Proposed changes to Annexes II and III of GB BPR 
 
This document contains tables that summarise the articles in GB BPR annexes II and III as they currently stand, alongside the suggested replacements for those points 
which have been drafted with input from specialist colleagues. The changes are to be made in line with article 85 of GB BPR, to ensure we are keeping step with 
scientific and technical advances, and these tables will form the basis of the SI instructions. 
 
 
 
Annex II Changes 
 Current GB BPR Wording Suggested new wording 
Point 2 
Paragraph 5 The applicant has the obligation to initiate a pre-submission consultation. In 
addition to the obligation set down in Article 62(2), applicants may also 
consult with the competent authority with regard to the proposed 
information requirements and in particular the testing on vertebrates that 
the applicant proposes to carry out.   The applicant shall initiate a pre-submission consultation with the 
prospective evaluating body. In addition to the obligation set out in 
Article 62(2), applicant may also consult with the competent authority that 
will evaluate the dossier with regard to the proposed information 
requirements and in particular the testing on vertebrates that the 
applicant proposes to carry out. The applicant shall document such pre-
submission consultations and their outcomes and shall include the 
relevant documents in the application. 
Point 5 3.      Tests submitted for the purpose of the approval of an active substance 
shall be conducted according to the methods described in 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, Evaluation, Authorisation and Restriction 
of Chemicals (REACH) (1  ). However, if a method is inappropriate or not 
described, other methods shall be used which are scientifically appropriate, 
whenever possible internationally recognised, and their appropriateness 
must be justified in the application. When test methods are applied to 
nanomaterials, an explanation shall be provided of their scientific 
appropriateness for nanomaterials, and where applicable, of the technical 
adaptations/ adjustments that have been made in order to respond to the 
specific characteristics of these materials.  Tests submitted for the purpose of the approval of an active substance 
shall be conducted in accordance with the methods described in 
Commission Regulation (EC) No 440/2008 (*1), or any revised version of 
these methods not yet included in that Regulation. However, if a method 
is inappropriate or not described in Commission Regulation (EC) 
No 440/2008, other methods shall be used which are scientifically 
appropriate and their appropriateness shall be justified in the application. 
When test methods are applied to nano-materials, an explanation shall be 
provided of their scientific appropriateness for nanomaterials, and where 
applicable, of the technical adaptations or adjustments that have been 
made in order to respond to the specific characteristics of these materials.  
 
 Title one table 
 Current GB BPR Wording Suggested new wording 
Heading 
of 
column 
3 Information required  All data 
is CDS 
unless 
indicated 
as ADS  Specific rules for adaptation from 
standard information concerning some 
of the information requirements that 
may require recourse to testing of 
vertebrates Information required  All data 
is CDS 
unless 
indicated 
as ADS  Specific rules for adaptation from 
column 1 
row 2 IDENTITY OF THE  ACTIVE SUBSTANCE 
- For the active substance, the 
information given in this Section shall 
be sufficient to enable the active 
substance to be identified. If it is not 
technically possible or if it does not 
appear scientifically necessary to give 
information on one or more of the 
items below, the reasons shall be 
clearly stated    IDENTITY OF THE ACTIVE 
SUBSTANCE (AND ITS 
PRECURSOR(S) IF THE ACTIVE 
SUBSTANCE IS GENERATED IN 
SITU) - For the active substance 
and, if applicable, its 
precursors, the information 
given in this Section shall be 
sufficient to enable the active 
substance to be identified. If it 
is not technically possible or if 
it does not appear scientifically 
necessary to give information 
on one or more of the items 
listed in this Section, the 
reasons shall be clearly stated   
row 2.5 Molecular and structural formula 
(including SMILES notation, if 
available and appropriate)    Molecular and structural 
formula (including SMILES 
notation, if available and 
appropriate). For precursor(s) 
and for active substances 
generated in situ, information 
about all generated chemical 
substances (intended and 
unintended)   In case it is not possible to exactly 
define the molecular structure of the 
precursor(s) and/or active substance, 
the molecular and structural formulas 
do not need to be provided. 
row 2.8 Method of manufacture (syntheses 
pathway) of active substance 
including information on starting 
materials and solvents including 
suppliers, specifications and 
commercial availability   Method of manufacture 
(syntheses pathways) of active 
substance including 
information on starting 
materials and solvents 
including suppliers, 
specifications and commercial 
availability. For active 
substances generated in situ, a   description of the reaction 
schemes including all 
intermediate reactions and 
their associated chemical 
substances (intended and 
unintended) shall be provided 
row 
2.11.1 N/A - NEW INSERTION   Analytical profile of at least five 
representative samples taken 
from the in situ generated 
substance(s), providing 
information on the content of 
the active substance(s), any 
other constituent above 0.1 % 
w/w, including residues of 
precursor(s), and where 
relevant any additional 
impurities referred to in 2.10.   
row 6.6 Efficacy data to support these claims 
on biocidal products and, where label 
claims are made, on treated articles, 
including any available standard 
protocols, laboratory tests or field 
trials used including performance 
standards where appropriate    Efficacy data to support:  
- the innate activity of the 
active substance for the 
intended use(s), and  
 
Efficacy data shall include any 
available standard protocols, 
laboratory tests or field trials 
and performance standards 
where appropriate, or data 
similar to those available for 
suitable reference products 
   
row 
6.7.2 Observations on undesirable or 
unintended side-effects, e.g. on 
beneficial and other non-target 
organisms      Observations on undesirable or 
unintended side effects on non-
target organisms or on objects 
and material to be protected     
8.1. Skin irritation or skin corrosion  
The assessment of this endpoint shall 
be carried out according to the 
sequential testing strategy for dermal 
irritation and corrosion set out in the 
Appendix to Test Guideline B.4. Acute 
Toxicity-Dermal  Irritation/Corrosion    Skin corrosion or irritation 
The assessment shall comprise 
the following tiers:  
(a) assessment of the available 
human, animal and non-animal 
data;  
(b) skin corrosion , in 
vitro testing;   
The study/ies in column 1 do(es) not 
need to be conducted if:  
the available information indicates 
that the substance meets the criteria 
for classification for skin corrosion or 
irritation, (Annex  B.4.  to Regulation (EC) No 
440/2008) (c) skin irritation, in 
vitro testing;  
(d) skin corrosion or 
irritation, in vivo testing the substance is a strong acid 
(pH≤ 2,0) or base (pH≥ 11,5), 
the substance is spontaneously 
flammable in air or in contact with 
water or moisture at room 
temperature, 
the substance meets the classification 
criteria for acute toxicity (Category 1) 
by the dermal route, or 
an acute toxicity study by the dermal 
route provides conclusive evidence 
on skin corrosion or irritation 
adequate for classification. 
 
If results from one of the two studies 
listed in point (b) or point (c) in 
column 1 of this row already allow 
conclusive decision on the 
classification of a substance or on the 
absence of skin irritation potential, 
the second study does not need to be 
conducted. 
 
