Food Supplement Registration in Spain - Overview
Spain is a significant market for food supplements in the EU, attracting companies in the sector. National regulations governed by the Spanish Royal Decree No. 1487/2009, implementing Directive 2002/46/EC, oversee the classification of food supplements. The classification of a product as a food supplement in other markets does not automatically classify it as such in the EU or Spain. Compliance with permitted substances, maximum levels, and banned substances is crucial. Ensuring accurate food labeling, advertising, and health claims verification is necessary to maintain safety and avoid sanctions, product withdrawal, or recalls.
The competent authority in Spain is AESAN (Agencia Española de Seguridad Alimentaria y Nutrición). AESAN has published guidelines over the years, providing valuable information for Food Business Operators (FBOs) on selling and advertising food supplements in Spain. Spain has not legislated on botanicals and does not have a positive list of botanicals. Maximum levels of vitamins and minerals are not established at the national level, requiring careful assessment to ensure compliance with the definition of food supplements. However, Spain does have a positive list of other substances with nutritional and physiological effects. AESAN (Agencia Española de Seguridad Alimentaria y Nutrición) has also provided indications for the use of probiotics, allowing the use of the term "probiotic" under the mutual recognition principle.
The Spanish market is of great interest to companies in sports nutrition, probiotics, botanicals, and mushroom food supplements. Importing and selling food supplements in Spain, including online platforms like Amazon or other e-commerce marketplaces, requires undergoing a notification procedure. Once the notification is complete, the product is included in a specific list with a unique registration code. Notification necessitates verification of formula compliance and product labeling. Nutrients used in food must have a significant History of Safe Use (HoSU) within the EU as evidence of safety. Failure to meet this criterion classifies the substance as a "novel food", requiring prior authorization. Novel food registration occurs at the EU level.
For those seeking to sell food supplements in Spain post-Brexit or from non-EU countries [including the United Kingdom (UK)], establishing a legal entity in an EU member state or appointing a third party as the product’s Legal Representative (LR) in Spain or other EU countries is necessary. The representative company must be mentioned on the label, act as the point of contact for the authority, and establish applicable procedures as per the regulations stated by the Spanish Agency for Food Safety and Nutrition.
Food products other than food supplements generally do not require notification in Spain. However, Foods for Specific Groups (FSG), such as infant formulas, follow-on formulas, total diet replacement products for weight control, or Foods for Special Medical Purposes (FSMP), may require notification as per Spain’s food safety law. Fortified foods do not necessitate notification. FBOs must ensure compliance with all food regulations regarding composition and labeling.
The food market in Spain and the EU is dynamic, requiring companies to keep up with rapid regulatory updates. Freyr, with an operational and delivery center in the EU, provides comprehensive food Regulatory services and support to manufacturers, distributors, and FBOs. Their services encompass Regulatory assessments of formulas or ingredients, health claims, food labeling, food supplement registration in Spain, advertising, product notification, Legal Representation (LR), as well as surveillance and vigilance.
Food Supplement Registration in Spain
Expertise
- Food Product Classification/Food Supplement Classification.
- Formula Review/Ingredients Assessment.
- Safety Assessment of Finished Products/Food Ingredients.
- Label and Claims Review.
- Nutritional and Health Claims Consultation and Substantiation.
- NHCR Claims Application (EU Register on Nutrition and Health Claims).
- Environmental Labeling/Recycling Labeling Review and Review of Green Claims.
- Packaging Material Requirements.
- Dossier Gap Analysis.
- Dossier Compilation and Submission.
- Food Regulatory Compliance Consulting.
- Product Notification/Registration.
- EU Country-specific Regulatory Support.
- Regulatory Strategy for the EU.
- EU Legal Representation (LR).
- Regulatory Intelligence (RI) Report.
- Product-specific Updates on the Regulatory Guidelines/Standards.
- Novel Food Authorization Request/Traditional Food from a Third Country Registration.
- Consultation Processes for Determining the Status (novel/not novel) of a Food Ingredient.
- Regulatory Guidance on Food Products/Food Supplements Import Services in the EU.
- Translation Support Services.
- Review of Advertising Promotional Material.
- Food Surveillance and Vigilance.
- Post-notification/Post-marketing Follow-up.
- Management of Alerts and Authorities’ Remarks.
- Food Business Operator (FBO) Support.
- Communication with Spanish Agency for Food Safety and Nutrition and Health Authorities (HAs).
- Product Compliance for European Economic Area Countries Outside the EU (Switzerland, Norway, and Iceland).
- End-to-end Services for Fortified Foods, Food for Special Medical Purposes (FSMP), Infant Formula, Follow-on Formula, and other Foods for Specific Groups (FSG).
Advantages
- End-to-end Regulatory consultation.
- Market-specific Regulatory consulting and advice.
- Harmonized compliance, local labeling, and local market support.
- Qualified team of experts with hands-on experience across all categories of foods.
- Support for region-specific Regulatory activities.
- Extensive partner network across the globe.
- A strong relationship with various HAs.