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CA-March14-Doc.7.2.1 1 (30)

3 March 2014

Agenda Point 7.2. Confidentiality claims check: key steps and guidelines

1. Background and objectivesECHA presented its proposal for the handling of confidentiality requests at the Biocides CA meeting on 16 May 2013, 11 July 2013 and 27 September 2013. This paper sets out the key steps authority users need to perform in R4BP for the assessment of confidentiality requests. Additionally, guidelines are presented in support of the work of the staff assessing the confidentiality requests.

The description of the key steps in R4BP is based on the Technical Note on the assessment of confidentiality requests in applications under the BPR, presented at the CA meeting of 25-27 September 2013, revised based on the comments received. The guidelines for assessing confidentiality requests and interacting with the applicants are based on the experience gained by ECHA on the assessment of confidentiality requests in REACH dossiers, adapted as necessary.

2. Overview

2.1 Legal basis

Articles 67(3) and 67(4) of the BPR determine for which information applicants may request confidentiality in their application.

The applicant may under justified circumstances request the following information confidential in active substance dossiers:

a) If essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;

b) The study summaries or the robust study summaries of studies submitted to support the approval of the active substance;

c) Information, other than listed in paragraph 1 of Art 67(3) contained in the safety data sheet;

d) The trade name(s) of the substance;

e) The assessment report.

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The applicant may under justified circumstances request the following information confidential in biocidal product dossiers:

a) The study summaries or the robust study summaries of studies submitted to support the approval of the active substance;

b) The assessment report.

In case confidentiality is requested on any of the information listed above, the applicant needs to submit a justification as to why publication of this information is potentially harmful for its commercial interests or any other party concerned. Where the justification is accepted as valid, the information concerned will not be made publicly available.

A non-confidential version of the assessment report will be disseminated. A confidentiality request on the AR applies to specific elements in the AR, and not to the AR as a whole.

2.2 Roles and Responsibilities

It is envisaged that MSCAs will assess the confidentiality requests, as an integral part of the evaluation and preparation of the assessment report (AR), as per practice under the Biocidal Product Directive.

It was agreed that ECHA will provide a supporting role as regards supplying the required functionality to applicants to make confidentiality requests in IUCLID, and collect and record MSCA decisions on the validity of the confidentiality requests. On 1 September 2013, ECHA published a manual for applicants on how to make confidentiality requests using the flags in IUCLID 5, available at http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals.

2.3 Criteria for admissibility of confidentiality requests

This document describes the key steps to be followed and the guidelines that can be followed by the MSCAs in case they are informed by ECHA that an applicant has successfully submitted an application containing one or more confidentiality requests.

Types of applications that can contain a confidentiality request

Confidentiality requests according to Article 67(3) and 67(4) only concern applications submitted under the BPR leading to the approval of an active substance or the authorisation of a biocidal product and submitted with a IUCLID dossier. Dossiers submitted under the BPD are not concerned.


http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals

http://echa.europa.eu/support/dossier-submission-tools/r4bp/biocides-submission-manuals

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Application type R4BP abbreviation Comments

Approval of active substance AS-APP

Renewal of active substance AS-RNL

Inclusion in Annex I

National authorisation - simplified procedure

SA-APP

National Authorisation NA-APP

Union Authorisation UA-APP

National authorisation minor change

NA-MIC Only if IUCLID dossier is submitted

National authorisation major change

NA-MAC Only if IUCLID dossier is submitted

Applications for mutual recognition are not concerned.

Confidentiality requests are in the IUCLID dossier

Confidentiality requests are set by the applicant in the IUCLID dossier, using the foreseen confidentiality flags next to the information it wishes to claim confidential.

The requests need to be accompanied by a justification as to why publication of the information would be potentially harmful to the commercial interest of the applicant or any other party concerned. These justifications are also entered by the applicant in the IUCLID dossier, inside the flag indicating the confidentiality request.

For more information on how applicants make confidentiality requests using the flags in IUCLID 5, please refer to Annex 1 – Setting a confidentiality flag.

ECHA informs the MSCA of a confidentiality request in the dossier

When a confidentiality request is present in the dossier, ECHA will inform the receiving or evaluating CA via R4BP (see 3.1). Dossiers for which the MSCA does not receive such a message can be considered not to contain confidentiality requests.


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2.4 General process description

Upon receipt of a confidentiality request in a successfully submitted biocide dossier, ECHA sends an ad-hoc communication via R4BP to the receiving or evaluating MSCA.

