Commission Delegated Regulation (EU) 2019/227 of 28 November 2018 amending Delegated Regulation (EU) No 1062/2014 as regards certain active substances/product-type combinations for which the competent authority of the United Kingdom has been designated as the evaluating competent authority (Text with EEA relevance.)
Commission Delegated Regulation (EU) 2019/227of 28 November 2018amending Delegated Regulation (EU) No 1062/2014 as regards certain active substances/product-type combinations for which the competent authority of the United Kingdom has been designated as the evaluating competent authority(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsOJ L 167, 27.6.2012, p. 1. and in particular the first subparagraph of Article 89(1) thereof,Whereas:(1)Commission Delegated Regulation (EU) No 1062/2014Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). sets out in its Annex II a list of active substance/product-type combinations included in the programme of review of existing active substances contained in biocidal products ("review programme").(2)The competent authority of the United Kingdom of Great Britain and Northern Ireland ("the United Kingdom") is the evaluating competent authority for several active substance/product-type combinations listed in Annex II to Delegated Regulation (EU) No 1062/2014.(3)The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. As a result, the United Kingdom will withdraw from the Union on 30 March 2019 and the Union legislation will no longer apply to and in the United Kingdom. A withdrawal agreement is currently being negotiated between the European Union and the United Kingdom, which includes a "transition period". According to draft provisions of the Withdrawal Agreement as agreed between the EU and the United Kingdom at negotiator's level, during the transition period, a competent authority of the United Kingdom can not act as evaluating competent authority for any active substance/product-type combination included in the review programme. Moreover, there is no certainty whether the Withdrawal Agreement, once finalised, will be signed and ratified by both parties, and this before the 30 March 2019.(4)Therefore, as regards the active substances/product-type combinations included in the review programme for which the competent authority of the United Kingdom has been designated as the evaluating competent authority, it is necessary to designate a new evaluating competent authority from among the competent authorities of the remaining 27 Member States of the European Union, EEA countries, or Switzerland, with effect from 30 March 2019.(5)Notwithstanding the stage of evaluation of the application, the Member States whose competent authorities are designated to replace that of the United Kingdom should be allowed to request fees for the services provided, in accordance with Article 80 of Regulation (EU) No 528/2012.(6)Taking into account that the review programme has to be finalised by the target date indicated in Article 89(1) of Regulation (EU) No 528/2012, appropriate time limits should be established for finalising the evaluations of the reallocated applications for active substance/product-type combinations.(7)Delegated Regulation (EU) No 1062/2014 should therefore be amended accordingly,HAS ADOPTED THIS REGULATION:
Article 1Delegated Regulation (EU) No 1062/2014 is amended as follows:(1)the following Article is inserted:
"Article 6aApplications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 20191.This Article is applicable to applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019 for the entries 79, 85, 113, 171, 187, 188, 321, 345, 346, 458, 531, 554, 571, 599, 609, 1045, 1046 and 1047 of Annex II.2.The evaluating competent authority of a Member State having replaced the competent authority of the United Kingdom in relation to an application that has been submitted before 30 March 2019, shall inform the participant of the fees payable under Article 80(2) of Regulation (EU) No 528/2012 at the latest by 30 April 2019, and shall reject the application if the participant fails to pay the fees within a period of time fixed by the evaluating competent authority. It shall inform the participant and the Agency accordingly.3.By derogation from the time limits laid down in Article 6(3), the assessment report and the conclusions shall be sent by the evaluating competent authority within either of the following time limits, whichever is the later:(a)31 December 2020;(b)the time limit for submitting the assessment report pursuant to Article 6(3)(b) set out in Annex III.";
(2)the table set out in Annex II is replaced by the table set out in the Annex to this Regulation.
