COMMISSION STAFF WORKING DOCUMENT Accompanying the document 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  SWD(2021) 128 final  COMMISSION STAFF WORKING DOCUMENT Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL  on the implementation of Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products    {COM(2021) 287 final}  
 
 
Table of Contents 

1. 

INTRODUCTION .......................................................................................................3 

2.  COMPETENT AUTHORITIES ..................................................................................6 

2.1.  Fees and reductions for small and medium-sized enterprises ............................7 
2.2.  Functioning of helpdesks and advice to small and medium enterprises ............9 

3.  ACTIVE SUBSTANCE APPROVAL ......................................................................10 

3.1.  Active substances in the Review Programme ..................................................10 
3.1.1.  Backlog reports ..................................................................................18 
3.1.2.  Withdrawal and taking over ...............................................................18 
3.2.  Active substances outside the Review Programme .........................................20 
3.2.1.  Existing active substances outside the Review Programme ..............20 
3.2.2.  New active substances .......................................................................21 
3.3.  Active substances which are micro-organisms ................................................22 
3.4.  Exclusion and substitution criteria ...................................................................23 
3.5.  Renewal of active substance approval .............................................................24 

4.  BIOCIDAL PRODUCT AUTHORISATION ...........................................................27 

4.1.  National authorisation ......................................................................................27 
4.2.  Mutual recognition ...........................................................................................29 
4.3.  Union authorisation ..........................................................................................33 
4.4.  Simplified authorisation ...................................................................................37 
4.5.  Authorisation  of  products  containing  an  active  substance  meeting 

exclusion criteria ..............................................................................................39 
4.6.  Product authorisation renewal ..........................................................................40 
4.7.  Authorisation granted on the basis of Article 19(5) of the BPR ......................42 
4.8.  Comparative assessment ..................................................................................43 
4.9.  Derogations from the requirements for authorisation ......................................45 
4.10.  Research and development ..............................................................................47 
4.11.  Notification of unexpected or adverse effects .................................................48 
4.12.  Parallel trade permits .......................................................................................48 
4.13.  Products made available on the market under the transitional measures .........49 

5.  TREATED ARTICLES .............................................................................................51 

6.  POISONING INCIDENTS ........................................................................................55 

7.  SUSTAINABLE USE ................................................................................................59 

1 

 
 
 
 
 
8.  ENFORCEMENT ......................................................................................................62 

9.  USE OF NANOMATERIALS IN BIOCIDAL PRODUCTS ...................................66 

10.  THE ROLE OF BIOCIDAL PRODUCTS IN THE COVID-19 PANDEMIC .........67 

2 

 
 
 
1. 

INTRODUCTION 

Regulation (EU) No 528/20121 (the Biocidal Products Regulation - BPR), which is applicable 
since 1 September 2013, lays down the rules for the making available on the market and use 
of  biocidal  products  and  articles  treated  with  such  products.  Biocidal  products  are  used  to 
control  unwanted  organisms  that  are  harmful  to  human  or  animal  health  or  to  the 
environment, or that cause damage to human activities, including pests (e.g. insects, rats or 
mice)  and  microorganisms  (e.g.  bacteria,  viruses,  mould).  Based  on  Article  114  TFEU,  the 
Regulation  aims  at  improving  the  functioning  of  the  internal  market  for  biocidal  products, 
while ensuring a high level of protection for human and animal health and the environment2. 
It  repealed  Directive  98/8/EC  of  the  European  Parliament  and  of  the  Council3  (Biocidal 
Products Directive).  

Biocidal  products  are  designed  to  have  impacts  on  unwanted  living  organisms.  Despite  the 
risks  inherent  to  their  use,  biocidal  products  play  an  important  role  in  the  daily  life  of  EU 
citizens. For example, insecticides and disinfectants are essential for the protection of public 
health  to  help  control  vector-borne  diseases  (such  as  malaria,  dengue  fever,  chikungunya, 
zika), food-borne diseases (such as salmonellosis, listeriosis) or hospital-acquired infections 
(such as MRSA infection). The crucial role of biocidal products for the protection of public 
health  has  been  particularly  highlighted  during  the  Covid-19  pandemic,  where  disinfecting 
products  have  been  critically  important  in  controlling  the  spread  of  the  disease.  Biocidal 
products  are  also  widely  used  in  materials  such  as  plastics,  paints,  textiles,  wood,  etc.  to 
protect these materials against microbial, fungi or insect-induced decay. 

The  BPR  establishes  a  two-step  approach  in  order  to  achieve  the  above-mentioned  goals. 
Active  substances,  which  exercise  the  action  on  the  target  organism(s),  must  either  be 
approved at the Union level and included in a Union list of approved active substances or be 
included  into  Annex  I  to  that  Regulation  before  they  can  be  used  in  biocidal  products4. 
Subsequently, biocidal products containing any active substance require an authorisation, at 
national or Union level, before they can be made available on the market and used.  

The BPR establishes a transitional period in order to implement  this system and, by way of 
exception, biocidal products containing active substances which were already on the market 
when  the  BPD  came  into  application  and  are  included  in  the  work  programme  for  the 
examination of existing biocidal active substances contained in biocidal products (commonly 

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   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.    

3   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). 

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

3 

 
 
                                                 
known as ‘Review Programme’) can be made available on the market and used in accordance 
with  national  laws  of  each  Member  State  pending  the  final  decision  on  the  approval  of  the 
active substance(s) they contain. Also, pending the decision on the approval of a new active 
substance, biocidal products containing it may be provisionally authorised for limited periods 
of time by Member States or the Commission if certain conditions are fulfilled. 

Active substances are approved for specified product-types. Annex V to the BPR categorises 
biocidal  products  into  22  product-types5,  categorised  in  four  main  groups:  disinfectants, 
preservatives,  pest  control  and  other  biocidal  products.  The  BPR  excludes  from  its  scope 
products  that  are  already  regulated  by  other  EU  legislations,  like  plant  protection  products 
(within the scope of Regulation (EC) 1107/2009), medicinal products for human use (within 
the  scope  of  Directive  2001/83/EC  and  Regulation  (EC)  726/2004),  veterinary  medicinal 
products  (within  the  scope  of  Regulation  (EU)  2019/6),  or  preservatives  used  for  food  and 
feedstock  (within  the  scope  of  Regulation  (EC)  No  1333/2008  or  Regulation  (EC)  No 
1831/2003).  Certain  products  may  have  a  dual  use,  like  detergents  being  also  disinfectant 
products,  and  must  therefore  comply  with  both  legislations  (e.g.  detergents  are  regulated 
under Regulation (EC) 648/2004). 

Annex  I  to  the  BPR  lists  active  substances  that  have  a  more  favourable  profile  as  regards 
impacts to human or animal health or the environment. With a view to encouraging the use of 
biocidal products containing these active substances, a simplified authorisation procedure is 
established for such products. Once authorised in a Member State, such products can be made 
available on the market of other Member States following a simple notification submitted to 
those other Member States. This list includes for instance certain substances also authorised 
as  food  additives,  substances  exempt  from  the  registration  requirements  under  the  REACH 
Regulation6, pheromones and other substances considered to have a low toxicity. 

The provisions of the BPR developed further certain concepts and procedures, or introduced 
new ones, compared to its predecessor, the BPD in particular:  

  extension  of  the  definition  of  biocidal  product  to  cover  clearly  active  substances 

generated in-situ; 

 

 

 

the concept of a Biocidal Product Family in order to authorise simultaneously a group 
of biocidal products with similar uses, same active substance(s), similar composition 
and similar levels of risk and efficacy; 

the  concept  of  Union  authorisation  granted  by  the  Commission,  which  allows  the 
making available on the market of products throughout the Union; 

the  concept  of  mutual  recognition  in  parallel,  by  means  of  which  a  company  can 
request  authorisation  for  a  biocidal  product  in  several  Member  States  at  the  same 
time. 

  specific rules concerning articles treated with biocidal products; 

5    https://echa.europa.eu/regulations/biocidal-products-regulation/product-types.  
6    Such substances are listed in Annex IV to Regulation (EC) No 1907/2006 of the European Parliament and of 
the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH), (OJ L 396 30.12.2006, p. 1). 

4 

 
                                                 
 

the  possibility  for  the  Commission,  upon  request  from  a  Member  State,  to  decide 
whether a specific product is a biocidal product, a treated article or neither of the two7. 

The  European  Chemical  Agency  (ECHA),  set  up  under  the  REACH  Regulation,  is 
responsible for providing technical and scientific support in the implementation of the BPR. 
Through its Biocidal Products Committee, it provides opinions to the Commission related to 
approval  of  active  substances,  Union  authorisation  of  biocidal  products  and  various  other 
scientific  and  technical  matters.  ECHA  also  produces  operational  guidance  documents  and 
provides  advice  and  assistance  to  companies  via  its  helpdesk.  ECHA  is  responsible  for 
maintaining  the  Register  for  Biocidal  Products,  which  is  used  by  applicants,  competent 
authorities,  ECHA  and  the  Commission  to  (i)  submit  applications  under  the  BPR,  (ii) 
exchange  information  during  the  assessment  of  the  applications  and  (iii)  disseminate 
information once active substances have been approved and products authorised. 

Pursuant to  Article 65 of the  BPR, Member States and the Commission  must report on the 
implementation of the Regulation. Member States have to submit to the Commission reports 
on  the  implementation  of  the  BPR  in  their  territories  every  five  years.  Article  65(3)  of  the 
BPR, indicates some elements8 to  which particular attention should be given in the reports. 
Pursuant  to  Article  65(4)  of  the  BPR,  the  composite  report  of  the  Commission  should  be 
drawn up on the basis of the reports provided by Member States and should be submitted to 
the Council and the European Parliament within 12 months from the deadline for submission 
of reports by Member States. The deadlines for submission of the first reports from Member 
States and from the Commission are 30 June 2020 and 30 June 2021, respectively, covering 
the  period  from  1  September  2013  (date  of  entry  into  application  of  the  BPR)  until  31 
December 2019.9 All Member States submitted their reports, with the exception of the Czech 
Republic10.  In  addition  to  the  information  provided  by  Member  States  in  their  reports,  this 
report  is  also  based  on  data  extracted  from  the  dedicated  IT  platform11  used  by  applicants, 
competent  authorities,  ECHA  and  the  Commission  for  the  submission  and  assessment  of 
applications and the exchange of information  in  relation  to  procedures under the BPR. The 
overview  report12  of  the  fact-finding  missions  carried  out  in  2017  and  2018  by  the 
Directorate-General for Health and Food Safety of the European Commission in five Member 
States in order to monitor and assess the implementation of certain provisions of the BPR was 
also used as a source of information. 

7   Since  the  entry  into  application  of  the  BPR  the  Commission  received  16  such  requests  and  adopted  9 

decisions, published at https://echa.europa.eu/regulations/biocidal-products-regulation/legislation. 

8 

(i)  information  on  results  of  official  controls,  (ii)information  on  poisoning  and  occupational  diseases 
involving  biocidal  products,  (iii)  information  on  adverse  environmental  effects  experienced  through  using 
biocidal  products  and  (iv)  information  on  use  of  nanomaterials  in  biocidal  products  and  potential  risk 
thereof. 

9   By  way  of  exception,  Chapter  10  of  this  report  describes  the  impact  of  the  Covid-19  pandemic  on  the 

implementation of the BPR during 2020. 

10  The  reports  are  available  at:  https://ec.europa.eu/health/biocides/key_documents_en.  [reports  not  yet 

published] 

11   Register for Biocidal Products, set up according to Article 71 of the BPR. 
12  https://op.europa.eu/en/publication-detail/-/publication/14fbda4b-329f-11ea-ba6e-01aa75ed71a1/language-

%20%20%20en/format-PDF/source-112325446  

5 

 
                                                 
2.  COMPETENT AUTHORITIES  

Pursuant  to  Article  81  of  the  BPR,  Member  States  must  designate  one  or  more  competent 
authorities (CAs) responsible for the application of the BPR. Member States must ensure that 
the CAs have a sufficient  number of suitably qualified and experienced staff in  order to  be 
able to carry out efficiently and effectively the obligations laid down in the BPR. There are 
44  CAs  operating  in  the  EU  Member  States,  EEA  States  and  Switzerland13  (collectively 
referred  to  in  this  document  as  “Member  States”).  20  Member  States  have  designated  one 
single authority responsible for the implementation of the BPR in their territory. In 7 Member 
States  (France,  Estonia,  Denmark,  Germany,  Lithuania,  Netherlands,  Spain)  there  are  two 
competent  authorities,  while  in  3  Member  States  (Greece,  Portugal,  Romania)  there  are  3 
competent  authorities.  6  competent  authorities  operate  in  Switzerland,  which  also  act  as 
evaluating  competent  authorities  for  the  applications  for  active  substance  approval  and 
biocidal products authorisation accepted by the competent authority of Liechtenstein. 

As mentioned in the introduction, in 2017 and 2018 the Directorate-General for Health and 
Food Safety of the European Commission carried out fact-finding missions in five Member 
States. The scope of the missions included, among others, the designation of CAs, as well as 
the  communication  and  co-operation  within  and  between  these  authorities.  The  overview 
report of the fact-finding missions indicates, together with other findings, the main challenges 
encountered  by  CAs  in  their  work.  One  main  challenge  faced  by  authorities  is  insufficient 
staff  resources  allocated  to  perform  the  tasks  required  for  the  implementation  of  the  BPR. 
Member  States  highlighted  the  importance  of  the  work  at  EU  level  in  order  to  achieve 
harmonisation  and  consistency  at  Union  level  in  the  approval  of  active  substances  and 
authorisation  of  biocidal  products  and  in  general  in  the  implementation  of  the  Regulation. 
However,  due  to  the  lack  of  resources,  not  all  Member  States  are  able  to  contribute  in  the 
same manner to the work at EU level, with some Member States being more active than the 
others. The possibility to exchange of experts between competent authorities, as well as the 
exchange  of  experiences  on  how  to  estimate  the  upcoming  workload  in  order  to  allocate 
resources  efficiently,  were  identified  in  this  report  as  potentially  beneficial  to  improve  the 
efficiency of the competent authorities. 

The  Commission  expert  group  called  “Competent  Authorities  for  the  implementation  of 
Regulation  (EU)  No  528/2012  concerning  the  making  available  on  the  market  and  use  of 
biocidal products” brings together the CAs of all Member States, EEA States and Switzerland 
in  regularly  organised  meetings  (4  to  5  times  a  year  on  average).  These  meetings  are  also 
attended by ECHA and observers from stakeholders (industry representatives, NGOs, etc.). It 
aims  at  facilitating  cooperation  between  CAs  competent  authorities,  the  Commission,  and 
ECHA  on  the  implementation  of  the  BPR  in  their  respective  areas  of  responsibility,  and 
achieving  an  EU-wide  harmonised  approach.  Some  CAs  participate  actively  in  this  group, 
while not all are able to attend all meetings. 

The Standing Committee on Biocidal Products is made up of representatives of EU countries 
and is chaired by a representative  of the European Commission. It meets regularly (4-5 times 
a  year  on  average)  and  delivers  opinions  on  draft  implementing  measures  that  the 
Commission intends to adopt. 

13   The  chapter  on  biocidal  product  in  the  agreement  between  the  European  Community  and  the  Swiss 
Confederation on mutual recognition in relation to conformity assessments covers since 14 April 2015 the 
BPR and the revised Swiss Ordinance on Biocidal Products of 15 July 2014.    

6 

 
                                                 
2.1.  Fees and reductions for small and medium-sized enterprises 

All  Member  States  have  adopted  national  legislation  setting  fees  for  services  that  they 
provide with respect to the procedures under the BPR, in accordance with Article 80(2) of the 
BPR. The Commission services issued specific guidance to help Member States in the setting 
of their fee system14. In almost all Member States, the fees are expressed as given amounts 
per  specific  procedure,  except  for  some,  where  the  fees  are  calculated  based  on  the  actual 
costs incurred (depending on number of staff involved in a certain procedure and the number 
of  days  worked).  Iceland  has  not  set  fees  for  active  substance-related  procedures.  Also,  in 
Norway  and  Hungary  fees  for  procedures  related  to  Union  authorisation  have  not  yet  been 
established. 

The  amount  of  fees  for  the  various  procedures  varies  greatly  between  Member  States.  For 
example, for an application for approval of an active substance for one product-type, the fees 
vary  between  €11,324  in  Bulgaria  and  €421,974  in  Sweden.  For  applications  for  product 
authorisation  the  fees  vary  between  €2,510  in  Spain  and  €100,000  in  Cyprus,  and  for 
applications for Union authorisation they vary between €4,320 in  Bulgaria and €100,000 in 
Cyprus.  The  fees  for  (national  or  Union)  authorisation  of  biocidal  products  families  are 
higher  than  the  ones  for  the  authorisation  of  single  biocidal  products;  in  many  cases  (e.g. 
Austria, Finland, Poland, Sweden, Greece, Ireland) the amount is double the amount of fees 
for single products. Table 2.1 illustrates the minimum and maximum amount of fees for the 
main procedures under the BPR. 

Table 2.1: Minimum and maximum fees for BPR procedures and the Member State where they apply 

BPR procedure 

Minimum amount* 

Maximum amount* 

Active substance approval 

€ 11,324 (BG) 

€ 421,974 (SE) 

Inclusion into Annex I to BPR 

€ 10,000 (EL) 

€ 332,000 (RO) 

Authorisation of a biocidal product (BP)  € 2,510 (ES) 

€ 100,000 (CY) 

Authorisation of a biocidal product 
family (BPF) 

Mutual recognition of an authorisation 
of a BP 

Mutual recognition of an authorisation 
of a BPF 

€ 6,901 (BG) 

€ 200,000 (CY) 

€ 400 (LU) 

€ 28,256 (LT) 

€ 800 (LU) 

€ 30,000 (FR) 

Union authorisation of a BP  

€ 4,320 (BG) 

€ 100,000 (CY) 

Union authorisation of a BPF 

€ 6,901 (BG) 

€ 200,000 (CY) 

     (* for Member States outside the Eurozone the amounts were converted into euro using the exchange 

rate of 16 December 2020) 

The  third  subparagraph  of  Article  80(2)  sets  up  the  possibility  for  Member  States  to  levy 
annual  fees  with  respect  to  biocidal  products  made  available  on  their  markets.  18  Member 

14  CA-Dec12-Doc.5.1.b - Final - Note for Guidance on Fees.doc available at: 

https://circabc.europa.eu/w/browse/b5c900a2-ef66-4a46-996d-00d5a29aee9a  

7 

 
                                                 
States  have  chosen  to  not  levy  annual  fees  from  product  authorisation  holders.  In  Member 
States where such annual fees are established, they vary between € 67 in Denmark and € 500 
in Austria for single biocidal products. These fees are higher for biocidal products families.  

