# Official Journal L 151/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 151 |
| | |
| English edition | Legislation | Volume 6612 June 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 151

English edition

Legislation

Volume 6612 June 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) 2023/1141 of 1 June 2023 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2023/1142 of 9 June 2023 amending Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 as regards the quantities that may be imported under certain tariff quotas following the agreement between the European Union and the United States of America | 5 |
| | * | Commission Implementing Regulation (EU) 2023/1143 of 9 June 2023 granting a Union authorisation for the single biocidal product Chemisept IPA-N in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 11 |
| | * | Commission Implementing Regulation (EU) 2023/1144 of 9 June 2023 granting a Union authorisation for the single biocidal product Bacticid IPA-N in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 20 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2023/1145 of 7 June 2023 amending Implementing Decision (EU) 2022/2333 concerning certain emergency measures relating to sheep pox and goat pox in Spain
  (notified under document C(2023)3806)

   (
  1
  ) | 28 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | * | Decision No 1/2023 of the Joint Committee established by the Agreement between the European Community and the United States of America of 26 May 2023 on the mutual recognition of certificates of conformity for marine equipment amending Annexes I, II and III [2023/1146] | 33 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) 2023/1141 of 1 June 2023 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2023/1142 of 9 June 2023 amending Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 as regards the quantities that may be imported under certain tariff quotas following the agreement between the European Union and the United States of America

5

*

Commission Implementing Regulation (EU) 2023/1143 of 9 June 2023 granting a Union authorisation for the single biocidal product Chemisept IPA-N in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

11

*

Commission Implementing Regulation (EU) 2023/1144 of 9 June 2023 granting a Union authorisation for the single biocidal product Bacticid IPA-N in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

20

DECISIONS

*

Commission Implementing Decision (EU) 2023/1145 of 7 June 2023 amending Implementing Decision (EU) 2022/2333 concerning certain emergency measures relating to sheep pox and goat pox in Spain
  (notified under document C(2023)3806)

   (
  1
  )

(notified under document C(2023)3806)

1

28

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

*

Decision No 1/2023 of the Joint Committee established by the Agreement between the European Community and the United States of America of 26 May 2023 on the mutual recognition of certificates of conformity for marine equipment amending Annexes I, II and III [2023/1146]

33

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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. |
| --- | --- |

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

| 12.6.2023 | EN | Official Journal of the European Union | L 151/1 |
| --- | --- | --- | --- |

12.6.2023

EN

Official Journal of the European Union

L 151/1

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COMMISSION REGULATION (EU) 2023/1141

of 1 June 2023

refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health

(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 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 18(5) thereof,

Whereas:

| (1) | Pursuant to Regulation (EC) No 1924/2006, health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in the Union list of permitted health claims. |
| --- | --- |

(1)

Pursuant to Regulation (EC) No 1924/2006, health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in the Union list of permitted health claims.

| (2) | Regulation (EC) No 1924/2006 also provides that applications for authorisation of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (‘the Authority’). |
| --- | --- |

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisation of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (‘the Authority’).

| (3) | Following the receipt of an application, the Authority is to inform without delay the other Member States and the Commission, and to deliver an opinion on the health claim concerned. |
| --- | --- |

(3)

Following the receipt of an application, the Authority is to inform without delay the other Member States and the Commission, and to deliver an opinion on the health claim concerned.

| (4) | The Commission is to decide on the authorisation of the health claim taking into account the opinion delivered by the Authority. |
| --- | --- |

(4)

The Commission is to decide on the authorisation of the health claim taking into account the opinion delivered by the Authority.

| (5) | Following an application from Nestlé S.A., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447). The claim proposed by the applicant was worded as follows: ‘Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal’. |
| --- | --- |

(5)

Following an application from Nestlé S.A., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447). The claim proposed by the applicant was worded as follows: ‘Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal’.

| (6) | On 8 April 2021, the Commission and the Member States received the scientific opinion (2) on that claim from the Authority, which concluded that, on the basis of the data presented, the effect of beta-glucans in reducing post-prandial blood glucose responses is well established. However, the evidence provided had been insufficient to establish an effect on reduction of post-prandial glycaemic responses at doses of 1,3 g beta-glucans per 25 g of available carbohydrate incorporated into ready-to-eat breakfast cereals manufactured by pressure cooking (i.e. either batch cooking or extrusion), as requested by the applicant. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
| --- | --- |

(6)

On 8 April 2021, the Commission and the Member States received the scientific opinion (2) on that claim from the Authority, which concluded that, on the basis of the data presented, the effect of beta-glucans in reducing post-prandial blood glucose responses is well established. However, the evidence provided had been insufficient to establish an effect on reduction of post-prandial glycaemic responses at doses of 1,3 g beta-glucans per 25 g of available carbohydrate incorporated into ready-to-eat breakfast cereals manufactured by pressure cooking (i.e. either batch cooking or extrusion), as requested by the applicant. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

| (7) | Following an application from Pharmactive Biotech Products, S.L., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Affron® and the contribution to the maintenance of a healthy mood (Question No EFSA-Q-2020-00617). The claim proposed by the applicant was worded as follows: ‘Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings’. |
| --- | --- |

(7)

Following an application from Pharmactive Biotech Products, S.L., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Affron® and the contribution to the maintenance of a healthy mood (Question No EFSA-Q-2020-00617). The claim proposed by the applicant was worded as follows: ‘Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings’.

| (8) | On 6 July 2021, the Commission and the Member States received the scientific opinion (3) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of Affron® and increase in positive mood. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
| --- | --- |

(8)

On 6 July 2021, the Commission and the Member States received the scientific opinion (3) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of Affron® and increase in positive mood. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

| (9) | Following an application from Praline i Cokolada j.d.o.o., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to MegaNatural®-BP grape seed extract and the maintenance of normal blood pressure (Question No EFSA-Q-2020-00718). The claim proposed by the applicant was worded as follows: ‘MegaNatural®-BP helps maintain healthy blood pressure’. |
| --- | --- |

(9)

Following an application from Praline i Cokolada j.d.o.o., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to MegaNatural®-BP grape seed extract and the maintenance of normal blood pressure (Question No EFSA-Q-2020-00718). The claim proposed by the applicant was worded as follows: ‘MegaNatural®-BP helps maintain healthy blood pressure’.

| (10) | On 9 August 2021, the Commission and the Member States received the scientific opinion (4) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of MegaNatural®-BP, a grape seed extract standardised for total phenolics, gallic acid and the sum of catechin and epicatechin content, and maintenance of normal blood pressure. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
| --- | --- |

(10)

On 9 August 2021, the Commission and the Member States received the scientific opinion (4) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided had been insufficient to establish a cause and effect relationship between the consumption of MegaNatural®-BP, a grape seed extract standardised for total phenolics, gallic acid and the sum of catechin and epicatechin content, and maintenance of normal blood pressure. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

| (11) | Following an application from Sensus B.V. (Royal Cosun), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Frutalose® and the maintenance of normal defecation (Question No EFSA-Q-2020-00631). The claim proposed by the applicant was worded as follows: ‘Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency’. The applicant also provided three alternative wordings for the claim. |
| --- | --- |

(11)

Following an application from Sensus B.V. (Royal Cosun), submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on the scientific substantiation of a health claim related to Frutalose® and the maintenance of normal defecation (Question No EFSA-Q-2020-00631). The claim proposed by the applicant was worded as follows: ‘Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency’. The applicant also provided three alternative wordings for the claim.

| (12) | On 12 August 2021, the Commission and the Member States received the scientific opinion (5) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Frutalose® and the maintenance of normal defecation under the proposed conditions of use. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised. |
| --- | --- |

(12)

On 12 August 2021, the Commission and the Member States received the scientific opinion (5) on that claim from the Authority, which concluded that, on the basis of the data presented, the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Frutalose® and the maintenance of normal defecation under the proposed conditions of use. Accordingly, as the health claim does not comply with the requirements of Regulation (EC) No 1924/2006 for the inclusion in the Union list of permitted health claims, it should not be authorised.

| (13) | The comments by Nestlé S.A. on the Authority’s opinion on the health claim relating to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447), received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006, have been considered when adopting this Regulation. |
| --- | --- |

(13)

The comments by Nestlé S.A. on the Authority’s opinion on the health claim relating to beta-glucans sourced from oats and/or barley in ready-to-eat breakfast cereals manufactured via pressure cooking and to the reduction of blood glucose rise after consumption (Question No EFSA-Q-2020-000447), received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006, have been considered when adopting this Regulation.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(14)

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

The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted health claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.

Article 2

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, 1 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 404, 30.12.2006, p. 9.

1

(2)  
  EFSA Journal 2021;19(4):6493.

2

EFSA Journal

(3)  
  EFSA Journal 2021;19(7):6669.

3

EFSA Journal

(4)  
  EFSA Journal 2021;19(8):6776.

4

EFSA Journal

(5)  
  EFSA Journal 2021;19(8):6775.

5

EFSA Journal

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ANNEX

Rejected health claims

| Application – Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
| --- | --- | --- | --- |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Beta-glucans sourced from oats and/or barley, incorporated into ready-to-eat breakfast cereals manufactured via pressure cooking (i.e. either by batch cooking or extrusion), and present at a level of at least 1,3 g per 25 g available carbohydrate in the ready-to-eat cereal | Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal | Q-2020-000447 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Affron®, aqueous saffron extract, with the sum of crocins and safranal concentration > 3,5 % and dextrin as inert carrier | Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings | Q-2020-00617 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | MegaNatural®-BP grape seed extract made entirely of California-grown grapes containing biologically active constituents: total phenolics (90–93 %), gallic acid (≥ 2 %) and catechin and epicatechin (≥ 5 %). The distribution of phenolic compounds in the MegaNatural®-BP is on average 9 % monomers, 69 % oligomers and 22 % polymers | MegaNatural®-BP helps maintain healthy blood pressure | Q-2020-00718 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Frutalose® chicory oligofructose | Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency
  (And three other alternative wordings) | Q-2020-00631 |

Application – Relevant provisions of Regulation (EC) No 1924/2006

Nutrient, substance, food or food category

Claim

EFSA opinion reference

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Beta-glucans sourced from oats and/or barley, incorporated into ready-to-eat breakfast cereals manufactured via pressure cooking (i.e. either by batch cooking or extrusion), and present at a level of at least 1,3 g per 25 g available carbohydrate in the ready-to-eat cereal

Consumption of beta-glucans from oats and/or barley in a ready-to-eat breakfast cereal contributes to a reduction of the blood glucose rise after that meal

Q-2020-000447

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Affron®, aqueous saffron extract, with the sum of crocins and safranal concentration > 3,5 % and dextrin as inert carrier

Affron® contributes to maintain a healthy mood by reducing the negative traits of depressive and anxiety feelings

Q-2020-00617

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

MegaNatural®-BP grape seed extract made entirely of California-grown grapes containing biologically active constituents: total phenolics (90–93 %), gallic acid (≥ 2 %) and catechin and epicatechin (≥ 5 %). The distribution of phenolic compounds in the MegaNatural®-BP is on average 9 % monomers, 69 % oligomers and 22 % polymers

MegaNatural®-BP helps maintain healthy blood pressure

Q-2020-00718

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Frutalose® chicory oligofructose

Frutalose® chicory oligofructose contributes to regular bowel function by increasing stool frequency

(And three other alternative wordings)

Q-2020-00631

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| 12.6.2023 | EN | Official Journal of the European Union | L 151/5 |
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12.6.2023

EN

Official Journal of the European Union

L 151/5

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/1142

of 9 June 2023

amending Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 as regards the quantities that may be imported under certain tariff quotas following the agreement between the European Union and the United States of America

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 187 thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2020/761 (2) lays down the rules for the management of import and export tariff quotas for agricultural products managed by a system of import and export licences and provides for specific rules. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) 2020/761 (2) lays down the rules for the management of import and export tariff quotas for agricultural products managed by a system of import and export licences and provides for specific rules.

| (2) | Commission Implementing Regulation (EU) 2020/1988 (3) lays down the rules for the administration of import tariff quotas designed to be used following the chronological order of dates of acceptance of customs declarations (‘first come, first served’ principle). |
| --- | --- |

(2)

Commission Implementing Regulation (EU) 2020/1988 (3) lays down the rules for the administration of import tariff quotas designed to be used following the chronological order of dates of acceptance of customs declarations (‘first come, first served’ principle).

