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Document 32015R0552
Commission Regulation (EU) 2015/552 of 7 April 2015 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 1,3-dichloropropene, bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products Text with EEA relevance
Commission Regulation (EU) 2015/552 of 7 April 2015 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 1,3-dichloropropene, bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products Text with EEA relevance
Commission Regulation (EU) 2015/552 of 7 April 2015 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 1,3-dichloropropene, bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin in or on certain products Text with EEA relevance
IO L 92, 8.4.2015, p. 20–85
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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- Date of document:
- 07/04/2015
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- 28/04/2015; Teacht i bhfeidhm Dáta foilsithe +20 Féach Airt. 3
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- An Coimisiún Eorpach
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- Rialachán
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- Ábharthacht maidir le LEE
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- An Conradh ar Fheidhmiú an Aontais Eorpaigh
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- 32005R0396 - A14P1PTA) 32005R0396 - A18P1PTB) 32005R0396 - A49P2
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Relation Act Comment Subdivision concerned From To Modifies 32005R0396 Leasú iarscríbhinn V 28/04/2015 Modifies 32005R0396 Leasú iarscríbhinn III 28/04/2015 Modifies 32005R0396 Leasú iarscríbhinn II 28/04/2015
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Relation Act Comment Subdivision concerned From To Corrected by 32015R0552R(01) (BG, CS, DA, DE, EL, EN, ES, ET, FI, FR, HU, IT, LT, LV, MT, NL, PL, PT, RO, SK, SL, SV, HR) - Instruments cited:
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8.4.2015 |
EN |
Official Journal of the European Union |
L 92/20 |
COMMISSION REGULATION (EU) 2015/552
of 7 April 2015
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 1,3-dichloropropene, bifenox, dimethenamid-P, prohexadione, tolylfluanid and trifluralin 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), Article 18(1)(b) and Article 49(2) thereof,
Whereas:
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(1) |
For dimethenamid-P and prohexadione, maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. For 1,3-dichloropropene and bifenox, MRLs were set in Part A of Annex III to that Regulation. For tolylfluanid and trifluralin, MRLs were set in Annex V to that Regulation. |
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(2) |
The non-inclusion of 1,3-dichloropropene in Annex I to Council Directive 91/414/EEC (2) is provided for in Commission Decision 2011/36/EU (3). All existing authorisations for plant protection products containing the active substance 1,3-dichloropropene have been revoked. In accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1) thereof the MRLs set out for that active substance in Annex III should therefore be deleted. This should not apply to those MRLs corresponding to CXLs based on uses in third countries provided that they are acceptable with regard to consumer safety. Nor should it apply in cases where MRLs have been specifically set as import tolerances. |
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(3) |
For bifenox, the European Food Safety Authority, hereinafter ‘the Authority’ submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (4). It recommended lowering the MRLs for barley grain, oats grain, rye grain and wheat grain. It concluded that concerning the MRLs for sunflower seed and rape seed some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. Those MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRLs for swine (meat, fat, liver, kidney), bovine (meat, fat, liver, kidney), sheep (meat, fat, liver, kidney), goat (meat, fat, liver, kidney), and milk (cattle, sheep, goat) no information was available and that further consideration by risk managers was required. The MRLs for these commodities should be set at the specific limit of determination or at the default MRL as set out in Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(4) |
For dimethenamid-P, 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 (5). It proposed to change the residue definition. It recommended lowering the MRLs for peanuts, sunflower seed, rape seed, soya bean, pumpkin seeds and sugar beet (root). For other products it recommended keeping the existing MRLs. It concluded that concerning the MRLs for spring onions, lettuce and herbs 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. Those 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) |
For prohexadione, 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 (6). It recommended lowering the MRLs for table and wine grapes, strawberries, cane fruit, other small fruit and berries, barley, wheat, hops, swine (meat, fat, liver, kidney), bovine (meat, fat, liver, kidney), sheep (meat, fat, liver, kidney) and goat (meat, fat, liver, kidney). For other products it recommended raising or keeping the existing MRLs. |
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(6) |
The removal of tolylfluanid from Annex I to Directive 91/414/EEC is provided for in Commission Directive 2010/20/EU (7). All existing authorisations for plant protection products containing the active substance tolylfluanid have been revoked. |
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(7) |
For tolylfluanid, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (8). It proposed to change the residue definition. It concluded that further consideration by risk managers was required. Taking into account the current scientific and technical knowledge, MRLs should be set at the specific limit of determination or at the default MRL in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(8) |
The non-inclusion of trifluralin in Annex I to Directive 91/414/EEC is provided for in Commission Decision 2010/355/EU (9). All existing authorisations for plant protection products containing the active substance trifluralin have been revoked. |
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(9) |
For trifluralin, the Authority submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (10). Taking into account the current scientific and technical knowledge, MRLs for those products should be set at the specific limit of determination or at the default MRL in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(10) |
As regards products of plant and animal origin for which neither relevant authorisations or import tolerances were reported at Union level nor CXLs were available, the Authority concluded that further consideration by risk managers was required. Taking into account the current scientific and technical knowledge, MRLs for those products should be set at the specific limit of determination or at the default MRL in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. |
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(11) |
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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(12) |
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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(13) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(14) |
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 lawfully produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained. |
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(15) |
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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(16) |
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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(17) |
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 accordance 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 lawfully produced before 28 April 2015.
