How Are Cosmetic Products Regulated in Singapore?

According to Statista, the beauty and personal care market in Singapore is estimated to be worth US$1.24B in 2024, with cosmetics alone accounting for some US$200M.

The past decades have seen Singapore adopt a regionally-aligned stance on regulating cosmetics, ever since the ASEAN Cosmetics Directive (ACD) was formally adopted on 2 September 2003 by treaty, and implemented on 1 January 2008.

Singapore’s laws cover several aspects of the commercial sale and supply of cosmetics, which would be of interest to sellers, suppliers, as well as consumers.

This article will cover:

• What are cosmetic products and non-cosmetic products?
• The HSA’s role as cosmetic products regulator 
• How are cosmetic products regulated in Singapore?
• What can consumers do if they experience an adverse reaction to a cosmetic product?

What are Cosmetic Products?

According to Singapore’s Health Products Act (HPA), the Health Sciences Authority (HSA) as well as the ASEAN Cosmetic Directive (ACD), a “cosmetic product” can be generally defined as:

“Any substance or preparation that is intended by its manufacturer to be placed in contact (a) with the various external parts of the human body or (b) with the teeth or the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, correcting body odours, protecting them, or keeping them in good condition.”

Some products that fit this description of a cosmetic product include:

• Hair care products, hair tints and bleaches;
• Make-up and make-up removers;
• Depilatories;
• Deodorants and antiperspirants;
• Cleansing lotions, shaving foams; and
• Face masks that do not involve chemical peeling.

Non-cosmetic products

The HSA has also listed some products that are not considered “cosmetic products”.  These include:

• Injections;
• Eye drops;
• Products that are consumed orally (e.g., tablets, capsules or beverages); and
• Products that are intended for treatment (e.g., acne treatment creams).

Some of these products may be classified as other types of health products, such as medical products or therapeutic products, and are thus subject to different requirements under the HPA.

Further, some of these examples are more obvious in not fitting the description of a cosmetic product, for example, beverages are not meant to be applied on the external surface or stay within the oral cavity.  Others may occupy a grey area that needs to be resolved and are referred to as “borderline products”.

“Borderline” products     

Just like their EU counterparts, the ASEAN Cosmetics Committee has also made decisions on “borderline” products, ruling on whether certain items are cosmetic products.  This is how we arrive at very fine distinctions.

For example, anti-acne treatment creams can be considered cosmetic if the anti-acne aspect is “used as a secondary function”, i.e., the product’s main purpose is not meant to treat acne even though it has that effect – otherwise they would be therapeutic and subject to different rules.

This may seem like a hair-splitting exercise, but it can have significant implications for suppliers, as it decides what products are considered “cosmetic products” and therefore subject to less stringent regulatory requirements as compared to medical or therapeutic products.

The HSA’s Role as Cosmetic Products Regulator 

In Singapore, the HPA is the law that governs “health products”, which is a rather broad class of products including:

• “Medical devices” such as wheelchairs, tongue depressors, bone fixation plates, heart valves, disease diagnosis standalone software, invasive fat removal apparatus, contraceptive implants;
• “Cosmetic products” which are discussed in this article;
• “Therapeutic products” such as substances for inducing anaesthesia, or substances exerting chemical effects for preventive purposes (outside of traditional or homoeopathic medicine) – these are defined by whether they contain any one of a long list of active ingredients and are meant for use on humans;
• Oral dental gum; and
• “Cell, tissue or gene therapy products”, such as bone grafts, gene-modified cells and vectors with therapeutic genes.

Each time the HPA mentions the “Authority” responsible for administering it, it is referring to the HSA (except when it comes to regulating health products or active ingredients intended for veterinary purposes).

HSA also administers the subsidiary legislation under the HPA. These include the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (Cosmetic Products Regulations) which sets out rules specifically for cosmetic products. These rules cover several topics, such as notification, contents, labelling, advertising, record-keeping and reporting of defects and adverse effects. The reason the Cosmetic Products Regulations have a long title referencing the ACD is because the latter is the source document for our local rules.

How are Cosmetic Products Regulated in Singapore?

Cosmetic products: A special type of health product that does not require licensing or registration

The HPA has several rules that apply generally to all health products. However, it also makes several exceptions for cosmetic products. To begin with, you do not need a licence to manufacture, import or wholesale cosmetic products, even though these are generally required for manufacturing, importing or wholesaling most other types of health products.

Furthermore, the general rules on registration and advertising also do not apply to cosmetic products as they have been replaced with specific rules on notification and advertising under the Cosmetic Products Regulations.

