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Document 32015R0401
Commission Regulation (EU) 2015/401 of 25 February 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 acetamiprid, chromafenozide, cyazofamid, dicamba, difenoconazole, fenpyrazamine, fluazinam, formetanate, nicotine, penconazole, pymetrozine, pyraclostrobin, tau-fluvalinate and tebuconazole in or on certain products Text with EEA relevance
Commission Regulation (EU) 2015/401 of 25 February 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 acetamiprid, chromafenozide, cyazofamid, dicamba, difenoconazole, fenpyrazamine, fluazinam, formetanate, nicotine, penconazole, pymetrozine, pyraclostrobin, tau-fluvalinate and tebuconazole in or on certain products Text with EEA relevance
Commission Regulation (EU) 2015/401 of 25 February 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 acetamiprid, chromafenozide, cyazofamid, dicamba, difenoconazole, fenpyrazamine, fluazinam, formetanate, nicotine, penconazole, pymetrozine, pyraclostrobin, tau-fluvalinate and tebuconazole in or on certain products Text with EEA relevance
OJ L 71, 14.3.2015, p. 114–156
(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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14.3.2015 |
EN |
Official Journal of the European Union |
L 71/114 |
COMMISSION REGULATION (EU) 2015/401
of 25 February 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 acetamiprid, chromafenozide, cyazofamid, dicamba, difenoconazole, fenpyrazamine, fluazinam, formetanate, nicotine, penconazole, pymetrozine, pyraclostrobin, tau-fluvalinate and tebuconazole 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) thereof,
Whereas:
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(1) |
For acetamiprid, cyazofamid, formetanate, pymetrozine, pyraclostrobin and tebuconazole maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. For penconazole MRLs were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For chromafenozide, dicamba, difenoconazole, fenpyrazamine, fluazinam, nicotine and tau-fluvalinate MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. |
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(2) |
In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance chromafenozide on pome fruit and grapes, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. |
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(3) |
As regards cyazofamid, such an application was made for grapes. As regards difenoconazole, such an application was made for peppers and aubergines. As regards fenpyrazamine, such an application was made for apricots, cherries, peaches and plums. As regards formetanate, such an application was made for strawberries. As regards penconazole, such an application was made for blackberries and raspberries. As regards pymetrozine, such an application was made for azarole. As regards pyraclostrobin, such an application was made for chicory roots. As regards tau-fluvalinate, such an application was made for pome fruits, peaches, apricots, grapes, tomatoes, aubergines, melons, broccoli, Brussels sprouts, kohlrabi, globe artichokes, lettuce and other salad plants. As regards tebuconazole, such an application was made for poppy seed. |
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(4) |
In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for acetamiprid on apricots and tree nuts. The applicant claims that the authorised uses of that substance on such crops in the United States lead to residues exceeding the MRLs in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops. |
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(5) |
Such applications were also submitted as regards dicamba on genetically modified soya bean and as regards fluazinam on ginseng root. The applicants claim that the authorised uses of those substances on such crops in the United States lead to residues exceeding the MRLs in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops. |
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(6) |
In accordance with Article 8 of Regulation (EC) No 396/2005 these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. |
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(7) |
The European Food Safety Authority, hereinafter ‘the Authority’, assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded these opinions to the Commission and the Member States and made them available to the public. |
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(8) |
The Authority concluded in its reasoned opinions that, as regards the use of fenpyrazamine on peaches, no modification of the existing MRL is required. As regards the use of tau-fluvalinate on pome fruit, apricots, peaches and tomatoes, the submitted data were not sufficient to set new MRLs. The existing MRLs should therefore remain unchanged. |
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(9) |
As regards dicamba, no residues were detected at harvest in dicamba-tolerant soya bean. The Authority concluded that the relevant component of the residues identified in dicamba-tolerant soya bean was the metabolite 3,6-dichlorosalicylic acid (DCSA). |
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(10) |
As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It 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 crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. |
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(11) |
As regards nicotine, by Commission Regulation (EU) No 897/2012 (3) temporary MRLs were set for wild mushrooms until 30 November 2014 pursuant to Article 16(1)(a) of Regulation (EC) No 396/2005, pending the submission and evaluation of new data and information on the natural occurrence or formation of nicotine in the concerned products. The Commission was informed of a research project which is being carried out to investigate on the sources of nicotine occurring in those crops. In view of the expected duration of the study and in order to provide the necessary time for the Commission to take its decision, it is appropriate to extend the validity of these MRLs until 19 October 2016. |
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(12) |
As regards formetanate, several MRLs were modified by Commission Regulation (EU) No 61/2014 (4). That Regulation lowers the MRL for strawberries to the limit of determination as of 14 August 2014. In the interest of legal certainty, it is appropriate for the MRL provided for by this Regulation, to apply from the same date. |
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(13) |
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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(14) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(15) |
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
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 November 2014. However, it shall apply from 14 August 2014 for the MRL for formetanate in strawberries.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 February 2015.
