Table 1.
Background information
| Process | Status | Comments, references |
|---|---|---|
| Approval status | Not approved |
Decision on inclusion of fenarimol for a limited period of time in Annex I of Council Directive 91/414/EEC by Decision 2006/134/EC (a) . Considering the several areas of concern that were identified during the peer review the inclusion of the active substance in Annex I already expired on 30 June 2008. |
| EFSA conclusion available | No | – |
| MRL review performed | No | – |
| EU MRL applications or other EU assessments | Yes, see comments |
The values of the CXL voted (CAC, 1997, 1999) are in line with the values of EU MRL in Reg (EC) 149/2008 (b) . However, the CXLs were revoked by CAC 2021 following discussion in CCPR 52 (2021). Review of MRLs of concern (Art. 43): Review of MRLs for apples, pears, peaches, bananas, tomatoes and peppers (EFSA, 2008). Legally implemented by Regulation (EC) 1097/2009 (c) . MRL application (Art. 10): Import tolerances in apples, bananas, cherries, cucumbers, melons, pumpkins, peaches, strawberries, table grapes and wine grapes, tomatoes and watermelons (EFSA, 2011). Legally implemented by Regulation (EU) No 318/2014 (d) . |
| Classification under CLP Regulation | See comments |
Lact. H362 ‘may cause harm to breast‐fed children’ Repr. 2, H361fd ‘suspected of damaging fertility. Suspected of damaging the unborn child’. (CLP00 (e) ). Cut‐off criteria regarding classification are not met. |
| Endocrine effects of a.s. | Yes, see comments | Although an ED assessment has not been performed fully according to ECHA and EFSA guidance (ECHA and EFSA, 2018), with the data available and taking into account the uncertainties, it can be concluded that endocrine disruptors criteria are met for fenarimol according to current standards. |
a.s: active substance; MRL: maximum residue limit; CXL: Codex maximum residue limit; CCPR: Codex Committee on Pesticide Residues; CAC: Codex Alimentarius Commission; CLP: classification, labelling and packaging; ED: endocrine disruptor; ECHA: European chemicals agency.
Commission Directive 2006/134/EC of 11 December 2006 amending Council Directive 91/414/EEC to include fenarimol as active substance OJ L 349, 12.12.2006, pp. 32–36. OJ L 314M, 1.12.2007, pp. 463–467.
Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex I. OJ L 58, 1.3.2008, pp. 1–398.
Commission Regulation (EC) No 1097/2009 of 16 November 2009 amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dimethoate, ethephon, fenamiphos, fenarimol, methamidophos, methomyl, omethoate, oxydemeton‐methyl, procymidone, thiodicarb and vinclozolin in or on certain products. OJ L 301, 17.11.2009, pp. 6–22.
Commission Regulation (EU) No 318/2014 of 27 March 2014 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 fenarimol, metaflumizone and teflubenzuron in or on certain products OJ L 93, 28.3.2014, p. 28–57.
Annex VI of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353, 31.12.2008, pp. 1–1355.