Numerous  small  and  medium-sized  enterprises  (SMEs)  are  active  in  the  field  of  biocides. 
According to the findings of a study conducted for the Commission15, more than 70% of the 
companies operating in this field in 2015 were SMEs (see Figure 2.1) 

Figure 2.1    Percentage of SMEs in the EU biocides market in 2015 

Article 80(3)(c) of the BPR provides that Member States, when setting the fees, should take 
into account  specific needs of SMEs, as appropriate. However, 22 Member States have not 
adopted  specific  measures  taking  into  account  specific  needs  of  SMEs.  In  those  Member 
States which adopted measures, these are either reduced fees based on the size (micro, small, 
medium)  of  the  company  (for  instance  in  Belgium,  Luxembourg,  Ireland,  Cyprus)  or  the 
possibility of payment of fees in instalments (for example in Austria and Germany). 

In addition  to  fees charged by Member States for the procedures under the BPR, fees must 
also  be paid  to  ECHA16 by  applicants  for (i) active substance related procedures (approval, 
renewal, inclusion into Annex I to the BPR), (ii) Union authorisation of biocidal products and 
(iii)  other  activities  (for  instance  submission  of  applications  for  mutual  recognitions).  Fee 
reductions  for  SMEs17  are  foreseen  for  procedures  related  to  active  substance  approval  and 
Union authorisation of biocidal products. 

15   Background  study  for  the  assessment  of  the  appropriateness  and  impact  of  the  existing  fee  model  for  the 
at: 

Biocidal 
https://echa.europa.eu/documents/10162/2200151/mb_25_2016_bpr_fee_model_en.pdf/2eaaeec2-4b6e-
448f-91ad-d9181b11b938  

Regulation 

available 

Products 

revision, 

possible 

and 

its 

16   Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and charges payable 

to the European Chemicals Agency, OJ L 167, 19.6.2013, p. 17–25 

17   The  reductions  are  60%,  40%  and  20%  of  the  standard  fee  for  micro,  small  and  medium  enterprises, 
respectively,  for  procedures  related  to  active  substances  and  30%,  20%  and  10%  of  the  standard  fee  for 
Union authorisation of biocidal products 

8 

 
 
                                                 
2.2. 

Functioning of helpdesks and advice to small and medium enterprises 

Article 81(2) requires Member States to provide advice to applicants, in particular to SMEs, 
and to other interested parties, on their responsibilities and obligations under the BPR. Such 
advice  may  be  provided  by  establishing  dedicated  helpdesks.  All  Member  States  have 
established BPR helpdesks, except for Liechtenstein, which has delegated the relevant tasks 
to the Swiss helpdesk. 

The  number  of  enquiries  received  by  Member  States  varies  significantly.  However,  three 
quarters of the helpdesks received on average more than 200 enquiries per year, and half of 
the helpdesks received on average more than 500 enquiries per year (up to an average of 2000 
for  Germany).  In  most  of  the  25  Member  States  who  provided  information18,  the  highest 
number of enquiries was received between 2017 and 2019 - and a slight yearly increase was 
registered  between  2017  and  2019  -  while  in  three  Member  States  the  highest  number  was 
registered in 2014 (first year after the entry into application of the BPR), notably in Germany, 
where more than 10,000 enquiries were received that year. Figure 2.2 shows the evolution of 
the total number of helpdesk enquiries in 25 Member States. 

Figure 2.2 Total number of helpdesk enquiries in 25 Member States 

Only five Member States were able to provide a breakdown of whether enquiries were related 
to active substances, biocidal products or treated articles. Where this information is available, 
it shows that the vast  majority  of the enquiries (on average more than 90%) was related to 
biocidal  products,  while  those  related  to  treated  articles  represented  a  maximum  of  8%  of 
total enquiries, and the remaining ones (around 2%) concerned active substances. 

15 Member States indicated that they provide specific advice to SMEs. This is done mainly 
by  means  of  tailored  meetings  with  SMEs  (mostly  meetings  before  the  submission  of 
applications for active substance approval or product authorisation), specific conferences and 
events targeted at SMEs and additional guidance provided to this type of companies. 

18   In six of these Member States data for 2013 and 2014 were not available. 

9 

 
 
 
 
                                                 
3.  ACTIVE SUBSTANCE APPROVAL 

Active substances have to be approved at Union level before an authorisation for a biocidal 
product containing them can be granted. The approval is valid for specified product-type(s). 

Applicant  must  submit  its  dossier  to  an  evaluating  Member  State  competent  authority 
responsible for its assessment, who forwards its assessment report to ECHA. A peer review 
by the experts of all other Member States is organised by ECHA within its Biocidal Products 
Committee (BPC), responsible to prepare, within 270 days an opinion on whether or not the 
active  substance  meets  the  criteria  for  approval.  Based  on  the  ECHA  BPC  opinion,  the 
European Commission prepares a decision either to approve (with relevant conditions) or not 
to approve, an active substance, which is subject to an opinion in the Standing Committee of 
Biocidal Products. The approval of an active substance is limited to period not exceeding 10 
years and is renewable. Short approval periods are granted in certain cases, for instance when 
an  active  substance  meeting  the  exclusion  criteria  set  out  in  Article  5(1)  of  the  BPR  is 
approved under one of the derogation possibilities established in Article 5(2). 

As set out in Article 6 of the BPR, an application for approval of an active substance must 
include  both  a  dossier  for  the  active  substance  and  a  dossier  for  at  least  one  representative 
product  containing  that  active  substance,  and  must  demonstrate  that  the  representative 
biocidal product(s) is (are) safe and effective. The data requirements for the active substance 
and product dossiers are laid down in Annexes II and III to the BPR, respectively.  

3.1.  Active substances in the Review Programme 

Directive  98/8/EC  (the  BPD),  the  predecessor  of  the  BPR,  which  was  the  first  Union-wide 
legislation on biocidal products, established a distinction between existing active substances 
which were on the market in biocidal products on 14 May 2000, and new active substances, 
which were not  on the  market  in  biocidal  products  on that date. As foreseen in  the BPD,  a 
work programme for the examination of the existing active substances, commonly known as 
the “Review Programme” was set up.  

A  specific  Implementing  Regulation19  laid  down  the  provisions  necessary  for  the 
implementation  of the Review Programme.  It  listed all existing active substances identified 
by  companies,  and  among  these  active  substances,  those  existing  substances  notified  by 
companies for inclusion in the review programme. In 2003, 954 active substances had been 
identified20  as  existing  active  substances.  Producers,  formulators,  associations  or  Member 
States expressed their interest to apply for approval of 220 of these active substances, which 
were  included  in  the  Review  Programme21  in  2003,  covering  a  total  of  624  active 
substance/product-type combinations. Rapporteur Member States (Member States performing 

19   Commission Regulation (EC) No 2032/2003 of 4 November 2003 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,  and  amending  Regulation  (EC)  No  1896/2000 
(OJ  L  307,  24.11.2003,  p.  1–96),  repealed  and  replaced  in  2007  by  Commission  Regulation  (EC)  No 
1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 
16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal 
products on the market (OJ L 325, 11.12.2007, p. 3–65) 

20   Annex I to Commission Regulation (EC) No 2032/2003 of 4 November 2003.  
21   Annex II to Commission Regulation (EC) No 2032/2003 of 4 November 2003. 

10 

 
                                                 
the  evaluation  of  the  application  dossiers)  were  also  designated  for  each  active  substance. 
Most  applications  for  approval  of  active  substances  in  the  Review  Programme  were 
submitted between April 2004 and October 2008 according to  four successive priority lists, 
depending on product-types. 

After the entry into application of the BPR, the rules for the implementation of the Review 
Programme were adapted to the provisions of the BPR by Regulation (EU) No 1062/201422 
(the  Review  Programme  Regulation).  The  Review  Programme  Regulation  also  includes 
specific  procedures  for  (i)  joining  or  replacing  a  participant  in  the  Review  Programme  by 
mutual  agreement,  (ii)  withdrawing  as  a  participant  and  (iii)  taking  over  the  role  of 
participant in certain situations.  

The  Review  Programme  Regulation  was  amended  three  times  (once  in  2017  and  twice  in 
2018),  in  order  to  better  reflect  the  actual  state  of  the  progress  of  work  programme.  In 
particular,  the  first  revision  of  201823  was  connected  to  the  redefinition  of  the  identity  of 
certain  existing  active  substances  generated  in-situ  already  covered  by  the  Review 
Programme. That revision also newly included in the work programme food and feed active 
substances  used  for  product-type  19  that  had  benefitted  from  a  previous  derogation  under 
Directive  98/8/EC  which  was  no  longer  valid  under  the  BPR.  Around  100  active 
substance/product-type combinations entries were added to the Review Programme with this 
revision, which led to an increase of the number of specific evaluations to be performed. The 
second revision of 201824 was needed in order to address the consequences of the withdrawal 
of  the  United  Kingdom  from  the  European  Union:  the  responsibility  for  evaluating  the 
applications  for  45  active  substance-product-type  combinations  were  re-assigned  from  the 
United Kingdom to other evaluating Member States. 

To  ensure  a  more  efficient  implementation,  the  Review  Programme  Regulation  also 
reorganised the priorities, setting six new priority lists, each with different deadlines for the 
submission of the assessment reports by the evaluating competent authorities to ECHA and 
for the submission of the opinions by the Biocidal Products Committee to the Commission. 
The  criteria  to  group  product-types  in  the  priority  lists  were  mainly  based  on  the  state  of 
completion of the assessments and the technical relevance, so that assessments conducted for 
a  product-type  could  be  beneficial  for  the  assessment  of  other  related  substances.  For 
instance, active substances supported in the Review Programme for product-types 1 to 5 are 
often the same; active substances for product-types 7, 9 and 10 are often the same and often 
present similar scientific or borderline issues between one another. The six priority lists and 
the respective deadlines are indicated in Table 3.1. 

22   Commission  Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the  work programme  for the 
systematic  examination  of  all  existing  active  substances  contained  in  biocidal  products  referred  to  in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014). 

23   Commission  Delegated  Regulation  (EU)  2019/157  of  6  November  2018  amending  Annex  II  to  Delegated 
Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active 
substances  contained  in  biocidal  products  referred  to  in  Regulation  (EU)  No  528/2012  of  the  European 
Parliament and of the Council (OJ L 31, 1.2.2019, p. 1–20). 

24   Commission  Delegated  Regulation  (EU)  2019/227  of  28  November  2018  amending  Delegated  Regulation 
(EU) No 1062/2014 as regards certain active substances/product-type combinations for which the competent 
authority  of  the  United  Kingdom  has  been  designated  as  the  evaluating  competent  authority  (OJ  L  37, 
8.2.2019, p. 1–21). 

11 

 
                                                 
Table 3.1: Priority lists established by the Review Programme Regulation 

Priority 

Existing active substances for 
product types 

Deadline for 
submission of the 
assessment report 

Deadline for 
submission of 
BPC opinions 

1st priority list 
2nd priority list 
3rd priority list 
4th priority list 
5th priority list 
6th priority list 

8, 14, 16, 18, 19, 21 

3, 4, 5 

1, 2 

6, 13 

7, 9, 10 

11, 12, 15, 17, 20, 22 

31/12/2015 

31/12/2016 

31/12/2018 

31/12/2019 

31/12/2020 

31/12/2022 

31/12/2016 

31/12/2017 

31/12/2019 

31/12/2020 

31/12/2021 

31/06/2024 

Although  initially  foreseen  to  be  completed  in  10  years,  the  duration  of  the  review 
programme  had  to  be  extended  –  first  by  amendment  to  the  BPD25,  and  subsequently  by 
Regulation  (EU)  No  736/2013  amending  the  BPR,  which  extended  the  deadline  for 
completion  of  the  review  programme  to  31  December  2024,  based  on  the  estimations 
available to the Commission at that time and assuming a target of 50 decisions to be adopted 
per year on average.  

On  1  September  2013,  the  date  of  entry  into  application  of  the  BPR,  the  Commission  had 
adopted  69  decisions26  on  approval  or  non-approval  of  existing  active  substances,  covering 
73  active  substance/product-type  combinations,  which  corresponded  to  11%  of  the  Review 
Programme at that time. The execution of the Review Programme was thus clearly delayed 
already at that time. 

As  explained  earlier,  the  first  step  in  the  process  of  the  evaluation  of  the  applications  for 
approval of active substances is the submission of the Competent Authority Report (CAR) to 
ECHA by the evaluating Competent Authority.  

The early years of implementation of the BPR were promising in the direction of reaching the 
target of 50 evaluation per year27, even if the target was not fully met. However, as shown in 
Figure 3.1, the number of CARs delivered by the Member States started to drop significantly 
since 2017, with only one CAR delivered in 2018.  

25   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. 40–42). 

26   One  Commission  decision  to  approve  or  non-approve  an  active  substance  may  cover  one  or  multiple 

product-types for the same active substance. 

27  Document CA-Sept13-Doc.8.3-Final-Review Programme of AS,  

https://circabc.europa.eu/w/browse/8a48f736-853c-4c5f-8fda-92ccc8d30415  

12 

 
 
 
                                                 
Figure 3.1    Number of Competent Authority Reports submitted per year 

Figure  3.2  shows  the  number  of  assessment  reports  submitted  between  2013  and  2019  by 
each Member State.  

Figure 3.2    Number of Competent Authority Reports submitted, by Rapporteur Member State 

When  considering  all  priority  lists  combined  (see  Figure  3.3),  the  best  performers  are 
Finland,  Ireland,  Latvia,  Austria,  France  and  Greece  (with  less  than  25%  of  the  active 
substance/product-type combinations still under evaluation), while the worst performers are 
Belgium,  Hungary,  Poland  and  Portugal,  with  more 
the  active 
substance/product-type combinations still under evaluation.  

than  70%  of 

When considering only the 1st priority list (with a deadline for submission of the assessment 
report  of  31  December  2015),  the  best  performers  are  Finland,  Ireland,  Norway  and  the 
Netherlands,  who  delivered  all  the  assessment  reports,  and  the  worst  performers  are  the 

13 

 
 
 
Czech Republic, Belgium and Spain, with 20% or more of the active substance/product-type 
combinations still under evaluation28.  

For  the  2nd  priority  list  (with  a  deadline  for  submission  of  the  assessment  report  of  31 
December  2015)  the  best  performers  are  Ireland  and  Norway,  who  delivered  all  the 
assessment reports and the worst performers are Belgium, Spain and Portugal, with more than 
50% of the active substance/product-type combinations still under evaluation.  

For  the  3rd  priority  list  (with  a  deadline  for  submission  of  the  assessment  report  of  31 
December 2018) the best performers are Ireland and Latvia, who submitted all the assessment 
reports,  and  the  worst  performers  are  Hungary,  Poland,  Portugal  and  Slovenia,  with  more 
than 70% of the active substance/product-type combinations still under evaluation.  

Finally, for the 4th priority list (with a deadline for submission of the assessment report of 31 
December  2019),  the  best  performer  is  Finland,  who  submitted  all  the  assessment  reports, 
while  Belgium,  Germany,  Italy,  Malta,  Portugal,  Sweden  and  Switzerland  have  not  yet 
submitted any of the assessment reports. 

          *(for the UK it corresponds to dossiers for which decisions were taken, as the other dossiers still under  assessment 

or peer review were transferred to other MS) 

            Figure 3.3    Performance of Member States for all priority lists 

Delays  in  the  submission  of  the  assessment  reports  can  be  attributed  to  lack  of  resources 
allocated  in  Member  States,  delays  of  applicants  in  submitting  additional  data,  complex 
technical questions on specific dossiers that need to be resolved first, evolution of technical 

28   It has to be noted that some delays are related to recent applications due to inclusion of some food and feed 

active substances combinations in the Review Programme in 2018 for product-type 19. 

14 

 
 
                                                 
guidance,  and  the  adoption  of  new  scientific  criteria29  for  the  determination  of  endocrine-
disrupting properties, which triggered the need for further data and further assessments. 

The  first  ECHA  BPC  opinions  on  active  substances  in  accordance  with  Article  8(4)  of  the 
BPR were delivered in  April 2014. The number of opinions delivered by  the  BPC shows a 
decrease from 2016 onwards, with the lowest number of opinions (3) delivered in 2019 (see 
Figure 3.4). In total, 163 BPC opinions were delivered until 31 December 2019, representing 
54% of the total expected opinions based on the target established in 2013. 

This  is  directly  correlated  with  the  delays  of  Member  States  in  delivering  the  CARs  or 
conducting further work emanating from the peer review of their CARs.  

Figure 3.4    Number of BPC opinions on existing active substances 

The  evolution  of  the  number  of  decisions  adopted  by  the  Commission  on  approval/non-
approval  of  active  substances30  follows  the  same  trend  as  the  number  of  BPC  opinions 
provided  to  the  Commission.  Figures  3.5  and  3.6  show  the  evolution  of  the  number  of 
active-
Commission  decisions  on 
substance/product-type  combinations  covered  by  these  decisions,  respectively.  While  the 
number  of  decisions  adopted  between  September  2013  and  2016  increased  steadily,  a 
significant decrease occurred in 2017 and 2018, with a small increase again in 2019.  

approval/non-approval 

the  number  of 

and 

29   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. 1–5) 

30  The Commission decision on approval/non-approval is in general adopted 6-9 months after the adoption of 

the respective BPC opinion(s).  

15 

 
 
                                                 
Figure 3.5: Number of decisions on approval/non-approval adopted by the Commission for an active 

substance covering one or more product-types 

Figure 3.6: Number of active substance/product-type combinations covered by Commissions decisions on 

approval/non-approval 

Figure  3.7  illustrates  the  cumulative  number  of  decisions  adopted  by  the  Commission  in 
terms of active substance-product-type combinations covered by those decisions. 