As an integral part of the evaluation and preparation of the assessment report, the MSCA will assess the confidentiality request in the application. Guidelines on how to perform the assessment are provided in this manual.

Assessing the request may require interaction with the applicant, alongside other information requests as part of the evaluation, and the applicant may wish to amend its confidentiality requests or the justification as the assessment proceeds. The assessment should be reflected in the final non-confidential version of the AR prepared by the MSCA.

The MSCA may invoice the applicant for the assessment of the confidentiality requests - in line with the national provisions.

When the assessment is completed, the MSCA shall inform the applicant and ECHA.

The assessment of the confidentiality requests should be concluded by the time the evaluation is concluded.


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3. Steps to be followed by the MSCAs

3.1 Step 1: Open the message

ECHA screens all incoming biocide dossiers for the presence of confidentiality requests. When a confidentiality request is detected in a successfully submitted biocide dossier, ECHA informs the receiving or evaluating MSCA via an ad-hoc communication in R4BP with as Topic “Confidentiality requests” and Subject “Report of the confidentiality request”.

The applicant receives a copy of this message.

The MSCA can open the message by clicking on the message item in the message list.

Figure 1: Open the message

The message contains an Excel report in attachment with the details of the confidentiality requests. The Excel report lists the items claimed confidential, the justifications, and information allowing to easily navigate to the requests and their justifications in the IUCLID dossier.


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Figure 2: Excel report sent by ECHA informing the MSCA of confidentiality requests to be assessed

3.2 Step 2: Open the justification for the confidentiality request

The justifications for the confidentiality requests are available in the Excel report.

Alternatively, using the IUCLID UUID (universal unique identifier) of the item claimed confidential, listed in the Excel report, the justification and the information claimed confidential in the IUCLID dossier can easily be accessed by entering the item’s UUID in the search function of the IUCLID application.

The full dossier content (including justifications) can easily be accessed by entering the dossier UUID in the search function of the IUCLID application. The IUCLID section numbers listed in the Excel report allow to easily navigate to each section containing a confidentiality request, via the dossier’s section tree.

For more information on how to navigate in IUCLID and open the justification, please refer to Annex 2 – Opening the justifications.


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3.3 Step 3: Assess the confidentiality request

3.3.1 General principles

In line with the jurisprudence of the European Court of Justice regarding the definition of what may constitute confidential material and the definition of undisclosed information in Article 39(2) of the World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, a number of common principles can be derived. The following principles are applied by ECHA when assessing whether a confidentiality request under Article 67 BPR can be accepted as valid:

Only a limited number of persons must know the information, i.e. it must not be in the public domain or general knowledge in the industry. Typically, the applicant or third party would have undertaken specific measures to keep the information secret.

The existence of a commercial interest must be demonstrated (the information must have some commercial value or legitimate commercial interests need to be at stake).

Disclosure of the information must potentially harm a applicant’s or a third party’s commercial interests and there must be a causal link between publication of the information and the potential harm.

Requests must be properly reasoned rather than simple statements.

ECHA recommends to use these criteria as reference, while noting that MSCAs may also bound to respect their own national provisions on transparency.

3.3.2 Assessment of the justification

In parallel with the evaluation of the application, the MSCA will need to assess the confidentiality requests in the application.

Assessment of a confidentiality request involves judging the justification provided by the applicant, confirming that the applicant has demonstrated (1) a commercial interest worthy of protection for non-disclosure of the information, and (2) that disclosure of the information would cause potential harm to its commercial interest or to the commercial interest of a third party.

An acceptable justification explains that disclosure of the information, possibly in combination with other publicly available information, would reveal or allow deducing certain (manufacturing, compositional, product, strategic or other) information to competitors or others, which is currently not known to them, leading them to undertake certain actions that could cause commercial harm to the applicant or a third party. The justification should be properly reasoned rather than simple statements.

Please refer to section 4 for further guidelines on how to assess a justification, depending on the type of dossier and the type of confidentiality request.

3.3.3 Public domain search

Since as a general principle, information can only be of confidential character as long as it is


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not already publicly available, additionally, it can be verified that the information is not found in the public domain.

A search could be conducted on public databases of other authorities (e.g. US-EPA), on the company or consortium website(s), or a general internet search (e.g. Google).

When using public search engines, it is very important that the search is performed without releasing the confidential information itself. Never use information claimed confidential to perform the search!

3.3.4 Overall conclusion

By combining the outcomes of the assessment of the justification (3.2.2) and the public domain search (3.2.3), an overall conclusion on the confidentiality request can be determined.

