353. Regulation of the Federal Minister for Agriculture, Forestry, the Environment and Water Management on the deadlines for the registration or registration of biocidal products containing active substances referred to in Article 16 (2) of the Biocidal Products Directive has been included in Annex I or IA to this Directive, and on which old active substances may no longer be placed on the market in biocidal products (Biocides-G-Altknitting Regulation)

Due to § 4 (2) of the Biocidal Products Act-Biocide G, BGBl. No 105/2000, in the version of the Federal Law BGBl. I No 151/2004, shall be ordered:

Active ingredient list

§ 1. (1) The active substances contained in the Annex to this Regulation for biocidal products within the meaning of the Biocidal Products Act-Biocide-G, BGBl. No 105/2000, shall be used as active substances which, in accordance with Article 16 (2) of Directive 98 /8/EC concerning the placing on the market of biocidal products (according to Article 2 (1) (1) of the Biocides Directive: Biocidal Products Directive), OJ L 136, 31.5.1998, p. No. 1 in Annex I or IA of this Directive.

(2) The information contained in the Annex to this Regulation concerning the conditions for the placing on the market and the authorisation or registration of the biocidal products containing one of the active substances listed in the Annex shall be binding. The contents and conclusions of the evaluation reports on the individual active substances, as set out in the relevant Directives of the Commission of the European Communities, with which active substances are listed in Annex I or IA of the Biocidal Products Directive , shall be taken into account as relevant information in the course of the authorisation or registration procedures of the respective biocidal products.

(3) Where an active substance is included in the Annex to this Regulation, biocidal products within the meaning of Article 2 (1) (2) (2) Biocidal Products containing this active substance may be placed on the market only if, in accordance with the following arrangements: the 3. Section of the Biocidal Products Act are approved or registered.

Conditions for the placing on the market of biocidal products subject to authorisation

§ 2. (1) For the purposes of Section 4 (1) and (2) Biocidal Products, the placing on the market of biocidal products which are not biocidal products with a low-risk potential and which is an active substance contained in the Annex to this Regulation, but no further, old The active substance (Article 2 (1) (16) of the Biocidal Products Act), which is listed in Annex II to Regulation (EC) No 1451/2007 concerning the second phase of the 10-year work programme referred to in Article 16 (2) of Directive 98 /8/EC concerning the placing of biocidal products on the market, OJ L 327, 30.11.1998, p. No. 3, is only permitted in the active substance/product-type combinations listed in the Annex to this Regulation if the biocidal product in question is already in the territory of the Federal Republic of Germany prior to the date of inclusion of the relevant active substance (s) in the territory of the Member State concerned. the active substance in Annex I of the Biocidal Products Directive has been placed on the market and

1.		no later than the date specified in column 4 of the Annex to this Regulation for the active substance/product-type combination concerned, an application for authorisation in accordance with Section 11 (1) or (15) of the Biocidal Products Act, or
2.		a written communication within the meaning of paragraph 2
has been introduced.

(2) A corresponding application (para. 1 (1) or a written communication (paragraph 1) 1 (2) above that an application is submitted in accordance with § 13 of the Biocidal Products Act no later than four months before the date specified in column 5 for the active substance/product type combination in question, and this notification shall be subject to the information provided for in section 13 (3) (c) of the Biocides Act. 1 Z 1 and 4 Biocides and, in accordance with Annex IIB, Sections I and X and, where appropriate, in accordance with Annex IVB Sections I and X of the Biocidal Products Directive, is a necessary condition for the admissibility of placing on the market during of the authorisation procedure. Such a request or notification may be submitted at the earliest three months before the date set out in column 4 of the Annex for the active substance/product-type combination in question, with the date of arrival always being the one in column 4. the date on which the active substance/product type combination concerned is concerned.

(3) Where no application is submitted pursuant to paragraph 1 (1) (1) (1), or a notification has been sent to the Authority pursuant to paragraph 1 (1) (2), the biocidal products concerned may only be submitted for a period not exceeding six months from the date in column 4 for the relevant Active substance/product type combination are placed on the market.

(4) Biocidal products subject to the authorisation requirement described in paragraphs 1 and 2 of this Regulation may be placed on the market provisionally up to the date set out in column 5 of the Annex to this Regulation for the active substance/product type combination concerned where an application or notification in accordance with paragraph 1 is submitted in due time. In the case of a communication pursuant to paragraph 1 (1) (2), it is also necessary that for the biocidal product concerned no later than four months before the combination given in column 5 of the Annex to this Regulation for the active substance/product-type combination concerned, A complete application has been submitted in accordance with § 13 Biocide-G. The admissibility of the further placing on the market is based on the decisions in the authorisation procedure.

(5) If the application for authorisation is rejected or rejected in a procedure in accordance with Article 11 (1) or (13) of the Biocidal Products Act, the biocidal product in question shall no longer be placed on the market from the date of the occurrence of the legal force of that decision. be brought. § 17 (6) Biocide-G is to be applied.