16 

 
 
 
Figure 3.7: Cumulative number of active substance/product-type combinations covered by Commissions 

decisions on approval/non-approval 

As a consequence of the significant delays in the evaluation of the applications by Member 
States, progress in the completion of the Review Programme on 31 December 2019 has been 
much slower than expected. Even for the first priority list for which the evaluating Member 
States had to submit their CARs to ECHA by 31 December 2015 only 77% of the work has 
been  finalised.  For  that  priority  list,  21  active  substances  are  still  under  evaluation  by  the 
evaluating Member States (in Austria, Belgium, Czech Republic, France, Germany, Greece, 
Portugal, Spain, Sweden, and one application in Switzerland)31. For the four first lists of the 
review programme for which all draft assessment reports should have been submitted during 
the period covered by this report, almost all Member States have not submitted on time their 
draft assessments for one or more dossiers, some Member States having still many dossiers 
under  evaluation.  The  work  related  to  the  Review  Programme  has  been  completed  only  in 
two Member States that were evaluating a relatively low number of active substances (Ireland 
and  Latvia).  As  shown  in  Figure  3.8,  apart  from  the  first  priority  list,  the  percentages  of 
completion of the Review Programme for each list are still very low, which is exacerbated by 
the fact that  most evaluations started between 2004 and 2008 (i.e. more than 10 years ago).  

31  It has to be noted that some delays are related to recent applications due to inclusion of some food and feed 

active substances combinations in the Review Programme in 2018 for product-type 19. 

17 

 
 
                                                 
Figure 3.8: Progress on the Review Programme per priority lists (in percentage) on 31 December 2019  

3.1.1.  Backlog reports 

Around 150 draft assessment reports were already submitted by the eCAs for peer review on 
1  September  2013  when  the  BPR  came  into  application  (usually  referred  to  as  “backlog 
reports”). At the beginning of the implementation of the BPR, a work plan was set up with 
ECHA  and  Member  States  in  order  to  complete  the  peer  review  of  these  active  substances 
within  3  years  (in  line  with  the  objective  of  50  opinions  per  year)32.  Pursuant  to  the 
transitional  provisions  set  up  under  Article  90(2),  for  these  dossiers  the  Commission  must 
base its decision on the criteria established by the BPD, which among other differences, did 
not contain exclusion criteria as now set out in Article 5 of the BPR or substitution criteria as 
now set out in Article 10 of BPR. 

However, despite this intention, on 31 December 2019, the peer review has been completed 
and decisions have been taken on only two thirds of these backlog dossiers, while 47 reports 
from 12 Member States (Denmark, France, Germany, Greece, Italy, Malta, the Netherlands, 
Portugal, Spain, Sweden, Slovakia) were still under peer review on 31 December 201933. For 
some of these reports supportive actions from the evaluating competent authorities are needed 
to make progress on the peer review, or further information requested from applicants is not 
yet submitted. 

3.1.2.  Withdrawal and taking over 

In  accordance  with  Article  11  of  the  Review  Programme  Regulation,  participants  in  the 
Review  Programme  may  withdraw  their  support  for  an  active  substance/product-type 
combination  for  which  they  had  submitted  an  application  for  approval.  When  that  occurs, 
ECHA publishes an invitation  to  prospective applicants  to  take over the role of participant, 
unless  that  opportunity  has  already  been  granted  once  as  provided  for  by  Article  14  of  the 

32   Work plan available at: https://circabc.europa.eu/w/browse/d46486e0-e951-4292-9101-086157ef413b 
33   Tracking report available at: https://circabc.europa.eu/w/browse/0e0cd459-7226-4f8b-8459-b27d12434b70 

18 

 
 
                                                 
same Regulation. In case of redefinitions of active substances, an invitation to take over the 
role of participant is also published by ECHA.  

In 2014, the Commission published a list34 of 88 active substance/product-type combinations 
no longer supported, for which interested companies could make a notification and take over 
the  role  of  participant.  8  of  these  active  substance/product-type  combinations  were  taken 
over.  Between  2013  and  2019,  ECHA  published  invitations  to  take  over  the  role  of 
participant  for  140  active  substance/product-type  combinations.  Of  those  140  active 
substance/product-type  combinations,  77  were  taken  over  by  new  participants.  Figure  3.9 
shows the number of active substance/product-type combinations covered by the invitations 
published from 2013 to 2019 and the number of active-substance/product-type combinations 
taken over35 by other participants following the publication of the invitations. 

Figure 3.9: Number AS/PT combinations for which an invitation to take over the role of participant was 

published and number of AS/PT combinations taken over 

The continuous significant delays in the evaluation of active substances led the Commission 
to  take  action.  In  2015  it  sent  letters  to  all  Member  States,  highlighting  the  importance  of 
completing the Review Programme, as main objective which underpins all other objectives of 
the  BPR,  and  inviting  them  to  ensure  that  competent  authorities  have  the  appropriate 
resources  to  fulfil  their  obligations  under  the  BPR.  In  2017  the  Commission  initiated 
discussions with all parties involved in the process (Competent Authorities, ECHA, industry 
associations) in order to better understand the main causes of the delays, to identify possible 
actions  to  minimise  such  delays,  and  renew  the  commitment  from  Member  States  in 
completing  their  tasks.  A  list  of  actions36  to  be  undertaken  by  applicants,  Member  States, 

34   Part 2 of Annex II to Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work 
programme  for the systematic examination of all existing active  substances contained in biocidal products 
referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council. 

35   The taking over occurs 12 months after the publication of the invitation, as prospective applicants have 12 

months to notify their interest to take over.  

36   Available at https://circabc.europa.eu/w/browse/f5b309a8-abef-4550-a4c7-fe14a67f2c13 

19 

 
 
 
                                                 
ECHA and the Commission was discussed in various meetings of Competent Authorities and 
eventually agreed in March 2018.  

ECHA  also  conducted  a  survey  addressed  to  Competent  Authorities  in  2018  in  order  to 
identify  the  causes  for  delays  and  propose  solutions.  ECHA  organised  a  workshop  on  the 
active  substance  approval  process  in  February  2019,  with  a  special  focus  on  the  Review 
Programme. In light of the survey results and of the information collected at the workshop, 
ECHA  proposed  an  Action  Plan37  aiming  to  advance  progress  on  the  Review  Programme, 
which  was  agreed  by  the  Commission  and  Member  States’  Competent  Authorities  in 
February 2020. In the context of the Action Plan, ECHA is closely cooperating with Member 
States, providing support beyond its initially foreseen role in the BPR. 

Apart from having insufficient resource and delays by the applicants in submitting additional 
information required by the evaluating Member State during the evaluation, one of the factors 
highlighted  by  Member  States  as  cause  for  recent  delays  in  their  evaluation  of  active 
substances was the requirement to perform the assessment of endocrine disrupting properties 
according to the scientific criteria which the Commission adopted as required by Article 5(3) 
of the  BPR38  and applicable since June 2018. According to  the specific actions included in 
the  Action  Plan,  ECHA  is  providing  Member  States  specific  further  advice  and  guidance 
related to this assessment. 

Status of Review Programme at the end of the reporting period 

On  31  December  2019,  474  active  substance-product/type  combinations  of  the  Review 
Programme  were  still  under  examination,  of  which  360  (76%)  still  under  evaluation  in 
Member  States  and  114  (24%)  under  peer  review  at  ECHA  level,  while  the  work  was 
completed  for  252  active  substance-product/type  combinations.  Thus,  five  years  before  the 
current  deadline  of  31  December  2014  to  complete  the  review  programme  started  in  2004, 
only 35% of the work programme had been completed. 

3.2.  Active substances outside the Review Programme 

3.2.1.  Existing active substances outside the Review Programme 

For some active substances identified as existing active substances, initially no company or 
Member State expressed an interest to support them, therefore those active substances were 
not  included  in  the  Review  Programme39,  or  they  were  included  only  for  specific  product-
types.  However,  applications  for  approval  of  these  substances  can  be  submitted  under  the 
BPR. 

Applications for 68 existing active substance/product-type combinations outside the Review 
Programme were submitted in the reporting period. 8 decisions on the approval/non-approval 

37   Available at https://circabc.europa.eu/w/browse/9b8a5c0c-9d25-4373-b89f-8ddfeeabe2e8  
38   Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017. 
39   For instance cholecalciferol, allyl isothiocyanate, benzyl alcohol. 

20 

 
 
                                                 
were  adopted,  covering  8  active  substance/product-type  combinations.  Of  these,  seven 
decisions approved the active substance/product-type combinations (Figure 3.10). 

4

3

2

1

0

1 

2 

2 

2 

2015

2016

2017

0 
0 
2018

1 

2019

Approval decisions

Non-approval decisions

Figure 3.10: Number of decisions on approval/non-approval of existing active substances outside the Review 

Programme  

3.2.2.  New active substances 

Active substances not on the market in a biocidal product on 14 May 2000 are considered as 
new active substances. In order to be able to place them on the market, companies have first 
to  apply  for  approval  by  submitting  a  dossier  to  ECHA.  After  ECHA  has  accepted  the 
application  as  set  out  in  Article  7(2)  of  the  BPR,  the  evaluating  competent  authority  of  a 
Member  State  chosen  by  the  company  carries  out  a  completeness  check  and,  when  finding 
the  dossier  complete,  has  to  conduct  an  evaluation  within  one  year.  As  for  existing  active 
substances, the CAR is forwarded to the Biocidal Products Committee of the Agency, which 
prepares an opinion within 270 days. The opinion serves as the basis for the decision of the 
Commission on approval (or not) of the active substance. In the meantime, it is not possible 
to make available and use in the EU such active substances in biocidal products. Provisional 
authorisations may be granted in certain cases until a decision on the approval of the active 
substance is adopted, as indicated in section 4.8(ii) of this document. 

10  new  active  substances  were  evaluated  since  the  entry  into  application  of  the  BPR,  9  of 
which were approved, while one was not approved. Of the 9 new active substances approved 
(covering  13  active  substance/product-type  combinations)  5  are  used  in  preservatives 
(product-types 7, 8, 9, 10), 2 are used in insecticides and 2 are used in anti-fouling products. 3 
of them are candidates for substitution and, therefore, were approved for 7 years only. One of 
the  approved  new  active  substances  is  a  micro-organism40  used  in  the  preservation  of 
construction  materials  (product-type  10).  The  new  active  substance  not  approved  is  also 
micro-organism41 intended to be used as preservative in industrial processing water systems 
(product-type 11). Applications related to 6 other new active substances, covering 10 active 
substance/product-type combinations are still under assessment. 

40   Pythium oligandrum strain M1. 
41   Willaertia magna c2c Maky. A new application for approval for product-types 11 and 12 has been submitted 

in the meantime. 

21 

 
 
                                                 
Figure 3.11 illustrates the number of Commission decisions related to new active substances 
adopted during the reporting period with respect to the number of active substance/product-
type combinations covered. 

Figure 3.11: Number of active substance/product-type combinations covered by Commission Decisions 

approving/non-approving new active substances 

For five of the approved new active substances the approval procedure followed the deadlines 
set  in  the  Regulation  without  major  delays  and  the  decision  to  approve  them  was  adopted 
within three years from the submission of the application (3.5 years in one case). However, 
for three of them the delays were more significant (the approval was granted after more than 
six  years  from  the  submission  of  the  application)  -  in  two  of  these  cases  the  evaluating 
Member  State  performed  the  evaluation  in  five  years  or  more  from  the  completeness 
validation.  For  the  other,  the  CAR  was  submitted  2  years  after  the  submission  of  the 
application  but  the  peer-review  took  4.5  years.  Overall,  the  performance  of  the  evaluating 
Member  States  for  new  active  substances  is  thus  somewhat  better  than  for  existing  active 
substances under the Review Programme, albeit with large divergences. 

3.3.  Active substances which are micro-organisms 

Micro-organisms are alternatives to chemical active substances and are expected to have less 
harmful effects on human health, animal health and/or the environment.  

So  far,  six  active  substances  consisting  of  micro-organisms  have  been  approved  under  the 
BPR, of which four42 for use in insecticides, one43 for use in veterinary hygiene disinfecting 
products  and  one44  for  use  as  construction  material  preservative.  One  micro-organism45, 
expected to be used in repellents or attractants, has been included into Annex I to the BPR. 

42   Bacillus  thuringiensis  subsp.  israelensis  serotype  H14  AM65-52,  Bacillus  thuringiensis subsp.  israelensis, 
strain SA3A,  Bacillus sphaericus 2362 ABTS-1743,   Bacillus thuringiensis subsp. kurstaki ABTS-351. 

43   Bacillus amyloliquefaciens strain ISB06. 
44   Pythium oligandrum strain M1. 
45   Saccharomyces cerevisiae. 

22 

 
 
                                                 
No other micro-organism is included in the Review Programme. An application for approval 
of a new active substance which is a micro-organism46 is under assessment.   

3.4.  Exclusion and substitution criteria 

In  order  to  achieve  a  high  level  of  protection  of  human  and  animal  health  and  the 
environment, the BPR introduced the so-called ‘exclusion criteria’ and ‘substitution criteria’. 

Exclusion criteria 

Active substances meeting the  exclusion criteria, which  are based on intrinsic properties of 
the  substance  considered  of  particularly  high  concern  to  human  health  or  the  environment, 
can in principle not be approved for use in biocidal products. These include: 

  classification  as  carcinogen,  mutagen  or  toxic  to  reproduction,  categories  1A  or  1B, 

according to the CLP Regulation47 

  endocrine  disrupting  properties  with  respect  to  humans  on  the  basis  of  the  criteria 
established  in  Regulation  (EU)  2017/2100  or  identified  as  endocrine  disruptor  in 
accordance with the REACH Regulation  

  persistent,  bioaccumulative  and  toxic  (PBT)  properties,  or  very  persistent  and  very 

bioaccumulative (vPvB) properties. 

Possibilities for derogation to exclusion are foreseen in Article 5(2) of the BPR on grounds of 
negligible  risks  from  exposure  to  the  substance,  essentiality  of  the  substance  to  prevent  or 
control  a  serious  danger  to  human  health,  animal  health  or  the  environment,  or 
disproportionate negative effect for society that a non-approval would cause when compared 
to the risks caused by the use of the active substance. In all cases, the availability of suitable 
and sufficient alternative substances or alternative techniques is a key consideration. In case a 
derogation possibility applies, the approval of the active substance is granted for a period of 
maximum five years. 

active 

So  far,  3  active  substances  meeting  exclusion  criteria,  covering  3  active  substance/product-
type combinations were not approved, due to due to the identification of unacceptable risks 
related to their use. 21 active substances meeting the exclusion criteria have been approved, 
covering  24 
active 
substance/product-type combinations were approved before the entry into application of the 
BPR  and  7  were  approved  under  the  BPR,  either  following  the  transitional  rules  as  set  out 
under  Article  90(2)  of  the  BPR  when  the  CAR  was  submitted  by  the  evaluating  Member 
States  prior  to  1  September  2013,  or  after  a  thorough  examination  of  the  derogation 
possibilities when the CAR was submitted by Member States after 1 September 2013. Among 
the  21  approved  active  substances,  10  are  rodenticides48  (one  them  is  a  new  active 

combinations.  17  of 

substance/product-type 

these 

46   Trichoderma harzianum strain T-720, for use as wood preservative. 
47   Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  on  classification,  labelling 
and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, 
and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1–1355). 

48   Difethialone,  difenacoum,  coumatetralyl,  bromaniolone,  chlorophacinone,  flocoumafen,  warfarin  sodium, 

brodifacoum, warfarin, cholecalciferol. 

23 

 
 
 
                                                 
substance49;  for  one  of  them,  the  approval  expired  in  201750),  while  the  others  are  active 
substances for use in preservatives, especially wood preservatives51. 

Substitution criteria  

Article 10 of the BPR lays down the criteria which qualify an active substance as candidate 
for  substitution  (and  they  include  those  substances  that  meet  one  or  more  of  the  exclusion 
criteria but may be approved according to the derogation possibilities mentioned above). The 
aim of this provision is to identify substances which despite not meeting the exclusion criteria 
are still of particular concern to public, animal health or the environment and to ensure that 
these substances are phased-out and replaced by more suitable alternatives over time. 

If, during the assessment of an application for approval, an active substance is identified by 
the  evaluating  competent  authority  as  potentially  meeting  any  of  the  criteria,  ECHA  has  to 
initiate  a  public  consultation  during  which  interested  third  parties  may  submit  relevant 
information,  including  on  available  alternatives.  The  input  received  during  the  public 
consultation has to be taken into consideration when ECHA’s BPC finalises its opinion on the 
active substance. The designation as a candidate for substitution has two consequences: (i) a 
shorter  approval  period  (maximum  of  seven  years)  and  (ii)  requirement  for  competent 
authorities  to  carry  out  a  comparative  assessment  when  applications  for  authorisation  of 
products containing them are submitted.  

So far, the participation to the public consultations was limited and/or the BPC did not reach 
a clear conclusion on availability of alternatives. 4 active substances meeting the substitution 
criteria, covering 9 active substance/product-type combinations were not approved, due to the 
identification  of  unacceptable  risks  related  to  their  use.  20  active  substances  meeting  the 
substitution criteria have been approved (other than active substances meeting the exclusion 
criteria  and  approved  under  the  derogation  possibilities),  corresponding  to  37  active 
substance/product-type  combinations.  The  approved  active  substances  are  used 
in 
disinfectants,  preservatives,  insecticides  or  antifouling  products.  26  of  these  active 
substance/product-type  combinations  were  approved  since  the  entry  into  application  of  the 
BPR.  

