EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL FINAL

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1 EURPEAN CMMISSIN HEALTH AND CNSUMERS DIRECTRATEGENERAL Directate E Safety of the food chain Unit E.3 Chemicals, contaminants, pesticides Sodium 5nitroguaiacolate, sodium o, sodium p SANC/210/08 rev May FINAL Review rept f the active substances sodium 5nitroguaiacolate, sodium o, sodium p Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 17 May 2013 in view of the inclusion of sodium 5nitroguaiacolate, sodium o and sodium p in Annex I of Directive 91/414/EEC 1. Procedure followed f the reevaluation process This review rept has been established as a result of the reevaluation of sodium 5 nitroguaiacolate, sodium o and sodium p, made in the context of the wk programme f review of existing active substances provided f in Article 8(2) of Directive 91/414/EEC concerning the placing of plant protection products on the market, with a view to the possible inclusion of this substance in Annex I to the Directive. Commission Regulation (EC) No 451/2000( 2 ) laying down the detailed rules f the implementation of the second and third stages of the programme of wk referred to in Article 8(2) of Council Directive 91/414/EEC, as last amended by Regulation (EC) No 1490/2002( 3 ), has laid down the detailed rules on the procedure accding to which the reevaluation has to be carried out. Sodium 5nitroguaiacolate, sodium o and sodium p are three of the existing active substances covered by this Regulation. In accdance with the provisions of Article 4 of Regulation (EC) No 451/2000, Arysta Lifescience S.A.S. notified to the Commission of their wish to secure the inclusion of the active substances sodium 5nitroguaiacolate, sodium o and sodium p in Annex I to the Directive. 1 n 17 May 2013 the Standing Committee on Food Chain and Animal Health has taken note of the revision of the review rept of the active substances sodium 5nitroguaiacolate, sodium o and sodium p, after the finalisation of groundwater assessment as referred to in point 7 of this rept (cf. infra). 2 J No L 55, , p J No L 224, , p.23. Regulation as last amended by Regulation (EC) No 1095/2007 (J L 246, , p. 19).

2 2 In accdance with the provisions of Article 5 of Regulation (EC) No 451/2000, the Commission, designated Greece as rappteur Member State to carry out the assessment of sodium 5nitroguaiacolate, sodium o and sodium p on the basis of the dossiers submitted by the notifier. In Regulation (EC) No 1490/2002 the Commission specified furtherme that the deadline f the notifier with regard to the submission to the rappteur Member States of the dossiers required under Article 7(2) of Regulation (EC) No 1490/2002, as well as f other parties with regard to further technical and scientific infmation was 30 November The notifier submitted by the deadline a dossier to the rappteur Member State which did not contain substantial data gaps, taking into account the suppted uses. Therefe Arysta Lifescience S.A.S. was considered to be the sole data submitter. In accdance with the provisions of Article 10(1) of Regulation (EC) No 1490/2002, Greece submitted on 27 September 2007 to the EFSA the rept of their examination, hereafter referred to as the draft assessment rept, including, as required, a recommendation concerning the possible inclusion of sodium 5nitroguaiacolate, sodium o and sodium p in Annex I to the Directive. Meover, in accdance with the provisions of Article 10(2) of Regulation (EC) 1490/2002, the Commission and the Member States received also the summary dossier on sodium 5nitroguaiacolate, sodium o and sodium p from the notifier. In accdance with the provisions of Article 11 of Regulation (EC) No 1490/2002, the EFSA ganised the consultation on the draft assessment rept by all the Member States as well as by Arysta Lifescience S.A.S. being the sole data submitter, on 24 ctober 2007 by making it available. The EFSA ganised an intensive consultation of technical experts from a certain number of Member States, to review the draft assessment rept and the comments received thereon (peer review). In accdance with the provisions of Article 11 (4) of Regulation 1490/2002 the EFSA sent to the Commission its conclusion on the risk assessment [Conclusions regarding the peer review of the pesticide risk assessment of the active substances sodium 5nitroguaiacolate, sodium o and sodium p (finalised 30 September 2008) 4 ]. This conclusion refers to background document A (draft assessment rept) and background document B (EFSA peer review rept). In accdance with the provisions of Article 12 of Regulation (EC) No 1490/2002, the Commission referred a draft review rept to the Standing Committee on the Food Chain and Animal Health, f final examination. The draft review rept was finalised in the meeting of the Standing Committee on 2 December The present review rept contains the conclusions of the final examination by the Standing Committee. Given the imptance of the conclusion of the EFSA, and the comments and clarifications submitted after the conclusion of the EFSA (background document C), these documents are also considered to be part of this review rept. 3 EFSA Scientific Rept (2008) n, 191.

