Guidance on the Biocidal Products Regulation . Volume I, Identity/physico-chemical properties/analytical methodology. Parts A+B+C: information requirements.
Date: 2018-12-11
Institutions: European Chemicals Agency
Subjects: biochemistry, chemical product, plant health product, regulation (EU), toxic substance, user guide

G U I D A N C E  

Guidance on the Biocidal Products Regulation 

Volume I: Identity of the active substance/physico-chemical 
properties/analytical methodology –  Information 
Requirements, Evaluation and Assessment. 
Parts A+B+C  

Version 2.0 
May 2018 

 
 
 
 
 
 
 
 
 
2 

Guidance on the BPR: Volume I Parts A+B+C  
Version 2.0 May 2018  

LEGAL NOTICE 

This document aims to assist users in complying with their obligations under the Biocidal 
Products Regulation (BPR). However, users are reminded that the text of the BPR is the 
only  authentic  legal  reference  and  that  the  information  in  this  document  does  not 
constitute legal advice. Usage of the information remains under the sole responsibility of 
the user. The European Chemicals Agency does not accept any liability with regard to the 
use that may be made of the information contained in this document 

Guidance on the Biocidal Products Regulation: Volume I:  Identity of the active 
substance/physico-chemical properties/analytical methodology - Parts A+B+C: 
Information Requirements, Evaluation and Assessment 

ECHA-18-G-03-EN 

Reference:  
Cat. Number:   ED-02-18-531-EN-N 
978-92-9020-504-3 
ISBN:  
10.2823/628864 
DoI:  
May 2018 
Publ.date:  
EN 
Language:  

© European Chemicals Agency, 2018 

If you have questions or comments in relation to this document please send them (quote 
the reference and issue date) using the information request form. The information 
request form can be accessed via the Contact ECHA page at: 
http://echa.europa.eu/contact.  

European Chemicals Agency 

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland 
Visiting address: Annankatu 18, Helsinki, Finland 

  
 
 
 
 
Guidance on the BPR: Volume I Parts A+B+C 
Version 2.0  2018 

DOCUMENT HISTORY 

Version 

Comment 

Version 1.0  First edition 

Version 1.1  Corrigendum: 

  Division of the guidance in the 4 volumes of the new 

BPR Guidance structure; 

  Minor editorial changes. 

3 

Date 

June 2013 

November 
2014 

Version 2.0  Corrigendum: 

May 2018 

 

In Preface: To update the text to reflect the changes to 
the structure of the BPR guidance and to align the text 
with that in the current published Parts B+C for 
Volumes II, III and IV; 

 

In Preface: to add text and links on “Applicability of 
Guidance”; 

  To amend the numbering of all sections to follow a 

normal sequential numbering format for the sections 
and to add in the heading for each section the relevant 
BPR Annex reference for clarification;  

  To relocate the “Finder” tables to follow the Table of 

Contents in “Notes for the Reader”;  

  To correct the explanation of the abbreviation ISO in 

the List of Abbreviations; 

  To delete references to the CLP transition arrangements 

and dates which no longer apply;  

  To correct the reference under Table 7; 

  To move the sections on “BPR Annexes II and III point 
7 Intended Uses and Exposure” to   Volume II, Part A. 

  To add a page for Section 4 for evaluation and 

assessment with a cross reference to currently available 
guidance in TNsG. 

 
 
 
4 

PREFACE  

Guidance on the BPR: Volume I Parts A+B+C  
Version 2.0 May 2018  

The Guidance on the Biocidal Products Regulation – Part A (information requirements) is 
to be applied to applications for active substance approval and product authorisation as 
submitted from 1 September 2013, the date of application (DoA) of the Biocidal Product 
Regulation (the BPR).  

This document describes the BPR obligations and how to fulfil them. 

The scientific guidance provides technical scientific advice on how to fulfil the information 
requirements set by the BPR, how to perform the risk assessment and the exposure 
assessment for the evaluation of the human health and environmental aspects and how 
to asses and evaluate the efficacy to establish the benefit arising from the use of biocidal 
products and that it is sufficiently effective (Parts B & C).  

In addition to the BPR guidance, the Biocidal Products Directive (BPD) guidance and 
other related documents are still considered applicable for new submissions under the 
BPR in the areas where the BPR guidance is under preparation.  Furthermore these 
documents are still valid in relation to the applications for active substance approval or 
applications for product authorisation under the BPD that may still be under 
evaluation.  Also the Commission has addressed some of the obligations in further detail 
in the Biocides competent authorities meetings documents which applicants are advised 
to consult. Please see ECHA Biocides Guidance website for links to these documents: 
[https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation]. 

The complete guidance series in support of the BPR is shown in the figure below:  

Figure 1: BPR guidance structure 

  
 
 
 
 
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Version 2.0  2018 

5 

The BPR guidance was developed based on the Technical Notes for Guidance (TNsG) on 
data requirements under the previous legislation, the Biocidal Products Directive (BPD). 
However, the information requirements compared to the BPD have changed in the BPR; 
the major differences are: 

1.  The term information requirement is used instead of data requirement. The new 

term reflects the fact that applicants do not, in all cases, need to supply data, i.e. 
information originating from studies but also general information such as 
addresses and names as well as (quantitative) structure–activity relationship 
(Q)SAR and so forth. 

2.  The harmonisation with Guidance from other legal frameworks was a key 

objective:  

a.  When applicable, endpoint sections entail a reference to a relevant REACH 
(Regulation (EC) No 1907/2006 on Registration, Evaluation, Authorisation 
and Restriction of Chemicals) Guidance if available; 

b.  When applicable, Guidance from the Plant Protection Products Regulation 
(PPPR, Regulation (EC) No 1107/2009) – Uniform Principles is referred to. 

3.  The structure has been modified in accordance with the new BPR Annex 

structure: 

a.  The core data set (CDS) and additional data set (ADS) are listed in the 

same section.  

b.  The specific rules for adaptation from standard information requirements 
(including those given by BPR Annex II and III column 3) are included in 
the respective endpoint sections, where available. 

4.  The core data requirements have been modified and certain long term animal 

studies are only required when necessary.  

5.  The BPR also allows for a more systematic approach to the adaptation of 

information requirements based on exposure as well as the use of techniques 
such as read-across, (Q)SAR and calculation methods.  

6.  The principle of proposing and accepting adaptations to the information 

requirements has been formalised and Member States have to inform and, if 
possible, assist the applicants with their adaptation requests.  

7.  It is possible to provide a reduced data package on a case-by-case basis when 

applying for product authorisation, taking into account the nature of the product 
and the expected level of exposure.  

Applicability of Guidance 

Guidance on applicability of new guidance or guidance related documents for active 
substance approval is given in the published document “Applicability time of new 
guidance and guidance-related documents in active substance approval” available on the 
BPC Webpage1 [https://echa.europa.eu/about-us/who-we-are/biocidal-products-
committee] and for applicability of guidance for product authorisation, please see the 
CA-document CA-july2012-doc6.2d (final), available on the ECHA Guidance page 
[https://echa.europa.eu/documents/10162/23036409/ca-july12-
doc_6_2d_final_en.pdf]. 

1  Link available under Working Procedures (right column) [https://echa.europa.eu/about-us/who-
we-are/biocidal-products-committee] 

 
 
 
                                           
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Guidance on the BPR: Volume I Parts A+B+C  
Version 2.0 May 2018  

Table of Contents 

LEGAL NOTICE ................................................................................................... 2 

DOCUMENT HISTORY .......................................................................................... 3 

PREFACE ........................................................................................................... 4 

LIST OF ABBREVIATIONS .................................................................................... 9 

1.  PART A: INTRODUCTION TO THE GUIDANCE ON INFORMATION REQUIREMENTS ... 13 
1.1 
General structure of the guidance on information requirements ............ 14 
1.2   Guiding principles with regard to information requirements in general ... 16 
On the use of additional Guidance documents .................................... 20 
1.3 
General guidance on generating the information ................................. 21 
1.4 
Guidance on non-submission of information ....................................... 23 
1.5 
Testing of metabolites and transformation products ............................ 23 
1.6 
Background documents ................................................................... 24 
1.7 
Sources of test methods and standards ............................................. 25 
1.8 
2. PART A: DOSSIER REQUIREMENTS FOR ACTIVE SUBSTANCES ............................. 27 
BPR ANNEX II, TITLE 1, POINTS 1-13 ............................................................... 27 
GENERAL INFORMATION ................................................................................. 27 
Point 1 Applicant ............................................................................ 27 
Point 11 Measures necessary to protect human health, animals and the 
environment .................................................................................. 27 
Point 12 Classification, labelling and packaging .................................. 30 
Point 13 Summary and evaluation .................................................... 32 
SPECIFIC INFORMATION ................................................................................. 33 
Point 2 Identity of the active substance ............................................. 33 
Point 3 Physical and chemical properties of the active substance .......... 38 
Point 4 Physical hazards and respective characteristics ........................ 46 
Point 5 Methods of detection and identification ................................... 51 

2.5 
2.6 
2.7 
2.8 

2.3 
2.4 

2.1 
2.2 

3  PART A: DOSSIER REQUIREMENTS FOR BIOCIDAL PRODUCTS ............................. 60 
BPR ANNEX III, TITLE 1, POINTS 1-13 .............................................................. 60 

3.1 
3.2 

GENERAL INFORMATION ................................................................................. 60 
Point 1 Applicant ............................................................................ 60 
Point 11 Measures to be adopted to protect humans, animals and the 
environment .................................................................................. 60 
Point 12 Classification, labelling and packaging .................................. 62 
Point 13 Evaluation and Summary .................................................... 64 

3.3 
3.4 

SPECIFIC INFORMATION ................................................................................. 65 
Point 2 Identity of the biocidal product .............................................. 65 
Point 3 Physical, chemical and technical properties ............................. 67 
Point 4 Physical hazards and respective characteristics ........................ 79 
Point 5 Methods of detection and identification ................................... 80 

3.5 
3.6 
3.7 
3.8 

4.  PARTS B+C: EVALUATION AND ASSESSMENT ................................................... 84 

REFERENCES AND BACKGROUND DOCUMENTS ...................................................... 85 

Figures 

Figure 1: BPR guidance structure ......................................................................... 4 
Figure 2: Structure of data/information requirements under the BPD and the BPR. ..... 15 

  
 
 
 
Guidance on the BPR: Volume I Parts A+B+C 
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7 

Tables 

Table 1: Section of Annex II BPR vs BPR Volume and section number ....................... 7 
Table 2: Section of Annex III BPR vs BPR Volume and section number ...................... 8 
Table 3 Three-column- structure of BPR information requirements in Annexes II and III 
of the BPR. ........................................................................................................ 15 
Table 4: Acceptable recovery values for residues or impurities ................................. 52 
Table 5: Tolerance limits of the active substance content at the point of manufacture . 66 
Table 6: Conditions for accelerated storage testing for heat sensitive active substances 68 
Table 7: Acceptable extrapolations for different packaging types for storage stability 
studies .............................................................................................................. 70 

NOTES to the reader:  

When reading this document, please note that the text written in italics originates 
from the BPR or its Annexes.  

The numbering of the requirements corresponds to the numbering in the BPR 
Annexes II and III. 

The section headings include a reference to the relevant section/point in the BPR 
Annex for ease of cross reference. 

The two tables below relate the sections of the BPR Annexes II and III with the 
Guidance Volume and section number.  

Table 1: Section of Annex II BPR vs BPR Volume and section number 

Annex II BPR section 

BPR Volume + section number 

1.  APPLICANT 

Volume I: Section 2.1 

1.  IDENTITY OF THE ACTIVE 

Volume I  Section 2.2 

SUBSTANCE 

2.  PHYSICAL, CHEMICAL AND 
TECHNICAL PROPERTIES 
3.  PHYSICAL HAZARDS AND 

RESPECTIVE CHARACTERISTICS 

Volume I  Section 2.3 

Volume I  Section 2.4 

4.  METHODS OF DETECTION AND 

Volume I  Section 2.5 

IDENTIFICATION 

5.  EFFECTIVENESS AGAINST TARGET 

Volume II: Section 2 

ORGANISMS 

6.  INTENDED USES AND EXPOSURE 

Volume II  Section 2.2 

7.  TOXICOLOGICAL PROFILE FOR 

Volume III: Section 2.1 

HUMANS AND ANIMALS 

8.  ECOTOXICOLOGICAL STUDIES 

Volume IV: Section 2.1 

9.  ENVIRONMENTAL FATE AND 

Volume IV: Section 2.2 

BEHAVIOUR 

10. MEASURES TO BE ADOPTED TO 

Volume I: Section 2.11   

PROTECT HUMANS, ANIMALS AND 
THE ENVIRONMENT 

11. CLASSIFICATION, LABELLING, AND 

Volume I: Section 2.12 

PACKAGING 

 
 
 
 
 
 
 
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Guidance on the BPR: Volume I Parts A+B+C  
Version 2.0 May 2018  

Table 2: Section of Annex III BPR vs BPR Volume and section number 

Annex III BPR section 

BPR Volume + section number 

2.  APPLICANT 

Volume I:  Section 3.1 

3.  IDENTITY OF THE BIOCIDAL 

Volume I:  Section 3.2  

PRODUCT 

4.  PHYSICAL, CHEMICAL AND 
TECHNICAL PROPERTIES 
5.  PHYSICAL HAZARDS AND 

RESPECTIVE CHARACTERISTICS 

Volume I:  Section 3.3  

Volume I:  Section 3.4  

6.  METHODS OF DETECTION AND 

Volume I:  Section 3.5  

IDENTIFICATION 

7.  EFFECTIVENESS AGAINST TARGET 

Volume II: Section 3.6 

ORGANISMS 

8.  INTENDED USES AND EXPOSURE 

Volume II:  Section 3.2  

9.  TOXICOLOGICAL PROFILE FOR 

Volume III: Section 3.1  

HUMANS AND ANIMALS 

10. ECOTOXICOLOGICAL STUDIES 

Volume IV: Section 3.1 

11. ENVIRONMENTAL FATE AND 

Volume IV: Section 3.2 

BEHAVIOUR 

12. MEASURES TO BE ADOPTED TO 

Volume I:  Section 3.11  

PROTECT HUMANS, ANIMALS AND 
THE ENVIRONMENT 

13. CLASSIFICATION, LABELLING, AND 

Volume I:  Section 3.12  

PACKAGING 

  
 
 
 
 
Guidance on the BPR: Volume I Parts A+B+C 
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9 

List of Abbreviations 

Standard term / 
Abbreviation 

Explanation 

°C  

AAS 

ADS 

AEL 

ASTM  

BPC 

BPD  

BPR 

Degree(s) Celsius (centigrade)  

Atomic absorption spectrometry 

Additional data set 

overall systemic limit value for the human population 

American Society for Testing and Materials  

Biocidal Products Committee (ECHA body) 

Biocidal Products Directive. Directive 98/8/EC of the European Parliament 
and of the Council on the placing on the market of biocidal products 

Biocidal Products Regulation. 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  

CAS  

Chemical abstract (Service or System)  

CAS registry 
number 

A CAS registry number (Chemical Abstract Service index number) is a 
unique numerical identifier for chemical compounds, polymers, biological 
sequences, mixtures and alloys and does not have any chemical 
significance  

CDS 

CEN  

CIPAC  

Core data set 

European Committee for Normalisation  

Collaborative International Pesticides Analytic Council Ltd.  

CLP (Regulation)  Classification, Labelling and Packaging Regulation. Regulation (EC) No 

1272/2008 of the European Parliament and of the Council on 
Classification, Labelling and Packaging of substances and mixtures 

Dw 

DAD 

DG  

Dry weight 

Diode array detector 

European Commission Directorate General  

DG SANCO 

European Commission Directorate-General for Health and Consumers 

DoA 

DSC 

DegT

DegT

50

90

DTA 

DWD 

EC   

Date of application 

Differential Scanning Calorimetry 

Period required for 50% degradation (define method of estimation)  

Period required for 90% degradation (define method of estimation)  

Differential Thermo-Analysis 

European Drinking Water Directive (Directive 98/83/EC) 

European Communities or European Commission  

EC method 

Test Method as listed in the Test Methods Regulation 

ECD 

ECHA 

EEA 

EEC  

Electron Capture Detector 

European Chemicals Agency 

European Economic Area.  
The EEA is composed of Iceland, Liechtenstein, Norway and the EU 
Member States. 

European Economic Community  

 
 
 
 
10 

Standard term / 
Abbreviation 

EFSA  

EINECS  

ELINCS  
EN  
EPA  
(DK, USA)  
EPPO/OEPP  

ESD 

EU  
EWPM  
FCM 

FID 

FPD 

g  

GC 

GLP  

h  

ha  

HLC 

HPLC  

ICP 

ICP-MS 

ICP-OES 

ILV 

Guidance on the BPR: Volume I Parts A+B+C  
Version 2.0 May 2018  

Explanation 

European Food Safety Agency 

European Inventory of Existing Commercial Chemical Substances 

European List of (new or notified) Chemical Substances  
European norm  
Environmental Protection Agency  
(of Denmark, or the United States of America)  
European and Mediterranean Plant Protection Organization 
Emission Scenario Document, Guidance developed under the BPD 
tailored for biocides  
European Union  
European Wood Preservation Manufacturers  
Food contact material 

Flame ionisation detector 

Flame photometric detector 

Gram(s)  

Gas chromatography 

Good laboratory practice  

Hour(s)  

Hectare(s)  

Henry’s Law Constant 

High performance (or pressure) liquid chromatography  

Inductively coupled plasma 

Inductively coupled plasma mass spectrometry 

Inductively coupled plasma optical emission spectrometry 

Independent laboratory validation 

INDEX number 

The INDEX number (format XXX-XXX-XX-X) is a European number 
attributed to substances listed on Part 3 of Annex VI to the CLP 
Regulation (List of harmonised classifications and labelling). 

IR  

IPCS 

ISBN  

ISO  

Infrared  

The WHO International Programme on Chemical Safety 

International standard book number  

International Organization for Standardization 

ISO  
(TC, SC, WG)  

International Organization for Standardization 
Technical Committee, Scientific Committee, Working Group  

ISSN 

IUCLID 

IUPAC  

JRC 

K 

kg  

International standard serial number  

International Uniform Chemical Information Database 

International Union for Pure and Applied Chemistry  

Joint Research Centre 

Kelvin 

Kilogram(s)  

  
 
Guidance on the BPR: Volume I Parts A+B+C 
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11 

Standard term / 
Abbreviation 

K

ow

kPa  

Kst 

L 

LEL 

LOC 

LOQ 

m  

mg  

MIE 

MIT 

MMAD  

mol 

MOTA 

MRL 

MS 

MSCA 

MSn 

MT  

nm 

NMR  

no.  

NOAEC 

NPD 

OECD  

OEL 

OH- 

OSHA 

Pa  

pH  

pKa  

pKb  

PNEC 

PPPR 

PT  

REACH 

Octanol-water partition coefficient  

Explanation 

Kilopascal(s)  

Dust explosion constant 

Litre(s)  

Lower explosion limit 

Limiting oxygen concentration 

Limit of quantification 

Metre  

Milligram(s)  

Minimum ignition energy 

Minimum ignition temperature  

Mass median aerodynamic diameter  

Mole(s) 

Manual of Technical Agreements of the Biocides Technical Meeting 

Maximum residue limit 

Mass spectrometry 

Member State competent authority 

A number of coupled mass spectrometers 

Material test  

Nanometre(s) 

Nuclear magnetic resonance  

Number  

No observed adverse effect concentration 

Nitrogen phosphorus detector 

Organisation for Economic Cooperation and Development  

Occupational exposure limit 

Hydroxide  

European Agency for Safety and Health at Work 

Pascal(s)  

pH-value, negative decadic logarithm of the hydrogen ion concentration  

Negative decadic logarithm of the acid dissociation constant  

Negative decadic logarithm (to the basis 10) of the base dissociation 
constant  

Predicted no effect concentration 

Plant Protection Products Regulation. Regulation (EC) No 1107/2009 of 
the European Parliament and of the Council of concerning the placing of 
plant protection products on the market 

Product-type  

Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals 

 
 
 
12 

Standard term / 
Abbreviation 

Guidance on the BPR: Volume I Parts A+B+C  
Version 2.0 May 2018  

Explanation 

RSD  

s 

SDS 

SMEs  

Relative standard deviation  

Second(s) 

Safety data sheet 

Small and medium-sized enterprises  

SMILES 

Simplified molecular-input line-entry system 

TC 

Technical material 
In accordance with FAO manual (FAO, 2010), TC is usually the final 
product from preparation of the active substance prior to being 
formulated into an end-use product. This may contain a stabiliser and/or 
anti-caking or anti-static agents (if required) but no other additives.  
TC is usually ≥900 g/kg with solvent(s) removed during synthesis, with 
only residual amounts remaining (usually ≤10%) and no solvent added 
subsequently. 

Test Methods 
Regulation 

Regulation (EC) No 440/2008 laying down test methods pursuant to the 
REACH Regulation 

TK 

TGD  

TNsG  

UN 

UV 

UVCB  

v/v  

VDI 

VIS  

w/w  

WHO  

μg  

Technical concentrate 
In accordance with FAO manual (FAO, 2010), TK may also be the final 
product from preparation of the active substance but it may contain 
additives (not formulants) in addition to a stabiliser, for example as 
safety agents. TK may also contain solvent(s) (including water), either 
deliberately added to a TC or not removed during preparation. 

Technical Guidance Document (EU, 2003)  

Technical Notes for Guidance  

United Nations 

Ultraviolet 

Unknown or variable composition, complex reaction products or biological 
material  

Volume per volume ratio  

Verein Deutscher Ingenieure (The Association of German Engineers) 

Visible  

Weight per weight ratio  

World Health Organisation  

Microgram(s)  

  
 
 
 
Guidance on the BPR: Volume I. Parts A+B+C 
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13 

1.  Part A: Introduction to the Guidance on Information 
Requirements 

Regulation (EU) No 528/2012, of the European Parliament and of the Council (Biocidal 
Products Regulation, the BPR) lays down rules and procedures for approval of the active 
substances in biocidal products at European Union (EU) level and for the authorisation of 
biocidal products in both Member States and at EU level2. The objective of the BPR is to 
improve the functioning of the internal market on biocidal products whilst ensuring a 
high level of environmental and both human and animal health protection. In addition, 
the BPR removes a number of deficiencies that were identified during the 
implementation of Directive 98/8/EC of the European Parliament and of the Council on 
the placing on the market of biocidal products (BPD). 

Study data and other information must fulfil the minimum requirements whilst being 
sufficient to conduct a proper risk and efficacy assessment in order to finally allow for a 
decision on the suitability of the substance to be approved or, the product to be 
authorised. 

The BPR set out rules on information requirements (especially in Articles 6-8). The 
information requirements are specified for active substances in Annex II, and for the 
respective biocidal products in Annex III (in Title 1 of Annex II and III for chemicals and 
Title 2 of Annex II and III for micro-organisms).  

Due to the wide scope of the BPR and the extensive variation of efficacy, exposure and 
risks of biocidal products, the general rules provided in the BPR and its Annexes have to 
be specified in order to ensure efficient and harmonised day-to-day implementation of 
the regulation. The aim of the Guidance is to provide detailed and practical direction on 
which study data and other information should be submitted, when applying for approval 
and authorisation according to the BPR. The requirements outlined in Volume II Efficacy  
are also applicable for the simplified authorisation procedure, i.e. those products that 
fulfil all conditions of the requirements listed in Article 25 of the BPR.  

It should be noted that only chemical biocidal products (Title 1 of Annex III to the BPR), 
including treated articles, and chemical active substances (Title 1 of Annex II to the BPR) 
are covered by the present document. Guidance on the information requirements for 
micro-organisms is available separately in Guidance on micro-organisms (Volume V). 
Guidance on substances of concern will be available in Parts B+C of Volumes III and IV. 

Several documents published by the Commission and ECHA have been used as a basis 
for the information requirements presented; see section 1.3 of this guidance. 

This Guidance is primarily addressed to  applicants, seeking approval of an active 
substance and for authorisation of a biocidal product, who submit information to the  
Member State competent authorities (MSCA). The MSCAs task is then to validate and 
evaluate the application, (adequacy and relevance) of the submitted information. 

2  The  terms  ‘EU’  or  ‘Community’  used  in  this  document  cover  the  EEA  States.   The  European 
Economic Area is composed of Iceland, Liechtenstein, Norway and the EU Member States. 

 
 
                                           
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Guidance on the BPR: Volume I. Parts A+B+C 
Version 2.0 May 2018 

1.1  General structure of the guidance on information 

requirements 

1.1.1 

 Information requirements in general 

The information requirements are two-tiered: 

I.  The core data set (CDS) is mandatory for all product-types. This information 
always has to be submitted, unless the rules for adaptation of standard 
information are applicable (see below).  

II.  The additional data set (ADS) might be required to perform the risk assessment 

under the following conditions (To Note: ADS is not applicable for Efficacy data 
requirements): 

a.  ADS information on physical chemical properties, methods of detection 

and identification and on the toxicological profile is required depending on 
the intrinsic properties of the active substance or the biocidal product.   

b.  ADS information on the ecotoxicological properties and the environmental 
fate and behaviour of the active substance or biocidal product is required 
depending on the product-type, i.e. the foreseen use and route of 
exposure.   

c.  ADS information on the ecotoxicological properties and the environmental 
fate and behaviour might be required to refine the initial risk assessment. 

1.1.2 

 Comparison of BPD-BPR 

Figure 2 represents a comparison of the structure of the data requirements or information 
requirements, respectively, under the BPD and under the BPR.  

In the BPD legal text as well as in the TNsG on data requirements (EU, 2008a), CDS and 
ADS are listed in separate Annexes. In contrast, the BPR text lists both CDS and ADS in 
the same Annexes, but includes an additional column to indicate if the requirement is 
ADS (see below). In addition, 'specific rules for adaptation from standard information 
concerning some of the information requirements that may require recourse to testing of 
vertebrates' represent data waiving possibilities and are listed alongside the respective 
endpoints in Annexes II and III in the BPR. 

 
 
 
Guidance on the BPR: Volume I. Parts A+B+C 
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15 

BPD 

Annex II 

CDS 
Product  III A 
Active Substance  II B 

ADS 
Product 
Active Substance  III B 

Annex III 

II A 

BPR 

Annex II 

Active Substance 

CDS and ADS 

Annex III 

Product 

CDS and ADS 

Specific rules for adaptation from 

Specific rules for adaptation from 

standard information 

standard information 

Figure 2: Structure of data/information requirements under the BPD and the 
BPR. 

Unlike the BPD, the information requirements in Annexes II and III of the BPR are listed 
in three columns:  

 

 

column 1 contains the actual requirements,  

column 2 indicates whether it is a CDS or an ADS,  

  column 3 contains waiving statements when applicable (see Table 1). General 

rules for data waiving can be found in Annex IV of the BPR. 

Table 3 Three-column- structure of BPR information requirements in Annexes II 
and III of the BPR. 

COLUMN 1 

COLUMN 2 

COLUMN 3 

Information requirement 

ADS label or no label 
(for CDS) 

Specific rules for adaptation 
from standard information 
concerning some of the 
information requirements that 
may require recourse to testing 
of vertebrates. 

 
 
 
 
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Guidance on the BPR: Volume I. Parts A+B+C 
Version 2.0 May 2018 

1.1.3  Volume I Parts A+B+C: Document structure 

This document (Volume I, Parts A+B+C) covers the following: 

  Part A: includes general information on information requirements (i.e. 

applicable to all four volumes) and the specific information requirements for 
identity/physico-chemical properties/analytics.  

  Other general information relevant for the whole dossier not dealing with 

information requirements. 

  Parts B+C: additional guidance on addressing evaluation and assessment for 

relevant sections of physico-chemical properties   

There are 4 sections:  

Section 1 contains general guiding principles for information requirements which apply 
(in general) to all four Volumes.  

Section 2 covers CDS and ADS information requirements as listed in Title 1 of Annex II 
to the BPR. The section explains the BPR requirements for active substances (chemical 
substances) and contains references to relevant test methods and further guidance. For 
example, it offers guidance on which test is the most suitable for specific cases. In 
addition, the section contains the specific rules for adaptation from standard information, 
where applicable. These waiving rules are generally accepted, scientifically or technically 
justified exemptions to the information requirements. Section 2, has been divided in two 
sub-sections: section 2.1 includes the general information requirements for the whole 
dossier (as explained above), and section 2.2 includes the specific information 
requirements for identity/physico-chemical properties/analytics. 

Section 3 provides CDS and ADS information requirements as listed in Title 1 of Annex 
III of the BPR. The section explains the BPR requirements for biocidal products (chemical 
products) and contains references to relevant test methods and further guidance. Similar 
to section 2, it also contains references to relevant test methods and explains the Annex 
III requirements. It also lists the specific rules for adaptation from standard information. 
Section 3, has also been divided in two sub-sections: section 3.1 includes the general 
information requirements for the whole dossier (as explained above) and section 3.2 the 
specific information requirements for identity/physico-chemical properties/analytics. 

Section 4 is for evaluation and assessment with a cross reference to currently available 
guidance in TNsG. 

1.2 Guiding principles with regard to information requirements in 

general 

The following guiding principles reflect the general guidance on information requirements 
which apply to all four volumes, as provided in the BPR.  

1.  The common core data set (CDS) forms the basis of the requirements. In 
general, it is regarded to be a minimum set required for all substances and 
product-types.  

2.  The additional data set (ADS) includes supplementary information 

requirements. These are indicated in column 2 in the BPR Annexes. This 
information may be required depending on the characteristics of the active 
substance and/or the product-type and on the expected exposure of humans, 
animals and the environment. The product’s use or application method needs to 
be taken into account under both the proposed normal use and a possible realistic 
worst case situation (Article 19(2) of the BPR). 

 
 
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3.  The adaptation of information requirements  outlined throughout this 

Guidance is possible in certain cases for both CDS and ADS. For example, some 
of the toxicological information requirements may be adapted occasionally when 
the exposure is limited or when other product-type-specific factors apply; or for 
the efficacy of new products with uses, mode of action or application technique 
that is not covered by the guidance, other efficacy tests than stated in the 
requirements can be more suitable. Sufficient and acceptable justification needs 
to be provided for the adaptation. In addition, the inherent physical and chemical 
properties of the substance or the product may justify waiving of some 
information requirements. The guidance on General Rules for the Adaptation of 
the Data Requirements  is under development by the Commission and will be 
made available accordingly. Until then please refer to Chapter 1 Section 1.4 of 
the TNsG on Data Requirements (EU, 2008a). REACH Guidance on QSARs and 
grouping of chemicals (ECHA, Guidance on information requirements and 
chemical safety assessment Chapter R.6: QSARs and grouping of chemicals)  
could also be useful.  

4.  The information requirements have been specified in as much detail as possible. 
However, in certain cases, expert judgement by the applicant and by the 
competent authority (CA) may be necessary in order to assess, for instance, 
whether an additional study is needed or on which organism or under which 
conditions a test should be performed. The applicant should propose the initial 
expert judgement, which is then examined during the evaluation. In making the 
decision as to whether additional testing is justified, the benefit for the risk 
assessment (including intended use), the compatibility with accepted risk 
assessment rationales, and the feasibility of the required tests may have to be 
considered. When providing an expert judgement one must, when relevant, take 
into account both the proposed normal use and a possible realistic worst case 
situation. Expert judgement decisions should be scientifically justified and 
transparent. In certain cases, the final decision on information requirements is 
made by the Biocidal Products Committee (BPC). Special attention is required in 
cases where there are endpoints of concern and clearly defined or standardised 
methods are lacking. Here, the applicant is obliged to investigate if relevant 
methods are applicable. New test methods are continuously being developed and 
it is the applicant's duty to be up-to-date with the state of science regarding test 
methods.  

5.  It is always the applicant who is responsible for the submission of the data. All 

data provided in the application must always be supported by study reports, 
other data or a letter of access. The information submitted by the applicant on 
both active substances and biocidal products, and also on substances of concern 
present in the biocidal product must be sufficient for conducting a risk 
assessment and an efficacy assessment, and decision-making both at EU level 
and on the level of the individual Member States. The applicant should consult a 
CA as to which data should be submitted. This will allow for proper risk mitigation 
measures to be decided upon if an active substance is likely to fail the criteria for 
entry into the Union list of approved active substances or if a product is likely to 
fail the criteria to be authorised at national or EU level. 

6.  The data submitted by the applicant will form the basis for classification and 

labelling according to the CLP Regulation (harmonised classification in case of 
active substances and self-classification in case of biocidal products). The active 
substances may be subject to harmonised classification for the first time or the 
data can be used to review a previous harmonised classification.   

7.  The data and test requirements should suit the individual circumstances and thus 
make it possible to assess the risks and efficacy under a range of conditions. The 

 
 
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following parameters should be taken into account when preparing the application 
for authorisation: 

a.  The characteristics of the application technique,  

b.  The user type (e.g. professional or non-professional users), and  

c.  The environment, in which the product is intended to be used or into 

which the product may be released. 

8.  Article 62 (1) of the BPR states that In order to avoid animal testing, testing on 

vertebrate animals for the purposes of this Regulation shall be undertaken only 
as a last resort. Testing on vertebrate animals shall not be repeated for the 
purposes of this Regulation. Concerning the latter, further detailed rules are 
provided in Article 62 (2) of the BPR. The data generated and collected under 
other legislative regimes, especially under Council Regulation (EU) No 544/2011, 
Council Regulation (EC) No 1907/2006 and Council Regulation (EC) No 
1272/2008 should be used, taking into account the rules on data protection. 
Sharing of vertebrate data submitted under the BPD or BPR is mandatory. 

9.  With regard to data sharing, for guidance see the ECHA Biocides Guidance 

webpages and the reference to the REACH Guidance on data sharing established 
by ECHA (in accordance with Regulation 1907/2006 (REACH) and the Explanatory 
Note clarifying which chapters are of relevance to the applicants under Biocidal 
Products Regulation (EU) No528/2012 (BPR), 
[http://echa.europa.eu/web/guest/guidance-documents/guidance-on-biocides-
legislation]. 

10. For renewal of a product authorisation the applicant must submit all relevant 

data required under Article 20 of the BPR, that it has generated since the 
initial authorisation. This requirement corresponds to the obligation to submit 
any new data after the authorisation has been granted (Article 13(2) of the BPR). 
This only applies to data that were generated by the applicant and not any other 
data that may be available. For example, if several reports on similar studies are 
available to the applicant they should all be submitted to allow a more sound risk 
assessment with, among others, assessment of inter-species variability. An 
exception to this rule, is for resistance when all available data including a 
literature search, should be provided. The additional data should be of an 
acceptable quality (see Annex IV, point 1 of the BPR). 

11. Point 8 (a) of Annex VI to the BPR states that for the evaluation of a biocidal 

product, the evaluating CA shall take into consideration other relevant technical 
or scientific information which is reasonably available to them with regard to the 
properties of the biocidal product, its components, metabolites, or residues. This 
means that Member States and other stakeholders should also submit relevant 
data to the evaluating CA relevant data, which is reasonably available to them 
but which has not been available to the applicant. The applicant is not responsible 
for this additional information. The applicant, however, is responsible to search 
for data from all sources which he or she may reasonably be expected to have 
access to.  

12. Public literature data can be used in the assessment if the following conditions are 

fulfilled: 

a.  The data comply with the BPR Annex II, III introduction points 5-9. 

b.  The identity, purity and the impurities of the substance have to be defined 
in the publication and to be comparable with the substance addressed in 
the application. 

 
 
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c.  The reporting of the study allows evaluation of the quality of the study. 

If conditions a-c are met the applicant can claim that adequate data is publicly 
available. Providing that the quality of public data fulfils the criteria, it can be 
used as key studies. 

13. There must be at least one key study or an accepted waiving justification for each 
CDS endpoint given in the BPR Annexes II and III (and for each PT if more than 
one PT is applied for). The same applies to ADS endpoints in the BPR Annexes II 
and III, depending on the product-type (in the case of ecotoxicology endpoints 
and environmental fate and behaviour) and on intrinsic physical-chemical or 
toxicological properties of the substance or the product, respectively. A key study 
is the critical study for a certain endpoint and has to be reliable and adequate to 
use for the risk assessment and efficacy assessment. For criteria on the selection 
of key studies and further information, see Parts B+C of each Volume for Efficacy, 
Human health and Environment. A study with a reliability indicator of 3 or 4 
cannot be a key study and can be used only as supportive information. 

14. When more than one adequate study is available, expert judgement should be 
used to decide whether mean or median values should be used instead of the 
result of a single key study. If there is divergent data from acceptable studies, a 
study summary should be provided for all these studies. The study summary of 
each key study must be presented in the IUCLID file.  

15. It is always possible to require additional information or studies if this is 

considered to be necessary for a proper risk assessment, efficacy assessment and 
decision making. The need for additional studies may be justified either by the 
properties of the chemical (i.e. hazard) or by the predicted exposure. In Article 
8(2) of the BPR it states that where it appears that additional information is 
necessary to carry out the evaluation, the evaluating competent authority shall 
ask the applicant to submit such information within a specified time limit, and 
shall inform the Agency accordingly. In that case, the stop-the-clock rule is 
applied. Data may also be required for a substance of concern present in the 
biocidal product other than the active substance. Similarly for a co-formulant3 
to demonstrate that it cannot be considered an active substance.. However, the 
detailed requirements are left mainly to be judged on a case-by-case basis and if 
the outcome of the applicant’s assessment indicates a need for more data, the 
applicant should already consider further studies. 

16. Point 11 of Annex VI to the BPR states that During the process of evaluation, 

applicants and the evaluating bodies shall cooperate in order to resolve quickly 
any questions on the data requirements, to identify at an early stage any 
additional studies required, to amend any proposed conditions for the use of the 
biocidal product, or to modify its nature or its composition in order to ensure full 
compliance with the requirements of Article 19 and of this Annex. The 
administrative burden, especially for SMEs, shall be kept to the minimum 
necessary without prejudicing the level of protection afforded to humans, animals 
and the environment. BPR Specifically SMEs should be allowed extensive 
guidance from the competent authorities in order to be able to fulfil the 
obligations laid down in the BPR. 

17. For the approval of the active substance a specification of the active substance 

will need to be derived. This specification must be representative for the 

3 For more information see Technical Agreement for Biocides [https://echa.europa.eu/about-
us/who-we-are/biocidal-products-committee/working-groups] 

 
 
                                           
 
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manufacturing process as well as for the (eco)toxicological batches tested or, in 
other words, the reference source would be the source for which the 
(eco)toxicological data submitted cover the specification. Therefore it needs to be 
ensured that all impurities in the proposed specification are considered in the 
environmental fate and (eco)toxicological studies (batches used for the 
environmental fate and (eco)toxicological studies may contain impurities at levels 
equal or higher than the proposed specifications or it can be justified why some 
impurities in the proposed specification are not covered by these studies). 

1.3  On the use of additional Guidance documents 

1.3.1  Existing biocides Guidance and other relevant documents 

Part A in each of the four Volumes of the BPR Guidance replaces the TNsG on Data 
Requirements in support of the BPD (EU, 2008a).  

In addition to the BPR guidance, Biocidal Products Directive (BPD) guidance and other 
related documents are still considered applicable for new submissions under the BPR in 
the areas where the BPR guidance is under preparation. Furthermore these documents 
are still valid in relation to the applications for active substances for Annex I inclusion or 
applications for product authorisation under the BPD that may still be under 
evaluation.  Also the Commission may have addressed some of the obligations in further 
detail in the Biocides competent authorities meetings documents which applicants are 
advised to consult. These document are available via a “related link” on the ECHA BPR 
webpage [https://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation]  

This BPD Guidance and relevant documents should be utilised notwithstanding the 
references to the BPD and without prejudice to the scientific content. The BPD Guidance 
and related documents consist of: 

  Emission Scenario Documents (ESD) which represent the main guidance to 

estimate the amount of substances released into the environment.  

  Technical Guidance Document (TGD) which forms the basis for the exposure- and 

risk assessment of both active substances and products.  

  Technical Notes for Guidance (TNsG) which deal specifically with biocides and BPD 

implementation. 

  The Manual of Technical Agreements (MOTA) which contains decisions from 

Biocides Technical Meetings on the technical aspects of the risk assessment (EU, 
2011a). The MOTA represents a living document, which is constantly updated. 
Comments from the MOTA are included in this Guidance where considered 
appropriate. 

  EU Evaluation Manual for the Authorisation of Biocidal Products (EU, 2012a). 

1.3.2  REACH Guidance 

In addition, REACH Guidance represents a major guidance source. The REACH Guidance 
should be taken into account for the evaluation of biocides, where relevant and 
indicated. The use of REACH Guidance is recommended for a number of endpoints with 
the intention of facilitating a harmonised approach. ECHA Guidance can be obtained from 
the ECHA website: https://echa.europa.eu/guidance-documents/guidance-on-reach.  

1.3.3  CLP Guidance  

In addition, the Guidance on the Application of the CLP Criteria (ECHA) represents an 
additional guidance source. This guidance document is a comprehensive technical and 

 
 
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scientific document on the application of the CLP Regulation. ECHA Guidance can be 
obtained from the ECHA website: https://echa.europa.eu/guidance-
documents/guidance-on-clp. 

1.4 

 General guidance on generating the information 

If new tests are performed in order to fulfil the data requirements, the following 
principles have to be followed: 

According to point 5 of Annex II and Annex III of the BPR, as a general principle, tests 
shall be conducted according to the methods described in Commission Regulation (EC) 
No 440/2008. These methods (“EC methods”) are based on methods recognised and 
recommended by international bodies, in particular OECD. In the event of a method 
being inappropriate or not described, other methods shall be used which are scientifically 
appropriate. Their use needs to be justified. Recommended test methods are listed in the 
endpoint sections.  

According to point 6 of BPR Annexes II and III, tests 'should comply with the relevant 
requirements of protection of laboratory animals, set out in Directive 2010/63/EU'.  

Furthermore, point 6 of BPR Annexes II and III explains that 'Tests performed should 
comply with… in the case of ecotoxicological and toxicological tests, good laboratory 
practice…. or other international standards recognised as being equivalent by the 
Commission or the Agency.' At the moment there are no “other international standards” 
considered equivalent to GLP.  

In addition point 6 of BPR Annexes II and III declares that 'Tests on physico-chemical 
properties and safety-relevant substance data should be performed at least according to 
international standards.') The test methods for the physico-chemical properties are 
described in the Test Methods Regulation (EC No 440/2008), whereas preferred tests for 
the purposes of physical hazard classification are referred to in Part 2 of Annex I to CLP 
Regulation, via references to the UN Recommendations on the Transport and Dangerous 
Goods, Manual of Test and Criteria, UN-MTC (UN, 2009). The testing according to 
international standards should be interpreted as testing carried out by laboratories 
complying with a relevant recognised standard (e.g. ISO/IEC 17025, ISO 9001). 

However, most of the methods listed in the Test Methods Regulation 'are developed 
within the framework of the OECD programme for Testing Guidelines, and should be 
performed in conformity with the principles of Good Laboratory Practice, in order to 
ensure as wide as possible ‘mutual acceptance of data’. From 1 January 2014, new tests 
for physical hazards must be carried out in compliance with a relevant recognised quality 
system or by laboratories complying with a relevant recognised standard as stipulated by 
Article 8(5) of the CLP Regulation. Where relevant recognised standards for testing are 
applicable, the use of the most recent updates is advised, for example the EN and ISO 
standards. 

Where test data exist that have been generated before the DoA of the BPR by methods 
other than those laid down in the Test Methods Regulation, the adequacy of such data 
for the purposes of the BPR and the need to conduct new tests according to the Test 
Methods Regulation must be decided on a case-by-case basis. Amongst other factors, 
the need to minimise testing on vertebrate animals needs to be taken into account 
(Article 90(2) of the BPR). Such a decision should first be proposed by the applicant 
when collecting data for the application and then evaluated by the CA when checking the 
completeness of the application and approving the justification provided for such a case. 
If a test has been performed, that does not comply with the Test Methods Regulation, 
the nature of the differences must be indicated and justified. The same applies to 
deviations from the test protocol used. The test protocol should be provided in full unless 
there is sufficient detail in the test report.  

 
 
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In certain cases, testing can be replaced by modelling using (Q)SAR, Quantitative 
Structure Activity Relation.  Guidance on information requirements and chemical safety 
assessment Chapter R.6: QSARs and grouping of chemicals is available on the ECHA 
website. The TGD on risk assessment for new notified substances and existing 
substances (EU, 2003) contains further information.  

As a general rule, tests on the active substance should be performed with the substance 
as manufactured. For some of the physical and chemical properties' tests, a purified form 
of the substance is being tested, which is indicated by footnote 2 in Annex II column 1 of 
the BPR, in other cases, the applicant is free to choose between testing on either purified 
form or the form as manufactured as indicated by footnote 1 in Annex II column 1 of the 
BPR. The “Active substance as manufactured” is the active substance in its natural state 
or as obtained by a production process. This includes any additive necessary to preserve 
the stability of the products and any impurity deriving from the process used. It 
excludes, however, any solvent which may be separated without affecting the stability of 
the substance or changing its composition. Furthermore, the identity, purity and the 
impurities of the substance have to be defined and to be comparable with the substance 
subject to the application. 

In order to implement the three R’s, Replacement, Refinement and Reduction of animals 
in research, the following should be taken into account when planning new tests: If there 
is an established EC test method or OECD test guideline for a given purpose, for example 
testing of acute oral toxicity, and in addition one or more alternative methods which may 
equivalently be used, the test method that requires a lower number of test animals 
and/or causes less pain should be used. A number of alternative tests either not using 
test animals or reducing the number of test animals are under development and when 
endorsed, these tests are preferred when new tests have to be performed.  

A substance which is approved  as an active substance (included in the Union list of 
approved active substances) should be related to the active compound in the 
formulation. This means that a case-by-case decision must be taken by the evaluating 
CA on the name to be given to the active substance. This could be for example simple 
ions or different molecular structures, precursor/activator, or unstable/breakdown active 
components, or multiple component products. The specifications of the used material 
need to be described in detail (point 7 of Annex IIto the BPR) i.e. a brief description of 
the composition for all batches used in tests is needed. Where testing is done using an 
active substance the material used should be of the same specification as that which 
would be used in the manufacture of preparations to be authorised except where radio 
labelled material is used. All batches of a substance or a product used for testing should 
be representative of typical commercial material for which the approval is applied for and 
within the production concentration range. If for any test the composition of the 
substance or product is different from that quoted for commercial material, full details 
must be provided. Certain exceptions on this general rule are provided in this Guidance. 
When the long term stability is in doubt, the composition should be determined before 
testing. Where appropriate, details of the stability of the substance in any vehicle used 
during testing should also be specified. For certain tests (e.g. some physico-chemical 
tests) there are specific requirements for purity of the active substance.  

In addition, the specific guidance provided in the relevant test guidelines should always 
be followed. For instance, guidance on when the testing of transformation products 
instead of the active substance is relevant may be found in the test guidelines 
concerned.  

Some active substances may have characteristics that impede testing or limit the 
methods that can be used. Substances, which are difficult to test, need special attention 
(OECD, 2000a). The difficulties may arise from the chemical nature of the substance 
(e.g. insoluble substances, metals, complex mixtures of chemicals, oxidising substances 

 
 
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23 

or surface active compounds (surfactants)). Further difficulties may be owing to the 
activity of the substance.  

Where studies are conducted using an active substance produced in the laboratory or in 
a pilot plant production system, the studies must be repeated using the active substance 
as manufactured unless it can be justified that the test material used for the purposes of 
testing and assessment is technically equivalent. In cases of uncertainty, appropriate 
bridging studies must be submitted to serve as a basis for a decision on the possible 
need to repeat studies. The test guidelines usually include guidance on the limitations of 
the method or give detailed guidance on how the method should be modified when 
testing chemicals with specific characteristics. Separate Guidance documents may be 
available for specific testing situations. For instance, Guidance on intermediate 
compounds has been published  Guidance on intermediates. The Guidance provided in 
the Technical Guidance Document concerning risk assessment of new and existing 
substances Part II (EU, 2003) should also be followed when designing the testing 
strategy for substances that are difficult to test.  

The test results must be reported properly and according to the guidelines used. The 
study summaries and full study reports of all key studies should be included in the data 
forwarded to the CA. Relevant analytical raw data should be provided on request. For 
example, individual data points should be provided in addition to mean values and 
calibration equations should be provided to allow a suitable evaluation of the study by an 
assessor.  

1.5  Guidance on non-submission of information 

The guidance text to be provided in this section is under development by the 
Commission and will be made accordingly. Until then please refer to Chapter 1 Section 
1.4 of the TNsG on Data Requirements (EU, 2008a). 

1.6  Testing of metabolites and transformation products 

For the efficacy aspects when metabolites or transformation products are formed, they 
are included in the test relevant for the use of the active substance and the biocidal 
product. Metabolites or transformation products should not be tested separately for 
efficacy.  

For the toxicology aspects of metabolites and transformation products, the possibility of 
the formation of metabolites not investigated by the usual testing must be taken into 
account. See section on metabolism studies in mammals in Volume III.  

For environmental aspects, metabolites relevant for the risk assessment can be 
distinguished as: 

  Major metabolite:  

o 

o 

formed in amounts of ≥ 10% of the active substance at any time of the 
degradation studies under consideration, or 

the metabolite appears at two consecutive sampling points at amounts ≥ 5%, 
or 

o  at the end of the study the maximum of formation is not yet reached but 

accounts for ≥ 5% of the active substance at the final time point; 

  Minor metabolite: all metabolites not meeting the above criteria; 

  Ecotoxicologically relevant metabolite: any minor or major metabolite which e.g. 

poses a comparable or higher hazard than the active substance.  

 
 
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In general, an environmental risk assessment for the relevant compartments needs to be 
performed for all major metabolites. However, as a first step a semi-quantitate 
assessment of these metabolites using the available data and expert judgement to fill 
data gaps may be sufficient. A quantitative assessment should be performed on a case-
by-case basis.  

If there is any reason for concern, a risk assessment also needs to be performed for 
those ecotoxicologically relevant metabolites which are minor metabolites. 

1.7  Background documents  

Legal texts 

For the detailed legal texts (plus amendments and annexes, when applicable) cited in 
this guidance document and listed below in this section, please visit the eur-lex 
bibliographic website: http://eur-lex.europa.eu or ECHA website: 
http://echa.europa.eu/regulations/biocidal-products-regulation/legislation. 

Regulations 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 
December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 
1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC; (REACH) 

Council 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); (Test Methods Regulation) 

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and mixtures, 
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006; (CLP Regulation).  

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 
October 2009 concerning the placing of plant protection products on the market and 
repealing Council Directives 79/117/EEC and 91/414/EEC; (PPPR). 

Commission Regulation (EU) No 1152/2010 of 8 December 2010 amending, for the 
purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 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). 

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and 
articles intended to come into contact with food. 

Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council as regards the data 
requirements for active substances.  

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; 
(BPR). 

Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of 
its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the 

 
 
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25 

European Parliament and of the Council on classification, labelling and packaging of 
substances and mixtures. 

Directives 

Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface 
water intended for the abstraction of drinking water in the Member States. 

Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater 
against pollution caused by certain dangerous substances. 

Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, 
regulations and administrative provisions of the Member States relating to the 
classification, packaging and labelling of dangerous preparations. 

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; (BPD).  

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for 
human consumption; (The Drinking Water Directive (DWD)). Consolidated version 2009-
08-07.  

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 
establishing a framework for Community action in the field of water policy; (The EU 
Water Framework Directive, WFD). Consolidated version 2009-06-25.  

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 
on the inspection and verification of good laboratory practice; (GLP). 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 
on the harmonisation of laws, regulations and administrative provisions relating to the 
application of the principles of good laboratory practice and the verification of their 
applications for tests on chemical substances; (GLP). 

Directive 2006/118/EC of the European Parliament and of the Council of 12 December 
2006 on the protection of groundwater against pollution and deterioration; The 
Groundwater Directive. 

Directive 2008/105/EC of the European Parliament and of the Council of 16 December 
2008 on environmental quality standards in the field of water policy, amending and 
subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 
84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European 
Parliament and of the Council; The Priority Substances Directive. 

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 
2010 on the protection of animals used for scientific purposes.  

Decisions 

2000/532/EC: Commission Decision of 3 May 2000 replacing Decision 94/3/EC 
establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on 
waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to 
Article 1(4) of Council Directive 91/689/EEC on hazardous waste. 

1.8  Sources of test methods and standards 

AFNOR Standards can be purchased from the website of AFNOR, the French Institute for 
Standardisation  (http://www.afnor.org/en/). 

ASTM Standards may be obtained from the American Society of Testing Methods, West 
Conshohocken, Pennsylvania, USA (http://www.astm.org). 

 
 
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BSI Standards can be purchased from the website of BSI, the English Institute for 
Standardisation  (https://www.bsigroup.com/#). 

CEB Methods can be purchased from the website of AFPP, the French Association for 
plant protection (http://www.afpp.net/). 

CIPAC methods may be purchased from the Collaborative International Pesticides 
Analytical Council (http://www.cipac.org).  

DIN Standards can be purchased from the website of DIN, the German Institute for 
Standardisation (http://www.din.de). 

DVG Standards can be purchased from the website of DVG, the German Veterinary 
Medical Society (http://www.desinfektion-dvg.de). 

EC methods are published in the Official Journal of the European Union. The testing 
methods are described in the Test Methods Regulation (Regulation (EC) No 440/2008). 
They are regularly updated with new methods introduced as required.  

EPPO Guidelines may be obtained from the Secretary of the European and Mediterranean 
Plant Protection Organisation (EPPO), Paris, France (http://www.eppo.int/).  

European Standards (CEN standards), transposed as national standards, can be 
purchased from National Members and Affiliates of the European Committee for 
Standardisation (CEN). Contact information for CEN National Members and also draft 
European Standards may be obtained from the CEN Central Secretariat, Brussels, 
Belgium (http://www.cen.eu). 

ISO International Standards: orders should be addressed to the ISO member bodies 
(non-USA users, if subscribing to Internet from a USA-based provider, should consult the 
ISO member list for ordering ISO standards in their country) which are normally the 
primary ISO sales agents, or for customers in countries where there is no member body, 
to the ISO Central Secretariat, Geneva, Switzerland (http://www.iso.org/iso/store.htm). 

OECD test methods can be obtained directly via their internet address 
(http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-
chemicals_chem_guide_pkg-en).  

US EPA Office of Prevention, Pesticides, and Toxic Substances Test Guidelines can be 
obtained from the EPA website 
(http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm). 

VAH Standards can be purchases from the website of VAH, the German Association for 
Applied Hygiene (http://www.mhp-verlag.de/en/home) 

VDI Guidelines can be obtained from the website of VDI, The Association of German 
Engineers (http://www.vdi.de). 

WHO guidelines for efficacy testing can be obtained from WHO website 
(http://www.who.int/whopes/guidelines/en/). 

 
 
 
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2. Part A: Dossier Requirements for Active Substances 

BPR Annex II, Title 1, points 1-13 

NOTE to the reader:  

The following section headings include a reference to the relevant section/point in 
the BPR Annex for ease of cross reference. 

GENERAL INFORMATION 

2.1 

 Point 1 Applicant  

2.1.1  Point 1.1 Name and address  

Name and address of the applicant (natural person or legal entity). If the applicant is a 
consortium; the composition of the consortium is required. 

2.1.2  Point 1.2 Contact person  

Names, address, telephone and fax numbers, email, and other contact information of the 
applicant. If the applicant is a consortium; the information on the contact person for 
each member of the consortium is required.  

2.1.3  Point 1.3 Active substance manufacturer (name, address 
and location of manufacturing plant(s)) 

Name and address of the manufacturer(s).  

Name, address and location of manufacturing plant(s). 

2.2  Point 11 Measures necessary to protect human health, 

animals and the environment  

2.2.1  Point 11.1 Recommended methods and precautions 
concerning handling, use, storage, transport or fire 

Provide technical safety precautions and where exposure cannot be prevented by other 
means, application of personal protective equipment (PPE) when handling the active 
substance, e.g. during different stages of the process, to minimise the risk of exposure 
to humans and the environment.  

As specified in point 62 of Annex VI to the BPR, the evaluating body shall, where 
appropriate, conclude the criterion (iii) under point (b) of Article 19(1) can only be 
complied with by application of prevention and protection measures including the design 
of work processes, engineering controls, use of adequate equipment and materials, 
application of collective protection measures including the wearing of personal protective 
equipment such as respirators, breathing-masks, overalls, gloves and goggles, in order 
to reduce exposure for professional operators.  

If sufficient ventilation is required, the ventilation rate must be specified (number of air 
changes per hour) and it must be explained how it can be achieved (e.g. window, air 
conditioning). 

Concerning PPE, details on the description of the equipment should be provided for 
example: 

 
 
 
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for gloves: information on the material, thickness, protection level (grade);  

for respiratory protection equipment: information on the type of mask (full, half, 
FFP, helmet, hood, mouthpiece) and the type and class of filter or SCBA; 

 

for coverall: type and EN standard. 

Appropriate precautions for substances which are flammable, oxidising etc. should be 
given. Handling, storage and transport must take into account any surface which could 
directly or indirectly come into contact with the product, including for example: 
processing equipment, piping, ventilators, transport vehicles and their washing and 
cleaning, as well as protective clothing and shower areas for workers. Storage 
precautions should include ventilation system to be used for storerooms (in general 
terms and other conditions for storage, e.g. temperature regime). Precautionary 
measures during service should especially be considered in addition to the prevention of 
environmental effects and measures to be taken when the substance is released to the 
environment due to an accident and misuse. 

Materials which are incompatible with the substance, e.g. substances and products which 
may react with the active substance evolving toxic gases, and also other dangers such 
as reactions resulting in a large increase in volume, aggressive acidity, the possibility of 
dust explosions etc. should be indicated. 

The precise type of fire-fighting equipment (i.e. both the type of extinguishing agent, 
including those to be avoided and any protective equipment), e.g. water or carbon 
dioxide, should be noted. 

2.2.2  Point 11.2 In case of fire, nature of reaction products, 
combustion gases etc. 

It should be stated what gases are evolved, either by experiment or on the basis of 
structure, when the substance burns or when heated in the absence of air so that it 
simply decomposes, e.g. nitrogen oxides, phosgene or soot.  

Especially the identity of dangerous substances formed should be given (e.g. analysed 
according to the ISO standard 9122, Part 3). 

2.2.3  Point 11.3 Emergency measures in case of accident 

Specific treatment in case of an accident, for example, first aid measures following 
accidental eye or skin contact, ingestion or inhalation, antidotes, medical treatment if 
available; emergency measures to protect the environment. 

Provide precise medical data regarding first aid, proven antidotes, and proven medical 
treatment. This should detail the effectiveness of first aid, suggested antidote doses, etc. 
and include full documentation of reference sources. The information here is intended for 
the purpose of immediate first-aid treatment. It is not intended to replace definitive 
diagnosis and treatment, which can only be undertaken by a qualified medical doctor. 

Measures and courses of action in response to different kinds of accident scenarios (e.g. 
threat of release of the biocidal product, the product is actually being released and 
release has already occurred) should be described. In addition, actions to avert or stop 
release, minimise impacts of release, protect human life and property, and recover the 
product and by-products should be indicated. 

 
 
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2.2.4  Point 11.4 Possibility of destruction or decontamination 

following: (a) Air, (b) Water, including drinking water, and 
(c) Soil  

This is on the prevention of health and environmental effects and measures to be taken 
when the product is released to the environment due to an accident or misuse.  

Provide  details  of  measures  necessary  to  quickly  limit  the  consequences  of  accidental 
release to the environment, and to decontaminate areas affected by the accidental release. 
These may include neutralisation, destruction and removal procedures. 

2.2.5  Point 11.5 Procedures for waste management of the active 

substance for industry or professional users 

Provide information necessary for safe disposal including treated material. If preliminary 
treatment of the waste is necessary, information about this must also be provided. If any 
waste generated from the substance is classified as hazardous waste (e.g. according to 
Commission Decision 2000/532/EC), this has to be mentioned separately and appropriate 
handling according to the related legislation has to be indicated. 

More information is provided in Section 3.1.3.5. 

2.2.6  Point 11.6 Possibility of reuse or recycling 

The  possibility  of  recovery  or  recycling  should  be  given  for  both  normal  uses  of  the 
substance and quantities involved in spills. 

2.2.7  Point 11.7 Possibility of neutralisation of effects 

Neutralisation procedures (e.g. by reaction with an alkali to form less toxic compounds) 
for use, for instance, in the event of accidental spillage must be described where they are 
feasible. Details to be given include: proposed procedures for small and large quantities, 
evaluation of products of neutralisation (in small and large quantities), and procedures for 
disposal of neutralised waste (in small and large quantities). 

2.2.8  Point 11.8 Conditions for controlled discharge including 
leachate qualities on disposal 

For instance, controlled landfill or extensive dilution (to be specified) before discharge to 
surface water. 

If  a controlled landfill is recommended  for use  as a disposal site, information about the 
necessary preliminary treatment, the fate of the waste in the landfill, the release of active 
substances or breakdown products from the waste etc. must be given. 

2.2.9  Point 11.9 Conditions for controlled incineration 

If the suggested waste disposal method is incineration, the compounds generated by 
burning (e.g. whether polychlorinated dioxins and furans or other halogen compounds 
can be formed), recommended incineration conditions (temperature, reaction time and 
oxygen content) and other information needed for the safe incineration of the waste 
must be provided. 

 
 
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2.2.10  Point 11.10 Identification of any substances falling within 
the scope of List I or List II of the Annex to Council Directive 
80/68/EEC  

Point 11.10 of Annex II to the BPR states that [….]of 17 December 1979 on the 
protection of groundwater against pollution caused by certain dangerous substances, of  
Annex I and II to Directive 2006/118/EC of the European Parliament and of the Council 
of 12 December 2006 on the protection of groundwater against pollution  and 
deterioration, of Annex I to Directive 2008/105/EC of the European  Parliament and of 
the Council of 16 December 2008 on environmental quality standards in the field of 
water policy, of Part B of Annex I to Directive 98/83/EC or Annex VIII and X to Directive 
2000/60/EC   

Substances that are listed in the respective Annexes of the following legal frameworks 
are considered hazardous substances and therefore need to be monitored. Specify if the 
active substance is listed in one of the following:  

  Council Directive 80/68/EEC on the protection of groundwater against pollution 

caused by certain dangerous substances. All biocides and their derivatives are 
classed in either List I or II. Direct discharge of substances in List I is prohibited. 
Discharge of substances in List II must be limited. In addition other substances 
(additives, impurities) may fall within the scope of the Lists.  

  Council Directive 2006/118/EC, the Groundwater Directive, establishes a regime 
which sets underground water quality standards and introduces measures to 
prevent or limit inputs of pollutants into groundwater. Annex I lists groundwater 
quality standards and Annex II lists threshold values for groundwater pollutants 
and indicators of pollution.  

  Council Directive 2008/105/EC, also known as the Priority Substances Directive, 
which sets environmental quality standards (EQS) for the substances in surface 
waters (river, lake, transitional and coastal) and confirmed their designation as 
priority or priority hazardous substances, the latter being a subset of particular 
concern. Annex I represents a list of priority substances.  

  Council Directive 98/83/EC concerns the quality of water intended for human 

consumption. It aims at protecting human health from the adverse effects of any 
contamination of water intended for human consumption by ensuring that it is 
wholesome and clean. Chemical quality standards are specified in Annex I.  

  Directive 2000/60/EC is the EU Water Framework Directive. Annex VIII lists the 
main pollutants. Annex X lists water policy priority substances and 'priority 
hazardous substances’.  

2.3  Point 12 Classification, labelling and packaging  

Hazard classification is a process involving identification of the physical, health and 
environmental hazards of a substance (or a mixture), followed by comparison of those 
hazards (including degree of hazard) with defined criteria in order to arrive at a 
classification of the substance (or mixture). The classification criteria are defined in 
Annex I to the CLP Regulation.  

Active substances are normally subject to harmonised classification and labelling for all 
hazard classes (consult the Guidance documents on the application of Regulation (EC) 
No 1272/2008). In the sections below guidance is given on how the applicant should 
report existing harmonised classification and labelling or propose one. Following the 
assessment during the evaluation of the application, the evaluating competent authority 
(but not the applicant) will prepare and submit the proposal for the harmonised 
classification and labelling of the active substance to the Agency (Articles 36(2) and 37 

 
 
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31 

of the CLP Regulation). It is advisable that the evaluating competent authority consults 
ECHA as early as possible to get the best support and advice in preparing the proposal.   

2.3.1  Point 12.1 State any existing classification and labelling. 

If available, state the existing classification and labelling as provided in Part 3 of Annex 
VI to the CLP Regulation, which contains lists of harmonised classifications and labelling 
of hazardous substances. If there is no harmonised classification for some/all endpoints 
or there is new information which may justify changing the existing harmonised 
classification, proceed to Point 12.2 below (section 2.4.2 of this guidance). 

2.3.2  Point 12.2 The hazard classification of the substance 
resulting from the application of Regulation (EC) No 
1272/2008 

Point 12.2 of Annex II to the BPR states that in addition, for each entry, the reasons why 
no classification is given for an endpoint should be provided. 

Propose hazard classification, labelling and packaging in line with the CLP criteria if no 
harmonised classification and labelling is provided in Part 3 of Annex VI to the CLP 
Regulation or if the new information justifies revision of the harmonised classification 
and labelling for a given endpoint. The need for classification should be considered based 
on relevant available information. The CLP Regulation does not require new testing for 
the purpose of classification for health or environmental hazards (Article 8(1) of the CLP 
Regulation); testing for the purposes of determining whether the substances entails any 
of the physical hazards referred to in part 2 of Annex I to the CLP Regulation, tests 
required in that Part are necessary unless adequate and reliable information is already 
available (Article 8(2) of the CLP Regulation). The background information should be 
clearly presented in the relevant sections of the dossier (see section 2.4 of this guidance, 
and also Volume III, section 2.1 and Volume IV, sections 2.1 and 2.2).  

2.3.2.1  Point 12.2.1Hazard Classification 

A substance (or a mixture) that fulfils the criteria relating to physical hazards, health 
hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I to the CLP 
Regulation is hazardous and must be classified in relation to the respective hazard 
classes provided for in that Annex. 

For further information on the classification criteria refer to Guidance on the application 
of the CLP criteria (ECHA). 

2.3.2.2  Point 12.2.1 Hazard pictogram 

A substance (or mixture) classified as hazardous must bear a label which includes 
relevant hazard pictograms in accordance with Article 19 of the CLP Regulation, where 
applicable.  

For further information on the hazard pictograms refer to Chapter 4.3 Hazard 
Pictograms in the Guidance document on Labelling and Packaging in accordance with 
Regulation (EC) No 1272/2008 (ECHA).  

Pictograms can be downloaded free of charge from the web page: 
http://www.unece.org/trans/danger/publi/ghs/pictograms.html. 

2.3.2.3   Point 12.2.3 Signal word 

A substance (or mixture) classified as hazardous must bear a label which includes a 
relevant signal word in accordance with Article 20 of the CLP Regulation, where 
applicable.  

 
 
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For further information on the signal word please refer to Chapter 4.4 Signal Words in 
the Guidance document on Labelling and Packaging in accordance with Regulation (EC) 
No 1272/2008 (ECHA). 

2.3.2.4   Point 12.2.4 Hazard statements 

A substance (or mixture) classified as hazardous must bear a label which includes the 
relevant hazard statements in accordance with Article 21 of the CLP Regulation, where 
applicable.  

For further information on the hazard statements please refer to Chapter 4.5 Hazard 
statement in the Guidance document on Labelling and Packaging in accordance with 
Regulation (EC) No 1272/2008 (ECHA). 

A substance (or mixture) classified as hazardous must bear a label which includes 
relevant supplemental hazard information in accordance with Article 25 of the CLP 
Regulation, where applicable.  

For further information on the supplemental hazard information please refer to Chapter 
4.8 Supplemental labelling information in the Guidance document on Labelling and 
Packaging in accordance with Regulation (EC) No 1272/2008 (ECHA). 

2.3.2.5  Point  12.2.5  Precautionary  statements  including  prevention, 
response, storage and disposal 

A substance (or mixture) classified as hazardous must bear a label which includes 
relevant precautionary statements in accordance with Article 22 of the CLP Regulation, 
where applicable.  

Annex I and Annex IV of the CLP Regulation outline the types of precautionary 
statements. 

For further information on the precautionary statements please refer to Chapter 4.6 
Precautionary Statements in the Guidance document on Labelling and Packaging in 
accordance with Regulation (EC) No 1272/2008 (ECHA). 

2.3.3  Point 12.3 Specific concentration limits, where applicable, 

resulting from the application of Regulation 1272/2008 

Specific concentration limits and M-factors for classification of substances and mixtures 
must be set, where applicable. 

