委员会条例(EU) 2016/567，就某些产品内外含有氯虫苯甲酰胺、丁氟螨酯、嘧菌环胺、烯酰吗啉、二硫代氨基甲酸酯、咪唑菌酮、氟吡菌酰胺、氟酰胺、咪草啶酸、苯菌酮、腈菌唑、丙环唑、 氟唑环菌胺和螺螨酯的最大残留量，修订欧洲议会和理事会条例(EC) No 396/2005 的附件II和II
技术法规类型：欧盟Eurlex法规 来源：tbtmap
EURLEX ID：32016R0567
OJ编号：OJ L 100, 15.4.2016, p. 1-60
中文标题：委员会条例(EU) 2016/567，就某些产品内外含有氯虫苯甲酰胺、丁氟螨酯、嘧菌环胺、烯酰吗啉、二硫代氨基甲酸酯、咪唑菌酮、氟吡菌酰胺、氟酰胺、咪草啶酸、苯菌酮、腈菌唑、丙环唑、 氟唑环菌胺和螺螨酯的最大残留量，修订欧洲议会和理事会条例(EC) No 396/2005 的附件II和III
原文标题：Commission Regulation (EU) 2016/567 of 6 April 2016 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 chlorantraniliprole, cyflumetofen, cyprodinil, dimethomorph, dithiocarbamates, fenamidone, fluopyram, flutolanil, imazamox, metrafenone, myclobutanil, propiconazole, sedaxane and spirodiclofen in or on certain products (Text with EEA relevance)
分类：03.50.20_植物健康;13.30.14_食品
文件类型：二级立法 Regulation|条例
生效日期：2016-05-05
废止日期：2058-12-31
法规全文：查看欧盟官方文件
| 15.4.2016 | EN | Official Journal of the European Union | L 100/1 |
COMMISSION REGULATION (EU) 2016/567
of 6 April 2016
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 chlorantraniliprole, cyflumetofen, cyprodinil, dimethomorph, dithiocarbamates, fenamidone, fluopyram, flutolanil, imazamox, metrafenone, myclobutanil, propiconazole, sedaxane and spirodiclofen 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:
| (1) | On 18 July 2014, Codex Alimentarius Commission (CAC) adopted Codex maximum residue limits (CXLs) for cyprodinil and flutolanil (2). On 11 July 2015, CAC adopted CXLs for aminocyclopyrachlor, benzovindiflupyr, buprofezin, chlorantraniliprole, clothianidin, cyflumetofen, dichlobenil, dimethomorph, dithiocarbamates, emamectin benzoate, fenamidone, fenpropathrin, fluensulfone, flufenoxuron, fluopyram, glufosinate-ammonium, imazamox, mesotrione, metrafenone, myclobutanil, phosmet, propamocarb, propiconazole, prothioconazole, pyraclostrobin, sedaxane, spirodiclofen, thiamethoxam, triadimefon, triadimenol and triforine (3). |
| (2) | Maximum residue levels (MRLs) are set for those substances in Regulation (EC) No 396/2005 except for cyflumetofen and sedaxane. As cyflumetofen and sedaxane are not included in Annex IV to Regulation (EC) No 396/2005, the default value of 0,01 mg/kg laid down in Article 18(1)(b) applies. |
| (3) | In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4), where international standards exist or their completion is imminent, they are to be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or where there is a scientific justification, or where they would result in a different level of protection from the one determined as appropriate in the Union. Moreover, in accordance with point (e) of Article 13 of that Regulation, the Union is to promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Union is not reduced. |
| (4) | The Union presented a reservation to the Codex Committee on Pesticides Residues (CCPR) on the CXLs proposed for the following pesticide/product combinations: aminocyclopyrachlor (all products); benzovindiflupyr (all products); buprofezin (coffee beans); cyprodinil (berries and other small fruits; brassica leafy vegetables; mammalian edible offal; fruiting vegetables other than cucurbits); dichlobenil (all products); dimethomorph (shelled beans; fruiting vegetables other than cucurbits); dithiocarbamates (cumin seed); fenamidone (flowerhead brassicas; fruiting vegetables other than cucurbits); fenpropathrin (all products); fluensulfone (all products); flufenoxuron (all products); flutolanil (brassica leafy vegetables); myclobutanil (peaches; peppers); propamocarb (leek); prothioconazole (bush berries; cucurbits); pyraclostrobin (peaches) and triforine (all products). |
| (5) | CXLs for chlorantraniliprole, cyflumetofen, cyprodinil, dimethomorph, dithiocarbamates, fenamidone, fluopyram, flutolanil, imazamox, metrafenone, myclobutanil, propiconazole, sedaxane and spirodiclofen, which are not listed in recital 4, should therefore be included in Regulation (EC) No 396/2005 as MRLs except where they relate to products which are not set out in Annex I to that Regulation or where they are set at a lower level than the current MRLs. Those CXLs are safe for consumers in the Union (5). |
