# Official Journal L 297/2020

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 297 |
| | |
| English edition | Legislation | Volume 6311 September 2020 |

ISSN 1977-0677

Official Journal

of the European Union

L 297

English edition

Legislation

Volume 6311 September 2020

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2020/1263 of 10 September 2020 approving the active substance sodium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 1 |
| | | DECISIONS |
| | * | Decision (EU) 2020/1264 of the European Central Bank of 8 September 2020 amending Decision (EU) 2019/1743 of the European Central Bank on the remuneration of holdings of excess reserves and of certain deposits (ECB/2020/38) | 5 |
| | * | Commission Implementing Decision (EU) 2020/1265 of 9 September 2020 allowing Germany to authorise biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage
  (notified under document C(2020) 6028) | 7 |
| | * | Commission Implementing Decision (EU) 2020/1266 of 9 September 2020 allowing Denmark to authorise biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage
  (notified under document C(2020) 6030) | 10 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2020/1263 of 10 September 2020 approving the active substance sodium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

1

DECISIONS

*

Decision (EU) 2020/1264 of the European Central Bank of 8 September 2020 amending Decision (EU) 2019/1743 of the European Central Bank on the remuneration of holdings of excess reserves and of certain deposits (ECB/2020/38)

5

*

Commission Implementing Decision (EU) 2020/1265 of 9 September 2020 allowing Germany to authorise biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage
  (notified under document C(2020) 6028)

in situ

(notified under document C(2020) 6028)

7

*

Commission Implementing Decision (EU) 2020/1266 of 9 September 2020 allowing Denmark to authorise biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage
  (notified under document C(2020) 6030)

in situ

(notified under document C(2020) 6030)

10

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
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EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 11.9.2020 | EN | Official Journal of the European Union | L 297/1 |
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11.9.2020

EN

Official Journal of the European Union

L 297/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1263

of 10 September 2020

approving the active substance sodium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 22(1) in conjunction with Article 13(2) thereof,

Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Austria received on 18 March 2016 an application from BIOFA AG for the approval of the active substance sodium hydrogen carbonate. On 21 January 2020, the Commission was informed of the transfer of the applicant holder rights from Biofa AG to SCC Legal GmbH. |
| --- | --- |

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Austria received on 18 March 2016 an application from BIOFA AG for the approval of the active substance sodium hydrogen carbonate. On 21 January 2020, the Commission was informed of the transfer of the applicant holder rights from Biofa AG to SCC Legal GmbH.

| (2) | In accordance with Article 9(3) of Regulation (EC) No 1107/2009, Austria, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application on 26 April 2016. |
| --- | --- |

(2)

In accordance with Article 9(3) of Regulation (EC) No 1107/2009, Austria, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) of the admissibility of the application on 26 April 2016.

| (3) | On 7 September 2017 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
| --- | --- |

(3)

On 7 September 2017 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (4) | The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in June 2018. |
| --- | --- |

(4)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of that Regulation, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in June 2018.

| (5) | On 17 August 2018 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance sodium hydrogen carbonate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public. |
| --- | --- |

(5)

On 17 August 2018 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance sodium hydrogen carbonate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

| (6) | On 24-25 January 2019 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for sodium hydrogen carbonate providing that sodium hydrogen carbonate is approved. |
| --- | --- |

(6)

On 24-25 January 2019 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for sodium hydrogen carbonate providing that sodium hydrogen carbonate is approved.

| (7) | The applicant was given the possibility to submit comments on the review report. |
| --- | --- |

(7)

The applicant was given the possibility to submit comments on the review report.

| (8) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
| --- | --- |

(8)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (9) | The Commission further considers that sodium hydrogen carbonate is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Sodium hydrogen carbonate is not a substance of concern and fulfils the conditions set in Annex II point 5 to Regulation (EC) No 1107/2009. |
| --- | --- |

(9)

The Commission further considers that sodium hydrogen carbonate is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Sodium hydrogen carbonate is not a substance of concern and fulfils the conditions set in Annex II point 5 to Regulation (EC) No 1107/2009.

| (10) | It is therefore appropriate to approve sodium hydrogen carbonate as a low-risk substance. |
| --- | --- |

(10)

It is therefore appropriate to approve sodium hydrogen carbonate as a low-risk substance.

| (11) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions. |
| --- | --- |

(11)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions.

| (12) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly. |
| --- | --- |

(12)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

The active substance sodium hydrogen carbonate, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force

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

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 September 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  
  EFSA Journal 2018;16(9):5407

2

EFSA Journal

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

3

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Sodium hydrogen carbonate
  CAS No: 144-55-8 | Sodium hydrogen carbonate | ≥ 990 g/kg
  Arsenic ≤ 3 mg/kg
  Lead ≤ 2 mg/kg
  Mercury ≤ 1 mg/kg | 1 October 2020 | 1 October 2035 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium hydrogen carbonate, and in particular Appendices I and II thereof, shall be taken into account. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Sodium hydrogen carbonate

CAS No: 144-55-8

Sodium hydrogen carbonate

≥ 990 g/kg

Arsenic ≤ 3 mg/kg

Lead ≤ 2 mg/kg

Mercury ≤ 1 mg/kg

1 October 2020

1 October 2035

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium hydrogen carbonate, and in particular Appendices I and II thereof, shall be taken into account.

