2012 concerning the making available on the market and use of biocidal products - Main contents

1. Legislative text

19.4.2017

Official Journal of the European Union

L 103/1

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,

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 (1) and in particular Article 89(1) thereof,

Whereas:

(1)	Commission Delegated Regulation (EU) No 1062/2014 (2) sets out, in its Annex II, an exhaustive list of existing active substances/product-type combinations included in the programme of review of existing biocidal active substances on 4 August 2014.

(2)

According to Article 14(3) of Delegated Regulation (EU) No 1062/2014, any person could have notified a substance/product-type combination included in part 2 of Annex II thereto within 12 months from the entry into force of that Regulation. Since that deadline has passed, part 2 of Annex II and Article 14(3) of that Regulation have become obsolete and Commission Implementing Decision (EU) 2016/1950 (3) has been taken not approving these substance/product type combinations.

(3)	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.

(4)

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.

(5)	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.

(6)	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.

(7)

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.

(8)	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.

(9)	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;’.

(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.’.

(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

(1)

OJ L 167, 27.6.2012, p. 1.

(2)

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 (OJ L 294, 10.10.2014, p. 1).

(3)

Commission Implementing Decision (EU) 2016/1950 of 4 November 2016 on the non-approval of certain biocidal active substances pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 300, 8.11.2016, p. 14).

ANNEX

‘

ANNEX II

SUBSTANCE/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

Formaldehyde

200-001-8

50-00-0

2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether (Piperonyl butoxide/PBO)

200-076-7

51-03-6

Bronopol

200-143-0

52-51-7

Ethanol

200-578-6

64-17-5

Formic acid

200-579-1

64-18-6

Salicylic acid

200-712-3

69-72-7

Propan-1-ol

200-746-9

71-23-8

Ethylene oxide

200-849-9

75-21-8

Citric acid

201-069-1

77-92-9

Glycolic acid

201-180-5

79-14-1

Peracetic acid

201-186-8

79-21-0

L-(+)-lactic acid

201-196-2

79-33-4

(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)

201-501-9

83-79-4

Symclosene

201-782-8

87-90-1

Biphenyl-2-ol

201-993-5

90-43-7

113

Cinnamaldehyde/3-phenyl-propen-2-al (Cinnamic aldehyde)

203-213-9

104-55-2

117

Geraniol

203-377-1

106-24-1

122

Glyoxal

203-474-9

107-22-2

133

Hexa-2,4-dienoic acid (Sorbic acid)

203-768-7

110-44-1

154

Clorophene (Chlorophene)

204-385-8

120-32-1

171

2-Phenoxyethanol

204-589-7

122-99-6

172

Cetylpyridinium chloride

204-593-9

123-03-5

179

Carbon dioxide

204-696-9

124-38-9

180

Sodium dimethylarsinate (Sodium Cacodylate)

204-708-2

124-65-2

185

Tosylchloramide sodium (Tosylchloramide sodium — Chloramin T)

204-854-7

127-65-1

187

Potassium dimethyldithiocarbamate

204-875-1

128-03-0

188

Sodium dimethyldithiocarbamate

204-876-7

128-04-1

195

Sodium 2-biphenylate

205-055-6

132-27-4

206

Thiram

205-286-2

137-26-8

210

Metam-sodium

205-293-0

137-42-8

227

2-thiazol-4-yl-1H-benzoimidazole (Thiabendazole)

205-725-8

148-79-8

235

Diuron

206-354-4

330-54-1

239

Cyanamide

206-992-3

420-04-2

253

Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet)

208-576-7

533-74-4

283

Terbutryn

212-950-5

886-50-0

288

N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide (Dichlofluanid)

214-118-7

1085-98-9

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)

214-619-0

1166-46-7

321

Monolinuron

217-129-5

1746-81-2

330

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine)

219-145-8

2372-82-9

336

2,2′-dithiobis[N-methylbenzamide] (DTBMA)

219-768-5

2527-58-4

339

1,2-benzisothiazol-3(2H)-one (BIT)

220-120-9

2634-33-5

341

2-methyl-2H-isothiazol-3-one (MIT)

220-239-6

2682-20-4

346

Sodium dichloroisocyanurate dihydrate

220-767-7

51580-86-0

345

Troclosene sodium

220-767-7

2893-78-9

348

Mecetronium ethyl sulphate (MES)

