# L_2016300EN.01001401.xml

| 8.11.2016 | EN | Official Journal of the European Union | L 300/14 |
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8.11.2016

EN

Official Journal of the European Union

L 300/14

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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

(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 the third subparagraph of Article 89(1) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) No 1062/2014 (2), in its Annex II, part 2, establishes a list of active substance/product-type combinations, which were not supported on 4 August 2014 and for which, pursuant to Article 14(3) of that Regulation, any person could notify its interest to take over the role of participant for one or more of these substance/product-type combinations within 12 months from the date of entry into force of that Regulation. |
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(1)

Commission Delegated Regulation (EU) No 1062/2014 (2), in its Annex II, part 2, establishes a list of active substance/product-type combinations, which were not supported on 4 August 2014 and for which, pursuant to Article 14(3) of that Regulation, any person could notify its interest to take over the role of participant for one or more of these substance/product-type combinations within 12 months from the date of entry into force of that Regulation.

| (2) | For some substance/product-type combinations no interest has been expressed, or, when an interest was expressed, the notification was rejected pursuant to paragraph 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014. |
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(2)

For some substance/product-type combinations no interest has been expressed, or, when an interest was expressed, the notification was rejected pursuant to paragraph 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014.

| (3) | In accordance with Article 20 of that Regulation, those substance/product-type combinations should not be approved for use in biocidal products. |
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(3)

In accordance with Article 20 of that Regulation, those substance/product-type combinations should not be approved for use in biocidal products.

| (4) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(4)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DECISION:

Article 1

The active substances listed in the Annex to this Decision are not approved for the product-types indicated therein.

Article 2

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 4 November 2016.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 167, 27.6.2012, p. 1.

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 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

2

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ANNEX

Active substance/product type combinations not approved:

| — | the substance/product-type combinations listed in the table below, including any nanomaterial forms, |
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—

the substance/product-type combinations listed in the table below, including any nanomaterial forms,

| — | any nanomaterial forms of all substance/product-type combinations listed in the table in Annex II, part 1 of Delegated Regulation (EU) No 1062/2014, except those nanomaterial forms listed in that table, and |
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—

any nanomaterial forms of all substance/product-type combinations listed in the table in Annex II, part 1 of Delegated Regulation (EU) No 1062/2014, except those nanomaterial forms listed in that table, and

| — | any nanomaterial forms of all active substance/product-type combinations approved by 4 August 2014, except those explicitly approved. |
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—

any nanomaterial forms of all active substance/product-type combinations approved by 4 August 2014, except those explicitly approved.

| Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014 | Substance name | Rapporteur Member State | EC number | CAS number | Product-type(s) |
| --- | --- | --- | --- | --- | --- |
| 1021 | 1,3-dichloro-5,5-dimethylhydantoin (redefined as per entry 152) | NL | 204-258-7 | 118-52-5 | 11 |
| 166 | Cetalkonium chloride (see entry 948) | IT | 204-526-3 | 122-18-9 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 167 | Benzyldimethyl(octadecyl)ammonium chloride (see entry 948) | IT | 204-527-9 | 122-19-0 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 213 | Benzododecinium chloride (see entry 948) | IT | 205-351-5 | 139-07-1 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 214 | Miristalkonium chloride (see entry 948) | IT | 205-352-0 | 139-08-2 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 331 | Didecyldimethylammonium bromide (see entry 949) | IT | 219-234-1 | 2390-68-3 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 384 | Dimethyldioctylammonium chloride (see entry 949) | IT | 226-901-0 | 5538-94-3 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 399 | Benzyldodecyldimethylammonium bromide (see entry 948) | IT | 230-698-4 | 7281-04-1 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 418 | Silicon dioxide — amorphous | FR | 231-545-4 | 7631-86-9 | 18 |
| 449 | Copper sulphate | FR | 231-847-6 | 7758-98-7 | 2 |
| 554 | p-[(diiodomethyl)sulphonyl]toluene | UK | 243-468-3 | 20018-09-1 | 2 |
| 587 | Decyldimethyloctylammonium chloride (see entry 949) | IT | 251-035-5 | 32426-11-2 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 601 | Benzyldimethyloleylammonium chloride (see entry 948) | IT | 253-363-4 | 37139-99-4 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 615 | 3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Permethrin) | IE | 258-067-9 | 52645-53-1 | 9 |
| 637 | Quaternary ammonium compounds, benzylcoco alkyldimethyl, chlorides (see entry 948) | IT | 263-080-8 | 61789-71-7 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 638 | Quaternary ammonium compounds, dicocoalkyl dimethyl, chlorides (see entry 949) | IT | 263-087-6 | 61789-77-3 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 639 | Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides (see entry 949) | IT | 263-090-2 | 61789-80-8 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 647 | Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides (see entry 948) | IT | 264-151-6 | 63449-41-2 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 668 | Quaternary ammonium compounds, di-C6-12-alkyldimethyl, chlorides (see entry 949) | IT | 269-925-7 | 68391-06-0 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 670 | Quaternary ammonium compounds, benzyl-C8-16-alkyldimethyl, chlorides (see entry 948) | IT | 270-324-7 | 68424-84-0 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 689 | Quaternary ammonium compounds, benzyl-C10-16-alkyldimethyl, chlorides (see entry 948) | IT | 273-544-1 | 68989-00-4 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 692 | Amines, C10-16-alkyldimethyl, N-oxides | PT | 274-687-2 | 70592-80-2 | 2 |
| 697 | Quaternary ammonium compounds, di-C8-18-alkyldimethyl, chlorides (see entry 949) | IT | 277-453-8 | 73398-64-8 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 1000 | Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) hexahydrate | PL | 279-013-0 | 14915-85-4 | 2 |
| 998 | Margosa extract other than from the kernels of Azadirachta indica extracted with water and further processed with organic solvents and other than from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide | DE | 283-644-7 | 84696-25-3 | 18 |
| 741 | Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, bromides (see entry 948) | IT | 293-522-5 | 91080-29-4 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 1020 | 1,3-dichloro-5-ethyl-5-methylimidazolidine-2,4-dione (redefined as per entry 777) | NL | 401-570-7 | 89415-87-2 | 11 |
| 778 | 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol (Tebuconazole) | DK | 403-640-2 | 107534-96-3 | 9 |
| 805 | Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide (Perestane) | HU | 432-790-1 | Not applicable | 2 |
| 923 | Alkyl-benzyl-dimethylammonium chloride/Benzalkonium chloride (see entry 948) | IT | Mixture | 8001-54-5 | 1, 2, 3, 4, 8, 10, 11, 12 |
| 949 | Quaternary ammonium compounds (dialkyldimethyl (alkyl from C6-C18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (DDAC) | IT | Mixture of Einecs listed substances | Not applicable | 1, 2, 3, 4, 8, 10, 11, 12 |
| 950 | Quaternary ammonium compounds (alkyltrimethyl (alkyl from C8-C18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (TMAC) | IT | Mixture of Einecs listed substances | Not applicable | 8 |
| 948 | Quaternary ammonium compounds (benzylalkyldimethyl (alkyl from C8-C22, saturated and unsaturated, tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or hydroxides) (BKC) | IT | Mixture of Einecs listed substances | Not applicable | 1, 2, 3, 4, 8, 10, 11, 12 |
| 849 | 3-phenoxybenzyl (1R)-cis,trans-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-Phenothrin) | IE | Not applicable | 188023-86-1 | 18 |
| 1001 | Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides (other than the substance covered by entry 671) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 8, 10, 11, 12, 22 |
| 1002 | Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, chlorides (other than the substance covered by entry 667) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 10, 11, 12, 22 |
| 1003 | Quaternary ammonium compounds, C12-14-alkyl[(ethylphenyl)methyl]dimethyl, chlorides (other than the substance covered by entry 725) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 10, 11, 12, 22 |
| 1005 | Quaternary ammonium compounds, benzyl-C12-14-alkyldimethyl, chlorides (other than the substance covered by entry 724) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 10, 11, 12, 22 |
| 1006 | Silver-zinc-aluminium-boronphosphate glass/Glass oxide, silver- and zinc-containing | SE | Not applicable | 398477-47-9 | 2, 7, 9 |
| 1009 | Quaternary ammonium compounds, di-C8-10-alkyldimethyl, chlorides (other than the substance covered by entry 673) | IT | Not applicable | Not applicable | 1, 2, 3, 4, 5, 6, 10, 11, 12 |
| 1011 | Quaternary ammonium compounds, coco alkyltrimethyl, chlorides (other than the substance covered by entry 635) | IT | Not applicable | Not applicable | 8 |
| 1012 | Aluminium sodium silicate-silver zinc complex/Silver-Zinc-Zeolite | SE | Not applicable | 130328-20-0 | 2, 7, 9 |
| 598 | (±)-1-(.beta.-allyloxy-2,4-dichlorophenylethyl)imidazole (Technical grade imazalil) | DE | Plant protection product | 73790-28-0 | 3 |

Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014

Substance name

Rapporteur Member State

EC number

CAS number

Product-type(s)

1021

1,3-dichloro-5,5-dimethylhydantoin (redefined as per entry 152)

NL

204-258-7

118-52-5

11

166

Cetalkonium chloride (see entry 948)

IT

204-526-3

122-18-9

1, 2, 3, 4, 8, 10, 11, 12

167

Benzyldimethyl(octadecyl)ammonium chloride (see entry 948)

IT

204-527-9

122-19-0

1, 2, 3, 4, 8, 10, 11, 12

213

Benzododecinium chloride (see entry 948)

IT

205-351-5

139-07-1

1, 2, 3, 4, 8, 10, 11, 12

214

Miristalkonium chloride (see entry 948)

IT

205-352-0

139-08-2

1, 2, 3, 4, 8, 10, 11, 12

331

Didecyldimethylammonium bromide (see entry 949)

IT

219-234-1

2390-68-3

1, 2, 3, 4, 8, 10, 11, 12

384

Dimethyldioctylammonium chloride (see entry 949)

IT

226-901-0

5538-94-3

1, 2, 3, 4, 8, 10, 11, 12

399

Benzyldodecyldimethylammonium bromide (see entry 948)

IT

230-698-4

7281-04-1

1, 2, 3, 4, 8, 10, 11, 12

418

Silicon dioxide — amorphous

FR

231-545-4

7631-86-9

18

449

Copper sulphate

FR

231-847-6

7758-98-7

2

554

p-[(diiodomethyl)sulphonyl]toluene

UK

243-468-3

20018-09-1

2

587

Decyldimethyloctylammonium chloride (see entry 949)

IT

251-035-5

32426-11-2

1, 2, 3, 4, 8, 10, 11, 12

601

Benzyldimethyloleylammonium chloride (see entry 948)

IT

253-363-4

37139-99-4

1, 2, 3, 4, 8, 10, 11, 12

615

3-phenoxybenzyl (1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate (Permethrin)

IE

258-067-9

52645-53-1

9

637

Quaternary ammonium compounds, benzylcoco alkyldimethyl, chlorides (see entry 948)

IT

263-080-8

61789-71-7

1, 2, 3, 4, 8, 10, 11, 12

638

Quaternary ammonium compounds, dicocoalkyl dimethyl, chlorides (see entry 949)

IT

263-087-6

61789-77-3

1, 2, 3, 4, 8, 10, 11, 12

639

Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides (see entry 949)

IT

263-090-2

61789-80-8

1, 2, 3, 4, 8, 10, 11, 12

647

Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides (see entry 948)

IT

264-151-6

63449-41-2

1, 2, 3, 4, 8, 10, 11, 12

668

Quaternary ammonium compounds, di-C6-12-alkyldimethyl, chlorides (see entry 949)

IT

269-925-7

68391-06-0

1, 2, 3, 4, 8, 10, 11, 12

670

Quaternary ammonium compounds, benzyl-C8-16-alkyldimethyl, chlorides (see entry 948)

