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,
Whereas:
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.
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.
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.
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.
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.
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 IISUBSTANCE/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 number
Substance name
Rapporteur Member State
EC number
CAS number
1
2
3
4
5
6
7
8
9
10
11
12
13
17
18
19
21
22
1
Formaldehyde
DE
200-001-8
50-00-0
x
x
x
9
Bronopol
ES
200-143-0
52-51-7
x
x
x
x
x
x
36
Ethanol
EL
200-578-6
64-17-5
x
x
x
37
Formic acid
BE
200-579-1
64-18-6
x
x
x
x
x
x
x
1025
Performic acid generated from formic acid and hydrogen peroxide
BE
x
x
x
x
x
x
x
43
Salicylic acid
NL
200-712-3
69-72-7
x
x
x
52
Ethylene oxide
NO
200-849-9
75-21-8
x
69
Glycolic acid
NL
201-180-5
79-14-1
x
x
x
1026
Peracetic acid generated from tetraacetylethylenediamine (TAED) and hydrogen peroxide
AT
x
1027
Peracetic acid generated from 1,3- diacetyloxypropan-2-yl acetate and hydrogen peroxide
AT
x
x
1028
Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrate
AT
x
1029
Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions
AT
x
71
L-(+)-lactic acid
DE
201-196-2
79-33-4
x
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)
UK
201-501-9
83-79-4
x
85
Symclosene
UK
201-782-8
87-90-1
x
x
x
x
x
x
92
Biphenyl-2-ol
ES
201-993-5
90-43-7
x
x
x
113
3-Phenyl-propen-2-al (Cinnamaldehyde)
UK
203-213-9
104-55-2
x
117
Geraniol
FR
203-377-1
106-24-1
x
x
122
Glyoxal
FR
203-474-9
107-22-2
x
x
x
133
Hexa-2,4-dienoic acid (Sorbic acid)
DE
203-768-7
110-44-1
x
154
Chlorophene
NO
204-385-8
120-32-1
x
171
2-Phenoxyethanol
UK
204-589-7
122-99-6
x
x
x
x
x
1072
Carbon dioxide
FR
204-696-9
124-38-9
x
179
Carbon dioxide generated from propane, butane or a mixture of both by combustion
FR
x
180
Sodium dimethylarsinate (Sodium Cacodylate)
PT
204-708-2
124-65-2
x
185
Tosylchloramide sodium (Chloramin T)
ES
204-854-7
127-65-1
x
x
x
x
187
Potassium dimethyldithiocarbamate
UK
204-875-1
128-03-0
x
x
x
188
Sodium dimethyldithiocarbamate
UK
204-876-7
128-04-1
x
x
x
195
Sodium 2-biphenylate
ES
205-055-6
132-27-4
x
x
x
x
x
x
206
Thiram
BE
205-286-2
137-26-8
x
210
Metam-sodium
BE
205-293-0
137-42-8
x
x
227
2-Thiazol-4-yl-1H-benzoimidazole (Thiabendazole)
ES
205-725-8
148-79-8
x
x
x
235
Diuron
DK
206-354-4
330-54-1
x
x
239
Cyanamide
DE
206-992-3
420-04-2
x
x
253
Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet)
BE
208-576-7
533-74-4
x
x
283
Terbutryn
SK
212-950-5
886-50-0
x
x
x
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)
DE
214-619-0
1166-46-7
x
321
Monolinuron
UK
217-129-5
1746-81-2
x
330
N-(3-Aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine)
PT
219-145-8
2372-82-9
x
x
x
x
x
x
x
x
336
2,2′-Dithiobis[N-methylbenzamide] (DTBMA)
PL
219-768-5
2527-58-4
x
339
1,2-Benzisothiazol-3(2H)-one (BIT)
ES
220-120-9
2634-33-5
x
x
x
x
x
x
341
2-Methyl-2H-isothiazol-3-one (MIT)
SI
220-239-6
2682-20-4
x
346
Sodium dichloroisocyanurate dihydrate
UK
220-767-7
51580-86-0
x
x
x
x
x
x
345
Troclosene sodium
UK
220-767-7
2893-78-9
x
x
x
x
x
x
348
Mecetronium ethylsulfate (MES)
PL
221-106-5
3006-10-8
x
359
Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm))
PL
222-720-6
3586-55-8
x
x
x
x
x
365
Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)
SE
223-296-5
3811-73-2
x
x
x
x
x
x
368
