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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Substance/product-type combinations notified pursuant to Article 14(3) and found compliant with Article 17(2) of Delegated Regulation (EU) No 1062/2014 should be included in part 1 of Annex II to that Regulation and removed from part 2 of that Annex.
According to Article 16(4) of Delegated Regulation (EU) No 1062/2014, an invitation was published where any person with an interest could notify the relevant active substance/product-type combination(s). One notification pursuant to Article 16(5) of Delegated Regulation (EU) No 1062/2014 and concerning dialuminium chloride pentahydroxide for use in product-type 2, was made before the deadline and was found compliant with Article 17(2) of Delegated Regulation (EU) No 1062/2014. Therefore this substance/product-type combination has to be included in part 1 of Annex II to that Regulation.
The Evaluating Competent Authority should be appointed pursuant to Article 81 of Regulation (EU) No 528/2012 for the active substance/product-type combinations mentioned in recital 3 and 4.
Active substance/product-type combinations for which a decision of approval or non-approval has been adopted since 4 August 2014 are no longer in the review programme, and therefore shall no longer be referred to in part 1 of Annex II to Delegated Regulation (EU) No 1062/2014.
The substance/product-type combinations listed in part 2 of Annex II to Delegated Regulation (EU) No 1062/2014 that were not notified pursuant to Article 14(3) of the Review Regulation should be removed from part 2 of that Annex. Part 2 of that Annex therefore becomes obsolete and should be removed.
Consequently, part 1 of Annex II to Delegated Regulation (EU) No 1062/2014 should become Annex II as it is the only remaining part in Annex II and references to Article 14(3) and part 1 of Annex II need to be removed.
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)
In Article 14, paragraph 3 is deleted.
- (2)
Article 17 is amended as follows:
- (a)
paragraph 1 is replaced by the following:
‘1.
Notifications pursuant to Article 14(2) or Article 16(5) shall be made to the Agency through the Register.’
- (b)
in paragraph 7, point (a) is replaced by the following:
‘(a)
where the notification has been submitted pursuant to Article 14(2), update the information in the Register with respect to the identity of the participant and, where relevant, of the substance;’.
- (a)
- (3)
In Article 20 points (b) and (c) are replaced by the following:
- ‘(b)
where no person has submitted a notification within the time limits provided for by Article 14(2) of this Regulation, or where such a notification has been submitted and rejected pursuant to Article 17(4) or Article 17(5) thereof;
- (c)
where a notification has been submitted within the time limits provided for by Article 14(2) of this Regulation and has been found compliant pursuant to Article 17(5) thereof, but the substance identity in the notification only covers part of the existing identity in Annex II to this Regulation.’.
- ‘(b)
- (4)
Annex II is replaced by the text 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 February 2017.
For the Commission
The President
Jean-Claude Juncker
ANNEX
‘ANNEX IISUBSTANCE/PRODUCT-TYPE COMBINATIONS INCLUDED IN THE REVIEW PROGRAMME ON 3 FEBRUARY 2017
Active substance/product-type combinations supported on 3 February 2017 excluding any other nanomaterial than those explicitly mentioned in entries 1017, 1019 and 1023
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
6
2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether (Piperonyl butoxide/PBO)
EL
200-076-7
51-03-6
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
43
Salicylic acid
NL
200-712-3
69-72-7
x
x
x
45
Propan-1-ol
DE
200-746-9
71-23-8
x
x
x
52
Ethylene oxide
N
200-849-9
75-21-8
x
60
Citric acid
BE
201-069-1
77-92-9
x
69
Glycolic acid
NL
201-180-5
79-14-1
x
x
x
70
Peracetic acid
FI
201-186-8
79-21-0
x
x
71
L-(+)-lactic acid
DE
201-196-2
79-33-4
x
x
x
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
Cinnamaldehyde/3-phenyl-propen-2-al (Cinnamic aldehyde)
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
Clorophene (Chlorophene)
N
204-385-8
120-32-1
x
x
171
2-Phenoxyethanol
UK
204-589-7
122-99-6
x
x
x
x
x
172
Cetylpyridinium chloride
UK
204-593-9
123-03-5
x
179
Carbon dioxide
FR
204-696-9
124-38-9
x
180
Sodium dimethylarsinate (Sodium Cacodylate)
PT
204-708-2
124-65-2
x
185
Tosylchloramide sodium (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
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
288
N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide (Dichlofluanid)
UK
214-118-7
1085-98-9
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
x
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 ethyl sulphate (MES)
PL
221-106-5
3006-10-8
x
359
(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
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
x
1023
Silver, as a nanomaterial
