Abstract
According to Article 12(1) of Regulation (EC) No 396/2005, 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 a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified eight active substances for which a review of MRLs is no longer considered necessary. EFSA prepared a statement explaining the reasons why a review of MRLs became obsolete. The relevant question numbers are considered addressed by this statement.
Keywords: Regulation (EC) No 396/2005, MRLs, peer review, active substance
Summary
Regulation (EC) No 396/2005 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. In accordance with Article 12(1) of that Regulation, the European Food Safety Authority (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 a reasoned opinion on the review of the existing MRLs for that active substance.
According to the legal provisions, EFSA shall base its reasoned opinion on the relevant assessment report prepared under Directive 91/414/EEC. The reasoned opinion should cover all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance, including analytical methods and limit of determination (LOD) for enforcement of the proposed MRLs. All proposed MRLs should accommodate uses authorised within the European Union (EU), and uses authorised in third countries that have a significant impact on international trade.
Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified eight active substances for which a review of MRLs is no longer considered necessary. EFSA therefore prepared a statement explaining the reasons why a review of MRLs became obsolete. The corresponding question numbers are considered addressed by this statement.
The statement was circulated to Member States for consultation via a written procedure before finalisation.
1. Introduction
Regulation (EC) No 396/20051 establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. In accordance with Article 12(1) of that Regulation, the European Food Safety Authority (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/EEC2 a reasoned opinion on the review of the existing MRLs for that active substance.
According to the legal provisions, EFSA shall base its reasoned opinion on the relevant assessment report prepared under Directive 91/414/EEC. The reasoned opinion should cover all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance, including analytical methods and limit of determination (LOD) for enforcement of the proposed MRLs. All proposed MRLs should accommodate uses authorised within the European Union (EU), and uses authorised in third countries that have a significant impact on international trade.
Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified eight active substances for which a review of MRLs is no longer considered necessary. EFSA therefore prepared a statement explaining the reasons why a review of MRLs is no longer considered necessary. The corresponding question numbers are considered addressed by this statement.
The draft statement was circulated to Member States for consultation via a written procedure. Comments received by 30 October 2017 were considered during the finalisation of this statement.
The collation of comments received on the draft statement is considered as background document to this statement and will be made publicly available.
2. Assessment
EFSA identified the following substances for which the dossier was submitted after entry into force of Regulation (EC) No 1107/20093 and thus the need for setting MRLs was considered in the EFSA conclusion. The European Commission proposed to amend the existing MRLs or set new MRLs on the basis of the EFSA conclusion. Therefore, the review of MRLs for the following substances becomes obsolete.
The non‐inclusion of the active substance tricyclazole in Annex I to Directive 91/414/EEC was provided for in Commission Decision 2008/770/EC.4 Following a new application in accordance with Article 7(1) of Regulation (EC) No 1107/2009, this active substance was not approved by Commission Implementing Regulation (EU) 2016/18265 on the basis of the EFSA conclusion (EFSA, 2015b). The MRLs for this substance are set at the limit of determination (LOD) by Commission Regulation (EU) 2017/9836 in accordance with Article 18 of Regulation (EC) No 396/2005. For the active substances for which all MRLs are reduced to the relevant LOD, default values are listed in Annex V in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. The Commission consulted the European Union reference laboratories as regards the need to adapt certain LODs. Those laboratories concluded that for certain commodities technical development permits the setting of lower LODs. Based on the information reported above, the review of MRLs for this substance becomes obsolete.
For the active substance halauxifen‐methyl, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014e). In that framework, Commission Regulation (EU) 2016/677 sets MRLs for this active substance covering the representative uses according to good agricultural practices in the Union. Considering that there are no other uses authorised in the EU or import tolerances in place, the risk assessment performed in the EFSA conclusion is expected to cover all existing uses. Moreover, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limit (CXLs)) for this active substance. The Commission also consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.
For the active substance sulfoxaflor, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014a). In that framework, Commission Regulation (EU) 2016/18 sets MRLs for this active substance covering both the representative uses according to Good Agricultural Practices (GAPs) in the Union and import tolerance requests from several third countries. Considering that there are no other uses authorised in EU or import tolerances in place, the risk assessment performed in the EFSA conclusion is expected to cover all existing uses. After the peer review, the existing CXLs were assessed by EFSA (2017) and legally implemented in the EU legislation by the Commission Regulation (EU) 2017/4059. The Commission consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.