3.5.  Renewal of active substance approval  

Applications for renewal of approval of an active substance must be submitted by interested 
companies to ECHA at the latest 1.5 years before the expiry of the approval. The evaluating 
competent  authority  (eCA)  has  to  decide,  based  on  the  information  available  in  the 
application  and  in  light  of  current  scientific  knowledge,  whether  a  full  evaluation  is 
necessary. Although flexibility exists in the BPR as to the choice of the eCA for renewal, for 
efficiency reasons and in order to ensure a level of guarantee to applicants that a competent 
authority will be willing to act as eCA, Member States agreed52 that the eCA for the renewal 
should be the same as for the original approval, unless a change of eCA is mutually agreed 

49   Cholecalciferol. 
50   Warfarin sodium. 
51   For instance thiacloprid, propiconazole, disodium tetraborate, boric acid, creosote, cyproconazole. 
52  Note agreed by Member States’ Competent Authorities for Biocidal Products, 
https://circabc.europa.eu/w/browse/c7442864-5851-4710-936e-fad2491b835e  

24 

 
                                                 
between  the  original  and  the  new  eCA  (and  with  the  prospective  applicant's  agreement 
whenever possible). If the evaluating competent authority decides that a full evaluation is not 
necessary, it has to provide to the BPC a recommendation on the renewal of approval within 
180 days. If a full evaluation is necessary, the  assessment report  and the recommendation 
have to be provided within 365 days from the acceptance of the application. 

The BPC must adopt an opinion within 270 days of the recommendation being submitted in 
the case of a full evaluation, or within 90 days, if a full evaluation was not necessary. This 
opinion  serves  as  a  basis  for  decision  by  the  Commission.  The  renewal  of  approval  of  an 
active  substance  may  be  granted  for  a  maximum  period  of  15  years  for  all  product-types 
concerned.  However,  when  an  active  substance  meets  the  exclusion  or  the  substitution 
criteria, the approval may be renewed for a period of maximum 7 years. 

By 31 December 2019, 19 applications for the renewal of approval of active substances had 
been  submitted,  of  which  8  concerned  anticoagulant  rodenticide  active  substances.  Figure 
3.12 shows when the applications for renewal of approval were submitted.  

Figure 3.12: Submissions of applications for renewal of approval of active substances  

The applications for renewal of anticoagulant rodenticides were submitted between 2013 and 
2015.  The  evaluation  of  all  these  applications  was  conducted  in  a  coordinated  manner  in 
order to  facilitate synergies in  the review and comparison  of the risks and benefits  of these 
active  substances,  as  well  as  of  the  risk  mitigation  measures  applied  to  them.  The  related 
CARs were submitted by Member States in 2016 and the BPC opinions were adopted in June 
2016.  The  respective  Commission  decisions  on  the  renewal  were  adopted  in  July  2017, 
granting a period of renewal of approval of seven years. 

The other 11 applications for renewal were submitted between 2017 and 2019. For none of 
them the CAR has been submitted to date.  

For eight active substances, no application for renewal of approval has been submitted. This 
concerns  mostly  active  substances  meeting  the  exclusion  or  substitution  criteria  (warfarin 
sodium 
thiametoxam, 
thiabendazole, fenpropimorph, tolylfluanid, cyproconazole for wood preservatives). 

rodenticides;  dichlofluanide, 

clothianidin, 

thiacloprid, 

for 

Pursuant to Article 14(5) of the BPR, where for reasons beyond the control of the applicant 
the approval of the active substance is likely to expire before a decision has been adopted on 

25 

 
 
its renewal, the Commission shall adopt decisions postponing the date of expiry of the active 
substance approval for a period sufficient to enable it to examine the application.  

So far, the Commission adopted 10 decisions postponing the expiry date of approval, related 
to  15  active  substances,  of  which  8  rodenticides,  6  wood  preservatives  and  1  insecticide. 
These  became  necessary  in  all  cases  except  for  the  rodenticides,  due  to  decisions  by  the 
respective evaluating competent authority to perform a full evaluation and due delays in the 
evaluations  of  the  applications.  The  extension  decisions  related  to  rodenticides  were  also 
needed  in  order  to  allow  for  the  simultaneous  assessment  at  renewal  of  all  anticoagulant 
rodenticide active substances, as explained above. 

Table 3.2 indicates the number of extension decisions adopted each year by the Commission 
and the active substances covered by the decisions. 

Year of decision 
postponing the expiry 
of approval 

Number of 
decisions 
adopted 

Active  substances  covered 
by the decisions 

2014 

2015 

2016 

2017 

2018 

2019 

1 

1 

1 

1 

1 

5 

Difethialone PT 14 
Difenacoum PT 14 

Bromadiolone PT 14 
Chlorophacinone PT 14 
Coumatetralyl PT 14 

Flocoumafen PT 14 
Brodifacoum PT 14 
Warfarin PT 14 

Creosote PT 8 

Sulfuryl fluoride PT 8 

IPBC PT 8 
Tebuconazole PT 8 
K-HDO PT 8 
Etofenprox PT 8 
Indoxacarb PT 18 

Table 3.2   Commission Decisions postponing the date of expiry of active substance approval 

26 

 
 
 
4.  BIOCIDAL PRODUCT AUTHORISATION 

As a general principle under the BPR, biocidal products need to be authorised before they can 
be  made  available  on  the  market.  The  active  substance(s)  they  contain  need  to  have  been 
approved  first.  Several  options  for  product  authorisation53  are  available  to  companies, 
depending  on  the  active  substance(s)  contained  in  the  product  and  the  number  of  Member 
States in which companies intend to make the product available: 

  National authorisation, referred to in Chapter VI (Articles 29 to 31) of the BPR, which 

provides for the authorisation in a Member;  

  Mutual  recognition  of national  authorisations  in  several Member States either at  the 
same time or sequentially, referred to in Chapter VII (Articles 33 to 39) of the BPR 
Regulation; 

  Union authorisation, valid in all Member States, referred to in Chapter VIII (Articles 

41 to 46) of the BPR; 

  Simplified  authorisation,  referred  to  in  Chapter  V  (Articles  25  to  28)  of  the  BPR, 
which  provides  for  an  accelerated  authorisation  procedure  for  products  containing 
only active substances included in Annex I to the Regulation. 

The  BPR  foresees  also  circumstances  in  which  it  is  possible  to  derogate  from  the  general 
principle mentioned above (see section 4.1.4). 

4.1.  National authorisation  

National authorisation is the most suitable type of authorisation if a company intends to make 
the product available only in one Member State. As provided for by Articles 29 and 30 of the 
BPR, the application for authorisation has to be submitted to the competent authority of that 
Member  State,  which  evaluates  the  application  and  makes  a  decision  on  the  authorisation 
within  365  days.  Authorisation  may  be  granted  for  a  single  biocidal  product  or  a  biocidal 
product family. National authorisation for a biocidal product can be granted for a maximum 
of 10 years and is renewable. For biocidal products containing an active substance which is a 
candidate for substitution, national authorisation  may be granted for a period not exceeding 
five  years.  In  any  case  the  authorisation  cannot  remain  valid  for  longer  than  the  approval 
period of the active substance(s) contained therein. 

The application for authorisation of a biocidal product already available on the market under 
the  transitional  provisions  of  Article  89  must  be  submitted  by  the  date  of  approval  of  the 
active substance, as such a product cannot be made available any longer after 180 days from 
the  date  of  approval  of  the  active  substance  and  existing  stocks  must  be  removed  from  the 
market 365 days after the approval date, as set out in Article 89(3) of the BPR. Applications 
for authorisation  can also be made at  a later date, but  until  the authorisation is  granted, the 
product cannot be made available on the market and cannot be used. 

Between  2013  and  2019,  2,642  biocidal  products  were  authorised  in  the Member  States  by 
national authorisation in accordance with the BPR. Figure 4.1 shows the number of products 

53  Further information on the product authorisation procedures is available at 

https://echa.europa.eu/regulations/biocidal-products-regulation/authorisation-of-biocidal-products 

27 

 
                                                 
authorised  in  each  Member  State.  The  highest  number  of  products  was  authorised  France 
(334), followed by the UK (318), Italy (252) and Spain (238).  

Figure 4.1: Number of products authorised by national authorisation in each Member State 

Figure  4.2  illustrates  the  number  of  products  authorised  by  national  authorisation  in 
accordance with the BPR in all Member States every year. 

28 

 
 
 
Figure 4.2:  Overall number of products authorised by national authorisation per year 

Of the products  authorised by national  authorisation  in  all Member States, 64% (1,698) are 
single biocidal products and 36% (944) are members of biocidal products families.  

4.2.  Mutual recognition 

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. The 
provisions  concerning  mutual  recognition  aim  to  avoid  duplication  of  the  evaluation 
procedures  and  to  ensure  free  movement  of  biocidal  products  within  the  Union.  Two 
procedures are available: 

-  Mutual recognition in sequence (Article 33 of the BPR): after national authorisation in 
one  Member  State  (the  reference  Member  State),  the  authorisation  holder  applies  in 
other  Member  States  (the  Member  States  concerned)  to  recognise  the  authorisation 
and authorise the product; 

-  Mutual  recognition  in  parallel  (Article  34  of  the  BPR):  the  applicant  submits  an 
application for authorisation in one Member State (the reference Member State) and at 
the  same  time  applies  in  other  Member  States  (the  Member  States  concerned).  The 
concerned  Member  States  participate  in  the  evaluation  conducted  by  the  reference 
member  States  and  all  must  eventually  authorise  the  product  at  the  same  time  in 
accordance with the agreed assessment. 

29 

 
 
Figure 4.3   Number of products authorised by mutual recognition and standalone national authorisation 

Figure  4.3  illustrates  the  number  of  products  authorised  in  each  Member  States  by  mutual 
recognition  and  the  comparison  with  the  number  of  products  authorised  by  national 
authorisation.  

In most Member States, EEA States and Switzerland (28 out of 31) the majority of products 
authorised on the national market were authorised following mutual recognition procedures. 
Overall  in  the  Member  States,  authorisation  by  mutual  recognition  was  granted  for  6,444 
products,  which  is  almost  twice  as  many  as  products  authorised  by  standalone  national 
authorisation (see Figure 4.4). Of the 6,444 products authorised by mutual recognition, 42% 
(2,724) are members of biocidal products families. 

30 

 
 
Figure  4.4:  Number  of  products  authorised  by  mutual  recognition  in  all  Member  States  and  number  of 

products authorised by national authorisation 

Based on the data available54, there are significant delays with respect to the legal timelines 
set  out  in  the  BPR  for  all  biocidal  product  authorisation  procedures  initiated  between  2010 
and  2020.  The  largest  delays  were  registered  in  mutual  recognition  procedures,  especially 
mutual recognition in parallel. On average, in all Member States, 63% of the procedures for 
mutual  recognition  in  sequence  were  delayed,  and  72  %  of  the  procedures  for  mutual 
recognition in parallel. In 18 Member States the latter percentage is higher than 80%.  

Disagreements during mutual recognition process 

Disagreements between Member States may arise during the mutual recognition process, with 
regard  to  the  conclusions  of  the  technical  assessment  performed  by  the  reference  Member 
State, or with regard to the summary of product characteristics. Points of disagreement are to 
be referred to the Coordination Group set up under of Article 35 of the BPR, which should try 
to  find  an  agreement  on  the  action  to  be  taken.  The  Coordination  Group  is  composed  of 
representatives of Member States and of the Commission, and the secretariat is provided by 
ECHA.  In  the  absence  of  an  agreement  between  Member  States  within  60  days,  the 
disagreement is referred in accordance with Article 36 of the BPR to the Commission, which 
takes a final decision by means of an implementing act.  

The  Coordination  Group  has  thus  a  key  role  in  harmonising  product  authorisations.  So  far  
180 referrals were submitted to the Coordination Group (see Figure 4.5) and agreement could 
be found for 158 (87%). Figure 4.6 indicates the number of referrals initiated by the specific 
Member States. 

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

31 

 
 
                                                 
Figure 4.5:  Number of referrals to the Coordination Group 

Figure 4.6: Number of referrals initiated* by Member States 
*For some referrals there were more than one initiating Member State; those referrals are counted in more than once 

Only 15 (8%) of the referrals resulted in disagreement and were referred to the Commission 
(see Figure 4.7). 

Figure 4.7:  Number of referrals – agreement reached, disagreement referred to the Commission and 

referrals withdrawn 

32 

 
 
 
 
For seven cases referred to it, the Commission adopted decisions.  

Derogation from mutual recognition 

Authorisations according to mutual recognition in parallel or in sequence should be granted 
under  the  same  terms  and  conditions  in  all  involved  Member  States.  However,  in  certain 
cases  indicated  in  Article  37  of  the  BPR  (e.g.  protection  of  health  and  life  of  humans  or 
animals, protection of the environment, public security), any of the concerned Member States 
may propose to adjust the conditions of the authorisation to be granted or refuse to grant an 
authorisation.  A  justification  for  the  derogation  needs  to  be  communicated  to  the  applicant 
and an agreement with the applicant on the proposed derogation needs to be sought.  

Altogether  10  Member  States  reported  data  related  to  the  number  of  such  derogations. 
Among these, Spain reported the highest number of derogations (177), followed by Belgium 
(77).  In  most  Member  States  an  increase  in  the  number  of  these  derogations  occurred 
between 2017 and 2019.  

If the Member State concerned cannot reach an agreement with the applicant on the proposed 
derogation,  the  matter  is  referred  to  the  Commission,  which  takes  a  final  decision  on  the 
derogation.  Since  the  entry  into  application  of  the  BPR  four  cases  were  referred  to  the 
Commission  and  in  all  cases  the  Commission  decision  confirmed  that  the  derogation 
proposed  by  the  concerned  Member  State  to  the  applicant  was  justified  in  accordance  with 
the grounds included in Article 37(1).  

4.3.  Union authorisation 

The BPR newly introduced the possibility for Union-wide authorisation of a biocidal product. 
As set out in Article 42 of the BPR, a Union authorisation may be granted by the Commission 
for certain biocidal products with similar conditions of use in all Member States. Whether a 
biocidal product has similar conditions of use across the Union may be assessed by Member 
States, ECHA and the Commission  already before the formal submission of the application 
(the  so-called  "pre-submission  phase")  in  accordance  with  guidance  agreed  by  Member 
States55. Biocidal  products  containing active substances that meet  the exclusion  criteria and 
those of product-types 14, 15, 17, 20 and 21 are not eligible for Union authorisation. 

The  application  for  a  Union  authorisation  must  be  submitted  to  ECHA.  For  the  reference 
product  applications  following  the  assessment  by  an  evaluating  competent  authority  of  a 
Member  State,  ECHA  organises  a  peer  review  process  resulting  in  an  opinion  by  its  BPC 
within  180  days.  Companies  can  also  apply  for  the  Union  authorisation  of  ‘same  biocidal 
products’ as set out in Article 4 of Commission Implementing Regulation (EU) No 414/2013. 
Applications under this Regulation are linked to a related reference product, which can be an 
already  authorised  product  or  a  product  subject  to  an  application  for  Union  authorisation. 
ECHA prepares an opinion on the application for the same biocidal product within 30 days 
from the validation of the application by ECHA, or, where applicable, on the subsequent date 
of submission of an opinion on the related reference product. ECHA opinions represent the 

55   CA-Feb13-Doc.5.1.e  –  Final  on  the  definition  of  similar  conditions  of  use  across  the  Union,  available  at  

https://circabc.europa.eu/w/browse/c39eb3a0-628a-4626-97ca-a86cfe492917 . 

33 

 
                                                 
basis for the Commission decisions on whether  or not  to  grant  the Union authorisation  and 
under which conditions. 

The timescale for initiating the Union authorisation varies, depending on whether the product 
contains  a  new  or  an  existing  active  substance.  Products  containing  new  active  substances, 
alone  or  in  combination  with  existing  active  substances,  have  become  eligible  for  Union 
authorisation from the entry into application of the BPR on 1 September 2013. For biocidal 
products containing existing active substances, the option of applying for Union authorisation 
has been made available in three stages, depending on the product-type (see Table 4.1). 

Table 4.1: Timescales for the possibility to apply for Union authorisation 

Product-types 

1, 3, 4, 5, 18, 19 

2, 6, 13 

7, 8, 9, 10, 11, 12, 16, 22 

Union authorisation available from 

1 September 2013 

1 January 2017 

1 January 2020 

Authorisations  granted  by  Union  authorisation  are  valid  throughout  the  Union  unless 
otherwise specified. However, in accordance with Article 44(5) of the BPR, a Member State 
can request the Commission to adjust certain conditions of the authorisation or that the Union 
authorisation  shall  not  apply  in  the  territory  of  that  Member  State.  A  Member  State  shall 
justify  the  request  on  the  grounds  included  in  Article  37(1)  of  the  BPR  (e.g.  protection  of 
health and life of humans or animals, protection of the environment, public security). No such 
request has been submitted to the Commission in the reporting period.   

As required by Article 42(3) of the BPR, the Commission submitted a report56 to the Council 
and  European  Parliament  on  the  implementation  of  the  provisions  related  to  Union 
authorisation until 31 December 2017. The report provided an overview of the number and 
type  of  applications  submitted  until  31  December  2017  and  included  some  preliminary 
conclusions  based  on  the  limited  experience  gained  until  that  moment  with  the  Union 
authorisation  process.  However,  since  no  Union  authorisation  had  been  granted  until  that 
date,  it  was  not  possible  to  provide  a  comprehensive  analysis  of  the  functioning  of  the 
provisions related to Union authorisation.  

Union authorisation of reference biocidal products  

Figure  4.8  shows  the  number  of  Union  authorisation  applications  submitted  until  31 
December  2019  and  indicates  the  type  of  authorisation  sought.  Of  the  138  applications 
submitted, 106 applications  (77%) sought an authorisation for a biocidal product family and 
32 (23%) sought an authorisation for a single biocidal product. 

56   Available at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A0342%3AFIN. 

34 

 
 
                                                 
Figure 4.8:  Number of applications for Union authorisation submitted per year and type of authorisation  

The  workload  for  the  assessment  of  applications  for  Union  authorisation  were  not  evenly 
distributed  among  Member  States  (see  Figure  4.9).  14  Member  States  accepted  the  role  of 
evaluating  competent  authority  for  Union  authorisation  applications,  with  the  Netherlands 
acting as evaluating competent authority for almost half of the applications. Article 43(1) of 
the BPR gives the applicant the right to freely choose the competent authority of the Member 
State  that  will  evaluate  the  application.  There  might  be  different  driving  factors  motivating 
the applicants' choice of Member States. Among those factors, the amount of the fees charged 
for  the  evaluation  of  the  application  seems  to  play  an  important  role.  However,  other  non-
quantifiable  elements  such  as  the  willingness  of  Member  States  to  act  as  evaluating 
competent  authority  (which  must  be  confirmed  in  writing  before  submission  of  the 
application) might also be relevant. Some Member States did not act as evaluating competent 
authority  for  any  Union  authorisation,  as  either  they  were  not  approached  by  applicants  to 
hold this role, or they have not agreed to be the evaluating competent authority. 