Article 37 of the CLP Regulation gives the procedure for submitting a proposal for 
harmonisation of classification and labelling of substances to ECHA together with, where 
appropriate, specific concentration limits or M-factors. 

Section 1.1.2.3 of Annex VI to the CLP Regulation provides further information on 
specific concentration limits and M-factors. 

2.4 

Point 13 Summary and evaluation 

Point 13 of Annex II to the BPR states that the key information identified from the 
endpoints in each sub-section (2-12) is summarised, evaluated and a draft risk 
assessment is performed. 

The summary and evaluation must be provided in separate assessment documents 
attached to the IUCLID file (the templates will be available on the ECHA website). 

 
 
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SPECIFIC INFORMATION 

2.5  Point 2 Identity of the active substance 

The information must be sufficient to identify the substance, to define it in terms of its 
specification and to characterise it in terms of its nature. The information submitted 
should, in any case, be sufficient to support a risk assessment demonstrating that the 
criteria referred to in BPR Article 4(1) are met. BPR Article 3(1)(c) defines ‘active 
substance’ as a substance or a micro-organism that has an action on or against harmful 
organisms. 

2.5.1  Point 2.1 Common name proposed or accepted by ISO and 
synonyms 

The name of the active substance must be provided as registered in the list in Part 3 of 
Annex VI to the CLP Regulation or, if the name is not included therein, as given in 
EINECS (the European Inventory of Existing Commercial chemical Substances) or in 
ELINCS (European List of New - or Notified- Chemical Substances) and the ISO common 
name of the substance, if available.  

ECHA’s classification and labelling inventory database may be used as a source for 
(common) names. 

Generally known names, trade names, abbreviations, etc. must be included.  

2.5.2  Point 2.2 Chemical name (IUPAC and CA nomenclature or 

other international chemical name(s)) 

The chemical name of the active substance must be provided according to IUPAC 
nomenclature and CAS nomenclature.  

For substances that may exist as isomers, each isomer, if scientifically applicable, should 
be given correct designation.  

For substances of unknown, variable composition, or biological origin (UVCB), identity 
and the proportion of constituents in the substance should be provided. As the chemical 
composition alone is insufficient for substance identification, the substance should in 
general be identified by its name, which will be generated by stating the origin or source 
of the starting materials and the most relevant steps taken during processing.  

The ECHA Guidance for identification and naming of substances under REACH and 
CLP, Chapter 4, (ECHA) should be applied for the purpose of identification of the 
active substancd 

2.5.3  Point 2.3 Manufacturer’s development code number(s) 

Company(ies) code number(s) or internal name(s). 

2.5.4  Point 2.4 CAS number plus EC, INDEX and CIPAC numbers 

The CAS number, EC number, INDEX and CIPAC number must be provided, if available.  

For reaction masses of isomers the CAS and/or EC numbers of the substance 
(comprising all isomers) and individual isomers should be provided, if available.  

The CIPAC code number system is an approach for an unambiguous coding of active 
ingredients and variants used for pesticides. 

 
 
 
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2.5.5  Point 2.5 Molecular and structural formula (including 

SMILES notation, if available and appropriate) 

The molecular formula should be provided according to the traditional Hill system and, 
where different, according to the CAS system. In addition, the SMILES notation should 
be provided, if available and appropriate. 

An empirical formula should be determined for substances of undefined or variable 
composition, if possible.  

For polymers the number average molecular weight (Mn) and the molecular weight 
distribution are required. 

Further Guidance: 

  ECHA Guidance for identification and naming of substances under REACH and 

CLP, Chapter 4, (ECHA). 

2.5.6  Point 2.6 Information on optical activity and full details of 
any isomeric composition (if applicable and appropriate) 

If the active substance is optically active the value for the specific rotation (in degrees) 
has to be specified, indicating the temperature of measurement (in °C) and the 
wavelength of the incident light source (nm). The direction of rotation should also be 
specified as either + or -. If a sample solution is used, the concentration and solvent 
name should also be provided. 

𝑇 
Typically, specific rotation is specified as follows:     [𝛼]𝜆
Where:  

[α]  

specific rotation [°],  

T  

temperature [°C],  

λ wavelength [nm] 

Full details of any isomeric composition must be included, i.e. the maximum content of 
each (active) isomer and the ratio of the content of isomers/ diastereoisomers, where 
relevant. All stereoisomers have to be determined using an appropriate analytical 
method. 

Further Guidance:  

  ECHA Guidance for identification and naming of substances under REACH and 

CLP, Appendix II (7), (ECHA). 

2.5.7  Point 2.7 Molar mass 

The molar mass (g/mol) must be provided. 

For polymers the number average molar mass and the molar mass distribution are 
required.  

2.5.8  Point 2.8 Method of manufacture (synthesis pathway) of 

active substance including information on starting 
materials and solvents including suppliers, specifications 
and commercial availability 

A description of the synthesis pathway in brief terms; the chemical reactions taking 
place, starting materials, intermediate steps, solvents and constiuents/intermediates 
generated in the synthesis etc. must be presented. 

 
 
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The methods of extraction and purification should be provided, where relevant. 

When relevant, where the data refers to a pilot plant production system, the information 
required must be resubmitted once the industrial scale production plant enters into 
operation and production has stabilised. This will be covered by an application for the 
assessment of technical equivalence. 

Chemical engineering data is not required as a rule, but submission may be required, 
where necessary (e.g. information on the temperatures and pressure at which synthesis 
takes place if not ambient and atmospheric while at such conditions dioxins could be 
formed). 

2.5.9  Point 2.9 Specification of purity of the active substance as 

manufactured in g/kg, g/l or %w/w (v/v) as appropriate, 
providing inclusively the upper and lower limit 

Give typical concentration and upper and lower limits for typical commercial batches of 
the active substance in g/kg or %w/w.   

For substances of unknown or variable composition the purity is 100% minus unreacted 
starting materials. 

The specification should be for the active as manufactured. Where the active is delivered 
in a solvent and/or stabilisers are present then an explanation should be provided e.g. 
the active is not stable in isolation as a dry technical material (TC), the active is 
delivered in a solvent for ease of manufacture (including manufacture of the biocidal 
product), transportation, or for classification purposes etc. 

An explanation as to how the specification has been set or derived must be provided e.g. 
based on a 5-batch analysis with the mean ± 3 standard deviation. 

Where the active substance is manufactured as a technical concentrate (TK) then as well 
as a specification for the active as manufactured, a dry weight specification must be 
provided. The dry weight specification can be calculated.  

If the specification relates to the 5-batch analysis data from a pilot plant then an 
updated specification based on the batch analysis data from full scale industrial 
production must be provided when this is available (see section 2.6.11 of this guidance).  

2.5.10  Point 2.10 The identity of any impurities and additives 

including by-products of synthesis, optical isomers, 
degradation products (if the substance is unstable) un-
reacted and end-groups etc. of polymers and un-reacted 
starting materials of UVC-substances 

The following information on impurities4 and additives, that includs by-products of 
synthesis, optical isomers, degradation products (if the substance is unstable), 

4 An impurity is an unintended constituent present in a substance as manufactured. It may 
originate from the starting materials or be the result of secondary or incomplete reactions during 
the production process. While it is present in the final substance it was not intentionally added. An 
impurity is regarded as significant if it occurs or potentially occurs in a quantity ≥ 1 g/kg in the 
substance as manufactured. A significant impurity may be considered relevant or non-relevant 
depending, in particular, on its known toxicological and ecotoxicological properties. An impurity 
can be considered of toxicological and/or ecotoxicological relevance. An impurity may be relevant 
even if it occurs in a quantity < 1 g/kg (e.g. very toxic substances like dioxin). Relevant impurities 
can be defined as substances, including but not limited to, that meet the criteria to be classified as 
hazardous in accordance with CLP Regulation, or the available information (e.g. from (Q)SARs) 

 
 
                                           
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unreacted and end-groups etc. of polymers and unreacted starting materials of UVCB 
substances  must be provided, where possible: 

  Common name and chemical name in conformity with sections 2.6.1 and 2.6.2 of this 

guidance 

  CAS and EC numbers, if available, 

  Molecular and structural formula, conform with section 2.6.5 of this guidance, 

  Molar mass, conform with section 2.6.7 of this guidance, 

  The typical concentration and the range of concentrations expressed as g/kg or 

percentage w/w. Details of how the specification has been derived (e.g. based on the 
5-batch analysis mean ± 3 standard deviations) must be provided. This should be for 
the active substance as manufactured. Where the active substance is manufactured 
as a technical concentrate (TK) then a dry weight specification must be provided as 
well as a specification for the active as manufactured. The dry weight specification can 
be calculated.  

  The maximum content of the active isomer(s) and the ratio of the content of isomers/ 

diastereoisomers, where relevant. 

  An indication of the functions of the components added to the active substance prior 
to the formulation of the biocidal product (e.g. stabiliser, antifreeze, antifoaming 
agent, dispersing agent, and inhibitors) must be provided. 

  If the specification relates to the 5-batch analysis data from a pilot plant then an 
updated specification based on the batch analysis data from full scale industrial 
production must be provided when this is available (see section 2.6.11 of this 
guidance).  

  Constituents present in quantities ≥1 g/kg must be identified. 

  Constituents that are regarded as (eco)toxicologically relevant even at levels below 1 

g/kg must be determined and identified. 

  The limit of 1 g/kg applies to a dry technical material (TC) and therefore for technical 
concentrates (TK) the limit will apply to theoretical dry material. Hence impurities, 
even if below this limit for the TK, must be determined if they are ≥ 1 g/kg on a dry 
weight basis. 

2.5.11  Point 2.11 Analytical profile of at least five representative 
batches  including information on content of the 
impurities referred to in point 2.10. 

For all active substances as manufactured, an analysis of at least five representative 
production batches is required. The analysis is one of the tools used to estimate whether 
the proposed specification of the active substance can be accepted as well as 
characterising the active substance in detail, in order to facilitate the risk assessment. 

Where the active substance is not isolated but manufactured as a technical concentrate 
(TK), the batch data on the technical concentrate should be provided (i.e. on the active 
as manufactured). For TK a specification for the active as manufactured (TK) and a 
theoretical dry weight specification must be provided.  

indicates that the impurity has an (eco)toxicological hazard. Relevant impurities have the inherent 
capacity to cause unacceptable effects within the meaning of Article 19(1)(b) of the BPR. 
Compared to the active substance, relevant impurities show additional (or more severe) toxic 
properties (in the sense of the definition above). 

 
 
                                           
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Where the active substance is generated in situ then data on the precursors used to 
generate the active substance may be required.  

2.5.11.1  General requirements 

  The report must be GLP compliant. 

  Data on the production date and size of the batches must be reported. 

 

It must be reported if the data come from pilot plant production or full scale 
industrial product. 

  Batch analysis must be performed on batches representative of the 

manufacturing process for each source (manufacturing plant) being specified. 

  The purity and impurity contents must be expressed in g/kg or percentage w/w. 

  The analytical closure of the individual batches should be at least 98%; meaning, 

at least 98% of the manufactured substance should be accounted for. Only fully 
identified impurities may be counted towards this total (excluding e.g. sulfated 
ash, volatiles, insolubles etc). 

  All impurities present ≥1 g/kg must be fully identified and quantified using a 
validated method of analysis. The limit of 1 g/kg applies to a dry technical 
material (TC) and therefore for technical concentrates (TK) the limit will apply to 
theoretical dry material. Hence impurities, even if below this limit for the TK, 
must be determined if they are ≥ 1 g/kg on a dry weight basis. 

  Analytical methods used must be reported in detail and should be highly specific 

or specific5. Details of the validation data requirements are outlined in section 2.9 
of this guidance.  

 

 

 

 

Isomeric ratios of constituents with chiral atoms must be investigated. 

If the possibility exists that exceptionally dangerous constituents (e.g., dioxins, 
nitrosamines or other dangerous substances) can be formed during manufacture, 
these must be investigated independent of their content (even below 1 g/kg) and 
categorised as relevant impurities or substances of concern. 

If the presence of heavy metals is expected (e.g. for inorganic compounds), data 
on the content of lead, arsenic, cadmium and, if relevant, of other heavy metals 
is required. 

In general, batches tested should be no older than five years from the date of 
dossier submission. Deviation is possible if the applicant can ensure the 
manufacturing process has not changed. Quality control data should be provide if 
the age of the batch analysis is >5 years but <10 years. The batch analysis 
should not be older than 10 years. 

  Where the data have been provided for pilot plant material then batch analysis 
data for at least five representative batches must be provided once full scale 
production commences.  

5 Non-specific method: Any analytical method in which quantification is based on a functional 
group (moiety) within the analyte rather than for the specific analyte. 

Specific method: HPLC or GC method with a retention match with a reference standard of the 
analyte. 

Highly specific method: LC-MS/MS with two ion transitions validated or GC-MS or LC-MS with three 
ion transitions validated and a retention time match with a reference standard of the analyte. 

 
 
                                           
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2.5.11.2 

Exceptions 

If a specific or highly specific analytical method is not feasible, the applicant may use a 
suitable non-specific method, e.g. for the determination of peroxide contents. 
Confirmation of identity may be required (e.g. using mass spectral data, NMR, analysis 
using a different technique).  

If a CIPAC method is used for quantification then, provided it has been established that 
the method is suitable for the substance and matrix, validation data and confirmation of 
identity do not need to be addressed. Example chromatograms to demonstrate the 
specificity of the method, where relevant, should be provided.  

For active substances and precursors that cannot be defined in detail (e.g. paraffin oils, 
plant extracts and other complex mixtures), other means of characterisation may be 
used if appropriate. Marker compounds may be chosen and/or relevant physical 
properties may be used (e.g. diffraction index, density). 

2.5.12  Point 2.12 The origin of the natural active substance or the 

precursor(s) of the active substance, e.g. an extract of a 
flower  

The scientific names of species, common names and strains, and polymer starting 
materials should be provided, if relevant. 

Further Guidance:  

  Guidance to Member States and industry on the data requirements for naturally 

occurring substances used as attractants / repellents (EU, 2005a); 

  Addendum to TNsG on Data Requirements for oils and extracts (PT 19) (EU, 

2011b). 

  ECHA Guidance for identification and naming of substances under REACH and 

CLP, Appendix II (7), (ECHA). 

2.6  Point 3 Physical and chemical properties of the active 

substance   

When assessing physico-chemical properties, priority is given to first hand experimental 
results (primary references) provided that the methods are suitable for the substance 
under investigation and that they operate within their validity range. In exceptional 
cases, it is acceptable to use reference book data for physico-chemical properties of 
organic or inorganic substances. However, data on physico-chemical properties should 
be of sufficient quality i.e. they must be reliable.  

Instead of verbal descriptions, an actual numeric value or a range should be used in the 
report, avoiding verbal terms such as “high” or “low” as far as possible.  Note that some 
of the data generated in this section affect the classification and labelling. 

For UVCB substances, some tests are scientifically not reasonable. Therefore either a 
justification for not providing an experimental result should be given instead. Further, a 
range of values, a representative value or values of the individual constituents should be 
given instead of a single value depending on the substance. For some of the endpoints, 
more specific Guidance regarding UVCB substances is given in the ECHA Guidance on 
information requirements and chemical safety assessment (ECHA)). 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1 Physicochemical properties 
(ECHA). 

 
 
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2.6.1  Point 3.1 Appearance  

NOTE to the reader:  

In contrast to what is stated in Annex II to the BPR for points 3.1.1 and 3.1.2, the 
information on the physical state should be submitted first and the information on 
aggregate state second.  Please take note that the sections below are presented in 
this order . 

2.6.1.1  Point 3.1.1 Physical state (at 20 °C and 101.3 kPa)  

In contrast to what is stated in Annex II to the BPR, the information on the physical 
state (at 20 °C and 101.3 kPa) should be provided under point 3.1.1. 

Footnote 4 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of a stated specification or for the active 
substance as manufactured, if different. 

The physical state should be stated for an ambient temperature of 20 °C  and an 
ambient atmospheric pressure of 101.3 kPa . The physical state may be solid, liquid, or 
gaseous.  

In addition, a substance may be a colloid, i.e. it is microscopically dispersed evenly 
throughout another substance in a system consisting of two separate phases. Colloids or 
colloidal systems may also be solid, liquid, or gaseous. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Chapter 2.1.4 Physical 

state, (ECHA). 

2.6.1.2  Point 3.1.2 Aggregate state (at 20 °C and 101.3 kPa) 

In contrast to what is stated in Annex II to the BPR, the information on the aggregate 
state (at 20 °C and 101.3 kPa) should be provided in the item 3.1.2. 

Footnote 4 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of a stated specification or for the active 
substance as manufactured, if different. 

A description of the form or structure must be reported, at an ambient temperature of 
20 °C  and an ambient atmospheric pressure of 101.3 kPa .  

This can be aerosol, compact, crystalline, dispersion, fibre, filament, flakes, particulates, 
paste, pellets, powder, suspension, viscous, or other. 

2.6.1.3  Point 3.1.3 Colour (at 20 °C and 101.3 kPa)   

Footnote 4 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of a stated specification or for the active 
substance as manufactured, if different. 

The colour must be reported, at an ambient temperature of 20 °C  and an ambient 
atmospheric pressure of 101.3 kPa . 

2.6.1.4  Point 3.1.4 Odour (at 20 °C and 101.3 kPa) 

Footnote 4 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of a stated specification or for the active 
substance as manufactured, if different. 

 
 
 
 
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A description of the odour associated with the active substance as manufactured and of a 
purified active substance as noted during the handling of the materials in laboratories or 
production plants, must be reported, at an ambient temperature of 20 °C  and an 
ambient atmospheric pressure of 101.3 kPa .  

This can be e.g. ammonia-like, biting, characteristic of sulphur-containing compounds, 
characteristic of aromatic compounds, faint, garlic-like, odourless, pungent, slight, 
sweetish or other. 

Odour should not be investigated for substances that are hazardous by inhalation. 

2.6.2  Point 3.2 Melting/freezing point  

Footnote 5 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of stated specification. 

The measurement of the melting/freezing point should be taken up to 360 °C. 

Usually the freezing point of liquid substances should be determined if above –20 °C. An 
indication that no freezing has occurred during preliminary tests is also acceptable. For 
viscous liquids the pour point is an acceptable alternative. 

Test according to EC method A.1 (Melting/Freezing Temperature). It is advisable to use 
the Differential Scanning Calorimetry (DSC) or Differential Thermo-Analysis (DTA) 
(discussed in EC method A.1) since they give additional information about the thermal 
stability of the substance such as decomposition onset and energy.   

If the melting/freezing point cannot be determined, the sublimation or decomposition 
temperature should be provided. 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 

Chapter R.7a: Endpoint specific guidance, R.7.1.2 Melting point/freezing point, 
(ECHA). 

2.6.3  Point 3.3 Acidity, alkalinity   

For active substances containing water, the pH-value of the active substance itself 
should be determined.  If the solid and non-aqueous liquid active substances are to be 
used in biocidal products applied as aqueous dilutions, pH-value of a 1% aqueous 
dilution, emulsion or dispersion of the active substance should be determined. Test 
according to CIPAC method MT 75.3. 

In cases where substances are acidic (pH<4) or alkaline (pH>10), test the 
acidity/alkalinity according to CIPAC method MT 31. Alternatively, test according to 
CIPAC method MT 191.   

Test according to the OECD Test Guideline ‘Determination of pH, Acidity and Alkalinity’ 
which is currently being developed. 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1.17 Dissociation Constant, 
(ECHA). 

2.6.4  Point 3.4 Boiling point 

Footnote 5 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of stated specification. 

 
 
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The measurement of the boiling point should be taken up to 360 °C. 

The boiling point should be measured at the normal atmospheric pressure of 101.3 kPa  
unless decomposition occurs, in which case reduced pressure can be used. 

If the boiling point cannot be determined, the sublimation or decomposition temperature 
should be provided. 

Test according to EC method A.2 (Boiling Temperature). DSC (discussed in EC method 
A.2) allows the determination of the melting and boiling point in a single test. 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1.3 Boiling point, (ECHA). 

2.6.5  Point 3.5 Relative Density 

Footnote 7 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of stated specification. 

The relative density of gas substances can be calculated from their molecular weight and 
the Ideal Gas Law. Polymer density should be determined by buoyancy methods, where 
appropriate. 

For liquids and solids, test according to EC method A.3 (Relative Density), based on 
OECD Test Guideline 109 (Density of Liquids and Solids), which was revised in October 
2012.  

Further Guidance:  

o  ECHA Guidance on information requirements and chemical safety assessment 

Chapter R.7a: Endpoint specific guidance, R.7.1.4 Relative Density, (ECHA). 

2.6.6  Point 3.6 Absorption spectra data (UV/Vis, IR, NMR) and a 
mass spectrum, molar extinction at relevant wavelengths, 
where relevant 

Footnote 8 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of stated specification. 

Absorption spectra and mass spectrum must be determined and reported for the 
identification of impurities of concern, too. 

For the UV/Vis (ultraviolet-visible spectral region), the spectra in neutral (pH = 7), acid 
(pH < 2) and alkaline (pH > 10) environments are required. The spectrum should be 
recorded in the range 200 – 400 nm for UV active substances and from 200 – 800 nm 
for substances which absorb in the Vis range. In addition, the molar absorption 
coefficient (ε) needs to be determined. 

The relevant OECD Test Guideline is guideline 101 (UV-VIS Absorption Spectra). 

Full interpretation of the data to support the structure is required.  

Further Guidance:  

  ECHA Guidance for identification and naming of substances under REACH and 

CLP, 4.2.1.3 Analytical Information, (ECHA) 

  Manual of decisions for implementation of the sixth and seventh amendments to 
Directive 67/548/EEC on dangerous substances (Directives 79/831/EEC and 
92/32/EEC), 9.6 Guidance on spectral analysis (EU, 2006) 

 
 
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2.6.7  Point 3.7 Vapour pressure 

Footnote 9 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of stated specification. 

Vapour pressure at two temperatures (at 20 °C and 25 °C) or as a vapour pressure 
curve should be recorded. The unit is the Pascal (Pa). 

Where the vapour pressure is less than 10-5 Pa at 20 °C, the vapour pressure at 20 °C 
and 25 °C may be estimated by a vapour pressure curve. 

The vapour pressure does not need to be measured, if calculations indicate that the 
value is  less than 10-5 Pa at 20 °C. 

The study does not need to be conducted if the melting point is above 300 °C. A limit 
value based on measurement or a recognised calculation method is sufficient where the 
melting point is between 200 °C and 300 °C. 

Test according to EC method A.4 (Vapour Pressure), based on OECD Test Guideline 104 
(Vapour Pressure). 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1.5 Vapour pressure, (ECHA) 

2.6.7.1  Point 3.7.1 Henry's law constant  

Point 3.7.1 of Annex II to the BPR states that the Henry’s law constant  must always be 
stated for solids and liquids if it can be calculated.  

The Henry’s law constant (HLC) depends on the water solubility, vapour pressure and 
molecular weight of a substance, and expresses the tendency of a substance to 
evaporate from aqueous solutions. The unit should be stated as Pa x m3 x mol-1. The 
water solubility and the vapour pressure used for a calculation of the HLC need to be 
given at the same temperature. 