| (6) | As regards clothianidin and thiamethoxam, it is appropriate to take the relevant CXLs into account separately, by considering an amendment to Commission Regulation (EU) 2016/156 (6). As regards mesotrione, it is appropriate to take the relevant CXLs into account separately, by considering an amendment to Commission Regulation (EU) 2016/53 (7). The MRLs for those substances are therefore not modified by the present Regulation. |
| (7) | In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance chlorantraniliprole on cauliflower and ‘other flowering brassica’ of code number 0241990, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. |
| (8) | In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an application was submitted for chlorantraniliprole used on pomegranate, beans (with pods), peas (with pods), globe artichokes, peanuts and hops. The applicant claims that the authorised uses of that substance on such crops in the United States lead to residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that higher MRLs are necessary to avoid trade barriers for the importation of those crops. |
| (9) | In accordance with Article 8 of Regulation (EC) No 396/2005, those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. |
| (10) | 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 a reasoned opinion on the proposed MRLs (8). It forwarded that opinion to the Commission and the Member States and made it available to the public. |
| (11) | The Authority concluded in its reasoned opinion that, as regards the use of chlorantraniliprole on peanuts and hops, the submitted data were not sufficient to set new MRLs. The existing MRLs should therefore be kept. |
| (12) | As regards the other uses covered by the 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 or the acute reference dose is exceeded. |
| (13) | Based on the reasoned opinion 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. |
| (14) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| (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 twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 6 April 2016.
For the Commission
The President
Jean-Claude JUNCKER
(2) http://www.codexalimentarius.org/download/report/917/REP14_PRe.pdf
Joint FAO/WHO food standards programme Codex Alimentarius Commission. Appendices II and III. 37th Session. Geneva, Switzerland, 14-18 July 2014.
(3) ftp://ftp.fao.org/codex/reports/reports_2015/REP15_PRe.pdf
Joint FAO/WHO food standards programme Codex Alimentarius Commission. Appendices III and IV. 38th Session. Geneva, Switzerland, 6-11 July 2015.
(4) 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).
(5) Scientific support for preparing an EU position for the 46th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2014;12(7):3737 [182 pp.].
(6) Commission Regulation (EU) 2016/156 of 18 January 2016 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 boscalid, clothianidin, thiamethoxam, folpet and tolclofos-methyl in or on certain products (OJ L 31, 6.2.2016, p. 1).
(7) Commission Regulation (EU) 2016/53 of 19 January 2016 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 diethofencarb, mesotrione, metosulam and pirimiphos-methyl in or on certain products (OJ L 13, 20.1.2016, p. 12).
(8) EFSA scientific reports available online: http://www.efsa.europa.eu:
Reasoned opinion on the modification of the existing maximum residue levels for chlorantraniliprole in various crops. EFSA Journal 2015;13(9):4216 [23 pp.].
ANNEX
Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:
| (1) | in Annex II, the columns for cyprodinil, dimethomorph, fenamidone, flutolanil, imazamox, metrafenone, myclobutanil and propiconazole are replaced by the following: ‘Pesticide residues and maximum residue levels (mg/kg)
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (2) | Annex III is amended as follows:
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(*) Indicates lower limit of analytical determination
(**) Pesticide-code combination for which the MRL as set in Annex III Part B applies.
(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 |
Cyprodinil (F) (R)
| (R) | = | The residue definition differs for the following combinations pesticide-code number: Cyprodinil — code 1000000 except 1020000, 1040000: Cyprodinil (sum of cyprodinil and CGA 304072 (free), expressed as cyprodinil) Cyprodinil — 1020000: Cyprodinil (Sum of cyprodinil and CGA 304072 (free and conjugated), expressed as cyprodinil) |
| (+) | The European Food Safety Authority identified some information on analytical and/or confirmatory 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 14 March 2017, 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.
|
| (+) | The European Food Safety Authority identified some information on analytical and/or confirmatory 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 14 March 2017, or, if that information is not submitted by that date, the lack of it.
|
Dimethomorph (sum of isomers)
| (+) | 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.
|
| (+) | 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.
|
Fenamidone
| (+) | The following MRL applies to Chilli peppers: 4 mg/kg.
|
Flutolanil (R)
| (R) | = | The residue definition differs for the following combinations pesticide-code number: code 1000000 except 1040000: Flutolanil (Flutolanil and metabolites containing the 2-trifluoromethylbenzoic acid moiety, expressed as flutolanil) |
| (+) | 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 17 April 2017, 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.
|
| (+) | The European Food Safety Authority identified some information on analytical methods 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 17 April 2017, 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, storage stability and metabolism in ruminants 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 17 April 2017, 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 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 17 April 2017, 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, storage stability and metabolism in ruminants 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 17 April 2017, 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 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 17 April 2017, or, if that information is not submitted by that date, the lack of it.
|
Imazamox (Sum of imazamox and its salts, expressed as imazamox)
| (+) | The European Food Safety Authority identified some information on plant metabolism with imazamox labelled at the imidazolinone ring 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 29 October 2016, 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 and plant metabolism studies with imazamox labelled at the imidazolinone ring 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 29 October 2016, or, if that information is not submitted by that date, the lack of it.
|
| (+) | The European Food Safety Authority identified some information on plant metabolism with imazamox labelled at the imidazolinone ring 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 29 October 2016, 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 and plant metabolism with imazamox labelled at the imidazolinone ring 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 29 October 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.
|
Metrafenone
| (+) | 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.
|
Myclobutanyl (R)
| (R) | = | The residue definition differs for the following combinations pesticide-code number: Myclobutanyl — code 1000000 except 1040000: Alpha-(3-hydroxybutyl) — alpha — (4-chloro-phenyl) — 1H — 1,2,4 — triazole -1-propanenitrile (RH9090) expressed as myclobutanil’ |
(***) Indicates lower limit of analytical determination
(2) 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 |
Chlorantraniliprole (DPX E-2Y45) (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.
|
Fluopyram (R)
| (R) | = | The residue definition differs for the following combinations pesticide-code number: Fluopyram — code 1000000 except 1040000: sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram |
| (+) | 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.
|
| (+) | 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.
|
| (+) | 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.
|
(****) Indicates lower 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.’
(*****) Indicates lower limit of analytical determination
(4) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram)
In brackets the origin of the residue (ma: maneb; mz: mancozeb; me: metiram; pr: propineb; t: thiram; z: ziram).
The MRLs expressed as CS2 can arise from different dithiocarbamates and therefore they do not reflect a single Good Agricultural Practice (GAP). It is therefore not appropriate to use these MRLs to check compliance with a GAP.
| (+) | (ma, mz, me, pr, t, z)
|
| (+) | (mz, me, t)
|
| (+) | (mz, me)
|
| (+) | (mz)
|
| (+) | 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.
|
Myclobutanyl (R)
| (R) | = | The residue definition differs for the following combinations pesticide-code number: Myclobutanyl — code 1000000 except 1040000: Alpha-(3-hydroxybutyl) — alpha — (4-chloro-phenyl) — 1H — 1,2,4 — triazole -1-propanenitrile (RH9090) expressed as myclobutanil |
Propiconazole
| (+) | 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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