An in vivo study for skin corrosion or 
irritation shall be considered only if 
the in vitro studies listed in points (b) 
and (c) in column 1 of this row are 
not applicable, or the results of these 
studies are not adequate for 
classification and risk assessment 
In vivo studies for skin corrosion or 
irritation that were carried out or 
initiated before [ IMPLEMENTATION 
DATE] shall be considered 
appropriate to address this 
information requirement 
8.2. Eye irritation 
The assessment of this endpoint shall 
be carried out according to the 
sequential testing strategy for eye 
irritation and corrosion as set down 
in the Appendix to Test Guideline   Serious eye damage or eye 
irritation 
The assessment shall comprise 
the following tiers:   
 
The study/ies in column 1 do(es) not 
need to be conducted if: 
the available information indicates 
that the substance meets the criteria B.5.Acute Toxicity: Eye 
Irritation/Corrosion  (Annex  B.5. to 
Regulation (EC) No 440/2008) (a) assessment of the available 
human, animal and non-animal 
data; 
(b) serious eye damage or eye 
irritation, in vitro testing; 
(c) serious eye damage or eye 
irritation, in vivo testing 
 for classification for eye irritation or 
causing serious damage to eyes, 
the substance is a strong acid 
(pH≤ 2,0) or base (pH≥ 11,5), 
the substance is spontaneously 
flammable in air or in contact with 
water or moisture at room 
temperature, or 
the substance meets the classification 
criteria for skin corrosion leading to 
classification of the substance as 
“serious eye damage” (category 1). 
 
If results from a first in vitro study do 
not allow a conclusive decision on the 
classification of the substance or on 
the absence of eye irritation potential 
(an)other(s) in vitro study(ies) for this 
endpoint shall be considered. 
An in vivo study for serious eye 
damage or eye irritation shall be 
considered only if the in 
vitro study(ies) listed in point (b) in 
column 1 of this row are not 
applicable, or the results obtained 
from these studies are not adequate 
for classification and risk assessment 
In vivo studies for serious eye damage 
or eye irritation that were carried out 
or initiated before 
[IMPLEMENTATION DATE ] shall be 
considered appropriate to address 
this information requirement 
 
8.3. Skin sensitisation  
The assessment of this endpoint shall 
comprise the following consecutive 
steps:  
1. an assessment of the available 
human, animal and alternative data  
2. in vivo testing   Step 2 does not need to be conducted 
if:  
— the available information indicates 
that the substance should be classified 
for skin sensitisation or corrosivity, or  
— the substance is a strong acid (pH < 
2,0) or base (pH > 11,5)  
 Skin sensitisation 
The information shall allow to 
conclude whether the 
substance is a skin sensitiser 
and whether it can be 
presumed to have the potential 
to produce significant 
sensitisation in humans   
The study/ies in column 1 do(es) not 
need to be conducted if: 
the available information indicates 
that the substance meets the criteria 
for classification for skin sensitisation 
or skin corrosion, The Murine Local Lymph Node Assay 
(LLNA) including, where appropriate, 
the reduced variant of the assay, is 
the first-choice method for in vivo 
testing.  
If another skin sensitisation test is 
used justification shall be provided. 
 (Category 1A). The information 
should be sufficient to perform 
a risk assessment where 
required 
The assessment shall comprise 
the following tiers: 
(a) assessment of the available 
human, animal and non-animal 
data; 
(b) skin sensitisation, in 
vitro testing. Information 
from in vitro or in chemico  test 
method(s) referred to in point 
5 of the introductory part of 
this Annex and addressing each 
of the following key events of 
skin sensitisation: 
(i) molecular interaction with 
skin proteins; 
(ii) inflammatory response in 
keratinocytes; 
(iii) activation of dendritic cells; 
(c) skin sensitisation in 
vivo testing. The Murine Local 
Lymph Node Assay (LLNA) is 
the first-choice method for in 
vivo testing. Another skin 
sensitisation test may only be 
used in exceptional cases. If 
another skin sensitisation test 
is used, justification shall be 
provided 
 the substance is a strong acid 
(pH≤ 2,0) or base (pH≥ 11,5), or 
the substance is spontaneously 
flammable in air or in contact with 
water or moisture at room 
temperature. 
 
In vitro tests do not need to be 
conducted if: 
- an in vivo study referred to in point 
(c) of column 1 of this row is 
available, or 
- the available in vitro or in 
chemico test methods are not 
applicable for the substance or the 
results obtained from those studies 
are not adequate for classification 
and risk assessment. 
If information from test method(s) 
addressing one or two of the key 
events described under point (b) in 
column 1 of this row allows for 
classification of the substance and 
risk assessment, studies addressing 
the other key event(s) do not need to 
be conducted. 
An in vivo study for skin sensitisation 
shall be conducted only if in vitro or in 
chemico test methods described 
under point (b) in column 1 of this 
row are not applicable, or the results 
obtained from those studies are not 
adequate for classification and risk 
assessment 
In vivo skin sensitisation studies that 
were carried out or initiated before 
[IMPLEMENTATION DATE ] shall be 
considered appropriate to address 
this information requirement 
 8.6.  In vivo genotoxicity study  
The assessment of this endpoint 
shall comprise the following 
consecutive steps:  
— If there is a positive result in any 
of the in vitro genotoxicity 
studies and there are no results 
available from an in vivo study 
already, an appropriate in vivo 
somatic cell genotoxicity study 
shall be proposed/conducted by 
the applicant  
— If either of the in vitro gene 
mutation tests is positive, an in 
vivo test to investigate 
unscheduled DNA synthesis shall 
be conducted  
— A second in vivo somatic cell test 
may be necessary, depending on 
the results, quality and relevance 
of all the available data  
— If there is a positive result from an 
in vivo somatic cell study 
available, the potential for germ 
cell mutagenicity should be 
considered on the basis of all 
available data, including 
toxicokinetic evidence to 
demonstrate that the substance 
reached the tested organ. If no 
clear conclusions about germ cell 
mutagenicity can be made, 
additional investigations shall be 
considered  ADS  The study/ies do(es) not generally 
need to be conducted if:  
— the results are negative for the 
three in vitro tests and if no 
metabolites of concern are 
formed in mammals or  
— valid in vivo micronucleus data is 
generated within a repeat dose 
study and the in vivo 
micronucleus test is the 
appropriate test to be conducted 
to address this  
information requirement  
— the substance is known to be 
carcinogenic category 1A or 1B or 
mutagenic category 1A, 1B or 2.    
In vivo genotoxicity study 
The assessment shall comprise 
the following tiers: 
(a)If there is a positive result in 
any of the in 
vitro genotoxicity studies as 
listed in 8.5 and there are no 
reliable results available 
from an appropriate in 
vivo somatic cell genotoxicity 
study, an appropriate in 
vivo somatic cell genotoxicity 
study shall be conducted; 
(b)A second in vivo somatic cell 
genotoxicity study may be 
necessary depending on 
the in vitro and in 
vivo results, type of effects, 
quality and relevance of all 
available data; 
(c)If there is a positive result 
from an in vivo somatic cell 
genotoxicity study available, 
the potential for germ cell 
mutagenicity should be 
considered based on all 
available data, including 
toxicokinetic evidence to 
demonstrate whether the 
substance has the capacity 
to reach germ cells. If no 
clear conclusions about germ 
cell mutagenicity can be 
made, additional 
investigations shall be 
considered 
 ADS The study/ies in column 1 do(es) not 
need to be conducted if: 
— the results are negative for the 
three in vitro tests listed in 8.5 and 
no other concern has been 
identified (e.g. metabolites of 
concern formed in mammals), or 
— the substance meets the criteria to 
be classified as a germ cell mutagen 
category 1A or 1B. 
The germ cell genotoxicity test does 
not need to be conducted if the 
substance meets the criteria to be 
classified as a carcinogen, category 
1A or 1B and a germ cell mutagen 
category 2 
8.10. Reproductive toxicity   The studies need not be conducted if:  Reproductive toxicity 
   The studies do not need to be 
conducted if: For evaluation of consumer safety of 
active substances that may end up in 
food or feed, it is necessary to 
conduct toxicity studies by the oral 
route  — the substance is known to be a 
genotoxic carcinogen and 
appropriate risk management 
measures are implemented 
including measures related to 
reproductive toxicity, or  
 
— the substance is known to be a 
germ cell mutagen and 
appropriate risk management 
measures are implemented 
including measures related to 
reproductive toxicity, or  
 
- the substance is of low 
toxicological activity (no evidence 
of toxicity seen in any of the tests 
available provided that the 
dataset is sufficiently 
comprehensive and informative), 
it can be proven from 
toxicokinetic data that no 
systemic absorption occurs via 
relevant routes of exposure (e.g. 
plasma/blood concentrations 
below detection limit using a 
sensitive method and absence of 
the substance and of metabolites 
of the substance in urine, bile or 
exhaled air) and the pattern of 
use indicates there is no or no 
significant human exposure   For evaluation of consumer 
safety of active substances that 
may end up in food or feed, it is 
necessary to conduct toxicity 
studies by the oral route — the substance meets the criteria to 
be classified as a genotoxic 
carcinogen (classified both as germ 
cell mutagen category 2, 1A or 1B 
and carcinogenic category 1A or 
1B), and appropriate risk 
management measures are 
implemented including measures 
related to reproductive toxicity, 
— the substance meets the criteria to 
be classified as a germ cell mutagen 
category 1A or 1B and appropriate 
risk management measures are 
implemented including measures 
related to reproductive toxicity, 
— the substance is of low toxicological 
activity (no evidence of toxicity 
seen in any of the tests available 
provided that the dataset is 
sufficiently comprehensive and 
informative), it can be proven from 
toxicokinetic data that no systemic 
absorption occurs via relevant 
routes of exposure (e.g. plasma or 
blood concentrations below 
detection limit using a sensitive 
method and absence of the 
substance and of metabolites of 
the substance in urine, bile or 
exhaled air) and the pattern of use 
indicates that there is no or 
negligible human or animal 
exposure, 
— the substance meets the criteria to 
be classified as reproductive 
toxicity category 1A or 1B: May 
damage fertility (H360F), and the 
available data are adequate to 
support a robust risk assessment, 
then no further testing for sexual function and fertility will be 
necessary. A full justification must 
be provided and documented if 
investigations for developmental 
toxicity are not conducted, or 
— the substance is known to cause 
developmental toxicity, meeting 
the criteria for classification as 
reproductive toxicity category 1A 
or 1B: May damage the unborn 
child (H360D), and the available 
data are adequate to support a 
robust risk assessment, then no 
further testing for developmental 
toxicity will be necessary. A full 
justification must be provided and 
documented if investigations for 
sexual function and fertility is not 
conducted. 
Notwithstanding the provisions of 
this column of this row, studies on 
reproductive toxicity may need to be 
conducted to obtain information on 
endocrine disrupting properties as 
laid down in 8.13.3.1. 
8.10 Reproductive toxicity  
For evaluation of consumer safety of 
active substances that may end up in 
food or feed, it is necessary to 
conduct toxicity studies by the oral 
route   The studies need not be conducted if:  
— the substance is known to be a 
genotoxic carcinogen and 
appropriate risk management 
measures are implemented 
including measures related to 
reproductive  
toxicity, or  
 
— the substance is known to be a 
germ cell mutagen and 
appropriate risk management 
measures are implemented 
including measures related to 
reproductive toxicity, or  
  
Reproductive toxicity 
For evaluation of consumer 
safety of active substances that 
may end up in food or feed, it is 
necessary to conduct toxicity 
studies by the oral route   The studies do not need to be 
conducted if: 
— the substance meets the criteria to 
be classified as a genotoxic 
carcinogen (classified both as germ 
cell mutagen category 2, 1A or 1B 
and carcinogenic category 1A or 
1B), and appropriate risk 
management measures are 
implemented including measures 
related to reproductive toxicity, 
— the substance meets the criteria to 
be classified as a germ cell mutagen 
category 1A or 1B and appropriate 
risk management measures are — the substance is of low 
toxicological activity (no evidence 
of toxicity seen in any of the tests 
available provided that the 
dataset is sufficiently 
comprehensive and informative), 
it can be proven from 
toxicokinetic data that no 
systemic absorption occurs via 
relevant routes of exposure (e.g. 
plasma/blood concentrations 
below detection limit using a 
sensitive method and absence of 
the substance and of metabolites 
of the substance in urine, bile or 
exhaled air) and the pattern of 
use indicates there is no or no 
significant human exposure. 
 
