80th 81st CA Meeting CA-Sept18Nov18-Doc.5.3

NOTE FOR DISCUSSION WITH MEMBER STATES' COMPETENT AUTHORITIES FOR BIOCIDAL

PRODUCTS

This document is drafted in the interest of consistency of the implementation ofRegulation (EU) No 528/2012 and with the aim of finding an agreement between

Member States' Competent Authorities for biocidal products on a harmonisedapproach. Please note, however, it does not represent the official position of the

Commission and that Member States are not legally obliged to follow the approach setout in this document, since only the Court of Justice of the European Union can give

authoritative interpretations on the contents of Union law.

Subject: Annex I to the BPR: outlining an update of the current approach

1. Background and purpose of the document

(1) In previous CA meetings in 2016 and 20171, discussions took place on whatshould be done for the renewal of active substances which are both approved andlisted in Annex I to the BPR. No conclusions have been reached so far.

(2) Other discussions took also place concerning the management of some activesubstances which benefitted from the food and feed derogation2, or corn cob3, andtheir possible inclusion into Annex I to the BPR.

(3) In 2013, some guidance was agreed to provide clarifications concerning theprovisions of the BPR related to Annex I and the simplified authorisationprocedure, and an approach was agreed to include additional substances intoAnnex I4. No additional substance has been listed so far in Annex I. In the light ofthe above-mentioned discussions, as well as more experience with theimplementation of the BPR, certain elements of this guidance document of 2013may need to be updated.

(4) Some Member States considered that it would be appropriate to include in AnnexI some active substances which were identified by the BPC as eligible for Annex I

1 At the 67th CA meeting of November 2016 (CA-Nov16-Doc.5.4 - Renewal for AS both approved andin Annex I to BPR.doc; 67th CA meeting final minutes (without ED session).doc), 70th CA meeting ofMarch 2017 (CA-March17-Doc.5.5 - Renewal for AS both approved and in Annex I to BPR.doc; 70thCA meeting final minutes.docx) and 72nd CA meeting of May 2017 (70th CA meeting finalminutes.docx; 72nd CA meeting final minutes.doc)

2 CA-March18-Doc.5.3 - Food and Feed under under Art 15(b)-16-17 of RR.doc; 77th CA meetingfinal minutes.docx

3 CA-March18-Doc.5.2 - Inclusion Corn Cob Annex I.doc; 77th CA meeting final minutes.docx

4 CA-Feb13-Doc.5.1.l - Final - Substances in Annex I of the BPR.doc

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inclusion, like citric acid, potassium sorbate or lactic acid. So far, only approvaldecisions were adopted for these substances for the concerned product types, andno Annex I inclusion was proposed, in the waiting of a more general discussionconcerning the management of Annex I.

(5) The objective of this document is therefore to discuss the current approach andsome challenges related to the implementation of Annex I to the BPR in order topromote the development of products presenting lower concern, to discusspossible evolutions, and make proposals related to the specific issue of themanagement of the renewal of active substances which are currently bothapproved and included into Annex I to the BPR.

2. Outline of relevant provisions in the BPR and guidance

(6) As defined in the recitals of the BPR, the use of products with a more favourableenvironmental or human or animal health profile shall be encouraged. One of themeasures that were introduced in the BPR to fulfil this objective is to provide forsimplified authorisation procedures for specific products that are expected topresent such characteristics. Among other criteria, such products can contain onlyactive substances that are listed in Annex I of the BPR.

(7) After receiving an opinion from ECHA, the Commission is empowered to modifyAnnex I by delegated acts, in order to include, restrict or remove the entry of asubstance in that Annex. It is empowered to do so at his own initiative, or at therequest of economic operator or a Member State providing the necessaryevidence. The Implementing Regulation (EU) No 88/2014 has been adopted tospecify procedures for the amendment of Annex I, and references to thatRegulation are made also in Regulation (EU) No 1062/2014.

(8) The conditions set out in Article 28(2) of the BPR for inclusion in Annex I arebased on the classification of the substances. The decision whether to include asubstance in Annex I is therefore hazard-based.

(9) Substances are included in Annex I by a Commission Delegated Act, and theirinclusion remains valid until it is modified. These active substances are notsubject to a regular renewal process (as opposed to other active substances whichare approved for a maximum period of 10 years), but may be reviewed when newinformation is available showing that the substances gives rise to concern. Theauthorisation of biocidal products containing active substances included in AnnexI have an expiry date. The authorisation shall be renewed for products authorisedvia the normal authorisation procedure. For products previously authorised oreligible for authorisation under the simplified authorisation procedure, a newapplication for authorisation must be submitted under such procedure.

