APPROVED: 05 February 2016 PUBLISHED: 15 February 2016

Transcription

1 STATEMENT APPROVED: 05 February 2016 PUBLISHED: 15 February 2016 doi: /j.efsa Assessment of the pesticide active substance carvone (d-/l-carvone at a ratio of at least 100:1) for inclusion in Annex IV of Regulation (EC) No 396/2005 Abstract European Food Safety Authority (EFSA) According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) was required to review the maximum residue levels (MRLs) currently established at European level for the pesticide active substance carvone (d-/l-carvone at a ratio of at least 100:1). Furthermore, the Netherlands compiled an application to include carvone in Annex IV of Regulation (EC) No 396/2005, which lists the active substances that do not require the setting of MRLs. EFSA s Scientific Committee also adopted a Scientific Opinion on the safety assessment of carvone, considering all sources of exposure to carvone. The outcome of the assessment was compared to the criteria defined by the European Commission for inclusion of pesticide active substances in Annex IV of the Regulation. As the consumer exposure resulting from the pesticide use of d-carvone was found to be lower than the exposure resulting from the other uses than pesticides, inclusion of d-carvone in Annex IV of Regulation (EC) No 396/2005 seems appropriate. European Food Safety Authority, 2016 Keywords: carvone, potatoes, MRL review, MRL application, Regulation (EC) No 396/2005 Requestor: European Commission Question numbers: EFSA-Q , EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(2):4405

2 Suggested citation: EFSA (European Food Safety Authority), Statement on the assessment of the pesticide active substance carvone (d-/l-carvone at a ratio of at least 100:1) for inclusion in Annex IV of Regulation (EC) No 396/2005. EFSA Journal 2016;14(2):4405, 14 pp. doi: /j.efsa ISSN: European Food Safety Authority, 2016 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2016;14(2):4405

3 Summary Carvone for uses as plant growth regulator (PGR) was included in Annex I to Directive 91/414/EEC on 1 August 2008 by Commission Directive 2008/44/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved before the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of the aforementioned regulation. The Netherlands, as the designated rapporteur Member State (RMS), prepared a supporting evaluation report and suggested carvone to be included in Annex IV of Regulation (EC) No 396/2005. This Annex lists the active substances that do not require the setting of MRLs. This RMS compiled subsequently an application to include carvone in Annex IV of Regulation (EC) No 396/2005 in accordance with Article 6 of this Regulation. The Netherlands drafted an evaluation report in line with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 29 February Apart from its use as a pesticide, consumer exposure to carvone may also result from other sources such as food flavouring, feed flavouring or, together with other active substances, in a zootechnical feed additive, personal care products and (veterinary) medicine. Furthermore, different ADI values for carvone had been established in the different food sector areas in the past. It was therefore necessary to involve the EFSA Scientific Committee, which adopted on 9 July 2014 a scientific opinion on the safety assessment of carvone, considering all sources of exposure, including pesticide authorisations and anticipated uses in the framework of Articles 10 and 12 of Regulation (EC) No 396/2005. Nevertheless, in addition to the scientific opinion of the EFSA Scientific Committee, it was still considered necessary to address the criteria as defined by the European Commission for inclusion of a pesticide active substance in Annex IV of Regulation (EC) No 396/2005. Hence, based on the assessment of the Scientific Committee, EFSA prepared in December 2015 a draft statement, which addresses these criteria and which was circulated to Member States for consultation via written procedure. Comments received by 26 January 2016 were considered during the finalisation of this reasoned opinion. A Member State consultation report (EFSA, 2016) was developed, which is considered as background document to this reasoned opinion and, thus, is made publicly available. The following conclusions are derived. While carvone is proposed for classification as a skin sensitizer 1 (H37), it is not reported to have carcinogenic, mutagenic or reprotoxic properties. This substance would therefore be eligible for inclusion in Annex IV to Regulation (EC) No 396/2005. According to Commission Directive 2008/44/EC, the pesticide active substance carvone is defined with a d/l ratio of at least 100:1 and the aggregated oral exposure assessment for d-carvone, considering all sources of exposure (including the pesticide use), did not result in an exceedance of the ADI of 0.6 mg/kg bw per day. The exposure resulting from the pesticide use of d-carvone was generally found to be lower than the natural exposure to d-carvone, except for toddlers where the pesticide exposure was found to be in the same range as the natural exposure. Furthermore, the exposure resulting from the pesticide use of d-carvone was found to be significantly lower that the exposure resulting from the other food chain related sources. Hence, it seems that criterion four for the inclusion of an active substance in Annex IV is fulfilled and inclusion of d-carvone in Annex IV of Regulation (EC) No 396/2005 seems to be appropriate. It is noted that the toxicity of l-carvone remains unknown and it is not clear whether exposures of d- carvone and l-carvone may need to be combined in the future. Although the pesticide active substance d-carvone may contain up to 1% of l-carvone, this is expected to have a minor impact on the aggregated exposure to l-carvone. It is also noted that l-carvone is the main constituent of another pesticide active substance called spearmint oil. However, this substance is not within the scope of this statement. 3 EFSA Journal 2016;14(2):4405