IT

270-324-7

68424-84-0

1, 2, 3, 4, 8, 10, 11, 12

689

Quaternary ammonium compounds, benzyl-C10-16-alkyldimethyl, chlorides (see entry 948)

IT

273-544-1

68989-00-4

1, 2, 3, 4, 8, 10, 11, 12

692

Amines, C10-16-alkyldimethyl, N-oxides

PT

274-687-2

70592-80-2

2

697

Quaternary ammonium compounds, di-C8-18-alkyldimethyl, chlorides (see entry 949)

IT

277-453-8

73398-64-8

1, 2, 3, 4, 8, 10, 11, 12

1000

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) hexahydrate

PL

279-013-0

14915-85-4

2

998

Margosa extract other than from the kernels of Azadirachta indica extracted with water and further processed with organic solvents and other than from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide

DE

283-644-7

84696-25-3

18

741

Quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, bromides (see entry 948)

IT

293-522-5

91080-29-4

1, 2, 3, 4, 8, 10, 11, 12

1020

1,3-dichloro-5-ethyl-5-methylimidazolidine-2,4-dione (redefined as per entry 777)

NL

401-570-7

89415-87-2

11

778

1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol (Tebuconazole)

DK

403-640-2

107534-96-3

9

805

Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide (Perestane)

HU

432-790-1

Not applicable

2

923

Alkyl-benzyl-dimethylammonium chloride/Benzalkonium chloride (see entry 948)

IT

Mixture

8001-54-5

1, 2, 3, 4, 8, 10, 11, 12

949

Quaternary ammonium compounds (dialkyldimethyl (alkyl from C6-C18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (DDAC)

IT

Mixture of Einecs listed substances

Not applicable

1, 2, 3, 4, 8, 10, 11, 12

950

Quaternary ammonium compounds (alkyltrimethyl (alkyl from C8-C18, saturated and unsaturated, and tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or methylsulphates) (TMAC)

IT

Mixture of Einecs listed substances

Not applicable

8

948

Quaternary ammonium compounds (benzylalkyldimethyl (alkyl from C8-C22, saturated and unsaturated, tallow alkyl, coco alkyl, and soya alkyl) chlorides, bromides, or hydroxides) (BKC)

IT

Mixture of Einecs listed substances

Not applicable

1, 2, 3, 4, 8, 10, 11, 12

849

3-phenoxybenzyl (1R)-cis,trans-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-Phenothrin)

IE

Not applicable

188023-86-1

18

1001

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides (other than the substance covered by entry 671)

IT

Not applicable

Not applicable

1, 2, 3, 4, 8, 10, 11, 12, 22

1002

Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, chlorides (other than the substance covered by entry 667)

IT

Not applicable

Not applicable

1, 2, 3, 4, 10, 11, 12, 22

1003

Quaternary ammonium compounds, C12-14-alkyl[(ethylphenyl)methyl]dimethyl, chlorides (other than the substance covered by entry 725)

IT

Not applicable

Not applicable

1, 2, 3, 4, 10, 11, 12, 22

1005

Quaternary ammonium compounds, benzyl-C12-14-alkyldimethyl, chlorides (other than the substance covered by entry 724)

IT

Not applicable

Not applicable

1, 2, 3, 4, 10, 11, 12, 22

1006

Silver-zinc-aluminium-boronphosphate glass/Glass oxide, silver- and zinc-containing

SE

Not applicable

398477-47-9

2, 7, 9

1009

Quaternary ammonium compounds, di-C8-10-alkyldimethyl, chlorides (other than the substance covered by entry 673)

IT

Not applicable

Not applicable

1, 2, 3, 4, 5, 6, 10, 11, 12

1011

Quaternary ammonium compounds, coco alkyltrimethyl, chlorides (other than the substance covered by entry 635)

IT

Not applicable

Not applicable

8

1012

Aluminium sodium silicate-silver zinc complex/Silver-Zinc-Zeolite

SE

Not applicable

130328-20-0

2, 7, 9

598

(±)-1-(.beta.-allyloxy-2,4-dichlorophenylethyl)imidazole (Technical grade imazalil)

DE

Plant protection product

73790-28-0

3

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