(10) When the BPR was adopted on 22 May 2012, there was a clear separationbetween the normal authorisation process, which was restricted to productscontaining active substances which are approved under the BPR, and thesimplified authorisation process which was restricted to products containingactive substances which are listed in Annex I to the BPR. A modification wasintroduced by Regulation (EU) No 334/2014 by providing further flexibility andencouraging the recourse to low concern active substances listed in Annex I to the

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BPR: the modification allowed products containing active substances approved orlisted in Annex I to the BPR to be authorised via the normal authorisationprocedure, in accordance with Article 19(1)(a) of the BPR (e.g. when a productcontaining a substance listed in Annex I does not meet the conditions set inArticle 25 for the simplified procedure). However, this modification has raisedinteraction issues for active substances which are currently both approved andlisted in Annex I to the BPR.

3. Discussion

3.1. In situ generation of active substances currently listed in Annex I

(11) Annex I does not provide whether the included active substances can begenerated in situ. It is necessary to clarify if it is possible to generate in situ activesubstances listed in Annex I.

Proposal:

(12) An approval of an active substance specifies whether this substance can begenerated in situ and under which conditions. In consistency with any other activesubstance approved under the BPR, an entry in Annex I does not cover the in situgeneration of the active substance unless explicitly mentioned in the entry.

3.2. Conditions applicable to active substances listed in category 6 of Annex Iand relation to Product-Types

(13) In page 9, section 3.4.1 of the Appendix of the document "CA-Feb13-Doc.5.1.l - Final", it is indicated: "It is assumed that substances of category 6 "Substances included in Annex I or IA to Directive 98/8/EC ", the limitationregarding the PT possibilities remains the same, even if not explicit, as it was theintention of the legislators to include them in Annex I because a low risk wasdemonstrated for a specific use and because the restrictions mentioned in Annex Irefer to those PTs."

(14) It has to be noted however that neither the BPR nor the conditionsspecified in Annex I for the concerned substances establish a restriction for use ina certain product-type a priori.

(15) It is to be reminded that, as for every product, companies have todemonstrate when requesting authorisation that their product is efficient and safefor the use requested. Companies have to provide the data required in Article20(1)(a) for a normal application for product authorisation, or Article 20(1)(b) foran authorisation via the simplified authorisation procedure. For the latter, the datarequirement allows Member States to request any relevant information in supportof the conclusions that the product meets the conditions of Article 25 in particularto demonstrate that the handling of the biocidal product and its intended use donot require personal protective equipment.

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Proposal:

(16) It is proposed to remove this specific paragraph from document "CA-Feb13-Doc.5.1.l - Final" in relation to PTs in category 6 of Annex I. Companiescould thus develop products containing these active substances listed on Annex Ifor any product-type, as for any active substances listed in the other categories ofAnnex I.

(17) Such an approach would be consistent with the approach followed for theactive substances listed in other categories of Annex I, where there is nolimitation for use in a specific product-type.

(18) The provisions of Article 95 of the BPR are applicable to activesubstances listed in category 6: consequently, alternative suppliers for these activesubstances could possibly supply it for use in any PT.

(19) Nitrogen and ZETDA are no longer in the review programme for any PT,as their review is already finalised. However, it is to be noted that carbon dioxideis still currently covered under the Review Programme Regulation (EU) No1062/2014 for both the non-in situ form (canisters of carbon dioxide) and the insitu form (generated from propane, butane or a mixture of both by combustion)for PT195. Therefore, should the current Annex I inclusion of carbon dioxide beconsidered as covering all PTs – thus also PT19 - the Commission services areanalysing the consequences for products already on the market, and how thetransition set out under Article 89 to pass from the national transitional systems tothe BPR product authorisation system could be arranged.

3.3. Management of substances currently both approved and included intoAnnex I to the BPR when the approval expires

(20) Detailed explanations on the issues linked to this situation were presentedin CA documents already discussed in earlier CA meetings1. Comments receivedduring these discussions are reflected in Appendix A to this document.

Proposal:

(21) At the expiry of the approvals of these active substances, it is preferable toavoid maintaining the active substances both approved and listed in Annex I, toavoid possible interactions issues contradicting or conflicting conditions inapprovals/inclusion, issues of interpretations related to specific PTs, etc. Theactive substance should only be listed in Annex I, as it is sufficient that an activesubstance is listed in Annex I to the BPR so that products containing it areauthorised. This also reduces the administrative burden to both economicoperators and authorities, avoiding a regular review of approval of low concernactive substances with limited added value.

