# L_2021160EN.01008901.xml

| 7.5.2021 | EN | Official Journal of the European Union | L 160/89 |
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7.5.2021

EN

Official Journal of the European Union

L 160/89

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/745

of 6 May 2021

amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distilation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/ sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea

(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 the first paragraph of Article 17 thereof,

Whereas:

| (1) | Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009. |
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(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

| (2) | Commission Implementing Regulation (EU) 2020/869 (3) extended the approval period of the active substances famoxadone and flumioxazine until 30 June 2021 and of the active substances beflubutamid, benthiavalicarb, bifenazate, boscalid, captan, dimethomorph, ethephon, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, S-metolachlor until 31 July 2021. Commission Implementing Regulation (EU) 2020/1160 (4) extended the approval period of the active substances aluminium ammonium sulphate, aluminium silicate, calcium carbonate, carbon dioxide, extract from tea tree, fat distillation residues, fatty acids C7 to C20, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, plant oils/rape seed oil, potassium hydrogen carbonate, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, Straight Chain Lepidopteran Pheromones, tebuconazole and urea until 31 August 2021. Commission Implementing Regulation (EU) 2017/195 (5) extended the approval period of the active substances metazachlor and cymoxanil until 31 July 2021 and 31 August 2021, respectively. Commission Implementing Regulation (EU) 2017/1527 (6) extended the approval period of the active substance heptamaloxyloglucan until 31 May 2021. |
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(2)

Commission Implementing Regulation (EU) 2020/869 (3) extended the approval period of the active substances famoxadone and flumioxazine until 30 June 2021 and of the active substances beflubutamid, benthiavalicarb, bifenazate, boscalid, captan, dimethomorph, ethephon, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, S-metolachlor until 31 July 2021. Commission Implementing Regulation (EU) 2020/1160 (4) extended the approval period of the active substances aluminium ammonium sulphate, aluminium silicate, calcium carbonate, carbon dioxide, extract from tea tree, fat distillation residues, fatty acids C7 to C20, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, plant oils/rape seed oil, potassium hydrogen carbonate, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, Straight Chain Lepidopteran Pheromones, tebuconazole and urea until 31 August 2021. Commission Implementing Regulation (EU) 2017/195 (5) extended the approval period of the active substances metazachlor and cymoxanil until 31 July 2021 and 31 August 2021, respectively. Commission Implementing Regulation (EU) 2017/1527 (6) extended the approval period of the active substance heptamaloxyloglucan until 31 May 2021.

| (3) | The approval of the active substance flurochloridone is set to expire on 31 May 2021 in accordance with Commission Directive 2011/34/EU (7). |
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(3)

The approval of the active substance flurochloridone is set to expire on 31 May 2021 in accordance with Commission Directive 2011/34/EU (7).

| (4) | Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (8). |
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(4)

Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (8).

| (5) | Due to the fact that the assessment of those active substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods. |
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(5)

Due to the fact that the assessment of those active substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

| (6) | In addition, an extension of the approval period is required for the active substances benthiavalicarb, calcium carbonate, dimethomorph, ethephon, fluoxastrobin, folpet, formetanate, gibberellic acid, gibberellins, metribuzin, milbemectin, phenmedipham, pirimiphos-methyl, propamocarb, prothioconazole, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea to provide the time necessary to carry out an assessment relating to endocrine disrupting properties of those active substances in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012. |
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(6)

In addition, an extension of the approval period is required for the active substances benthiavalicarb, calcium carbonate, dimethomorph, ethephon, fluoxastrobin, folpet, formetanate, gibberellic acid, gibberellins, metribuzin, milbemectin, phenmedipham, pirimiphos-methyl, propamocarb, prothioconazole, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea to provide the time necessary to carry out an assessment relating to endocrine disrupting properties of those active substances in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.

| (7) | As regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date. |
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(7)

As regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

| (8) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(8)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(9)

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

Article 2

This Regulation shall enter into force on the third 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, 6 May 2021.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  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).

2

(3)  Commission Implementing Regulation (EU) 2020/869 of 24 June 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, dimethomorph, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and S-metolachlor (OJ L 201, 25.6.2020, p. 7).

