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Official Journal EN
of the European Union L series
2026/351 19.2.2026
COMMISSION IMPLEMENTING REGULATION(EU) 2026/351
of 18 February 2026
renewing the approval of the active substance spinosad in accordance with Regulation (EC)
No 1107/2009 of the European Parliament and of the Council 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 20(1) thereof,
Whereas:
(1) Commission Directive 2007/6/EC(2) included spinosad as an active substance in Annex I to Council
Directive 91/414/EEC(3).
(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation
(EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU)
No 540/2011(4).
(3) The approval of the active substance spinosad, as set out in Part A of the Annex to Implementing Regulation (EU)
No 540/2011 expires on 31 October 2026.
(4) An application for the renewal of the approval of the active substance spinosad was submitted to the Netherlands, the
rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission
Implementing Regulation (EU) No 844/2012(5)and within the time period provided for in that Article.
(5) The applicant submitted the supplementary dossier required to the rapporteur Member State, the co-rapporteur
Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with
Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the
rapporteur Member State.
(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur
Member State and submitted it to the Authority and the Commission on 30 March 2017. In its draft renewal
assessment report, the rapporteur Member State proposed to renew the approval of spinosad.
(1) OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj.
(2) Commission Directive 2007/6/EC of 14 February 2007 amending Council Directive 91/414/EEC to include metrafenone, Bacillus
subtilis, spinosad and thiamethoxam as active substances (OJ L 43, 15.2.2007, p. 13, ELI: http://data.europa.eu/eli/dir/2007/6/oj).
(3) 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).
(4) 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).
(5) 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, ELI:
http://data.europa.eu/eli/reg_impl/2012/844/oj).
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(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the
draft renewal assessment report to the applicant and to the Member States for comments and launched a public
consultation on it. The Authority forwarded the comments received to the Commission.
(8) On 4 April 2018, the Authority communicated to the Commission its conclusion(6) on whether spinosad can be
expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.
(9) In its conclusion, the Authority proposed that spinosad be classified as toxic for reproduction category 2 according to
Regulation (EU) No 1272/2008 of the European Parliament and of the Council(7). Furthermore, adverse effects were
observed on multiple organs including endocrine organs. On this basis, the Authority concluded that the interim
criteria for the consideration of endocrine disrupting properties concerning human health of point 3.6.5 of Annex II
to Regulation (EC) No 1107/2009, as it stood at that time, may be met, leading to a critical area of concern.
(10) The Commission presented a draft renewal report for spinosad to the Standing Committee on Plants, Animals, Food
and Feed on 24 October 2018.
(11) Since it was not possible for risk managers to conclude whether spinosad is an endocrine disruptor in accordance
with the new scientific criteria for the determination of endocrine disrupting properties set out in points 3.6.5
and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as introduced by Commission Regulation
(EU) 2018/605(8), the Commission requested the Authority on 14 January 2019 to re-assess the existing
information, to request additional information from the applicant if needed and to update its conclusion on the
endocrine disrupting potential of spinosad pursuant to Article 13(3a), first subparagraph, of Implementing
Regulation (EU) No 844/2012.
(12) In July 2024, the rapporteur Member State made an updated draft renewal assesment report available to the
Authority, the Member States and the Commission. In its updated draft renewal assessment report, the rapporteur
Member State considered, upon request of the Authority, the additional information regarding the criteria to identify
endocrine disrupting properties and proposed renewing the approval of spinosad.
(13) On 12 December 2024, the Authority communicated to the Commission its updated conclusion(9)indicating that,
taking into account the approval criteria laid down in Annex II to Regulation (EC) No 1107/2009, plant protection
products containing spinosad can be expected to meet the approval criteria provided for in Article 4 of Regulation
(EC) No 1107/2009. The Authority concluded that, based on the scientific evidence, spinosad does not meet the
criteria for endocrine disruption.
(14) The Commission presented an updated renewal report on 11 March 2025 and a draft of this Regulation on 9 July
2025 to the Standing Committee on Plants, Animals, Food and Feed.
(15) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance
with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The
applicant submitted its comments, which have been carefully examined and taken into consideration.
(6) Conclusion on pesticides peer review of the pesticide risk assessment of the active substance spinosad (EFSA Journal2018;16:e5252,
available online: https://doi.org/10.2903/j.efsa.2018.5252).
(7) 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. ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
(8) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out
scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33, ELI: http://data.europa.eu/eli/
reg/2018/605/oj).
(9) Updated conclusion on pesticides peer review of the pesticide risk assessment of the active substance spinosad (EFSA Journal
2025;23:e9193, available online: https://doi.org/10.2903/j.efsa.2025.9193).