5 CA-March15-Doc.5.1- Final - Substances generated in situ.doc. The eCA has recently informed thatthe non-in situ form (eg. CO2 in gaz, solid form..) is no longer supported in the review programme forPT19 by the participant.

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(22) The summary presented in Appendix B shows that a case by case approachis necessary as the context is different for each active substance (conditions set inthe existing approvals, conditions listed in Annex I to BPR, etc…).

3.3.1. (Z,E)-Tetradec-9,12-dienyl acetate (ZETDA)

(23) ZETDA is approved for use in PT 19 biocidal products under certainconditions set in the approval.

(24) ZETDA is listed in Annex I to the BPR with no specific conditions orrestriction.

Proposal:

(25) It is proposed that no specific application of renewal of approval for PT19is submitted. No particular action is needed, the approval will expire and theactive substance remains listed in Annex I, category 6, and may still be used inbiocidal products.

(26) It has to be noted that product authorisations have nevertheless to berenewed before they expire, and applicants have to submit their application in duetime. Depending on the nature of the product, the authorisation holder wouldeither have to apply for another authorisation via the simplified authorisationprocedure, or to apply for the renewal of its product authorisation via the normalauthorisation procedure (ie. for products not eligible to the simplifiedauthorisation procedure).

(27) It is also to be noted that, being listed article 95 category 6, the provisionsof Article 95 remain applicable, as provided under Article 95(6) of the BPR toensure a level-playing field for active substances suppliers.

3.3.2. Carbon dioxide and Nitrogen

(28) Carbon dioxide is approved for use in PT14, PT15 and PT18 biocidalproducts under certain conditions set in the approvals, and still under evaluationfor PT19.

(29) Carbon dioxide is listed in Annex I to the BPR with the restriction "Onlyfor use in ready-for-use gas canisters functioning together with a trappingdevice". This restriction sterns from the former Annex IA for carbon dioxide forPT14 under the BPD, but Annex I to the BPR does not specify a use in specificPT(s).

(30) Nitrogen is approved for use in PT18 biocidal products under certainconditions set in the approval.

(31) Nitrogen is listed in Annex I with the restriction "Only for use in limitedquantities in ready-for-use canisters". This condition was set in the BPR, but isnot taken from the former evaluation under the BPD for nitrogen for PT18.

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(32) Contrary to ZETDA, if no action is taken on these substances when theapprovals expire for the relevant product types, only products compliant with theconditions in Annex I could be authorised in the future for these 2 substances.Other products may nevertheless be present on the market today (e.g. uses whichrequire the wearing of PPE, like fumigation of furniture in a plastic bubble forinsecticide treatment, fumigation of geese with CO2…).

Proposal :

(33) If companies would like maintain on the market or request in the future anauthorisation for products which are not meeting the conditions set currently inAnnex I for the substances (ie. products other than for use in ready-for-use gascanisters functioning together with a trapping device), instead of submitting anapplication for renewal of approval for the relevant PTs, interested companiesshould rather submit an application to request an amendment of the conditions ofthe Annex I for these substances. Such an application could be submitted at thelatest 550 days before the earliest expiry date of approval for the active substance,i.e. 29/04/2018 for carbon dioxide and 28/02/2020 for nitrogen6. Most principlesagreed for normal renewals will also apply (coordination by ECHA, same eCA asoriginal evaluation, possibly joint application by companies, 2-month submissionwindow)7. This implies that Member States and the BPC should consider theinclusion into Annex I only on the own merits of the substance meeting theconditions set out in Article 28(2) of the BPR.

(34) As regards to the appropriate revised conditions to set in Annex I for thesesubstances, there could be two options:

a. Option 1: To not include any condition anymore, as for several of theother substances listed in Annex I so far. This is already the case forZETDA (despite the former conditions in the Annex I and IA to the BPDfor this substance). At product authorisation, it would still be necessary todemonstrate that the conditions for authorisation are met, in particular inaccordance with Article 25 applications under the simplified procedure,and the granted authorisation will set up the appropriate conditions of usefor each product ((i.e. SPC etc.) as reminded in paragraph 15 above; or

b. Option 2: To include specific conditions. However, these are low concernactive substances, and it is the objective of the provisions in the BPR toreduce the administrative burden to the minimum necessary, both foreconomic operators and authorities, and to facilitate the placing on themarket of products containing these active substances. In this context, thesetting of conditions should consider the following :

i. ensure that the conditions are not too restrictive, as they have toallow companies to apply for product authorisation under both thenormal approval process or the simplified authorisation process.Furthermore, too restrictive conditions would prevent theauthorisation of new "low concern" products for uses beyond those

6 An application for renewal of approval of carbon dioxide for PT14 has been submitted already. Thisapplication has been put on hold until a way forward is defined in the CA meeting concerning thepresent document.

