# Official Journal L 27/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 27 |
| | |
| English edition | Legislation | Volume 6631 January 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 27

English edition

Legislation

Volume 6631 January 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2023/196 of 25 November 2022 amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2023/197 of 24 January 2023 approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (Steirisches Kürbiskernöl (PGI)) | 6 |
| | * | Commission Regulation (EU) 2023/198 of 30 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin in or on certain products (
  1
  ) | 7 |
| | * | Commission Implementing Regulation (EU) 2023/199 of 30 January 2023 approving the low-risk active substance Trichoderma atroviride AT10 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 22 |
| | * | Commission Implementing Regulation (EU) 2023/200 of 30 January 2023 concerning the non-approval of lemon essential oil (Citrus limon essential oil) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (
  1
  ) | 26 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2023/201 of 30 January 2023 setting the date on which operations of the Schengen Information System start pursuant to Regulation (EU) 2018/1861 of the European Parliament and of the Council and Regulation (EU) 2018/1862 of the European Parliament and of the Council | 29 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | * | Decision No 01/2022 of the Committee on Customs of the Free Trade Agreement between the European Union and the Republic of Singapore of 20 December 2022 modifying certain elements in Protocol 1 concerning the definition of the concept of originating products and methods of administrative cooperation and its Annexes [2023/202] | 33 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2023/196 of 25 November 2022 amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2023/197 of 24 January 2023 approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (Steirisches Kürbiskernöl (PGI))

6

*

Commission Regulation (EU) 2023/198 of 30 January 2023 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin in or on certain products (
  1
  )

1

7

*

Commission Implementing Regulation (EU) 2023/199 of 30 January 2023 approving the low-risk active substance Trichoderma atroviride AT10 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

Trichoderma atroviride

1

22

*

Commission Implementing Regulation (EU) 2023/200 of 30 January 2023 concerning the non-approval of lemon essential oil (Citrus limon essential oil) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (
  1
  )

Citrus limon

1

26

DECISIONS

*

Commission Implementing Decision (EU) 2023/201 of 30 January 2023 setting the date on which operations of the Schengen Information System start pursuant to Regulation (EU) 2018/1861 of the European Parliament and of the Council and Regulation (EU) 2018/1862 of the European Parliament and of the Council

29

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

*

Decision No 01/2022 of the Committee on Customs of the Free Trade Agreement between the European Union and the Republic of Singapore of 20 December 2022 modifying certain elements in Protocol 1 concerning the definition of the concept of originating products and methods of administrative cooperation and its Annexes [2023/202]

33

| | |
| --- | --- |
| | (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

| 31.1.2023 | EN | Official Journal of the European Union | L 27/1 |
| --- | --- | --- | --- |

31.1.2023

EN

Official Journal of the European Union

L 27/1

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COMMISSION DELEGATED REGULATION (EU) 2023/196

of 25 November 2022

amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances

(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 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (1), and in particular Article 15 thereof,

Having regard to Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (2), and in particular Article 30a thereof,

Whereas:

| (1) | Regulation (EC) No 273/2004 lays down measures for monitoring trade in drug precursors within the Union, while Regulation (EC) No 111/2005 governs trade in drug precursors between the Union and third countries. Annex I to Regulation (EC) No 273/2004 and the Annex to Regulation (EC) No 111/2005 each contain a list of scheduled substances, which are subject to a number of harmonised control and monitoring measures provided for by those Regulations. |
| --- | --- |

(1)

Regulation (EC) No 273/2004 lays down measures for monitoring trade in drug precursors within the Union, while Regulation (EC) No 111/2005 governs trade in drug precursors between the Union and third countries. Annex I to Regulation (EC) No 273/2004 and the Annex to Regulation (EC) No 111/2005 each contain a list of scheduled substances, which are subject to a number of harmonised control and monitoring measures provided for by those Regulations.

| (2) | By means of Decisions 65/4, 65/5 and 65/6 of the Commission on Narcotic Drugs of the United Nations, taken at its sixty-fifth session from 14 to 18 March 2022, the substances N-phenylpiperidin-4-amine (4-AP), tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP) and N-phenyl-N-(piperidin-4-yl)propanamide (norfentanyl) have been added to Table I of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances done at Vienna on 19 December 1988 and approved by Council Decision 90/611/EEC (3) (‘the 1988 UN Convention’). |
| --- | --- |

(2)

By means of Decisions 65/4, 65/5 and 65/6 of the Commission on Narcotic Drugs of the United Nations, taken at its sixty-fifth session from 14 to 18 March 2022, the substances N-phenylpiperidin-4-amine (4-AP), tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP) and N-phenyl-N-(piperidin-4-yl)propanamide (norfentanyl) have been added to Table I of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances done at Vienna on 19 December 1988 and approved by Council Decision 90/611/EEC (3) (‘the 1988 UN Convention’).

| (3) | 4-AP is a substitute chemical for N-phenethyl-4-piperidone (NPP) to synthesize 4-anilino-N-phenethylpiperidine (ANPP), which itself is an immediate precursor for the manufacture of fentanyl and some of its analogues. |
| --- | --- |

(3)

4-AP is a substitute chemical for N-phenethyl-4-piperidone (NPP) to synthesize 4-anilino-N-phenethylpiperidine (ANPP), which itself is an immediate precursor for the manufacture of fentanyl and some of its analogues.

| (4) | 1-boc-4-AP is a chemically protected derivative of 4-AP, which could be converted to 4-AP, norfentanyl or a number of norfentanyl analogues. |
| --- | --- |

(4)

1-boc-4-AP is a chemically protected derivative of 4-AP, which could be converted to 4-AP, norfentanyl or a number of norfentanyl analogues.

| (5) | Norfentanyl is an immediate precursor of fentanyl and a number of fentanyl analogues. |
| --- | --- |

(5)

Norfentanyl is an immediate precursor of fentanyl and a number of fentanyl analogues.

| (6) | NPP and ANPP are already scheduled substances in Regulations (EC) No 273/2004 and (EC) No 111/2005. Fentanyl and fentanyl analogues are very potent narcotic drugs, typically 10 to 100 times stronger than heroin. Their high potency continues to result in overdose deaths in users. |
| --- | --- |

(6)

NPP and ANPP are already scheduled substances in Regulations (EC) No 273/2004 and (EC) No 111/2005. Fentanyl and fentanyl analogues are very potent narcotic drugs, typically 10 to 100 times stronger than heroin. Their high potency continues to result in overdose deaths in users.

| (7) | National competent authorities have indicated the seizure of diethyl (phenylacetyl) propanedioate (DEPAPD) and ethyl 3-(2H-1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK ethyl glycidate). |
| --- | --- |

(7)

National competent authorities have indicated the seizure of diethyl (phenylacetyl) propanedioate (DEPAPD) and ethyl 3-(2H-1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK ethyl glycidate).

| (8) | DEPAPD is used to produce 1-Phenyl-2-propanone (P-2-P), also known as benzyl methyl ketone (BMK). BMK is a precursor of amphetamine and methamphetamine, two of the most common drugs illicitly produced in the Union. Both have severe consequences for human health. |
| --- | --- |

(8)

DEPAPD is used to produce 1-Phenyl-2-propanone (P-2-P), also known as benzyl methyl ketone (BMK). BMK is a precursor of amphetamine and methamphetamine, two of the most common drugs illicitly produced in the Union. Both have severe consequences for human health.

| (9) | PMK ethyl glycidate is a precursor of 3,4-Methylenedioxyphenylpropan-2-one (PMK), which, in turn, is used to produce 3,4-methylenedioxymethamphetamine (MDMA), commonly known as ‘ecstasy’. |
| --- | --- |

(9)

PMK ethyl glycidate is a precursor of 3,4-Methylenedioxyphenylpropan-2-one (PMK), which, in turn, is used to produce 3,4-methylenedioxymethamphetamine (MDMA), commonly known as ‘ecstasy’.

| (10) | BMK, as well as some of its other pre-precursors which are very similar to DEPAPD (such as methyl alpha-phenylacetoacetate (MAPA) or alpha-phenylacetoacetamide (APAA)), and PMK are already scheduled substances in Regulations (EC) No 273/2004 and (EC) No 111/2005. |
| --- | --- |

(10)

BMK, as well as some of its other pre-precursors which are very similar to DEPAPD (such as methyl alpha-phenylacetoacetate (MAPA) or alpha-phenylacetoacetamide (APAA)), and PMK are already scheduled substances in Regulations (EC) No 273/2004 and (EC) No 111/2005.

| (11) | Amphetamine, methamphetamine and MDMA are some of the most common drugs illicitly produced in the Union. They have severe consequences for human health and are causing serious social and public health problems in some regions of the Union. |
| --- | --- |

(11)

Amphetamine, methamphetamine and MDMA are some of the most common drugs illicitly produced in the Union. They have severe consequences for human health and are causing serious social and public health problems in some regions of the Union.

| (12) | 4-AP, 1-boc-4-AP, norfentanyl, DEPAPD and PMK ethyl glycidate have been designed by criminal organisations to avoid the strict controls of scheduled substances provided for by Regulations (EC) No 273/2004 and (EC) No 111/2005. Therefore, 4-AP, 1-boc-4-AP, norfentanyl, DEPAPD and PMK ethyl glycidate should also be scheduled at Union level to reinforce the control and monitoring of those substances. |
| --- | --- |

(12)

4-AP, 1-boc-4-AP, norfentanyl, DEPAPD and PMK ethyl glycidate have been designed by criminal organisations to avoid the strict controls of scheduled substances provided for by Regulations (EC) No 273/2004 and (EC) No 111/2005. Therefore, 4-AP, 1-boc-4-AP, norfentanyl, DEPAPD and PMK ethyl glycidate should also be scheduled at Union level to reinforce the control and monitoring of those substances.

| (13) | The scheduled substances listed in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005 are divided into categories for which different measures apply, so as to achieve a proportionate balance between the level of threat posed by each specific substance and the burden on licit trade. The strictest control and monitoring measures apply to substances of Category 1. |
| --- | --- |

(13)

The scheduled substances listed in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005 are divided into categories for which different measures apply, so as to achieve a proportionate balance between the level of threat posed by each specific substance and the burden on licit trade. The strictest control and monitoring measures apply to substances of Category 1.

| (14) | 4-AP, 1-boc-4-AP and norfentanyl, should be scheduled as Category 1 substances because they can be easily transformed to support the production of fentanyl and its analogues and pose a significant threat to social and public health in the Union. |
| --- | --- |

(14)

4-AP, 1-boc-4-AP and norfentanyl, should be scheduled as Category 1 substances because they can be easily transformed to support the production of fentanyl and its analogues and pose a significant threat to social and public health in the Union.

| (15) | DEPAPD and PMK ethyl glycidate should be scheduled as Category 1 substances because they can be easily transformed to support the production of methamphetamine, amphetamine and MDMA and pose a significant threat to social and public health in the Union. |
| --- | --- |

(15)

DEPAPD and PMK ethyl glycidate should be scheduled as Category 1 substances because they can be easily transformed to support the production of methamphetamine, amphetamine and MDMA and pose a significant threat to social and public health in the Union.

| (16) | 4-AP, 1-boc-4-AP, norfentanyl, DEPAPD and PMK ethyl glycidate have no known licit production, trade or use, except for research purposes. Therefore, including those substances under Category 1 in Annex I to Regulation (EC) No 273/2004 and under Category 1 in the Annex to Regulation (EC) No 111/2005 would be an adequate response to avoid their use in the illicit manufacture of narcotic drugs and, at the same time, would not entail any significant extra administrative burden for economic operators and competent authorities in the Union. |
| --- | --- |

(16)

4-AP, 1-boc-4-AP, norfentanyl, DEPAPD and PMK ethyl glycidate have no known licit production, trade or use, except for research purposes. Therefore, including those substances under Category 1 in Annex I to Regulation (EC) No 273/2004 and under Category 1 in the Annex to Regulation (EC) No 111/2005 would be an adequate response to avoid their use in the illicit manufacture of narcotic drugs and, at the same time, would not entail any significant extra administrative burden for economic operators and competent authorities in the Union.

| (17) | Regulations (EC) No 273/2004 and (EC) No 111/2005 should therefore be amended accordingly. |
| --- | --- |

(17)

Regulations (EC) No 273/2004 and (EC) No 111/2005 should therefore be amended accordingly.

| (18) | The Commission Implementing Regulation (EU) 2021/1832 of 12 October 2021 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (4) reclassified ANPP and NPP. Regulations (EC) No 273/2004 and (EC) No 111/2005 should therefore be amended and corrected accordingly. |
| --- | --- |

(18)

The Commission Implementing Regulation (EU) 2021/1832 of 12 October 2021 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (4) reclassified ANPP and NPP. Regulations (EC) No 273/2004 and (EC) No 111/2005 should therefore be amended and corrected accordingly.

| (19) | Regulations (EC) No 273/2004 and (EC) No 111/2005 jointly implement the drug precursors related provisions of the 1988 UN Convention. In view of the close substantive link between the empowerments contained in those Regulations, it is appropriate to adopt the amendments by way of one single delegated act, |
| --- | --- |

(19)

Regulations (EC) No 273/2004 and (EC) No 111/2005 jointly implement the drug precursors related provisions of the 1988 UN Convention. In view of the close substantive link between the empowerments contained in those Regulations, it is appropriate to adopt the amendments by way of one single delegated act,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 273/2004

Annex I to Regulation (EC) No 273/2004 is amended in accordance with Annex I to this Regulation.

Article 2

Amendments to Regulation (EC) No 111/2005

The Annex to Regulation (EC) No 111/2005 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 25 November 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 47, 18.2.2004, p. 1.

1

(2)  
  OJ L 22, 26.1.2005, p. 1.

2

(3)  Council Decision 90/611/EEC of 22 October 1990 concerning the conclusion, on behalf of the European Economic Community, of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (OJ L 326, 24.11.1990, p. 56).

3

(4)  
  OJ L 385, 29.10.2021, p. 1.