For the Commission
The President
Jean-Claude JUNCKER
(2) EFSA scientific reports available online: http://www.efsa.europa.eu:
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Reasoned opinion on the modification of the existing maximum residue level (MRL) for acetamiprid in apricots and tree nuts. EFSA Journal 2013;11(12):3506 [30 pp.]. doi:10,2903/j.efsa.2013.3506. |
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Reasoned opinion on the modification of the existing MRLs for chromafenozide in pome fruits and grapes. EFSA Journal 2014;12(2):3569 [25 pp.]. doi:10,2903/j.efsa.2014.3569. |
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Reasoned opinion on the modification of the existing MRLs for cyazofamid in grapes. EFSA Journal 2013;11(10):3402 [23 pp.]. doi:10,2903/j.efsa.2013.3402. |
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Reasoned opinion on the modification of the MRL for dicamba in genetically modified soybean. EFSA Journal 2013;11(10):3440 [38 pp.]. doi:10,2903/j.efsa.2013.3440, |
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Reasoned opinion on the modification of the existing MRLs for difenoconazole in peppers and aubergines. EFSA Journal 2014;12(4):3676 [27 pp.]. doi:10,2903/j.efsa.2014.3676. |
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Reasoned opinion on the modification of the existing MRLs for fenpyrazamine in apricots, cherries, peaches and plums. EFSA Journal 2014;12(3):3619 [25 pp.]. doi:10,2903/j.efsa.2014.3619. |
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Reasoned opinion on modification of the existing MRL for fluazinam in ginseng root. EFSA Journal 2014;12(5):3690 [20 pp.]. doi:10,2903/j.efsa.2014.3690, |
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Reasoned Opinion on the modification of the existing MRL for formetanate in strawberries. EFSA Journal 2014;12(3):3596 [23 pp.]. doi:10,2903/j.efsa.2014.3596. |
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Reasoned opinion on the setting of new MRLs for penconazole in blackberries and raspberries. EFSA Journal 2014;12(3):3618 [24 pp.]. doi:10,2903/j.efsa.2014.3618. |
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Reasoned opinion on the modification of the existing MRLs for pymetrozine in azaroles, celery and fennel. EFSA Journal 2013;11(8):3348 [27 pp.]. doi:10,2903/j.efsa.2013.3348. |
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Reasoned opinion on the modification of the existing MRL for pyraclostrobin in chicory roots. EFSA Journal 2014;12(5):3685 [23 pp.]. doi:10,2903/j.efsa.2014.3685. |
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Reasoned opinion on the modification of the existing MRLs for tau-fluvalinate in various crops. EFSA Journal 2014;12(1):3548 [49 pp.]. doi:10,2903/j.efsa.2014.3548. |
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Reasoned opinion on the modification of the existing MRL for tebuconazole in poppy seed. EFSA Journal 2013;11(5):3248 [31 pp.]. doi:10,2903/j.efsa.2013.3248. |
(3) Commission Regulation (EU) No 897/2012 of 1 October 2012 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 acibenzolar-S-methyl, amisulbrom, cyazofamid, diflufenican, dimoxystrobin, methoxyfenozide and nicotine in or on certain products (OJ L 266, 2.10,2012, p. 1).