Figure 4.9:  Distribution of Union authorisation by evaluating competent authority 

The  first  Commission  Implementing  Regulations  granting  a  Union  authorisation  were 
adopted  in  2018.  The  Commission  granted  11  Union  authorisations  in  2018  and  2019,  of 

35 

 
 
 
which 10 concerned biocidal products families and 1 concerned a single biocidal product (see 
Figure 4.10).  

Figure 4.10: Number of Union authorisation authorisations by type of authorisation granted 

Altogether the Union authorisations granted cover 67 biocidal products (see Figure 4.11). All 
products authorised are disinfectants and the great majority (63) are products for veterinary 
hygiene (product-type 3) and 4 of them are disinfectants not intended for direct application to 
humans or animals and disinfectants for food and feed area (product-types 2 and 4). 

Figure 4.11    Number of products authorised by Union authorisation 

As described in the earlier report from the Commission adopted in 2018, delays occur also in 
the Union authorisation procedures. Up to now it was not possible to complete the procedure 
for Union authorisation within the three years of the date of approval of the active substance, 
as specified in Article 89(3) of the BPR.  The complexity of the dossiers, related in particular 
to the submission of extensive biocidal product families, additional information which needs 
to  be  submitted  by  the  applicant,  and  the  insufficient  resources  at  competent  authorities  to 
address the number of applications, are the main reasons for the non-timely granting of the 
Union authorisations.  

Union authorisation of same biocidal products 

By  31  December  2019,  183  applications  for  Union  authorisation  of  same  biocidal  products 
had  been  submitted,  of  which  78  concerned  single  biocidal  products  and  105  concerned 
biocidal products families (see Figure 4.12). 

36 

 
 
 
Figure 4.12:  Number of applications for Union authorisation of same biocidal products 

The Commission granted so far two Union authorisations for same biocidal products in 2018, 
since  the  evaluation  of  the  related  reference  products  for  the  other  applications  is  still 
ongoing. They concern biocidal products families and cover 10 products used for veterinary 
hygiene (product-type 3).  

4.4. 

Simplified authorisation 

The  simplified  authorisation  procedure  established  in  Article  26  of  the  BPR  aims  to 
encourage the use of biocidal products which are less harmful for human and animal health 
and the environment. Biocidal  products  containing an active substance included in  Annex I 
and which meet specific conditions (contain no substances of concern or nanomaterials, are 
sufficiently  effective  and  their  handling  does  not  require  the  use  of  personal  protective 
equipment) are eligible for the simplified authorisation procedure (Article 25 of the BPR).  

The procedure for authorisation is similar to the procedure for national authorisation but the 
information  requirements  are  much  fewer  and  the  deadline  for  completing  the  procedure  is 
shorter  (the  competent  authority  evaluates  the  application  and  makes  a  decision  on  the 
authorisation in 90 days compared to 365 days for a national authorisation).  

Products  authorised  in  one  Member  State  may  be  made  available  in  other  Member  States 
without going through a mutual recognition procedure. A simple notification to the relevant 
Member State before actually placing the products on its market is sufficient (Article 27(1)).  

So  far,  239  biocidal  products  were  authorised  overall  in  Member  States  by  simplified 
procedure,  of  which  36  are  single  biocidal  products  and  203  are  members  of  biocidal 
products  families.  Almost  70%  of  these  products  contain  lactic  acid  as  an  active  substance 
product-types 1 to  4) and 20% of them  contain tartaric acid  and sodium  benzoate as  active 
substances, in product-types 1, 2 and 4. Figure 4.13 shows the number of products authorised 
by simplified authorisation per year in all Member States and figure 4.14 shows the number 
of products authorised by simplified authorisation by each  Member States. 7 Member States 
granted simplified authorisations.  

37 

 
 
Figure 4.13: Overall number of products authorised by simplified authorisation per year 

Figure 4.14:  Number of products authorised by simplified authorisation in Member States 

Biocidal  products  authorised  via  simplified  authorisation  may  be  made  available  on  the 
market in all Member States, following a notification submitted by the authorisation holder to 
the respective Member States. Notifications of making available on the market were received 
by all Member States and their overall number is 474. Most notifications were submitted in 
France (52), followed by Germany (29) and Belgium (28). Figure 4.15 shows the number of 
notifications to Member States submitted in the reporting period. 

38 

 
 
 
 
Figure 4.15:  Number of notifications of making available on the market in the various Member States 

4.5.  Authorisation  of  products  containing  an  active  substance  meeting  exclusion 

criteria 

Products  containing  an  active  substance  which  meets  one  or  more  of  the  exclusion  criteria 
may be authorised only if there is negligible risks from the exposure to the substance, if the 
product is essential to prevent or control a serious danger to human health, animal health or 
the  environment,  or  if  not  authorising  the  product  would  have  a  disproportionate  negative 
effect for society when compared to the risks caused by the use of the product (Article 5(2) of 
the  BPR).  In  all  cases,  the  availability  of  suitable  and  sufficient  alternative  substances  or 
alternative techniques should be a key consideration. In case a derogation possibility applies, 
the product authorisation is granted for a maximum period of five years. 

Data on the number of applications for authorisation assessed according to Article 5(2) were 
provided by 21 Member States. These vary greatly, with 5 Member States having performed 
more than 100 such assessments  (Germany,  Ireland, Poland, Greece, United Kingdom)  and 
one Member State (France) having performed more than 300.  

In  14  Member  States  all  the  assessments  resulted  in  authorisations.  In  the  other  Member 
States, the percentage of assessments resulting in non-authorisations varies between 3% and 

39 

 
 
20%. Figure 4.16 shows the number of assessments in each Member State and indicates how 
many of them resulted in non-authorisations.  

Figure 4.16: Number of Article 5(2) assessments resulting in authorisations and non-authorisations 

4.6.  Product authorisation renewal 

Applications  for  renewal  of  authorisations  of  a  biocidal  product  must  be  submitted  at  least 
550 days before the expiry date of the authorisation, otherwise the product has to be removed 
from  the  market  within  180  days  after  the  expiry  of  the  initial  authorisation.  So  far  the 
authorisations (granted by standalone national authorisation, mutual recognition or simplified 
authorisation)  of  2,144  biocidal  products  were  renewed.  Figure  4.17  shows  the  number  of 
products for which the authorisation was renewed in each Member State.  

40 

 
 
Figure 4.17:  Number of renewals of product authorisations in each Member State 

Figure  4.18  shows  the  overall  number  of  products  whose  authorisation  was  renewed  each 
year in all Member States. 

Figure 4.18:   Number of renewals of product authorisations per year in all Member States 

41 

 
 
 
4.7.  Authorisation granted on the basis of Article 19(5) of the BPR 

According  to  the  conditions  laid  down  in  Article  19(1)(iii)  and  (iv)  of  the  BPR,  biocidal 
products  which  have  unacceptable  effects  on  the  health  of  humans  or  animals  or  on  the 
environment  cannot  be authorised. Article 19(4)(c) establishes that biocidal  products  which 
contain a (active or non-active) substance having PBT/vPvB properties cannot be authorised 
for use by the general public. However, as provided in Article 19(5) of the BPR, by way of 
derogation from these provisions, products having unacceptable effects on human or animal 
health or on the environment can be authorised, and products containing a substance having 
PBT/vPvB properties can be authorised for use by the general public, when not authorising 
such products would have a disproportionate negative impact for society when compared to 
the  risks  for  human  health,  animal  health  or  the  environment  resulting  from  the  use  of  the 
products.  Appropriate  risk  mitigation  measures  must  be  set  at  the  authorisation  of  such 
products,  in  order  to  minimise  the  exposure  of  humans  and  the  environment  to  those 
products. 

Altogether  14  Member  States  reported  to  have  granted  authorisations  pursuant  to  Article 
19(5).  The  number  of  authorisations  varies  greatly  among  Member  States,  with  the  higher 
number reported by France (356 authorisations), followed by the United Kingdom (211), the 
Netherlands (30) and Denmark (28) (Figure 4.19). 

Figure 4.19:  Number of authorisations granted pursuant to Article 19(5) of the BPR 

Figure 4.20 illustrates the number of authorisations pursuant to  Article 19(5) granted in the 
Union  every  year.  Overall  712  such  authorisations  were  granted,  with  the  highest  number 
recorded in 2014 (205).  

42 

 
 
 
Figure 4.20:  Number of authorisations granted according to Article 19(5) 

4.8.  Comparative assessment  

If  the  application  for  authorisation  concerns  a  product  containing  an  active  substance 
identified as candidate for substitution in accordance with Article 10(1) (see section 3 above), 
the evaluating competent  authority  must perform a  comparative assessment  as provided for 
by Article 23 of the BPR, in order to assess whether alternative authorised products or other 
methods are available for the use specified in the application which present a lower overall 
risk for human health, animal health and the environment, are sufficiently effective, present 
no  other  economic  or  practical  disadvantages  and  provide  sufficient  chemical  diversity  to 
minimise  the  occurrence  of  resistance  in  the  target  harmful  organism.  The  comparative 
assessment  may  lead  to  an  authorisation  without  restrictions,  an  authorisation  with 
restrictions  or  to  the  prohibition  to  make  that  product  available  on  the  market.  If  an 
authorisation  (with  or  without  restrictions)  is  granted,  its  maximum  duration  is  5  years. 
Member State may authorise such a product without conducting a comparative assessment in 
exceptional cases, where it is necessary to acquire experience first through using that product 
in practice, but only for four years. 

The  number  of  comparative  assessments  performed  varies  greatly  among  the  17  Member 
States who reported on this, with a maximum of 364 comparative assessments performed by 
France during the reporting period (see Figure 4.21). Most Member States indicated to have 
performed the highest number of assessments in 2014.  

43 

 
 
 
Figure 4.21: Number of comparative assessments performed in the 17 Member States that reported on this 

issue 

The vast majority of the comparative assessment performed – and for several Member States 
all the assessments performed – led to an authorisation without restrictions. Overall the rate 
of  comparative  assessments  resulting  in  restrictions  or  refusals  varied  between  0  (in  2013) 
and 16% (in 2019). 

Figure 4.22:  Overall number of comparative assessments performed and number of restrictions 

A notable example of products for the authorisation of which a comparative assessments has 
to be performed are anticoagulant rodenticides (Art. 14), since all approved active substances 
for use in such products are candidates for substitution. In addition to assessing whether the 

44 

 
 
 
derogation  possibilities  in  Article  5(2)  are  met,  as  these  active  substances  meets  also  the 
exclusion criteria, Member States must also perform a comparative assessment. 

Specific  questions  arising  during  the  comparative  assessment  can  be  referred  by  Member 
States  to  the  Commission.  According  to  Article  23(5)  of  the  BPR,  where  the  comparative 
assessment involves a question which, by reason of its scale or consequences, would be better 
addressed  at  Union  level,  in  particular  where  it  is  relevant  to  two  or  more  competent 
authorities, the competent authority may refer the question to the Commission for a decision 
In  2015,  in  the  context  of  the  comparative  assessment  to  be  carried  out  at  the  renewal  of 
anticoagulant  rodenticide  products,  five  questions  were  referred  to  the  Commission.  A 
Commission Implementing Decision57 addressing those questions was adopted in 2017, based 
on an opinion delivered by the BPC58 upon request of the Commission.  

4.9.  Derogations from the requirements for authorisation 

Article  55  of  the  BPR  foresees  several  instances  in  which  biocidal  products  can  be  made 
available on the market without authorisation.  

(i) Permission for limited and controlled use in the event of danger to human health, animal 
health and the environment, which cannot be contained by other means 

According to Article 55 (1) of the BPR, Member States can permit the making available on 
the market and use of non-authorised biocidal products for a period not exceeding 180 days 
(often referred to as emergency permits). 

In the period 2014 to 2019, 9 Member States granted a total of 135 permits for limited and 
controlled  use.  57  permits  were  issued  for  product-type  3  products  used  in  apiaries. 
Emergency  permits  have  also  been  issued  for  insecticides  (product-type  18);  rodenticides 
(product-type  14)  repellents  for  the  control  of  pine  processionary  caterpillars  (product-type 
19) and products for the control of other vertebrates (product-type 20) (see Figure 4.23).  

Figure 4.23:  Permits granted by Member States in accordance with Article 55(1) 

57   Commission Implementing Decision (EU) 2017/1532. OJ L 232, 8.9.2017, p. 11–16) 
58  https://echa.europa.eu/documents/10162/24209689/bpc_opinion_comparative-

assessment_ar_en.pdf/bf81f0a5-3e95-6b7d-d601-37db9bb16fa5 

45 

 
 
                                                 
When granting such permits Member States are required to inform the other Member States 
and the Commission of the permits and of the justification for issuing them. The Commission 
publishes the notifications received and keeps an updated overview59 of all notifications.  

These temporary permits may be extended by a Member States for a maximum of 550 days 
following a reasoned request from that Member State to the Commission and adoption of a 
Commission Decision after a vote in the Standing Committee for Biocidal Products allowing 
the  Member  State  to  extend  the  original  permit.  The  Commission  had  to  decide  on  six 
requests for extension and in all cases it allowed an extension of the permits for the maximum 
period  envisaged.  Five  of  the  six  Commission  Decisions  allowing  an  extension  concerned 
insecticides60 and one concerned a biocidal product for the control of other vertebrates61. In 
five of these cases, the requesting Member States were either evaluating the application for 
regular product authorisation or were seeking ways to authorise the product on their territory 
by  mutual  recognition  of  the  product  already  authorised  in  another  Member  State.  In  one 
case, the active substance contained in the biocidal product was still under evaluation by the 
same Member State requesting the extension. 

(ii)  Provisional  authorisation  for  a  biocidal  product  containing  a  new  active  substance, 
which is not yet approved.  

In accordance with Article 55(2) of the BPR, provisional authorisation may be granted for a 
maximum of three years (and renewed for one year) if a competent authority that evaluated 
an  application  for  the  approval  of  the  active  substance  has  submitted  a  recommendation  to 
ECHA  for  approval,  and  the  Member  State  receiving  the  application  for  provisional 
authorisation  (or  ECHA  for  Union  authorisation)  considers  that  the  biocidal  product  is 
expected to comply with the conditions for authorisation laid down in Article 19. 

So far, only France granted one provisional authorisation pursuant to Article 55(2) in 2013, 
for  a  biocidal  product  containing  Bacillus  thuringiensis  subsp.  kurstaki,  strain  ABTS-351 
used  for  the  control  of  oak  processionary  caterpillars.  The  provisional  authorisation  was 
renewed for one year in 2016. Following the completion of the peer review by the BPC, the 
Commission adopted a decision to approve the active substance at the end of 2016. 

(iii) Authorisation for the protection of cultural heritage  

In  accordance  with  Article  55(3),  Member  States  may,  upon  derogation  granted  by  the 
Commission, authorise biocidal products containing a non-approved active substance if it is 
proven  that  the  active  substance  is  essential  for  the  protection  of  cultural  heritage  and  no 
appropriate alternatives are available. In order to obtain such derogation, Member States have 
to apply to the Commission and provide due justification. 

59   Available at https://circabc.europa.eu/w/browse/92bd0162-f4b3-49a7-9351-76cf1037287a 
60   Three  decisions  concerned  products  containing  Bacillus  thuringiensis  subsp.  israelensis  for  the  control  of 
larvae  and  adult  invasive  mosquitoes  (in  two  cases)  and  midges  (in  one  case);  one  concerned  a  product 
containing  Bacillus  thuringiensis  subsp.  israelensis  and  Bacillus  sphaericus  for  the  control  of  larvae  of 
exotic mosquites; one concerned a product containing (Z)-13-hexadecen-11-yn-1-yl acetate for the control of 
pine processionary caterpillars. 

61   The  decision  concerned  a  product  containing  aluminium  phosphide  releasing  phosphine  for  the  control  of 

rabbits on the site of the Zaventem airport. 

46 

 
                                                 
During  the  reporting  period,  no  authorisation  was  granted  by  Member  States  pursuant  to 
Article 55(3). However, in 2019, Austria and Spain applied to the Commission requesting a 
derogation  allowing  them  to  authorise  products  consisting  of  in-situ  generated  nitrogen  for 
the protection of cultural heritage62, given that many museums and cultural institutions have 
been  using  nitrogen  generated  in-situ  in  specific  treatment  chambers  to  control  harmful 
organisms on cultural heritage objects. 

Currently,  nitrogen  is  included  in  Annex  I  to  the  BPR  with  the  restriction  that  it  is  only 
allowed for use in limited quantities in ready-for-use canisters. Nitrogen is also approved for 
use in biocidal products in product-type 18 (insecticides). However, nitrogen generated in situ 
is  not  approved,  not  included  in  Annex  I,  and  not  included  in  the  Review  Programme. 
Following  the  submission  of  the  applications  by  Austria  and  Spain,  discussions  took  place 
between  the  Commission,  Member  States  and  two  international  organisations  representing 
museums and cultural heritage institutions (International Council of Museums - ICOM63 and 
International  Council  on  Monuments  and  Sites  -  ICOMOS64).  The  two  organisations 
representing  museums  and  cultural  heritage  sites  undertook  to  pursue  a  long-term  solution 
and indicated their intention to submit an application for inclusion of nitrogen generated  in-
situ into Annex I to the BPR, which is expected to be submitted in 2021. In the meantime, 
following the two applications submitted in  2019, the Commission  has adopted Decisions65 
allowing  Austria  and  Spain  to  authorise  products  consisting  of  in-situ  nitrogen  for  the 
protection of cultural heritage.  

4.10.  Research and development 

To  encourage  research  and  development  in  relation  to  active  substances  and  biocidal 
products, Article 56 of the BPR allows experiments or tests involving non-authorised biocidal 
products  and  non-approved  active  substances  intended  exclusively  for  use  in  biocidal 
products, under certain conditions. 

Experiments  or tests that may involve or result in  the release of the biocidal product  in  the 
environment  must  be  notified  in  advance  to  the  competent  authority  of  the  Member  State 
where the experiment or test will take place. The competent authority may decide to prohibit 
or restrict them, where they could have harmful effects on the health of humans or animals or 
unacceptable effects on the environment. 

