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 authorityText with EEA relevance.

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) 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 products OJ 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 1062/2014 Commission 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 1

Delegated Regulation (EU) No 1062/2014 is amended as follows: (1) the following Article is inserted:

Article 6a

Applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019

1. 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 2

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 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 Commission The President Jean-Claude Juncker

Annex

ANNEX The 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 number1234567891011121317181921221FormaldehydeDE200-001-850-00-0xxx9BronopolES200-143-052-51-7xxxxxx36EthanolEL200-578-664-17-5xxx37Formic acidBE200-579-164-18-6xxxxxxx1025Performic acid generated from formic acid and hydrogen peroxideBExxxxxxx43Salicylic acidNL200-712-369-72-7xxx52Ethylene oxideNO200-849-975-21-8x69Glycolic acidNL201-180-579-14-1xxx1026Peracetic acid generated from tetraacetylethylenediamine (TAED) and hydrogen peroxideATx1027Peracetic acid generated from 1,3-diacetyloxypropan-2-yl acetate and hydrogen peroxideATxx1028Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrateATx

1029Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditionsATx71L-(+)-lactic acidDE201-196-279-33-4x79(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)PL201-501-983-79-4x85SymcloseneDE201-782-887-90-1xxxxxx92Biphenyl-2-olES201-993-590-43-7xxx1133-Phenyl-propen-2-al (Cinnamaldehyde)PL203-213-9104-55-2x117GeraniolFR203-377-1106-24-1xx122GlyoxalFR203-474-9107-22-2xxx133Hexa-2,4-dienoic acid (Sorbic acid)DE203-768-7110-44-1x154CloropheneNO204-385-8120-32-1x1712-PhenoxyethanolIT204-589-7122-99-6xxxxx1072Carbon dioxideFR204-696-9124-38-9x179Carbon dioxide generated from propane, butane or a mixture of both by combustionFRx 180Sodium dimethylarsinate (Sodium Cacodylate)PT204-708-2124-65-2x185Tosylchloramide sodium (Chloramin T)ES204-854-7127-65-1xxxx187Potassium dimethyldithiocarbamateSE204-875-1128-03-0xxx188Sodium dimethyldithiocarbamateSE204-876-7128-04-1xxx195Sodium 2-biphenylateES205-055-6132-27-4xxxxxx206ThiramBE205-286-2137-26-8x210Metam-sodiumBE205-293-0137-42-8xx2272-Thiazol-4-yl-1H-benzoimidazole (Thiabendazole)ES205-725-8148-79-8xxx235DiuronDK206-354-4330-54-1xx239CyanamideDE206-992-3420-04-2xx253Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet)BE208-576-7533-74-4xx283TerbutrynSK212-950-5886-50-0xxx292(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 321MonolinuronHU217-129-51746-81-2x330N-(3-Aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine)PT219-145-82372-82-9xxxxxxxx3362,2′-Dithiobis[N-methylbenzamide] (DTBMA)PL219-768-52527-58-4x3391,2-Benzisothiazol-3(2H)-one (BIT)ES220-120-92634-33-5xxxxxx3412-Methyl-2H-isothiazol-3-one (MIT)SI220-239-62682-20-4x346Sodium dichloroisocyanurate dihydrateDE220-767-751580-86-0xxxxxx345Troclosene sodiumDE220-767-72893-78-9xxxxxx348Mecetronium ethylsulfate (MES)PL221-106-53006-10-8x359Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm))PL222-720-63586-55-8xxxxx365Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)SE223-296-53811-73-2xxxxxx368Methenamine 3-chloroallylochloride (CTAC)PL223-805-04080-31-3xxx 3772,2′,2″-(Hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (HHT)PL225-208-04719-04-4xxxx382Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD)ES226-408-05395-50-6xxxxx392Methylene dithiocyanateFR228-652-36317-18-6x3931,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH)PL229-222-86440-58-0xx397Didecyldimethylammonium chloride (DDAC)IT230-525-27173-51-5xxxxxxxx401SilverSE231-131-37440-22-4xxxx1023Silver, as a nanomaterialSE231-131-37440-22-4xxx405Sulfur dioxide generated from sulfur by combustionDEx424Active bromine generated from sodium bromide and sodium hypochloriteNLxxx1030Active bromine generated from sodium bromide and calcium hypochloriteNLxxx1031Active bromine generated from sodium bromide and chlorineNLxxx

1032Active bromine generated from sodium bromide by electrolysisNLxxx1033Active bromine generated from hypobromous acid and urea and bromoureaNLxx1034Active bromine generated from sodium hypobromite and N-bromosulfamate and sulfamic acidNLx1035Active bromine generated from ozone and bromide of natural water and sodium bromideNLx434TetramethrinDE231-711-67696-12-0x439Hydrogen peroxideFI231-765-07722-84-1xx1036Hydrogen peroxide released from sodium percarbonateFIxxx4447a-Ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO)PL231-810-47747-35-5xx450Silver nitrateSE231-853-97761-88-8x453Disodium peroxodisulfatePT231-892-17775-27-1x432Active chlorine released from sodium hypochloriteITxx 455Active chlorine released from calcium hypochloriteITx457Active chlorine released from chlorineITx458Monochloramine generated from ammonium sulfate and a chlorine sourceFRxx1016Silver chlorideSE232-033-37783-90-6xxxxx473Pyrethrins and PyrethroidsES232-319-88003-34-7xx491Chlorine dioxideDE233-162-810049-04-4xxxxxx1037Chlorine dioxide generated from sodium chlorite by electrolysisPTxxxxxx1038Chlorine dioxide generated from sodium chlorite by acidificationPTxxxxxx1039Chlorine dioxide generated from sodium chlorite by oxidationPTxxxxxx1040Chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acidPTxxxx 1041Chlorine dioxide generated from sodium chloride by electrolysisDExxxxxx1042Chlorine dioxide generated from sodium chlorite and sodium bisulfate and hydrochloric acidDExx1043Chlorine dioxide generated from sodium chlorite and sodium bisulfateDExxxxxx1044Chlorine dioxide generated from sodium chlorite and sodium persulfateDExxxxxx4942,2-Dibromo-2-cyanoacetamide (DBNPA)DK233-539-710222-01-2xxxxxx501CarbendazimDE234-232-010605-21-7xxx1022Dialuminium chloride pentahydroxideNL234-933-112042-91-0x515Bromide activated chloramine (BAC) generated from precursors ammonium bromide and sodium hypochloriteSExx522Pyrithione zincSE236-671-313463-41-7xxxxxx524Dodecylguanidine monohydrochlorideES237-030-013590-97-1xx 529Active bromine generated from bromine chlorideNLx531(Benzyloxy)methanolAT238-588-814548-60-8xx550D-Gluconic acid, compound with N,N′-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG)PT242-354-018472-51-0xxx554p-[(Diiodomethyl)sulphonyl]tolueneCH243-468-320018-09-1xxxx559(Benzothiazol-2-ylthio)methyl thiocyanate (TCMTB)NO244-445-021564-17-0xx5622-Methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin)EL245-387-923031-36-9x563Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate)DE246-376-124634-61-5x566Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) (HPT)ATxxxx5712-Octyl-2H-isothiazol-3-one (OIT)FR247-761-726530-20-1xxxxxx577Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chlorideES248-595-827668-52-6xxx 588Bromochloro-5,5-dimethylimidazolidine-2,4-dione (BCDMH)NL251-171-532718-18-6xxx5903-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon)DE251-835-434123-59-6xx5971-[2-(Allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole (Imazalil)DE252-615-035554-44-0x599S-[(6-Chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos)IT252-626-035575-96-3x608Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloridePL255-451-841591-87-1x1045Eucalyptus citriodora oil, hydrated, cyclizedCZ1245629-80-4x1046Cymbopogon winterianus oil, fractionated, hydrated, cyclizedCZNot availableNot availablex1047Eucalyptus citriodora oil and citronellal, hydrated, cyclizedCZNot availableNot availablex6092-Hydroxy-α,α,4-trimethylcyclohexanemethanolCZ255-953-742822-86-6x6193-Iodo-2-propynylbutylcarbamate (IPBC)DK259-627-555406-53-6xxx

620Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)MT259-709-055566-30-8xxx6484,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro-2-octyl-2H-isothiazol-3-one (DCOIT))NO264-843-864359-81-5xxxx656Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2) (MBO)ATxxxxx667Alkyl (C12-18) dimethylbenzyl ammonium chloride (ADBAC (C12-18))IT269-919-468391-01-5xxxxxxxx671Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16))IT270-325-268424-85-1xxxxxxxx673Didecyldimethylammonium chloride (DDAC (C8-10))IT270-331-568424-95-3xxxxxxxx690Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS)MT273-545-768989-01-5xx691Sodium N-(hydroxymethyl)glycinateAT274-357-870161-44-3x692Amines, C10-16-alkyldimethyl, N-oxidesPT274-687-270592-80-2x 693Pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS)SI274-778-770693-62-8xxxx939Active chlorine generated from sodium chloride by electrolysisSKxxxxxx1048Active chlorine released from hypochlorous acidSKxxxx1049Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate)SIxxxx1050Active chlorine generated from seawater (sodium chloride) by electrolysisFRx1051Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysisFRx1052Active chlorine generated from magnesium chloride hexahydrate by electrolysisFRx1053Active chlorine generated from potassium chloride by electrolysisDKxx1054Active chlorine generated from sodium N-chlorosulfamateSIxxx 1055Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) and sulfamic acidSIxx1056Active chlorine generated from hydrochloric acid by electrolysisSIxxx701Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) (MMPP)PL279-013-084665-66-7x1024Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxideDEx724Alkyl (C12-C14) dimethylbenzylammonium chloride (ADBAC (C12-C14))IT287-089-185409-22-9xxxxxxxx725Alkyl (C12-C14) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C12-C14))IT287-090-785409-23-0xxxxxxxx731Chrysanthemum cinerariaefolium, ext.ES289-699-389997-63-7x 1057Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solventESxx1058Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxideESxx744Lavender, Lavandula hybrida, ext./Lavandin oilPT294-470-691722-69-9x779Reaction products of: glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin)DE403-950-8164907-72-6xx7856-(Phthalimido)peroxyhexanoic acid (PAP)IT410-850-8128275-31-0xx7912-Butyl-benzo[d]isothiazol-3-one (BBIT)CZ420-590-74299-07-4xxxxx792Chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidificationDExx811Silver sodium hydrogen zirconium phosphateSE422-570-3265647-11-8xxxxx

794sec-Butyl 2-(2-hydroxyethyl)piperidine-1-carboxylate (Icaridine)DK423-210-8119515-38-7x797cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC)PL426-020-351229-78-8xx813Peroxyoctanoic acidFR33734-57-5xxx1014Silver zeoliteSENot availableNot availablexxxxx152Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH)NLNot availableNot availablex459Reaction mass of titanium dioxide and silver chlorideSENot availableNot availablexxxxxxx777Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH)NLNot availableNot availablex810Silver phosphate glassSENot available308069-39-8xxx824Silver zinc zeoliteSENot available130328-20-0xxxx1013Silver 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 availablex854(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 product231937-89-6x855(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 product260359-57-7x8434-Bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr)PTPlant protection product122453-73-0x859Polymer 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 1802181-67-4xxx869Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26)ITPolymer94667-33-1xxx872N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine)ELPolymer214710-34-6x1059 Capsicum oleoresin Extractives 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 available8023-77-6x1060 Capsicum 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 availablex1062D-FructoseAT200-333-357-48-7x1063HoneyAT8028-66-8x1064 Malt, 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.

AT232-310-98002-48-0x1065 Vinegar (food grade containing a maximum of 10 % acetic acid) ATNot available8028-52-2x1066CheeseATNot availableNot availablex1067Powdered eggNLNot availableNot availablex1068Saccharomyces cerevisiaeNLNot available68876-77-7x 1069Concentrated apple juiceNLNot availableNot availablex1070 Orange, 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. CH232-433-88028-48-6x1071 Garlic, 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