7 CA-July17-Doc.5.3 - Final - AS renewals 2016-2020.docx

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already seen by authorities. The BPR system is a 2-step processwhere products are managed by the product authorisation system,and the active substance approval/inclusion system should not berestrictive for the product-level unless there is clear regulatoryneed. Being too restrictive could generate the need to amendseveral times the conditions listed in Annex I for the samesubstance. It has to be kept in mind that these are low concernactive substances.

ii. ensure that the conditions also take into account the approachfollowed in normal approvals which call only for "attentions to bepaid" to particular issues, except where specific bans/restrictionsmust be put already at the approval stage.

(35) It has to be noted that product authorisations have to be renewed in allcases before they expire, and applicants have to submit their applications in duetime. Depending on the nature of the product, the authorisation holder wouldeither have to apply for another authorisation via the simplified authorisationprocedure, or apply for the renewal of its products via the normal authorisationprocedure (for products not eligible to the simplified authorisation procedure).

(36) It is also to be noted that, being listed article 95 category 6, the provisionsof Article 95 remain applicable as provided under Article 95(6) of the BPR toensure a level-playing field for active substances suppliers.

(37) Considering the advantages and disadvantages of both options, and thepossible difficulty and investment needed to find suitable conditions for eachactive substance taking into account the constraints mentioned above (notblocking development of new products, for any PT, etc.), it is rather proposed tofollow option 1.

3.4. Management of substances for which the BPC opinion indicated a possibleinclusion into Annex I to the BPR, and which were approved but notincluded in Annex I

(38) Over the recent years, the BPC identified in its opinions a few activesubstances which are eligible for inclusion into Annex I: citric acid8, potassiumsorbate9 or lactic acid10.

(39) Some of these substances are still in the review programme for other PTs :

c. Lactic acid is still under review for PT06

d. Potassium sorbate is still under review for PT06

8 Citric acid for PT2

9 Potassium sorbate for PT8

10 Lactic acid for PT1; PT2, PT3, PT4

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e. Citric acid is currently still in the review programme for PT01. However,the applicant withdrew its participation, and a non-approval decision willsoon be adopted.

(40) So far, the Commission has taken no action as regards to an Annex Iinclusion as none of the participants for these substances specifically requestedsuch an inclusion. In addition, questions were raised concerning the managementof the remaining dossiers under assessment for these substances, and thetransition under Article 89 to the BPR authorisation phase for the concernedproducts.

(41) The empowerment provided for by the BPR allows the Commission toinclude substances in Annex I at its own initiative or at the request of a MemberState. Solutions could also be found in order to manage the transition for the PTsstill under the review programme for the substance under Article 89 to the BPRauthorisation phase for the concerned products.

(42) Some Member States also requested a possible inclusion in Annex I to theBPR for such active substances.

(43) Several options could be considered:

f. Option 1: To proceed now with an Annex I inclusion of these substances.

i. Advantages :

1. this could allow companies to apply for productauthorisation via the simplified procedure, and facilitate theaccess to market of products with better profiles for humanhealth, animal health and/or the environment.

2. this could reduce the workload for the approval process oftwo active substances

g. Option 2: Wait that the last dossier in the review programme for theconcerned active substance is reviewed, and proceed at that moment withan Annex I inclusion.

i. Advantages :

1. this would allow the full evaluation of the currentapplications for approval submitted for the remaining PTsand could facilitate the product authorisation stage for thesePTs.

ii. Disadvantages :

1. this would maintain the full workload in the reviewprogramme for two active substances

2. this would not allow yet the authorisation via the simplifiedauthorisation procedure for the products which could beeligible (ie. efficient, no substances of concern in theproduct, no nanomaterials, no use of PPE). This would not

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facilitate the development of biocidal product presentinglow concerns.

h. Option 3: Continue proceeding with approvals, and proceed with anAnnex I inclusion only after the transition under Article 89 is over for theproducts containing these active substances, and before the renewal ofapproval process for the concerned active substance.

i. Advantages:

1. This would allow to gain experience with the authorisationof products containing these substances, and theirproperties

ii. Disadvantages :

1. this would maintain the full workload in the reviewprogramme for two active substances

2. this would not allow yet the authorisation via the simplifiedauthorisation procedure for the products which could beeligible (ie. efficient, no substances of concern in theproduct, no nanomaterials, no use of PPE). This would notfacilitate the development of biocidal product presentinglow concerns.