221-106-5

3006-10-8

359

(ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm))

222-720-6

3586-55-8

365

Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione)

223-296-5

3811-73-2

368

Methenamine 3-chloroallylochloride (CTAC)

223-805-0

4080-31-3

377

2,2′,2′-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (HHT)

225-208-0

4719-04-4

382

Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD)

226-408-0

5395-50-6

392

Methylene dithiocyanate

228-652-3

6317-18-6

393

1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH)

229-222-8

6440-58-0

397

Didecyldimethylammonium chloride (DDAC)

230-525-2

7173-51-5

401

Silver

231-131-3

7440-22-4

1023

Silver, as a nanomaterial

231-131-3

7440-22-4

405

Sulphur dioxide

231-195-2

7446-09-5

424

Sodium bromide

231-599-9

7647-15-6

432

Sodium hypochlorite

231-668-3

7681-52-9

434

Tetramethrin

231-711-6

7696-12-0

439

Hydrogen peroxide

231-765-0

7722-84-1

444

7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO)

231-810-4

7747-35-5

450

Silver nitrate

231-853-9

7761-88-8

453

Disodium peroxodisulphate/Sodium persulphate

231-892-1

7775-27-1

455

Calcium hypochlorite

231-908-7

7778-54-3

457

Chlorine

231-959-5

7782-50-5

458

Ammonium sulphate

231-984-1

7783-20-2

1016

Silver chloride

232-033-3

7783-90-6

473

Pyrethrins and Pyrethroids

232-319-8

8003-34-7

491

Chlorine dioxide

233-162-8

10049-04-4

494

2,2-dibromo-2-cyanoacetamide (DBNPA)

233-539-7

10222-01-2

501

Carbendazim

234-232-0

10605-21-7

1022

Dialuminium chloride pentahydroxide

234-933-1

12042-91-0

515

Ammonium bromide

235-183-8

12124-97-9

522

Pyrithione zinc (Zinc pyrithione)

236-671-3

13463-41-7

524

Dodecylguanidine monohydrochloride

237-030-0

13590-97-1

526

Potassium 2-biphenylate

237-243-9

13707-65-8

529

Bromine chloride

237-601-4

13863-41-7

531

(benzyloxy)methanol

238-588-8

14548-60-8

541

Sodium p-chloro-m-cresolate

239-825-8

15733-22-9

550

D-gluconic acid, compound with N,N′-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG)

242-354-0

18472-51-0

554

p-[(diiodomethyl)sulphonyl]toluene

243-468-3

20018-09-1

559

(benzothiazol-2-ylthio)methyl thiocyanate (TCMTB)

244-445-0

21564-17-0

562

2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin)

245-387-9

23031-36-9

563

Potassium (E,E)-hexa-2,4-dienoate (Potassium Sorbate)

246-376-1

24634-61-5

566

.alpha.,.alpha.′,.alpha.′-trimethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol (HPT)

246-764-0

25254-50-6

571

2-octyl-2H-isothiazol-3-one (OIT)

247-761-7

26530-20-1

577

Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride

248-595-8

27668-52-6

588

Bromochloro-5,5-dimethylimidazolidine-2,4-dione (BCDMH/Bromochlorodimethylhydantoin)

251-171-5

32718-18-6

590

3-(4-isopropylphenyl)-1,1-dimethylurea/Isoproturon

251-835-4

34123-59-6

597

1-[2-(allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole (Imazalil)

252-615-0

35554-44-0

599

S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos)

252-626-0

35575-96-3

606

.alpha.-cyano-3-phenoxybenzyl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Cyphenothrin)

254-484-5

39515-40-7

608

Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloride

255-451-8

41591-87-1

609

Mixture of cis- and trans-p-menthane-3,8 diol (Citriodiol)

255-953-7

42822-86-6

614

(RS)-α-cyano-3phenoxybenzyl-(1RS)- cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Cypermethrin)

257-842-9

52315-07-8

618

1-ethynyl-2-methylpent-2-enyl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Empenthrin)

259-154-4

54406-48-3

619

3-iodo-2-propynylbutylcarbamate (IPBC)

259-627-5

55406-53-6

620

Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS)

259-709-0

55566-30-8

648

4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro- 2-octyl-2H- isothiazol-3-one (DCOIT))

