# L_2021180EN.01007801.xml

| 21.5.2021 | EN | Official Journal of the European Union | L 180/78 |
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21.5.2021

EN

Official Journal of the European Union

L 180/78

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COMMISSION DELEGATED REGULATION (EU) 2021/806

of 10 March 2021

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include carbon dioxide generated from propane, butane or a mixture of both by combustion as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That lists includes carbon dioxide generated from propane, butane or a mixture of both by combustion. |
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(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That lists includes carbon dioxide generated from propane, butane or a mixture of both by combustion.

| (2) | Carbon dioxide generated from propane, butane or a mixture of both by combustion has been evaluated for use in biocidal products of product-type 19, repellents and attractants, as described in Annex V to Regulation (EU) No 528/2012. |
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(2)

Carbon dioxide generated from propane, butane or a mixture of both by combustion has been evaluated for use in biocidal products of product-type 19, repellents and attractants, as described in Annex V to Regulation (EU) No 528/2012.

| (3) | France was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the European Chemicals Agency (‘the Agency’) on 18 September 2019. |
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(3)

France was designated as the rapporteur Member State and its evaluating competent authority submitted the assessment report together with its conclusions to the European Chemicals Agency (‘the Agency’) on 18 September 2019.

| (4) | In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinion of the Agency on 16 June 2020 (3), having regard to the conclusions of the evaluating competent authority. |
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(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the Biocidal Products Committee adopted the opinion of the Agency on 16 June 2020 (3), having regard to the conclusions of the evaluating competent authority.

| (5) | According to that opinion, biocidal products of product-type 19 using carbon dioxide generated from propane, butane or a mixture of both by combustion may be expected to satisfy the requirements of Article 19(1)(b) of Regulation (EU) No 528/2012. The opinion of the Agency also concluded that this active substance does not give rise to concern and is eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
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(5)

According to that opinion, biocidal products of product-type 19 using carbon dioxide generated from propane, butane or a mixture of both by combustion may be expected to satisfy the requirements of Article 19(1)(b) of Regulation (EU) No 528/2012. The opinion of the Agency also concluded that this active substance does not give rise to concern and is eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (6) | Taking into account the opinion of the Agency, it is therefore appropriate to include carbon dioxide generated from propane, butane or a mixture of both by combustion in Annex I to Regulation (EU) No 528/2012. As carbon dioxide generated from propane, butane or a mixture of both by combustion has been assessed based on an active substance dossier complying with the requirements set out in Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (4), carbon dioxide generated from propane, butane or a mixture of both by combustion should be included in category 6 of Annex I to Regulation (EU) No 528/2012, ‘Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC’. |
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(6)

Taking into account the opinion of the Agency, it is therefore appropriate to include carbon dioxide generated from propane, butane or a mixture of both by combustion in Annex I to Regulation (EU) No 528/2012. As carbon dioxide generated from propane, butane or a mixture of both by combustion has been assessed based on an active substance dossier complying with the requirements set out in Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (4), carbon dioxide generated from propane, butane or a mixture of both by combustion should be included in category 6 of Annex I to Regulation (EU) No 528/2012, ‘Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC’.

| (7) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to carbon dioxide generated from propane, butane or a mixture of both by combustion for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 July 2022, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
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(7)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to carbon dioxide generated from propane, butane or a mixture of both by combustion for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 July 2022, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of carbon dioxide generated from propane, butane or a mixture of both by combustion for product-type 19 is 1 July 2022.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 March 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

2

(3)  Biocidal Products Committee Opinion on the application for approval of the active substance: Carbon dioxide generated from propane, butane or a mixture of both by combustion, Product type: 19, ECHA/BPC/249/2020, adopted on 16 June 2020.

3

(4)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

4

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ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 6 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
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| ‘204-696-9 | Carbon dioxide generated from propane, butane or a mixture of both by combustion (*1) | | CAS No 124-38-9 |

EC number

Name/group

Restriction

Comment

‘204-696-9

Carbon dioxide generated from propane, butane or a mixture of both by combustion (*1)

CAS No 124-38-9

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(*1)  The date of approval of carbon dioxide generated from propane, butane or a mixture of both by combustion for product-type 19 for the purposes of Article 89(3) is 1 July 2022.’.

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