Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 528/2012 as regards the extension of certain data protection periods
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, data protection, market approval, marketing standard

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   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  COM(2025) 1020 final 2025/0408 (COD)  Simplification Omnibus Package Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 528/2012 as regards the extension of certain data protection periods  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The proposal is part of the cross-cutting legislative simplification package announced in the 
European  Commission’s  Vision  for  Agriculture  and  Food1.  The  aim  of  the  package  is  to 
reduce unnecessary regulatory burdens identified as particularly burdensome by industry and 
authorities  while  maintaining  high  standards  for  food  and  feed  safety,  and  the  protection  of 
human  and  animal  health,  and  the  environment.  The  package  responds  to  repeated  requests 
from stakeholders and EU Member States for faster and clearer regulatory procedures. It aims 
to  simplify  certain  provisions  and  procedures  of  the  following  acts:  Regulation  (EC)  No 
1107/2009,  Regulation  (EC)  No  396/2005,  Regulation  (EU)  No  528/2012,  Regulation  (EC) 
1829/2003, Regulation (EC) No 1831/2003, Regulation (EC) No 852/2004, Regulation (EC) 
No  853/2004,  Regulation  1099/2009,  Regulation  (EC)  No  999/2001,  Regulation  (EU) 
2017/625, Directive 98/58/EC and Directive 2009/128/EC. 

More  specifically,  this  initiative  aims  at  modifying  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  products2,  in  order  to  address  specific  concerns  which  have 
been expressed by Member States  competent  authorities on biocidal  products  and economic 
operators  regarding  the  expiry  of  the  protection  of  certain  data  by  31  December  2025  in 
accordance with Article 95(5) of that Regulation. 

The  completion  of  the  review  programme  of  existing  biocidal  active  substances  set  out  in 
Article 89 of Regulation (EU) No 528/2012  has  suffered from major delays. Initiated on 14 
May  2000  under  Directive  98/8/EC3,  and  planned  to  be  completed  by  14  May  2010,  the 
review programme had to be extended a first time in 2009 until 14 May 20144, a second time 
in 2013 until 31 December 20245, and recently a third time until 31 December 20306. 

The vast majority of the Member State competent authorities have not met the time limits for 
submitting the assessment reports for applications for approval of existing active substances. 
The  main  reasons  for  the  delays,  as  identified  in  the  Commission  implementation  report 

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the  market 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food 
Shaping  together  an  attractive  farming  and  agri-food  sector  for  future  generations,  COM/2025/75, 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 
OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj. 
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing  of  biocidal  products  on 
(OJ  L  123,  24.4.1998,  pp.  1–63, 
ELI: http://data.europa.eu/eli/dir/1998/8/oj) 
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, ELI: http://data.europa.eu/eli/dir/2009/107/oj). 
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 
(OJ  L  204,  31.7.2013,  p.  25, 
for  examination  of  existing  biocidal  active  substances 
ELI: http://data.europa.eu/eli/reg_del/2013/736/oj). 
Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 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 (OJ L, 
2024/1398, 22.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1398/oj). 

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submitted  to  the  Council  and  the  European  Parliament  in  June  20217,  are:  i)  the  lack  of 
resources  in  Member  State  competent  authorities;  ii)  quality  of  the  initial  applications  and 
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 scientific criteria for determining endocrine disrupting properties8, which triggered the 
need  for  further  data  and  assessments.  That  implementation  report  also  announced  that, 
instead of a second implementation report, an evaluation of the Regulation (EU) No 528/2012 
will start in 2025 with the aim of analysing the fitness of the regulatory system set out in the 
Regulation.  While  any  fundamental  changes  to  Regulation  (EU)  No  528/2012  should  await 
the  outcome  of  that  evaluation,  a  few  targeted  amendments  should  be  enacted  earlier  to 
increase the efficiency of its implementation.  

