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
Date: 2021-06-07
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, biocide, chemical product, market approval, marketing standard

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.6.2021  COM(2021) 287 final  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 {SWD(2021) 128 final}  
 
 
Table of Contents 

1. 

INTRODUCTION .......................................................................................................2 

2.  STATUS  OF  THE  IMPLEMENTATION  OF  THE  BIOCIDAL  PRODUCTS 

REGULATION ............................................................................................................3 

2.1.  Active substance approval .................................................................................3 
2.2.  Product authorisation .........................................................................................5 
2.3.  Treated articles ...................................................................................................7 
2.4.  Poisoning incidents ............................................................................................8 
2.5.  Enforcement .......................................................................................................8 
2.6.  Use of nanomaterials in biocidal products .........................................................9 

3.  CONCLUSIONS .........................................................................................................9 

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 

 
 
 
 
 
 
 
 
 
 
1. 

INTRODUCTION 

Regulation (EU) No 528/20121 (hereinafter referred to as the BPR) entered into application 
on 1 September 2013 and lays down the rules for the making available on the market and use 
of  biocidal  products.  It  repealed  Directive  98/8/EC  concerning  the  placing  of  biocidal 
products on the market2 (hereinafter referred to as the BPD).  

Biocidal  products  are  designed  to  control  organisms  that  are  harmful  to  human  or  animal 
health or to materials  (such as wood). Biocidal  products play an important role in the daily 
life  of  EU  citizens:  e.g.  insecticides  and  disinfectants  are  essential  to  help  control  vector-
borne  diseases,  food-borne  diseases  or  hospital-acquired  infections.  The  crucial  role  of 
biocidal products for the protection of public health has been particularly highlighted during 
the COVID-19 pandemic, where disinfecting products are critically important in controlling 
the spread of the disease. 

The BPR establishes a two-step approach in order to achieve its objectives of improving the 
functioning  of  the  biocidal  products  market  in  the  EU,  while  ensuring  a  high  level  of 
protection for human and animal health and the environment3. Active substances, which are 
the ingredients in biocidal products responsible for the action against the target organism(s), 
must be approved at the Union level or be included into Annex I to the BPR, which lists the 
so-called "low-risk active substances"4. In order to obtain an approval for an active substance, 
applicants  must  submit  comprehensive  dossiers,  which  are  first  assessed  by  an  evaluating 
Member State. The assessment of the evaluating Member State is peer-reviewed by the other 
Member  States  representatives  within  the  Biocidal  Products  Committee  (BPC)  of  the 
European Chemicals Agency (ECHA). The BPC prepares an opinion of the Agency, which is 
the basis for the Commission’s decision on the approval. Approvals are time-limited, but can 
be  renewed  following  the  evaluation  of  a  renewal  application.  Active  substances  are 
approved  for  specific  product-types  as  set  out  in  Annex  V  to  the  BPR,  which  defines  22 
product-types5. Subsequently, biocidal products containing such active substances require an 
authorisation - at national or Union level - before they can be made available on the market 
and used.  

By way of exception, biocidal products containing active substances that are included in the 
work  programme  for  the  examination  of  existing  biocidal  active  substances6  (the  “Review 

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  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. 1). 

3  Additional 

information 

on 

Regulation 

(EU) 

No 

528/2012 

is 

available 

at   

https://ec.europa.eu/health/biocides/regulation_en  and  https://echa.europa.eu/regulations/biocidal-products-
regulation/understanding-bpr. 

4  Additional  information  on  the  approval  of  active  substances  for  use  in  biocidal  products  is  available  at 
and  https://echa.europa.eu/regulations/biocidal-

https://ec.europa.eu/health/biocides/active_substances_en 
products-regulation/approval-of-active-substances. 

5  https://echa.europa.eu/regulations/biocidal-products-regulation/product-types. 
6  Commission  Delegated  Regulation  (EU)  No  1062/2014  (OJ  L  294,  10.10.2014,  p.1).  Existing  active 
substances  are  active  substances  which  were  present  on  the  market  in  biocidal  products  on  14  May  2000. 
Active  substances  not  present  on  the  market  in  biocidal  products  on  that  date  are  considered  new  active 
substances (Article 3(1)(d) and (e) of the BPR). 

2 

 
                                                 
Programme”) can be made available on the market and used according to national legislation 
of each Member State pending the final  decision on the approval  of the active substance(s) 
they contain. Possibilities for derogation from the BPR rules are also foreseen in the event of 
a danger to public or animal health or the environment: in such situations Member States may 
grant  temporary permits to  make available on the market  non-authorised  products.  Member 
States  may  also  authorise  products  containing  non-approved  active  substances  for  the 
protection  of  cultural  heritage  following  a  derogation  granted  by  the  Commission.  Lastly, 
biocidal  products  containing  a  new  active  substance  under  evaluation  may  be  authorised 
when certain conditions7 are met. 

This report has been established as required by Article 65(4) of the BPR, according to which 
the Commission, based on the reports submitted by Member States on the implementation of 
the BPR in their respective territories, is to draw up a composite report to be submitted to the 
European Parliament and to the Council. All Member States submitted their reports, except 
for  the  Czech  Republic.  Article  65(3)  requires  Member  States  to  include  in  particular 
information  on  (i)  results  of  official  controls,  (ii)  poisonings,  (iii)  adverse  environmental 
effects  and  (iv)  use  of  nanomaterials.  However,  no  information  was  provided  by  Member 
States on adverse environmental effects, due to the difficulty for Member States to gather this 
type of data for the first reporting. The Commission will discuss with Member States how to 
ensure that they will start gathering these data for the next report (due in 2025). The report 
covers  the  period  from  the  entry  into  application  of  the  BPR  (1  September  2013)  until  31 
December 2019. In addition to the information provided by Member States, this report is also 
based  on  data  extracted  from  the  IT  platform8  used  for  the  submission  and  assessment  of 
applications and on information contained in the overview report9 of the fact-finding missions 
carried out in 2017 and 2018 by the Commission’s Directorate-General for Health and Food 
Safety.  This  report  is  accompanied  by  a  Staff  Working  Document10  presenting  detailed 
evidence for the findings outlined in the report. 

2.  STATUS OF THE IMPLEMENTATION OF THE BIOCIDAL PRODUCTS REGULATION 

2.1.  Active substance approval 

Existing active substances in the Review Programme 
The Review Programme11 started under the BPD and was initially foreseen to be completed 
in 10 years. However, its duration had to be extended twice since it had become apparent that 

7  A full active substance evaluation dossier has been submitted by the evaluating competent authority and it is 

believed that both the active substance and the biocidal product meet the conditions set out in the BPR 
(Article 55(2) of the BPR). 

8  Register for Biocidal Products (R4PB) (Article 71 of the BPR). 
9   https://op.europa.eu/en/publication-detail/-/publication/14fbda4b-329f-11ea-ba6e-01aa75ed71a1/language-   

en/format-PDF/source-112325446. 

10  SWD(2021)128  
11 Commission Regulation (EC) No 2032/2003 on the second phase of the 10-year work programme referred to 
in  Article  16(2)  of  Directive  98/8/EC  (OJ  L  307,  24.11.2003,  p.  1),  repealed  and  replaced  by  Commission 
Regulation (EC) No 1451/2007 (OJ L 325, 11.12.2007, p. 3–65). 

3 

 
                                                 
the evaluations of the application dossiers would not be completed within the initial deadline, 
first under the BPD12 - to 14 May 2014 - and then under the BPR13 - to 31 December 2024.  

The execution of the Review Programme still remains affected by significant delays. By 31 
December  2019,  only  35%  of  the  related  work  has  been  completed.  Commission  decisions 
approving  or  not  approving  active  substances  were  taken  for  252  active  substance/product-
type  combinations  (of  which  179  were  adopted  under  the  BPR),  while  474  active 
substance/product-type  combinations  are  still  under  examination.  A  steady  increase  in  the 
number of decisions was recorded between 2014 and 2016, however, a significant decrease 
occurred in 2017 and 2018, as illustrated in Figure 1. 

Figure  1:  Number  of  active  substance/product-type  combinations  covered  by  Commissions  decisions  on 

approval/non-approval 

This decrease was caused by the falling number of evaluations completed by Member States. 
While 130 assessment reports were submitted overall by Member States to  ECHA between 
2014  and  2018,  only  1  report  was  submitted  in  2018  and  7  in  2019.  The  main  factors 
indicated by Member States as causing the delays are: insufficient resources available, delays 
by applicants in submitting additional data required by Member States during the evaluation, 
complex  technical  questions  on  specific  dossiers,  evolution  of  technical  guidance,  and  the 
adoption of new scientific criteria14 for the determination of endocrine-disrupting properties.  

The  Commission  and  ECHA  took  action  to  address  the  continuous  delays  in  the  Review 
Programme. Already in 2015 the Commission sent letters to Member States, highlighting the 
importance  of  completing  the  Review  Programme.  In  2017,  the  Commission  initiated 
discussions with Member States and stakeholders in order to understand the main causes of 

12 Directive 2009/107/EC of the European Parliament and the Council 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).. 

13 Commission Delegated Regulation (EU) No 736/2013 amending Regulation (EU) No 528/2012 as regards the 
duration of the work programme for examination of existing biocidal active substances (OJ L 204, 31.7.2013, 
p. 25). 

14  Commission  Delegated  Regulation  (EU)  2017/2100  setting  out  scientific  criteria  for  the  determination  of 
endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 (OJ L 301, 17.11.2017, p. 1).  

4 

 
 
                                                 
the delays and to identify possible actions for improvement. A list of actions15 was agreed in 
March 2018. In light of the results of a survey among Member States and of the information 
collected  at  a  workshop  of  2019,  ECHA  proposed  an  Action  Plan16  that  was  agreed  by  the 
Commission and Member States’ Competent Authorities in February 2020.  

New active substances 

Innovation  with  regard  to  new  biocidal  active  substances  has  been  rather  limited.  Only  10 
new active substances were evaluated since the entry into application of the BPR, of which 9 
were approved, covering 13 active substance/product-type combinations.  

Exclusion and substitution criteria  
The BPR introduced exclusion criteria17 to ensure that the most hazardous active substances 
are  phased  out,  and  substitution  criteria  for  substances  presenting  a  specific  concern18.  In 
principle,  substances  meeting  the  exclusion  criteria  cannot  be  approved,  unless  certain 
derogation  possibilities  apply19.  So  far,  3  active  substances  meeting  the  exclusion  criteria, 
covering 3 active substance/product-type combinations, and 4 active substances meeting the 
substitution  criteria,  covering  9  active  substance/product-type  combinations  were  not 
approved.  21  active  substances  meeting  the  exclusion  criteria20,  covering  24  active 
substance/product-type  combinations,  and  20  active  substances  meeting  the  substitution 
criteria  covering  37  active  substance/product-type  combinations  are  approved.  Of  the 
approved  active  substances  meeting  the  exclusion  criteria,  9  are  rodenticides,  which  are 
deemed  essential  to  control  a  danger  to  human,  animal  health  or  the  environment  in  the 
absence  of  sufficiently  effective  alternatives;  for  the  other  12  active  substances  the 
transitional provisions in Article 90(2) of the BPR applied, according to which the decisions 
on approval had to be taken on the basis of the former BPD, which did not contain exclusion 
criteria. To date, it is not yet possible to assess whether the exclusion and substitution criteria 
are a driver for the substitution of hazardous substances with safer alternatives. Nevertheless, 
the  exclusion  criteria  provide  a  disincentive  to  apply  for  renewal  of  approval,  since  no 
application for renewal was submitted for 6 active substances meeting the exclusion criteria 
and 2 active substances meeting the substitution criteria.  

2.2.  Product authorisation 

As a consequence of the delays in the Review Programme, the majority of the products on the 
market (several tens of thousands) still fall under national legislations, which are very diverse 
among  Member  States.  In  many  Member  States  only  a  notification21  is  necessary  before 
making the products available on the market, while in others products need to be authorised.  