The highest number of such notifications was submitted in the Netherlands (overall 96 in the 
reported  period),  followed  by  the  UK  (90  notifications)  and  Spain  (50  notifications)  (see 
Figure  4.24).  In  the  Member  States  having  received  more  than  10  notifications  in  the 
reporting  period,  approximately  80%  of  the  experiments  notified  were  allowed,  and  20%  
were prohibited. 

62   In  2020,  other  six  Member  States  (Denmark,  France,  Germany,  the  Netherlands,  Poland  and  Portugal) 
requested similar derogation  pursuant to  Article 55(3) and Decisions  following  five  of them  were adopted 
(Implementing Decisions (EU) 2020/1047, 2020/1049, 2020/1265, 2020/1266 and 2020/1755). 

63   https://icom.museum/en/ 
64   https://www.icomos.org/en 
65   Implementing Decisions (EU) 2020/1040 and 2020/1050.  

47 

 
                                                 
Figure 4.24:  Number of test/experiment notifications and number of prohibitions in 7 Member States 

4.11.  Notification of unexpected or adverse effects 

As set out in Article 47 of the BPR, the holder of an authorisation has the obligation to notify 
the  competent  authority  having  granted  a  national  authorisation  and  ECHA  (or  the 
Commission  and  ECHA  in  case  of  Union  authorisation)  if  he  becomes  aware  of  new 
information, that may affect the authorisation, on adverse effects of the biocidal product or of 
the active substance contained therein, of data regarding the potential of the active substance 
for the development  of resistance and of new information  indicating that  the product  is  not 
sufficiently  effective.  Based  on  the  information  provided  by  the  authorisation  holder,  the 
competent authority (or the Agency, in case of Union authorisations) may decide to amend or 
cancel the authorisation. 

No notification of unexpected or adverse effects were submitted so far. 

4.12.  Parallel trade permits 

For the purpose of facilitating the movement of biocidal products in the Union, Article 53 of 
the BPR provides for the granting of parallel trade permits. Parallel trade permit allows, upon 
request from the applicant, the making available on the market of a Member State (Member 
State  of  introduction)  of  a  product  authorised  in  another  Member  State  (Member  State  of 
origin), if it is deemed by the competent authority of the Member State of introduction that 
the  product  is  identical66  to  a  biocidal  product  already  authorised  in  the  Member  State  of 
introduction. 

During the reporting period, 18 applications for parallel trade permits were submitted and 14 
permits were granted (see Figure 4.25). Member States having granted parallel trade permits 
are Belgium (2), Cyprus (7), Ireland (3 ) and the Netherlands (2). 

66   The product is manufactured by the same company or in accordance with the same manufacturing process, 

contains the same active substances and has essentially identical composition. 

48 

 
 
                                                 
Figure 4.25:  Number of applications for parallel trade permits and permits granted per year 

4.13. 

Products made available on the market under the transitional measures 

As  foreseen  in  Article  89(3)  of  the  BPR,  biocidal  products  containing  active  substance(s) 
included in the Review Programme (see section 3.1) can be made available on the market and 
used subject to national laws of Member States, pending the final decision on the approval or 
non-approval of the active substance(s).  

All Member States except for Iceland and Austria have informed about national measures or 
legislation for the making available on the market of biocidal products during the transitional 
period. The situation in Member States is very diverse. In some cases the national system is a 
notification system (i.e. companies must submit a notification and the notification has to be 
accepted by the competent authority before products may be made available on the market). 
Several  Member  States  (e.g.  Belgium,  France,  Latvia,  Slovenia,  Spain)  keep  a  national 
database/register/inventory67 of products made available on their market. In some cases (e.g. 
Spain) such database does not include all product-types and is limited to specific ones. The 
Netherlands  requires  that  an  authorisation  is  granted  -  following  national  assessment 
procedures - before products may be made available on the market. In some Member States 
(e.g. Belgium, Denmark, Norway, Spain, Sweden) biocidal products of certain product-types 
or  for  specific  uses  within  a  product-type  need  to  be  authorised  following  a  limited  or  full 
scientific assessment of the properties of the products.  

Not  all  Member  States  were  able  to  provide  data  regarding  the  number  of  products  made 
available on the market under a national regime. Where submitted, data were in some cases 
incomplete and did not include all product-types. Member States reported the data related to 
products  made  available  on  the  market  under  the  transitional  measures  differently  -  some 
reported  the  number  of  products  newly  made  available  on  the  market  each  year,  some 
referred  to  the  total  number  of  products  available  on  the  market  each  year  and  some  other 
ones  only  reported  the  number  products  whose  making  available  on  the  market  required, 
under their system, an authorisation. Consequently data cannot be aggregated at Union level. 

67  The French national database is available at https://simmbad.fr/public/servlet/accueilGrandPublic.html 

For Belgium https://www.health.belgium.be/en/list-authorised-biocides-and-annual-report#1 

49 

 
 
                                                 
However,  it  can  be  concluded  from  the  data  available  that  the  number  of  products  made 
available  under  the  transitional  measures  is,  globally,  in  the  order  of  several  tens  of 
thousands. It appears that most of these products are disinfection products, followed by pest 
control products and preservatives. 

These  data  and  the  data  reported  in  section  4.3  and  4.4.  (national  authorisation  and  mutual 
recognition)  indicate  that,  in  line  with  the  limited  progress  of  the  Review  Programme  as 
reported in section 3.1, the majority of biocidal  products currently present on the market in 
the Member States is still made available under national transitional rules and without having 
undergone a full assessment in line with the criteria set out in the BPR.  

50 

 
 
 
5.  TREATED ARTICLES 

Treated  articles  are  defined  as  any  substance,  mixture  or  article  which  intentionally 
incorporates  or  has  been  treated  with  one  or  more  biocidal  products  (Article  3(1)(l)).  The 
BPR regulates the placing on the market of treated articles (the first making available on the 
market) and according to its provisions all articles placed on the Union market can only be 
treated  with  biocidal  products  containing  approved  active  substances  or,  according  to  the 
transitional measures, included in the Review Programme. 

A  wide  range  of  everyday  products  are  treated  with  biocidal  products  –  mainly  for  the 
purpose  of  preservation:  paints,  furniture,  sport  articles,  kitchen  utensils,  textile  products, 
flooring products, etc. 

To  enable  consumers  to  make  informed  choices  and  to  facilitate  enforcement,  the  BPR 
established specific labelling requirements  for treated articles (Article 58). When a claim is 
made  regarding  the  biocidal  properties  of  the  article  or  when  the  conditions  set  at  the 
approval of the active substance require so, manufacturers, importers or others who place the 
treated  articles  on  the  market  are  required  to  label  them.  The  label  must  contain  specific 
elements,  among  which  the  statement  that  the  article  incorporates  one  or  more  biocidal 
products and the name of the active substance contained in the product(s). At the same time, 
companies manufacturing or supplying treated articles must be  ready  to  provide consumers 
free of charge with information about the biocidal treatment of the article they are selling if 
the consumer so requests.  

Seven  Member  States  reported  information  on  controls  performed  between  2013  and  2018. 
The  controls  on  the  legal  presence  of  the  active  substance  in  treated  articles  revealed  that 
relatively  few  articles  were  treated  with  non-allowed  active  substance.  The  percentage  of 
non-compliances varied between 0 % (Switzerland) and 28% (Lithuania). Germany reported 
the highest number of controls performed (1112) and identified approximately 10% of non-
compliant cases. On the other hand, controls on the completeness and correctness of the label 
of treated articles found that overall at least 30% of the articles controlled had an incorrect or 
incomplete  labelling  and  in  some  Member  States  this  percentage  was  particularly  high,  for 
instance 78% in Belgium and 83% in Sweden, and 60 % in Switzerland.  

Some  Member  States  organised  specific  campaigns  and  surveys  intended  to  monitor  and 
assess  the  situation  on  their  market  with  regard  to  treated  articles  (e.g.,  market  survey  on 
articles treated with biocides run by the Swedish Chemicals Agency68 and market monitoring 
of  façade  coatings  containing  biocidal  products  run  by  the  Swiss  Federal  Office  for  Public 
Health69).  The  market  survey  run  by  the  Swedish  Chemicals  Agency  in  2016  showed  that 
numerous treated articles were present on the market, mainly treated with biocidal products in 
the  following  product-types:  product-type  2  (disinfectants  and  algaecides  not  intended  for 

68   The study is available at 

https://www.kemi.se/download/18.60cca3b41708a8aecdbb6a8c/1586793296149/pm-6-16-market-survey-
on-articles-treated-with-biocides.pdf  

69   The  project  report  is  available  at  https://www.anmeldestelle.admin.ch/dam/chem/en/dokumente/download-
listen/chemikalien-kampagnen/bericht-kampagne-biozide-in-fassaden-2016-2017.pdf.download.pdf/report-
biocidal-products-in-facade-coatings-campaign-2016-2017.pdf 

51 

 
 
                                                 
application to humans or animals), product-type 3 (veterinary hygiene), product-type 4 (food 
and  feed  area),  product-type  6  (preservatives  for  products  during  storage),  product-type  7 
(film  preservatives),  product-type  9  (fibre,  leather,  rubber  and  polymerised  preservatives), 
product-type  10  (construction  material  preservatives),  product-type  18  (insecticides)  and 
product-type  19  (repellents  and  attractants).  The  majority  of  the  articles  considered  for  the 
survey failed to comply with the labelling requirements and only in few cases the name of the 
active  substance  was  indicated.  The  survey  showed  that  many  actors  on  the  market, 
especially suppliers of treated articles, were not aware of the requirements under the BPR.  

BEF-1 enforcement project 

Following  the  information  collected  by  7  Member  States  between  2013  and  2018,  a 
coordinated programme of controls with regard to treated articles was carried out in 2019 in 
the  context  of  the  first  harmonised  enforcement  project  run  by  the  BPR  Subgroup  of  the 
Forum70. The main objectives of the project, in which 22 Member States participated, were to 
check compliance - with regard to the legality of the active substance in the treated article and 
to  the  correctness  and  completeness  of  labelling  -  and  to  assess  the  awareness  and 
competence  among  the  actors  on  the  market  concerning  the  BPR  requirements  for  treated 
articles. 

More  than  1800  treated  articles  were  checked,  of  which  70%  were  articles  and  30%  were 
mixtures71. The most controlled categories of treated articles were clothing and bedding (for 
articles) and paints and chemical mixtures (for mixtures). The majority of inspections (84%) 
were  carried  out  on-site,  while  10%  were  desktop  inspections  (conducted  from  the    office) 
and  10%  were  performed  as  web  survey.  The  majority  of  the  companies  inspected  were 
making available treated articles on the market and in 16% of the cases companies had a dual 
role,  both  placing  and  making  available  treated  articles  on  the  market.  Most  controlled 
companies were micro-sized enterprises, followed by small- and medium-sized companies. 

The most frequent product-types identified for the biocidal product used for the treatment or 
incorporation  were  product-type  2  and  product-type  9  for  articles  and  product-type  6  and 
product-type  7  for  mixtures.  The  majority  of  the  treated  articles  checked  (73%)  were 
manufactured  within  the  European  Union,  11%  were  imported  and  16%  were  of  unknown 
origin. 

  Findings on the legality of the presence of active substance(s) in treated articles 

One  of  the  central  elements  in  the  BPR  -  that  only  allowed  active  substances  (either 
approved or in the Review Programme or for which an application for approval has been 
submitted  before  1st  September  2016)  may  be  used  to  treat  articles  -  seemed  to  be  very 
well  fulfilled.  Less  than  2.5%  of  the  treated  articles  checked  contained  an  illegal  active 
substance. 

70   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 

71  The definition of treated article in Article 3(1)(l) of the BPR covers both, articles and mixtures as defined in 

the REACH Regulation. 

52 

 
                                                 
The ten most frequent  active substances present  in articles and in mixtures, respectively, 
are indicated in Tables 5.1 and 5.2 below. 

Table 5.1: Ten most common active substances identified in articles 

Active substance identified in articles 

Pyrithione zinc 

Reaction mass of titanium dioxide and silver chloride 

Permethrin 

Tosylchloramide sodium (Chloramin T) 

Geraniol 

Silver phosphate glass 

1,2-benzisothiazol-3(2H)-one (BIT) 

Alkyl  (C12-16)  dimethylbenzyl  ammonium  chloride  /  (ADBAC/BKC 
C12-C16) 

Silver 

Copper(II) carbonate-copper(II) hydroxide (1:1) 

Table 5.2   Ten most common active substances identified in mixtures 

% of articles 
containing the 
active substance 

9 

6 

5 

5 

4 

4 

4 

4 

4 

3 

Active substances found in mixtures 

% of the mixtures 
containing the 
active substance 

1,2-benzisothiazol-3(2H)-one (BIT) 

Mixture  of  5-chloro-2-methyl-2H-isothiazol-3-one  (EINECS  247-500-7) 
and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (CMIT/MIT) 

2-methyl-2H-isothiazol-3-one (MIT) 

3-iodo-2-propynylbutylcarbamate (IPBC) 

2-Octyl-2H-isothiazol-3-one (OIT) 

4,5-dichloro-2-octyl-2H-isothiazol-3-one (DCOIT) 

Pyrithione zinc 

Bronopol 

Terbutryn 

5-Chloro-2-methyl-2H-isothiazol-3-one (CIT) 

31 

22 

22 

17 

14 

12 

6 

3 

2 

2 

53 

 
 
 
The most frequent non-allowed active substances found in articles were silver chloride (2% 
of  the  articles  checked)  and  silver  (1%),  while  in  mixtures  these  were  1,2-benzisothiazol-
3(2H)-one (BIT) and bronopol. In most cases they were used in a different product type than 
the one(s) allowed, therefore their specific use was incompliant with the requirements of the 
BPR. 

  Findings on labelling requirements 

The  compliance  rate  was  high  (90%)  as  to  the  presence  of  the  label  when  required,  with 
almost  100%  compliance  rate  for  mixtures.  However,  when  considering  the  quality  and 
completeness  of  the  information  to  be  provided  on  the  label,  only  58%  of  the  articles  and 
77%  of  the  mixtures  were  compliant.  The  most  common  deficiencies  in  labelling  were  the 
lack  of  indication  of  the  name  of  the  active  substance  and  the  statement  that  the  article 
incorporates/was  treated  with  a  biocidal  product.  The  requirement  for  labels  in  the  national 
language  seems  to  be  well  met,  but  there  was  great  variation  between  Member  States.  For 
Member States with dual official languages this type of incompliance was high. 

The  identified  non-compliances  led  to  various  enforcement  measures.  The  most  frequent 
measure  was  written  advice  (in  45%  of  the  cases),  followed  by  verbal  advice  (17%  of  the 
cases), administrative orders (8%) and fines (4%). 

With regard to the consumers’ right to information as set out in Article 58(5), it appears that 
it is  either not  very  well known by  consumers or, if known, consumer interest  seems  to  be 
low, as less than 20% of the companies indicated to have received a consumer request about a 
treated  article.  However,  when  requests  were  submitted  by  consumers,  over  75%  of  the 
companies answered the questions in due time. 

The  project  report72  identified  a  need  for  industry  and  competent  authorities  of  Member 
States to take measures to raise awareness and increase knowledge among companies about 
responsibilities  and  legal  requirements  in  relation  to  treated  articles.  The  report  also 
concluded  that  efforts  should  be  made  by  companies  to  improve  the  quality  of  the  labels.

72   Available 

at 

https://echa.europa.eu/documents/10162/13555/bef_1_report_en.pdf/8e0e4520-3c41-92d2-

0e9f-199109ee8f5f 

54 

 
                                                 
6.  POISONING INCIDENTS 

All Member States have appointed poison centres or bodies that offer the services of a poison 
centre,  where  incidents  related  to  the  use  of  biocides  involving  human  or  animals  are 
reported. Poison centres in different Member States use different scales to record the severity 
of the incidents and some of them do not differentiate between incidents involving biocides 
and plant protection products. Therefore, a full aggregation and comparison of data to cover 
all  Member  States  is  not  possible.  Some  Member  States  were  not  able  to  provide  data  for 
every year of the reporting period, especially for the very first years. Latvia, in addition to the 
incidents reported to the poison centre, also included in the reporting the number of cases of 
persons  admitted  to  the  emergency  services  of  hospitals  due  to  suspected  poisonings  with 
biocidal products.  

Some  Member  States  differentiated  between  fatal  and  near  fatal  incidents  (i.e.  incidents 
leading to death or severe health impairments) and incidents with other severity level. 

Figure 6.1 provides a summary of the data provided by 19 Member States73, where data were 
available  for  most  of  the  reporting  years  and  could  be  aggregated.  The  highest  number  of 
poisoning incidents involved disinfectants (between 47% and 59% of the incidents recorded 
yearly)  and  pest  control  products  (between  39  and  50%),  followed  by  preservatives 
(approximately 2% of the reported incidents) and other biocidal products (less than 1% of the 
cases. 

For  the  incidents  with  disinfection  products  the  information  available  indicates  that  a  great 
part  of  the  of  cases  involved  product-type  2  disinfectants  (for  instance  chlorine-based 
products and products containing quaternary ammonium compounds). They concerned adults 
and the main route of exposure was inhalation, due to either improper use, mostly by mixing 
the products with strong acids during cleaning operations, or due to the instability of the solid 
forms  (in  the  case  of  chlorine-based  products,  for  instance  pool  disinfecting  products  in 
granules  or  tablets).  For  poisonings  with  pest  control  products,  the  information  available 
shows that rodenticides and products to combat ants, crawling insects and flies were the most 
often  involved,  followed  by  insect  repellents.  The  incidents  mainly  concerned  children  and 
animals/pets  and  the  exposure  route  was  mainly  oral  (ingestion  of  baits).  When  incidents 
concerned pets ingesting rodenticide baits, they were fatal in most of the cases.  

Some  Member  States  consider  rodenticides  to  be  among  the  most  problematic  biocidal 
products  that  are available to  the  general  public.  In Sweden, a strong increase in poisoning 
incidents of cats through rodenticides containing alphachloralose was reported in 2019. This 
led  the  competent  authority  to  amend  the  authorisation  of  products  containing  this  active 
substance in accordance with Article 48 of the BPR, restricting the use to trained professional 
users only. 

