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
Date: 2016-10-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, chemical product, delegated legislation, market approval, marketing standard, plant health control, plant health product, transfer of competence

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 11.10.2016  COM(2016) 650 final   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  
 
 
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 

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 only if a marketing authorisation is granted by the 
competent authorities.  

The requirements and procedures for authorising the marketing of biocidal products are 
laid  down  principally  in  Regulation  (EU)  No  528/20121  (hereinafter,  “the  BPR”)  ,  as 
amended  by  Regulation  (EU)  No  736/20132,  Regulation  (EU)  No  837/20133  and 
Regulation  (EU)  No  334/20144.  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.  

Article  83(1)  of  the  BPR  empowers  the  Commission  to  adopt  delegated  acts  subject  to 
the conditions laid down in this 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)],  

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  Commission  Delegated  Regulation  (EU)  No  736/2013  of  17  May  2013  amending  Regulation  (EU)  No 
528/2012 of the European Parliament and of the Council as regards the duration of the work programme 
for examination of existing biocidal active substances, OJ L 204, 31.7.2013, p. 25. 
3 Commission Delegated Regulation (EU) No 837/2013 of 25 June 2013 amending Annex III to Regulation 
(EU) No 528/2012 of the European Parliament and of the Council as regards the information requirements 
for authorisation of biocidal products, OJ L 234, 3.9.2013, p. 1. 
4  Regulation  (EU)  No  334/2014  of  the  European  Parliament  and  of  the  Council  of  11  March  2014 
amending  Regulation  (EU)  No  528/2012  concerning  the  making  available  on  the  market  and  use  of 
biocidal products, with regard to certain conditions for access to the market, OJ L 103, 5.4.2014, p. 22. 

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- 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  supplementary  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  work  programme  for  the  systematic  examination  of  all 
existing  active  substances  commenced  in  accordance  with  Article  16(2)  of  Directive 
98/8/EC5  and  specification  of  the  related  rights  and  obligations  of  the  competent 
authorities and the participants in the programme extension of the duration of the work 
programme for a determined period [Article 89(1)]. 

2. EXERCISE OF THE DELEGATION 

During the period concerned by this report, the Commission adopted four delegated acts  
in  order  to  supplement  or  amend  certain  non-essential  elements  of  the  BPR.  The 
following acts were adopted: 

2.1. Commission Delegated Regulation (EU) No 736/2013 

The  BPR  provides  for  the  continuation  of  the  work  programme  for  the  systematic 
examination  of  all  existing  active  substances  used  in  biocidal  products  commenced  in 

5 OJ L 123, 24.4.1998, p. 1. 

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accordance with Article 16(2) of Directive 98/8/EC. The second subparagraph of Article 
89(1) of the BPR states that “Depending upon the progress of the work programme, the 
Commission shall be empowered to adopt delegated acts in accordance with Article 83 
concerning  the  extension  of  the  duration  of  the  work  programme  for  a  determined 
period”. 

Initially, the first paragraph of Article 89(1) of the BPR provided the work programme to 
be achieved by 14 May 2014. However, as pointed out in the Communication from the 
Commission to the European Parliament pursuant to Article 294(6) of the Treaty on the 
Functioning  of  the  European  Union  concerning  the  position  of  the  Council  on  the 
adoption of a Regulation of the European Parliament and of the Council concerning the 
placing on the market and use of biocidal products6, the examination of all existing active 
substances used in biocidal products will only be finalised by 31 December 2024. 

As a consequence, on the basis of the second subparagraph of Article 89(1) of the BPR, 
Regulation  (EU)  No  736/2013  amended  the  first  subparagraph  of  Article  89(1)  of  the 
BPR in order to extend the duration of the work programme until 31 December 2024. 

The  Biocides  competent  authorities  expert  group  ("hereinafter,  "Biocides  CA  expert 
group")  served  as  expert  group  in  accordance  with  the  applicable  inter-institutional 
arrangements. In this setting the draft delegated act was discussed in the meetings of  19-
21 September 2012  and  of  12-14  December  2012.  The  Biocides  CA  Expert  Group  was 
consulted  on  the  draft  Commission  Delegated  Regulation  and  an  updated  draft  of  the 
delegated  act was made  public in advance of each of those meetings.  The Commission 
adopted the delegated act on 17 May 2013 and notified it to the European Parliament and 
the Council. Neither institution objected to the delegated act within the two-month period 
provided  for  in  Article  83(5)  of  the  BPR.  Commission  Delegated  Regulation  (EU) 
No 736/2013 was published in the Official Journal of 31 July 2013 and entered into force 
on 20 August 2013. 

2.2. Commission Delegated Regulation (EU) No 837/2013 

This legal act was adopted on the basis of Article 85 of the BPR specifying:, “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”. 

Regulation  (EU)  No  837/2013  amended  Annex  III  to  the  BPR  in  order  to  include  the 
proof of establishment of technical equivalence pursuant to Article 54 in the information 
requirement for authorisation of biocidal products. A biocidal product may be authorised 
even if one or more of the active substances contained therein has been manufactured in a 
different  location  or  according  a  different  process,  including  from  different  starting 
materials, than those of the substance evaluated for approval pursuant to Article 9 of the 
BPR.  This  delegated  act  was  aimed  at  ensuring  in  such  a  situation  that  the  active 
substance  contained  in  a  biocidal  product  does  not  have  significantly  more  hazardous 
properties than the substance which has been evaluated for the purpose of approval.  

