REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the sustainable use of biocides pursuant to Article 18 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: 2016-03-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: chemical product, environmental protection, labelling, market approval, marketing standard, plant health product, public health

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 17.3.2016  COM(2016) 151 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the sustainable use of biocides pursuant to Article 18 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)  
 
 
Contents 

1. 

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

1.1.  The Biocidal Products Regulation (the BPR) .................................................... 3 
1.2.  Sustainable use .................................................................................................. 4 
1.3.  Objective of the report ....................................................................................... 4 

2.  HOW DOES THE BPR CONTRIBUTE TO THE SUSTAINABLE USE OF 

BIOCIDES ................................................................................................................... 5 

2.1.  Promotion of best practices to reduce the use of biocidal products .................. 5 

2.1.1. 

Introducing  best  practices  through  product  authorisations  or 
substance approval ............................................................................... 5 
2.2.  Effective approaches for monitoring the use of biocidal products .................... 6 
Integrated  pest  management  principles  (IPM)  and  use  of  biocidal 
2.3. 
products – best practices .................................................................................... 6 
2.3.1.  Best practice codes .............................................................................. 6 
2.3.2.  HACCP ................................................................................................ 7 
2.3.3.  Standards and certification .................................................................. 7 
2.4.  Risks in specific areas such as schools, workplaces, kindergartens etc. ........... 7 
2.4.1.  State of play ......................................................................................... 7 
2.4.2.  Dissemination of information .............................................................. 8 

2.5.  The  role  of  improved  performance  of  equipment  used  to  apply 

biocidal products ............................................................................................... 9 

3.  TOOLS 

TO 

STIMULATE 

INNOVATION  AND 

PROMOTE 

SUSTAINABLE USE ............................................................................................... 10 

3.1.  Exclusion, substitution and comparative assessment ...................................... 10 
3.2.  Labelling schemes ........................................................................................... 10 
3.2.1.  The EU Ecolabel Regulation ............................................................. 10 
Industry initiatives ............................................................................. 11 
3.2.2. 

3.3.  Best  available  techniques  under  Directive  2010/75/EU  on  industrial 

emissions ......................................................................................................... 11 

4.  CONCLUSIONS ....................................................................................................... 12 

2 

 
 
 
1. 

INTRODUCTION 

1.1.  The Biocidal Products Regulation (the BPR) 

Regulation  (EU)  No  528/2012  of  the  European  Parliament  and  of  the  Council  of 
22 May 20121 (hereafter referred to as ‘the BPR’) regulates the making available on 
the  market  and  use  of  biocidal  products.  The  BPR  repealed  Directive  98/8/EC2 
(hereafter  referred  to  as  ‘the  BPD’)  and  entered  into  application  on  1  September 
2013. 

Biocidal  products,  such  as  disinfectants,  wood  preservatives,  insecticides,  insect 
repellents  or  rodenticides,  are  a  family  of  products  intended  to  destroy  or  control 
harmful  or  unwanted  organisms  (such  as  viruses,  bacteria,  fungi,  insects  or 
vertebrate animals) that have detrimental effects on the environment, on animals, on 
humans,  their  activities or  the products they use or  produce. Biocidal  products are 
used in a wide variety of ways by both industrial and professional users as well as 
by the general public. 

The objective of the BPR is to improve the functioning of the internal market whilst 
ensuring  a  high  level  of  protection  of  human  health,  animal  health  and  the 
environment. 

The authorisation scheme of biocidal products is based on a two-step approach. 

First, the active substance responsible for the biocidal effect has to be approved at 
EU level, after an assessment of its hazardous properties and possible risks. 

Second, every biocidal product has to be authorised at EU or national level. 

However,  for  active  substances  that  were  already  on  the  market  when  the  BPD 
entered  into  force,  the  approach  is  the  reverse.  The  BPD  has  established  a 
transitional  period  for  the  assessment  of  these  active  substances,  during  which  the 
biocidal  products  containing  these  active  substances  can  still  be  placed  on  the 
market in accordance with Member States national practices.  