3

(4)  Commission Implementing Regulation (EU) 2020/1160 of 5 August 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, blood meal, calcium carbonate, carbon dioxide, extract from tea tree, fat distillation residues, fatty acids C7 to C20, garlic extract, gibberellic acid, gibberellins, hydrolysed proteins, iron sulphate, kieselgur (diatomaceous earth), plant oils/rape seed oil, potassium hydrogen carbonate, quartz sand, fish oil, repellents by smell of animal or plant origin/sheep fat, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (OJ L 257, 6.8.2020, p. 29).

4

(5)  Commission Implementing Regulation (EU) 2017/195 of 3 February 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of several active substances listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012 (AIR IV renewal programme) (OJ L 31, 4.2.2017, p. 21).

5

(6)  Commission Implementing Regulation (EU) 2017/1527 of 6 September 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances cyflufenamid, fluopicolide, heptamaloxyloglucan and malathion (OJ L 231, 7.9.2017, p. 3).

6

(7)  Commission Directive 2011/34/EU of 8 March 2011 amending Council Directive 91/414/EEC to include flurochloridone as active substance and amending Commission Decision 2008/934/EC (OJ L 62, 9.3.2011, p. 27).

7

(8)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

8

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ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in the sixth column, expiration of approval, of row 35, Famoxadone, the date is replaced by ‘30 June 2022’; |
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(1)

in the sixth column, expiration of approval, of row 35, Famoxadone, the date is replaced by ‘30 June 2022’;

| (2) | in the sixth column, expiration of approval, of row 39, Flumioxazine, the date is replaced by ‘30 June 2022’; |
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(2)

in the sixth column, expiration of approval, of row 39, Flumioxazine, the date is replaced by ‘30 June 2022’;

| (3) | in the sixth column, expiration of approval, of row 88, Phenmedipham, the date is replaced by ‘31 July 2022’; |
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(3)

in the sixth column, expiration of approval, of row 88, Phenmedipham, the date is replaced by ‘31 July 2022’;

| (4) | in the sixth column, expiration of approval, of row 97, S-metolachlor, the date is replaced by ‘31 July 2022’; |
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(4)

in the sixth column, expiration of approval, of row 97, S-metolachlor, the date is replaced by ‘31 July 2022’;

| (5) | in the sixth column, expiration of approval, of row 109, Bifenazate, the date is replaced by ‘31 July 2022’; |
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(5)

in the sixth column, expiration of approval, of row 109, Bifenazate, the date is replaced by ‘31 July 2022’;

| (6) | in the sixth column, expiration of approval, of row 110, Milbemectin, the date is replaced by ‘31 July 2022’; |
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(6)

in the sixth column, expiration of approval, of row 110, Milbemectin, the date is replaced by ‘31 July 2022’;

| (7) | in the sixth column, expiration of approval, of row 142, Ethephon, the date is replaced by ‘31 July 2022’; |
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(7)

in the sixth column, expiration of approval, of row 142, Ethephon, the date is replaced by ‘31 July 2022’;

| (8) | in the sixth column, expiration of approval, of row 145, Captan, the date is replaced by ‘31 July 2022’; |
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(8)

in the sixth column, expiration of approval, of row 145, Captan, the date is replaced by ‘31 July 2022’;

| (9) | in the sixth column, expiration of approval, of row 146, Folpet, the date is replaced by ‘31 July 2022’; |
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(9)

in the sixth column, expiration of approval, of row 146, Folpet, the date is replaced by ‘31 July 2022’;

| (10) | in the sixth column, expiration of approval, of row 147, Formetanate, the date is replaced by ‘31 July 2022’; |
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(10)

in the sixth column, expiration of approval, of row 147, Formetanate, the date is replaced by ‘31 July 2022’;

| (11) | in the sixth column, expiration of approval, of row 150, Dimethomorph, the date is replaced by ‘31 July 2022’; |
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(11)

in the sixth column, expiration of approval, of row 150, Dimethomorph, the date is replaced by ‘31 July 2022’;

| (12) | in the sixth column, expiration of approval, of row 152, Metribuzin, the date is replaced by ‘31 July 2022’; |
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(12)

in the sixth column, expiration of approval, of row 152, Metribuzin, the date is replaced by ‘31 July 2022’;

| (13) | in the sixth column, expiration of approval, of row 153, Phosmet, the date is replaced by ‘31 July 2022’; |
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(13)

