Executive Summary:
Commission Implementing Regulation (EU) 2022/1480 amends Implementing Regulation (EU) No 540/2011, extending the approval periods for several active substances used in plant protection products. This extension is necessary to allow for the completion of the assessment of these substances and, in some cases, to evaluate their endocrine-disrupting properties. The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Key Points / Main Content:
Extension of Approval Periods:
* Extends the approval periods of various active substances listed in the Annex of Implementing Regulation (EU) No 540/2011.
* The extensions apply to substances in Part A, Part B and Part E of the Annex.
* New expiration dates are specified for each substance in the Annex.
Specific Extension Dates:
* Substances such as Deltamethrin, Flufenacet, Fosthiazate, Chlorotoluron, Daminozide, MCPA, MCPB, Prosulfocarb, Fludioxonil, Clomazone, Bensulfuron, Sodium 5-nitroguaiacolate, Sodium o-nitrophenolate, Sodium p-nitrophenolate, Tebufenpyrad, are extended until 31 October 2023.
* Substances such as Chlormequat, Propaquizafop, Quizalofop-P-ethyl, Quizalofop-P-tefuryl, Tritosulfuron are extended until 30 November 2023.
* Substances such as Amidosulfuron, Nicosulfuron, Clofentezine, Dicamba, Difenoconazole, Lenacil, Picloram, Bifenox, Diflufenican, Fenoxaprop-P, Fenpropidin, Dimethachlor, Etofenprox, Penconazole, Triallate, Triflusulfuron, Sulphur, Tetraconazole, Paraffin oils, 2-phenylphenol, Prohexadione, 8-hydroxyquinoline, Fenpyrazamine, Esfenvalerate are extended until 31 December 2023.
* Flumetralin is extended until 11 December 2023.
Renewal Assessment:
* The assessment of some active substances has been delayed, necessitating the extensions.
* Extensions provide time to assess endocrine-disrupting properties for substances including amidosulfuron, clomazone, daminozide, difenoconazole, diflufenican, fenoxaprop-P, fludioxonil, flufenacet, and tritosulfuron.
Commission Actions:
* If an active substance's approval is not renewed, the Commission will set the expiry date at the same date as before this Regulation or at the date of entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later.
* If the Commission renews an active substance, it will endeavour to set the earliest possible application date.
Impact Analysis:
European Commission:
Impact: Responsible for setting expiry dates and application dates for active substances, and for regulation amendments.
Action Required: Implement the changes to Implementing Regulation (EU) No 540/2011 and assess the active substances.
Plant Protection Product Manufacturers/Applicants:
Impact: Benefit from extended approval periods, allowing continued use of the listed active substances.
Action Required: Monitor the new expiration dates for active substances and ensure compliance with regulations.
Member States:
Impact: Must apply the amended regulation.
Action Required: Enforce the updated approval periods for the active substances.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Implementing Regulation EU No 540/2011: A European Union regulation implementing Regulation (EC) No 1107/2009 as regards the list of approved active substances.
Regulation EC No 1107/2009: A regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Deltamethrin: An active substance used in plant protection products, the approval of which is extended by this regulation.
Flufenacet: An active substance used in plant protection products, the approval of which is extended by this regulation.
Fosthiazate: An active substance used in plant protection products, the approval of which is extended by this regulation.
Brussels: The location where the regulation was adopted.
8.9.2022 EN Official Journal of the European Union L 233/43
COMMISSION IMPLEMENTING REGULATION (EU) 2022/1480
of 7 September 2022
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval
periods of the active substances 2-phenylphenol (including its salts such as the sodium salt),
8-hydroxyquinoline, amidosulfuron, bensulfuron, bifenox, chlormequat, chlorotoluron,
clofentezine, clomazone, daminozide, deltamethrin, dicamba, difenoconazole, diflufenican,
dimethachlor, esfenvalerate, etofenprox, fenoxaprop-P, fenpropidin, fenpyrazamine, fludioxonil,
flufenacet, flumetralin, fosthiazate, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, paraffin oil,
penconazole, picloram, prohexadione, propaquizafop, prosulfocarb, quizalofop-P-ethyl, quizalofop-
P-tefuryl, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, sulphur,
tebufenpyrad, tetraconazole, tri-allate, triflusulfuron and tritosulfuron
(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 17, first paragraph, 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 whereas Part B of that Annex sets out the
active substances approved under Regulation (EC) No 1107/2009 and Part E sets out the active substances
approved under Regulation (EC) No 1107/2009 as candidates for substitution.
(2) Commission Implementing Regulation (EU) 2021/1449(3) extended the approval period of the active substances
chlorotoluron, clomazone, daminozide, deltamethrin, fludioxonil, flufenacet, fosthiazate, MCPA, MCPB and
prosulfocarb until 31 October 2022, of the active substances chlormequat, propaquizafop, quizalofop-P-ethyl,
quizalofop-P-tefuryl and tritosulfuron until 30 November 2022 and of the active substances 2-phenylphenol,
8-hydroxyquinoline, amidosulfuron, bifenox, clofentezine, dicamba, difenoconazole, diflufenican, dimethachlor,
etofenprox, fenoxaprop-P, fenpropidin, lenacil, nicosulfuron, paraffin oils, paraffin oil, penconazole, picloram,
sulphur, tetraconazole, tri-allate and triflusulfuron until 31 December 2022. Commission Implementing Regulation
(EU) 2017/555(4) extended the approval period of the active substances bensulfuron, sodium 5-nitroguaiacolate,
(1) OJ L 309, 24.11.2009, p. 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).
(3) Commission Implementing Regulation (EU) 2021/1449 of 3 September 2021 amending Implementing Regulation (EU) No 540/2011
as regards the extension of the approval periods of the active substances 2-phenylphenol (including its salts such as the sodium salt),
8-hydroxyquinoline, amidosulfuron, bifenox, chlormequat, chlorotoluron, clofentezine, clomazone, cypermethrin, daminozide,
deltamethrin, dicamba, difenoconazole, diflufenican, dimethachlor, etofenprox, fenoxaprop-P, fenpropidin, fludioxonil, flufenacet,
fosthiazate, indoxacarb, lenacil, MCPA, MCPB, nicosulfuron, paraffin oils, paraffin oil, penconazole, picloram, propaquizafop,
prosulfocarb, quizalofop-P-ethyl, quizalofop-P-tefuryl, sulphur, tetraconazole, tri-allate, triflusulfuron and tritosulfuron (OJ L 313,
6.9.2021, p. 20).
(4) Commission Implementing Regulation (EU) 2017/555 of 24 March 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 80, 25.3.2017, p. 1).L 233/44 EN Official Journal of the European Union 8.9.2022
sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad until 31 October 2022. Commission
Implementing Regulation (EU) 2019/291(5) extended the approval period of the active substance prohexadione
until 31 December 2022.
(3) The approval of the active substance esfenvalerate is set to expire on 31 December 2022 in accordance with
Commission Implementing Regulation (EU) 2015/2047(6).
(4) The approval of the active substance fenpyrazamine is set to expire on 31 December 2022 in accordance with
Commission Implementing Regulation (EU) No 595/2012(7).
(5) The approval of the active substance flumetralin is set to expire on 11 December 2022 in accordance with
Commission Implementing Regulation (EU) 2015/2105(8).
(6) Applications for the renewal of the approval of those active substances were submitted in accordance with
Commission Implementing Regulation (EU) No 844/2012(9). Although Implementing Regulation (EU)
No 844/2012 was repealed by Commission Implementing Regulation (EU) 2020/1740(10), for the renewal of the
approval of those active substances, the provisions of Implementing Regulation (EU) No 844/2012, continue to
apply pursuant to Article 17 of Implementing Regulation (EU) 2020/1740.
(7) 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 to provide the time necessary to complete the
assessment.
(8) In addition, an extension of the approval period is required for the active substances amidosulfuron, clomazone,
daminozide, difenoconazole, diflufenican, fenoxaprop-P, fludioxonil, flufenacet, and tritosulfuron 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.
(9) 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
(5) Commission Implementing Regulation (EU) 2019/291 of 19 February 2019 amending Implementing Regulation (EU) No 540/2011
as regards the extension of the approval periods of the active substances 1-naphthylacetamide, 1-naphthylacetic acid, acrinathrin,
azoxystrobin, fluazifop p, fluroxypyr, imazalil, kresoxim-methyl, oxyfluorfen, prochloraz, prohexadione, spiroxamine, tefluthrin and
terbuthylazine (OJ L 48, 20.2.2019, p. 17).
(6) Commission Implementing Regulation (EU) 2015/2047 of 16 November 2015 renewing the approval of the active substance
esfenvalerate, as a candidate for substitution, 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 the Annex to Commission
Implementing Regulation (EU) No 540/2011 (OJ L 300, 17.11.2015, p. 8).
(7) Commission Implementing Regulation (EU) No 595/2012 of 5 July 2012 approving the active substance fenpyrazamine, 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 the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 176,
6.7.2012, p. 46).
(8) Commission Implementing Regulation (EU) 2015/2105 of 20 November 2015 approving the active substance flumetralin, as a
candidate for substitution, 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 (OJ L 305, 21.11.2015, p. 31).
(9) 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).
(10) Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 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, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020,
p. 20).8.9.2022 EN Official Journal of the European Union L 233/45
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.
(10) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(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 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 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, 7 September 2022.