15 Available at https://circabc.europa.eu/w/browse/f5b309a8-abef-4550-a4c7-fe14a67f2c13.  
16 Available at https://circabc.europa.eu/w/browse/9b8a5c0c-9d25-4373-b89f-8ddfeeabe2e8 . 
17  See Article 5(1) of the BPR. 
18 See Article 10(1) of the BPR. 
19  See Article 5(2) of the BPR for the grounds for derogation. 
20 10 active substances are rodenticides, and the others are mostly preservatives (especially wood preservatives) 

and insecticides. 

21  A notification system implies that no evaluation of the safety or efficacy of a product takes place. 

5 

 
                                                 
Around 9,000 products are authorised according to the BPR rules following the approval of 
the active substances contained therein. The majority of products authorised under the BPR 
were  authorised  through  mutual  recognition  procedures22  (around  6,400),  and  around  2,600 
by standalone national authorisation.  

As  for  the  review  programme  for  existing  active  substances,  Member  States  do  not  respect 
the  deadlines  foreseen  in  the  BPR  for  the  various  procedures  for  product  authorisation23. 
Especially for mutual recognition, more than 60% of procedures are delayed (about one third 
of them for 1-2 years and about half for more than 2 years).  

The  BPR  contains  specific  provisions24  for  the  resolution  of  disagreements  that  may  arise 
between  Member  States  in  the  context  of  mutual  recognition  procedures  and  these  have 
worked well so far. Most of the disagreements were settled in the context of the Coordination 
Group25, with only 8% of them resulting in a referral to the Commission.  

Products  containing  active  substances  which  are  candidates  for  substitution  may  only  be 
authorised following a comparative assessment. 1,394 such assessments were performed, of 
which the  great  majority (1,289) led to  the authorisation being  granted without  restrictions. 
Conversely,  a  simplified  procedure  is  foreseen  for  the  authorisation  of  products  containing 
active  substances  which  are  less  harmful.  232  products  were  authorised  so  far  by  the 
simplified procedure and altogether 474 notifications of making available these products on 
the market were submitted in the Member States.  

138  applications  for  Union  authorisation26  were  submitted  so  far,  of  which  106  concerned 
biocidal product families27. The Commission granted 11 Union authorisations, of which one 
concerned a single product, while the other 10 were for biocidal products families, for a total 
of 66 products. 183 applications for Union authorisation of so-called same biocidal products28 
have  been  submitted  so  far,  of  which  105  concerned  biocidal  products  families,  and  2 
authorisations were granted so far. Delays occur also in the Union authorisation procedures, 
in particular during the assessment by the evaluating Member State, and up to now it was not 
possible to complete any procedure for Union authorisation within the deadlines: about two 
thirds are delayed up to one year, about 20% between 1-2 years and about 10 % more than 2 
years.  

22  If  a  company  wishes  to  place  the  same  product  on  the  market  in  more  than  one  Member  States,  it  has  the 
option  to  apply  in  those  other  Member  States  for  recognition  of  an  authorisation  granted  by  one  Member 
State, acting as so-called reference Member State (Articles 33 to 39 of the BPR). 

23  Monitoring report - authorisation of biocidal products, available at 

https://circabc.europa.eu/w/browse/a5982814-9d5e-4279-83b1-32ff42fa0792. 

24  See Articles 35 and 36 of the BPR. 
25 The Coordination Group is composed of representatives of Member States and of the Commission, and the 

secretariat is provided by ECHA (Article 35 of the BPR). 

26  As  required  by  Article  42(3)  of  the  BPR,  the  Commission  submitted  a  report  to  the  Council  and  European 
Parliament on the implementation of the provisions related to Union authorisation until 31 December 2017: 
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A0342%3AFIN. 

27 A biocidal product family is defined as defined as a group of biocidal products with similar uses, same active 

substance(s), similar composition and similar levels of risk and efficacy (Article 3(1)(s) of the BPR).  

28  The  same  biocidal  product  is  identical  to  another  biocidal  product  or  product  family  which  has  been 

authorised or for which an application for authorisation has been submitted. 