73   Austria,  Belgium,  Sweden,  Estonia,  Denmark,  Romania,  Germany,  Lithuania,  Hungary,  Slovakia,  United 

Kingdom, Netherlands, Spain, Latvia, Poland, Luxembourg, Norway, Malta, Ireland 

55 

 
 
 
                                                 
Figure 6.1: Number of poisoning incidents by main group of products 

The  number  of  poisoning  incidents  reported  to  the  poison  centres  shows  an  increase  from 
2016 to 2017, followed by a stable trend. The increase from 2016 and 2017 may be explained 
by the increased quantities of biocides made available on the market (as reported for instance 
by Belgium) and increased use by population (therefore an increased exposure), but also by 
an increased visibility of poison centres among the general public. 

Figure  6.2  illustrates  the  evolution  per  year  of  the  total  number  of  poisoning  incidents 
reported by the 19 Member States, which were able to provide such data, by main group of 
product-types. 

Overall, the vast majority of exposures were accidental and a minority of the cases were due 
to  intentional  or  occupational  exposure.  Only  one  Member  State  (Latvia)  reported  data 
regarding  occupational  diseases  related  to  biocides.  24  cases  were  registered  in  Latvia 
between 2015 and 2017, they mostly involved disinfectants and the professionals concerned 
were generally healthcare professionals (e.g. nurses, anaesthesiologists).  

As  to  the  severity  of  the  poisonings,  the  highest  number  of  fatal  or  near  fatal  incidents 
involved  pest  control  products.  Between  50  and  95  such  cases  per  year  were  registered 
overall  (in  the  19  Member  States  having  provided  detailed  data).  For  incidents  involving 
disinfectants,  the number of fatal or near fatal incidents  ranged between  5 and 76 per  year, 
while  for  the  ones  involving  preservatives  and  other  biocidal  products  the  number  ranged 
between 3 and 13 and 2 and 5, respectively. However, when considered in proportion to the 
total  of  cases  reported  for  the  respective  main  group  of  biocidal  products,  the  incidents 
involving disinfectants were very severe (fatal or near fatal) in 0.1 to 1% of the cases; in 2 to 

56 

 
 
7% of the cases for preservatives, 1 to 3% of the cases for pest control products and in 3 to 
10% of the cases for other biocidal products. 

Figure 6.2    Overall number of poisoning incidents by year in 19 Member States 

Some Member States carried out specific investigations with regard to poisoning incidents in 
their  territories.  In  France  several  studies  were  performed  on  the  exposure  to  and  incidents 
related  to  the  use  of  various  biocidal  products  (e.g.  accidental  exposure  to  chlorinated 
cleaning products for swimming pools and spas, exposure to products containing phosphides 
related  to  the  transport  or  handling  of  shipping  containers,  skin  and  eye  reactions  to  insect 
repellent bracelets74). 

The study on accidental exposure to chlorinated cleaning products for swimming pools and 
spas75 analysed 1494 cases recorded by poison centres in France between January 2010 and 
June 2019. A marked seasonality was observed, with a maximum number of cases recorded 
in the third quarter of each year. Almost all cases occurred in the general public, with a very 
small proportion concerning work-related exposure (96,6% vs. 3,4%). Adults were involved 
in 60,4% of the cases, while in the case of  children, - who accounted for 38,6% of the cases – 
very  young  children  (of  less  than  5  years  of  age)  were  involved  in  21,7%  of  the  cases. 
Overall, inhalation was the most common route of exposure and it concerned the majority of 
adults  involved,  while  for  very  young  children  most  frequently  exposure  occurred  by  oral 

74  Study report available at https://www.anses.fr/fr/system/files/Toxicovigilance2012SA0277Ra.pdf  
75  Study report available at https://www.anses.fr/fr/system/files/Toxicovigilance2019SA0192Ra.pdf  

57 

 
 
                                                 
route.  Of  the  cases  analysed,  10  were  severe76  and  9  of  these  concerned  adults.  The  study 
concludes that the majority of cases in  adults  could  have been avoided by  compliance with 
precautionary measures (concerning for instance the opening of packaging, mixing with other 
products) and highlights a clear lack of awareness of the risks associated with the handling of 
chlorinated products, despite the instructions for use and the warnings on the packaging. As a 
follow-up of this study, the French competent authority published in July 2019 a news item 
on its website, recalling the instructions for preservation, handling and compliance with doses 
of  these  products.  In  the  presence  of  humidity,  phosphides  release  phosphine,  which  may 
cause irritant or corrosive effects or even cause severe systemic poisoning, depending on the 
concentration. 

The French study on exposure products containing phosphides during unloading and opening 
of  containers77  analysed  incident  reported  to  the  poison  centres  between  1999  and  2007. 
Phosphide containing products are used as insecticides or rodenticides and are used, among 
others,  to  treat  storage  places  such  as  containers,  by  fumigation.  12  exposure  cases  were 
analysed, all occurring in professional context and concerning males with an average age of 
35,7  years.  The  most  frequently  involved  route  of  exposure  was  respiratory,  sometimes 
associated with dermal or eye exposure. All cases of symptomatic exposure were subject to 
medical  consultation,  mostly  in  an  emergency  service  (9  cases).  The  study  shows  that 
occupational  exposure to  phosphide or phosphine release, although poorly documented, has 
been  a  reality  in  recent  years  for  staff  working  in  contact  with  containers.  The  report  also 
makes  reference to  a 2018 report78 of the European Agency for Safety and Health at  Work 
(EU-OSHA),  which  mentions  the  presence  of  phosphine  in  a  significant  percentage  of 
containers in European ports report and notices the lack of proper labelling and security rules. 
The  French study report recommended  authorities  to  strengthen the monitoring of labelling 
and also recommended regular awareness-raisings for people handling containers, as well as 
systematic detection of residues of fumigant gases when containers are opened. 

In Germany the Federal Institute for Risk Assessment in co-operation with the eight poison 
centres carried out a pilot study79 as part of a research project on all pesticides in relation to 
which  enquiries  to  the  poison  centres  were  made  between  May  2018  and  2019.  The  study 
reported around 2 600 cases involving plant protection products or biocides, of which around 
300  concerned  exposure  to  repellents.  The  study  showed  that  the  most  common  exposure 
route in children was the oral route (more than 50%), while inhalation was the predominant 
exposure  route  for  the  elderly  and  adults  (around  45%),  followed  by  oral  and  dermal 
exposure.  In  2  cases  moderate  symptoms  were  reported,  while  none  of  the  cases  was  life-
threatening.  The  study  also  showed  that  products  whose  authorisation  expired  or  that  were 
banned already  for some time are still privately  owned and involved in poisoning incidents  
(e.g. parathion, banned in the Union since 2001). 

76   The gravity of the cases was differentiated between low, moderate and severe. 
77   Study report available at https://www.anses.fr/fr/system/files/Toxicovigilance2018SA0290Ra.pdf  
78  https://osha.europa.eu/en/publications/handling-fumigated-containers-ports-health-risks-and-prevention-

practices-0/view  

79  Study  report  available  at  https://www.bmu.de/themen/forschung-foerderung/forschung/forschungs-und-

entwicklungsberichte/details/pilotstudie-zur-etablierung-eines-nationalen-vergiftungsmonitorings-im-
verbund-mit-der-gesellschaft/ 

58 

 
 
 
                                                 
7.  SUSTAINABLE USE 

Measures  to  achieve  a  more  sustainable  use  of  biocidal  products  have  the  objective  of 
reducing the risks and impacts of the use of biocidal products on human health, animal health 
and  the  environment  and  of  promoting  the  use  of  integrated  pest  management  and  of 
alternative  approaches  or  techniques,  where  feasible,  such  as  non-chemical  alternatives  to 
biocidal  products.  At  present,  the  Directive  on  the  Sustainable  Use  of  Pesticides  does  not 
apply to biocidal products80 and options for extending its scope to cover biocidal products are 
not  being  considered  during  the  impact  assessment  for  the  revision  of  this  Directive81.  The 
usefulness of such an extension will be considered in the context of a future evaluation of the 
BPR.   

In  March  2016,  as  required  by  the  provisions  of  Article  18  of  the  BPR,  the  Commission 
submitted to the Council and the European Parliament a report82 on how the BPR contributes 
to the sustainable use of biocidal products. The report highlighted that the procedures under 
the  BPR  for  substance  approval,  product  authorisation  and  comparative  assessment  of 
biocidal  products  containing  candidates  for  substitution  (with  the  aim  of  phasing-out  their 
use) were already important contributions to the objective of fostering the sustainable use of 
biocidal products. The main priorities identified by the report for promoting the sustainable 
use  of  biocidal  products  were  therefore  the  completion  of  the  ongoing  assessment  of  all 
existing active substances (the Review Programme) and the subsequent timely authorisation 
of products containing them according to the BPR rules.  

This  finding  remains  still  valid  and  crucial,  especially  considering  the  slow  progress  in  the 
past  years  towards  the  completion  of  the  Review  Programme  and  the  significant  delays  in 
both the active substance approval and product authorisation processes.  

As a follow-up of the report, Member States were requested to provide information on four 
elements  stemming  from  the  report:  availability  of  best  practice  documents,  availability  of 
certification or training schemes for professional users, information to the public on risks and 
benefits associated with the use of biocidal products and measures taken to address the risk 
from  the  use  of  biocidal  products  in  specific  settings  (such  as  schools,  work  places,  public 
spaces). In the majority of Member States actions were taken under at least one of these four 
elements, while this was not the case in four Member States (Greece, Luxembourg, Cyprus 
and Italy).  

In 13 Member States best practices documents were developed in order to reduce the use of 
biocidal products or to use biocides with less impact on human health and the environment. 
These  are  available  in  the  form  of  guidance  documents,  brochures  or  standards  and  most 
often concern best practices related to the use of pest control products (product-types 14, 18, 
19, 20)83. The majority of these documents concern the safe use of rodenticides and methods 

80  See recital 2 of Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 
establishing  a  framework  for  Community  action  to  achieve  the  sustainable  use  of  pesticides  (OJ  L  309, 
24.11.2009, p. 71–86).  

81  https://ec.europa.eu/food/plant/pesticides/sustainable_use_pesticides_en  
82  Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:52016DC0151 
83  Some examples: in Denmark https://www2.mst.dk/Udgiv /publikationer/2019/05/978- 87-7038-075-1.pdf , 

https://mst.dk/media/94459 /vejledning-tilautorisationsbekg_ 2016_04 07.pdf, in Ireland 
https://www.pcs.agriculture.gov.ie/media/pesticides/content/biocides/Permanent%20Baiting%20Rules.pdf, 

59 

 
                                                 
for  the  control  of  rodents  in  professional  settings  (farms,  food  and  feed  production).  Some 
best practices documents regard the use of disinfection products and alternatives to traditional 
anti-fouling  products.  In  Belgium  a  general  document  covering  biocides  was  developed,  as 
well  as  a  yearly  brochure  on  the  use  of  pesticides  (including  biocides)  at  home  and  in  the 
garden. 

Certification or training schemes for professional users are present in 20 Member States and 
under development in two others. In all Member States where such schemes exist, training or 
certification  is  compulsory  for  operators  providing  professional  pest  control  services  using 
insecticides  and  rodenticides.  Rodent  control  and  proper  training  to  operators  is  given  high 
consideration in all Member States. In Finland a specific qualification for the use by farmers 
of rodenticides restricted to trained professionals is foreseen. Special attention is also given in 
some  Member  States  (e.g.  Germany  and  Switzerland)  to  the  use  of  insecticides  by 
fumigation. In eight Member States such schemes cover professional disinfection services, in 
particular  the  use  of  product-type  2  products  (mainly  for  swimming  pool  disinfection)  and 
product-type 5 products  (drinking water disinfection). Specific certification schemes for the 
professional application of wood preservatives (product-type 8) are foreseen in six Member 
States  (Estonia,  France,  Germany,  Netherlands,  Finland,  Sweden),  Liechtenstein  and 
Switzerland.  Specific  authorisations  are  needed  in  several  Member  States  for  the  use  of 
gaseous pest control products of product-type 20. In the Netherlands, even though no training 
scheme is in place, a specific network (Biocides knowledge network84) is set up to increase 
and exchange knowledge about biocides. 

The provisions of Article 17(5) of the BPR require Member States to take necessary measures 
to provide the public with appropriate information on benefits and risks associated to the use 
of biocidal products and on ways of minimising their use. 21 Member States reported to have 
taken measures to convey such information to the public. In most cases this is done by means 
of information published on the website of competent authorities on specific biocides-related 
topics and on appropriate handling of and alternatives to biocidal products. For instance, in 
Sweden information is available on antifouling paints85, wood protection86 and pest control87; 
in Denmark information is available on modalities to prevent and remove algae without using 
biocides88,  modalities  to  remove  and  prevent  insects  in  kitchens89;  in  Germany  information 
on the use of biocides (including best practice, storage, disposal and non-biocidal methods of 
control)90is available. 

https://www.pcs.agriculture.gov.ie/media/pesticides/content/biocides/EffectiveControlRodentPestsFarms300
916.pdf, the Netherlands 
https://kpmb.nl/KPMB/media/KPMB/Documenten/IPM%20Rattenbeheersing/20160222-KPMB-Handboek-
beheersing-rattenpopulaties-buiten-gebouwen-Versie-2-0.pdf  

84  https://www.kennisnetwerkbiociden.nl/ 
85  https://www.kemi.se/kemikalier-i-vardagen/rad-om-kemikalier-som-du-har-hemma/batbottenfarger 
86  https://www.kemi.se/download/18.6df1d3df171c243fb237665a/1590504275284/faktablad-information-om-      

impregnerat-virke.pdf 

87  https://www.kemi.se/privatpersoner/rad-om-kemikalier-som-du-har-hemma/medel-mot-skadedjur-och-

insekter 

88  https://mst.dk/kemi/biocider/borger-og-biocider/alger-paa-fliser-og-terrasser/ 
89  https://mst.dk/kemi/biocider/borger-og-biocider/insekter-i-koekkenet/ 
90  https://www.umweltbundesamt.de/themen/chemikalien/biozide 

60 

 
                                                                                                                                                        
Some Member States have organised information campaigns on specific topics. For instance, 
in  Finland  such  campaigns  related  to  treated  articles91  (in  2015-2016),  insecticides  and 
repellents92  (in  2017-2018)  and  antifouling  products93  (2015  to  2019).  In  Belgium  a  yearly 
event  is  organised  (“Week  without  pesticides”),  where  updated  brochures  and  folders  are 
distributed  to  the  public  and  information  campaigns  are  organised  also  at  regional  level  in 
order to minimise the use of biocides by the general public94. In Lithuania public awareness 
campaigns  on  the  safe  and  sustainable  use  of  biocides  are  organised  every  year,  with 
information published on internet websites, interviews in local and national press, television 
and  radio.  In  Latvia  informative  lectures  are  given  yearly  by  the  competent  authority  in 
universities;  seasonal  information  campaigns  on  the  use  of  specific  biocides  (for  instance 
rodenticides, insecticides) are published in the media. 

Sixteen Member States reported to have taken measures to address the risk related to the use 
of  biocides  in  specific  areas  such  as  schools,  kindergartens,  workplaces  and  public  spaces. 
Many of these were information campaigns on the safe use of rodenticides and on permanent 
baiting in public spaces and others were specifically targeted to children. In Finland, in 2014 
information95 was published on the use of biocides in public places. In Slovenia, leaflets with 
information on the excessive use of repellents and on classification and labelling of chemicals 
were distributed in schools. 

91  https://tukes.fi/-/tarkeaa-tietoa-biosideilla-kasitellyista-tuotteista,  

https://tukes.fi/-/ala-osta-myrkyllisia-sahkopylvai-1 

92  https://tukes.fi/-/valta-turhaa-biosidien-kayttoa-hyonteisten-torjunnassa,  

https://tukes.fi/-/osta-vain-suomessa-hyvaksyttyja-hyonteiskarkotteita-ja-lue-kayttoohjeet-huolel-1 

93  https://tukes.fi/-/veneilykausi-alkaa-saasta-ymparistoa-ja-valta-antifoulingvalmisteiden-kaytt-1, 

https://tukes.fi/-/vastuullinen-veneilija-ei-kayta-myrkkymaaleja, 
https://tukes.fi/documents/5470659/11781251/Antifouling-esite/0c8ab6a0-6d13-df8b-0381-
723573598d18/Antifouling-esite.pdf 
94  https://www.vmm.be/mijn-gifvrije-tuin 
95  https://tukes.fi/-/tietoa-ja-harkintaa-tarvitaan-kaytettaessa-desinfiointiaineita-julkisissa-tilois-1 

61 

 
 
 
                                                 
8.  ENFORCEMENT 

Enforcement  of  the  BPR,  as  for  other  pieces  of  EU  chemicals  legislation,  is  a  national 
responsibility. An effective enforcement of the BPR in Member States is crucial for achieving 
its objectives. As set out in Article 65(2) of the BPR, 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.  In  13  Member  States  (e.g.  Finland, 
Sweden,  France,  Slovenia)  one  authority  is  responsible  for  the  BPR  enforcement  while  in 
eight Member States the enforcement responsibility is shared between multiple authorities. In 
some Member States (e.g. Austria, Germany, Spain) enforcement is carried out by authorities 
at  regional  level;  co-operation  and  co-ordination  between  these  regional  authorities  is 
foreseen in order to ensure a harmonised enforcement in the respective Member States. 

Enforcement strategies 

A  well  designed  enforcement  strategy  should  allow  enforcement  to  be  effective,  achieving 
the best possible outcome in terms of compliance, while keeping costs low. According to the 
reports  provided  by  Member  States,  an  overall  strategy  for  BPR  enforcement  has  been 
implemented  in  20  Member  States.  In  most  cases  it  comprises  both  proactive  (risk-based) 
controls  and  reactive  interventions,  following  complaints  or  as  follow-up  controls.  The 
proactive  controls  may  be  in  the  form  of  controls  in  the  context  of  annual  control  plans  or 
special  enforcement  campaigns  (e.g.  controls  of  specific  groups  of  products),  periodic 
controls of authorisation holders or random check of products or distributors.  