Further Guidance:   

  ECHA Guidance on information requirements and chemical safety assessment 

Chapter R.7a: Endpoint specific guidance, Appendix R.7.1-1 Henry’s law constant 
and evaporation rate, (ECHA). 

2.6.8  Point 3.8 Surface tension 

Footnote 10 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of a stated specification. 

The surface tension should be measured using an aqueous solution of sufficient 
concentration such that any surface activity potential is expressed; i.e. at 90% of 
saturation (the concentration must be quoted) to maximum concentration of 1g/l (where 
viscosity permits).  

Inconsistencies between the water solubility result and the solubility reported should be 
fully addressed. 

If the data demonstrate that the active substance is surface active the critical micelle 
concentration (CMC) needs to be determined. 

Test according to EC method A.5 (Surface Tension), based on OECD Test Guideline 115 
(Surface Tension of Aqueous Solutions). 

Further Guidance:  

 
 
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  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1.6 Surface tension, (ECHA). 

2.6.9  Point 3.9 Water solubility  

Footnote 11 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified active substance of stated specification. 

The studies must include the effect of pH (5 to 9) and temperature on solubility. 

The water solubility should be determined at  20 °C.  

The temperature dependent solubility at 10 °C and 30 °C should be reported. 

The water solubility should be determined unless the substance is hydrolytically 
unstable. Phrases such as “insoluble in water” are insufficient; instead a limit test should 
be performed so that a positive statement can be made (e.g. down to the analytical 
limit). For complex mixtures, a mass balance may be the only practical method. 
However, the extract should be compared (e.g. HPLC) with the mixture to check for 
differential solubility values of the components. 

Where the stability of the active substance in aqueous media is such that the water 
solubility cannot be determined, a justification based on test data must be submitted. 

Colloid and micelle formation and other possible observations must be reported. 

No single method is available to cover the whole range of solubility values in water, from 
“relatively soluble” to “very low soluble” substances. General test guidelines (OECD Test 
Guideline 105 (Water Solubility); EC method A.6 (Water Solubility)) include two test 
methods which cover the whole range of solubility values but are not applicable to 
volatile substances. For metals and sparingly soluble inorganic metal compounds a 
specific water solubility approach (OECD Guidance Document 29 on 
Transformation/Dissolution of Metals and Metal Compounds in Aqueous media) was 
designed to measure transformation to the dissolved fraction under standard conditions. 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1.7 Water Solubility, (ECHA). 

2.6.10  Point 3.10 Partition coefficient (n-octanol/water) and its 

pH dependency  

Footnote 12 of Point 3.1 of Annex II to the BPR states that the information provided 
should be for the purified substance of stated specification. 

For substances which dissociate within an environmentally relevant pH range (pKa 5-9), 
values for Kow must be derived for the neutral form and also for the dissociated form. 

Where the stability of the active substances in aqueous media is such that the partition 
coefficient cannot be determined, a justification based on test data must be submitted. 

For those substances, which are extremely soluble in one of the phases, a limit value 
should be provided. If necessary, it can be based on the individual solubility values in n-
octanol and water. 

If the test cannot be performed a calculated value along with calculation details should 
be provided, if relevant. 

Test according to EC method A.8 (Partition Coefficient), corresponding partly to OECD 
Test Guideline 107 (Partition Coefficient (n-octanol/water): Shake Flask Method) and 
partly similar to OECD Test Guideline 117 (Partition Coefficient (n-octanol/water), HPLC 

 
 
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Method). In addition, the OECD Test Guideline 123, Slow-stirring method, can be used to 
generate data for this endpoint. 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 

Chapter R.7a: Endpoint specific guidance, R.7.1.8 Partition coefficient, (ECHA). 

2.6.11  Point 3.11 Thermal stability, identity of breakdown 

products  

In contrast to what is stated in Annex II to the BPR, footnote 13 of Point 3.1 of Annex II 
to the BPR states that the information should be provided for the active substance as 
manufactured.  

Data on thermal stability, namely the  melting point, sublimation or decomposition is to 
be identified. 

If possible, thermal breakdown compounds are to be evaluated and the possibility of 
formation of dangerous degradation products is to be considered. 

There is no relevant EC method. Test according to OECD Test Guideline 113 (Screening 
Test for Thermal Stability and Stability in Air). 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, 2.9.3.3.1 Thermal stability 

tests and temperature control, (ECHA). 

2.6.12  Point 3.12 Reactivity towards container material 

Suitable container materials which are resistant against corrosion and do no react with 
the substance in question, and/or container materials that cannot be used with the 
substance, must be specified taking into consideration the properties of the chemicals 
(e.g. pH and impurities) and storage conditions (e.g. pressure and temperature). 

The information can be obtained from experience in use and the chemical structure of 
the substance. A comprehensive explanation should be provided. 

2.6.13  Point 3.13 Dissociation constant (ADS)  

The information provided should be for the purified active substance of stated 
specification unlike implied by the BPR. 

The acid-base constant (pKa, pKb) should always be provided if it can be determined. 

Test according to OECD Test Guideline 112 (Dissociation Constants in Water). 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1.17 Dissociation Constant, 
(ECHA). 

2.6.14  Point 3.14 Granulometry 

Must be determined and reported for active substances such as powders or granules 
etc.. 

Granulometry determines the particle size distribution. A presentation of the particle size 
distribution is necessary to interpret the data (e.g. in the form of a histogram of the 
particle size vs. mass, particles size vs. number of particles, etc).  

 
 
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The percentage of particles in mass with aerodynamic diameter <50 µm must be 
determined (see also Volume III, section 2.1.7.2 on acute toxicity by inhalation). 

Many methods are available for particle size measurements, but none of them are 
applicable to the entire size range. For further information on granulometry testing, 
please consult the REACH guidance on information requirements and chemical safety 
assessment Chapter R.7 (ECHA). The guidance provides more detailed information on 
the available international methods for measuring particle size distribution. The applicant 
should select the most appropriate method for their substance. 

Please follow more specific Guidance in section 3.7.5.6 of this guidance  

2.6.15  Point 3.15 Viscosity (ADS) 

This data is always required for liquid substances. 

The viscosity should be determined at 20 °C and 40 ºC.  

There is no relevant EC method. Test according to OECD Test Guideline 114 (Viscosity of 
Liquids) where the following determination methods are recommended:  

  Capillary viscometer; 

  Flowcup; 

  Rotational viscometer; 

  Rolling ball viscometer; 

  Drawing ball viscometer. 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 

Chapter R.7a: Endpoint specific guidance, R.7.1.18 Viscosity, (ECHA). 

2.6.16  Point 3.16 Solubility in organic solvents, including effect of 
temperature on solubility (ADS)  

Footnote 14 of Point 3.1 of Annex II to the BPR states that The information provided 
should be for the purified active substance of a stated specification. 

Must be examined using at least two common solvents with different polarities. 

Results should be provided as mg/l of solvent. 

Test according to CIPAC method MT 181 (Solubility in Organic Solvents). The method is 
not suitable for substances with solubility under 10 mg/l. 

2.6.17  Point 3.17 Stability in organic solvents used in biocidal 
products and identity of relevant breakdown products (ADS) 

Footnote 15 of Point 3.1 of Annex II to the BPR states that The information provided 
should be for the purified active substance of a stated specification or the active 
substance as manufactured, if different. 

The information is only required if the active substance as manufactured is delivered in 
an organic solvent. 

Information on the stability of a test substance in a solvent is relevant, particularly when 
samples are to be stored. Factors affecting the rate of degradation include rates of 
hydrolysis, of photolysis and of oxidation. Identification of the degradation products will 
allow an assessment of whether they are likely to be more toxic than the parent material 
in subsequent ecotoxicity studies.  

 
 
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Further Guidance:  

Guidance on the BPR: Volume I Parts A+B+C 
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  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R.7a: Endpoint specific guidance, R.7.1.16 Stability in organic solvent 
and degradation products, (ECHA). 

2.7  Point 4 Physical hazards and respective characteristics   

The physical hazards of the active substance (endpoints 4.1 to 4.16, Annex II to the 
BPR) correspond to the physical hazard classes included in the CLP Regulation. The 
criteria and testing methods or standards for each of these physical hazards required in 
the BPR are described in the corresponding section of Part 2 of Annex I to the CLP 
Regulation. 

For the purposes of determining whether a substance entails any of the physical hazards 
referred to in Part 2 of Annex I to the CLP Regulation: the manufacturer, importer or 
downstream user must perform the tests required by the above mentioned Part 2, unless 
there is adequate and reliable information available (see Article 8(2) of the CLP 
Regulation). Further to this for each relevant physical hazard a reference to the 
corresponding test according to UN Recommendations on the Transport and Dangerous 
Goods, Manual of Test and Criteria, UN-MTC (UN, 2009), starting with a UN test method 
name is provided.  

Further information can be found in the Guidance on the Application of the CLP Criteria 
(ECHA). 

2.7.1  Point 4.1 Explosives 

Criteria for explosives are described in the section 2.1 of Annex I to the CLP Regulation. 

Test according to UN Test series 1 to 3 (further test series 4 to 6 are necessary for 
classification) described in Part I of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.2 Explosives 

(ECHA). 

2.7.2  Point 4.2 Flammable gases 

Criteria for flammable gases are described in the section 2.2 of Annex I to the CLP 
Regulation, 

Test according to ISO 10156 and EN 1839. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.3 Flammable 

gases (ECHA). 

2.7.3  Point 4.3 Flammable aerosols 

Criteria for flammable aerosols are described in the section 2.36 of Annex I to the CLP 
Regulation. 

Test according to 75/324/EC amended by 2008/47/EC which are harmonised with UN-
MTC Section 31. 

6 Please note that the 4th Adaptation to Technical Progress (ATP) will amend the criteria in Section 
2.3, Annex I, the CLP Regulation. 

 
 
                                           
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Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.4 Flammable 

aerosols (ECHA). 

2.7.4  Point 4.4 Oxidising gases  

Criteria for oxidising gases are described in the section 2.4 of Annex I to the CLP 
Regulation. 

Tests or calculation methods as described in ISO 10156 (Gases and gas mixtures. 
Determination of fire potential and oxidising ability for the selection of cylinder valve 
outlets) as amended should be performed. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.5 Oxidising gases 

(ECHA). 

2.7.5  Point 4.5 Gases under pressure 

Criteria for gases under pressure are described in the section 2.5 of Annex I to the CLP 
Regulation. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.6 Gases under 

pressure (ECHA). 

2.7.6  Point 4.6 Flammable liquids 

Criteria for flammable liquids are described in the section 2.6 of Annex I to the CLP 
Regulation.  

Possible test methods for determining the flash point of flammable liquids are listed in 
Table 2.6.3, Section 2.6.4.4. of Annex I to CLP. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.7 Flammable 

liquids (ECHA). 

2.7.7  Point 4.7 Flammable solids 

Criteria for flammable solids are described in the section 2.7 of Annex I to the CLP 
Regulation. 

Test according to UN Test N.1 as described in Section 33.2.1 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, 2.8 Flammable solids 

(ECHA). 

2.7.8  Point 4.8 Self-reactive substances and mixtures 

Criteria for self-reactive substances and mixtures are described in the section 2.8 of 
Annex I to the CLP Regulation. 

Test according to the tests series A to H, as described in the Part II of the UN-MTC. 

Further Guidance:  

 
 
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  ECHA Guidance on the Application of the CLP Criteria, Section 2.9 Self-reactive 

substances and mixtures (ECHA). 

2.7.9  Point 4.9 Pyrophoric liquids 

Criteria for pyrophoric liquids are described in the section 2.9 of Annex I to the CLP 
Regulation. 

Test according to UN Test N.3 as described in Section 33.3.1.5 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.10 Pyrophoric 

liquids and solids (ECHA). 

2.7.10  Point 4.10 Pyrophoric solids 

Criteria for pyrophoric solids are described in the section 2.10 of Annex I to the CLP 
Regulation. 

Test according to UN Test N.2 as described in Section 33.3.1.4 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.10 Pyrophoric 

liquids and solids (ECHA). 

2.7.11  Point 4.11 Self-heating substances and mixtures  

Criteria for self-heating substances and mixtures are described in the section 2.11 of 
Annex I to the CLP Regulation. 

Test according to UN Test N.4 as described in Section 33.3.1.6 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.11 Self-heating 

substances and mixtures (ECHA). 

2.7.12  Point 4.12 Substances and mixtures which in contact with 

water emit flammable gases 

Criteria for substances and mixtures which in contact with water emit flammable gases 
are described in section 2.12 of Annex I to the CLP Regulation. 

Test according to UN Test N.5 as described in Section 33.4.1.4 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.12 Substances 

and mixtures which in contact with water emit flammable gases (ECHA). 

2.7.13  Point 4.13 Oxidising liquids 

Criteria for oxidising liquids are described in the section 2.13 of Annex I to the CLP 
Regulation. 

Test according to UN Test O.2 as described in Section 34.4.2 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.13 Oxidising 

liquids and Oxidising solids (ECHA). 

 
 
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2.7.14  Point 4.14 Oxidising solids 

Criteria for oxidising solids are described in the section 2.14 of Annex I to the CLP 
Regulation. 

Test according to UN Test O.17 as described in Section 34.4.1 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.4 Oxidising gases 

(ECHA). 

2.7.15  Point 4.15 Organic peroxides 

Criteria for organic gases are described in the section 2.15 of Annex I to the CLP 
Regulation. 

Test according to UN Test series A to H as described in Section 28 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.14 Organic 

peroxides (ECHA). 

2.7.16  Point 4.16 Corrosive to metals  

Criteria for corrosive to metals are described in the section 2.16 of Annex I to the CLP 
Regulation. 

Test according to UN Test C.1 as described in Section 37.4 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.15 Corrosive to 

metals (ECHA). 

2.7.17  Point 4.17 Additional physical indicators for hazards  

2.7.17.1  Point 4.17.1 Auto-ignition temperature (liquids and gases)  

For liquids and gases, the term ‘auto-ignition’ instead of ‘self-ignition’ is generally 
used. Auto-ignitability is of high importance for the assignment of temperature classes in 
explosion protection (i.e. ATEX in Europe) of plants and equipment.  

Test according to EC method A.15, which references several national and international 
standards (e.g. EN 14522, etc.). The test procedure is applicable to gases, liquids and 
vapours which, in the presence of air, can be ignited by a hot surface.  

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 

Chapter R.7a: Endpoint specific guidance, R.7.1.12.1 Auto-ignition, (ECHA). 

7 At the time of writing, work is in progress at the UN-level to modify Test O.1: Test for oxidising 
solids. This includes changing the reference substance and introducing a gravimetric method for 
the measurement. For further information, see document UN/SCEGHS/23/INF.17 available at the 
following link: http://www.unece.org/fileadmin/DAM/trans/doc/2012/dgac10c4/ST-SG-AC10-C4-
2012-11e-ST-SG-AC.10-C3-2012-75e.pdf    

 
 
                                           
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2.7.17.2  Point 4.17.2 Relative self ignition temperature for solids 

Criteria for self-heating substances are described in Section 2.11 of Annex I to the CLP 
Regulation. 

Test according to UN Test N.4 as described in Section 33.3.1.6 of the UN-MTC. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria, Section 2.11 Self-heating 

substances and mixtures (ECHA). 

2.7.17.3  Point 4.17.3 Dust explosion hazard 

A dust explosion hazard is applicable to all powders and products containing, or able to 
produce, dust that can either ignite or explode when exposed to an ignition source when 
dispersed in air (relevant for particulates up to 1 mm in diameter). 

Materials that cannot be oxidised are exempt from testing (e.g. most inorganic salts). If 
active substances are prone to dust explosions, describe measures to reduce the chance 
of dust explosions. Next to investigation of the relevant variables, which will indicate the 
chance and force of dust explosions in certain situations, it is also possible to dissolve an 
active substance in a carrier (e.g. water or oil), to form a technical concentrate (TK), to 
reduce the chance of dust formation. 

Perform a screening method based on an open Hartman Tube according to VDI 2263 
Part 1: VDI manual Chemical and process engineering – Volume 4: Occupational safety 
Part 1. IT-security for industrial automation – General mode) to determine whether a 
dust should be considered: 

  Group A: Combustible dusts which ignite and propagate flame (explosive);  

  Group B: Non-combustible dusts which do not ignite (non-explosive).  

Category A substances should then be further tested. The following variables should be 
determined for explosive dusts: 

Lower explosion limit 

The lower explosion limit (LEL, expressed in g.m-3) is defined as the minimum 
concentration of dust in air which can explode when exposed to an ignition source. A 
standardised test method is available, i.e. EN 14034 (part 3). 

Explosion constant, maximum explosion pressure and minimum ignition energy 

If a dust explosion hazard is expected, the dust explosion constant (Kst) should be 
determined by means of the explosion indices test (EN 14034, part 2), expressed in 
bar.m.s-1, and the minimum ignition energy (MIE) by means of the method EN 13821. 
When determining the Kst, the pmax (maximum explosion pressure) is also determined. 

Minimum ignition temperature and smouldering temperature 

Explosions may also be induced by hot surfaces. Therefore, the minimum ignition 
temperature (MIT) and smouldering temperature should be investigated according to EN 
50281. 

If the applicant can motivate that no dust layers will be formed on top of electrical 
equipment, the MIT may be waved. 

Silos and limiting oxygen concentrations 

In case of storage in silos, it is advisable to investigate the Limiting Oxygen 
Concentration (LOC). Tests are not described in this Guidance Document, considering 
storage of dusty substances in silos is thought to be rare for biocides.  

 
 
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2.8  Point 5 Methods of detection and identification   

The applicant has to supply validated analytical methods required for the determination 
of the active substances (and where appropriate, for relevant degradation products, 
isomers and impurities of active substances and their additives), and for relevant 
residues thereof in/on soil, in air, in drinking and surface water, in body fluids and 
tissues, and in treated food or feeding stuffs.  

For substances, which are difficult to analyse, a description of the problems should be 
provided. 

The objective of validating analytical methods is to demonstrate that they are suitable 
for their intended uses. The methods should allow the user to determine all of the 
analytes to fully characterise the active as manufactured and all the analytes included in 
the residues definitions established during evaluation. The methods should use 
commonly available techniques/equipment and avoid hazardous substances (e.g. 
carcinogenic substances like diazomethane, benzene or chloroform). Enforcement 
methods are required to demonstrate appropriate limits of quantification (LOQ), to be 
sufficiently selective, so that the interfering substances never exceed  a percentage of 
the LOQ (see specific information outlined below under section 2.9.1 and 2.9.2 of this 
guidance ), and demonstrate acceptable recovery and repeatability. 

Description of an analytical method 

Full descriptions of validated methods must be provided. The submitted method 
description must include the following points: 

  Definition of the analyte; 

  Apparatus; 

  Reagents (including purity as well as full details of standard compounds purity 

and associated method of determination or clear reference of origin, if 
commercially available); 

  Analytical procedure including sample processing, extraction, clean up, 

derivatisation, determination (if appropriate); 

  Description of calibration including the use of matrix matched standards (if 

appropriate); 

  Procedure for the calculation of results from raw data; 

  Result tables (if results are not presented in separate studies). 

The following information should be offered if appropriate: 
  Schematic diagram of the analytical procedure; 

  Stages where an interruption of the procedure is possible; 

  Hazards or precautions required; 

  A statement about extraction efficiency of solvents used. 

Analytical methods should use instrumentation regarded as "commonly 
available":  

  GC detectors: FPD, NPD, ECD, FID, MS, MSn (incl. ion trap and MS/MS),  

  GC columns: capillary columns; 

  HPLC detectors: MS, MS/MS, FLD, UV, DAD; 

  HPLC columns: reversed phase, ion-exchange, normal phase; 

  AAS, ICP-MS, ICP-OES; 
 

further analytical techniques in certain cases. 

 
 
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If reference is sought with regard to the stability of the samples, the OECD Guidance 
document on pesticide residue analytical methods (OECD, 2007a) should be consulted.  

Further Guidance:  

  OECD Guidance Document on pesticide residue analytical methods, (OECD, 

2007a); 

  DG SANCO Guidance document on pesticide residue analytical methods, (EU, 

2010a). 

2.8.1  Point 5.1 Analytical methods including validation 

parameters for the determination of active substance as 
manufactured and where appropriate, for relevant 
residues, isomers and impurities of the active substance 
and additives (e.g. stabilisers).   

Point 5.1 of Annex II to the BPR states that for impurities other than relevant impurities 
this only applies if they are present at ≥ 1g/kg.  

Information on analytical methods is required concerning the determination of the active 
substance, isomers, impurities and residues of the starting materials and additives (e.g. 
stabilisers), which are of toxicological or ecotoxicological concern (i.e. which are relevant 
for risk assessment) or which are present in quantities ≥ 1 g/kg in the active substance 
as manufactured. 

The following validation parameters must be addressed for the active 
substance, impurities and additives: 

Recovery (Accuracy)  

The determination of recovery for the active substance in the technical material (TC) is 
not required. However, for technical concentrates (TK) an assessment of accuracy in 
terms of recovery is required.  

For impurities and additives, recovery rates should be determined at the level of the 
measurements i.e. for the determination of the active substance in a formulation or an 
impurity at a constant level, one recovery rate (measured at the stated composition) is 
sufficient.  

For the determination of residues or impurities of varying levels the recovery rates 
should be determined for at least two concentration levels: one near the LOQ and one at 
two to three orders of magnitude higher and within the range of the calibration curve. 

The following recoveries would be regarded as acceptable:  

Table 4: Acceptable recovery values for residues or impurities 

% active 
(nominal) 

>10 

1-10 

<1 

0.01-0.1 

<0.01 

Mean % recovery  % impurities 

Mean % recovery 

(nominal) 

>1 

0.1-1 

<0.1 

90-110 

80-120 

75-125 

98-102 

97-103 

95-105 

90-110 

80-120 

Source: SANCO 3030/99 (EU, 2000a) 

 
 
 
 
 
 
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Repeatability 

Repeatability of the determination of the active substance and impurities and additives 
should be addressed by the analysis of at least five independent sample solutions of the 
same batch of TC or TK. The repeatability for the active and the repeatability for 
impurities for the technical grade active substance should be compared, if available, to 
the modified Horwitz ratio, an inter-laboratory precision index. 

Calibration 

Analytical calibration should extend over a range appropriate for the lowest and highest 
(±20%) nominal concentration of the analyte in relevant analytical solutions. Duplicate 
determinations at three or more concentrations or single determinations at five or more 
concentrations should be performed.   

Raw data of calibration have to be provided with the studies. The equation and plot of 
the calibration and the correlation coefficient (R2) must be provided.  

Specificity  

Fully labelled chromatograms from the analysis of the active and all impurities and 
additives must be provided. These should include chromatograms from the analysis of 
the reference standards and the technical material. An explanation must be provided for 
any interference which contributes more than ± 3% to the total quantity determined. 

Derivatisation 

For the technical grade active substance the mean yield and precision of any 
derivatisation step does not need to be addressed. 