First placing on the market of a biocidal product after the inclusion of the active substance in Annex I of the Biocidal Products Directive

§ 3. biocidal products in the active substance/product combination in question, which are not low-risk biocidal products and which contain an active substance contained in the Annex to this Regulation but do not include any other old active substance, listed in Annex II to Regulation (EC) No 1451/2007, which have not been placed on the market in the territory of the Federal Republic of Germany prior to the date of inclusion of the active substance concerned in Annex I to the Biocidal Products Directive, must be made available from the date of the inclusion of the active substance concerned in Annex I to the Biocidal Products Directive meets the requirements of § 4 (1) Z 1 Biocide G and is subject to the obligation to be admitted in accordance with § § 8, 10, 11, 13 and 15 ff. Biocide G.

Conditions for the placing on the market of biocidal products subject to registration

§ 4. (1) For the purposes of Section 4 (1) and (2) of Biocidal Products, the placing on the market of low-risk biocidal products containing an active substance contained in the Annex to this Regulation, but not containing any other active substance included in Annex II, shall be included in Annex II. of Regulation (EC) No 1451/2007, may only be made in the active substance/product-type combinations listed in the Annex to this Regulation if the low-risk biocidal product in question already exists in the Federal Republic of Germany before the Date of inclusion of the active substance concerned in Annex IA to the Biocidal Products Directive has been placed on the market and

1.		no later than the date specified in column 4 of the Annex to this Regulation for the active substance/product-type combination concerned, a registration request in accordance with § 11 (2) or § 15 Biocides G or
2.		a communication within the meaning of paragraph 2
has been introduced.

(2) A corresponding application (para. 1 (1) or a written communication (paragraph 1) 1 (2) above that an application is submitted in accordance with § 14 of the Biocidal Products Act no later than two months before the date specified in column 5 for the active substance/product type combination concerned, and this notification shall be subject to the information provided for in Article 14 (1) (2) of the Biocides Act. 1 and 6 and 7 of the Biocide-G are to be connected to it, is a necessary condition for the admissibility of the placing on the market during the registration process. Such a request or notification may be submitted at the earliest three months before the date referred to in column 4 of the Annex, the date of arrival of which shall always be the date referred to in column 4.

(3) Where no application pursuant to paragraph 1 (1) (1) (1) is submitted, or a communication pursuant to paragraph 1 (2) has been submitted to the Authority, the low-risk biocidal products in question shall only be allowed to apply for a maximum of six months from the one in column 4 for the an active substance/product-type combination in question is placed on the market.

(4) Low-risk biocidal products which are subject to the registration requirement as described in paragraphs 1 and 2 may be provisional up to the date specified in column 5 of the Annex to this Regulation for the active substance/product type combination concerned shall be placed on the market when a corresponding request or notification has been submitted in due time pursuant to paragraph 1. In the case of a communication pursuant to paragraph 1 (2) (2), it is also necessary that for the biocidal product concerned with a low risk potential no later than two months before that in column 5 of the Annex to this Regulation for the relevant biocidal product, it shall be Active substance/product-type combination, a complete application has been submitted in accordance with § 14 Biocide G. The admissibility of the further placing on the market is based on the decision in the registration procedure.

(5) If the application for registration is rejected or rejected in a procedure in accordance with Article 11 (2) or (14) of the Biocidal Products Act, the biocidal product in question shall be entitled to a low risk potential from the date of the occurrence of the legal force of such a biocidal product. decision no longer be placed on the market. § 17 (6) Biocide-G is to be applied.

First placing on the market of a biocidal product with low risk potential after inclusion of the active substance in Annex IA of the Biocidal Products Directive

§ 5. Low-risk biocidal products in the relevant active substance/product combination, containing an active substance contained in the Annex to this Regulation but not containing any other old active substance listed in Annex II to Regulation (EC) No 1451/2007, which has not been placed on the territory of the Federal Republic of Germany prior to the date of inclusion of the active substance concerned in Annex IA to the Biocidal Products Directive, must be carried out from the date on which the relevant active substance has been added to the Biocidal Products Directive. Active substance in Annex IA of the Biocidal Products Directive the condition of § 4 (1) Z 2 Biocide G and are subject to the obligation to register in accordance with § § 9, 10, 11, 14 and 15 ff. Biocide G.

Biocidal products containing more than one active substance

§ 6. A biocidal product containing, in addition to an active substance contained in the Annex to this Regulation, at least one other active substance, not included, of the active substance/product-type combination concerned, as defined in Annex II to Regulation (EC) No 1451/2007, the authorisation or registration requirement for the purposes of § § 2 and 4 shall not be subject to the requirement for the active substance/product-type combination listed in Annex I or IA of the Biocidal Products Directive with the latest date. the date referred to in column 4 of the Annex to this Regulation.

