Commission Implementing Regulation (EU) No 993/2011 of 6 October 2011 approving the active substance 8-hydroxyquinoline, 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 (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2011/993@2011-10-06/en
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, and in particular Article 13(2) and Article 78(2) thereof,
Whereas:
(1) In accordance with Article 80(1)(c) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which completeness has been established in accordance with Article 6 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I. 8-hydroxyquinoline is an active substance for which completeness has been established in accordance with that Regulation.
(2) Commission Regulations (EC) No 451/2000 and (EC) No 1490/2002 lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish lists of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. These lists included 8-hydroxyquinoline.
(3) For 8-hydroxyquinoline no complete dossier was submitted within the prescribed time limit. Consequently, Commission Decision 2006/797/EC of 22 November 2006 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances was adopted on the non-inclusion of 8-hydroxyquinoline.
(4) Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter the applicant) submitted a new application requesting the regular procedure to be applied, as provided for in Articles 3 to 12 of Regulation (EC) No 33/2008.
(5) The application was submitted to Spain, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. That application complies with the substantive and procedural requirements of Articles 3 and 4 of Regulation (EC) No 33/2008.
(6) Spain evaluated the information submitted and prepared a draft assessment report. It communicated that report to the European Food Safety Authority (hereinafter the Authority) and to the Commission on 3 August 2009. The Authority communicated the draft assessment report to the other Member States and the applicant for comments and forwarded the comments received to the Commission. The Authority also made the draft assessment report available to the public. In accordance with Article 10 of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on the risk assessment of 8-hydroxyquinoline to the Commission on 17 December 2010. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 15 July 2011 in the format of the Commission review report for 8-hydroxyquinoline.
(7) It has appeared from the various examinations made that plant protection products containing 8-hydroxyquinoline may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve 8-hydroxyquinoline in accordance with Regulation (EC) No 1107/2009.
(8) 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, however, necessary to include certain conditions and restrictions.
(9) Without prejudice to the conclusion that 8-hydroxyquinoline should be approved, it is, in particular, appropriate to require further confirmatory information.
(10) In accordance with Article 13(4) of Regulation (EC) No 1107/2009 the Annex to 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 should be amended accordingly.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1 Approval of active substance
The active substance 8-hydroxyquinoline, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
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 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 6 October 2011. For the Commission The President José Manuel Barroso
ANNEX
ANNEX I
Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions 8-hydroxyquinoline CAS No 148-24-3 (8-hydroxyquinoline) CIPAC No 677 (8-hydroxyquinoline) 8-quinolinol ≥ 990 g/kg 1 January 2012 31 December 2021
PART A
Only uses as fungicide and bactericide in greenhouses may be authorised.
PART B
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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate. The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards: The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
(1) the method of analysis for air;
(2) a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions 18 8-hydroxyquinoline CAS No 148-24-3 (8-hydroxyquinoline) CIPAC No 677 (8-hydroxyquinoline) 8-quinolinol ≥ 990 g/kg 1 January 2012 31 December 2021
PART A
Only uses as fungicide and bactericide in greenhouses may be authorised.
PART B
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 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate. The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards: The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
(1) the method of analysis for air;
(2) a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.
Versions
Cited by
- Commission Implementing Regulation (EU) 2024/2781 of 31 October 2024 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 8-hydroxyquinoline, aminopyralid, azoxystrobin, Candida oleophila strain O, chlorantraniliprole, fluroxypyr, imazalil, kresoxim-methyl, metobromuron, oxyfluorfen, Paecilomyces fumosoroseus strain FE 9901, tefluthrin and terbuthylazine (Text with EEA relevance) Regulation · Grade B
Commission Implementing Regulation (EU) No 993/2011 approved the active substance 8-hydroxyquinoline until 31 December 2021. Commission Implementing Regulation (EU) No 891/2014 approved the active substance aminopyralid until 31 December 2024. Commission Implementing Regulation (EU) No 703/2011 approved the active substance azoxystrobin until 31 December 2021. Commission Implementing Regulation (EU) No 373/2013 approved the active substance Candida oleophila strain O until 30 September 2023. Commission Implementing Regulation (EU) No 1199/2013 approved the active substance chlorantraniliprole
- Commission Implementing Regulation (EU) 2017/2065 of 13 November 2017 confirming the conditions of approval of the active substance 8-hydroxyquinoline, as set out in Implementing Regulation (EU) No 540/2011 and modifying Implementing Regulation (EU) 2015/408 as regards the inclusion of the active substance 8-hydroxyquinoline in the list of candidates for substitution (Text with EEA relevance) Regulation · Grade B
The active substance 8-hydroxyquinoline was approved in accordance with Regulation (EC) No 1107/2009 by Commission Implementing Regulation (EU) No 993/2011 and is listed in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011. In accordance with row 18 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, only uses as fungicide and bactericide in greenhouses may be authorised.