It  is  important  to  highlight  that,  despite  the  risks  inherent  to  their  use,  biocidal 
products play an important role in EU citizens' daily life. For example, insecticides 
and disinfectants are essential for 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). Biocidal 
products  are  also  widely  used  in  materials  such  as  plastics,  paints,  textiles,  wood, 
etc. to protect these materials against microbial, fungi or insect decay.  

Responding to this societal demand requires important investments from companies 
placing biocidal products on the market, in particular to provide the data required to 
demonstrate that their products are safe and effective. 

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 Text with EEA relevance - 
OJ L 167, 27.6.2012, p. 1–123. 

2   Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 

placing of biocidal products on the market - OJ L 123, 24.4.1998, p. 1–63. 

3 

 
 
                                                 
As stated above, biocidal products are used in many and very diverse sectors3. This 
brings  many  challenges,  in  particular  for  the  communication  with  and  awareness-
raising of end-users and stakeholders. 

1.2. 

Sustainable use 

Sustainable use can be defined for biocidal products as 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  such  as  non-chemical  alternatives  to  biocidal 
products.  

It should however be noted that biocidal products are also important tools to protect 
human health, animal health and the environment and that non-chemical alternatives 
may not always be effective, practical or even available. Therefore, sustainable use 
strategies  shall  also  ensure  that  sufficient  biocidal  products  remain  available  to 
achieve these objectives.  

1.3.  Objective of the report 

Article  18  of  the  BPR  stipulates  that  the  Commission  shall,  on  the  basis  of 
experience  gained  with  the  application  of  the  BPR,  present  to  the  Council  and  the 
European Parliament a report on how the BPR contributes to the sustainable use of 
biocidal  products.  This  report  shall  also  reflect  on  the  need  to  introduce  additional 
measures, in particular for professional users, in view of reducing the risks posed to 
human health, animal health and the environment by biocidal products. 

The same article lays down elements that need to be examined and which relate to:  

 

 

 

 

 

the  promotion  of  best  practices  as  a  means  of  reducing  the  use  of  biocidal 
products to a minimum; 

the most effective approaches for monitoring the use of biocidal products; 

the  development  and  application  of  integrated  pest  management  principles 
with regard to the use of biocidal products; 

the  risks  posed  by  the  use  of  biocidal  products  in  specific  areas  such  as 
schools, workplaces, kindergartens etc., and whether additional measures are 
needed to address those risks; 

the  role  of  improved  performance  of  the  equipment  used  for  applying 
biocidal products. 

The purpose of this report is therefore to examine the elements listed in Article 18 of the 
BPR (section 2) but also to reflect on additional ones (section 3). 

This  report  is  based  on  a  preliminary  study4,  which  included  a  large  survey  of 
representatives from Member State Competent Authorities, industry and NGOs (hereafter 
referred to as ‘the study’). 

3   The BPR covers 4 main groups of biocidal products themselves divided into 22 product-types ranging 
from  disinfectants  for  human  hygiene  to  embalming  and  taxidermist  fluids,  through  in-can 
preservatives, insecticides, rodenticides and antifoulings products. 

4   Analysis of measures geared to the sustainable use of biocidal products, by Milieu Ltd 2015. 

4 

 
 
 
 
                                                 
2.  HOW DOES THE BPR CONTRIBUTE TO THE SUSTAINABLE USE OF BIOCIDES 

This section gives an overview of the findings of the study and shows how the BPR 
is contributing or can contribute to the sustainable use of biocides. 

2.1. 

Promotion of best practices to reduce the use of biocidal products 

A  best  practice  is  an  exemplary  approach  or  methodology,  frequently 
presented  in  guidelines  aimed  at  reducing  risks  and  at  promoting  technical 
understanding when applying a product or technique. From the point of view 
of  implementation  and applicability  (preferably  EU  wide), the  involvement 
of  stakeholders  in  developing  best  practice  guidelines  is  essential.  Best 
practice guidelines focus on the use phase of biocidal products and are a tool 
to be used beyond the authorisation process to promote the sustainable use of 
these products. 