If a substance is known to have an 
adverse effect on fertility, meeting 
the criteria for classification as 
Reproductive toxicity Cat 1A or 1B: 
May damage fertility (H360F), and the 
available data are adequate to 
support a robust risk assessment, 
then no further testing for fertility will 
be necessary. However, testing for 
developmental toxicity must be 
considered  
— If a substance is known to cause 
developmental toxicity, meeting 
the criteria for classification as 
ductive toxicity Cat 1A or 1B:  
 May  damage  the  unborn  child  
(H360D), and the available data are 
adequate to support a robust risk 
assessment, then no further testing for 
developmental toxicity will be 
necessary. However, testing for effects 
on fertility must be considered  implemented including measures 
related to reproductive toxicity, 
— the substance is of low toxicological 
activity (no evidence of toxicity 
seen in any of the tests available 
provided that the dataset is 
sufficiently comprehensive and 
informative), it can be proven from 
toxicokinetic data that no systemic 
absorption occurs via relevant 
routes of exposure (e.g. plasma or 
blood concentrations below 
detection limit using a sensitive 
method and absence of the 
substance and of metabolites of 
the substance in urine, bile or 
exhaled air) and the pattern of use 
indicates that there is no or 
negligible human or animal 
exposure, 
— the substance meets the criteria to 
be classified as reproductive 
toxicity category 1A or 1B: May 
damage fertility (H360F), and the 
available data are adequate to 
support a robust risk assessment, 
then no further testing for sexual 
function and fertility will be 
necessary. A full justification must 
be provided and documented if 
investigations for developmental 
toxicity are not conducted, or 
— the substance is known to cause 
developmental toxicity, meeting 
the criteria for classification as 
reproductive toxicity category 1A 
or 1B: May damage the unborn 
child (H360D), and the available 
data are adequate to support a 
robust risk assessment, then no 
further testing for developmental  
 toxicity will be necessary. A full 
justification must be provided and 
documented if investigations for 
sexual function and fertility is not 
conducted. 
Notwithstanding the provisions of 
this column of this row, studies on 
reproductive toxicity may need to be 
conducted to obtain information on 
endocrine disrupting properties as 
laid down in 8.13.3.1. 
8.10.1 Pre-natal developmental toxicity 
study, preferred species is rabbit; 
oral route of administration is the 
preferred route.  
The study shall be initially performed 
on one species    
Pre-natal development toxicity 
study (OECD TG 414) on two 
species, preferred first species 
is rabbit (non-rodent) and 
preferred second species is rat 
(rodent); oral route of 
administration is the preferred 
route   The study on the second species shall 
not be conducted if the study 
performed on the first species or 
other available data indicate that the 
substance causes developmental 
toxicity meeting the criteria for 
classification as toxic for reproduction 
category 1A or 1B: May damage the 
unborn child (H360D), and the 
available data are adequate to 
support a robust risk assessment 
8.10.2 Two-generation reproductive 
toxicity study, rat, oral route of 
administration is the preferred 
route.  
If another reproductive toxicity test is 
used justification shall be provided. 
The extended one-generation 
reproductive toxicity study adopted 
at OECD level shall be considered as 
an alternative approach to the multi-
generation study   Extended One-Generation 
Reproductive Toxicity Study 
(OECD TG 443), with cohorts 1A 
and 1B and extension of cohort 
1B to include the F2 generation 
with the aim to produce 20 
litters per dose group, F2 pups 
must be followed to weaning 
and investigated similarly as F1 
pups. Rat is the preferred 
species and oral route of 
administration is the preferred 
route. 
The highest dose level should 
be based on toxicity and 
selected with the aim to induce 
reproductive and/or other 
systemic toxicity   A two-generation reproductive 
toxicity study conducted in 
accordance with OECD TG 416 
(adopted 2001 or later) or equivalent 
information shall be considered 
appropriate to address this 
information requirement, if the study 
is available and was initiated before 
[IMPLEMENTATION DATE ]. 8.10.3 Further pre-natal developmental 
toxicity study. A decision on the need 
to perform additional studies on a 
second species or mechanistic studies 
should be based on the outcome of 
the first test (8.10.1) and all other 
relevant available data (in particular 
rodent reprotox studies). Preferred 
species is rat, oral route of 
administration    Developmental neurotoxicity 
Developmental Neurotoxicity 
Study in accordance with OECD 
TG 426, or any relevant study 
(set) providing equivalent 
information, or cohorts 2A 
and 2B of an Extended One-
Generation Reproductive 
Toxicity study (OECD TG 443) 
with additional investigation 
for cognitive functions.  ADS The study shall not be conducted if 
the available data: 
— indicate that the substance causes 
developmental toxicity and meets 
the criteria to be classified as toxic 
for reproduction category 1A or 1B: 
May damage the unborn child 
(H360D), and 
— are adequate to support a robust 
risk assessment 
 
The study shall be conducted only if 
triggered by one of the following: 
- neurotoxicity occurs in adult 
animals; or 
- the active substance interacts with 
molecules in the nervous system of 
the target organism; or 
- thyroid toxicity (including changes in 
thyroid hormones) occurs in adult 
animals  
 
 
8.10.4 N/A – new insertion   Further studies 
A decision on the need to 
perform additional studies 
including those informing on 
the mechanisms should be 
based on the outcomes of the 
studies listed in 8.10.1, 8.10.2 
and 8.10.3 and all other 
relevant available data ADS  
8.11.2 Carcinogenicity testing in a second 
species    Carcinogenicity testing in a 
second species 
(a)A second carcinogenicity 
study should be conducted 
using the mouse as test 
species;   The second carcinogenicity study 
does not need to be conducted if the 
applicant can justify on the basis of 
scientific grounds that it is not 
necessary — A second carcinogenicity study 
should normally be conducted 
using the mouse as test species  
— For evaluation of consumer safety 
of active substances that may end up 
in food or feed, it is necessary to 
conduct toxicity studies by the oral 
route (b)For evaluation of consumer 
safety of active substances 
that may end up in food or 
feed, it is necessary to 
conduct toxicity studies by 
the oral route 
 
8.12.1 – 
8.12.8 
are 
replaced 
by 
8.12.1 – 
8.12.3 8.12.1 Medical surveillance data on 
manufacturing plant personnel  
8.12.2. Direct observation, e.g. 
clinical cases, poisoning incidents 
8.12.3. Health records, both from 
industry and any other available 
sources 
8.12.4. Epidemiological studies on the 
general population 
8.12.5. Diagnosis of poisoning 
including specific signs of poisoning 
and clinical tests 
8.12.6. Sensitisation/allergenicity 
 observations 
8.12.7. Specific treatment in case of 
an accident or poisoning: first aid 
measures, antidotes and medical  
treatment, if known 
8.12.8. Prognosis following poisoning   8.12.1 Information on signs of 
poisoning, clinical tests, first aid 
measures, antidotes, medical 
treatment and prognosis 
following poisoning 
8.12.2 Epidemiological studies 
8.12.3 Medical surveillance 
data, health records and case 
reports    
8.13.2 Neurotoxicity including 
developmental neurotoxicity  
— The preferred test species is the 
rat unless another test species is 
justified to be more appropriate  
— For delayed neurotoxicity tests 
the preferred species will be the 
adult hen  
— If anticholinesterase activity is 
detected a test for response to 
reactivating agents should be 
considered  ADS   Neurotoxicity 
If the active substance is an 
organophosphorus compound 
or if there is an indication, 
knowledge of the mechanism 
of action or knowledge from 
acute or repeated dose studies 
that the active substance may 
have neurotoxic properties, 
additional information or 
specific studies (such as OECD 
TG 424 or OECD TG 418 or 419 
or equivalent) will be required ADS  If the active substance is an 
organophosphorus compound or if 
there is any evidence e.g. knowledge 
of the mechanism of action or from 
repeat dose studies that the active 
substance may have neurotoxic or 
developmental neurotoxic properties 
then additional information or 
specific studies will be required.  
For evaluation of consumer safety of 
active substances that may end up in 
food or feed, it is necessary to 
conduct toxicity studies by the oral 
route  If anticholinesterase activity is 
detected a test for response to 
reactivating agents should be 
considered 
For evaluation of consumer 
safety of active substances that 
may end up in food or feed, it is 
necessary to conduct toxicity 
studies by the oral route 
8.13.3 Endocrine disruption  
If there is any evidence from in vitro, 
repeat dose or reproduction toxicity 
studies, that the active substance 
may have endocrine disrupting 
properties then additional 
information or specific studies shall 
be required to:  
— elucidate the mode/mechanism of  
action  
— provide sufficient evidence for 
relevant adverse effects  
For evaluation of consumer safety of 
active substances that may end up in 
food or feed, it is necessary to 
conduct toxicity studies by the oral 
route  ADS   Endocrine disruption 
The assessment of endocrine 
disruption shall comprise the 
following tiers: 
(a)An assessment of the 
available information from 
the following studies and 
any other relevant 
information, including in 
vitro and in silico methods: 
(i)8.9.1 A 28- day oral toxicity 
study in rodents (OECD TG 
407); 
(ii) 8.9.2 A 90-day oral 
toxicity study in rodents 
(OECD TG 408); 
(iii)8.9.4 A repeated dose 
oral toxicity study in non-
rodents (OECD TG 409); 
(iv) 8.10.1 A prenatal 
developmental toxicity 
study (OECD TG 414); 
(v) 8.10.2 An extended one-
generation reproductive   Where sufficient weight of evidence 
to conclude on the presence or 
absence of a particular endocrine 
disrupting mode of action is available: 
— further testing on vertebrate 
animals for that effect shall be 
omitted for that mode of action, 
— further testing not involving 
vertebrate animals may be omitted 
for that mode of action. 
In all cases, adequate and reliable 
documentation shall be provided toxicity study (OECD TG 
443) or two-generation 
reproductive toxicity 
study (OECD TG 416); 
(vi) 8.10.3 A developmental 
neurotoxicity study 
(OECD TG 426); 
(vii) 8.11.1 A combined 
carcinogenicity study and 
long-term repeated dose 
toxicity study (OECD TG 
451-3); 
(viii)A systematic review of 
the literature including 
studies on mammals 
and non-mammalian 
organisms; 
 
