CELEX: 32022R0719
Language: en
Date: 2022-05-10 00:00:00
Title: Commission Regulation (EU) 2022/719 of 10 May 2022 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (Text with EEA relevance)

11.5.2022   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 134/1
               
            
         COMMISSION REGULATION (EU) 2022/719
         of 10 May 2022
         refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 18(5) thereof,
         Whereas:
         
                     (1)
                  
                  
                     Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.
                  
               
                     (2)
                  
                  
                     Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (‘the Authority’), for a scientific assessment, as well as to the Commission and the Member States for information.
                  
               
                     (3)
                  
                  
                     The Authority is to deliver an opinion on the health claim concerned.
                  
               
                     (4)
                  
                  
                     The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.
                  
               
                     (5)
                  
                  
                     Following an application from DuPont Nutrition Biosciences ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related Biﬁdobacterium animalis subsp. lactis Bi-07 (Bi-07) and the contribution to increasing lactose digestion (Question No EFSA-Q-2020-00024). The claim proposed by the applicant was worded as follows: ‘Bifidobacterium animalis subsp. lactis Bi-07 contributes to the improvement of lactose digestion in individuals who have difficulty digesting lactose’.
                  
               
                     (6)
                  
                  
                     The Commission, the Member States and the applicant received the scientific opinion (2) on that claim from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of Biﬁdobacterium animalis subsp. lactis Bi-07 and a beneﬁcial physiological effect (i.e. the improvement of symptoms of lactose maldigestion) in individuals with lactose maldigestion. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted claims, it should not be authorised.
                  
               
                     (7)
                  
                  
                     Following an application from Tchibo GmbH, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientiﬁc substantiation of a health claim related to Coffee C21 and the protection of DNA from strand breaks (Question No EFSA-Q-2019-00423). The claim proposed by the applicant was worded as follows: ‘regular consumption of Coffee C21 contributes to the maintenance of DNA integrity in cells of the body’.
                  
               
                     (8)
                  
                  
                     The Commission, the Member States and the applicant received the scientific opinion (3) on that claim from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of Coffee C21 and the protection of DNA from strand breaks. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted claims, it should not be authorised.
                  
               
                     (9)
                  
                  
                     Following an application from NattoPharma ASA, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to MenaQ7® and the maintenance of the elastic properties of the arteries (Question No EFSA-Q-2019-00229). The claim proposed by the applicant was worded as follows: ‘MenaQ7®, vitamin K2 as menaquinone-7, improves arterial stiffness’.
                  
               
                     (10)
                  
                  
                     The Commission, the Member States and the applicant received the scientific opinion (4) on that claim from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of MenaQ7® and the maintenance of the elastic properties of the arteries. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted claims, it should not be authorised.
                  
               
                     (11)
                  
                  
                     The comments from DuPont Nutrition Biosciences ApS and Tchibo GmbH received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006, have been considered when adopting this Regulation.
                  
               
                     (12)
                  
                  
                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
                  
               HAS ADOPTED THIS REGULATION:
         
            Article 1
            The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.
         
         
            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
         
         
            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 10 May 2022.
            
               
                  For the Commission
               
               
                  The President
               
               Ursula VON DER LEYEN
            
         
         
            (1)  OJ L 404, 30.12.2006, p. 9.
         
            (2)  EFSA Journal 2020;18(7):6198.
         
            (3)  EFSA Journal 2020;18(3):6055.
         
            (4)  EFSA Journal 2020;18(1):5949.
      
      
         
            ANNEX
            Rejected health claims
            
                        Application – Relevant provisions of Regulation (EC) No 1924/2006
                     
                     
                        Nutrient, substance, food or food category
                     
                     
                        Claim
                     
                     
                        EFSA opinion reference
                     
                  
                        Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
                     
                     
                        
                           Biﬁdobacterium animalis subsp. lactis Bi-07 (Bi-07)
                     
                     
                        
                           Biﬁdobacterium animalis subsp. lactis Bi-07 contributes to the improvement of lactose digestion in individuals who have difficulty digesting lactose
                     
                     
                        Q-2020-00024
                     
                  
                        Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
                     
                     
                        Coffee C21, a blend of pure Arabica roast coffees (Coffea arabica L.) without any non-coffee ingredients
                     
                     
                        Regular consumption of Coffee C21 contributes to the maintenance of DNA integrity in cells of the body
                     
                     
                        Q-2019-00423
                     
                  
                        Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data
                     
                     
                        MenaQ7®, vitamin K2 as menaquinone-7
                     
                     
                        MenaQ7®, vitamin K2 as menaquinone-7, improves arterial stiffness
                     
                     
                        Q-2019-00229