Toggle navigation Food Supplements Notification Form Language: English English Malti default Caution: JavaScript execution is disabled in your browser or for this website. You may not be able to answer all questions in this survey. Please, verify your browser parameters. Food Supplements Notification Form FORM DETAILS Applications will not be considered valid unless the application form is duly completed and all correct documents and correct labels have been submitted with this form. Payment has to be effected within 3 days from the submission of this form for the application to be considered valid. It is recommended that proof of payment of the applicable fees is submitted via the upload section available hereunder, otherwise the application will not be processed until payment is performed. NAME OF NOTIFIER Note: Indicate name of the notifier as it will appear on the notification receipt. Format requirement: kindly provide the name of company (importer). (This question is mandatory) Identity of notifier e.g. Happy Life Ltd. or Mr John Smith NOTIFIER'S CONTACT DETAILS Note: these details will not appear on notification receipt; details are kept within the non-public database of food supplements notified under Legal Notice 239/2003, held by the MCCAA. Format requirement: kindly provide the full postal address (P.O. Box address not accepted), email address, contact number and full name of the contact person. (This question is mandatory) Address (This question is mandatory) Email address Please check the format of your answer. Please ensure that the email address is correct as it will be used for acknowledgement purposes and also to get in touch with you. (This question is mandatory) Contact no. Only numbers may be entered in this field. (This question is mandatory) Contact person NAME OF PRODUCT Note: indicate name of the product as it will appear on the notification receipt. Format requirement: kindly provide the manufacturer's name and the specific name of the product. (This question is mandatory) Manufacturer's name e.g. Healthy Living (This question is mandatory) Product name e.g. Vitamin C (1000mg) PRODUCT'S WEIGHT Format requirement: kindly provide the product's weight or volume. (This question is mandatory) Product's weight e.g. 30 / 60 / 90 capsules or 50g / 100g / 500g or 50ml / 100ml / 500ml ACTIVE INGREDIENTS LIST Format requirement: kindly list all the active ingredients present in product. The active ingredients are those ingredients with a nutritional and / or physiological function. For any products containing herbal (botanical) ingredients, you are kindly asked to provide a full scientific (Latin) name and the specific plant part. (This question is mandatory) Active ingredients e.g. Sodium, Vitamin A, Vitamin D, Vitamin E, Vitamin C, Thiamin, Riboflavin, Niacin, Vitamin B6 e.g. Ginger (Zingiber officinale, root) RECOMMENDED DAILY DOSAGE Format requirement: kindly indicate the recommended daily dosage as suggested by the manufacturer. (This question is mandatory) Recommended daily dosage e.g. 2 capsules daily or 2 tablespoons daily or 2 scoops (50g) daily CHECKLIST Format requirement: The below check list ensures that the ingredients, nutrition and/or health claims found in the product are acceptable for use in food supplement. Kindly indicate 'yes' or 'no' as an answer to the question presented. (This question is mandatory) Vitamins: Does the product contain vitamins providing a maximum upper dose in excess of the maximum upper level (MUL)1 stipulated in Third Schedule to Legal Notice 239/2003 (Food Supplements Regulations)?2 Yes No (Kindly click on hyperlink for further details) 1Maximum Upper Levels have been established for the following vitamins: Vitamin E (727mg), Vitamin B6 (10mg), Beta carotene (7mg). 2Food supplements providing vitamins in excess of the stipulated maximum upper level will be notified with special conditions for marketing and may only be sold from pharmacies. (This question is mandatory) Vitamins & Minerals: Does the product contain vitamins, minerals and mineral substances which are not listed in Annexes I and II of Directive 2002/46/EC relating to food supplements? Yes No (This question is mandatory) Citrus aurantium (synephrine): Does the product provide more than 30mg of synephrine (corresponding to 800mg Citrus aurantium with 4% synephrine) per recommended daily of product consumed?1 Yes No Note: Kindly refer to the Food Safety Commission "Decision on the use of synephrine in foodstuffs". The use of synephrine in food is allowed up to a maximum of 30mg per day corresponding to 800mg Citrus aurantium with 4% synephrine. Foodstuffs which exceed the above mentioned maximum daily dose shall only be sold from a pharmacy. 1The content of synephrine (in mg) should be clearly stated on the label along with the following warning statement or words to this effect: "Warning: Patients with cardiovascular disease and / or hypertension should consult a doctor before taking this product. Not recommended during pregnancy. lactation and for children below the age of 12." (This question is mandatory) Novel Food Ingredients: Does the product contain unauthorised novel food ingredients1 as defined in Regulation (EU) No. 2015/2283 concerning novel foods and novel food ingredients"? Kindly refer to the Novel Food Catalogue and the Union List of Authorised Novel Foods (Commission Implementing Regulation (EU) 2017/2470). Yes No (Kindly click on hyperlink for further details) 1Unauthorised novel food ingredients are food ingredients for which there is no significant history of consumption within the European Union prior to 15 May 1997 and for which an authorisation is required under Regulation (EU) No. 2015/2283 on novel foods. (This question is mandatory) Botanical Ingredients (part 1): Does the product contain