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(1)  Further details on identity and specification of active substance are provided in the review report.

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ANNEX II

In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘24 | Sodium hydrogen carbonate
  CAS No: 144-55-8 | Sodium hydrogen carbonate | ≥ 990 g/kg
  Arsenic ≤ 3 mg/kg
  Lead ≤ 2 mg/kg
  Mercury ≤ 1 mg/kg | 1 October 2020 | 1 October 2035 | For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium hydrogen carbonate, and in particular Appendices I and II thereof, shall be taken into account.’ |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘24

Sodium hydrogen carbonate

CAS No: 144-55-8

Sodium hydrogen carbonate

≥ 990 g/kg

Arsenic ≤ 3 mg/kg

Lead ≤ 2 mg/kg

Mercury ≤ 1 mg/kg

1 October 2020

1 October 2035

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium hydrogen carbonate, and in particular Appendices I and II thereof, shall be taken into account.’

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(1)  Further details on identity and specification of active substance are provided in the review report.

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DECISIONS

| 11.9.2020 | EN | Official Journal of the European Union | L 297/5 |
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11.9.2020

EN

Official Journal of the European Union

L 297/5

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DECISION (EU) 2020/1264 OF THE EUROPEAN CENTRAL BANK

of 8 September 2020

amending Decision (EU) 2019/1743 of the European Central Bank on the remuneration of holdings of excess reserves and of certain deposits (ECB/2020/38)

THE GOVERNING COUNCIL OF THE EUROPEAN CENTRAL BANK,

Having regard to the Treaty on the Functioning of the European Union, and in particular the first indent of Article 127(2) thereof,

Having regard to the Statute of the European System of Central Banks and of the European Central Bank, and in particular the first indent of Article 3.1 and Articles 17 to 19 thereof,

Whereas:

| (1) | The Governing Council considers that the funds mandatorily deposited with the ECB for the purpose of repaying financial assistance under Council Regulation (EU) 2020/672 (1) should be exempt from negative interest rates. |
| --- | --- |

(1)

The Governing Council considers that the funds mandatorily deposited with the ECB for the purpose of repaying financial assistance under Council Regulation (EU) 2020/672 (1) should be exempt from negative interest rates.

| (2) | Therefore, Decision (EU) 2019/1743 (ECB/2019/31) (2) should be amended accordingly, |
| --- | --- |

(2)

Therefore, Decision (EU) 2019/1743 (ECB/2019/31) (2) should be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Amendment

Article 2 of Decision (EU) 2019/1743 (ECB/2019/31) is replaced as follows:

‘Article 2

Remuneration of certain deposits held with the ECB

Accounts maintained with the ECB in accordance with Decision ECB/2003/14 of the European Central Bank (*1), Decision ECB/2010/31 of the European Central Bank (*2), Decision ECB/2010/17 of the European Central Bank (*3) and Council Regulation (EU) 2020/672 (*4) shall continue to be remunerated at the deposit facility rate. However, when deposits need to be held in those accounts in advance of the date on which a payment must be made in accordance with the legal or contractual rules applicable to the relevant facility, such deposits shall be remunerated during this advance period at zero per cent or the deposit facility rate, whichever is higher.

Article 2

Entry into force

This Decision shall enter into force on the fifth day following that of its publication in the Official Journal of the European Union. It shall apply from the sixth reserve maintenance period of 2020 starting on 16 September 2020.

Done at Frankfurt am Main, 8 September 2020.

For the Governing Council

The President of the ECB

Christine LAGARDE

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(1)  Council Regulation (EU) 2020/672 of 19 May 2020 on the establishment of a European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) following the COVID-19 outbreak (OJ L 159, 20.5.2020, p. 1).

1

(2)  Decision (EU) 2019/1743 of the European Central Bank of 15 October 2019 on the remuneration of holdings of excess reserves and of certain deposits (ECB/2019/31) (OJ L 267, 21.10.2019, p. 12).

