COMMISSION DELEGA TED REGUL ATION (EU) 2019/1823 
of 8 August 2019 
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include 
D-fr uctose as an activ e subst ance in Annex I thereto 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concer ning 
the making available on the mark et and use of biocidal products (1), and in particular Article 28(1) thereof, 
Whereas: 
(1) The active substance D-fr ucto se, insof ar as it constituted food or feed intended for use as a repellent or attractant of 
product type 19, used to benefit from the food and feed derogation provi ded for in Article 6 of Commission 
Regulation (EC) No 1451/2007 (2). 
(2) A notifi cation was submitted pursuant to Article 16(5) of Commission Deleg ated Regulation (EU) No 1062/2014 (3) 
for D-fr uctose for product type 19 benefi ting from the food and feed derog ation. The European Chemicals Agen cy 
(‘the Agency’) declared the notification to be compl iant and informed the Commission of the compl iance pursuant 
to Article 17 of that Regulation. D-fr ucto se was consequently included for product type 19 in the list of substance/ 
product type combinations included in the programme of review of existing active substances contained in biocidal 
products (4). 
(3) On 31 Januar y 2017 the Commission aske d the Age ncy for an opinion on whether D‐fr uctose gives rise to concer n 
according to Article 28(2) of Regulation (EU) No 528/2012. The opinion of the Agency (5) concluded that D-fr ucto se 
does not give rise to concer n and is theref ore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. 
(1)OJ L 167, 27.6.2012, p. 1. 
(2)Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in 
Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concer ning the placing of biocidal products on the 
market (OJ L 325, 11.12.2007, p. 3). 
(3)Commission Delegat ed Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of 
all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament 
and of the Council (OJ L 294, 10.10.2014, p. 1). 
(4)Commission Delegat ed Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegat ed Regulation (EU) No 
1062/2014 on the work programme for the system atic examination of all existing active substances contained in biocidal products 
referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1). 
(5)Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for 
inclusion into Annex I to the BPR, ECH A/BPC/186/2017. EN Offi cial Jour nal of the European Union 31.10.2019                                                                                                                                       L 279/13   (4) Taking into account the opinion of the Agen cy, it is appropr iate to include D-fr ucto se in Annex I to Regulation (EU) 
No 528/2012. As D-fr ucto se is of natural origin, it should be included in cate gory 4 ‘Traditionally used substances of 
natural origin’ . D‐fr ucto se should be included in that Annex only insofar as it falls within the definit ion of ‘food’ or 
‘feed’ refer red to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that D-fr ucto se only 
benefited from the food and feed derogat ion provid ed for in Article 6 of Regulation (EC) No 1451/2007 if it was 
food or feed. 
(5) Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance 
included in the work programme for the systematic examination of existing active substances is approved in 
accordance with that Regulation. With respect to D-fr ucto se for product-type 19, the date of appro val for the 
purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow suffi cient time for 
applications for author isation to be submitted in accordance with the second subparagraph of Article 89(3) of that 
Regulation, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation. 
Article 2 
For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of D‐fr ucto se for product-type 19 
is 1 June 2021. 
Article 3 
This Regulation shall enter into force on the twentieth day followi ng 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, 8 August 2019.  
For the Commission 
The President 
Jean-Claude JUNCKER     EN Offi cial Jour nal of the European Union L 279/14                                                                                                                                       31.10.2019   ANNEX 
In Annex I to Regulation (EU) No 528/2012, in Categor y 4 of the list of active substances referred to in Article 25(a), the 
follo wing entr y is added:                                                              
EC number Name/group Restr iction Comment 
‘200-333-3 D-Fr ucto se (*)  Excluding D-fr uctose that is 
not food or feed. CAS No 57-48-7 
(*)  The date of approval of D-fr uctose for product-type 19 for the purposes of Article 89(3) is 1 June 2021.’.   EN Offi cial Jour nal of the European Union 31.10.2019                                                                                                                                       L 279/15