- Council Decision (EU) 2017/1391 of 17 July 2017 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to that Agreement Decision · Grade B
Ukraine undertakes to approximate its legislation to the following Union legislation within the timeframes listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for approximation Chapter I — General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2016 Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the orga
- Commission Implementing Regulation (EU) 2025/1152 of 11 June 2025 renewing the approval of the active substance quinolin-8-ol as a candidate for substitution in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulations (EU) No 540/2011 and (EU) 2015/408 (Text with EEA relevance) Regulation · Grade B
Commission Implementing Regulation (EU) No 993/2011 included 8-hydroxyquinoline (common name for quinolin-8-ol) as an active substance in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011.
- Council Decision 2019/1748 of 7 October 2019 on the position to be taken on behalf of the European Union within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to Chapter 4 of that Agreement Act · Grade B
Ukraine undertakes to approximate its legislation to the following Union legislation with the deadlines for adoption as listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for adoption Chapter I – General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2018 Council Directive No 97/78/EC of 18 December 1997 laying down the principles governi
- 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 (Text with EEA relevance) Regulation · Grade B
The approval of the active substance 8-hydroxyquinoline is set to expire on 31 December 2021 in accordance with Commission Implementing Regulation (EU) No 993/2011.
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
That active substance was approved for a duration of 10 years under Commission Implementing Regulation (EU) No 993/2011 of 6 October 2011 approving the active substance 8‑hydroxyquinoline, 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 2011 L 263, p. 1).
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
According to Annex I to Implementing Regulation No 993/2011, which lays down the conditions of approval of 8‑hydroxyquinoline, only uses as fungicide and bactericide in greenhouses may be authorised. Those conditions are now set out in Row 18 of Part B of the Annex to 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 2011 L 153, p. 1).
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
In that regard, it must be recalled that, under Article 1 of the contested Implementing Regulation, the Commission, after examining the substance, rejected the applicant’s request for amendment of the conditions of approval of 8‑hydroxyquinoline and thus confirmed the conditions attached to the initial approval of that active substance, carried out under Regulation No 993/2011. That refusal requires the Member States which have granted authorisations for plant protection products containing 8‑hydroxyquinoline to continue to limit the use of those products in greenhouses and does not allow them
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
It should be noted that, in the context of this plea in law, the question arises as to the relationship between the procedure for the amendment of the harmonised classification and labelling of 8‑hydroxyquinoline (see paragraphs 11 to 14 above), on the one hand, and the procedure for the amendment of the conditions of approval of 8‑hydroxyquinoline (see paragraphs 15 to 25 above), on the other. As stated in those paragraphs, 8‑hydroxyquinoline, the active substance approved under Implementing Regulation No 993/2011, also underwent a procedure for harmonised classification and labelling under R
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
In that respect, it must be recalled that, as is apparent from recitals 6 and 10 of the contested Implementing Regulation, the fact that 8‑hydroxyquinoline was to be classified as toxic for reproduction category 1B is the first ground for the refusal to amend the conditions of approval of that active substance (see paragraphs 27 and 29 above). According to point 3.6.4 of Annex II to Regulation No 1107/2009, the fact that an active substance is or has to be classified, in accordance with the provisions of Regulation No 1272/2008, as toxic for reproduction category 1B precludes, in principle, th
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
First of all, 8‑hydroxyquinoline was classed as toxic for reproduction category 1B under Regulation 2017/776 (see paragraph 12 above), which, according to point 3.6.4 of Annex II to Regulation No 1107/2009, precludes, in principle, the approval of that active substance. Next, by its letter of 28 September 2017, the competent Spanish authority refused to implement the proposal to amend the harmonised classification and labelling elements of 8‑hydroxyquinoline (see paragraph 14 above), with the result that the Commission was required to take into account those elements for the purposes of the pr
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
In the present case, as the Commission states in paragraph 9 of the defence, 8‑hydroxyquinoline was approved for a period of 10 years under Implementing Regulation No 993/2011 (see paragraph 2 above). It is apparent from recital 1 of that Implementing Regulation that, under the transitional provision of Article 80(1)(c) of Regulation No 1107/2009, 8‑hydroxyquinoline was approved in accordance with the substantive conditions laid down in Directive 91/414.
- Judgment of the General Court (Fifth Chamber) 19 December 2019 Judgment · Grade B
As is apparent from recital 7 of Implementing Regulation No 993/2011, 8‑hydroxyquinoline was precisely approved in accordance with the substantive conditions laid down in Article 5(1) of Directive 91/414 under the transitional provision of Article 80(1)(c) of Regulation No 1107/2009 (see paragraph 126 above). It follows that points 3.6.4 and 3.6.5 of Annex II to Regulation No 1107/2009 did not apply during the procedure for the approval of 8‑hydroxyquinoline. Furthermore, as is apparent from recitals 5 to 7 of the contested Implementing Regulation, ECHA and EFSA adopted their conclusions on th
- P9_TA(2022)0363 Active substances, including 8-hydroxyquinoline, chlorotoluron and difenoconazole European Parliament resolution of 18 October 2022 on 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 (2022/2785(RSP)) 2023/C 149/01 Notice · Grade B
whereas the active substance 8-hydroxyquinoline was approved in accordance with Regulation (EC) No 1107/2009 by Commission Implementing Regulation (EU) No 993/2011;