2

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| 11.9.2020 | EN | Official Journal of the European Union | L 297/7 |
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EN

Official Journal of the European Union

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COMMISSION IMPLEMENTING DECISION (EU) 2020/1265

of 9 September 2020

allowing Germany to authorise biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage

(notified under document C(2020) 6028)

(Only the German text is authentic)

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 55(3) thereof,

After consulting the Standing Committee for Biocidal Products,

Whereas:

| (1) | Annex I to Regulation (EU) No 528/2012 contains active substances which have a more favourable environmental or human or animal health profile. Products containing these active substances may therefore be authorised under a simplified procedure. Nitrogen is included in Annex I to Regulation (EU) No 528/2012 subject to the restriction that it is used in limited quantities in ready-for-use canisters. |
| --- | --- |

(1)

Annex I to Regulation (EU) No 528/2012 contains active substances which have a more favourable environmental or human or animal health profile. Products containing these active substances may therefore be authorised under a simplified procedure. Nitrogen is included in Annex I to Regulation (EU) No 528/2012 subject to the restriction that it is used in limited quantities in ready-for-use canisters.

| (2) | Pursuant to Article 86 of Regulation (EU) No 528/2012, nitrogen is approved as active substance for use in biocidal products of product-type 18, insecticides (2). Biocidal products consisting of nitrogen as approved are authorised in several Member States including Germany and are supplied in gas cylinders (3). |
| --- | --- |

(2)

Pursuant to Article 86 of Regulation (EU) No 528/2012, nitrogen is approved as active substance for use in biocidal products of product-type 18, insecticides (2). Biocidal products consisting of nitrogen as approved are authorised in several Member States including Germany and are supplied in gas cylinders (3).

| (3) | Nitrogen can also be generated in situ from ambient air. In situ generated nitrogen is currently not approved for use in the Union and it is neither listed in Annex I to Regulation (EU) No 528/2012, nor inserted in the list of active substances included in the review programme of existing active substances in biocidal products in Annex II to Commission Delegated Regulation (EU) No 1062/2014 (4). |
| --- | --- |

(3)

Nitrogen can also be generated in situ from ambient air. In situ generated nitrogen is currently not approved for use in the Union and it is neither listed in Annex I to Regulation (EU) No 528/2012, nor inserted in the list of active substances included in the review programme of existing active substances in biocidal products in Annex II to Commission Delegated Regulation (EU) No 1062/2014 (4).

| (4) | Pursuant to Article 55(3) of Regulation (EU) No 528/2012, on 24 April 2020 Germany submitted to the Commission an application for derogation from Article 19(1)(a) of that Regulation asking to allow it to authorise biocidal products consisting of nitrogen generated in situ from ambient air for the protection of cultural heritage (‘the application’). |
| --- | --- |

(4)

Pursuant to Article 55(3) of Regulation (EU) No 528/2012, on 24 April 2020 Germany submitted to the Commission an application for derogation from Article 19(1)(a) of that Regulation asking to allow it to authorise biocidal products consisting of nitrogen generated in situ from ambient air for the protection of cultural heritage (‘the application’).

| (5) | Cultural heritage can be damaged by a wide range of harmful organisms, from insects to microorganisms. The presence of those organisms not only can lead to the loss of the cultural good itself, but also poses the risk of those harmful organisms being spread to other objects nearby. Without an appropriate treatment, objects could be irremediably damaged, putting the cultural heritage at serious risk. |
| --- | --- |

(5)

Cultural heritage can be damaged by a wide range of harmful organisms, from insects to microorganisms. The presence of those organisms not only can lead to the loss of the cultural good itself, but also poses the risk of those harmful organisms being spread to other objects nearby. Without an appropriate treatment, objects could be irremediably damaged, putting the cultural heritage at serious risk.

| (6) | In situ generated nitrogen is used to create a controlled atmosphere with a very low concentration of oxygen (anoxia) in permanent or temporary sealed treatment tents or chambers for the control of harmful organisms on cultural heritage objects. Nitrogen is separated from the ambient air and is pumped into the treatment tent or chamber, where the nitrogen content of the atmosphere is increased to 99 % approximately and consequently oxygen is almost completely depleted. The humidity of the nitrogen pumped into the treatment area is set according to the demands of the object to be treated. Harmful organisms cannot survive under the conditions created in the treatment tent or chamber. |
| --- | --- |

(6)

In situ generated nitrogen is used to create a controlled atmosphere with a very low concentration of oxygen (anoxia) in permanent or temporary sealed treatment tents or chambers for the control of harmful organisms on cultural heritage objects. Nitrogen is separated from the ambient air and is pumped into the treatment tent or chamber, where the nitrogen content of the atmosphere is increased to 99 % approximately and consequently oxygen is almost completely depleted. The humidity of the nitrogen pumped into the treatment area is set according to the demands of the object to be treated. Harmful organisms cannot survive under the conditions created in the treatment tent or chamber.

| (7) | According to the information submitted by Germany, the use of in situ generated nitrogen appears to be the only effective technique for the control of harmful organisms that can be used for all types of materials and combinations of materials present in cultural institutions without damaging them. |
| --- | --- |

(7)

According to the information submitted by Germany, the use of in situ generated nitrogen appears to be the only effective technique for the control of harmful organisms that can be used for all types of materials and combinations of materials present in cultural institutions without damaging them.

| (8) | The method of anoxia or modified or controlled atmosphere is listed in the standard EN 16790:2016 ‘Conservation of cultural heritage – Integrated pest management (IPM) for protection of cultural heritage’ and nitrogen is described in this standard as ‘most used’ for creating anoxia. |
| --- | --- |

(8)

The method of anoxia or modified or controlled atmosphere is listed in the standard EN 16790:2016 ‘Conservation of cultural heritage – Integrated pest management (IPM) for protection of cultural heritage’ and nitrogen is described in this standard as ‘most used’ for creating anoxia.

| (9) | Other techniques for the control of harmful organisms are available, such as low temperature treatment, heat treatment, humidity controlled warm air treatment. In addition, other active substances can be used for that purpose. However, according to Germany, each of those techniques has limitations in terms of materials on which they can be applied. |
| --- | --- |

(9)

Other techniques for the control of harmful organisms are available, such as low temperature treatment, heat treatment, humidity controlled warm air treatment. In addition, other active substances can be used for that purpose. However, according to Germany, each of those techniques has limitations in terms of materials on which they can be applied.

| (10) | As stated in the application, treatment with biocidal products containing other active substances leaves residues on the treated objects that may be progressively released into the environment and pose a risk to human health. This is particularly relevant in the case of cultural objects exhibited in museums and documents available for consulting in archives and libraries. |
| --- | --- |

(10)

As stated in the application, treatment with biocidal products containing other active substances leaves residues on the treated objects that may be progressively released into the environment and pose a risk to human health. This is particularly relevant in the case of cultural objects exhibited in museums and documents available for consulting in archives and libraries.

| (11) | According to the information submitted by Germany, thermal shock processes (freezing or heat treatments) have undesired effects on a number of materials. Temperature increase or decrease may cause irreversible damage to cultural heritage objects. |
| --- | --- |

(11)

According to the information submitted by Germany, thermal shock processes (freezing or heat treatments) have undesired effects on a number of materials. Temperature increase or decrease may cause irreversible damage to cultural heritage objects.

| (12) | According to the information in the application, the use of nitrogen in cylinders is not an appropriate alternative for cultural institutions, as it presents practical disadvantages. The limited quantities in cylinders require frequent transport and a separate storage facility. Moreover, the weight capacity of the floors in some historical museum buildings might be exceeded due to the weight of the required number of cylinders. In addition, the treatment with nitrogen in cylinders does not allow the control of the relative humidity in the treatment area, which is needed for the treatment of some materials. |
| --- | --- |

(12)

According to the information in the application, the use of nitrogen in cylinders is not an appropriate alternative for cultural institutions, as it presents practical disadvantages. The limited quantities in cylinders require frequent transport and a separate storage facility. Moreover, the weight capacity of the floors in some historical museum buildings might be exceeded due to the weight of the required number of cylinders. In addition, the treatment with nitrogen in cylinders does not allow the control of the relative humidity in the treatment area, which is needed for the treatment of some materials.

| (13) | Requesting cultural institutions to use several techniques to control harmful organisms – each of them suitable for specific materials and objects – instead of using one technique already used and suitable to all materials, would involve additional costs for cultural institutions and make it more complicated for them to reach the objective of moving away from the use of more hazardous active substances in their IPM. |
| --- | --- |

(13)

Requesting cultural institutions to use several techniques to control harmful organisms – each of them suitable for specific materials and objects – instead of using one technique already used and suitable to all materials, would involve additional costs for cultural institutions and make it more complicated for them to reach the objective of moving away from the use of more hazardous active substances in their IPM.

| (14) | Discussions related to a possible derogation pursuant to Article 55(3) of Regulation (EU) No 528/2012 for in situ generated nitrogen took place in several meetings (5) of the Commission expert group of Competent Authorities for Biocidal Products in 2019. |
| --- | --- |

(14)

Discussions related to a possible derogation pursuant to Article 55(3) of Regulation (EU) No 528/2012 for in situ generated nitrogen took place in several meetings (5) of the Commission expert group of Competent Authorities for Biocidal Products in 2019.

| (15) | In addition, at the request of the Commission, following the first, similar application for derogation for products consisting of in situ generated nitrogen from Austria, the European Chemicals Agency conducted a public consultation on that application, allowing all interested parties to provide their views. The vast majority of the 1487 comments received were in favour of the derogation. Many contributors outlined the disadvantages of the alternative techniques available: thermal treatments may damage certain materials; the use of other active substances leaves toxic residues on artefacts that are progressively released to the environment; the use of nitrogen in cylinders does not allow the control of the relative humidity in the treatment area, which is needed for the treatment of some materials. |
| --- | --- |

(15)

In addition, at the request of the Commission, following the first, similar application for derogation for products consisting of in situ generated nitrogen from Austria, the European Chemicals Agency conducted a public consultation on that application, allowing all interested parties to provide their views. The vast majority of the 1487 comments received were in favour of the derogation. Many contributors outlined the disadvantages of the alternative techniques available: thermal treatments may damage certain materials; the use of other active substances leaves toxic residues on artefacts that are progressively released to the environment; the use of nitrogen in cylinders does not allow the control of the relative humidity in the treatment area, which is needed for the treatment of some materials.

| (16) | Two international organisations representing museums and cultural heritage sites – International Council of Museums and International Council on Monuments and Sites – have expressed their intention to submit an application for inclusion of in situ generated nitrogen in Annex I to Regulation (EU) No 528/2012, which would allow Member States to authorise products consisting of in situ generated nitrogen without the need for a derogation in accordance with Article 55(3) of that Regulation. However, performing the evaluation of such an application, including the substance into Annex I to Regulation (EU) No 528/2012 and obtaining product authorisations require time. |
| --- | --- |

(16)

Two international organisations representing museums and cultural heritage sites – International Council of Museums and International Council on Monuments and Sites – have expressed their intention to submit an application for inclusion of in situ generated nitrogen in Annex I to Regulation (EU) No 528/2012, which would allow Member States to authorise products consisting of in situ generated nitrogen without the need for a derogation in accordance with Article 55(3) of that Regulation. However, performing the evaluation of such an application, including the substance into Annex I to Regulation (EU) No 528/2012 and obtaining product authorisations require time.

| (17) | The application shows that no appropriate alternatives are available in Germany, since all the alternative techniques currently available present disadvantages either due to non-suitability for the treatment of all materials or practical disadvantages. |
| --- | --- |

(17)

The application shows that no appropriate alternatives are available in Germany, since all the alternative techniques currently available present disadvantages either due to non-suitability for the treatment of all materials or practical disadvantages.

| (18) | Based on all those arguments it is appropriate to conclude that in situ generated nitrogen is essential for the protection of cultural heritage in Germany and that no appropriate alternatives are available. Germany should therefore be allowed to authorise the making available on the market and use of biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage. |
| --- | --- |

(18)

Based on all those arguments it is appropriate to conclude that in situ generated nitrogen is essential for the protection of cultural heritage in Germany and that no appropriate alternatives are available. Germany should therefore be allowed to authorise the making available on the market and use of biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage.

| (19) | The possible inclusion of in situ generated nitrogen into Annex I to Regulation (EU) No 528/2012 and the subsequent authorisation by Member States of products consisting of in situ generated nitrogen requires time. It is therefore appropriate to allow a derogation for a period that would allow the completion of the underlying procedures, |
| --- | --- |

(19)

The possible inclusion of in situ generated nitrogen into Annex I to Regulation (EU) No 528/2012 and the subsequent authorisation by Member States of products consisting of in situ generated nitrogen requires time. It is therefore appropriate to allow a derogation for a period that would allow the completion of the underlying procedures,

HAS ADOPTED THIS DECISION:

Article 1

Germany may authorise the making available on the market and use of biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage until 31 December 2024.

Article 2

This Decision is addressed to the Federal Republic of Germany.

Done at Brussels, 9 September 2020.

For the Commission

Stella KYRIAKIDES

Member of the Commission

---

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

1

(2)  Commission Directive 2009/89/EC of 30 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include nitrogen as an active substance in Annex I thereto (OJ L 199, 31.7.2009, p. 19).

2

(3)  List of authorised products available at https://echa.europa.eu/fr/information-on-chemicals/biocidal-products

3

(4)  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).

4

(5)  83rd, 84th, 85th and 86th meetings of the Commission Expert Group of representatives of Member States Competent Authorities for the implementation of Regulation (EU) No 528/2012, held in May 2019, July 2019, September 2019 and November 2019, respectively. The minutes of the meetings are available at https://ec.europa.eu/health/biocides/events_en#anchor0

5

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| 11.9.2020 | EN | Official Journal of the European Union | L 297/10 |
| --- | --- | --- | --- |

11.9.2020

EN

Official Journal of the European Union

L 297/10

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COMMISSION IMPLEMENTING DECISION (EU) 2020/1266

of 9 September 2020

allowing Denmark to authorise biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage

(notified under document C(2020) 6030)

(Only the Danish text is authentic)

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 55(3) thereof,

After consulting the Standing Committee for Biocidal Products,

Whereas:

| (1) | Annex I to Regulation (EU) No 528/2012 contains active substances which have a more favourable environmental or human or animal health profile. Products containing these active substances may therefore be authorised under a simplified procedure. Nitrogen is included in Annex I to Regulation (EU) No 528/2012, subject to the restriction that it is used in limited quantities in ready-for-use canisters. |
| --- | --- |

(1)

Annex I to Regulation (EU) No 528/2012 contains active substances which have a more favourable environmental or human or animal health profile. Products containing these active substances may therefore be authorised under a simplified procedure. Nitrogen is included in Annex I to Regulation (EU) No 528/2012, subject to the restriction that it is used in limited quantities in ready-for-use canisters.

| (2) | Pursuant to Article 86 of Regulation (EU) No 528/2012, nitrogen is approved as active substance for use in biocidal products of product-type 18, insecticides (2). Biocidal products consisting of nitrogen as approved are authorised in several Member States including Denmark and are supplied in gas cylinders (3). |
| --- | --- |

(2)

Pursuant to Article 86 of Regulation (EU) No 528/2012, nitrogen is approved as active substance for use in biocidal products of product-type 18, insecticides (2). Biocidal products consisting of nitrogen as approved are authorised in several Member States including Denmark and are supplied in gas cylinders (3).

| (3) | Nitrogen can also be generated in situ from ambient air. In situ generated nitrogen is currently not approved for use in the Union and it is neither listed in Annex I to Regulation (EU) No 528/2012, nor inserted in the list of active substances included in the review programme of existing active substances in biocidal products in Annex II to Commission Delegated Regulation (EU) No 1062/2014 (4). |
| --- | --- |

(3)

Nitrogen can also be generated in situ from ambient air. In situ generated nitrogen is currently not approved for use in the Union and it is neither listed in Annex I to Regulation (EU) No 528/2012, nor inserted in the list of active substances included in the review programme of existing active substances in biocidal products in Annex II to Commission Delegated Regulation (EU) No 1062/2014 (4).

| (4) | Pursuant to Article 55(3) of Regulation (EU) No 528/2012, on 29 April 2020 Denmark submitted to the Commission an application for derogation from Article 19(1)(a) of that Regulation asking to allow it to authorise biocidal products consisting of nitrogen generated in situ from ambient air for the protection of cultural heritage (‘the application’). |
| --- | --- |

(4)

Pursuant to Article 55(3) of Regulation (EU) No 528/2012, on 29 April 2020 Denmark submitted to the Commission an application for derogation from Article 19(1)(a) of that Regulation asking to allow it to authorise biocidal products consisting of nitrogen generated in situ from ambient air for the protection of cultural heritage (‘the application’).

| (5) | Cultural heritage can be damaged by a wide range of harmful organisms, from insects to microorganisms. The presence of those organisms not only can lead to the loss of the cultural good itself, but also poses the risk of those harmful organisms being spread to other objects nearby. Without an appropriate treatment, objects could be irremediably damaged, putting the cultural heritage at serious risk. |
| --- | --- |

(5)

Cultural heritage can be damaged by a wide range of harmful organisms, from insects to microorganisms. The presence of those organisms not only can lead to the loss of the cultural good itself, but also poses the risk of those harmful organisms being spread to other objects nearby. Without an appropriate treatment, objects could be irremediably damaged, putting the cultural heritage at serious risk.

| (6) | In situ generated nitrogen is used to create a controlled atmosphere with a very low concentration of oxygen (anoxia) in permanent or temporary sealed treatment tents or chambers for the control of harmful organisms on cultural heritage objects. Nitrogen is separated from the ambient air and is pumped into the treatment tent or chamber, where the nitrogen content of the atmosphere is increased to 99 % approximately and consequently oxygen is almost completely depleted. The humidity of the nitrogen pumped into the treatment area is set according to the demands of the object to be treated. Harmful organisms cannot survive under the conditions created in the treatment tent or chamber. |
| --- | --- |

(6)

In situ generated nitrogen is used to create a controlled atmosphere with a very low concentration of oxygen (anoxia) in permanent or temporary sealed treatment tents or chambers for the control of harmful organisms on cultural heritage objects. Nitrogen is separated from the ambient air and is pumped into the treatment tent or chamber, where the nitrogen content of the atmosphere is increased to 99 % approximately and consequently oxygen is almost completely depleted. The humidity of the nitrogen pumped into the treatment area is set according to the demands of the object to be treated. Harmful organisms cannot survive under the conditions created in the treatment tent or chamber.

| (7) | According to the information in the application, the use of in situ generated nitrogen appears to be the only effective technique for the control of harmful organisms that can be used for all types of materials and combinations of materials present in cultural institutions. According to Denmark, it is the method with the least known negative and potentially damaging effects on the materials and combinations of materials of which cultural heritage objects are made. |
| --- | --- |

(7)

According to the information in the application, the use of in situ generated nitrogen appears to be the only effective technique for the control of harmful organisms that can be used for all types of materials and combinations of materials present in cultural institutions. According to Denmark, it is the method with the least known negative and potentially damaging effects on the materials and combinations of materials of which cultural heritage objects are made.

