Commission Regulation (EU) 2019/1561Show full title

Commission Regulation (EU) 2019/1561

of 17 September 2019

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 chlormequat in cultivated fungi

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC(1), and in particular Article 14(1)(a) and Article 16(1)(a) thereof,

Whereas:

(1) For chlormequat, maximum residue levels (MRLs) are set in Annex II to Regulation (EC) No 396/2005.

(2) The MRLs for chlormequat were recently modified by Commission Regulation (EU) 2017/693(2) in accordance with Article 12(1) of Regulation (EC) No 396/2005. In that framework, a temporary MRL for cultivated fungi was set at 0,9 mg/kg due to monitoring data showing that residues occurred on untreated cultivated fungi at a level higher than the limit of determination where such residues may result from cross-contamination of cultivated fungi with straw lawfully treated with chlormequat.

(3) Mushroom growers submitted to the Commission recent monitoring data specifically on oyster mushrooms showing that residues occur in those products at higher levels than the current temporary MRL set for cultivated fungi. Those residues result from a cross-contamination of cultivated fungi with straw lawfully treated with chlormequat. Several Member States submitted additional monitoring data from official controls performed specifically on oyster mushrooms, which confirmed those findings.

(4) Germany compiled and evaluated an application for modification of the existing MRL in accordance with Article 6(3) of Regulation (EC) No 396/2005 and forwarded the evaluation report to the Commission.

(5) The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals and gave a scientific statement on the proposed MRL(3). It forwarded that statement to the applicant, the Commission and the Member States and made it available to the public.

(6) The Authority concluded in its scientific statement that the modification to the MRL requested by Germany was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.

(7) In light of the Authority's conclusions on risk to consumers, the MRL for oyster mushrooms should be set at the level corresponding to the 95th percentile of all the sample results while maintaining the existing MRL for other cultivated fungi. That MRL will be reviewed; the review will take into account the information available within 13 April 2021.

(8) Regulation (EC) No 396/2005 should therefore be amended accordingly.

(9) 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 U.K.

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2 U.K.

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, 17 September 2019.

For the Commission

The President

Jean-Claude Juncker

ANNEX U.K.

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

(1)

in Annex II, the column for chlormequat is deleted;

(2)

in Part A of Annex III, the following column for chlormequat is added:

‘Pesticide residues and maximum residue levels (mg/kg)