| (3) | The Agreement between the European Union and the United States of America pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff rate quotas included in the EU Schedule CLXXV as a consequence of the United Kingdom`s withdrawal from the European Union, concluded by Council Decision (EU) 2023/912 (4), amends the quantities of products to be imported under some tariff quotas opened in favour of the United States and some tariff quotas opened for all other countries. The tariff quotas with following order numbers are concerned: 09.0035, 09.0040, 09.0041, 09.0055, 09.0056, 09.0059, 09.0070, 09.0073, 09.0083, 09.0089, 09.0093, 09.0094, 09.0123, 09.0147, 09.4002, 09.4038, 09.4116, 09.4123, 09.4127 and 09.4170. |
| --- | --- |

(3)

The Agreement between the European Union and the United States of America pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff rate quotas included in the EU Schedule CLXXV as a consequence of the United Kingdom`s withdrawal from the European Union, concluded by Council Decision (EU) 2023/912 (4), amends the quantities of products to be imported under some tariff quotas opened in favour of the United States and some tariff quotas opened for all other countries. The tariff quotas with following order numbers are concerned: 09.0035, 09.0040, 09.0041, 09.0055, 09.0056, 09.0059, 09.0070, 09.0073, 09.0083, 09.0089, 09.0093, 09.0094, 09.0123, 09.0147, 09.4002, 09.4038, 09.4116, 09.4123, 09.4127 and 09.4170.

| (4) | The amendments made by that Agreement should be reflected in Annexes to Implementing Regulations (EU) 2020/761 and (EU) 2020/1988. |
| --- | --- |

(4)

The amendments made by that Agreement should be reflected in Annexes to Implementing Regulations (EU) 2020/761 and (EU) 2020/1988.

| (5) | Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 should therefore be amended accordingly. |
| --- | --- |

(5)

Implementing Regulations (EU) 2020/761 and (EU) 2020/1988 should therefore be amended accordingly.

| (6) | Transitional provisions are needed to clarify how to handle the situations that may arise as a result of the amendments of quantities of products to be imported under the tariff quotas concerned. This concerns tariff quotas that are managed in periods divided into sub-periods. It also concerns tariff quotas that are managed in accordance with the first come, first served principle, where the amendment of quantities leads to either an increase of the quantity of a tariff quota that was exhausted or to a decrease of the available quantity of a tariff quota for products that were already released for free circulation in the Union. |
| --- | --- |

(6)

Transitional provisions are needed to clarify how to handle the situations that may arise as a result of the amendments of quantities of products to be imported under the tariff quotas concerned. This concerns tariff quotas that are managed in periods divided into sub-periods. It also concerns tariff quotas that are managed in accordance with the first come, first served principle, where the amendment of quantities leads to either an increase of the quantity of a tariff quota that was exhausted or to a decrease of the available quantity of a tariff quota for products that were already released for free circulation in the Union.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Implementing Regulation (EU) 2020/761

Annexes II, III, VIII, and X are amended in accordance with Annex I to this Regulation.

Article 2

Amendment to Implementing Regulation (EU) 2020/1988

Annex I is amended in accordance with Annex II to this Regulation.

Article 3

Transitional provisions

1.   With regard to the amendments introduced by Article 1, where the tariff quota period of a given tariff quota has already started on the day of entry into force of this Regulation, the difference between the new quantity and the quantity already allocated shall be made available:

| (a) | from the first application period after the entry into force of this Regulation, if the tariff quota period is not divided into sub-periods; |
| --- | --- |

(a)

from the first application period after the entry into force of this Regulation, if the tariff quota period is not divided into sub-periods;

| (b) | according to the specific rules applicable to each tariff quota, if the tariff quota has a period divided in sub-periods. |
| --- | --- |

(b)

according to the specific rules applicable to each tariff quota, if the tariff quota has a period divided in sub-periods.

If one or more sub-periods have already expired at the moment of the entry into force of this Regulation, the difference between the new quantity available in the sub-periods expired before the entry into force of this Regulation and the quantity actually allocated shall be made available as from the first application period after the entry into force of this Regulation.

2.   With regard to the amendments introduced by Article 2, the difference between the new quantity and the quantity already released for free circulation before the entry into force of this Regulation shall be made available from the day of entry into force of this Regulation.

In case of an increase of the quantity set out in Annex I to Implementing Regulation (EU) 2020/1988, if on the day of entry into force of this Regulation the relevant tariff quota period has already started and the quantity previously available is exhausted, the difference between the new quantity and the previous quantity shall be allocated to operators following the chronological order of the acceptance date of the customs declaration for release for free circulation. Operators who imported their goods out of quota before the entry into force of this Regulation, and who will benefit of the allocation of the additional quantity, shall be reimbursed the difference between the duty already paid and the in-quota duty.

In case of a decrease of the quantity set out in Annex I to Implementing Regulation (EU) 2020/1988, if on the day of entry into force of this Regulation the relevant tariff quota period has already started and a quantity higher than the new one has already been released for free circulation, operators shall not be required to pay any additional duty for the in-quota quantities imported exceeding the new available volumes.

Article 4

Entry into force and application

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

Official Journal of the European Union

Article 1 shall apply from the first licence application period starting after the entry into force of this Regulation.

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

Done at Brussels, 9 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 347, 20.12.2013, p. 671.

1

(2)  Commission Implementing Regulation (EU) 2020/761 of 17 December 2019 laying down rules for the application of Regulations (EU) No 1306/2013, (EU) No 1308/2013 and (EU) No 510/2014 of the European Parliament and of the Council as regards the management system of tariff quotas with licences (OJ L 185, 12.6.2020, p. 24).

2

(3)  Commission Implementing Regulation (EU) 2020/1988 of 11 November 2020 laying down rules for the application of Regulations (EU) No 1308/2013 and (EU) No 510/2014 of the European Parliament and of the Council as regards the administration of import tariff quotas in accordance with the ‘first come, first served’ principle (OJ L 422, 14.12.2020, p. 4).

3

(4)  Council Decision (EU) 2023/912 of 25 April 2023 on the conclusion, on behalf of the Union, of the Agreement between the European Union and the United States of America pursuant to Article XXVIII of the General Agreement on Tariffs and Trade (GATT) 1994 relating to the modification of concessions on all the tariff rate quotas included in the EU schedule CLXXV as a consequence of the United Kingdom’s withdrawal from the European Union (OJ L 119, 5.5.2023, p. 1).

4

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ANNEX I

Annexes I, II, III, VIII, and X to Implementing Regulation (EU) 2020/761 are amended as follows:

| (1) | in Annex I, the row relating to the tariff quota with order number 09.4170 is deleted; |
| --- | --- |

(1)

in Annex I, the row relating to the tariff quota with order number 09.4170 is deleted;

| (2) | in Annex II, in the table relating to the tariff quota with order number 09.4123, the row ‘Quantity in kg’ is replaced by the following:






  ‘Quantity in kg | 572 000 000 kg’ |
| --- | --- | --- |

(2)

in Annex II, in the table relating to the tariff quota with order number 09.4123, the row ‘Quantity in kg’ is replaced by the following:

‘Quantity in kg

572 000 000 kg’

| (3) | Annex III is amended as follows:






  (a) | in the table relating to the tariff quota with order number 09.4116, the row ‘Quantity in kg’ is replaced by the following:






  ‘Quantity in kg | 1 910 000 kg, divided as follows:
  1 910 000 kg for sub-period 1 January to 30 June
  Carry over from previous sub-periods, for sub-period 1 July to 31 August
  Carry over from previous sub-periods, for sub-period 1 September to 31 December’ |
| --- | --- | --- | --- |

(3)

Annex III is amended as follows:

(a)

in the table relating to the tariff quota with order number 09.4116, the row ‘Quantity in kg’ is replaced by the following:

‘Quantity in kg

1 910 000 kg, divided as follows:

1 910 000 kg for sub-period 1 January to 30 June

Carry over from previous sub-periods, for sub-period 1 July to 31 August

Carry over from previous sub-periods, for sub-period 1 September to 31 December’

| (b) | in the table relating to the tariff quota with order number 09.4127, the row ‘Quantity in kg’ is replaced by the following:






  ‘Quantity in kg | 25 772 000 kg, divided as follows:
  7 153 000 kg for sub-period 1 January to 31 March
  11 466 000 kg for sub-period 1 April to 30 June
  7 153 000 kg for sub-period 1 July to 31 August
  Carry over from previous sub-periods, for sub-period 1 September to 30 September’ |
| --- | --- | --- |

(b)

in the table relating to the tariff quota with order number 09.4127, the row ‘Quantity in kg’ is replaced by the following:

‘Quantity in kg

25 772 000 kg, divided as follows:

7 153 000 kg for sub-period 1 January to 31 March

11 466 000 kg for sub-period 1 April to 30 June

7 153 000 kg for sub-period 1 July to 31 August

Carry over from previous sub-periods, for sub-period 1 September to 30 September’

| (4) | in Annex VIII, in the table relating to the tariff quota with order number 09.4002, the row ‘Quantity in kg’ is replaced by the following:






  ‘Quantity in kg | 10 500 000 kg product weight, divided as follows: the quantity available for each sub-period shall correspond to one twelfth of the total quantity’ |
| --- | --- | --- |

(4)

in Annex VIII, in the table relating to the tariff quota with order number 09.4002, the row ‘Quantity in kg’ is replaced by the following:

‘Quantity in kg

10 500 000 kg product weight, divided as follows: the quantity available for each sub-period shall correspond to one twelfth of the total quantity’

| (5) | Annex X is amended as follows:






  (a) | in the table relating to the tariff quota with order number 09.4038, the row ‘Quantity in kg’ is replaced by the following:






  ‘Quantity in kg | 5 720 000 kg product weight, divided as follows: 25 % for each sub-period’ |
| --- | --- | --- | --- |

(5)

Annex X is amended as follows:

(a)

in the table relating to the tariff quota with order number 09.4038, the row ‘Quantity in kg’ is replaced by the following:

‘Quantity in kg

5 720 000 kg product weight, divided as follows: 25 % for each sub-period’

| (b) | the table relating to the tariff quota with order number 09.4170 is deleted. |
| --- | --- |

(b)

the table relating to the tariff quota with order number 09.4170 is deleted.

---

ANNEX II

Annex I to Implementing Regulation (EU) 2020/1988 is amended as follows:

| (1) | the section under the heading ‘Tariff quotas in the sector of cereals’ is amended as follows:






  (a) | in the table relating to the tariff quota with order number 09.0073, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 2 800 000 kg net weight’ |
| --- | --- | --- | --- |

(1)

the section under the heading ‘Tariff quotas in the sector of cereals’ is amended as follows:

(a)

in the table relating to the tariff quota with order number 09.0073, the row ‘Quantity’ is replaced by the following:

‘Quantity

2 800 000 kg net weight’

| (b) | in the table relating to the tariff quota with order number 09.0089, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 1 732 000 kg net weight’ |
| --- | --- | --- |

(b)

in the table relating to the tariff quota with order number 09.0089, the row ‘Quantity’ is replaced by the following:

‘Quantity

1 732 000 kg net weight’

| (c) | in the table relating to the tariff quota with order number 09.0070, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 2 700 000 kg net weight’ |
| --- | --- | --- |

(c)

in the table relating to the tariff quota with order number 09.0070, the row ‘Quantity’ is replaced by the following:

‘Quantity

2 700 000 kg net weight’

| (2) | in the section under the heading ‘Tariff quotas in the sector of rice’, in the table relating to the tariff quota with order number 09.0083, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 7 000 kg’ |
| --- | --- | --- |

(2)

in the section under the heading ‘Tariff quotas in the sector of rice’, in the table relating to the tariff quota with order number 09.0083, the row ‘Quantity’ is replaced by the following:

‘Quantity

7 000 kg’

| (3) | the section under the heading ‘Tariff quotas in the sector of fruits and vegetables’ is amended as follows:






  (a) | in the table relating to the tariff quota with order number 09.0094, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 472 000 kg’ |
| --- | --- | --- | --- |

(3)

the section under the heading ‘Tariff quotas in the sector of fruits and vegetables’ is amended as follows:

(a)

in the table relating to the tariff quota with order number 09.0094, the row ‘Quantity’ is replaced by the following:

‘Quantity

472 000 kg’

| (b) | in the table relating to the tariff quota with order number 09.0056, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 1 244 000 kg’ |
| --- | --- | --- |

(b)

in the table relating to the tariff quota with order number 09.0056, the row ‘Quantity’ is replaced by the following:

‘Quantity

1 244 000 kg’

| (c) | in the table relating to the tariff quota with order number 09.0059, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 647 000 kg’ |
| --- | --- | --- |

(c)

in the table relating to the tariff quota with order number 09.0059, the row ‘Quantity’ is replaced by the following:

‘Quantity

647 000 kg’

| (d) | in the table relating to the tariff quota with order number 09.0035, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 9 770 000 kg’ |
| --- | --- | --- |

(d)

in the table relating to the tariff quota with order number 09.0035, the row ‘Quantity’ is replaced by the following:

‘Quantity

9 770 000 kg’

| (e) | in the table relating to the tariff quota with order number 09.0040, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 151 000 kg’ |
| --- | --- | --- |

(e)

in the table relating to the tariff quota with order number 09.0040, the row ‘Quantity’ is replaced by the following:

‘Quantity

151 000 kg’

| (f) | in the table relating to the tariff quota with order number 09.0041, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 86 223 000 kg’ |
| --- | --- | --- |

(f)

in the table relating to the tariff quota with order number 09.0041, the row ‘Quantity’ is replaced by the following:

‘Quantity

86 223 000 kg’

| (4) | in the section under the heading ‘Tariff quotas in the sector of processed fruits and vegetables’, in the table relating to the tariff quota with order number 09.0093, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 6 551 000 kg’ |
| --- | --- | --- |

(4)

in the section under the heading ‘Tariff quotas in the sector of processed fruits and vegetables’, in the table relating to the tariff quota with order number 09.0093, the row ‘Quantity’ is replaced by the following:

‘Quantity

6 551 000 kg’

| (5) | in the section under the heading ‘Tariff quotas in the sector of milk and milk products’, in the table relating to the tariff quota with order number 09.0147, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 62 917 000 kg’ |
| --- | --- | --- |

(5)

in the section under the heading ‘Tariff quotas in the sector of milk and milk products’, in the table relating to the tariff quota with order number 09.0147, the row ‘Quantity’ is replaced by the following:

‘Quantity

62 917 000 kg’

| (6) | in the section under the heading ‘Tariff quotas in the sector of pigmeat’, in the table relating to the tariff quota with order number 09.0123, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 4 786 000 kg’ |
| --- | --- | --- |

(6)

in the section under the heading ‘Tariff quotas in the sector of pigmeat’, in the table relating to the tariff quota with order number 09.0123, the row ‘Quantity’ is replaced by the following:

‘Quantity

4 786 000 kg’

| (7) | in the section under the heading ‘Tariff quotas in the sector of other products listed in Section 2 of Part XXIV of Annex I to Regulation (EU) No 1308/2013’, in the table relating to the tariff quota with order number 09.0055, the row ‘Quantity’ is replaced by the following:






  ‘Quantity | 4 295 000 kg’ |
| --- | --- | --- |

(7)

in the section under the heading ‘Tariff quotas in the sector of other products listed in Section 2 of Part XXIV of Annex I to Regulation (EU) No 1308/2013’, in the table relating to the tariff quota with order number 09.0055, the row ‘Quantity’ is replaced by the following:

‘Quantity

4 295 000 kg’

---

| 12.6.2023 | EN | Official Journal of the European Union | L 151/11 |
| --- | --- | --- | --- |

12.6.2023

EN

Official Journal of the European Union

L 151/11

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1143

of 9 June 2023

granting a Union authorisation for the single biocidal product ‘Chemisept IPA-N’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(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 44(5), first subparagraph, thereof,

Whereas:

| (1) | On 24 April 2019, AS Chemi-Pharm submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Chemisept IPA-N’, of product-type 1, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-UU051173-14 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22. |
| --- | --- |

(1)

On 24 April 2019, AS Chemi-Pharm submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Chemisept IPA-N’, of product-type 1, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-UU051173-14 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22.

| (2) | The same single biocidal product ‘Chemisept IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1. |
| --- | --- |

(2)

The same single biocidal product ‘Chemisept IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 1.

| (3) | On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Chemisept IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. |
| --- | --- |

(3)

On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Chemisept IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

| (4) | The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

| (5) | On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(5)

On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Chemisept IPA-N’. |
| --- | --- |

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Chemisept IPA-N’.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027678-0000 is granted to AS Chemi-Pharm for the making available on the market and use of the same single biocidal product ‘Chemisept IPA-N’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 2 July 2023 until 31 July 2032.

Article 2

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, 9 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 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 (OJ L 125, 7.5.2013, p. 4).

2

(3)  ECHA opinion for ‘Chemisept IPA-N’, 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation

3

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

4

---

ANNEX

Summary of product characteristics for a biocidal product

Chemisept IPA-N

Product type 1 – Human hygiene (Disinfectants)

Authorisation number: EU-0027678-0000

R4BP asset number: EU-0027678-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

| Trade name(s) | Chemisept IPA-N |
| --- | --- |

Trade name(s)

Chemisept IPA-N

1.2.   Authorisation holder

| Name and address of the authorisation holder | Name | Chemi-Pharm AS |
| --- | --- | --- |
| Address | Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia |
| Authorisation number | EU-0027678-0000 |
| R4BP asset number | EU-0027678-0000 |
| Date of the authorisation | 2.7.2023 |
| Expiry date of the authorisation | 31.7.2032 |

Name and address of the authorisation holder

Name

Chemi-Pharm AS

Address

Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia

Authorisation number

EU-0027678-0000

R4BP asset number

EU-0027678-0000

Date of the authorisation

2.7.2023

Expiry date of the authorisation

31.7.2032

1.3.   Manufacturer(s) of the product

| Name of manufacturer | AS Chemi-Pharm |
| --- | --- |
| Address of manufacturer | Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
| Location of manufacturing sites | AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |

Name of manufacturer

AS Chemi-Pharm

Address of manufacturer

Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia

Location of manufacturing sites

AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia

1.4.   Manufacturer(s) of the active substance(s)

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | OQ Chemicals GmbH (formerly Oxea GmbH) |
| Address of manufacturer | Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
| Location of manufacturing sites | OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States |

Active substance

Propan-1-ol

Name of manufacturer

OQ Chemicals GmbH (formerly Oxea GmbH)

Address of manufacturer

Rheinpromenade 4a, 40789 Monheim am Rhein Germany

Location of manufacturing sites

OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | BASF SE |
| Address of manufacturer | Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
| Location of manufacturing sites | BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |

Active substance

Propan-1-ol

Name of manufacturer

BASF SE

Address of manufacturer

Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany

Location of manufacturing sites

BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | SASOL Chemie GmbH & Co. KG |
| Address of manufacturer | Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa |
| Location of manufacturing sites | Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa |

Active substance

Propan-1-ol

Name of manufacturer

SASOL Chemie GmbH & Co. KG

Address of manufacturer

Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa

Location of manufacturing sites

Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | INEOS Solvent Germany GmbH |
| Address of manufacturer | Römerstrasse 733, 47443 Moers Germany |
| Location of manufacturing sites | INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany
  INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany |

Active substance

Propan-2-ol

Name of manufacturer

INEOS Solvent Germany GmbH

Address of manufacturer

Römerstrasse 733, 47443 Moers Germany

Location of manufacturing sites

INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany

INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany

2.   PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Propan-1-ol | | Active Substance | 71-23-8 | 200-746-9 | 30,0 |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 45,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-1-ol

Active Substance

71-23-8

200-746-9

30,0

Propan-2-ol

Active Substance

67-63-0

200-661-7

45,0

2.2.   Type of formulation

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS

| Hazard statements | Flammable liquid and vapour.
  Causes serious eye damage.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Keep container tightly closed.
  Avoid breathing vapours.
  Use only outdoors or in a well-ventilated area.
  IF INHALED:Remove person to fresh air and keep comfortable for breathing.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER/doctor.
  Store in a well-ventilated place.Keep cool.
  Store locked up.
  Dispose of container to an authorised waste collection point. |

Hazard statements

Flammable liquid and vapour.

Causes serious eye damage.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

Keep container tightly closed.

Avoid breathing vapours.

Use only outdoors or in a well-ventilated area.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER/doctor.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of container to an authorised waste collection point.

4.   AUTHORISED USE(S)

4.1.   Use description

Table 1

Use # 1 – hygienic handrub, liquid

| Product type | PT01 – Human hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: no data
  Common name: Bacteria
  Development stage: no data
  Scientific name: no data
  Common name: Mycobacteria
  Development stage: no data
  Scientific name: no data
  Common name: Yeasts
  Development stage: no data
  Scientific name: no data
  Common name: Enveloped viruses
  Development stage: no data |
| Field(s) of use | Indoor






  — | hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients) |

Product type

PT01 – Human hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: no data

Common name: Bacteria

Development stage: no data

Scientific name: no data

Common name: Mycobacteria

Development stage: no data

Scientific name: no data

Common name: Yeasts

Development stage: no data

Scientific name: no data

Common name: Enveloped viruses

Development stage: no data

Field(s) of use

Indoor

—

hospitals and other health care institutions, ambulances, surgeries, nursing homes (including home-care of patients)

| — | hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands |
| --- | --- |

—

hospital canteens, large kitchens, pharmaceutical industries, production sites, laboratories: hygienic handrub onto visibly clean and dry hands

| — | for professional use only |
| --- | --- |

—

for professional use only

Application method(s)

Method: Manual application

Detailed description:

Rubbing

Application rate(s) and frequency

Application Rate: Dosage: At least 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml) Contact time: 30 s

Dilution (%): Ready-to-use product

Number and timing of application:

There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases.

The product may be used at any time and as often as required.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps;

5 000 ml transparent/white HDPE canister with HDPE screwed cap.

4.1.1.   Use-specific instructions for use

The products can be applied directly or the products can be used in a dispenser or with a pump.

For hygienic handrub use 3 ml of product and keep hands wet for 30 seconds.

Do not refill.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

4.2.   Use description

Table 2

Use # 2 – surgical handrub, liquid

| Product type | PT01 – Human hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: no data
  Common name: Bacteria
  Development stage: no data
  Scientific name: no data
  Common name: Mycobacteria
  Development stage: no data
  Scientific name: no data
  Common name: Yeasts
  Development stage: no data
  Scientific name: no data
  Common name: enveloped viruses
  Development stage: no data |
| Field(s) of use | Indoor
  Hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.
  For professional use only. |
| Application method(s) | Method: Manual application
  Detailed description:
  Rubbing |
| Application rate(s) and frequency | Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact time: 90 s
  Dilution (%): Ready-to-use product
  Number and timing of application:
  There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases.
  The product may be used at any time and as often as required. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps;
  5 000 ml transparent/white HDPE canister with HDPE screwed cap. |

Product type

PT01 – Human hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: no data

Common name: Bacteria

Development stage: no data

Scientific name: no data

Common name: Mycobacteria

Development stage: no data

Scientific name: no data

Common name: Yeasts

Development stage: no data

Scientific name: no data

Common name: enveloped viruses

Development stage: no data

Field(s) of use

Indoor

Hospitals and other health care institutions: surgical handrub onto visibly clean and dry hands and forearms.

For professional use only.

Application method(s)

Method: Manual application

Detailed description:

Rubbing

Application rate(s) and frequency

Application Rate: Dosage: Rub sufficient amount in portions of 3 ml (use dispensers: for example set to 1,5 ml per stroke, 2 strokes per 3 ml). Contact time: 90 s

Dilution (%): Ready-to-use product

Number and timing of application:

There is no restriction in the number and timing of applications. No safety intervals need to be considered between the application phases.

The product may be used at any time and as often as required.

Category(ies) of users

Professional

Pack sizes and packaging material

100, 125, 500, 1 000 ml in transparent/white high-density polyethylene (HDPE) bottles with polypropylene (PP) flip top caps;

5 000 ml transparent/white HDPE canister with HDPE screwed cap.

4.2.1.   Use-specific instructions for use

The products can be applied directly or the products can be used in a dispenser or with a pump.

For surgical handrub use as many portions of 3 ml as necessary to keep hands wet for 90 seconds.

Do not refill.

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use

For professional use only.

5.2.   Risk mitigation measures

Avoid contact with eyes.

Keep out of reach of children.

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

Information to Healthcare personnel/doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Accidental release measures:

Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.

Prevent entry to sewers and public waters.

Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.

Recommended storage temperature: 0– 30 °C

Do not store at temperatures below 0 °C

Do not store near food, drink and animal feedingstuff. Keep away from combustible material.

6.   OTHER INFORMATION

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

---

| 12.6.2023 | EN | Official Journal of the European Union | L 151/20 |
| --- | --- | --- | --- |

12.6.2023

EN

Official Journal of the European Union

L 151/20

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1144

of 9 June 2023

granting a Union authorisation for the single biocidal product ‘Bacticid IPA-N’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(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 44(5), first subparagraph, thereof,

Whereas:

| (1) | On 24 April 2019, Chemi-Pharm AS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Bacticid IPA-N’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-SM051156-28 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22. |
| --- | --- |

(1)

On 24 April 2019, Chemi-Pharm AS submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal product, as referred to in Article 1 of that Regulation, named ‘Bacticid IPA-N’, of product-types 2 and 4, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-SM051156-28 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference biocidal product family ‘Knieler & Team Propanol Family’, recorded in the Register under case number BC-AQ050985-22.

| (2) | The same single biocidal product ‘Bacticid IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. |
| --- | --- |

(2)

The same single biocidal product ‘Bacticid IPA-N’ contains propan-1-ol and propan-2-ol as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

| (3) | On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Bacticid IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013. |
| --- | --- |

(3)

On 8 December 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of ‘Bacticid IPA-N’ in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.

| (4) | The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion concludes that the proposed differences between the same single biocidal product and the related reference biocidal product are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), and that based on the assessment of the related reference biocidal product family ‘Knieler & Team Propanol Family’ and subject to compliance with the draft SPC, the same single biocidal product meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.

| (5) | On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(5)

On 24 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Bacticid IPA-N’. |
| --- | --- |

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘Bacticid IPA-N’.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027679-0000 is granted to Chemi-Pharm AS for the making available on the market and use of the same single biocidal product ‘Bacticid IPA-N’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 2 July 2023 until 31 July 2032.

Article 2

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, 9 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 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 (OJ L 125, 7.5.2013, p. 4).

2

(3)  ECHA opinion for ‘Bacticid IPA-N’, 8 December 2021, https://echa.europa.eu/opinions-on-union-authorisation

3

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

4

---

ANNEX

Summary of product characteristics for a biocidal product

Bacticid IPA-N

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0027679-0000

R4BP asset number: EU-0027679-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

| Trade name(s) | Bacticid IPA-N |
| --- | --- |

Trade name(s)

Bacticid IPA-N

1.2.   Authorisation holder

| Name and address of the authorisation holder | Name | Chemi-Pharm AS |
| --- | --- | --- |
| Address | Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia |
| Authorisation number | EU-0027679-0000 |
| R4BP asset number | EU-0027679-0000 |
| Date of the authorisation | 2.7.2023 |
| Expiry date of the authorisation | 31.7.2032 |

Name and address of the authorisation holder

Name

Chemi-Pharm AS

Address

Tänassilma tee 11, 76406 Tänassilma küla, Saku vald Estonia

Authorisation number

EU-0027679-0000

R4BP asset number

EU-0027679-0000

Date of the authorisation

2.7.2023

Expiry date of the authorisation

31.7.2032

1.3.   Manufacturer(s) of the product

| Name of manufacturer | AS Chemi-Pharm |
| --- | --- |
| Address of manufacturer | Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |
| Location of manufacturing sites | AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia |

Name of manufacturer

AS Chemi-Pharm

Address of manufacturer

Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia

Location of manufacturing sites

AS Chemi-Pharm, Tänassilma tee 11, 76406 Tänassilma küla, Saku vald, Harju maakond Estonia

1.4.   Manufacturer(s) of the active substance(s)

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | OQ Chemicals GmbH (formerly Oxea GmbH) |
| Address of manufacturer | Rheinpromenade 4a, 40789 Monheim am Rhein Germany |
| Location of manufacturing sites | OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States |

Active substance

Propan-1-ol

Name of manufacturer

OQ Chemicals GmbH (formerly Oxea GmbH)

Address of manufacturer

Rheinpromenade 4a, 40789 Monheim am Rhein Germany

Location of manufacturing sites

OQ Chemicals Corperation (formerly Oxea Coperation), 2001 FM 3057 TX, 77414 Bay City United States

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | BASF SE |
| Address of manufacturer | Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |
| Location of manufacturing sites | BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany |

Active substance

Propan-1-ol

Name of manufacturer

BASF SE

Address of manufacturer

Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany

Location of manufacturing sites

BASF SE, Carl-Bosch-Str. 38, 67056 Ludwigshafen Germany

| Active substance | Propan-1-ol |
| --- | --- |
| Name of manufacturer | SASOL Chemie GmbH & Co. KG |
| Address of manufacturer | Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa |
| Location of manufacturing sites | Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa |

Active substance

Propan-1-ol

Name of manufacturer

SASOL Chemie GmbH & Co. KG

Address of manufacturer

Secunda Chemical Operations, Sasol Place, 50 Katherine Street, 2090 Sandton South Africa

Location of manufacturing sites

Secunda Chemical Operations, PDP Kruger Street, 2302 Secunda South Africa

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | INEOS Solvent Germany GmbH |
| Address of manufacturer | Römerstrasse 733, 47443 Moers Germany |
| Location of manufacturing sites | INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany
  INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany |

Active substance

Propan-2-ol

Name of manufacturer

INEOS Solvent Germany GmbH

Address of manufacturer

Römerstrasse 733, 47443 Moers Germany

Location of manufacturing sites

INEOS Solvent Germany GmbH, Römerstrasse 733, 47443 Moers Germany

INEOS Solvent Germany GmbH, Shamrockstrasse 88, 44623 Herne Germany

2.   PRODUCT COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the product

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Propan-1-ol | | Active Substance | 71-23-8 | 200-746-9 | 35,0 |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 35,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-1-ol

Active Substance

71-23-8

200-746-9

35,0

Propan-2-ol

Active Substance

67-63-0

200-661-7

35,0

2.2.   Type of formulation

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS

| Hazard statements | Flammable liquid and vapour.
  Causes serious eye damage.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Keep container tightly closed.
  Avoid breathing vapours.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection..
  IF INHALED:Remove person to fresh air and keep comfortable for breathing.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER/doctor.
  Store in a well-ventilated place.Keep cool.
  Store locked up.
  Dispose of container to an authorised waste collection point. |

Hazard statements

Flammable liquid and vapour.

Causes serious eye damage.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

Keep container tightly closed.

Avoid breathing vapours.

Use only outdoors or in a well-ventilated area.

Wear eye protection..

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER/doctor.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of container to an authorised waste collection point.

4.   AUTHORISED USE(S)

4.1.   Use description

Table 1

Use # 1 – hard non-porous small surface disinfection RTU liquid

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: no data
  Common name: Bacteria
  Development stage: no data
  Scientific name: no data
  Common name: Yeasts
  Development stage: no data
  Scientific name: no data
  Common name: viruses (limited spectrum virucidal activity)
  Development stage: no data |
| Field(s) of use | Indoor
  Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces):
  disinfection of small hard/non-porous surfaces.
  For professional use only. |
| Application method(s) | Method: Manual application
  Detailed description:
  Ready-to-use surface disinfectant at room temperature (20 ± 2 °C).
  The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2 to keep the surface wet during the contact time. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: — for the control of bacteria, yeasts and enveloped viruses: 60 sec — for the control of viruses (limited spectrum virucidal activity): 5 min
  Dilution (%): Ready-to-use product
  Number and timing of application:
  A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | 100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head);
  5 000 ml transparent/white HDPE canister with HDPE screwed cap. |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: no data

Common name: Bacteria

Development stage: no data

Scientific name: no data

Common name: Yeasts

Development stage: no data

Scientific name: no data

Common name: viruses (limited spectrum virucidal activity)

Development stage: no data

Field(s) of use

Indoor

Health care facilities and pharmaceutical and cosmetic industry, for example patient-near surrounding, working areas/desks, general equipment (excluding food contact surfaces):

disinfection of small hard/non-porous surfaces.

For professional use only.

Application method(s)

Method: Manual application

Detailed description:

Ready-to-use surface disinfectant at room temperature (20 ± 2 °C).

The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2 to keep the surface wet during the contact time.

Application rate(s) and frequency

Application Rate: Minimum exposure time: — for the control of bacteria, yeasts and enveloped viruses: 60 sec — for the control of viruses (limited spectrum virucidal activity): 5 min

Dilution (%): Ready-to-use product

Number and timing of application:

A reasonable frequency of disinfection in a patient’s room is 1-2 per day. Maximum number of applications is 6 per day. No safety intervals need to be considered between the application phases.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head);

5 000 ml transparent/white HDPE canister with HDPE screwed cap.

4.1.1.   Use-specific instructions for use

Surfaces should always be visibly clean prior to disinfection. Maximum number of applications is 6 per day.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use

4.2.   Use description

Table 2

Use # 2 – hard non-porous small surface disinfection RTU liquid

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: no data
  Common name: Bacteria
  Development stage: no data
  Scientific name: no data
  Common name: Yeasts
  Development stage: no data |
| Field(s) of use | Indoor
  Health care facilities and in food industry, for example food preparation and handling in kitchens/restaurants: disinfection of small hard/non-porous surfaces.
  For professional use only. |
| Application method(s) | Method: Manual application
  Detailed description:
  Ready-to-use surface disinfectant at room temperature (20 ± 2 °C).
  The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time. |
| Application rate(s) and frequency | Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20 °C: 60 sec
  Dilution (%): Ready-to-use product
  Number and timing of application:
  The products can be used as often as necessary. A reasonable frequency in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases. |
| Category(ies) of users | Industrial
  Professional |
| Pack sizes and packaging material | 100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head);
  5 000 ml transparent/white HDPE canister with HDPE screwed cap. |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: no data

Common name: Bacteria

Development stage: no data

Scientific name: no data

Common name: Yeasts

Development stage: no data

Field(s) of use

Indoor

Health care facilities and in food industry, for example food preparation and handling in kitchens/restaurants: disinfection of small hard/non-porous surfaces.

For professional use only.

Application method(s)

Method: Manual application

Detailed description:

Ready-to-use surface disinfectant at room temperature (20 ± 2 °C).

The entire surface to be disinfected is wetted by pouring or spraying from a short distance and subsequently thoroughly wiped with a cloth. The amount of product should be sufficient (max. 50 ml/m2) to keep the surface wet during the contact time.

Application rate(s) and frequency

Application Rate: Minimum exposure time: for the control of bacteria and yeasts at 20 °C: 60 sec

Dilution (%): Ready-to-use product

Number and timing of application:

The products can be used as often as necessary. A reasonable frequency in kitchens is 1-2 per day. No safety intervals need to be considered between the application phases.

Category(ies) of users

Industrial

Professional

Pack sizes and packaging material

100, 500, 750 and 1 000 ml transparent/white high-density polyethylene (HDPE) bottle with polypropylene (PP) flip top caps (accessory: PP screw closure with spray head);

5 000 ml transparent/white HDPE canister with HDPE screwed cap.

4.2.1.   Use-specific instructions for use

Surfaces should always be visibly clean prior to disinfection.

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.

4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.

4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use

For professional use only.

5.2.   Risk mitigation measures

The use of eye protection during handling of the product is mandatory.

Keep out of reach of children

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

First-aid measures general: Move the affected person away from the contaminated area. Get medical advice/attention if you feel unwell. If possible, show this sheet.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

Information to Healthcare personnel/doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

Accidental release measures:Stop leak if safe to do so. Remove ignition sources. Use special care to avoid static electric charges. No open flames. No smoking.Prevent entry to sewers and public waters.Wipe up with absorbent material (for example cloth). Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Take up mechanically (sweeping, shovelling). Dispose of in accordance with relevant local regulations.

5.4.   Instructions for safe disposal of the product and its packaging

Disposal must be done according to official regulations. Do not empty into drains. Do not dispose of with domestic waste. Dispose of contents/container to an authorised waste collection point. Empty the packaging completely prior to disposal. When totally empty, containers are recyclable like any other packing.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf-life: 24 months

Store in dry, cool, well-ventilated area. Keep container tightly closed. Keep out of direct sunlight.

Recommended storage temperature: 0– 30 °C

Do not store at temperatures below 0 °C

Do not store near food, drink and animal feedingstuff. Keep away from combustible material.

6.   OTHER INFORMATION

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.

