Health Supplements Regulation and Registration In UAE
- Induja Ratakonda
- Jun 10, 2024
- 8 min read
Updated: 1 day ago
The world we see today is more aligned with health. They tend to be more health conscious than ever. This is the reason for an increased demand for health supplements. This is not different when coming to the United Arab Emirates, which is showing a steady increase in the sales of food supplements. The UAE government, for the protection and well being of the consumers and their safety, has framed a regulatory framework ensuring the safety and efficacy of the food supplements released into the UAE market.
It is strictly stated that food supplement registration is mandatory for the sale or other activities concerning health supplements. Read below to know more about the food supplement registration in UAE, nutritional claims, labelling, documentation requirements and more.
What are considered as Health Supplements in UAE?
Health supplements, also referred to as food or nutritional supplements, are products designed to augment the regular diet by providing additional nutrients. These supplements typically contain one or more dietary ingredients such as vitamins, minerals, herbs, amino acids, and enzymes. Proper labeling is essential to differentiate these products from traditional foods, ensuring they are recognized for their role in supplementing the diet with essential nutrients. Health supplements are available as tablets, capsules, powders, and liquids, and must be distinctly labeled as supplements.
Understanding the Regulation of Health Supplements in the 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. Selling unregistered health supplements is illegal and can result in fines, product confiscation, and a ban on future sales. A penalty of 10000 AED to 50,000 AED can be imposed against the person who violates the applicable regulations. 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
The Dubai Municipality has established specific guidelines for the content and composition of health supplements, based on the CAC/GL 55:2015 Guidelines for Vitamins and Mineral Health Supplements (UAE.S GSO CAC GL 55:2015). This includes a detailed list of permissible vitamins, minerals, and their upper intake levels. Additionally, there is a comprehensive list of banned ingredients that cannot be included in health supplements.
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
Manufacturers, distributors, and importers who intend to market health supplements in the UAE must complete this registration process. The supplements must be free from prohibited tastes, colors, and chemicals, and products making false health claims or containing inaccurate information will be banned. While clinical trials are generally not required, a safety assessment may be necessary.
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.In addition to product-specific documents, certain company-related information is also essential:
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.
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 advertisment 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. What are the general labelling requirements for health supplements in UAE?
The labelling for health supplements requires brand and product name, ingredients, manufacturer details, country of origin, storage condition, manufacturing and expiry date, pack size, amount per serving and % Daily Value (%DV) must be mentioned for vitamins and minerals present in the product, dosage and instructions for use, any warnings, product indications, batch number and identification code.
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.
References –
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