Submission of information in the public consultation on potential candidates for substitution under the biocidal products regulation.
Date: 2015-10-14
Institutions: European Chemicals Agency
Subjects: EC Regulation, European Chemicals Agency, chemical industry, chemical product, dangerous substance, environmental protection, environmental risk prevention, health risk, market, public consultation, scientific research

Submission of information in the public consultation on potential candidates for substitution 
under the Biocidal Products Regulation 

Submission of information in the public consultation on 
potential candidates for substitution under the Biocidal 
Products Regulation 

Version 2.0 
August 2015 

1 

 
 
 
 
 
 
 
 
Submission of information in the public consultation on potential candidates for substitution under the 
Biocidal Products Regulation 

Legal note 

This document contains guidance on 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 
(Biocidal Products Regulation, BPR). This document describes the BPR obligations and how to fulfil them. 
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. The European Chemicals Agency does not 
accept any liability with regard to the contents of this document. 

Version 

1.0 

  2.0 

Changes 

Date 

  November 2013 

  Modified structure of the webform 

  August 2015 

Submission of information in the public consultation on potential candidates for substitution under the 
Biocidal Products Regulation 

Reference: 
ISBN: 
DoI: 
Catalogue number:  
Date: 
Language: 

ECHA-15-B-13-EN 
978-92-9247-512-3 
10.2823/243018 
ED-04-15-533-EN-N 
August 2015 
English 

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

© European Chemicals Agency, 2015 

Reproduction is authorised provided the source is fully acknowledged in the form “Source: European 
Chemicals Agency, http://echa.europa.eu/”, and provided written notification is given to the ECHA 
Communications Unit (info@echa.europa.eu). 

European Chemicals Agency, P.O.Box 400, FI-00120 Helsinki, Finland 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
  
 
 
  
  
 
 
  
  
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission of information in the public consultation on potential candidates for substitution under the 
Biocidal Products Regulation 

Table of Contents 

1. 

Introduction ........................................................................................................................ 4 

1.1  

PREAMBLE .......................................................................................................................................... 4 

1.2  

PURPOSE OF THE PUBLIC CONSULTATION ON POTENTIAL CANDIDATES FOR SUBSTITUTION ......... 4 

2.  Submission of information during the public consultation on potential candidates for 

substitution ........................................................................................................................ 4 

2.1 

2.2 

CONFIDENTIALITY ............................................................................................................................... 5 

PROVIDING INFORMATION ................................................................................................................ 5 

3 

 
 
 
 
 
 
 
 
 
Submission of information in the public consultation on potential candidates for substitution under the 
Biocidal Products Regulation 

1. 

Introduction 

1.1   PREAMBLE  

The purpose of this document is to provide interested third parties with guidelines to submit information for 
the public consultation on active substances considered as potential candidates for substitution. 

The document will give indications in relation to confidentiality issues and on the organisation and 
submission of information. 

1.2   PURPOSE OF THE PUBLIC CONSULTATION ON POTENTIAL CANDIDATES 
FOR SUBSTITUTION  

When the evaluating competent authority concludes in its evaluation that the active substance meets the 
criteria for substitution of Article 10(1) of the Biocidal Products Regulation (BPR), ECHA makes publicly 
available information on potential candidates for substitution and will initiate the public consultation as 
mentioned in Article 10(3) of the BPR. The purpose of the public consultation is to gather relevant 
information, especially information on available substitutes or alternatives. The information on the 
availability of possible alternatives is of high importance at the product authorisation stage when a 
comparative assessment needs to be performed. The information submitted by interested third parties will 
be taken into due account by the Biocidal Products Committee (BPC) before finalising its opinion. Third 
parties are requested to submit their information in English. The BPC will not take into account information 
received after the deadline in their opinion making process. 

Each public consultation will last 60 days and will apply to applications for approval or renewal of the 
approval of an active substance, as described respectively in Article 7 or 13 of the BPR, as well as to 
active substances included in the Review Programme and to applications for new active substances 
submitted under Article 11 of the Biocidal Products Directive (BPD). 

2. 

Submission of information during the public consultation on 
potential candidates for substitution  

Interested third parties can submit information via a secure webform on ECHA’s website.  The webform 
allows the submission of information for one Product Type at a time. After sending the information the 
user will have the option to submit information concerning other PTs. In this case the user will be 
prompted to the same webform, pre-filled with the information already provided in sections I and II 
(personal information and organisation) and where a different PT can be selected from the drop-down list. 

The information on the possible alternative and further analysis on its suitability may be provided as non-
confidential or it may be claimed confidential. In this latter case a justification needs to be included on why 
the information should be kept confidential (cfr. section 2.1 below on confidentiality). 

All non-confidential information submitted during the public consultation will be made available to the BPC 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission of information in the public consultation on potential candidates for substitution under the 
Biocidal Products Regulation 

members, accredited stakeholders, applicant(s) and the BPC and ECHA Secretariat. The comments will 
appear on the ECHA website during the public consultation. 

Information claimed to be confidential will be available only to the BPC members and the BPC and ECHA 
Secretariat. 

2.1  CONFIDENTIALITY  

Please note that any information submitted to ECHA is subject to Regulation 1367/2006 on the 
application of the provisions of the Aarhus Convention on Access to Information and to Regulation (EC) 
No 1049/2001 regarding public access to European Parliament, Council and Commission documents. 
Therefore, interested third parties submitting information during the public consultation on potential 
candidates for substitution are asked to provide a justification for confidentiality. If the submitter’s 
justification is sufficient and falls under one of the exceptions envisaged in Regulation 1049/2001, there 
will in principle be no need to request further clarification from the submitter why a request for access to 
part or all information marked confidential in the submission should be denied. 

