Infokiri

2025-March-19-SCBP_Summary Report Cover Note.pdf

European Commission, B-1049 Brussels – Belgium

Telephone (+32-2) 299.11.11 Office B-B232 03/071 Telephone direct line (+32-2) 296.33.56 E-Mail-Address: [email protected]

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL

sante.g.3(2025)4319821

To: Permanent Representations of all 27 Member States

Missions of Iceland, Norway and Switzerland

Copy to: Contacts Standing Committee on Biocidal Products of all 27

Member States - preset

Contacts DG Health and Food Safety and other - preset

Summary Report

Health and Food Safety Directorate General / Unit E4

Meeting: Standing Committee on Biocidal Products

Date: 19 March 2025

Summary Report: Attached in Annex 1

Please find attached the Summary Report of the Standing Committee Meeting on Biocidal

Products, held on 19 March 2025.

N.B. The drafts on which the Committee expressed an opinion are subject to a defined

procedure in relation to the formal adoption by the Commission.

BITTERHOF Almut

Acting Head of Unit

Annex 1 – Summary Report

HANS INGELS(GROW.F.2)

DE AVILA Cristina(ENV.B.2)

Electronically signed on 09/04/2025 12:23 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121

E-kiri.eml

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Tere!

Edastan.

Parimate soovidega

Tiiu Noobel
Sekretär
Eesti Vabariigi alaline esindus EL juures
Rue Guimard 11/13, 1040 Brüssel
Tel: + 32 2227 4337, [email protected]
https://eu.mfa.ee/et/

-----Original Message-----
From: Esindus EL juures üldaadress
Sent: Thursday, April 10, 2025 11:46 AM
To: Tiiu Noobel
Subject: FW: Summary report 87th meeting of the Standing Committee on
Biocidal Products, 19 March 2025 - Ares(2025)2927827

-----Original Message-----
From: DOLHA Elena Adriana (SANTE)
Sent: Thursday, April 10, 2025 11:39 AM
To: (Mission of Iceland to the EU = Mission de l'Islande auprès de l'UE)
; (Mission of Liechtenstein to the EU = MIssion du
Liechtenstein auprès de l'UE) ; (Mission
of Switzerland to the EU = Mission de la Suisse auprès de l'UE)
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Représentation permanente de l'Autriche) ;
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Belgique) ; (Permanent Representation of
Bulgaria = Représentation permanente de la Bulgarie)
; (Permanent Representation of Croatia =
Représentation permanente de la Croatie) ; (Permanent
Representation of Cyprus = Représentation permanente de Chypre)
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Republic = Représentation permanente de la République tchèque)

Subject: Summary report 87th meeting of the Standing Committee on Biocidal
Products, 19 March 2025 - Ares(2025)2927827

Dear all,

Please find attached the summary report of the Standing Committee on
Biocidal Products 19 march 2025.

Kind regards,
Elena Dolha

2025-March-19-SCBP_Summary Report Cover Note.pdf

European Commission, B-1049 Brussels – Belgium

Telephone (+32-2) 299.11.11 Office B-B232 03/071 Telephone direct line (+32-2) 296.33.56 E-Mail-Address: [email protected]

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL

sante.g.3(2025)4319821

To: Permanent Representations of all 27 Member States

Missions of Iceland, Norway and Switzerland

Copy to: Contacts Standing Committee on Biocidal Products of all 27

Member States - preset

Contacts DG Health and Food Safety and other - preset

Summary Report

Health and Food Safety Directorate General / Unit E4

Meeting: Standing Committee on Biocidal Products

Date: 19 March 2025

Summary Report: Attached in Annex 1

Please find attached the Summary Report of the Standing Committee Meeting on Biocidal

Products, held on 19 March 2025.

N.B. The drafts on which the Committee expressed an opinion are subject to a defined

procedure in relation to the formal adoption by the Commission.

BITTERHOF Almut

Acting Head of Unit

Annex 1 – Summary Report

HANS INGELS(GROW.F.2)

DE AVILA Cristina(ENV.B.2)

Electronically signed on 09/04/2025 12:23 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121

SummaryReport_2025-March-19-SCBP_SCBP.pdf

EUROPEAN COMMISSION

Health and Food Safety Directorate General

sante.g.3(2025)4319821

87th Standing Committee on Biocidal Products

19 March 2025

CIRCABC Link: https://circabc.europa.eu/ui/group/8b6b0199-c74b-43bd-a9dd-

79bdcae3b825/library/9e8ba86c-5490-4874-86b4-8d46f1414a09?p=1&n=10&sort=modified_DESC

SUMMARY REPORT

A.01 Adoption of the Agenda

The agenda was adopted.