264-843-8

64359-81-5

656

3,3′-methylenebis[5-methyloxazolidine] (Oxazolidin/MBO)

266-235-8

66204-44-2

667

Alkyl (C12-18) dimethylbenzyl ammonium chloride (ADBAC (C12-18))

269-919-4

68391-01-5

671

Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16))

270-325-2

68424-85-1

673

Didecyldimethylammonium chloride (DDAC (C8-10))

270-331-5

68424-95-3

690

Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS)

273-545-7

68989-01-5

691

Sodium N-(hydroxymethyl)glycinate

274-357-8

70161-44-3

692

Amines, C10-16-alkyldimethyl, N-oxides

274-687-2

70592-80-2

693

Pentapotassium bis(peroxymonosulphate) bis(sulphate)

274-778-7

70693-62-8

701

Magnesium monoperoxyphthalate hexahydrate (MMPP)

279-013-0

84665-66-7

1015

Margosa extract

283-644-7

84696-25-3

1024

Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide

283-644-7

84696-25-3

724

Alkyl (C12-C14) dimethylbenzylammonium chloride (ADBAC (C12-C14))

287-089-1

85409-22-9

725

Alkyl (C12-C14) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C12-C14))

287-090-7

85409-23-0

731

Chrysanthemum cinerariaefolium, ext.

289-699-3

89997-63-7

744

Lavender, Lavandula hybrida, ext./Lavandin oil

294-470-6

91722-69-9

779

Reaction products of: glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin)

403-950-8

164907-72-6

785

6-(phthalimido)peroxyhexanoic acid (PAP)

410-850-8

128275-31-0

791

2-butyl-benzo[d]isothiazol-3-one (BBIT)

420-590-7

4299-07-4

792

Tetrachlorodecaoxide complex (TCDO)

420-970-2

92047-76-2

811

Silver sodium hydrogen zirconium phosphate

422-570-3

265647-11-8

794

sec-butyl 2-(2-hydroxyethyl)piperidine-1-carboxylate/Icaridine (Icaridine)

423-210-8

119515-38-7

797

cis-1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC)

426-020-3

51229-78-8

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)

428-790-6

72963-72-5

807

(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine (Clothianidin)

433-460-1

210880-92-5

952

Bacillus sphaericus other than Bacillus sphaericus 2362, strain ABTS-1743

Micro-organism

143447-72-7

955

Bacillus thuringiensis subsp.israelensis Serotype H14, other than strain AM65-52 and other than strain SA3A

Micro-organism

Not applicable

957

Bacillus subtilis

Micro-organism

Not applicable

939

Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ

Mixture

Not applicable

813

Peroxyoctanoic acid

Not applicable

33734-57-5

1014

Silver zeolite

Not applicable

152

Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH)

Not available

459

Reaction mass of titanium dioxide and silver chloride

Not available

777

Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH)

Not available

810

Silver phosphate glass

Not available

308069-39-8

824

Silver zinc zeolite

Not available

130328-20-0

1013

Silver copper zeolite

Not available

130328-19-7

1017

Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale)

Not available

1019

Silicon dioxide (as a nanomaterial formed by aggregates and agglomerates)

Not available

68909-20-6

831

Silicium dioxide (Silicium dioxide/Kieselguhr)

Plant protection product

61790-53-2

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)

Plant protection product

231937-89-6

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)

Plant protection product

260359-57-7

848

N-((6-Chloro-3-pyridinyl)methyl)-N′-cyano-N-methylethanimidamide (Acetamiprid)

Plant protection product

160430-64-8

835

Esfenvalerate/(S)-.alpha.-Cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate (Esfenvalerate)

Plant protection product

66230-04-4

843

4-bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr)

Plant protection product

122453-73-0

859

Polymer of N-Methylmethanamine (Einecs 204-697-4 with (chloromethyl)oxirane (Einecs 203-439-8)/Polymeric quaternary ammonium chloride (PQ Polymer)

Polymer

25988-97-0

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)

Polymer

27083-27-8/32289-58-0

868

Poly(hexamethylenebiguanide)

Polymer

91403-50-8

869

Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26)

Polymer

94667-33-1

872

N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine)

Polymer

214710-34-6

’

This summary has been adopted from EUR-Lex.