4

---

ANNEX I

In Regulation (EC) No 273/2004, in Annex I, in the table for Category 1,

| (1) | the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:








  Substance | CN designation (if different) | CN Code | CAS No |
| --- | --- | --- | --- | --- |
| ‘diethyl (phenylacetyl) propanedioate (DEPAPD) | | 2918 30 00 | 20320-59-6’ |
| ‘ethyl 3-(2H-1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK ethyl glycidate) | | 2932 99 00 | 28578-16-7’ |
| ‘N-phenylpiperidin-4-amine (4-AP) | | 2933 39 99 | 23056-29-3’ |
| ‘tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP) | | 2933 39 99 | 125541-22-2’ |
| ‘N-phenyl-N-(piperidin-4-yl)propanamide (norfentanyl) | | 2933 39 99 | 1609-66-1’ |

(1)

the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:

Substance

CN designation (if different)

CN Code

CAS No

‘diethyl (phenylacetyl) propanedioate (DEPAPD)

2918 30 00

20320-59-6’

‘ethyl 3-(2H-1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK ethyl glycidate)

2932 99 00

28578-16-7’

‘N-phenylpiperidin-4-amine (4-AP)

2933 39 99

23056-29-3’

‘tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP)

2933 39 99

125541-22-2’

‘N-phenyl-N-(piperidin-4-yl)propanamide (norfentanyl)

2933 39 99

1609-66-1’

| (2) | for:









  Substance | CN designation (if different) | CN Code | CAS No |
| --- | --- | --- | --- | --- |
| ‘4-anilino-N- phenethylpiperidine (ANPP) | | 2933 39 99 | 21409-26-7’ |
| ‘N-phenethyl-4-piperidone (NPP) | | 2933 39 99 | 39742-60-4’ |

(2)

for:

Substance

CN designation (if different)

CN Code

CAS No

‘4-anilino-N- phenethylpiperidine (ANPP)

2933 39 99

21409-26-7’

‘N-phenethyl-4-piperidone (NPP)

2933 39 99

39742-60-4’

read:

| Substance | CN designation (if different) | CN Code | CAS No |
| --- | --- | --- | --- |
| ‘N-phenyl-1-(2-phenylethyl)piperidin-4-amine | 4-anilino-N- phenethylpiperidine (ANPP) | 2933 36 00 | 21409-26-7’ |
| ‘1-(2-phenylethyl)piperidin-4-one | N-phenethyl-4-piperidone (NPP) | 2933 37 00 | 39742-60-4’ |

Substance

CN designation (if different)

CN Code

CAS No

‘N-phenyl-1-(2-phenylethyl)piperidin-4-amine

4-anilino-N- phenethylpiperidine (ANPP)

2933 36 00

21409-26-7’

‘1-(2-phenylethyl)piperidin-4-one

N-phenethyl-4-piperidone (NPP)

2933 37 00

39742-60-4’

---

ANNEX II

In Regulation (EC) No 111/2005, in the Annex, in the table for Category 1,

| (1) | the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:








  Substance | CN designation (if different) | CN Code | CAS No |
| --- | --- | --- | --- | --- |
| ‘diethyl (phenylacetyl) propanedioate (DEPAPD) | | 2918 30 00 | 20320-59-6’ |
| ‘ethyl 3-(2H-1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK ethyl glycidate) | | 2932 99 00 | 28578-16-7’ |
| ‘N-phenylpiperidin-4-amine (4-AP) | | 2933 39 99 | 23056-29-3’ |
| ‘tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP) | | 2933 39 99 | 125541-22-2’ |
| ‘N-phenyl-N-(piperidin-4-yl)propanamide (norfentanyl) | | 2933 39 99 | 1609-66-1’ |

(1)

the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:

Substance

CN designation (if different)

CN Code

CAS No

‘diethyl (phenylacetyl) propanedioate (DEPAPD)

2918 30 00

20320-59-6’

‘ethyl 3-(2H-1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK ethyl glycidate)

2932 99 00

28578-16-7’

‘N-phenylpiperidin-4-amine (4-AP)

2933 39 99

23056-29-3’

‘tert-butyl 4-anilinopiperidine-1-carboxylate (1-boc-4-AP)

2933 39 99

125541-22-2’

‘N-phenyl-N-(piperidin-4-yl)propanamide (norfentanyl)

2933 39 99

1609-66-1’

| (2) | for:









  Substance | CN designation (if different) | CN Code | CAS No |
| --- | --- | --- | --- | --- |
| ‘4-anilino-N- phenethylpiperidine (ANPP) | | 2933 39 99 | 21409-26-7’ |
| ‘N-phenethyl-4-piperidone (NPP) | | 2933 39 99 | 39742-60-4’ |

(2)

for:

Substance

CN designation (if different)

CN Code

CAS No

‘4-anilino-N- phenethylpiperidine (ANPP)

2933 39 99

21409-26-7’

‘N-phenethyl-4-piperidone (NPP)

2933 39 99

39742-60-4’

read:

| Substance | CN designation (if different) | CN Code | CAS No |
| --- | --- | --- | --- |
| ‘N-phenyl-1-(2-phenylethyl)piperidin-4-amine | 4-anilino-N- phenethylpiperidine (ANPP) | 2933 36 00 | 21409-26-7’ |
| ‘1-(2-phenylethyl)piperidin-4-one | N-phenethyl-4-piperidone (NPP) | 2933 37 00 | 39742-60-4’ |

Substance

CN designation (if different)

CN Code

CAS No

‘N-phenyl-1-(2-phenylethyl)piperidin-4-amine

4-anilino-N- phenethylpiperidine (ANPP)

2933 36 00

21409-26-7’

‘1-(2-phenylethyl)piperidin-4-one

N-phenethyl-4-piperidone (NPP)

2933 37 00

39742-60-4’

---

| 31.1.2023 | EN | Official Journal of the European Union | L 27/6 |
| --- | --- | --- | --- |

31.1.2023

EN

Official Journal of the European Union

L 27/6

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/197

of 24 January 2023

approving non-minor amendments to the product specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Steirisches Kürbiskernöl’ (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Austria’s application for the approval of amendments to the specification for the protected geographical indication ‘Steirisches Kürbiskernöl’, registered under Commission Regulation (EC) No 1263/96 (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Austria’s application for the approval of amendments to the specification for the protected geographical indication ‘Steirisches Kürbiskernöl’, registered under Commission Regulation (EC) No 1263/96 (2).

| (2) | Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation. |
| --- | --- |

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

| (3) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved, |
| --- | --- |

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the product specification published in the Official Journal of the European Union regarding the name ‘Steirisches Kürbiskernöl’ (PGI) are hereby approved.

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, 24 January 2023.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1263/96 of 1 July 1996 supplementing the Annex to Regulation (EC) No 1107/96 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Regulation (EEC) No 2081/92 (OJ L 163, 2.7.1996, p. 19).

2

(3)  
  OJ C 327, 30.8.2022, p. 5.

3

---

| 31.1.2023 | EN | Official Journal of the European Union | L 27/7 |
| --- | --- | --- | --- |

31.1.2023

EN

Official Journal of the European Union

L 27/7

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COMMISSION REGULATION (EU) 2023/198

of 30 January 2023

amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a) and Article 49(2) thereof,

Whereas:

| (1) | For abamectin, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

For abamectin, maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005.

| (2) | During the review of those MRLs in accordance with Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (‘the Authority’), identified in its reasoned opinion (2) some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers and the data gaps were indicated in Annex II of that Regulation specifying the date by which the missing information was to be submitted to the Authority in support of the proposed MRLs. |
| --- | --- |

(2)

During the review of those MRLs in accordance with Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (‘the Authority’), identified in its reasoned opinion (2) some information as unavailable for certain products. The available information was sufficient for the Authority to propose MRLs that are safe for consumers and the data gaps were indicated in Annex II of that Regulation specifying the date by which the missing information was to be submitted to the Authority in support of the proposed MRLs.

| (3) | The applicant submitted the missing data together with a request based on Article 6 of Regulation (EC) No 396/2005 to modify the existing MRLs for abamectin in certain products. |
| --- | --- |

(3)

The applicant submitted the missing data together with a request based on Article 6 of Regulation (EC) No 396/2005 to modify the existing MRLs for abamectin in certain products.

| (4) | In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. |
| --- | --- |

(4)

In accordance with Article 8 of Regulation (EC) No 396/2005, the application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.

| (5) | The Authority assessed the application and the evaluation report, examining in particular risks to consumers and, where relevant, to animals. |
| --- | --- |

(5)

The Authority assessed the application and the evaluation report, examining in particular risks to consumers and, where relevant, to animals.

| (6) | On 23 January 2020, the Authority published a reasoned opinion on the evaluation of the confirmatory data submitted following the MRL review under Article 12 of Regulation (EC) No 396/2005 and on the request to modify the existing maximum residue levels for abamectin in various commodities (3). |
| --- | --- |

(6)

On 23 January 2020, the Authority published a reasoned opinion on the evaluation of the confirmatory data submitted following the MRL review under Article 12 of Regulation (EC) No 396/2005 and on the request to modify the existing maximum residue levels for abamectin in various commodities (3).

| (7) | For almonds, hazelnuts/cobnuts, walnuts, currants (black, red and white), gooseberries (green, red and yellow), papayas and witloofs/Belgian endives information concerning residue trials was not submitted by the applicant. The Authority concluded that the data gap was thus not sufficiently addressed and that risk managers may consider setting or keeping those MRLs at the limit of determination (LOD). Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the LOD. It is therefore appropriate to amend the Annex II and to delete the reference concerning additional information from that Annex. |
| --- | --- |

(7)

For almonds, hazelnuts/cobnuts, walnuts, currants (black, red and white), gooseberries (green, red and yellow), papayas and witloofs/Belgian endives information concerning residue trials was not submitted by the applicant. The Authority concluded that the data gap was thus not sufficiently addressed and that risk managers may consider setting or keeping those MRLs at the limit of determination (LOD). Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the LOD. It is therefore appropriate to amend the Annex II and to delete the reference concerning additional information from that Annex.

| (8) | For quinces, medlars, loquats/Japanese medlars, the applicant proposed to derive an MRL based on an alternative Good Agricultural Practices (GAP). This use and the residue trials were already assessed in a previous reasoned opinion (4). The Authority concluded that the residue data were sufficient to support lower MRL proposals for those products. Therefore, for those products, MRLs in Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the Authority. |
| --- | --- |

(8)

For quinces, medlars, loquats/Japanese medlars, the applicant proposed to derive an MRL based on an alternative Good Agricultural Practices (GAP). This use and the residue trials were already assessed in a previous reasoned opinion (4). The Authority concluded that the residue data were sufficient to support lower MRL proposals for those products. Therefore, for those products, MRLs in Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the Authority.

| (9) | For celery leaves, beans with pods and peas with pods, Authority concluded that residue data were sufficient to support the MRL for those products. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level requested by the applicant. |
| --- | --- |

(9)

For celery leaves, beans with pods and peas with pods, Authority concluded that residue data were sufficient to support the MRL for those products. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level requested by the applicant.

| (10) | In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 applications for import tolerances were submitted for abamectin used in the United States on certain products. |
| --- | --- |

(10)

In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 applications for import tolerances were submitted for abamectin used in the United States on certain products.

| (11) | The applicant states that the authorised uses of abamectin on such crops in that country lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops. |
| --- | --- |

(11)

The applicant states that the authorised uses of abamectin on such crops in that country lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops.

| (12) | In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member State concerned and the evaluation report was forwarded to the Commission. |
| --- | --- |

(12)

In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.

| (13) | The Authority assessed the applications and the evaluation report, examining in particular risks to consumers and, where relevant, to animals. |
| --- | --- |

(13)

The Authority assessed the applications and the evaluation report, examining in particular risks to consumers and, where relevant, to animals.

| (14) | On 10 July 2020, the Authority published a reasoned opinion on setting of import tolerances for abamectin in various crops (5). |
| --- | --- |

(14)

On 10 July 2020, the Authority published a reasoned opinion on setting of import tolerances for abamectin in various crops (5).

| (15) | As regards modifications to MRLs requested by the applicant for avocados, cresses and other sprouts and shoot, land cresses, Roman rocket/rucola, baby leaf crops (including brassica species), other lettuces and salad plants, purslanes, Florence fennels and cotton seeds, the Authority concluded, that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicant were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to the substance via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level requested by the applicant. |
| --- | --- |

(15)

As regards modifications to MRLs requested by the applicant for avocados, cresses and other sprouts and shoot, land cresses, Roman rocket/rucola, baby leaf crops (including brassica species), other lettuces and salad plants, purslanes, Florence fennels and cotton seeds, the Authority concluded, that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicant were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to the substance via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level requested by the applicant.

| (16) | In the context of the procedure for the renewal of the approval of the active substance abamectin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (6), the Authority published a conclusion on the peer review of the risk assessment (7) of that active substance. The Authority proposed, based on the developmental neurotoxicity studies, that a lower acceptable daily intake (ADI) and acute reference dose (ARfD) should be established. |
| --- | --- |

(16)

In the context of the procedure for the renewal of the approval of the active substance abamectin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (6), the Authority published a conclusion on the peer review of the risk assessment (7) of that active substance. The Authority proposed, based on the developmental neurotoxicity studies, that a lower acceptable daily intake (ADI) and acute reference dose (ARfD) should be established.

| (17) | On 3 February 2021 and in accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion assessing the risks on certain existing MRLs for abamectin that may pose to consumers in light of the lower ADI and ARfD. |
| --- | --- |

(17)

On 3 February 2021 and in accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion assessing the risks on certain existing MRLs for abamectin that may pose to consumers in light of the lower ADI and ARfD.

| (18) | On 6 October 2021, the Authority published a reasoned opinion on the focussed assessment of certain existing maximum residues levels of concern for abamectin (8). |
| --- | --- |

(18)

On 6 October 2021, the Authority published a reasoned opinion on the focussed assessment of certain existing maximum residues levels of concern for abamectin (8).

| (19) | For apples, pears and escaroles/broad-leaved endives, the Authority identified unacceptable risks concerning the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. For apples and pears, a fall-back GAP could not proposed by the Member States. Supporting data was not available for the GAP reported for escaroles/broad-leaved endives. Therefore, no MRL could be derived for apples, pears and escaroles/broad-leaved endives. Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the LOD. |
| --- | --- |

(19)

For apples, pears and escaroles/broad-leaved endives, the Authority identified unacceptable risks concerning the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. For apples and pears, a fall-back GAP could not proposed by the Member States. Supporting data was not available for the GAP reported for escaroles/broad-leaved endives. Therefore, no MRL could be derived for apples, pears and escaroles/broad-leaved endives. Therefore, for these products, it is appropriate to set the MRLs in Annex II to Regulation (EC) No 396/2005 at the LOD.

| (20) | For strawberries, tomatoes, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, chervil and parsley, the Authority identified unacceptable risks concerning the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. Member States identified such GAPs for strawberries, tomatoes, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, chervil and parsley. The Authority therefore recommended lowering the MRLs for those products. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. |
| --- | --- |

(20)

For strawberries, tomatoes, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, chervil and parsley, the Authority identified unacceptable risks concerning the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. Member States identified such GAPs for strawberries, tomatoes, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, chervil and parsley. The Authority therefore recommended lowering the MRLs for those products. Therefore, for these products, MRLs should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority.

| (21) | For sweet peppers/bell peppers, the Authority identified unacceptable risks for consumers with the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. The Authority concluded that although Member States identified a fall-back GAP for sweet peppers/bell peppers, some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for sweet peppers/bell peppers should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. This MRL will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
| --- | --- |

(21)

For sweet peppers/bell peppers, the Authority identified unacceptable risks for consumers with the current MRLs. Member States were consulted and requested to report potential fall-back GAPs which would lead to safe MRLs for consumers. The Authority concluded that although Member States identified a fall-back GAP for sweet peppers/bell peppers, some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for sweet peppers/bell peppers should be set in Annex II to Regulation (EC) No 396/2005 at the level identified by the Authority. This MRL will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

| (22) | The Commission consulted the European Union reference laboratories for residues of pesticides on the need to adapt certain LODs. For abamectin, those laboratories proposed product specific LODs that are analytically feasible. |
| --- | --- |

(22)

The Commission consulted the European Union reference laboratories for residues of pesticides on the need to adapt certain LODs. For abamectin, those laboratories proposed product specific LODs that are analytically feasible.

| (23) | Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
| --- | --- |

(23)

Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

| (24) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(24)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (25) | In order to allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced in the Union or imported into the Union before the modified MRLs start applying and for which information shows that a high level of consumer protection is maintained. This is the case for all products except for apples, pears, strawberries, tomatoes, sweet peppers/bell peppers, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, escaroles/broad-leaved endives, chervil and parsley. |
| --- | --- |

(25)

In order to allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced in the Union or imported into the Union before the modified MRLs start applying and for which information shows that a high level of consumer protection is maintained. This is the case for all products except for apples, pears, strawberries, tomatoes, sweet peppers/bell peppers, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, escaroles/broad-leaved endives, chervil and parsley.

| (26) | A reasonable period should be allowed to elapse before the modified MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to meet the new requirements which will result from the modification of the MRLs. |
| --- | --- |

(26)

A reasonable period should be allowed to elapse before the modified MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to meet the new requirements which will result from the modification of the MRLs.

| (27) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(27)

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

Annex II to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.

