REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant 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 products in accordance with Article 83(2) of that Regulation
Date: 2024-05-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, biocide, chemical product, delegated legislation, market approval, marketing standard, plant health product, scientific progress, technological change, transfer of competence

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 27.5.2024  COM(2024) 214 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant 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 products in accordance with Article 83(2) of that Regulation    
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 

on the exercise of the delegation conferred on the Commission pursuant 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 
products in accordance with Article 83(2) of that Regulation 

1. INTRODUCTION AND LEGAL BASIS 

The  EU  legal  framework  for  biocidal  products  is  intended  to  ensure  a  high  level  of 
protection  of  both  human  and  animal  health  and  the  environment  and  to  improve  the 
functioning  of  the  internal  market.  The  framework  works  on  the  principle  that  biocidal 
products can be placed on the market and used only if a marketing authorisation is granted 
by the competent authorities.  

The  requirements  and  procedures  for  authorising  the  marketing  and  use  of  biocidal 
products are laid down in Regulation (EU) No 528/20121 (hereinafter, “the BPR”). This 
report is to meet the obligation set for the Commission by Article 83(2) of the BPR. Article 
83(2) requires the Commission to present to the European Parliament and to the Council a 
report on the exercise of the delegation conferred on the Commission by the BPR. The 
report shall be drawn up not later than nine months before the end of the five-year period 
of  the  delegation,  running  from  17  July  2012.  The  delegation  of  power  shall  be  tacitly 
extended  for  periods  of  an  identical  duration,  unless  the  European  Parliament  or  the 
Council opposes such extension not later than three months before the end of each period.  

The first report on the exercise of the delegation conferred on the Commission was adopted 
by the Commission on 11 October 2016 and covered the period from 17 July 2012 up to 
11 October 2016.2 

This is the second report on the exercise of the delegation conferred on the Commission. 
This second report should have been issued by 17 October 2021 and is thus significantly 
delayed.  In  particular,  during  that  period  the  Commission  focused  its  attention  on  the 
submission of the first report from the Commission to the European Parliament and the 
Council  on  the  implementation  of  Regulation  (EU)  No  528/2012  of  the  European 
Parliament and of the Council concerning the making available on the market and use of 

1 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 products, OJ L 167, 27.6.2012, p. 1  
2 Report from the Commission to the European Parliament and the Council on the exercice of the delegation 
conferred in the Commission pursuant 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 products, 
COM/2016/0650 final  

1 

 
 
 
 
 
 
 
biocidal  products  (COM/2021/287  final),  and  the  accompanying  Staff  Working 
Document3.  

The  delegation  of  power  to  the  Commission  was  tacitly  extended  by  the  European 
Parliament or the Council for the period from 17 July 2022 to 17 July 2026. However, in 
order  to  comply  with  its  obligation,  the  Commission  now  issues  this  second  report, 
covering the period from 12 October 2016 up to 31 December 2023, in order to provide an 
up-to-date comprehensive view of the actions taken by the Commission.  

Article 83(1) of the BPR empowers the Commission to adopt delegated acts subject to the 
conditions laid down in that Article in order to: 

-   adapt the definition of nanomaterial set out in the BPR in view of technical and scientific 

progress [Article 3(4)], 

-   specify  scientific  criteria  for  the  determination  of  endocrine-disrupting  properties 

[Article 5(3)],  

-   specify criteria for determining what constitutes adequate justification to adapt the data 
requirements for an application for approval of an active substance in case the data are 
not necessary owing to the exposure associated with the proposed use of the product 
[Article 6(4)],  

-   specify criteria for defining when the exposure associated with the proposed uses of the 
product would justify adapting the data requirements for the applications for biocidal 
products authorisations [Article 21(3)],  

-   specify the criteria for determining when comparative assessments of biocidal products 
involve  questions  better  addressed  at  Union  level  and  the  procedures  for  such 
comparative assessments [Article 23(5)],  

-   amend Annex I in order to include active substances that do not give rise to concern 

[Article 28(1)],  

-   amend Annex I in order to restrict or to remove the entry for an active substance if there 
is  evidence  that  biocidal  products  containing  that  substance  do  give  rise  to  concerns 
[Article 28(3)],  

-   adopt  supplementary  rules  for  the  renewal  of  authorisations  subject  to  mutual 

recognition [Article 40],  

-   adopt  specific  rules  supplementing  the  BPR  provisions  on  research  and  development 

[Article 56(4)], 

-   adopt acts supplementing the BPR rules for the use of the Register for Biocidal Products 

[Article 71(9)],  

-   adapt Annexes II, III and IV to scientific and technical progress [Article 85],  

-   establish  the  rules  on  the  review    programme  for  the  systematic  examination  of  all 
existing  active  substances  commenced  in  accordance  with  Article  16(2)  of  Directive 

3  Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the  implementation  of 
Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  concerning  the  making 
available on the market and use of biocidal products, COM/2021/287 final  

2 

 
 
 
98/8/EC4  and  specification  of  the  related  rights  and  obligations  of  the  competent 
authorities and the participants in the programme and extend the duration of the review 
programme for a determined period [Article 89(1)]. 

2. EXERCISE OF THE DELEGATION 

During the period concerned by this report, the Commission adopted sixteen delegated acts 
in order to fulfil obligations laid down in the BPR and supplement or amend certain non-
essential elements of the BPR. The following acts were adopted  from 12 October 2016 
until 31 December 2023: 

2.1. Commission Delegated Regulation (EU) No 2017/6985 

This Delegated Regulation was adopted on the basis of Article 89(1), first subparagraph, 
of the BPR, according to which “The Commission shall be empowered to adopt delegated 
acts in accordance with Article 83 concerning the carrying out of the work programme 
and specification of the related rights and obligations of the competent authorities and the 
participants in the programme”. 

Commission Delegated Regulation (EU) No 1062/2014 sets out the review programme of 
existing  active  substance  (the  ‘Review  Programme  Regulation’)6.  It  had  set  out,  in  its 
Annex  II,  an  exhaustive  list  of  existing  active  substances/product-type  combinations 
included in the programme of review of existing biocidal active substances on 4 August 
2014. According to the Review Programme Regulation, any person could have notified to 
ECHA  a  substance/product-type  combination  included  in  Part  2  of  Annex  II  within  12 
months from the entry into force of that Review Programme Regulation. After the expiry 
of  that  deadline,  Annex  II  and  Article  14(3)  of  that  Regulation  needed  to  be  updated. 
Consequently, Delegated Regulation (EU) No 2017/698 was adopted in order to remove 
from Part 2 of Annex II to Review Programme Regulation those substance/product type 
combinations which were not approved and include in Part 1 of Annex II to that Review 
Programme Regulation those notified and found compliant. 

The Biocides CA Expert Group was consulted on the draft Delegated Regulation in the 
meetings  of  16-17  March  2016  and  of  25-26  May  2016.  The  Commission  adopted  the 
Delegated Regulation on 3 February 2017 and notified it to the European Parliament and 
the Council. Neither institution objected to the Delegated Regulation within the two-month 
period provided for in Article 83(5) of the BPR. Delegated Regulation (EU) No 2017/698 
was published in the Official Journal of 19 April 2017 and entered into force on 9 May 
2017. 

4  Directive  98/8/EC  of  the  European  Parliament  and of  the  Council  of 16  February 1998  concerning  the 
placing of biocidal products on the market, OJ L 123, 24.4.1998, p. 13  
5 Commission Delegated Regulation (EU) 2017/698 of 3 February 2017 amending 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  concerning  the  making  available  on  the  market  and  use  of  biocidal  products,  OJ  L  103, 
19.4.2017, p. 1  
6 Commission Delegated 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  
3 

 
 
 
 
2.2. Commission Delegated Regulation (EU) No 2017/21007 

This legal act was adopted on the basis of Article 5(3) of the BPR which provides that “No 
later than 13 December 2013, the Commission shall adopt delegated acts in accordance 
with Article 83 specifying scientific criteria for the determination of endocrine-disrupting 
properties”.   

Delegated  Regulation  (EU)  No  2017/2100  sets  out  the  scientific  criteria  for  the 
determination of endocrine-disrupting (ED) properties. These criteria reflect  the current 
state of scientific and technical knowledge and allow identifying substances having such 
properties more accurately. This delegated act was under preparation when the first report 
of 11 October 2016 on the exercise of the delegation conferred on the Commission was 
submitted to the European Parliament and to the Council. 

