EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10873/2018 CIS 
(POOL/E4/2018/10873 -EN CIS.docx)  
[…](2019) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes II and III 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  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Regulation (EU) No 528/2012 of the European Parliament and of the Council 
concerning the making  available on the market and use of biocidal products1 
(hereinafter the BPR) aims to improve the functioning of the internal market for 
biocidal products, whilst ensuring a high level of protection of human and animal 
health and the environment. Annexes II  and III to th e BPR  set out the information 
requirements for active substances  and biocidal products .  
According to Article 5(1)(d) of the BPR, active substances considered as having 
endocrine -disrupting properties on the basis of the scientific criteria s pecified in 
Commission Delegated Regulation (EU) 2017/21002 shall not be approved unless it 
is shown that at least one of the conditions in Article 5(2) of the BPR is met. 
Commission Delegated Regulation (EU) 2017/2100 applies since 7 June 2018. The 
Europe an Chemical Agency ( ECHA ) and the European Food Safety Authority 
(EFSA) have develop ed, with the support of the Joint Research Centre (JRC), a 
common guidance document for implementing the criteria laid down in that 
Regulation, specifying an assessment str ategy and information requirements 
supporting such an assessment3. 
Therefore, the information requirements in Annexes II and III to the BPR should be 
adapted to scientific and technical progress in relation to the determination of 
endocrine -disrupting prop erties. In addition, these Annexes should also be adapted to 
the current state of science, for example in relation to new test methods ensuring a 
better protection of human and animal health or reducing the number of tests 
conducted on vertebrate animals.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission has consulted an expert group (the 'Biocides CA meeting') attended 
by representatives of Member States' competent authorities for biocidal products, the 
European Chemicals Agency and observers in 6 meetings between September 2018 
and September 2019 on possible amendments of the BPR Annexes II and III.  A draft 
Commission Delegated act was discussed in February 2020  and May 2020.  
In accordance with the Better Regulation agenda , the draft Commission Delegated 
act was open for feedback for a period of four weeks4. During this consultation 
concerns were raised pertaining to … Those concerns were taken into account in the 
final proposal as follows:  
                                                 
1 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 
concerning the making 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 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 E uropean Parliament and Council (OJ L 301, 17.11.2017, p. 1) . 
3 The Guidance has been  published in t he EFSA Journal:   
https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa. 2018.5311 .  
4 Add ref to the have your say portal  EN 2  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATE D ACT  
The legal basis for the delegated act is Article 85 of the BPR. The delegated act 
amends Annex es II and III to Regulation (EU) No 528/2012 , and adapts them  to 
scientific and technical progress . EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes II and III 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  
(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 availab le on the market and use of biocidal 
products5 and in particular Article 85 thereof,  
Whereas:  
(1) Annexes II and III to Regulation (EU) No 528/2012 set out the information 
requirements for respectively active substances and biocidal products  which an 
applicati on for approval of an active subst ance and an application for authorisation of 
a biocidal product need to fulfil . 
(2) It is necessary to modify the information requirements concerning biocidal active 
substances and biocidal products in order to take into accou nt new methods for 
generating better information on toxicological properties (such as irritation, 
neurotoxicity, genotoxicity , etc.), new testing strategies favouring in vitro  tests against 
in vivo  tests in order to reduce testing on vertebrate animals  and a testing strategy and 
methods for the determination of endocrine disrupting properties  of substances  in 
accordance with the criteria laid down in Commission Delegated Regulation (EU) No 
2017/21006. 
(3) A dossier should be considered as complete if it complies with the requirements of 
Article 6(1) and Article 20(1), and in particular with the information requirements of 
Annexes II and III to Regulation  (EU) No 528/2012 . Pre-submission consultations 
betwee n the applicant for the approval of an active substance or for the authorisation 
of a biocidal product and the evaluating competent authority contribute to the quality 
of the dossier and the progress of the evaluation process. The text of paragraphs 5 and 
7, respectively, of points 2 of the introductory parts of Annexes II and III should be 
modified to ensure that the applicants include the conclusions of such consultation in 
the application to ensure the smooth operation of the procedure.   