Article 2

As regards active substance abamectin in and on all products except apples, pears, strawberries, tomatoes, sweet peppers/bell peppers, cucumbers, courgettes, lamb’s lettuces/corn salads, lettuces, escaroles/broad-leaved endives, chervil and parsley, Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 20 August 2023.

Article 3

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

It shall apply from 20 August 2023.

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

Done at Brussels, 30 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for abamectin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2014;12(9):3823.

2

(3)  European Food Safety Authority; Reasoned opinion on evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for abamectin in various commodities. EFSA Journal 2020;18(1):5989.

3

(4)  European Food Safety Authority; Reasoned opinion on the modification of the existing MRLs forabamectin in various crops. EFSA Journal 2015;13(7):4189.

4

(5)  European Food Safety Authority; Reasoned opinion on setting of import tolerances for abamectin in various crops. EFSA Journal 2020;18(7):6173.

5

(6)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1).

6

(7)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance abamectin. EFSA Journal 2020;18(8):6227.

7

(8)  European Food Safety Authority; Focused assessment of certain existing MRLs of concern for abamectin. EFSA Journal 2021;19(10):6842.

8

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ANNEX

In Annex II to Regulation (EC) No 396/2005, the column for abamectin is replaced by the following:

"
  Pesticide residues and maximum residue levels (mg/kg)

| Code number | Groups and examples of individual products to which the MRLs apply (1) | Abamectin (sum of avermectin B1a, avermectin B1b and delta-8,9 isomer of avermectin B1a, expressed as avermectin B1a) (R) (F) |
| --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | |
| 0110000 | Citrus fruits | 0,04 |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others (2) | |
| 0120000 | Tree nuts | 0,01
   ((*)) |
| 0120010 | Almonds | |
| 0120020 | Brazil nuts | |
| 0120030 | Cashew nuts | |
| 0120040 | Chestnuts | |
| 0120050 | Coconuts | |
| 0120060 | Hazelnuts/cobnuts | |
| 0120070 | Macadamias | |
| 0120080 | Pecans | |
| 0120090 | Pine nut kernels | |
| 0120100 | Pistachios | |
| 0120110 | Walnuts | |
| 0120990 | Others (2) | |
| 0130000 | Pome fruits | |
| 0130010 | Apples | 0,006
   ((*)) |
| 0130020 | Pears | 0,006
   ((*)) |
| 0130030 | Quinces | 0,02 |
| 0130040 | Medlars | 0,02 |
| 0130050 | Loquats/Japanese medlars | 0,02 |
| 0130990 | Others (2) | 0,01
   ((*)) |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | 0,02 |
| 0140020 | Cherries (sweet) | 0,01  ((*)) |
| 0140030 | Peaches | 0,02 |
| 0140040 | Plums | 0,01  ((*)) |
| 0140990 | Others (2) | 0,01  ((*)) |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) | grapes |

Code number

Groups and examples of individual products to which the MRLs apply (1)

Abamectin (sum of avermectin B1a, avermectin B1b and delta-8,9 isomer of avermectin B1a, expressed as avermectin B1a) (R) (F)

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,04

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others (2)

0120000

Tree nuts

0,01
   ((*))

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others (2)

0130000

Pome fruits

0130010

Apples

0,006
   ((*))

0130020

Pears

0,006
   ((*))

0130030

Quinces

0,02

0130040

Medlars

0,02

0130050

Loquats/Japanese medlars

0,02

0130990

Others (2)

0,01
   ((*))

0140000

Stone fruits

0140010

Apricots

0,02

0140020

Cherries (sweet)

0,01  ((*))

0140030

Peaches

0,02

0140040

Plums

0,01  ((*))

0140990

Others (2)

0,01  ((*))

0150000

Berries and small fruits

0151000

(a)

grapes

0,01  ((*))

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | strawberries |
| --- | --- |

(b)

strawberries

0,08

0153000

| (c) | cane fruits |
| --- | --- |

(c)

cane fruits

0153010

Blackberries

0,08

0153020

Dewberries

0,01  ((*))

0153030

Raspberries (red and yellow)

0,08

0153990

Others (2)

0,01  ((*))

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

other small fruits and berries

0,01  ((*))

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others (2)

0160000

Miscellaneous fruitswith

0161000

| (a) | edible peel |
| --- | --- |

(a)

edible peel

0,01  ((*))

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats

0161050

Carambolas

0161060

Kaki/Japanese persimmons

0161070

Jambuls/jambolans

0161990

Others (2)

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

inedible peel, small

0,01  ((*))

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others (2)

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

inedible peel, large

0163010

Avocados

0,02

0163020

Bananas

0,02

0163030

Mangoes

0,01  ((*))

0163040

Papayas

0,01
   ((*))

0163050

Granate apples/pomegranates

0,01  ((*))

0163060

Cherimoyas

0,01  ((*))

0163070

Guavas

0,01  ((*))

0163080

Pineapples

0,01  ((*))

0163090

Breadfruits

0,01  ((*))

0163100

Durians

0,01  ((*))

0163110

Soursops/guanabanas

0,01  ((*))

0163990

Others (2)

0,01  ((*))

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01  ((*))

0211000

| (a) | potatoes |
| --- | --- |

(a)

potatoes

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

tropical root and tuber vegetables

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others (2)

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

other root and tuber vegetables except sugar beets

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others (2)

0220000

Bulb vegetables

0,01  ((*))

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others (2)

0230000

Fruiting vegetables

0231000

| (a) | Solanaceae and Malvaceae |
| --- | --- |

(a)

Solanaceae and Malvaceae

0231010

Tomatoes

0,015

0231020

Sweet peppers/bell peppers

0,03 (+)

0231030

Aubergines/eggplants

0,09

0231040

Okra/lady's fingers

0,01  ((*))

0231990

Others (2)

0,01  ((*))

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

cucurbits with edible peel

0232010

Cucumbers

0,02

0232020

Gherkins

0,04

0232030

Courgettes

0,02

0232990

Others (2)

0,04

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

cucurbits with inedible peel

0,01  ((*))

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others (2)

0234000

| (d) | sweet corn |
| --- | --- |

(d)

sweet corn

0,01  ((*))

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

other fruiting vegetables

0,01  ((*))

0240000

Brassica vegetables(excluding brassica roots and brassica baby leaf crops)

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

flowering brassica

0,01  ((*))

0241010

Broccoli

0241020

Cauliflowers

0241990

Others (2)

0242000

| (b) | head brassica |
| --- | --- |

(b)

head brassica

0,01  ((*))

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others (2)

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

leafy brassica

0243010

Chinese cabbages/pe-tsai

0,05

0243020

Kales

0,01  ((*))

0243990

Others (2)

0,01  ((*))

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

kohlrabies

0,01  ((*))

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

lettuces and salad plants

0251010

Lamb's lettuces/corn salads

0,08

0251020

Lettuces

0,03

0251030

Escaroles/broad-leaved endives

0,01
   ((*))

0251040

Cresses and other sprouts and shoots

0,08

0251050

Land cresses

0,08

0251060

Roman rocket/rucola

0,08

0251070

Red mustards

0,01  ((*))

0251080

Baby leaf crops (including brassica species)

3

0251990

Others (2)

0,08

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

spinaches and similar leaves

0252010

Spinaches

0,01  ((*))

0252020

Purslanes

0,1

0252030

Chards/beet leaves

0,01  ((*))

0252990

Others (2)

0,1

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

grape leaves and similar species

0,01  ((*))

0254000

| (d) | watercresses |
| --- | --- |

(d)

watercresses

0,01  ((*))

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

witloofs/Belgian endives

0,01  ((*))

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

herbs and edible flowers

0256010

Chervil

0,03

0256020

Chives

2

0256030

Celery leaves

0,03

0256040

Parsley

0,03

0256050

Sage

2

0256060

Rosemary

2

0256070

Thyme

2

0256080

Basil and edible flowers

2

0256090

Laurel/bay leaves

2

0256100

Tarragon

2

0256990

Others (2)

0,02  ((*))

0260000

Legume vegetables

0260010

Beans (with pods)

0,08

0260020

Beans (without pods)

0,01  ((*))

0260030

Peas (with pods)

0,08

0260040

Peas (without pods)

0,01  ((*))

0260050

Lentils

0,01  ((*))

0260990

Others (2)

0,01  ((*))

0270000

Stem vegetables

0270010

Asparagus

0,01  ((*))

0270020

Cardoons

0,01  ((*))

0270030

Celeries

0,05

0270040

Florence fennels

0,03

0270050

Globe artichokes

0,01  ((*))

0270060

Leeks

0,01  ((*))

0270070

Rhubarbs

0,01  ((*))

0270080

Bamboo shoots

0,01  ((*))

0270090

Palm hearts

0,01  ((*))

0270990

Others (2)

0,01  ((*))

0280000

Fungi, mosses and lichens

0,01  ((*))

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01  ((*))

0300000

PULSES

0,01  ((*))

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others (2)

0400000

OILSEEDS AND OIL FRUITS

0401000

Oilseeds

0401010

Linseeds

0,01  ((*))

0401020

Peanuts/groundnuts

0,01  ((*))

0401030

Poppy seeds

0,01  ((*))

0401040

Sesame seeds

0,01  ((*))

0401050

Sunflower seeds

0,01  ((*))

0401060

Rapeseeds/canola seeds

0,01  ((*))

0401070

Soyabeans

0,01  ((*))

0401080

Mustard seeds

0,01  ((*))

0401090

Cotton seeds

0,02

0401100

Pumpkin seeds

0,01  ((*))

0401110

Safflower seeds

0,01  ((*))

0401120

Borage seeds

0,01  ((*))

0401130

Gold of pleasure seeds

0,01  ((*))

0401140

Hemp seeds

0,01  ((*))

0401150

Castor beans

0,01  ((*))

0401990

Others (2)

0,01  ((*))

0402000

Oil fruits

0,01  ((*))

0402010

Olives for oil production

0402020

Oil palms kernels

0402030

Oil palms fruits

0402040

Kapok

0402990

Others (2)

0500000

CEREALS

0,01  ((*))

0500010

Barley

0500020

Buckwheat and other pseudocereals

0500030

Maize/corn

0500040

Common millet/proso millet

0500050

Oat

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat

0500990

Others (2)

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,05  ((*))

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0631000

| (a) | flowers |
| --- | --- |

(a)

flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others (2)

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others (2)

0633000

| (c) | roots |
| --- | --- |

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others (2)

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

any other parts of the plant

0640000

Cocoa beans

0650000

Carobs/Saint John's breads

0700000

HOPS

0,1

0800000

SPICES

0810000

Seed spices

0,05  ((*))

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others (2)

0820000

Fruit spices

0,05  ((*))

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others (2)

0830000

Bark spices

0,05  ((*))

0830010

Cinnamon

0830990

Others (2)

0840000

Root and rhizome spices

0840010

Liquorice

0,05  ((*))

0840020

Ginger (10)

0840030

Turmeric/curcuma

0,05  ((*))

0840040

Horseradish (11)

0840990

Others (2)

0,05  ((*))

0850000

Bud spices

0,05  ((*))

0850010

Cloves

0850020

Capers

0850990

Others (2)

0860000

Flower pistil spices

0,05  ((*))

0860010

Saffron

0860990

Others (2)

0870000

Aril spices

0,05  ((*))

0870010

Mace

0870990

Others (2)

0900000

SUGAR PLANTS

0,01  ((*))

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others (2)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Commodities from

1011000

| (a) | swine |
| --- | --- |

(a)

swine

0,01  ((*))

1011010

Muscle

1011020

Fat

1011030

Liver

1011040

Kidney

1011050

Edible offals (other than liver and kidney)

1011990

Others (2)

1012000

| (b) | bovine |
| --- | --- |

(b)

bovine

1012010

Muscle

0,01  ((*))

1012020

Fat

0,01  ((*))

1012030

Liver

0,02

1012040

Kidney

0,01  ((*))

1012050

Edible offals (other than liver and kidney)

0,02

1012990

Others (2)

0,01  ((*))

1013000

| (c) | sheep |
| --- | --- |

(c)

sheep

1013010

Muscle

0,02

1013020

Fat

0,05

1013030

Liver

0,025

1013040

Kidney

0,02

1013050

Edible offals (other than liver and kidney)

0,05

1013990

Others (2)

0,01  ((*))

1014000

| d) | goat |
| --- | --- |

d)

goat

1014010

Muscle

0,01  ((*))

1014020

Fat

0,01  ((*))

1014030

Liver

0,02

1014040

Kidney

0,01  ((*))

1014050

Edible offals (other than liver and kidney)

0,02

1014990

Others (2)

0,01  ((*))

1015000

| (e) | equine |
| --- | --- |

(e)

equine

1015010

Muscle

0,01  ((*))

1015020

Fat

0,01  ((*))

1015030

Liver

0,02

1015040

Kidney

0,01  ((*))

1015050

Edible offals (other than liver and kidney)

0,02

1015990

Others (2)

0,01  ((*))

1016000

| (f) | poultry |
| --- | --- |

(f)

poultry

0,01  ((*))

1016010

Muscle

1016020

Fat

1016030

Liver

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others (2)

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

other farmed terrestrial animals

1017010

Muscle

0,01  ((*))

1017020

Fat

0,01  ((*))

1017030

Liver

0,02

1017040

Kidney

0,01  ((*))

1017050

Edible offals (other than liver and kidney)

0,02

1017990

Others (2)

0,01  ((*))

1020000

Milk

0,01  ((*))

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others (2)

1030000

Birds eggs

0,01  ((*))

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others (2)

1040000

Honey and other apiculture products (7)

0,05  ((*))

1050000

Amphibians and Reptiles

0,01  ((*))

1060000

Terrestrial invertebrate animals

0,01  ((*))

1070000

Wild terrestrial vertebrate animals

0,01  ((*))

1100000

PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)

1200000

PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL FEED PRODUCTION (8)

1300000

PROCESSED FOOD PRODUCTS (9)

Abamectin (sum of avermectin B1a, avermectin B1b and delta-8,9 isomer of avermectin B1a, expressed as avermectin B1a) (R) (F)

| (R) | The residue definition differs for the following combinations pesticide-code number: Abamectin — code 1000000 except 1040000: avermectin B1a |
| --- | --- |

(R)

The residue definition differs for the following combinations pesticide-code number: Abamectin — code 1000000 except 1040000: avermectin B1a

| (F) | Fat soluble |
| --- | --- |

(F)

Fat soluble

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 31 January 2025, or, if that information is not submitted by that date, the lack of it.

