# L_2018271EN.01002601.xml

| 30.10.2018 | EN | Official Journal of the European Union | L 271/26 |
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30.10.2018

EN

Official Journal of the European Union

L 271/26

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COMMISSION IMPLEMENTING DECISION (EU) 2018/1622

of 29 October 2018

on the non-approval of certain active substances in biocidal products 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), as amended by Delegated Regulation (EU) 2017/698 (3), establishes in its Annex II a list of active substance/product-type combinations included in the review programme of existing active substances in biocidal products on 3 February 2017. |
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(1)

Commission Delegated Regulation (EU) No 1062/2014 (2), as amended by Delegated Regulation (EU) 2017/698 (3), establishes in its Annex II a list of active substance/product-type combinations included in the review programme of existing active substances in biocidal products on 3 February 2017.

| (2) | For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner. |
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(2)

For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.

| (3) | As regards some active substances generated in situ, the name of those active substances and their precursors which are supported in the review programme has been clarified in a more precise manner. This has lead in certain cases to a redefinition of the active substance in accordance with Article 13 of Delegated Regulation (EU) No 1062/2014. |
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(3)

As regards some active substances generated in situ, the name of those active substances and their precursors which are supported in the review programme has been clarified in a more precise manner. This has lead in certain cases to a redefinition of the active substance in accordance with Article 13 of Delegated Regulation (EU) No 1062/2014.

| (4) | A notification was published inviting persons wishing to support those active substance/product-types combinations which have been redefined and currently not supported, including the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, so that the role of participant may be taken over. |
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(4)

A notification was published inviting persons wishing to support those active substance/product-types combinations which have been redefined and currently not supported, including the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, so that the role of participant may be taken over.

| (5) | For some active substance/product-type combinations no notification has been submitted or a notification has been submitted and rejected pursuant to paragraphs 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014. |
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(5)

For some active substance/product-type combinations no notification has been submitted or a notification has been submitted and rejected pursuant to paragraphs 4 or 5 of Article 17 of Delegated Regulation (EU) No 1062/2014.

| (6) | In accordance with Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products. |
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(6)

In accordance with Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.

| (7) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(7)

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 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, 29 October 2018.

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

(3)  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).

3

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ANNEX

Active substance/product type combinations not approved, including any nanomaterial forms:

| — | the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, except when the active substance is generated from the precursor(s) mentioned in the entry of the table of that Annex for the concerned active substance/product-type combinations; |
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—

the generation in situ of the active substances for the product-types listed in Annex II to Delegated Regulation (EU) No 1062/2014, except when the active substance is generated from the precursor(s) mentioned in the entry of the table of that Annex for the concerned active substance/product-type combinations;

| — | the substance/product-type combinations listed in the table below, including any generation in situ of these substances using any precursor that is not mentioned in Annex II to Delegated Regulation (EU) No 1062/2014:










