EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/138 Rev. 3  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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 fosetyl -Al, 
potassium phosphonates and disodium phosphonates in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue level s for fosetyl -Al, 
potassium phosphonates and disodium phosphonates 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 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/EEC1, and in particular 
Article  14(1) , point (a), thereof,  
Whereas:  
(1) For fosetyl -Al, potassium phosphonates  and disodium phosphonates , maximum 
residue levels (‘MRLs ’) were set in Part A of Annex  III to Regulation (EC) 
No 396/2005.  
(2) The Commission requested  the European Food Safety Authority (‘the Authority’) to 
conduct a review of all the existing MRLs for fosetyl -Al, potassium phosphonates and 
disodium phosphonate in accordance with Article  12(1) of Regulation (EC) 
No 396/2005. As these three active substances degrade to phosphonic acid, it was 
appropriate to jointly assess  their residues .  
(3) Besides their use as active substances in plant protection prod ucts, potassium 
phosphonates are also ingredients in other products of agricultural relevance (e.g., 
fertilisers, plant strengtheners, manure, soil amendments). Therefore, the authorised  
treatment of plants with such products may lead to the d etection of phosphonic acid 
residues in pertinent agricultural products, and it is appropriate to consider the 
contribution of such other uses than for plant protection when setting the relevant 
MRLs. The Commission requested  the Authority to deliver, in accordance with Article 
43 of Regulation (EC) No  396/2005, a reasoned opinion on the joint review of MRLs 
for fosetyl -Al, potassium phosphonates and disodium phosphonate , taking into 
account also residue s from sources  other than the use of plant protection products . 
(4) The Authority submitted a reasoned opinion on the joint review of MRLs for fosetyl -
Al, disodium phosphonate and potassium phosphonates in accord ance with  
Article  12(1) and Article 43 of Regulation (EC) No 396/20052. In its opinion, i t 
 
1 OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj . 
2 Reasoned opinion on the joint review of maximum residue levels (MRLs) for fosetyl, disodium 
phosphonate and potassium phosphonates according to Articles 12 and 43 of Regulation (EC) 
No 396/2005. EFSA Journal 2021;19(8):6782.  EN 2  EN proposed to change the residue definition for enforcement purposes for the three active 
substances from ‘Fosetyl -Al (sum of fosetyl, phosphonic acid and their salts, 
expressed as fosetyl) ’ to ‘phosphonic  acid and its salts, expressed as phosphonic acid ’, 
and proposed new MRLs based on that residue definition. The Commission considers  
it appropriate to establish  this new residue definition and to set the MRLs at the level 
identified by the Authority  accor dingly.  
(5) The European Union Reference Laboratories noted that the following limits of 
determination ( ‘LOD ’) are technically achievable:  0,1 mg/kg in high water and acidic 
plant origin matrices , 0,2 mg/kg in high fat and dry/high starch content plant origin 
matrices , 0,05 mg/kg  in milk, 0,2 mg/kg in fat and 0,5 mg/kg in liver, kidney and 
muscle.  Nevertheless, in view of the persistence of the residue s of these substances, 
and of the potential multit ude of residue sources , it was considered appropriate to 
maintain the existing lowest MRL  at 2 mg/kg,  adjusted to a level of 1,5  mg/kg  as to 
take into account the revised residue definition.  For teas, coffee, herbal infusions, 
cocoa and carobs , a lowest MR L of 20  mg/kg is appropriate  to take into account the 
occurrence of phosphonic acid from such other sources.  
(6) The Authority concluded that concerning the MRLs for oranges , grapefruits, apples, 
pears, pineapples, cucurbits with inedible peel and peas dr y, some information 
concerning residue tri als was not available and that therefore further consideration by 
risk managers was required  whether  or not those MRLs could  be set . As there is no 
risk for consumers, those  MRLs should be set. The MRLs for those products  will 
therefore be reviewed ; the review will take into account the information available 
within two years from the publication of this Regulation.  
(7) The Authority concluded that concerning the MRLs  for dates, figs, kumquats, 
carambola, jambolan, lychee, passion fruits, prickly pear, star apples, America 
persimmon, papaya, cherimoya, guava, bread fruit, durian, soursop, cassava, yams, 
arrowroots, Jerusalem artichokes, parsnips, parsley roots, salsify, swedes, turnips, 
okra, grape leaves and similar species, watercress, beans (fresh, without pods), fresh 
lentils, cardoons, celery, fennel, bamboo shoots, palm hearts, mosses and lichens, 
algae and prokaryotes organisms, dry lentils, dry pea s, dry lupins, oilseeds, oil palm 
kernel, oil palm fruits, kapok, barley, maize, common millet, oat, sorghum, coffee 
beans, herbal infusions (from flowers, roots), cocoa beans, carobs, spices (bark, roots 
and rhizome, buds, flower stigma, aril), sugar beet  roots and sugar cane , some 
information concerning monitoring data was not available and that therefore further 
consideration by risk managers was required  whether or not those MRLs could be set . 