Article 95(5) of Regulation (EU) No 528/2012 foresees that on 31 December 2025 protection 
expires for all data submitted for existing active substance/product-type combinations in the 
review programme but for which a decision on inclusion in Annex I to Directive 98/8/EC was 
not  taken before 1 September 2013 and which will still  be under examination in  the  review 
programme  after 31 December 2025. The protection  period was set  to  expire 10 years after 
mandatory listing of active substance suppliers of existing active substances on a specific list 
maintained by the European Chemicals Agency (ECHA) that took effect on 1 September 2015 
(the  Article  95  list).  The  purpose  was  to  guarantee  a  fair  compensation  period  for  review 
programme  participants,  considering  also  that,  for  most  participants,  their  data  had  already 
been  protected  since  2004-2008  (the  time  of  submission  of  most  of  the  applications  for 
approval  in  the  review  programme),  while  foreseeing  the  possibility  for  other  economic 
operators  to  use  freely  the  data  as  from  the  beginning  of  2026  to  access  more  easily  the 
market and bring down costs for the producers of biocidal products who buy active substances 
from the suppliers – and hence ultimately for the users of the biocidal products. 

However, a number of active substance suppliers and their representative organisations have 
repeatedly  raised  concerns  that,  in  the  light  of  the  delays  in  the  completion  of  the  review 
programme,  as  described  above,  the  expiry  of  all  data  protection  needs  to  be  reconsidered, 
among others, at an Implementation Dialogue on the Regulation (EU) No 528/2012 held on 
15  July  2025  with  stakeholders  representing  businesses  (active  substance  manufacturers, 
product  formulators  and  downstream  users)  and  civil  society9,  in  recent  discussions  with 
experts of Member State competent  authorities on biocidal  products10, as well as during the 

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is 

at 

this 

link: 

available 

Parliament 

and  Council 

https://eur-lex.europa.eu/legal-
The  Commission  Report 
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 
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 
1,  ELI: 
the  European 
http://data.europa.eu/eli/reg_del/2017/2100/oj). 
The  dialogue  aimed  to  gather  feedback  from  companies  on  the  main  challenges  faced  in  bringing 
biocidal active substances and products to the market and their ideas on how to address them and, more 
in  general,  on  how  to  simplify  the  regulatory  framework  for  biocidal  products  and  encourage 
innovation.  It  also  aimed  to  obtain  views  of  non-industry  stakeholders  on  the  implementation  of  the 
Biocidal Products Regulation and on its contribution to a high level of safety for humans, animals and 
the  environment.  This  constituted  a  first  step  for  the  evaluation  of  the  Biocidal  Products  Regulation 
(https://health.ec.europa.eu/events/implementation-dialogue-biocides-2025-07-15_en). 
Commission  expert  group  ‘Competent  Authorities  for  Biocidal  Products  (Regulation  (EU)  No 
528/2012)’  (the  ‘CA  meetings’),  Register  Code  E03125  (Register  of  Commission  expert  groups  and 

17.11.2017, 

(OJ  L 

301, 

p. 

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Call  for  Evidence  on  the  Food  and  Feed  Safety  Simplification  Omnibus11.  In  fact,  the 
adoption  of  new  scientific  criteria  for  determining  endocrine  disrupting  properties,  which 
were  adopted  by  Commission  Delegated  Regulation  (EU)  2017/210012  and  are  applicable 
since 7 June 2018, required that specific data had to be generated since then  – or are still in 
the  process  of  being  generated  –  for  those  active  substances  still  under  examination  in  the 
review programme after 31 December 2025. In addition, other data had also to be generated 
and submitted due to the lack of quality of initial data submitted in the concerned applications 
and/or  due  the  need  to  submit  new  data  following  the  evolution  of  technical  guidance  or 
requirements.  These  data  would  currently  not  benefit  from  appropriate  periods  of  data 
protection (or no data protection at all). Therefore, the end date for the protection of the data 
for existing active substances that were still in the review programme on 7 June 2018 should 
be  extended,  striking  a  balance  between  the  interests  of  review  programme  participants,  on 
one  side,  and  the  interests  of  alternative  suppliers  of  active  substance  and  product 
authorisation applicants, on the other side. The scope of the data concerned by the extension 
of the protection, as well as the duration of the extended protection, should be considered for 
this  balance.  Until  the  proposal  is  eventually  adopted  by  the  Council  and  the  European 
Parliament the potential risks for the competitiveness of review programme participants and 
incentives  for  innovation,  referred  to  by  stakeholders,  will  remain.  In  practical  terms,  this 
means that other companies, in particular the alternative suppliers of active substances who do 
not support the active substance in the review programme, will be able to re-use freely data 
without having to negotiate compensation for access rights with the owners of the data.  

