# L_2021279EN.01003201.xml

| 3.8.2021 | EN | Official Journal of the European Union | L 279/32 |
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3.8.2021

EN

Official Journal of the European Union

L 279/32

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COMMISSION IMPLEMENTING DECISION (EU) 2021/1283

of 2 August 2021

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| (2) | For a number of active substance/product-type combinations included in that list, all the participants have withdrawn or are considered to have withdrawn their support in a timely manner.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For a number of active substance/product-type combinations included in that list, all the participants have withdrawn or are considered to have withdrawn their support in a timely manner.

| (3) | In accordance with Article 14(1) of Delegated Regulation (EU) No 1062/2014, the European Chemicals Agency (‘the Agency’) published an open invitation 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 the notification has been rejected pursuant to Article 17(4) or (5) of that Regulation. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (b), of Delegated Regulation (EU) No 1062/2014, should not be approved for use in biocidal products are the following: metam-sodium (product-types 9 and 11); thiram (product-type 9); bronopol (product-type 9); peroxyoctanoic acid (product-type 2, 3, 4); Malt, ext. – Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae (product-type 19); 2,2-Dibromo-2-cyanoacetamide (product-type 13). |
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(3)

In accordance with Article 14(1) of Delegated Regulation (EU) No 1062/2014, the European Chemicals Agency (‘the Agency’) published an open invitation 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 the notification has been rejected pursuant to Article 17(4) or (5) of that Regulation. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (b), of Delegated Regulation (EU) No 1062/2014, should not be approved for use in biocidal products are the following: metam-sodium (product-types 9 and 11); thiram (product-type 9); bronopol (product-type 9); peroxyoctanoic acid (product-type 2, 3, 4); Malt, ext. – Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae (product-type 19); 2,2-Dibromo-2-cyanoacetamide (product-type 13).

| (4) | In addition, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, the Agency informed the Commission of those active substance/product-type combinations for which all participants have withdrawn or are considered to have withdrawn their support in a timely manner, and for which the role of participant had previously been taken over. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (a), of that Regulation, should not be approved for use in biocidal products are the following: silver, as a nanomaterial (product-types 2, 4, 9); Eucalyptus citriodora oil and citronellal, hydrated, cyclized (product-type 19); 2-Hydroxy-α,α,4-trimethylcyclohexanemethanol (product-type 19); chlorine dioxide generated from sodium chlorite and sodium persulfate (product-types 2, 3, 4, 5, 11); amines, C10-16-alkyldimethyl, N-oxides (product-type 4); Capsicum oleoresin (product-type 19); Capsicum annuum, ext. (product-type 19); reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3-methoxy-2-methylphenyl)-8- methylnonanamide (product-type 19). |
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(4)

In addition, in accordance with Article 12(3) of Delegated Regulation (EU) No 1062/2014, the Agency informed the Commission of those active substance/product-type combinations for which all participants have withdrawn or are considered to have withdrawn their support in a timely manner, and for which the role of participant had previously been taken over. Those active substance/product-type combinations which, in accordance with Article 20, first paragraph, point (a), of that Regulation, should not be approved for use in biocidal products are the following: silver, as a nanomaterial (product-types 2, 4, 9); Eucalyptus citriodora oil and citronellal, hydrated, cyclized (product-type 19); 2-Hydroxy-α,α,4-trimethylcyclohexanemethanol (product-type 19); chlorine dioxide generated from sodium chlorite and sodium persulfate (product-types 2, 3, 4, 5, 11); amines, C10-16-alkyldimethyl, N-oxides (product-type 4); Capsicum oleoresin (product-type 19); Capsicum annuum, ext. (product-type 19); reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3-methoxy-2-methylphenyl)-8- methylnonanamide (product-type 19).

| (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, 2 August 2021.

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

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ANNEX

Active substance/product-type combinations not approved:

| Entry Number in Annex II to Regulation (EU) No 1062/2014 | Substance name | Rapporteur Member State | EC number | CAS number | Product-type(s) |
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| 9 | Bronopol | ES | 200-143-0 | 52-51-7 | 9 |
| 206 | Thiram | BE | 205-286-2 | 137-26-8 | 9 |
| 210 | Metam-sodium | BE | 205-293-0 | 137-42-8 | 9, 11 |
| 1023 | Silver, as a nanomaterial | SE | 231-131-3 | 7440-22-4 | 2, 4, 9 |
| 494 | 2,2-Dibromo-2-cyanoacetamide (DBNPA) | DK | 233-539-7 | 10222-01-2 | 13 |
| 1047 | Eucalyptus citriodora oil and citronellal, hydrated, cyclized | CZ | n/a | n/a | 19 |
| 609 | 2-Hydroxy-α,α,4-trimethylcyclohexanemethanol | CZ | 255-953-7 | 42822-86-6 | 19 |
| 813 | Peroxyoctanoic acid | FR | n/a | 33734-57-5 | 2, 3, 4 |
| 1044 | Chlorine dioxide generated from sodium chlorite and sodium persulfate | DE | n/a | n/a | 2, 3, 4, 5, 11 |
| 1064 | Malt, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae | AT | 232-310-9 | 8002-48-0 | 19 |
| 692 | Amines, C10-16-alkyldimethyl, N-oxides | PT | 274-687-2 | 70592-80-2 | 4 |
| 1059 | Capsicum oleoresin

  Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Capsicum frutescens, Solanaceae) | BE | Not available | 8023-77-6 | 19 |
| 1060 | Capsicum annuum, ext.
  Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Capsicum annuum, Solanaceae. | BE | 283-403-6 | 84625-29-6 | 19 |
| 1061 | Reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3- methoxy-2-methylphenyl)-8- methylnonanamide | BE | Not available | Not available | 19 |

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

Substance name

Rapporteur Member State

EC number

CAS number

Product-type(s)

9

Bronopol

ES

200-143-0

52-51-7

9

206

Thiram

BE

205-286-2

137-26-8

9

210

Metam-sodium

BE

205-293-0

137-42-8

9, 11

1023

Silver, as a nanomaterial

SE

231-131-3

7440-22-4

2, 4, 9

494

2,2-Dibromo-2-cyanoacetamide (DBNPA)

DK

233-539-7

10222-01-2

13

1047

Eucalyptus citriodora oil and citronellal, hydrated, cyclized

CZ

n/a

n/a

19

609

2-Hydroxy-α,α,4-trimethylcyclohexanemethanol

CZ

255-953-7

42822-86-6

19

813

Peroxyoctanoic acid

FR

n/a

33734-57-5

2, 3, 4

1044

Chlorine dioxide generated from sodium chlorite and sodium persulfate

DE

n/a

n/a

2, 3, 4, 5, 11

1064

Malt, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hordeum, Gramineae

AT

232-310-9

8002-48-0

19

692

Amines, C10-16-alkyldimethyl, N-oxides

PT

274-687-2

70592-80-2

4

1059

Capsicum oleoresin

Extractives and their physically modified derivatives. It is a product which may contain resin acids and their esters, terpenes, and oxidation or polymerization products of these terpenes. (Capsicum frutescens, Solanaceae)

BE

Not available

8023-77-6

19

1060

Capsicum annuum, ext.

Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Capsicum annuum, Solanaceae.

BE

283-403-6

84625-29-6

19

1061

Reaction mass of (6E)-N-(4-hydroxy-3-methoxy-2-methylphenyl)-8-methylnon-6-enamide and N-(4-hydroxy-3- methoxy-2-methylphenyl)-8- methylnonanamide

BE

Not available

Not available

19

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