EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11220/2019 Rev.3  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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 clethodim, 
dazomet, hexythiazox, metam and sethoxydim in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 clethodim, 
dazomet, hexythiazox, metam and sethoxydim in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Reg ulation (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/EEC1, and in particular 
Article 14(1) (a) and Article 49(2) thereof,  
Whereas:  
(1) For clethodim, dazomet, hexythiazox and metam , maximum residue levels (MRLs) 
were set in  Part A of  Annex III to Regulation (EC) No 396/2005.  
(2) For clethodim , the European Food Safety Authority ( "the Authority" ) submitted a 
reasoned opinion on the review of the existing MRLs in accordance with Article  12(1) 
of Regulation (EC) No  396/20052. It proposed to change the current residue definition  
for clethodim, which also covers the non -approved substance sethoxydim a nd to list 
MRLs for clethodim and sethoxydim separately. It is appropriate to change the residue 
definition for clethodim accordingly and to insert a new entry for sethoxydim in 
Annex V.  It concluded that , concerning MRLs  for clethodim , some information wa s 
not available and the genotoxic potential of the clethodim metabolite  3-chloroallyl 
alcohol  could not be concluded, no toxicological reference values could be derived for 
this metabolite  and further consideration by risk managers was required.  From a ris k 
management perspective, it is appropriate to set MRLs for clethodim  in Annex  II to 
Regulation (EC) No 396/2005 at the specific limit of determination (LOD)  and to 
include  sethoxydim in Annex  V to Regulation (EC) No  396/2005 at the specific LOD  
or at the default MRL as set out in Article  18(1)(b) of Regulation (EC) No  396/2005.  
(3) For dazomet and metam , the Authority submitted reasoned opinion s on the existing 
MRLs in accordance with Article  12(1) of Regulation (EC) No  396/200534. It 
proposed a revised resid ue definition based on  methylisothiocyanate  a common 
                                                 
1 OJ L 070, 16.3.2005 , p. 1.  
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for clethodim  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(5):5706. 
3 European Food Safety Au thority; Reasoned opinion on the review of the existing maximum residue 
levels for dazomet  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(1):5562. 
4 European Food Safety Authority; Reasoned opinion on the review of the existin g maximum residue 
levels for metam  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(1):5561 .  
EN 2  EN metabolite for dazomet and metam . It is appropriate to change the residue definition 
accordingly. The Authority  recommended lowering the MRLs for grapefruits, oranges, 
lemons, limes, mandarins, apples, p ears, quinces, medlars, loquats/Japanese medlars, 
apricots, cherries (sweet), peaches, plums, table and wine grapes, blackberries, 
dewberries, raspberries (red and yellow), blueberries, cranberries, currants (black, red 
and white), gooseberries (green, red  and yellow), rose hips, mulberries (black and 
white), azaroles/Mediterranean medlars, elderberries, figs, table olives, kumquats, 
kaki/Japanese persimmons, kiwi fruits (green, red, yellow), prickly pears/cactus fruits, 
avocados, mangoes and granate apples /pomegranates . For other products, it 
recommended raising or keeping the existing MRLs . The MRLs for those products 
should be set in Annex  II to Regulation (EC) No  396/2005 at the level identified by 
the Authority . The Authority concluded that concerning the MRLs for strawberries, 
beetroots, carrots , celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, 
parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, 
turnips, tomato es, sweet peppers/bell peppers, aubergines/eggplants, okra/lady's 
fingers, cucumbers, gherkins, courgettes, melons, pumpkins, watermelons, Chinese 
cabbages/pe -tsai, kales, lamb's lettuces/corn salads, lettuces, escaroles/broad -leaved 
endives, cresses and o ther sprouts and shoots, land cresses, Roman rocket/rucola, red 
mustards, baby leaf crops (including brassica species), spinaches, purslanes , 
chards/beet leaves , herbal infusions from roots and hops  some information was not 
available and that further consi deration by risk managers was required.  As there is no 
risk for consumers, the MRLs for those products also should be set in Annex  II to 
Regulation (EC) No  396/2005 at the level identified by the Authority. All of t hese 
MRLs will be reviewed; the review wi ll take into account the information available 
within two years from the publication of this Regulation.  
(4) For hexythiazox , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article  12(1) of Regulation (EC) No  396/20055. It proposed to 
change the residue definition. It recommended lowering the MRLs for grapefruits, 
oranges, lemons, limes, mandarins, almonds, brazil nuts, cashew nuts, chestnuts, 
coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, pistachios, 
walnuts, apples, pears, quinces, medlars, loquats/Japanese medlars, peaches, 
blackberries, dewberries, raspberries (red and yellow), blueberries, cranberries, 
currants (black, red and white), gooseberries (green, red and yellow), rose hips, 
mulberries (bla ck and white),  azaroles/Mediterranean medlars,  elderberries, tomatoes, 
sweet peppers/bell peppers, aubergines/eggplants , cucumbers, gherkins, courgettes, 
melons, pumpkins, watermelons, maize/corn and hops . For other products, it 
recommended raising or keep ing the existing MRLs.  The MRLs for those products 
should be set in Annex  II to Regulation (EC) No  396/2005 at the level identified by 
the Authority . The Authority  also concluded that concerning the MRL s for apricots, 
cherries (sweet) plums , soyabeans  and products of animal origin some information 
was not available and that further consideration by risk managers was required. As 
there is no risk for consumers, the MRLs for those products should be set in Annex  II 
to Regulation (EC) No  396/2005 at the l evel identified by the Authority. All of t hese 
MRLs will be reviewed; the review will take into account the information available 
within two years from the publication of this Regulation.   
                                                 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for hexythiazox  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2019;17(1):5559.  
EN 3  EN (5) Existing Codex maximum residue limits (CXLs)  were taken into accoun t in the 
reasoned opinions of the Authority. CXLs which are safe for consumers in the Union 
were considered for MRL setting.  
(6) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerance s or CXLs  exist, MRLs should be set at 
the specific LOD  or the default MRL should apply, as provided for in Article  18(1)(b) 
of Regulation (EC) No  396/2005.  
(7) The Commission consulted the European Union reference laboratories for residues of 
pesticides as re gards the need to adapt certain limits of determination. As regards 
several substances, those laboratories concluded that for certain commodities technical 
development requires the setting of specific LODs . 
(8) Based on the reasoned opinions of the Authority a nd taking into account the factors 
relevant to the matter under consideration, the appropriate modifications to the MRLs 
fulfil the requirements of Article  14(2) of Regulation (EC) No  396/2005.  
(9) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(10) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(11) In order to allow for the normal marketing, processing and consumption of products, 
this Regulati on should provide for a transitional arrangement for products which have 
been produced before the modification of the MRLs and for which information shows 
that a high level of consumer protection is maintained.  
(12) A reasonable period should be allowed to elap se before the modified MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(13) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II , III and V  to Regulation (EC) No 396/2005 are amended in accordan ce with the 
Annex to this Regulation.  
Article 2  
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced in the Union or imported into the Union 
before [ Office of Publication: p lease insert date 6 months after entry into force ]. 
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union .  
It shall apply from [Office of Publication: please i nsert date 6 months after entry into force] .  
EN 4  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN