Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 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 CouncilText with EEA relevance.

Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 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 (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 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 (OJ L 294, 10.10.2014, p. 1). , as amended by Commission Delegated Regulation (EU) 2017/698 Commission Delegated Regulation (EU) 2017/698 of 3 February 2017 amending Delegated Regulation (EU) No 1062/2014 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 concerning the making available on the market and use of biocidal products (OJ L 103, 19.4.2017, 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 on 3 February 2017. (2) The identities of certain active substances listed in Annex II which can be generated in situ have been redefined pursuant to Article 13 of Delegated Regulation (EU) No 1062/2014 in order to indicate in a more precise manner the active substances and their precursors presently covered in the work programme for systematic examination. (3) Any person with an interest could notify a combination of an active substance and its precursors not yet covered by the new identity. Substance/product-type combinations notified pursuant to Article 14(1)(b) and found compliant by the European Chemicals Agency (the Agency) with Article 17(2) of the Delegated Regulation (EU) No 1062/2014 should be included in Annex II to that Regulation pursuant to its Article 18. (4) Following the declarations received pursuant to Article 16(4) of Delegated Regulation (EU) No 1062/2014, an invitation was published by the Agency where any person with an interest could notify active substances in product-type 19 that benefitted from the derogation for food and feed provided for by Article 6 of Commission Regulation (EC) No 1451/2007 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

. The substance/product-type combinations notified pursuant to Article 16(5) and found compliant by the Agency with Article 17(2) of the Delegated Regulation (EU) No 1062/2014 should be included in Annex II to that Regulation pursuant to its Article 18. (5) It is appropriate to indicate the Member States the competent authorities of which shall be the evaluating competent authorities for the active substance/product-type combinations to be added to Annex II to Delegated Regulation (EU) No 1062/2014. (6) Active substance/product-type combinations for which a decision of approval or non-approval has been taken after 3 February 2017 should no longer be included in Annex II to Delegated Regulation (EU) No 1062/2014. (7) In order to reflect the actual situation and for reasons of legal certainty it is appropriate to provide a list of active substance/product-type combinations included in the programme of review of existing active substances contained in biocidal products on the day of adoption of this Regulation. (8) Delegated Regulation (EU) No 1062/2014 should therefore be amended accordingly, HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Delegated Regulation (EU) No 1062/2014 is replaced by 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 November 2018. For the Commission The President Jean-Claude Juncker

Annex

ANNEX

Annex

ANNEX II SUBSTANCE/PRODUCT-TYPE COMBINATIONS INCLUDED IN THE REVIEW PROGRAMME ON 6 NOVEMBER 2018 Active substance/product-type combinations supported on 6 November 2018, excluding any other nanomaterial than those explicitly mentioned in entries 1017 and 1023, and excluding any generation in situ of the active substance except when explicitly mentioned with the reference to the supported precursor(s). 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 peroxideATxx 1028Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrateATx1029Peracetic 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)UK201-501-983-79-4x85SymcloseneUK201-782-887-90-1xxxxxx92Biphenyl-2-olES201-993-590-43-7xxx1133-Phenyl-propen-2-al (Cinnamaldehyde)UK203-213-9104-55-2x117GeraniolFR203-377-1106-24-1xx122GlyoxalFR203-474-9107-22-2xxx133Hexa-2,4-dienoic acid (Sorbic acid)DE203-768-7110-44-1x154ChloropheneNO204-385-8120-32-1x1712-PhenoxyethanolUK204-589-7122-99-6xxxxx1072Carbon dioxideFR204-696-9124-38-9x

179Carbon dioxide generated from propane, butane or a mixture of both by combustionFRx180Sodium dimethylarsinate (Sodium Cacodylate)PT204-708-2124-65-2x185Tosylchloramide sodium (Chloramin T)ES204-854-7127-65-1xxxx187Potassium dimethyldithiocarbamateUK204-875-1128-03-0xxx188Sodium dimethyldithiocarbamateUK204-876-7128-04-1xxx195Sodium 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 321MonolinuronUK217-129-51746-81-2x330N-(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 dihydrateUK220-767-751580-86-0xxxxxx345Troclosene sodiumUK220-767-72893-78-9xxxxxx348Mecetronium 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)PL223-805-04080-31-3xxx3772,2′,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)ES226-408-05395-50-6xxxxx392Methylene 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 chlorineNLxxx1032Active bromine generated from sodium bromide by electrolysisNLxxx1033Active bromine generated from hypobromous acid and urea and bromoureaNLxx 1034Active 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 hypochloriteITxx455Active chlorine released from calcium hypochloriteITx457Active chlorine released from chlorineITx458Monochloramine generated from ammonium sulfate and a chlorine sourceUKxx1016Silver chlorideSE232-033-37783-90-6xxxxx

473Pyrethrins 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 acidPTxxxx1041Chlorine 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)DK233-539-710222-01-2xxxxxx 501CarbendazimDE234-232-010605-21-7xxx1022Dialuminium chloride pentahydroxideNL234-933-112042-91-0x515Bromide activated chloramine (BAC) generated from precursors ammonium bromide and sodium hypochloriteSExx522Pyrithione zincSE236-671-313463-41-7xxxxxx524Dodecylguanidine monohydrochlorideES237-030-013590-97-1xx529Active bromine generated from bromine chlorideNLx531(Benzyloxy)methanolUK238-588-814548-60-8xx550D-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]tolueneUK243-468-320018-09-1xxxx559(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)EL245-387-923031-36-9x 563Potassium (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)UK247-761-726530-20-1xxxxxx577Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chlorideES248-595-827668-52-6xxx588Bromochloro-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)UK252-626-035575-96-3x608Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloridePL255-451-841591-87-1x1045Eucalyptus citriodora oil, hydrated, cyclizedUK1245629-80-4x 1046Cymbopogon winterianus oil, fractionated, hydrated, cyclizedUKNot availableNot availablex1047Eucalyptus citriodora oil and citronellal, hydrated, cyclizedUKNot availableNot availablex6092-Hydroxy-α,α,4-trimethylcyclohexanemethanolUK255-953-742822-86-6x6193-Iodo-2-propynylbutylcarbamate (IPBC)DK259-627-555406-53-6xxx620Tetrakis(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))IT270-331-568424-95-3xxxxxxxx

690Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS)MT273-545-768989-01-5xx691Sodium N-(hydroxymethyl)glycinateAT274-357-870161-44-3x692Amines, C10-16-alkyldimethyl, N-oxidesPT274-687-270592-80-2x693Pentapotassium 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 electrolysisFRx 1052Active chlorine generated from magnesium chloride hexahydrate by electrolysisFRx1053Active chlorine generated from potassium chloride by electrolysisDKxx1054Active chlorine generated from sodium N- chlorosulfamateSIxxx1055Active 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))IT287-089-185409-22-9xxxxxxxx 725Alkyl (C12-C14) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C12-C14))IT287-090-785409-23-0xxxxxxxx731Chrysanthemum cinerariaefolium, ext.ES289-699-389997-63-7x1057Chrysanthemum 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)CZ420-590-74299-07-4xxxxx 792Chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidificationDExx811Silver sodium hydrogen zirconium phosphateSE422-570-3265647-11-8xxxxx794sec-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 available130328-20-0xxxx

1013Silver copper zeoliteSENot available130328-19-7xxxx1017Silver 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 available68876-77-7x1069Concentrated apple juiceNLNot availableNot availablex 1070 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.