(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union. 

(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 has established a Union list of novel foods. 

(3) On 30 June 2023, the company Chemi S.p.A. (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place L-alpha-glycerylphosphorylcholine (L-alphaGPC) from soya phospholipids (lecithin) on the Union market as a novel food. The applicant requested for the novel food to be used in food supplements as defined in Directive 2002/46/EC intended for the general population, excluding food supplements for infants and young children. 

(4) On 30 June 2023, the applicant also made a request to the Commission for the protection of the following proprietary data: identity of the novel food, production process, compositional data, Absorption, distribution, metabolism and excretion (ADME) and toxicological information. 

(5) On 12 February 2024, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to provide a scientific opinion on L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) as a novel food. 

(6) On 4 March 2026, the Authority adopted its scientific opinion on the ‘Safety of Lalpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) as a novel food pursuant to Regulation (EU) 2015/2283’ in accordance with Article 11 of Regulation (EU) 2015/2283. 

(7) In its scientific opinion, the Authority concluded that that the novel food, L-alphaglycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin), is safe under the proposed conditions of use. 

(8) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data concerning the production process, compositional data and certain toxicological information, without which it could not have assessed the novel food and reached its conclusion. 

(9) The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2), point (b), of Regulation (EU) 2015/2283. 

(10) The applicant declared that they held proprietary and exclusive rights of reference to the relevant studies, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data. 

(11) The Commission assessed all the information provided by the applicant and considers that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data concerning the production process, compositional data and certain toxicological information, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place L-alphaglycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) on the market within the Union during a period of five years from the entry into force of this Regulation. 

(12) However, such restriction of the authorisation and the reference to the data contained in the applicant’s file for their sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation. 

(13) Considering that L-alpha-glycerylphosphorylcholine (L-alpha-GPC) is derived from soya phospholipids (lecithin), and that soybeans are listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council among the substances or products causing allergies or intolerances, food supplements containing the novel food should be labelled in accordance with Article 21 of that Regulation. 

(14) It is appropriate that the inclusion of L-alpha-glycerylphosphorylcholine (L-alphaGPC) from soya phospholipids (lecithin) as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. 

(15) L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. 

(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,