The confidentiality request is acceptable

If the justification is judged to be sufficiently reasoned and the information is not found in the public domain, the confidentiality request is accepted and the information is not disseminated.

The confidentiality request is not acceptable: request further information

Since confidentiality requests on information in the IUCLID dossier are new under the BPR, it might happen that no justifications are present: applicants may have inadvertently set a flag in their IUCLID database, or may not be aware that justification is necessary. In this case, it should be clarified with the applicant if a confidentiality request was intended. In case a justification is present but it is not sufficiently reasoned and/or the information is found in the public domain, the confidentiality request cannot be accepted as such. In this case, it is also recommended to interact with the applicant.

The options to be offered to the applicant are to withdraw the request or to provide further information. For an example letter to the applicant, please see Annex 3 – Example letter to the applicant in case of insufficient justification. The applicant should be informed that its current confidentiality request will not be accepted as such and that it has the possibility to update its justification within a certain time (~ 2 months) and further justify the request and/or refute the availability in the public domain. Alternatively, if the confidentiality request is no longer relevant, the applicant can withdraw it.

It is recommended that the MSCA and the applicant interact via R4BP.

The MSCA can inform the applicant via an ad-hoc communication with as Topic “Confidentiality requests” and Subject “Report of the confidentiality request”. It is important to set a deadline in the message, so the applicant can reply via R4BP. For more information on how to send messages in R4BP, please consult the Biocides Manual for authority users: How to run BPR processes with R4BP 3 in Member State competent authorities.

Possibly the request for further information on the confidentiality request can be combined with a request for further information in the context of the evaluation of the dossier.

Second assessment of the confidentiality request


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A second assessment of the confidentiality request should be performed after the deadline for submission of the further information has expired. The criteria for the second assessment are the same as for the initial assessment. Therefore, if the applicant does not submit any further information within the given deadline, the claim should be rejected.

If the applicant submits an updated justification and all the identified shortcomings have been addressed, the confidentiality request should be accepted, otherwise it should be rejected.

If the applicant withdraws the confidentiality request, no second assessment is needed.

As the assessment of the confidentiality requests should be concluded by the time the evaluation is concluded, it is recommended to allow sufficient time for the second assessment of a request in case the applicant needs to provide further information.

Ensure consistency in the assessment report

The MSCA should take care that information accepted as confidential in the IUCLID dossier is not available in the non-confidential version of the assessment report.

3.4 Step 4: Inform the applicant of the outcome of the assessment

When the assessment of the confidentiality requests is concluded, the applicant shall be informed of the outcome, especially in case of rejection, as it may request ECHA for an assessment of the confidentiality request (see separate document) and/or use national remedies against the MSCA decision, where available.

3.5 Step 5: Reply to ECHA

Outcome of the assessment

When the assessment of the confidentiality requests in an application is concluded, the Excel report listing the confidentiality requests is to be filled in by the MSCA with the outcomes (accepted / rejected / withdrawn). Then, it should be sent back to ECHA via an ad-hoc message in R4BP, with as Topic “Confidentiality requests” and Subject “Report of the confidentiality request”.

The applicant can be copied in to the message.

If a confidentiality request is accepted, the MSCA will fill in “accepted” in the Excel report; ECHA will then not disseminate the information covered by the confidentiality request.

If the applicant has withdrawn the confidentiality request, the MSCA will fill in “withdrawn” in the Excel report. ECHA will then disseminate the information.

If a confidentiality request is not accepted, the MSCA will fill in “not accepted” in the Excel report.


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Figure 3: Excel report - Reply to ECHA

Under Article 67 of the BPR, ECHA is responsible for making certain information publicly available, free of charge on the ECHA website. ECHA will carefully record the decisions on the assessments of the confidentiality requests to ensure adequate dissemination.

Over time, ECHA will further develop its technical support of this process and determine how assessments of confidentiality requests can be managed throughout the life cycle of an application. For the shorter term, ECHA recommends the MSCA to focus on the assessment of confidentiality requests in new applications for active substances and biocidal products.

Important dates and contact person

If a confidentiality request is not accepted, the MSCA will also indicate the deadline for national remedies in the Excel report. This is the deadline given to the applicant to request an administrative review or a court action against the MSCA decision. If no national remedies are available to the applicant, the MSCA will fill in “not applicable” for the deadline. This will ensure that ECHA does not disseminate the information before the applicant has had a chance to use the legal remedies available to it.

If a confidentiality request is not accepted, the MSCA will also indicate the date the applicant was notified in the Excel report. This will ensure that the applicant is given


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sufficient time to request an assessment by ECHA before the information is disseminated.