0231020 Sweet peppers/bell peppers"

---

((*))  Indicates lower limit of analytical determination

(*)

(1)  For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I

1

---

| 31.1.2023 | EN | Official Journal of the European Union | L 27/22 |
| --- | --- | --- | --- |

31.1.2023

EN

Official Journal of the European Union

L 27/22

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/199

of 30 January 2023

approving the low-risk active substance Trichoderma atroviride AT10 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | On 30 October 2018, France received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from Agrotecnologías Naturales S.L. for the approval of the active substance Trichoderma atroviride AT10. |
| --- | --- |

(1)

On 30 October 2018, France received an application pursuant to Article 7(1) of Regulation (EC) No 1107/2009 from Agrotecnologías Naturales S.L. for the approval of the active substance Trichoderma atroviride AT10.

| (2) | In accordance with Article 9(3) of Regulation (EC) No 1107/2009, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 15 February 2019 of the admissibility of the application. |
| --- | --- |

(2)

In accordance with Article 9(3) of Regulation (EC) No 1107/2009, France, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 15 February 2019 of the admissibility of the application.

| (3) | On 18 September 2020, after assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority. |
| --- | --- |

(3)

On 18 September 2020, after assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority.

| (4) | Pursuant to Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the draft assessment report to the applicant and the other Member States. |
| --- | --- |

(4)

Pursuant to Article 12(1) of Regulation (EC) No 1107/2009, the Authority circulated the draft assessment report to the applicant and the other Member States.

| (5) | In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested the applicant to supply additional information to the Member States, the Commission and the Authority. |
| --- | --- |

(5)

In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested the applicant to supply additional information to the Member States, the Commission and the Authority.

| (6) | The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report. |
| --- | --- |

(6)

The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the form of an updated draft assessment report.

| (7) | On 20 January 2022, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Trichoderma atroviride AT10 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public. |
| --- | --- |

(7)

On 20 January 2022, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance Trichoderma atroviride AT10 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

| (8) | On 14 July 2022, the Commission presented a review report regarding Trichoderma atroviride AT10 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed. |
| --- | --- |

(8)

On 14 July 2022, the Commission presented a review report regarding Trichoderma atroviride AT10 and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed.

| (9) | The Commission invited the applicant to submit its comments on the review report. The applicant submitted its comments, which have been carefully examined. |
| --- | --- |

(9)

The Commission invited the applicant to submit its comments on the review report. The applicant submitted its comments, which have been carefully examined.

| (10) | It has been established, with respect to one representative use of at least one plant protection product containing the active substance, which was examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
| --- | --- |

(10)

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

| (11) | The Commission further considers that Trichoderma atroviride AT10 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Trichoderma atroviride AT10 is not a microorganism of concern and fulfils the conditions set in Annex II point 5.2 to Regulation (EC) No 1107/2009. |
| --- | --- |

(11)

The Commission further considers that Trichoderma atroviride AT10 is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Trichoderma atroviride AT10 is not a microorganism of concern and fulfils the conditions set in Annex II point 5.2 to Regulation (EC) No 1107/2009.

| (12) | It is therefore appropriate to approve Trichoderma atroviride AT10 as a low-risk active substance. |
| --- | --- |

(12)

It is therefore appropriate to approve Trichoderma atroviride AT10 as a low-risk active substance.

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

(13)

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

| (14) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009 in conjunction with Article 22(2) thereof, Commission Implementing Regulation (EU) No 540/2011 (3) should therefore be amended accordingly. |
| --- | --- |

(14)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009 in conjunction with Article 22(2) thereof, Commission Implementing Regulation (EU) No 540/2011 (3) should therefore be amended accordingly.

| (15) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(15)

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

HAS ADOPTED THIS REGULATION:

Article 1

Approval of the active substance

The active substance Trichoderma atroviride AT10, is approved subject to the conditions set out in Annex I to this Regulation.

Trichoderma atroviride

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

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

Article 3

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 30 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain AT10. https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2022.7200. EFSA Journal 2022;7200. DOI: 10.2903/j.efsa.2022.7200.

2

Trichoderma atroviride

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

3

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Trichoderma atroviride AT10 | n.a. | The nominal content of Trichoderma atroviride AT10 in the technical product should be
  Minimal: 1 x 1011 CFU/kg
  Nominal: 5 x 1011CFU/kg
  Maximal: 1 x 1012 CFU/kg
  No relevant impurities | 20 February 2023 | 20 February 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride AT10 and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Trichoderma atroviride AT10

n.a.

The nominal content of Trichoderma atroviride AT10 in the technical product should be

Minimal: 1 x 1011 CFU/kg

Nominal: 5 x 1011CFU/kg

Maximal: 1 x 1012 CFU/kg

No relevant impurities

20 February 2023

20 February 2038

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride AT10 and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites;

| — | the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be considered to reduce dermal and inhalation exposure. |
| --- | --- |

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be considered to reduce dermal and inhalation exposure.

---

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

---

ANNEX II

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

| No | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘43 | Trichoderma atroviride AT10 | n.a. | The nominal content of Trichoderma atroviride AT10 in the technical product and formulation is
  Minimal: 1 x 1011 CFU/kg
  Nominal: 5 x 1011CFU/kg
  Maximal: 1 x 1012 CFU/kg
  No relevant impurities | 20 February 2023 | 20 February 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride AT10 and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  — | the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites; |

No

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘43

Trichoderma atroviride AT10

n.a.

The nominal content of Trichoderma atroviride AT10 in the technical product and formulation is

Minimal: 1 x 1011 CFU/kg

Nominal: 5 x 1011CFU/kg

Maximal: 1 x 1012 CFU/kg

No relevant impurities

20 February 2023

20 February 2038

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride AT10 and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the specification of the technical material as commercially manufactured used in plant protection products, including full characterisation of relevant secondary metabolites;

| — | the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be considered to reduce dermal and inhalation exposure. |
| --- | --- |

—

the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers. Use of PPE/RPE might be considered to reduce dermal and inhalation exposure.

---

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

1

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| 31.1.2023 | EN | Official Journal of the European Union | L 27/26 |
| --- | --- | --- | --- |

31.1.2023

EN

Official Journal of the European Union

L 27/26

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/200

of 30 January 2023

concerning the non-approval of lemon essential oil (Citrus limon essential oil) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) in conjunction with Article 23(5) thereof,

Whereas:

| (1) | On 6 June 2020, the Commission received an application from Cugargestion Management S. L. (‘the applicant’) for the approval of lemon essential oil as a basic substance to be used in plant protection as an acaricide, insecticide and fungicide on citrus fruit trees. In November 2020, the Commission received a revised application, which was accompanied by the information required under Article 23(3), second subparagraph, of Regulation (EC) No 1107/2009. |
| --- | --- |

(1)

On 6 June 2020, the Commission received an application from Cugargestion Management S. L. (‘the applicant’) for the approval of lemon essential oil as a basic substance to be used in plant protection as an acaricide, insecticide and fungicide on citrus fruit trees. In November 2020, the Commission received a revised application, which was accompanied by the information required under Article 23(3), second subparagraph, of Regulation (EC) No 1107/2009.

| (2) | The relevant evaluations, carried out in accordance with other Union legislation, as referred to in Article 23(2) of Regulation (EC) No 1107/2009, were available. As regards the lemon essential oil, an evaluation from the FEEDAP Panel of the European Food Safety Authority (‘the Authority’) was available (2). As regards the main component of lemon essential oil, namely d-limonene, the available relevant evaluations included a Conclusion on the peer review of the pesticide risk assessment issued by the Authority (3) as well as an opinion of the Risk Assessment Committee of the European Chemicals Agency (ECHA) (4). The outcome of these evaluations have been taken into account by the Authority as well as by the Commission. |
| --- | --- |

(2)

The relevant evaluations, carried out in accordance with other Union legislation, as referred to in Article 23(2) of Regulation (EC) No 1107/2009, were available. As regards the lemon essential oil, an evaluation from the FEEDAP Panel of the European Food Safety Authority (‘the Authority’) was available (2). As regards the main component of lemon essential oil, namely d-limonene, the available relevant evaluations included a Conclusion on the peer review of the pesticide risk assessment issued by the Authority (3) as well as an opinion of the Risk Assessment Committee of the European Chemicals Agency (ECHA) (4). The outcome of these evaluations have been taken into account by the Authority as well as by the Commission.

| (3) | The Commission asked the Authority for scientific assistance. The Authority provided the Commission with a technical report on lemon essential oil on 20 September 2021 (5). |
| --- | --- |

(3)

The Commission asked the Authority for scientific assistance. The Authority provided the Commission with a technical report on lemon essential oil on 20 September 2021 (5).

| (4) | With regard to human health, the Authority concluded that, even though no Union harmonised classification has been established for lemon essential oil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (6) on classification, labelling and packaging of chemical substances and mixtures, the main hazard associated with lemon essential oil is its toxicity by inhalation and skin sensitisation properties. The main component of lemon essential oil, d-limonene, is classified (7) as a substance that may be fatal if swallowed and when it enters airways (Asp. Tox.1), as a skin irritant (Skin Irrit 2) and as a substance that may cause an allergic skin reaction (Skin Sens.1B). Additionally, due to the absence of data, the Authority could not conclude its assessment of non-dietary risks for operators, workers, bystanders and residents. |
| --- | --- |

(4)

With regard to human health, the Authority concluded that, even though no Union harmonised classification has been established for lemon essential oil under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (6) on classification, labelling and packaging of chemical substances and mixtures, the main hazard associated with lemon essential oil is its toxicity by inhalation and skin sensitisation properties. The main component of lemon essential oil, d-limonene, is classified (7) as a substance that may be fatal if swallowed and when it enters airways (Asp. Tox.1), as a skin irritant (Skin Irrit 2) and as a substance that may cause an allergic skin reaction (Skin Sens.1B). Additionally, due to the absence of data, the Authority could not conclude its assessment of non-dietary risks for operators, workers, bystanders and residents.

| (5) | As regards the effect of lemon essential oil on the environment, the Authority noted that lemon essential oil is toxic to aquatic organisms. D-limonene is classified (8) as very toxic to aquatic life (Aquatic Acute 1) and as very toxic to aquatic life with long lasting effects (Aquatic Chronic 3). Moreover, the available data were not sufficient to demonstrate acceptable risk to non-target organisms. |
| --- | --- |

(5)

As regards the effect of lemon essential oil on the environment, the Authority noted that lemon essential oil is toxic to aquatic organisms. D-limonene is classified (8) as very toxic to aquatic life (Aquatic Acute 1) and as very toxic to aquatic life with long lasting effects (Aquatic Chronic 3). Moreover, the available data were not sufficient to demonstrate acceptable risk to non-target organisms.

| (6) | The Commission presented the review report, concluding that the approval criteria for basic substances are not fulfilled in the case of lemon essential oil and that it is therefore not to be approved as a basic substance, as well as a draft of this Implementing Regulation to the Standing Committee on Plants, Animals, Food and Feed on 12 April 2022 and 14 October 2022, respectively. |
| --- | --- |

(6)

The Commission presented the review report, concluding that the approval criteria for basic substances are not fulfilled in the case of lemon essential oil and that it is therefore not to be approved as a basic substance, as well as a draft of this Implementing Regulation to the Standing Committee on Plants, Animals, Food and Feed on 12 April 2022 and 14 October 2022, respectively.

| (7) | The Commission invited the applicant to submit its comments on the technical report of the Authority and on the Commission’s review report. The applicant submitted its comments, which were taken into due consideration. |
| --- | --- |

(7)

The Commission invited the applicant to submit its comments on the technical report of the Authority and on the Commission’s review report. The applicant submitted its comments, which were taken into due consideration.

| (8) | However, despite the arguments put forward by the applicant, the concerns related to the safety of using this substance with regard to the protection of human health and environment could not be eliminated. |
| --- | --- |

(8)

However, despite the arguments put forward by the applicant, the concerns related to the safety of using this substance with regard to the protection of human health and environment could not be eliminated.

| (9) | Consequently, it has not been established that the conditions laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to establish that lemon essential oil is not approved as a basic substance. |
| --- | --- |

(9)

Consequently, it has not been established that the conditions laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to establish that lemon essential oil is not approved as a basic substance.

| (10) | This Regulation does not prevent the submission of a further application for the approval of lemon essential oil as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009. |
| --- | --- |

(10)

This Regulation does not prevent the submission of a further application for the approval of lemon essential oil as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

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

(11)

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 substance lemon essential oil (Citrus limon essential oil) is not approved as a basic substance.

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, 30 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), Bampidis V, Azimonti G, Bastos ML, Christensen H, Kouba M, Faŝmon Durjava M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brantom P, Chesson A, Westendorf J, Galobart J, Manini P, Pizzo F and Dusemund B, 2021. Scientific Opinion on the safety and efficacy of feed additives consisting of expressed lemon oil and its fractions from Citrus limon (L.) Osbeck and of lime oil from Citrus aurantiifolia (Christm.) Swingle for use in all animal species (FEFANA asbl). EFSA Journal 2021;19(4):6548, 55 pp. https://doi.org/10.2903/j.efsa.2021.6548.

2

(3)  EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance orange oil. EFSA Journal 2013;11(2):3090. 55 pp. https://doi.org/10.2903/j.efsa.2013.3090.

3

(4)  ECHA (European Chemicals Agency) Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and labelling at EU level of (R)-p-mentha-1,8-diene; d-limonene. Adopted 15 March 2019. Available at https://echa.europa.eu/documents/10162/10c233b2-019e-4e59-e0c1-550133aed912.

4

(5)  EFSA (European Food Safety Authority), 2021. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for approval of lemon essential oil to be used in plant protection as an acaricide, insecticide and fungicide in fruit trees (citrus). EFSA supporting publication 2021: EN-6873. 147 pp. doi:10.2903/sp.efsa.2021.EN-6873.

5

(6)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

6

(7)  Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 188, 28.5.2021, p. 27).

7

(8)  Delegated Regulation (EU) 2021/849.

