EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11547/2017 
(POOL/E4/2017/11547/11547 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
According to Regulation (EU) No 528/2012 of the European Parli ament and of the 
Council of 22 M ay 2012 concerning the making available on the market and use of 
biocidal products, a work programme shall be carried out to review all active 
substances used in biocidal products which were alread y on the market on 14 May 
2000. This on -going work programme for the systematic examination of all existing 
active substances used in biocidal products is foreseen  to run until 31 December 
2024.  
Commission Delegated Regulation (EU) No 1062/201 4, the so -called "Review 
Regulation", amended by Commissi on Delegated Regulation (EU) No 2017/698, 
lays down the detailed rules for the examination of these existing active substances. 
It also sets out  in its Annex II the substance/product -type combinations included in 
this work programme  on 3 February 2017.  
Since the adoption of the Review Regulation t he identities of certain active 
substance /product -type combinations  in Annex II  which can be generated in situ  
have been redefined  pursuant to Article 13 of the same Regulation.  
At the same time, following the de clarations received pursuant to Article 16(4) of the 
Review Regulation, an invitation was published where persons  with an interest could 
notify active substances in product -type 19 that had benefitted from the derogation 
for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007 . The 
substance/product -type combinations for which notifications have been found 
compliant with Article 17(2)  of the Review Regulation should be included in Annex 
II of this Regulation.   
In addition, s ome of the su bstance/product -type combinations originally included in 
this work programme are no longer supported and t he Commission also adopted a 
number of approval and non -approval decisions pursuant to Article 89(1) of 
Regulation (EU) No 528/2012 with a view to app rove or not approve certain active 
substances for use in biocidal products. Hence, these substance/product -type 
combinations should no longer be included in the work programme.  
Consequently, Annex II of the Review Regulation needs to be updated . 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission has consulted an expert group (the 'Biocides CA meeting') 
consisting of representatives of Member States' competent authorities for biocidal 
products, of the European Chemicals Agency, of the bi ocides industry and of the 
civil society in the meetings of 14-16 March 2018.  A draft of the delegated act was 
made pu blic in advance of the  meeting.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delegated act amends Annex II  to Regulation (EU) No 1062/2014, and updates it 
in line with the actual state of the work programme.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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 Counc il 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making avai lable on the market and use of biocidal 
products1 and in particular the first subparagraph of Article  89(1)  thereof,  
Whereas:  
(1) Commission Delegated Regulation (EC) No 1 062/20142, as amended by Commission 
Delegated Regulation (EU) No 2017/6983, sets out in i ts Annex II a list of active 
substance/product -type combinations included in the programme of review of existing 
active substances contained in biocidal products on 3 February 2017.   
(2) The identities  of certain active substance s listed in Annex II  which can be generated in 
situ have been redefined  pursuant to Article 13 of Delegated Regulation (EC) 
No 1062/2014  in order to indicate in a more precise manner  the active substance s and 
their precursor s presently covered  in the work programme for systematic examination.  
(3) Any person with an interest could notif y a combination  of an active substance  and 
their precursors  not yet covered by the new identity. Substance/product -type 
combinations notified pursuant to Article 14(1 )(b) and fou nd compliant by the 
European Chemicals Agency (the Agency) with Article 17(2) of the Delegated 
Regulation (EC) No 1062/2014  should be included in Annex II to that Regulation 
pursuant to Article 18.  
(4) Following the declarations received pursuant t o Article 16(4) of Delegated Regulation 
(EC) No 1062/2014 , an invitation was published by the Agency where any person with 
an interest could notify  active substance s in product -type 19 that  benefitted from the 
derogation for food and feed provided for by A rticle 6 of Commission Regulation 
                                                 
1 OJ L 167, 27.6.2012 , p. 1.  
2 Commission Regulation (EC) No 1062/2014  of 4 August 2014 on the work programme for the 
systematic examination of all existing active substances contained i n biocidal products referred to in 
Regulation (EU) No 528/2012  (OJ L 294, 10.10.2014, p. 1 ). 
3 Commission Delegated Regulation (EU) No 2017/698 of 3 February 2017 amending 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 concerning the making available on the market and use of 
biocidal products  (OJ L 103, 19.4 .2017, p 1).   
EN 3  EN (EC) No 1451/ 20074. The substance/product -type combinations  notified pursuant to 
Article 16(5) and found compliant by the Agency  with Article 17 (2) of the Delegated 
Regulation (EC) No 1062/2014  should be included in Annex II to that Regulation 
pursuant to Article 18.  
(5) It is appropriate to indicate the Member States the competent authorities of which shall 
be the evaluating competent authorities  for the active substance/product -type 
combinations  to be added to Annex II to Delegated Regulation (EC) No 1062/2014 . 
(6) Active substance/product -type combinations for which a decision of approval or non -
approval has been taken after  3 February  2017 should  no longer be included  in Annex 
II to Delegated Regulation (EC) No 1062/2014 . 
(7) In order to reflect the actual situation and for reasons of legal certainty it is appropriate 
to provide a list of active substance/product -type combinations included in the 
programme of review of existing active substances contained in biocidal products o n 
the day of adoption of this Regulation.  
(8) Delegated Regulation (EC) No 1062/2014  should therefore be amended accordingly , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Delegated Regulation (EC) No 1062/2014  is replaced by the Annex to this 
Regulation . 
Article  2 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude J UNCKER  
                                                 
4 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 p roducts on the market (OJ L 325, 11.12.2007, p. 3).