EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
PLAN/2023/1943 
(POOL/E4/2023/1943 -EN.doc)  
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
as regards a further extension of the duration of the work programme for the systematic 
examination of all existing biocidal active substances  
(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 C ommission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
According to Article 89(1) of 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 (‘the B iocidal Products Regulation’ ), the 
Commission must continue to carry out the work programme for the systematic 
examination of a ll existing active substances in accordance with Article 16(2) of 
Directive 98/8/EC . The C ommission  aims to complete the work programme  by 31 
December 2024. It is empowered to adopt delegated acts in accordance with Article 
83 on carrying out the work programme and specif ying the related rights and 
obligations of the competent authorities and the participants in the programme.  
The review programme of existing active substances under Directive 98/8/EC started 
in 2000 with the ident ification and notification of existing active substances placed 
on the EU market for biocidal purposes before 14 May 2000.  
Commission Regulation (EU) No 2032/2003 set up the list of identified existing 
active substances, and the list of  existing active sub stances  notified  to the 
Commission by prospective applicants to support their approval for one or more 
biocidal product -types (PTs). According to this Regulation, most applications had to 
be submitted between 2004 and 2008 depending on the PTs.   
Initially planned to be completed by 14 May 2010 under Directive 98/8/EC , the 
review programme had first been extended in 2009 until 14 May 20142. This date 
was kept by the Council and the European Parliament when the Biocidal Products 
Regulation was adopted. In 201 3, after  discussion with experts of Member States 
competent authorities  on biocidal products  within the meetings of the Commission 
expert group ‘Competent Authorities for Biocidal Products (Regulation (EU) No 
528/2012 )’ – Register Code E03125 (the ‘CA meetings’), the review programme was 
re-organised and its duration further extended . Commission Delegated Regulation 
(EU) No 736/2013 of 17 May 2013 extended the review programme  until 31 
December 20243. Specifically , the review programme was re -arranged  into 6 
different priority lists with time limits  for the submission of the assessment reports to 
the Eu ropean Chemicals Agency (ECHA) , and a number of principles on a more 
efficient management of the dossiers were agreed between the Commission and the 
Membe r States competent authorities. Regulation  (EU)  No 1062/2014 ( ‘the Review 
Regulation ’) was adopted to reflect those agreements , setting in particular these time 
limits in Annex III . 
Considering the number of applications still under examination in 2014, ECHA 
needed to adopt 50 opinions per year to complete the review programme by the 
deadline of 31 December 2024.  
                                                 
1 OJ L 167, 27.6.2012 , p. 1.  
2 Directive 2009/107/EC of the European Parliament and of the Council of 16 September 2009 amending 
Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of 
certain time periods (OJ L 262, 6.10.2009, p. 40).  
3 Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 amending Regulation (EU) N o 
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) .  
EN 2  EN Although the speed  increased and the objective of adopting 50 decisions per year was 
almost reached in 2016, the speed of progress started to decline from that year. The 
vast majority of Member States have not met the time limits for submi tting the 
assessment reports by their competent authorities to ECHA. The Commission 
presented a detailed assessment of this situation to  the Council and the European 
Parliament in the implementation report of the B iocidal Products Regulation  in June  
20214. The main reasons for the delays are : i) the lack of resources allocated in 
Member States  competent authorities  for completing their tas ks under the B iocidal 
Products Regulation;  ii) delays by applicants in submitting additional data ; iii)  
complex technical questions on specific dossiers that need to be resolved first ; iv) 
evolution of technical guidance ; and v) the adoption of new scienti fic criteria for 
determin ing endocrine disrupting properties5, which triggered the need for further 
data and assessments. Commission er Kyridakides responsible for Health and Food 
Safety  sent letters to the responsible Ministers in all Member States to express her 
concerns about the  delays in implementati ng the B iocidal Products Regulation  
(active substances assessments, product authorisations), and called on Member States 
to take action, including allocating sufficient resources6. However, so far , no 
significant improvement has been noticed regard ing the resources available in the 
Member States  or the submission of the draft assessment reports to ECHA . 
Since 2015, discussions  regularly  took place in the CA meeting s, and agreements 
were reached on a number of actions7. Workshops were organised by ECHA, and an 
ECHA action plan on active substances has also been agreed8. Regular reports are 
presented  at each CA meeting.  
The Commission has  also taken further action . In 20 23, it  launched the call 
‘Contributing to more sustainable and circular food production systems by boosting 
Member States’ capacities to evaluate and remove from the market unsafe pesticides 
and biocides – SMP -FOOD -2022 -BIOCIDES -PESTICIDES -IBA’. It provides for 
EUR 10 million in grants to Member States to the authorities responsible for biocides 
(and plant protection products) to help them achieving progress in the 
implementation of the B iocidal Products Regulation  (and the Plant Protection 
Products Regualtion) s ubject to the condition that a full  cost recovery system is 
established or maintained. Nine Member States have successfully applied for this 
grant  for biocides . 
Despite these actions, and although some progress can st ill be achieved before 31 
December 2024, the review programme will clearly not be finalised by that date  
given that , on 1 October 2023, only 4 6% of the work programme was completed.  
In accordance with Article 89(1), second subparagraph, of the Biocidal Pro ducts 
Regulation , depending upon the progress of the work programme, the Commission is 
                                                 