8

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DECISIONS

| 31.1.2023 | EN | Official Journal of the European Union | L 27/29 |
| --- | --- | --- | --- |

31.1.2023

EN

Official Journal of the European Union

L 27/29

---

COMMISSION IMPLEMENTING DECISION (EU) 2023/201

of 30 January 2023

setting the date on which operations of the Schengen Information System start pursuant to Regulation (EU) 2018/1861 of the European Parliament and of the Council and Regulation (EU) 2018/1862 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 (1), and in particular Article 66(2) thereof,

Having regard to Regulation (EU) 2018/1862 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of police cooperation and judicial cooperation in criminal matters, amending and repealing Council Decision 2007/533/JHA, and repealing Regulation (EC) No 1986/2006 of the European Parliament and of the Council and Commission Decision 2010/261/EU (2), and in particular Article 79(2) thereof,

Whereas:

| (1) | Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 lay down the new rules on the establishment, operation and use of the Schengen Information System. They increase the effectiveness and strengthen the technical and operational efficiency of the Schengen Information System and extend its use by introducing new alert categories and functionalities. In addition, Regulation (EU) 2018/1860 of the European Parliament and of the Council (3) established a new type of alert on the return of third-country nationals. |
| --- | --- |

(1)

Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 lay down the new rules on the establishment, operation and use of the Schengen Information System. They increase the effectiveness and strengthen the technical and operational efficiency of the Schengen Information System and extend its use by introducing new alert categories and functionalities. In addition, Regulation (EU) 2018/1860 of the European Parliament and of the Council (3) established a new type of alert on the return of third-country nationals.

| (2) | Regulation (EU) 2018/1861 constitutes the legal basis for the Schengen Information System in respect of matters falling within the scope of Chapter 2 of Title V of Part Three of the Treaty and Regulation (EU) 2018/1862 constitutes the legal basis for the Schengen Information System in respect of matters falling within the scope of Chapters 4 and 5 of Title V of Part Three of the Treaty. The fact that the legal basis for the Schengen Information System consists of separate instruments does not affect the principle that the Schengen Information System constitutes one single information system that should operate as such. |
| --- | --- |

(2)

Regulation (EU) 2018/1861 constitutes the legal basis for the Schengen Information System in respect of matters falling within the scope of Chapter 2 of Title V of Part Three of the Treaty and Regulation (EU) 2018/1862 constitutes the legal basis for the Schengen Information System in respect of matters falling within the scope of Chapters 4 and 5 of Title V of Part Three of the Treaty. The fact that the legal basis for the Schengen Information System consists of separate instruments does not affect the principle that the Schengen Information System constitutes one single information system that should operate as such.

| (3) | Since the entry into force of Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862, the Commission, Member States and the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) have been completing the necessary technical and legal arrangements to implement the new rules at both central and national level, to be able to process data and exchange supplementary information according to the new rules. |
| --- | --- |

(3)

Since the entry into force of Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862, the Commission, Member States and the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) have been completing the necessary technical and legal arrangements to implement the new rules at both central and national level, to be able to process data and exchange supplementary information according to the new rules.

| (4) | Pursuant to Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862, the new rules are to apply in successive stages in order to allow sufficient time for the necessary legal, operational and technical measures and arrangements to be put in place. On that basis, various provisions of Regulations (EU) 2018/1861 and (EU) 2018/1862 have started to apply on 28 December 2018, 28 December 2019 and 28 December 2020, respectively. As regards the start of application of the provisions that provide for the most complex changes having an overall impact on the technical implementation and operations of the Schengen Information System, those Regulations provide for a specific mechanism for a deferred start of application to ensure that those elements only become applicable after the necessary preparatory steps have been taken allowing for the continuous and uninterrupted operations of the system. |
| --- | --- |

(4)

Pursuant to Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862, the new rules are to apply in successive stages in order to allow sufficient time for the necessary legal, operational and technical measures and arrangements to be put in place. On that basis, various provisions of Regulations (EU) 2018/1861 and (EU) 2018/1862 have started to apply on 28 December 2018, 28 December 2019 and 28 December 2020, respectively. As regards the start of application of the provisions that provide for the most complex changes having an overall impact on the technical implementation and operations of the Schengen Information System, those Regulations provide for a specific mechanism for a deferred start of application to ensure that those elements only become applicable after the necessary preparatory steps have been taken allowing for the continuous and uninterrupted operations of the system.

| (5) | In accordance with that mechanism, the Commission is to set the date on which the operations of the Schengen Information System start, following verification that the legal, technical and operational conditions laid down in Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862 are met. |
| --- | --- |

(5)

In accordance with that mechanism, the Commission is to set the date on which the operations of the Schengen Information System start, following verification that the legal, technical and operational conditions laid down in Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862 are met.

| (6) | The Commission has verified that the implementing acts necessary for the application of Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862 were adopted; that Member States notified the Commission that they have made the necessary technical and legal arrangements to process Schengen Information System data and exchange supplementary information pursuant to the said Regulations and that eu-LISA notified the Commission of the successful completion of all testing activities with regard to Central SIS and the interaction between the a technical support function of Central SIS (CS-SIS) and the national systems (N.SIS). It is therefore appropriate to set the date on which the operations of the Schengen Information System pursuant to Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862 are to start. |
| --- | --- |

(6)

The Commission has verified that the implementing acts necessary for the application of Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862 were adopted; that Member States notified the Commission that they have made the necessary technical and legal arrangements to process Schengen Information System data and exchange supplementary information pursuant to the said Regulations and that eu-LISA notified the Commission of the successful completion of all testing activities with regard to Central SIS and the interaction between the a technical support function of Central SIS (CS-SIS) and the national systems (N.SIS). It is therefore appropriate to set the date on which the operations of the Schengen Information System pursuant to Regulations (EU) 2018/1860, (EU) 2018/1861 and (EU) 2018/1862 are to start.

| (7) | By virtue of Article 66(5) of Regulation (EU) 2018/1861 of the European Parliament and of the Council and Article 79(5) of Regulation (EU) 2018/1862 of the European Parliament and of the Council, these regulations shall apply from the date set in this Decision. In addition, by virtue of Article 20 of Regulation (EU) 2018/1860 of the European Parliament and of the Council, the provisions establishing a new type of alert on the return of third-country nationals in the Schengen Information System provided for in that Regulation are to apply from the start date set in this Decision. |
| --- | --- |

(7)

By virtue of Article 66(5) of Regulation (EU) 2018/1861 of the European Parliament and of the Council and Article 79(5) of Regulation (EU) 2018/1862 of the European Parliament and of the Council, these regulations shall apply from the date set in this Decision. In addition, by virtue of Article 20 of Regulation (EU) 2018/1860 of the European Parliament and of the Council, the provisions establishing a new type of alert on the return of third-country nationals in the Schengen Information System provided for in that Regulation are to apply from the start date set in this Decision.

| (8) | Given that, the Commission is to set a future date on which the operations of the Schengen Information System start, there is no need for any intermediate time period between the date of publication and the date of entry into force of this Decision. Therefore, this Decision should enter into force on the day of its publication. |
| --- | --- |

(8)

Given that, the Commission is to set a future date on which the operations of the Schengen Information System start, there is no need for any intermediate time period between the date of publication and the date of entry into force of this Decision. Therefore, this Decision should enter into force on the day of its publication.

| (9) | In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark did not take part in the adoption of Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 and is not bound by them or subject to their application. However, given that Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 build upon the Schengen acquis, Denmark, in accordance with Article 4 of that Protocol, notified on 26 April 2019 its decision to implement Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 in its national law. Denmark is therefore bound under international law to implement this Decision. |
| --- | --- |

(9)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark did not take part in the adoption of Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 and is not bound by them or subject to their application. However, given that Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 build upon the Schengen acquis, Denmark, in accordance with Article 4 of that Protocol, notified on 26 April 2019 its decision to implement Regulation (EU) 2018/1861 and Regulation (EU) 2018/1862 in its national law. Denmark is therefore bound under international law to implement this Decision.

| (10) | Ireland is taking part in this Decision to the extent that it concerns Regulation (EU) 2018/1862 in accordance with Article 5(1) of Protocol No 19 on the Schengen acquis integrated into the framework of the European Union, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union and Article 6(2) of Council Decision 2002/192/EC (4), read in conjunction with Council Implementing Decision (EU) 2020/1745 (5). |
| --- | --- |

(10)

Ireland is taking part in this Decision to the extent that it concerns Regulation (EU) 2018/1862 in accordance with Article 5(1) of Protocol No 19 on the Schengen acquis integrated into the framework of the European Union, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union and Article 6(2) of Council Decision 2002/192/EC (4), read in conjunction with Council Implementing Decision (EU) 2020/1745 (5).

| (11) | As regards Iceland and Norway, this Decision constitutes a development of provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning these States’ association with the implementation, application and development of the Schengen acquis (6), which fall within the area referred to in Article 1, point (G) of Council Decision 1999/437/EC (7). |
| --- | --- |

(11)

As regards Iceland and Norway, this Decision constitutes a development of provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning these States’ association with the implementation, application and development of the Schengen acquis (6), which fall within the area referred to in Article 1, point (G) of Council Decision 1999/437/EC (7).

| (12) | As regards Switzerland, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (8), which fall within the area referred to in Article 1, point (G), of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (9) and Article 3 of Council Decision 2008/149/JHA (10). |
| --- | --- |

(12)

As regards Switzerland, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (8), which fall within the area referred to in Article 1, point (G), of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (9) and Article 3 of Council Decision 2008/149/JHA (10).

| (13) | As regards Liechtenstein, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (11), which fall within the area referred to in Article 1, point (G), of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (12) and Article 3 of Council Decision 2011/349/EU (13). |
| --- | --- |

(13)

As regards Liechtenstein, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (11), which fall within the area referred to in Article 1, point (G), of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (12) and Article 3 of Council Decision 2011/349/EU (13).

| (14) | As regards Bulgaria and Romania, this Decision constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 4(2) of the 2005 Act of Accession and should be read in conjunction with Council Decisions 2010/365/EU (14) and (EU) 2018/934 (15). |
| --- | --- |

(14)

As regards Bulgaria and Romania, this Decision constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 4(2) of the 2005 Act of Accession and should be read in conjunction with Council Decisions 2010/365/EU (14) and (EU) 2018/934 (15).

| (15) | Concerning Cyprus, this Decision constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 3(2) of the 2003 Act of Accession, |
| --- | --- |

(15)

Concerning Cyprus, this Decision constitutes an act building upon, or otherwise relating to, the Schengen acquis within the meaning of Article 3(2) of the 2003 Act of Accession,

HAS ADOPTED THIS DECISION:

Article 1

The operations of the Schengen Information System pursuant to Regulations (EU) 2018/1861 and (EU) 2018/1862 shall start on 7 March 2023.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

Done at Brussels, 30 January 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 312, 7.12.2018, p. 14.

1

(2)  
  OJ L 312, 7.12.2018, p. 56.

2

(3)  Regulation (EU) 2018/1860 of the European Parliament and of the Council of 28 November 2018 on the use of the Schengen Information System for the return of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).

3

(4)  Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20).

4

acquis

(5)  Council Implementing Decision (EU) 2020/1745 of 18 November 2020 on the putting into effect of the provisions of the Schengen acquis on data protection and on the provisional putting into effect of certain provisions of the Schengen acquis in Ireland (OJ L 393, 23.11.2020, p. 3).

5

acquis

acquis

(6)  
  OJ L 176, 10.7.1999, p. 36.

6

(7)  Council Decision 1999/437/EC of 17 May 1999 on certain arrangements for the application of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the association of those two States with the implementation, application and development of the Schengen acquis (OJ L 176, 10.7.1999, p. 31).

7

acquis

(8)  
  OJ L 53, 27.2.2008, p. 52.

8

(9)  Council Decision 2008/146/EC of 28 January 2008 on the conclusion, on behalf of the European Community, of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 1).

9

(10)  Council Decision 2008/149/JHA of 28 January 2008 on the conclusion on behalf of the European Union of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (OJ L 53, 27.2.2008, p. 50).

10

acquis

(11)  
  OJ L 160, 18.6.2011, p. 21.

11

(12)  Council Decision 2011/350/EU of 7 March 2011 on the conclusion, on behalf of the European Union, of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation's association with the implementation, application and development of the Schengen acquis, relating to the abolition of checks at internal borders and movement of persons (OJ L 160, 18.6.2011, p. 19).

12

(13)  Council Decision 2011/349/EU of 7 March 2011 on the conclusion on behalf of the European Union of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis, relating in particular to judicial cooperation in criminal matters and police cooperation (OJ L 160, 18.6.2011, p. 1).

13

acquis

(14)  Council Decision 2010/365/EU of 29 June 2010 on the application of the provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Bulgaria and Romania (OJ L 166, 1.7.2010, p. 17).

14

acquis

(15)  Council Decision (EU) 2018/934 of 25 June 2018 on the putting into effect of the remaining provisions of the Schengen acquis relating to the Schengen Information System in the Republic of Bulgaria and Romania (OJ L 165, 2.7.2018, p. 37).

15

acquis

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ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 31.1.2023 | EN | Official Journal of the European Union | L 27/33 |
| --- | --- | --- | --- |

31.1.2023

EN

Official Journal of the European Union

L 27/33

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DECISION No 01/2022 OF THE COMMITTEE ON CUSTOMS OF THE FREE TRADE AGREEMENT BETWEEN THE EUROPEAN UNION AND THE REPUBLIC OF SINGAPORE

of 20 December 2022

modifying certain elements in Protocol 1 concerning the definition of the concept of ‘originating products’ and methods of administrative cooperation and its Annexes [2023/202]

THE COMMITTEE ON CUSTOMS,

Having regard to the Free Trade Agreement between the European Union and the Republic of Singapore (hereinafter, ‘the Agreement’), and in particular Article 34 of Protocol 1 and Article 16.2 of the Agreement,

Whereas:

| (1) | Article 34 (Amendments to this Protocol) of Protocol 1 to the Agreement provides that the Parties may, by decision in the Committee on Customs established pursuant to Article 16.2 (Specialised Committees) of the Agreement, amend the provisions of Protocol 1 to the Agreement. |
| --- | --- |

(1)

Article 34 (Amendments to this Protocol) of Protocol 1 to the Agreement provides that the Parties may, by decision in the Committee on Customs established pursuant to Article 16.2 (Specialised Committees) of the Agreement, amend the provisions of Protocol 1 to the Agreement.

| (2) | Amendments were introduced on 1 January 2012, on 1 January 2017 and on 1 January 2022 in relation to the nomenclature governed by the Convention on the Harmonized Commodity Description and Coding System (‘HS’). The Parties have agreed to update Protocol 1 to reflect the latest version of the HS. |
| --- | --- |

(2)

Amendments were introduced on 1 January 2012, on 1 January 2017 and on 1 January 2022 in relation to the nomenclature governed by the Convention on the Harmonized Commodity Description and Coding System (‘HS’). The Parties have agreed to update Protocol 1 to reflect the latest version of the HS.

| (3) | The Parties have agreed to modify the scope of the annual quotas set out in Annex B(a) to Protocol 1 for canned luncheon meat, curry fish balls and cuttlefish balls. |
| --- | --- |

(3)

The Parties have agreed to modify the scope of the annual quotas set out in Annex B(a) to Protocol 1 for canned luncheon meat, curry fish balls and cuttlefish balls.

| (4) | Article 17 (Conditions for Making Out an Origin Declaration) of Protocol 1 establishes that an origin declaration may be made out, in the European Union by, inter alia, an exporter who is an approved exporter, and in Singapore by, inter alia, a registered exporter. To provide for equal treatment of the economic operators in both Parties, Protocol 1 should be amended so that each Party may decide, according to its laws and regulations, which exporter may make out an origin declaration. For that purpose, a definition of ‘exporter’ would therefore be necessary. |
| --- | --- |

(4)

Article 17 (Conditions for Making Out an Origin Declaration) of Protocol 1 establishes that an origin declaration may be made out, in the European Union by, inter alia, an exporter who is an approved exporter, and in Singapore by, inter alia, a registered exporter. To provide for equal treatment of the economic operators in both Parties, Protocol 1 should be amended so that each Party may decide, according to its laws and regulations, which exporter may make out an origin declaration. For that purpose, a definition of ‘exporter’ would therefore be necessary.

| (5) | Considering the new definition of ‘exporter’, the term ‘exporter’ in the definition of ‘consignment’ in point (d) of Article 1(1), Article 13 (Non Alteration) and Article 14 (Exhibitions) of Protocol 1 needs to be replaced by the term ‘consignor’. |
| --- | --- |

(5)

Considering the new definition of ‘exporter’, the term ‘exporter’ in the definition of ‘consignment’ in point (d) of Article 1(1), Article 13 (Non Alteration) and Article 14 (Exhibitions) of Protocol 1 needs to be replaced by the term ‘consignor’.

| (6) | Paragraph 5 of Article 17 (Conditions for Making Out an Origin Declaration) provides that an origin declaration is to bear the original signature of the exporter in manuscript. The Parties have agreed to waive this requirement to facilitate trade and to decrease the administrative burden of benefiting from the tariff preferences of the Agreement. |
| --- | --- |

(6)

Paragraph 5 of Article 17 (Conditions for Making Out an Origin Declaration) provides that an origin declaration is to bear the original signature of the exporter in manuscript. The Parties have agreed to waive this requirement to facilitate trade and to decrease the administrative burden of benefiting from the tariff preferences of the Agreement.