(b)If there is any information 
suggesting that the active 
substance may have 
endocrine disrupting 
properties, or if there is 
incomplete information on 
key parameters relevant for 
concluding on endocrine 
disruption, then additional 
information or specific 
studies shall be required to 
elucidate: 
(1)the mode or the 
mechanism of action; 
and/or 
(2)potentially relevant 
adverse effects in humans 
or animals 
 
For evaluation of consumer 
safety of active substances that 
may end up in food or feed, it is 
necessary to consider the oral route and conduct animal 
studies by the oral route 
8.13.3.1 N/A new insertion   Specific additional studies to 
investigate potential endocrine 
disrupting properties may 
include, but are not limited to 
the following: 
(a) the mammalian toxicity 
studies listed in 8.13.3(a); 
(b) the in vitro assays: 
(i) Estrogen receptor 
transactivation assay 
(OECD TG 455); 
(ii) Androgen receptor 
transactivation assay, 
(OECD TG 458); 
(iii) H295R steroidogenesis 
assay (OECD TG 456); 
(iv)  the Aromatase assay 
(human recombinant) 
OPPTS 890.1200; 
 
(c) Uterotrophic bioassay in 
rodents (OECD TG 440) and 
Hershberger bioassay in rats 
(OECD TG 441); 
(d) Pubertal development and 
Thyroid Function in Intact 
Juvenile or Peripubertal 
Male Rats (OPPTS 890.1500).  
The decision to carry out 
studies in mammals shall be 
taken based on all available 
information, including a 
systematic review of the 
literature (including ADS  information on endocrine 
disrupting effects in non-target 
organisms) and the availability 
of suitable in silico or in 
vitro methods 
8.13.4 Immunotoxicity including 
developmental immunotoxicity  
If there is any evidence, from skin 
sensitisation, repeat dose or 
reproduction toxicity studies, that 
the active substance may have 
immunotoxic properties then 
additional information or specific 
studies shall be required to:  
- elucidate the mode/mechanism 
of  
action  
- provide sufficient evidence for 
relevant adverse effects in 
humans  
For evaluation of consumer safety of 
active substances that may end up in 
food or feed, it is necessary to 
conduct toxicity studies by the oral 
route  ADS   Immunotoxicity and 
developmental immunotoxicity 
If there is any evidence from 
repeat dose or reproductive 
toxicity studies that the active 
substance may have 
immunotoxic properties, then 
additional information or 
specific studies shall be 
required to elucidate: 
(1)the mode or the mechanism 
of action; and/or 
(2)potentially relevant adverse 
effects in humans or 
animals. 
For evaluation of consumer 
safety of active substances that 
may end up in food or feed, it is 
necessary to consider the oral 
route and conduct animal 
studies by the oral route ADS Immunotoxicity and developmental 
immunotoxicity 
If there is any evidence from repeat 
dose or reproductive toxicity studies 
that the active substance may have 
immunotoxic properties, then 
additional information or specific 
studies shall be required to elucidate: 
(1)the mode or the mechanism of 
action; and/or 
(2)potentially relevant adverse effects 
in humans or animals. 
For evaluation of consumer safety of 
active substances that may end up in 
food or feed, it is necessary to 
consider the oral route and conduct 
animal studies by the oral route 
8.13.5 Mechanistic data — any studies 
necessary to clarify effects reported 
in toxicity studies  ADS   Further mechanistic studies 
A decision on the need to 
perform additional studies 
should be based on all relevant 
data ADS Further mechanistic studies 
A decision on the need to perform 
additional studies should be based on 
all relevant data 
8.18 Summary of mammalian toxicology  
Provide overall evaluation and 
conclusion with regard to all 
toxicological data and any other 
information concerning the active 
substances including NOAEL   DELETED   9.1.1.  Short-term toxicity testing on fish  
When short-term fish toxicity data is 
required  the  threshold 
 approach  
(tiered strategy) should be applied   The study does not need to be 
conducted if:  
— a valid long-term aquatic toxicity 
study on fish is available  Short-term toxicity testing on 
fish 
When short-term fish toxicity 
data is required, the threshold 
approach (tiered strategy) 
should be applied. 
Long-term toxicity testing on 
fish in accordance with point 
9.1.6.1 shall be considered if 
the substance is poorly water 
soluble, i.e. below 1 mg/L  The study does not need to be 
conducted if: 
— a valid long-term aquatic toxicity 
study on fish is available, 
— sufficient weight of evidence 
including the use of other data such 
as the Fish Embryo Acute Toxicity 
(FET, OECD TG 236) and/or results 
obtained from non- animal methods 
is available for this data 
requirement. 
 
9.1.6.1 Long term toxicity testing on Fish  
(a) Fish Early Life Stage (FELS) Test  
(b) Fish short term toxicity test on 
embryo and sack fry stages  
(c) Fish juvenile growth test  
Fish full life cycle test  ADS   Long term toxicity testing on 
fish 
The information shall be 
provided from long-term 
toxicity testing on fish in which 
early life-stages (eggs, larvae or 
juveniles) are exposed ADS  
9.10 Identification of endocrine activity  ADS   Endocrine disruption 
The assessment of endocrine 
disruption properties shall 
comprise the following tiers: 
(a)An assessment of the 
mammalian data set in 
accordance with 8.13.3 to 
assess whether the 
substance has endocrine 
disrupting properties based 
on data in relation to 
mammals; 
(b)If it cannot be concluded 
based on the mammalian 
data in accordance with 
8.13.3 or 9.1.6.1 that the 
substance has endocrine 
disrupting properties, then    studies set out in 9.10.1 or 
9.10.2 shall be considered 
taking account of any other 
available relevant 
information, including a 
systematic review of the 
literature. 
 