---

DECISIONS

| 12.6.2023 | EN | Official Journal of the European Union | L 151/28 |
| --- | --- | --- | --- |

12.6.2023

EN

Official Journal of the European Union

L 151/28

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COMMISSION IMPLEMENTING DECISION (EU) 2023/1145

of 7 June 2023

amending Implementing Decision (EU) 2022/2333 concerning certain emergency measures relating to sheep pox and goat pox in Spain

(notified under document C(2023)3806)

(Only the Spanish text is authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (1), and in particular Article 259(1) thereof,

Whereas:

| (1) | Commission Implementing Decision (EU) 2022/2333 (2) was adopted within the framework of Regulation (EU) 2016/429, and it lays down emergency measures relating to outbreaks of sheep pox and goat pox in Spain, that were detected in the regions of Andalusia and Castilla-La Mancha, where they form two distinct clusters, one in each region. That Implementing Decision applies until 31 October 2023. |
| --- | --- |

(1)

Commission Implementing Decision (EU) 2022/2333 (2) was adopted within the framework of Regulation (EU) 2016/429, and it lays down emergency measures relating to outbreaks of sheep pox and goat pox in Spain, that were detected in the regions of Andalusia and Castilla-La Mancha, where they form two distinct clusters, one in each region. That Implementing Decision applies until 31 October 2023.

| (2) | More particularly, Implementing Decision (EU) 2022/2333 provides that the protection, surveillance and further restricted zones, to be established by Spain following outbreaks of sheep pox and goat pox, in accordance with Article 21 of Commission Delegated Regulation (EU) 2020/687 (3), are to comprise at least the areas listed in the Annex to that Implementing Decision. |
| --- | --- |

(2)

More particularly, Implementing Decision (EU) 2022/2333 provides that the protection, surveillance and further restricted zones, to be established by Spain following outbreaks of sheep pox and goat pox, in accordance with Article 21 of Commission Delegated Regulation (EU) 2020/687 (3), are to comprise at least the areas listed in the Annex to that Implementing Decision.

| (3) | In addition to the protection and surveillance zones, a further restricted zone was established, in accordance with Article 21(1), point (c), of Delegated Regulation (EU) 2020/687, in both the regions of Andalusia and Castilla-La Mancha, where Spain is required to apply certain measures regarding restrictions on the movements of sheep and goats outside that further restricted zone, with a view to preventing the spread of sheep pox and goat pox to the rest of its territory and to the rest of the Union. |
| --- | --- |

(3)

In addition to the protection and surveillance zones, a further restricted zone was established, in accordance with Article 21(1), point (c), of Delegated Regulation (EU) 2020/687, in both the regions of Andalusia and Castilla-La Mancha, where Spain is required to apply certain measures regarding restrictions on the movements of sheep and goats outside that further restricted zone, with a view to preventing the spread of sheep pox and goat pox to the rest of its territory and to the rest of the Union.

| (4) | After the adoption of Implementing Decision (EU) 2022/2333, Spain notified the Commission of a number of additional outbreaks of sheep pox and goat pox in establishments where sheep and/or goats were kept. As a result, the areas listed as protection and surveillance zones, as well as the areas listed as further restricted zones for Spain, in the Annex to Implementing Decision (EU) 2022/2333, were subsequently amended. The last amendment to that Annex was made by the Commission Implementing Decision 2023/872 (4). |
| --- | --- |

(4)

After the adoption of Implementing Decision (EU) 2022/2333, Spain notified the Commission of a number of additional outbreaks of sheep pox and goat pox in establishments where sheep and/or goats were kept. As a result, the areas listed as protection and surveillance zones, as well as the areas listed as further restricted zones for Spain, in the Annex to Implementing Decision (EU) 2022/2333, were subsequently amended. The last amendment to that Annex was made by the Commission Implementing Decision 2023/872 (4).

| (5) | Since the date of adoption of Implementing Decision (EU) 2023/872, Spain has notified the Commission of one additional outbreak of sheep pox and goat pox in establishments where sheep and/or goats were kept, in the region of Castilla-La Mancha, more specifically in the Province of Cuenca, outside the surveillance zone already established in that region. |
| --- | --- |

(5)

Since the date of adoption of Implementing Decision (EU) 2023/872, Spain has notified the Commission of one additional outbreak of sheep pox and goat pox in establishments where sheep and/or goats were kept, in the region of Castilla-La Mancha, more specifically in the Province of Cuenca, outside the surveillance zone already established in that region.

| (6) | The competent authority of Spain has taken the necessary disease control measures required in accordance with Delegated Regulation (EU) 2020/687, including the establishment of protection and surveillance zones around the new outbreak. Spain has also maintained the previously established restricted zones, around the previous outbreaks, recorded since the beginning of 2023 in Castilla-La Mancha, in the Province of Ciudad Real. |
| --- | --- |

(6)

The competent authority of Spain has taken the necessary disease control measures required in accordance with Delegated Regulation (EU) 2020/687, including the establishment of protection and surveillance zones around the new outbreak. Spain has also maintained the previously established restricted zones, around the previous outbreaks, recorded since the beginning of 2023 in Castilla-La Mancha, in the Province of Ciudad Real.

| (7) | Therefore, the areas listed as protection, surveillance and further restricted zones for Spain in the Annex to Implementing Decision (EU) 2022/2333 should be amended, spatially and temporally, taking into account the current epidemiological situation as regards sheep pox and goat pox in the region of Castilla-La Mancha. |
| --- | --- |

(7)

Therefore, the areas listed as protection, surveillance and further restricted zones for Spain in the Annex to Implementing Decision (EU) 2022/2333 should be amended, spatially and temporally, taking into account the current epidemiological situation as regards sheep pox and goat pox in the region of Castilla-La Mancha.

| (8) | Given the urgency of the epidemiological situation in the Union as regards the spread of sheep pox and goat pox, it is important that the amendments to be made to the Annex to Implementing Decision (EU) 2022/2333 by this Decision take effect as soon as possible. |
| --- | --- |

(8)

Given the urgency of the epidemiological situation in the Union as regards the spread of sheep pox and goat pox, it is important that the amendments to be made to the Annex to Implementing Decision (EU) 2022/2333 by this Decision take effect as soon as possible.

| (9) | In addition, taking into account the current epidemiological situation in the Union as regards sheep pox and goat pox, the period of application of Implementing Decision (EU) 2022/2333 should be prolonged until 31 December 2023. |
| --- | --- |

(9)

In addition, taking into account the current epidemiological situation in the Union as regards sheep pox and goat pox, the period of application of Implementing Decision (EU) 2022/2333 should be prolonged until 31 December 2023.

| (10) | Implementing Decision (EU) 2022/2333 should therefore be amended accordingly. |
| --- | --- |

(10)

Implementing Decision (EU) 2022/2333 should therefore be amended accordingly.

| (11) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(11)

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

HAS ADOPTED THIS DECISION:

Article 1

Amendments to Implementing Decision (EU) 2022/2333

Implementing Decision (EU) 2022/2333 is amended as follows:

| 1. | Article 5 is replaced by the following:

  ‘Article 5
  Application
  This Decision shall apply until 31 December 2023.’
  ; |
| --- | --- |

1.

Article 5 is replaced by the following:

‘Article 5

Application

This Decision shall apply until 31 December 2023.’

| 2. | the Annex to Implementing Decision (EU) 2022/2333 is replaced by the text set out in the Annex to this Decision. |
| --- | --- |

2.

the Annex to Implementing Decision (EU) 2022/2333 is replaced by the text set out in the Annex to this Decision.

Article 2

Addressee

This Decision is addressed to the Kingdom of Spain.

Done at Brussels, 7 June 2023.

For the Commission

Stella KYRIAKIDES

Member of the Commission

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(1)  
  OJ L 84, 31.3.2016, p. 1.

1

(2)  Commission Implementing Decision (EU) 2022/2333 of 23 November 2022 concerning certain emergency measures relating to sheep pox and goat pox in Spain and repealing Implementing Decision (EU) 2022/1913 (OJ L 308, 29.11.2022, p. 22).

2

(3)  Commission Delegated Regulation (EU) 2020/687 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules for the prevention and control of certain listed diseases (OJ L 174, 3.6.2020, p. 64).

3

(4)  Commission Implementing Decision (EU) 2023/872 of 20 April 2023 amending Implementing Decision (EU) 2022/2333 concerning certain emergency measures relating to sheep pox and goat pox in Spain (OJ L 113, 28.4.2023, p. 49).

4

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ANNEX

‘ANNEX

A.   Protection and surveillance zones established around confirmed outbreaks

| Region and ADIS reference number of the outbreak | Areas established as protection and surveillance zones, part of the restricted zones in Spain as referred to in Article 1 | Date until applicable |
| --- | --- | --- |
| Region of Castilla–La Mancha

  ES-CAPRIPOX-2023-00003
  ES-CAPRIPOX-2023-00004
  ES-CAPRIPOX-2023-00005
  ES-CARPIPOX-2023-00006
  ES-CARPIPOX-2023-00007 | Protection zone:
  A protection zone that comprises the following areas:
  In the province of Ciudad Real the municipalities of:






  — | Alcázar de San Juan |

Region and ADIS reference number of the outbreak

Areas established as protection and surveillance zones, part of the restricted zones in Spain as referred to in Article 1

Date until applicable

Region of Castilla–La Mancha

ES-CAPRIPOX-2023-00003

ES-CAPRIPOX-2023-00004

ES-CAPRIPOX-2023-00005

ES-CARPIPOX-2023-00006

ES-CARPIPOX-2023-00007

Protection zone:

A protection zone that comprises the following areas:

In the province of Ciudad Real the municipalities of:

—

Alcázar de San Juan

| — | Campo de Criptana |
| --- | --- |

—

Campo de Criptana

| — | Pedro Muñoz |
| --- | --- |

—

Pedro Muñoz

In the province of Albacete the municipality of:

| — | Minaya |
| --- | --- |

—

Minaya

In province of Cuenca the municipalities of:

| — | Sisante |
| --- | --- |

—

Sisante

| — | Casas de Fernando Alonso |
| --- | --- |

—

Casas de Fernando Alonso

| — | Casas de Haro |
| --- | --- |

—

Casas de Haro

| — | Casas de los Pinos |
| --- | --- |

—

Casas de los Pinos

| — | El Pedernoso |
| --- | --- |

—

El Pedernoso

| — | El Provencio |
| --- | --- |

—

El Provencio

| — | Las Mesas |
| --- | --- |

—

Las Mesas

| — | Las Pedroñeras |
| --- | --- |

—

Las Pedroñeras

| — | Mota del Cuervo |
| --- | --- |

—

Mota del Cuervo

| — | Pozoamargo |
| --- | --- |

—

Pozoamargo

| — | San Clemente |
| --- | --- |

—

San Clemente

| — | Santa María de los Llanos |
| --- | --- |

—

Santa María de los Llanos

| — | Vara de Rey |
| --- | --- |

—

Vara de Rey

20.7.2023

Surveillance zone:

A surveillance zone that comprises the following areas:

In the province of Ciudad Real the municipalities of:

| — | Villarta de San Juan |
| --- | --- |

—

Villarta de San Juan

| — | Villarrubia de los Ojos |
| --- | --- |

—

Villarrubia de los Ojos

| — | Tomelloso |
| --- | --- |

—

Tomelloso

| — | Socuéllamos |
| --- | --- |

—

Socuéllamos

| — | Puerto Lápice |
| --- | --- |

—

Puerto Lápice

| — | Manzanares |
| --- | --- |

—

Manzanares

| — | Llanos de Caudillo |
| --- | --- |

—

Llanos de Caudillo

| — | Las Labores |
| --- | --- |

—

Las Labores

| — | Herencia |
| --- | --- |

—

Herencia

| — | Daimiel |
| --- | --- |

—

Daimiel

| — | Argamasilla de Alba |
| --- | --- |

—

Argamasilla de Alba

| — | Arenas de San Juan |
| --- | --- |

—

Arenas de San Juan

| — | Arenales de San Gregorio |
| --- | --- |

—

Arenales de San Gregorio

In the province of Toledo the municipalities of:

| — | Villafranca de los Caballeros |
| --- | --- |

—

Villafranca de los Caballeros

| — | Villacañas |
| --- | --- |

—

Villacañas

| — | Quintanar de la Orden |
| --- | --- |

—

Quintanar de la Orden

| — | Quero |
| --- | --- |

—

Quero

| — | Miguel Esteban |
| --- | --- |

—

Miguel Esteban

| — | Madridejos |
| --- | --- |

—

Madridejos

| — | La Villa de Don Fabrique |
| --- | --- |

—

La Villa de Don Fabrique

| — | La Puebla de Almoradiel |
| --- | --- |

—

La Puebla de Almoradiel

| — | El Toboso |
| --- | --- |

—

El Toboso

| — | Camuñas |
| --- | --- |

—

Camuñas

In the province of Cuenca the municipalities of:

| — | Atalaya del Cañavate |
| --- | --- |

—

Atalaya del Cañavate

| — | Cañada Juncosa |
| --- | --- |

—

Cañada Juncosa

| — | El Cañavate |
| --- | --- |

—

El Cañavate

| — | Honrubia |
| --- | --- |

—

Honrubia

| — | Pinarejo |
| --- | --- |

—

Pinarejo

| — | Alarcón |
| --- | --- |

—

Alarcón

| — | Casas de Benítez |
| --- | --- |

—

Casas de Benítez

| — | Casas de Guijarro |
| --- | --- |

—

Casas de Guijarro

| — | Casasimarro |
| --- | --- |

—

Casasimarro

| — | El Picazo |
| --- | --- |

—

El Picazo

| — | Pozorrubielos de la Mancha |
| --- | --- |

—

Pozorrubielos de la Mancha

| — | Quintanar del Rey |
| --- | --- |

—

Quintanar del Rey

| — | Tébar |
| --- | --- |

—

Tébar

| — | Valhermoso de la Fuente |
| --- | --- |

—

Valhermoso de la Fuente

| — | Villanueva de la Jara |
| --- | --- |

—

Villanueva de la Jara

| — | Belmonte |
| --- | --- |

—

Belmonte

| — | Carrascosa de Haro |
| --- | --- |

—

Carrascosa de Haro

| — | La Alberca de Záncara |
| --- | --- |

—

La Alberca de Záncara

| — | Los Hinojosos |
| --- | --- |

—

Los Hinojosos

| — | Monreal del Llano |
| --- | --- |

—

Monreal del Llano

| — | Rada de Haro |
| --- | --- |

—

Rada de Haro

| — | Santa María del Campo Rus |
| --- | --- |

—

Santa María del Campo Rus

| — | Villaescusa de Haro (only the exclave of Dehesa de Alcahozo) |
| --- | --- |

—

Villaescusa de Haro (only the exclave of Dehesa de Alcahozo)

In the province of Albacete the municipalities of:

| — | Fuensanta |
| --- | --- |

—

Fuensanta

| — | La Roda |
| --- | --- |

—

La Roda

| — | Munera |
| --- | --- |

—

Munera

| — | Tarazona de la Mancha |
| --- | --- |

—

Tarazona de la Mancha

| — | Villalgordo del Júcar |
| --- | --- |

—

Villalgordo del Júcar

| — | Villarrobledo |
| --- | --- |

—

Villarrobledo

7.8.2023

Surveillance zone:

A surveillance zone that comprises the following areas:

In the province of Ciudad Real the municipalities of:

| — | Alcázar de San Juan |
| --- | --- |

—

Alcázar de San Juan

| — | Campo de Criptana |
| --- | --- |

—

Campo de Criptana

| — | Pedro Muñoz |
| --- | --- |

—

Pedro Muñoz

In the province of Albacete the municipality of:

| — | Minaya |
| --- | --- |

—

Minaya

In province of Cuenca the municipalities of:

| — | Sisante |
| --- | --- |

—

Sisante

| — | Casas de Fernando Alonso |
| --- | --- |

—

Casas de Fernando Alonso

| — | Casas de Haro |
| --- | --- |

—

Casas de Haro

| — | Casas de los Pinos |
| --- | --- |

—

Casas de los Pinos

| — | El Pedernoso |
| --- | --- |

—

El Pedernoso

| — | El Provencio |
| --- | --- |

—

El Provencio

| — | Las Mesas |
| --- | --- |

—

Las Mesas

| — | Las Pedroñeras |
| --- | --- |

—

Las Pedroñeras

| — | Mota del Cuervo |
| --- | --- |

—

Mota del Cuervo

| — | Pozoamargo |
| --- | --- |

—

Pozoamargo

| — | San Clemente |
| --- | --- |

—

San Clemente

| — | Santa María de los Llanos |
| --- | --- |

—

Santa María de los Llanos

| — | Vara de Rey |
| --- | --- |

—

Vara de Rey

21.7.2023-7.8.2023

B.   Further restricted zones

| Region | Areas established as further restricted zones, part of the restricted zones in Spain as referred to in Article 1 | Date until applicable |
| --- | --- | --- |
| Region of Castilla–La Mancha | A further restricted zone that comprises the following provinces:






  — | Albacete |

Region

Areas established as further restricted zones, part of the restricted zones in Spain as referred to in Article 1

Date until applicable

Region of Castilla–La Mancha

A further restricted zone that comprises the following provinces:

—

Albacete

| — | Ciudad Real |
| --- | --- |

—

Ciudad Real

| — | Cuenca |
| --- | --- |

—

Cuenca

| — | Toledo |
| --- | --- |

—

Toledo

25.9.2023

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ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 12.6.2023 | EN | Official Journal of the European Union | L 151/33 |
| --- | --- | --- | --- |

12.6.2023

EN

Official Journal of the European Union

L 151/33

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DECISION No 1/2023 OF THE JOINT COMMITTEE ESTABLISHED BY THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE UNITED STATES OF AMERICA

of 26 May 2023

on the mutual recognition of certificates of conformity for marine equipment amending Annexes I, II and III [2023/1146]

THE JOINT COMMITTEE,

Having regard to the Agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment, and in particular Article 7 thereof;

Whereas:

| (1) | Pursuant to Article 7(3)(d) of the Agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment (‘the Agreement’), the Joint Committee established under Article 7(1) of the Agreement may amend the Annexes thereto. |
| --- | --- |

(1)

Pursuant to Article 7(3)(d) of the Agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment (‘the Agreement’), the Joint Committee established under Article 7(1) of the Agreement may amend the Annexes thereto.

| (2) | In order to support the proper implementation of the legislation that is within the scope of the Agreement it is important to include interpretations developed by the notified body coordination group established under Directive 2014/90/EU of the European Parliament and of the Council (1) as well as policy guidance issued by the U.S. Coast Guard in the list of laws, regulations and administrative provisions listed in Annex I. |
| --- | --- |

(2)

In order to support the proper implementation of the legislation that is within the scope of the Agreement it is important to include interpretations developed by the notified body coordination group established under Directive 2014/90/EU of the European Parliament and of the Council (1) as well as policy guidance issued by the U.S. Coast Guard in the list of laws, regulations and administrative provisions listed in Annex I.

| (3) | Therefore, Annex I to the Agreement should be amended accordingly. |
| --- | --- |

(3)

Therefore, Annex I to the Agreement should be amended accordingly.

| (4) | In accordance with Article 7(3)(a) of the Agreement, the Joint Committee is responsible for developing and maintaining the list in Annex II of products and associated legislative, regulatory and administrative provisions that the Parties have determined to be equivalent. |
| --- | --- |

(4)

In accordance with Article 7(3)(a) of the Agreement, the Joint Committee is responsible for developing and maintaining the list in Annex II of products and associated legislative, regulatory and administrative provisions that the Parties have determined to be equivalent.

| (5) | Taking into account technical progress and changes to the international instruments, the European Union and the United States of America have agreed on the modification of the product coverage for mutual recognition. |
| --- | --- |

(5)

Taking into account technical progress and changes to the international instruments, the European Union and the United States of America have agreed on the modification of the product coverage for mutual recognition.

| (6) | Therefore, Annex II of the Agreement should be amended accordingly. |
| --- | --- |

(6)

Therefore, Annex II of the Agreement should be amended accordingly.

| (7) | The list of regulatory authorities and their addresses should be updated and the regulatory authority of the United Kingdom should be removed. |
| --- | --- |

(7)

The list of regulatory authorities and their addresses should be updated and the regulatory authority of the United Kingdom should be removed.

| (8) | Therefore, Annex III of the Agreement should be amended accordingly, |
| --- | --- |

(8)

Therefore, Annex III of the Agreement should be amended accordingly,

HAS DECIDED AS FOLLOWS:

Annexes I, II and III of the Agreement are replaced by the text in the Annex to this Decision.

This Decision, done in duplicate, shall be signed by representatives of the Joint Committee who are authorised to act on behalf of the Parties for purposes of amending the Agreement. This Decision shall be effective from the date of the later of these signatures.

On behalf of the United States of America

Sushan DEMIRJIAN

Signed in Brussels, on 26 May 2023

On behalf of the European Union

Lucian CERNAT

Signed in Brussels, on 26 May 2023

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(1)  Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).

1

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ANNEX

‘ANNEX I

LEGISLATION, REGULATIONS AND ADMINISTRATIVE PROVISIONS

EU legislation, regulations and administrative provisions:

| — | Directive 2014/90/EU (hereinafter referred to as ‘MED’) and the implementing acts adopted in accordance with Articles 35(2) and (3) of that Directive, which are published in the Official Journal of the European Union and made available on https://portal.med.emsa.europa.eu/. |
| --- | --- |

—

Directive 2014/90/EU (hereinafter referred to as ‘MED’) and the implementing acts adopted in accordance with Articles 35(2) and (3) of that Directive, which are published in the Official Journal of the European Union and made available on https://portal.med.emsa.europa.eu/.

| — | Guidelines for the implementation of, in particular, conformity assessment procedures falling under the MED are provided by:






  — | The ‘Blue Guide’ on the implementation of EU product rules 2022; and |
| --- | --- | --- |

—

Guidelines for the implementation of, in particular, conformity assessment procedures falling under the MED are provided by:

—

The ‘Blue Guide’ on the implementation of EU product rules 2022; and

| — | Interpretations developed by the notified body coordination group established under Directive 2014/90/EU (MarED), approved by the Committee on Safe Seas and prevention of pollution from ships established under Council Regulation (EC) No 2099/2002 (COSS) and made available to the public on https://portal.med.emsa.europa.eu/. |
| --- | --- |

—

Interpretations developed by the notified body coordination group established under Directive 2014/90/EU (MarED), approved by the Committee on Safe Seas and prevention of pollution from ships established under Council Regulation (EC) No 2099/2002 (COSS) and made available to the public on https://portal.med.emsa.europa.eu/.

U.S. legislation, regulations and administrative provisions:

| — | United States Code, Title 46 (46 U.S.C. 3306), provides statutory authority to the United States Coast Guard (through delegation by the Secretary of the Department of Homeland Security) to issue regulations for approval of marine equipment. |
| --- | --- |

—

United States Code, Title 46 (46 U.S.C. 3306), provides statutory authority to the United States Coast Guard (through delegation by the Secretary of the Department of Homeland Security) to issue regulations for approval of marine equipment.

| — | United States Code of Federal Regulations






  — | Title 46, Subpart 2.75 and Part 159, related to the authorities and procedures for U.S. Coast Guard approval of marine equipment; |
| --- | --- | --- |

—

United States Code of Federal Regulations

—

Title 46, Subpart 2.75 and Part 159, related to the authorities and procedures for U.S. Coast Guard approval of marine equipment;

| — | Title 46, Parts 160 to 164, for lifesaving equipment, electrical equipment, engineering systems; |
| --- | --- |

—

Title 46, Parts 160 to 164, for lifesaving equipment, electrical equipment, engineering systems;

| — | Title 47, Part 80 for radio equipment. Equipment which includes a radio transmitter is regulated by the U.S. Federal Communications Commission (FCC) and requires FCC type-certification before such equipment may be marketed, sold or used in the United States. These items are identified by ‡ in Annex II. |
| --- | --- |

—

Title 47, Part 80 for radio equipment. Equipment which includes a radio transmitter is regulated by the U.S. Federal Communications Commission (FCC) and requires FCC type-certification before such equipment may be marketed, sold or used in the United States. These items are identified by ‡ in Annex II.

| — | Policy guidance issued by the U.S. Coast Guard






  — | Navigation and Vessel Inspection Circular (NVIC) 02-19 pertaining to approvals issued by the U.S. Coast Guard under the MRA; |
| --- | --- | --- |

—

Policy guidance issued by the U.S. Coast Guard

—

Navigation and Vessel Inspection Circular (NVIC) 02-19 pertaining to approvals issued by the U.S. Coast Guard under the MRA;

| — | NVIC 08-01, for approval of navigation equipment; |
| --- | --- |

—

NVIC 08-01, for approval of navigation equipment;

| — | Additional guidance posted on: https://www.dco.uscg.mil/CG-ENG-4/Equipment/. |
| --- | --- |

—

Additional guidance posted on: https://www.dco.uscg.mil/CG-ENG-4/Equipment/.