Article 2This 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 30 March 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 28 November 2018.For the CommissionThe PresidentJean-Claude JunckerANNEXThe table set out in Annex II to Delegated Regulation (EU) No 1062/2014 is replaced by the following table:
"Entry numberSubstance nameRapporteur Member StateEC numberCAS number123456789101112131718192122
1FormaldehydeDE200-001-850-00-0xxx
9BronopolES200-143-052-51-7xxxxxx
36EthanolEL200-578-664-17-5xxx
37Formic acidBE200-579-164-18-6xxxxxxx
1025Performic acid generated from formic acid and hydrogen peroxideBExxxxxxx
43Salicylic acidNL200-712-369-72-7xxx
52Ethylene oxideNO200-849-975-21-8x
69Glycolic acidNL201-180-579-14-1xxx
1026Peracetic acid generated from tetraacetylethylenediamine (TAED) and hydrogen peroxideATx
1027Peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxideATxx
1028Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrateATx
1029Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditionsATx
71L-(+)-lactic acidDE201-196-279-33-4x
79(2R,6aS,12aS)-1,2,6,6a,12,12a-Hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one (Rotenone)PL201-501-983-79-4x
85SymcloseneDE201-782-887-90-1xxxxxx
92Biphenyl-2-olES201-993-590-43-7xxx
1133-Phenyl-propen-2-al (Cinnamaldehyde)PL203-213-9104-55-2x
117GeraniolFR203-377-1106-24-1xx
122GlyoxalFR203-474-9107-22-2xxx
133Hexa-2,4-dienoic acid (Sorbic acid)DE203-768-7110-44-1x
154CloropheneNO204-385-8120-32-1x
1712-PhenoxyethanolIT204-589-7122-99-6xxxxx
1072Carbon dioxideFR204-696-9124-38-9x
179Carbon dioxide generated from propane, butane or a mixture of both by combustionFRx
180Sodium dimethylarsinate (Sodium Cacodylate)PT204-708-2124-65-2x
185Tosylchloramide sodium (Chloramin T)ES204-854-7127-65-1xxxx
187Potassium dimethyldithiocarbamateSE204-875-1128-03-0xxx
188Sodium dimethyldithiocarbamateSE204-876-7128-04-1xxx
195Sodium 2-biphenylateES205-055-6132-27-4xxxxxx
206ThiramBE205-286-2137-26-8x
210Metam-sodiumBE205-293-0137-42-8xx
2272-Thiazol-4-yl-1H-benzoimidazole (Thiabendazole)ES205-725-8148-79-8xxx
235DiuronDK206-354-4330-54-1xx
239CyanamideDE206-992-3420-04-2xx
253Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet)BE208-576-7533-74-4xx
283TerbutrynSK212-950-5886-50-0xxx
292(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-Tetramethrin)DE214-619-01166-46-7x
321MonolinuronHU217-129-51746-81-2x
330N-(3-Aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine)PT219-145-82372-82-9xxxxxxxx
3362,2′-Dithiobis[N-methylbenzamide] (DTBMA)PL219-768-52527-58-4x
3391,2-Benzisothiazol-3(2H)-one (BIT)ES220-120-92634-33-5xxxxxx
3412-Methyl-2H-isothiazol-3-one (MIT)SI220-239-62682-20-4x
346Sodium dichloroisocyanurate dihydrateDE220-767-751580-86-0xxxxxx
345Troclosene sodiumDE220-767-72893-78-9xxxxxx
348Mecetronium ethylsulfate (MES)PL221-106-53006-10-8x
359Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm))PL222-720-63586-55-8xxxxx
365Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)SE223-296-53811-73-2xxxxxx
368Methenamine 3-chloroallylochloride (CTAC)PL223-805-04080-31-3xxx
3772,2′,2″-(Hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (HHT)PL225-208-04719-04-4xxxx
382Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD)ES226-408-05395-50-6xxxxx
392Methylene dithiocyanateFR228-652-36317-18-6x
3931,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH)PL229-222-86440-58-0xx
397Didecyldimethylammonium chloride (DDAC)IT230-525-27173-51-5xxxxxxxx
401SilverSE231-131-37440-22-4xxxx
1023Silver, as a nanomaterialSE231-131-37440-22-4xxx
405Sulfur dioxide generated from sulfur by combustionDEx
424Active bromine generated from sodium bromide and sodium hypochloriteNLxxx
1030Active bromine generated from sodium bromide and calcium hypochloriteNLxxx
1031Active bromine generated from sodium bromide and chlorineNLxxx
1032Active bromine generated from sodium bromide by electrolysisNLxxx
1033Active bromine generated from hypobromous acid and urea and bromoureaNLxx
1034Active bromine generated from sodium hypobromite and N-bromosulfamate and sulfamic acidNLx
1035Active bromine generated from ozone and bromide of natural water and sodium bromideNLx
434TetramethrinDE231-711-67696-12-0x
439Hydrogen peroxideFI231-765-07722-84-1xx
1036Hydrogen peroxide released from sodium percarbonateFIxxx