In this context, to ensure that the period during which the data will not be protected is limited 
to the minimum possible, a proposal separate from the rest of the other measures proposed in 
the  Food  and  Feed  Safety  Simplification  Omnibus,  which  is  dedicated  solely  to  the 
modification of the data protection under Article 95(5) of Regulation (EU) No 528/2012 and 
related modifications, is needed. This is the purpose of the present initiative. 

• 

Consistency with existing policy provisions in the policy area 

The proposal is part of a package of measures concerning simplification, aiming at reducing 
administrative burden and costs for industries. 

• 

Consistency with other Union policies 

This  initiative  contributes  to  simplification  and  reduction  of  regulatory  burdens  for  the 
agrifood sector, as  announced in the Vision on  Agriculture  and  Food  while maintaining  the 
high standards of protection for the human, animal health and the environment. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

Article 114 of the Treaty on the Functioning of the European Union (TFEU). 

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other  similar  entities)  ;  CA-June25-Doc.7.10  -  Point  from  NL  on  data  protection.pdf,  CA-June23-
Doc.11.b - CEFIC-BfE-Data Protection.pdf 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14824-Food-and-feed-safety-
simplification-omnibus_en  
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 
1–5, 
Parliament 
the 
ELI: http://data.europa.eu/eli/reg_del/2017/2100/oj). 

17.11.2017, 

European 

Council 

301, 

and 

(OJ 

pp. 

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• 

Subsidiarity (for non-exclusive competence)  

The proposed amendment is adopted at EU level as the Regulation concerned was adopted at 
EU level before and only a modification of the provisions of Article 95(5) of Regulation (EU) 
No 528/2012 performed at EU level can address the issue on data protection. Accordingly, an 
amendment to this Regulation needs to be made at EU level. 

• 

Proportionality 

The initiative only proposes to modify a specific provision of Regulation (EU) No 528/2012 
related to the expiry of data protection for data related to active substances still in the review 
programme  of  existing  active  substances  on  7  June  2018,  and  does  not  go  beyond  what  is 
necessary  to  achieve  the  objectives  of  ensuring  an  appropriate  period  protection  of  data 
generated by review programme participants. 

• 

Choice of the instrument 

This proposal for revision is a legislative proposal as the relevant Regulation to be amended 
was adopted by co-decision / ordinary legislative procedure. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

This  proposal  is  accompanied  by  a  Commission  Staff  Working  Document  that  includes  a 
detailed  overview  of  the  positive  impacts  of  the  proposed  amendment  of  the  relevant 
provisions of food and feed safety legislation, based on existing data and information gathered 
during  the  Call  for  evidence  and  the  previous  analyses,  including  on  the  specific  data 
protection issue under Article 95(5) of Regulation (EU) No 528/2012. 

• 

Stakeholder consultations 

The limitation of data protection until  31 December 2025 for existing active substances in the 
review programme, as set out in Article 95(5) of Regulation (EU) No 528/2012, has triggered 
calls from parts of industry as well as some Member States’ competent authorities on biocidal 
products for action to provide appropriate protection for data only recently generated (or still 
to  be  generated)  for  the  purposes  of  the  review  programme  for  existing  active  substances, 
which  is  significantly  delayed.  Several  industry  stakeholders  requested  meetings  with  the 
responsible  Commission  services  on  this  topic.  CEFIC  (Biocides  for  Europe)  requested  an 
extension  of data protection  for all data generated since 7 June 2018 (date of application of 
the  scientific  criteria  for  identifying  endocrine  disrupting  properties).  Member  State 
competent authorities for biocidal products requested to extend data protection for substances 
in the Review Programme, at least those related to endocrine disrupting (ED) properties, until 
31 December 2031. On the other hand, the Commission services have also been contacted by 
companies  who  reported  difficulties  in  obtaining  letters  of  access  to  protected  data  or  in 
getting agreement from established review programme participants to join them in the support 
of  the  substance  and  may  thus  benefit  from  free  access  to  data.  For  instance,  SME  United 
indicated  the  importance  to  strive  for  a  balance  between  the  interest  of  data  owners  in  the 
review programme and other actors13. 

