# L_2020227EN.01006801.xml

| 16.7.2020 | EN | Official Journal of the European Union | L 227/68 |
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16.7.2020

EN

Official Journal of the European Union

L 227/68

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COMMISSION IMPLEMENTING DECISION (EU) 2020/1036

of 15 July 2020

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 last amended by Commission Delegated Regulation (EU) 2019/227 (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 30 March 2019. |
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(1)

Commission Delegated Regulation (EU) No 1062/2014 (2), as last amended by Commission Delegated Regulation (EU) 2019/227 (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 30 March 2019.

| (2) | For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.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For a number of active substance/product-type combinations included in that list, all the participants have withdrawn their support in a timely manner.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) | The Commission was informed, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, of those active substance/product-type combinations for which all participants made a timely withdrawal and for which the role of participant had previously been taken over. In accordance with point (a) of the first paragraph of 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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(3)

The Commission was informed, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, of those active substance/product-type combinations for which all participants made a timely withdrawal and for which the role of participant had previously been taken over. In accordance with point (a) of the first paragraph of Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.

| (4) | An open invitation was published to take over the role of participant for those active substance/product-type combinations for which the role of participant had not previously been taken over. For some of those combinations no notification has been submitted or a notification has been submitted and rejected pursuant to paragraph 4 or paragraph 5 of Article 17 of Delegated Regulation (EU) No 1062/2014. In accordance with point (b) of the first paragraph of 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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(4)

An open invitation was published to take over the role of participant for those active substance/product-type combinations for which the role of participant had not previously been taken over. For some of those combinations no notification has been submitted or a notification has been submitted and rejected pursuant to paragraph 4 or paragraph 5 of Article 17 of Delegated Regulation (EU) No 1062/2014. In accordance with point (b) of the first paragraph of Article 20 of Delegated Regulation (EU) No 1062/2014, those active substance/product-type combinations should not be approved for use in biocidal products.

| (5) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(5)

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, 15 July 2020.

For the Commission

The President

Ursula VON DER LEYEN

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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) 2019/227 of 28 November 2018 amending Delegated Regulation (EU) No 1062/2014 as regards certain active substances/product-type combinations for which the competent authority of the United Kingdom has been designated as the evaluating competent authority (OJ L 37, 8.2.2019, p. 1).

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ANNEX

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

| Entry Number in Annex II to Regulation (EU) No 1062/2014 | Substance name | Rapporteur Member State | EC number | CAS number | Product-type(s) |
| --- | --- | --- | --- | --- | --- |
| 37 | Formic acid | BE | 200-579-1 | 64-18-6 | 11, 12 |
| 1025 | Performic acid generated from formic acid and hydrogen peroxide | BE | n/a | n/a | 3, 5, 6 |
| 1027 | Peracetic acid generated from 1,3- diacetyloxypropan-2-yl acetate and hydrogen peroxide | AT | n/a | n/a | 4 |
| 1028 | Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrate | AT | n/a | n/a | 3 |
| 1029 | Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions | AT | n/a | n/a | 2 |
| 85 | Symclosene | DE | 201-782-8 | 87-90-1 | 12 |
| 195 | Sodium 2-biphenylate | ES | 205-055-6 | 132-27-4 | 4, 6, 7, 9, 10, 13 |
| 253 | Tetrahydro-3,5-dimethyl-1,3,5-thiadiazine-2-thione (Dazomet) | BE | 208-576-7 | 533-74-4 | 6, 12 |
| 346 | Sodium dichloroisocyanurate dihydrate | DE | 220-767-7 | 51580-86-0 | 12 |
| 345 | Troclosene sodium | DE | 220-767-7 | 2893-78-9 | 12 |
| 359 | Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm)) | PL | 222-720-6 | 3586-55-8 | 2 |
| 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 | 2 |
| 1035 | Active bromine generated from ozone and bromide of natural water and sodium bromide | NL | n/a | n/a | 2 |
| 1036 | Hydrogen peroxide released from sodium percarbonate | FI | n/a | n/a | 5 |
| 473 | Pyrethrins and Pyrethroids | ES | 232-319-8 | 8003-34-7 | 18, 19 |
| 1041 | Chlorine dioxide generated from sodium chloride by electrolysis | DE | n/a | n/a | 2, 3, 4, 5, 11, 12 |
| 1044 | Chlorine dioxide generated from sodium chlorite and sodium persulfate | DE | n/a | n/a | 12 |
| 597 | 1-[2-(Allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole (Imazalil) | DE | 252-615-0 | 35554-44-0 | 3 |
| 939 | Active chlorine generated from sodium chloride by electrolysis | SK | n/a | n/a | 12 |
| 1052 | Active chlorine generated from magnesium chloride hexahydrate by electrolysis | FR | n/a | n/a | 2 |
| 1053 | Active chlorine generated from potassium chloride by electrolysis | DK | n/a | n/a | 2, 4 |
| 1055 | Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS) and sulfamic acid | SI | n/a | n/a | 2, 3 |
| 1056 | Active chlorine generated from hydrochloric acid by electrolysis | SI | n/a | n/a | 2, 4, 5 |
| 731 | Chrysanthemum cinerariaefolium, ext. | ES | 289-699-3 | 89997-63-7 | 18 |
| 811 | Silver sodium hydrogen zirconium phosphate | SE | 422-570-3 | 265647-11-8 | 1 |
| 1014 | Silver zeolite | SE | n/a | n/a | 5 |
| 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 | 1802181-67-4/32289-58-0 | 3, 9, 11 |