The  Biocides  CA  Expert  Group  was  consulted  on  the  draft  Commission  Delegated 
Regulation in the meetings of 19-21 September 2012 and of 12-14 December 2012. An 

6 COM(2011) 498 final. 

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updated  draft  of  the  draft  delegated  act  was  made  public  in  advance  of  each  of  those 
meetings. The Commission adopted the delegated act on 25 June 2013 and notified it to 
the European Parliament and the Council. Neither institution objected to the delegated act 
within  the  two-month  period  provided  for  in  Article  83(5)  of  the  BPR.  Commission 
Delegated  Regulation  (EU)  No 837/2013  was  published  in  the  Official  Journal  of 
3 September 2013 and entered into force on 23 September 2013. 

2.3 Commission Delegated Regulation (EU) No 492/20147 

The legal act was adopted on the basis of the first subparagraph of Article 40 of the BPR, 
specifying “The Commission shall be empowered to adopt delegated acts in accordance 
with  Article  83  laying  down  supplementary  rules  for  the  renewal  of  authorisations 
subject to mutual recognition”. The Commission adopted Regulation (EU) No 492/2014 
in  order  to  lay  down  supplementary  rules  for  the  renewal  of  authorisations  subject  to 
mutual  recognition  procedures,  both  in  the  Member  State  having  granted  the  first 
authorisation and in those Member States having granted an authorisation through mutual 
recognition  of  that  first  authorisation.  The  delegated  act  provides  that  the  European 
Chemicals  Agency  shall  draw  up  guidelines  on  the  details  related  to  the  handling  of 
renewals. 

The  Biocides  CA  Expert  Group  was  consulted  on  the  draft  Commission  Delegated 
Regulation in meetings of 15-17 May 2013, 10-12 July 2013 and 25-27 September 2013. 
An  updated  draft  of  the  delegated  act  was  made  public  in  advance  of  each  of  those 
meetings. The Commission adopted the delegated act on 7 March 2014 and notified it to 
the European Parliament and the Council. Neither institution objected to the delegated act 
within  the  two-month  period  provided  for  in  Article  83(5)  of  the  BPR.  Commission 
Delegated Regulation (EU) No 492/2014 was published in the Official Journal of 14 May 
2014 and entered into force on 3 June 2014. 

2.4 Commission Delegated Regulation (EU) No 1062/20148 

In relation to the work programme for the  systematic examination of all existing active 
substances commenced in  accordance with  Article 16(2) of Directive 98/8/EC, the first 
subparagraph of Article 89(1) of the BPR 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”. 

On the basis of this provision, the Commission adopted Regulation (EU) No 1062/2014 
in order to supplement the BPR as regards the detailed rules for the continuation of the 
review  programme  which  was  previously  carried  out  according  to  rules  based  on 
Directive 98/8/EC. Since the BPR repealed the Directive, the existing detailed rules had 
to be updated adapted to the provisions of the BPR. The delegated act defines the rights 
and obligations of competent authorities and of participants in the work programme. In 
addition, the delegated act specifies in which situations a prospective applicant would be 

7 Commission Delegated Regulation (EU) No 492/2014 of 7 March 2014 supplementing Regulation (EU) 
No  528/2012  of  the  European  Parliament  and  of  the  Council  as  regards  the  rules  for  the  renewal  of 
authorisations of biocidal products subject to mutual recognition (OJ L 139, 14.5.2014, p. 1). 
8 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) 

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allowed  to  join  or  replace  an  existing  participant  or  to  take  over  the  support  of  an 
included substance in the review programme.  

The  Biocides  CA  Expert  Group  was  consulted  on  the  draft  Commission  Delegated 
Regulation in meetings of 25-27 September 2013, 11-13 December 2013, 12-13 March 
2014 and of 14-15 May 2014. An updated draft of the delegated act was made public in 
advance  of  each  of  those  meetings.  The  Commission  adopted  the  delegated  act  on  4 
August  2014  and  notified  it  to  the  European  Parliament  and  the  Council.  Neither 
institution  objected  to  the  delegated  act  within  the  two-month  period  provided  for  in 
Article  83(5)  of  the  BPR.  Commission  Delegated  Regulation  (EU)  No  492/2014  was 
published  in  the  Official  Journal  of  10  October  2014  and  entered  into  force  on  30 
October 2014. 

3e. Other delegations 

The BPR provides for further delegated powers.  

As regards the delegation in Article 5(3) of the BPR, experts are currently discussing a 
draft delegated regulation in line with the new inter-institutional agreement9. Following 
these discussions,  the Commission is going to adopt as soon as possible  the delegated 
regulation supplementing the BPR and specifying scientific criteria for the determination 
of endocrine-disrupting properties. 

So  far  the  Commission  has  not  yet  exercised  the  delegated  powers  provided  for  other 
legal bases10. With the exception of Article 5(3) the BPR allows – but does not oblige – 
the Commission adopt delegated acts. It is important to note that the BPR has only been 
applied since 1 September 2013. 

CONCLUSION 

To date the Commission has exercised the delegated powers provided for by the BPR in 
four occasions. One draft delegated act is currently being discussed by experts.  

The  Commission  is  of  the  view  that  the  delegated  powers  conferred  by  Article  83(2) 
should remain in force. 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 The draft Commission Delegated Regulation setting out scientific criteria for the determination of 
endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 was endorsed by the College of 
Commissioners on 15 June 2016. More information on the dedicated web portal: 
http://ec.europa.eu/health/endocrine_disruptors/policy/index_en.htm.  
10 Article 3(4), Article 6(4), Article 21(3), Article 23(5), Article 28(1), Article 28(3), Article 56(4), Article 
71(9) and Article 85. 

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