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CA-Sept25-Doc.7.11 - SMEunited feedback.pptx 

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During  the Call for  Evidence  on the  Food and  Feed Safety  Simplification Omnibus, a large 
number of companies and associations criticised the current hard stop of  data protection for 
substances in the review programme, arguing that it is misaligned with the extended review 
programme  and  creates  free-rider  risks,  distorts    competition,  and  disincentives  to  invest  in 
data packages, notably the costly studies that are necessary for the application of the scientific 
criteria  to  identify  endocrine  disrupting  properties.  Many  explicitly  supported  extending  or 
resetting  protection  for  all  data  generated  after  2018  and  not  solely  those  data  submitted  to 
determine  endocrine  disrupting  properties  as  they  argued  that  other  updated  data  had  to  be 
generated due to the evolution of other technical documents or requirements, but had diverse 
views on what should be the extension period: until the end of the review programme; a 10-
year  extension  from  2025  (i.e.  until  2035);  normal  application  of  Article  60  of  Regulation 
(EU) No 528/2012 which provides for data protection after the approval of a substance for a 
period of 10 years; up to 15 years after the decision on the approval of the active substance; 
until  the  end  of  the  review  programme  or  10  years  after  the  approval  of  the  substance, 
whichever  is  the  earliest.  Manufacturers  warned  that  companies  that  invested  early  in 
compliance  would  lose  protection  before  competitors  have  to  share  costs,  undermining 
innovation and supply security. On the other side, a stakeholder was against the extension of 
data  protection  beyond  2025  and  worried  about  over-changing  the  rules  which  were  clear 
since  2013,  extending  exclusivity  and  complicating  data-sharing,  potentially  slowing 
authorisations  if  access  negotiations  stall,  discouraging  innovation  by  prolonged  market 
protection  for  the  benefit  of  a  few  companies.  It  indicated  that  steady  delays  in  the  review 
programme resulted already in considerably longer amortisation of costs periods, and that an 
extension  of  data  protection  decreases  competition  and  keeps  product  costs  at  high  level, 
maintaining  oligopolistic-like  situations.  It  described  difficult  experiences  in  data  sharing 
negotiations. NGOs and citizens did not provide comments. This proposal takes into account 
the  input  received,  with  the  objective  to  strive  for  a  balance  between  the  interests  of  data 
owners who are participants in the review programme of existing active substances and other 
actors, taking also into account the original intentions of the expiry date for data protection set 
in Article 95(5).  

• 

Collection and use of expertise 

Different suggestions for clarifying certain provisions of food and feed safety legislation and 
removing the excessive administrative burden stemming from these provisions have emerged 
through  stakeholders’  proposals  concerning  the  provisions  of  Article  95(5)  of  Regulation 
(EU)  No  528/2012,  as  described  above.  Furthermore,  in  response  and  the  follow-up  of  the 
Call  of  evidence  mentioned  above,  the  Commission  received  detailed  position  papers  from 
stakeholders. 

• 

Impact assessment 

The  proposed  simplification  measures  are  highly  technical  in  nature.  There  are  no  viable 
alternatives  to  achieve  the  objectives,  and  the  proposed  measures  do  not  alter  core  policy 
objectives  or  introduce  significant  new  obligations.  For  these  reasons,  a  full  impact 
assessment  would  not  bring  added  value.  Instead,  the  proposal  is  accompanied  by  an 
analytical staff working document. The document clearly explains the proposed measures and 
present  the underlying evidence, analysis and stakeholders’ views,  as well  as estimating  the 
potential cost savings.  