| (8) | The method of anoxia or modified or controlled atmosphere is listed in the standard EN 16790:2016 ‘Conservation of cultural heritage – Integrated pest management (IPM) for protection of cultural heritage’ and nitrogen is described in this standard as ‘most used’ for creating anoxia. |
| --- | --- |

(8)

The method of anoxia or modified or controlled atmosphere is listed in the standard EN 16790:2016 ‘Conservation of cultural heritage – Integrated pest management (IPM) for protection of cultural heritage’ and nitrogen is described in this standard as ‘most used’ for creating anoxia.

| (9) | Other techniques for the control of harmful organisms are available, such as thermal shock techniques (high or low temperatures) and use of biocidal products containing other active substances. However, according to Denmark, each of those techniques has limitations in terms of materials on which they can be applied. |
| --- | --- |

(9)

Other techniques for the control of harmful organisms are available, such as thermal shock techniques (high or low temperatures) and use of biocidal products containing other active substances. However, according to Denmark, each of those techniques has limitations in terms of materials on which they can be applied.

| (10) | As stated in the application, other active substances are seldom used in cultural institutions due to their hazard profile. After treatment with those substances, the residues on the treated objects can be progressively released into the environment, which poses a risk to human health and environment. This is particularly relevant for the cultural institutions that are open for visitors and also for the people who work with and handle cultural heritage objects. Furthermore, the use of some active substances can cause changes in colour and appearance of cultural heritage objects. |
| --- | --- |

(10)

As stated in the application, other active substances are seldom used in cultural institutions due to their hazard profile. After treatment with those substances, the residues on the treated objects can be progressively released into the environment, which poses a risk to human health and environment. This is particularly relevant for the cultural institutions that are open for visitors and also for the people who work with and handle cultural heritage objects. Furthermore, the use of some active substances can cause changes in colour and appearance of cultural heritage objects.

| (11) | According to the information in the application, thermal shock processes (freezing or heat treatments) have undesired effects on several materials. After heating treatments, oils from impregnation treatments of wooden objects can protrude to the surface leaving stains, thus changing the appearance of the objects. Waxes and resins can melt during heat treatments. Similarly, low temperature treatments could affect painted surfaces and materials containing shellac, alkyds and acrylics. The method of low temperature is considered inconvenient and less sustainable since all objects need to be tightly packed in plastic foil to avoid condensation after treatment. |
| --- | --- |

(11)

According to the information in the application, thermal shock processes (freezing or heat treatments) have undesired effects on several materials. After heating treatments, oils from impregnation treatments of wooden objects can protrude to the surface leaving stains, thus changing the appearance of the objects. Waxes and resins can melt during heat treatments. Similarly, low temperature treatments could affect painted surfaces and materials containing shellac, alkyds and acrylics. The method of low temperature is considered inconvenient and less sustainable since all objects need to be tightly packed in plastic foil to avoid condensation after treatment.

| (12) | According to the information in the application, the use of nitrogen in cylinders is not an appropriate alternative for cultural institutions, as it presents practical disadvantages. The limited quantities in cylinders require frequent transport and a separate storage facility. Furthermore the storage of cylinders poses a security challenge. The treatment with nitrogen in cylinders would also generate high costs for the cultural institutions. |
| --- | --- |

(12)

According to the information in the application, the use of nitrogen in cylinders is not an appropriate alternative for cultural institutions, as it presents practical disadvantages. The limited quantities in cylinders require frequent transport and a separate storage facility. Furthermore the storage of cylinders poses a security challenge. The treatment with nitrogen in cylinders would also generate high costs for the cultural institutions.

| (13) | Requesting cultural institutions to use several techniques to control harmful organisms – each of them suitable for specific materials and objects – instead of using one technique already used and suitable to all materials, would involve additional costs for cultural institutions and make it more complicated for them to reach the objective of moving away from the use of more hazardous active substances in their IPM. In addition, discontinuing the use of facilities and equipment acquired for in situ generated nitrogen anoxia would result in a loss of previous investments. |
| --- | --- |

(13)

Requesting cultural institutions to use several techniques to control harmful organisms – each of them suitable for specific materials and objects – instead of using one technique already used and suitable to all materials, would involve additional costs for cultural institutions and make it more complicated for them to reach the objective of moving away from the use of more hazardous active substances in their IPM. In addition, discontinuing the use of facilities and equipment acquired for in situ generated nitrogen anoxia would result in a loss of previous investments.

| (14) | Discussions related to a possible derogation pursuant to Article 55(3) of Regulation (EU) No 528/2012 for in situ generated nitrogen took place in several meetings (5) of the Commission expert group of Competent Authorities for Biocidal Products in 2019. |
| --- | --- |

(14)