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(16) It has been established with respect to one or more representative uses of at least one plant protection product
containing spinosad that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are
satisfied. It is therefore appropriate to renew the approval of spinosad.
(17) Although the risk assessment for the renewal of the approval of the active substance spinosad is based on a limited
number of representative uses, this does not restrict the uses for which plant protection products containing
spinosad may be authorised. It is therefore appropriate not to maintain the restriction to use as an insecticide.
(18) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the
light of current scientific and technical knowledge as well as the outcome of the risk assessment, it is, however,
necessary to provide for certain conditions.
(19) It is, in particular, appropriate that the Member States pay particular attention to the assessment of the consumer
intake, taking into account the residues of the metabolites of spinosad and considering the impact of storage and
processing; the protection of operators, in particular for hand-held applications in low crops; and the protection of
wild mammals, aquatic organisms, bees and non-target arthropods.
(20) In addition, to increase confidence in the decision, the applicant should submit to the Commission, the Member
States and the Authority the following confirmatory information: an in vitro interspecies comparative metabolism
study; an overall assessment of DNT (developmental neurotoxicity), including the submission of data from an in vitro
DNT test battery; the toxicity and magnitude of residues in plant and animal matrices of spinosyn B and K, PsA and
MET A-Li-4(5b) to confirm the residue definitions for risk assessment; the effect of water treatment processes on the
nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking
water; as well as information regarding the chronic effects on honeybees (adults and larvae).
(21) Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(22) Commission Implementing Regulation (EU) 2025/99(10) extended the approval period of spinosad to 31 October
2026 in order to allow the renewal process to be completed before the expiry of the approval period of that active
substance. However, given that a decision on the renewal has been taken ahead of that extended expiry date, this
Regulation should start to apply earlier than that date.
(23) 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
Renewal of the approval of the active substance
The approval of the active substance spinosad, as specified in Annex I to this Regulation, is renewed, subject to the
conditions laid down in that Annex.
(10) Commission Implementing Regulation (EU) 2025/99 of 21 January 2025 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances Aureobasidium pullulans(strains DSM 14940 and DSM 14941),
Bacillus amyloliquefaciens subsp. plantarum D747, benalaxyl-M, cyprodinil, dichlorprop-P, formetanate, fosetyl, halosulfuron-methyl,
imazamox, milbemectin, phenmedipham, pirimicarb, Pseudomonassp. strain DSMZ 13134, pyrimethanil, pyriofenone, pyroxsulam,
spinosad, sulphur, Trichoderma harzianum Rifai strains T-22 and ITEM 908, Trichoderma asperellum (formerly T. harzianum) strains
ICC012, T-25 and TV-1, Trichoderma atroviride(formerly T. harzianum) strain T11, Trichoderma gamsii(formerly T. viride) strain ICC080,
triticonazole and ziram (OJ L, 2025/99, 22.1.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/99/oj).
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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 and date of application
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 1 April 2026.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 18 February 2026.
For the Commission
The President
Ursula VON DER LEYEN
4/8 ELI: http://data.europa.eu/eli/reg_impl/2026/351/ojANNEX I
Common Name,
Expiration of
Identification IUPAC Name Purity(1) Date of approval Specific provisions
approval
Numbers
Spinosad Spinosyn A: (50–95 %) ≥ 850 g/kg 1 April 2026 1 April 2041 For the implementation of the uniform
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)- principles as referred to in Article 29(6) of
CAS No: with 50–95 % of
2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)- Regulation (EC) No 1107/2009, the
Spinosad: spinosyn A
13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D- conclusions of the renewal report on
168316-95-8 and 5–50 % of
erythropyranosyloxy)- spinosad of 11 December 2025, and in
Spinosyn A: 9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b- spinosyn D particular, Appendices I and II thereto,
131929-60-7 hexadecahydro-14-methyl-1H-as-indaceno[3,2-d] shall be taken into account.
Spinosyn D: oxacyclododecine-7,15-dione
In this overall assessment Member States
131929-63-0
Spinosyn D: (50–5 %) shall pay particular attention to:
CIPAC No: 636 (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)- — the assessment of the consumer intake,
2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)- taking into account the residues of the
13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D- metabolites of spinosad and
erythropyranosyloxy)- considering the impact of storage and
9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b- processing;
hexadecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d] — the protection of operators, in
oxacyclododecine-7,15-dione particular for hand-held applications in
low crops;
— the protection of wild mammals,
aquatic organisms, bees and non-target
arthropods.
Conditions of use shall include risk
mitigation measures, where appropriate.