No direct cost savings are expected for industry, since the data in question must in any case be 
generated and submitted to complete the assessment of the active substance, and in particular 
for  the  assessment  of  endocrine-disrupting  properties.  However,  data  owners  would  benefit 

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from  greater  legal  certainty  and  the  possibility  of  obtaining  compensation  from  other 
interested  companies  through  letters  of  access.  Access  to  protected  data  may  be  granted  to 
alternative  suppliers  of  the  same  active  substance,  or  to  companies  seeking  product 
authorisations once the substance is approved. The terms of access could vary, ranging from 
financial compensation to free access when data owners also act as substance suppliers. 

In  the  Impact  Assessment  performed  in  2009  for  the  proposal  of  Regulation  (EU)  No 
528/2012 revising the former Directive 98/8/EC, the cost of preparation of an application for 
approval of an active was estimated between 3 to 5 million euros (based on a study performed 
in 2007)14. Although no specific figures are available on the average costs of generating data 
related  to  endocrine-disrupting  properties,  these  studies  are  generally  considered  highly 
costly, particularly because they often involve vertebrate testing. The costs for the generation 
of new studies related to other elements of an application are highly variable, depending on 
the  particular  issue  for  which  evaluating  competent  authorities  have  requested  a  new  study. 
By  ensuring  an  appropriate  period  of  protection,  the  measure  helps  secure  a  fair  return  on 
these  investments  and  maintains  incentives  for  data  generation,  which  is  essential  for  the 
scientific robustness of the review programme. 

• 

Regulatory fitness and simplification 

This  proposal  is  part  of  the  commitment  of  the  European  Commission  to  lighten  the 
regulatory  burden  for  people,  businesses  and  administrations  in  the  EU  to  boost  prosperity 
and resilience of the EU. The proposal is part of a package of measures which are therefore 
aiming  at  simplifying  provisions  of  food  and  feed  safety  legislation,  reducing  unnecessary 
burdens  and  costs  for  businesses  and  authorities,  without  undermining  the  protection  of 
human and animal health and the environment. 

• 

Fundamental rights 

The proposal respects the fundamental rights enshrined in the Charter of Fundamental Rights 
of  the  European  Union  and  adheres  to  the  principles  recognised  therein.  The  reduction  of 
administrative burden on companies should lead to societal gains in terms of wealth creation, 
employment and innovation. At the same time, the proposal will not undermine the objective 
of ensuring a high level of protection of human health and of the environment. 

4. 

BUDGETARY IMPLICATIONS 

This  initiative  will  not  imply  any  additional  costs  for  the  Commission  or  any  regulatory 
Agency.  

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The Commission will monitor the implementation and application of the new provisions and 
compliance with them. Furthermore, the Regulation to be amended by this proposal is subject 
to  regular  evaluation  of  its  efficiency,  effectiveness  in  reaching  its  objectives,  relevance, 

14 

See pages 13, 14, 85 and 86 of Commission Staff Working document Accompanying document to the 
Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the 
market and use of biocidal products, Impact assessment, SEC(2009)774, https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:52009SC0773 

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coherence and value added in accordance with better regulation principles. This proposal does 
not require an implementation plan. 

• 

Detailed explanation of the specific provisions of the proposal 

The cut-off date  for the  protection of data  related to  existing  active substances, which were 
still  under  review  in  the  review  programme  on  1  September  2013,  should  be  reconsidered, 
striking  a  balance  between  the  interests  of  review  programme  participants,  on  the  one  side, 
and  the  interests  of  alternative  suppliers  of  active  substance  and  applicants  for  product 
authorisation, on the other side, taking also into account the original intentions of the expiry 
of data protection set out in Article 95(5) of Regulation (EU) No 528/2012. The balance in the 
various interests should be reflected in the scope of the active substances and data concerned 
by the extension of protection, as well as in the duration of protection. 