  Entry Number in Annex II to Delegated Regulation (EU) No 1062/2014 | Substance name | Rapporteur Member State | EC number | CAS number | Product-type(s) |
| --- | --- | --- | --- | --- | --- | --- |
| 60 | Citric acid | BE | 201-069-1 | 77-92-9 | 1 |
| 172 | Cetylpyridinium Chloride | UK | 204-593-9 | 123-03-5 | 2 |
| 195 | Sodium 2-biphenylate | ES | 205-055-6 | 132-27-4 | 1, 2, 3 |
| 288 | N-(Dichlorofluoromethylthio)-N′,N′-dimethyl-N-phenylsulfamide (Dichlofluanid) | UK | 214-118-7 | 1085-98-9 | 7 |
| 365 | Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione) | SE | 223-296-5 | 3811-73-2 | 3 |
| 401 | Silver | SE | 231-131-3 | 7440-22-4 | 9 |
| 405 | Sulphur dioxide | DE | 231-195-2 | 7446-09-5 | 4 |
| 424 | Sodium bromide | NL | 231-599-9 | 7647-15-6 | 2, 11, 12 |
| 458 | Ammonium sulphate | UK | 231-984-1 | 7783-20-2 | 11,12 |
| 1016 | Silver chloride | SE | 232-033-3 | 7783-90-6 | 10, 11 |
| 515 | Ammonium bromide | SE | 235-183-8 | 12124-97-9 | 11, 12 |
| 526 | Potassium 2-biphenylate | ES | 237-243-9 | 13707-65-8 | 6, 9, 10, 13 |
| 529 | Bromine chloride | NL | 237-601-4 | 13863-41-7 | 11 |
| 541 | Sodium p-chloro-m-cresolate | FR | 239-825-8 | 15733-22-9 | 1, 2, 3, 6, 9, 13 |
| 609 | Mixture of cis- and trans-p-menthane-3,8 diol (Citriodiol) | UK | Not available | Not available | 19 |
| 620 | Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS) | MT | 259-709-0 | 55566-30-8 | 2 |
| 673 | Didecyldimethylammonium chloride (DDAC (C8-10)) | IT | 270-331-5 | 68424-95-3 | 5 |
| 785 | 6-(Phthalimido)peroxyhexanoic acid (PAP) | IT | 410-850-8 | 128275-31-0 | 3, 4 |
| 792 | Tetrachlorodecaoxide complex (TCDO) | DE | 420-970-2 | 92047-76-2 | 1 |
| 952 | Bacillus sphaericus other than Bacillus sphaericus 2362, strain ABTS-1743 | IT | Micro-organism | 143447-72-7 | 18 |
| 955 | Bacillus thuringiensis subsp.israelensis Serotype H14, other than strain AM65-52 and other than strain SA3A | IT | Micro-organism | Not available | 18 |
| 957 | Bacillus subtilis | DE | Micro-organism | Not available | 3 |
| 939 | Active Chlorine: manufactured by the reaction of hypochlorous acid and sodium hypochlorite produced in situ | SK | Mixture | Not available | 2, 3, 4, 5, 11, 12 |
| 824 | Silver zinc zeolite | SE | Not available | 130328-20-0 | 5 |
| 1013 | Silver copper zeolite | SE | Not available | 130328-19-7 | 5 |
| 835 | Esfenvalerate/(S)-.alpha.-Cyano-3-phenoxybenzyl (S)-2-(4-chlorophenyl)-3-methylbutyrate (Esfenvalerate) | PT | Plant protection product | 66230-04-4 | 18 |

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the substance/product-type combinations listed in the table below, including any generation in situ of these substances using any precursor that is not mentioned in Annex II to Delegated Regulation (EU) No 1062/2014:

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

Substance name

Rapporteur Member State

EC number

CAS number

Product-type(s)

60

Citric acid

BE

201-069-1

77-92-9

1

172

Cetylpyridinium Chloride

UK

204-593-9

123-03-5

2

195

Sodium 2-biphenylate

ES

205-055-6

132-27-4

1, 2, 3

288

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

UK

214-118-7

1085-98-9

7

365

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

SE

223-296-5

3811-73-2

3

401

Silver

SE

231-131-3

7440-22-4

9

405

Sulphur dioxide

DE

231-195-2

7446-09-5

4

424

Sodium bromide

NL

231-599-9

7647-15-6

2, 11, 12

458

Ammonium sulphate

UK

231-984-1

7783-20-2

11,12

1016

Silver chloride

SE

232-033-3

7783-90-6

10, 11

515

Ammonium bromide

SE

235-183-8

12124-97-9

11, 12

526

Potassium 2-biphenylate

ES

237-243-9

13707-65-8

6, 9, 10, 13

529

Bromine chloride

NL

237-601-4

13863-41-7

11

541

Sodium p-chloro-m-cresolate

FR

239-825-8

15733-22-9

1, 2, 3, 6, 9, 13

609

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

UK

Not available

Not available

19

620

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

MT

259-709-0

55566-30-8

2

673

Didecyldimethylammonium chloride (DDAC (C8-10))

IT

270-331-5

68424-95-3

5

785

6-(Phthalimido)peroxyhexanoic acid (PAP)

IT

410-850-8

128275-31-0

3, 4

792

Tetrachlorodecaoxide complex (TCDO)

DE

420-970-2

92047-76-2

1

952

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

IT

Micro-organism

143447-72-7

18

955

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

IT

Micro-organism

Not available

18

957

Bacillus subtilis

DE

Micro-organism

Not available

3

939

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

SK

Mixture

Not available

2, 3, 4, 5, 11, 12

824

Silver zinc zeolite

SE

Not available

130328-20-0

5

1013

Silver copper zeolite

SE

Not available

130328-19-7

5

835

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

PT

Plant protection product

66230-04-4

18

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