(44) Should such Annex I inclusion be proposed, considering that dossierswere submitted for an approval, the substances would be listed in category 6 ofAnnex I which corresponds to this type of situation, and ensures the application ofArticle 95 provisions for the level-playing field of active substances suppliers.

(45) Should such Annex I inclusion be proposed, similar reflexions aspresented in section 3.3 of this document would be necessary to define whetherinclusion conditions are appropriate, and if so, what would be such conditions. Inaddition, in line with section 2.3 of this document, the inclusion should not belimited to the PTs examined in the review programme for these substances.

(46) The approach finally chosen should also be applied to other substancesidentified in the future for Annex I inclusion by ECHA and still currently underexamination in the review programme.

(47) Considering the advantages and disadvantages of these options, it isproposed to follow option 1.

(48)

4. Actions requested

The Member States' competent authorities are invited to reflect on these topics and on theproposals, in order to have a discussion and a possible agreement during the 80th 81st CAmeeting.

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Appendix A

Past discussions on the management of renewal of approval of activesubstance currently both approved and listed in Annex I to the BPR

** Comments received from Member States after the 81st CA meeting ofSeptember 2018

The United Kingdom (11/10/18)

Issue in section 3.1

As indicated at the September meeting, the UK CA agrees with COM ‘s proposal that theAnnex I entry should not cover the in situ generation of the AS unless specified in theentry.

Issue in section 3.2

A decision on Annex I listing of an AS is based on a consideration of the identifiedhazards against those listed in Article 28. The risks associated with any PT are irrelevant.(The risks will be considered against the Article 25 criteria at the product authorisationstage.) Therefore, the UK CA agrees with COM’s proposal that it is not necessary toinclude the PT in the Annex I category 6 entries.

Issue in section 3.3

As for section 3.2, consideration for Annex I listing is based on the hazard profile of theAS. Any specific restrictions on the use of the product will be based on assessment of theassociated risks when used in a particular way. These restrictions will be considered atproduct authorisation.

Hence, if carbon dioxide is included in Annex I without any restrictions, there may bepossibilities for implementing the simplified authorisation procedure for uses beyond‘ready-for-use gas canisters’. Should an application for, for example, fumigation of aflour mill be submitted, presumably several restrictions, including the need for PPE, willbe required. Therefore, according to Art 25 the simplified procedure will not beappropriate for this fumigation use.

Therefore, UK CA concludes that the inclusion of restrictions in Annex I may berestrictive and is not necessary, but that specific restrictions can be addressed at productauthorisation when it will be determined whether or not the simplified authorisationprocedure can be used..

Issue in section 3.4

If we agree that it is not necessary to include the PT or any restrictions in Annex I, then itfollows that there is no need to wait for the evaluation of an AS in all supported PTsbefore including that AS in Annex I.

However, there is a fairness issue, where some participants / applicants will have paid forthe evaluation of their dossier, whereas later PTs / applications will not have thisexpense.

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Finland (16/10/18)

Section 3.1

FI agrees with COM ‘s proposal that in consistency with any other active substanceapproved under the BPR, an entry in Annex I does not cover the in situ generation of theactive substance unless ex-plicitly mentioned in the entry.

Section 3.2

FI agrees with COM’s proposal that it is not necessary to include the PT in the Annex Icategory 6 en-tries.

Section 3.3

FI agrees that the active substance should only be listed in Annex I, as it is sufficient thatan active substance is listed in Annex I to the BPR so that products containing it areauthorised.

3.3.1. ZETDA:

FI agrees with COM’s proposal that no specific application of renewal ofapproval for PT19 is submitted.

3.3.2. Carbon dioxide and Nitrogen:

FI agrees with COM’s proposal of Option 1. We think that Art25 includessufficient possibilities to set necessary restrictions for simplified authorisations.If, for example, carbon dioxide would be used for fumigation of rooms in largequantities, there will be necessary PPE needs and thus the simplified authorisationprocess would not be possible.

Section 3.4

FI agrees with COM proposal in Option 1: To proceed now with an Annex I inclusion ofthese substances.

Denmark (18/10/2018)

Thanks to the Commission for providing us with this document. DK CAfinds the subject on how to update Annex I to the BPR of great interest. Ingeneral terms we can support the effort of updating Annex I in order topromote the development of products presenting lower concern. Please findbelow our comment to the specific discussion points in the document

3.1. In situ generation

We can agree with the proposal in (12), as it will make sense to be consistentwith how active substances are approved under the BPR.

3.2 Cat. 6 of Annex I in relation to Product-Types

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We follow the arguments given by the Commission for removing the linkbetween PTs and active substances listed in category 6 of Annex 1. Adecision on Annex I listing of an AS is based on a consideration of theidentified hazards against those listed in Article 28.

