Food Regulation in Malaysia: Where We Stand on Synthetic Food Dyes

With the U.S. FDA banning Red Dye No. 3 and planning to phase out other petroleum-based synthetic food dyes, the spotlight is now on how Malaysia is responding.

As global regulators tighten food regulation around synthetic colourants, the key question is:

Are these dyes still permitted in Malaysia, and how do our food regulations compare to global standards?

Current Malaysia’s Food Regulation Framework on Synthetic Food Dyes

Malaysia’s use of synthetic dyes is governed by the Food Regulations 1985 under the Food Act 1983, enforced by the Food Safety and Quality Division (FSQD) under Ministry of Health (MOH).

Under the Seventh Schedule, Table I, several synthetic food dyes are still permitted in Malaysia, provided they comply with specific food regulation requirements:

• Proper labelling on packaging

• Use in food & nutraceutical categories in allowed preparations

What About Health Supplement?

For health supplements, synthetic colour regulation falls under the oversight of the National Pharmaceutical Regulatory Agency (NPRA).

NPRA permits the use of synthetic dyes in health supplements; however, Tartrazine is restricted to external use only and is not allowed in oral or nasal preparations, including capsule shells.

Malaysia vs. U.S.: A Quick Regulatory Comparison

Features	United States (US FDA)	Malaysia (MOH)
Red Dye No. 3	Banned (2025)	Permitted
Regulation Direction	Phasing out petroleum-based dyes	Allow synthetic dyes with conditions
Labelling Instruction	Stronger labelling being implemented	Basic declaration required
Natural Alternative	Actively Encouraged	Permitted
Influencing Bodies	FDA & HHS	FSQD & NPRA

What This Means for Businesses and Consumers

For Consumers:

The FDA banned Red Dye No. 3 due to scientific concerns about the health effects of certain synthetic dyes. This reflects a broader shift in consumer behaviour, more consumers are reading labels, avoiding artificial additives, and choosing clean-label or naturally coloured products.

For Manufacturers and Brands:

Companies exporting to the U.S. or other markets with stricter food regulations may need to reformulate products. Even within Malaysia, there is an opportunity to lead the way by shifting to natural food colouring agents.

For Regulators:

Malaysia may eventually follow suit, especially if public demand and international food regulation standards continue to move toward greater transparency and clean-label compliance.

Conclusion

The FDA’s ban on Red Dye No. 3 highlights a global shift in food regulation toward cleaner food standards. While Malaysia still allows some synthetic dyes, it may soon need to reassess its regulations to stay aligned with international clean-label trends.

As the global regulatory landscape continues to evolve, staying informed is more important than ever especially for those in the food, health, and wellness industries. Follow our blog and stay tuned for continuous updates on regulatory changes in Malaysia and abroad. Whether it’s new standards, ingredient bans, or policy shifts, we’re here to keep you ahead of the curve.

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Aqurate Ingredients is an international player in supplying functional ingredients and providing innovative solutions to the food & beverage, nutraceutical, pharmaceutical and cosmeceutical industry. We believe, a satisfied customer is a repeat customer.