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Document 32018R0686
Commission Regulation (EU) 2018/686 of 4 May 2018 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 chlorpyrifos, chlorpyrifos-methyl and triclopyr in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2018/686 of 4 May 2018 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 chlorpyrifos, chlorpyrifos-methyl and triclopyr in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2018/686 of 4 May 2018 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 chlorpyrifos, chlorpyrifos-methyl and triclopyr in or on certain products (Text with EEA relevance)
C/2018/2654
OJ L 121, 16.5.2018, p. 30–62
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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16.5.2018 |
EN |
Official Journal of the European Union |
L 121/30 |
COMMISSION REGULATION (EU) 2018/686
of 4 May 2018
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 chlorpyrifos, chlorpyrifos-methyl and triclopyr 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/EEC (1), and in particular Article 14(1)(a) and Article 49(2) thereof,
Whereas:
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(1) |
For chlorpyrifos and chlorpyrifos-methyl maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For triclopyr MRLs were set in Part A of Annex III to that Regulation. |
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(2) |
For chlorpyrifos, the European Food Safety Authority, hereinafter ‘the Authority’, submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (2). The Authority identified a risk for consumers concerning the MRL for wine grapes. It is therefore appropriate to lower this MRL. It recommended lowering the MRLs for quinces, medlars, apricots, cherries, pumpkins, sweet corn, broccoli, Brussels sprouts, kales, kohlrabies, lettuces and salad plants, spinaches, legume vegetables, asparagus, globe artichokes, pulses, poppy seed, sunflower seed, rape seed, mustard seed, gold of pleasure seed, olive for oil production, buckwheat grain, millet grain, coffee beans and poultry (muscle, fat and liver). For other products, it recommended raising or keeping the existing MRLs. It concluded that concerning the MRLs for almonds, hazelnuts/cobnuts, pecans, walnuts, apples, pears, table grapes, beetroots, radishes, garlic, shallots, spring onions/green onions and Welsh onions, tomatoes, sweet peppers/bell peppers, aubergines/eggplants, Chinese cabbages/pe-tsai, lamb’s lettuces/corn salads, lettuces, escaroles/broad-leaved endives, Roman rocket/rucola, beans (with pods), beans (without pods), peas (with pods), peas (without pods), asparagus, globe artichokes, beans, peas, lupins/lupini beans, poppy seeds, sunflower seeds, rapeseeds/canola seeds, soyabeans, mustard seeds, cotton seeds, gold of pleasure seeds, olives for oil production, buckwheat and other pseudo-cereals, common millet/proso millet, teas, spices (seed, fruit, root and rhizome), swine (muscle and fat tissue), bovine (muscle and fat tissue), sheep (muscle and fat tissue), goat (muscle and fat tissue), poultry (muscle and fat tissue) and milk (cattle, sheep and goat), 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 existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
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(3) |
For chlorpyrifos-methyl, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (3). The Authority proposed to change the residue definition to the sum of chlorpyrifos-methyl and desmethyl chlorpyrifos-methyl for cereals. It recommended lowering the MRLs for strawberries, currants (black, red and white), kiwi, potatoes, maize/corn, rye, sorghum, wheat, swine (liver and kidney), bovine (liver and kidney), sheep (liver and kidney), goat (liver and kidney) and poultry (muscle, fat, liver and kidney). For other products, it recommended raising or keeping the existing MRLs. It concluded that concerning the MRLs for spices (seed, fruit, root and rhizome), barley, oat, rice, swine (meat, fat, liver and kidney), bovine (meat, fat, liver and kidney), sheep (meat, fat, liver and kidney), goat (meat, fat, liver and kidney), poultry (meat, fat, liver and kidney), milk (cattle, sheep and goat) and birds eggs, 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 existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. Monitoring data shows that residues occur on untreated pulses, oilseeds and cereals at a level higher than the new limit of determination (LOD) identified by the Authority but lower than the existing LOD. Such residues result from a cross-contamination with crops lawfully treated with chlorpyrifos-methyl. As the assessment demonstrates that there is no unacceptable risk to consumers or animals at the existing LOD, the MRLs for these crops should be temporarily set at the level of the existing LOD. These MRLs will be reviewed; the review will take into account the information available within four years from the publication of this Regulation. |
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(4) |
For triclopyr, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (4). The Authority recommended lowering the MRLs for apples, pears, apricots, peaches, rice grain, swine (muscle, fat, liver and kidney), bovine kidney, sheep kidney, goat kidney and milk (cattle, sheep and goat). For other products, it recommended raising or keeping the existing MRLs. It concluded that concerning the MRLs for grapefruits, oranges, lemons, mandarins, apples, pears, apricots, peaches and rice 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 existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. |
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(5) |
As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or Codex maximum residue limits (CXLs) exist, MRLs should be set at the specific limit of determination or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(6) |
The Commission consulted the European Union reference laboratories for residues of pesticides as regards 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 limits of determination. |
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(7) |
Based on the reasoned opinions of the Authority and 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. |
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(8) |
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. |