A contact person in the MSCA should be indicated in case ECHA needs further clarification.

Non-confidential version of the AR

When the evaluation of the dossier is concluded, the AR is to be uploaded in R4BP. The non-confidential version is to be uploaded with type: public.

Table 1: Check list - 5 steps

Check list – 5 steps

Open the message from ECHA in R4BP Open the excel report

Open the justification for the confidentiality request

Assess the confidentiality request

Assess the justification provided by the applicant Perform a public domain search Make an overall decision Further information may need to be requested from the applicant + a second

assessment

Inform the applicant of the outcome of the assessment

Reply to ECHA via a message in R4BP

Fill in the Excel report with the outcomes for each item claimed confidential In case of rejection, indicate the deadline to challenge the decision (if applicable) and

notification date Indicate a contact person in case ECHA needs further clarification


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4. Guidelines for the assessment of a justification

4.1 General principles

An acceptable justification explains that (1) publication of the information, possibly in combination with other publicly available information, would reveal or allow deducing certain manufacturing, compositional, product, company-strategic and/or other sensitive information to competitors, clients or the general public, which they currently do not know, and explains (2) which actions could be undertaken based on this information that would cause commercial harm to the applicant.

The justification should be properly reasoned rather than simple statements.

Valid lines of argumentation

In the next section some examples of valid lines of argumentation can be found, based on justifications for confidentiality requests received by ECHA under REACH, adapted to the biocides context where necessary. Examples are organised by type of confidentiality request. These examples are not exhaustive.

In addition to these type-specific justifications, the applicant can refer to a secrecy agreement in its justification. In case the justification explains that the applicant has a secrecy agreement or non-disclosure agreement with the data-holder, some evidence of the actual existence of such an agreement needs to be provided by the applicant (e.g. declaration that such an agreement exists or extract from the agreement describing the relevant clauses preventing disclosure) to be accepted as a valid justification.

4.2 Degree of purity and identity of hazardous impurities/additives of active substances (Art. 67(3)(a))

Hazardous impurities, additives, and the degree of purity of the active substance have to be claimed confidential separately in the IUCLID dossier. In many cases, only one justification relating to the impurity profile of the substance is provided.


Examples of potentially valid lines of argumentation would state that disclosure would reveal or allow deducing:

Sourcing information (e.g. sourcing location or strategy of the raw materials);

Manufacturing information (e.g. a specific production technology or synthesis route).

In such cases, potential harm could be caused by the fact that competitors could compete for the raw material or competitors could reproduce the production technology.

Information published

The identity of a hazardous impurity or additive covers its IUPAC name, EC name, EC number, CAS number and molecular formula. The identity of impurities and additives which are not


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dangerous is not disseminated on the ECHA website. The typical concentration and concentration range of the impurity/additive is also not disseminated. This information is reported in section 2.9 of the IUCLID dossier.

4.3 Study summaries and robust study summaries of studies submitted to support the approval of the active substance (Art. 67(3)(b))



R&D related information (e.g. elements of the technological process);

Specific test methodology.

In such cases, potential harm could be caused by the fact that competitors could reproduce technology or methodology or a loss of competitive advantage.

The justifications can be very different depending on the type of study performed.

Invalid lines of argumentation

A justification focussing on concerns about theft of the data when disseminated, and use of the data (in other parts of the world) without compensation for the testing costs is not considered acceptable.

The concern that others could use information made publicly available for the purpose of applications under the BPR, or other regulatory regimes , as such, is not deemed to be a commercial interest “worthy of protection” to justify a confidentiality request on the robust study summary. This concern could apply indistinctively for any applicant and any information to be made publicly available on ECHA’s website in accordance with Article 67 of the BPR. However, the EU legislator, by introducing the principle that certain information is to be made available to the general public (unless exceptional circumstances justify a derogation), has explicitly accepted this risk.

Additionally, attention also needs to be paid that the justification for the confidentiality request is not because of the results of the study or because of information which is not disseminated by ECHA (see next).


Study summaries or robust study summaries are reported in sections 3, 4, 6, 8, 9 and 10 of the IUCLID dossier.

For each piece of information reported on the different types of studies, ECHA determined whether it is (1) part of the results of the study, (2) part of the (robust) study summary, or (3) not part of the (robust) study summary.

For active substances, the results of the study are always disseminated, in accordance with Articles 67(1)(d) and 67(1)(e) of the BPR, even if the robust study summary has been claimed confidential. The exception to this the “Efficacy data” in IUCLID section 6, for which the BPR does not foresee that the results are actively disseminated.