The applicant shall submit confirmatory
information as regards:
(1) an in vitrointerspecies comparative
metabolism study;
(2) an overall assessment of DNT
(developmental neurotoxicity),
including the submission of data from
an in vitroDNT test battery;
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ENCommon Name,
Expiration of
Identification IUPAC Name Purity(1) Date of approval Specific provisions
approval
Numbers
(3) the toxicity and magnitude of residues
in plant and animal matrices of
spinosyn B and K, PsA and MET A-Li-
4(5b) to confirm the residue definitions
for risk assessment;
(4) the effect of water treatment processes
on the nature of residues present in
drinking water;
(5) chronic effects on honeybees (adults
and larvae).
The applicant shall submit the information
referred to in point 1, 3, and 4 to the
Commission, the Member States and the
Authority by 11 March 2028.
The applicant shall submit to the
Commission, the Member States and the
Authority the information referred to in
point 2 within two years after adoption of
a guidance document on assessing DNT.
The applicant shall submit to the
Commission, the Member States and the
Authority the information referred to in
point 5 within two years after the
adoption of a guidance document with a
revised risk assessment methodology for
honeybees.
(1) Further details on the identity and specification of the active substance are provided in the renewal report.
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19.2.2026ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, entry 139 on spinosad is deleted;
(2) in Part B, the following entry is added:
Common Name,
Expiration of
No Identification IUPAC Name Purity(1) Date of approval Specific provisions
approval
Numbers
‘177 Spinosad Spinosyn A: (50–95 %) ≥ 850 g/kg 1 April 2026 1 April 2041 For the implementation of the uniform
(2R,3aS,5aR,5bS,9S,13S,14 principles as referred to in Article 29(6) of
CAS No: with 50–95 % of
R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O- Regulation (EC) No 1107/2009, the
Spinosad: spinosyn A
methyl-α-L-mannopyranosyloxy)- conclusions of the renewal report on spinosad
168316-95-8 and 5–50 % of
13-(4-dimethylamino-2,3,4,6-tetradeoxy- of 11 December 2025, and in particular
Spinosyn A: β-D-erythropyranosyloxy)- spinosyn D Appendices I and II thereto, shall be taken into
131929-60-7 9-ethyl-2,3,3a,5a,5 account.
Spinosyn D: b,6,7,9,10,11,12,13,14,15,16a,16b-
In this overall assessment Member States shall
131929-63-0 hexadecahydro-14-methyl-1H-as-
pay particular attention to:
indaceno[3,2-d]
CIPAC No: 636 — the assessment of the consumer intake,
oxacyclododecine-7,15-dione
taking into account the residues of the
Spinosyn D: (50–5 %) metabolites of spinosad and considering
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)- the impact of storage and processing;
2-(6-deoxy-2,3,4-tri-O-methyl-α-L- — the protection of operators, in particular for
mannopyranosyloxy)- hand-held applications in low crops;
13-(4-dimethylamino-2,3,4,6-tetradeoxy- — the protection of wild mammals, aquatic
β-D-erythropyranosyloxy)- organisms, bees and non-target arthropods.
9-ethyl-2,3,3a,5a,5
Conditions of use shall include risk mitigation
b,6,7,9,10,11,12,13,14,15,16a,16b-
measures, where appropriate.
hexadecahydro-4,14-dimethyl-1H-as-
indaceno[3,2-d] The applicant shall submit confirmatory
oxacyclododecine-7,15-dione information as regards:
(1) an in vitro interspecies comparative
metabolism study;
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ENCommon Name,
Expiration of
No Identification IUPAC Name Purity(1) Date of approval Specific provisions
approval
Numbers
(2) an overall assessment of DNT
(developmental neurotoxicity) including
the submission of data from an in vitroDNT
test battery;
(3) the toxicity and magnitude of residues in
plant and animal matrices of spinosyn B
and K, PsA and MET A-Li-4(5b) to confirm
the residue definitions for risk assessment;
(4) the effect of water treatment processes on
the nature of residues present in drinking
water;
(5) chronic effects on honeybees (adults and
larvae).
The applicant shall submit the information
referred to in point 1, 3, and 4 to the
Commission, the Member States and the
Authority by 11 March 2028.
The applicant shall submit to the Commission,
the Member States and the Authority the
information referred to in point 2 within two
years after adoption of a guidance document
on assessing DNT. The applicant shall submit
to the Commission, the Member States and the
Authority the information referred to in point
5 within two years after the adoption of a
guidance document with a revised risk
assessment methodology for honeybees.’
(1) Further details on the identity and specification of the active substance are provided in the renewal report.
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