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(9) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(10) |
In order to allow for the normal marketing, processing and consumption of products, this Regulation 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. Because a risk to consumers cannot be excluded at the current MRL, the value for chlorpyrifos of 0,01 mg/kg for wine grapes should apply from the date of application of this Regulation. |
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(11) |
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 will result from the modification of the MRLs. |
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(12) |
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 and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
As regards the active substances chlorpyrifos-methyl and triclopyr in and on all products, Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced before 5 December 2018.
As regards the active substance chlorpyrifos in and on all products except wine grapes, Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced before 5 December 2018.
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 5 December 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 May 2018.
For the Commission
The President
Jean-Claude JUNCKER
(2) European Food Safety Authority; Review of the existing maximum residue levels for chlorpyrifos according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(3):4733.
(3) European Food Safety Authority; Review of the existing maximum residue levels for chlorpyrifos-methyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(3):4734.
(4) European Food Safety Authority; Review of the existing maximum residue levels for triclopyr according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(3):4735.
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
Annex II is amended as follows:
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(2) |
Annex III is amended as follows:
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(*1) Limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
(F)= Fat soluble
Chlorpyrifos (F)
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(+) |
The European Food Safety Authority identified some information on analytical methods and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil and seed treatments as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil and seed treatments as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after seedl treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods and residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods, residue trials and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods and residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods and residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on residue trials and crop metabolism after soil treatment as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods and residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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Chlorpyrifos-methyl (F) (R)
(R)= The residue definition differs for the following combinations pesticide-code number:
Chlorpyrifos-methyl - code 500000: sum of chlorpyrifos-methyl and desmethyl chlorpyrifos-methyl
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it. Monitoring data show that cross-contamination of untreated pulses may occur with crops lawfully treated with chlorpyrifos-methyl. This cross-contamination may not be fully avoidable in all cases. When reviewing the MRL, the Commission will take into account the information, if it is submitted by 16 May 2022, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it. Monitoring data show that cross-contamination of oilseeds may occur with crops lawfully treated with chlorpyrifos-methyl. This cross-contamination may not be fully avoidable in all cases. When reviewing the MRL, the Commission will take into account the information, if it is submitted by 16 May 2022, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it. The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it. Monitoring data show that cross-contamination of cereals may occur with crops lawfully treated with chlorpyrifos-methyl. This cross-contamination may not be fully avoidable in all cases. When reviewing the MRL, the Commission will take into account the information, if it is submitted by 16 May 2022, or, if that information is not submitted by that date, the lack of it
|
|
(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it. The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
|
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it. Monitoring data show that cross-contamination of cereals may occur with crops lawfully treated with chlorpyrifos-methyl. This cross-contamination may not be fully avoidable in all cases. When reviewing the MRL, the Commission will take into account the information, if it is submitted by 16 May 2022, or, if that information is not submitted by that date, the lack of it.
|
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
|
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(+) |
The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.
|
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(+) |
The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on the storage conditions of the samples of the livestock feeding studies as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(*2) Limit of analytical determination
(*3) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
Triclopyr
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(+) |
The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods used in the storage stability studies as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods used in the storage stability studies and residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on analytical methods used in the storage stability studies as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
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(+) |
The European Food Safety Authority identified some information on storage stability as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 16 May 2020, or, if that information is not submitted by that date, the lack of it.
|
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(+) |
The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.
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