The evaluation of active substances/product-type combinations which were still in the review 
programme on 7 June 2018 has been further delayed due to the need to generate new data to 
allow  for  the  evaluation  of  the  new  scientific  criteria  for  determining  endocrine  disrupting 
properties15 that became applicable on that day. Furthermore, since that date, other data had 
also  to  be  generated  and  submitted  to  evaluating  Member  States  who  considered  this 
necessary  due  to  the  lack  of  quality  of  initial  data  submitted  in  the  concerned  applications 
and/or  following  the  evolution  of  technical  guidance  or  updated  data  requirements.  It  is 
therefore  proposed  to  extend  the  protection  period  for  all  data  for  active  substance/product-
type combinations for which a decision on the approval had not been adopted in accordance 
with Article 89(1), third subparagraph, of Regulation (EU) No 528/2012 by 7 June 2018. In 
order  to  ensure  a  simple  application  of  the  new  provision  by  all  parties,  the  extension  of 
protection covers all data without any distinction. 

The  completion  of  the  review  programme  of  existing  biocidal  active  substances  has  been 
extended  until  31  December  203016.  It  is  therefore  proposed  to  extend  the  protection  of  the 
concerned data until the same date. This corresponds to a period of maximum 11.5 years for 
data  generated  since  7  June  2018,  which  is  considered  an  appropriate  period  of  time  of 
protection  during  which  participants  in  the  review  programme  can  obtain  compensation  for 
the  costs  of  the  generation  of  data  required  by  evaluating  Member  States.  It  should  also  be 
noted that under the rules of Regulation (EU) No 528/2012, the evaluation of an application 
of an active substance should last normally for one year during which the  data is protected, 
followed by a 10-year period of protection after the finalisation of the evaluation and adoption 
of the decision on the approval, which overall would correspond to a period of 11-12 years of 
protection of the data17. While the period of protection will be shorter for data generated only 
in  recent  years,  the  proposed  extension  of  protection  will  cover  all  data  in  the  application, 

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Commission  Delegated  Regulation  (EU)  2017/2100  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,  pp.  1–5,  http://data.europa.eu/eli/reg_del/2017/2100/oj),  entered  into 
application on 7 June 2018. 
Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 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 (OJ L, 
2024/1398, 22.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1398/oj). 
Duration  of  evaluation  by  the  evaluating  Member  State  of  12  months  with  possible  suspension  of  6 
months, followed by a peer review by ECHA of 9 months, and the time for decision-making process at 
Commission level. 

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including  data  submitted  since  the  submission  of  the  applications  which  have  already 
benefitted  from  a  longer  period  of  protection18.  It  remains  necessary  to  maintain  the  initial 
objectives  of  Article  95(5).  For  these  reasons,  no  clause  of  revision  of  this  new  period  of 
protection  is  proposed.  Furthermore,  the  Commission  will  conduct  a  full  evaluation  of 
Regulation  (EU)  No  528/2012  in  the  course  of  2026/2027,  including  its  rules  on  data 
protection, which will provide a basis for the consideration of potential changes in the future. 

Article 95(5) is modified to achieve this extension of data protection. 

Until the proposal is adopted, there will be a period during which the concerned data will no 
longer be protected, i.e. from 1st January 2026 until the data is protected again in application 
of  the  new  provisions  in  Article  95(5).  Article  60(1),  second  subparagraph,  established  that 
data for which the protection period has expired shall not be protected again. As a protection 
will be conferred again to the concerned data, Article 60(1), second subparagraph, is modified 
to establish a derogation to that rule for the concerned data. A provision is also established in 
Article  95(5)  to  allow  data  owners  to  claim  compensation  from  a  substance  supplier  or 
product supplier having benefitted from the absence of protection and having been included in 
the Article 95 list during that period, if they find it appropriate. 

18 

Most of the applications were submitted since 2004-2008. 