In order to ensure a harmonised approach to the sustainable use of biocidal 
products across the EU, one of the challenges is to ensure dissemination of 
best  practice  and  adherence  to  the  principles  of  sustainable  use  of  biocidal 
products.  

2.1.1.  Introducing  best  practices 
substance approval 

through  product  authorisations  or 

Product authorisations shall stipulate the terms and conditions relating to the 
making available on the market and use of the products they are granted for. 
In particular, they shall contain instructions for the safe use and disposal of 
biocidal products. 

One  of  the  means  to  promote  the  dissemination  of  available  guidance 
documents  or  best  practice  codes  is  to  make  a  reference  to  these  in  the 
product  authorisation,  so  that  the  instructions  for  use  of  the  product 
explicitly  refer  to  them.  For  example,  in  Germany,  authorisations  of 
anticoagulant  rodenticides  include  a  legally  binding  reference  to  a  best 
practice  code  for  the  application  of  these  products  by  specialised  and 
licensed  professionals,  which  is  based  on  existing  industry  guidelines  and 
EU legal provisions5.  This option however expects the end-user to read and 
correctly follow the recommendations given. 

If  a  certification  or  training  scheme  is  available,  reference  to  such  scheme 
can  be  made  in  the  authorisation.  For  example,  this  approach  is  being 
adopted  in  the  UK  in  relation  to  the  authorisation  of  rodenticides,  where 
compliance with a proposed industry stewardship scheme will be required as 
a condition of authorisation of anticoagulant rodenticides6.  

With antifoulants, all active substances approved to date contain a provision 
that obliges persons making antifouling products available on the market for 
non-professional users to supply these products with appropriate gloves.  

5  http://www.baua.de/de/Chemikaliengesetz-Biozidverfahren/Biozide/pdf/Allgemeine-Kriterien-

Version1-3-englisch.pdf?__blob=publicationFile&v=2 

6   Second Generation Anticoagulant Rodenticide (SGAR) Stewardship Regime 

5 

 
                                                 
This  is  an  example  of  obligations  imposed  on  points  of  sale  to  ensure  that 
not only the information but also personal protective equipment reaches the 
end-user.  It  shows  how  requirements  can  be  imposed  on  the  supply  chain 
and in particular at the retail level to disseminate best practices and to foster 
the sustainable use of biocidal products.  

Such  obligations  are  made  possible  since  the  scope  of  the  BPR  covers  the 
making available of biocidal products (i.e. from first supply up to the point 
of  use)  and  since  active  substances  are  approved  through  implementing 
Regulations, measures of general scope, allowing the adoption of provisions 
aimed at the supply chain. 

Through  substance  approval,  prohibitions  of  over-the-counter  or  internet 
sales  could,  for  instance,  be  applied  to  biocidal  products  containing  active 
substances meeting the exclusion criteria but approved and authorised on the 
basis of the derogation provided under Article 5(2) of the BPR. Additionally, 
for  such  biocidal  products,  one  could  consider  restricting  distribution  and 
sale by adequately qualified professionals.  

2.2.  Effective approaches for monitoring the use of biocidal products 

The  study  revealed  that  today  very  little  information  is  collected  by  the 
Member States on the use of biocidal products.  

At  EU-level,  there  is  currently  no  specific  monitoring  system  for  annual 
sales  data  on  biocidal  products.    In  the  future,  the  Register  for  Biocidal 
Products  (R4BP)  hosted  by  the  European  Chemicals  Agency  might  offer  a 
tool to collect such data7.  

However,  it  is  important  to  clearly  define  what  would  be  the  required 
content and purpose of collecting this information and how it could support 
the objectives of the BPR, including sustainable use. 

2.3. 

Integrated  pest  management  principles  (IPM)  and  use  of  biocidal 
products – best practices 

The study revealed that a wide range of best practice documents relating to 
different product types have already been developed by industry associations 
or Member States.  