4 Table of contents Abstract... 1 Summary Introduction The active substance and its use pattern Legal background Terms of reference Addressing the terms of reference Assessment The active substance is not approved as a basic substance under Regulation (EC) No 1107/ The compound is not listed in Annex I of Regulation (EC) No 396/ The compound has identified hazardous properties Natural exposure is higher than the one linked to the use as PPP Consumer exposure is forecasted Conclusions and recommendations... 9 References Abbreviations Annex A Good Agricultural Practices (GAPs) Annex B Structural formula and structure of carvone EFSA Journal 2016;14(2):4405

5 1. Introduction 1.1. The active substance and its use pattern Carvone is the ISO common name for 5-isopropenyl-2-methylcyclohex-2-en-1-one (IUPAC). Carvone belongs to the group of terpenoids compounds which are used as plant growth regulators (PGR) on potatoes. The mode of action as a sprout inhibitor in potatoes is currently unknown, but it is assumed that the mode of action is based on a blockage of an essential enzyme in the biosynthesis of mevalonic acid. The blockage is reversible and after the removal of carvone, the potatoes will sprout. Carvone occurs naturally as dextrorotatory (d-) and levorotatory (l-) enantiomers in several food items such as mint and caraway. The enantiomers may also be used as food flavouring, feed flavouring or, together with other active substances, in a zootechnical feed additive, personal care products and (veterinary) medicine. In the field of pesticides, the active substance carvone is defined with a d/l ratio of at least 100:1. This statement therefore mainly assesses d-carvone. It is noted that l-carvone is the main constituent of another pesticide active substance called spearmint oil, but this substance is not within the scope of this statement. Hence, in order to avoid confusion, the pesticide active substance carvone, will hereafter be referred to as d-carvone. The chemical formula and structure of the active substance are reported in Appendix B. d-carvone was evaluated in the framework of Directive 91/414/EEC, with the Netherlands designated as rapporteur Member State (RMS). The representative uses supported for the peer review process were, (a) sprout regulator and (b) sprout correction of seed potatoes for post-harvest treatment. Following the peer review, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2008/44/EC, which entered into force on 1 August According to Regulation (EU) No 540/2011, d-carvone is deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to uses as PGR only. As EFSA was then not yet involved in the peer review of d-carvone, an EFSA Conclusion on this active substance is not available; however a recent scientific opinion prepared by the EFSA Scientific Committee (SC) on the safety assessment of carvone reviewed all the data available and the previous assessments. It addressed d-carvone and l-carvone separately and limited its assessment to the oral intake of d- and l-carvone. Key uncertainties were outlined (EFSA Scientific Committee, 2014). EU MRLs for d-carvone are not established in Annexes II and III of Regulation (EC) No 396/2005 and according to Art 18(1)(b) of this Regulation the default MRL of 0.01 mg/kg applies to d-carvone. CXLs are not established for d-carvone. According to the available information, the use of d-carvone is currently authorised for post-harvest treatment of seed potatoes as supported in the framework of the peer-review, and a similar GAP is now also intended for starch and ware potatoes. The details of the authorised and intended GAP(s) for carvone are given in Appendix A Legal background Regulation (EC) No 396/ establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. Article 12(2) of that Regulation stipulates that EFSA shall provide within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC 2 a reasoned opinion on the review of the existing MRLs for d-carvone. As d-carvone was included in Annex I to Council Directive 91/414/EEC on 1 August 2008 by means of Commission Directive 2008/44/EC, 3 and has been deemed to be approved under 1 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, , p Repealed by Regulation (EC) No 1107/ Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances. OJ L 94, , p EFSA Journal 2016;14(2):4405