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 28 October 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 April 2015.
For the Commission
The President
Jean-Claude JUNCKER
(2) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).
(3) Commission Decision 2011/36/EU of 20 January 2011 concerning the non-inclusion of 1,3-dichloropropene in Annex I to Council Directive 91/414/EEC (OJ L 18, 21.1.2011, p. 42).
(4) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for bifenox according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(4):3215. (36 pp.).
(5) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for dimethenamid-P according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(4):3216. (53 pp.).
(6) European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for prohexadione according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(4):3192. (36 pp.).
(7) Commission Directive 2010/20/EU of 9 March 2010 amending Council Directive 91/414/EEC to remove tolylfluanid as active substance and on the withdrawal of authorisations for plant protection products containing that substance (OJ L 60, 10.3.2010, p. 20).
(8) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for tolylfluanid according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(7):3300. (37 pp.).
(9) Commission Decision 2010/355/EU of 25 June 2010 concerning the non-inclusion of trifluralin in Annex I to Council Directive 91/414/EEC (OJ L 160, 26.6.2010, p. 30).
(10) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels (MRLs) for trifluralin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2013;11(4):3193. (16 pp.).
ANNEX
Annexes II, III and V 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) |
In Annex III, the columns for dimethenamid-P, prohexadione, 1,3-dichloropropene and bifenox are deleted. |
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(3) |
Annex V is amended as follows:
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(1) Indicates lower limit of analytical determination
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(**) |
Pesticide-code combination for which the MRL as set in Annex III Part B applies. |
Dimethenamid including other mixtures of constituent isomers including dimethenamid-P (sum of isomers)
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(+) |
The European Food Safety Authority identified some information on plant metabolism 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 8 April 2017, 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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Prohexadione (prohexadione (acid) and its salts expressed as prohexadione-calcium)
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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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(2) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
Dimethenamid including other mixtures of constituent isomers including dimethenamid-P (sum of isomers)
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(+) |
The European Food Safety Authority identified some information on plant metabolism 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 8 April 2017, 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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Prohexadione (prohexadione (acid) and its salts expressed as prohexadione-calcium)
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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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(3) Indicates lower limit of analytical determination
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(**) |
Pesticide-code combination for which the MRL as set in Annex III Part B applies. |
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(F) |
= |
Fat soluble |
Bifenox (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 8 April 2017, 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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(4) 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 |
Bifenox (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 8 April 2017, 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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(5) Indicates lower limit of analytical determination
(6) 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 |
Tolylfluanid (Sum of tolylfluanid and dimethylaminosulfotoluidide expressed as tolylfluanid) (F) (R)
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(R) |
= |
The residue definition differs for the following combinations pesticide-code number: |
Tolylfluanid — code 1000000 except 1040000: Dimethylaminosulfotoluidide
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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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Trifluralin
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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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(7) Indicates lower limit of analytical determination
(8) 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 |
1,3-Dichloropropene
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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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