF file is not available or established for the product placed on market.
• PIF file is not updated with the latest quality and safety information supporting safe usage.

Each of these pitfalls can result in costly delays or enforcement actions that damage your brand’s credibility.

How TRC Can Help

At The Reg Consultants (TRC), we provide end-to-end pharma regulatory services to help companies manage the complex requirements of cosmetic product notification. With expertise in regulatory affairs, TRC offers:

• Comprehensive PIF reviews and support during audit by the authority 
• Ingredient screening against the ACD and HSA’s database.
• Labelling and claims review 
• Acting as a local cosmetic notification holder 
• Ongoing annual updates and file maintenance to ensure that your PIF remains inspection-ready and avoids unpleasant surprises.
  

As experienced regulatory affairs consultants in Singapore, we understand both the technical requirements of PIF compilation and the practical challenges companies face during cosmetic product notification. 

Stay Audit- and Market-Ready with TRC

A compliant PIF is both a defensive shield against enforcement actions and a strategic asset that supports smooth market entry. For companies going through the cosmetic product notification process in Singapore, keeping a PIF inspection-ready is non-negotiable.

With TRC by your side, you can rest assured that your PIF is always audit-ready and aligned with HSA expectations. More than a compliance check, we become a trusted partner, helping you safeguard timelines, protect brand reputation, and enter the Singapore market with confidence.

Contact us to safeguard your brand today.

In Singapore’s bustling cosmetic market, the allure of new and innovative products can sometimes distract businesses from the crucial need for regulatory compliance. While consumers eagerly seek the latest beauty trends, many businesses may unknowingly supply un-notified cosmetic products. This oversight not only poses risks to consumer safety but also poses serious consequences for businesses, including hefty fines and damage to their reputation. In this article, we’ll uncover the hidden dangers of un-notified products and highlight why adhering to notification requirements is essential.

Regulatory Requirements

In Singapore, the notification requirements for cosmetic products are clearly defined. Before launching a new product, businesses must notify their cosmetic product with  Health Sciences Authority (HSA). This process ensures that all cosmetics meet essential safety standards and comply with local regulations. Similarly, un-notified health supplements face the same level of scrutiny, as they must follow specific notification requirements to protect consumer health. Additionally, nutraceutical regulations play a vital role in ensuring that health-related products are safe and effective. By understanding these regulations, companies can avoid the pitfalls linked to un-notified products and play a critical role in safeguarding consumer well-being.

Penalties for Non-Compliance

Failing to comply with cosmetic product notification can lead to serious repercussions. Businesses supplying un-notified cosmetic products face hefty penalties for non-compliance. They must stop the sale of these products and take all reasonable steps to recall them. Under the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations 2007, companies could face fines of up to $20,000 and/or a prison sentence of up to 12 months. Such penalties can significantly impact a company’s financial health and growth, so adhering to these regulations is crucial for maintaining a successful business. The same strict penalties apply to un-notified health products, underscoring the importance of compliance across all product categories.

Consumer Safety Concerns

One of the biggest concerns with un-notified cosmetic products is their potential risk to consumer safety. Without proper notification, there’s no guarantee that these products have undergone thorough testing for safety and effectiveness. This uncertainty can result in adverse reactions and health risks for consumers. Therefore, dealers and importers of cosmetic products have the ultimate responsibility to ensure their products, whether cosmetics or health supplements, are safe for public use. Complying with local regulatory requirements is vital for protecting consumer well-being in both sectors. Health Sciences Authority regularly publish updates on consumer safety news about unsafe products such as the ones below:

• https://www.hsa.gov.sg/consumer-safety/articles/details/dubious-weight-loss-products
• https://www.hsa.gov.sg/consumer-safety/articles/details/magic-water-facial-solution-skin-peeling-chemical-burns
• https://www.hsa.gov.sg/consumer-safety/articles/details/staying-safe-cosmetic-products

Impact on Business Reputation

The consequences of supplying un-notified cosmetic products go beyond regulatory penalties and safety risks; it can also severely impact a business’s reputation. In an age where consumers are more conscious about product safety and transparency, failing to comply can erode trust and credibility. Negative publicity related to non-compliance can tarnish a company’s image, making it hard to win back consumer confidence. Businesses need to prioritise compliance to avoid penalties, safeguard their reputation, and maintain customer loyalty, particularly in markets filled with cosmetic and health products.

