People across the UAE are paying more attention to diet and nutrition, leading to a sharp rise in food and dietary supplement use. To protect consumers and maintain product quality, the UAE has made registration a must before any supplement can be sold. The process, handled by Dubai Municipality under the Montaji system, checks everything from ingredients to labeling.
Here’s how the Health supplements registration process works in UAE — including the main regulations, labeling rules, and documentation you’ll need to comply with.
What are considered as Health Supplements in UAE?
In the UAE market, products sold as health supplements are those taken in measured doses to support normal nutrition or specific physiological functions. They are not consumed as regular food, nor are they meant to replace meals. Instead, they are formulated to provide concentrated amounts of certain nutrients or substances that may not be sufficiently obtained from a daily diet.
Such products may contain nutrients like vitamins or minerals, plant-based extracts, amino acids, beneficial bacteria, or other similar substances. Because they are taken in controlled amounts rather than eaten freely like food, they are placed on the market in clearly measured formats. Before being sold, they must be identified as supplements and reviewed under the applicable local regulatory framework.
Understanding the Regulation of Health Supplements in UAE
A pre-market approval is required for the health supplement activities like its manufacturing, import, sale, distribution advertisement. This is acquired via the Montaji system. The regulations that are concerned with the health supplements in UAE are:
- GSO 2571/2021: This Gulf Technical Standard outlines the general requirements for Health Supplements.
- GSO CAC/GL 55:2015 : Guidelines For Vitamins And Minerals Food Supplements
- Local Orders: Specific regulations issued by individual emirates. For example, Dubai Municipality has issued Technical Guidelines for health Supplements.
It is mandatory to register the health supplements with the Dubai Municipality or other relevant emirates prior to its market entry as well as other activities concerned with it. Putting a supplement on sale before completing registration can create problems. The product may be pulled from the market, and fines between AED 10,000 and AED 50,000 are possible. For health supplements imported into the UAE for re-export, compliance with the Consumer Products Listing Service is mandatory.
Nutritional Claims for Health Supplements in the UAE
Health supplements marketed in Dubai are reviewed against GCC technical standards that define acceptable nutrient levels and permitted ingredients. During assessment, the declared vitamin and mineral content is checked against established upper limits. Ingredients that fall outside the approved list may lead to rejection.
Two types of claims are allowed for the health supplements in UAE :
- Health Claim and
- Structure / Functional Claim
Health Claim: It involves general health claims or nutrient support claims which are intended for health maintenance and well-being, nutritional supplementation (beyond the normal nutritional value obtained from the food). Certain claims (vitamin /mineral supplementation) are allowed only when the relevant vitamin or mineral used in the product is >30% of RDA (recommended dietary allowance) value. The health claims must be supported by sound scientific evidence. Examples of some health claims are strengthening the body, relieving weakness and general tiredness…
Structure or Functional Claim: This is when the ingredient is intended to affect the normal function or structure of the body. Such claims must be backed up by adequate ingredient-based evidence and product-based evidence when necessary. Examples of some functional claims are general support in maintenance of healthy functions, assisting with maintaining joint mobility etc…
Given that these directives are implemented by national legislation in each Gulf Cooperation Council (GCC) member state, there can be slight variations in their application. These differences can influence the definition of a food supplement and the permissible substances within them.
Maximum Daily Limit for Vitamins and Minerals
The maximum daily limit for some common vitamins and minerals as per the guideline of Dubai Municipality are:
| Vitamins/ Minerals |
Daily Allowed Upper Limit
|
| Vitamin A | 3000 mcg/day |
| Vitamin B1 & B2 | 100 mg/day |
| Vitamin B3, Pantothenic acid | 500 mg/day |
| Vitamin B6 | 100 mg/day |
| Vitamin B12, Folic acid | 1000 mcg/day |
| Vitamin C | 2000 mg/day |
| Vitamin D | 100 mcg/day |
| Vitamin E | 1000 mg/day |
| Vitamin K | 120 mcg/day |
| Biotin | 2500 mcg |
| Calcium | 2500 mg/day |
| Sodium | 2300 mg/day |
| Copper | 10 mg/day |
| Magnesium | 500 mg/day |
| Potassium | 200 mg/day |
| Iron | 45 mg/day |
| Zinc |
50 mg/day (women) 35 mg/day (Men) |
| Selenium | 400 mcg/day |
| Manganese | 9 mg/day |
| Iodine | 1100 mcg/day |
| Phosphorous | 4000 mg/day |
Pre-requisites for regulation and registration of Health supplements in the UAE
Any company planning to place a health supplement on the UAE market needs to go through registration first. During review, the product’s formulation, claims, and labeling are checked closely. Items containing restricted substances or unsupported claims are unlikely to move forward. In most cases, clinical trials are not expected, but authorities may request supporting safety information if questions arise.
The domestic manufacturer or the importer or the agent of foreign manufacturer can apply for the health supplement registration.
The applicant must fulfil below pre-requisites to initiate the registration –
- Company must be incorporated with Dubai Municipality or have a warehouse is Dubai.
- Company must have a valid trade license for Health Supplements
Documentation Requirements For Registration of Health Supplements In Dubai
The documents needed for the food supplement registration with Dubai Municipality are:
- Clear Artwork of Product: Alongside the product image, an artwork or design related to the product is needed. This illustration should include all relevant information and serve as a visual representation of the product.
- Free Sale Certificate: It is a document which shows that the health supplement is being sold legally in its country of origin without any restrictions. The regulatory authority of the country of origin is the one who should issue the FSC. At the time of submission and request, valid must be the FSC.