Discussions related to a possible derogation pursuant to Article 55(3) of Regulation (EU) No 528/2012 for in situ generated nitrogen took place in several meetings (5) of the Commission expert group of Competent Authorities for Biocidal Products in 2019.

| (15) | In addition, at the request of the Commission, following the first, similar application for derogation for products consisting of in situ generated nitrogen from Austria, the European Chemicals Agency conducted a public consultation on that application, allowing all interested parties to provide their views. The vast majority of the 1 487 comments received were in favour of the derogation. Many contributors outlined the disadvantages of the alternative techniques available: thermal treatments may damage certain materials; the use of other active substances leaves toxic residues on artefacts that are progressively released to the environment; the use of nitrogen in cylinders does not allow the control of the relative humidity in the treatment area, which is needed for the treatment of some materials. |
| --- | --- |

(15)

In addition, at the request of the Commission, following the first, similar application for derogation for products consisting of in situ generated nitrogen from Austria, the European Chemicals Agency conducted a public consultation on that application, allowing all interested parties to provide their views. The vast majority of the 1 487 comments received were in favour of the derogation. Many contributors outlined the disadvantages of the alternative techniques available: thermal treatments may damage certain materials; the use of other active substances leaves toxic residues on artefacts that are progressively released to the environment; the use of nitrogen in cylinders does not allow the control of the relative humidity in the treatment area, which is needed for the treatment of some materials.

| (16) | Two international organisations representing museums and cultural heritage sites – International Council of Museums and International Council on Monuments and Sites – have expressed their intention to submit an application for inclusion of in situ generated nitrogen in Annex I to Regulation (EU) No 528/2012, which would allow Member States to authorise products consisting of in situ generated nitrogen without the need for a derogation in accordance with Article 55(3) of that Regulation. However, performing the evaluation of such an application, including the substance into Annex I to Regulation (EU) No 528/2012 and obtaining product authorisations require time. |
| --- | --- |

(16)

Two international organisations representing museums and cultural heritage sites – International Council of Museums and International Council on Monuments and Sites – have expressed their intention to submit an application for inclusion of in situ generated nitrogen in Annex I to Regulation (EU) No 528/2012, which would allow Member States to authorise products consisting of in situ generated nitrogen without the need for a derogation in accordance with Article 55(3) of that Regulation. However, performing the evaluation of such an application, including the substance into Annex I to Regulation (EU) No 528/2012 and obtaining product authorisations require time.

| (17) | The application shows that no appropriate alternatives are available in Denmark, since all the alternative techniques currently available present disadvantages either due to non-suitability for the treatment of all materials or practical disadvantages. |
| --- | --- |

(17)

The application shows that no appropriate alternatives are available in Denmark, since all the alternative techniques currently available present disadvantages either due to non-suitability for the treatment of all materials or practical disadvantages.

| (18) | Based on all those arguments it is appropriate to conclude that in situ generated nitrogen is essential for the protection of cultural heritage in Denmark and that no appropriate alternatives are available. Denmark should therefore be allowed to authorise the making available on the market and use of biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage. |
| --- | --- |

(18)

Based on all those arguments it is appropriate to conclude that in situ generated nitrogen is essential for the protection of cultural heritage in Denmark and that no appropriate alternatives are available. Denmark should therefore be allowed to authorise the making available on the market and use of biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage.

| (19) | The possible inclusion of in situ generated nitrogen into Annex I to Regulation (EU) No 528/2012 and the subsequent authorisation by Member States of products consisting of in situ generated nitrogen requires time. It is therefore appropriate to allow a derogation for a period that would allow the completion of the underlying procedures, |
| --- | --- |

(19)

The possible inclusion of in situ generated nitrogen into Annex I to Regulation (EU) No 528/2012 and the subsequent authorisation by Member States of products consisting of in situ generated nitrogen requires time. It is therefore appropriate to allow a derogation for a period that would allow the completion of the underlying procedures,

HAS ADOPTED THIS DECISION:

Article 1

Denmark may authorise the making available on the market and use of biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage until 31 December 2024.

Article 2

This Decision is addressed to the Kingdom of Denmark.

Done at Brussels, 9 September 2020.

For the Commission

Stella KYRIAKIDES

Member of the Commission

---

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

1

(2)  Commission Directive 2009/89/EC of 30 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include nitrogen as an active substance in Annex I thereto (OJ L 199, 31.7.2009, p. 19).

2

(3)  List of authorised products available at https://echa.europa.eu/fr/information-on-chemicals/biocidal-products

3

(4)  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).

4

(5)  83rd, 84th, 85th and 86th meetings of the Commission Expert Group of representatives of Member States Competent Authorities for the implementation of Regulation (EU) No 528/2012, held in May 2019, July 2019, September 2019 and November 2019, respectively. The minutes of the meetings are available at https://ec.europa.eu/health/biocides/events_en#anchor0

5

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