Compliance Strategies

To reduce the risks linked to un-notified cosmetic products, businesses should embrace effective compliance strategies. This involves staying up-to-date with regulatory changes, establishing strong internal processes for product notification, and seeking professional regulatory affairs services when necessary. By cultivating a culture of compliance within their organisations, companies can significantly lower non-compliance risks and ensure that their cosmetic and health products meet the required safety standards.

Navigating the landscape of cosmetic products in Singapore requires a thorough understanding of regulatory requirements and a genuine commitment to consumer safety. Prioritising compliance with notification requirements helps businesses shield themselves from penalties, protect their reputation, and, most importantly, ensure consumer safety. As the demand for cosmetic and health products continues to rise, companies must be proactive in their compliance efforts. Partnering with experienced regulatory affairs service providers can provide invaluable support and peace of mind for those needing guidance in regulatory affairs and the complexities of product notification. 

Contact The Reg Consultants today to ensure your products are compliant, safe, and ready for market success. Our expert team is here to assist you every step of the way. Head to our website for more information on what we offer!

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

 

Fueled by a consumer base eager to try out new, up-and-coming products from around the world, Singapore’s cosmetics and personal care industry has experienced remarkable growth in recent years. However, this surge has also caused the demand for quality to rise, with more customers expecting better efficacy and product safety. This increases the challenge that companies in the cosmetics and personal care sector face with regulatory compliance. In this article, we’ll talk about the regulatory challenges that companies should pay attention to and the steps that need to be taken to ensure product safety, compliance, and sustainable growth. 

Learn More: 3 Facts to Know When Importing Cosmetics Into Singapore

1. Product Safety Assessment

The Health Sciences Authority (HSA) has made it mandatory for manufacturers to conduct rigorous safety assessments, such as toxicological evaluations, to identify any potential risks that their products could cause. This is because, all products, whether for medical applications or personal care, must be safe for use and must not cause any adverse reactions that could pose an issue for public health. 

2. Ingredient Restrictions

Apart from product safety assessments, HSA has also established strict regulations regarding the use of specific ingredients in cosmetic and personal care products to further ensure safety. 

Businesses must review and update their product formulations regularly to remove restricted ingredients or limit their use in order to comply with these regulatory standards. Additionally, they should invest in research and development to identify safer alternatives, and collaborate with suppliers who provide compliant raw materials. 

3. Product Labelling and Packaging

All product labels are required to display essential information about the product to provide customers with accurate information about what they are purchasing and for regulatory authorities to trace products in case of issues. They should include the manufacturer’s contact details, product name, a detailed ingredient list, warnings, and clear usage instructions.

To meet these requirements, businesses must work with designers and regulatory experts to craft labels that adhere to the guidelines, as well as conduct regular reviews of packaging and labelling to ensure they remain compliant with changing regulations. 

When it comes to complying with product labelling guidelines, there are numerous intricate details that require attention. We recommend working with a regulatory consulting service to ensure that you do not miss out on any key information.

4. Substantiating Claims

Any product claims, such as “anti-ageing” or “skin whitening,” must be substantiated by scientific evidence. HSA closely monitors these claims, and businesses advertising any misleading or unsupported claims can face penalties. 

If companies wish to include any of these claims in their product information or advertisement, research findings and data from scientific studies and clinical trials must be provided to validate these claims. Businesses can also work with qualified dermatologists or experts in related fields to conduct independent assessments of product efficacy. 

