HSA Cosmetic Notification and Fragrance Allergens: What to Demand From Your Fragrance Supplier

Updated

August 6, 2026

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HSA Cosmetic Notification

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Key takeaway: Singapore regulates cosmetics through the ASEAN Cosmetic Directive, implemented locally from 1 January 2008 and enforced by the Health Sciences Authority. There is no pre-market approval. You notify the product, HSA does not vet it, and full legal liability for safety and compliance sits with you, the dealer. The ACD annexes that govern prohibited and restricted ingredients were last updated in June 2026 and are revised roughly twice a year. Because most restricted fragrance allergens sit inside a composition you cannot see, your compliance position is only as good as the documentation your fragrance supplier gives you. If they will not give you a full allergen declaration and an IFRA conformity certificate, you are carrying their risk on your licence.

How Singapore actually regulates cosmetics

The structure surprises people who are used to registration regimes.

Cosmetic products in Singapore fall under the Health Products Act and the Health Products (Cosmetic Products, ASEAN Cosmetic Directive) Regulations. The ASEAN Cosmetic Directive is a harmonisation agreement across ASEAN member states designed to reduce technical barriers to trade, and Singapore implemented it on 1 January 2008.

The operative points for a manufacturer or brand owner:

  • You must notify a cosmetic product before selling it in Singapore. Notification is submitted to HSA through PRISM.
  • A notification is valid for one year and must be renewed.
  • Notification is not approval. HSA does not assess your formulation before it goes to market. There is no safety review at the gate.
  • The legal responsibility for product safety and regulatory compliance rests entirely with the dealer. You are asserting compliance, not being granted it.
  • You must hold a Product Information File and be able to produce it on demand.
  • Enforcement is through post-market surveillance. The regulator finds problems after your product is on shelf, which is the worst possible time to discover that your fragrance contained a restricted substance above its permitted limit.

That last point is the whole reason this article exists. In a notification regime, the compliance burden shifts upstream to you, and from you to your ingredient suppliers. Nobody is going to catch the error for you.

The annexes are a moving target

The ACD controls ingredients through a set of annexes:

  • Annex II lists substances that must not form part of a cosmetic composition at all.
  • Annex III lists substances that may be used only subject to restrictions and conditions. This is where fragrance allergens live, along with concentration limits and mandatory warning statements.
  • Annex IV lists permitted colouring agents.
  • Annex VI lists permitted preservatives.
  • Annex VII lists permitted UV filters.

The ASEAN Cosmetic Committee and the ASEAN Cosmetic Scientific Body meet twice a year to review and amend these annexes. HSA published the most recent update to the annexes in June 2026.

The consequence for anyone buying fragrance: a fragrance that was compliant when you notified the product may not be compliant twelve months later. Substances move onto Annex III. Concentration limits tighten. New warning-statement requirements attach.

A fragrance is not a one-time compliance check. It is a subscription.

The fragrance labelling rule, and the trap inside it

Under the ASEAN cosmetic labelling requirements, you must declare the full ingredient list using International Nomenclature of Cosmetic Ingredients names, in descending order of weight at the time of addition.

Fragrance gets a concession. Perfume and aromatic compositions and their raw materials may be declared collectively using the words “perfume”, “fragrance”, “aroma” or “flavour”, rather than by naming every constituent. This is what protects the perfumer’s formula as a trade secret, and it is why almost every cosmetic INCI list ends with “PARFUM”.

Here is the trap. The concession does not extend to restricted substances. Where a fragrance contains a substance listed in Annex III, that substance is subject to the Annex III conditions, which can include individual declaration on the label, a concentration limit, and a mandatory warning.

So the “PARFUM” line on your label is not a compliance shield. It is a summary of everything except the parts that matter most. The named allergens have to come out from behind it.

And you, the brand owner, cannot see them. Only your fragrance supplier knows what is in the composition.

This is the structural problem at the heart of cosmetic fragrance compliance in Singapore. Your legal exposure is determined by information you do not possess.

IFRA 51 is now fully in force

Alongside the regulatory annexes sits the International Fragrance Association’s Standards, the self-regulatory safety framework the fragrance industry applies to itself. IFRA Standards set usage restrictions, specifications and prohibitions for fragrance materials by product category.

The 51st Amendment to the IFRA Standards was notified on 30 June 2023. It introduced 59 new rules, bringing the total to 263 Standards. Its compliance deadlines have now both passed: 30 March 2024 for new creations, and 30 October 2025 for products already on the market before that date.

In other words, as of today there is no transition period left to hide in. Any fragrance in any product you are selling should be IFRA 51 compliant, and your supplier should be able to prove it with a Certificate of Conformity issued against the specific product category and dosage you are using.

Note the phrase “specific product category and dosage”. IFRA limits are category-dependent. A fragrance compliant at 1 percent in a rinse-off shower gel may be non-compliant at the same 1 percent in a leave-on face cream. An IFRA certificate that does not name your category and your use level is not telling you what you need to know.

The oxidation problem nobody puts in the compliance file

There is a failure mode specific to this region that connects compliance to shelf life, and it is routinely missed.

Two of the most common restricted fragrance allergens, limonene and linalool, are not strong sensitisers in their pure form. They become sensitisers when they oxidise. Air, heat and light convert them into hydroperoxides that are considerably more allergenic than the parent molecule.

