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Official Journal EN
of the European Union L series
2024/2221 9.9.2024
COMMISSION IMPLEMENTING REGULATION (EU) 2024/2221
of 6 September 2024
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval
periods of the active substances acequinocyl, aluminium silicate, emamectin, fatty acids C7 to C20,
pendimethalin, plant oils / rape seed oil and triclopyr
(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 subparagraph, thereof,
Whereas:
(1) Commission Directive 2006/74/EC(2) approved the active substance triclopyr until 31 May 2017. Commission
Directive 2008/127/EC(3)approved the active substances aluminium silicate, fatty acids and plant oils / rape seed
oil until 31 August 2019.
(2) According to Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Council
Directive 91/414/EEC(4)are deemed to have been approved under Regulation (EC) No 1107/2009.
(3) Commission Implementing Regulation (EU) No 828/2013(5) approved the active substance emamectin until
30 April 2024. Commission Implementing Regulation (EU) No 496/2014(6) approved the active substance
acequinocyl, until 31 August 2024. Commission Implementing Regulation (EU) 2017/1114(7) renewed the
approval of the active substance pendimethalin until 31 August 2024.
(1) OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.
(2) Commission Directive 2006/74/EC of 21 August 2006 amending Council Directive 91/414/EEC to include dichlorprop-P,
metconazole, pyrimethanil and triclopyr as active substances (OJ L 235, 30.8.2006, p. 17, ELI: http://data.europa.eu/eli/dir/2006/74/
oj).
(3) Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active
substances (OJ L 344, 20.12.2008, p. 89, ELI: http://data.europa.eu/eli/dir/2008/127/oj).
(4) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1, ELI: http://data.europa.eu/eli/dir/1991/414/oj).
(5) Commission Implementing Regulation (EU) No 828/2013 of 29 August 2013 approving the active substance emamectin, 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 232,
30.8.2013, p. 23, ELI: http://data.europa.eu/eli/reg_impl/2013/828/oj).
(6) Commission Implementing Regulation (EU) No 496/2014 of 14 May 2014 approving the active substance acequinocyl, 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 143,
15.5.2014, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2014/496/oj).
(7) Commission Implementing Regulation (EU) 2017/1114 of 22 June 2017 renewing the approval of the active substance
pendimethalin, 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 162, 23.6.2017, p. 32, ELI: http://data.europa.eu/eli/reg_impl/2017/1114/oj).
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(4) The approvals of the active substances aluminium silicate, fatty acids, plant oils / rape seed oil and triclopyr,
respectively, are listed in Part A of the Annex to Implementing Regulation (EU) No 540/2011(8). The approvals of
the active substances acequinocyl and emamectin, respectively, are listed in Part B of the Annex to Implementing
Regulation (EU) No 540/2011. The approval of the active substance pendimethalin is listed in Part E of the Annex
of Implementing Regulation (EU) No 540/2011.
(5) Commission Implementing Regulation (EU) 2020/2007(9) extends the respective approval periods of the active
substances acequinocyl, emamectin and pendimethalin until 30 November 2024.
(6) Commission Implementing Regulation (EU) 2023/1446(10) extends the respective approval periods of the active
substances aluminium silicate, fatty acids, plant oils / rape seed oil until 15 December 2024.
(7) Commission Implementing Regulation (EU) 2023/689(11) extends the approval period of the active substance
triclopyr until 15 December 2024.
(8) Applications and supplementary dossiers for the renewal of the approvals of each of these active substances were
submitted, in accordance with Commission Implementing Regulation (EU) 2020/1740(12), 3 years before the
extended expiry date of the active substances. On 23 May 2023, 6 December 2016, 29 February 2016, 23 August
8, 4 June 2018, 9 December 2015, 1 February 2022, 29 September 2016and 4 September 2014respectively, the
rapporteur Member States for acequinocyl, aluminium silicate, emamectin, fatty acids C7 to C20, pendimethalin,
(8) 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, ELI: http://data.
europa.eu/eli/reg_impl/2011/540/oj).
(9) Commission Implementing Regulation (EU) 2020/2007 of 8 December 2020 amending Implementing Regulation (EU) No 540/2011
as regards the extension of the approval periods of the active substances 1-decanol, 1,4-dimethylnaphthalene, 6-benzyladenine,
acequinocyl, Adoxophyes orana granulovirus, aluminium sulfate, amisulbrom, Aureobasidium pullulans (strains DSM 14940 and
DSM 14941), azadirachtin, Bacillus pumilus QST 2808, benalaxyl-M, bixafen, bupirimate, Candida oleophila strain O, chlorantra
niliprole, disodium phosphonate, dithianon, dodine, emamectin, flubendiamide, fluometuron, fluxapyroxad, flutriafol, hexythiazox,
imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin,
penflufen, penthiopyrad, potassium phosphonates, prosulfuron, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone,
pyroxsulam, quinmerac, S-abscisic acid, sedaxane, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, Streptomyces lydicus
strain WYEC 108, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate, zinc phosphide (OJ L 414, 9.12.2020,
p. 10, ELI: http://data.europa.eu/eli/reg_impl/2020/2007/oj).
(10) Commission Implementing Regulation (EU) 2023/1446 of 12 July 2023 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aluminium
ammonium sulphate, aluminium phosphide, aluminium silicate, calcium carbide, cymoxanil, dodemorph, ethylene, extract from tea
tree, fat distillation residues, fatty acids C7-C20, flonicamid (IKI-220), gibberellic acid, gibberellins, halosulfuron-methyl, hydrolysed
proteins, iron sulphate, magnesium phosphide, maltodextrin, metamitron, plant oils/clove oil, plant oils/rape seed oil, plant oils/spear
mint oil, pyrethrins, sulcotrione, tebuconazole and urea (OJ L 178, 13.7.2023, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2023/
1446/oj).
(11) Commission Implementing Regulation (EU) 2023/689 of 20 March 2023 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus
thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain
AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains
ATCC 74040 and GHA, clodinafop, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl,
malathion, mepanipyrim, metconazole, metrafenone, pirimicarb, pyridaben, pyrimethanil, rimsulfuron, spinosad, Trichoderma
asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strain T11,
Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac,
triticonazole and ziram (OJ L 91, 29.3.2023, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2023/689/oj).
(12) 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,
ELI: http://data.europa.eu/eli/reg_impl/2020/1740/oj).
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plant oils / rape seed oil and triclopyr, respectively informed the co-rapporteur Member State, the Commission and
the European Food Safety Authority (the ‘Authority’) that they had assessed the admissibility, in particular the
completeness and the timeliness, of each of these applications, and concluded that they were admissible.
(9) With regard to the renewal of the approvals of the active substances acequinocyl, emamectin, fatty acids C7 to C20
and pendimethalin, respectively, the Authority needs additional time to conclude the risk assessment carried out for
these substances, including, where appropriate, a public consultation and a consultation of experts. Additional time
is necessary for the Commission to adopt the ensuing risk management decision.
(10) For the active substances aluminium silicate, plant oils / rape seed oil and triclopyr, the Authority has submitted its
conclusion to the applicant, the Member States and the Commission. The Commission has presented a renewal
report and a draft Regulation on the renewal of these active substances’ approvals to the Standing Committee on
Plants, Animals, Food and Feed.
(11) Given that it is therefore likely that no decision on the renewal of the approval of those active substances can be
taken before the expiry of their respective approval periods on 15 November 2024, 30 November 2024 and
15 December 2024, and that the reasons for the delays in the renewal procedures are beyond the control of the
respective applicants, the approval periods of those active substances should be extended in order to enable the
completion of the assessments required and to finalise the respective procedures on renewal of approval.
(12) As the Authority needs additional time to reach a conclusion on the risk assessment of the active substances
acequinocyl, emamectin and fatty acids C7 to C20, the duration of the extension of the approval period for these
active substances should be set at 23 months and 2 weeks. For the active substance pendimethalin, 2 additional
months are necessary to finalise the public consultation pursuant to Article 12 of Implementing Regulation
(EU) 2020/1740, therefore the extension of the approval period for this active substance should be set at
25 months and 2 weeks.
