In Portugal, the regulation and notification of food supplements are managed by the Directorate-General for Food and Veterinary (Direção-Geral de Alimentação e Veterinária, DGAV). The legal framework aligns with Directive 2002/46/EC of the European Parliament and Council, which harmonizes the laws of Member States concerning food supplements.
Definition of Food Supplements
Food supplements are defined as foodstuffs intended to supplement the normal diet and are concentrated sources of nutrients or other substances with a nutritional or physiological effect. They are marketed in dose form, such as capsules, tablets, powders, or liquids.
Notification Process.
Before marketing a food supplement in Portugal, businesses are required to notify the DGAV. This notification must occur prior to placing the product on the Portuguese market.
Steps for Notification
1.
Preparation of Documentation:
Notification Table: A specific form must be completed, which can be obtained on the DGAV website. This form requires information about the responsible company as well as the manufacturing company. It also requires specific information about the product, such as its name, presentation form, ingredients, health or nutritional claims, etc.
Label Copy: A copy of the product label in Portuguese, including all variations in pack sizes or flavors.
2.
Submission of Notification:
The notification, along with the required documents, should be sent electronically to the DGAV via the email address [email protected].
There is no fee for the notification process.
3.
Processing:
Once the operator notifies the food supplement, it can be immediately placed on the market, with the operator responsible for ensuring compliance with legal requirements.
Labeling Requirements
The labeling of food supplements must comply with the requirements of Regulation (EU) No 1169/2011 and national legislation. All information should be in Portuguese and include:
- Product Name: Including the term “Suplemento Alimentar” (food supplement).
- List of Ingredients: Including active substances and their content per daily dose.
- Recommended Daily Intake: Specified amount for consumption.
- Warnings and Contraindications: As applicable.
- Nutritional Information: Per serving.
- Manufacturer or Distributor Details: Name and address.
- Net Quantity: Amount of the product.
- Storage Instructions: As necessary.
Accurate labeling is crucial to avoid misleading consumers and to ensure compliance with Portuguese food law provisions.
Additional Considerations
If the product contains substances other than vitamins and minerals that are not regulated in Portuguese legislation, it may still be marketed in Portugal under the principle of mutual recognition. This requires proof of prior legal marketing in another EU Member State.
By meticulously following these guidelines and collaborating with local regulatory experts, companies can ensure their food supplements comply with Portuguese regulations, facilitating successful market entry and distribution.
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