6 

 
                                                 
Derogations from the requirements for authorisation 

Between  2014  and  2019,  9  Member  States  made  use  of  the  possibility  foreseen  in  Article 
55(1)  and  granted  135  temporary  permits  for  products  that  they  considered  necessary  to 
combat a danger to public or animal health or the environment. As of March 2020, almost all 
Member  States  made  extensive  use  of  this  provision  to  allow  the  making  available  on  the 
market of additional disinfectants needed to address the huge demand to control the spread of 
COVID-19. Almost 600 notifications of national  permits were received by the Commission 
between March and November 2020. Eight months after the outbreak of the pandemic it can 
be  concluded  that  this  emergency  measure  in  the  BPR  has  allowed  to  address  the 
unprecedented situation during the COVID-19 pandemic. 

Only  one  Member  State  granted  a  provisional  authorisation  for  a  product  containing  a  new 
active substance not yet approved.  

By end of 2019, 2 Member States had applied for a derogation pursuant to Article 55(3) of 
the BPR allowing them to authorise products consisting of in-situ generated nitrogen for the 
protection of cultural heritage. 5 others applied in 2020. The Commission granted in all cases 
the derogation.  

2.3.  Treated articles 

Article  58  of  the  BPR  contains  provisions  on  articles  which  have  been  treated  with  or 
incorporate a biocidal product. A wide range of everyday products are treated with biocidal 
products, mainly for the purpose of preservation, for instance wood, paints, textile products. 
Such articles can only be treated with active substances allowed for the relevant product-type 
(either  approved  or  included  in  the  Review  Programme,  or  for  which  an  application  for 
approval  was  submitted  before  September  2013)  and  have  to  meet  any  conditions  or 
restrictions included in the approval of the active substance. The BPR also lays down specific 
labelling provisions for treated articles. 

The controls carried out by Member States between 2014 and 201829 indicated that relatively 
few  articles  were  treated  with  non-allowed  active  substances,  while  non-compliance  was 
higher with respect to the labelling requirements. At least 30% of the articles checked had an 
incorrect  or  incomplete  label  and  in  two  Member  States30  the  non-compliance  rate  was 
around 80%.  

In 2019 Member States executed a coordinated enforcement project of the BPR Subgroup of 
the Forum31. The results32 showed high  compliance  with  the requirement that  only  allowed 
active  substances  may  be  used  to  treat  articles.  The  controls  also  revealed  very  high 
compliance  as  to  the  presence  of  the  label  when  required.  However,  when  considering  the 

29  Only 7 Member States reported these data. 
30  Belgium and Sweden. 
31    The  Forum  for  Exchange  of  Information  on  Enforcement  (Forum)  is  an  ECHA  body  which  coordinates  a 
network  of  authorities  responsible  for  the  enforcement  of  chemicals  regulations  in  the  EU.  The  BPR 
Subgroup  of 
the  BPR: 
https://echa.europa.eu/about-us/who-we-are/enforcement-forum. 

focuses  on  coordinated  and  harmonised  enforcement  of 

the  Forum 

32  Available at https://echa.europa.eu/documents/10162/13555/bef_1_report_en.pdf/8e0e4520-3c41-92d2-0e9f-

199109ee8f5f. 

7 

 
                                                 
quality  and  completeness  of  the  information  to  be  provided  on  the  label,  compliance  was 
lower.  

In three cases Member States requested the Commission to decide whether a specific product 
was a biocidal product or treated article33. Three such Commission decisions were adopted34.  

2.4.  Poisoning incidents 

All Member States have appointed poison centres, but record poisoning incidents differently. 
The total number of incidents recorded35 varied between 5,248 in 2013 and 14,135 in 2018. 
The  data  available  indicates  that  most  poisoning  incidents  involved  disinfectants  (between 
47% and 59% of the incidents recorded yearly) and pest control products (between 39% and 
50%). In terms of severity of the incidents, the highest number of fatal or near fatal incidents 
- involving humans or non-target animals - involved pest control products. 

The  most  relevant  exposure  route  causing  incidents  is  ingestion  for  children  and  animals 
(pets), while for adults inhalation is the most prevalent.  