in the sixth column, expiration of approval, of row 153, Phosmet, the date is replaced by ‘31 July 2022’;

| (14) | in the sixth column, expiration of approval, of row 154, Propamocarb, the date is replaced by ‘31 July 2022’; |
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(14)

in the sixth column, expiration of approval, of row 154, Propamocarb, the date is replaced by ‘31 July 2022’;

| (15) | in the sixth column, expiration of approval, of row 156, Pirimiphos-methyl, the date is replaced by ‘31 July 2022’; |
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(15)

in the sixth column, expiration of approval, of row 156, Pirimiphos-methyl, the date is replaced by ‘31 July 2022’;

| (16) | in the sixth column, expiration of approval, of row 158, Beflubutamid, the date is replaced by ‘31 July 2022’; |
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(16)

in the sixth column, expiration of approval, of row 158, Beflubutamid, the date is replaced by ‘31 July 2022’;

| (17) | in the sixth column, expiration of approval, of row 163, Benthiavalicarb, the date is replaced by ‘31 July 2022’; |
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(17)

in the sixth column, expiration of approval, of row 163, Benthiavalicarb, the date is replaced by ‘31 July 2022’;

| (18) | in the sixth column, expiration of approval, of row 164, Boscalid, the date is replaced by ‘31 July 2022’; |
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(18)

in the sixth column, expiration of approval, of row 164, Boscalid, the date is replaced by ‘31 July 2022’;

| (19) | in the sixth column, expiration of approval, of row 166, Fluoxastrobin, the date is replaced by ‘31 July 2022’; |
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(19)

in the sixth column, expiration of approval, of row 166, Fluoxastrobin, the date is replaced by ‘31 July 2022’;

| (20) | in the sixth column, expiration of approval, of row 167, Paecilomyces lilacinus strain 251, the date is replaced by ‘31 July 2022’; |
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(20)

in the sixth column, expiration of approval, of row 167, Paecilomyces lilacinus strain 251, the date is replaced by ‘31 July 2022’;

| (21) | in the sixth column, expiration of approval, of row 168, Prothioconazole, the date is replaced by ‘31 July 2022’; |
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(21)

in the sixth column, expiration of approval, of row 168, Prothioconazole, the date is replaced by ‘31 July 2022’;

| (22) | in the sixth column, expiration of approval, of row 217, Metazachlor, the date is replaced by ‘31 July 2022’; |
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(22)

in the sixth column, expiration of approval, of row 217, Metazachlor, the date is replaced by ‘31 July 2022’;

| (23) | in the sixth column, expiration of approval, of row 219, Aluminium ammonium sulphate, the date is replaced by ‘31 August 2022’; |
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(23)

in the sixth column, expiration of approval, of row 219, Aluminium ammonium sulphate, the date is replaced by ‘31 August 2022’;

| (24) | in the sixth column, expiration of approval, of row 220, Aluminium silicate, the date is replaced by ‘31 August 2022’; |
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(24)

in the sixth column, expiration of approval, of row 220, Aluminium silicate, the date is replaced by ‘31 August 2022’;

| (25) | in the sixth column, expiration of approval, of row 224, Calcium carbonate, the date is replaced by ‘31 August 2022’; |
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(25)

in the sixth column, expiration of approval, of row 224, Calcium carbonate, the date is replaced by ‘31 August 2022’;

| (26) | in the sixth column, expiration of approval, of row 225, Carbon dioxide, the date is replaced by ‘31 August 2022’; |
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(26)

in the sixth column, expiration of approval, of row 225, Carbon dioxide, the date is replaced by ‘31 August 2022’;

| (27) | in the sixth column, expiration of approval, of row 228, Extract from tea tree, the date is replaced by ‘31 August 2022’; |
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(27)

in the sixth column, expiration of approval, of row 228, Extract from tea tree, the date is replaced by ‘31 August 2022’;

| (28) | in the sixth column, expiration of approval, of row 229, Fat distillation residues, the date is replaced by ‘31 August 2022’; |
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(28)

in the sixth column, expiration of approval, of row 229, Fat distillation residues, the date is replaced by ‘31 August 2022’;

| (29) | in the sixth column, expiration of approval, of row 230, Fatty acids C7 to C20, the date is replaced by ‘31 August 2022’; |
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(29)