| (7) | In the definition of ‘ex-works price’ in point (f) of Article 1(1), it is necessary to clarify how the term ‘manufacturer’ is to be understood when the last working or processing is subcontracted. |
| --- | --- |

(7)

In the definition of ‘ex-works price’ in point (f) of Article 1(1), it is necessary to clarify how the term ‘manufacturer’ is to be understood when the last working or processing is subcontracted.

| (8) | Considering that both Parties are to apply a system of registered exporters, the document on origin made out in the Parties should be renamed from ‘origin declaration’ to ‘statement on origin’. |
| --- | --- |

(8)

Considering that both Parties are to apply a system of registered exporters, the document on origin made out in the Parties should be renamed from ‘origin declaration’ to ‘statement on origin’.

| (9) | As a transitional measure, it should be provided that for a period of 3 months starting from the date of entry into force of this Decision, Singapore will accept origin declarations made out in accordance with Article 17 (Conditions for Making Out an Origin Declaration) and Article 18 (Approved Exporter) of Protocol 1 to the Agreement in force prior to the date of entry into force of this Decision. |
| --- | --- |

(9)

As a transitional measure, it should be provided that for a period of 3 months starting from the date of entry into force of this Decision, Singapore will accept origin declarations made out in accordance with Article 17 (Conditions for Making Out an Origin Declaration) and Article 18 (Approved Exporter) of Protocol 1 to the Agreement in force prior to the date of entry into force of this Decision.

| (10) | Protocol 1 to the Agreement and several of its Annexes should therefore be modified, |
| --- | --- |

(10)

Protocol 1 to the Agreement and several of its Annexes should therefore be modified,

HAS ADOPTED THIS DECISION:

Article 1

Protocol 1 to the Agreement is amended as follows:

| (1) | the table of contents of Protocol 1 is replaced by the following:

  ‘TABLE OF CONTENTS







  SECTION 1 | GENERAL PROVISIONS |
| --- | --- | --- |

(1)

the table of contents of Protocol 1 is replaced by the following:

‘TABLE OF CONTENTS

SECTION 1

| ARTICLE 1 | Definitions |
| --- | --- |

ARTICLE 1

| SECTION 2 | DEFINITION OF THE CONCEPT OF “ORIGINATING PRODUCTS” |
| --- | --- |

SECTION 2

| ARTICLE 2 | General requirements |
| --- | --- |

ARTICLE 2

| ARTICLE 3 | Cumulation of Origin |
| --- | --- |

ARTICLE 3

| ARTICLE 4 | Wholly Obtained Products |
| --- | --- |

ARTICLE 4

| ARTICLE 5 | Sufficiently Worked or Processed Products |
| --- | --- |

ARTICLE 5

| ARTICLE 6 | Insufficient Working or Processing |
| --- | --- |

ARTICLE 6

| ARTICLE 7 | Unit of Qualification |
| --- | --- |

ARTICLE 7

| ARTICLE 8 | Accessories, Spare Parts and Tools |
| --- | --- |

ARTICLE 8

| ARTICLE 9 | Sets |
| --- | --- |

ARTICLE 9

| ARTICLE 10 | Neutral Elements |
| --- | --- |

ARTICLE 10

| ARTICLE 11 | Accounting Segregation |
| --- | --- |

ARTICLE 11

| SECTION 3 | TERRITORIAL REQUIREMENTS |
| --- | --- |

SECTION 3

| ARTICLE 12 | Principle of Territoriality |
| --- | --- |

ARTICLE 12

| ARTICLE 13 | Non Alteration |
| --- | --- |

ARTICLE 13

| ARTICLE 14 | Exhibitions |
| --- | --- |

ARTICLE 14

| SECTION 4 | DRAWBACK OR EXEMPTION |
| --- | --- |

SECTION 4

| ARTICLE 15 | Prohibition of Drawback of, or Exemption from, Customs Duties |
| --- | --- |

ARTICLE 15

| SECTION 5 | STATEMENT ON ORIGIN |
| --- | --- |

SECTION 5

| ARTICLE 16 | General Requirements |
| --- | --- |

ARTICLE 16

| ARTICLE 17 | Conditions for Making Out a Statement on Origin |
| --- | --- |

ARTICLE 17

| ARTICLE 19 | Validity of Statement on Origin |
| --- | --- |

ARTICLE 19

| ARTICLE 20 | Submission of Statement on Origin |
| --- | --- |

ARTICLE 20

| ARTICLE 21 | Importation in Instalments |
| --- | --- |

ARTICLE 21

| ARTICLE 22 | Exemptions from Statement on Origin |
| --- | --- |

ARTICLE 22

| ARTICLE 23 | Supporting Documents |
| --- | --- |

ARTICLE 23

| ARTICLE 24 | Preservation of Statement on Origin and Supporting Documents |
| --- | --- |

ARTICLE 24

| ARTICLE 25 | Discrepancies and Formal Errors |
| --- | --- |

ARTICLE 25

| ARTICLE 26 | Amounts Expressed in Euro |
| --- | --- |

ARTICLE 26

| SECTION 6 | ARRANGEMENTS FOR ADMINISTRATIVE COOPERATION |
| --- | --- |

SECTION 6

| ARTICLE 27 | Cooperation between Competent Authorities |
| --- | --- |

ARTICLE 27

| ARTICLE 28 | Verification of Statements on Origin |
| --- | --- |

ARTICLE 28

| ARTICLE 29 | Administrative Enquiries |
| --- | --- |

ARTICLE 29

| ARTICLE 30 | Settlement of Disputes |
| --- | --- |

ARTICLE 30

| ARTICLE 31 | Penalties |
| --- | --- |

ARTICLE 31

| SECTION 7 | CEUTA AND MELILLA |
| --- | --- |

SECTION 7

| ARTICLE 32 | Application of this Protocol |
| --- | --- |

ARTICLE 32

| ARTICLE 33 | Special Conditions |
| --- | --- |

ARTICLE 33

| SECTION 8 | FINAL PROVISIONS |
| --- | --- |

SECTION 8

| ARTICLE 34 | Amendments to this Protocol |
| --- | --- |

ARTICLE 34

| ARTICLE 35 | Transitional Provisions for Goods in Transit or Storage |
| --- | --- |

ARTICLE 35

List of Appendices

| ANNEX A: | INTRODUCTORY NOTES TO THE LIST IN ANNEX B |
| --- | --- |

ANNEX A:

| ANNEX B: | LIST OF WORKING OR PROCESSING REQUIRED TO BE CARRIED OUT ON NON-ORIGINATING MATERIALS IN ORDER THAT THE PRODUCT MANUFACTURED CAN OBTAIN ORIGINATING STATUS |
| --- | --- |

ANNEX B:

| ANNEX B (a): | ADDENDUM TO ANNEX B |
| --- | --- |

ANNEX B (a):

| ANNEX C: | MATERIALS EXCLUDED FROM CUMULATION UNDER PARAGRAPH 2 OF ARTICLE 3 |
| --- | --- |

ANNEX C:

| ANNEX D: | PRODUCTS REFERRED TO IN PARAGRAPH 9 OF ARTICLE 3 FOR WHICH MATERIALS ORIGINATING IN AN ASEAN COUNTRY SHALL BE CONSIDERED AS MATERIALS ORIGINATING IN A PARTY |
| --- | --- |

ANNEX D:

| ANNEX E: | TEXT OF THE STATEMENT ON ORIGIN |
| --- | --- |

ANNEX E:

Joint Declarations

JOINT DECLARATION CONCERNING THE PRINCIPALITY OF ANDORRA

JOINT DECLARATION CONCERNING THE REPUBLIC OF SAN MARINO

JOINT DECLARATION CONCERNING THE REVISION OF THE RULES OF ORIGIN CONTAINED IN PROTOCOL 1’;

| (2) | Article 1 is replaced by the following:

  ‘ARTICLE 1
  Definitions

  1.   For the purposes of this Protocol:






  (a) | “ASEAN country” means a member state of the Association of Southeast Asian Nations which is not a Party to this Agreement; |
| --- | --- | --- |

(2)

Article 1 is replaced by the following:

‘ARTICLE 1

Definitions

1.   For the purposes of this Protocol:

(a)

“ASEAN country” means a member state of the Association of Southeast Asian Nations which is not a Party to this Agreement;

| (b) | “chapters” and “headings” and “sub-headings” mean the chapters, the headings (four digit codes) and sub-headings (six digit codes) used in the nomenclature which makes up the Harmonized Commodity Description and Coding System, referred to in this Protocol as the “Harmonized System” or “HS”; |
| --- | --- |

(b)

“chapters” and “headings” and “sub-headings” mean the chapters, the headings (four digit codes) and sub-headings (six digit codes) used in the nomenclature which makes up the Harmonized Commodity Description and Coding System, referred to in this Protocol as the “Harmonized System” or “HS”;

| (c) | “classified” refers to the classification of a product or material under a particular chapter, heading, or sub-heading of the Harmonized System; |
| --- | --- |

(c)

“classified” refers to the classification of a product or material under a particular chapter, heading, or sub-heading of the Harmonized System;

| (d) | “consignment” means products which are either sent simultaneously from one consignor to one consignee or covered by a single transport document covering their shipment from the consignor to the consignee or, in the absence of such a document, by a single invoice; |
| --- | --- |

(d)

“consignment” means products which are either sent simultaneously from one consignor to one consignee or covered by a single transport document covering their shipment from the consignor to the consignee or, in the absence of such a document, by a single invoice;

| (e) | “customs value” means the value as determined in accordance with the Customs Valuation Agreement; |
| --- | --- |

(e)

“customs value” means the value as determined in accordance with the Customs Valuation Agreement;

| (f) | “ex-works price” means the price paid for the product ex-works to the manufacturer in whose undertaking the last working or processing is carried out, provided that the price includes the value of all the materials used and all other costs related to its production, minus any internal taxes which are, or may be, repaid when the product obtained is exported.
  Where the actual price paid does not reflect all costs related to the manufacturing of the product which are actually incurred in the Union or in Singapore, the ex-works price means the sum of all those costs, minus any internal taxes which are, or may be, repaid when the product obtained is exported.
  Where the last working or processing has been subcontracted to a manufacturer, the term “manufacturer” may refer to the enterprise that has employed the subcontractor. |
| --- | --- |

(f)

“ex-works price” means the price paid for the product ex-works to the manufacturer in whose undertaking the last working or processing is carried out, provided that the price includes the value of all the materials used and all other costs related to its production, minus any internal taxes which are, or may be, repaid when the product obtained is exported.

Where the actual price paid does not reflect all costs related to the manufacturing of the product which are actually incurred in the Union or in Singapore, the ex-works price means the sum of all those costs, minus any internal taxes which are, or may be, repaid when the product obtained is exported.

Where the last working or processing has been subcontracted to a manufacturer, the term “manufacturer” may refer to the enterprise that has employed the subcontractor.

| (g) | “exporter” means a person, located in a Party, who, in accordance with the requirements in the laws and regulations of the Party, exports or produces the originating product and who may make out a statement on origin; |
| --- | --- |

(g)

“exporter” means a person, located in a Party, who, in accordance with the requirements in the laws and regulations of the Party, exports or produces the originating product and who may make out a statement on origin;

| (h) | “fungible materials” means materials that are of the same kind and commercial quality, with the same technical and physical characteristics, and which cannot be distinguished from one another once they are incorporated into the finished product; |
| --- | --- |

(h)

“fungible materials” means materials that are of the same kind and commercial quality, with the same technical and physical characteristics, and which cannot be distinguished from one another once they are incorporated into the finished product;

| (i) | “goods” means both materials and products; |
| --- | --- |

(i)

“goods” means both materials and products;

| (j) | “juridical person” means any legal entity duly constituted or otherwise organised under applicable law, whether for profit or otherwise, and whether privately-owned or governmentally-owned, including any corporation, trust, partnership, joint venture, sole proprietorship, or association; |
| --- | --- |

(j)

“juridical person” means any legal entity duly constituted or otherwise organised under applicable law, whether for profit or otherwise, and whether privately-owned or governmentally-owned, including any corporation, trust, partnership, joint venture, sole proprietorship, or association;

| (k) | “manufacture” means any kind of working or processing including assembly; |
| --- | --- |

(k)

“manufacture” means any kind of working or processing including assembly;

| (l) | “material” means any ingredient, raw material, component or part, etc., used in the manufacture of the product; |
| --- | --- |

(l)

“material” means any ingredient, raw material, component or part, etc., used in the manufacture of the product;

| (m) | “person” means a natural person or juridical person; |
| --- | --- |

(m)

“person” means a natural person or juridical person;

| (n) | “product” means the product being manufactured, even if it is intended for later use in another manufacturing operation; |
| --- | --- |

(n)

“product” means the product being manufactured, even if it is intended for later use in another manufacturing operation;

| (o) | “value of materials” means the customs value at the time of importation of the non-originating materials used, or, if this is not known and cannot be ascertained, the first ascertainable price paid for the materials in the Union or in Singapore.’ |
| --- | --- |

(o)

“value of materials” means the customs value at the time of importation of the non-originating materials used, or, if this is not known and cannot be ascertained, the first ascertainable price paid for the materials in the Union or in Singapore.’

| (3) | Article 13(3) is replaced by the following:

  ‘3.   Without prejudice to Section 5, the splitting of consignments may take place where carried out by the consignor or under his responsibility provided they remain under customs supervision in the country(ies) of transit.’
  ; |
| --- | --- |

(3)

Article 13(3) is replaced by the following:

‘3.   Without prejudice to Section 5, the splitting of consignments may take place where carried out by the consignor or under his responsibility provided they remain under customs supervision in the country(ies) of transit.’

| (4) | points (a) and (b) of Article 14(1) are replaced by the following:






  ‘(a) | a consignor has consigned these products from a Party to the country in which the exhibition is held and has exhibited them there; |
| --- | --- | --- |

(4)

points (a) and (b) of Article 14(1) are replaced by the following:

‘(a)

a consignor has consigned these products from a Party to the country in which the exhibition is held and has exhibited them there;

| (b) | the products have been sold or otherwise disposed of by that consignor to a person in a Party;’; |
| --- | --- |

(b)

the products have been sold or otherwise disposed of by that consignor to a person in a Party;’;

| (5) | Article 17 is replaced by the following:

  ‘ARTICLE 17
  Conditions for Making Out a Statement on Origin

  1.   A statement on origin as referred to in Article 16 (General Requirements) may be made out by the exporter.


  2.   A statement on origin may be made out if the products concerned can be considered as products originating in the Union or in Singapore and fulfil the other requirements of this Protocol.


  3.   The exporter making out a statement on origin shall be prepared to submit at any time, at the request of the customs authorities of the exporting Party, all appropriate documents as referred to under Article 23 (Supporting Documents) proving the originating status of the products concerned as well as the fulfilment of the other requirements of this Protocol.


  4.   A statement on origin shall be made out by the exporter by typing, stamping or printing on the invoice, the delivery note or another commercial document, the declaration, the text of which appears in Annex E to this Protocol, in accordance with the domestic law of the exporting Party. If the statement is hand-written, it shall be written in ink in capital characters. In the case of exports from Singapore, the statement on origin shall be set out using the English version and in the case of exports from Union, the statement on origin may be set out in one of the linguistic versions in Annex E to this Protocol.


  5.   By derogation from paragraph 1, a statement on origin may be made out after exportation (“retrospective statement”) on condition that it is presented in the importing Party no later than two years, in the case of the Union, and one year, in the case of Singapore, after the entry of the goods into the territory.’

  ; |
| --- | --- |

(5)

Article 17 is replaced by the following:

‘ARTICLE 17

Conditions for Making Out a Statement on Origin

1.   A statement on origin as referred to in Article 16 (General Requirements) may be made out by the exporter.

2.   A statement on origin may be made out if the products concerned can be considered as products originating in the Union or in Singapore and fulfil the other requirements of this Protocol.

3.   The exporter making out a statement on origin shall be prepared to submit at any time, at the request of the customs authorities of the exporting Party, all appropriate documents as referred to under Article 23 (Supporting Documents) proving the originating status of the products concerned as well as the fulfilment of the other requirements of this Protocol.

4.   A statement on origin shall be made out by the exporter by typing, stamping or printing on the invoice, the delivery note or another commercial document, the declaration, the text of which appears in Annex E to this Protocol, in accordance with the domestic law of the exporting Party. If the statement is hand-written, it shall be written in ink in capital characters. In the case of exports from Singapore, the statement on origin shall be set out using the English version and in the case of exports from Union, the statement on origin may be set out in one of the linguistic versions in Annex E to this Protocol.

5.   By derogation from paragraph 1, a statement on origin may be made out after exportation (“retrospective statement”) on condition that it is presented in the importing Party no later than two years, in the case of the Union, and one year, in the case of Singapore, after the entry of the goods into the territory.’

| (6) | in the Table of Contents, and in Article 3(6), Article 3(13), Article 11(5), Article 14(2), Article 15(1), Article 15(3), the title of Section 5, Article 16(1), Article 16(2), the title of Article 19, Article 19(1), Article 19(2), Article 19(3), the title of Article 20, Article 20, Article 21, the title of Article 22, Article 22(1), Article 23, the title of Article 24, Article 24(1), Article 24(2), Article 25(1), Article 25(2), Article 27(1), Article 27(2), the title of Article 28, Article 28(1), Article 28(2), Article 30(1), Article 33(3), and Article 35, the term ‘origin declaration’ is replaced by the term ‘statement on origin’; |
| --- | --- |

(6)

in the Table of Contents, and in Article 3(6), Article 3(13), Article 11(5), Article 14(2), Article 15(1), Article 15(3), the title of Section 5, Article 16(1), Article 16(2), the title of Article 19, Article 19(1), Article 19(2), Article 19(3), the title of Article 20, Article 20, Article 21, the title of Article 22, Article 22(1), Article 23, the title of Article 24, Article 24(1), Article 24(2), Article 25(1), Article 25(2), Article 27(1), Article 27(2), the title of Article 28, Article 28(1), Article 28(2), Article 30(1), Article 33(3), and Article 35, the term ‘origin declaration’ is replaced by the term ‘statement on origin’;

| (7) | Article 18 is deleted; |
| --- | --- |

(7)

Article 18 is deleted;

| (8) | Article 26 is replaced by the following:

  ‘ARTICLE 26
  Amounts Expressed in Euro

  1.   For the application of the provisions of paragraph 3 of Article 22 (Exemptions from Statement on Origin) in cases where products are invoiced in a currency other than euro, amounts in the national currencies of the Member States of the Union equivalent to the amounts expressed in euro shall be fixed annually by each of the countries concerned.


  2.   A consignment shall benefit from the provisions of paragraph 3 of Article 22 (Exemptions from Statement on Origin ) by reference to the currency in which the invoice is drawn up, according to the amount fixed by the Party concerned.


  3.   The amounts to be used in any given national currency shall be the equivalent in that currency of the amounts expressed in euro as at the first working day of October. The amounts shall be communicated to the European Commission by 15 October and shall apply from 1 January the following year. The European Commission shall notify all countries concerned of the relevant amounts.


  4.   A Member State of the Union may round up or down the amount resulting from the conversion into its national currency of an amount expressed in euro. The rounded amount may not differ from the amount resulting from the conversion by more than five percent. A Member State of the Union may retain unchanged its national currency equivalent of an amount expressed in euro if, at the time of the annual adjustment provided for in paragraph 3, the conversion of that amount, prior to any rounding-off, results in an increase of less than fifteen percent in the national currency equivalent. The national currency equivalent may be retained unchanged if the conversion would result in a decrease in that equivalent value.


  5.   The amounts expressed in euro shall be reviewed by the Parties in the Committee on Customs established pursuant to Article 16.2 (Specialised Committees) at the request of the Union or of Singapore. When carrying out this review, the Parties shall consider the desirability of preserving the effects of the limits concerned in real terms. For these purposes, the Parties may, by decision in the Committee on Customs, modify the amounts expressed in euro.’

  ; |
| --- | --- |

(8)

Article 26 is replaced by the following:

‘ARTICLE 26

Amounts Expressed in Euro

1.   For the application of the provisions of paragraph 3 of Article 22 (Exemptions from Statement on Origin) in cases where products are invoiced in a currency other than euro, amounts in the national currencies of the Member States of the Union equivalent to the amounts expressed in euro shall be fixed annually by each of the countries concerned.

2.   A consignment shall benefit from the provisions of paragraph 3 of Article 22 (Exemptions from Statement on Origin ) by reference to the currency in which the invoice is drawn up, according to the amount fixed by the Party concerned.

3.   The amounts to be used in any given national currency shall be the equivalent in that currency of the amounts expressed in euro as at the first working day of October. The amounts shall be communicated to the European Commission by 15 October and shall apply from 1 January the following year. The European Commission shall notify all countries concerned of the relevant amounts.

4.   A Member State of the Union may round up or down the amount resulting from the conversion into its national currency of an amount expressed in euro. The rounded amount may not differ from the amount resulting from the conversion by more than five percent. A Member State of the Union may retain unchanged its national currency equivalent of an amount expressed in euro if, at the time of the annual adjustment provided for in paragraph 3, the conversion of that amount, prior to any rounding-off, results in an increase of less than fifteen percent in the national currency equivalent. The national currency equivalent may be retained unchanged if the conversion would result in a decrease in that equivalent value.

5.   The amounts expressed in euro shall be reviewed by the Parties in the Committee on Customs established pursuant to Article 16.2 (Specialised Committees) at the request of the Union or of Singapore. When carrying out this review, the Parties shall consider the desirability of preserving the effects of the limits concerned in real terms. For these purposes, the Parties may, by decision in the Committee on Customs, modify the amounts expressed in euro.’

| (9) | Annex B is amended as set out in Annex 1 to this Decision; |
| --- | --- |

(9)

Annex B is amended as set out in Annex 1 to this Decision;

| (10) | Annex B(a) is amended as set out in Annex 2 to this Decision; |
| --- | --- |

(10)

Annex B(a) is amended as set out in Annex 2 to this Decision;

| (11) | Annex D is amended as set out in Annex 3 to this Decision; |
| --- | --- |

(11)

Annex D is amended as set out in Annex 3 to this Decision;

| (12) | Annex E is amended as set out in Annex 4 to this Decision. |
| --- | --- |

(12)

Annex E is amended as set out in Annex 4 to this Decision.

Article 2

Entry into force

This Decision shall enter into force on 1 January 2023.

Done at Brussels, 20 December 2022.

For the EU-Singapore Committee on Customs

On behalf of the European Union

Mr Jean-Michel GRAVE

On behalf of the Republic of Singapore

Mr Lim Teck LEONG

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ANNEX 1

Annex B to Protocol 1 is amended as follows:

| (1) | in the row related to HS Heading ‘0305’, the text in the column ‘description of product’ is replaced by the following:

  ‘Fish, dried, salted or in brine; smoked fish, whether or not cooked before or during the smoking process’; |
| --- | --- |

(1)

in the row related to HS Heading ‘0305’, the text in the column ‘description of product’ is replaced by the following:

‘Fish, dried, salted or in brine; smoked fish, whether or not cooked before or during the smoking process’;

| (2) | in the row related to HS Heading ‘ex 0306’, the text in the column ‘description of product’ is replaced by the following:

  ‘Crustaceans, whether in shell or not, dried, salted or in brine; smoked crustaceans, whether in shell or not, whether or not cooked before or during the smoking process; crustaceans, in shell, cooked by steaming or by boiling in water, whether or not chilled, frozen, dried, salted or in brine’; |
| --- | --- |

(2)

in the row related to HS Heading ‘ex 0306’, the text in the column ‘description of product’ is replaced by the following:

‘Crustaceans, whether in shell or not, dried, salted or in brine; smoked crustaceans, whether in shell or not, whether or not cooked before or during the smoking process; crustaceans, in shell, cooked by steaming or by boiling in water, whether or not chilled, frozen, dried, salted or in brine’;

| (3) | in the row related to HS Heading ‘ex 0307’, the text in the column ‘description of product’ is replaced by the following:

  ‘Molluscs, whether in shell or not, dried, salted or in brine; smoked molluscs, whether in shell or not, whether or not cooked before or during the smoking process’; |
| --- | --- |

(3)

in the row related to HS Heading ‘ex 0307’, the text in the column ‘description of product’ is replaced by the following:

‘Molluscs, whether in shell or not, dried, salted or in brine; smoked molluscs, whether in shell or not, whether or not cooked before or during the smoking process’;

| (4) | between the row related to HS Heading ‘ex 0307’ and the row related to HS Heading ‘Chapter 4’, the following rows are inserted:







  ‘ex 0308 | Aquatic invertebrates other than crustaceans and molluscs, dried, salted or in brine; smoked aquatic invertebrates other than crustaceans and molluscs, whether or not cooked before or during the smoking process | Manufacture in which all the materials of Chapter 3 used are wholly obtained |
| --- | --- | --- | --- |
| 0309 | Flours, meals and pellets of fish, crustaceans, molluscs and other aquatic invertebrates, fit for human consumption | Manufacture in which all the materials of Chapter 3 used are wholly obtained’ |

(4)

between the row related to HS Heading ‘ex 0307’ and the row related to HS Heading ‘Chapter 4’, the following rows are inserted:

‘ex 0308

Aquatic invertebrates other than crustaceans and molluscs, dried, salted or in brine; smoked aquatic invertebrates other than crustaceans and molluscs, whether or not cooked before or during the smoking process

Manufacture in which all the materials of Chapter 3 used are wholly obtained

0309

Flours, meals and pellets of fish, crustaceans, molluscs and other aquatic invertebrates, fit for human consumption

Manufacture in which all the materials of Chapter 3 used are wholly obtained’

| (5) | in the row related to HS Heading ‘ex Chapter 15’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Animal, vegetable or microbial fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes; except for:’; |
| --- | --- |

(5)

in the row related to HS Heading ‘ex Chapter 15’, the text in the column ‘description of product ’ is replaced by the following:

‘Animal, vegetable or microbial fats and oils and their cleavage products; prepared edible fats; animal or vegetable waxes; except for:’;

| (6) | in the row related to HS Heading ‘1509 and 1510’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Olive oil and its fractions, other oils and their fractions obtained solely from olives’; |
| --- | --- |

(6)

in the row related to HS Heading ‘1509 and 1510’, the text in the column ‘description of product ’ is replaced by the following:

‘Olive oil and its fractions, other oils and their fractions obtained solely from olives’;

| (7) | in the row related to HS Heading ‘1516 and 1517’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Animal, vegetable or microbial fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared;
  Margarine; edible mixtures or preparations of animal, vegetable or microbial fats or oils or of fractions of different fats or oils of this Chapter, other than edible fats and oils or their fractions of heading 15.16’; |
| --- | --- |

(7)

in the row related to HS Heading ‘1516 and 1517’, the text in the column ‘description of product ’ is replaced by the following:

‘Animal, vegetable or microbial fats and oils and their fractions, partly or wholly hydrogenated, inter-esterified, re-esterified or elaidinised, whether or not refined, but not further prepared;

Margarine; edible mixtures or preparations of animal, vegetable or microbial fats or oils or of fractions of different fats or oils of this Chapter, other than edible fats and oils or their fractions of heading 15.16’;

| (8) | in the row related to HS Heading ‘Chapter 16’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Preparations of meat, of fish, of crustaceans, molluscs or other aquatic invertebrates, or of insects’; |
| --- | --- |

(8)

in the row related to HS Heading ‘Chapter 16’, the text in the column ‘description of product ’ is replaced by the following:

‘Preparations of meat, of fish, of crustaceans, molluscs or other aquatic invertebrates, or of insects’;

| (9) | in the row related to HS Heading ‘ex Chapter 24’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Tobacco and manufactured tobacco substitutes; products, whether or not containing nicotine, intended for inhalation without combustion; other nicotine containing products intended for the intake of nicotine into the human body; except for;’; |
| --- | --- |

(9)

in the row related to HS Heading ‘ex Chapter 24’, the text in the column ‘description of product ’ is replaced by the following:

‘Tobacco and manufactured tobacco substitutes; products, whether or not containing nicotine, intended for inhalation without combustion; other nicotine containing products intended for the intake of nicotine into the human body; except for;’;

| (10) | between the row related to HS Heading ‘ex 2402’ and the row related to HS Heading ‘ex Chapter 25’, the following rows are inserted:







  ‘2404 12 | Products intended for inhalation without combustion, not containing tobacco or reconstituted tobacco, and containing nicotine | Manufacture from materials of any heading, except that of the product. However, materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the ex-works price of the product
  or
  Manufacture in which the value of all the materials used does not exceed 40 % of the ex-works price of the product |
| --- | --- | --- | --- |
| ex 2404 19 | Cartridges and refills, filled for electronic cigarettes | Manufacture from materials of any heading, except that of the product. However, materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the ex-works price of the product
  or
  Manufacture in which the value of all the materials used does not exceed 40 % of the ex-works price of the product |
| 2404 91 | Other products than products intended for inhalation without combustion, for oral application | Manufacture from materials of any heading, except that of the product, in which:






  — | the individual weight of sugar and of the materials of Chapter 4 used does not exceed 20 % of the weight of the final product, and |

(10)

between the row related to HS Heading ‘ex 2402’ and the row related to HS Heading ‘ex Chapter 25’, the following rows are inserted:

‘2404 12

Products intended for inhalation without combustion, not containing tobacco or reconstituted tobacco, and containing nicotine

Manufacture from materials of any heading, except that of the product. However, materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the ex-works price of the product

or

Manufacture in which the value of all the materials used does not exceed 40 % of the ex-works price of the product

ex 2404 19

Cartridges and refills, filled for electronic cigarettes

Manufacture from materials of any heading, except that of the product. However, materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the ex-works price of the product

or

Manufacture in which the value of all the materials used does not exceed 40 % of the ex-works price of the product

2404 91

Other products than products intended for inhalation without combustion, for oral application

Manufacture from materials of any heading, except that of the product, in which:

—

the individual weight of sugar and of the materials of Chapter 4 used does not exceed 20 % of the weight of the final product, and

| — | the total combined weight of sugar and the materials of Chapter 4 used does not exceed 40 % of the weight of final product |
| --- | --- |

—

the total combined weight of sugar and the materials of Chapter 4 used does not exceed 40 % of the weight of final product

2404 92 ,

2404 99

Other products than products intended for inhalation without combustion, for transdermal application and for other than oral application

Manufacture from materials of any heading, except that of the product. However, materials of the same heading as the product may be used, provided that their total value does not exceed 20 % of the ex-works price of the product

or

Manufacture in which the value of all the materials used does not exceed 40 % of the ex-works price of the product’;

| (11) | between the row related to HS Heading ‘ex Chapter 38’ and the row related to HS Heading ‘3823’, the following rows are inserted:







