The United Arab Emirates (UAE) is a thriving market for Health Supplements, driven by a growing awareness of health and wellness. To ensure the safety and efficacy of these products, the UAE government has established stringent regulations for their registration. This blog provides a detailed guide on the registration process for Health Supplements in the UAE, covering key requirements, procedures, and tips for successful compliance
What are considered as Health Supplements in the 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
In UAE, all health supplement must be registered with the Dubai Municipality or any of the other Emirates, prior to being manufactured, imported or sold, ensuring compliance with UAE regulations. Health Supplements in the UAE must comply with several regulations, including:
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 Guideliness for health Supplements.
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
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.
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
When registering Health Supplements with the Dubai Municipality, it is crucial to provide a comprehensive set of documents to facilitate the process. Below is a list of the essential documents required:
Picture of Product: A clear image showcasing the product's packaging and appearance is necessary. This helps in identifying the product and ensuring its visual compliance.
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: This certificate is issued from the country of origin and must confirm that the product is freely sold there. It should be issued by the relevant government sector or attested by the governmental authority in the country of origin, ensuring that the dietary supplement meets local regulations.
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.
Certificate of Analysis (CoA): A CoA from a reputable laboratory is required to provide scientific evidence of the product’s composition and quality. This document verifies the product's quality and purity through laboratory testing, demonstrating that it meets safety and quality standards.
GMP Certificate: The Good Manufacturing Practices (GMP) certificate indicates that the product is manufactured following high-quality standards. This certification shows adherence to good manufacturing practices and quality control standards.
Additional Supporting Documents**: Depending on the product, additional documents such as a Halal Certificate
In addition to product-specific documents, certain company-related information is also essential:
In addition to product-specific documents, certain company-related information is also essential:
Company Profile: This should include details about the business entity, such as background, structure, and activities.
Copy of the Company’s License: A valid business license is necessary to demonstrate legal operations.
Product Label Details / Labeling Information: Detailed information on the product label must be provided, ensuring it meets the Dubai Municipality’s labeling standards.
Company Address, Website, Contact Number, and Email Address: These contact details are necessary for communication purposes during the registration process.
Manufacturing Details: If the dietary supplement is manufactured in Dubai, a copy of the manufacturing license issued by the relevant authority should be included.
Sample and Lab Test Report: A product sample and lab test report from the Dubai Central Laboratory or an accredited laboratory with relevant scope of accreditation might be required.
Other Documents or Certificates: Additional documents such as a GMP certificate for locally manufactured products, a safety data sheet, or a Halal certificate might be requested based on the product specifics.
Valid Product Registration Certificate or Certificate of Conformity (COC): If the product was registered with any official health authorities in the UAE, such as the Ministry of Health and Prevention or the Ministry of Industry and Advanced Technology, this certificate should be provided.
Label Assessment Report: This report verifies that the product label contains accurate and comprehensive information, including ingredients, dosage, warnings, and country of origin, ensuring compliance with labeling standards.
Labeling Requirements for Health Supplements in Dubai
When it comes to labeling Health Supplements in Dubai, strict guidelines must be followed to ensure compliance with both local regulations and consumer safety standards. The labels must be in both Arabic and English, ensuring the content is identical in each language. It is mandatory for the labels to clearly state that the products are supplements and not substitutes for regular food.
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 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 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.
Timelines, Fees, and Validity for Health Supplement Registration in Dubai
Timelines
Registering health supplements with the Dubai Municipality typically takes up to 6-8 weeks from the date the application is completed. It's crucial for companies to ensure all required documentation is in order to avoid delays and facilitate a smooth registration process.
Fees
The registration fees are structured as follows:
AED 10 per application: This is the base fee for submitting an application.
AED 10 for each product added to the same application: If you're adding variants of the same product, there is an additional fee for each variant.
AED 200 for each registration certificate requested after product approval (optional): Once your product is approved, you can request a registration certificate for an additional fee.
Validity
The registration certificate for health supplements is valid for five years from the issuance date. After this period, it is necessary to renew the registration to continue selling the product legally in Dubai. Ensuring timely renewal is essential to maintain compliance with Dubai Municipality regulations and avoid any disruptions in trading.
Registering Health Supplements in the UAE involves a detailed and rigorous process designed to ensure consumer safety and product efficacy. By understanding the regulatory framework, preparing comprehensive documentation, and working with local agents, companies can successfully navigate this process and tap into the growing UAE market for health and wellness products.
Stay diligent, stay informed, and ensure compliance to smoothly bring your Health Supplements to the vibrant market of the UAE.
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