EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11776/2020  
(POOL/E4/2020/11776/11776 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Delegated Regulation (EU) No 1062/2014 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  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 2  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
According to Regulation (EU) No 528/2012 of the European Parli ament and of the 
Council of 22 M ay 2012 concerning the making available on the market and use of 
biocidal products, a work programme shall be carried out to review all active 
substances used in biocidal products , which were alread y on the market on 14 May 
2000. This on -going work programme for the systematic examination of all existing 
active substances used in biocidal products is foreseen  to run until 31 December 
2024.  
Commission Delegated Regulation (EU) No 1062/201 4, the so -called "Review 
Regulation"  lays down the detai led rules for the examination of these existing active 
substances. It also sets out  in its Annex II the substance/product -type combinations 
included in this work programme  on 6 November 2018 .  
Since the adoption of the Review Regulation , Annex II has been updated several 
times in light of the progress of the execution of the review programme, the last 
times by Commission Delegated Regulation s (EU) 2019/157  and (EU) 2019/227. 
Since the adoption of those  Delegated Regulation s, some of the substance/product -
type combinations included in this work programme are no longer supported . The 
Commission also adopted a number of approval and non -approval decisions pursuant 
to Article 89(1) of Regulation (EU) No 528/2012 approving or not approving  certain 
active substa nces for use in biocidal products  and a number of delegated acts 
pursuant to Article 28(1) of Regulation (EU) No 528/2012 including certain active 
substances in Annex I to that Regulation . Hence, these substance/product -type 
combinations should no longer b e included in the work  programme.  In addition , the 
identity of  several  active substance was redefined pursuant to Article 13 of the 
Review Regulation and the active substance/product -type combination noti fied 
pursuant to Article 14(1)(b) and found complian t with Article 17(2) of the Review 
Regulation should be included in the work programme.  Also, following the 
declarations received pursuant to Article 16(4) of the Review Regulation, an 
invitation was published where persons with an interest could notify ac tive 
substances in product -type 19 that had benefitted from the derogation for food and 
feed provided for by Article 6 of Regulation (EC) No 1451/2007. Two active 
substance/product -type combination s for which the notification has  been found 
compliant with Article 17(2) of the Review Regulation should be included in Annex 
II of this Regulation . 
Consequently, Annex II of the Review Regulation needs to be updated . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission has c onsulted an expert group (the 'Biocides CA meeting') 
consisting of representatives of Member States' competent authorities for biocidal 
products, of the European Chemicals Agency, of the biocides industry and of the 
civil society in the meeting of 28-29 Se ptember 2021 . A draft of the delegated act 
was made pu blic in advance of the  meeting.   
EN 3  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delegated act amends Annex II  to Regulation (EU) No 1062/2014, and updates it 
in line with the actual state of the work programme.   
EN 4  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Delegated Regulation (EU) No 1062/2014 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  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard 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 concerning the making available on the market and use of biocidal 
products1 and in particular the first subparagraph of Article  89(1)  thereof,  
Whereas:  
(1) Annex II  to Commission Delegated Regulation (EC) No 1 062/20142 includes  a list of 
active substance /product -type combinations  included in the programme of review of 
existing active substances contained in biocidal products on 6 November 2018 .  
(2) The identities  of certain active substance s listed in Annex II  to Delegated Regulation 
(EC) No 1062/2014  have been redefined  pursuant to Article 13 of that Regulation in 
order to identify  in a more precise manner  those active substance s and establish the 
corresponding   new substance identity . 
(3) Following the publication by the European Chemicals Agency (‘the Agency’) of an 
open invitation to take over the role of participant for certain active substance/product -
type combination s covered by the existing substance identity  but not  by the new 
substance identity, s ubstance/product -type combinations notified pursuant to Article 
14(1) , point (b), and fou nd by the Agency  to be compliant  with Article 17(2) of 
Delegated Regulation (EC) No 1062/2014  should be included in Annex II to that 
Regulation pursuant to Article 18  of that Regulation . 
(4) Following the declarations received pursuant to Article 16(4) of Delegated Regulation 
(EC) No 1062/2014 , the Agency published an invitation so that any person with an 
interest could notify  active substance s in product -type 19 that  benefitted from the 
derogation for food and feed provided for by Article 6 of Commission Regulation 
(EC) No 1451/ 20073. Two notifications for  peanut butter and brandy for use in 
product -type 19 were submitted  pursuant to Article 16(5) and found  by the Agency  to 
be compliant with Article 17 (2) of Delegated Regulation (EC) No 1062/2014 . Those 
                                                 
1 OJ L 167, 27.6.2012 , p. 1.  
2 Commission Regulation (EC) 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  (OJ L 294, 10.10.2014, p. 1 ). 
3 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).   
EN 5  EN active substances  should  therefore  be included in Annex II to that Regulation pursuant 
to Article 18  of that Regulation . 
(5) In the Annex  to this Regulation , it is appropriate to state the Member States  whose  
competent authorities should  be the evaluating competent authorities  for the active 
substance/product -type combinations  to be added to Annex II to Delegated Regulation 
(EC) No 1062/201 4. 
(6) Active substances  for which a decision of approval or non -approval has been adopted   
after 6 November 2018 for one or more product -types, or which were included in 
Annex I to Regulation (EU) No 528/2012 pursuant to Article 28(1) of that Regulation , 
are no longer in the review programme . Therefore , those active substances  should no 
longer be included in Annex II to Delegated Regulation (EC) No 1062/2014  for the 
concerned product -types . 
(7) In order to reflect the actual situation and for transparency,  it is appropriate to provide 
a list of active substance/product -type combinations included in the programme of 
review of existing active substances contained in biocidal products on the day of 
adoption of this Regulation .  
(8) Delegated Regulation (EC) No 106 2/2014  should therefore be amended accordingly , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Delegated Regulation (EC) No 1062/2014  is replaced by the Annex to this 
Regulation . 
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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN