CELEX: 32019R0387
Language: en
Date: 2019-03-11 00:00:00
Title: Commission Implementing Regulation (EU) 2019/387 of 11 March 2019 authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

12.3.2019   
               
               
                  EN
               
               
                  Official Journal of the European Union
               
               
                  L 70/17
               
            
         COMMISSION IMPLEMENTING REGULATION (EU) 2019/387
         of 11 March 2019
         authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:
         
                     (1)
                  
                  
                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list 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 (2) establishing a Union list of authorised novel foods was adopted.
                  
               
                     (3)
                  
                  
                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.
                  
               
                     (4)
                  
                  
                     Commission Implementing Decision (EU) 2015/545 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market in the Union of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food to be used in a number of foods.
                  
               
                     (5)
                  
                  
                     Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees.
                  
               
                     (6)
                  
                  
                     On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to change the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium sp. (ATCC PTA-9695) oil to fruit and vegetable purees.
                  
               
                     (7)
                  
                  
                     The proposed extension of use of the novel food does not change the safety considerations that supported the authorisation for extension of use of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 to fruit and vegetable purees and it does not either pose any safety concern. Taking into account those considerations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283.
                  
               
                     (8)
                  
                  
                     On 10 September 2018, the company DSM Nutritional Products Europe also made a request to the Commission to authorise the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requests the deletion of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food as listed in the Union list and from the labelling of foods containing it.
                  
               
                     (9)
                  
                  
                     The Applicant considers that the change of the designation and the labelling requirements for Schizochytrium sp. (ATCC PTA-9695) oil is necessary because the indication of the strain ‘(ATCC PTA-9695)’ on the labelling of foods containing Schizochytrium sp. (ATCC PTA-9695) oil is not understandable nor relevant for consumers.
                  
               
                     (10)
                  
                  
                     There are four oils from Schizochytrium sp. currently authorised and listed in the Union list of novel foods. However, Schizochytrium sp. (ATCC PTA-9695) oil is the only one for which the strain must be specified on the label. Therefore, the change of the designation and labelling of Schizochytrium sp. (ATCC PTA-9695) oil will ensure consistency in the designation and labelling of all oils from Schizochytrium sp. authorised as novel foods without having a negative impact on human health and consumer interests.
                  
               
                     (11)
                  
                  
                     Considering the removal of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil, the wording ‘(ATCC PTA 9695)’ should be included in the specifications as it is necessary for a proper identification of the novel food. Therefore, the specifications of the entry ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be amended accordingly.
                  
               
                     (12)
                  
                  
                     The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil, the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil and the subsequent updating of the Union list are not liable to have an effect on human health.
                  
               
                     (13)
                  
                  
                     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
            
               1.   The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance Schizochytrium sp. (ATCC PTA-9695) oil shall be amended as specified in the Annex to this Regulation.
            
            
               2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
            
         
         
            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
         
         
            Article 3
            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, 11 March 2019.
            
               
                  For the Commission
               
               
                  The President
               
               Jean-Claude JUNCKER
            
         
         
            (1)  OJ L 327, 11.12.2015, p. 1.
         
            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
         
            (3)  Commission Implementing Decision (EU) 2015/545 of 31 March 2015 authorising the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 90, 2.4.2015, p. 7).
         
            (4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel foods ingredients (OJ L 43, 14.2.1997, p. 1).
         
            (5)  Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 authorising the extension of use of oil from the micro algae Schizochytrium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 185, 23.7.2018, p. 9).
      
      
         
            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
            
                        (1)
                     
                     
                        The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 1 (Authorised novel foods) is replaced by the following:
                        
                                    Authorised novel food
                                 
                                 
                                    Conditions under which the novel food may be used
                                 
                                 
                                    Additional specific labelling requirements
                                 
                                 
                                    Other requirements
                                 
                              
                                    ‘
                                          Schizochytrium
                                       
                                       sp. (ATCC PTA-9695) oil
                                    
                                 
                                 
                                    
                                       Specified food category
                                    
                                 
                                 
                                    
                                       Maximum levels of DHA
                                    
                                 
                                 
                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’’
                                 
                                 
                                     
                                 
                              
                                    Dairy products except milk-based drinks
                                 
                                 
                                    200 mg/100 g or for cheese products 600 mg/100 g
                                 
                              
                                    Dairy analogues except drinks
                                 
                                 
                                    200 mg/100 g or for analogues to cheese products 600 mg/100 g
                                 
                              
                                    Spreadable fats and dressings
                                 
                                 
                                    600 mg/100 g
                                 
                              
                                    Breakfast cereals
                                 
                                 
                                    500 mg/100 g
                                 
                              
                                    Food Supplements as defined in Directive 2002/46/EC
                                 
                                 
                                    250 mg DHA/day for general population
                                 
                              
                                    450 mg DHA/day for pregnant and lactating women
                                 
                              
                                    Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control
                                 
                                 
                                    250 mg/meal
                                 
                              
                                    Milk-based drinks and similar products intended for young children
                                 
                                 
                                    200 mg/100 g
                                 
                              
                                    Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen
                                 
                              
                                    Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014
                                 
                              
                                    Foods for special medical purposes as defined in Regulation (EU) No 609/2013
                                 
                                 
                                    In accordance with the particular nutritional requirements of the persons for whom the products are intended
                                 
                              
                                    Bakery products (breads, rolls, and sweet biscuits)
                                 
                                 
                                    200 mg/100 g
                                 
                              
                                    Cereal bars
                                 
                                 
                                    500 mg/100 g
                                 
                              
                                    Cooking fats
                                 
                                 
                                    360 mg/100 g
                                 
                              
                                    Non-alcoholic beverages (including dairy analogue and milk-based drinks)
                                 
                                 
                                    80 mg/100 ml
                                 
                              
                                    Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013
                                 
                                 
                                    In accordance with Regulation (EU) No 609/2013
                                 
                              
                                    Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013
                                 
                                 
                                    200 mg/100 g
                                 
                                 
                                     
                                 
                              
                                    Fruit/vegetable puree
                                 
                                 
                                    100 mg/100 g
                                 
                              
                  
                        (2)
                     
                     
                        The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 (Specifications) is replaced by the following:
                        
                                    Authorised novel food
                                 
                                 
                                    Specification
                                 
                              
                                    ‘
                                          Schizochytrium
                                       
                                       sp. (ATCC PTA-9695) oil
                                    
                                 
                                 
                                    The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.
                                    Peroxide value (PV): ≤ 5,0 meq/kg oil
                                    Unsaponifiables: ≤ 3,5 %
                                    Trans-fatty acids: ≤ 2,0 %
                                    Free fatty acids: ≤ 0,4 %
                                    Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %
                                    DHA content: ≥ 35 %’