The Commission expert group ‘Competent Authorities for Biocidal Products’ (hereinafter, 
"Biocides CA Expert Group") served as expert group in accordance with the applicable 
inter-institutional  arrangements.  In  this  setting,  the  draft  Delegated  Regulation  was 
discussed  in  the  Biocides  CA  Expert  Group  meetings  of  16-18  November  2016,  21 
December  2016  and  28  February  2017.  The  Commission  adopted  the  Delegated 
Regulation  on  4  September  2017  and  notified  it  to  the  European  Parliament  and  the 
Council. Neither institution objected to the  Delegated Regulation  within the two-month 
period provided for in Article 83(5) of the BPR. Delegated Regulation (EU) No 2017/2100 
was published in the Official Journal of 17 November 2017 and entered into force on 7 
December 2017. 

2.3 Commission Delegated Regulation (EU) No 2019/1578 

This  Delegated  Regulation  was  adopted  in  accordance  with  Article  89(1),  first 
subparagraph, of the BPR, on the basis of which “The Commission shall be empowered to 
adopt delegated acts in accordance with Article 83 concerning the carrying out of the work 
programme  and  specification  of  the  related  rights  and  obligations  of  the  competent 
authorities and the participants in the programme”. 

The  Review  Programme  Regulation,  as  amended  by  the  abovementioned  Commission 
Delegated  Regulation  (EU)  2017/698,  had  set  out  in  its  Annex  II  a  list  of  active 
substance/product-type  combinations  included  in  the  programme  of  review  of  existing 
active  substances  contained  in  biocidal  products  on  3  February  2017.  The  identities  of 
certain active substances listed in Annex II to the Review Programme Regulation, which 
could be generated in situ, were redefined in order to indicate in a more precise manner the 
active substances and their precursors presently covered in the  review programme. Any 
person with an interest could notify a combination of an active substance and its precursors 
not yet covered by the new identity as well as active substances in product-type 19 which 

7 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for 
the  determination  of  endocrine-disrupting  properties  pursuant  to  Regulation  (EU)  No  528/2012  of  the 
European Parliament and Council, OJ L 301, 17.11.2017, p. 1  
8 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 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  
4 

 
 
 
benefitted from the derogation for food and feed, provided for by Commission Regulation 
(EC) No 1451/20079.  

The aim of Delegated Regulation  (EU) No 2019/157  was to  include in Annex  II to  the 
Review Programme Regulation substance/product-type combinations which were notified 
and found compliant by ECHA and to remove those for which a decision of approval or 
non-approval was taken after 3 February 2017. 

The Biocides CA Expert Group was consulted on the draft Delegated Regulation in the 
meeting of 16-18 March 2018.  The Commission adopted the Delegated Regulation on 6 
November  2018  and  notified  it  to  the  European  Parliament  and  the  Council.  Neither 
institution objected to the Delegated Regulation within the two-month period provided for 
in Article 83(5) of the BPR. Delegated Regulation (EU) No 2019/157 was published in the 
Official Journal of 1 February 2019 and entered into force on 21 February 2019. 

2.4 Commission Delegated Regulation (EU) No 2019/22710  

This Delegated Regulation was adopted on the basis of Article 89(1), first subparagraph, 
of the BPR which empowers the Commission “to adopt delegated acts in accordance with 
Article 83 concerning the carrying out of the work programme and specification of the 
related  rights  and  obligations  of  the  competent  authorities  and  the  participants  in  the 
programme”. 

The Commission adopted Delegated Regulation (EU) No 2019/227 to amend the Review 
Programme  Regulation,  in  order  to  designate  new  evaluating  competent  authorities  in 
charge  of  carrying  out  the  assessment  of  certain  active  substances  in  the  EU  biocides 
review programme, following the withdrawal of the UK from the EU. Given that the UK 
was  the  evaluating  competent  authority  for  several  active  substance/product-type 
combinations,  it  was  considered  necessary  to  designate  new  evaluating  competent 
authorities  from  the  remaining  27  Member  States  of  the  EU,  EEA  countries,  or 
Switzerland11, with effect from 30 March 2019. 