2.3.1.  Best practice codes 

Guidelines or  best practice codes can be  developed by industry to  promote 
the sustainable use of biocidal products on the basis of IPM principles. 

In that respect, a noteworthy development is the 'Guideline on Best Practice 
in  the  Use  of  Rodenticide  Baits  as  Biocides  in  the  European  Union'8, 
produced by the European biocides industry. This guideline  describes what 
to  do  before,  during  and  after  rodenticide  applications,  gives  practical 
guidance  that  should  be  followed  in  the  many  varied  situations  of 

7  http://echa.europa.eu/support/dossier-submission-tools/r4bp 
8   http://www.rrac.info/content/uploads/CEFIC-EBPF-RWG-Guideline-Best-Practice-for-Rodenticide-

Use-FINAL-S-.pdf  

6 

 
                                                 
rodenticide  use,  describes  how  to  monitor  for  the  presence  of  rodent 
infestations  without  the  permanent  application  of  rodenticide  baits  and 
discusses alternatives to rodenticides. The guidance document also provides 
advice on where to obtain information about anticoagulant resistance and the 
best way to manage it. 

2.3.2.  HACCP 

The  application  of  the  principles  of  Hazard  Analysis  and  Critical  Control 
Points  (HACCP)  is  obligatory  for  food  business  operators9.  Likewise,  feed 
business operators who carry out specific operations must apply procedures 
based on the HACCP principles.10 

Especially  for  disinfectants,  HACCP  is  a  preventative  approach  (including 
the monitoring of the potential risks) which, if applied correctly, provides for 
sound  hygiene  management,  which  may  also  help  using  disinfectants  in 
accordance with the principles of sustainable use. 

Furthermore,  HACCP  systems,  together  with  the  specific  codes  and 
guidelines  developed  in  these  sectors,  commonly  address  disinfection,  pest 
control and training of operators. 

2.3.3.  Standards and certification 

The  development  of  standards,  combined  with  a  certification  process,  can 
also be used to ensure proper and sustainable use of biocidal products.  

The  recently  adopted  European  Standard  (EN  16636)11  provides  a  good 
example of what can be achieved.  

Compliance  with  EN  16636  will  enable  pest  management  providers  to 
demonstrate  that  they  have  the  necessary  competence  and  know-how  to 
deliver  pest  management  services,  that  they  have  a  management  system  to 
ensure  a  consistent  level  of  quality  and  that  they  systematically  minimise 
risks  for  clients  and  the  public,  as  well  as  the  risk  of  potential  negative 
impacts on the environment and animal welfare. 

Such  initiatives  directly  contribute  to  the  sustainable  use  of  biocidal 
products. 

2.4.  Risks in specific areas such as schools, workplaces, kindergartens etc.  

2.4.1.  State of play 

Based on the analysis of the majority of active substances approved to date 
under  the  BPR  (wood  preservatives,  insecticides,  repellents  and  attractants 
and  antifouling  products),  the  study  concluded  that  either  no  specific  risk 

9  Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the 

hygiene of foodstuffs - OJ L 139, 30.4.2004, p. 1–54. 

10  Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying 

down requirements for feed hygiene - OJ L 35, 8.2.2005, p. 1. 

11  European  Standard  for  pest  management  services  (EN  16636)  -  CEN,  European  Committee  for 

Standardisation 

7 

 
                                                 
was reported, or that the risk mitigation measures laid down in the specific 
conditions of the product authorisation do sufficiently cover the risks at the 
use stage of those biocidal products.  

For  the  other  product  types  which  are  placed  on  the  market  in  accordance 
with national rules, no specific risk was reported.  

It should also be noted that Article 17(5) of the BPR requires Member States 
to  take  measures  to  provide  the  public  with  appropriate  information  about 
the  benefits  and  risks  associated  with  biocidal  products  and  ways  of 
minimising  their  use.    The  study  acknowledges  the  importance  of  this 
information, particularly for uses in areas where vulnerable people, such as 
children, can be exposed to products.  