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2025/0408 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EU) No 528/2012 as regards the extension of certain data 
protection periods 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 

Having regard to the opinion of the European Economic and Social Committee, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

1 

2 

3 

In its Communication A Vision for Agriculture and Food1, the Commission announced 
a  cross-cutting  simplification  package  aimed  at  reducing  unnecessary  regulatory 
burdens  while  maintaining  high  standards  for  food  and  feed  safety,  for  human  and 
animal health, and environmental protection. 
Regulation (EU) No 528/2012 of the European Parliament and of the Council2 sets out 
the procedures for approval of biocidal active substances and authorisation and placing 
on  the  market  of  biocidal  products.  The  vast  majority  of  Member  State  competent 
authorities  have  not  met  the  time  limits  for  submitting  the  assessment  reports  for 
applications  for  approval  of  existing  active  substances,  which  has  delayed  the 
finalisation of the review programme of existing biocidal active substances set out in 
Article  89  of  that  Regulation.  The  main  reasons  for  the  delays,  as  identified  in  the 
Commission  implementation  report  submitted  to  the  Council  and  to  the  European 
Parliament  in  June  20213,  are:  i)  the  lack  of  resources  in  Member  States  competent 
authorities;  ii)  the  quality  of  the  initial  applications  and  delays  by  applicants  in 
submitting additional data; iii) complex technical questions arising on specific dossiers 
that need to  be resolved; iv) evolution  of technical  guidance;  and v) the  adoption  of 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food 
Shaping  together  an  attractive  farming  and  agri-food  sector  for  future  generations,  COM/2025/75, 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 
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, pp. 
1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) 
https://eur-lex.europa.eu/legal-
The  Commission  Report 
at 
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 

available 

link: 

this 

is 

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(3) 

(4) 

(5) 

4 

5 

6 

new scientific criteria for determining endocrine disrupting properties by Commission 
Delegated Regulation (EU) 2017/21004. 

Article  95(5)  of  Regulation  (EU)  No  528/2012  provides,  by  way  of  derogation  from 
Article  60,  that  all  data  protection  periods  for  active  substance/product-type 
combinations listed in Annex II to Commission Regulation (EC) No 1451/20075, but 
for  which  a  decision  on  inclusion  in  Annex  I  to  Directive  98/8/EC  of  the  European 
Parliament and of the Council6 was not taken before 1 September 2013, are to end on 
31  December  2025.  The  objective  was,  on  the  one  hand,  to  provide  for  a  fair 
compensation  of  review  programme  participants  which  are  data  owners,  and  on  the 
other hand, to avoid avoiding the establishment of monopolies and a disproportionate 
protection  period,  by  foreseeing  the  possibility  for  other  economic  operators  to  use 
freely the data as from the beginning of 2026 in order to access more easily the market 
and  to  reduce  the  costs  for  the  producers  of  biocidal  products  who  buy  active 
substances from the suppliers and ultimately for the users of the biocidal products. 

Due  to  the  delays  in  the  finalisation  of  the  review  programme,  the  end  date  of  31 
December 2025 for the protection of data set out in Article 95(5) of Regulation (EU) 
No  528/2012  should  be  adapted,  to  strike  a  balance  between  the  interests  of  review 
programme participants  on  the one hand,  and the interests of  alternative  suppliers of 
active substances and applicants for product authorisation, on the other hand. Such a 
balance  between  the  various  interests  should  concern  the  scope  of  the  active 
substances  and  data  concerned  by  the  extension  of  protection,  as  well  as  in  the 
extended duration of protection. 

In particular, the evaluation of active substance/product-type combinations which were 
still in the review programme on 7 June 2018 has been further delayed due to the need 
to  generate  new  data  to  allow  for  the  evaluation  of  the  new  scientific  criteria  for 
determining  endocrine  disrupting  properties  which  became  applicable  on  that  date. 
Furthermore,  since  then,  other  new  data  had  also  to  be  generated  on  request  of  the 
evaluating  Member  States  due  to  the  lack  of  quality  of  initial  data  submitted  in  the 
concerned  applications  and  following  the  evolution  of  technical  guidance  or  data 
requirements.  As  a  consequence,  due  to  the  end  date  for  data  protection  periods 
currently  specified  in  Article  95(5)  of  Regulation  (EU)  No  528/2012,  the  protection 
period for such newly generated data for active substance/product-type combinations 
for which a decision on the approval had not been adopted in accordance with Article 
89(1), third subparagraph, of Regulation (EU) No 528/2012, by 7 June 2018, would be 
considerably  shorter  than  for  other  data  generated  earlier.  Therefore,  the  period  of 
protection  for  such  data  should  be  extended.  In  order  to  ensure  an  administratively 

and 

European 

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 
1–5, 
Council 
Parliament 
ELI: http://data.europa.eu/eli/reg_del/2017/2100/oj) 
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, pp. 3–65, 
ELI: https://eur-lex.europa.eu/eli/reg/2007/1451/oj/eng) 
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing  of  biocidal  products  on 
(OJ  L  123,  24.4.1998,  pp.  1–63, 
ELI: http://data.europa.eu/eli/dir/1998/8/oj). 