(4) Commission Regulation (EU) No 61/2014 of 24 January 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 cyromazine, fenpropidin, formetanate, oxamyl and tebuconazole in or on certain products (OJ L 22, 25.1.2014, p. 1).
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
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(1) |
In Annex II, the columns for acetamiprid, cyazofamid, formetanate, penconazole, pymetrozine, pyraclostrobin and tebuconazole are replaced by the following: ‘Pesticide residues and maximum residue levels (mg/kg)
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(2) |
Annex III is amended as follows:
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(1) Indicates lower limit of analytical determination
(2) Pesticide-code combination for which the MRL as set in Annex III Part B applies.
(3) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
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(F) |
= |
Fat soluble |
Acetamiprid (R)
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(R) |
= |
The residue definition differs for the following combinations pesticide-code number: Acetamiprid — code 1000000 except 1040000: Sum of acetamiprid and N-desmethyl-acetamiprid (IM-2-1), expressed as acetamiprid |
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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 5 February 2016, or, if that information is not submitted by that date, the lack of it.
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Cyazofamid
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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 23 April 2016, 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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Formetanate: Sum of formetanate and its salts expressed as formetanate(hydrochloride)
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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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Pymetrozine (A) (R)
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(A) |
= |
The EU reference labs identified the reference standards for 6-hydroxymethylpymetrozine and its phosphate conjugate as commercially not available. When re-viewing the MRL, the Commission will take into account the commercial availability of the reference standards referred to in the first sentence by 23 April 2015, or, if those reference standards are not commercially available by that date, the unavailability of them. |
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(R) |
= |
The residue definition differs for the following combinations pesticide-code number: Pymetrozine — code 1020000: pymetrozine, 6-hydroxymethylpymetrozine and its phosphate conjugate, expressed as pymetrozine |
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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 23 April 2016, 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 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 23 April 2016, 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 23 April 2016, 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 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 23 April 2016, 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 23 April 2016, 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 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 23 April 2016, 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 23 April 2016, 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 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 23 April 2016, 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 23 April 2016, 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 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 23 April 2016, 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 23 April 2016, 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 23 April 2016, 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 23 April 2016, or, if that information is not submitted by that date, the lack of it.
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Pyraclostrobin (F)
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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 13 July 2015, 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 13 July 2015, 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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Tebuconazole (R)
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(R) |
= |
The residue definition differs for the following combinations pesticide-code number: tebuconazole-code 1000000 except 1040000: sum of tebuconazole, hydroxy-tebuconazole, and their conjugates, expressed as tebuconazole |
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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 25 January 2016, 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 25 January 2016, or, if that information is not submitted by that date, the lack of it.
|
|
(+) |
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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(4) Indicates lower limit of analytical determination
(5) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
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(F) |
= |
Fat soluble |
Chromafenozide
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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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Dicamba
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(+) |
The following MRL applies to dicamba-tolerant soya bean: 0,4 mg/kg of 3,6-dichloro-salicylic acid (DCSA) and its conjugates, expressed as DCSA.
|
|
(+) |
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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Difenoconazole
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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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Fenpyrazamine
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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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Fluazinam (F)
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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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Nicotine
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(+) |
Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.
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(+) |
The following MRLs apply to dried wild mushrooms: 2.3 mg/kg for ceps, 1.2 mg/kg for dried wild mushrooms other than ceps. Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.
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|
(+) |
Scientific evidence is not conclusive to demonstrate that nicotine occurs naturally in the concerned crop and to elucidate its mechanism of formation. When re-viewing the MRL, the Commission will take into account the information, if it is submitted by 19 October 2016, or, if that information is not submitted by that date, the lack of it.
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Tau-Fluvalinate (F)
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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.
|
(6) Indicates lower limit of analytical determination
(7) 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 |
Penconazole (F)
|
(+) |
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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