New biocidal products

§ 7. If a biocidal product contains, as active substances, only active substances contained in the Annex to this Regulation and if the biocidal product concerned does not comply with the earliest date in column 4 at the latest in column 4, Annex I or IA of the Biocidal Products Directive, which has been placed on the market in the territory of the Federal Republic of Germany (new biocidal product), the authorisation or registration procedure shall be adopted in accordance with the provisions of the third paragraph of this Article. to carry out a section of the Biocides Act without having to consider the time limits or dates specified in § § 2 or 4. Such a biocidal product may not be placed on the market until the authorisation or registration has been granted.

Old active substances which may no longer be placed on the market

§ 8. (1) It is established that active substances listed in Annex I to Regulation (EC) No 1451/2007 may not be placed on the market as such and in biocidal products.

(2) It is established that those old active substances which have been adopted pursuant to Regulation (EC) No 1896/2000 on the first phase of the programme referred to in Article 16 (2) of Directive 98 /8/EC, OJ L 327, 30.4.1998, p. No. 6 and Regulation (EC) No 1687/2002 laying down an additional time-limit for the notification of certain active substances already on the market for use in biocidal products, OJ L 228, 9.8.2002, p. No. 15, have been notified but have not been included in Annex I, IA or IB to the Biocidal Products Directive, and which have been notified to the Commission,

1.		the Commission Decision concerning the non-inclusion of certain active substances under the 10-year work programme referred to in Article 16 (2) of Directive 98 /8/EC OJ L 136, 30.4.1998, p. No. OJ L 216, 21.08.2007 p. 17,
2.		in the Commission Decision concerning the non-inclusion of guazatin triacetate in Annex I, IA or IB to Directive 98 /8/EC, OJ L 327, 30.4.1998, p. No. OJ L 230, 01.09.2007 p. 18
, as such and in biocidal products belonging to the active substance/product-type combinations referred to in the respective decisions of the Commission of the European Communities, after the end of one year from the date of entry into force of the shall not be placed on the market any more.

Implementation Notice

§ 9. This Regulation shall:

1.		Directive 2006 /140/EC amending Directive 98 /8/EC of the European Parliament and of the Council with a view to the inclusion of the active substance sulphuryl fluoride in Annex I, OJ L 327, 30.4.2006, p. No. OJ L 414, 30.12.2006 p. 78;
2.		Directive 2007 /20/EC amending Directive 98 /8/EC of the European Parliament and of the Council with a view to the inclusion of the active substance dichlofluanid in Annex I, OJ L 327, 30.11.2007, p. No. OJ L 94, 4.4.2007 p. 23;
3.		Directive 2007 /69/EC 2007 amending Directive 98 /8/EC of the European Parliament and of the Council to include difethialon as an active substance in Annex I, OJ L 136, 31.5.2007, p. No. OJ L 312, 30.11.2007 p. 23;
4.		Directive 2007 /70/EC amending Directive 98 /8/EC of the European Parliament and of the Council with a view to the inclusion of the active substance carbon dioxide in Annex IA, OJ L 136, 31.5.2007, p. No. OJ L 312, 30.11.2007 p. 26;
5.		Directive 2008 /15/EC amending Directive 98 /8/EC of the European Parliament and of the Council with a view to the inclusion of the active substance clothianidin in Annex I, OJ L 327, 31.12.2008, p. No. OJ L 42, 16.2.2008 p. 45;
6.		Directive 2008 /16/EC amending Directive 98 /8/EC of the European Parliament and of the Council with a view to the inclusion of the active substance Etofenprox in Annex I, OJ L 327, 30.4.2008, p. No. OJ L 42, 16.2.2008 p. 48;
7.		Directive 2008 /75/EC amending Directive 98 /8/EC of the European Parliament and of the Council with a view to the inclusion of the active substance carbon dioxide in Annex I, OJ L 139, 30.4.2008, p. No. OJ L 197, 25.7.2008, p. 54;
8.		Directive 2008 /77/EC amending Directive 98 /8/EC of the European Parliament and of the Council with a view to the inclusion of thiamethoxam as active substance in Annex I, OJ L 327, 30.4.2008, p. No. OJ L 198, 26.7.2008, p. 41;
9.		Directive 2008 /78/EC amending Directive 98 /8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I, OJ L 327, 30.4.2008, p. No. OJ L 198, 26.7.2008, p. 44;
10.		Directive 2008 /79/EC amending Directive 98 /8/EC of the European Parliament and of the Council for the inclusion of the active substance IPBC in Annex I, OJ L 327, 30.4.2008, p. No. OJ L 200, 29.7.2008, p.12;
11.		Directive 2008 /80/EC amending Directive 98 /8/EC of the European Parliament and of the Council to include cyclohexylhydroxydiazen-1-oxide, potassium salt (K-HDO) as an active substance in Annex I, OJ L 206, 22.7.2008, p. No. OJ L 200, 29.7.2008, p. 15;
12.		Directive 2008 /81/EC amending Directive 98 /8/EC of the European Parliament and of the Council to include difenacoum as an active substance in Annex I, OJ L 327, 30.12.2008, p. No. OJ L 201, 30.7.2008, p. 46;
.

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