3 3 2. Purposes of this review rept This review rept, including the background documents and appendices thereto, has been developed and finalised in suppt of the Directive 2009/11/EC 5 concerning the inclusion of sodium 5nitroguaiacolate, sodium o and sodium p in Annex I to Directive 91/414/EEC, and to assist the Member States in decisions on individual plant protection products containing sodium 5nitroguaiacolate, sodium o and sodium p they have to take in accdance with the provisions of that Directive, and in particular the provisions of article 4(1) and the unifm principles laid down in Annex VI. This review rept provides also f the evaluation required under Section A.2.(b) of the above mentioned unifm principles, as well as under several specific sections of part B of these principles. In these sections it is provided that Member States, in evaluating applications and granting authisations, shall take into account the infmation concerning the active substance in Annex II of the directive, submitted f the purpose of inclusion of the active substance in Annex I, as well as the result of the evaluation of those data. In accdance with the provisions of Article 13 of Regulation (EC) No 1490/2002, Member States will keep available make available this review rept f consultation by any interested parties will make it available to them on their specific request. The infmation in this review rept is, at least partly, based on infmation which is confidential and/ protected under the provisions of Directive 91/414/EEC. It is therefe recommended that this review rept would not be accepted to suppt any registration outside the context of Directive 91/414/EEC, e.g. in third countries, f which the applicant has not demonstrated to have regulaty access to the infmation on which this review rept is based. 3. verall conclusion in the context of Directive 91/414/EEC The overall conclusion from the evaluation is that it may be expected that plant protection products containing sodium 5nitroguaiacolate, sodium o and sodium p will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. This conclusion is however subject to compliance with the particular requirements in sections 4, 5, 6 and 7 of this rept, as well as to the implementation of the provisions of Article 4(1) and the unifm principles laid down in Annex VI of Directive 91/414/EEC, f each sodium 5nitroguaiacolate, sodium o and sodium p containing plant protection product f which Member States will grant review the authisation. Furtherme, these conclusions were reached within the framewk of the uses which were proposed and suppted by the main data submitter and mentioned in the list of uses suppted by available data (attached as Appendix II to this review rept). Extension of the use pattern beyond those described above will require an evaluation at Member State level in der to establish whether the proposed extensions of use can satisfy the 5 J L 48,

4 4 requirements of Article 4(1) and of the unifm principles laid down in Annex VI of Directive 91/414/EEC. The following reference values have been finalised as part of this reevaluation: ADI : Na onp: Na pnp: mg/kg bw/day ArfD : Na onp: Na pnp: mg/kg bw AEL : Na onp: Na pnp: mg/kg bw/day With particular regard to residues, the review has established that the residues arising from the proposed uses, consequent on application consistent with good plant protection practice, have no harmful effects on human animal health. The maximum Theetical Maximum Daily Intake f toddler is 23.5 % of the Acceptable Daily Intake (ADI), based on the UK data. Estimates of acute dietary exposure of adults and toddlers revealed that the Acute Reference Dose (ARfD) would not be exceeded maximum f sugar beet 4.3 % ). The review has identified several acceptable exposure scenarios f operats, wkers and bystanders, which require however to be confirmed f each plant protection product in accdance with the relevant sections of the above mentioned unifm principles. The review has also concluded that under the proposed and suppted conditions of use there are no unacceptable effects on the environment, as provided f in Article 4 (1) (b) (iv) and (v) of Directive 91/414/EEC, provided that certain conditions are taken into account as detailed in section 6 of this rept. 4. Identity The identity of the three active substances sodium 5nitroguaiacolate (), sodium o (Na onp) and sodium p (Na pnp) is given in Appendix I. The review has established that f the active substance sodium 5nitroguaiacolate notified by the sole data submitter Arysta Lifescience S.A.S. none of the manufacturing impurities considered are, on the basis of infmation currently available, of toxicological ecotoxicological concern. However the minimum purity of Na 5 NG technical could not be concluded on, as the experts at the PRAPeR Meeting 51 (June 2008) did not accept the technical specification f this active substance. Additionally f the active substances sodium o and sodium p it was agreed that the minimum purity of the two technical materials is 980 g/kg and 998 g/kg (value cresponding to the dihydrate fm) respectively. The manufacturing impurities phenol, 2,4dinitrophenol and 2,6dinitrophenol in Na onp and Na pnp technical materials are toxicologically relevant and their upper level in the technical specification of the each active substance should be the LQ. The LQs f 2,4dinitrophenol, 2,6dinitrophenol and phenol in Na onp and Na pnp are given in appendix 1. No FA specifications f the three active substances sodium 5nitroguaiacolate, sodium o and sodium p exist.