For the active substance flumetralin, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014d). In that framework, Commission Regulation (EU) 2016/48610 sets MRLs for this active substance covering the representative uses according to GAPs in the Union. Considering that there are no other uses authorised in EU or import tolerances in place, the risk assessment performed in the EFSA conclusion is expected to cover all existing uses. Moreover, no CXLs are established by the Codex Alimentarius Commission for this active substance. The Commission consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.
For the active substance 3‐decen‐2‐one, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for the inclusion of that active substance in Annex IV to Regulation (EC) No 396/2005. The active substance was not approved in accordance with Regulation (EC) No 1107/2009 by Commission Decision 2008/770/EC4 on the basis of EFSA conclusion (EFSA, 2015a). It is therefore not appropriate to include the substance in Annex IV to Regulation (EC) No 396/2005 and the MRLs are set at the relevant LOD via Commission Regulation (EU) 2016/186611. The Commission consulted the European Union reference laboratories on the appropriate LODs. Therefore the review of MRLs for this substance becomes obsolete.
For the active substance cyantraniliprole, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2014c). Following the peer review, Commission Regulation (EU) 2017/17112 sets MRLs for this active substance covering the representative uses according to good agricultural practices in the Union and MRL applications for table grapes and various crops assessed by EFSA under Article 10 of Regulation 396/2005 (EFSA, 2015d, 2016a). The existing CXLs were also assessed by EFSA (2014b, 2015c, 2016b) and legally implemented in the EU legislation by the Commission Regulations (EU) 2015/84513 and 2017/62614. The Commission consulted the European Union reference laboratories on the appropriate limits of determination. Therefore, the review of MRLs for this substance becomes obsolete.
For the active substance methyl nonyl ketone, EFSA submitted a conclusion on the peer review of the pesticide risk assessment (EFSA, 2012). The approval of this active substance was withdrawn with the Commission Implementing Regulation (EU) 2017/78115. However, this substance was also provisionally included in Annex IV of Regulation (EC) No 396/2005 by Commission Regulation (EU) 839/2008, which means that no MRL are currently required. Moreover, neither import tolerances nor CXLs are currently in place for methyl nonyl ketone.
Quassia was not included in Annex I to Council Directive 91/414/EEC following voluntarily withdrawal. The MRLs have been set to the default MRL of 0.01 mg/kg according to Art 18(1)(b) Regulation (EC) No 396/2005. Therefore, the review of MRLs for this substance becomes obsolete.
Based on the above explanation, the following question numbers are considered addressed.
| Question number (MRL review) | Active substance | RMS | Status under Reg (EU) No 1107/2009 | Assessment made by EFSA | MRL Regulation |
|---|---|---|---|---|---|
| EFSA‐Q‐2009‐00021 | Tricyclazole | IT | Not approved | EFSA (2015b) | Commission Regulation (EU) 2017/983 |
| EFSA‐Q‐2015‐00476 | Halauxifen‐methyl | UK | Approved | EFSA (2014e) | Commission Regulation (EU) 2016/67 |
| EFSA‐Q‐2015‐00485 | Sulfoxaflor | IE | Approved | EFSA (2014a, 2017) | Commission Regulation (EU) 2016/1, 2017/405 |
| EFSA‐Q‐2015‐00740 | Flumetralin | HU | Approved | EFSA (2014d) | Commission Regulation (EU) 2016/486 |
| EFSA‐Q‐2016‐00116 | 3‐decen‐2‐one | NL | Not approved | EFSA (2015a) | Commission Regulation (EU) 2016/1866 |
| EFSA‐Q‐2016‐00549 | Cyantraniliprole | UK | Approved | EFSA (2014b,c, 2015c,d, 2016a,b) | Commission Regulation (EU) 2017/171, 2015/845, 2017/626 |
| EFSA‐Q‐2009‐00094 | Quassia | IT | Not approved | No peer review by EFSA | Regulation (EC) No 396/2005 |
| EFSA‐Q‐2009‐00175 | Methyl nonyl ketone | BE | Not approved | EFSA (2012) | Annex IV of Regulation (EC) No 396/2005 |
RMS: rapporteur Member State; MRL: maximum residue level.