Most Member States have taken measures to educate the general public and raise awareness 
on  the  safe  use  of  biocides  and  on  the  risks  and  benefits  associated  with  their  use. 
Encouraging  the  limited  use  of  biocides  and  providing  information  on  their  safe  use 
(especially  of  disinfectants  and  rodenticides)  by  all  Member  States  could  contribute  to  the 
prevention of poisoning incidents. 

2.5.  Enforcement 

Each Member State is required to ensure that an appropriate system of official controls is in 
place in order to enforce compliance with the BPR. Administrative structures differ between 
Member States and often more than one authority plays a role in the enforcement of the BPR. 
Overall strategies for enforcement of the BPR have been implemented in 20 Member States. 
In  most  cases  they  comprise  both  proactive  (risk-based)  controls  and  reactive  controls 
following complaints.  

The compliance rate of the controls carried out by Member States in the reporting period vary 
greatly  between  Member  States.  Some  Member  States  reported  high  compliance  rates  with 
the BPR rules for making products available on the market, while in others compliance rates 
were  low.  In  some  Member  States  the  high  rate  of  non-compliance  might  be  related  to  the 
fact that most controls performed followed complaints concerning suspected illegal products 
on the market. 

33   In accordance with Article 3(3) of the BPR. 
34  Available  at  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016D0903&from=EN, 
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015D1985&from=EN  and  https://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016D0678. 

35  19 Member States provided relevant data. 

8 

 
                                                 
The controls on biocidal products containing active substances in the Review Programme still 
under evaluation and made available on the market according to national legislation of each 
Member State also revealed very diverse situations in Member States36. 

Only four Member States (Estonia, Poland, Slovakia and Sweden) reported data on controls 
on  residues  in  food  and  feed.  In  most  cases,  however,  it  was  not  possible  to  attribute  the 
residues to a specific use (from plant protection use, from biocidal use, or from other uses). 
Data provided indicate that in very few cases the residues in food and feed were higher than 
the allowed maximum residue limit.  

Harmonisation of enforcement 

The  BPR  Subgroup  of  the  Forum  for  the  exchange  of  information  on  enforcement  (BPRS) 
contributes  to  the  harmonisation  of  enforcement  at  EU  level.  The  first  harmonised 
enforcement project, concerning treated articles (see section 2.3), had its operational phase in 
2019. The second project, focusing on active substances in biocidal products, is scheduled to 
have its operational phase in 2022. 

2.6.  Use of nanomaterials in biocidal products 

The  BPR  incorporates  the  definition  of  nanomaterials  as  laid  down  in  the  Commission 
Recommendation  of  18  October  201137,  and  contains  specific  rules  for  nanomaterials. 
According  to  Article  4(4)  of  the  BPR,  the  approval  of  an  active  substance  does  not  cover 
nanomaterials,  except  where  explicitly  mentioned.  When  nanomaterials  are  present  in  a 
biocidal  product,  the  risk  to  human  health,  animal  health  and  the  environment  has  to  be 
assessed separately (Article 19(1)(f)) and biocidal products containing nanomaterials are not 
eligible  for  simplified  authorisation  (Article  25(c)).  If  biocidal  products  containing 
nanomaterials  are  used  to  treat  an  article,  the  label  of  the  treated  article  has  to  indicate  the 
name of all nanomaterials contained in the biocidal product. 

So  far,  only  two  biocidal  active  substance  which  are  nanomaterials  have  been  approved38. 
Only one product was authorised in 11 Member States39. For this product it was  concluded 
that  no  exposure  to  the  nanoscale  primary  particles  is  expected  during  its  use.  Two  other 
active substances which are nanomaterials are included within the Review Programme40. 

3.  CONCLUSIONS 

Eight years after the adoption of the BPR, all provisions are fully operational. The importance 
of  biocides,  notably  of  disinfectants  for  human  hygiene  and  surface  disinfection,  was 

36   For further details see SWD(2021)128 
37   Commission Recommendation of 18 October 2011 on the definition of nanomaterial (OJ L 275, 20.10.2011, 

p. 38–40). 

38    Pyrogenic,  synthetic  amorphous,  nano,  surface  treated  silicon  dioxide,  and  synthetic  amorphous  silicon 

dioxide (nano). 

