REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation of the Union authorisation of biocidal products in accordance with Article 42(3) 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 (Text with EEA relevance)
Date: 2018-05-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: decontamination, market approval, marketing standard, plant health product, preservative

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 28.5.2018  COM(2018) 342 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation of the Union authorisation of biocidal products in accordance with Article 42(3) 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  
 
 
Table of Contents 

1. 

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

2.  NUMBER  AND  TYPE  OF  APPLICATIONS 

FOR  UNION 

AUTHORISATION ...................................................................................................4 

3.  ACTIVE  SUBSTANCES  AND  PRODUCT-TYPES  FOR  WHICH  UNION 

AUTHORISATION APPLICATIONS HAVE BEEN SUBMITTED ..................7 

4.  MEMBER  STATES  THAT  ARE  EVALUATING  THE  APPLICATIONS 

FOR UNION AUTHORISATION ...........................................................................9 

5.  STATUS OF THE APPLICATIONS FOR UNION AUTHORISATION .........10 

6.  THE  USE  OF  UNION  AUTHORISATION  PROCEDURES  BY  SMALL 

AND MEDIUM-SIZE ENTERPRISES (SMES) ..................................................13 

7.  PRELIMINARY CONCLUSIONS ........................................................................14 

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

 
 
 
 
 
 
 
1. 

INTRODUCTION 

Regulation (EU) 528/20121, which is applicable since 1 September 2013, lays down the rules 
for the placing on the market and use of biocidal products. This Regulation aims at improving 
the  functioning  of  the  biocidal  products  market  in  the  EU,  while  ensuring  a  high  level  of 
protection for humans and the environment2. It repealed Directive 98/8/EC of the European 
Parliament and of the Council3. 

Regulation  (EU)  528/2012  establishes  a  two-step  approach  in  order  to  achieve  the  above-
mentioned goals. Active substances must be included in Annex I to that Regulation (the so-
called "low-risk active substances") or approved at the Union level and included in a Union 
list  of  approved  active  substances  before  they  can  be  used  in  biocidal  products4.  Then 
biocidal  products  containing  any  active  substance  require  an  authorisation,  as  described 
further down, before they can be placed on the market and used.  

Regulation (EU) 528/2012 introduced the concept of a biocidal product family, as defined in 
Article 3(1)(s) of the Regulation. Accordingly, one product authorisation may cover a group 
of similar biocidal products. This concept also allows the holder of the authorisation to place 
on  the  market  new  products  falling  within  the  boundaries  of  the  family  following  a  simple 
notification process in accordance with Article 17(6) of the Regulation. 

Article  17(7)  of  Regulation  (EU)  528/2012  also  introduced  the  possibility  to  authorise 
biocidal products for the same or different enterprises under the same terms and conditions. 
Details  of  this  so-called  “same  biocidal  product”  procedure  are  laid  down  by  Commission 
Implementing Regulation (EU) No 414/20135. Applications under this Regulation are linked 
to a related reference product, which can be an already authorised product or a product being 
subject to an application in the context of the different authorisation procedures established in 
Regulation (EU) 528/2012, which are described in the paragraph below. 

Regulation  (EU)  528/2012  lays  down  different  application  routes  for  the  authorisation  of 
biocidal products6. Depending on the properties of the active substance used in the biocidal 
product and the targeted markets in the Union, applicants may choose the most appropriate 
route: 

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 
and  https://echa.europa.eu/regulations/biocidal-

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

5  Commission  Implementing  Regulation  (EU)  No  414/2013  specifying  a  procedure  for  the  authorisation  of 
same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of 
the Council (OJ L 125, 7.5.2013, p. 4.). 

6  Additional 

information 

authorisation 
https://ec.europa.eu/health/biocides/biocidal_products_en 
products-regulation/authorisation-of-biocidal-products  

the 

on 

biocidal 

of 
at 
and  https://echa.europa.eu/regulations/biocidal-

available 

products 

is 

2 

 
                                                 
- a simplified authorisation procedure referred to in Chapter V (Articles 25 to 28) of the 
Regulation, which provides for an accelerated authorisation of products containing only 
low risk active substances included in Annex I to the Regulation.  

-  a  national  authorisation  procedure  referred  to  in  Chapter  VI  (Articles  29  to  31)  of  the 
Regulation, which provides for the authorisation in a Member State of biocidal products 
containing any active substance (either in the Union list or in Annex I to the Regulation); 

-  mutual recognition of national authorisations referred to in Chapter VII (Articles 33 to 
39) of the Regulation in several Member States either at the same time or sequentially. 
-  a Union authorisation7 referred to in Chapter VIII (Articles 41 to 46) of the Regulation, 

which is valid in all Member States.  

The possibility for a Union authorisation did not exist in Directive 98/8/EC, the predecessor 
of  Regulation  (EU)  No  528/2012.  As  defined  in  Article  3(1)(n)  of  the  Regulation,  a  Union 
authorisation is granted by the Commission and aims at facilitating the making available on 
the market throughout the Union of 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 (i.e. the so-called "pre-submission phase") in accordance with 
agreed Union guidance8. Article 42(1) of Regulation (EU) 528/2012 specifies that the Union 
authorisation  procedure  is  not  possible  for  biocidal  products  that  contain  active  substances 
that  fall  under  Article  5  of  the  Regulation  (i.e.  meeting  the  exclusion  criteria)  and  those  of 
product-types 14, 15, 17, 20 and 21. 

While  the  cost  of  preparing  the  file  and  the  time  for  issuing  a  Union  authorisation  is  
approximately similar to the alternative application process of mutual recognition in parallel, 
it gives the authorisation holder direct access to the markets of all EU Member States.  

In a nutshell, the procedure for Union authorisation is the following: the European Chemicals 
Agency  (ECHA)  receives  the  application  and,  following  its  assessment  by  an  evaluating 
competent authority of a Member State, ECHA organises a peer review process resulting in 
an  opinion  delivered  by  its  Biocidal  Products  Committee  (BPC).  This  opinion  will  be  the 
basis for the Commission to decide on whether or not to grant the Union authorisation, and 
under which conditions. ECHA charges fees for the services provided in the context of Union 
authorisation procedures. These fees are laid down in Commission Implementing Regulation 
(EU) No 564/20139. 

Article 42 (3) of Regulation (EU) No 528/2012 introduced an obligation for the Commission 
to  report  to  the  European  Parliament  and  the  Council  on  Union  authorisation  of  biocidal 
products by 31 December 2017: 

7  Additional  information  on  Union  authorisation  is  available  at  https://echa.europa.eu/regulations/biocidal-

products-regulation/authorisation-of-biocidal-products/union-authorisation  

8  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  

9  Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and charges payable to 
the European Chemicals Agency pursuant to 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 (OJ L 167, 19.6.2013, 
p. 17). 

3 

 
                                                 
“3.  The  Commission  shall  submit  a  report  to  the  European  Parliament  and  the 
Council on the application of this Article by 31 December 2017. That report shall 
contain  an  assessment  of  the  exclusion  of  product-types  14,  15,  17,  20  and  21 
from the Union authorisation. 

The  report  shall,  if  appropriate,  be  accompanied  by  relevant  proposals  for 
adoption in accordance with the ordinary legislative procedure”. 

By 31 December 2017, no Union authorisation has been granted yet, as the regulatory process 
for the first applications requesting a Union authorisation has not been completed. Therefore, 
the Commission is not in a position to make a comprehensive analysis of the functioning of 
current  provisions  in  the  Regulation  on  Union  authorisation,  including  the  exclusion  of  the 
above-mentioned product-types 14, 15, 17, 20 and 21 from the Union authorisation. Gaining 
further  experience  is  needed  before  any  firm  conclusions  can  be  drawn  and  any  relevant 
proposals for changes can be considered.  

Consequently,  this  report  provides  a  factual  overview  of  the  applications  for  Union 
authorisation submitted until 1 October 2017 and some preliminary conclusions based on the 
limited experience gained so far with the existing applications for Union authorisation.  

2.  NUMBER AND TYPE OF APPLICATIONS FOR UNION AUTHORISATION  

Table 1 shows the number of Union authorisation applications submitted over the last three 
years. It reflects whether these applications have been submitted in accordance with Article 
43  of  Regulation  (EU)  No  528/2012  or  under  Article  4  of  Commission  Implementing 
Regulation  (EU)  No  414/2013  as  "same  biocidal  products",  as  well  as  the  type  of 
authorisation sought (single biocidal product or biocidal product family as defined in Article 
3(1)(r) and (s) of Regulation (EU) No 528/2012, respectively). 

Table  1:  Number  of  applications  for  Union  authorisation  submitted  split  by  type  of 
procedure, year of submission and type of authorisation sought. 

Year of submission 

2015 
Type of 
authorisation 
sought 

2016 
Type of 
authorisation 
sought 

2017 
Type of 
authorisation 
sought 

Type of 
procedure 

Single 
biocidal 
product 

Biocidal 
product 
family 

Single 
biocidal 
product 

Biocidal 
product 
family 

Single 
biocidal 
product 

Biocidal 
product 
family 

Total by 
type of 
procedure 

43 

Article 
Regulation 
No 528/2012 

of 
(EU) 

of 

Article 
4 
Commission 
Implementing 
Regulation 

(EU) 

12 

8 

5 

9 

36 

70 

25 

45 

0 

0 

12 

2 

5 

1 

4 

 
 
 
 
 
 
 
 
 
No 414/2013  

Subtotal by type 
of 
authorisation/year 
Total by year 

0 

14 

6 

20 

14 

61 

14 

26 

75 

TOTAL 

115 

The first application for Union authorisation was submitted in September 2015. Until the end 
of 2017, a total of 115 applications for Union authorisations have been submitted, 70 (60.9%) 
thereof  under  Article  43  of  Regulation  (EU)  No  528/2012  while  45  (39.1%)  have  been 
submitted  under  Article  4  of  Commission  Implementing  Regulation  (EU)  No  414/2013. 
Regarding the type of authorisation sought, 20 applications (17.4%) involved single biocidal 
products  while  95  (82.6%)  involved  biocidal  product  families.  This  latter  figure  is 
significantly higher than the estimates in a survey carried out by two industry associations10 
in  2015,  which  estimated  that  44%  of  the  total  applications  planned  to  be  submitted  in  the 
next few years would be for biocidal product families. 

The figures in Table 1 show an increasing trend in the number of applications submitted over 
time.  The  deadline  for  the  submission  of  applications  for  product  authorisation,  which  in 
accordance  with  Article  89(3)  of  Regulation  (EU)  No  528/2012  corresponds  to  the  date  of 
approval of the relevant active substance(s) contained in the biocidal product, seems to be the 
main driving factor for this trend. For instance, the number of applications submitted in 2017 
reflects  the  deadlines  for  certain  widely  used  disinfectants  (e.g.  hydrogen  peroxide  or 
peracetic acid). The above-mentioned increasing trend can also be seen as an indication that 
Union  authorisation  has  become  more  attractive  to  companies  operating  in  the  biocides 
sector, especially for the authorisation of biocidal product families. Therefore, it is interesting 
to compare the number of applications received with some estimations made in the past. 

Tables  2  and  3  show  the  number  of  applications  submitted  compared  with  the  estimates 
considered in the background study for the assessment of the appropriateness and impact of 
the existing fee model for the Biocidal Products Regulation and its possible revision11. 

Table  2:  Number  of  applications  for  Union  authorisation  submitted  in  2016  and  2017 
compared to the estimates for three scenarios (pessimistic, baseline and optimistic). 

Pessimistic scenario 
Baseline scenario 
Optimistic scenario 
Applications submitted under Article 43 of Regulation (EU) No 528/2012 only 
Total number of applications submitted, including applications under Article 4 
of Commission Implementing Regulation (EU) No 414/2013 

2016  2017  Total 
27 
35 
54 
41 

16 
20 
23 
17 

43 
55 
77 
58 

26 

75 

101 

10  A.I.S.E.  &  EBPF  survey  on  the  BPR  Impact  on  Biocidal  Products  and  Innovation  -  2015,  available  at 

https://www.aise.eu/documents/document/20160212173604-aise_ebpf_survey_bpr_2015_-_report.pdf   

11 Ecorys, 15 April 2016. Available at: 

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

5 

 
 
 
 
 
                                                 
Table  3:  Number  of  applications  for  Union  authorisation  submitted  in  2016  and  2017 
considering the type of authorisation sought compared to the estimates for the three scenarios. 

Applications for single biocidal products 
Pessimistic scenario 
Baseline scenario 
Optimistic scenario 
Applications submitted under Article 43 of Regulation (EU) No 528/2012 only 
Total number of applications submitted, including applications under Article 4 
of Commission Implementing Regulation (EU) No 414/2013 
Applications for biocidal product families 
Pessimistic scenario 
Baseline scenario 
Optimistic scenario 
Applications submitted under Article 43 of Regulation (EU) No 528/2012 only 
Total number of applications submitted, including applications under Article 4 
of Commission Implementing Regulation (EU) No 414/2013 

2016  2017  Total 
13 
16 
27 
5 

6 
10 
11 
5 

29 
26 
38 
10 

6 

9 

15 

2016  2017  Total 
14 
19 
27 
36 

10 
10 
12 
12 

24 
29 
39 
48 

20 

61 

81 

The  figures  in  Table  2  show  that  the  number  of  applications  submitted  under  Article  43  of 
Regulation  (EU)  No  528/2012  is  similar  to  the  estimates  for  the  baseline  scenario  in  the 
study. However, the total number of applications (i.e. including the applications under Article 
4 of Commission Implementing Regulation (EU) No 414/2013) is clearly above the estimates 
in the optimistic scenario.  

The  figures  in  Table  3  also  indicate  that  the  number  of  applications  submitted  for  single 
biocidal  products,  even  when  considering  the  total  number  of  applications  (i.e.  including 
applications under Article 4 of Commission Implementing Regulation (EU) No 414/2013), is 
clearly below the estimates in the pessimistic scenario. The contrary applies to the number of 
applications submitted under Article 43 of Regulation (EU) No 528/2012 for biocidal product 
families, which is clearly above the estimates in the optimistic scenario. This evidence is even 
more  significant  when  considering  the  total  number  of  applications  (i.e.  including 
applications under Article 4 of Commission Implementing Regulation (EU) No 414/2013), as 
the number of applications are double those of the estimates in the optimistic scenario.  

Overall,  the  available  data  show  that  the  Union  authorisation  procedure  is  mainly  used  by 
applicants to request the authorisation of biocidal product families that cover a high number 
of  existing  (and/or  new)  products  in  the  markets  of  Member  States.  This  finding  is  also 
consistent  with  the  survey  carried  out  by  the  two  industry  associations  in  2015,  which 
indicated  that  about  75%  of  products  expected  to  remain  on  the  market  in  the  future  (from 
that survey) were intended to be grouped into biocidal product families.  

The Union authorisation of a biocidal product family thus seems to be attractive in terms of 
expected cost savings and reduced administrative burden for applicants under the current fee 
rates laid down in Commission Implementing Regulation (EU) No 564/2013. 

6 

 
 
Another  possible  driver  to  apply  for  authorisation  of  biocidal  products  families  may  be  the 
amendment  of  Commission  Implementing  Regulation  (EU)  No  414/2013  made  in  201612. 
This amendment introduced the possibility to go from wider to narrower authorisations (i.e. 
from a biocidal product family to a subset of one or more of the individual products included 
in the family) or markets (i.e. from Union authorisation to national authorisation). This means 
in practice that companies operating in one Member State may support their existing products 
through  applications  for  national  authorisation  of  a  same  biocidal  product  of  a  biocidal 
product belonging to an application for Union authorisation of a biocidal product family. So 
far, 14 of the applications for Union authorisation submitted in 2017 are acting as reference 
product  for  135  applications  submitted  to  competent  authorities  of  Member  States  in 
accordance with Article 3(1a) of Commission Implementing Regulation (EU) No 414/2013.   

3.  ACTIVE  SUBSTANCES  AND  PRODUCT-TYPES  FOR  WHICH  UNION  AUTHORISATION 

APPLICATIONS HAVE BEEN SUBMITTED  

Table 4 shows the active substances and the relevant product types for which applications for 
Union authorisation have been submitted.  

Table  4:  Number  of  applications  for  Union  authorisation  split  by  active  substance(s)  and 
product-type(s) as defined in Annex V to Regulation (EU) No 528/2012. 

Active substance(s) 

Iodine 
Iodine (as PVP-iodine) 
Iodine & PVP-iodine  
Octanoic acid & decanoic acid 
Octanoic acid 
Propan-2-ol 
Hydrogen Peroxide 
Glutaraldehyde13 & CMIT/MIT  2, 4 
Glutaraldehyde13 

Product-type(s)  Total 
3 
3 
3, 4 
4 
4 
1, 2, 4 
1, 2, 3, 4, 5 

CMIT/MIT 
Peracetic acid 
Biphenyl-2-ol 
Clothianidin13 & pyriproxyfen 
Transfluthrin 
Permethrin 
Permethrin & S-methoprene 

2, 4, 6, 11, 12 
2,  4,  6,  11,  12, 
13 
2, 3, 4, 5, 11, 12 
6, 13 
18 
18 
18 
18 

Total 

- 

6 
1 
4 
1 
1 
16 
25 
2 
5 
17 

30 
1 
2 
1 
2 
1 
115 

12  Commission  Implementing  Regulation  (EU)  2016/1802  of  11  October  2016  amending  Implementing 
Regulation  (EU)  No  414/2013  specifying  a  procedure  for  the  authorisation  of  same  biocidal  products  in 
accordance with  Regulation  (EU)  No 528/2012 of  the  European Parliament  and of  the Council  (OJ  L  275, 
12.10.2016, p. 34.). 

13   Active substances meeting the substitution criteria as per Article 10(1) of Regulation (EU) No 528/2012. For 
these applications, a comparative assessment pursuant to Article 23 of that Regulation must be performed. 

7 

 
 
                                                 
Table 5 shows the distribution of applications for Union authorisation according to the main 
groups of product-types that are eligible for the Union authorisation procedure.  

Table 5: Number of applications for Union authorisation split by the main groups of product-
type(s) as defined in Annex V to Regulation (EU) No 528/2012. 

Main Group 

Number of applications (%) 

Disinfectants (product-types 1 to 5) 
Preservatives (product-types 6 to 13) 
Disinfectants and preservatives 
Pest control (product-types 18 and 19) 
Total (%) 

56 (48.7) 
1 (0.8) 
52 (45.2) 
6 (5.2) 
115 (100) 

The product-types  involved  in  the current  applications are  consistent with  the provisions in 
Article 42(1) of Regulation (EU) No 528/2012, which establish the progressive authorisation 
of  different  product-types  under  Union  authorisation.  The  main  group  'disinfectants' 
represents  almost  half  of  the  applications  (48.7%)14,  followed  by  applications  including  a 
combination  of  uses  as  disinfectants  and  preservatives  (45.2%)  and  finally  by  insecticides 
(5.2%)  which  corresponds  to  product-type  18.  No  application  for  Union  authorisation  for 
repellents or attractants (product-type 19) has been submitted so far. 

Most  applications  for  Union  authorisation  (98  of  the  total  115,  i.e.  85%)  are  intended  for 
more  than  one  product-type.  This  is  in  particular  relevant  in  case  of  applications  for 
authorisation  of  biocidal  product  families,  where  it  must  be  decided  whether  some  of  the 
intended  uses  in  the  application  can  be  considered  to  be  “similar”  as  required  by  the 
definition of a biocidal product family in Article 3(1)(s) of Regulation (EU) No 528/2012.  

Applications  for  Union  authorisation  concern  16  active  substances  representing  38  active 
substance/product-type combinations. All of these are existing active substances as defined in 
Article  3(1)(d)  of  Regulation  (EU)  No  528/2012.  None  of  the  applications  involves  a  new 
active  substance  as  defined  in  Article  3(1)(e)  of  Regulation  (EU)  No  528/2012,  while  the 
Union  list  of  approved  active  substances  which  may  be  used  in  biocidal  products  already 
includes 8 new active substances that are eligible for the Union authorisation procedure (i.e. 
new  active  substances  not  meeting  the  exclusion  criteria  referred  to  in  Article  5(1)  of  the 
Regulation).  

These 38 active substance/product-type combinations included in the applications for Union 
authorisation  represent  42.7%  of  the  89  combinations  that  were  eligible  for  Union 
authorisation and for which the deadline for application for product authorisation according 
to Article 89(3) of the Regulation fell between 1 September 2013 and 1 October 2017. The 16 
active substances represent 31% of the 52 approved active substances that were eligible for 
Union authorisation during that period of time. 

14   It has to be noted that disinfectants represent the largest group of product-types, as reflected in the Industry 

survey of 2015. 

8 

 
 
 
                                                 
Finally, only 2 out of the 16 active substances fulfil one of the substitution criteria referred to 
in Article 10(1)(b) to (f) of Regulation (EU) No 528/2012. This finding is consistent with the 
objective  of  discouraging  prospective  applicants  to  submit  applications  for  Union 
authorisation  of  products  containing  active  substances  fulfilling  the  substitution  criteria,  as 
indicated  in  Recital  (4)  of  Commission  Implementing  Regulation  (EU)  No  564/2013.  The 
additional  fee  of  40,000  Euros  when  the  evaluating  competent  authority  has  to  perform  a 
comparative assessment in accordance with Article 23 of the Regulation, the validity of the 
Union authorisation being limited to 5 years only and the lack of any fee reduction for SMEs 
seem to have contributed to achieve the above-mentioned policy objective.  

4.  MEMBER  STATES  THAT  ARE  EVALUATING  THE  APPLICATIONS  FOR  UNION 

AUTHORISATION  

Table  6  provides  information  on  the  Member  States  acting  as  the  evaluating  competent 
authority referred to in Articles 43 and 44 of Regulation (EU) No 528/2012. It has to be noted 
that pursuant to Article 4(6) of Commission Implementing Regulation (EU) No 414/2013, for 
the  45  applications  submitted  under  this  procedure,  the  role  of  the  evaluating  competent 
authority  is  attributed  to  ECHA.  This  role  is  mainly  restricted  to  the  validation  of  the 
application, as there is no technical assessment of the same biocidal product (i.e. it relies on 
the  assessment  of  the  related  reference  product  which  is  first  conducted  by  an  evaluating 
Member State).  

Table 6: Distribution of the 70 applications for Union authorisation submitted under Article 
43  of  Regulation  (EU)  No  528/2012  with  regard  to  the  Member  State  acting  as  evaluating 
competent authority. 

Member State 

Total 

Austria 
Belgium 
Germany 
Denmark 

Finland 

France 
Latvia 

The Netherlands 

United Kingdom 

Total 

4 
3 
7 
2 

1 

3 
1 

41 

8 
70 

Evaluation fee for a biocidal product family 
(Euros)15 

90.000,00 
30.000,00 
90.000,00 
54.690,00 
Basic fee of 54.000,00 with a maximum fee of 
152.000,00  depending on the complexity of the 
application 
80.000,00 
77.048,20 
Basic fee of 40.000,00 with a gradual fee 
depending on the complexity of the application 
By hours spent on the application 

15   These  figures  are  based  on  the  information  available  in  Annex  3  to  the  Ecorys  report  and  some  update 
provided by the involved Member States. In Belgium and the Netherlands new fees apply as from 1 January 
2018  (BE:  50.000  Euros  +  500  Euros  per  product;  NL:  45.000  Euros  +  gradual  fee  depending  on  the 
complexity of the application). 

9 

 
 
 
 
                                                 
The information in Table 6 shows that the evaluation of applications is not distributed among 
the  Member  States  in  a balanced  way.  41  out  of  the  70  applications (58%)  are  assessed  by 
one Member State (the Netherlands).  

In fact, Article 43(1) of Regulation (EU) No 528/2012 gives the applicant the right to freely 
choose  the  competent  authority  of  the  Member  State  that  will  evaluate  the  application, 
provided  that  there  is  written  confirmation  that  that  competent  authority  agrees  to  do  so. 
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. 

It  should  be  noted  that  different  applicants  submitted  similar  applications  for  the  same 
active/product-type combinations to different evaluating competent authorities. This led to a 
need for an intensive coordination activity by ECHA in order to harmonise the evaluations, 
where relevant, as much as possible. This fact points out the key role to be played by ECHA 
in terms of coordinating activities during the evaluating phase, even before the peer review 
process. 

5.  STATUS OF THE APPLICATIONS FOR UNION AUTHORISATION 

All the applications submitted so far under Article 43 of the Regulation have been considered 
as  concerning  biocidal  products  having  similar  conditions  of  use  across  the  Union.  In  the 
context  of  the  "pre-submission  phase"  during  which  this  verification  is  made,  ,  it  is  also 
checked whether the product falls within the scope of the Regulation and if it is allocated to 
the  appropriate  product-type(s).  A  scope  issue  was  raised  affecting  5  applications  for  the 
same active substance/product type combination. Following a formal request from Germany, 
the Commission took a decision pursuant to Article 3(3)16 of Regulation (EU) No 528/2012 
and concluded that the products did fall under the scope of the Regulation. 

Table 7 provides an overview of state of progress of the applications for Union authorisation 
submitted  according  to  the  different  procedural  steps  referred  to  in  Articles  43  and  44  of 
Regulation (EU) No 528/2012. These procedural steps are: 

 
 

 
 

the acceptance of the application by ECHA;  
the  validation  and  the  evaluation  of  the  application  by  the  evaluating  competent 
authority;  
the peer review by ECHA leading to the preparation of the ECHA opinion; and  
the  final  decision  on  whether  the  Union  authorisation  can  be  granted  by  the 
Commission through implementing acts  adopted in accordance with the examination 
procedure. 

16  Commission Implementing Decision (EU) 2016/904 of 8 June 2016 pursuant to Article 3(3) of Regulation 
(EU) No 528/2012 of the European Parliament and of the Council on propan-2-ol containing products used 
for hand disinfection (OJ L 152, 9.6.2016, p. 45.). 

10 

 
 
                                                 
 
Regarding the applications submitted under Commission Implementing Regulation (EU) No 
414/2013, table 7 refers to:  

 
 
 

the acceptance and the validation by ECHA;  
the preparation of the ECHA opinion; and  
the  final  decision  on  whether  the  Union  authorisation  can  be  granted  by  the 
Commission through implementing acts adopted in accordance with the examination 
procedure.  

Table 7: State of progress of the applications submitted for Union authorisation according to 
the  different  procedural  steps  referred  to  in  Articles  43  and  44  of  Regulation  (EU)  No 
528/2012 or in Articles 4 and 6 of Commission Implementing Regulation (EU) No 414/2013. 

Procedural step 

Type of 
procedure 

Acceptance  Validation  Evaluation 

Peer review -  
ECHA level 

Commission 
Decision 

Total 

11 

19 

37 

10 

15 

20* 

3 

0 

0 

0 

70 

45 

No 

Article  43  of 
Regulation 
(EU) 
528/2012 
Article  4  of 
Commission 
Implementing 
Regulation 
(EU) 
414/2013 

No 

Total 

115 
*Applications  already  validated  by  ECHA  and  for  which  the  related  reference  products  is 
under evaluation. 

21 

34 

57 

3 

0 

The  evaluation  phase  has  only  been  completed  for  3  applications  so  far,  and  such  limited 
sample  does  not  allow  any  robust  analysis  of  the  available  data.  However,  as  40  and  20 
applications  have  been  already  validated  by  the  evaluating  competent  authorities  or  by 
ECHA, respectively, the functioning of these processes can be further analysed. 

Table  8  provides  information  on  the  minimum,  maximum  and  median  time  taken  for  the 
whole  validation  period  (in  days).  Therefore,  this  period  includes  any  suspension  of  the 
validation  in  order  to  request  further  information  to  applicants  in  accordance  with  Article 
43(4)  of  Regulation  (EU)  No  528/2012  or  Article  4(4)  of  Commission  Implementing 
Regulation (EU) No 414/2013). 

Table 8: Minimum, maximum and median of time (days) taken for the validation step. 

Type of procedure 

Number of 
applications 
validated 

11 

Minimum  Maximum  Median 

 
 
 
 
 
 
 
Article  43  of  Regulation  (EU) 
No 528/2012 
Article  4  of  Commission 
Implementing Regulation (EU) 
No 414/2013 

40 

20 

30 days 

541days 

198 days 

29 days 

147 days 

73 days 

Concerning the amount of time used by the evaluating competent authorities to validate the 
applications submitted under Article 43 of Regulation (EU) No 528/2012, the median of 198 
days shows that half of them have required more than 6 months for the validation. There were 
a few cases for which the validation of the application took more than one year. This finding 
indicates  that  a  significant  number  of  applications  were  incomplete  and  that  the  evaluating 
competent  authorities  had  to  suspend  the  validation  in  accordance  with  Article  43(4)  of 
Regulation  (EU)  No  528/2012.  The  median  for  the  suspension  period  was  90  days,  with  a 
maximum up to 259 days. This shows that for half of the applications the suspension period 
was longer than the 90-day period referred to in Article 43(4) of the Regulation, which should 
not normally be exceeded. Among the possible corrective measures, the following should be 
further investigated: 

-   On  the  applicants'  side,  better  preparing  the  dossier  and  checking  its  completeness 
before  the  submission  of  the  application.  The  combination  of  applications  for  the 
authorisation  of  biocidal  product  families  involving  different  product-types  might 
have  played  a  role  in  the  complexity  of  the  dossiers.  In  this  respect,  early  pre-
submission meetings with the evaluating competent authority could be very useful in 
order to ensure a smooth validation of the application. 

-   On the evaluating competent authorities' side, avoiding making any assessment of the 
quality  or  the  adequacy  of  the  data  or  justifications  submitted,  as  indicated  in  the 
second  subparagraph  of  Article  43(3)  of  Regulation  (EU)  No  528/2012,  should 
contribute to shortening the time necessary for validation. In the same vein, additional 
information that is requested during validation should rather be requested during the 
evaluation.   

Article 89(3) provides for a total of 3 years for the authorisation of existing biocidal products 
under  Regulation  (EU)  No  528/2012.  Therefore,  a  timely  validation  of  the  applications  is 
essential  in  order  to  keep  as  much  time  as  possible  for  the  subsequent  and  more  complex 
procedural  steps  (assessment  by  the  evaluating  competent  authority,  peer  review  by  ECHA 
and authorisation by the Commission).  

Regarding  the  amount  of  time  used  by  ECHA  to  validate  the  applications  submitted  under 
Article  4  of  Commission  Implementing  Regulation  (EU)  No  414/2013  for  'same  biocidal 
products', the median of 73 days shows that half of them have required more than 2 months 
for the validation. This finding indicates that checking the proposed differences between the 
same product and the related reference product referred to in Article 4(5) of that Regulation 
may be a complex task, particularly for biocidal product families. It has to be noted though 
that delays in the validation of these specific applications for 'same biocidal products' do not 
have significant consequences, as they are put on hold until the assessment of the reference 
product has been finalised. 

12 

 
 
 
6.  THE  USE  OF  UNION  AUTHORISATION  PROCEDURES  BY  SMALL  AND  MEDIUM-SIZE 

ENTERPRISES (SMES)  

Table 9 provides information on the share of SMEs among the companies having submitted 
applications for Union authorisation. 

Table 9: Use of Union Authorisation by SMEs. 

Indicator 

Total 

Number of applicants 
Number  of  applications  under  Article  43  of  Regulation 
(EU) No 528/2012 (all) 
Number  of  applications  under  Article  43  of  Regulation 
(EU) No 528/2012 (as single biocidal product) 
Number  of  applications  under  Article  43  of  Regulation 
(EU) No 528/2012 (as biocidal product families) 
Number  of  applications  under  Article  4  of  Commission 
Implementing Regulation (EU) No 414/2013  

48 

70 

10 

60 

45 

Number of 
SMEs 
10 

% of 
SMEs 
20.8 

10 

4 

6 

0 

14.3 

40.0 

10.0 

0 

About  21%  of  the  applicants  having  submitted  Union  authorisation  applications  are  SMEs. 
This  is  a  significantly  lower  percentage  than  the  estimated  overall  percentage  of  SME-
companies  active  in  the  biocides  sector  reported  in  the  study  for  the  assessment  of  the 
appropriateness  and  impact  of  the  existing  fee  model  for  the  Biocidal  Products  Regulation 
and  its  possible  revision,  according  to  which  the  share  of  SMEs  ranges  from  73  to  86% 
according to the size class by turnover or by number of employees, respectively17.   

Union  authorisation  can  be  a  key  instrument  for  any  company  to  facilitate  the  making 
available  on  the  market  of  biocidal  products  throughout  the  Union.  It  is  obvious  that  large 
companies  have  a  higher  capacity  than  SMEs  to  be  present  in  a  larger  number  of  Member 
States.  According  to  the  survey  carried  out  in  the  context  of  the  above-mentioned  study,  it 
was  estimated  that  the  threshold  for  choosing  Union  authorisation  was  having  sales,  on 
average, in more than 10 Member States.  Many SMEs, by reason of their size, due to their 
focus on niche markets or language barriers, may rather be interested in operating in one or 
few Member States only18. This might explain the lower number of SMEs applying for Union 
authorisation compared to larger companies.  

On the other hand, Article 3(1a) of Commission Implementing Regulation (EU) No 414/2013 
now  allows  SMEs  to  apply  for  national  authorisation  of  same  biocidal  products  in  cases 
where the related reference product is the subject of an application for Union authorisation. In 
fact, so far 135 applications have been submitted to competent authorities of Member States 
referring  to  14  applications  for  Union  authorisation.  This  could  be  a  particularly  attractive 
option for SMEs and might also explain why SMEs have not submitted applications for the 
same biocidal products at Union level. 

17   See information available at page 78 of the Ecorys report referenced in footnote 10. 
18   This  argument  was put forward by  the relevant accredited  stakeholder organisations  in  the biocides sector 
(EBPF-Cefic,  Aise  and  EUAPME)  and  it  the  main  reason  triggering  the  amendment  of  Commission 
Implementing Regulation (EU) No 414/2013 in 2016. 

13 

 
 
                                                 
Both  in  the  above-mentioned  study  and  industry  surveys,  companies  (in  general)  indicated 
the relevance that the annual fee to be paid following the granting of a Union authorisation 
plays  in  their  choice  between  Union  authorisation  or  national  authorisation  followed  by 
mutual recognition. This aspect, together with the lack of a possibility to pay the relevant fees 
in several instalments, might also have played a role affecting the number of applications for 
Union authorisation submitted by SMEs. 

Although the number of applications under Article 43 of Regulation  (EU) No 528/2012 for 
Union  authorisation  of  single  biocidal  products  is  limited  (10),  the  share  of  applications 
submitted  by  SMEs  (40%)  is  higher  than  the  share  for  the  applications  for  authorisation  of 
biocidal  product  families  (10%).  This  finding  might  be  due  to  more  reduced  product 
portfolios of SMEs compared to larger companies. However, it could also indicate that some 
SMEs might still need to increase their capacity, or to make further use of the help of external 
consultancies, in order to prepare and support more complex dossiers for the authorisation of 
biocidal product families. It remains to be further analysed how the guidance19 developed by 
the Commission in order to support SMEs, and particularly the practical guide on consortia, 
will  have  a  positive  effect  in  that  respect  and  increase  the  number  applications  for  Union 
authorisation submitted by SMEs in the future. 

7.  PRELIMINARY CONCLUSIONS 

The number of applications submitted under Article 43 of Regulation (EU) No 528/2012 is 
comparable to the baseline estimate in the study for the assessment of the appropriateness and 
impact  of  the  existing  fee  model  for  the  Biocidal  Products  Regulation.  However,  the  total 
number of applications submitted (i.e. including applications under Article 4 of Commission 
Implementing Regulation (EU) No 414/2013) is clearly above the estimates in the optimistic 
scenario  in  that  study.  In  addition,  the  trend  of  submission  of  applications  for  Union 
authorisation over the recent years shows that the procedure is increasingly used.  

This finding seems to indicate that Union authorisation is attractive under the current fee rates 
laid  down  in  Commission  Implementing  Regulation  (EU)  No  564/2013,  particularly  with 
regard  to  biocidal  product  families.  However,  it  will  only  be  possible  to  fully  assess  the 
success of this procedure some years after the actual delivery of Union authorisations. While 
decision-making  on  the  first  four  applications  is  in  the  final  stage,  so  far  no  Union 
authorisation has been granted yet. 

The  main  product-types  covered  by  the  current  applications  are  disinfectants  (48.7%), 
followed  by  applications  including  a  combination  of  disinfectant  and  preservative  uses 
(45.2%). Therefore, Union authorisation seems to respond to the needs of applicants to reach 
the  whole  Union  market  for  widely  used  biocidal  products  with  similar  conditions  of  use 
across EU.  

All  the  16  actives  substances  included  in  the  applications  are  approved  existing  active 
substances as defined in Article 3(1)(e) and (d) of Regulation (EU) No 528/2012. Only 2 out 
of  these  16  active  substances  fulfil  one  of  the  substitution  criteria  referred  to  in  Article 
10(1)(b) to (f) of Regulation (EU) No 528/2012. This finding is consistent with the objective 

19 Available at https://echa.europa.eu/practical-guides/bpr-practical-guides  

14 

 
 
                                                 
of discouraging applications for Union authorisation of products containing active substances 
fulfilling the substitution criteria. 

The Union authorisation procedure is mainly used by applicants to request the authorisation 
of biocidal product families (82.6% of the applications) that cover a high number of existing 
products  in  the  markets  of  Member  States.  Taking  into  account  that  most  applications  for 
Union authorisation are also intended for more than one product-type (85%), this may add a 
certain  degree  of  difficulty  for  the  evaluating  competent  authorities  to  timely  validate  and 
assess the applications. 

Following  the  amendment  of  Commission  Implementing  Regulation  (EU)  No  414/2013, 
applications  for  Union  authorisation  are  serving  as  reference  products  for  national 
applications in accordance with Article 3(1a) of that Regulation (135 so far). This will help 
applicants,  and  particularly  SMEs,  to  obtain  authorisation  for  their  existing  products  at 
Member State level. 

The  choice  of  the  evaluating  competent  authority  by  applicants  does  not  follow  a  balanced 
distribution  among  Member  States,  and  58%  of  applications  are  today  assessed  by  one 
Member  State  only.  The  driving  factors  behind  the  applicants'  choice  of  Member  States 
should  be  further  explored  in  order  to  find  a  more  balanced  distribution  of  the  workload 
between Member States. 

The available information on the validation of the applications by the evaluating competent 
authorities indicates that a significant proportion of applications was incomplete and required 
further submission of information. The main reasons leading to this situation and any possible 
corrective measures have to be further investigated, both on the applicants' and the evaluating 
competent authorities' sides. In this respect, proper planning of early pre-submission meetings 
between the applicant and the evaluating competent authority should be further promoted. 

About  21%  of  the  applicants  having  submitted  Union  authorisation  applications  are  SMEs. 
The  fact  that  a  significant  proportion  of  SMEs  may  be  interested  in  operating  in  only  a 
limited  number  of  Member  States  may  play  a  role  in  this  respect.  Some  other  factors  like 
their  capacity  to  prepare  and  support  dossiers,  the  role  of  the  amendment  to  Commission 
Implementing  Regulation  (EU)  No  414/2013,  the  level  of  the  reduction  of  the  fees  to  be 
payed to ECHA or the possibility to implement a system of payment of fees by instalments 
should  be  further  considered  in  order  to  better  understand  their  effect  on  the  number  of 
applications submitted by SMEs.  

The Commission will include a more comprehensive assessment of the Union authorisation 
procedure  in  its  composite  report  to  the  European  Parliament  and  the  Council  on  the 
implementation  of  Regulation  (EU)  No  528/2012  in  accordance  with  Article  65(4)  of  that 
Regulation. The composite report will be based on the reports submitted by Members States 
to  the  Commission  on  the  implementation  of  the  Regulation  in  their  respective  territories, 
which are due by 30 June 2020 in accordance with Article 65(3) of the Regulation.  

15