  ‘ex 3816 | Dolomite ramming mix | Manufacture from materials of any heading, except that of the product
  or
  Manufacture in which the value of all the materials used does not exceed 40 % of the ex- works price of the product |
| --- | --- | --- | --- |
| ex 3822 | Malaria diagnostic test kits
  Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale
  Immunological products, mixed, not put up in measured doses or in forms or packings for retail sale
  Immunological products, put up in measured doses or in forms or packings for retail sale
  Blood-grouping reagents | Manufacture from materials of any heading’; |

(11)

between the row related to HS Heading ‘ex Chapter 38’ and the row related to HS Heading ‘3823’, the following rows are inserted:

‘ex 3816

Dolomite ramming mix

Manufacture from materials of any heading, except that of the product

or

Manufacture in which the value of all the materials used does not exceed 40 % of the ex- works price of the product

ex 3822

Malaria diagnostic test kits

Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale

Immunological products, mixed, not put up in measured doses or in forms or packings for retail sale

Immunological products, put up in measured doses or in forms or packings for retail sale

Blood-grouping reagents

Manufacture from materials of any heading’;

| (12) | in the first row related to HS Heading ‘6306’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Tarpaulins, awnings and sunblinds; tents (including temporary canopies and similar articles); sails for boats, sailboards or landcraft; camping goods’; |
| --- | --- |

(12)

in the first row related to HS Heading ‘6306’, the text in the column ‘description of product ’ is replaced by the following:

‘Tarpaulins, awnings and sunblinds; tents (including temporary canopies and similar articles); sails for boats, sailboards or landcraft; camping goods’;

| (13) | in the row related to HS Heading ‘8522, the text in the column ‘description of product ’ is replaced by the following:

  ‘Parts and accessories suitable for use solely or principally with the apparatus of heading 8519 or 8521
  ’; |
| --- | --- |

(13)

in the row related to HS Heading ‘8522, the text in the column ‘description of product ’ is replaced by the following:

‘Parts and accessories suitable for use solely or principally with the apparatus of heading 8519 or 8521
  ’;

| (14) | in the row related to HS Heading ‘8529, the text in the column ‘description of product’ is replaced by the following:

  ‘Parts suitable for use solely or principally with the apparatus of headings 8524 to 8528
  ’; |
| --- | --- |

(14)

in the row related to HS Heading ‘8529, the text in the column ‘description of product’ is replaced by the following:

‘Parts suitable for use solely or principally with the apparatus of headings 8524 to 8528
  ’;

| (15) | in the row related to HS Heading ‘8548’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Electrical parts of machinery or apparatus, not specified or included elsewhere in this Chapter’; |
| --- | --- |

(15)

in the row related to HS Heading ‘8548’, the text in the column ‘description of product ’ is replaced by the following:

‘Electrical parts of machinery or apparatus, not specified or included elsewhere in this Chapter’;

| (16) | between the row related to HS Heading ‘8548’ and the row related to HS Heading ‘ex Chapter 86’, the following row is inserted:







  ‘8549 | Electrical and electronic waste and scrap. | Manufacture from materials of any heading, except that of the product
  or
  Manufacture in which the value of all the materials used does not exceed 50 % of the ex-works price of the product’; |
| --- | --- | --- | --- |

(16)

between the row related to HS Heading ‘8548’ and the row related to HS Heading ‘ex Chapter 86’, the following row is inserted:

‘8549

Electrical and electronic waste and scrap.

Manufacture from materials of any heading, except that of the product

or

Manufacture in which the value of all the materials used does not exceed 50 % of the ex-works price of the product’;

| (17) | in the row related to HS Heading ‘ex Chapter 86’, the text in the column ‘HS Heading’ and the text in the column ‘description of product’ are replaced respectively by the following:

  ‘Chapter 86’ and ‘Railway or tramway locomotives, rolling-stock and parts thereof; railway or tramway track fixtures and fittings and parts thereof; mechanical (including electro-mechanical) traffic signalling equipment of all kinds’; |
| --- | --- |

(17)

in the row related to HS Heading ‘ex Chapter 86’, the text in the column ‘HS Heading’ and the text in the column ‘description of product’ are replaced respectively by the following:

‘Chapter 86’ and ‘Railway or tramway locomotives, rolling-stock and parts thereof; railway or tramway track fixtures and fittings and parts thereof; mechanical (including electro-mechanical) traffic signalling equipment of all kinds’;

| (18) | between the row related to HS Heading ‘ex 8804’ and the row related to HS Heading ‘Chapter 89’, the following row is inserted:







  ‘ex 8806 | Unmanned aircraft
  Television cameras, digital cameras and video camera recorders | Manufacture from materials of any heading, except that of the product and of heading 8529
  or
  Manufacture in which the value of all the materials used does not exceed 50 % of the ex-works price of the product’; |
| --- | --- | --- | --- |

(18)

between the row related to HS Heading ‘ex 8804’ and the row related to HS Heading ‘Chapter 89’, the following row is inserted:

‘ex 8806

Unmanned aircraft

Television cameras, digital cameras and video camera recorders

Manufacture from materials of any heading, except that of the product and of heading 8529

or

Manufacture in which the value of all the materials used does not exceed 50 % of the ex-works price of the product’;

| (19) | in the row related to HS Heading ‘9013’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Lasers, other than laser diodes; other optical appliances and instruments, not specified or included elsewhere in this Chapter’; |
| --- | --- |

(19)

in the row related to HS Heading ‘9013’, the text in the column ‘description of product ’ is replaced by the following:

‘Lasers, other than laser diodes; other optical appliances and instruments, not specified or included elsewhere in this Chapter’;

| (20) | between the row related to HS Heading ‘9016’ and the row related to HS Heading ‘9025’, the following row is inserted:







  ‘ex 9021 | Materials for orthopaedic or fracture appliances and for dental fitting:






  — | Nails, tacks, drawing pins, corrugated nails, staples (other than those of heading 8305 ) and similar articles, of iron or steel, whether or not with heads of other material, but excluding such articles with heads of copper |
| --- | --- | --- | --- |

(20)

between the row related to HS Heading ‘9016’ and the row related to HS Heading ‘9025’, the following row is inserted:

‘ex 9021

Materials for orthopaedic or fracture appliances and for dental fitting:

—

Nails, tacks, drawing pins, corrugated nails, staples (other than those of heading 8305 ) and similar articles, of iron or steel, whether or not with heads of other material, but excluding such articles with heads of copper

| — | Threaded articles and non-threaded articles of iron or steel, excluding coach screws, wood screws, screw hooks and screw rings, spring washers and other lock washers, rivets |
| --- | --- |

—

Threaded articles and non-threaded articles of iron or steel, excluding coach screws, wood screws, screw hooks and screw rings, spring washers and other lock washers, rivets

Manufacture from materials of any heading, except that of the product

or

Manufacture in which the value of all the materials used does not exceed 50 % of the ex-works price of the product

| — | Titanium and articles thereof, including waste and scrap |
| --- | --- |

—

Titanium and articles thereof, including waste and scrap

Manufacture from materials of any heading’;

| (21) | in the row related to HS Heading ‘Chapter 94’, the text in the column ‘description of product ’ is replaced by the following:

  ‘Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, not elsewhere specified or included; illuminated signs, illuminated name-plates and the like; prefabricated buildings’. |
| --- | --- |

(21)

in the row related to HS Heading ‘Chapter 94’, the text in the column ‘description of product ’ is replaced by the following:

‘Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, not elsewhere specified or included; illuminated signs, illuminated name-plates and the like; prefabricated buildings’.

---

ANNEX 2

Annex B(a) to Protocol 1 is amended as follows:

| (1) | paragraph 3 of the common provisions is deleted; |
| --- | --- |

(1)

paragraph 3 of the common provisions is deleted;

| (2) | paragraph 4 of the common provisions is renumbered to paragraph 3; |
| --- | --- |

(2)

paragraph 4 of the common provisions is renumbered to paragraph 3;

| (3) | paragraph 5 of the common provisions is renumbered to paragraph 4; |
| --- | --- |

(3)

paragraph 5 of the common provisions is renumbered to paragraph 4;

| (4) | in the row related to HS Heading

  ‘
  ex 1602 32


  ex 1602 41


  ex 1602 49


  ex 1602 50
  ’,
  the text ‘Canned luncheon meat of pork, chicken and beef (午餐肉)’ in the column ‘description of product ’ is replaced by the following:

  ‘Canned luncheon meat or meat loaf of pork (containing more than 40 % by weight of pork meat or meat offal), canned luncheon meat or meat loaf of chicken (containing more than 20 % by weight of chicken meat or meat offal), canned luncheon meat or meat loaf of beef (containing more than 20 % by weight of beef meat or meat offal)’; |
| --- | --- |

(4)

in the row related to HS Heading

‘
  ex 1602 32

ex 1602 41

ex 1602 49

ex 1602 50
  ’,

the text ‘Canned luncheon meat of pork, chicken and beef (午餐肉)’ in the column ‘description of product ’ is replaced by the following:

‘Canned luncheon meat or meat loaf of pork (containing more than 40 % by weight of pork meat or meat offal), canned luncheon meat or meat loaf of chicken (containing more than 20 % by weight of chicken meat or meat offal), canned luncheon meat or meat loaf of beef (containing more than 20 % by weight of beef meat or meat offal)’;

| (5) | in the row related to HS Heading ‘ex 1604 20’ the text ‘Curry fish balls made of fish meat, curry, wheat starch, salt, sugar, and compound condiments’ in the column ‘description of product’ is replaced by the following:

  ‘fish balls and fish cakes made of fish meat except of tuna and of mackerel, starch, salt, sugar, and compound condiments’; |
| --- | --- |

(5)

in the row related to HS Heading ‘ex 1604 20’ the text ‘Curry fish balls made of fish meat, curry, wheat starch, salt, sugar, and compound condiments’ in the column ‘description of product’ is replaced by the following:

‘fish balls and fish cakes made of fish meat except of tuna and of mackerel, starch, salt, sugar, and compound condiments’;

| (6) | the row related to HS Heading

  ‘
  ex 1605 10


  ex 1605 90


  ex 1605 20


  ex 1605 20


  ex 1605 20


  ex 1605 30
  ’

  is replaced by the following:







  ‘ex 1605 10 | Crab balls made of wheat starch, salt, sugar, compound condiments, crab meat and filling | Manufacture from materials of any heading, except that of the product’ |
| --- | --- | --- | --- |
| ex 1605 54 | Cuttlefish balls made of fish meat, cuttlefish filling, starch, salt, sugar, and compound condiments | |
| ex 1605 21 | Hargow made of prawn, wheat starch, tapioca, water, scallion, ginger, sugar, and salt | |
| ex 1605 29 | Shaomai made of prawn predominantly, chicken, corn starch, vegetable oil, black pepper, sesame oil, and water | |
| ex 1902 20 | Fried prawn wonton made of prawn, salt, oil, sugar, ginger, pepper, egg, vinegar, and soy sauce. | |
| ex 1605 54 | Lobster flavoured balls: cuttlefish meat, fish meat and crab meat. | |

(6)

the row related to HS Heading

‘
  ex 1605 10

ex 1605 90

ex 1605 20

ex 1605 20

ex 1605 20

ex 1605 30
  ’

is replaced by the following:

‘ex 1605 10

Crab balls made of wheat starch, salt, sugar, compound condiments, crab meat and filling

Manufacture from materials of any heading, except that of the product’

ex 1605 54

Cuttlefish balls made of fish meat, cuttlefish filling, starch, salt, sugar, and compound condiments

ex 1605 21

Hargow made of prawn, wheat starch, tapioca, water, scallion, ginger, sugar, and salt

ex 1605 29

Shaomai made of prawn predominantly, chicken, corn starch, vegetable oil, black pepper, sesame oil, and water

ex 1902 20

Fried prawn wonton made of prawn, salt, oil, sugar, ginger, pepper, egg, vinegar, and soy sauce.

ex 1605 54

Lobster flavoured balls: cuttlefish meat, fish meat and crab meat.

---

ANNEX 3

Annex D to Protocol 1 is amended as follows:

| (1) | in the row related to HS Code ‘2909’, the text in the column ‘description’ is replaced by the following:

  ‘Ethers, ether-alcohols, ether-phenols, ether-alcohol-phenols, alcohol peroxides, ether peroxides, acetal and hemiacetal peroxides, ketone peroxides (whether or not chemically defined), and their halogenated, sulphonated, nitrated or nitrosated derivatives’; |
| --- | --- |

(1)

in the row related to HS Code ‘2909’, the text in the column ‘description’ is replaced by the following:

‘Ethers, ether-alcohols, ether-phenols, ether-alcohol-phenols, alcohol peroxides, ether peroxides, acetal and hemiacetal peroxides, ketone peroxides (whether or not chemically defined), and their halogenated, sulphonated, nitrated or nitrosated derivatives’;

| (2) | in the row related to HS Code ‘9013’, the text in the column ‘description’ is replaced by the following:

  ‘Lasers, other than laser diodes; other optical appliances and instruments, not specified or included elsewhere in this Chapter’. |
| --- | --- |

(2)

in the row related to HS Code ‘9013’, the text in the column ‘description’ is replaced by the following:

‘Lasers, other than laser diodes; other optical appliances and instruments, not specified or included elsewhere in this Chapter’.

---

ANNEX 4

Annex E to Protocol 1 is amended as follows:

| (1) | in the title of Annex E, the term ‘origin declaration’ is replaced by the term ‘statement on origin’; |
| --- | --- |

(1)

in the title of Annex E, the term ‘origin declaration’ is replaced by the term ‘statement on origin’;

| (2) | the first paragraph of Annex E is replaced by the following:

  ‘The statement on origin, the text of which is given below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced.’; |
| --- | --- |

(2)

the first paragraph of Annex E is replaced by the following:

‘The statement on origin, the text of which is given below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced.’;

| (3) | footnote (1) is replaced by the following:

  ‘Indicate the reference number by which the exporter is identified. For the Union exporter, this will be the number assigned in accordance with the laws and regulations of the Union. For Singapore, this will be the number assigned in accordance with the laws and regulations of Singapore. Where the exporter has not been assigned a number, this field may be left blank’; |
| --- | --- |

(3)

footnote (1) is replaced by the following:

‘Indicate the reference number by which the exporter is identified. For the Union exporter, this will be the number assigned in accordance with the laws and regulations of the Union. For Singapore, this will be the number assigned in accordance with the laws and regulations of Singapore. Where the exporter has not been assigned a number, this field may be left blank’;

| (4) | the last sentence before the footnotes is replaced by the following:

  ‘(Name of the exporter)’; |
| --- | --- |

(4)

the last sentence before the footnotes is replaced by the following:

‘(Name of the exporter)’;

| (5) | footnote (4) is deleted. |
| --- | --- |

(5)

footnote (4) is deleted.

---

JOINT DECLARATION CONCERNING TRANSITIONAL MEASURES AFTER THE DATE OF ENTRY INTO FORCE OF THE DECISION

By way of derogation from Article 17 (Conditions for Making Out a Statement on Origin) of Protocol 1 to the Agreement, as amended by this Decision, Singapore shall continue to grant the preferential tariff treatment under this Agreement to goods originating in the Union and exported from the Union upon the presentation of an origin declaration made out in accordance with Article 17 (Conditions for Making Out an Origin Declaration) and Article 18 (Approved Exporter) of Protocol 1 to the Agreement in force prior to the date of entry into force of this Decision. This transitional measure shall apply for a period of 3 months starting from the date of entry into force of this Decision.

---