Confirmation of identity  

Provided the analytical method used to quantify the active, impurity or additive is 
specific or highly specific (see Section 2.2.1.11 for method definitions) then analysis 
using a confirmatory method is not required. Where a non-specific method (e.g. a 
titration) is used then confirmation of identity will be required. This requirement does not 
need to be addressed where a CIPAC method has been used. Information on the 
approaches to assess confirmation of identity is outlined in Section 2.2.4.2.   

Further Guidance:  

  ECHA Guidance for identification and naming of substances under REACH and 

CLP; Chapters 4.2.1.3. / 4.2.2.3. / 4.2.3.2. (ECHA). 

2.8.2  Point 5.2 Analytical methods for monitoring purposes 

including recovery rates and the limits of quantification 
and detection for the active substance, and for residues 
thereof in/on the following where relevant 

Analytical methods for monitoring purposes including recovery rates and the limits of 
quantification and detection for the active substance, and for residues thereof in soil, air, 
water and sediment as well as animal and human fluids and tissues need to be provided, 
where relevant. 

Analytical methods normally have to be validated to ascertain whether the method is 
suitable for the purpose. It is nevertheless possible that a specific method is not fully 
validated but can still be concluded as acceptable for the purpose if it is a specific 
method with official status (e.g. published by ISO, CEN, OSHA). Some flexibility should 
be allowed for such situations. 

The following Guidance applies to the information requirements 5.2.1 to 5.2.4: 

 
 
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  Methods for the analysis of parent compounds and/or metabolites of concern 

must be submitted. 

  For each method and for each relevant representative matrix, the specificity, 

precision, recovery, and LOQ must be experimentally determined and reported. 
Information on calibration is a key validation parameter. 

 

In principle, the residue methods proposed should be multi-residue methods; a 
standard multi-residue method must be assessed and reported in terms of its 
suitability for residue determination. Where the residue methods proposed are 
not multi-residue methods, or are incompatible with such methods, an alternative 
method must be proposed. Where this requirement results in an excessive 
number of methods for individual compounds, a "common moiety method" may 
be acceptable. 

The following validation data are required for residue monitoring methods: 

Calibration 

Analytical calibration should extend over a range appropriate for the lowest and highest 
(±20%) nominal concentration of the analyte in relevant analytical solutions. Duplicate 
determinations at three or more concentrations or single determinations at five or more 
concentrations should be performed. Raw data of calibration have to be provided with 
the studies. The equation and plot of the calibration and the correlation coefficient (R2) 
should be provided. 

Selectivity/Specificity (matrix interference) 

Uncorrected recoveries and blank (control) values should be reported. Blank values in 
the area of analytical interest (untreated samples and procedural blanks) have to be 
determined from the matrices used in fortification experiments and should not be higher 
than 30% of the LOQ. If this is exceeded, detailed justification should be provided. 
Matrix effects such as peak suppression and enhancement can also occur with some 
techniques such as HPLC/MS-MS and GC. To check for these effects, the calibration 
curve generated using standards prepared in matrix extracts of an untreated sample 
(matrix matched standards) should be compared with the calibration curve generated 
with standards in solvents. 

Fully labelled chromatograms should be provided. These should cover the analysis of a 
standard, a fortified sample at the lowest fortification level and an unfortified (blank) 
sample. Two blank control samples should be analysed per matrix.  

Range of acceptable recoveries 

In general, the mean recovery at each fortification level and for each commodity should 
be in the range of 70-110%. 

Precision - Repeatability (expressed as relative standard deviation) 

The precision of the method in a validation study should be reported as the relative 
standard deviation (RSD) at each fortification level. Five determinations should be made 
at each fortification level. In general, the RSD should be ≤ 20% per commodity and 
level. Where outliers have been identified (e.g. via Dixon’s or Grubb’s test) and 
discarded, this fact, the data of the outlier and the statistical significance must be clearly 
indicated. A maximum of one outlier may be disregarded at each fortification level. 

Where an MRL is required then fortification at this level will also be required.  

Confirmatory techniques 

Confirmatory methods are required to demonstrate the selectivity of the primary method 
for all representative sample matrices. It has to be confirmed that the primary method 

 
 
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detects the right analyte (analyte identity) and that the analyte signal of the primary 
method is quantitatively correct and not affected by any other compound.  

Confirmation simultaneous to primary detection 

A confirmation simultaneous to the primary detection using one fragment ion in GC-MS 
and HPLC-MS or one transition in HPLC-MS/MS may be accomplished by one of the 
following approaches: 

 

 

In GC-MS, HPLC-MS, by monitoring at least two additional fragment ions 
(preferably m/z > 100) for low resolution system and at least one additional 
fragment ion for high resolution/accurate mass system; 
In GC-MSn (incl. Ion Traps and MS/MS), HPLC-MS/MS, by monitoring at least one 
additional SRM transition. 

For all mass spectrometric techniques, a mass spectrum (for a single MS) or a product 
ion spectrum (in case of MSn) should be provided to justify the selection of the 
additional ions. 

Confirmation by an independent analytical technique 

Confirmation can also be achieved by an independent analytical method. The following 
are considered sufficiently independent confirmatory techniques: 

 

chromatographic principle different from the original method 

o  e.g. HPLC instead of GC; 

  different stationary phase and/or mobile phase with significantly different 

selectivity: 

o 

the following are not considered significantly different: 

 

 

in GC: stationary phases of 100% dimethylsiloxane and of 95% 
dimethylsiloxane + 5% phenylpolysiloxane; 
in HPLC: C18- and C8-phases. 

  alternative detector: 

o  e.g. GC-MS vs. GC-ECD, HPLC-MS vs. HPLC-UV/DAD. 

  derivatisation, if it was not the first choice method; 
  high resolution/accurate mass MS; 
 

in mass spectrometry an ionisation technique that leads to primary ions with a 
different m/z ratio than the primary method (e.g. ESI negative ions vs. positive 
ions). 

It is preferred that confirmation data are generated with the same samples and extracts 
used for validation of the primary method. 

For the CIPAC titration method, no confirmatory method is needed. 

Derivatisation 

For analysis of some compounds, such as those with high polarity or with poor 
chromatographic properties, derivatisation may be necessary. Derivatives may be 
prepared prior to chromatographic analysis or as part of the chromatographic procedure 
(pre- or post-column). The use of derivatisation methods should be fully reported and 
justified. The derivative should be stable and its formation reproducible. The calibration 
is preferably conducted using standard solutions of that derivative, unless the 
derivatisation step is an integral part of the detection system. If the derivative is 
unavailable as a reference standard it should be generated with the sample 
derivatisation procedure and a full justification should be submitted. The method is 
considered to be specific to the analyte of interest if the derivatised species is specific to 
that analyte. 

 
 
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If the standard solution of the analyte is also derivatised then for complex matrices, the 
mean yield and precision of the derivatisation step must be addressed by using matrix 
matched standards. 

Independent laboratory validation studies 

Independent laboratory validation (ILV) studies are necessary to perform when 
compliance with an MRL is required in order to demonstrate the reproducibility of the 
analytical method. ILV studies are generally needed for the determination of residues in 
plant materials and additionally for methods for the determination of residues in food of 
animal origin, if such methods are required.  

An ILV is not required for confirmatory methods. Usually, an independent laboratory 
validation should be conducted with samples of the representative commodities and 
tissues. The sample set (number of samples and fortification levels) of the primary 
validation has to be applied for the ILV also.  

The laboratory chosen to conduct the ILV trials must not have been involved in the 
method development and in its subsequent use. Provided this criterion is met, the 
laboratory chosen to conduct the ILV trials may be in the applicant’s organisation, but 
must not be at the same location. If the chosen laboratory requires communication with 
the developers of the method to carry out the analysis, this should be reported. Any 
subsequent additions or modifications to the original method should also be reported. 

An ILV may not be necessary if available published multi-residue methods have been 
validated for the representative commodities. 

2.8.2.1  Point 5.2.1 Soil 

Generally, it is confirmed during evaluation, where relevant, which compounds (parent 
and/or metabolites) should be monitored based on the evaluation of fate and behaviour 
of the active substance in the environment.  

The proposed LOQ must not exceed the PNEC soil, if technically possible without 
exceeding the general limit of 0.05 mg/kg dw. 

If the active substance degrades very quickly, i.e. DegT50 and DegT90 values of the active 
substance and the relevant metabolites are lower than two and three days; respectively, 
analytical methods for residues in soil are not required except in the case of continuous 
exposure. 

2.8.2.2  Point 5.2.2 Air 

If the substance is volatile (i.e. if the vapour pressure >0.01 Pa) or sprayed, or 
occurrence in air is otherwise probable, the respective analytical methods need to be 
submitted. 

Relevant health based limit values or relevant exposure levels need to be taken into 
account when judging the suitability of the proposed LOQ. 

No confirmatory methods are required for the determination of residues in air if sufficient 
confirmatory methods are available (sufficient validation data are available) for the 
determination in soil or water (EU, 2010a). 

Generally, the active substance or a relevant volatile degradation product are considered 
to be the relevant residues in air for monitoring purposes. 

Limit of quantification 

In the case of analytical methods for air regarding the general population, the LOQ must 
be equal or lower than the concentration C which is defined as: 

 
 
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[mg/m3 air] 

Where: 

0.1 

60  

20  

safety factor 

body weight [kg] 

air intake [volume per day in m³] 

AEL   overall systemic limit value for the human population as a whole – 
resembling the AOEL. The lowest AEL value available should be used. 

The approach using AEL is preferred to that using the occupational exposure limit (OEL) 
also in the case of analytical methods for air concerning professional users.  

The methods must be suitable for detecting both particle associated and gaseous 
residues. 

2.8.2.3  Point 5.2.3 Water (surface, drinking, etc.) and sediment 

If the substance itself and any of its degradation products fall within the definition of 
pesticides given in Annex I to Council Directive 98/83/EC (European Drinking Water 
Directive, DWD); analytical methods must be submitted that allow determination of the 
relevant parametric values specified in the DWD with adequate reliability. 

Analytical methods must be submitted, which allow monitoring of the quality of surface 
water and groundwater which meet the criteria stipulated by the Directive 2000/60/EC 
(EU Water Framework Directive). 

Detection and analytical methods for surface water obtained from ponds, rivers, 
streams, etc. and sediment, analytical methods for marine surface water as well as 
marine sediment should be provided if relevant exposure can be expected. 

Residue definition 

Generally, it has to be confirmed during evaluation, where relevant, which compounds 
(parent and/or relevant metabolites) should be monitored based on the evaluation of 
fate and behaviour of the active substance in the environment and the toxicological and 
ecotoxicological potential.  

Limit of quantification for drinking water 

The LOQ in drinking water must be ≤0.1 μg/L (EU drinking water limit based on DWD) or 
the toxicologically derived standard for drinking water where this is lower than the 
general limit of 0.1 µg/L. 

Limit of quantification for surface water 

The LOQ must be below the PNEC water if technically possible.  

2.8.2.4  Point 5.2.4 Animal and human body fluids and tissues  

Where an active substance is classified as toxic or very toxic, validated analytical 
methods must be submitted which allow determination of the active substance at the 
NOAEC. 

Residue definition 

Active substances classified as toxic or very toxic are considered to be the relevant 
residues in human body fluids and tissues. They must be analysed for monitoring 
purposes. The inclusion of metabolites may be confirmed during evaluation.  

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Limit of quantification 

The LOQ should be set at 0.05 mg/L for body fluids and 0.1 mg/kg for tissues. 

2.8.3  Point 5.3 Analytical methods for monitoring purposes 

including recovery rates and the limit of quantification and 
detection for the active substance, and for residues 
thereof, in/on food of plant and animal origin or feeding 
stuffs and other products where relevant (ADS)  

Point 5.3 of Annex II to the BPR states that [….] (not necessary if neither the active 
substance nor articles treated with it come into contact with food producing animals, 
food of plant or animal origin, or feeding stuffs).  

Analytical methods for the residues of the active substance may be required for 
monitoring purposes in various matrices, for control of MRL compliance, for the 
identification of misuse and for the estimation of human and animal exposure.  

These methods should be specific for the purpose, use commonly available equipment 
and non-hazardous chemicals. Furthermore, a confirmatory method needs to be 
submitted. Residue analytical methods (primary methods, confirmatory methods and 
ILV) must be validated according to the latest versions of Guidance for biocides or plant 
protection products.  

Analytical methods for residues are required, presuming that the biocidal product may 
come into contact with food, foodstuffs and feeding stuffs. This is always the situation for 
product-types 3, 4, 5 and also for certain uses of other product-types. For biocides of 
product-type 21 residue analytical methods must be submitted for fish and shellfish. The 
need for residue analytical methods for other product-types depends on the assessment 
of the transfer of the active substance into food and feeding stuffs. 

Analytical methods in food, foodstuffs and feeding stuffs are not required for naturally 
occurring non-toxic active substances. 

The residue analytical methods must be able to determine the relevant residue of the 
active substance with an LOQ below the relevant action levels or MRLs. The definition of 
the relevant residue is based on the physical and chemical properties of the active 
substance, the toxicological properties as well as the metabolism in plants and livestock. 
Separate residue definitions for risk assessment and for monitoring purposes must be 
set. Therefore, the active substance and/or relevant metabolites and degradation 
products could be included in the residue definition. If the active substance undergoes a 
complex metabolism it is highly recommended to define a marker compound.  

Generally, an LOQ of 0.01 mg/kg should be met. In special cases, the LOQ may need to 
be lower than 0.01 mg/kg (e.g. in infant formulae and follow-on formulae). 

Further Guidance:  

  Guidance on pre-registration of Plant Protection Products, (EU, 2000b). This 

Guidance is applicable for generating residue data for the estimation of consumer 
exposure and supporting studies on the fate and behaviour of the active 
substance in foodstuffs, the environment, ecotoxicology and toxicology. 

  Guidance on post-registration monitoring of pesticide residues, (EU, 2010a). This 
Guidance explains the requirements and the assessment on residue analytical 
methods for monitoring of pesticides. 

The following Guidance documents are intended for the use in official laboratories 
involved in pesticide control in food and feed: 

 
 
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  Guidance Document on Method Validation and Quality Control Procedures for 

Pesticide Residues Analysis in Food and Feed, (EU, 2011c). 

  OECD Guidance Document on pesticide residue analytical methods, (OECD, 

2007a). 

  OECD series on emission scenario documents number 19. Complementing 

guideline for writing emission scenario documents: the life-cycle step "service-
life" (OECD, 2008a). While the OECD document talks about emission mechanisms 
of substances from (solid) articles, it is highly relevant for the evaluation of 
biocides uses in (solid) articles. 

  Guidance on information requirements and chemical safety assessment Chapter 
R.17: Estimation of exposure from articles (ECHA). The Guidance is relevant for 
the calculation/modelling of exposure from articles during service life. It also 
gives valuable guidance on how to summarise release from articles accumulated 
in society, emitting the same substance. 

 
 
 
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3 

Part A: Dossier Requirements for Biocidal Products 

BPR Annex III, Title 1, points 1-13 

NOTE to the reader:  

The following section headings include a reference to the relevant section/point in 
the BPR Annex for ease of cross reference. 

GENERAL INFORMATION 

3.1  Point 1 Applicant 

Applications for authorisation of a biocidal product may be made by, or on behalf of, 
prospective authorisation holders. 

3.1.1  Point 1.1 Name and address 

Name and address of the applicant and prospective authorisation holder (natural person 
or legal entity) if different. 

3.1.2  Point 1.2 Contact person 

Names, address, telephone and fax numbers, email, and other contact information of the 
applicant and prospective authorisation holder, if different.  

The authorisation holder must be established in the EU. 

3.1.3  Point 1.3 Manufacturer and formulator of the biocidal 

product and the active substance(s) (names, addresses, 
including location of plant(s)) 

Name, address and location of manufacturing plant(s). 

3.2  Point 11 Measures to be adopted to protect humans, animals 

and the environment  

3.2.1  Point 11.1 Recommended methods and precautions 

concerning handling, use, storage, disposal, transport or 
fire 

See guidance in section 2.2.1 of this guidance . 

3.2.2  Point 11.2 Identity of relevant combustion products in 

cases of fire 

See guidance in section 2.2.2 of this guidance . 

3.2.3  Point 11.3 Specific treatment in case of an accident, e.g. 

first-aid measures, antidotes, medical treatment if 
available; emergency measures to protect the 
environment 

See guidance in section 2.2.3 of this guidance . 

 
 
 
 
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3.2.4  Point 11.4 Possibility of destruction or decontamination 

following release in or on the following: 

3.2.4.1  Point 11.4.1 Air  

See guidance in section 2.2.4 of this guidance . 

3.2.4.2  Point 11.4.2 Water, including drinking water 

See guidance in section 2.2.4 of this guidance . 

3.2.4.3  Point 11.4.3 Soil  

See guidance in section 2.2.4 of this guidance . 

3.2.5  Point 11.5 Procedures for waste management of the 

biocidal product and its packaging for industrial use, use 
by trained professionals, professional users and non-
professional users (e.g. possibility of reuse or recycling, 
neutralisation, conditions for controlled discharge, and 
incineration) 

Provide information necessary for safe disposal. If preliminary treatment of the waste is 
necessary, information about this must also be provided. If any waste generated is 
classified as hazardous waste (e.g. according to Commission Decision 2000/532/EC), 
this has to be mentioned separately and appropriate handling according to the related 
legislation has to be indicated.  

The possibility of recovery or recycling should be indicated for both normal uses of the 
substance and quantities involved in spills. 

A chemical or other disposal method for the product should be indicated. Furthermore, 
information on disposal methods for the waste generated when using the product should 
also be provided (e.g. precipitates generated, instruments for spreading, residues 
treated with the product). 

Information must be provided on how the package is to be emptied and cleaned and on 
the recycling or disposal method for empty packages. 

Recycling or disposal methods for the waste generated from a treated product, and in 
the processing of the treated product (e.g. shavings, cuttings or other waste from the 
treated product) and for treated products no longer in use (e.g. impregnated wood) 
should be described, if applicable. 

Recycling or disposal methods for the waste generated from a treated material (e.g. for 
chips from metal-cutting where the product is used), and in the processing of the 
possible treated material (e.g. waste from treated paper pulp or porous sand strata for 
product-type 12) and for treated material or treated process water or metal working fluid 
no longer used should be provided, if applicable. 

The Guidance provided for the corresponding data requirement for the active substance 
applies also here. 

When the product is applied to a system with water which is to be released into surface 
water with or without pre-treatment, as may be for product-type 11 and 12, information 
on the necessary waste water treatment methods and times and/or the on minimum 
dilution for the active substance in waste water should be provided (in order to assure a 
sufficient degree of degradation or dilution before being released into a water course to 
protect aquatic organisms from harmful effects). 

 
 
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3.2.6  Point 11.6 Procedures for cleaning application equipment 

where relevant 

The procedures should be such that the likelihood of accidental contamination of water 
or its sediments is minimised. 

3.2.7  Point 11.7 Specify any repellents or poison control 

measures included in the product that are present to 
prevent action against non-target organisms 

If mitigation measures are proposed to prevent action against non-target organisms 
then accuracy of these mitigation measures must be proved resulting in a safe use. 

3.3  Point 12 Classification, labelling and packaging  

Point 12 of Annex III of the BPR states that As established in point (b) of Article 20(1), 
proposals including justification for the hazard and precautionary statements in 
accordance with the provisions set in Directive 1999/45/EC and Regulation (EC) No 
1272/2008 must be submitted. 

Example labels, instructions for use and safety data sheets shall be provided. 

An applicant for authorisation of a biocidal product must propose classification, labelling 
and packaging which complies with the CLP Regulation. 

Directive 67/548/EEC (Dangerous Substances Directive, DSD) and Directive 1999/45/EC 
(Dangerous Preparations Directive, DPD) were repealed from 1 June 2015 and 
classification according to these directives is no longer allowed. The CLP criteria must be 
applied for classification, labelling and packaging of both substances and mixtures.  

In accordance with Article 15 of the CLP Regulation, when manufacturers, importers or 
downstream users placing a substance or mixture on the market may have to re-classify 
it at any time in light of new scientific or technical information, or following a change in 
composition. 

In accordance with Article 4 of the CLP Regulation, the responsibility for classification lies 
with the manufacturer, importer or downstream user who places a (substance or) 
mixture, such as biocidal products, on the market. The CLP Regulation requires self-
classification8 by industry of the (substances or) mixtures they supply. Mixtures must 
always be self-classified according to the criteria and rules provided in the CLP 
Regulation text. All biocidal active substances are normally subject to harmonised C&L 
for all endpoints, however this is not the case for non-active ingredients (please consult 
Annex VI and (Article 36(2) of the CLP Regulation)).  

Hazard classification is a process involving identification of the physical, health and 
environmental hazards of a substance or a mixture, followed by comparison of those 
hazards (including degree of hazard) with defined criteria in order to arrive at a 
classification of the (substance or) mixture.  

The need for classification of biocidal products must be considered based on relevant 
available information. According to the CLP Regulation, for mixtures (such as biocidal 
products), classification for physical hazards should normally be based on the results of 
tests carried out on the mixtures themselves. When considering health and 

8 For the purposes of this Guidance self-classification is defined as the decision on a particular 
hazard C&L of a (substance or) mixture is taken by the manufacturer, importer or downstream 
user of that (substance or) mixture, or, where applicable, by those producers of articles who have 
the obligation to classify. 

 
 
                                           
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environmental hazards, the classification should preferably be based on available 
information (including test data) on the mixture itself, except when classifying for e.g. 
CMR effects or for the evaluation in relation to the bioaccumulation and degradation 
properties within the ‘hazardous to the aquatic environment’ hazard class referred to in 
Sections 4.1.2.8 and 4.1.2.9 of Annex I to the CLP Regulation. In these cases 
classification of the mixtures should be based on the information on the substances. If 
no in vivo test data are available on a mixture, such data should normally not be 
generated; rather, all available information on the ingredients of the mixture should be 
used to derive a classification. Only when the manufacturer, importer or downstream 
user has exhausted all other means of generating information, new tests may be 
performed. The background information should be clearly presented in the relevant 
sections of the dossier (see section 3.6 and 3.7 of this guidance, and also in Volume III, 
section 2.1 and Volume IV, sections 3.1 and 3.2).  

The Guidance documents on the application of Regulation (EC) No 1272/2008 (ECHA) 
provide a detailed guide on the application of the CLP criteria. These documents should 
be used in the light of BPR requirements.  

3.3.1  Point 12.1 Hazard classification 

A (substance or a) mixture fulfilling the criteria relating to physical hazards, health 
hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I to the CLP 
Regulation is hazardous and must be classified in relation to the respective hazard 
classes provided for in that Annex. 

For further information on the classification criteria refer to Guidance on the application 
of the CLP criteria, Part 1 (ECHA). 

3.3.2  Point 12.2 Hazard pictogram  

A (substance or) mixture classified as hazardous must bear a label which includes 
relevant hazard pictograms in accordance with Article 19 of the CLP Regulation, where 
applicable.  

For further information on the hazard pictograms refer to Chapter 4.3 Hazard Pictograms 
in the Guidance document on Labelling and Packaging in accordance with Regulation 
(EC) No 1272/2008 (ECHA). 