5 5 It should be noted that the specifications f the three technical materials currently should be regarded as provisional (December 2008) until they are confirmed and suppted by appropriate analytical data. 5. Endpoints and related infmation In der to facilitate Member States, in granting reviewing authisations, to apply adequately the provisions of Article 4(1) of Directive 91/414/EEC and the unifm principles laid down in Annex VI of that Directive, the most imptant endpoints were identified during the reevaluation process. These endpoints are listed in the conclusion of the EFSA, and at section 3 of this rept. 6. Particular conditions to be taken into account on sht term basis by Member States in relation to the granting of authisations of plant protection products containing sodium 5nitroguaiacolate, sodium o and sodium p n the basis of the proposed and suppted uses (as listed in Appendix II), the following particular issues have been identified as requiring particular and sht term attention from all Member States, in the framewk of any authisations to be granted, varied withdrawn, as appropriate. Member States should pay particular attention to: the specification of the technical materials as commercially manufactured must be confirmed and suppted by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material; the protection of the operats and wkers safety. Authised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure; the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/ climatic conditions. Conditions of authisation should include risk mitigation measures, where appropriate. 7. List of studies to be generated Some studies were identified which were at this stage considered necessary in relation to the inclusion of sodium 5nitroguaiacolate, sodium o and sodium p in Annex I under the current inclusion conditions. The Member States concerned shall request the submission of further studies to address the risk to groundwater. They shall ensure that the notifiers provide such studies to the Commission by 31 ctober Some endpoints may require the generation submission of additional studies to be submitted to the Member States in der to ensure authisations f use under certain conditions. The list of studies to be generated, still ongoing available but not peer reviewed can be found in the relevant part of the EFSA Scientific rept. n 17 May 2013 the Standing Committee on the Food Chain and Animal Health has taken note of the revision of this review rept after the assessment of the confirmaty data as referred to above in this paragraph (cf. supra). This assessment has been carried out in line

6 6 with the Guidance document on the procedures f submission and assessment of confirmaty data following inclusion of an active substance in Annex I of Council Directive 91/414/EEC 6 and with the Guidance document on the assessment of the relevance of metabolites in groundwater off substances regulated under Council Directive 91/414/EEC 7. The Committee agrees that, on the basis of the current outcome, the risk to groundwater has now been addressed and it is acceptable. Therefe, the conclusions of the iginal risk assessment are not substantially modified by the evaluation of the submitted confirmaty data. No further review by EFSA has been considered necessary. 8. Infmation on studies with claimed data protection F infmation of any interested parties, the rappteur Member State will keep available a document which gives infmation about the studies f which the main data submitter has claimed data protection and which during the reevaluation process were considered as essential with a view to annex I inclusion. This infmation is only given to facilitate the operation of the provisions of Article 13 of Directive 91/414/EEC in the Member States. It is based on the best infmation available but it does not prejudice any rights obligations of Member States operats with regard to its uses in the implementation of the provisions of Article 13 of the Directive 91/414/EEC and neither does it commit the Commission. 9. Updating of this review rept The infmation in this rept may require to be updated from time to time in der to take account of technical and scientific developments as well as of the results of the examination of any infmation referred to the Commission in the framewk of Articles 7, of Directive 91/414/EEC. Any such adaptation will be finalised in the Standing Committee on the Food Chain and Animal Health, in connection with any amendment of the inclusion conditions f sodium 5nitroguaiacolate, sodium o and sodium p in Annex I of the Directive. 6 Doc. SANC/5634/2009 rev 3, Doc. SANC/221/2000 rev 10,

