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Regulation on the authorisation of biocidal products and other chemical-legal processes on biocidal products and biocidal active substances

Original Language Title: Verordnung über die Zulassung von Biozid-Produkten und sonstige chemikalienrechtliche Verfahren zu Biozid-Produkten und Biozid-Wirkstoffen

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Regulation on the authorisation of biocidal products and other chemicals-related procedures for biocidal products and biocidal active substances (Biocidal Authorisation Regulation-ChemBiocide ZulV)

Unofficial table of contents

ChemBiocide ZulV

Date of completion: 04.07.2002

Full quote:

" Biocidal Admissions Ordinance of 4 July 2002 (BGBl. 2514), as defined by Article 15 of the Law of 22 August 2006 (BGBl I). 1970).

Status: Amended by Art. 15 G v. 22.8.2006 I 1970

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 9.7.2002 + + +) 

The V was referred to as Article 1 (d). G v. 4.7.2002 I 2514 issued by the Federal Government after consultation of the parties concerned with the consent of the Federal Council. She's gem. Art. 4 of this V entered into force on 9 July 2002. Unofficial table of contents

§ 1 Scope, purpose

This Regulation shall apply to:
1.
the approval of biocidal products according to § 12a sentence 1 and § 12c of the Chemicals Act,
2.
the determination to discontinue the need for authorisation in accordance with § 12a sentence 2 No. 4 of the Chemicals Act,
3.
the registration of biocidal products according to § 12f of the Chemicals Act,
4.
the recognition of foreign authorisations and registrations pursuant to § 12g of the Chemicals Act,
5.
the examination of biocidal active substances according to § 12h of the Chemicals Act,
6.
the submission of documents, including records and notification of amendments in cases of scientific or process-oriented research and development pursuant to Section 12i (2) of the Chemicals Act,
7.
the approval of experiments in which the release into the environment can occur, according to § 12i (3) of the Chemicals Act,
8.
the notification of changes and new findings in accordance with § 16f (1) sentence 1 (1) and (2) of the Chemicals Act.
It is used to regulate further details of these procedures, which specify the legal regulations in partial areas. Unofficial table of contents

§ 2 General provisions on the submission of documents

(1) Documents to be submitted to the Admissions Office in one of the procedures referred to in § 1 shall be submitted to the Admissions Office in four equal sentences each. The Admissions Office may:
1.
require the use of any form or form of form other than the form of a medium,
2.
authorise the transmission of information on another suitable medium;
3.
require the transmission of further copies of the submitted documents, insofar as this is done with regard to the participation of the authorities referred to in § 12j (2) sentence 2 of the Chemicals Act or in order to comply with the provisions of Section 22 (1a) No. 4 of this Act Information requirements are required.
(2) Applications and documents which initiate any of the procedures referred to in § 1 shall include details of the name and address of the applicant or the party responsible, the location of the manufacturing plant and the identity of the biocidal product. including all the biocidal active substances or the biocidal active substance contained in it, and a summary of the essential content of the dossier submitted. If the applicant is not a manufacturer of the biocidal active substance, additional information shall be provided on the production operation of the biocide active substance. Biocidal active substances are used in accordance with the provisions of Annex I to Council Directive 67 /548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 327, 30.4.1967, p. EC No C 196 p. 1) in its latest version, as published in the Official Journal of the European Communities, or, if the name is not listed there, with the name given in the European Waste List EINECS, or, if the name is not listed there, including the common name (ISO Common Name) commonly used by the International Organisation for Standardisation or, where such a name is not present, at least the chemical name after the name of the System of the International Union for Pure and Applied Chemistry (IUPAC nomenclature) . Reference should be made to documents which have already been submitted by the applicant or the registrant for the same biocidal product or biocidal active substance. In the case of importation, the name and address of the manufacturer shall also be designated. In the event of an application by an authorised representative, the authorization shall be demonstrated by a written declaration by the manufacturer or importer. Unofficial table of contents