3. Conclusions
Among the active substances that need to be reviewed under Article 12 of Regulation (EC) No 396/2005, EFSA identified eight active substances for which a review of MRLs is not needed. EFSA therefore prepared a statement explaining the reasons why a review of MRLs is no longer necessary for these active substances. The corresponding question numbers are considered addressed by this statement.
Other statements addressing additional active substances that do not require a review of MRLs (e.g. in view of inclusion in Annex IV of Regulation (EC) No 396/2005) may be issued by EFSA if needed.
Abbreviations
- CAC
Codex Alimentarius Commission
- CCPR
Codex Committee on Pesticide Residues
- CXL
codex maximum residue limit
- EURLs
European Union Reference Laboratories for Pesticide Residues (former CRLs)
- GAP
Good Agricultural Practice
- LOD
limit of determination
- MRL
maximum residue level
- OECD
Organisation for Economic Co‐operation and Development
- RMS
rapporteur Member State
Suggested citation: EFSA (European Food Safety Authority) , 2017. Statement on pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(12):5080, 8 pp. 10.2903/j.efsa.2017.5080
Requestor: European Commission
Question number: EFSA‐Q‐2009‐00021, EFSA‐Q‐2009‐00094, EFSA‐Q‐2009‐00175, EFSA‐Q‐2015‐00476, EFSA‐Q‐2015‐00485, EFSA‐Q‐2015‐00740, EFSA‐Q‐2016‐00116, EFSA‐Q‐2016‐00549
Approved: 22 November 2017
Notes
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, 16.3.2005, p. 1–16.
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. 1–32. Repealed by Regulation (EC) No 1107/2009.
Regulation (EC) No 1107/2009 of 21 October 2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009, p. 1–50.
Commission Decision 2008/770/EC of 30 September 2008 concerning the non‐inclusion of tricyclazole in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance. OJ L 263, 2.10.2008, p. 16.
Commission Implementing Regulation (EU) 2016/1826 of 14 October 2016 concerning the non‐approval of the active substance tricyclazole, 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. OJ L 279, 15.10.2016, p. 88.
Commission Regulation (EU) 2017/983 of 9 June 2017 amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for tricyclazole in or on certain products. OJ L 148, 10.6.2017, p. 27–37.
Commission Regulation (EU) 2016/67 of 19 January 2016 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for ametoctradin, chlorothalonil, diphenylamine, flonicamid, fluazinam, fluoxastrobin, halauxifen‐methyl, propamocarb, prothioconazole, thiacloprid and trifloxystrobin in or on certain products. OJ L 15, 22.1.2016, p. 2–50.
Commission Regulation (EU) 2016/1 of 3 December 2015 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bifenazate, boscalid, cyazofamid, cyromazine, dazomet, dithiocarbamates, fluazifop‐P, mepanipyrim, metrafenone, picloram, propamocarb, pyridaben, pyriofenone, sulfoxaflor, tebuconazole, tebufenpyrad and thiram in or on certain products. OJ L 2, 5.1.2016, p. 1–62.
Commission Regulation (EU) 2017/405 of 8 March 2017 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for sulfoxaflor in or on certain products. OJ L 63, 9.3.2017, p. 71–82.
Commission Regulation (EU) 2016/486 of 29 March 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyazofamid, cycloxydim, difluroacetic acid, fenoxycarb, flumetralin, fluopicolide, flupyradifurone, fluxapyroxad, kresoxim‐methyl, mandestrobin, mepanipyrim, metalaxyl‐M, pendimethalin and tefluthrin in or on certain products. OJ L 90, 6.4.2016, p. 1–66.
Commission Regulation (EU) 2016/1886 of 17 October 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 3‐decen‐2‐one, acibenzolar‐S‐methyl and hexachlorobenzene in or on certain products. OJ L 286, 21.10.2016, p. 4–31.