Methenamine 3-chloroallylochloride (CTAC)
PL
223-805-0
4080-31-3
x
x
x
377
2,2′,2″-(Hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (HHT)
PL
225-208-0
4719-04-4
x
x
x
x
382
Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD)
ES
226-408-0
5395-50-6
x
x
x
x
x
392
Methylene dithiocyanate
FR
228-652-3
6317-18-6
x
393
1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH)
PL
229-222-8
6440-58-0
x
x
397
Didecyldimethylammonium chloride (DDAC)
IT
230-525-2
7173-51-5
x
x
x
x
x
x
x
x
401
Silver
SE
231-131-3
7440-22-4
x
x
x
x
1023
Silver, as a nanomaterial
SE
231-131-3
7440-22-4
x
x
x
405
Sulfur dioxide generated from sulfur by combustion
DE
x
424
Active bromine generated from sodium bromide and sodium hypochlorite
NL
x
x
x
1030
Active bromine generated from sodium bromide and calcium hypochlorite
NL
x
x
x
1031
Active bromine generated from sodium bromide and chlorine
NL
x
x
x
1032
Active bromine generated from sodium bromide by electrolysis
NL
x
x
x
1033
Active bromine generated from hypobromous acid and urea and bromourea
NL
x
x
1034
Active bromine generated from sodium hypobromite and N-bromosulfamate and sulfamic acid
NL
x
1035
Active bromine generated from ozone and bromide of natural water and sodium bromide
NL
x
434
Tetramethrin
DE
231-711-6
7696-12-0
x
439
Hydrogen peroxide
FI
231-765-0
7722-84-1
x
x
1036
Hydrogen peroxide released from sodium percarbonate
FI
x
x
x
444
7a-Ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO)
PL
231-810-4
7747-35-5
x
x
450
Silver nitrate
SE
231-853-9
7761-88-8
x
453
Disodium peroxodisulfate
PT
231-892-1
7775-27-1
x
432
Active chlorine released from sodium hypochlorite
IT
x
x
455
Active chlorine released from calcium hypochlorite
IT
x
457
Active chlorine released from chlorine
IT
x
458
Monochloramine generated from ammonium sulfate and a chlorine source
UK
x
x
1016
Silver chloride
SE
232-033-3
7783-90-6
x
x
x
x
x
473
Pyrethrins and Pyrethroids
ES
232-319-8
8003-34-7
x
x
491
Chlorine dioxide
DE
233-162-8
10049-04-4
x
x
x
x
x
x
1037
Chlorine dioxide generated from sodium chlorite by electrolysis
PT
x
x
x
x
x
x
1038
Chlorine dioxide generated from sodium chlorite by acidification
PT
x
x
x
x
x
x
1039
Chlorine dioxide generated from sodium chlorite by oxidation
PT
x
x
x
x
x
x
1040
Chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acid
PT
x
x
x
x
1041
Chlorine dioxide generated from sodium chloride by electrolysis
DE
x
x
x
x
x
x
1042
Chlorine dioxide generated from sodium chlorite and sodium bisulfate and hydrochloric acid
DE
x
x
1043
Chlorine dioxide generated from sodium chlorite and sodium bisulfate
DE
x
x
x
x
x
x
1044
Chlorine dioxide generated from sodium chlorite and sodium persulfate
DE
x
x
x
x
x
x
494
2,2-Dibromo-2-cyanoacetamide (DBNPA)
DK
233-539-7
10222-01-2
x
x
x
x
x
x
501
Carbendazim
DE
234-232-0
10605-21-7
x
x
x
1022
Dialuminium chloride pentahydroxide
NL
234-933-1
12042-91-0
x
515
Bromide activated chloramine (BAC) generated from precursors ammonium bromide and sodium hypochlorite
SE
x
x
522
Pyrithione zinc
SE
236-671-3
13463-41-7
x
x
x
x
x
x
524
Dodecylguanidine monohydrochloride
ES
237-030-0
13590-97-1
x
x
529
Active bromine generated from bromine chloride
NL
x
531
(Benzyloxy)methanol
UK
238-588-8
14548-60-8
x
x
550
D-Gluconic acid, compound with N,N′-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG)
PT
242-354-0
18472-51-0
x
x
x
554
p-[(Diiodomethyl)sulphonyl]toluene
UK
243-468-3
20018-09-1
x
x
x
x
559
(Benzothiazol-2-ylthio)methyl thiocyanate (TCMTB)
NO
