Sending a notification regarding the marketing of food supplements in Portugal (mutual recognition)
In order to market food supplements in Portugal that are not yet on the Portuguese market and are already marketed in at least one European Union (EU) Member State (MS), the economic operator must notify the DGAV that it complies with the requirements for mutual recognition.
To be considered to be a food supplement, foodstuffs must be:
- concentrated sources of nutrients and/or other substances with nutritional or physiological value;
- presented in dose form (tablets, capsules, sachets and other pharmaceutical-like forms, including measuring spoons, cups, dispensers);
- intended to be consumed in measured units of small quantities.
Service channels
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Access the service online
You will need one of the following means of authentication to access this service:
- Digital Mobile Key (CMD)
- Citizen Card
- Digital Certificate
Procedure and requirements
Time of issue/decision
A DGAV responde no prazo de 15 dias úteis após a receção do pedido para:
- comunicar ao operador económico que o pedido foi aceite. O operador pode começar a comercializar o produto
- comunicar ao operador económico que o pedido não foi aceite
- caso existam erros no pedido, contactar a autoridade competente pelo produto no EM de origem para pedir mais informações. A resposta deve ser dada no prazo de 15 dias úteis. Depois de receber a resposta, a DGAV tem mais 15 dias úteis para comunicar ao operador económico que o pedido foi aceite ou recusado.
How much
It's free of charge.
Additional Data
If you have any questions about the marketing of food supplements under the mutual recognition procedure, please contact the DGAV by email at reconhecimentomutuo@dgav.pt.
Products that do not require a notification
The DGAV considers that products for sportspersons sold in dose form but in measured units of more than 25 g or 25 ml, and/or which have a total daily intake of more than 50 Kcal per day, fall under the classification of ordinary foodstuffs and therefore the DGAV does not need to be notified in order for them to be marketed.
See more information in Borderline ‘food supplement’ and ‘food for sportspersons’ products and in the Report from the Commission to the European Parliament and the Council on food intended for sportspeople.
Legislation, refusals, contests, claims
Legislation
Decreto-Lei n.º 118/2015 - Diploma Nacional referente aos suplementos alimentares.
DIR.2002/46 - Relativa aos suplementos alimentares.
REG.1169/2011 - Relativo à informação ao consumidor.
REG.1333/2008 - Relativo aos aditivos alimentares.
REG.2017/625 - Relativo aos controlos oficiais.
REG.178/2002 - Relativo aos princípios e normas gerais da legislação alimentar.
REG.1924/2006 - Relativo às alegações nutricionais e de saúde sobre os alimentos.
REG.2015/2283 - Relativo a novos alimentos.
REG.432/2012 - Lista de alegações de saúde permitidas relativas.