the  market 

17.11.2017, 

301, 

(OJ 

pp. 

L 

EN 

2 

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(6) 

(7) 

(8) 

simple implementation of the new provision by all parties, the extension of protection 
should cover all data for the concerned active substance/product-type combinations. 

The  completion  of  the  review  programme  of  existing  biocidal  active  substances  has 
been  extended  until  31  December  20307.  The  period  of  protection  of  the  concerned 
data  should  therefore  be  extended  until  31  December  2030.  This  corresponds  to  a 
period  of  maximum  11.5  years  for  data  generated  since  7  June  2018,  which  is 
considered an appropriate period of time of protection during which participants in the 
review  programme  can  obtain  compensation  for  the  costs  of  the  generation  of  data 
required by evaluating Member States. While the period of protection will be shorter 
for data generated only in recent years, the proposed extension of protection will cover 
all  data  in  the  application,  including  data  submitted  since  the  submission  of  the 
applications  which  have  already  benefitted  from  a  longer  period  of  protection. 
Furthermore,  the  Commission  will  conduct  a  full  evaluation  of  Regulation  (EU)  No 
528/2012 in the course of 2026/2027, including its rules on data protection, which will 
provide a basis for the consideration of potential changes in the future. 

Article 95(5) should be amended to extend the data protection period accordingly. 

From  1  January  2026  and  until  this  Regulation  enters  into  force,  the  data  concerned 
will  no  longer  be  protected.  Article  60(1),  second  subparagraph,  of  Regulation  (EU) 
No 528/2012 provides that data for which the protection period has expired is not to be 
protected  again.  As  protection  will  be  conferred  again  to  the  data  concerned,  that 
second subparagraph should be amended to establish a derogation to that rule for such 
data. As alternative substance suppliers and product suppliers that will be included in 
the  Article  95  list  during  the  period  of  absence  of  protection  could  have  benefitted 
from the investments done by the review programme participants for the generation of 
such data, a provision should also be established in Article 95(5) to allow data owners 
to claim compensation from these suppliers, if they find it appropriate,  

HAVE ADOPTED THIS REGULATION: 

Article 1 

Amendments to Regulation (EU) No 528/2012 

Regulation (EU) No 528/2012 is amended as follows: 

(1) 

in Article 60, paragraph 1, the second subparagraph is replaced by the following: 

‘Without  prejudice  to  Article  95(5),  second  subparagraph,  protection  periods  under 
this Article, which have expired, shall not start to run again.’; 

(2) 

in Article 95, paragraph 5, the following subparagraph is added: 

‘By  way  of  derogation  from  the  first  subparagraph,  all  data  protection  periods  for 
active substance/product-type combinations for which a decision on the approval has 
not  been  adopted  in  accordance  with  Article  89(1),  third  subparagraph,  by  7  June 
2018,  shall  end  on  31  December  2030.  Data  owners  may  claim  compensation  for 
access  to  their  data  for  the  period  starting  from  1  January  2026  until  [OP,  please 
insert  the  date:  date  of  the  entry  into  force  of  this  Regulation]  from  a  substance 

7 

Commission Delegated Regulation (EU) 2024/1398 of 14 March 2024 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 (OJ L, 
2024/1398, 22.5.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1398/oj). 

EN 

3 

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supplier  or  product  supplier  having  benefitted  from  the  absence  of  protection  and 
having been included in the list referred to in paragraph 1 during that period.’ 

Article 2 

Entry into force 

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 Strasbourg, 

For the European Parliament 
The President 

For the Council 
The President 

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