                                                 
5 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 
concerning the making 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).  
6 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 Eu ropean Parliament and Council (OJ L 301, 17.11.2017, p. 1).  EN 4  EN (4) In accord ance w ith Annexes II and III to Regulation (EU) No 528/2012 , tests 
submitted for the purpose of the approval of an active substance or the authorisation of 
a biocidal product, respectively, are to be  conducted in accordance with the methods 
described in Commissi on Regulation (EC) No 440/20087. As there may be a period  
between the validation of an internationally recognised test method and its inclusion in 
Regulation (EC) No  440/2008, point 5 of the introductory parts of Annexes II and III 
to Regulation (EU) No 52 8/2012  should be amended to allow applicants to apply the 
most updated version of test methods.  
(5) Specific rules for the adaptation of the information requirements listed  in the first 
column of the table s in Titles I and II of Annex es II and III to Regulatio n (EU) No 
528/2012 are limited to concerns related to  the recourse to testing  of vertebrates . As 
some requirements listed in that first column do  not include  testing of vertebrates , the 
scope of adaptations listed in th e third column of the tables listed in Titles I and II of 
Annexes II and III should be extended to cover cases where no test ing of vertebrates is 
involved . 
(6) Section 2 of Title 1 of Annex II sets out the information requirements for the 
identification of the active substan ce. Th ose requirements need to be adapted in order 
to allow identif ication of  active substances generated in situ .  
(7) Section 6 of Title 1 of Annexes II and III set out the requirements for the assessment 
of the effectiveness of an active substance or a biocidal product, respectively , against 
target organisms . Such effectiveness  should be demonstrated for the activity of an 
active substance in the absence of other substances that may affect the effectiveness. 
For treated articles , the effectiveness of the  biocidal pro perties conferred to the article  
should be demonstrated . Moreover, the current provisions on unintended side -effects 
in Section 6 do not specify on which type of organisms or objects, information should 
be provided. Therefore, it  should be cla rified that any observation o n undesirable or 
unintended side effects is to be limited to non -target organisms or objects  and material 
to be protected by the active substance or biocidal product . 
(8) Article 62 of Regulation (EU) No 528/2012 requires that testing on vertebrate animals  
be undertaken as, a last resort. In setting data requirements for the approval of active 
substances and the authorisation of biocidal products, priority should be given to 
reliable  in vitro  methods as a substitute to in vivo metho ds requiring the use of 
vertebrate animals. The testing strategies included in Annexes II and III to Regulation 
(EU) No 528/2012 therefore  need to be adapted to recent validated O rganisation for 
Economic Co -operation and Development (O ECD ) in vitro  test gu idelines and other 
international standards.  
(9) The first mandatory requirement for following up on a positive in vitro  gene mutation 
test is currently the in vivo unscheduled DNA synthesis (UDS) test, which has inherent 
limitations and low sensitivity. The E uropean Food Safety Authority  Scientific 
Committee8 concluded in an opinion published in November 2017 that negative UDS 
results are not a proof that a substance does not induce gene mutation. The reference to 
the UDS test should be removed and replaced by a reference to an appropriate in vivo  
somatic cell genotoxicity study.  
                                                 
7 Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to  
Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, 
Evaluat ion, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).  
8 Scientiﬁc Opinion on the clariﬁcation of some aspects related to genotoxicity assessment. EFSA Journal 
2017;15(12):5113, 25 pp. https://doi. org/10.2903/j.efsa.2017.5113  EN 5  EN (10) The current data requirements in Annex II  to Regulation (EU) No 528/2012  require a 
two-generation reproductive toxicity st udy (TGRTS) to be used to investigate the 
reproductive toxicity of a substance. Th at Annex furthermore stipulates that the 
extended one -generation reproductive toxicity study (EOGRTS) can be considered as 
an alternative approach to the TGRTS. The EOGRTS of fers a number of advantages in 
comparison to the TGRTS as it assesses in addition to effects on the male and female 
reproductive system more toxicological effects linked to endocrine -disrupting mode of 
actions. Therefore, if there is no  TGRTS available, an  EOGRTS should be performed 
instead.  