botanical ingredients which are classified under the red category of the "List of herbal (botanical) substances"? Yes No If 'Yes', please attach the Determination Letter along with this form in the 'Other Documents' section The Determination Letter is sent by the Borderline Classification Committee of the Medicines Authority. This letter must declare that the product is non-medicinal, so as to proceed with the notification of the product. (This question is mandatory) Botanical Ingredients (part 2): Does the product contain botanical ingredients which are classified under the amber category of the "List of herbal (botanical) substances", with daily botanical dosages which exceed the levels provided in the comments column of the same list? Yes No If 'Yes', please attach the Determination Letter along with this form in the 'Other Documents' section The Determination Letter is sent by the Borderline Classification Committee of the Medicines Authority. This letter must declare that the product is non-medicinal, so as to proceed with the notification of the product. (This question is mandatory) Nutrition and health claims: Does the product contain unauthorised nutrition and health claims as listed in the EU register for nutrition and health claims made on foods? Only authorised claims listed in the EU Register of Health Claims are permitted. Claims on botanical ingredients which are still pending review by EFSA are also permitted to be used. Yes No (Kindly click on the hyperlink for further details) (This question is mandatory) Statements and warnings: Does product label satisfy the requirements set out by regulation 6.4 of Legal Notice 239/2003 (Food Supplements Regulations)? Yes No (Kindly click on hyperlink for further details) LABEL OF THE PRODUCT Note: kindly attach a PDF of the outer label of the product (including, if applicable, outer label, outer box, label, product leaflet and / or insert). Please name the PDF document as 'LABEL'. Kindly attach any relevant documents and labelling which include: Outer label Outer box Label Product leaflet Insert Any other label appertaining to the product Please upload between 1 and 10 files Upload files × Upload files PAYMENT Payment of €10 to be effected within 3 days from submission of application (This question is mandatory) Payment Method Choose one of the following answers Bank transfer Cheque (payable to the MCCAA) As per Central Bank of Malta's Directive No. 19, which entered into force on the 1st January 2022, cheques will only be accepted for payments exceeding twenty euro (€20). (This question is mandatory) Please input the Transaction number or any other form of identification traceable to the transaction (This question is mandatory) Please insert the cheque number Bank Account Details Bank name: Bank of Valletta IBAN number: MT14VALL22013000000040019986609 Swift code: VALLMTMT Kindly attach a PDF of the proof of payment (copy of bank transfer or cheque). Please name the PDF document as 'PAYMENT'. Please upload one file Upload files × Upload file OTHER DOCUMENTS Kindly attach a PDF of any other relevant documents. Moreover, upload any Determination Letter as stated in the previous if Botanical Ingredients (Part 1) or (Part 2) where answered 'Yes'. Please upload between 1 and 10 files Upload files × Upload files DECLARATIONS (This question is mandatory) Notification Declaration Check all that apply This notification shall not constitute official approval or authorisation of the product, nor does it exempt the notifier from any other obligation under the Food Supplements Regulations or any other relevant legislation or administrative provision. Failure to provide any supporting documentation, as may be required by the Food Safety Commission in accordance with the Food Supplements Regulations (Legal Notice 239/2003), shall constitute an offence under those regulations. The notifier is reminded of the obligation to submit a fresh notification in the event of any change in the composition of the product and/or its labelling. You are reminded of your obligation to submit correct information to the best of your ability. Failure to do so and in case of submission of missing or incorrect information, legal action might be taken according to the Food Safety Act Cap. 449. Signing of this declaration constitutes full responsibility for the placing on the market of the specific product. (This question is mandatory) Content Declaration Check all that apply I, hereby declare that the details furnished in this application (including any documents mentioned therein) are true and correct to the best of my knowledge and belief and I undertake to inform the Malta Competition and Consumer Affairs Authority of any changes therein, immediately. In case any of the above information is found to be false, untrue, misleading or misrepresenting, I am aware that I may be held liable for it. I confirm that I have attached all relevant documents with this application form. (This question is mandatory) Data Protection Declaration Check all that apply The Malta Competition and Consumer Affairs Authority ("the Controller") will process your personal data in accordance with the relevant provisions of the General Data Protection Regulation (GDPR), the Data Protection Act (Chapter 586 of the Laws of Malta) and other regulations made thereunder. The Controller will process your personal data for licensing and administrative purposes and to comply with its legal obligations. For further information on how your personal data will be processed refer to the Controllers's privacy policy. I, the data subject, hereby consent to having the Malta Competition and Consumer Affairs Authority collect and process my personal information from this application. Submit Please confirm you want to clear your response? Exit and clear survey ×