In Spain, the regulation and notification of food supplements are overseen by the Spanish Agency for Food Safety and Nutrition (Agencia Española de Seguridad Alimentaria y Nutrición, AESAN). The primary legal frameworks governing food supplements include Royal Decree 1487/2009, which transposes Directive 2002/46/EC into Spanish law, and Royal Decree 130/2018, which regulates substances other than vitamins and minerals in food supplements.
Definition of Food Supplements
Food supplements are defined as food products consisting of concentrated sources of nutrients or other substances with a nutritional or physiological effect, intended to supplement the normal diet. These products may contain vitamins, minerals, amino acids, essential fatty acids, fiber, or various plant and herbal extracts.
Notification Process.
Before marketing a food supplement in Spain, it is mandatory to notify AESAN of the product’s placement on the market. This notification must also cover any changes affecting the product (e.g., labeling, composition) and the cessation of marketing.
Required Documentation
The following documents are necessary for the notification:
- Notification Form: Completed and signed. The form is available on the AESAN website.
- Product Label: A label in Spanish that complies with Regulation (EU) No 1169/2011 on food information provided to consumers, including mandatory food information as specified in Article 9.
- Proof of Payment of Fee: Evidence of payment of the applicable fee, except in cases of notification of cessation.
Depending on the product’s composition, additional documentation may be required:
Proof of Prior Lawful Marketing in Another Member State: Documents demonstrating that the product has been legally marketed in another EU Member State, along with a simple responsible translation thereof.
Product Label in Another Member State: The label used in the other Member State where the product is marketed.
Labeling Requirements
The product label must include the following mandatory information:
- Legal Name: The term “Complemento Alimenticio” (food supplement) must appear on the label.
- List of Ingredients: Including the categories of nutrients or substances that characterize the product.
- Net Quantity: The amount of the product.
- Best Before Date: Indicating the product’s shelf life.
- Recommended Daily Dose: Instructions on the recommended daily intake.
- Warnings: Statements advising not to exceed the recommended daily dose and that the product should not be used as a substitute for a balanced diet.
- Storage Conditions: Any specific storage instructions.
- Company Details: Name and address of the business operator responsible for marketing the product.
Additional Considerations
If the product contains substances other than vitamins and minerals that are not regulated in Spanish legislation, it may still be marketed in Spain under the principle of mutual recognition. This requires proof of prior legal marketing in another EU Member State.
Failure to notify AESAN before marketing a food supplement can lead to economic sanctions and the withdrawal of the product from the market. Therefore, it is advisable to seek expert guidance to ensure compliance with legal and technical requirements in the notification process.
By meticulously following these guidelines and collaborating with local regulatory experts, companies can ensure their food supplements comply with Spanish regulations, facilitating successful market entry and distribution.
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