# L_2011175EN.01002801.xml

| 2.7.2011 | EN | Official Journal of the European Union | L 175/28 |
| --- | --- | --- | --- |

2.7.2011

EN

Official Journal of the European Union

L 175/28

---

COMMISSION DECISION

of 1 July 2011

concerning the non-inclusion of certain substances in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market

(notified under document C(2011) 4596)

(Text with EEA relevance)

(2011/391/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. |
| --- | --- |

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC.

| (2) | For a number of substance/product type combinations included in that list, either all participants have discontinued their participation in the review programme, or no complete dossier was received within the time period specified in Articles 9 and 12(3) of Regulation (EC) No 1451/2007 by the Member State designated as rapporteur for the evaluation. |
| --- | --- |

(2)

For a number of substance/product type combinations included in that list, either all participants have discontinued their participation in the review programme, or no complete dossier was received within the time period specified in Articles 9 and 12(3) of Regulation (EC) No 1451/2007 by the Member State designated as rapporteur for the evaluation.

| (3) | Consequently, and pursuant to Articles 11(2), 12(1) and 13(5) of Regulation (EC) No 1451/2007, the Commission informed the Member States accordingly. That information was also made public by electronic means. |
| --- | --- |

(3)

Consequently, and pursuant to Articles 11(2), 12(1) and 13(5) of Regulation (EC) No 1451/2007, the Commission informed the Member States accordingly. That information was also made public by electronic means.

| (4) | Within the period of 3 months from those publications, a number of companies indicated an interest in taking over the role of participant for the substances and product-types concerned. However, those companies subsequently failed to submit a complete dossier. |
| --- | --- |

(4)

Within the period of 3 months from those publications, a number of companies indicated an interest in taking over the role of participant for the substances and product-types concerned. However, those companies subsequently failed to submit a complete dossier.

| (5) | Pursuant to Article 12(5) of Regulation (EC) No 1451/2007, the substances and product types concerned should therefore not be included in Annexes I, IA or IB to Directive 98/8/EC. |
| --- | --- |

(5)

Pursuant to Article 12(5) of Regulation (EC) No 1451/2007, the substances and product types concerned should therefore not be included in Annexes I, IA or IB to Directive 98/8/EC.

| (6) | In the interest of legal certainty, the date should be specified after which biocidal products containing active substances for the product-types indicated in the Annex to this Decision should no longer be placed on the market. |
| --- | --- |

(6)

In the interest of legal certainty, the date should be specified after which biocidal products containing active substances for the product-types indicated in the Annex to this Decision should no longer be placed on the market.

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

(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 substances indicated in the Annex to this Decision shall not be included for the product-types concerned in Annexes I, IA or IB to Directive 98/8/EC.

Article 2

For the purposes of Article 4(2) of Regulation (EC) No 1451/2007, biocidal products containing active substances for the product-types indicated in the Annex to this Decision shall no longer be placed on the market with effect from 1 July 2012.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 1 July 2011.

For the Commission

Janez POTOČNIK

Member of the Commission

---

(1)  
  OJ L 123, 24.4.1998, p. 1.

1

(2)  
  OJ L 325, 11.12.2007, p. 3.

2

---

ANNEX

Substances and product types not to be included in Annexes I, IA or IB to Directive 98/8/EC

| Name | EC number | CAS number | Product-type | Rapporteur Member State |
| --- | --- | --- | --- | --- |
| Formaldehyde | 200-001-8 | 50-00-0 | 1 | DE |
| Formaldehyde | 200-001-8 | 50-00-0 | 5 | DE |
| Formaldehyde | 200-001-8 | 50-00-0 | 9 | DE |
| Formaldehyde | 200-001-8 | 50-00-0 | 23 | DE |
| 2-chloroacetamide | 201-174-2 | 79-07-2 | 3 | EE |
| 2-chloroacetamide | 201-174-2 | 79-07-2 | 6 | EE |
| 2-chloroacetamide | 201-174-2 | 79-07-2 | 13 | EE |
| Thiabendazole | 205-725-8 | 148-79-8 | 2 | ES |
| Thiabendazole | 205-725-8 | 148-79-8 | 13 | ES |
| 2,2'-dithiobis[N-methylbenzamide] | 219-768-5 | 2527-58-4 | 13 | PL |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 1 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 2 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 5 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 6 | DE |
| Sulphur dioxide | 231-195-2 | 7446-09-5 | 13 | DE |
| Reaction product of dimethyl adipate, dimethyl glutarate, dimethyl succinate with hydrogen peroxide/Perestane | 432-790-1 | — | 4 | HU |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 1 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 1 | FR |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 5 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 5 | FR |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 6 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 6 | FR |
| Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride) | Polymer | 374572-91-5 | 13 | FR |
| Poly(hexamethylendiamine guanidinium chloride) | Polymer | 57028-96-3 | 13 | FR |

Name

EC number

CAS number

Product-type

Rapporteur Member State

Formaldehyde

200-001-8

50-00-0

1

DE

Formaldehyde

200-001-8

50-00-0

5

DE

Formaldehyde

200-001-8

50-00-0

9

DE

Formaldehyde

200-001-8

50-00-0

23

DE

2-chloroacetamide

201-174-2

79-07-2

3

EE

2-chloroacetamide

201-174-2

79-07-2

6

EE

2-chloroacetamide

201-174-2

79-07-2

13

EE

Thiabendazole

205-725-8

148-79-8

2

ES

Thiabendazole

205-725-8

148-79-8

13

ES

2,2'-dithiobis[N-methylbenzamide]

219-768-5

2527-58-4

13

PL

Sulphur dioxide

231-195-2

7446-09-5

1

DE

Sulphur dioxide

231-195-2

7446-09-5

2

DE

Sulphur dioxide

231-195-2

7446-09-5

5

DE

Sulphur dioxide

231-195-2

7446-09-5

6

DE

Sulphur dioxide

231-195-2

7446-09-5

13

DE

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

432-790-1

—

4

HU

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

1

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

1

FR

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

5

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

5

FR

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

6

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

6

FR

Oligo(2-(2-ethoxy)ethoxyethylguanidinium chloride)

Polymer

374572-91-5

13

FR

Poly(hexamethylendiamine guanidinium chloride)

Polymer

57028-96-3

13

FR

---