9.10.1 
 N/A New insertion   Endocrine disruption in fish 
Specific studies to investigate 
potential endocrine disrupting 
properties may include, but are 
not limited to the following 
data requirements: 
(a)Medaka extended one-
generation test (MEOGRT, 
OECD TG 240); 
(b)Fish life cycle toxicity test 
(FLCTT, OPPTS 850.1500) 
covering all the ‘estrogen-, 
androgen- and 
steroidogenic-mediated’ 
(EAS) parameters foreseen 
to be measured in the 
MEOGRT study 
   The study does not need to be carried 
out if: 
— there is no indication for endocrine 
activity or endocrine related effects 
from a sufficient mammalian data 
set in accordance with 8.13.3 or 
from any other relevant 
information (e.g. literature), and 
— valid in vivo data is available, with 
no information suggesting that the 
active substance may elicit 
endocrine activity or effects 
potentially related to endocrine 
activity in either the Fish short term 
reproduction assay (FSTRA; OECD 
TG 229), or the 21-days fish assay 
(OECD TG 230) or Fish sexual 
developmental test (FSDT, OECD TG 
234). 
If other data are available covering 
the estrogenic, androgenic and 
steroidogenic, (EAS) related 
modalities or parameters investigated 
in OECD TG 229 or OECD TG 230 or 
OECD TG 234, then those data can be 
used instead 
9.10.2 
 N/A New insertion   Endocrine disruption in 
amphibians 
Specific additional studies to 
investigate potential endocrine 
disrupting properties may 
include, but are not limited to 
Larval amphibian growth and   The study does not need to be carried 
out if: 
— there is no indication for endocrine 
activity or endocrine related effects 
from a sufficient mammalian data 
set in accordance with 8.13.3 or development assay (LAGDA; 
OECD TG 241) from any other relevant 
information (e.g. literature), and 
— valid in vivo data is available, with 
no information suggesting that the 
active substance may have 
endocrine disrupting properties in 
an Amphibian metamorphosis 
assay (AMA; OECD 231) 
 
9.10.3 N/A New insertion   If there is information 
suggesting that the active 
substance may have endocrine 
disrupting properties, or if 
there is incomplete information 
on key parameters relevant for 
concluding on endocrine 
disruption, additional 
information or specific studies, 
as necessary, shall be required 
to elucidate: 
(a)the mode or the mechanism 
of action; and/or 
(b)potentially relevant adverse 
effects in humans or 
animals. 
 ADS If there is information suggesting that 
the active substance may have 
endocrine disrupting properties, or if 
there is incomplete information on 
key parameters relevant for 
concluding on endocrine disruption, 
additional information or specific 
studies, as necessary, shall be 
required to elucidate: 
(a) the mode or the mechanism of 
action; and/or 
(b) potentially relevant adverse effects 
in humans or animals. 
 
 
(3) Title 2 table 
 
 Current GB BPR Wording Suggested new wording 
Heading 
of column 
3 Column 1 
Information required Column 2 
All data is 
CDS unless 
indicated as 
ADS Column 3 
Specific rules for adaptation from 
standard information concerning 
some of the 
information requirements that 
may require recourse to testing 
of vertebrates Column 1 
Information required Column 2 
All data is CDS 
unless 
indicated as 
ADS Column 3 
 
Specific rules for adaptation 
from column 1 2.4 Methods, procedures and criteria 
used to establish the presence and 
identity of the micro-organism   Specification of the technical grade 
active ingredient   
2.4.1 N/A new insertion   Content of the active micro-
organism and identity and content 
of relevant metabolites or toxins   
2.4.2 N/A new insertion    
Identity and content of impurities, 
additives, contaminating micro-
organisms 
   
2.4.3 N/A new insertion   Analytical profile of batches   
2.5 Specification of the technical grade 
active ingredient     
Method of production and quality 
control 
   
2.6 Method of production and quality 
control    DELETED   
2.7 Content of the micro-organism    DELETED   
2.8 Identity and content of impurities, 
additives, contaminating  
micro-organisms    DELETED   
2.9 Analytical profile of batches    DELETED   
3.5 Information on the production of 
metabolites (especially toxins)   Information on the production of 
relevant metabolites and toxins   
4.1 Analytical methods for the analysis 
of the micro-organism as 
manufactured    Methods, procedures and criteria 
used to establish the presence and 
identity of the micro-organism   
4.2 Methods used for monitoring 
purposes to determine and 
quantify residues (viable or non-
viable)    Analytical methods for the analysis 
of the micro-organism as 
manufactured   4.3 N/A new insertion   Methods used for monitoring 
purposes to determine and 
quantify residues (viable or non-
viable)   
 
  Annex III Changes 
Introductory part 
 Current GB BPR Wording Suggested new wording 
Point 2 
Paragraph 4 For some of the information requirements set out in this Annex, it may be 
possible to satisfy these requirements based on available information of the 
properties of the active substance(s) contained in the product and the 
properties of non-active substance(s) included in the product. For non-
active substances, applicants shall use the information provided to them in 
the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and 
the information made available by the competent authority in accordance 
with point (e) of Article 77(2) of that Regulation. For some of the information requirements set out in this Annex, it may be 
possible to satisfy these requirements based on available information of 
the properties of the active substance(s) contained in the product and the 
properties of non-active substance(s) included in the product. For non-
active substances, applicants shall use the information provided to them 
in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, 
and the information made available by the Agency in accordance with 
point (e) of Article 77(2) of that Regulation. However, the information may 
be not sufficient or adequate to determine whether a non-active 
substance contained in a biocidal product has hazardous properties and 
the evaluating body may conclude that further data are required. 
Point 2 
paragraph 7 The applicant has the obligation to initiate a pre-submission consultation. In 
addition to the obligation set out in Article 62(2), applicants may also 
consult with the competent authority with regard to the proposed 
information requirements and in particular the testing on vertebrates that 
the applicant proposes to carry out. The applicant shall initiate a pre-submission consultation with the 
prospective evaluating body. In addition to the obligation set out in 
Article 62(2), the applicant may also consult with the competent authority 
that will evaluate the dossier with regard to the proposed information 
requirements and in particular the testing on vertebrates that the 
applicant proposes to carry out. The applicant shall document such pre-
submission consultations and their outcomes and shall include the 
relevant documents in the application 
Point 5 5. Tests submitted for the purpose of authorisation shall be 
conducted according to the methods described in Regulation (EC) No 
440/2008. However, if a method is inappropriate or not described, other 
methods shall be used which are scientifically appropriate, whenever 
possible internationally recognised, and their appropriateness must be 
justified in the application. When test methods are applied to 
nanomaterials, an explanation shall be provided of their scientific 
appropriateness for nanomaterials, and, where applicable, of the technical 
adaptations/adjustments that have been made in order to respond to the 
specific characteristics of these materials.  
Tests submitted for the purpose of authorisation shall be conducted in 
accordance with the methods described in Commission Regulation (EC) 
No 440/2008, or any revised version of these methods not yet included in 
that Regulation. 
However, if a method is inappropriate or not described in Commission 
Regulation (EC) No 440/2008,  (*1) other methods shall be used which are 
scientifically appropriate and their appropriateness shall be justified in the 
application. 
When test methods are applied to nano-materials, an explanation shall be 
provided of their scientific appropriateness for nanomaterials, and where 
applicable, of the technical adaptations or adjustments that have been 
made in order to respond to the specific characteristics of these materials. 
 Title 1 table 
 Current GB BPR Wording Suggested new wording 
Heading 
of column 
3 Column 1 
Information required: Column 2 
All data is 
CDS unless 
indicated as 
ADS Column 3 
Specific rules for adaptation from 
standard information concerning 
some of the 
information requirements that 
may require recourse to testing 
of vertebrates Column 1 
Information required: Column 2 
All data is CDS 
unless 
indicated as 
ADS Column 3 
Specific rules for adaptation 
from column 1. 
 