Otherwise, one simple way to ensure compliance is to avoid the mention of these terms. 

5. Good Manufacturing Practices (GMP)

Lastly, companies are required to follow a set of good manufacturing practices in order to better guarantee product quality and safety. They include, but are not limited to:

• Maintaining cutting-edge facilities designed to prevent contamination and ensure cleanliness
• Maintaining comprehensive records of manufacturing processes, testing, and quality control procedures
• Proper storage and distribution practices
• Providing adequate training and education to employees.

Regulatory affairs management in Singapore’s cosmetics and personal care industry is difficult to navigate but an important step to go through. By addressing the above-mentioned challenges effectively, companies can not only ensure compliance with local regulations but also enhance their reputation and competitiveness in the market.

The Reg Consultants is a regulatory service provider that offers both local and overseas cosmetics and personal care companies regulatory assistance. Contact us today to find out how we can help you. 

Cosmetic products are substances or mixtures intended for application to the external parts of the body, such as the skin, hair, nails, lips and teeth, for purposes including cleansing, perfuming, protecting or enhancing appearance.

In Singapore, cosmetic products are regulated by the Health Sciences Authority and are subject to a mandatory cosmetic product notification prior to supply in the market.

Cosmetics are required to be notified through the cosmetic product notification process before they can be sold in the market unless they fall under the circumstances below:

1. Supplied solely as a sample in connection with any advertising, sponsorship or promotional activity
2. Supplied solely for testing or trial use in connection with any research or development of that product
3. Manufactured by or in accordance with the specifications of a medical practitioner and supplied solely by that medical practitioner for the use of patients under his care

Companies intending to place cosmetic products on the Singapore market are required to complete the notification process prior to supply. You may refer to our cosmetic product notification support services for further details.

Before supplying cosmetics in Singapore, we need to perform the following steps:

1. Classification 

The first step is to determine whether the product falls within the definition of a cosmetic in the local context. As shared in the previous article: https://theregconsultants.com/regulatory-classification-of-medical-products/, a “cosmetic product” is defined as any substance or preparation designed for application to the external parts of the body, including teeth and oral mucous membranes. These products must undergo a cosmetic product notification process before they can be legally marketed in Singapore.

• Cleaning
• Perfuming
• Changing appearance
• Correcting body odours
• Protecting
• Keeping in good condition

 

Examples of products that are not cosmetics are:

• Oral supplements for beauty purposes
• Injections/injectable products
• Massage and essential oils
• Aesthetic/beauty devices
• Lubricants
• Insect repellents
• Sanitary pads
• Hand sanitisers
• Creams for treating acne, eczema, and psoriasis
• Toothbrushes
• Dental floss
• Detergents
• Temporary tattoos
• Fake eyelashes
• Nail stickers
• LED lights used in dental kits (note that whitening gel is considered a cosmetic product)

 

2. Safety and Testing 

In terms of product safety, companies need to consider the main components, such as the composition, labelling, claims, and whether the product manufactured meets the specifications set. 

Companies should ensure that cosmetic products do not contain ingredients listed in the prohibited or restricted annexes under the ASEAN Cosmetic Directive.

Labelling of cosmetics should contain the key information below:

1. Name of the cosmetic product
2. Function of the cosmetic product
3. Instructions for use
4. Full ingredients listing
5. Country of manufacture
6. Contents (weight/volume)
7. Batch number
8. Manufacturing/expiry date (expiry date is only required for products with less than 30 months durability)
9. Name and address in Singapore of the company responsible for placing the product in the market
10. Special precautions, if any (especially those listed in Annex III, VI, VII in the ASEAN Cosmetic Directive)

Cosmetic claims should be appropriately assigned based on the key ingredient function, target site of application, and physiological effects of cosmetics. Some examples of claims that are unacceptable in accordance with the ASEAN Cosmetic Claims Guide can be found here:

To ensure product meets safety and quality consistency,  manufacture should follows Good Manufacturing Practices (GMP) or ISO standard 22716:2007, conducts local testing for potential contaminants, and ensures the product is free from common adulterants.