The submitter’s justification for confidentiality should contain the following three elements: 

Demonstration of Commercial Interest 
Description of the nature of the third party commercial interest and demonstration that this commercial 
interest is worthy of protection by the non-disclosure of information. Demonstration of any specific 
measures the submitter has taken to keep the information claimed confidential secret to date. 

Demonstration of Potential Harm 
Explanation of why release of the information claimed confidential would be likely to cause potential harm 
to the commercial interest and the specific nature of those harmful effects. A causal link between 
disclosure and such harmful effects should be clearly explained. 

Limitation to Validity of Claim 
The period of time for which the claim will be valid: until a certain date, until the occurrence of a 
particular event (which should be clearly specified), or indefinitely. 

2.2  PROVIDING INFORMATION  

The purpose of this section is to help interested third parties in providing information on potential 
candidates for substitution by filling in the various fields of section III (Information) of the web form. The 
fields in Section III refer to information on the following topics: 

1. Alternative identity and properties 

You may find the following guidance useful for this section: Guidance for identification and naming of 
substances under REACH and CLP (http://echa.europa.eu/documents/10162/13643/substance_id_en.pdf). 

If the alternative is a chemical substance, describe it by the following sections of Annex II, Title 1 of BPR: 2. 
Identity of the active substance, 3. Physical and chemical properties of the active substance, 4. Physical 
hazards and respective characteristics, 5. Methods of detection and identification, 6. Effectiveness against 

5 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission of information in the public consultation on potential candidates for substitution under the 
Biocidal Products Regulation 

target organisms, 7. Intended uses and exposure, 11. Measures necessary to protect humans, animals and 
the environment, 12. Classification, labelling and packaging. 

If the alternative is a micro-organism, describe it by the following sections of Annex II, title 2 of BPR: 2. 
Identity of the micro-organism, 3. Biological properties of the micro-organism, 4. Methods of detection and 
identification, 5. Effectiveness against target organisms, 6. Intended uses and exposure, 10. Measures 
necessary to protect humans, animals and the environment, 11. Classification, labelling and packaging of 
the micro-organism. 

If the alternative is neither a chemical substance nor a micro-organism, provide a description of it. 

If the alternative is any combination thereof, please provide all of the above. 

2. Technical feasibility 
Show that the alternative you propose can fulfil the function of the potential candidate for substitution. 

Describe  the  precise  functions  or  tasks  performed  by  the  alternative  for  the  use(s)  in  question.  Include  a 
description  and  outcome  of  the  process  and,  where  relevant,  under  what  process  conditions  the  function 
must be performed. 

If possible, discuss any adaptations or changes in the technology, process, procedure, device, modification 
of end product or other solutions necessary to replace the potential candidate for substitution for the 
specified use(s) (e.g., the requirements for equipment, risk management measures, energy, personnel 
changes and training needs, raw materials, waste, etc.) and how these affect the technical feasibility of the 
alternative. 

If possible, include any other benefits (corporate image, compliance legislation, worker safety, relation with 
community, etc.) and obstacles or difficulties identified or expected in relation to replacing the potential 
candidate for substitution for the specified use(s). 

If possible, support  your analysis  with information  on research and  development activities. Document the 
methodology,  data  sources  and  their  reliability,  assumptions  made,  uncertainties  and  their  effects  on  the 
conclusions on the technical feasibility of the alternative. 

3. Economic feasibility 

If possible, estimate the direct and indirect costs and revenues associated with the transitioning to the 
alternative. Detail the methodology, the sources of data and its quality and reliability, the assumptions and 
uncertainties in the analysis and their impact on the conclusions of the assessment. Clearly set out the 
boundaries of the assessment and show the reasoning for the setting of these boundaries. 

4. Hazard and risks of the alternative 

Describe the risks to human health and the environment associated with the use of the alternative for which 
you are providing comments. 

Discuss whether the transfer to the alternative would result in reduced overall risks to human health and 
the environment. In the risk assessment of the alternative, consider any relevant risks and effects 
associated with the alternative. These may also be related to other aspects affecting the overall hazard/risk 
reduction capacity of the transfer to the alternative, such as changes in energy or raw material 
consumption. 

Support your analysis with information on research and development activities, if appropriate. Describe the 
methodology of comparing the risks of potential candidate for substitution and the alternative. Document 

6 

 
 
 
 
 
 
 
 
 
 
 
Submission of information in the public consultation on potential candidates for substitution under the 
Biocidal Products Regulation 

the data sources used, their quality and reliability, the assumptions made, the uncertainties in the analysis 
and their impact on the conclusions of the assessment. 

5. Availability 

For suitable alternatives, discuss whether they are available (in the required quantity) without undue delay. 
Include information on the data sources and their reliability. 

6. Conclusion on suitability and availability of the alternative 

Conclude on the overall suitability and availability of the alternative for the potential candidate for 
substitution for which you are submitting this information. 

7. Other comments 
Include other information you may have on the alternative. 

References 

Ensure that the information you provide is well-referenced throughout the document. Include a list of 
references here. 

Appendices 

Include other information that you consider relevant for the analysis, e.g., list of data sources, data 
collection approach, organisations consulted, methodologies and tools used, summary of assumptions, etc. 

7 

 
 
 
 
 
 
 
 
 
 
european chemicals agency 
annankatu 18, p.o. box 400, fi-00121 
helsinki, finland, echa.europa.eu