Complaints 

In many cases controls follow complaints concerning alleged infringements of the BPR. Data 
with  regard  to  complaints  were  available  in  23  Member  States  and  indicate  that  in  11 
Member  States  more  than  100  complaints  were  received  over  the  reporting  period.  The 
highest number of complaints was recorded in Romania (1284), followed by Germany (823), 
Denmark  (758),  the  Netherlands  (716)  and  Poland  (639).  It  was  not  reported  how  many  of 
these  complaints  lead  to  inspections  and  sanctions.  Figure  8.1  shows  the  evolution  of  the 
overall number of complaints in the reporting Member States. 

1268 

1280 

1026 

967 

1400
1300
1200
1100
1000
900
800
700
600
500
400

660 

671 

574 

2013

2014

2015

2016

2017

2018

2019

Figure 8.1: Overall number of complaints per year in the reporting 23 Member States  

62 

 
 
 
 
Official controls 

Member  States  were  requested  to  submit  data  related  to  controls  on  compliance  with  BPR 
rules  for  making  available  biocidal  products  on  the  market,  controls  on  biocidal  products 
made available under the transitional rules, controls on manufacturers, controls on end-users, 
controls on residues and controls on treated articles. The information reported with regard to 
controls of treated articles is included in section 5 above. Substantial differences exist in the 
number and type of controls carried out by Member States. 

Not all Member States were able to provide actual figures of controls and non-compliances 
and where they did, in some cases, data was not available per  year or for every  year of the 
reporting  period.  Therefore  the  reported  data  on  controls  by  Member  States  does  not  allow 
the aggregation of data at Union level. 

  Controls  on  compliance  with  the  BPR  rules  for  making  products  available  on  the   

market  

The controls reported cover biocidal products made available on the market, records kept by 
authorisation holders, classification, labelling and packaging of biocidal products, safety data 
sheets, and advertising. 

The  results  of  the  controls  on  biocidal  products  vary  greatly  between  Member  States.  The 
reported  non  compliances  refer  to  products  containing  an  active  substance  not  approved  or 
not  approved  for  the  specific  product-type  of  the  product,  products  subject  to  BPR 
authorisation  but  not  authorised,  and  products  made  available  not  in  accordance  with  the 
conditions in the authorisation.  

In  Austria  the  overall  non-compliance  rate  during  the  reporting  period  was  12%  for 
disinfectants,  10%  for  preservatives,  11%  for  pest  control  products  and  18%  for  other 
biocidal  products.  Relatively  low  non-compliance  rates  were  also  reported  by  Lithuania 
(between 3 and 7% non-compliance rate) and Hungary96 (around 6% non-compliances). On 
the  other  hand,  France  reported  higher  non-compliance  findings:  more  than  27%  for 
disinfectants, preservatives and pest control products and higher than 20% for other products, 
with  peaks  of  around  40%  non-compliances  registered  in  2017  and  2018.  High  non-
compliance rates were also reported by Latvia (between 15% and 55% during the reporting 
period), Luxembourg (with an average of 58% non-compliances), Estonia (between 27% and 
61%)  and  Denmark  (more  than  80%  non-compliances).  The  high  rate  of  non-compliance 
reported  by  some  Member  States  might  be  related  to  the  fact  that  most  controls  performed 
were reactive controls, i.e. following complaints of suspected non-compliant products on the 
market.  

Controls  on  classification,  labelling  and  packaging  of  biocidal  products  (as  laid  down  in 
Article 69 of  the BPR) indicated overall non-compliance rates (for all product-types during 
the reporting period) of 11% in Austria, 8% in Belgium, 20% in France, 6% in Hungary, 35% 
in Estonia and 1% in Lithuania.  

High compliance was  generally registered in Member States with regard to the requirement 
of  inclusion  of  active  substance  suppliers  in  the  official  list  referred  to  in  Article  95  of  the 
BPR.  

96  Data was available only for controls performed in 2018 and 2019. 

63 

 
 
                                                 
  Controls  on  biocidal  products  made  available  on  the  market  under  the  transitional 

measures 

Again, different situations were reported by Member States. With regard to the controls of the 
active  substances  contained  in  products97,  in  some  Member  States  the  level  of  compliance 
was high or very high (for instance in Belgium, France, Latvia, Hungary the non-compliance 
rate was less than 8%), while in others compliance was lower (for instance in Denmark and 
Germany)  

Compliance of these products with national legislation was lower in all Member States. The 
non-compliance rate was 18% in Belgium and Latvia, 12% in France, up to 37% in Estonia, 
65% in Luxembourg and more than 80% in Denmark. 

  Controls on manufacturers 

Controls  regarding  the  availability  of  appropriate  documentation  in  relation  to  the 
manufacturing  process  (as  required  by  Article  65(2))  indicate  high  compliance  in  some 
Member States (e.g. Hungary, Austria), while in other Member States the level of compliance 
seems low (e.g. in Estonia, where the average non-compliance rate was 52% and almost all 
controls from 2016 to 2019 resulted in non-compliances). 

  Controls on end-users 

Controls on end-users check whether biocidal products are used according to the terms  and 
conditions in their authorisation. In some Member States these controls concerned mainly the 
use  of  disinfection  products  in  health  care  settings,  farms  or  food-processing  sectors  and 
revealed  low  non-compliance  rates  (an  average  of  2.5%  in  Lithuania  and  5%  in  Estonia, 
between  0.3  and  3%  in  Belgium).  Higher  non-compliance  rates  were  reported  by  the 
Netherlands for controls in poultry farms (76% non-compliance in 2017), and tattoo/piercing 
shops (73% in 2017, 44% in 2018) and by Denmark with regard to controls on the use of pest 
control products (between 90% and 100% non-compliances during the reporting period). The 
controls  in  Denmark  were  re-active  controls,  due  to  complaints,  and  concerned  the  illegal 
possession  and  use  of  rodenticides  which,  according  to  their  authorisation,  were  to  be 
possessed and used only by authorised and trained professionals. 

  Controls on residues of active substances in food and feed 

Only four Member States (Estonia, Poland, Slovakia and Sweden) reported data on controls 
on the presence of residues of active substances 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 indicates that in very few cases the residues in food and feed were higher than 
the EU harmonised maximum residue limit set in Regulation (EC) No 396/2005: on average 
0.3%  of  the  controls  in  Estonia,  0.8%  in  Sweden,  1.2%  in  Poland  and  9%  in  Slovakia 
revealed residues higher than the maximum residue limit.  

97  Active substances contained in such products must be included in the Review Programme. 

64 

 
 
                                                 
Harmonisation of enforcement 
The BPR Subgroup of the Forum for the exchange of information on enforcement (BPRS)98, 
which  started  its  operation  in  2017,  contributes  to  the  harmonisation  of  enforcement  at  EU 
level.  Practical  issues  encountered  by  inspectors  during  enforcement  are  discussed  in  this 
forum and common solutions and conclusions are identified, allowing inspectors in Member 
States to approach in the same (harmonised) manner future similar cases.  

The BPRS also designs and manages harmonised enforcement projects, which entail that the 
same  type  of  control  is  carried  out  in  all  participating  Member  States  at  the  same  time, 
following the same procedure. The first harmonised enforcement project, on treated articles, 
had its operational phase in 2019 (see section 5 above for further information). The second 
project,  focusing  on  active  substances  in  biocidal  products,  is  under  preparation  and  is 
scheduled to have its operational phase in 2022. 

98  https://echa.europa.eu/about-us/who-we-are/enforcement-forum 

65 

 
                                                 
9.  USE OF NANOMATERIALS IN BIOCIDAL PRODUCTS 

The BPR was the first piece of legislation that incorporates the definition of nanomaterials99 
as laid down in the Commission Recommendation of 18 October 2011100. Nanomaterials are 
materials which often have specific properties due to their small particle size. In the light of 
current  knowledge,  nanomaterials  are  similar  to  normal  chemical  substances,  in  that  some 
may  be  toxic  and  some  may  not.  Possible  risks  are  related  to  specific  nanomaterials  and 
specific uses. Therefore, nanomaterials require a risk assessment which should be performed 
on a case-by-case basis, using pertinent information.  

Specific rules for nanomaterials are included in the BPR. For instance, 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 - when required according to Article 58(3) - has to 
indicate  the  name  of  all  nanomaterials  contained  in  the  biocidal  product,  followed  by  the 
word ‘nano’ in brackets. 

So  far,  two  active  substances  which  are  nanomaterials  have  been  approved:  pyrogenic, 
synthetic  amorphous,  nano,  surface  treated  silicon  dioxide  and  synthetic  amorphous  silicon 
dioxide  (nano),  both  for  use  in  insecticide  products.  One  product  containing  the  approved 
active  substance  synthetic  amorphous  silicon  dioxide  (nano)  was  authorised  in  11  Member 
States101.  For  this  product,  due  to  aggregation/agglomeration  in  the  final  product,  it  was 
concluded  that  no  exposure  to  the  nanoscale  primary  particles  is  expected  during  its  use, 
therefore no particular safety measures in relation to the presence of nanomaterial needed to 
be put in place for the use of the product. 

Two other active substances were still under assessment within the review programme: silver 
as a nanomaterial102 and silver adsorbed on silicon dioxide as a nanomaterial in the form of a 
stable aggregate with primary particles in the nanoscale. 

99    Nanomaterial  means  a  natural  or  manufactures  active  (or  non-active)  substance  containing  particles,  in  an 
unbound state or as an aggregate or as  an agglomerate and where, for 50% or more of the particles in the 
number  size  distribution,  one  or  more  external  dimensions  is  in  the  size  range  1-100  nm.  Fullerenes, 
graphene  flakes  and  single-wall  carbon  nanotubes  with  one  or  more  external  dimensions  below  1nm  are 
considered as nanomaterials. 

100  Commission Recommendation of 18 October 2011 on the definition of nanomaterial (OJ L 275, 20.10.2011, 

p. 38–40). 

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

0000/authorisationid 

102  In 2020 the related application for approval was rejected due to applicant’s failure to pay the fees. 

66 

 
 
 
 
 
                                                 
10.  THE ROLE OF BIOCIDAL PRODUCTS IN THE COVID-19 PANDEMIC  

Although the COVID-19 pandemic started in 2020, hence outside the period covered by this 
Staff Working Document, the particular importance of biocidal products in this context and 
the actions taken by the Commission, Member States, and industry should be mentioned.  

In  fact,  good  hygiene  practices  are  a  key  preventative  measure  against  the  spread  of 
pathogens such as SARS-CoV-2. Apart from washing hands with soap and water, the use of 
alcohol-based  hand  disinfectants  was  recommended  by  the  World  Health  Organisation  as  a 
means to control the spread of the virus.  

Already during the first weeks of the pandemic in February/March 2020, severe shortages in 
the supply of disinfectants of product-type 1 (mainly hand disinfectants) and product-type 2 
(surface  disinfectants)  became  apparent,  following  a  steep  increase  in  demand.  The 
Commission  engaged  immediately  in  dialogue  with  both  Member  States  and  industry 
associations  representing  suppliers  of  active  substances  and  disinfectant  products.  Periodic 
surveys (weekly or bi-monthly) provided by relevant industry associations to the Commission 
allowed to monitor the market situation for disinfectants and understand the challenges faced 
by  companies.  Major  challenges  identified  were  related  to  the  availability  of  some  active 
substances  and  co-formulants  for  mixture  formulations  of  disinfectants,  limited  production 
capacities,  lack  of  personnel  at  factory  level,  sourcing  of  primary  packaging  for  these 
products and supply chain disruptions due to uncoordinated border closures. 

To address the shortages of disinfectants, and to prevent the occurrence of future shortages, it 
was  necessary  to  speed  up  the  supply  by  making  full  use  of  all  possible  provisions  of  the 
BPR.  As  described  in  section  4.9  Article  55(1)  allows  Member  States  to  grant  emergency 
permits for products that, although containing an approved active substance, do not have an 
authorisation  under  the  BPR  on  grounds  of,  among  others,  danger  to  public  health.  Such 
products  contain  for  example  propan-1-ol,  propan-2-ol,  active  chlorine  generated  from 
sodium  hypochlorite  or  hydrogen  peroxide.  For  products  containing  active  substances  still 
under  evaluation  in  the  Review  Programme  (notably  ethanol),  Member  States  can  apply 
suitable provisions under national legislation (in accordance with Article 89(3) of the BPR) 
for possible emergency derogations.  

In addition to numerous exchanges by mail, the Commission organised an ad-hoc meeting of 
competent authorities and ECHA on 26 March 2020 to discuss and clarify all possibilities to 
increase the supply in disinfectants and published103 information and guidance documents for 
Member  States.  It  also  encouraged104  Member  States  to  refrain  from  establishing  unilateral 
national  restrictions  to  the  free  movement  of  essential  supplies  like  disinfection  products, 
which create significant barriers and negatively affected Member States’ capacity to contain 
the COVID-19 pandemic. The Commission also provided input to the document on surface 
disinfectants105 developed by the European Centre for Disease Prevention and Control. 

103  https://circabc.europa.eu/w/browse/b47e31f5-0a5a-493b-813e-198b73c1efff. 
104  Commission  communication  on  a  coordinated  economic  response 

to 

the  COVID-19  Outbreak, 

https://ec.europa.eu/info/sites/info/files/communication-coordinated-economic-response-covid19-march-
2020_en.pdf. 

105  https://www.ecdc.europa.eu/sites/default/files/documents/Environmental-persistence-of-SARS_CoV_2-

virus-Options-for-cleaning2020-03-26_0.pdf. 

67 

 
                                                 
ECHA  also  launched  dedicated  webpages106  with  information  for  industry  and  national 
authorities. Industry associations developed a practical guide107 aiming to assist companies in 
complying with their obligations under the BPR or under national laws during the COVID-19 
pandemic. 

In  order  to  use  new  sources  of  approved  active  substances  (for  instance  propan-1-ol  or 
propan-2-ol), manufacturers need to submit a request for technical equivalence assessment of 
the  new  source.  To  accelerate  the  process  ECHA  put  in  place  a  fast  track  procedure  for 
technical  equivalence  applications  for  propan-1-ol  and  propan-2-ol108.  ECHA  also  issued 
recommendations on the compositional requirements for these two active substances109, and 
for  the  active  substances  active  chlorine  released  from  sodium  hypochlorite,  hydrogen 
peroxide and peracetic acid110. 

As a result of this activities, 26 Member States made use of the possibility to grant temporary 
permits for disinfectants in accordance with Article 55(1). Some Member States (for example 
France,  Estonia,  the  Netherlands)  issued  generic  derogations  for  products  formulated  in 
accordance  with  WHO  recommended  formulations,  while  others  (for  instance  Belgium, 
Slovakia,  Italy)  granted  permits  for  individual  products.  More  than  500  notifications111  of 
permits granted by Member States were received by the Commission until November 2020. 
The permits were addressed either at specific companies or at broader categories of operators, 
like pharmacies or chemical companies and covered mainly products of product-type 1 (hand 
disinfectants) and 2 (surface disinfectants), both  for professional and general public use. 12 
Member States  also  granted permits for product-type 4 products  (disinfectants  for food and 
feed area). Among Member States that issued permits for individual products,  Italy granted 
the highest number of permits (around 250), followed by Belgium (84) and Slovakia (44). 

Eight  months  after  the  outbreak  of  the  pandemic  it  can  be  concluded  that  the  provisions in 
place  under  the  current  regulatory  system  to  react  to  emergency  situations  have  allowed  to 
address the unprecedented situation during the Covid-19 pandemic. Thanks to the concerted 
efforts  of  industry,  Member  States  and  the  Commission,  new  suppliers  of  biocidal  active 
substances  and  disinfectants  entered  the  market  and  existing  suppliers  expanded  their 
production capacity to meet the hugely increased demand in disinfectants. Several companies 
donated substantial quantities of alcohol to the healthcare sector to make up for the shortages 

106  https://echa.europa.eu/covid-19. 
107  https://specialty-chemicals.eu/ebpf-covid-19-practical-guide/. 
108  https://echa.europa.eu/documents/10162/28801697/accelerated_te_propanol_isopropanol_en.pdf/fe8d0741-

3271-2938-1da8-f0e06b2aba8d. 

109  “Recommended  requirements  for  the  active  substances  Propan-1-ol  and  Propan-2-ol,  for  the  purpose  of 
at 
derogations 
https://echa.europa.eu/documents/10162/28801697/recommended_requirements_propanol_isopropanol_en.p
df/ff333754-ea2f-f81c-ca96-874e59802806. 

under  Article 

the  BPR”, 

23  March 

available 

2020, 

55(1) 

of 

110  “Recommended requirements for the active  substances active  chlorine released from sodium  hypochlorite, 
at 
hydrogen 
https://echa.europa.eu/documents/10162/28801697/recommended_requirements_propanol_isopropanol_en.p
df/ff333754-ea2f-f81c-ca96-874e59802806. 

peracetic 

available 

peroxide 

acid”, 

2020, 

April 

and 

7 

111  The  notifications 

at  https://circabc.europa.eu/w/browse/47c6e2b3-27a1-4137-83e4-
9605a64e2de7. An overview of all notifications is available at https://circabc.europa.eu/w/browse/92bd0162-
f4b3-49a7-9351-76cf1037287a. 

are  published 

68 

 
                                                 
registered. However, the high demand of disinfectants appeared to attract some new suppliers 
that took advantage of the situation, as authorities reported cases of disinfectants that do not 
have the required authorisation or permit, or lack the proper labelling112. 

The  feedback  received  from  Member  States  and  economic  operators’  representatives 
indicated  that  the  situation  with  regard  to  shortages  started  to  subside  after  the  first  few 
months  of  the  pandemic  and  no  significant  shortages  were  reported  thereafter.  Besides 
additional disinfection products being made available on the market under the Article 55(1) 
derogation  system,  many  disinfectant  producers  increased  their  operational  capacity,  thus 
allowing to  meet  the increased demand of these  products.128 companies  were  added  to  the 
list  of  suppliers  referred  to  in  Article  95  of  the  BPR  either  as  active  substance  supplier  or 
product supplier for ethanol and propan-2-ol (119 companies for ethanol and 9 for propan-2-
ol). Only 2 Member States requested an extension of the temporary permits granted according 
to Article 55(1) and less Member States granted emergency permits than at the outset of the 
pandemic. 

112  https://echa.europa.eu/-/eu-member-states-report-illegal-and-ineffective-disinfectants . 

69