4 The Commission Report is available at this link: https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1623326515401&uri=CELEX%3A52021DC0287   and the Staff Working 
Document, which presents detailed evide nce for the findings outlined in the report,  is available here: 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A52021SC0128&qid=162367052 7414  
5 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).  
6 Similar letters were also sent in 2015 . 
7 CA-March18 -Doc.5.1a - Final - Actions for AS review pro gramme.pd f 
8 CA-Feb20 -Doc.5.2 - Final - AS Action Plan.doc   
EN 3  EN empowered to adopt delegated acts in accordance with Article 83 on exten ding the 
duration of the work programme for a determined period.  
Given that the review programme will not be finalised by 31 December 2024 , the 
duration of the work programme needs to be extended. After discussion with experts 
of Member States ’ competent authorities on biocidal products, the Commissio n 
deems it appropriate to  extend the duration of the work programme until 31 
December 2030. At this stage, it is considered unreasonable to postpone the 
finalisation of the review programme to an even later date, given that most 
applications for approval were submitted in 2004 -2008 and that all the products 
containing those active substances are still placed on the market under transitional 
provisions applicable in Member States  pending a decision on approval . 
Furthermore, the Commission intends to conduct a REFIT evaluation of the  Biocidal 
Products Regulation  to be concluded in 2026 . Any  potential changes that may result  
from the evaluation should be in place by the end of 2030.  
Article 89(1) , first subparagraph, of the Biocidal Products Regulation  needs to be 
amended accordingly . This is the purpose of th is delegated act. 
Other actions may be neeeded  to achieve progress in the review programme , 
including revising certain provisions in the Review Regulation  to amend the rules 
governing the programme in order to help complet e it.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission has consulted the expert group ‘Competent Authorities for Biocidal 
Products (Regulation (EU) No 528/2012 )’ – Register Code E03125  – consisting of 
experts  of Member States ’ competent authorities  for biocidal products  and of ECHA , 
as well as observers from industry and civil society , in meetings o n XXXX . A draft 
of the delegated act was made pu blic before  meeting s. 
A four -week public consultation was held from XXXX  to XXXX  via the Better 
Regulation Portal.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delega ted act amends Article 89(1), first subparagraph, of Regulation (EU) No 
528/2012 of the European Parliament and of the Council of 22 May 2012 concerning 
the making availab le on the market and use of biocidal products , and extends the 
duration of the work programme until 31 December 20 30. 
The legal basis of this act is Article 89(1), second subparagraph, of Regulation (EU) 
No 528/2012 . 
  
EN 4  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
as regards a further extension of the duration of the work programme for the systematic 
examination of all existing biocidal active substances  
(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 the making available on the market and use of biocidal 
products9, and in particular Article 89(1) , second subparagraph , thereof,  
Whereas:  
(1) Regulation (EU) No 528/2012 provides for the continuation of the work programme 
for the systematic examination of all existing active substances used in biocidal 
products commenced in accordance with Article  16(2) of Directive  98/8/EC10. 
(2) In accordance with Article  89(1) , first subparagraph , of Regulation (EU) No 528/2012 , 
the work programme is to be achieved by 31 December 2024. 
(3) There are substantial delays in the completion of the work programme. The 
Commission presented a detailed assessment of this situati on to the Council and the 
European Parliament in the implementation report of Regulation (EU) No 528/2012 in 
June 202111. The main reasons for them  are the lack of resources allocated in Member 
States, delays by applicants in submitting additional data, complex technical questions 
on specific dossiers that need to be resolved, evolution of technical guidance and the 
new scientific criteria for the determination of endocrine disrupting properties  
introduced  by Commission Delegated Regulation (EU) 2017/210012, which triggered 
the need for further data and further assessments.  
(4) Since 2015, discussions have taken  place regularly with experts of the Member States ’ 
competent authorities on biocidal products, and agreements have been reached on a 
number of actions.  Workshops have been organised by the European Chemicals 
Agency (ECHA), and an ECHA Action Plan on Active Substances has also been 
                                                 
9 OJ L 167, 27.6.2012, p. 1 , ELI:  http://data.europa.eu/eli/reg/2012/528/oj .  
10 OJ L 123, 24.4.1998, p. 1 , ELI:  http://data.europa.eu/eli/dir/1998/8/oj . 
11 The Report is available at this link: https://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1623326515401&uri =CELEX%3A52021DC0287   and the Staff Working 
Document, which presents detailed evidence for the findings outlined in the report,  is available here: 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A52021SC0128&qid=1623670527414  
12 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria 
for the determination of endocrine -disrupting properties pursuant t o Regulation (EU) No 528/2012 of 
the European Parliament and Council (OJ L 301, 17.11.2017, p. 1 , ELI: 
http://data.europa.eu/eli/reg_del/2017/2100/oj ).  
EN 5  EN agreed. Despite the actions  taken so far  and the progress that can still be achieved 
before 31 December 2024, it is clear tha t the work  programme will not be finalised by 
that date.  
(5) Considering that the work  programme will not be finalised by 31 December 2024, it is 
necessary to extend its duration. After discussion with experts of the Member States ’ 
competent authorities on bio cidal products, the Commission deems it appropriate to 
extend the duration of the work programme .  
(6) Regulation (EU) No 528/2012  should therefore be amended accordingly , 
HAS ADOPTED THIS REGULATION:  
Article 1 
In Article  89(1) , first subparagraph , of Regulation (EU) No 528/2012 , the first sentence  is 
replaced by the following : 
‘The Commission shall carry on with the work programme for the systematic examination of 
all existing active substances commenced in accordance with Article  16(2) of Directive 
98/8/EC with the aim of achieving it by 31 December 20 30.’.  
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 entire ty and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN