Date: 2018-10-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2018/1515 of 10 October 2018 amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diphenylamine and oxadixyl in or on certain products (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Regulation (EU) 2018/1515 amends Regulation (EC) No 396/2005 regarding maximum residue levels (MRLs) for diphenylamine and oxadixyl. This amendment deletes existing MRLs for these substances in Annex III and sets new MRLs at the limit of determination (LOD) in Annex V due to the non-approval/non-inclusion of these active substances. The regulation takes effect on May 1, 2019, but includes a transitional arrangement for products produced or imported before this date.
Key Points / Main Content:
Maximum Residue Levels (MRLs) Amendment:
* Annex III of Regulation (EC) No 396/2005 is amended to delete the columns for diphenylamine and oxadixyl.
* Annex V of Regulation (EC) No 396/2005 is amended to add columns for diphenylamine and oxadixyl, setting MRLs at the limit of determination (LOD).
* MRL for diphenylamine is set at 0.05 mg/kg for various product groups.
* MRL for oxadixyl is set at 0.01 or 0.02 mg/kg for various product groups, depending on the commodity.
Justification for Amendment:
* Diphenylamine was not approved by Commission Implementing Regulation (EU) No 578/2012.
* Oxadixyl was not included in Annex I to Directive 91/414/EEC by Commission Regulation (EC) No 2076/2002.
* All existing authorizations for plant protection products containing these active substances have been revoked.
* Recent monitoring data indicates that residues of diphenylamine and oxadixyl no longer occur at levels above the relevant LOD.
Transitional Arrangement:
* Regulation (EC) No 396/2005, as it stood before this amendment, remains applicable to products produced in the Union or imported into the Union before May 1, 2019.
Effective Date:
* This Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
* It applies from May 1, 2019.
Impact Analysis:
Member States:
* Impact: Must prepare to meet new requirements resulting from the modification of MRLs.
* Action Required: Ensure compliance with the amended MRLs from May 1, 2019.
Third Countries:
* Impact: Must comply with the amended MRLs for products exported to the Union.
* Action Required: Ensure compliance with the amended MRLs from May 1, 2019.
Food Business Operators:
* Impact: Must ensure that products placed on the market comply with the new MRLs.
* Action Required: Ensure compliance with the amended MRLs from May 1, 2019; adhere to transitional arrangement for products produced/imported before May 1, 2019.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Parliament: One of the legislative bodies of the European Union.
Council Directive 91/414/EEC: A former directive of the European Council concerning the placing of plant protection products on the market.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EC No 396/2005: A regulation of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin.
diphenylamine: An active substance, formerly used in plant protection products, for which maximum residue levels (MRLs) are being modified.
oxadixyl: An active substance, formerly used in plant protection products, for which maximum residue levels (MRLs) are being modified.
Brussels: The city where the regulation was done.
12.10.2018 EN Official Journal of the European Union L 256/33
COMMISSION REGULATION (EU) 2018/1515
of 10 October 2018
amending Annexes III and V to Regulation (EC) No 396/2005 of the European Parliament and of
the Council as regards maximum residue levels for diphenylamine and oxadixyl 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:
(1) For diphenylamine and oxadixyl, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation
(EC) No 396/2005.
(2) The active substance diphenylamine was not approved by Commission Implementing Regulation (EU)
No 578/2012 (2). The active substance oxadixyl was not included in Annex I to Directive 91/414/EEC by
Commission Regulation (EC) No 2076/2002 (3). All existing authorisations for plant protection products
containing these active substances have been revoked. It is therefore appropriate to delete the existing MRLs set
out for these substances in Annex III in accordance with Article 17 of Regulation (EC) No 396/2005 in
conjunction with Article 14(1)(a) thereof.
(3) For diphenylamine temporary MRLs were set by Regulation (EU) No 772/2013 (4) for apples and pears until
2 September 2015, to address an unavoidable cross-contamination that affected untreated apples and pears and
which was due to the presence of residues of diphenylamine in storage facilities. Commission Regulation
(EU) 2016/67 (5) extended the validity of those MRLs until 22 January 2018 to provide the necessary time for
business operators to completely remove the residues of diphenylamine in storage facilities. The European Food
Safety Authority (‘the Authority’) and food business operators submitted recent monitoring data showing that
residues of diphenylamine no longer occur at levels above the relevant limit of determination (LOD).
(4) For oxadixyl temporary MRLs were set by Regulation (EU) No 592/2012 (6) for parsley, celeries and the group of
lettuces and salad plants until 31 December 2014, to address an unavoidable cross-contamination that affected
untreated crops and which was due to the presence of residues of oxadixyl in soil. Commission Regulation
(EU) 2016/46 (7) extended the validity of those MRLs until 19 January 2018 in view of the persistence of that
active substance in soil. The Authority and food business operators submitted recent monitoring data showing
that residues of oxadixyl no longer occur at levels above the relevant LOD.
(1) OJ L 70, 16.3.2005, p. 1.
(2) Commission Implementing Regulation (EU) No 578/2012 of 29 June 2012 concerning the non approval of the active substance
diphenylamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the
placing of plant protection products on the market (OJ L 171, 30.6.2012, p. 2).
(3) Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council
Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of
authorisations for plant protection products containing these substances (OJ L 319, 23.11.2002, p. 3).
(4) Commission Regulation (EU) No 772/2013 of 8 August 2013 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 diphenylamine in or on certain products (OJ L 217,
13.8.2013, p. 1).
(5) Commission Regulation (EU) 2016/67 of 19 January 2016 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 ametoctradin, chlorothalonil, diphenylamine,
flonicamid, fluazinam, fluoxastrobin, halauxifen-methyl, propamocarb, prothioconazole, thiacloprid and trifloxystrobin in or on
certain products (OJ L 15, 22.1.2016, p. 2).
(6) Commission Regulation (EU) No 592/2012 of 4 July 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 bifenazate, captan, cyprodinil, fluopicolide, hexythiazox,
isoprothiolane, metaldehyde, oxadixyl and phosmet in or on certain products (OJ L 176, 6.7.2012, p. 1).
(7) Commission Regulation (EU) 2016/46 of 18 January 2016 amending Annex III to Regulation (EC) No 396/2005 of the European
Parliament and of the Council as regards maximum residue levels for oxadixyl and spinetoram in or on certain products (OJ L 12,
19.1.2016, p. 28).L 256/34 EN Official Journal of the European Union 12.10.2018
(5) In view of the non-approval of the active substance diphenylamine and the non-inclusion of the active substance
oxadixyl in Annex I to Directive 91/414/EEC, the MRLs for these substances should be set at the LOD in
accordance with Article 18 of Regulation (EC) No 396/2005. For the active substances for which all MRLs
should be reduced to the relevant LOD, default values should be listed in Annex V in accordance with
Article 18(1)(b) of Regulation (EC) No 396/2005.
(6) 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.
(7) Regulation (EC) No 396/2005 should therefore be amended accordingly.
(8) 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.
(9) 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.
(10) 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 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 produced in the Union or imported into the Union before 1 May 2019.
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 1 May 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 October 2018.
For the Commission
The President
Jean-Claude JUNCKERANNEX
Annexes III and V to Regulation (EC) No 396/2005 are amended as follows:
(1) in Part A of Annex III, the columns for diphenylamine and oxadixyl are deleted;
(2) in Annex V, the columns for diphenylamine and oxadixyl are added:
‘Pesticide residues and maximum residue levels (mg/kg)
Code
Groups and examples of individual products to which the MRLs apply(a)
number
enimalynehpiD
lyxidaxO
12.10.2018 EN Official Journal of the European Union L 256/35
(1) (2) (3) (4)
0100000 FRUITS, FRESH or FROZEN; TREE NUTS 0,05(*) 0,01(*)
0110000 Citrus fruits
0110010 Grapefruits
0110020 Oranges
0110030 Lemons
0110040 Limes
0110050 Mandarins
0110990 Others (2)
0120000 Tree nuts
0120010 Almonds
0120020 Brazil nuts
0120030 Cashew nuts
0120040 Chestnuts
0120050 Coconuts
0120060 Hazelnuts/cobnuts
0120070 Macadamias
0120080 Pecans
0120090 Pine nut kernels
0120100 Pistachios
0120110 Walnuts
0120990 Others (2)
0130000 Pome fruits
0130010 Apples
0130020 Pears
0130030 Quinces
0130040 Medlars
0130050 Loquats/Japanese medlars
0130990 Others (2)
0140000 Stone fruits
0140010 Apricots
0140020 Cherries (sweet)
0140030 Peaches
0140040 Plums
0140990 Others (2)L 256/36 EN Official Journal of the European Union 12.10.2018
(1) (2) (3) (4)
0150000 Berries and small fruits
0151000 (a) grapes
0151010 Table grapes
0151020 Wine grapes
0152000 (b) strawberries
0153000 (c) cane fruits
0153010 Blackberries
0153020 Dewberries
0153030 Raspberries (red and yellow)
0153990 Others (2)
0154000 (d) other small fruits and berries
0154010 Blueberries
0154020 Cranberries
0154030 Currants (black, red and white)
0154040 Gooseberries (green, red and yellow)
0154050 Rose hips
0154060 Mulberries (black and white)
0154070 Azaroles/Mediterranean medlars
0154080 Elderberries
0154990 Others (2)
0160000 Miscellaneous fruits with
0161000 (a) edible peel
0161010 Dates
0161020 Figs
0161030 Table olives
0161040 Kumquats
0161050 Carambolas
0161060 Kaki/Japanese persimmons
0161070 Jambuls/jambolans
0161990 Others (2)
0162000 (b) inedible peel, small
0162010 Kiwi fruits (green, red, yellow)
0162020 Litchis/lychees
0162030 Passionfruits/maracujas
0162040 Prickly pears/cactus fruits
0162050 Star apples/cainitos
0162060 American persimmons/Virginia kaki
0162990 Others (2)
0163000 (c) inedible peel, large
0163010 Avocados
0163020 Bananas
0163030 Mangoes
0163040 Papayas12.10.2018 EN Official Journal of the European Union L 256/37
(1) (2) (3) (4)
0163050 Granate apples/pomegranates
0163060 Cherimoyas
0163070 Guavas
0163080 Pineapples
0163090 Breadfruits
0163100 Durians
0163110 Soursops/guanabanas
0163990 Others (2)
0200000 VEGETABLES, FRESH or FROZEN 0,05(*) 0,01(*)
0210000 Root and tuber vegetables
0211000 (a) potatoes
0212000 (b) tropical root and tuber vegetables
0212010 Cassava roots/manioc
0212020 Sweet potatoes
0212030 Yams
0212040 Arrowroots
0212990 Others (2)
0213000 (c) other root and tuber vegetables except sugar beets
0213010 Beetroots
0213020 Carrots
0213030 Celeriacs/turnip rooted celeries
0213040 Horseradishes
0213050 Jerusalem artichokes
0213060 Parsnips
0213070 Parsley roots/Hamburg roots parsley
0213080 Radishes
0213090 Salsifies
0213100 Swedes/rutabagas
0213110 Turnips
0213990 Others (2)
0220000 Bulb vegetables
0220010 Garlic
0220020 Onions
0220030 Shallots
0220040 Spring onions/green onions and Welsh onions
0220990 Others (2)
0230000 Fruiting vegetables
0231000 (a) Solanaceae and Malvaceae
0231010 Tomatoes
0231020 Sweet peppers/bell peppers
0231030 Aubergines/eggplants
0231040 Okra/lady's fingers
0231990 Others (2)L 256/38 EN Official Journal of the European Union 12.10.2018
(1) (2) (3) (4)
0232000 (b) cucurbits with edible peel
0232010 Cucumbers
0232020 Gherkins
0232030 Courgettes
0232990 Others (2)
0233000 (c) cucurbits with inedible peel
0233010 Melons
0233020 Pumpkins
0233030 Watermelons
0233990 Others (2)
0234000 (d) sweet corn
0239000 (e) other fruiting vegetables
0240000 Brassica vegetables (excluding brassica roots and brassica baby
leaf crops)
0241000 (a) flowering brassica
0241010 Broccoli
0241020 Cauliflowers
0241990 Others (2)
0242000 (b) head brassica
0242010 Brussels sprouts
0242020 Head cabbages
0242990 Others (2)
0243000 (c) leafy brassica
0243010 Chinese cabbages/pe-tsai
0243020 Kales
0243990 Others (2)
0244000 (d) kohlrabies
0250000 Leaf vegetables, herbs and edible flowers
0251000 (a) lettuces and salad plants
0251010 Lamb's lettuces/corn salads
0251020 Lettuces
0251030 Escaroles/broad-leaved endives
0251040 Cresses and other sprouts and shoots
0251050 Land cresses
0251060 Roman rocket/rucola
0251070 Red mustards
0251080 Baby leaf crops (including brassica species)
0251990 Others (2)
0252000 (b) spinaches and similar leaves
0252010 Spinaches
0252020 Purslanes12.10.2018 EN Official Journal of the European Union L 256/39
(1) (2) (3) (4)
0252030 Chards/beet leaves
0252990 Others (2)
0253000 (c) grape leaves and similar species
0254000 (d) watercresses
0255000 (e) witloofs/Belgian endives
0256000 (f) herbs and edible flowers
0256010 Chervil
0256020 Chives
0256030 Celery leaves
0256040 Parsley
0256050 Sage
0256060 Rosemary
0256070 Thyme
0256080 Basil and edible flowers
0256090 Laurel/bay leaves
0256100 Tarragon
0256990 Others (2)
0260000 Legume vegetables
0260010 Beans (with pods)
0260020 Beans (without pods)
0260030 Peas (with pods)
0260040 Peas (without pods)
0260050 Lentils
0260990 Others (2)
0270000 Stem vegetables
0270010 Asparagus
0270020 Cardoons
0270030 Celeries
0270040 Florence fennels
0270050 Globe artichokes
0270060 Leeks
0270070 Rhubarbs
0270080 Bamboo shoots
0270090 Palm hearts
0270990 Others (2)
0280000 Fungi, mosses and lichens
0280010 Cultivated fungi
0280020 Wild fungi
0280990 Mosses and lichens
0290000 Algae and prokaryotes organisms
0300000 PULSES 0,05(*) 0,01(*)
0300010 Beans
0300020 LentilsL 256/40 EN Official Journal of the European Union 12.10.2018
(1) (2) (3) (4)
0300030 Peas
0300040 Lupins/lupini beans
0300990 Others (2)
0400000 OILSEEDS AND OIL FRUITS 0,05(*) 0,02(*)
0401000 Oilseeds
0401010 Linseeds
0401020 Peanuts/groundnuts
0401030 Poppy seeds
0401040 Sesame seeds
0401050 Sunflower seeds
0401060 Rapeseeds/canola seeds
0401070 Soyabeans
0401080 Mustard seeds
0401090 Cotton seeds
0401100 Pumpkin seeds
0401110 Safflower seeds
0401120 Borage seeds
0401130 Gold of pleasure seeds
0401140 Hemp seeds
0401150 Castor beans
0401990 Others (2)
0402000 Oil fruits
0402010 Olives for oil production
0402020 Oil palms kernels
0402030 Oil palms fruits
0402040 Kapok
0402990 Others (2)
0500000 CEREALS 0,05(*) 0,01(*)
0500010 Barley
0500020 Buckwheat and other pseudocereals
0500030 Maize/corn
0500040 Common millet/proso millet
0500050 Oat
0500060 Rice
0500070 Rye
0500080 Sorghum
0500090 Wheat
0500990 Others (2)
0600000 TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS 0,05(*) 0,02(*)
0610000 Teas
0620000 Coffee beans
0630000 Herbal infusions from
0631000 (a) flowers
0631010 Chamomile
0631020 Hibiscus/roselle12.10.2018 EN Official Journal of the European Union L 256/41
(1) (2) (3) (4)
0631030 Rose
0631040 Jasmine
0631050 Lime/linden
0631990 Others (2)
0632000 (b) leaves and herbs
0632010 Strawberry
0632020 Rooibos
0632030 Mate/maté
0632990 Others (2)
0633000 (c) roots
0633010 Valerian
0633020 Ginseng
0633990 Others (2)
0639000 (d) any other parts of the plant
0640000 Cocoa beans
0650000 Carobs/Saint John's breads
0700000 HOPS 0,05(*) 0,02(*)
0800000 SPICES 0,05(*)
0810000 Seed spices 0,02(*)
0810010 Anise/aniseed
0810020 Black caraway/black cumin
0810030 Celery
0810040 Coriander
0810050 Cumin
0810060 Dill
0810070 Fennel
0810080 Fenugreek
0810090 Nutmeg
0810990 Others (2)
0820000 Fruit spices 0,02(*)
0820010 Allspice/pimento
0820020 Sichuan pepper
0820030 Caraway
0820040 Cardamom
0820050 Juniper berry
0820060 Peppercorn (black, green and white)
0820070 Vanilla
0820080 Tamarind
0820990 Others (2)
0830000 Bark spices 0,02(*)
0830010 Cinnamon
0830990 Others (2)L 256/42 EN Official Journal of the European Union 12.10.2018
(1) (2) (3) (4)
0840000 Root and rhizome spices
0840010 Liquorice 0,02(*)
0840020 Ginger (10) 0,02(*)
0840030 Turmeric/curcuma 0,02(*)
0840040 Horseradish (11)
0840990 Others (2) 0,02(*)
0850000 Bud spices 0,02(*)
0850010 Cloves
0850020 Capers
0850990 Others (2)
0860000 Flower pistil spices 0,02(*)
0860010 Saffron
0860990 Others (2)
0870000 Aril spices 0,02(*)
0870010 Mace
0870990 Others (2)
0900000 SUGAR PLANTS 0,05(*) 0,01(*)
0900010 Sugar beet roots
0900020 Sugar canes
0900030 Chicory roots
0900990 Others (2)
1000000 PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS 0,05(*) 0,01(*)
1010000 Commodities from
1011000 (a) swine
1011010 Muscle
1011020 Fat
1011030 Liver
1011040 Kidney
1011050 Edible offals (other than liver and kidney)
1011990 Others (2)
1012000 (b) bovine
1012010 Muscle
1012020 Fat
1012030 Liver
1012040 Kidney
1012050 Edible offals (other than liver and kidney)
1012990 Others (2)
1013000 (c) sheep
1013010 Muscle
1013020 Fat
1013030 Liver12.10.2018 EN Official Journal of the European Union L 256/43
(1) (2) (3) (4)
1013040 Kidney
1013050 Edible offals (other than liver and kidney)
1013990 Others (2)
1014000 (d) goat
1014010 Muscle
1014020 Fat
1014030 Liver
1014040 Kidney
1014050 Edible offals (other than liver and kidney)
1014990 Others (2)
1015000 (e) equine
1015010 Muscle
1015020 Fat
1015030 Liver
1015040 Kidney
1015050 Edible offals (other than liver and kidney)
1015990 Others (2)
1016000 (f) poultry
1016010 Muscle
1016020 Fat
1016030 Liver
1016040 Kidney
1016050 Edible offals (other than liver and kidney)
1016990 Others (2)
1017000 (g) other farmed terrestrial animals
1017010 Muscle
1017020 Fat
1017030 Liver
1017040 Kidney
1017050 Edible offals (other than liver and kidney)
1017990 Others (2)
1020000 Milk
1020010 Cattle
1020020 Sheep
1020030 Goat
1020040 Horse
1020990 Others (2)
1030000 Birds eggs
1030010 Chicken
1030020 Duck
1030030 Geese
1030040 Quail
1030990 Others (2)L 256/44 EN Official Journal of the European Union 12.10.2018
(1) (2) (3) (4)
1040000 Honey and other apiculture products (7)
1050000 Amphibians and Reptiles
1060000 Terrestrial invertebrate animals
1070000 Wild terrestrial vertebrate animals
1100000 PRODUCTS OF ANIMAL ORIGIN - FISH, FISHPRODUCTS AND ANY
OTHER MARINE AND FRESHWATER FOOD PRODUCTS (8)
1200000 PRODUCTS OR PART OF PRODUCTS EXCLUSIVELY USED FOR ANIMAL
FEED PRODUCTION (8)
1300000 PROCESSED FOOD PRODUCTS (9)
(*) Limit of analytical determination
(a) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.’