Regarding the  risk  to  water or  groundwater, the study encouraged Member 
States  to  utilise  information  available  from  other  monitoring  regimes,  such 
as  the  monitoring  of  priority  substances  and  river  basin  specific  pollutants 
under  the Water  Framework  Directive,  which could  usefully  inform  on  the 
specific  risks  to  the  water  environment  from  biocidal  products.  In  this 
context,  a  watch-list  mechanism12  has  been  developed  to  ensure  targeted 
EU-wide monitoring of substances of possible concern (including emerging 
pollutants)  to  support  the  prioritisation  process  in  future  reviews  of  the 
priority substances list. 

In addition, the 'Information Platform for Chemical Monitoring' (IPCheM)13 
designed and implemented by the Commission, offers a single access point 
to  chemical  monitoring  data  collections  managed  by  and  available  to 
European  Commission  bodies,  Member  States,  international  and  national 
organisations and researchers. 

2.4.2.  Dissemination of information 

As stated above, training and the sharing of information are fundamental to 
ensure  that  risk  mitigation  measures  are  appropriately  applied  in  order  to 
protect specific areas. 

Therefore,  should  further  measures  be  required  to  ensure  the  proper 
application of risk mitigation measures, these can largely be pinned down to 
measures to increase the dissemination of information to the end-user and to 
strengthen education and training. 

Training  and  information  should  also  address  how  to  avoid  unnecessary 
applications and use possible non-chemical alternatives. 

In  that  respect,  several  Member  States  (such  as  Belgium14  or  Denmark15) 
have already made noticeable and even creative efforts to communicate the 
principles on the sustainable use of biocidal products to the general public. 

12  Article 8b of Directive 2013/39/EU  amending Directives 2000/60/EC and 2008/105/EC; Commission 

Decision (EU) 2015/495 

13  https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html  
14  http://www.belgium.be/fr/publications/publ_ongewenste-gasten-in-huis-of-tuin.jsp 
15  http://www.hverdagsgifte.dk/ 

8 

 
                                                 
2.5.  The role of improved performance of equipment used to apply biocidal 

products 

It should be noted that many biocidal products – in particular those intended 
for the general public - are applied without equipment or the equipment used 
mainly concerns items like gloves and other personnel protective equipment, 
already regulated by Directive 89/686/EEC16. 

Therefore,  when  specific  equipment  is  used,  it  is  mainly  in  industrial  or 
service  sectors  where  a  lot  of  equipment  is  already  designed  to  minimise 
exposure (e.g. automated systems for wood treatment) and avoid overdosing  
(e.g.  calibrated  dosing  of  in-can  preservatives,  calibration  of  sprayers  for 
antifouling paints) and considered fit for purpose. 

Furthermore,  should  specific  restrictions  or  requirements  be  desired,  they 
could be  ensured, on a case-by-case basis,  by including specific conditions 
in the substance approval or product authorisation.  

Lastly, if the use of appropriate dosing equipment is an important factor in 
the  application  of  some  biocidal  products,  there  are  other  factors  that  need 
also to be considered in order to minimise exposure, such as the selection of 
the  appropriate  product,  determination  of  weather  conditions,  the  level  of 
infestation,  etc.  This  again  demonstrates  the  relevance  of  proper  use 
instructions adapted to each product type being available to the users.  

16  Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member 

States relating to personal protective equipment, OJ L 399 of 30 December 1989. 

9 

 
 
 
                                                 
3.  TOOLS TO STIMULATE INNOVATION AND PROMOTE SUSTAINABLE USE 

Other  tools  or  actions,  which  could  be  used  to  stimulate  innovation  and  the 
development of new products with a better profile, have been considered. 