For the Commission
The President
Ursula VON DER LEYENL 233/46 EN Official Journal of the European Union 8.9.2022
ANNEX
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(a) Part A is amended as follows:
(1) in the sixth column, expiration of approval, of row 40, Deltamethrin, the date is replaced by β31 October 2023β;
(2) in the sixth column, expiration of approval, of row 65, Flufenacet, the date is replaced by β31 October 2023β;
(3) in the sixth column, expiration of approval, of row 69, Fosthiazate, the date is replaced by β31 October 2023β;
(4) in the sixth column, expiration of approval, of row 102, Chlorotoluron, the date is replaced by β31 October 2023β;
(5) in the sixth column, expiration of approval, of row 104, Daminozide, the date is replaced by β31 October 2023β;
(6) in the sixth column, expiration of approval, of row 107, MCPA, the date is replaced by β31 October 2023β;
(7) in the sixth column, expiration of approval, of row 108, MCPB, the date is replaced by β31 October 2023β;
(8) in the sixth column, expiration of approval, of row 160, Prosulfocarb, the date is replaced by β31 October 2023β;
(9) in the sixth column, expiration of approval, of row 161, Fludioxonil, the date is replaced by β31 October 2023β;
(10) in the sixth column, expiration of approval, of row 162, Clomazone, the date is replaced by β31 October 2023β;
(11) in the sixth column, expiration of approval, of row 169, Amidosulfuron, the date is replaced by β31 December
2023β;
(12) in the sixth column, expiration of approval, of row 170, Nicosulfuron, the date is replaced by β31 December
2023β;
(13) in the sixth column, expiration of approval, of row 171, Clofentezine, the date is replaced by β31 December 2023β;
(14) in the sixth column, expiration of approval, of row 172, Dicamba, the date is replaced by β31 December 2023β;
(15) in the sixth column, expiration of approval, of row 173, Difenoconazole, the date is replaced by β31 December
2023β;
(16) in the sixth column, expiration of approval, of row 176, Lenacil, the date is replaced by β31 December 2023β;
(17) in the sixth column, expiration of approval, of row 178, Picloram, the date is replaced by β31 December 2023β;
(18) in the sixth column, expiration of approval, of row 180, Bifenox, the date is replaced by β31 December 2023β;
(19) in the sixth column, expiration of approval, of row 181, Diflufenican, the date is replaced by β31 December 2023β;
(20) in the sixth column, expiration of approval, of row 182, Fenoxaprop-P, the date is replaced by β31 December
2023β;
(21) in the sixth column, expiration of approval, of row 183, Fenpropidin, the date is replaced by β31 December 2023β;
(22) in the sixth column, expiration of approval, of row 186, Tritosulfuron, the date is replaced by β30 November
2023β;
(23) in the sixth column, expiration of approval, of row 271, Bensulfuron, the date is replaced by β31 October 2023β;8.9.2022 EN Official Journal of the European Union L 233/47
(24) in the sixth column, expiration of approval, of row 272, Sodium 5-nitroguaiacolate, the date is replaced by
β31 October 2023β;
(25) in the sixth column, expiration of approval, of row 273, Sodium o-nitrophenolate, the date is replaced by
β31 October 2023β;
(26) in the sixth column, expiration of approval, of row 274, Sodium p-nitrophenolate, the date is replaced by
β31 October 2023β;
(27) in the sixth column, expiration of approval, of row 275, Tebufenpyrad, the date is replaced by β31 October 2023β;
(28) in the sixth column, expiration of approval, of row 276, Chlormequat, the date is replaced by β30 November
2023β;
(29) in the sixth column, expiration of approval, of row 278, Propaquizafop, the date is replaced by β30 November
2023β;
(30) in the sixth column, expiration of approval, of row 279, Quizalofop-P-ethyl and Quizalofop-P-tefuryl, the date is
replaced by β30 November 2023β;
(31) in the sixth column, expiration of approval, of row 284, Dimethachlor, the date is replaced by β31 December
2023β;
(32) in the sixth column, expiration of approval, of row 285, Etofenprox, the date is replaced by β31 December 2023β;
(33) in the sixth column, expiration of approval, of row 287, Penconazole, the date is replaced by β31 December
2023β;
(34) in the sixth column, expiration of approval, of row 288, Tri-allate, the date is replaced by β31 December 2023β;
(35) in the sixth column, expiration of approval, of row 289, Triflusulfuron, the date is replaced by β31 December
2023β;
(36) in the sixth column, expiration of approval, of row 292, Sulphur, the date is replaced by β31 December 2023β;
(37) in the sixth column, expiration of approval, of row 293, Tetraconazole, the date is replaced by β31 December
2023β;
(38) in the sixth column, expiration of approval, of row 294, Paraffin oils, the date is replaced by β31 December 2023β;
(39) in the sixth column, expiration of approval, of row 295, Paraffin oil, the date is replaced by β31 December 2023β;
(40) in the sixth column, expiration of approval, of row 299, 2-phenylphenol (including its salts such as the sodium
salt), the date is replaced by β31 December 2023β;
(b) Part B is amended as follows:
(1) in the sixth column, expiration of approval, of row 6, Prohexadione, the date is replaced by β31 December 2023β;
(2) in the sixth column, expiration of approval, of row 18, 8-hydroxyquinoline, the date is replaced by β31 December
2023β;
(3) in the sixth column, expiration of approval, of row 25, Fenpyrazamine, the date is replaced by β31 December 2023β;
(c) Part E is amended as follows:
(1) in the sixth column, expiration of approval, of row 1, Flumetralin, the date is replaced by β11 December 2023β;
(2) in the sixth column, expiration of approval, of row 2, Esfenvalerate, the date is replaced by β31 December 2023β.