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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 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.
(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. 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

(Kindly click on hyperlink for further details)

1Maximum Upper Levels have been established for the following vitamins: Vitamin E (727mg), Vitamin B6 (10mg), Vitamin B12 (1mg), 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?
(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

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. 215/2283 concerning novel foods and novel food ingredients"? Kindly refer to the Novel Food Catalogue.

(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"?
If 'Yes', please attach the Determination Letter along with this form
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?
If 'Yes', please attach the Determination Letter along with this form
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?
(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)?
(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) Moreover, upload any Determination Letter as stated in the previous questions if Botanical Ingredients (Part 1) or (Part 2) where answered 'Yes
Kindly attach any relevant documents
Note: Use this section to upload proof of payment as well.
PAYMENT
Payment of €10 to be effected within 3 days from submission of application
(This question is mandatory)
Payment method

Bank Account Details

Bank name: Bank of Valletta

IBAN number: MT14VALL22013000000040019986609

Swift code: VALLMTMT

DECLARATIONS
(This question is mandatory)
Notification Declaration
(This question is mandatory)
Details
(This question is mandatory)
Content Declaration
(This question is mandatory)
Data Protection Declaration