3.1.  Exclusion, substitution and comparative assessment 

The  BPR  provides,  with  the  exclusion  and  substitution  criteria  for  active 
substances,  and  with  the  comparative  assessment  for  biocidal  products 
containing  active  substance  candidates  for  substitution,  very  powerful 
mechanisms  to  phase  out  the  use  of  substances  of  high  and  very  high 
concern. In addition, this creates incentives to develop better alternatives. 

These mechanisms have not yet reached their full potential, as many active 
substances are still under evaluation and many biocidal products are still to 
be authorised. But they are expected to make a significant contribution to the 
sustainable use of biocides. 

3.2.  Labelling schemes 

The study explored means of easily and visibly identifying biocidal products 
that  would  have  a  lesser  impact  on  human  health,  animal  health  and  the 
environment,  with  the  objective  of  helping  end-users  make  informed 
choices,  but  also  of  giving  those  products  an  advantage  towards  their 
competitors, thereby creating a clear incentive for industry to develop better 
products.  

The study in particular analysed whether existing eco-label schemes (such as 
the EU Ecolabel, the Blue-Angel or Nordic-swan eco-labels) could be used 
for that  purpose and  whether industry  associations or individual companies 
had developed (voluntary) schemes, which could be a source of inspiration. 

3.2.1.  The EU Ecolabel Regulation  

The purpose of Regulation (EC) No 66/201017 (hereafter referred to as ‘the 
Ecolabel  Regulation’)  is  to  provide  a  voluntary  EU  award  scheme  to  help 
consumers identify products and services that have a reduced environmental 
impact  throughout  their  life  cycle,  from  the  extraction  of  raw  material 
through to production, use and disposal.  

The  study  however  showed  that  biocidal  products  are  not  perceived  as 
suitable or eligible for the scheme, because of their inherent properties and 
of their very purpose of controlling unwanted organisms 

The  wide  variety  of  biocidal  products  and  multiple  sectors of  use  was also 
pointed  out  as  a  difficulty  since  EU  Ecolabel  criteria  are  developed  on  a 
product specific basis.  

Finally,  the  EU  Ecolabel  promotes  available  alternatives  to  biocidal 
products,  such  as  biocide-free  materials  as  an  alternative  to  conventionally 
impregnated materials. 

17  Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on 

the EU Ecolabel, OJ L 27/1, 30.1.2010. 

10 

 
                                                 
3.2.2.  Industry initiatives 

A  few  initiatives  have  been  taken  by  industry  or  industry  associations  to 
promote sustainable practices or to highlight the ‘green’ credentials of their 
products.  

Even  if  limited  to  individual  company  initiatives,  often  as  part  of  their 
product  stewardship  or  of  their  marketing  strategy,  these  initiatives 
demonstrate that measures can be taken by companies to reduce the impact 
of biocidal products on the environment.  

In addition, they provide useful elements which could be used more widely 
to  stimulate  innovation  or  the  development  of  new  products  with  a  better 
profile  for  human  health,  animal  health  and  the  environment  and  more 
generally contribute to the sustainable use of biocidal products.  

3.3.  Best  available  techniques  under  Directive  2010/75/EU  on  industrial 

emissions18  

At  the  EU  level,  the  development  and  review  of  the  'best  available 
techniques  reference  documents'  (BREFs)19,20,  under  the  framework  of 
Directive  2010/75/EU  on  industrial  emissions,  can  provide opportunities  to 
identify and promote best practice on the sustainable use of biocides in the 
context of industrial manufacturing.  

Through  these  BREFs,  the  use  of  less  hazardous  substances  is  encouraged 
and some of them, directly or indirectly, address the use of biocidal products 
in specific industrial sectors. 

18  Directive  2010/75/EU  of  the  European  Parliament  and  of  the  Council  of  24  November  2010  on 

industrial emissions (integrated pollution prevention and control) (Recast), OJ L 334, 17.12.2010 

19  Article 13(1) of the Industrial Emissions Directive (IED, 2010/75/EU) 
20  http://eippcb.jrc.ec.europa.eu/reference/ 

11 

 
                                                 
4.  CONCLUSIONS 

As  stated  in  the  introduction,  the  BPR  has  been  fully  operational  only  since  1 
September 2013. This means that limited experience has been gained to date with 
the current legislation.  