As there is no risk for consumers, those  MRLs should be set.  The MRLs for those 
products  will be reviewed; the review will take into account the information available 
within five years from the publication of this Regulation.  
(8) The Authority concluded that concerning the MRL for potatoes , some information 
concerning  processing studies on process waste and dried pulp  was not available and 
that therefore further consideration by risk managers was required  whether or not 
those MRLs could be set . As there is no risk for consumers, those  MRLs should be set. 
The MRL for potatoes  will be reviewed; the review will take into account the 
information available within two years from the publication of this Regulation.  
(9) In its reasoned opinion, the Authority did not recommend specific MRLs for the 
categories ‘others ’ of the various groups  of plant and animal products . In view of the 
persistence of the residue s of these substances, and o f the potential multitude of EN 3  EN resid ue sources , it is therefore appropriate to set those MRLs  to the lowest MRL 
applicable to one of the products within that same product group.   
(10) As regards  the MRL for ‘Solanaceae and Malvaceae, others’, one Member  State 
informed t he Commission that an authorisation for fosetyl -Al for the group of fruiting 
vegetables of Solanaceae exist s in its national territory. Therefore, it is therefore 
appropriate to set that MRL at 70  mg/kg accordingly.  
(11) As regards  the MRL for ‘ lettuces and salad plants , others ’ one Member State informed 
the Commission that an authorisation for those substances for the group of lettuces and 
salad plants  exists in its national territory. Therefore, it is therefore appropriate to set 
that MRL at 150  mg/kg accordingly.  
(12) In its reasoned opinion, the Authority did not recommend specific MRLs for the 
categories ‘edible offals (other than liver and kidney) ’ of the various groups of animal 
products . To ensure that those MRLs are established a t a realistic levels,  it is 
appropriate to set them  to the highest MRL applicable to one of the products within 
that same product group.  
(13) In its reasoned opinion, the Authority did not recommend specific MRLs for the group 
‘other farmed terrestrial animals ’. Since those MRLs are usually set at the same value s 
as for the group ‘bovine ’, it is therefore appropriate to set those MRLs accordingly.  
(14) As no risk for consumers  was identified , the MRLs for fosetyl -Al, potassium 
phosphonates and disodium phosphonates  should be set in Annex II to Regulation 
(EC) No  396/2005.  
(15) While the assessment of fosetyl -Al, disodium phosphonate and potassium 
phosphonates according to Article  12(1) and Article 43 of Regulation (EC) 
No 396/2005  was ongoing, and before the proposed new enforcement residue 
definition was legally e stablished , several  applications pursuant to Article 6(1) of 
Regulation (EC) No 396/2005 requesting modifications of the existing MRLs for 
fosetyl -Al, potassium phosphonates  and disodium phosphonates were submitted for 
citrus fruits, apricots, cherries, plums, chards/beet leaves, herbal infusions from leaves 
and herbs, and honey.  
(16) In accordance with Articles 8 and 9 of Regulation (EC) No  396/2005, the Member 
State s concerned evaluated all those application s and forwarded the evaluation report s 
to the Commission.  
(17) The Authority assessed the application s and the evaluation report s. It examined in 
particular the risks to consumers and, where relevant, to animals, and gave reasone d 
opinion s on the proposed MRLs3. It forwarded its reasoned opinion s to the applicant s, 
the Commission and the Member States and made it available to the public .  
 
3 Reasoned Opinion on the modification of the existing MRLs for potassium phosphonates in lemons, 
limes and mandarins and in herbal infusions from leaves and herbs. EFSA Journal 2021;19(6):6673.  
 Reasoned Opinion on the modification of the existing maximum residue levels for fosetyl/phosphonic 
acid in citrus fruits resulting from the use of potassium phosphonates. EFSA Journal 2021;19(11):6926 . 
 Reas oned Opinion on the modification of the existing maximum residue levels for fosetyl/phosphonic 
acid in chards/beet leaves and honey resulting from the use of potassium phosphonates. EFSA Journal 
2022;20(1):6992.  
 Reasoned Opinion on the modification of the existing maximum residue levels for fosetyl/phosphonic 
acid in apricots, cherries and plums resulting from the use of potassium phosphonates. EFSA Journal 
2022;20(1):7106.  EN 4  EN (18) In its reasoned opinions, the Authority concluded that the data submitted by the 
applicant concerning those active substances in apricots was insufficient to set a new 
MRL. As regards the other products, the Authority concluded that risk manage ment  
considerations were required to establish the appropriate MRLs in view of the residue 
definition for enforcement  that was established.  As the Authority proposed to change 
the residue definition for enforcement purposes for the three active substances from 
‘Fosetyl -Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl) ’ to 
‘phosphonic acid and its salts, expressed as phosphonic acid ’, it is appropriate to set 
the new MRLs based on that residue definition.  