The  Biocides  CA  Expert  Group  was  consulted  on  the  draft  Delegated  Regulation  in 
meetings of 5-6 July 2018 and 27-28 September 2018. Updated drafts of the Delegated 
Regulation  were  made  public  in  advance  of  each  of  those  meetings.  The  Commission 
adopted the Delegated Regulation on 28 November 2018 and notified it to the European 
Parliament  and  the  Council.  Neither  institution  objected  to  the  Delegated  Regulation 
within  the  two-month  period  provided  for  in  Article  83(5)  of  the  BPR.  Delegated 

9 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. 
10 Commission Delegated Regulation (EU) 2019/227 of 28 November 2018 amending Delegated Regulation 
(EU) No 1062/2014 as regards certain active substances/product-type combinations for which the competent 
authority  of  the  United  Kingdom  has  been  designated  as  the  evaluating  competent  authority,  OJ  L  37, 
8.2.2019, p. 1  
11 Switzerland can act as an evaluating competent authority in accordance with Decision No 1/2015 of the 
Committee established under the Agreement between the European Community and the Swiss Confederation 
on mutual recognition in relation to conformity assessment of 14 April 2015 on the amendment of Chapter 
16 on construction products, Chapter 18 on biocidal products and the update of legal references listed in 
Annex 1, OJ L 171, 2.7.2015, p. 25 

5 

 
 
 
Regulation (EU) No 2019/227 was published in the Official Journal of 8 February 2019 
and entered into force on 28 February 2019. 

2.5 Commission Delegated Regulation (EU) No 2021/52512 

This Delegated Regulation was adopted in accordance with Article 85 of the BPR which 
provides “In order to allow the provisions of this Regulation to be adapted to scientific 
and technical progress, the Commission shall be empowered to adopt delegated acts in 
accordance with Article 83 concerning the adaptation of Annexes II, III and IV to such 
scientific and technical progress”. 

Annexes II and III to the BPR set out the information requirements for active substances 
and biocidal products. It was considered necessary to modify the information requirements 
on active substances and biocidal products in order to take into account new methods for 
generating better information on toxicological properties, new testing strategies favouring 
in vitro tests instead of in vivo tests in order to reduce testing on vertebrate animals and a 
testing strategy and methods for the determination of endocrine disrupting properties of 
substances. 

The Biocides CA Expert Group was consulted on the draft Delegated Regulation from its 
80th to 88th meetings (from September 2018 to May 2020). Updated drafts of the Delegated 
Regulation  were  made  public  in  advance  of  each  of  those  meetings.  The  Commission 
adopted  the  Delegated  Regulation  on  19  October  2020  and  notified  it  to  the  European 
Parliament  and  the  Council.  Neither  institution  objected  to  the  Delegated  Regulation 
within  the  two-month  period  provided  for  in  Article  83(5)  of  the  BPR.  Delegated 
Regulation (EU) No 2021/525 was published in the Official Journal of 26 March 2021 and 
entered into force on 15 April 2021. 

2.6 Commission Delegated Regulation (EU) No 2022/82513 

This  Delegated  Regulation  was  adopted  in  accordance  with  Article  89(1),  first 
subparagraph, of the BPR, which empowers the Commission to “adopt delegated acts in 
accordance  with  Article  83  concerning  the  carrying  out  of  the  work  programme  and 
specification  of  the  related  rights  and  obligations  of  the  competent  authorities  and  the 
participants in the programme”. 

to 

Annex  II 
list  of  active 
the  Review  Programme  Regulation  contained  a 
substance/product-type  combinations  included  in  the  programme  of  review  of  existing 
active substances contained in biocidal products on 6 November 2018. Through Delegated 
Regulation (EU) No 2022/825, substance/product-type combinations whose notifications 
were found compliant by ECHA, namely peanut butter and brandy for use in product-type 
19,  were  therefore  included  in  Annex  II  to  the  Review  Programme  Regulation.  Active 
substances for which a decision of approval or non-approval was adopted after 6 November 

12 Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to 
Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  concerning  the  making 
available on the market and use of biocidal products, OJ L 106, 26.3.2021, p. 3  
13 Commission Delegated Regulation (EU) 2022/825 of 17 March 2022 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, OJ L 147, 30.5.2022, p. 3 

6 

 
 
 
2018, or which were included in Annex I to the BPR, were removed from Annex II for the 
concerned product-types. 