Furthermore,  substance approval, product authorisation, comparative assessment 
of  biocidal  products  containing  candidates  for  substitution  with  the  aim  of 
phasing-out  their  use,  are  already  important  contributions  to  the  objective  of 
fostering the sustainable use of biocidal products.  

Therefore, the completion of the on-going assessment of all the active substances 
that  were  already  on  the  market  when  the  BPD  entered  into  force  and  the 
authorisation of biocidal products containing these active substances, shall be the 
first  and  main  priority  with  a  view  to  promoting  the  sustainable  use  of  biocidal 
products.  

Member  States  as  well  as  industry  need  thus  to  concentrate  their  efforts  and 
resources on substance approval and product authorisation. 

In  addition,  Member  States  will  need  to  invest  additional  resources  on 
enforcement activities to ensure that no product is illegally placed on their market 
and that biocidal products are properly labelled. 

With regard to possible additional measures, to reduce the risks posed to human 
health,  animal  health  and  the  environment  by  biocidal  products,  the  study 
concluded that the risks are already appropriately addressed by measures imposed 
through  the  conditions  of  approval  of  active  substances  or  the  authorisation  of 
biocidal products. 

More  particularly,  for  professional  users,  the  study  concluded  that  the  control 
measures  applied  under  EU  worker  health  and  safety  legislation  as  well  as 
chemicals legislation combined with the risk mitigation measures specified at the 
stage  of  the  biocidal  product  authorisation  were  sufficient  –  if  adhered  to  –  to 
address risk from exposure. 

Furthermore, due to the very diverse nature of biocidal products and the variety of 
applications,  it  does  not  seem  appropriate  to  simply  extend  the  scope  of  the 
Framework  Directive  on  the  Sustainable  Use  of  Pesticides  to  biocidal  products. 
Instead, the key objectives of that Directive in relation to biocidal products can be 
achieved  through  different  means  and  more  targeted  actions.  For  the  same 
reasons, extending the scope of the Machinery Directive to biocidal products does 
not seem appropriate either. 

With  regard  to  the  means  and  targeted  actions,  the  correct,  safe  and  sustainable 
use  of  biocidal  products  requires  the  availability  and  effective  dissemination  of 
appropriate guidance or information, whether that use be in a professional context 
or not. 

For industrial use, when BREFs are developed, best practice guidelines on the use 
of biocidal products should, where relevant, be incorporated.  

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For  professional  use,  developing  guidance  documents,  providing  training  and 
certification of the users on application of best practices, go hand in hand. 

For  non-professional  use,  emphasis  should  be  put  on  the  provisions  in  the 
authorisation and the labelling of the product. Technical solutions like smart tags 
or  quick  response  codes  (QR)  providing  a  link  to  the  authorisation  holder’s 
website  can  be  helpful  to  allow  users  to  refer  to  specific  product  properties  and 
use instructions.  

In  conclusion,  the  Commission  will  pursue  the  following  actions,  and  invite 
Member States to do the same: 

 

focus  and  strengthen  efforts  on  the  review  programme  of  existing  active 
substances to ensure it is completed at the latest by end 2024; 

  ensure  that  once  active  substances  are  approved,  product  authorisations  are 

granted, amended or cancelled within 3 years;  

 

invest additional resources on enforcement activities; 

  benefit from the legislative tools available, in particular by closely following 
the developments of BREFs that can be relevant for biocidal products used in 
industrial processes;  

  encourage  communication  and  awareness  raising  campaigns  to  inform  end-
users, through websites, in-store leaflets or videos, quick response codes on 
biocidal products, etc.;  

  encourage  the  development  and  implementation  of  standards  (e.g.  under 

CEN) that could contribute to the sustainable use of biocidal products; 

  welcome  research  initiatives  on  the  sustainable  use  of  biocides  and 

alternatives to biocidal products. 

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