A.02 Adoption of the minutes of the 86th SCBP meeting

The minutes of the 86th SCBP meeting were adopted.

A.03 Discussion on the application of approval of formaldehyde released from the

reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1), as

an existing active substance for use in biocidal products of product-types 2, 6, 11

and 13 , and of reaction products of paraformaldehyde and 2-

hydroxypropylamine (ratio 3:2) as an existing active substance for use in biocidal

products of product-types 2, 6, 11, 12 and 13

A discussion took place on the application of approval of formaldehyde released from

the reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1), as an

existing active substance for use in biocidal products of product-types 2, 6, 11 and 13,

and of reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) as

an existing active substance for use in biocidal products of product-types 2, 6, 11, 12

and 13.

A.04 Discussion on the application of approval of DBNPA as an existing active

substance for use in biocidal products of product-type 11

A discussion took place on the application of approval of DBNPA as an existing active

substance for use in biocidal products of product-type 11.

A.05 Discussion on the application of renewal of approval of medetomidine as an

existing active substance for use in biocidal products of product-type 21

A discussion took place on the application of renewal of approval of medetomidine as

an existing active substance for use in biocidal products of product-type 21.

A.06 Information on a draft Commission Implementing Regulation specifying a

procedure for the authorisation of same biocidal products in accordance with

Regulation (EU) No 528/2012 of the European Parliament and of the Council

(repealing Commission Implementing Regulation (EU) No 414/201)

The Commission provided information on a draft Implementing Regulation specifying

a procedure for the authorisation of same biocidal products in accordance with

Regulation (EU) No 528/2012 of the European Parliament and of the Council (repealing

Commission Implementing Regulation (EU) No 414/2013).

A.07 Information on the unresolved objections regarding the conditions for granting an

authorisation for the biocidal product families Cypermethrin liquids and

Cypermethrin solids, and on the biocidal product Icon 10 CS, in accordance with

Regulation (EU) No 528/2012 of the European Parliament and of the Council

The Commission informed that internal discussions are still on-going within the

Commission.

A.08 Information on decisions on amendments to Union authorisations under

preparation or published

The Commission informed on amendments to Union authorisations under preparation

or published. The Commission recalled the importance of the quality check of the

translations of the Summary of Products Characteristics annexed to the authorisation.

B.01 Exchange of views and possible opinion of the Committee on a draft

Commission Implementing Decision on the non-approval of ethylene oxide for use

in biocidal products of product type 2 in accordance with Regulation (EU) No

528/2012 of the European Parliament and of the Council

The Commission introduced the draft Decision. A discussion took place and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.02 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation approving 2,2-Dibromo-2-cyanoacetamide (DBNPA) as

an existing active substance for use in biocidal products of product-type 6 in

accordance with Regulation (EU) No 528/2012 of the European Parliament and of

the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.03 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation approving formic acid as an existing active substance

for use in biocidal products of product-type 6 in accordance with Regulation (EU)

No 528/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.04 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation approving 1,2-Benzisothiazol-3(2H)-one (BIT) as an

existing active substance for use in biocidal products of product-types 6 and 13 in

accordance with Regulation (EU) No 528/2012 of the European Parliament and of

the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.05 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation (EU) granting a Union authorisation for the biocidal

product family ‘B.Braun Medical Propanol Family’ in accordance with

Regulation (EU) No 528/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.06 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation (EU) granting a Union authorisation for the biocidal

product family ‘BPF Propan-2-ol Dr Deppe’ in accordance with Regulation (EU)

No 528/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.07 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation (EU) granting a Union authorisation for the single

biocidal product ‘Fernox Biocide AF10’, in accordance with Regulation (EU) No

582/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.08 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation (EU) granting a Union authorisation for the single

biocidal product ‘Hydrocid 306’, in accordance with Regulation (EU) No 582/2012

of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.09 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Regulation (EU) granting a Union authorisation for the biocidal

product family ‘PAA family UCO Group’, in accordance with Regulation (EU) No

582/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place, and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

B.10 Exchange of views and possible opinion of the Committee on a draft Commission

Implementing Decision concerning the extension of the action taken by the

Environment Agency of Luxembourg permitting the making available on the

market and use of the biocidal product Biobor JF in accordance with Regulation

(EU) No 528/2012 of the European Parliament and of the Council

The Commission introduced the draft Decision. A discussion took place and the

Commission informed that the draft will be included in the next written consultation of

the Standing Committee.

