All foods for special medical purposes (FSMP) supplied to the market must be labelled in the official language and comply with European Union and national requirements. Compliance must be ensured both when introducing a new product to the market and when importing or exporting products to new markets.
Product labelling refers to all information related to food products for special medical purposes: words, data, trademarks, and registered names. The definition of labelling also includes pictorial material or symbols appearing on the packaging, document, information leaflet, label, and ring or band accompanying or referring to such a product.
The labelling of foods for special medical purposes is a complex service that helps to ensure compliance with the relevant standards and avoid risks such as product recall, the need to re-label packaging, reputational damage, etc.
Taking into account regulatory standards and best practices in target markets, we advise on how to:
- Apply relevant legislation.
- Formulate labelling instructions and claims.
- Avoid challenges inherent in the labelling process.
If necessary, we also assist clients in various stages of SMPMP labelling:
- Assess the legal compliance of packaging layouts with EU and national requirements.
- We help ensure that the product name complies with its legal name.
- We prepare regulatory translations of label texts.
- We check product labelling texts.
- We unify label texts adapted to different markets.
- We participate in the creation of packaging layouts and label designs.
Countries where we provide this service
The labelling of food products for special medical purposes is closely linked to national requirements. We provide regulatory translations into national languages and ensure the legal compliance of food products in the Baltic countries, Poland, and other countries (subject to separate agreement). Compliance is ensured separately for each market where the product is distributed.
Placing food products for special medical purposes on the market: what to pay attention to?
- Every SMPMP supplied to the market must be labelled in the official language.
- SMPMP must be notified. Trade in unnotified products is prohibited.
- Product notification in one country is not valid in another country.
- Optimal course of action: regulatory translations into national languages based on the master text for target markets, preparation of layouts (package designs).
Why is it worth turning to experts?
Correct labelling of food products for special medical purposes ensures not only legal compliance but also transparent communication with the consumer. A clearly and consistently labelled product promotes consumer confidence, reduces the risk of legal liability and penalties, and helps to expand the product into new markets more smoothly. With our help, you will gain a better understanding of the nuances of the labelling process and receive specific recommendations and valuable insights that will help you effectively address the challenges that arise throughout the process.
We strive to build successful partnerships with responsible and quality-oriented customers to ensure a smooth and secure launch of SMPM products on the market.
Let us know your needs, and we’ll help you find the right solution!