- Ingredients Report / Product Formulation: A detailed list of all ingredients and their respective quantities in the product must be provided. This report, issued by the manufacturer or brand owner, ensures transparency and helps the Dubai Municipality assess the safety and compliance of the product.
- Analysis report & certificate: The detailed physical, chemical and microbiological analysis of the product is mentioned in this report. A Certificate of Analysis (might be called in other names) is issued in the country of origin of the product by the manufacturer. The research and development department of the manufacturer must sign and stamp this certificate.
- GMP Certificate: A Good Manufacturing Practice Certificate must be submitted. It should be valid at the time of submission. The GMP certificate must be from the certified bodies of the product’s country of origin. Other quality certificates of manufacturing (issued by the certified bodies) can be submitted if a GMP certificate is not issued.
- Laboratory test report: A detailed report on the results of the health supplement’s laboratory tests. This must be issued by a certified lab and the test methods used must be accredited.
- Valid Product Registration Certificate or Certificate of Conformity (CoC) issued to the product by any of the official health authorities in UAE like the MOHAP or Ministry of Industry and Advanced Technology (MoIAT), if any.
- Additional Supporting Documents**: Depending on the product, additional documents such as a Halal Certificate, Organic Certificate, Safety Assessment Report for a specific ingredient, clinical studies backing up the claims etc.
Labeling Requirements for Health Supplements in Dubai
The components of the label must be stated in clear English and /or Arabic language. The label must NOT contain any inconsistent illustrations and claims relating to cure, treatment or prevention of any disease. The latter should not even be included in brochures, leaflets, advertisements or in any other way. A supplement facts panel which contains the active ingredients per serving and also any other added ingredients must be there in the label of all dietary supplements.
Read the detailed labelling requirements for Health Supplements in UAE here
Registration of Health Supplements in UAE:
The registration process for health supplements in the UAE, particularly in Dubai, follows protocols overseen by the Dubai Municipality (DM). Known as Montaji, this consumer product registration initiative utilizes unique barcodes to ensure product safety and information accuracy.
The food supplement registration is a 2-step process –
- Company Registration
- Product Registration
A login ID and the password will be sent to the email upon registering the company (Step 1) in the Montaji Portal (https://montaji.dm.gov.ae/Consumer/Login). The product registration process begins with the submission of product registration application in the Montaji Portal, along with the necessary government fees. Essential documents such as a valid trade license and label assessment must be provided.
The DM then reviews the application to ensure compliance with standards regarding ingredients and labeling. If approved, a registration certificate is issued, valid for five years. However, rejection may occur if products fail to meet standards such as
- Containing banned ingredients
- Providing unclear or misleading information.
- Undisclosed ingredients
- Non-compliance with language requirements (Arabic or English).
The DM can reply as approved, rejected or to be completed via the website. Let’s take a look at this in the image given below.
The Dubai Municipality reserves the right to request laboratory tests based on product type and risk analysis criteria. Failure to provide necessary documentation or inaccurate product information may lead to immediate rejection or automatic cancellation of the application.
Additionally, an advertising permit must be obtained before launching any indoor or outdoor advertisement of health supplements.
Who All Must Apply for Registration?
The following should apply for registration:
- Individuals that manufacture health supplements locally.
- Individuals that import food supplements.
- Product manufactured or imported on their behalf.
In case of local manufacturers, they must connect with the Registration and Permits section for the registration of health or food supplements. It is the responsibility of the local manufacturer’s agent to take the appropriate steps to make sure the registration of food supplements before its entry into the market. This is also applicable for foreign manufacturers. Their agents must make sure the registration of products before food supplements are imported to Dubai.
Timelines, Fees, and Validity for Health Supplement Registration in Dubai
Timelines
The registration takes up to 12 working days from the date of completion of the requirements of product registration.
Fees
The registration fees are structured as follows:
- Application Fee: AED 10
- Any additional products or variant of the product added to the application: AED 10/ addition
- AED 200 per copy for printing of the registration certificate (optional)
- AED 20 for knowledge and innovation (optional)
Validity
The Health supplement registration certificate is valid for a period of 5 years and can be extended after 5 years by renewal. When applying for renewal, it is reviewed and then usually the registration certificate is renewed.
Conclusion
The food supplement registration in UAE is a mandatory process as it make sure the safety and quality of the product as well as the consumer’s safety and well-being. It is important to follow the requirements both country and culture wise (Eg. The Halal Certificate) for those who wish to market their products in the UAE. This can be done by effective navigation of the regulatory framework.
Artixio, with its 20+ years of experience can streamline this process for you. Our regional subject matter experts can provide full assistance in registration of health supplements in the UAE. We can guide you through activities and documents needed to be performed and submitted to demonstrate compliance with the regulatory. Connect with us through info@artixio.com
FAQ’s
Q. What is the Montaji system?
The Montaji system is an online portal used for the registration of health supplements in Dubai. Health supplements prior to its manufacture, import, export, distribution or any kind of marketing in Dubai must be registered and it is done via Montaji system.
Q. Is it possible to distribute samples of food supplements in UAE?
Yes, distribution of samples of registered product is allowed and it must be free of cost. It does not require an approval from the Dubai Municipality.
Q. What is the classification of health supplements in UAE?
The Health supplements are classified as vitamins, minerals, essential fatty acids, amino acids, enzymes, botanical and herbs, prebiotics and probiotics according to the Technical Guidelines for Health Supplements provided by the Dubai Municipality.