Commission Regulation (EU) 2017/171 of 30 January 2017 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aminopyralid, azoxystrobin, cyantraniliprole, cyflufenamid, cyproconazole, diethofencarb, dithiocarbamates, fluazifop‐P, fluopyram, haloxyfop, isofetamid, metalaxyl, prohexadione, propaquizafop, pyrimethanil, Trichoderma atroviride strain SC1 and zoxamide in or on certain products. OJ L 30, 3.2.2017, p. 45–111.
Commission Regulation (EU) 2015/845 of 27 May 2015 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, chlorantraniliprole, cyantraniliprole, dicamba, difenoconazole, fenpyroximate, fludioxonil, glufosinate‐ammonium, imazapic, imazapyr, indoxacarb, isoxaflutole, mandipropamid, penthiopyrad, propiconazole, pyrimethanil, spirotetramat and trinexapac in or on certain products. OJ L 138, 4.6.2015, p. 1–69.
Commission Regulation (EU 2017/626 of 31 March 2017 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acetamiprid, cyantraniliprole, cypermethrin, cyprodinil, difenoconazole, ethephon, fluopyram, flutriafol, fluxapyroxad, imazapic, imazapyr, lambda‐cyhalothrin, mesotrione, profenofos, propiconazole, pyrimethanil, spirotetramat, tebuconazole, triazophos and trifloxystrobin in or on certain products. OJ L 96, 7.4.2017, p. 1–43.
Commission Implementing Regulation (EU) 2017/781 of 5 May 2017 withdrawing the approval of the active substance methyl nonyl ketone, 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 Commission Implementing Regulation (EU) No 540/2011. OJ L 118, 6.5.2017, p. 1–3.
References
- EFSA (European Food Safety Authority), 2012. Conclusion on the peer review of the pesticide risk assessment of the active substance methyl nonyl ketone. EFSA Journal 2012;10(1):2495, 36 pp. 10.2903/j.efsa.2012.2495 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2014a. Conclusion on the peer review of the pesticide risk assessment of the active substance sulfoxaflor. EFSA Journal 2014;12(5):3692, 170 pp. 10.2903/j.efsa.2014.3692 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2014b. Scientific support for preparing an EU position for the 46th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2014;12(7):3737, 182 pp. 10.2903/j.efsa.2014.3737 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA (European Food Safety Authority), 2014c. Conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole. EFSA Journal 2014;12(9):3814, 249 pp. 10.2903/j.efsa.2014.3814 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2014d. Conclusion on the peer review of the pesticide risk assessment of the active substance flumetralin. EFSA Journal 2014;12(12):3912, 62 pp. 10.2903/j.efsa.2014.3912 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2014e. Conclusion on the peer review of the pesticide risk assessment of the active substance halauxifen‐methyl (XDE‐729 methyl). EFSA Journal 2014;12(12):3913, 93 pp. 10.2903/j.efsa.2014.3913 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2015a. Conclusion on the peer review of the pesticide risk assessment of the active substance (3E)‐3‐decen‐2‐one (applied as 3‐decen‐2‐one). EFSA Journal 2015;13(1):3932, 43 pp. 10.2903/j.efsa.2015.3932 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2015b. Conclusion on the peer review of the pesticide risk assessment of the active substance tricyclazole. EFSA Journal 2015;13(2):4032, 65 pp. 10.2903/j.efsa.2015.4032 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2015c. Scientific support for preparing an EU position in the 47th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2015;13(7):4208, 178 pp. 10.2903/j.efsa.2015.4208 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA (European Food Safety Authority), 2015d. Reasoned opinion on the modification of the existing maximum residue levels for cyantraniliprole in various crops. EFSA Journal 2015;13(10):4263, 25 pp. 10.2903/j.efsa.2015.4263 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2016a. Reasoned opinion on the modification of the existing maximum residue level for cyantraniliprole in table grapes. EFSA Journal 2016;14(7):4553, 14 pp. 10.2903/j.efsa.2016.4553 [DOI] [Google Scholar]
- EFSA (European Food Safety Authority), 2016b. Scientific support for preparing an EU position in the 48th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2016;14(8):4571, 166 pp. 10.2903/j.efsa.2016.4571 [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA (European Food Safety Authority), 2017. Scientific support for preparing an EU position in the 49th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2017;15(7):4929, 162 pp. 10.2903/j.efsa.2017.4929 [DOI] [PMC free article] [PubMed] [Google Scholar]