§ 3 Presentation of test certificates, test methods

(1) Upon presentation of proof of proof in one of the procedures referred to in § 1, the applicant or the person responsible for notification shall have to declare in writing that the nature of the biocidal product, the biocidal active substance or, where appropriate, the other Substance to which the information in the application or notification relates, which corresponds to the biocidal product being tested, biocidal active substance or ingredient. The determination of physical and chemical properties of a biocide active substance is to be carried out on the pure biocide active substance, if necessary. The composition of the sample shall be given in each case. The declaration shall be accompanied by the names of the bodies responsible for carrying out the tests. (2) Examination under the procedures laid down in Article 1 (1), (3) and (5) shall be carried out in accordance with the procedures laid down in Annex V to Directive 67 /548/EEC, in each of the following cases: Published version of the Official Journal of the European Communities and in compliance with the principles of good laboratory practice. Examinations initiated may be completed in accordance with the law applicable at the time of the commencement of the tests. The tests shall be carried out in accordance with other internationally recognised scientific methods, if:
1.
Directive 67 /548/EEC does not contain any provisions for certain tests,
2.
the test methods referred to in Directive 67 /548/EEC are not suitable for the examination of a particular property, or
3.
the other methods, with a lower number of animals, or with a lower burden on the animals, result in equivalent results in comparison with the test methods set out in Annex V to Directive 67 /548/EEC.
In the case of equivalent test methods, it shall be applied in each case to the one which permits the renunciation of animal testing or, if this is not possible, the smallest possible number of test animals or in which the lowest load for the test animals is required. Test animals occur. § 20a of the Chemicals Act remains unaffected. If, before 9 July 2002, tests have been carried out with test methods other than those referred to in sentences 1 to 4, the appropriate test certificates shall be submitted. The admissions office shall accept these verifications if they are sufficient for the purpose of the test and in this way to avoid further tests on vertebrate animals. (3) If a test with regard to a particular substance property is not if the substance is to be converted to the expected test and exposure conditions, the test may be carried out on the conversion product instead of the substance. (4) Proof of proof must be given the complete results of the tests carried out . Full information shall be provided on the test methods used. In the cases referred to in the third sentence of paragraph 2, point 2 and point 3, the use of the methods chosen shall be justified. Unofficial table of contents

§ 4 Restrictions on eligibility for certain biocidal products

Biocidal products of product types 15 (avicides), 17 (fish control products) and 23 (products against other vertebrate animals) of Annex V to Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing on the market of Biocidal products (OJ EC No 1) may not be registered in accordance with § 12a sentence 1, also in conjunction with Section 12c (1), or registered in accordance with § 12f of the Chemicals Act. A recognition of foreign authorisations or registrations of such biocidal products according to § 12g of the Chemicals Act must not be granted. § 12c (2) of the Chemicals Act remains unaffected. Unofficial table of contents

§ 5 Determination of the need for approval in accordance with § 12a sentence 2 no. 4 of the Chemicals Act

(1) A biocidal product may be obtained from another Member State of the European Communities or State Party to the Agreement on the European Economic Area using the derogation provided for in Article 12a sentence 2 (4) of the Chemicals Act. only if it has been established by the admissions office that the relevant conditions are met. The declaration must be made in writing at the admissions office. (2) Applications referred to in paragraph 1 must contain
1.
the information referred to in Annex IIB (I) and (II) of Directive 98 /8/EC,
2.
proof of the authorisation or registration of the biocidal product in the Member State of the European Communities or of the State Party to the Agreement on the European Economic Area from which the biocidal product is to be imported,
3.
the designation of the reference product registered or registered in Germany;
4.
a written confirmation from the manufacturer of the biocidal product that both the biocidal product to be introduced and the reference product have been manufactured by him, a company affiliated with him or in a licence according to the same formula, and that the Biocidal active substances used are identical.
(3) The Admissions Office shall establish that the need for authorisation in accordance with § 12a of the Chemicals Act shall not apply if:
1.
for the biocidal product to be imported in the Member State of the European Communities or State Party to the Agreement on the European Economic Area from which it is established, a valid authorisation or registration,
2.
for the reference product, a valid registration or registration in Germany exists and the requirements laid down in this authorisation or registration are also satisfied with regard to the biocidal product to be introduced,
3.
both biocidal products are manufactured by the same company or affiliated company or under the same licence in accordance with the same formula,
4.
the biocidal active substances are identical and
5.
there is no evidence that the two biocidal products have different effects, or that there are other differences which may be relevant to the protection of human and animal health or the environment.
The determination of the product to be determined shall be determined only with the proviso that the conditions relating to the imported or imported biocidal product do not change retrospectionally and that the authorisation or registration of the biocidal product shall be subject to the following conditions: the biocidal product introduced or to be imported in the country of origin and the reference product in Germany is not altered or expires. Unofficial table of contents

§ 6 Samples

The Admissions Office may, from the applicants and the person responsible for notification of the procedures referred to in § 1, be admitted to the admission or registration, the determination of the determination in accordance with § 5, the acceptance of a Biocidal active substance in Annex I to Directive 98 /8/EC or the termination of the tests in accordance with § 12i of the Chemicals Act at any time the submission of samples of the biocidal product, the biocidal active substance or the reference product, including the respective Packaging, labelling, instructions for use and, where appropriate, the Require safety data sheets.