Unlike other health products, cosmetic products are also subject to some special additional rules:

• For manufacturing and importing, if the purpose of manufacturing or importing cosmetic products is for export (or re-export) out of Singapore, additional regulations apply concerning maximum mercury levels.
• Manufacturers of cosmetic products can also apply for a Good Manufacturing Practice certificate for cosmetic products, which is a way to obtain permission for certain types of content that would otherwise be prohibited. While not legally mandatory, HSA’s position is that all manufacturers should apply for this.

Furthermore, all imports are subject to the general laws concerning imports, although the compliance requirements for suppliers and resellers here are quite streamlined. HSA’s guidance document helpfully points to the Certificate of Free Sale application form maintained by Singapore Customs, which deals with the regular import requirements that also apply to cosmetic products.

Online sales and foreign sources

There is no exception to the import, manufacture or other rules just because a product is being sold online.  However, products directly purchased from overseas suppliers are not subject to HSA’s oversight, and Singapore consumers should exercise caution when buying directly from overseas or unfamiliar sources.

Even online platforms such as Shopee require their sellers to comply with the Cosmetic Products Regulations. In Shopee’s case, the reason is explicitly stated i.e.,  the platform has an interest in not being seen as abetting criminal offences or supplying “prohibited material” against the public interest, and not wasting time and other resources responding to investigations against sellers.

Notification in lieu of registration

Notification is required before placing a cosmetic product on the market. Unlike other health products subject to a potentially complicated and time-consuming registration process, the notification process for cosmetic products is quite straightforward – every supplier has to notify HSA for each cosmetic product they are putting to market, and this is done conveniently through an online portal.

However, each notification is valid for only one year and requires re-notification for further supply. Industrial players can do this at HSA’s cosmetic products notification page. Breach of the notification requirements is an offence that can result in a fine of up to $20,000 and/or jail of up to 12 months.

Notification is not required for certain types of cosmetic products.These are advertising/promotional samples or gifts, for research/development purposes, or when supplied by a medical practitioner for patients under their care. Nonetheless, such types of cosmetic products are still subject to other requirements such as content, labelling and advertising (described more fully below).

Finally, notification is not the only thing that needs to be done. In view of the numerous regulatory requirements that need to be complied with, sellers and suppliers need to invest much time and effort to ensure their products are already in compliance before going to market. To this end, HSA has issued a helpful advisory to suppliers on assessing safety and quality.

Content control

Cosmetic products are subject to different types of content control. These are detailed in Parts I to V of the Cosmetic Products Regulations’ Third Schedule. Briefly:

• Part I substances: these are more than 1,000 substances, each of which is prohibited from cosmetic products unless the presence of the substance (a) is in trace amount, (b) is technically unavoidable in “good manufacturing practice”, or (c) complies with alternative overriding conditions found in Part I. Examples of such Part I substances include chlorofluorocarbons, antibiotics and lidocaine.
• Part II substances: these are substances prohibited from cosmetic products unless they satisfy all the conditions set out per respective row in Part II. These conditions typically relate to the type of product hosting the substance, maximum concentrations, and other issues such as minimum user age, restrictions to professional use, maximum post-application concentrations, and so on.  Examples of these include boric acid, ammonia and hydroquinone.
• Part III, IV and V substances: these are hair colouring agents (e.g., Green 10006), preservatives (e.g., benzoic acid) and ultraviolet filters (e.g., oxybenzone) respectively. All are prohibited from cosmetic products unless they satisfy requirements relating to matters such as maximum concentrations, product types, and warning labels.

A cosmetic product that fails the content requirements is deemed “unwholesome”, and an unwholesome product is subject to two consequences, as follows:

• It is deemed “defective”, thus triggering reporting requirements (detailed in “Records and reporting” below); and
• It is deemed “non-compliant” thus triggering liability to enforcement, such as seizure, forced recall and forced cessation of supply.

Labelling requirements

These requirements are presented differently in different places. HSA arranges the requirements by the type of information required, whereas the Cosmetic Products Regulations arranges the requirements by method, e.g., what must be listed, and how it must be arranged. The positive requirements include:

• Information rules, including name, function, instructions, ingredients, origin, manufacture/expiry date, special precautions, and local supplier details.
• Presentation rules, such as how ingredient listing is ordered, language and nomenclature, legibility, use of the metric system, and label placement in relation to packaging.

There are also negative requirements, against misleading labelling:

• Labelling must not have words or graphics suggesting HSA promotion/endorsement of the cosmetic product.
• Labelling must not create erroneous impressions regarding formulation, composition, quality or safety of the cosmetic product.

A breach of any of the labelling requirements can lead to a fine of up to $50,000 and/or a jail term of up to 2 years.

Advertising requirements

The advertising requirements prohibit against claiming therapeutic benefit/purpose for a cosmetic product, and creating erroneous impressions regarding the formulation, composition, quality or safety of a cosmetic product.

The HSA has also required compliance with Appendix III of the ACD: the ASEAN Cosmetic Claims Guidelines, which is a much more elaborate set of rules including examples of prohibited claims, and methods of softening claims, e.g.:

• Unacceptable claims for cosmetic products include saying that hair care products “eliminate dandruff completely” or “stimulate hair growth”.
• An unacceptable claim such as “removes all oil from skin” can be softened to “suitable for oily skin types”.

While the ASEAN Cosmetic Claims Guidelines do not have the status of law, strictly speaking, documents like it are referenced by HSA from time to time. These background documents (together with other policies such as requiring a Good Manufacturing Practice certificate) can nevertheless be useful.  They serve as a guide to best industrial practices. They also illustrate how regulators are likely to approach the issues addressed in these documents, or interpret the actual laws. Therefore, potential sellers and suppliers should not dismiss such informal guidance too easily.

Records and reporting

Sellers and suppliers of cosmetic products are also required to keep supply records for 2 years from each supply, for inspection by HSA. The records should contain details such as product name and notification number, date of supply, name and address of recipient, quantity of supply, and identifying details of the cosmetic product. While a breach of these recording requirements can lead to a fine of up to $10,000 and/or jail of up to 6 months, the maximum punishment is doubled if the records are false or misleading.

Sellers and suppliers are also required to report product defects, as well as adverse effects arising from the use of their cosmetic products. This includes defective status arising from failure to comply with content requirements.

The more severe the defect or adverse effect, the shorter the reporting deadline. For example, if an adverse effect has caused death or is life-threatening, a report must be made within 7 days of the seller or supplier becoming aware of the adverse effect occurring. Where only a hospitalisation has occurred, the deadline is 15 days. Non-compliance with reporting requirements can result in a fine of up to $20,000 and/or a jail term of up to 12 months.

HSA has helpfully issued a guidance document covering supplier/seller reporting, as well as the mechanics of a product recall.

What Can Consumers Do If They Experience An Adverse Reaction to a Cosmetic Product?

HSA’s adverse effect reporting form is detailed and unwieldy because it is meant for industrial players, i.e., sellers, suppliers and medical professionals. So, what should a consumer do when they encounter a product defect, or experience an adverse reaction to a cosmetic product?

Of course, prevention is usually better than cure, and HSA has issued an “all you need to know” smart consumer guide. Some useful tips include trying a skin product on a small area before further use, and taking note if the product packaging has any logos or marks to signify an endorsement by HSA.

Nevertheless, if you are unfortunately affected by the use of a product, the first step is to protect yourself – stop using the product immediately, assess the seriousness of the situation, and bring the product with you to consult your doctor if the condition does not go away or worsens. Preserve all evidence, including any medical reports. Take photographs if applicable, write down details of your use of the product (and your reaction to it) as soon as possible, and then contact HSA by email to hsa_info@hsa.gov.sg.

In some cases, you may consider other – possibly non-medical – remedies.  Even outside of defects and adverse effects leading to personal injury, there is the possibility of online scams and misleading advertisements. Raising the issue directly with the seller/supplier, or with third parties such as the Consumer Association of Singapore or even the regulators such as HSA, may help in small ways.

However, we also recommend finding a lawyer to assess the severity of the situation and whether the case can be pursued from there. A lawyer should be able to help you identify the legal issues arising from your use and/or purchase of a cosmetic product, and advise on the potential next steps, be it making a direct claim or pursuing some other form of dispute resolution.

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Singapore imposes robust and multi-layered regulations on cosmetic products. The compliance burden on sellers and suppliers is heavy, especially if they are not themselves the manufacturers of such products. This is for good reason, since there is a high likelihood of personal injury to a very large number of people who use such products regularly.

If you intend to enter this market as a seller or supplier, it is best to familiarise yourself not only with the formal law, but the guidance and compliance mechanisms, including the various Government-to-Business portals for notification, reporting and other matters. To this end, you should consider engaging a corporate lawyer for advice on the legal compliances and laws applicable in the cosmetic industry, over and above the usual concerns with setting up any business.

Knowing the basics of cosmetic product regulation is also beneficial for consumers, because the available remedies they have may depend on an accurate assessment of what went wrong, whether an advertising claim was legitimate, and whether the product was regulated in the first place.

You can get quick legal advice from an experienced lawyer via our Call A Lawyer service.