a Limit of analytical determination
b For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.
Chlormequat (sum of chlormequat and its salts, expressed as chlormequat-chloride)
(+) Recent monitoring data show that chlormequat levels in pears are declining but still occur at levels above the limit of determination due to former uses. It is therefore appropriate to set a temporary MRL at a value of 0,07 mg/kg pending the submission of further monitoring data. When reviewing the MRL, the Commission will take into account the information, if it is submitted by 13 April 2021, or, if that information is not submitted by that date, the lack of it. 0130020 Pears
(+) The following MRL applies to oyster mushrooms: 6 mg/kg. Monitoring data show that cross-contamination of untreated cultivated fungi may occur with straw lawfully treated with chlormequat. When reviewing the MRL, the Commission will take into account the information, if it is submitted by 13 April 2021, or, if that information is not submitted by that date, the lack of it. 0280010 Cultivated fungi
(+) The European Food Safety Authority identified some information on crop 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 13 April 2019, or, if that information is not submitted by that date, the lack of it. 0401060 Rapeseeds/canola seeds’
Code number	Groups and examples of individual products to which the MRLs applyb	Chlormequat (sum of chlormequat and its salts, expressed as chlormequat-chloride)
(1)	(2)	(3)
0100000	FRUITS, FRESH or FROZEN; TREE NUTS
0110000	Citrus fruits	0,01a
0110010	Grapefruits
0110020	Oranges
0110030	Lemons
0110040	Limes
0110050	Mandarins
0110990	Others (2)
0120000	Tree nuts	0,01a
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	0,01a
0130020	Pears	0,07 (+)
0130030	Quinces	0,01a
0130040	Medlars	0,01a
0130050	Loquats/Japanese medlars	0,01a
0130990	Others (2)	0,01a
0140000	Stone fruits	0,01a
0140010	Apricots
0140020	Cherries (sweet)
0140030	Peaches
0140040	Plums
0140990	Others (2)
0150000	Berries and small fruits
0151000	(a) grapes	0,05
0151010	Table grapes
0151020	Wine grapes
0152000	(b) strawberries	0,01a
0153000	(c) cane fruits	0,01a
0153010	Blackberries
0153020	Dewberries
0153030	Raspberries (red and yellow)
0153990	Others (2)
0154000	(d) other small fruits and berries	0,01a
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	0,01a
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	Papayas
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
0210000	Root and tuber vegetables	0,01a
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	0,01a
0220010	Garlic
0220020	Onions
0220030	Shallots
0220040	Spring onions/green onions and Welsh onions
0220990	Others (2)
0230000	Fruiting vegetables	0,01a
0231000	(a) Solanaceae and Malvaceae
0231010	Tomatoes
0231020	Sweet peppers/bell peppers
0231030	Aubergines/eggplants
0231040	Okra/lady's fingers
0231990	Others (2)
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)	0,01a
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	0,01a
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	Purslanes
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	0,01a
0260010	Beans (with pods)
0260020	Beans (without pods)
0260030	Peas (with pods)
0260040	Peas (without pods)
0260050	Lentils
0260990	Others (2)
0270000	Stem vegetables	0,01a
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	0,9 (+)
0280020	Wild fungi	0,01a
0280990	Mosses and lichens	0,01a
0290000	Algae and prokaryotes organisms	0,01a
0300000	PULSES	0,01a
0300010	Beans
0300020	Lentils
0300030	Peas
0300040	Lupins/lupini beans
0300990	Others (2)
0400000	OILSEEDS AND OIL FRUITS
0401000	Oilseeds
0401010	Linseeds	0,01a
0401020	Peanuts/groundnuts	0,01a
0401030	Poppy seeds	0,01a
0401040	Sesame seeds	0,01a
0401050	Sunflower seeds	0,01a
0401060	Rapeseeds/canola seeds	7 (+)
0401070	Soyabeans	0,01a
0401080	Mustard seeds	0,01a
0401090	Cotton seeds	0,7
0401100	Pumpkin seeds	0,01a
0401110	Safflower seeds	0,01a
0401120	Borage seeds	0,01a
0401130	Gold of pleasure seeds	0,01a
0401140	Hemp seeds	0,01a
0401150	Castor beans	0,01a
0401990	Others (2)	0,01a
0402000	Oil fruits	0,01a
0402010	Olives for oil production
0402020	Oil palms kernels
0402030	Oil palms fruits
0402040	Kapok
0402990	Others (2)
0500000	CEREALS
0500010	Barley	3
0500020	Buckwheat and other pseudocereals	0,01a
0500030	Maize/corn	0,01a
0500040	Common millet/proso millet	0,01a
0500050	Oat	15
0500060	Rice	0,01a
0500070	Rye	8
0500080	Sorghum	0,01a
0500090	Wheat	7
0500990	Others (2)	0,01a
0600000	TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS	0,05a
0610000	Teas
0620000	Coffee beans
0630000	Herbal infusions from
0631000	(a) flowers
0631010	Chamomile
0631020	Hibiscus/roselle
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	0,05a
0800000	SPICES
0810000	Seed spices	0,05a
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	0,05a
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	0,05a
0830010	Cinnamon
0830990	Others (2)
0840000	Root and rhizome spices
0840010	Liquorice	0,05a
0840020	Ginger (10)	0,05a
0840030	Turmeric/curcuma	0,05a
0840040	Horseradish (11)
0840990	Others (2)	0,05a
0850000	Bud spices	0,05a
0850010	Cloves
0850020	Capers
0850990	Others (2)
0860000	Flower pistil spices	0,05a
0860010	Saffron
0860990	Others (2)
0870000	Aril spices	0,05a
0870010	Mace
0870990	Others (2)
0900000	SUGAR PLANTS	0,01a
0900010	Sugar beet roots
0900020	Sugar canes
0900030	Chicory roots
0900990	Others (2)
1000000	PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS
1010000	Commodities from
1011000	(a) swine
1011010	Muscle	0,3
1011020	Fat	0,15
1011030	Liver	1,5
1011040	Kidney	1,5
1011050	Edible offals (other than liver and kidney)	1,5
1011990	Others (2)	0,01a
1012000	(b) bovine
1012010	Muscle	0,3
1012020	Fat	0,15
1012030	Liver	1,5
1012040	Kidney	1,5
1012050	Edible offals (other than liver and kidney)	1,5
1012990	Others (2)	0,01a
1013000	(c) sheep
1013010	Muscle	0,3
1013020	Fat	0,15
1013030	Liver	1,5
1013040	Kidney	1,5
1013050	Edible offals (other than liver and kidney)	1,5
1013990	Others (2)	0,01a
1014000	(d) goat
1014010	Muscle	0,3
1014020	Fat	0,15
1014030	Liver	1,5
1014040	Kidney	1,5
1014050	Edible offals (other than liver and kidney)	1,5
1014990	Others (2)	0,01a
1015000	(e) equine
1015010	Muscle	0,3
1015020	Fat	0,15
1015030	Liver	1,5
1015040	Kidney	1,5
1015050	Edible offals (other than liver and kidney)	1,5
1015990	Others (2)	0,01a
1016000	(f) poultry
1016010	Muscle	0,05
1016020	Fat	0,05
1016030	Liver	0,15
1016040	Kidney	0,15
1016050	Edible offals (other than liver and kidney)	0,15
1016990	Others (2)	0,01a
1017000	(g) other farmed terrestrial animals
1017010	Muscle	0,3
1017020	Fat	0,15
1017030	Liver	1,5
1017040	Kidney	1,5
1017050	Edible offals (other than liver and kidney)	1,5
1017990	Others (2)	0,01a
1020000	Milk	0,5
1020010	Cattle
1020020	Sheep
1020030	Goat
1020040	Horse
1020990	Others (2)
1030000	Birds eggs	0,15
1030010	Chicken
1030020	Duck
1030030	Geese
1030040	Quail
1030990	Others (2)
1040000	Honey and other apiculture products (7)	0,05a
1050000	Amphibians and Reptiles	0,01a
1060000	Terrestrial invertebrate animals	0,01a
1070000	Wild terrestrial vertebrate animals	0,3
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)

(1)

OJ L 70, 16.3.2005, p. 1.

(2)

Commission Regulation (EU) 2017/693 of 7 April 2017 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 bitertanol, chlormequat and tebufenpyrad in or on certain products (OJ L 101, 13.4.2017, p. 1).

(3)

EFSA scientific reports available online: http://www.efsa.europa.eu:

Statement on the dietary risk assessment for the proposed temporary maximum residue level for chlormequat in oyster mushrooms. EFSA Journal 2019;17(5):5707.