Description: Urgent regulatory alert for Malaysian skincare brands. NPRA Circular No. 3/2024 bans Benzophenone and limits Benzophenone-3 in body lotions. Check your compliance before the November 2026 deadline!
Introduction
Imagine this: You have thousands of bottles of your best-selling body lotion sitting in your warehouse. The packaging is perfect, the scent is lovely, and customers buy it every day. Then, you receive a letter stating you cannot sell a single unit because one ingredient—just 5% of your formula is now illegal.
This is not a hypothetical nightmare. It is the reality facing Malaysian brand owners who do not prepare for NPRA Circular No. 3/2024.
On 30 December 2024, the National Pharmaceutical Regulatory Agency (NPRA) aligned Malaysia with the strict new ASEAN Cosmetic Directive (ACD). The clock is ticking. You have until 19 November 2026 to clean up your ingredient list.
If your products contain specific UV filters or stabilisers, you need to act now. Here is the specific data you need to save your brand from a product recall.
The Immediate Ban on Benzophenone
First, check your labels for Benzophenone (CAS No. 119-61-9).
You might not even know this is in your product. It is not always a sunscreen filter; it is often used as a stabiliser. If you sell clear shampoos, serums, or perfumes in transparent bottles, your chemist likely added Benzophenone to stop the colour from fading in the sunlight.
- The New Rule: As of the November 2026 deadline, Benzophenone is Prohibited (Annex II).
- What You Must Do: If you use this to protect your product’s colour, you must reformulate immediately. There are safer stabilisers available that do the same job without breaking the law.
Why Did the Government Ban It?
The ban is not arbitrary. It stems from the ASEAN Cosmetic Committee adopting the European Union’s classification of Benzophenone as a CMR Substance (Category 1B).
- Carcinogenic (Cancer-causing)
- Mutagenic (DNA-damaging)
- Reprototoxic (Damaging to fertility or unborn children)
As Malaysia is a voting member of the ACC, we are legally obligated to harmonise our laws with the ASEAN Cosmetic Directive (ACD). The NPRA has fully enforced this safety standard to ensure Malaysian products match the strict safety protocols used across the entire ASEAN region.
Toxicological reviews determined that Benzophenone induces liver tumours in animal studies. Consequently, regulators concluded that there is no safe margin of exposure for cosmetic use, necessitating a total ban.
If your product label lists this specific ingredient, you must remove it entirely. However, there is good news. Safe alternatives exist that provide the exact same stability without violating the new ban.
Why Are Safety Limits Tightening for Benzophenone-3?
The most significant disruption in the market affects Benzophenone-3 (Oxybenzone), one of the most common UV filters in Malaysia. The NPRA and the ASEAN Cosmetic Committee have tightened these limits following global safety reviews which cited concerns regarding potential carcinogenicity and endocrine disruption risks associated with high concentrations of these compounds.
This restriction disproportionately affects body care products. Body lotions that currently rely on high percentages of this filter will soon become non-compliant.
Why is Body Lotion Restricted to 2.2% but Face Cream remains at 6%?
The government applies a calculation based on Body Surface Area (BSA) and Aggregate Exposure:
- Face Cream: Applied to a small surface area (the face). Systemic absorption into the blood is low. Therefore, 6% is safe.
- Body Lotion: Applied to a massive surface area (arms, legs, torso). This leads to significantly higher absorption of the chemical into the bloodstream. At 6%, the toxicity risk is too high. Therefore, the limit is reduced to 2.2%.
| Product Category | Old Maximum Limit | New Maximum Limit | Status for 5% Formulas |
| Face Creams | 6.0% | 6.0% | ✅ Compliant |
| Hand Creams | 6.0% | 6.0% | ✅ Compliant |
| Body Lotions | 6.0% | 2.2% | ⚠️ Non-Compliant |
| Aerosol Sprays | 6.0% | PROHIBITED | ❌ Banned |
Table 2: New Concentration Limits for Benzophenone-3
Why is this dangerous for you?
Many whitening body lotions currently on the market use 5% Benzophenone-3 to achieve an SPF 30 rating. Right now, that is legal. But come November 2026, that exact formula will be non-compliant. If you do not lower the percentage (and add a booster to keep the SPF high), your product will be illegal.Pro Tip: Check your “Whitening Body Lotion” formulations first. These are the most likely to exceed the new 2.2% limit.
Critical Ingredients Added to the Prohibited List
It is dangerous to assume this circular only affects sunscreens. The directive adds multiple substances to the prohibited list which could be hiding in your other SKUs. We have highlighted the six most relevant ingredients that frequently appear in cosmetic formulations below.
| Ref No. | Ingredient Name | Common Function | CAS Number | Specific Reason for Ban |
| 1703 | Benzophenone | Light Stabiliser | 119-61-9 | Carcinogenic Risk (CMR 1B) |
| 1718 | Pentetic Acid | Chelating Agent | 67-43-6 | Reproductive Toxicity |
| 1723 | Margarosa Extract | Skin Conditioning | 84696-25-3 | Toxic Effects on Organs |
| 1724 | Theophylline | Slimming Agent | 58-55-9 | Cardiovascular Side Effects |
| 1711 | Melamine | pH Buffer | 108-78-1 | Renal (Kidney) Toxicity |
| 1728 | Nitrobenzene | Fragrance Masking | 98-95-3 | Blood Toxicity (Methemoglobinemia) |
Note: Manufacturers should consult the full NPRA Circular No. 3/2024 to view the complete register of all 28 newly banned substances.
Table 3: Top 6 Critical Ingredients Added to Annex II (Prohibited)
Secure Your Brand Future with Biocoslab
Regulatory updates create a strategic opportunity to upgrade your formulations before your competitors do. At Biocoslab, our R&D team has already secured a comprehensive supply of ACD 2026 Compliant raw materials.
We are ready to assist you with the following solutions:
- Replacement of Benzophenone with safe and legal colour stabilisers.
- Reformulation of Body Lotions to meet the strict 2.2% limit while maintaining high SPF ratings.
- Comprehensive Audits of your ingredient lists against the new Prohibited and Restricted tables.
Do not wait for the deadline to force your hand. Contact Biocoslab today to review your formulation and ensure your brand remains safe, legal, and profitable.