244-445-0
21564-17-0
x
x
562
2-Methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin)
EL
245-387-9
23031-36-9
x
563
Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate)
DE
246-376-1
24634-61-5
x
566
Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) (HPT)
AT
x
x
x
x
571
2-Octyl-2H-isothiazol-3-one (OIT)
UK
247-761-7
26530-20-1
x
x
x
x
x
x
577
Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride
ES
248-595-8
27668-52-6
x
x
x
588
Bromochloro-5,5-dimethylimidazolidine-2,4-dione (BCDMH)
NL
251-171-5
32718-18-6
x
x
x
590
3-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon)
DE
251-835-4
34123-59-6
x
x
597
1-[2-(Allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole (Imazalil)
DE
252-615-0
35554-44-0
x
599
S-[(6-Chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos)
UK
252-626-0
35575-96-3
x
608
Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloride
PL
255-451-8
41591-87-1
x
1045
Eucalyptus citriodora oil, hydrated, cyclized
UK
1245629-80-4
x
1046
Cymbopogon winterianus oil, fractionated, hydrated, cyclized
UK
Not available
Not available
x
1047
Eucalyptus citriodora oil and citronellal, hydrated, cyclized
UK
Not available
Not available
x
609
2-Hydroxy-α,α,4-trimethylcyclohexanemethanol
UK
255-953-7
42822-86-6
x
619
3-Iodo-2-propynylbutylcarbamate (IPBC)
DK
259-627-5
55406-53-6
x
x
x
620
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)
MT
259-709-0
55566-30-8
x
x
x
648
4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro- 2-octyl-2H- isothiazol-3-one (DCOIT))
NO
264-843-8
64359-81-5
x
x
x
x
656
Reaction products of paraformaldehyde and 2- hydroxypropylamine (ratio 3:2) (MBO)
AT
x
x
x
x
x
667
Alkyl (C12-18) dimethylbenzyl ammonium chloride (ADBAC (C12-18))
IT
269-919-4
68391-01-5
x
x
x
x
x
x
x
x
671
Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16))
IT
270-325-2
68424-85-1
x
x
x
x
x
x
x
x
673
Didecyldimethylammonium chloride (DDAC (C8-10))
IT
270-331-5
68424-95-3
x
x
x
x
x
x
x
x
690
Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS)
MT
273-545-7
68989-01-5
x
x
691
Sodium N-(hydroxymethyl)glycinate
AT
274-357-8
70161-44-3
x
692
Amines, C10-16-alkyldimethyl, N-oxides
PT
274-687-2
70592-80-2
x
693
Pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS)
SI
274-778-7
70693-62-8
x
x
x
x
939
Active chlorine generated from sodium chloride by electrolysis
SK
x
x
x
x
x
x
1048
Active chlorine released from hypochlorous acid
SK
x
x
x
x
1049
Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate)
SI
x
x
x
x
1050
Active chlorine generated from seawater (sodium chloride) by electrolysis
FR
x
1051
Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysis
FR
x
1052
Active chlorine generated from magnesium chloride hexahydrate by electrolysis
FR
x
1053
Active chlorine generated from potassium chloride by electrolysis
DK
x
x
1054
Active chlorine generated from sodium N- chlorosulfamate
SI
x
x
x
1055
Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) and sulfamic acid
SI
x
x
1056
Active chlorine generated from hydrochloric acid by electrolysis
SI
x
x
x
701
Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) (MMPP)
PL
279-013-0
84665-66-7
x
1024
Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide
DE
x
724
Alkyl (C12-C14) dimethylbenzylammonium chloride (ADBAC (C12-C14))
IT
287-089-1
85409-22-9
x
x
x
x
x
x
x
x
725
Alkyl (C12-C14) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C12-C14))
IT
287-090-7
85409-23-0
x
x
x
x
x
x
x
x
731
Chrysanthemum cinerariaefolium, ext.