39    https://echa.europa.eu/information-on-chemicals/biocidal-products/-/disbp/factsheet/FR-0013670-

0000/authorisationid.  

40   In 2020 the application for authorisation of one of them was rejected, due to applicant’s failure to pay the 

fees.  

9 

 
                                                 
particularly  highlighted  during  the  COVID-19  pandemic.  The  use  of  the  derogation 
provisions  in  place  under  the  BPR  to  react  to  emergency  situations  allowed  to  address  the 
severe  shortages  in  the  supply  of  disinfectants  following  the  steep  increase  in  the  demand. 
The concerted efforts of industry, Member States and the Commission allowed to address the 
unprecedented situation created by the COVID-19 pandemic.  

The main problems identified in this report are the slow progress with the evaluation of active 
substances included in the Review Programme and the continuous substantial delays in both 
active  substance  approval  and  product  authorisation  processes.  The  slow  progress  with  the 
evaluation of the active substances in the Review Programme, already identified41 under the 
BPD,  continued  after  the  entry  into  application  of  the  BPR.  Thus,  5  years  before  the  twice 
extended  deadline  of  31  December  2024,  only  35%  of  the  work  programme  has  been 
completed.  

Very  limited  innovation  on  new  active  substances  occurred  under  the  BPR.  According  to 
stakeholders, innovation  is  hindered by high regulatory costs and very long procedures, the 
relatively  small  market  for  biocides  and  its  fragmentation,  and  the  small  returns  on 
investment.  The slow progress  with  the Review  Programme has been a further disincentive 
for  developing  new  active  substances,  since  products  containing  active  substances  in  the 
Review  Programme  and  still  under  evaluation  can  be  made  available  on  the  market  under 
national  rules  without  having  to  respect  restrictions  put  in  place  under  the  BPR  to  protect 
health and environment. Public investment into research could help to increase innovation in 
this area. 

The  completion  of  the  Review  Programme  is  thus  crucial  for  the  achievement  of  the 
objectives  of  the  BPR.  The  longer  the  completion  of  the  work  programme  is  delayed,  the 
longer  biocidal  products  containing  active  substances  not  yet  evaluated  for  safety  and 
efficacy  may  be  made  available  on  the  market.  It  is  therefore  imperative  to  accelerate  the 
pace of the evaluation of existing active substances and complete the Review Programme as 
soon as possible. 

In  addition,  the  Commission  receives  an  increasing  number  of  correspondence  from 
companies,  who  cannot  find  an  evaluating  Member  State  for  the  approval  or  renewal  of 
approval of active substances or for the authorisation of biocidal products (either as reference 
Member State for mutual recognition or evaluating Member State for Union authorisation), as 
all Member States approached refuse to do so.  

The main reason for all delays observed – and the difficulties for companies finding reference 
or evaluating Member States accepting applications  – is a systemic lack of resources in the 
Member States.  

The Commission therefore calls on Member States to ensure that competent authorities have 
the  appropriate  resources  to  fulfil  all  their  obligations  under  the  BPR  within  the  applicable 
deadlines.  The  Commission  invites  Member  States  to  review  the  situation  of  the  fees 
collected  for  BPR  procedures,  with  regard  to  the  appropriateness  of  their  level  and  the 
potential need to ring-fence the revenue derived from them for activities related to the BPR. 

41    Impact  assessment  accompanying  the  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the 

Council concerning the placing on the market and use of biocidal products (COM/2009/0267 final). 

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The  Commission  will  also  launch  a  call  to  set  up  a  contract  for  providing  Member  States’ 
competent  authorities  specific  technical  support  to  complete  their  evaluations.  A  full 
evaluation  of  the  BPR,  planned  for  2025,  will  analyse  in-depth  the  fitness  of  the  current 
regulatory framework as a basis for deciding on the need for further action.  

If  Member  States  do  not  take  the  necessary  measures  to  ensure  that  their  authorities  can 
execute  the  role  of  evaluating  authority  for  applications  for  approvals,  authorisations  and 
renewals, the regulatory system set out in the BPR cannot function properly. 

11