(19) In addition, a s the assessments  were performed in parallel  and were based on different 
Good Agricultural Practices and datasets, in certain of its reasoned opinions  the 
Authority  proposed diverging MRL values for the same product. Therefore, the 
Commission required additional guidance from the Authority  on the a ppropriate 
MRLs to be considered for fosetyl -Al, potassium phosphonates  and disodium 
phosphonates for cases when different values were derived in separate reasoned 
opinions , and considering the new residue definition for enforcement ‘phosphonic acid 
and i ts salts, expressed as phosphonic acid ’ proposed by the Authority . The Authority 
was also requested to re-assess the MRL for fosetyl -Al in kiwi fruits (green, red, 
yellow), that was recently established by Commission Regulation (EU) 2022/13244 in 
view of  the proposed new residue definition.  
(20) The Authority submitted a scientific statement5 on the MRLs for fosetyl -Al, disodium 
phosphonate and potassium phosphonates in accordance with Article 31 of Regulation 
(EC) No 178/20026, for all the products that were covered by the relevant  reasoned 
opinions , with the exception of apricots for which the Authority previously concluded 
that the provided data was insufficient to set a new MRL . 
(21) In its statement , the Authority conc luded that for all  modifications to the MRL s for 
those substances , requested by the applicants for citrus fruits, cherries, plums, 
chards/beet leaves, herbal infusions from leaves and herbs, and honey , all data 
requirements had been met and that such modif ications were acceptable with regard to 
consumer safety on the basis of a consumer exposure assessment for 27  specific 
European consumer groups. The Authority took into account the most recent 
information on the toxicological properties of the substances. Neither the lifetime 
exposure to these substances via consumption of all food products that may contain 
them nor the short -term exposure due to high consumption of the relevant products 
show a risk that the acceptable daily intake or the acute reference do se are exceeded.  
(22) Subsequently, another application pursuant to Article 6(1) of Regulation (EC) 
No 396/2005 requesting modifications of the existing MRLs for those active 
substances was submitted for leeks and spring onions/green onions/Welsh onions.  
 
4 Commission Regulation (EU) 2022/1324 of 28 July 2022 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 benzovindiflupyr, boscalid, fenazaquin, fluazifop -P, flupyradifurone, fluxapyroxad, fosetyl -Al, 
isofetamid, metaflumizone , pyraclostrobin, spirotetramat, thiabendazole and tolclofos -methyl in or on 
certain products (OJ L 200, 29.7.2022, p. 68 , ELI : http://data.europa.eu/eli/reg/2022/1324/o  j). 
5 Scientific statement on the maximum residue levels for potassium phosphonates. EFSA Journal 
2022;20(7):7400.  
6 Regulation (EC)  No 178/2002 of the European Parliament and  of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1 , ELI 
http://data.europa.eu/eli/reg/2002/178/oj  ). EN 5  EN (23) In accordance with Articles 8 and 9 of Regulation (EC) No  396/2005, the Member  
State concerned evaluated this application and forwarded the evaluation report to the 
Commission.  
(24) The Authority assessed the application and the evaluation report. It examined in 
particular the  risks to consumers and, where relevant, to animals, and gave a reasoned 
opinion on the proposed MRLs7. It forwarded its reasoned opinion to the applicant, the 
Commission and the Member States and made it available to the public.  
(25) In its reasoned opinion , the Authority concluded that for all  modifications to the MRL s 
for those substances requested by the applicant all data requirements had been met and 
that such modifications were acceptable with regard to consumer safety on the basis of 
a con sumer exposure assessment for 27 specific European consumer groups. The 
Authority took into account the most recent information on the toxicological 
properties of the substances. Neither the lifetime exposure to these substances via 
consumption of all food  products that may contain them nor the short -term exposure 
due to high consumption of the relevant products show a risk that the acceptable daily 
intake or the acute reference dose are exceeded.  
(26) Based on the reasoned opinion s and the statement  of the A uthority and taking into 
account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, it 
is concluded that the proposed modification to the MRL s are acceptable.  
(27) 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.  
(28) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(29) For all active substances covered by this Regulation, in order to allow for the normal 
marketing, processi ng and consumption of products, this Regulation should provide 
for a transitional arrangement for products which have been placed on the market in 
the Union  before the modification of the MRLs  and for which a high level of 
consumer p rotection is maintained . 
(30) A reasonable period should be allowed to elapse 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 result from the 
amendments.   
(31) 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 RE GULATION:  
Article 1  
Annex es II and  III to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
 
7 Reasoned Opinion on the modification of the existing maximum residue levels in leeks and spring 
onions/green onions/Welsh onions resulting from the use of potassium phosphonates. EFSA Journal 
2023;21(5):8033.  EN 6  EN Article 2  
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were placed on the market in the Union before … 
[6 months after date of entry into force of  this Regulation ]. 
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 … [6 months after date of entry into force  of this Regulation ]. 
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