6 Regulation (EC) No 1107/2009, 4 in accordance with Commission Implementing Regulation (EU) No 540/2011, 5 as amended by Commission Implementing Regulation (EU) No 541/2011, 6 EFSA initiated the review of all existing MRLs for that active substance. For this purpose, the Netherlands, as the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, prepared a supporting evaluation report which was submitted to EFSA on 31 May 2010 (Netherlands, 2010). Meanwhile, the Netherlands also received an application from the company Makhteshim Agan 7 to include the active substance carvone (d-/l-carvone at a ratio of at least 100:1) in Annex IV of Regulation (EC) No 396/2005, which lists the active substances that do not require the setting of MRLs. This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the Netherlands in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission and to EFSA on 29 February 2012 (Netherlands, 2012). As d-carvone is currently only authorised for use as plant growth regulator (PGR) in seed potatoes, the application to include d-carvone in Annex IV to Regulation (EC) No 396/2005 was considered necessary by the Netherlands in order to allow for the authorisation of a new intended use of d- carvone on starch and ware potatoes Terms of reference According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on: the inclusion of the active substance in Annex IV to the Regulation, when appropriate; the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation; the inclusion of the recommended MRLs in Annex II or III to the Regulation; the setting of specific processing factors as referred to in Article 20(2) of the Regulation. In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the evaluating Member State (EMS), provide a reasoned opinion on the risks to the consumer associated with the application. The general principles for the establishment and update of Annex IV are laid down in Article 5 of Regulation (EC) No 396/2005, which requires that for an active substance which shall be included in Annex IV account should be taken of: 1.4. the use of the active substance; the scientific and technical knowledge available; the result of an assessment of any potential risks to consumers with a high intake and high vulnerability and, where appropriate, to animals; the results of any evaluations and decisions to modify the use of plant protection products. Addressing the terms of reference Apart from its use as a pesticide, consumer exposure to d-carvone may also result from other sources such as food flavouring, feed flavouring or, together with other active substances, in a zootechnical feed additive, personal care products and (veterinary) medicine. Furthermore, different toxicological 4 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. OJ L 309, , p 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, , p Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 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, , p Makhteshim Agan, P.O. Box 355, 3830 AK Leusden, The Netherlands 6 EFSA Journal 2016;14(2):4405

7 reference values for d-carvone had been applied in the different food sector areas in the past. It was therefore necessary to involve the EFSA Scientific Committee, which adopted on 9 July 2014 a scientific opinion on the safety assessment of carvone, considering all sources of exposure, including information provided in the framework of Articles 10 and 12 of Regulation (EC) No 396/2005. EFSA subsequently verified with Member States that no other uses are currently authorised than those considered by the Scientific Committee in its assessment. This was done in the framework of a completeness check period which was initiated by EFSA on 20 November 2015 and finalised on 11 December Replies were received by Austria, the United Kingdom, Finland and Greece confirming that no national authorisation for d-carvone exist other than those for seed, starch and ware potatoes. It can therefore be concluded that the exposure assessment performed by the Scientific Committee covers the authorisations which should be considered in the framework of Articles 10 and 12 of the Regulation, and specific reasoned opinions were no longer considered relevant by EFSA. Nevertheless, it was still considered necessary to address the criteria for inclusion of this active substance in Annex IV of the Regulation. Hence, based on the assessment of the Scientific Committee, EFSA prepared in December 2015 a draft statement, which is only intended to address the criteria for inclusion of a substance in Annex IV of the Regulation. This draft statement was submitted to Member States for commenting via a written procedure. All comments received by 26 January 2016 were considered by EFSA during the finalisation of the statement. A Member State consultation report (EFSA, 2016) was developed which is considered as background document to this reasoned opinion and, thus, is made publicly available. 2. Assessment Criteria for inclusion of active substances into Annex IV of Regulation (EC) No 396/2005 were defined in a guidance document of the European Commission (2015). According to the decision tree (Figure 1) outlined in this guidance document, an active substance should comply with one of the following criteria in order to be recommended for inclusion in Annex IV of Regulation (EC) No 396/2005: Criterion one: The active substance is approved as a basic substance under Regulation (EC) No 1107/2009 Criterion two: The compound is listed in Annex I of Regulation (EC) No 396/2005 Criterion three: The compound has no identified hazardous properties Criterion four: Natural exposure is higher than the one linked to the use of PPP Criterion five: No consumer exposure is forecasted linked to the mode of application of the PPP Mainly based on the outcome of the EFSA Scientific Committee s assessment on carvone (EFSA Scientific Committee, 2014), EFSA aimed at addressing each of these criteria in the framework of this assessment The active substance is not approved as a basic substance under Regulation (EC) No 1107/2009 d-carvone is not approved as a basic substance and therefore does not comply with criterion one of the guidance document The compound is not listed in Annex I of Regulation (EC) No 396/2005 Although d-carvone represents a major component of a number of food items which are listed in Annex I of Regulation (EC) No 396/2005, d-carvone itself is not listed in this Annex. It therefore does not comply with criterion two. 7 EFSA Journal 2016;14(2):4405

8 2.3. The compound has identified hazardous properties According to the guidance, by no means carcinogenic, mutagenic or reprotoxic (CMR) substances (all categories) nor those with potentially endocrine disrupting properties, are eligible candidates for Annex IV inclusion, and an active substance could be recommended for inclusion in Annex IV when it is of very low toxicity. It has to be noted that according to ECHA s Risk Assessment Committee carvone is not proposed for classification as a carcinogenic, mutagenic or reprotoxic substance. Nevertheless, the same Committee proposed carvone to be classified as skin sensitiser 1 (H37) (ECHA Risk Assessment Committee, 2013), which is not compatible with the criterion of very low toxicity. Furthermore, the need to establish an ADI for carvone was recently confirmed by EFSA s Scientific Committee who established an ADI of 0.6 mg/kg bw/day for d-carvone (EFSA Scientific Committee, 2014). The Scientific Committee was not able to derive an ADI for l-carvone due to a lack of data on this isomer, although this is considered of less relevance in the framework of this statement because Commission Directive 2008/44/EC defines the pesticide specification of carvone with a d/l ratio of at least 100:1. Hence, although d-carvone is not reported to have carcinogenic, mutagenic or reprotoxic properties, it cannot be considered to be of very low toxicity and therefore does not fully meet criterion three Natural exposure is higher than the one linked to the use as PPP The guidance specifies for criterion four that the natural exposure to the component is higher than the one linked to the use as PPP. In that case, a weight of evidence approach may be used, e.g. taking into account that natural exposure is higher than the one linked to use as PPP, to justify inclusion in Annex IV. This criterion is fulfilled for d-carvone based on the exposure assessment outlined in the EFSA Opinion (EFSA Scientific Committee, 2014). The Scientific Committee considered oral exposure of humans to carvone from: its presence in natural sources through the diet where it is a normal constituent, its current and intended use as a pesticide, its use as flavouring substances, its use as a feed additive, its use as a (veterinary) medicinal product, its use in personal care products (toothpaste, mouthwash). In the field of pesticides, carvone is defined with a d/l ratio of at least 100:1 as described in section 1.1. of this statement. Therefore, the consumer exposure scenarios calculated for d-carvone are considered to be the most relevant within this framework. Indeed, the Scientific Committee concluded that the exposure to d-carvone from its authorised use as anti-sprouting agent on seed potatoes is negligible. Furthermore, the anticipated exposure to d- carvone from the intended new pesticide use (sprouting inhibitor) on ware and starch potatoes is about one magnitude lower than the natural food exposure to d-carvone, except for toddlers where it is in the same range (see Table 7 of EFSA Scientific Committee, 2014). It is noted that natural exposure as referred to in the Commission s guidance document, may also be interpreted as exposure resulting from other uses in the food chain and/or natural background. According to this interpretation, the contribution the new intended use on ware and starch potatoes to the aggregate exposure would range on average from 3% up to 21%, depending on the quantity of potato-based products consumed in the country considered. Overall, this new intended use of d-carvone would not result in the overall exposure to d-carvone exceeding the ADI. The Scientific Committee also noted that the aggregated exposure to l-carvone is three-fold that of d- carvone and that the toxicity of l-carvone remains unknown. Hence, the Scientific Committee also recommended studies investigating the mode of action of both d- and l-carvone and addressing the relative toxicity of the enantiomers, because this information would be necessary to decide whether the two enantiomers should be considered together to establish a group ADI. Nevertheless, since the pesticide active substance d-carvone may contain up to 1% of l-carvone, the pesticide use of d-carvone is expected to result in an exposure to l-carvone, which is estimated to range between and mg/kg bw/d, depending on the age group considered (1% of the 8 EFSA Journal 2016;14(2):4405

9 anticipated exposure to d-carvone from pesticide intended use, see Table 7 of EFSA Scientific Committee, 2014). This exposure would be two to four orders of magnitude lower than exposure resulting from other uses of l-carvone, including the pesticide use of spearmint oil (see Table 8 of EFSA Scientific Committee, 2014). Although it is not clear whether exposures of d-carvone and l- carvone may need to be combined in the future (depending information that may become available), exposure to l-carvone resulting from the pesticide use of d-carvone is expected to be minor Consumer exposure is forecasted Criterion five targets the possibility that no consumer exposure is forecasted linked to the mode of application of the PPP. This would not be the case for the anticipated use of d-carvone on starch and ware potatoes (see also section 2.4). Criterion five is therefore not met. 3. Conclusions and recommendations While carvone is proposed for classification as a skin sensitizer 1 (H37), it is not reported to have carcinogenic, mutagenic or reprotoxic properties. This substance would therefore be eligible for inclusion in Annex IV to Regulation (EC) No 396/2005. According to Commission Directive 2008/44/EC, the pesticide active substance carvone is defined with a d/l ratio of at least 100:1 and the aggregated oral exposure assessment for d-carvone, considering all sources of exposure (including the pesticide use), did not result in an exceedance of the ADI of 0.6 mg/kg bw per day. The exposure resulting from the pesticide use of d-carvone was generally found to be lower than the natural exposure to d-carvone, except for toddlers where the pesticide exposure was found to be in the same range as the natural exposure. Furthermore, the exposure resulting from the pesticide use of d-carvone was found to be significantly lower than the exposure resulting from the other food chain related sources. Hence, it seems that criterion four for the inclusion of an active substance in Annex IV is fulfilled and inclusion of d-carvone in Annex IV of Regulation (EC) No 396/2005 seems to be appropriate. It is noted that the toxicity of l-carvone remains unknown and it is not clear whether exposures of d- carvone and l-carvone may need to be combined in the future. Although the pesticide active substance d-carvone may contain up to 1% of l-carvone, this is expected to have a minor impact on the aggregated exposure to l-carvone. It is also noted that l-carvone is the main constituent of another pesticide active substance called spearmint oil. However, this substance is not within the scope of this statement. 9 EFSA Journal 2016;14(2):4405

10 References ECHA (European Chemicals Agency), Committee for Risk Assessment (RAC), Opinion proposing harmonised classification and labelling at EU level of carvone. CLH-O /F, adopted on 4 June EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active substance plant oils/spearmint oil. EFSA Journal 2012;10(11): pp. doi: /j.efsa EFSA (European Food Safety Authority), Member States consultation report on the assessment of the pesticide active substance carvone (d-/l-carvone at a ratio of at least 100:1) for inclusion in Annex IV of Regulation (EC) No 396/2005 prepared by EFSA, 29 January Available online: EFSA Scientific Committee, Scientific Opinion on the safety assessment of carvone, considering all sources of exposure. EFSA Journal 2014;12(7): pp. doi: /j.efsa European Commission, Review report for the active substance carvone. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 22 January 2008 in view of the inclusion of carvone in Annex I of Council Directive 91/414/EEC. SANCO/3920/2007- Final, 21 January European Commission, Guidance document on criteria for the inclusion of active substances into Annex IV of Regulation (EC) No 396/2005. SANCO/11188/2013-Rev.2, 14 September Netherlands, Evaluation report prepared by the rapporteur Member State Netherlands under Article 12 of Regulation (EC) No 396/2005. Review of MRLs for carvone, May Netherlands, Evaluation report prepared by the evaluating Member State Netherlands under Article 8 of Regulation (EC) No 396/2005. Setting of MRLs for carvone in potatoes (or inclusion in Annex IV), January EFSA Journal 2016;14(2):4405