The Biocides CA Expert Group was consulted on the draft Delegated Regulation in  the 
meeting of 28-29 September 2021. The Commission adopted the Delegated Regulation on 
17  March  2022  and  notified  it  to  the  European  Parliament  and  the  Council.  Neither 
institution objected to the Delegated Regulation within the two-month period provided for 
in Article 83(5) of the BPR. Delegated Regulation (EU) No 2022/825 was published in the 
Official Journal of 30 May 2022 and entered into force on 19 June 2022. 

2.7 Commission Delegated Regulations on the inclusion of active substances in 
Annex I to Regulation (EU) No 528/2012  

Article  28(1)  of  the  BPR  empowers  the  Commission  to  “adopt  delegated  acts  in 
accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, 
in order to include active substances provided that there is evidence that they do not give 
rise to concern according to paragraph 2 of this Article”. 

Annex I to the BPR lists active substances which do not give rise to concern in accordance 
with the criteria established in Article 28(2) of the BPR. Products that contain only those 
active substances and comply with the requirements established in Article 25 of the BPR, 
are eligible for a simplified authorisation procedure. 

The Commission has adopted several delegated acts on the basis of Article 28(1) in the 
period from 2019 to 2021 as set out in the following three subsections. 

2.7.1 Commission Delegated Regulations adopted in 2019 

On 8 August 2019, in accordance with the opinion of the European Chemicals Agency14, 
the Commission adopted a series of delegated acts, namely Delegated Regulations (EU) 
2019/181915,  2019/182016,  2019/182117,  2019/182218,  2019/182319,  2019/182420  and  

14 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, ECHA/BPC/186/2017 
15  Commission  Delegated  Regulation  (EU)  2019/1819  of  8  August  2019  amending  Regulation  (EU)  No 
528/2012 of the European Parliament and of the Council to include vinegar as an active substance in Annex 
I thereto, OJ L 279, 31.10.2019, p. 1  
16  Commission  Delegated  Regulation  (EU)  2019/1820  of  8  August  2019  amending  Regulation  (EU)  No 
528/2012 of the European Parliament and of the Council to include Saccharomyces cerevisiae as an active 
substance in Annex I thereto, OJ L 279, 31.10.2019, p. 4  
17 Commission Delegated Regulation 2019/1821 of 8 August 2019 amending Regulation (EU) No 528/2012 
of the European Parliament and of the Council to include powdered egg as an active substance in Annex I 
thereto, OJ L 279, 31.10.2019, p. 7  
18 Commission Delegated Regulation (EU) 2019/1822 of 8 August 2019 amending Regulation (EU) No 
528/2012 of the European Parliament and of the Council to include honey as an active substance in Annex 
I thereto, OJ L 279, 31.10.2019, p. 10–12  
19 Commission Delegated Regulation (EU) 2019/1823 of 8 August 2019 amending Regulation (EU) No 
528/2012 of the European Parliament and of the Council to include D-fructose as an active substance in 
Annex I thereto, OJ L 279, 31.10.2019, p. 13  
20  Commission  Delegated  Regulation  (EU)  2019/1824  of  8  August  2019  amending  Regulation  (EU)  No 
528/2012 of the European Parliament and of the Council to include cheese as an active substance in Annex 
I thereto, OJ L 279, 31.10.2019, p. 16 

7 

 
 
 
2019/182521  with  the  objective  of  respectively  including  in  Annex  I  to  the  BPR  the 
following food and feed active substances: vinegar, saccharomyces cerevisiae, powdered 
egg, honey, D-fructose, cheese and concentrated apple juice.  

The  Biocides  CA  Expert  Group  was  consulted  on  the  draft  Delegated  Regulations  in 
meetings of 27-28 September 2018, 13-15 March 2019 and 16-17 May 2019. Successive 
updated  drafts  of  the  Delegated  Regulations  were  made  public  in  advance  of  those 
meetings.  The  Commission  adopted  the  Delegated  Regulations  on  8  August  2019  and 
notified them to the European Parliament and the Council. Neither institution objected to 
the Delegated Regulations within the two-month period provided for in Article 83(5) of 
the BPR. These were published in the Official Journal of 31 October 2019 and entered into 
force on 20 November 2019. 