(13) As for the active substances aluminium silicate, plant oils / rape seed oil and triclopyr, the delivery of an opinion of
the Standing Committee on Plants, Animals, Food and Feed is pending, and in light of the time required to
accomplish each renewal procedure, the duration of the extension of the approval periods for those active
substances should be set at 15 months and 2 weeks and Implementing Regulation (EU) No 540/2011 should
therefore be amended accordingly.
(14) In case the Commission adopts a Regulation providing that the approval of an active substance referred to in the
Annex to this Regulation is not renewed, the Commission will set the expiry date at the date of entry into force of
that Regulation or at the same date as it stood before the adoption of this Regulation, whichever date is later. In case
the Commission adopts a Regulation providing for the renewal of the approval of an active substance referred to in
the Annex to this Regulation, the Commission will set the earliest possible application date, as appropriate under the
circumstances.
(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
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
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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, 6 September 2024.
For the Commission
The President
Ursula VON DER LEYEN
4/6 ELI: http://data.europa.eu/eli/reg_impl/2024/2221/ojANNEX
1. Part A is amended as follows:
(1) in the sixth column, expiration of approval, of row 136, triclopyr, the date is replaced by ‘31 March 2026’;
(2) in the sixth column, expiration of approval, of row 220, aluminium silicate, the date is replaced by ‘31 March 2026’;
(3) in the sixth column, expiration of approval, of row 242, plant oils / rape seed oil, the date is replaced by ‘31 March 2026’;
(4) row 230, Fatty acids C7 to C20, is replaced by the following:
No. Common Name, IUPAC Name Purity(1) Date of approval Expiration of approval Specific provisions
Identification Numbers
‘230 Fatty acids C7 to C20
CAS No 112-05-0 Nonanoic acid ≥ 889 g/kg (Pelargonic 1 September 2009 1 December 2026 PART A
(Pelargonic Acid) Caprylic Acid, Pelargo Acid)
Only uses as insecticide, acari
nic Acid, Capric Acid,
67701-09-1 (Fatty acids ≥ 838 g/kg fatty acids cide, and herbicide and plant
Lauric Acid, Oleic Acid
C7-C18 and C18 unsa growth regulator may be
(ISO in each case) ≥ 99 % fatty acid methyl
turated potassium salts) authorised.
esters
Octanoic Acid, Nona
124-07-2 (Caprylic PART B
noic Acid, Decanoic
Acid)
Acid, Dodecanoic Acid, For the implementation of the
334-48-5 (Capric Acid)
cis-9-Octadecenoic Acid uniform principles as referred
(IUPAC in each case) to in Article 29(6) of Regula
tion (EC) No 1107/2009, the
Fatty acids, C7-C10, Me
conclusions of the review
esters
report on fatty acids
143-07-7 (Lauric Acid) Nonanoic acid ≥ 889 g/kg (Pelargonic 1 September 2009 31 August 2024 (SANCO/2610/2008) and in
Acid) particular Appendices I and II
112-80-1 (Oleic Acid) Caprylic Acid, Pelargo
thereof, as finalised in the
nic Acid, Capric Acid, ≥ 838 g/kg fatty acids
85566-26-3 (Fatty acids Standing Committee on the
Lauric Acid, Oleic Acid
C8-C10 Me esters) ≥ 99 % fatty acid methyl Food Chain and Animal Health
(ISO in each case)
esters shall be taken into account.
111-11-5 (Methyl
Octanoic Acid, Nona
octanoate) Conditions of use shall include,
noic Acid, Decanoic
where appropriate, risk miti
110-42-9 (Methyl Acid, Dodecanoic Acid,
gation measures.’
decanoate) cis-9-Octadecenoic Acid
CIPAC No not allocated
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EN(IUPAC in each case)
Fatty acids, C7-C10, Me
esters
(1) Further details on the identity and specification of the active substance are provided in the renewal report.
2. Part B is amended as follows:
(1) in the sixth column, expiration of approval, of row 49, emamectin, the date is replaced by ‘15 November 2026’;
(2) in the sixth column, expiration of approval, of row 72, acequinocyl, the date is replaced by ‘15 November 2026’;
3. Part E, in the sixth column, expiration of approval, of row 7, pendimethalin, the date is replaced by ‘15 January 2027’.
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