in the sixth column, expiration of approval, of row 230, Fatty acids C7 to C20, the date is replaced by ‘31 August 2022’;

| (30) | in the sixth column, expiration of approval, of row 232, Gibberellic acid, the date is replaced by ‘31 August 2022’; |
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(30)

in the sixth column, expiration of approval, of row 232, Gibberellic acid, the date is replaced by ‘31 August 2022’;

| (31) | in the sixth column, expiration of approval, of row 233, Gibberellins, the date is replaced by ‘31 August 2022’; |
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(31)

in the sixth column, expiration of approval, of row 233, Gibberellins, the date is replaced by ‘31 August 2022’;

| (32) | in the sixth column, expiration of approval, of row 234, Hydrolysed proteins, the date is replaced by ‘31 August 2022’; |
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(32)

in the sixth column, expiration of approval, of row 234, Hydrolysed proteins, the date is replaced by ‘31 August 2022’;

| (33) | in the sixth column, expiration of approval, of row 235, Iron sulphate, the date is replaced by ‘31 August 2022’; |
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(33)

in the sixth column, expiration of approval, of row 235, Iron sulphate, the date is replaced by ‘31 August 2022’;

| (34) | in the sixth column, expiration of approval, of row 242, Plant oils/rape seed oil, the date is replaced by ‘31 August 2022’; |
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(34)

in the sixth column, expiration of approval, of row 242, Plant oils/rape seed oil, the date is replaced by ‘31 August 2022’;

| (35) | in the sixth column, expiration of approval, of row 244, Potassium hydrogen carbonate, the date is replaced by ‘31 August 2022’; |
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(35)

in the sixth column, expiration of approval, of row 244, Potassium hydrogen carbonate, the date is replaced by ‘31 August 2022’;

| (36) | in the sixth column, expiration of approval, of row 247, Quartz sand, the date is replaced by ‘31 August 2022’; |
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(36)

in the sixth column, expiration of approval, of row 247, Quartz sand, the date is replaced by ‘31 August 2022’;

| (37) | in the sixth column, expiration of approval, of row 248, Fish oil, the date is replaced by ‘31 August 2022’; |
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(37)

in the sixth column, expiration of approval, of row 248, Fish oil, the date is replaced by ‘31 August 2022’;

| (38) | in the sixth column, expiration of approval, of row 249, Repellents by smell of animal or plant origin/ sheep fat, the date is replaced by ‘31 August 2022’; |
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(38)

in the sixth column, expiration of approval, of row 249, Repellents by smell of animal or plant origin/ sheep fat, the date is replaced by ‘31 August 2022’;

| (39) | in the sixth column, expiration of approval, of row 255, Straight Chain Lepidopteran Pheromones, the date is replaced by ‘31 August 2022’; |
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(39)

in the sixth column, expiration of approval, of row 255, Straight Chain Lepidopteran Pheromones, the date is replaced by ‘31 August 2022’;

| (40) | in the sixth column, expiration of approval, of row 263, Cymoxanil, the date is replaced by ‘31 August 2022’; |
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(40)

in the sixth column, expiration of approval, of row 263, Cymoxanil, the date is replaced by ‘31 August 2022’;

| (41) | in the sixth column, expiration of approval, of row 268, Tebuconazole, the date is replaced by ‘31 August 2022’; |
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(41)

in the sixth column, expiration of approval, of row 268, Tebuconazole, the date is replaced by ‘31 August 2022’;

| (42) | in the sixth column, expiration of approval, of row 257, Urea, the date is replaced by ‘31 August 2022’; |
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(42)

in the sixth column, expiration of approval, of row 257, Urea, the date is replaced by ‘31 August 2022’;

| (43) | in the sixth column, expiration of approval, of row 298, Heptamaloxyloglucan, the date is replaced by ‘31 May 2022’; |
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(43)

in the sixth column, expiration of approval, of row 298, Heptamaloxyloglucan, the date is replaced by ‘31 May 2022’;

| (44) | in the sixth column, expiration of approval, of row 354, Flurochloridone, the date is replaced by ‘31 May 2022’. |
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(44)

in the sixth column, expiration of approval, of row 354, Flurochloridone, the date is replaced by ‘31 May 2022’.

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