‘ANNEX II

PRODUCT COVERAGE FOR MUTUAL RECOGNITION

Lifesaving appliances

| Product item identification | EU item number | U.S. item |
| --- | --- | --- |
| Position- indicating lights for life- saving appliances:
  for survival craft and rescue boats | MED/1.2a | 161.101 |
| Position- indicating lights for life- saving appliances:
  for lifebuoys | MED/1.2b | 161.110 |
| Position- indicating lights for life- saving appliances:
  for lifejackets | MED/1.2c | 161.112 |
| Lifebuoy self- activating smoke signals
  Note: Expiration date not to exceed 48 months after month of manufacture. | MED/1.3 | 160.157 |
| Rocket parachute flares (pyrotechnics)
  Note: Expiration date not to exceed 48 months after month of manufacture. | MED/1.8 | 160.136 |
| Hand flares (pyrotechnics)
  Note: Expiration date not to exceed 48 months after month of manufacture. | MED/1.9 | 160.121 |
| Buoyant smoke signals (pyrotechnics)
  Note: Expiration date not to exceed 48 months after month of manufacture. | MED/1.10 | 160.122 |
| Line-throwing appliances
  Note: Expiration date not to exceed 48 months after month of manufacture. | MED/1.11 | 160.040 |
| Rigid liferafts
  Note: The emergency pack is not covered by the Agreement | MED/1.13 | 160.118 |
| Automatically self- righting liferafts (rigid liferafts only/inflatable liferafts not covered)
  Note: The emergency pack is not covered by the Agreement | MED/1.14b | 160.118 |
| Canopied reversible liferafts (rigid liferafts only/inflatable liferafts not covered)
  Note: The emergency pack is not covered by the Agreement | MED/1.15 | 160.118 |
| Float- free arrangements for liferafts (hydrostatic release units) | MED/1.16 | 160.162 |
| Release mechanism for:
  Lifeboats and rescue boats
  (launched by a fall or falls)
  Limited to Davit-launched liferaft automatic release hook | MED/1.26a | 160.170 |
| Release mechanism for:
  Liferafts (launched by a fall or falls)
  Limited to Davit-launched liferaft automatic release hook | MED/1.26b | 160.170 |
| Marine evacuation systems | MED/1.27 | 160.175 |
| Embarkation Ladders | MED/1.29 | 160.117 |
| Retro-reflective materials | MED/1.30 | 164.018 |

Product item identification

EU item number

U.S. item

Position- indicating lights for life- saving appliances:

for survival craft and rescue boats

MED/1.2a

161.101

Position- indicating lights for life- saving appliances:

for lifebuoys

MED/1.2b

161.110

Position- indicating lights for life- saving appliances:

for lifejackets

MED/1.2c

161.112

Lifebuoy self- activating smoke signals

Note: Expiration date not to exceed 48 months after month of manufacture.

MED/1.3

160.157

Rocket parachute flares (pyrotechnics)

Note: Expiration date not to exceed 48 months after month of manufacture.

MED/1.8

160.136

Hand flares (pyrotechnics)

Note: Expiration date not to exceed 48 months after month of manufacture.

MED/1.9

160.121

Buoyant smoke signals (pyrotechnics)

Note: Expiration date not to exceed 48 months after month of manufacture.

MED/1.10

160.122

Line-throwing appliances

Note: Expiration date not to exceed 48 months after month of manufacture.

MED/1.11

160.040

Rigid liferafts

Note: The emergency pack is not covered by the Agreement

MED/1.13

160.118

Automatically self- righting liferafts (rigid liferafts only/inflatable liferafts not covered)

Note: The emergency pack is not covered by the Agreement

MED/1.14b

160.118

Canopied reversible liferafts (rigid liferafts only/inflatable liferafts not covered)

Note: The emergency pack is not covered by the Agreement

MED/1.15

160.118

Float- free arrangements for liferafts (hydrostatic release units)

MED/1.16

160.162

Release mechanism for:

Lifeboats and rescue boats

(launched by a fall or falls)

Limited to Davit-launched liferaft automatic release hook

MED/1.26a

160.170

Release mechanism for:

Liferafts (launched by a fall or falls)

Limited to Davit-launched liferaft automatic release hook

MED/1.26b

160.170

Marine evacuation systems

MED/1.27

160.175

Embarkation Ladders

MED/1.29

160.117

Retro-reflective materials

MED/1.30

164.018

Fire protection

| Product item identification | EU item number | U.S. item number |
| --- | --- | --- |
| Primary deck coverings | MED/3.1 | 164.106 |
| ‘A’ & ‘B’ Class divisions fire integrity:
  ‘A’ class divisions: A-60 deck assemblies | MED/3.11a | 164.105 |
| ‘A’ & ‘B’ Class divisions fire integrity:
  ‘A’ class divisions: A-60 structural insulation | MED/3.11a | 164.107 |
| ‘A’ & ‘B’ Class divisions fire integrity:
  ‘B’ class divisions. - bulkheads. | MED/3.11b | 164.108 |
| ‘A’ & ‘B’ Class divisions fire integrity:
  ‘B’ class divisions. - ceilings. | MED/3.11b | 164.110 |
| Non-combustible materials | MED/3.13 | 164.109 |
| Fire doors
  Limited to fire doors without windows or with total window area no more than 645 cm2 in each door leaf, unless hose stream, heat flux, and/or temperature rise tests are conducted according to USCG approval guidance.
  Approval limited to maximum door size tested.
  Doors must be used with a fire tested frame design. | MED/3.16 | 164.136 |
| Fire door control systems components. | MED/3.17 | 164.146 |
| Surface materials and floor coverings with low flame-spread characteristics:
  decorative veneers. | MED/3.18a | 164.112 |
| Surface materials and floor coverings with low flame-spread characteristics:
  paint systems. | MED/3.18b | 164.112 |
| Surface materials and floor coverings with low flame-spread characteristics:
  floor coverings. | MED/3.18
  c | 164.117 |
| Surface materials and floor coverings with low flame-spread characteristics:
  combustible ducts membrane. | MED/3.18f | 164.112 |
| Draperies, curtains and other suspended textile materials and films | MED/3.19 | 164.111 |
| Upholstered furniture:
  Cover material for flame-retardant filling material | MED/3.20b | 164.144 |
| Upholstered furniture:
  Cover material for flame-retardant filling material
  (tested in specific combination as intended for the later application). | MED/3.20c | 164.144 |
| Bedding components | MED/3.21 | 164.142 |
| Fire dampers | MED/3.22 | 164.139 |
| Penetrations through ‘A’ class
  electric cable transits. | MED/3.26a | 164.138 |
| Penetrations through ‘A’ class
  pipe, duct, trunk, etc. penetrations | MED/3.26b | 164.138 |
| Fire restricting materials (except furniture) for high-speed craft | MED/3.32 | 164.201 |
| Fire restricting materials for furniture for high-speed craft | MED/3.33 | 164.201 |
| Fire resisting divisions for high-speed craft | MED/3.34 | 164.207 |
| C class divisions | MED/3.64 | 164.109 |

Product item identification

EU item number

U.S. item number

Primary deck coverings

MED/3.1

164.106

‘A’ & ‘B’ Class divisions fire integrity:

‘A’ class divisions: A-60 deck assemblies

MED/3.11a

164.105

‘A’ & ‘B’ Class divisions fire integrity:

‘A’ class divisions: A-60 structural insulation

MED/3.11a

164.107

‘A’ & ‘B’ Class divisions fire integrity:

‘B’ class divisions. - bulkheads.

MED/3.11b

164.108

‘A’ & ‘B’ Class divisions fire integrity:

‘B’ class divisions. - ceilings.

MED/3.11b

164.110

Non-combustible materials

MED/3.13

164.109

Fire doors

Limited to fire doors without windows or with total window area no more than 645 cm2 in each door leaf, unless hose stream, heat flux, and/or temperature rise tests are conducted according to USCG approval guidance.

Approval limited to maximum door size tested.

Doors must be used with a fire tested frame design.

MED/3.16

164.136

Fire door control systems components.

MED/3.17

164.146

Surface materials and floor coverings with low flame-spread characteristics:

decorative veneers.

MED/3.18a

164.112

Surface materials and floor coverings with low flame-spread characteristics:

paint systems.

MED/3.18b

164.112

Surface materials and floor coverings with low flame-spread characteristics:

floor coverings.

MED/3.18
  c

164.117

Surface materials and floor coverings with low flame-spread characteristics:

combustible ducts membrane.

MED/3.18f

164.112

Draperies, curtains and other suspended textile materials and films

MED/3.19

164.111

Upholstered furniture:

Cover material for flame-retardant filling material

MED/3.20b

164.144

Upholstered furniture:

Cover material for flame-retardant filling material

(tested in specific combination as intended for the later application).

MED/3.20c

164.144

Bedding components

MED/3.21

164.142

Fire dampers

MED/3.22

164.139

Penetrations through ‘A’ class

electric cable transits.

MED/3.26a

164.138

Penetrations through ‘A’ class

pipe, duct, trunk, etc. penetrations

MED/3.26b

164.138

Fire restricting materials (except furniture) for high-speed craft

MED/3.32

164.201

Fire restricting materials for furniture for high-speed craft

MED/3.33

164.201

Fire resisting divisions for high-speed craft

MED/3.34

164.207

C class divisions

MED/3.64

164.109

Navigation equipment

| Product item identification | EU item | US item number |
| --- | --- | --- |
| Magnetic compass
  Class A for ships | MED/4.1 | 165.101 |
| Transmitting heading device THD (magnetic method) | MED/4.2 | 165.102 |
| Echo-sounding equipment | MED/4.6 | 165.107 |
| Speed and distance measuring equipment (SDME) | MED/4.7 | 165.105 |
| Rate- of- turn- indicator | MED/4.9 | 165.106 |
| Heading control system (HCS) | MED/4.16 | 165.110 |
| Rudder Angle Indicator | MED/4.20 | 165.167 |
| Propeller revolution indicator | MED/4.21 | 165.168 |
| Pitch Indicator | MED/4.22 | 165.169 |
| Voyage data recorder (VDR) | MED/4.29 | 165.150 |
| Electronic chart display and information system (ECDIS) with backup, and raster chart display system (RCDS) | MED/4.30 | 165.123
  165.124 |
| Universal automatic identification system equipment (AIS) | MED/4.32 | 165.155 |
| Track control system
  (working at ship’s speed from minimum manoeuvring speed up to 30 knots) | MED/4.33 | 165.112 |
| Radar reflector passive type | MED/4.39 | 165.160 |
| Heading control system for high-speed craft | MED/4.40 | 165.210 |
| Transmitting heading device THD (GNSS method) | MED/4.41 | 165.102 |
| Searchlight for high-speed craft | MED/4.42 | 165.252 |
| Night vision equipment for high-speed craft | MED/4.43 | 165.251 |
| Transmitting heading device THD (Gyroscopic method) | MED/4.46 | 165.102 |
| Simplified voyage data recorder (S- VDR) | MED/4.47 | 165.151 |
| Pilot ladder | MED/4.49 | 163.003 |
| Daylight signaling lamp | MED/4.52 | 165.166 |
| Bridge Navigational Watch Alarm System (BNWAS) | MED/4.57 | 165.142 |
| Sound reception system | MED/4.58 | 165.165 |
| Integrated navigation system | MED/4.59 | 165.141 |
| GPS equipment | MED/4.63 | 165.130 |
| GLONASS equipment | MED/4.63 | 165.131 |
| DGPS equipment | MED/4.63 | 165.132 |
| DGLONASS equipment | MED/4.63 | 165.133 |
| Radar equipment CAT 1
  (Radar equipment used with ARPA must have separate EU and USA certifications) ‡ | MED/4.64 | 165.115 |
| Radar equipment CAT 2
  (Radar equipment used with ATA must have separate EU and USA certifications) ‡ | MED/4.64 | 165.116 |
| Radar equipment CAT 3
  (Radar equipment used with EPA must have separate EU and USA certifications) ‡ | MED/4.64 | 165.117 |
| Radar equipment for high-speed craft applications (CAT 1H) ‡ | MED/4.64 | 165.216 |
| Radar equipment for high-speed craft applications (CAT 2H) ‡ | MED/4.64 | 165.217 |
| Gyro compass | MED/4.65 | 165.103 |
| Gyro compass for high-speed craft | MED/4.65 | 165.203 |

Product item identification

EU item

US item number

Magnetic compass

Class A for ships

MED/4.1

165.101

Transmitting heading device THD (magnetic method)

MED/4.2

165.102

Echo-sounding equipment

MED/4.6

165.107

Speed and distance measuring equipment (SDME)

MED/4.7

165.105

Rate- of- turn- indicator

MED/4.9

165.106

Heading control system (HCS)

MED/4.16

165.110

Rudder Angle Indicator

MED/4.20

165.167

Propeller revolution indicator

MED/4.21

165.168

Pitch Indicator

MED/4.22

165.169

Voyage data recorder (VDR)

MED/4.29

165.150

Electronic chart display and information system (ECDIS) with backup, and raster chart display system (RCDS)

MED/4.30

165.123

165.124

Universal automatic identification system equipment (AIS)