(11) Exposure to developmental neurotoxicants in utero or during childhood can contribute 
to a variety of neurodevelopmental and neurological disorders that manifest 
themselves only as the person  ages, and may contribute to neurodegenerative diseases 
such as Parkinson's or Alzheimer's diseases. To address this concern, test guidelines to 
adequately screen and characterise active substances potentially toxic for the 
developing brain should be included in Annex II to Regulation  (EU) No 528/2012.  
(12) The current structure of the information requirements relating to health data and 
medical treatment in point s 8.12.1 to 8.12.8 of Title 1  of Annex II to Regulation (EU) 
No 528/2012 may lead to submission of overlapping  information under a number of 
those point s. The data requirements should therefore be streamlined to reduce 
compliance costs and unnecessary delays in the evaluation of applications.  
(13) An evaluation of the potential for unintended effects of substances on the immune 
system sh ould be conducted. However, as no specific developmental immunotoxicity 
study is available in a OECD test guideline, relevant data should be required to be 
provided as additional data set.  
(14) Point 8.18 of Title 1 of Annex II  to Regulation (EU) No 528/2012  duplicat es the 
content of Section 13  of that Title and should therefore be deleted . 
(15) Point 9.1.1 of Title 1 of Annex II to Regulation (EU) No 528/2012 should be amended 
in order to clarify when long -term toxicity testing on fish is to be carried out . The list 
of OECD test methods in point 9.1.6.1 is to be replaced in order to take into account 
on-going developments as regards the information requirements on long -term toxicity 
studies on fish . 
(16) Several information requirements for microorganisms included in Title 2 of Annexes 
II and III to Regulation (EU) No 528/2012 are either overlapping with other provisions 
in the Annexes or are irrelevant for microorganisms . Title 2 of Annexes II and III to 
Regulation (EU) No 528/2012  should therefore be amended  in or der to eliminate such 
overlaps and irrelevant information requirements . 
(17) The fourth p aragraph of point 2 of the introductory part of Annex III to Regulation 
(EU) No 528/2012 provides that for non -active substances , the applicants are to use  
the information provided to them in the context of Title IV of Regulation (EC) No 
1907/2006. Th at paragraph should be amended in order to clarify that applicants may 
need to provide additional information on substances of concern included in biocidal 
products in particula r in order to prepare a data set that enables the identification of 
their endocrine disrupting properties ] 
(18) In order to avoid imposing a disproportionate burden on economic operators , certain 
tests required by Annex II or Annex III to Regulation (EU) No 528/2012 that were 
already initiated  or carried out  before the date of application  of this Regulation should 
be considered appropriate to address the  information requirements.  EN 6  EN (19) A reasonable period should be allowed to elapse before th e data requirements , as 
modified by this Delegated Regulation  become applicable so that the applicants can 
make the necessary arrangements to meet those requirements.  However, in the 
interests of the protection of human and animal health and of the environ ment, the 
applicants should be  allowed to apply the changes introduced by this Regulation 
before its da te of application on a voluntary basis.  
(20) Regulation (EU) No 528/2012 should therefore be amended accordingly,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex  II to Regulation (EU) No 528/2012 is amended in accordance with Annex I to this 
Regulation.  
Annex III to Regulation (EU) No 528/2012 is amended in accordance with Annex II to this 
Regulation.  
Article 2 
Notwithstanding the date of application of this Regul ation laid down in Article 3, a pplications 
for approval of an active substance and applications for authorisation of a biocidal product 
submitted before … [ OJ: please insert a date - 12 months after entry into force of this 
amending Regulation ] shall be evaluated based on  information requirements applicable on the 
day of submission of such applications.  
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European  Union .  
It shall apply from … [OJ: please insert a date - 12 months after entry into force  of this 
amending  Regulatio n]. 
By way of derogation, applicants may choose to apply the data requirements as set out in the 
Annexes I and II to this Regulation from … [OJ: please insert the date of entry into force of 
this amending Regulation ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula Von der Leyen