Guide to Food Product Registration in Malaysia

If you are planning to start an F&B business in Malaysia, it is mandatory to register your products with FSQD before you can market and sell your food products. The FSQD registration ensures that food items meet safety, quality, and labeling standards set by the authorities and facilitates market access to F&B businesses in the country.

In this article, we will walk you through the necessary steps, requirements, and regulations for registering your food products in Malaysia.

Overview of Food Product Registration in Malaysia

In Malaysia, food product registration is managed by the Food Safety and Quality Division (FSQD) under the Ministry of Health (MOH).

To ensure public health and safety, the FSQD enforces the following regulations:

• Food Act 1983 – The main legislation for food safety, covering labeling and hygiene.
• Food Regulations 1985 – Specifies registration requirements, including labeling standards and maximum pesticide residue limits. 

Products requiring FSQD Registration in Malaysia

Before starting the food registration process, you need to understand which food products in Malaysia require registration with the FSQD. The Food Regulations 1985 has outlined different classification of foods that need to be registered with the FSQD including the following:

1. Products Containing 100% Food Ingredients:  such as conventional food products made entirely from food-grade materials.
2. Food Products with or Without Active Ingredients (e.g., Herbs, Vitamins, Minerals): such as premix coffee, tea, chocolate, soy, cereal, meat essence liquid products, canned or packaged drinks, cordial Products with a recommended dilution ratio, liquid vinegar products, and liquid honey Products
3. Special Purpose Food Products: Includes sports nutrition products, isotonic drinks,  and foods intended for special dietary purposes.
4. Products in Conventional Food Forms: such as biscuits, cakes, confectioneries, candies/sweets, gummies, and noodles.
5. Products for Cooking and Food Preparation: such as cooking oils, herbs, and spices.
6. Herbs and Spices in Crude Form: when no medicinal or health claims are made.

For food products that blur the line between food and medicine, they will need to go through a classification process  to determine whether they are “food” or “pharmaceutical”. These products are referred to as Food-Drug Interface (FDI) products. 

These products generally resemble conventional foods but contain active ingredients or make health-related claims. Depending on the classification, either the NPRA (if it’s pharmaceutical) or the FSQD (for general food products) will be responsible for registration.

Who Needs to Secure FSQD Registration in Malaysia?

If your company is involved in manufacturing, importing or exporting, or trading food products in Malaysia, you need to register your company with the FSQD. 

• Manufacturers – Companies producing food products must register their items to ensure compliance with Malaysian food safety regulations.
• Importers – Entities importing food products into Malaysia are also required to secure registration to secure an import license. They must ensure that the products meet local safety standards and regulations before they can be sold in the market. 
• Distributors – Those involved in distributing food products may need to assist in the registration process, particularly if they are marketing products that require specific certifications.

Step-by-Step Food Product Registration Process with the FSQD

1. Preparation of Necessary Documentation

To register your food products in Malaysia, you need to have proper documentation and must comply with labeling standards by the FSQD. Here’s what you’ll need to register your F&B products: 

• FSQD Application Form – A completed application form specific to the type of food product being registered.
• Product Labeling – Samples of product labels that comply with Malaysian labeling regulations, including:
  • Product name
  • Ingredients list
  • Nutritional information
  • Manufacturer’s details
  • Expiry date and batch number
• Certificate of Analysis – A document from a recognized laboratory confirming that the product meets safety and quality standards.
• Good Manufacturing Practice (GMP) Certificate – Proof that the manufacturing facility adheres to GMP standards.
• For food prod products with health claims like FDA goods, you must ensure that claims are substantiated by scientific evidence through clinical studies, research papers, or other relevant documentation. 

For foreign manufacturers, a local representative or agent in Malaysia may be required to facilitate the registration process. To help you prepare for your application, Emerhub will assist in gathering all the necessary documents for registration of your food products in Malaysia. We can help accurately classify your food products, and help acquire all the documentation needed to guarantee safety and efficacy. 

2. Application Submission via FoSIM

Once you have all the needed documents, Emerhub can facilitate this step by submitting your application online with the Food Safety Information System (FoSIM) portal. If you do not have an account, we can assist the registration process on the FoSIM platform. This typically involves providing your business details and contact information.

For foreign companies who want to register their food products in Malaysia, you need to appoint a Product Holder. As your representative, Emerhub can expedite the registration process, facilitate better communication with local authorities, and reduce possible delays. 

3. Review Process by the FSQD

Upon submission, the FSQD conducts an initial assessment to ensure that all submitted documents are complete and meet the necessary requirements. This includes checking for compliance with labeling regulations, safety standards, and product formulation. 

The review process is conducted in stages starting with a detailed technical evaluation of the product. This involves reviewing the safety and efficacy data, ingredients, and any health claims made by the product. If the product is classified as a Food-Drug Interface (FDI), it will undergo additional scrutiny to determine whether it should be regulated as a food or a drug.

In cases where there are uncertainties regarding safety or compliance, the FSQD will consult with relevant experts or committees to assess the product further. If necessary, an inspection of the manufacturing facility is required to ensure compliance with Good Manufacturing Practices. 

4. Issuance of Registration Certificate

If the application meets all requirements and passes the review process, a registration certificate will be issued. This certificate allows the product to be marketed legally in Malaysia. The registration is typically valid for three years, after which renewal is required.

After registration, FSQD may conduct post-market surveillance to monitor product safety and compliance with regulations. If rejected, however, the FSQD will provide reasons for the decision, and you can address these issues or appeal.

Emerhub’s regulatory experts will handle the necessary submissions on your behalf to ensure accuracy and minimize delays. For more information, fill out the form below and we will put you in touch with one of our experts.