Pictograms can be downloaded free of charge from the webpage: 

http://www.unece.org/trans/danger/publi/ghs/pictograms.html 

3.3.3  Point 12.3 Signal word 

A (substance or) mixture classified as hazardous must bear a label which includes a 
relevant signal word in accordance with Article 20 of the CLP Regulation, where 
applicable.  

For further information on the signal word please refer to Chapter 4.4 Signal Words in 
the Guidance document on Labelling and Packaging in accordance with Regulation (EC) 
No 1272/2008 (ECHA). 

3.3.4  Point 12.4 Hazard statements 

A (substance or) mixture classified as hazardous must bear a label which includes the 
relevant hazard statements in accordance with Article 21 of the CLP Regulation, where 
applicable.  

 
 
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For further information on the hazard statements please refer to Chapter 4.5 Hazard 
statement in the Guidance document on Labelling and Packaging in accordance with 
Regulation (EC) No 1272/2008 (ECHA). 

A (substance or) mixture classified as hazardous must bear a label which includes 
relevant supplemental hazard information in accordance with Article 25 of the CLP 
Regulation, where applicable.  

For further information on the supplemental hazard information please refer to Chapter 
4.8 Supplemental labelling information in the Guidance document on Labelling and 
Packaging in accordance with Regulation (EC) No 1272/2008 (ECHA). 

3.3.5  Point 12.5 Precautionary statements including prevention, 

response, storage and disposal 

A mixture classified as hazardous must bear a label which includes relevant 
precautionary statements in accordance with Article 22 of the CLP Regulation, where 
applicable.  

Annex I and Annex IV of the CLP Regulation outline the types of precautionary 
statements.  

For further information on the precautionary statements please refer to Chapter 4.6 
Precautionary Statements in the Guidance document on Labelling and Packaging in 
accordance with Regulation (EC) No 1272/2008 (ECHA). 

3.3.6  Point 12.6 Proposals for safety data sheets should be 

provided, where appropriate 

Safety data sheets for active substances and biocidal products should be prepared and 
made available in accordance with Article 31 of Regulation (EC) No 1907/2006, where 
applicable. They must be included in the application for product authorisation, where 
appropriate. 

Further Guidance:  

  ECHA Guidance on the compilation of safety data sheets (ECHA), under 

revision. 

3.3.7  Point 12.7 Packaging (type, materials, size, etc.), 

compatibility of the product with proposed packaging 
materials to be included 

A justification for the packaging (type, materials, size etc.) and the compatibility of the 
product with proposed packaging materials must be provided. Packaging must be in 
compliance with Article 35 of the CLP Regulation. 

Further Guidance:  

  ECHA Guidance on the Application of the CLP Criteria (ECHA). 

3.4  Point 13 Evaluation and Summary  

Point 13 of Annex III to the BPR states that the key information identified from the 
endpoints in each subsection (2-12) is summarised, evaluated and a draft risk 
assessment is performed. 

The summary and evaluation must be provided in separate assessment documents 
attached to the IUCLID file (the templates will be available on the ECHA website). 

 
 
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The Decision on technical equivalence if relevant should be also provided. 

SPECIFIC INFORMATION 

3.5  Point 2 Identity of the biocidal product  

The information must be sufficient to identify the biocidal product, to define it in terms of 
its specification and to characterise it in terms of its nature. The information submitted 
should, in any case, be sufficient to support a risk assessment demonstrating that the 
criteria referred to in BPR Article 19 are met. Article 3(1)(a) of the BPR defines ‘biocidal 
product’ as: 

  any substance or mixture, in the form in which it is supplied to the user, 

consisting of, containing or generating one or more active substances, with the 
intention of destroying, deterring, rendering harmless, preventing the action of, 
or otherwise exerting a controlling effect on, any harmful organism by any means 
other than mere physical or mechanical action, 

  any substance or mixture, generated from substances or mixtures which do not 

themselves fall under the first indent, to be used with the intention of destroying, 
deterring, rendering harmless, preventing the action of, or otherwise exerting a 
controlling effect on, any harmful organism by any means other than mere 
physical or mechanical action. 

3.5.1  Point 2.1Trade name or proposed trade name 

If different trade names are used in different Member States, all of those have to be 
cited. 

3.5.2  Point 2.2 Manufacturer's development code and number of 

the product, if appropriate 

Company(ies) code number(s) or internal name(s). 

3.5.3  Point 2.3 Complete quantitative (g/kg, g/l or % w/w (v/v) 

composition of the biocidal product 

Point 2.3 of Annex III of the BPR states that i.e. declaration of all active substances and 
non-active substances (substance or mixture according to Article 3 of Regulation (EC) No 
1907/2006), which are intentionally added to the biocidal product (formulation) as well 
as detailed quantitative and qualitative information on the composition of the active 
substance(s) contained. For non-active substances, a safety data sheet in compliance 
with Article 31 of regulation (EC) No 1907/2006 has to be provided. In addition, all 
relevant information on individual ingredients, their function and, in case of a reaction 
mixture, the final composition of the biocidal product shall be given. 

It is recognised that the  content of the active substance will vary from batch to batch on 
manufacture and as a result of sampling and analytical errors. To account for these 
variations the following general limits should be applied to the active substance content 
at the point of manufacture: 

 
 
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Table 5: Tolerance limits of the active substance content at the point of 
manufacture 

Declared nominal content 
of active [g/kg or g/L] 

Up to 25 

Tolerance limit 

±15% of the declared nominal content for homogenous 
formulations  (e.g.  emulsifiable  concentrates,  soluble 
concentrates, aqueous suspension concentrates) 

±25%  of  the  declared  content  for  non-homogenous 
preparations (e.g. granules, water dispersible granules) 

Above 25 up to 100 

±10% of the declared nominal content 

Above 100 up to 250 

±6% of the declared nominal content 

Above 250 up to 500 

±5% of the declared nominal content 

Above 500 

±25 g/kg or g/L of the declared nominal content 

For dilute products or heterogeneous products then alternative limits can be specified 
but must be justified.   

The following information must be provided: 

 

Information on individual ingredients (active substance(s) and co-formulants) 
before mixing and the final composition of the product;  

  The chemical name of each ingredient according to IUPAC or CA and their content 

in the product (g/kg) as well as trade names:  

  CAS number and EC number (EINECS, ELINCS or No Longer Polymer List 

number); 

  Structure or structural formula; 
  Functions of the ingredients (e.g. solvent); 
  Classification of components or mixtures according to Regulation (EC) No 

1272/2008 of the European Parliament and of the Council  of 16 December 2008 
on classification, labelling and packaging of substances and mixtures (amending 
and repealing Directives 67/548/EEC and 1999/45/EC), as appropriate; 
Indication of any substances of concern.  

 

If a non-active ingredient is a preparation, full quantitative and qualitative specification 
of this preparation must be provided. 

Further Guidance:  

  ECHA Guidance for identification and naming of substances under REACH and 

CLP, (ECHA). 

3.5.4  Point 2.4 Formulation type and nature of the biocidal 

product, e.g. emulsifiable concentrate, wettable powder, 
solution 

Further Guidance:  

  Manual on development and use of FAO and WHO specifications for pesticides, 

second revision, (FAO, 2010). 

  ECHA Guidance for identification and naming of substances under REACH and 

CLP, Chapter 4.3.1.1 Information on chemical composition, (ECHA). 

 
 
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3.6  Point 3 Physical, chemical and technical properties  

Data must be provided to demonstrate that the physical, chemical and technical 
properties of the formulation will be acceptable and that in use the biocidal product 
under practical conditions will result in an acceptable performance. 

For further Guidance, see the Evaluation manual (EU, 2012a) and the FAO manual (FAO, 
2010). 

3.6.1  Point 3.1 Appearance (at 20 °C and 101.3 kPa) 

Please follow guidance in section 2.6.1 of this guidance. 

3.6.1.1  Point 3.1.1 Physical state (at 20 °C and 101.3 kPa) 

Please follow guidance in section 2.6.1.1 of this guidance. 

3.6.1.2  Point 3.1.2 Colour (at 20 °C and 101.3 kPa) 

Please follow guidance section 2.6.1.3 of this guidance in. 

3.6.1.3  Point 3.1.3 Odour (at 20 °C and 101.3 kPa) 

Please follow guidance section 2.6.1.4 of this guidance in. 

3.6.2  Point 3.2 Acidity/alkalinity  

Point 3.2 of Annex III of the BPR states that The test is applicable when the pH of the 
biocidal product or its dispersion in water (1%) is outside the pH range 4-10. 

In the case of aqueous biocidal products, the pH value of the biocidal product as 
formulated should be determined and reported. In the case of solid and non-aqueous 
liquid biocidal products which are to be applied as aqueous dilutions or dispersions the 
pH of a 1 % dilution or dispersion of the biocidal product should be determined and 
reported. Test according to CIPAC method MT 75.3. 

The acidity/alkalinity must be determined when the pH of the biocidal product as 
formulated or its 1% dilution or dispersion is < 4 or >10.  The acidity/alkalinity should 
be determined using CIPAC method MT 31. Alternatively, test according to CIPAC 
method MT 191.  

Test according to the OECD Test Guideline ‘Determination of pH, Acidity and Alkalinity’ 
which is currently being developed. 

3.6.3  Point 3.3 Relative density (liquids) and bulk, tap density 

(solids) 

In contrast to what is stated in Annex II to the BPR, the relative density should be 
determined in gases, liquids and solids. Please follow the guidance in section 2.6.5 of 
this guidance . The bulk and tap density can only be determined in solids. The 
recommended method is OECD Test Guideline 109 (Density of Liquids and Solids), 
updated in October 2012. This update includes bulk and tap density for solids, based on 
the CIPAC method MT 186 (Bulk density). Please note that OECD Test Guideline 109 
(Density of Liquids and Solids) can also be used for testing the relative density (as 
already stated in section 2.6.5 of this guidance). 

3.6.4  Point 3.4 Storage stability, stability and shelf-life  

Data are required to demonstrate that the biocidal product is stable on storage under the 
conditions and for the shelf life claimed for the product.  

 
 
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3.6.4.1  Point 3.4.1 Storage stability tests 

3.6.4.1.1  Point 3.4.1.1 Accelerated storage test 

The relevant test method is CIPAC method MT 46.3 (storage at 54 °C for two weeks). 

Accelerated storage data generated can be used to give an indication that the biocidal 
product will be stable for two years at ambient temperature. These data can be used to 
demonstrate that the product is likely to be stable for two years at ambient storage to 
support an authorisation. Yet, this does not negate the need to generate ambient 
storage data, which must be generated to confirm the ambient storage of the biocidal 
product.  

The accelerated storage stability test does not necessarily have to be conducted in the 
sales packaging. As outlined in CIPAC method MT 46.3, the accelerated storage study 
could be conducted in a glass jar.  

The data also give an indication of the stability of the biocidal product if for intermittent 
periods it was subject to higher than normal temperatures. If it can be clearly 
demonstrated that the biocidal product will not be subjected to temperatures above 30⁰C 
during storage then accelerated storage data will not be required provided that a full 
ambient storage study has been provided. Appropriate label phrases will be required to 
indicate that the biocidal product must not be stored at higher temperatures. 

If the active is heat sensitive then the following conditions can be used to generate 
accelerated storage data: 

Table 6: Conditions for accelerated storage testing for heat sensitive active 
substances 

Temperature (±2°C) 

Time (weeks) 

54 

50 

45 

40 

35 

30 

2 

4 

6 

8 

12 

18 

3.6.4.1.2  Point 3.4.1.2 Long term storage test at ambient temperature  

Data must be generated in the worst case commercial packaging to support the ambient 
storage of the product for the claimed shelf life.  

It is recognised that generating ambient storage data to support a shelf life of greater 
than two years may be problematic. To support these longer shelf life claims then, in 
general, an ambient storage study for two years should be provided along with relevant 
quality control data that assesses key parameters prior to and after storage for the 
required shelf life. The following information/data must be provided with the quality 
control data:   

  Details of the storage conditions (length of storage, temperature and details of 

packaging the product has been stored in); 

  Details and supporting validation data used to determine the active content (to be 

reported under section 3.8.1 of this guidance); and 

 
 
 
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 

Justification of the physical chemical and technical properties determined in the 
QC data and how this supports the stability of the product. 

For formulations that can be categorised according to the formulation types as included 
in revision 2 of the FAO manual (Manual on development and use of FAO and WHO 
specification for pesticides – November 2010 (FAO, 2010)), primarily, GIFAP (Croplife 
International) monograph no. 17 (Croplife, 2009) is the leading Guidance. Information 
on the relevant physical, chemical and technical properties for different formulation 
types is outlined in the Evaluation manual (EU, 2012a) and the FAO manual (FAO, 
2010). 

For all proposed packaging types, packaging suitability should be addressed. 

Guidance is not yet available for all types of biocides e.g. for product-type 21 and 
product-type 6. 

3.6.4.1.3  Point 3.4.1.3 Low temperature stability test (liquids)  

The relevant test method is CIPAC method MT 39.3. 

The stability of the product on storage at 0°C for seven days should be addressed.  

If the label gives clear instructions that the product must not be stored under conditions 
of ≤ 0°C (e.g. a phrase like ‘protect from frost’ on the label) then the low temperature 
storage does not need to be addressed. 

For some formulation types the stability on freeze/thaw cycles may have to be 
investigated.  

3.6.4.2  Point  3.4.2  Effects  on  content  of  the  active  substance  and 
technical characteristics of the biocidal product 

In the storage stability studies the active substance content, relevant physical and 
chemical properties (e.g. pH) and relevant technical properties must be determined prior 
to and after storage. 

Where relevant the effects of light, temperature and humidity must be investigated as 
part of the storage stability studies.  

For the ambient storage studies, the biocidal product must be stored in the worst case 
commercial packaging and the stability of the packaging must be assessed. This should 
include observations on the appearance of the packaging and an assessment of the 
weight change on storage. 

In these studies a storage in the worst case packaging is representative for the other 
commercial packaging. An assessment of all packaging types must be made. In general, 
the product should be stored in the worst case packaging and the relevance of these 
data to the other packaging types specified must be clearly outlined. Acceptable 
extrapolations for different packaging types are outlined below:  

 
 
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Table 7: Acceptable extrapolations for different packaging types for storage 
stability studies 

Packaging used in shelf life study 

Acceptable extrapolations 

Water based  formulations e.g aqueous suspension concentrates, soluble 
concentrates 

Any, except metal 

All packaging types, apart from metal are 
supported with no further data 

Solvent based formulations e.g. emulsifiable concentrates 

HDPE 

HDPE/EVOH or 

HDPE/F or 

HDPE/PA  

Seepage data 

HDPE/EVOH, HDPE/F, HDPE/PA packs 
would all be supported without further 
data 

Data generated in one of these three 
packaging will support authorisation in the 
other two packagings with acceptable 
seepage data in the required packaging 

HDPE packs would be supported with 
acceptable seepage data 

Data are only required to demonstrate that the required packaging is stable for the 
required shelf life (e.g. no leakage, no ballooning, no panelling of the packaging, no 
deformations) rather than a new shelf life study in which all chemical and physical 
properties are investigated prior to and after storage. The weight change on storage 
should also be determined.  

Where seepage is observed then the new packaging cannot be authorised. Any panelling 
and/or ballooning in the new packaging is an indication that the new packaging is not 
fully resistant to the formulation and/or air entrainment. In such cases, to ensure no 
adverse effects on the physical and chemical properties of the biocidal product then a 
complete shelf life study conducted in the new packaging will be required.  

Solid preparations 

Extrapolation to all types of packaging is acceptable except to more flexible packs. For 
solid formulations sold in flexible packs the effects of stacking on the packaging and the 
physical and chemical properties must be investigated. The stacking undertaken must 
reflect those encountered in commercial practice.  

Trigger sprayers 

For ready for use biocidal products applied via a trigger sprayer then the satisfactory 
operation of the trigger sprayer prior to and after storage should be addressed. This 
should include the spray pattern, the amount of spray delivered with each operation and 
observations on the nozzle for blockages. Where the product is stored with the trigger 
sprayer then the satisfactory operation should be addressed after storage. Where the 
biocidal product is not applied in one single operation then the intermittent use of the 
sprayer during the storage internal should also be addressed: the satisfactory operation 
of the sprayer following successive uses followed by storage of the biocidal product must 
reflect commercial practice and cover the stated shelf life.  

The satisfactory operation of aerosols prior to and after storage should also be 
addressed.  

 
 
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The active substance content should be determined using a validated method of 
analysis. It is generally recognised that a decrease in the active content of ≤10 % should 
not adversely affect the efficacy and risk assessment of the product. Where the 
degradation of the active content is >10%, or in cases where a decrease of <10% may 
impact on the efficacy and/or the risk assessment, then a justification for the 
acceptability of the decrease should be provided. This may require an assessment of the 
degradation on the efficacy and risk assessment. The fate (degradation products) of the 
active substance may have to be assessed. Alternatively, a more appropriate shelf life, in 
which the degradation of the active content is considered acceptable, should be 
proposed. For this reason, particularly when the active is known to degrade, it is 
advantageous to perform ambient storage studies in which the active content is assessed 
at interim time periods. 

Substances of concern and relevant impurities should be considered for inclusion in the 
storage stability/shelf life studies. The level of the substance of concern or relevant 
impurity prior to storage and after storage should be determined using a fully validated 
method of analysis.  

In cases where the substance of concern or relevant impurity cannot possibly increase 
on manufacture or storage of the biocidal product then they do not need to be included 
in the storage stability/shelf life study. A justification outlining clearly why the substance 
of concern or relevant impurity has not been included in the storage stability/shelf life 
study should be provided.  

The relevance of the levels of the substance of concern or relevant impurity, including 
where relevant changes observed on storage, in the biocidal product should be 
addressed.  

Where a substance of concern or relevant impurity is determined on storage then it 
should be determined using a validated method of analysis.   

Where relevant the retention of palatability should be addressed. Reference to the 
efficacy assessment is acceptable to address this requirement.  

Where an aversive agent9 is present in the product and the presence of the aversive 
agent has been referenced in the risk assessment then its stability on storage, using a 
validated method of analysis, must be assessed.  

3.6.4.2.1  Point 3.4.2.1 Light  

This endpoint is addressed in this section 3.6.4.2 (above). 

3.6.4.2.2  Point 3.4.2.2 Temperature and humidity 

This endpoint is addressed in this section 3.6.4.2  (above). 

3.6.4.2.3  Point 3.4.2.3 Reactivity towards container material 

Please follow guidance in sections 3.6.4.1 and 3.6.4.2 (above) of this guidance. 

3.6.5  Point 3.5 Technical characteristics of the biocidal product 

Technical characteristics applicable to the formulation type must be addressed. Where 
relevant these must be generated to cover the maximum and minimum in use 
concentrations specified for the biocidal product. 

9 An aversive agent is a substance which is added to a biocidal product with the intent of 
deterring or limiting its ingestion. 

 
 
                                           
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Information on the relevant physical, chemical and technical properties for different 
formulation types is outlined in the Evaluation manual (EU, 2012a) and the FAO manual 
(FAO, 2010). 

3.6.5.1  Point 3.5.1 Wettability 

The relevant test method is CIPAC method MT 53.3.1. 

Wettability is determined to ensure the preparation is readily wetted in use. The data are 
required for solid preparations which are to be dispersed in water. 

The method as written describes the wetting of wettable powder preparations but it also 
applicable to water soluble powders, water soluble granules and water dispersible 
granules. 

A preparation is considered acceptable if there is complete wetting in one minute without 
swirling. Where a preparation is outside this limit then evidence must be submitted 
demonstrating acceptable wetting on use of the biocidal product e.g. in the application 
equipment. 

3.6.5.2  Point 3.5.2 Suspensibility, spontaneity and dispersion stability 

Applicability depends on the formulation type (nature) of the biocidal product.  

Suspensibility  

Test according to CIPAC method MT 15.1 for wettable powders, CIPAC method  MT 161 
for aqueous suspension concentrates, CIPAC method MT 168 for water dispersible 
granules, CIPAC method MT 177 for water dispersible powders (simplified method) and 
CIPAC method MT 184 for suspensibility of formulations forming suspensions on dilutions 
with water. 

Suspensibility is determined to demonstrate that a sufficient amount of the active 
substance is suspended to give a homogeneous mixture during application. For the 
determination of suspensibility, chemical assay (‘active’ suspensibility) is the only fully 
reliable method to measure the mass of an active substance still in suspension.  

However, gravimetric determination (total suspensibility) or solvent extraction 
determination may be used providing that these methods have been shown to give 
equivalent results to those of the chemical assay. 

Where there is more than one insoluble active substance present in the preparation, 
chemical assay (‘active’ suspensibility) is the only acceptable method. 

The test should be performed at the highest and lowest dilutions recommended for use 
of the preparation. 

The mean measured active suspensibility must not be less than 60% or greater than 
110%. Where a preparation is outside these limits then evidence must be submitted 
demonstrating that the preparation is homogeneous on application through appropriate 
application equipment e.g. determination of the active substance content in the spray at 
the beginning, middle and end of a spraying operation at the highest and lowest use 
rates on the label. 

Spontaneity of dispersion and dispersion stability 

Test according to CIPAC method MT 160 regarding suspension concentrates and CIPAC 
method MT 174 on the degree of dispersion of water dispersible granules. 

The spontaneity of dispersion is determined to show the preparation is rapidly dispersed 
when diluted with water. 

As for the determination of suspensibility, chemical assay is the only reliable means to 
measure the mass of an active substance in suspension. 

 
 
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However, gravimetric determination or solvent extraction determination may be used on 
a routine basis providing that these methods have been shown to give equivalent results 
to those of the chemical assay. 

Where there is more than one insoluble active substance present in the preparation, 
chemical assay is the only acceptable method. 

The mean measured minimum active suspensibility or dispersibility must not be less 
than 60% or greater than 105%. Where a preparation is outside these limits then 
evidence must be submitted demonstrating that the preparation is homogeneous on 
application. 

3.6.5.3  Point 3.5.3 Wet sieve analysis and dry sieve test  

Applicability depends on the formulation type (nature) of the biocidal product.  

Wet sieve test 

Test according to CIPAC method MT 59.3 Wettable powders, suspension concentrates, 
capsule suspensions and CIPAC method MT 167 Wet sieving after dispersion of water 
dispersible granules, CIPAC method MT 179 Degree of dissolution and solution stability, 
CIPAC method MT 182 Wet sieve test with re-cycled water and CIPAC method MT 185 
Wet sieve test. 

The residue remaining on a sieve is determined after dispersion to ensure no 
unacceptable residue remains which cause the blockage of nozzles or filters on 
application equipment. 

The test is applicable to wettable powders, suspension concentrates, water dispersible 
granules, aqueous capsule suspensions, dispersible concentrates, suspo-emulsions, 
water soluble granules and water soluble powders. 

A maximum of 2% may be retained on a 75 mm sieve. Where a preparation is outside 
this limit then evidence must be submitted showing the preparation may be satisfactorily 
applied through appropriate application equipment with no blockages. 

Dry sieve  

Test according to CIPAC method MT 59.1 for dusts and CIPAC method MT 59.2 (MT 58) 
for granular formulations (GR). 