4447a-Ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO)PL231-810-47747-35-5xx
450Silver nitrateSE231-853-97761-88-8x
453Disodium peroxodisulfatePT231-892-17775-27-1x
432Active chlorine released from sodium hypochloriteITxx
455Active chlorine released from calcium hypochloriteITx
457Active chlorine released from chlorineITx
458Monochloramine generated from ammonium sulfate and a chlorine sourceFRxx
1016Silver chlorideSE232-033-37783-90-6xxxxx
473Pyrethrins and PyrethroidsES232-319-88003-34-7xx
491Chlorine dioxideDE233-162-810049-04-4xxxxxx
1037Chlorine dioxide generated from sodium chlorite by electrolysisPTxxxxxx
1038Chlorine dioxide generated from sodium chlorite by acidificationPTxxxxxx
1039Chlorine dioxide generated from sodium chlorite by oxidationPTxxxxxx
1040Chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acidPTxxxx
1041Chlorine dioxide generated from sodium chloride by electrolysisDExxxxxx
1042Chlorine dioxide generated from sodium chlorite and sodium bisulfate and hydrochloric acidDExx
1043Chlorine dioxide generated from sodium chlorite and sodium bisulfateDExxxxxx
1044Chlorine dioxide generated from sodium chlorite and sodium persulfateDExxxxxx
4942,2-Dibromo-2-cyanoacetamide (DBNPA)DK233-539-710222-01-2xxxxxx
501CarbendazimDE234-232-010605-21-7xxx
1022Dialuminium chloride pentahydroxideNL234-933-112042-91-0x
515Bromide activated chloramine (BAC) generated from precursors ammonium bromide and sodium hypochloriteSExx
522Pyrithione zincSE236-671-313463-41-7xxxxxx
524Dodecylguanidine monohydrochlorideES237-030-013590-97-1xx
529Active bromine generated from bromine chlorideNLx
531(Benzyloxy)methanolAT238-588-814548-60-8xx
550D-Gluconic acid, compound with N,N′-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG)PT242-354-018472-51-0xxx
554p-[(Diiodomethyl)sulphonyl]tolueneCH243-468-320018-09-1xxxx
559(Benzothiazol-2-ylthio)methyl thiocyanate (TCMTB)NO244-445-021564-17-0xx
5622-Methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin)EL245-387-923031-36-9x
563Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate)DE246-376-124634-61-5x
566Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) (HPT)ATxxxx
5712-Octyl-2H-isothiazol-3-one (OIT)FR247-761-726530-20-1xxxxxx
577Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chlorideES248-595-827668-52-6xxx
588Bromochloro-5,5-dimethylimidazolidine-2,4-dione (BCDMH)NL251-171-532718-18-6xxx
5903-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon)DE251-835-434123-59-6xx
5971-[2-(Allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole (Imazalil)DE252-615-035554-44-0x
599S-[(6-Chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos)IT252-626-035575-96-3x
608Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloridePL255-451-841591-87-1x
1045Eucalyptus citriodora oil, hydrated, cyclizedCZ1245629-80-4x
1046Cymbopogon winterianus oil, fractionated, hydrated, cyclizedCZNot availableNot availablex
1047Eucalyptus citriodora oil and citronellal, hydrated, cyclizedCZNot availableNot availablex
6092-Hydroxy-α,α,4-trimethylcyclohexanemethanolCZ255-953-742822-86-6x
6193-Iodo-2-propynylbutylcarbamate (IPBC)DK259-627-555406-53-6xxx
620Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)MT259-709-055566-30-8xxx
6484,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro-2-octyl-2H-isothiazol-3-one (DCOIT))NO264-843-864359-81-5xxxx
656Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) (MBO)ATxxxxx
667Alkyl (C12-18) dimethylbenzyl ammonium chloride (ADBAC (C12-18))IT269-919-468391-01-5xxxxxxxx
671Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16))IT270-325-268424-85-1xxxxxxxx
673Didecyldimethylammonium chloride (DDAC (C8-10))IT270-331-568424-95-3xxxxxxxx
690Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS)MT273-545-768989-01-5xx
691Sodium N-(hydroxymethyl)glycinateAT274-357-870161-44-3x
692Amines, C10-16-alkyldimethyl, N-oxidesPT274-687-270592-80-2x
693Pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS)SI274-778-770693-62-8xxxx
939Active chlorine generated from sodium chloride by electrolysisSKxxxxxx
1048Active chlorine released from hypochlorous acidSKxxxx
1049Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate)SIxxxx
1050Active chlorine generated from seawater (sodium chloride) by electrolysisFRx
1051Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysisFRx
1052Active chlorine generated from magnesium chloride hexahydrate by electrolysisFRx
1053Active chlorine generated from potassium chloride by electrolysisDKxx
1054Active chlorine generated from sodium N-chlorosulfamateSIxxx
1055Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) and sulfamic acidSIxx
1056Active chlorine generated from hydrochloric acid by electrolysisSIxxx
701Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) (MMPP)PL279-013-084665-66-7x
1024Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxideDEx
724Alkyl (C12-C14) dimethylbenzylammonium chloride (ADBAC (C12-C14))IT287-089-185409-22-9xxxxxxxx
725Alkyl (C12-C14) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C12-C14))IT287-090-785409-23-0xxxxxxxx
731Chrysanthemum cinerariaefolium, ext.ES289-699-389997-63-7x
1057Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solventESxx
1058Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxideESxx
744Lavender, Lavandula hybrida, ext./Lavandin oilPT294-470-691722-69-9x
779Reaction products of: glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin)DE403-950-8164907-72-6xx
7856-(Phthalimido)peroxyhexanoic acid (PAP)IT410-850-8128275-31-0xx
7912-Butyl-benzo[d]isothiazol-3-one (BBIT)CZ420-590-74299-07-4xxxxx
792Chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidificationDExx
811Silver sodium hydrogen zirconium phosphateSE422-570-3265647-11-8xxxxx
794sec-Butyl 2-(2-hydroxyethyl)piperidine-1-carboxylate (Icaridine)DK423-210-8119515-38-7x
797cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC)PL426-020-351229-78-8xx
813Peroxyoctanoic acidFR33734-57-5xxx
1014Silver zeoliteSENot availableNot availablexxxxx
152Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH)NLNot availableNot availablex
459Reaction mass of titanium dioxide and silver chlorideSENot availableNot availablexxxxxxx
777Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH)NLNot availableNot availablex
810Silver phosphate glassSENot available308069-39-8xxx
824Silver zinc zeoliteSENot available130328-20-0xxxx
1013Silver copper zeoliteSENot available130328-19-7xxxx
1017Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale)SENot availableNot availablex
854(RS)-3-Allyl-2-methyl-4-oxocyclopent-2-enyl-(1R,3R;1R,3S)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 4 isomers 1R trans, 1R: 1R trans, 1S: 1R cis, 1R: 1R cis, 1S 4:4:1:1) (d-Allethrin)DEPlant protection product231937-89-6x
855(RS)-3-Allyl-2-methyl-4-oxocyclopent-2-enyl (1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 2 isomers 1R trans: 1R/S only 1:3) (Esbiothrin)DEPlant protection product260359-57-7x
8434-Bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr)PTPlant protection product122453-73-0x
859Polymer of N-Methylmethanamine (Einecs 204-697-4 with (chloromethyl)oxirane (Einecs 203-439-8)/Polymeric quaternary ammonium chloride (PQ Polymer)HUPolymer25988-97-0xx
868Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4,7 (PHMB(1415;4,7))FRPolymer32289-58-0 and 1802181-67-4xxx
869Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26)ITPolymer94667-33-1xxx
872N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine)ELPolymer214710-34-6x
1059Capsicum oleoresinExtractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Capsicum frutescens, Solanaceae)BENot available8023-77-6x
1060Capsicum annuum, ext.Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Capsicum annuum, Solanaceae.BE283-403-684625-29-6x
1061Reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnonanamideBENot availableNot availablex
1062D-FructoseAT200-333-357-48-7x
1063HoneyAT8028-66-8x
1064Malt, ext.Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae.AT232-310-98002-48-0x
1065Vinegar(food grade containing a maximum of 10 % acetic acid)ATNot available8028-52-2x
1066CheeseATNot availableNot availablex
1067Powdered eggNLNot availableNot availablex
1068Saccharomyces cerevisiaeNLNot available68876-77-7x
1069Concentrated apple juiceNLNot availableNot availablex
1070Orange, sweet, ext.Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus sinensis, Rutaceae.CH232-433-88028-48-6x
1071Garlic, ext.Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Allium sativum, Liliaceae.AT232-371-18008-99-9x"