ES
289-699-3
89997-63-7
x
1057
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvent
ES
x
x
1058
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide
ES
x
x
744
Lavender, Lavandula hybrida, ext./Lavandin oil
PT
294-470-6
91722-69-9
x
779
Reaction products of: glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin)
DE
403-950-8
164907-72-6
x
x
785
6-(Phthalimido)peroxyhexanoic acid (PAP)
IT
410-850-8
128275-31-0
x
x
791
2-Butyl-benzo[d]isothiazol-3-one (BBIT)
CZ
420-590-7
4299-07-4
x
x
x
x
x
792
Chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidification
DE
x
x
811
Silver sodium hydrogen zirconium phosphate
SE
422-570-3
265647-11-8
x
x
x
x
x
794
sec-Butyl 2-(2-hydroxyethyl)piperidine-1-carboxylate (Icaridine)
DK
423-210-8
119515-38-7
x
797
cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC)
PL
426-020-3
51229-78-8
x
x
813
Peroxyoctanoic acid
FR
33734-57-5
x
x
x
1014
Silver zeolite
SE
Not available
Not available
x
x
x
x
x
152
Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH)
NL
Not available
Not available
x
459
Reaction mass of titanium dioxide and silver chloride
SE
Not available
Not available
x
x
x
x
x
x
x
777
Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH)
NL
Not available
Not available
x
810
Silver phosphate glass
SE
Not available
308069-39-8
x
x
x
824
Silver zinc zeolite
SE
Not available
130328-20-0
x
x
x
x
1013
Silver copper zeolite
SE
Not available
130328-19-7
x
x
x
x
1017
Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale)
SE
Not available
Not available
x
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)
DE
Plant protection product
231937-89-6
x
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)
DE
Plant protection product
260359-57-7
x
843
4-Bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr)
PT
Plant protection product
122453-73-0
x
859
Polymer of N-Methylmethanamine (Einecs 204-697-4 with (chloromethyl)oxirane (Einecs 203-439-8)/Polymeric quaternary ammonium chloride (PQ Polymer)
HU
Polymer
25988-97-0
x
x
868
Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4.7 (PHMB(1415;4.7))
FR
Polymer
32289-58-0 and 1802181-67-4
x
x
x
869
Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26)
IT
Polymer
94667-33-1
x
x
x
872
N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine)
EL
Polymer
214710-34-6
x
1059
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)
BE
Not available
8023-77-6
x
1060
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.
BE
283-403-6
84625-29-6
x
1061
Reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnonanamide
BE
Not available
Not available
x
1062
D-Fructose
AT
200-333-3
57-48-7
x
1063
Honey
AT
8028-66-8
x
1064
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.
AT
232-310-9
8002-48-0
x
1065
Vinegar
(food grade containing a maximum of 10 % acetic acid)
AT
Not available
8028-52-2
x
1066
Cheese
AT
Not available
Not available
x
1067
Powdered egg
NL
Not available
Not available
x
1068
Saccharomyces cerevisiae
NL
Not available
68876-77-7
x
1069
Concentrated apple juice
NL
Not available
Not available
x
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.
CH
232-433-8
8028-48-6
x
1071
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.
AT
232-371-1
8008-99-9
x’