MED/4.32

165.155

Track control system

(working at ship’s speed from minimum manoeuvring speed up to 30 knots)

MED/4.33

165.112

Radar reflector passive type

MED/4.39

165.160

Heading control system for high-speed craft

MED/4.40

165.210

Transmitting heading device THD (GNSS method)

MED/4.41

165.102

Searchlight for high-speed craft

MED/4.42

165.252

Night vision equipment for high-speed craft

MED/4.43

165.251

Transmitting heading device THD (Gyroscopic method)

MED/4.46

165.102

Simplified voyage data recorder (S- VDR)

MED/4.47

165.151

Pilot ladder

MED/4.49

163.003

Daylight signaling lamp

MED/4.52

165.166

Bridge Navigational Watch Alarm System (BNWAS)

MED/4.57

165.142

Sound reception system

MED/4.58

165.165

Integrated navigation system

MED/4.59

165.141

GPS equipment

MED/4.63

165.130

GLONASS equipment

MED/4.63

165.131

DGPS equipment

MED/4.63

165.132

DGLONASS equipment

MED/4.63

165.133

Radar equipment CAT 1

(Radar equipment used with ARPA must have separate EU and USA certifications) ‡

MED/4.64

165.115

Radar equipment CAT 2

(Radar equipment used with ATA must have separate EU and USA certifications) ‡

MED/4.64

165.116

Radar equipment CAT 3

(Radar equipment used with EPA must have separate EU and USA certifications) ‡

MED/4.64

165.117

Radar equipment for high-speed craft applications (CAT 1H) ‡

MED/4.64

165.216

Radar equipment for high-speed craft applications (CAT 2H) ‡

MED/4.64

165.217

Gyro compass

MED/4.65

165.103

Gyro compass for high-speed craft

MED/4.65

165.203

‘ANNEX III

REGULATORY AUTHORITIES

EUROPEAN UNION

| Belgium | SPF Mobilité (FPS Mobility) |
| --- | --- |
| Rue du Progrès 56 |
| 1210 Bruxelles |

Belgium

SPF Mobilité (FPS Mobility)

Rue du Progrès 56

1210 Bruxelles

| FOD Mobiliteit (FPS Mobility) |
| --- |
| Vooruitgangstraat 56 |
| 1210 Brussel |

FOD Mobiliteit (FPS Mobility)

Vooruitgangstraat 56

1210 Brussel

Bulgaria

| Министерство на транспорта, информационните технологии и съобщенията |
| --- |
| ул. "Дякон Игнатий" No 9 |
| София 1000, |

Министерство на транспорта, информационните технологии и съобщенията

ул. "Дякон Игнатий" No 9

София 1000,

| Ministry of Transport, Information Technology and Communications |
| --- |
| 9, Dyakon Ignatiy str. |
| Sofia 1000 |

Ministry of Transport, Information Technology and Communications

9, Dyakon Ignatiy str.

Sofia 1000

Czech Republic

Ministerstvo dopravy (Ministry of Transport)

P.O. Box 9

Nábřeží Ludvíka Svobody 12

110 15 Praha 1

Denmark

| Erhvervsministeriet |
| --- |
| (Ministry of Industry, Business and Financial Affairs) |
| Slotsholmsgade 10-12 |
| DK-1216 Copenhagen K |

Erhvervsministeriet

(Ministry of Industry, Business and Financial Affairs)

Slotsholmsgade 10-12

DK-1216 Copenhagen K

Germany

| Bundesministerium für Verkehr und digitale Infrastruktur (Ministry of Transport and Digital Infrastructure) |
| --- |
| Invalidenstr. 44, |
| 10115 Berlin |

Bundesministerium für Verkehr und digitale Infrastruktur (Ministry of Transport and Digital Infrastructure)

Invalidenstr. 44,

10115 Berlin

Estonia

| Majandus- ja Kommunikat- siooniministeerium (Ministry of Economic Affairs and Infrastructure) |
| --- |
| Suur- Ameerika 1 |
| 10122 Tallinn |

Majandus- ja Kommunikat- siooniministeerium (Ministry of Economic Affairs and Infrastructure)

Suur- Ameerika 1

10122 Tallinn

Ireland

| Department of Transport |
| --- |
| Leeson Lane |
| Dublin D02 TR60 |

Department of Transport

Leeson Lane

Dublin D02 TR60

| An Roinn Iompair |
| --- |
| Lána Liosáin |
| Baile Átha Cliath D02 TR60 |

An Roinn Iompair

Lána Liosáin

Baile Átha Cliath D02 TR60

Greece

| Υπουργείο Ναυτιλίας & Νησιωτικής Πολιτικής |
| --- |
| Ακτή Βασιλειάδη, Πύλη Ε 1 - Ε 2, |
| Τ.Κ. 185 10, Πειραιάς |

Υπουργείο Ναυτιλίας & Νησιωτικής Πολιτικής

Ακτή Βασιλειάδη, Πύλη Ε 1 - Ε 2,

Τ.Κ. 185 10, Πειραιάς

| Ministry of Shipping and Island Policy |
| --- |
| Akti Vassiliadi, Gates E1- E2 |
| 18510 Piraeus |

Ministry of Shipping and Island Policy

Akti Vassiliadi, Gates E1- E2

18510 Piraeus

Spain

| Ministerio de Fomento (Ministry of Public Works) |
| --- |
| Paseo de la Castellana, 67 |
| 28071 Madrid |

Ministerio de Fomento (Ministry of Public Works)

Paseo de la Castellana, 67

28071 Madrid

France

| Ministère de la transition écologique et solidaire |
| --- |
| 246, Boulevard St. Germain |
| 75007 Paris |

Ministère de la transition écologique et solidaire

246, Boulevard St. Germain

75007 Paris

Croatia

| Ministarstvo mora, prometa i infrastructure (Ministry of the Sea, Transport and Infrastructure) |
| --- |
| Prisavlje 14, |
| 10 000 Zagreb |

Ministarstvo mora, prometa i infrastructure (Ministry of the Sea, Transport and Infrastructure)

Prisavlje 14,

10 000 Zagreb

Italy

| Ministero delle Infrastrutture e dei Trasporti (Ministry for Infrastructure and Transport) |
| --- |
| Piazzale di Porta Pia 1 |
| 00198 Roma |

Ministero delle Infrastrutture e dei Trasporti (Ministry for Infrastructure and Transport)

Piazzale di Porta Pia 1

00198 Roma

Cyprus

| Υπουργείο Μεταφορών, Επικοινωνιών και Έργω |
| --- |
| Αχαιών 28, |
| 1424 Λευκωσία |

Υπουργείο Μεταφορών, Επικοινωνιών και Έργω

Αχαιών 28,

1424 Λευκωσία

| Ministry of Transport, Communications and Works |
| --- |
| Axaion 28 |
| 1424 Nicosia |

Ministry of Transport, Communications and Works

Axaion 28

1424 Nicosia

Latvia

| Satiksmes ministrija (Ministry for Transport and Communications) |
| --- |
| Gogola iela 3, |
| Riga 1743 |

Satiksmes ministrija (Ministry for Transport and Communications)

Gogola iela 3,

Riga 1743

Lithuania

| Susisiekimo ministeriją (Ministry of Transport and Communications) |
| --- |
| Gedimino av. 17 |
| 01505 Vilnius |

Susisiekimo ministeriją (Ministry of Transport and Communications)

Gedimino av. 17

01505 Vilnius

Luxembourg

| Ministère du Développement durable et des Infrastructures |
| --- |
| 4, Place de l'Europe |
| 1499 Luxembourg |

Ministère du Développement durable et des Infrastructures

4, Place de l'Europe

1499 Luxembourg

Hungary

| Nemzeti Fejlesztési Minisztérium (Ministry of National Development) |
| --- |
| Fő u. 44- 50. |
| 1011 Budapest |

Nemzeti Fejlesztési Minisztérium (Ministry of National Development)

Fő u. 44- 50.

1011 Budapest

Malta

| Ministeru għat- Trasport, Infrastruttura u Proġetti Kapitali/ Ministry for Transport, Infrastructure and Capital Projects |
| --- |
| Triq Francesco Buonamici |
| Floriana FRN1700 |

Ministeru għat- Trasport, Infrastruttura u Proġetti Kapitali/ Ministry for Transport, Infrastructure and Capital Projects

Triq Francesco Buonamici

Floriana FRN1700

Netherlands

| Ministerie van Infrastructuur en Waterstaat |
| --- |
| (Ministry of Infrastructure and Water Management) |
| Rijnstraat 8, 2515 XP ‘s Gravenhage |
| Postbus 20901 |
| 2500 EX's Gravenhage |

Ministerie van Infrastructuur en Waterstaat

(Ministry of Infrastructure and Water Management)

Rijnstraat 8, 2515 XP ‘s Gravenhage

Postbus 20901

2500 EX's Gravenhage

Austria

| Bundesministerium für Verkehr, Innovation und Technologie (Ministry for Transport, Innovation and Technology) |
| --- |
| Radetzkystraße 2 |
| 1030 Wien |

Bundesministerium für Verkehr, Innovation und Technologie (Ministry for Transport, Innovation and Technology)

Radetzkystraße 2

1030 Wien

Poland

| Ministerstwo Infrastruktury (Ministry of Infrastructure and Construction) |
| --- |
| ul. Chałubińskiego 4/6 |
| 00 928 Warszawa |

Ministerstwo Infrastruktury (Ministry of Infrastructure and Construction)

ul. Chałubińskiego 4/6

00 928 Warszawa

Portugal

| Direção-Geral de Recursos Naturais, Segurança e Serviços Marítimos (Directorate-General for Natural Resources, Safety and Maritime Services) |
| --- |
| Av. Brasília |
| 1449- 030 Lisboa |

Direção-Geral de Recursos Naturais, Segurança e Serviços Marítimos (Directorate-General for Natural Resources, Safety and Maritime Services)

Av. Brasília

1449- 030 Lisboa

Romania

| Ministerul Transporturilor (Ministry of Transport) |
| --- |
| 38, Blvd. Dinicu Golescu |
| Sector 1 – Bucureşti |

Ministerul Transporturilor (Ministry of Transport)

38, Blvd. Dinicu Golescu

Sector 1 – Bucureşti

Slovenia

| Ministrstvo za infrastrukturo (Ministry of Infrastructure) |
| --- |
| Langusova 4 |
| SI –1535 Ljubljana |

Ministrstvo za infrastrukturo (Ministry of Infrastructure)

Langusova 4

SI –1535 Ljubljana

Slovakia

| Ministerstvo dopravy a výstavby (Ministry of Transport and Construction) |
| --- |
| Námestie slobody 6 |
| 810 05 Bratislava |

Ministerstvo dopravy a výstavby (Ministry of Transport and Construction)

Námestie slobody 6

810 05 Bratislava

Finland

| Liikenne- ja viestintäministeriö (Ministry of Transport and Communications) |
| --- |
| Eteläesplanadi 16, Helsinki |
| P.O. Box 31 |
| 00023 Government |

Liikenne- ja viestintäministeriö (Ministry of Transport and Communications)

Eteläesplanadi 16, Helsinki

P.O. Box 31

00023 Government

| Kommunikationsministeriet (Ministry of Transport and Communications) |
| --- |
| Södra esplanaden 16, Helsingfors |
| PB 31, |
| 00023 Statsrådet |

Kommunikationsministeriet (Ministry of Transport and Communications)

Södra esplanaden 16, Helsingfors

PB 31,

00023 Statsrådet

Sweden

| Närings-departementet (Ministry of Enterprise and Innovation) |
| --- |
| Mäster Samuelsgatan 70, Stockholm |
| 103 33 Stockholm |

Närings-departementet (Ministry of Enterprise and Innovation)

Mäster Samuelsgatan 70, Stockholm

103 33 Stockholm

European Commission

| Directorate General Mobility and Transport (DG MOVE) |
| --- |
| Maritime Safety Unit |
| 200, rue de la Loi |
| 1049 Brussels, Belgium |

Directorate General Mobility and Transport (DG MOVE)

Maritime Safety Unit

200, rue de la Loi

1049 Brussels, Belgium

| UNITED STATES OF AMERICA |
| --- |
| United States Coast Guard |
| Office of Design and Engineering Standards (CG- ENG) |
| 2703 Martin Luther King Jr Ave SE |
| STOP 7509 |
| Washington DC 20593-7509 |

UNITED STATES OF AMERICA

United States Coast Guard

Office of Design and Engineering Standards (CG- ENG)

2703 Martin Luther King Jr Ave SE

STOP 7509

Washington DC 20593-7509

---