2.7.2 Commission Delegated Regulation adopted in 2020 

On  3  November  2020,  in  accordance  with  the  opinion  of  the  European  Chemicals 
Agency22,  the  Commission  adopted  Delegated  Regulation  (EU)  2021/40723  which 
included in Annex I to the BPR the active substance citric acid. The Biocides CA Expert 
Group was consulted on the draft Delegated Regulation in the meeting of 25 September 
2020.  The  Commission  adopted  the  Delegated  Regulation  on  3  November  2020  and 
notified it to the European Parliament and the Council. Neither institution objected to the 
Delegated  Regulation  within the two-month period provided  for in Article 83(5) of the 
BPR. Delegated Regulation (EU) No 2021/407 was published in the Official Journal of 9 
March 2021 and entered into force on 29 March 2021. 

2.7.3 Commission Delegated Regulations adopted in 2021 

On 10 March 2021, in accordance with the opinions of the European Chemicals Agency24 
25,  the  Commission  adopted  Delegated  Regulations  (EU)  2021/80626  and  2021/80727, 
which  incorporated  in  Annex  I  to  the  BPR  carbon  dioxide  and  potassium  sorbate, 
respectively.  The  Biocides  CA  Expert  Group  was  consulted  on  the  draft  Commission 
Delegated Regulations in the meeting of 8-9 December 2020. The Commission adopted 

21  Commission  Delegated  Regulation  (EU)  2019/1825  of  8  August  2019  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, OJ L 279, 31.10.2019, p. 19 
22 Biocidal Products Committee Opinion on the application for approval of the active substance: Citric acid, 
Product type: 2, ECHA/BPC/088/2016, adopted on 16 February 2016  
23  Commission  Delegated  Regulation  (EU)  2021/407  of  3 November  2020  amending  Regulation  (EU) 
No 528/2012 of the European Parliament and of the Council to include citric acid as an active substance in 
Annex I thereto, OJ L 81, 9.3.2021, p. 15  
24 Biocidal Products Committee Opinion on the application for approval of the active substance: Carbon 
dioxide generated from propane, butane or a mixture of both by combustion, Product type: 19, 
ECHA/BPC/249/2020, adopted on 16 June 2020   
25 Biocidal Products Committee Opinion on the application for approval of the active substance: Potassium 
sorbate, Product type: 8, ECHA/BPC/37/2014, adopted on 4 December 2014  
26  Commission  Delegated  Regulation  (EU)  2021/806  of  10 March  2021  amending  Regulation  (EU) 
No 528/2012  of  the  European  Parliament  and  of  the  Council  to  include  carbon  dioxide  generated  from 
propane, butane or a mixture of both by combustion as an active substance in Annex I thereto, OJ L 180, 
21.5.2021, p. 78  
27Commission Delegated Regulation (EU) 2021/807 of 10 March 2021 amending Regulation (EU) 
No 528/2012 of the European Parliament and of the Council to include potassium sorbate as an active 
substance in Annex I thereto, OJ L 180, 21.5.2021,p. 81 

8 

 
 
 
the Delegated Regulations on 10 March 2021 and notified them to the European Parliament 
and the Council. Neither institution objected to the Delegated Regulations within the two-
month period provided for in Article 83(5) of the BPR. Commission Delegated Regulation 
(EU)  No  2021/806  and  Commission  Delegated  Regulation  (EU)  No  2021/807  were 
published in the Official Journal of 21 May 2021 and entered into force on 10 June 2021. 

3. Other delegations 

The Commission has not yet exercised the delegated powers provided for in some of the 
areas referred in section I of this report (i.e.powers referred in Article 3(4), Article 6(4), 
Article 21(3), Article 23(5), Article 28(3), Article 56(4), Article 71(9) of the BPR), but 
may do so in the future if found necessary during the implementation of the BPR. 

CONCLUSION 

In the period covered by this report, the Commission has exercised the delegated powers 
provided  for  by  the  BPR  on  sixteen  occasions  in  compliance  with  the  delegations 
conferred.  

The implementation of the BPR is advancing and technical and scientific progress takes 
place. Therefore, the Commission may be required to adopt further delegated acts in the 
future in order to keep the legal framework up to date. 

9