In the Commission Implementing Regulation 88/2014 paragraph (1) is itstated “The inclusion in category 6 of that Annex requires the submission ofa data package allowing a full risk assessment for the intended use”? Wewould tend to understand the reference to “intended use” as PT-specific?How does this match with the proposal?

3.3. Active substances both approved and included into Annex I

In general, we are concerned about removing the restrictions for the activesubstances already included in Annex 1. The entries in Annex 1 regardingCO2 and N2 are very limited and only for use of the active substances inlimited quantities. Further, the specific conditions in the implementingregulations states that the products shall only be used by trainedprofessionals. For CO2 also appropriate measures regarding protection ofbystanders shall be taken. Will this be considered adequately under thesimplified authorisation procedure? Exposure to as well CO2 as N2 can bydifferent mechanisms be lethal under specific circumstances, and this willonly be addressed properly during a risk assessment which Article 25 do notallow for. However, in (33) it is proposed that the Annex I entry for thesetwo substances should be changed only after a request from an applicant toamend the conditions of the Annex I, and only after the Member States andthe BPC have given their opinion. Hence, any concerns regarding the AnnexI inclusion will be properly dealt with during this procedure. Takingeverything into account we would prefer option 2, which allows for theinclusion of specific conditions.

3.4. Active substances identified eligible for inclusion into Annex I

Denmark can in general support the inclusion into Annex I for activesubstances identified eligible for inclusion by BPC.

When it comes to the three options given in the document regarding thetimelines, we do see the benefits of option 1 in terms of reducing theworkload for as well the active substance approval processes as for theauthorisations of the relevant biocidal products. However, we have someconcerns and questions, if the substances are included now (option 1). Oneconcern is the level playing field for the applicants who had already appliedfor product authorisations or are preparing their dossier. For citric acid(PT2), potassium sorbate (PT8) and L-(+)-lactic acid (PT1) the deadlines forproduct applications have already passed. How many applications will beaffected by this, and how should these applications be dealt with? Shouldthey then be treated as applications after the simplified authorisationprocedure, if wanted by the applicant? And what about the fee already paid?

In this perspective option 2 will have almost the same issues in terms of theproduct applications. Some applications (products in the last PT approved)will have the advantage to be treated after the simplified authorisation

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procedure, while others (the PT’s already authorized) will be treated after theArticle 19 authorisation procedure.

Option 3 might be the option treating all applicants equal by maintaining theArticle 19 authorisations procedure until after the transition under Article 89is over. However, this would maintain the workload for a number of years –for both the member states and the applicants, while knowing the productapplications may be eligible for a simplified authorisation procedure. Andapplications for new products submitted after the transition would stillbenefit from an easier authorisation process in comparison to the existingproducts on the marked.

Taking all this into consideration, we tend to favor option 1. However, we dohave some concerns, and we would like to hear the point of view from theapplicants affected by an annex 1 inclusion of the substances.

Sweden (18/10/2018)

The Swedish Chemicals Agency have considered the proposals put forwardby the Commission and have the following responses:

Section 3.1: We agree that the Annex I entry should not cover the in situgeneration of the active substance unless specified in the entry.

Section 3.2: The listing of an active substance is based on a consideration ofthe identified hazards against those listed in Article 28. We would not go sofar as to say that risks arising from the substance’s use(s) in biocidal productshave no bearing on the inclusion as a whole. However, we agree that there isno longer any need to specify product types under category 6.

Section 3.3: We agree that most conditions to specify necessary riskmitigation measures can be stipulated at product authorisation. We aresomewhat concerned that Article 27(2) does not allow for objections onspecific conditions concerning risk management in accordance with Articles35 and 36 to be raised. We see there a potential for disagreements over riskmanagement where there is no formal basis for resolutions to objectionsshould they occur within the simplified procedure. Given that we arediscussing what should be low risk products we can hope that suchdisagreements would be rare. On the other hand, for products containingactive substances listed on Annex 1, presumably Article 35 shall apply. Itmight be possible, therefore, for us to consider removing the condition thatall authorised products can only be for use by trained professionals. Thatwould enable companies with innovative products to apply for productauthorisation, even for use by professional operators in general or byconsumers. However, we feel strongly that a condition shall remain for theuses that do pose risks that require very strict risk management in order forthem to be considered acceptable.

As far as we can see, at present, there would only be two cases affected atpresent and those would be nitrogen and carbon dioxide. The conditions thatwe consider necessary are the conditions from the inclusions in Annex I of

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the Biocidal Products Directive (98/8/EC) that are specific and not coveredby the general requirements of Article 19. In both cases, this involves arestriction to use by trained professionals and in the case of nitrogen arequirement for measures to protect bystanders (although this would berelevant for the carbon dioxide uses as well). Other conditions, such as thosereferring to the protection of operators, are covered by biocides andworkplace legislation and would not need to be included in Annex I.