The test is designed to determine the size distribution of dustable powders and granules 
for direct application to allow acceptable application. 

For dustable powders, the active substance content of material remaining on the sieve 
must be determined to demonstrate there was no separation of the active substance 
from the carrier if > 5% of the preparation is retained on a 75 µm sieve. Not more than 
(0.005 x AI content in g/kg) % should be present as the AI in the residue on the sieve. 

3.6.5.4  Point  3.5.4  Emulsifiability,  re-emulsifiability  and  emulsion 
stability  

Applicability depends on the formulation type (nature) of the biocidal product.  

The relevant test methods are CIPAC method MT 36.3 for 0.1 – 5% dilutions, CIPAC 
method MT 173 for 0.1% - 2% dilution, and CIPAC method MT 180 on Dispersion 
stability of suspo-emulsions. 

The data are required to determine whether a preparation forms and maintains a stable 
emulsion.  

Tests should be performed in CIPAC water A and D and at the highest and lowest 
concentrations recommended for use.  

 
 
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The emulsion generated under the conditions of MT 36.3 may be at maximum 2ml cream 
after 30 minutes, trace of oil. If any separation is observed re-emulsification should be 
complete after 24 hours. 

The emulsion generated under the conditions of MT 180 may be at maximum 2ml cream 
after 30 minutes, trace of oil. If any separation is observed, re-emulsification should be 
complete after 24 hours. 

The absorbance measured for the formulation under the conditions of MT 173 must 
between 95-105% after four hours. 

Where a preparation is outside these limits then evidence must be submitted showing 
the preparation remains homogeneous when applied.  

If more than a trace of oil separates consideration should be given to reformulation. 

3.6.5.5  Point 3.5.5 Disintegration time 

The disintegration time is applicable to all products that are tablets and depend on 
disintegration of the tablet in a solvent (water) for optimal efficacy. Applicable to ST 
(water soluble tablets) and WT (water dispersible tablets) formulations. 

There is no relevant standard method available.  

The data should demonstrate the tablet disintegrates rapidly on addition to water and 
that the formulation is readily dispersed and no blockages occur in the application 
equipment on use. A maximum disintegration time is to be specified. 

The specified disintegration time should be supported by a study showing the 
disintegration is achieved within the specified maximum time, and that the product is 
sufficiently dispersed. If continuous agitation is required, this should be specified on the 
instructions for use/label. 

3.6.5.6  Point  3.5.6  Particle  size  distribution,  content  of  dust/fines 
attrition, friability  

Particle size distribution  

The particle size distribution of powder biocidal products and granules must be 
addressed. The data generated must be sufficient to categorise the formulation type and 
is required to demonstrate that the biocidal product can be successfully applied using the 
appropriate application equipment. The relevant test methods are as follows: 

Size distribution (powders):  

  CIPAC Method MT 187: Particle size analysis by laser diffraction  

Nominal size range (granules): 

  CIPAC Method MT 170: Dry sieve analysis of water dispersible granules  
  CIPAC Method MT 187: Particle size analysis by laser diffraction 

For all powder biocidal products and biocidal products that are applied in a manner that 
generates exposure to aerosols, particles or droplets then the MMAD (mass medium 
aerodynamic diameter) must be determined. The percentage of particles in mass with 
aerodynamic diameter <50 µm must be established. Information regarding suitable test 
methods is outlined in the ECHA Guidance on information requirements and chemical 
safety assessment Chapter R.7a: Endpoint specific guidance, R.7.1.14 Granulometry, 
(ECHA). 

Dust 

The dust content of solid preparations (granules and powders) must be determined to 
ensure there is no unacceptable risk to operators or bystanders or potential for blockage 
of application equipment. 

 
 
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The dust content should be generated using the following test method:  

  CIPAC Method MT 171: Dustiness of granular products 

Where the apparent dust content is >1% (by weight), the particle size and nature of the 
dust must be investigated in order to evaluate the potential risk to operators and 
bystanders. Methods applicable for determining the particle size of the dust are outlined 
in the ECHA Guidance on information requirements and chemical safety assessment 
(ECHA). 

Where a granular material is described as 'dusty' then evidence is required that the 
material may be satisfactorily applied through application equipment. 

Attrition, friability 

Attrition is defined as the wearing away of the surface of a granule by friction or impact, 
particularly by granule-to-granule interaction. 

Friability is defined as the tendency of a granule to crumble, breaking down into smaller 
particles.  

These data are required to determine whether a granular material is robust under 
normal conditions of use and transport. 

The relevant test methods (applicable for granules or tablets) are: 

  CIPAC Method MT 178: Attrition resistance of granules  
  CIPAC Method MT 178.2: Attrition resistance of dispersible granules 

Where the material has an attrition resistance of <98% then the particle size of the dust 
must be determined and the risk to operators and bystanders must be addressed. 
Information on assessing the particle size of the dust is outlined above.  

Where the material has an attrition resistance of <98% then evidence is required that 
the material may be satisfactorily applied through the application equipment. 

3.6.5.7  Point 3.5.7 Persistent foaming 

Applicability depends on the formulation type (nature) of the biocidal product. The data 
are required when the product is applied in water for use. The data are not required 
when the product is intended to be for foam application. 

Persistent foam is determined to measure the amount of foam likely to be present in a 
spray tank or other application equipment following dilution of the preparation. 

Although CIPAC method MT 47.2 was standardised for the determination of persistent 
foam in suspension concentrates it is also applicable to other preparations which are 
dispersed in water. 

The test must be performed at the highest and lowest in use concentrations 
recommended for use.  

The level of foam generated under the conditions of CIPAC method MT47.2 should not 
exceed 60ml after 1 minute. Where a preparation is outside these limits then evidence 
must be submitted showing that there is no unacceptable risk to operators following use 
of the preparation through the appropriate application equipment. 

3.6.5.8  Point 3.5.8 Flowability / Pourability / Dustability 

Applicability depends on the formulation type (nature) of the biocidal product. 

Flowability 

The relevant test method is CIPAC method MT 172. 

 
 
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The data are required to demonstrate that granular materials remain free flowing after 
storage under pressure. 

Data are only required for granular formulations applied through application equipment 
that would subject the granules to pressure and/or heat.  

The method is not appropriate to those granules where water has been added as a 
formulant. For such granules alternative data to demonstrate that application through 
the equipment would be satisfactory must be provided.  

The sample should flow through the sieve after a maximum of five liftings. 

Pourability (rinsability) 

The relevant test method is CIPAC method MT 148. 

The data are required to demonstrate that the user can make use of the maximum 
amount of the preparation and that an excessive amount of the material does not remain 
in the container. The method is appropriate to suspension concentrates, capsule 
suspensions and suspoemulsions. 

The residue observed with MT 148 should not exceed 5% residue and the rinsed residue 
should not be more than 0.25%. 

The test can be performed in the commercial packaging using the recommended rinsing 
instructions if the standard lab test is failed.  

Higher residues may cause hazardous situations during waste disposal. A justification is 
required on why high residues would not pose an issue or instructions should be 
provided on safe waste disposal. 

Higher residues may also affect the ability to prepare the biocidal product at the 
maximum in use rate and hence adversely affect the efficacy. Appropriate evidence that 
the efficacy will not be adversely affected maybe required. 

Dustability 

The relevant test method is CIPAC method MT 34. However, the equipment used in this 
method is not readily available. Therefore, data are required showing the preparation 
may be satisfactorily applied as a dust through the proposed application equipment and 
that there is no unacceptable compaction or caking following a heat test under pressure. 

3.6.5.9  Point 3.5.9 Burning rate - smoke generators 

Evidence is required that the preparation may be satisfactorily applied as a smoke and 
that the burning rate and burning completeness (see also sections 3.7.5.10 and 3.7.5.11 
of this guidance) support the proposed use. Where relevant the data must support 
intermittent use of the product.   

The duration and burning rate of a smoke generator should be specified to establish how 
long it takes before the preparation stops generating smoke. A test is required, based on 
a representative in-use situation, to show the burning rate and duration comply with the 
specified rates. 

The burning rate should correspond with the proposed use. 

There is no relevant standard method available. 

3.6.5.10  Point 3.5.10 Burning completeness - smoke generators  

Burning completeness must be determined by weighing the preparation before and after 
use. It should be demonstrated that by far the largest part of the active substance went 
up in smoke. This also requires determination of the concentration active substance in 
the residue. 

 
 
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There is no relevant standard method available.  

3.6.5.11  Point 3.5.11 Composition of smoke - smoke generators  

The smoke composition must be analysed for the concentration of the active substance 
and decomposition products, if any, to guarantee that the produced smoke does indeed 
contain the active substance and no decomposition products. 

There is no relevant standard method available. 

The smoke should deliver the required active concentration and any decomposition 
products to be efficacious and the amount of active and any decomposition products 
should be supported by the toxicological and environmental risk assessments.  

If, based on theoretical considerations, e.g. based on the endpoints provided for the 
active substance (degradation/combustion products after decomposition), or the heat 
generated during the generation of smoke is well below the decomposition temperature 
of the active substance and/or the absence of halogens or other compounds which may 
generate toxic fumes, a test may be waived. 

3.6.5.12  Point 3.5.12 Spraying pattern - aerosols  

Homogeneity must be determined according to FEA method 644 (Filled Aerosols Packs – 
Evaluation of Aerosol Spray Patterns). 

Spray diameter must be determined at 30 cm distance. 

3.6.5.13  Point 3.5.13 Other technical characteristics 

Any other relevant technical characteristics that are not covered by this Guidance should 
be reported here. 

3.6.6  Point 3.6 Physical and chemical compatibility with other 

products including other biocidal products with which its 
use is to be authorised  

Data to address the physical and chemical compatibility must be provided when label 
recommendations are made to co-apply the biocidal product with other substances, 
mixtures or biocidal or non-biocidal products (e.g. dyes).  

If all properties of each component are known and it can be clearly demonstrated that a 
chemical reaction can be excluded then data to demonstrate the chemical compatibility 
will not be required. 

Any known incompatibilities (physical and chemical) should be mentioned.  

3.6.6.1  Point 3.6.1 Possible physical incompatibility with any products 
should be mentioned.  

Method ASTM E1518 (Standard Practice for Evaluation of Physical Compatibility of 
Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method) can be used to 
investigate the physical compatibility.  

3.6.6.2  Point 3.6.2 Possible chemical incompatibility with any products 
should be mentioned. 

3.6.7  Point 3.7 Degree of dissolution and dilution stability 

Applicability depends on the formulation type (nature) of the biocidal product.  

Degree of dissolution 

The information is required for products used in a water soluble bag and for all tablets. 

 
 
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The dissolution rate should be demonstrated regarding tablets and products used in 
water soluble bags in water and that the formulation dissolves or disperses rapidly. The 
test should be performed at the highest concentration. As the greater the amount of 
solid to water the more difficult it will be to disperse.  

The relevant test method is CIPAC method MT176 (water soluble bag). There is no 
specific method for tablets.  

Dilution stability 

The relevant test methods are CIPAC method MT 179 and MT41.  

The dilution stability is determined to ensure that water-soluble preparations dissolve 
readily and/or, when diluted, produce stable solutions without precipitation, flocculation, 
etc. The results submitted should fully describe the appearance and amount of any 
separation or sediment. 

The test should be conducted at the maximum in use concentration specified on the 
label. 

For method MT 41, the acceptable limit would be a ‘trace’ of sediment after 30 minutes. 
For method MT 179, the amount of residue obtained on a 75 µm sieve should not exceed 
2%. Where a preparation is outside this limit then evidence must be submitted showing 
the material separated will not block application equipment or present an unacceptable 
risk to the operator or affect the efficacy. 

3.6.8  Point 3.8 Surface tension 

Test according to EC method A.5 (Surface Tension) and OECD Test Guideline 115 
(Surface Tension of Aqueous Solutions). 

For all liquid biocidal products the surface tension at the highest in use concentration 
recommended for use should be determined.  

For liquid biocidal products containing ≥10% hydrocarbons and for which the kinematic 
viscosity is less than 7 x 10-6 m2/sec at 40 °C the surface tension of the biocidal product 
as formulated should be determined at 25 °C. 

For further Guidance see section 2.6.8 of this guidance. 

Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 
Chapter R7a: Endpoint specific guidance, R.7.1.6 Surface Tension, (ECHA). 

3.6.9  Point 3.9 Viscosity 

This data is always required for liquid formulations. 

The viscosity should be determined at 20 °C and 40 ºC.  

There is no relevant EC method. Test according to OECD Test Guideline 114 (Viscosity of 
Liquids), where the following determination methods are recommended: 

  Capillary viscometer; 
  Flowcup; 
  Rotational viscometer; 
  Rolling ball viscometer 
  Drawing Ball Viscometer. 

For liquid biocidal products containing ≥10% hydrocarbons and for which the kinematic 
viscosity is less than 7 x 10-6 m2/sec at 40 °C the surface tension of the biocidal product 
as formulated should be determined at 25 °C. 

 
 
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Further Guidance:  

  ECHA Guidance on information requirements and chemical safety assessment 

Chapter R7a: Endpoint specific guidance, R.7.1.18 Viscosity, (ECHA) 

3.7  Point 4 Physical hazards and respective characteristics   

The physical hazards of the biocidal products (endpoints 4.1 to 4.16, Annex III of the 
BPR), correspond to the physical hazards classes for mixtures included in the CLP 
Regulation. The criteria and testing methods or standards for each of these physical 
hazards required in the BPR are described in the corresponding section of Part 2 of 
Annex I to the CLP Regulation. 

For the purposes of determining whether a product entails any of the physical hazards 
referred to in Part 2 of Annex I to the CLP Regulation: the manufacturer, importer or 
downstream user must perform the tests required by the above mentioned Part 2, unless 
there is adequate and reliable information available (Article 8(2), of the CLP Regulation). 
Furthermore, in this guidance for each relevant physical hazard a reference to the 
corresponding test according to UN Recommendations on the Transport and Dangerous 
Goods, Manual of Test and Criteria ,UN-MTC (UN, 2009), starting with an UN test 
method name is provided.  

Further information can be found in the Guidance on the Application of the CLP Criteria 
(ECHA).  

3.7.1  Point 4.1 Explosives 

Please follow the guidance in section 2.7.1 of this guidance. 

3.7.2  Point 4.2 Flammable gases  

Please follow the guidance in section 2.7.2 of this guidance. 

3.7.3  Point 4.3 Flammable aerosols  

Please follow the guidance in section 2.7.3 of this guidance. 

3.7.4  Point 4.4 Oxidising gases 

Please follow the guidance in section 2.7.4 of this guidance. 

3.7.5  Point 4.5 Gases under pressure 

Please follow the guidance in section 2.7.5 of this guidance. 

3.7.6  Point 4.6 Flammable liquids 

Please follow the guidance in section 2.7.6 of this guidance. 

3.7.7  Point 4.7 Flammable solids 

Please follow the guidance in section 2.8.7 of this guidance. 

3.7.8  Point 4.8 Self-reactive substances and mixtures 

Please follow the guidance in section 2.7.8 of this guidance. 

3.7.9  Point 4.9 Pyrophoric liquids  

Please follow the guidance in section 2.7.9 of this guidance. 

 
 
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3.7.10  Point 4.10 Pyrophoric solids 

Please follow the guidance in section 2.7.10 of this guidance. 

3.7.11  Point 4.11 Self heating substances and mixtures 

Please follow the guidance in section 2.7.11 of this guidance. 

3.7.12  Point 4.12 Substances and mixtures which in contact with 

water emit flammable gases 

Please follow the guidance in section 2.7.12 of this guidance. 

3.7.13  Point 4.13 Oxidising liquids 

Please follow the guidance in section 2.7.13 of this guidance. 

3.7.14  Point 4.14 Oxidising solids 

Please follow the guidance in section 2.7.14 of this guidance. 

3.7.15  Point 4.15 Organic peroxides 

Please follow the guidance in section 2.7.15 of this guidance. 

3.7.16  Point 4.16 Corrosive to metals 

Please follow the guidance in section 2.7.16 of this guidance. 

3.7.17  Point 4.17 Additional physical indications of hazard  

3.7.17.1  Point 4.17.1 Auto-ignition temperatures of products (liquids and 
gases) 

Please follow the guidance in section 2.7.17.1 of this guidance . 

3.7.17.2  Point 4.17.2 Relative self-ignition temperature for solids 

Please follow the guidance in section 2.7.14.2 of this guidance 

3.7.17.3  Point 4.17.3 Dust explosion hazard 

Please follow the guidance in section 2.7.17.3 of this guidance. 

3.8  Point 5 Methods of detection and identification   

Information on analytical methods is required for assessing compliance with conditions 
for issuing authorisation for a biocidal product. This information is also required for the 
post-authorisation control and monitoring purposes, and for the assessment of 
justifications which should be provided for the methods used for the generation of data 
as required in accordance with the BPR. If there are multiple active substances, an 
analytical method should be able to distinguish and individually quantify them. Validation 
of analytical methods does not have to be performed and reported to GLP. In particular 
cases where a specific analytical method cannot be developed, a common moiety 
approach or titration method may be acceptable. 

Please also follow guidance in section 2.8 of this guidance. 

 
 
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Further Guidance:  

  ECHA Guidance for identification and naming of substances under REACH; 

chapters 4.2.1.3. / 4.2.2.3. / 4.2.3.2., (ECHA). 

3.8.1  Point 5.1 Analytical method including validation parameters 
for  determining 
the  active 
substance(s), residues, relevant impurities and substances 
of concern in the biocidal product 

concentration  of 

the 

The analytical method must be suitable to accurately determine the active substance 
content. In the case of a preparation containing more than one active substance, a 
method capable of determining each, in the presence of the other, should be provided. If 
a combined method is not submitted, the technical reasons must be stated. 

Generally, linearity, specificity, recovery and repeatability should be addressed.  

Linearity 

See information for the technical material in section 2.8 of this guidance.  

Specificity (Selectivity) 

Example chromatograms from the analysis of a standard, sample and a blank 
formulation are required. The blank formulation should contain all the formulants and no 
active substance. Where the formulation contains two or more active substances and 
each has been determined using a separate method then adequate data must be 
provided to demonstrate that each active substance does not interfere with the 
determination of the others.  

Repeatability  

See information for the technical material in section 2.8 of this guidance.  

Recovery (Accuracy)  

The accuracy of the method should be reported as mean recovery for the pure active 
substance in the biocidal product. At least two recovery determinations should be made 
on representative samples containing a known quantity of the analyte. Samples should 
ideally be laboratory-prepared co-formulant mixes to which a known quantity of analyte 
is added and the whole sample analysed to reduce sampling error. However, where it is 
not possible to prepare a sample matrix without the presence of the analyte or there are 
difficulties in replicating the sample to be analysed (for example with pellet 
formulations), the standard addition method may be used.  

The recovery data should meet the following requirements:  

Table 7 Acceptable recovery values for residues or impurities 

% active (nominal) 

Mean % recovery 

A>10 

1-10 

<1 

0.01-0.1 

<0.01 

98-102 

97-103 

95-105 

90-110 

80-120 

     Source: SANCO 3030/99 (EU, 2000a) 

Where available the active content can be determined in the formulation using a CIPAC 
method. When a CIPAC method has been validated for the active substance in the same 

 
 
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formulation type then full validation data are not required. In such cases only specificity 
data are required. 

For substances of concern and relevant impurities, the same requirements are applicable 
as for the active substance with additional requirements to confirm the identity of the 
impurity. If the method used to determine the substance of concern or relevant impurity 
is not regarded as highly specific then confirmation of the result using a fully validated 
confirmatory method of analysis is required. See footnote 5 in section 2.6.11 of this 
guidance 

For further information on procedures for confirmation of identity see section 2.8.2 of 
this guidance . 

3.8.2  Point 5.2 In so far as not covered by Annex II 5.2 and 5.3, 
analytical methods for monitoring purposes (ADS)  

Point 5.2 of Annex III to the BPR states that [….]including recovery rates and the limits 
of determination of relevant components of the biocidal product and/or residues thereof, 
where relevant in or on the following: 

Residue definition 

Generally, it has to be confirmed during evaluation, where relevant, which relevant 
components of the biocidal products should be monitored in addition based on its 
evaluation of fate and behaviour of the components and the toxicological and 
ecotoxicological potential. 

Components of the biocidal product classified as toxic or very toxic are considered to be 
the toxicologically relevant components (see section 2.6.11 of this guidance ). They 
must be analysed for monitoring purposes if human exposure cannot be excluded. 
Validation of the analytical methods employed must be performed. 

Limit of quantification 

The LOQ should correspond to the limits for the active substance in section 2.8.2.4 of 
this guidance  

Components of the biocidal product classified as dangerous for the environment are 
considered to be the ecotoxicologically relevant components (see section 2.6.11 of this 
guidance ). They must be analysed for monitoring purposes if environmental exposure 
cannot be excluded. Validation of the analytical methods employed must be performed. 

Limit of quantification  

The LOQ should correspond to the limits for the active substance in section 2.8.2 of this 
guidance. 

3.8.2.1  Point 5.2.1 Soil (ADS) 

Please follow guidance in section 2.8.2.1 of this guidance  

3.8.2.2  Point 5.2.2 Air (ADS) 

Please follow guidance in section 2.8.2.2 of this guidance  

3.8.2.3  Point 5.2.3 Water (including drinking water) and sediment (ADS) 

Please follow guidance in section 2.8.2.3 of this guidance  

3.8.2.4  Point 5.2.4 Animal and human body fluids and tissues (ADS) 

Please follow guidance in section 2.8.2.4 of this guidance  

 
 
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3.8.3  Point  5.3  Analytical  methods  for  monitoring  purposes 
including recovery rates and the limit of quantification and 
detection for the active substance, and for residues thereof, 
in/on food of plant and animal origin or feeding stuffs and 
other products where relevant (ADS) 

Point 5.3 of Annex III to the BPR states that [….] (not necessary if neither the active 
substance or the material treated with it come into contact with food producing animals, 
food of plant and animal origin or feeding stuffs 

The requirements for the active substance itself are given in section 2.8.3 of this 
guidance. Analytical methods are required for all active substances in a biocidal product. 

The quantification of residues of non-active ingredients is required for substances with 
toxicological concern and for residue levels exceeding 0.01 mg/kg.  

Please follow guidance in section 2.8.3 of this guidance. 

 
 
 
 
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4.  Parts B+C: Evaluation and Assessment 

Guidance on evaluation and assessment of physico-chemical properties is given in the 
TNsG on Product Evaluation (Chapter 3) [TNsG Chapter 3]10. 

There is no ECHA BPR guidance developed for this section, however with experience of 
evaluation of dossiers under the BPR, the BPC Working Group on Analytical Methods and 
Physico-chemical Properties may in the future consider that this section needs to be 
developed.  In the meantime the evaluation and assessment should be carried out using 
the principles described in the TNsG on Product Evaluation (Chapter 3).  

10  Link  to  ECHA  BPD  guidance  page:  https://echa.europa.eu/guidance-documents/guidance-on-
biocides-legislation/biocidal-products-directive  

 
 
 
                                           
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nets and their subsequent use. 

 
 
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