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“Results” include the numerical values and the information needed to put it into context, such as for example: study result type, year and report date, test guideline, test animal species, strain and sex, route of administration, test results, remarks on results, etc. The owner company of the reported study will also be disseminated for biocides dossiers.

The robust study summary information is disseminated unless claimed confidential.

The information which is not part of the robust study summary is not disseminated. There are three same fields in each endpoint study record which are not disseminated and which applicants can use for communicating to the authorities any information that is considered to fall otherwise outside of the scope of a (robust) study summary. These fields are:

1. Confidential test material (to be used to provide information on the analytical purity, composition and impurities of the test material, the purity test date, the lot or batch number, the expiration date of the lot/batch, and the isomers composition etc.)

2. Any other information on materials and methods including tables (to be used to provide the names of suppliers of animals and cages, etc.)

3. Overall remarks

The IUCLID fields for the names of test labs are not disseminated. The name of the author of the study (usually the study director) is only disseminated for published articles, but not for company studies.

If the information of interest to the applicant, as explained in the justification, is of category 1 (part of the results of the study, e.g. explosiveness of the substance) or 3 (not part of the (robust) study summary, e.g. confidential test material), the confidentiality request1 should not be accepted, because the acceptance would not make a difference to the dissemination of the information of interest, and the robust study summary information which is not of interest to the applicant would be withheld from dissemination.

Further information on the dissemination, with screenshots of the IUCLID dossier indicating for each piece of information how it will be disseminated, will soon be made available. In the meantime, the REACH manuals can be consulted at http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals?panel=panelDSM (Technical Annexes to the Data Submission Manual 15).

4.4 Information contained in the safety data sheet for the active substance (Art. 67(3)(c))

ECHA has to make publicly available over the internet the information which is contained in the safety data sheet, and which is not already disseminated under other articles of the BPR, unless the applicant successfully claims confidentiality. Since a copy of the safety data sheet of the active substance is not part of the data submitted as part of the application, it has been determined which information has to be listed in both the safety data sheet and the active substance application. Information listed in both that is not already disseminated for other reasons (in accordance with Article 67 of the BPR) is considered “safety data sheet information”.1 This refers to confidentiality requests in the sense of requests to not have the information disseminated by ECHA. Confidentiality requests on information of category 1 or 2 can be accepted by the MSCA in the context of Access to Documents requests or in the context of preparing the Assessment Report or SPC.


http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals?panel=panelDSM

http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals?panel=panelDSM

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It includes (1) the name of the active substance manufacturer, (2) the use, and (3) the results of the PBT (Persistent, Bioaccumulative and Toxic chemicals) and vPvB (very Persistent and very Bioaccumulative) assessment.

4.4.1 Name of the active substance manufacturer(s)Examples of potentially valid lines of argumentation would state that disclosure would reveal or allow deducing:

Manufacturing information (e.g. a specific manufacturing technology);

Product information (e.g. envisaged use of the substance);

Market information (e.g. the competitive structure of the market);

Company strategic information (e.g. the production concept of the company or the applicant role in the supply chain).

In such cases, potential harm could be caused by the fact that competitors could copy some elements of the company strategy or could identify growing market opportunities.


The name of the active substance manufacturer includes the name of the company and the physical address, reported in section 1.3 of the IUCLID dossier.

4.4.2 UsesIn general, an acceptable justification explains that disclosure of the uses would for example reveal or allow deducing certain use-related information to competitors or clients, which is currently not known to them, allowing them to undertake certain actions that would cause commercial harm to the applicant.

ECHA cannot advise on valid lines of argumentation for the use, since the experiences under REACH pertain mainly to the existence of specific unknown uses, whereas under the BPR the substance is known to be used as an active substance in a biocidal product.


The use includes the product type, all elements of the use pattern, and the detailed description of uses including in treated articles, reported in section 7.1 of the IUCLID dossier.

4.4.3 PBT and vPvB assessmentIn general, an acceptable justification explains that disclosure of the PBT or vPvB assessment would for example reveal certain assessment-related information to competitors or clients, allowing them to undertake certain actions that would cause commercial harm to the applicant.

ECHA cannot advise on valid lines of argumentation for the PBT or vPvB assessment, since to date no such confidentiality requests have been accepted under REACH.