6.6 The proposed label claims for the 
product and, where label claims 
are made, for treated articles    The proposed claims for the 
product and, where claims are 
made, for treated articles regarding 
the biocidal properties conferred 
to the article.   
6.9.2 Observations on undesirable or 
unintended side effects e.g. on 
beneficial and other non-target 
organisms   Observations on undesirable or 
unintended side-effects on non-
target organisms or on objects and 
material to be protected.   
8.1 Skin corrosion or skin irritation  
The assessment of this endpoint 
shall be carried out according to 
the sequential testing strategy for 
dermal irritation and corrosion 
set out in the Appendix to Test 
Guideline B.4.  
Acute  Toxicity-Dermal  Irritation/  
Corrosion  (Annex  B.4.  to  
Regulation (EC) No 440/2008)   Testing on the product/mixture 
does not need to be conducted 
if:  
— there are valid data available 
on each of the components in 
the mixture sufficient to allow 
classifi cation of the mixture 
according to the rules laid down 
in Directive 1999/45/EC and 
Regulation (EC) No 1272/2008 
(CLP), and syner gistic effects 
between any of the components 
are not expected   
Skin corrosion or irritation 
The assessment shall comprise the 
following tiers: 
(a) assessment of the available 
human, animal and non-animal 
data; 
(b) skin corrosion, in vitro testing; 
(c) skin irritation, in vitro testing; 
(d) skin corrosion or irritation, in 
vivo testing 
   Testing of the product or 
mixture does not need to be 
conducted if: 
— there are sufficient valid 
data on each component of 
the product or mixture to 
allow its classification in 
accordance with Regulation 
(EC) No 1272/2008, and 
synergistic effects between 
any of the components are 
not expected, 
— the product or mixture is a 
strong acid (pH≤ 2,0) or 
base (pH≥ 11,5), 
— the product or mixture is 
spontaneously flammable 
in air or in contact with 
water or moisture at room 
temperature, — the product or mixture 
meets the classification 
criteria for acute toxicity 
category 1 by the dermal 
route, or 
— an acute toxicity study by 
the dermal route provides 
conclusive evidence on skin 
corrosion or irritation 
adequate for classification. 
If results from one of the two 
studies listed in points (b) or 
(c) in column 1 of this row 
already allow conclusive 
decision on the classification 
of product or mixture or on 
the absence of skin irritation 
potential, the second study 
does not need to be 
conducted 
An in vivo study for skin 
corrosion or irritation shall be 
considered only if the in 
vitro studies listed in points 
(b) and (c) in column 1 of this 
row are not applicable, or the 
results of these studies are 
not adequate for classification 
and risk assessment and the 
calculation method or 
bridging principles laid down 
in Regulation (EC) 
No 1272/2008 are not 
applicable 
In vivo studies for skin 
corrosion or irritation that 
were carried out or initiated 
before 15 April 2022 shall be 
considered appropriate to address this information 
requirement 
8.2 Eye irritation (1  )  
The assessment of this endpoint 
shall be carried out according to 
the  
sequential testing strategy for eye 
irritation and corrosion as set 
down in the Appendix to Test 
Guideline B.5.Acute Toxicity: Eye 
Irritation/  
Corrosion  (Annex  B.5.  to  
Regulation (EC) No 440/2008)   Testing on the product/mixture 
does not need to be conducted 
if:  
— there are valid data available 
on each of the components 
in the mixture to allow 
classification of the mixture 
according to the rules laid 
down in  
Directive 1999/45/ECand 
Regulation (EC) No 1272/2008 
(CLP), and synergistic effects 
between any of the components 
are not expected  Serious eye damage or eye 
irritation 
The assessment shall comprise the 
following tiers: 
(a) assessment of the available 
human, animal and non-animal 
data; 
(b) serious eye damage or eye 
irritation, in vitro testing; 
(c)serious eye damage or eye 
irritation, in vivo testing 
   Testing on the product or 
mixture does not need to be 
conducted if: 
— there are sufficient valid 
data available on each 
component of the product 
or mixture to allow its 
classification in accordance 
with Regulation (EC) 
No 1272/2008, and 
synergistic effects between 
any of the components are 
not expected, 
— the product or mixture is a 
strong acid (pH≤ 2,0) or 
base (pH≥ 11,5), 
— the product or mixture is 
spontaneously flammable 
in air or in contact with 
water or moisture at room 
temperature, or 
— the product or mixture 
meets the classification 
criteria for skin corrosion 
leading to its classification 
as “serious eye damage” 
category 1 
If results from a first in 
vitro study do not allow a 
conclusive decision on the 
classification of the product or 
mixture or on the absence of 
eye irritation potential 
(an)other(s) in vitro study(ies) 
for this endpoint shall be 
considered An in vivo study for serious 
eye damage or eye irritation 
shall be considered only if 
the in vitro study(ies) under 
point (b) in column 1 of this 
row are not applicable, or the 
results obtained from these 
studies are not adequate for 
classification and risk 
assessment and the 
calculation method or 
bridging principles laid down 
in Regulation (EC) 
No 1272/2008 are not 
applicable 
In vivo studies for serious eye 
damage or eye irritation that 
were carried out or initiated 
before 15 April 2022 shall be 
considered appropriate to 
address this information 
requirement 
8.3 Skin sensitisation  
The assessment of this endpoint 
shall comprise the following 
consecutive steps:  
1. an assessment of the available 
human, animal and alternative 
data 2. in vivo testing  
The Murine Local Lymph Node 
Assay (LLNA) including, where 
appropriate, the reduced variant 
of the assay, is the first-choice 
method for in vivo testing. If 
another skin sensitisation test is 
used justification shall be provided   Testing on the product/mixture 
does not need to be conducted 
if:  
— there are valid data available 
on each of the components 
in the mixture to allow 
classification of the mixture 
according to the rules laid 
down in  
Directive 1999/45/EC and 
Regulation (EC) No 
1272/2008 (CLP), and 
synergistic effects between 
any of the components are 
not expected  
— the available information 
indicates that the product 
should be classified for skin Skin sensitisation 
The information shall allow to 
conclude whether the substance is 
a skin sensitiser and whether it can 
be presumed to have the potential 
to produce significant sensitisation 
in humans (Category 1A). The 
information should be sufficient to 
perform a risk assessment where 
required 
The assessment shall comprise the 
following tiers: 
(a) assessment of the available 
human, animal and non-animal 
data; 
(b) skin sensitisation, in 
vitro testing. Information 
from in vitro or in chemico  test   Testing on the product or 
mixture does not need to be 
conducted if: 
— there are sufficient valid 
data available on each 
component of the product 
or mixture to allow its 
classification in accordance 
with Regulation (EC) 
No 1272/2008, and 
synergistic effects between 
any of the components are 
not expected, 
— the available information 
indicates that the product 
or mixture should be 
classified for skin sensitisation or corrosivity; 
or  
— the substance is a strong acid 
(pH < 2,0) or base (pH > 11,5)  method(s) conducted in 
accordance with point 5 of the 
introductory part of this Annex 
and addressing each of the 
following key events of skin 
sensitisation: 
(i) molecular interaction with 
skin proteins; 
(ii)  inflammatory response in 
keratinocytes; 
(iii) activation of dendritic cells. 
 
