EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11168/2018 
(POOL/E4/2018/11168/11168 -EN.doc)  
[…](2019) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
to include concentrated apple juice as an active substance in Annex I thereto  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 28(1) of Regulation (EU) No 528/2012 (the BPR) empowers the Commission 
to adopt delegated acts in order to include an active substance into Annex I to the 
BPR after receiving the opinion of the European Chemicals Agency (ECHA), 
provided that there is evidence that the active substance do not give rise to concern 
according to the condi tions set out in Article 28(2) of that Regulation.  A simplified 
authorisation procedure is provided in Chapter V of the BPR for biocidal products 
containing active substances  listed in Annex I to the BPR and fulfilling other 
conditions set out in Article 2 5 of that Regulation . 
Article 15(b)  of Regulation (EU) No 1062/2014 (the Review Regulation) provided 
economic operators with an opportunity to support those active substances that 
benefitted from the food and feed derogation provided for by Article 6 of Re gulation 
(EC) No 1451/2007 . The concerned active substances are food and feed used in 
biocidal products of product -type 19 "Repellents and Attractants". The products 
supplied on the market as biocidal products containing these substances do not 
benefit fro m the exemption of the scope of the BPR set out in Article 2(5))(a) of the 
BPR, as this exemption covers only food or feed being placed on the market as food 
or feed in compliance with EU food or feed legislation (e.g. manufacturing, 
marketing and labellin g requirements) but used by the user for biocidal purposes . As 
these active substances do not benefit from derogation under the BPR anymore, and 
following the submission of successful notifications by economic operators pursuant 
to Articles 15 to 17 of the  Review Regulation , ECHA was able to identify potential 
candidates for inclusion into Annex I to the BPR among these substances.  
After discussion with Member States Competent Authorities for Biocidal Products, 
the Commission requested on 31 January  2017 an  opinion to the European 
Chemicals Agency in accordance with Article 75(1)(g) of Regulation (EU) No 
528/2012 as to whether each food or feed active substance for which ECHA accepted 
a declaration of interest to notify  give rise to concern in accordance wit h Article 
28(2) of the BPR .  
The opinion of the European Chemicals Agency was formulated on 1 4 December 
2017 by the Biocidal Products Committee and confirmed that concentrated apple 
juice  does not give rise to concern and is eligible for inclusion in Annex  I to 
Regulation (EU) No 528/2012.  This opinion is considered as an opinion of the 
Agency pursuant to Article 28(1) of  Regulation (EU) No 528/2012 . 
This draft Delegated Regulation therefore proposes to include concentrated apple 
juice  in Annex I to Regulat ion (EU) No 528/2012 . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission has consulted an expert group (the 'Biocides CA meeting') 
consisting of representatives of Member States' competent authorities for biocidal 
products, of the European Ch emicals Agency, of the biocides industry and of the 
civil society  in the meetings of 27-28 September 2018 , 13-15 March 2019  and 16 -17 
May 2019 . EN 2  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delega ted act amends Annex I to Regulation (EU) No 528/2012 . EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
to include concentrated apple juice as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning th e making available on the market and use of biocidal 
products1, and in particular Article 28(1) thereof,  
Whereas:  
(1) The active substance concentrated apple juice , insofar 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 provided for in Article 6 of Commission Regulation (EC) 
No 1451/20072.  
(2) A notification w as submitted pursuant to Article 16(5) of Commission Delegated 
Regulation (EU) No 1062/20143 for concentrated apple juice  for product type 19  
benefiting from the food and feed derogation . The European Chemicals Agency  (‘the 
Agency’) declared the notification to be compliant and informed the Commission of 
the compliance pursuant to Article 17 of that R egulation . Concentrated apple juice  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 products4.  
(3) On 31 January 2017 t he Commission asked the Agency for an opinion on whether 
concentrated apple juice  gives rise to concern according to Article 28(2) of 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 concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3) . 
3 Commission Delegated Regula tion (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) N o 528/2012 of the European Parliament and of the Council  (OJ L 294, 10.10.2014 , 
p. 1). 
4 Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to 
Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic e xamination 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). EN 4  EN (4) The opinion of the Agency5 concluded that concentrated apple juice  does not give rise 
to concer n and is therefore  eligible for inclusion in Annex I to Regulation (EU) 
No 528/2012 . 
(5) Taking into account the opinion of the Agency , it is appropriate to include 
concentrated apple juice  in Annex I to Regulation (E U) No 528/2012 . As concentrated 
apple juice  is of natural or igin, it should be included in category 4 "Trad itionally used 
substances of natural or igin".  Concentrated apple juice  should be included in that 
Annex only in so far it  falls within the definition in point (2) of Part I of Annex I to 
Council Directive 2001/112/EC6.  
(6) Article 89(3) of Regulation (E U) 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 accor dance with that 
Regulation. With respect to concentrated apple juice  for product -type 19, the date of 
approval for the purposes of Article 89(3) of that Regulation should be set at  1 June 
2021 , in order to allow sufficient time for applications for authori sation to be 
submitted in accordance with the second subparagraph of Article 89(3) of that 
Regulation , 
HAS ADOPTED THIS REGULATION:  
Article 1 
Annex I to Regulation (E U) No 528/2012  is amended in accordance with the  Annex to this 
Regulation . 
Article 2 
For the purposes of Article 89(3) of Regulation (E U) No 528/2012, the date of approval  of 
concentrated apple juice  for product -type 19 is 1 June 2021. 
Article  3 
This Regulation shall enter into force on the twentieth  day following that of its publication i n 
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,  
 For the Commission  
 The President  
 Jean -Claude J UNCKER  
                                                 
5 Biocidal Products Committee (BPC) Opinion of 14 December 2017  on the e ligibility of certain food 
and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017 . 
6 Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar 
products intended for human consumption  (OJ L 10, 12.1.2002 , p. 58).