A mere statement that the PBT/vPvB assessment is of commercial interest is not sufficient to demonstrate that disclosure of the PBT/vPvB assessment will lead to harm to the commercial interest. The applicant needs to explain in detail the causal relationship between the disclosure


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on the ECHA website of the PBT/vPvB assessment (i.e. in the entries for persistence, bioaccumulation or toxicity in the IUCLID dossier) and the harmful effects of this disclosure. The justification should describe in detail that such harmful effects cannot occur from any Safety Data Sheet(s) circulating in the supply chain in relation to this substance or, in the alternative, that the applicant has taken measures for the information to remain limited to its supply chain.


The PBT/vPvB assessment includes all information on persistence, bioaccumulation or toxicity reported in the results of detailed PBT/vPvB assessment in section 13.1 of the IUCLID dossier.

The endpoint summary of the PBT assessment (also in section 13.1) will be entirely disseminated under article 67(1)(c), since it contains the summary of whether the active substance meets the criteria for being PBT or vPvB, which is one of the exclusion criteria set out in Article 5(1).

4.5 Trade name of the active substance (Art. 67(3)(d))



The composition/purity of the substance behind the trade name;

Which different trade names are behind the same substance.

In such cases, potential harm could be caused by the fact that competitors could identify growing market opportunities.


The trade names (if any) are reported in section 2.1 of the IUCLID dossier.

4.6 Assessment report on the active substance (Art. 67(3)(e))

A confidentiality request on the Assessment Report does not apply to the AR in its entirety, but to certain elements of it.

For a confidentiality request on the AR, the applicant should clearly indicate in the AR which specific elements are claimed confidential, and each element should be justified. MSCAs can continue their past practices with the applicants concerning how to indicate the confidential elements within/annexed to the Draft Assessment Report.

Should the information claimed confidential in the AR correspond to information claimed confidential in the dossier, the justifications can be taken from there (or vice-versa).

If confidentiality is accepted, the MSCA must ensure that those elements are not present in the non-confidential version of the AR which will be disseminated on the ECHA website.

While evaluating a claim on the AR, the assessor should consider the whole dossier and take into account the outcome of the assessments of any other claims present


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in the dossier.

As under the Biocidal Product Directive, the assessment report will be disseminated.

4.7 Study summaries and robust study summaries of studies submitted to support the biocidal product authorisation (Art. 67(4)(a))

The same applies as for confidentiality claims on (robust) study summaries submitted to support the active substance approval, except that for biocidal products, the BPR does not foresee that the results of the study will be disseminated if there is a confidentiality request. Therefore, justifications explaining the commercial interest of the results of the study and the potential harm if the information is disseminated could be acceptable.

4.8 Assessment report on the biocidal product (Art. 67(4)(b))

The same applies as for confidentiality claims on (robust) study summaries submitted to support the active substance approval.


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4.9 Example of a valid justification

We claim the Degree of Purity and Identity of Impurities of Active Substance Name confidential in accordance with BPR Art 67 (3)(a).

We hereby declare that, to the best of our knowledge as of today (01 January 2014), and in accordance with the due measures of protection that we have implemented, a member of the public should not be able to obtain access to the information claimed confidential without our consent or that of the third party whose commercial interests are at stake, and in particular that the information is not publicly available in any of the public databases (list).

We have sourced supplies of plant-based raw materials from an area of the Mato Grosso do Sul region of Brazil, building up relationships with suppliers over many years. In combination with purification technology developed in-house, this gives our active substance a much higher degree of purity compared to our competitors, which is the unique selling point for our product.

Our product has a purity higher than that possible with commonly known production technologies, and contains particular impurities arising from raw materials used. Thus dissemination of the degree of purity or identity of impurities will reveal to our competitors our technology lead and / or the location from which our raw materials are sourced. This would allow our competitors to attempt to buy up our raw materials at source, or begin to attempt to copy our novel production technology, thereby harming our market position and commercial interest.

4.10 Invalid justifications

Below some examples of invalid justifications can be found, based on justifications for confidentiality requests received by ECHA under REACH. These examples are not an exhaustive list.

The justification is an unsubstantiated statement. It only states that the information is confidential or sensitive, or that the applicant does not wish it to be disseminated, e.g.

o Publication on the internet would be detrimental to our business

o Confidential due to business sensitive information

o Protection of knowhow against competitors

The justification is insufficiently reasoned. It vaguely hints that disclosure of the information could reveal certain information, but too little information is provided to make the justification acceptable or it is not possible to follow the applicant’s reasoning.

The justification does not address the (type of) information claimed confidential.