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

Substance name

Rapporteur Member State

EC number

CAS number

Product-type(s)

37

Formic acid

BE

200-579-1

64-18-6

11, 12

1025

Performic acid generated from formic acid and hydrogen peroxide

BE

n/a

n/a

3, 5, 6

1027

Peracetic acid generated from 1,3- diacetyloxypropan-2-yl acetate and hydrogen peroxide

AT

n/a

n/a

4

1028

Peracetic acid generated from tetraacetylethylenediamine (TAED) and sodium perborate monohydrate

AT

n/a

n/a

3

1029

Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions

AT

n/a

n/a

2

85

Symclosene

DE

201-782-8

87-90-1

12

195

Sodium 2-biphenylate

ES

205-055-6

132-27-4

4, 6, 7, 9, 10, 13

253

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

BE

208-576-7

533-74-4

6, 12

346

Sodium dichloroisocyanurate dihydrate

DE

220-767-7

51580-86-0

12

345

Troclosene sodium

DE

220-767-7

2893-78-9

12

359

Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm))

PL

222-720-6

3586-55-8

2

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

2

1035

Active bromine generated from ozone and bromide of natural water and sodium bromide

NL

n/a

n/a

2

1036

Hydrogen peroxide released from sodium percarbonate

FI

n/a

n/a

5

473

Pyrethrins and Pyrethroids

ES

232-319-8

8003-34-7

18, 19

1041

Chlorine dioxide generated from sodium chloride by electrolysis

DE

n/a

n/a

2, 3, 4, 5, 11, 12

1044

Chlorine dioxide generated from sodium chlorite and sodium persulfate

DE

n/a

n/a

12

597

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

DE

252-615-0

35554-44-0

3

939

Active chlorine generated from sodium chloride by electrolysis

SK

n/a

n/a

12

1052

Active chlorine generated from magnesium chloride hexahydrate by electrolysis

FR

n/a

n/a

2

1053

Active chlorine generated from potassium chloride by electrolysis

DK

n/a

n/a

2, 4

1055

Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS) and sulfamic acid

SI

n/a

n/a

2, 3

1056

Active chlorine generated from hydrochloric acid by electrolysis

SI

n/a

n/a

2, 4, 5

731

Chrysanthemum cinerariaefolium, ext.

ES

289-699-3

89997-63-7

18

811

Silver sodium hydrogen zirconium phosphate

SE

422-570-3

265647-11-8

1

1014

Silver zeolite

SE

n/a

n/a

5

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

1802181-67-4/32289-58-0

3, 9, 11

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