SE
231-131-3
7440-22-4
x
x
x
405
Sulphur dioxide
DE
231-195-2
7446-09-5
x
424
Sodium bromide
NL
231-599-9
7647-15-6
x
x
x
432
Sodium hypochlorite
IT
231-668-3
7681-52-9
x
x
x
x
x
x
x
434
Tetramethrin
DE
231-711-6
7696-12-0
x
439
Hydrogen peroxide
FI
231-765-0
7722-84-1
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 peroxodisulphate/Sodium persulphate
PT
231-892-1
7775-27-1
x
455
Calcium hypochlorite
IT
231-908-7
7778-54-3
x
x
x
x
x
457
Chlorine
IT
231-959-5
7782-50-5
x
x
x
458
Ammonium sulphate
UK
231-984-1
7783-20-2
x
x
1016
Silver chloride
SE
232-033-3
7783-90-6
x
x
x
x
x
x
x
473
Pyrethrins and Pyrethroids
ES
232-319-8
8003-34-7
x
x
491
Chlorine dioxide
PT
233-162-8
10049-04-4
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
Ammonium bromide
SE
235-183-8
12124-97-9
x
x
522
Pyrithione zinc (Zinc pyrithione)
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
526
Potassium 2-biphenylate
ES
237-243-9
13707-65-8
x
x
x
x
529
Bromine chloride
NL
237-601-4
13863-41-7
x
531
(benzyloxy)methanol
UK
238-588-8
14548-60-8
x
x
541
Sodium p-chloro-m-cresolate
FR
239-825-8
15733-22-9
x
x
x
x
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)
N
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
.alpha.,.alpha.′,.alpha.′-trimethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol (HPT)
AT
246-764-0
25254-50-6
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/Bromochlorodimethylhydantoin)
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
606
.alpha.-cyano-3-phenoxybenzyl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Cyphenothrin)
EL
254-484-5
39515-40-7
x
608
Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloride
PL
255-451-8
41591-87-1
x
609
Mixture of cis- and trans-p-menthane-3,8 diol (Citriodiol)
UK
255-953-7
42822-86-6
x
614
(RS)-α-cyano-3phenoxybenzyl-(1RS)- cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Cypermethrin)
BE
257-842-9
52315-07-8
x
618
1-ethynyl-2-methylpent-2-enyl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Empenthrin)
BE
259-154-4
54406-48-3
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
x
648
4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro- 2-octyl-2H- isothiazol-3-one (DCOIT))
N
264-843-8
64359-81-5
x
x
x
x
656
3,3′-methylenebis[5-methyloxazolidine] (Oxazolidin/MBO)
AT
266-235-8
66204-44-2
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
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(peroxymonosulphate) bis(sulphate)
SI
274-778-7
70693-62-8
x
x
x
x
701
Magnesium monoperoxyphthalate hexahydrate (MMPP)
PL
279-013-0
84665-66-7
x
1015
Margosa extract
DE
283-644-7
84696-25-3
x
1024
Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide
DE
283-644-7
84696-25-3
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
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
x
x
791
2-butyl-benzo[d]isothiazol-3-one (BBIT)
CZ
420-590-7
4299-07-4
x
x
x
x
x
792
Tetrachlorodecaoxide complex (TCDO)
DE
420-970-2
92047-76-2
x
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 (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
800
[2,4-Dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-cis-chrysanthemate;[2,4-Dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-trans-chrysanthemate (Imiprothrin)
UK
428-790-6
72963-72-5
x
807
(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine (Clothianidin)
DE
433-460-1
210880-92-5
952
Bacillus sphaericus other than Bacillus sphaericus 2362, strain ABTS-1743
IT
Micro-organism
143447-72-7
x
955
Bacillus thuringiensis subsp.israelensis Serotype H14, other than strain AM65-52 and other than strain SA3A
IT
Micro-organism
Not applicable
x
957
Bacillus subtilis
DE
Micro-organism
Not applicable
x
939
Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ
SK
Mixture
Not applicable
x
x
x
x
813
Peroxyoctanoic acid
FR
Not applicable
33734-57-5
x
x
x
1014
Silver zeolite
SE
Not applicable
Not applicable
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
x
1013
Silver copper zeolite
SE
Not available
130328-19-7
x
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
1019
Silicon dioxide (as a nanomaterial formed by aggregates and agglomerates)
FR
Not available
68909-20-6
x
831
Silicium dioxide (Silicium dioxide/Kieselguhr)
FR
Plant protection product
61790-53-2
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
848
N-((6-Chloro-3-pyridinyl)methyl)-N′-cyano-N-methylethanimidamide (Acetamiprid)
BE
Plant protection product
160430-64-8
x
835
Esfenvalerate/(S)-.alpha.-Cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate (Esfenvalerate)
PT
Plant protection product
66230-04-4
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
863
Monohydro chloride of polymer of N,N″-1,6-hexanediylbis[N′-cyanoguanidine] (Einecs 240-032-4) and hexamethylenediamine (Einecs 204-679-6)/Polyhexamethylene biguanide (monomer: 1,5-bis(trimethylen)-guanylguanidinium monohydrochloride) (PHMB)
FR
Polymer
27083-27-8/32289-58-0
x
868
Poly(hexamethylenebiguanide)
FR
Polymer
91403-50-8
x
x
x
x
x
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’