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5. Subsequent assessment by ECHA where requestedThe procedure for an applicant to ask ECHA for a “second opinion” on a confidentiality request is still under development.

Indeed, as per Article 67(3) and (4) of the BPR, if a confidentiality request is accepted by either the MSCA or ECHA the information concerned will not be published. Therefore, following the rejection of a confidentiality request by a MSCA, it remains a possibility for an applicant to request ECHA for a subsequent assessment of the confidentiality request. This would be without prejudice to an applicant’s option to use national remedies against the MSCA decision, where available.

This process (pre-requisites, timelines, etc.) is further elaborated in a separate document submitted to the CA meeting.

ECHA will not disseminate the information covered by a rejected confidentiality request before the applicant’s deadline to pursue national remedies against the MSCA decision has expired. If the applicant does not challenge the rejection by the MSCA and does not request a separate assessment by ECHA, ECHA will disseminate the information covered by the rejected confidentiality request.


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6. Dissemination

6.1 Publication on the ECHA website

Under Article 67 BPR, ECHA is responsible for making certain information publicly available, free of charge. ECHA will carefully record the decisions on the assessments of the confidentiality requests to ensure adequate dissemination.

The information will be published on the ECHA website, and can be accessed and searched by selecting “Information on Chemicals” from the ECHA home page, or by entering the following address: http://echa.europa.eu/web/guest/information-on-chemicals. Alternatively, one can search for a substance via the “Search for Chemicals” box on the top right of the ECHA home page.

The BPR foresees that, for active substances, dissemination (i.e. publication on the ECHA website), will take place as from the date of approval of the active substance2. The non-confidential version of the AR will be published on the ECHA website, together with the IUCLID dossier, from which the information covered by confidentiality requests that have been accepted is removed.

For biocidal products, the BPR foresees that dissemination will take place as from the date of authorisation of the biocidal product. The non-confidential version of the AR will be published on the ECHA website, together with the IUCLID dossier, from which the information covered by confidentiality requests have been accepted is removed. Furthermore, the summary of the biocidal product characteristics (SPC) and the terms and conditions of the authorisation will also be published.

In a first phase, rejected confidentiality requests will temporarily be considered as accepted by ECHA’s Dissemination systems, until the “second opinion” procedure is in place. Also, confidentiality requests with a pending assessment at the time of approval/authorisation will temporarily be considered as accepted by ECHA’s Dissemination systems, and the dossier will be republished after the assessment is finalised – where needed.

2 The Commission has proposed an amendment to the BPR which, if adopted, will amend the introductory sentence of Article 67 as follows:

From the date on which the Commission adopts a Regulation in accordance with Article 9(1)(a), the following up-to-date information held by the Agency or the Commission on that active substance shall be made publicly and easily available free of charge:

This proposed amendment would give ECHA a legal basis to disseminate earlier in the approval process than is currently the practice, and consequently shorten the time for the evaluating MSCA to finalise the non-confidential version of the AR.


http://echa.europa.eu/web/guest/information-on-chemicals

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6.2 What is disseminated

Articles 67(1) and (2) of the BPR determine which information from the application will be published on the ECHA website, without possibility of claiming it confidential. In addition to this information, the information listed in Articles 67(3) and (4) which was not claimed confidential, or which was not accepted as valid, will be published on the ECHA website.

“BPR Article 67 – Electronic Public Access:

1. From the date on which an active substance is approved, the following up-to-date information held by the Agency or the Commission on active substances shall be made publicly and easily available free of charge:

a) where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;

b) if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;

c) the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);

d) physicochemical endpoints and data on pathways and environmental fate and behaviour;

e) the result of each toxicological and ecotoxicological study;f) acceptable exposure level or predicted no-effect concentration established in

accordance with Annex VI;g) the guidance on safe use provided in accordance with Annexes II and III;h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of

Title 2 of Annex II.

2. From the date on which a biocidal product is authorised, the Agency shall make publicly and easily available free of charge the following up-to-date information:

a) the terms and conditions of the authorisation;b) the summary of the biocidal product characteristics; andc) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of

Title 2 of Annex III.


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Annex 1. Setting a confidentiality flag

The setting of a confidentiality flag in the IUCLID dossier is done by the applicant. IUCLID gives the opportunity to define confidentiality claim flags at various places of the data structure to specify whether associated data are to be protected (in the sense that they are not automatically disclosed).

Figure 4: Example of an unset Flag in IUCLID

Click on the flag to bring up the flag’s dialogue box.