7 1 Sodium 5nitroguaiacolate, Sodium o, Sodium p Appendix I Identity, physical and chemical properties APPENDIX I Identity SDIUM 5NITRGUAIACLATE, SDIUM onitrphenlate, SDIUM pnitrphenlate Common name (IS) Sodium 5 nitroguaiacolate Sodium o Sodium p Chemical name (IUPAC) Chemical name (CA) (No IS common name is allocated) Sodium 2methoxy5 3hydroxy4 methoxynitrobenzene sodium salt (No IS common name is allocated) Sodium 2 ; sodium o Sodium o (No IS common name is allocated) Sodium 4 ; sodium p Sodium p CIPAC No Not allocated Not allocated Not allocated CAS No EEC No Not allocated Not allocated Not allocated FA SPECIFICATIN Not allocated Minimum purity 980 g/kg 980 g/kg 998 g/kg (cresponds to dihydrate fm) Identity of relevant impurities (of toxicological, environmental and/ other significance) in the active substance as manufactured (g/kg) None Phenol Max content: 0.1 g/kg 2,4 dinitrophenol max content: 0.14 g/kg 2,6 dinitrophenol max content: 0.32 g/kg Phenol max content:0. 1 g/kg 2,4 dinitrophenol max content: 0.07 g/kg 2,6 dinitrophenol max content:0.09 g/kg Molecular fmula C 7 H 6 NNa 4 C 6 H 4 NNa 3 C 6 H 4 NNa 3 Molecular mass g/mol g/mol g/mol Structural fmula Na + N + Na + Na + N + N +

8 APPENDIX II List of uses suppted by available data SDIUM 5NITRGUAIACLATE, SDIUM onitrphenlate, SDIUM pnitrphenlate Crop and/ situation (a) Member State Country Product name F G I (b) Pests Group of pests controlled (c) Fmulation Application Application rate per treatment PHI (days) (l) Remarks: (m) Sugar beet N ATNIK F Sugar beet S ATNIK F ilseed rape N ATNIK F stimulat stimulat stimulat Type (df) Conc. of as (i) method kind (fh) Spraying Spraying Spraying growth stage & season (j) From BBCH 12 To BBCH 49 From BBCH 12 To BBCH 49 From BBCH 31 to BBCH 69 number min max (k) interval between applications (min) g as/hl min max wate r l/ha min max g as/ha min max

9 Crop and/ situation (a) Member State Country Product name F G I (b) Pests Group of pests controlled (c) Fmulation Application Application rate per treatment PHI (days) (l) Remarks: (m) Type (df) Conc. of as (i) method kind (fh) growth stage & season (j) number min max (k) interval between applications (min) g as/hl min max 0.5 wate r l/ha min max g as/ha min max ilseed rape S ATNIK F Tomato N ATNIK Tomato S ATNIK F G F G stimulat stimulat stimulat Spraying Spraying spraying From BBCH 31 to BBCH 69 BBCH 59 BBCH 69 BBCH 71 BBCH 79 BBCH 81 BBCH 59 BBCH 69 BBCH 71 BBCH 79 BBCH

10 Remarks: (a) F crops, the EU and Codex classifications (both) should be used; (i) g/kg g/l where relevant, the use situation should be described (j) Growth stage at last treatment (BBCH Monograph, Growth Stages (e.g. fumigation of a structure) of Plants, 1997, Blackwell, ISBN ), including (b) utdo field use (F), glasshouse application (G) indo application (I) where relevant, infmation on season at time of application (c) e.g. biting and suckling insects, soil bn insects, foliar fungi, weeds (k) The minimum and maximum number of application possible (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) under practical conditions of use must be provided (e) GCPF Codes GIFAP Technical Monograph No 2, 1989 (l) PHI minimum preharvest interval (f) All abbreviations used must be explained (m) Remarks may include: Extent of use/economic imptance/restrictions (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants type of equipment used must be indicated