In summary, we do not support a complete abolition of conditions in Annex Iand would welcome a further discussion about how our concerns can beaccommodated.

Section 3.4: We have no objection to the inclusion of active substanceswithout delay. We consider that the issues of fairness will have to beaddressed whether the actives are included now or later. Inclusion now willenable companies that are developing low risk products to apply forauthorisation sooner.

Germany (19/10/2018)

Question:

Should a Annex I entry cover the in situ generation of the active substance?

German CA:

Generally speaking, biocide procedures distinguish between active substances that aregene-rated in-situ or non-in situ. Thus, formally, an entry in annex 1 would not includein-situ gene-rated active substances.

However, an objective of the BPR is to promote low-risk approaches. If an activesubstance is included in annex I since it fulfils the requirements of article 28 of the BPR,and the assessment shows that the precursor of the active substance is equally fulfillingthese conditions, one may conclude that the whole system is suitable for an Annex 1entry. In our view, for these cases, the annex I entry should also include in-situ generatedsubstances for cases where it has been demonstrated that the precursor fulfills therequirements of article 28.

Question:

Should the specific paragraph from document "CA-Feb13-Doc.5.1.l - Final" in relation toPTs in category 6 of Annex I be removed?

German CA:

Yes.

Question:

Should the active substance only be listed in Annex I, as it is sufficient that an active sub-stance is listed in Annex I to the BPR so that products containing it can be authorised?

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German CA:

Yes, in our view an annex I entry is considered sufficient. Standard productauthorisations are possible for active substances of annex I, thus, extended life of theunion list is not required.

Remark on nitrogen:

Nitrogen does not have a direct effect on the target organisms since it is an oxygenscavanger. In case generating an oxygen free environment is construed as biocidalactivity (and thus nitrogen is considered as an active substance), the status of othersubstances may have to be reconsidered. E.g. in case pest organisms are drowned,consequently, water would be the active substance.

Nitrogen does not chemically react with the target organisms. Thus, no concentration canbe determined as lethal dose. For the target organism it does not make a differencewhether a 90% or 98% concentration is generated, since the lethal effect is exclusivelybased on the available oxygen concentration. If the oxygen falls below a certainconcentration, lethal effects are to be expected. Accordingly, the oxygen is responsiblefor the effect on the target organism (but not the presence as for most other substances,but the absence).

In this sense, oxygen would have to be construed as the active substance since theabsence of it has a direct and lethal effect on the target organism. Nitrogen could becompared to a catalyser that generates the lethal concentration of the active substance.But it seems not helpful to construe oxygen as active substance in accordance to the BPR.But neither would it be useful to construe nitrogen as active substance withoutendogenous effect on the target organism.

Question:

How to manage substances for which the BPC opinion indicated a possible inclusion intoAnnex I to the BPR, and which were approved but not included in Annex I?

German CA:

Proceed now with an Annex I inclusion of these substances (Option 1).

** Comments received after the 70th CA meeting of March 2017

Sweden

We apologise for having missed earlier opportunities to comment but we realise now thatwe have concerns regarding the Commission’s proposal specifically for carbon dioxide.Some of these concerns may be relevant for other active substances too but the currentcommenting period has not been sufficient for us to analyse the proposal for otheractives. It is not clear that carbon dioxide fulfils any of the criteria in Article 28(2)(a). It could beargued that because exposure to it can be lethal that it fulfils the provision in the last

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paragraph of Article 28 but that would be open to debate. In any case, applying thatparagraph would exclude its use in biocidal products that could be innovative, low riskand suitable for the simplified authorisation procedure described in Article 25 so it maynot be desirable to apply that provision in any case. The Commission has explained that removing all conditions from the entry for carbondioxide in Annex I would allow companies to apply for the authorisation of biocidalproducts in accordance with Article 25 without the need to apply for renewal of approvalof carbon dioxide itself. Our particular problem with that solution is that the riskmanagement of biocidal products that use large volumes of carbon dioxide is essential toits safe use and Article 25 does not allow for a risk assessment in order to identify risksor risk management measures. It is even unclear at what volumes or on the basis of whichother parameters a borderline could be drawn in order to set a condition for productswhere an authorisation by the normal procedure would be required. Where all CompetentAuthorities might predict that ready-for-use rodent traps are suitable for the simplifiedprocedure and that fumigation products are not, application for authorisation of productsin the middle of that scale of use could easily result in differing interpretations of whichproducts are suitable. In such cases a consultation with other Member States via HelpExwould be appropriate before the application was accepted. A condition might help todefine this borderline but for an unclassified substance wording a sufficiently specificcondition may be difficult.We have insufficient time before the deadline for comments to come with a proposal fora condition or some other solution that might address the above concerns. We wonderhow the Commission views the need for full approvals for biocidal products containingcarbon dioxide and, potentially, even nitrogen (which has some similar uses and riskmanagement issues) and we ask the Commission to delay finalising their document untilthe issue has been discussed further.