These dialogue boxes all have the same design and include both the Confidentiality flags and Regulatory purpose flags, which can be used by the applicant to filter out the flagged data in subsequent operations such as exporting, printing or Dossier creation.

Under the heading 'Restriction of specific regulatory purposes' one or more checkboxes can be selected in order to indicate specific regulatory purpose(s) for which the data are intended to be used, e.g. EU: REACH, EU: BPD or EU: BPR, etc. These regulatory purpose flags do not constitute confidentiality requests.

To claim the information confidential the Confidentiality flag must be set to ‘CBI’ (Confidential Business Information), ‘IP’ (Intellectual Property), or ‘no PA’ (Not Publicly Available).

Figure 5: ‘Flag dialogue box’ popup window in IUCLID

Click on the Confidentiality Dropdown arrow next to the ‘Confidentiality’ text box to select ‘CBI’, ‘IP’ or ‘no PA’. There is no difference in the treatment of confidentiality claims flagged ‘CBI’, ‘IP’ or ‘no PA’. The selected type is simply for the information of the applicant.


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Figure 6: Confidentiality Dropdown Pick List

Click on the justification text box to enter a justification for the confidentiality claim.

Figure 7: Confidentiality Justification Text Box

When ‘OK’ is clicked to close the ‘Set Flags’ window, the flag should be shaded to indicate it is set, and the text entered in the justification text box should be visible.

Figure 8: Example of a Set Confidentiality Claim Flag

Once the confidentiality flag next to a piece of information has been set, the information is regarded as having been claimed confidential.


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Annex 2. Opening the justifications

The confidentiality flags set by the applicant are visible in the IUCLID dossier and the justification can be found inside the confidentiality claim flag. To open it, click on the confidentiality claim flag. Then, click on the ‘magnifying glass’ to see the whole justification.

Figure 9: Justification inside the flag - opening the justification

Figure 10: Justification - Full view


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Annex 3. Example letter to the applicant in case of insufficient justification

CompanyNameStreetStreet2PostalCode, TownCountry

REQUEST FOR FURTHER INFORMATION ON YOUR JUSTIFICATION(S) FOR CONFIDENTIALITY REQUEST(S)

Dear Sir/Madam,

In accordance with Article 67 of the Biocidal Products Regulation, the [MSCA name] is currently examining the validity of the provided justification(s) for confidentiality request(s) in your application for SubstanceName or ProductName by CompanyName.

Following an initial assessment, [MSCA name] considers that the justification for the confidentiality request in your dossier does not contain sufficient information to allow [MSCA name] to accept your request as valid. Details on which information is missing or insufficient for each request can be found in Annex 1. You are requested to add the missing information to your justification and submit the revised justification for the confidentiality request at the latest by [date]. For instructions on how to submit the revised justification, please consult Annex 2.

After receipt of the revised justification, [MSCA name] will perform the final assessment of your confidentiality request and will make its final decision.

Please note: If the justification is not updated within the given deadline, [MSCA name] will make its final decision based on the current justification, which does not contain sufficient information, and will reject the confidentiality request. The corresponding information in your application will then be made publicly available on the website of ECHA.

Alternatively, if the confidentiality request is no longer relevant for you, you can withdraw the confidentiality request. For instructions on how to withdraw the request, please consult Annex 2.


Submission date: SubmissionDateCase number: CaseNumberCommunication number: CommunicationNumber

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If you have a specific concern about the content of this letter or the requirements to accept a confidentiality request as valid, you can contact [MSCA name] at [MSCA contact address].

Yours faithfully,


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ANNEX 1

Report on the initial assessment of confidentiality request(s)

The justifications for the following claim(s) were insufficiently reasoned or some required elements were missing:

Request for confidentiality on [item], in accordance with Article [article number].

You are requested to provide the information detailed below.

• The justification has to contain as a minimum the elements explained in the Biocides Submission Manual 6: Confidentiality requests for biocide applications. In particular:

- A declaration has to be included to show that, to your best knowledge, the information is not in the public domain or general knowledge in the industry with your permission.

- You are required to demonstrate a commercial interest worthy of protection for non-disclosure of the information.

- You are required to demonstrate that disclosure of the information would cause potential harm to your commercial interest or to the commercial interest of a third party. The causal relationship between the publication of the information and the harmful effects of this disclosure has to be explained.

[add details on reason why the justification as currently present in the dossier is not acceptable]


http://echa.europa.eu/documents/10162/14938692/bsm_06_confidentiality_requests_en.pdf

28 (30)Annex 4. Excel report sent by ECHA to inform the MSCA of a confidentiality request


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