Regulation on the reporting of biocidal products in accordance with the Chemicals Act (Biocides Ordinance-ChemBiocide Reporting V)

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ChemBiocides

Date of completion: 14.06.2011

Full quote:

" Biocidal Reporting Ordinance of 14 June 2011 (BGBl. I p. 1085) "

The V will expire at the end of the day, which is referred to in § 28 (11) sentence 1 of the Chemicals Act

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The obligations laid down in Directive 98 /34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of the provisions relating to the services of The Information Society (OJ C 37), as last amended by Directive 2006 /96/EC (OJ L 327, 21.12.2006, p. 81), has been complied with.

Footnote

(+ + + Text certificate: 18.6.2011 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 ERL 34/98 (CELEX Nr: 31998L0034) + + +) 

  

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Input formula

Pursuant to Section 28 (11) and Section 14 (1) (3) (a) and (3) of the Chemicals Act, § 28 (11) of the Act of 11 August 2010 (BGBl) by Article 4 (3) of the Law of 11 August 2010. 1163), the Federal Government, after consulting the parties concerned, is responsible for: Unofficial table of contents

§ 1 Scope

This Regulation shall apply to biocidal products within the meaning of Section 3b (1) (1) of the Chemicals Act, which contain only active substances which are already used for purposes other than scientific or process-oriented purposes before 14 May 2000. Research and development on the market and which have not yet been listed in Annex I or Annex IA 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 (OJ L 327, 22.11.1998, p. 1, L 150, 8.6.2002, p. 71), as last amended by Directives 2011 /10/EU, 2011 /11/EU, 2011 /12/EU and 2011 /13/EU (OJ L 123, 24.4.2011, p. 41, 45, 49 and 52). Unofficial table of contents

§ 2 obligation to apply the registration number

(1) Biocidal products according to § 1 may only be placed on the market if a registration number is applied to the biocidal product concerned. The registration number must be requested by manufacturers, importers or by using its own trade name in accordance with the procedure laid down in Section 3 (1) of the Chemicals Act at the Admissions Office pursuant to Section 12j (1) of the Chemicals Act. Sentence 1 shall apply to biocidal products, for which a registration number has already been registered under the Biocidal Products Ordinance of 24 May 2005 (BGBl. 1410), provided that this registration number is to be applied. (2) For biocidal products placed on the market until 17 June 2011, the registration number shall be registered by 1 August 2011 in accordance with the procedure laid down in Article 3 (1). Application for authorisation. For biocidal products as set out in the first sentence, the persons referred to in the second sentence of paragraph 1 shall be required to ensure that the registration number is applied until 1 November 2011. Sentence 1 shall not apply to biocidal products for which a registration number has already been issued in accordance with the Biocidal Reporting Ordinance of 24 May 2005. Unofficial table of contents

§ 3 Procedure for the issue of the registration number

(1) The biocidal product for which a registration number is required is to be reported to the admissions office by electronic means using the electronic form provided on the website of the admissions office. The notification shall be submitted at the same time as a registration number is issued. The following information shall be communicated to the Admissions Office:

1.

Trade name of the biocidal product,

2.

the name and address of the applicant in accordance with the second sentence of Article 2 (1),

3.

the product type (s) referred to in Annex V to Directive 98 /8/EC, for which the biocidal product is to be awarded, and

4.

the name of the biocidal active substances contained in the biocidal product, indicating where available,

a)

the CAS number corresponding to the entry in Annex II of 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 the Council on the placing on the market of biocidal products (OJ L 327, 30.4.2004 3), as amended by Regulation (EU) No 298/2010 (OJ L 297, 15.11.2010, p. OJ L 90, 10.4.2010, p. 4), and

b)

the EC number corresponding to the entry in Annex II to the Regulation referred to in point (a).

The authorisation body shall examine whether the biocidal active substances specified in the application referred to in paragraph 1 are listed in Annex II to Regulation (EC) No 1451/2007. When the specified biocidal active substances are listed in Annex II, it shall consider whether the biocidal product for which a registration number is requested belongs to a product type specified in Annex II for the active substance or active substances. The admissions office shall also examine whether, for one of these active substances, a decision by the Commission concerning the non-inclusion in Annex I or Annex IA to Directive 98 /8/EC, as referred to in Article 4 (2) of Regulation (EC) No 178/EC, for the product type concerned is considered. 1451/2007. Within 30 calendar days from the date of receipt of the application, the authorisation body shall notify the applicant of the outcome of its examination and shall issue a registration number for the application to the biocidal product concerned, provided that the entry in Annex II to the application is submitted to the applicant. Regulation (EC) No 1451/2007 and no non-acceptance decision within the meaning of sentence 3. Unofficial table of contents

§ 4 Electronic directory

The Admissions Office shall provide on its website an electronic directory of the biocidal products for which a registration number has been issued, to the national authorities responsible for monitoring. The list must be updated at least once a quarter. The list shall contain, in particular, the information referred to in the third sentence of Article 3 (1), the respective registration number and, where appropriate, the date referred to in Article 4 (2) of Regulation (EC) No 1451/2007 and the data subject to the non-acceptance decision. Product type. Unofficial table of contents

§ 5 Administrative Offences

Contrary to the provisions of Section 26 (1) (5) (c) of the Chemicals Act, who intentionally or negligently is acting in accordance with the provisions of the German Chemical Law

1.

in accordance with the first sentence of Article 2 (1), including in conjunction with the third sentence, a biocidal product shall be placed on the market, or

2.

Contrary to § 2, paragraph 2, sentence 2, it does not ensure that a registration number is applied in good time.

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§ 6 Entry into force, expiry of the external force

This Regulation shall enter into force on the day following the date of delivery. It shall expire at the end of the day referred to in the first sentence of Article 28 (11) of the Chemicals Act. Unofficial table of contents

Final formula

The Federal Council has agreed.