11 Abbreviations a.s. ADI ARfD BMD BMDL 10 bw CXL d DAR EC ECHA EFSA EMS GAP LOQ MRL MS PGR PHI PPP RA RMS active substance acceptable daily intake acute reference dose bench mark dose the 95 % lower confidence limit for benchmark does response of 10 % of 60 mg/kg bw/day body weight Codex Alimentarius Commission maximum residue limit day draft Assessment Report (prepared under Council Directive 91/414/EEC) European Commission European Chemicals Agency European Food Safety Authority evaluating Member State good agricultural practice limit of quantification maximum residue level Member State plant growth regulator pre-harvest interval plant protection product risk assessment reporting Member State 11 EFSA Journal 2016;14(2):4405

12 Annex A Good Agricultural Practices (GAPs) Crop and/or situation (a) NEU, SEU, MS or country F G or I (b) Pests or Group of pests controlled (c) Preparation Application Application rate per treatment Type (d-f) Conc. a.s. (i) Method kind (f-h) Range of growth stages & season (j) Number min-max (k) Interval between application (min) g a.s./ton min-max (l) Water L/ha minmax g a.s./ha minmax (l) PHI (weeks) (m) Remarks Potatoes (seed) NL l Sprout regulator AL 950 g/kg Use internal ventilation. Apply the product with a suitable fogging equipment into the air stream behind the fan During storage season; before start of sprouting 22 (for 6 months storage) 1 week n.a. Max 323 at least 4-6 (before planting in the field) Critical GAP currently authorised List of uses supported by available data (SANCO/3920/2007- rev.final) Potatoes (seed) NL l Sprout correction (emergency measure) AL 950 g/kg As above When product was not applied before and sprouts are already visible n.a at least 4-6 (before planting in the field) List of uses supported by available data (SANCO/3920/2007- rev.final) 12 EFSA Journal 2016;14(2):4405

13 Crop and/or situation (a) Ware and starch potatoes NEU, SEU, MS or country F G or I (b) Pests or Group of pests controlled (c) NL l Sprout regulation Preparation Application Application rate per treatment Type (d-f) Conc. a.s. (i) AL 930 g/kg Method kind (f-h) As above Range of growth stages & season (j) During storage season; at start of sprouting (BBCH01) Nov-June (a): For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use situation should be described (e.g. fumigation of a structure) (b): Outdoor or field use (F), greenhouse application (G) or indoor application (I) (c): e.g. biting and sucking insects, soil born insects, foliar fungi, weeds (d): e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e): CropLife International Technical Monograph no 2, 6th Edition. Revised May Catalogue of pesticide (f): All abbreviations used must be explained (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 planttype of equipment used must be indicated Number min-max (k) Interval between application (min) g a.s./ton min-max (l) Water L/ha minmax g a.s./ha minmax (l) PHI (weeks) (m) Remarks days n.a. n.a. n.a. GAP intended for authorisation in NL. Application scheme according top directions of use starting with with 22.3 g as/tonne decreasing to 13.4 g as/tonne. Maximum total application of 600 g/tonne (i): g/kg or g/l. Normally the rate should be given for the active substance (according to ISO) and not for the variant in order to compare the rate for same active substances used in different variants (e.g. fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to give the rate for the variant (e.g. benthiavalicarb-isopropyl). (j): Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (k): Indicate the minimum and maximum number of applications possible under practical conditions of use (l): The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of g/ha or 12.5 g/ha instead of kg/ha (m): PHI minimum pre-harvest interval 13 EFSA Journal 2016;14(2):4405

14 Annex B Structural formula and structure of carvone Code/trivial name Chemical name/smiles notation (a) Structural formula (a) Carvone (RS)-5-isopropenyl-2-methylcyclohex-2-en-1- one or (RS)-p-mentha-6,8-dien-2-one H 3 C CH 2 CC1=CCC(CC1=O)C(C)=C O CH 3 d-carvone (5S)-5-isopropenyl-2-methylcyclohex-2-en-1- one H 3 C CH 2 CC1=CC[C@@H](CC1=O)C(C)=C O CH 3 l-carvone (5R)-5-isopropenyl-2-methylcyclohex-2-en-1- one H 3 C CH 2 CC1=CC[C@H](CC1=O)C(C)=C O CH 3 (a): ACD/Labs 2015 Release, Advanced Chemistry Development, Inc., Toronto, ON, Canada, EFSA Journal 2016;14(2):4405