The regulation (EU) 2019/515 deals with the concept of Mutual Recognition, a fundamental principle in the EU single market, which allows products legally marketed in one EU country to be sold in another EU country without the need for further authorisation or additional labelling requirements.

• This principle applies to botanical nutraceuticals, and companies can use it for marketing their products across different EU countries once they have been authorised in one member state.
• The product does not need to originate from the Member State where it is legally marketed. Any Member State would work. However, the product must adhere to the national laws of the Member State in which it is made accessible to end users.
• However, it is important to note that national authorities can restrict or prohibit the sale of products based on public health or safety concerns.
• In addition, the mutual recognition principle does not apply to products with a specific national authorisation procedure or to products considered medicinal products. Therefore, companies must ensure that their products comply with the national laws and regulations of the country where they are being marketed. In addition, they may need to obtain additional authorisations or comply with specific labelling requirements [1].