Vote Postponed

C.01 Exchange of views of the Committee on a draft Commission Implementing

Regulation amending Implementing Regulation (EU) No 564/2013 as regards the

adaptation of fees to inflation

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.02 Exchange of views of the Committee on a draft Commission Implementing

Regulation approving 2-methyl-2H-isothiazol-3-one (MIT) as an existing active

substance for use in biocidal products of product-type 6 in accordance with

Regulation (EU) No 528/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.03 Exchange of views of the Committee on a draft Commission Implementing

Regulation approving 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride for

use in biocidal products of product type 6 in accordance with Regulation (EU) No

528/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.04 Exchange of views of the Committee on a draft Commission Implementing

Regulation approving peracetic acid generated from 1,3-diacetyloxypropan-2-yl

acetate and hydrogen peroxide as an existing active substance for use in biocidal

products of product-type 2 in accordance with Regulation (EU) No 528/2012 of the

European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.05 Exchange of views of the Committee on a draft Commission Implementing

Regulation renewing the approval of epsilon-metofluthrin as an active substance

for use in biocidal products of product type 18 in accordance with Regulation (EU)

No 528/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.06 Exchange of views of the Committee on a draft Commission Implementing

Decision repealing Implementing Decision (EU) 2024/2460 postponing the expiry

date of the approval of metofluthrin for use in biocidal products of product-type

18 in accordance with Regulation (EU) No 528/2012 of the European Parliament

and of the Council

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.07 Exchange of views of the Committee on a draft Commission Implementing

Decision on the non-approval of epsilon-metofluthrin for use in biocidal products

of product type 19 in accordance with Regulation (EU) No 528/2012 of the

European Parliament and of the Council

As the draft Decision was not yet available, no discussion took place on this agenda

item.

C.08 Exchange of views of the Committee on a draft Commission Implementing

Decision not approving certain active substances for use in biocidal products in

accordance with Regulation (EU) No 528/2012 of the European Parliament and of

the Council

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.09 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval of nonanoic acid for use

in biocidal products of product-type 2

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.10 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval of bis(N-cyclohexyl-

diazenium-dioxy)-copper (Cu-HDO) for use in biocidal products of product-type

8

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.11 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval decanoic acid for use in

biocidal products of product-type 4

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.12 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval octanoic acid for use in

biocidal products of product-type 8

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.13 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval iodine for use in biocidal

products of product-type 3

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.14 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval polyvinylpyrrolidone

iodine for use in biocidal products of product-types 1 and 3

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.15 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval 1R-trans phenothrin for

use in biocidal products of product-type 18

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.16 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval S-methoprene for use in

biocidal products of product-type 18

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.17 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval medetomidine for use in

biocidal products of product-type 21

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.18 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval IPBC for use in biocidal

products of product-type 8

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.19 Exchange of views of the Committee on a draft Commission Implementing

Decision (EU) postponing the expiry date of the approval DDACarbonate for use

in biocidal products of product-type 8

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.20 Exchange of views of the Committee on a draft Commission Implementing

Regulation (EU) granting a Union authorisation for the biocidal product family

‘desmanol pure’ in accordance with Regulation (EU) No 528/2012 of the European

Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.21 Exchange of views of the Committee on a draft Commission Implementing

Regulation (EU) granting a Union authorisation for the single biocidal product

‘exeol air cid 01’, in accordance with Regulation (EU) No 582/2012 of the

European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.22 Exchange of views of the Committee on a draft Commission Implementing

Regulation (EU) granting a Union authorisation for the biocidal product family

‘PRODHYNET's Lactic acid based products’, in accordance with Regulation (EU)

No 582/2012 of the European Parliament and of the Council

The Commission introduced the draft Regulation. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.23 Exchange of views of the Committee on a draft Commission Implementing

Regulation granting a Union authorisation for the biocidal product family

‘CHLOROCRESOL BASED PRODUCTS-CID Lines NV’ in accordance with

Regulation (EU) No 528/2012 of the European Parliament and of the Council

The Commission explained that no documents were provided but that following the

receipt of the Agency’s opinion on an Article 75(1)(g) request a revised version will be

prepared for the next meeting.

C.24 Exchange of views of the Committee on a draft Commission Implementing

Decision concerning the extension of the action taken by the Ministry of Health of

the Czech Republic permitting the making available on the market and use of the

biocidal product Tandem in accordance with Regulation (EU) No 528/2012 of the

European Parliament and of the Council

The Commission introduced the draft Decision. A discussion took place and the

Committee agreed that the draft will be included in a written consultation of the

Standing Committee as soon as possible.

C.25 Exchange of views of the Committee on a draft Commission Implementing

Decision concerning the extension of the action taken by the Dutch Ministry of

Infrastructure and Water Management permitting the making available on the