Singapore sits in ICH Climatic Zone IVb, the hot and very humid zone, with long-term stability storage conditions of 30 degrees Celsius and 75 percent relative humidity. These are aggressive oxidation conditions.

The implication is uncomfortable and important. A product can be allergen-compliant on the day it is filled and drift out of compliance on the shelf, as the fragrance oxidises and the sensitiser load rises. Your notification was accurate. Your product, six months into a Singapore supply chain, may not be.

Managing this is a formulation and packaging problem, not a paperwork problem: antioxidant systems, low-headspace and opaque packaging, appropriate use of terpeneless or folded materials, and stability testing that actually runs at Zone IVb conditions rather than temperate ones. We cover the chemistry in Formulating for the Tropics.

What to demand from your fragrance supplier

Do not accept a sample and a price. For any fragrance going into a product notified in Singapore, require the following before you specify it in.

  1. IFRA Certificate of Conformity, issued against the current IFRA Standards, and naming your product category and your intended use level.
  2. Full allergen declaration, listing every restricted substance present and its concentration in the fragrance compound, so you can calculate the level in the finished product and determine your labelling obligation.
  3. ASEAN Cosmetic Directive annex screening, confirming the composition contains no Annex II substance and that all Annex III substances are within limits at your use level.
  4. Full quantitative formula, either disclosed to you or lodged directly with your safety assessor under confidentiality. If a supplier will disclose to neither, they are asking you to sign a safety assessment you cannot support.
  5. Safety Data Sheet and Certificate of Analysis for the supplied batch.
  6. INCI listing for the composition as supplied.
  7. Stability and compatibility data in a base comparable to yours, at Zone IVb conditions.
  8. A written change-notification commitment. If the perfumer reformulates, you must be told, because your notification, your safety assessment and your label may all become wrong at once.

Item four is the one that separates serious suppliers from the rest. A fragrance house that will not disclose its formula to a qualified safety assessor under NDA is not a supplier you can build a compliant portfolio on.

The Product Information File is a shared document

Your PIF is your defence when HSA asks questions. It must cover product description, method of manufacture and a GMP statement, the safety assessment, and supporting data.

A large portion of the material needed to build that file does not originate with you. It originates with your fragrance and ingredient suppliers. If your suppliers are slow, vague or unwilling, your PIF has holes in it, and those holes are your liability, not theirs.

Choose fragrance partners on documentation quality, not only on the quality of the scent. A brilliant fragrance you cannot defend is a commercial liability.

If your product is also halal positioned, the documentation burden compounds, because the ethanol carrier and any animal-derived materials in the composition come under separate scrutiny. See MUIS Halal Certification for Flavours and Fragrances for what to ask for. And if the product is a food or beverage rather than a cosmetic, the parallel exercise is set out in Nutri-Grade Reformulation.

How Norex supports cosmetic manufacturers

Norex has supplied fragrances, essential oils and aroma chemicals into personal care and cosmetics since 1994, alongside our flavour and mint products ranges. Our Quality Assurance department operates independently of Quality Control and Production, our manufacturing operates under documented quality systems, and our certifications span quality management, food safety and pharmaceutical compliance including REACH registration.

If you are notifying a cosmetic product in Singapore and need a fragrance supplier who will supply the documentation rather than avoid the question, contact our team.

Frequently asked questions

Does Singapore require pre-market approval for cosmetics?

No. Singapore operates a notification regime under the ASEAN Cosmetic Directive, enforced by the Health Sciences Authority. Products are notified through PRISM and the notification is valid for one year. HSA does not assess the formulation before market entry, and full legal responsibility for safety and compliance rests with the dealer. Enforcement is through post-market surveillance.

Can I declare fragrance simply as “PARFUM” on my label in Singapore?

Partly. Under ASEAN cosmetic labelling requirements, perfume and aromatic compositions and their raw materials may be declared collectively as “perfume”, “fragrance”, “aroma” or “flavour”. However, this concession does not extend to substances restricted under Annex III of the ASEAN Cosmetic Directive. Restricted fragrance allergens remain subject to their Annex III conditions, which can include individual declaration, concentration limits and mandatory warnings.

How often do the ASEAN Cosmetic Directive annexes change?

The ASEAN Cosmetic Committee and the ASEAN Cosmetic Scientific Body meet twice a year to review and amend the annexes. HSA published the most recent update in June 2026. A fragrance that was compliant at the time of notification may not remain compliant, so annex screening should be periodic rather than one-time.

Is IFRA 51 still in a transition period?

No. The 51st Amendment to the IFRA Standards was notified on 30 June 2023 and introduced 59 new rules for a total of 263 Standards. The compliance deadline for new creations was 30 March 2024 and the deadline for products already on the market was 30 October 2025. Both have passed, so all fragrances currently on sale should be IFRA 51 compliant.

Why do limonene and linalool matter for fragrance compliance?

Limonene and linalool are weak sensitisers in pure form but become significantly more allergenic when they oxidise into hydroperoxides on exposure to air, heat and light. Singapore sits in ICH Climatic Zone IVb, with stability conditions of 30 degrees Celsius and 75 percent relative humidity, which accelerates that oxidation. A product can therefore be allergen-compliant at fill and drift out of compliance during shelf life, which makes antioxidant systems, packaging and Zone IVb stability testing a compliance issue and not just a quality issue.