"The European Commission has updated the Novel Food Status Catalogue to clarify the regulatory status of the microbial culture of Lactobacillus gasseri,reuteri and salivarius. According to information available to the competent authorities of the EU Member States, the microbial culture of Lactobacillus gasseri,reuteri and salivarius was used in food supplements within the European Union prior to 15 May 1997.
On this basis, its use in food supplements is not considered novel and is therefore not subject to pre-market authorisation under Regulation (EU) 2015/2283 on novel foods.
The clarification applies exclusively to food supplement uses. Any use of the microbial culture of Lactobacillus gasseri,reuteri and salivarius in foods other than food supplements may be regarded as novel and could require prior authorisation in accordance with the Novel Food Regulation before being placed on the EU market.
Furthermore, operators are reminded that additional EU or national legislation may impose specific conditions or restrictions on the marketing of this microbial culture. It is therefore recommended that businesses verify applicable requirements with the competent authorities of the relevant Member State(s) prior to market placement."