(c) skin sensitisation in vivo testing. 
The Murine Local Lymph Node 
Assay (LLNA) is the first-choice 
method for in vivo testing. 
Another skin sensitisation test 
may only be used in exceptional 
circumstances. If another skin 
sensitisation test is used, 
scientific justification shall be 
provided. 
 sensitisation or skin 
corrosion, 
— the product or mixture is a 
strong acid (pH≤ 2,0) or 
base (pH≥ 11,5), or 
— the product or mixture is 
spontaneously flammable 
in air or in contact with 
water or moisture at room 
temperature. 
In vitro tests do not need to 
be conducted if: 
— an in vivo study referred to 
in point (c) in column 1 of 
this row is available, or 
— the available in vitro or in 
chemico test methods are 
not applicable for the 
product or mixture or the 
results obtained from these 
studies are not adequate 
for classification and risk 
assessment. 
If information from test 
method(s) addressing one or 
two of the key events 
described in point (b) in 
column 1 of this row already 
allows for classification of the 
substance and risk 
assessment, studies 
addressing the other key 
event(s) do not need to be 
conducted 
An in vivo study for skin 
sensitisation shall be 
considered only if in vitro or in 
chemico studies referred to in 
point (b) in column 1 of this row are not applicable, or the 
results obtained from these 
studies are not adequate for 
classification and risk 
assessment and the 
calculation method or 
bridging principles laid down 
in Regulation (EC) 
No 1272/2008 are not 
applicable 
In vivo studies for skin 
sensitisation that were carried 
out or initiated before 15 
April 2022 shall be considered 
appropriate to address this 
information requirement. 
8.7 Available toxicological data 
relating to:  
—  non-active  substance(s)  (i.e.  
substance(s) of concern), or  
— a mixture that a substance(s) of 
concern is a component of  
If insufficient data are available for 
a non-active substance(s) and 
cannot be inferred through read-
across or other accepted non-
testing approaches, targeted 
test(s) described in Annex II shall 
be carried out for the substance(s) 
of concern or a mixture that a 
substance(s) of concern is a 
component of   Testing on the product/mixture 
does not need to be conducted 
if:  
— there are valid data available 
on each of the components 
in the mixture to allow 
classification of the mixture 
according to the rules laid 
down in Directive 
1999/45/EC and Regulation  
(EC) No 1272/2008 (CLP)   Available toxicological data relating 
to: 
(a) non-active substance(s) (i.e. 
substance(s) of concern); and 
(b) a mixture that a substance(s) of 
concern is a component of 
Tests listed in Section 8 of the table 
in Title 1 of Annex II shall be carried 
out for the substance(s) of concern 
or a mixture that a substance(s) of 
concern is a component of if 
insufficient data are available and 
cannot be inferred through read-
across, in silico or other accepted 
non-testing approaches   Testing on the product or 
mixture does not need to be 
conducted if all of the 
following conditions are met: 
— there are valid data 
available on each of the 
components in the mixture 
to allow classification of the 
mixture in accordance with 
the rules laid down in 
Regulation (EC) 
No 1272/2008, 
— a conclusion can be made 
whether the biocidal 
product can be considered 
as having endocrine 
disrupting properties, 
— synergistic effects between 
any of the components are 
not expected. 
 
9.1 Information relating to the 
ecotoxicity of the biocidal product 
which is sufficient to enable a 
decision to be made concerning   Available ecotoxicological data 
relating to:   Testing on the product or 
mixture does not need to be the classification of the product is 
required  
— Where there are valid data 
available on each of the 
components in the mixture 
and synergistic effects 
between any of the 
components are not 
expected, classification of the 
mixture can be made 
according to the rules laid 
down in  
Directive 1999/45/EC, 
Regulation (EC) No 1907/2006 
(REACH) and Regulation (EC) 
No 1272/ 2008 (CLP)  
— Where valid data on the 
components are not available or 
where synergistic effects may be 
expected then testing of 
components and/or the biocidal 
product itself may be necessary  (a) non-active substance(s) (i.e. 
substance(s) of concern); 
(b) a mixture that a substance(s) of 
concern is a component of 
Tests listed in Section 9 of Title 1 of 
Annex II shall be carried out for the 
substance(s) of concern or a 
mixture that a substance(s) of 
concern is a component of if 
insufficient data are available and 
cannot be inferred through read-
across, in silico or other accepted 
non-testing approaches conducted if all the following 
conditions are met: 
— there are valid data 
available on each of the 
components in the mixture 
to allow classification of the 
mixture in accordance with 
the rules laid down in 
Regulation (EC) 
No 1272/2008, 
— a conclusion can be made 
whether the biocidal 
product can be considered 
as having endocrine 
disrupting properties, 
— synergistic effects between 
any of the components are 
not expected. 
 
 
Title 2 table 
 Current GB BPR Wording Suggested new wording 
Heading 
of column 
3 Column 1  
Information required:  Column 
2  
All data 
is CDS 
unless 
indicated 
as ADS  Column 3 
Specific rules for adaptation from 
standard information concerning 
some of the  
information requirements that 
may require recourse to testing of 
vertebrates  Column 1 
Information required:  Colum 2 
All data 
is CDS 
unless 
indicated 
as ADS  Column 3 
Specific rules for adaptation from 
column 1 
 
2.3 Detailed quantitative (g/kg, g/l or 
% w/w (v/v)) and qualitative 
information on the constitution, 
composition and function of the 
biocidal product, e.g. micro-
organism, active substance(s) and 
product non-active substances   Detailed quantitative (g/kg, g/l, % 
w/w (v/v), cfu/g, cfu/l or IU/mg or 
any other appropriate unit) and 
qualitative information on the 
constitution, composition and 
function of the biocidal product, 
e.g. micro-organism, active 
substance(s) and non-active   and any other relevant 
components.  
All relevant information on 
individual ingredients and the final 
composition of the biocidal 
product shall be given  substances and any other relevant 
components 
All relevant information on 
individual ingredients and the final 
composition of the biocidal 
product shall be given 
3.6.8 Burning rate — smoke 
generators   
   DELETED   
3.6.9 Burning  completeness 
 —  smoke 
generators   DELETED   
3.6.10 Composition of smoke — 
smoke generators    DELETED   
3.6.11 Spraying patterns — 
aerosols    DELETED   
3.6.12 Other technical 
characteristics    DELETED   
3.6.8 N/A – new insertion   Spraying patterns – aerosols   
3.6.9 N/A – new insertion   Other technical characteristics   
4.   PHYSICAL 
 HAZARDS AND 
RESPECTIVE 
CHARACTERISTICS 
   4.PHYSICAL HAZARDS AND 
RESPECTIVE CHARACTERISITICS 
   
4.1.  Explosives    4.1. Explosives 
   
4.2.  Flammable gases    4.2. Flammable aerosols 
   
4.3.  Flammable aerosols    4.3. Flammable liquids 
   
4.4.  Oxidising gases    4.4. Flammable solids 
   
4.5.  Gases under pressure    4.5. Oxidising liquids 
   
4.6.  Flammable liquids    4.6. Oxidising solids 
   
4.7.  Flammable solids    4.7. Corrosive to metals 
   
4.8.  Oxidising liquids    4.8. Other physical indications of 
hazard 
   4.9.  Oxidising solids    4.8.1. Auto-ignition temperatures 
of products (liquids and 
gases) 
   
4.10.  Organic peroxides    4.8.2. Relative self-ignition 
temperature for solids 
   
4.11.  Corrosive to metals    4.8.3.  Dust explosion hazard 
   
4.12.  Other physical indications 
of hazard        
4.12.1.  Auto-ignition 
 temperatures  of 
products (liquids and 
gases)        
4.12.2.  Relative self-ignition 
temperature for solids         
4.12.3.  Dust explosion hazard        
10.3.  Leaching behaviour  ADS  Leaching behaviour and/or 
mobility ADS