Examples of appropriate testing on products are provided below:

Product Type	Claims
Teeth whitening products	To test the concentration of hydrogen peroxide. Hydrogen peroxide, when in high concentrations, is corrosive and may cause irritation to the eyes, mucous membranes, and skin. Only products with hydrogen peroxide of concentration up to 0.1% can be allowed for supply to consumers directly.
Skin Whitening creams	To test for the presence of adulterants e.g., Hydroquinone, tretinoin, and mercury. Hydroquinone and tretinoin are potent ingredients that are not suitable for use in skincare cosmetic products. The inappropriate use of hydroquinone could result in changes in skin color and hypersensitivity reactions such as rashes, redness, tingling, and burning of the skin. Tretinoin could lead to redness and peeling of the skin and should only be used under medical supervision.

In practice, a structured regulatory review is often required to assess ingredient acceptability, claims and supporting documentation prior to notification.

3. On-site requirements 

Cosmetic product notification should be performed by a locally registered company acting as the Responsible Person for placing the product in the Singapore market. This may be the importer, distributor, retailer, or an appointed local representative.

As cosmetic products are not evaluated by the authorities prior to supply, the Responsible Person remains accountable for ensuring the safety and quality of the product.

The following key documentation that should be maintained and kept on site as as follow and must be ready for inspection:

• Product information file: This file contains all the quality and safety records of the cosmetics to comply with the relevant standards. It should be kept updated in accordance with what is happening at the manufacturing end that could impact your product.
• Records of cosmetic supply to the market: Records should be maintained for two years in accordance with the Guidelines on the Control of Cosmetics. The record should contain the product’s name and notification number, the company’s name and address, and the batch number, date, and quantity of the product supplied.
• Monitor and report any product defect/adverse events to the authority and perform a prompt recall for the product: The reporting timeline is seven days for adverse events that are life-threatening or result in death and 15 days for adverse events that result in hospitalisation or any persistent or significant disability or incapacity.

TRC supports clients on an end-to-end basis, from classification and regulatory assessment through to cosmetic product notification and post-market compliance.

You may refer to our cosmetic regulatory support services or contact us to discuss your specific requirements.

Frequently Asked Questions

1. What is cosmetic product notification?

Cosmetic product notification is a mandatory requirement in Singapore. Companies must notify their products to the authority before supplying them in the market.

2. Which cosmetic regulation does Singapore follow?

Singapore follows the ASEAN Cosmetic Directive, which establishes guidelines for cosmetic product safety, labelling, and claims. Products must undergo cosmetic product notification before entering the market.

3. Do I need a cosmetic product safety report for notification?

Yes, during the cosmetic product notification process, safety assessments, including toxicological evaluations, must be conducted to ensure the product is safe for use.

4. What is HSA cosmetic product notification?

HSA cosmetic product notification is a mandatory process that ensures cosmetic products meet Singapore’s regulatory and safety standards before being sold.

5. What is the process for notifying cosmetic products in Singapore?

The process is carried out through the Product Registration and Information System (PRISM). Manufacturers and importers must submit the required information and documentation to the Health Sciences Authority (HSA) via this online platform.

6. Do I need a local company to notify cosmetic products in Singapore?

Yes. Cosmetic product notification must be performed by a company registered in Singapore, acting as the Responsible Person for placing the product in the market.

The Responsible Person is accountable for ensuring that the product complies with all applicable regulatory requirements, including safety, labelling and post-market obligations.

7. What are common issues encountered during cosmetic product notification?

Common issues include incorrect product classification, use of restricted or prohibited ingredients, non-compliant labelling, and unsupported product claims.

In practice, these issues are often identified only at a later stage, resulting in delays or the need for product reformulation prior to market entry.