** Comments received after the 67th CA meeting of November 2016

Ireland

The applicant (Rentokil) has provided the following position in relation to N2 and CO2:

“Nitrogen

We have commented periodically on the regulatory status of nitrogen as activeingredient under the Biocidal Product Directive / Regulation. In 2014, we submitted ourviews about in-situ generation of nitrogen as an active ingredient when it was cited thatuse of nitrogen to create deoxygenated environments would have to be considered on acase by case basis about whether they are regarded as biocidal products. At this time,we agreed to postpone the decision about whether Nitrogen should remain in scope ofthe BPR until renewal of the Article 95 decision in ca. 2021, and this would allowRentokil Initial to use their Article 95 listing held for the active.

We believe the original rationale of Nitrogen being a physical means of control stillapplies, thereby moving it out of scope of BPR (Nitrogen itself has no toxic effect, theeffect is a result of physical displacement of oxygen). If the COM can agree, then norenewal or decision on Annex I listing need be made for Nitrogen, which would fall outof scope after expiry of the Article 95 decision.

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Carbon dioxide

We believe there is sufficient concern about potential toxic effects of carbon dioxide forthis material not to be considered as a candidate for inclusion as a low risk activeingredient, and it does not meet the conditions in Article 28(2) of the BPR.

1. A substance is considered to give rise to concern where:

(a) it meets the criteria for classification according to Regulation (EC) No 1272/2008 as: explosive/highly flammable,

While it is not explosive, carbon dioxide is supplied in canisters and labelled H280 Gasunder pressure, may explode if heated. This classification is new under the CLPregulation because an equivalent classification did not exist under DSD and as suchcarbon dioxide was non hazardous for supply at the time of first authorisation under theDirective.

In addition, carbon dioxide has a direct toxic effect on the blood and causes rapidasphyxiation that comes about so quickly that victims may not be aware and unable toprotect themselves.

Carbon dioxide as an active ingredient has a direct toxic effect if applied incorrectly, sothe suitability of carbon dioxide as an active ingredient giving no cause for concern is amisnomer. The hazard from application of carbon dioxide is such that all biocidalproducts based on it should have a full assessment under BPR to ensure the correct riskmitigation measures are applied.

We accept that the RADAR rodent trapping unit referred to in Annex I category 6 of BPRhas very low levels of carbon dioxide giving rise to no causes for concern but this wasthe conclusion only after full consideration under the conventional route forauthorisation under BPD. We believe there are very few circumstances where the levelof carbon dioxide is low enough for it to meet the criteria of Article 28(2) of the BPRmaking its inclusion as a low risk active ingredient effectively meaningless and as suchcarbon dioxide should be removed from Annex I and be listed only in Article 95.

Please note that Rentokil Initial 1927 plc plan to renew the Article 95 listing for PT14and PT18 applications”.

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Appendix B

1. List of active substances which are currently approved for certain product types and listed into Annex I to the BPR

PT

Name of ASYear of

approvalReference

Duration ofapproval (in years)

Date ofapproval

Expiry date ofapproval

Deadline forapplications for

renewal

14 Carbon dioxide 2008Directive 2008/75/EC

(Annex I A to the BPD for PT14 :Directive 2007/70/EC)

10 01/11/2009 31/10/2019 29/04/2018

18 Nitrogen 2009Directive 2009/89/EC

(No Annex IA to the BPD)10 01/09/2011 31/08/2021 28/02/2020

18 Carbon dioxide 2010Directive 2010/74/EU

(No Annex IA to the BPD for PT18)10 01/11/2012 31/10/2022 29/04/2021

19(Z,E)-Tetradec- 9,12-dienyl acetate(ZETDA)

2011Directive 2011/11/EU

(covering both Annex I and IA to theBPD)

10 01/02/2013 31/01/2023 30/07/2021

15 Carbon dioxide 2015 Approval Regulation (EU) 2015/292 10 01/06/2015 31/05/2025 31/05/2025

2. Extract from Annex I to the BPR of active substances which are also approved

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