Regulation on the authorisation of biocidal products and other chemicals legislation on biocidal products and biocidal active substances (Biocidal Authorisation Regulation-ChemBiocide ZulV)Non-official Table of Contents
Date of delivery: 04.07.2002
" Biocidal Admissions Regulation of 4. July 2002 (BGBl. 2514), as defined by Article 15 of the Law of 22. August 2006 (BGBl. 1970). "
|:||Modified by Art. 15 G v. 22.8.2006 I 1970|
For details, see the Notes
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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. Non-official table of contents
§ 1 Scope of application, purpose
This regulation applies to
- the approval of biocidal products according to § 12a sentence 1 and § 12c of the Chemicals Act,
- determining the need for approval in accordance with § 12a sentence 2 no. 4 of the Chemicals Act,
- the registration of biocidal products according to § 12f of the Chemicals Act,
- the recognition foreign authorisations and registrations according to § 12g of the Chemicals Act,
- the examination of biocidal active substances according to § 12h of the Chemicals Act,
- the submission of documents, including records and notification of changes in cases of scientific or process-oriented Research and development according to § 12i (2) of the Chemicals Act,
- The approval of experiments in which a release into the environment can occur, according to § § § 12i (2) of the Chemicals Act,
- 12i (3) of the Chemicals Act,
- the notification of amendments and new findings in accordance with § 16f (1) sentence 1 no. 1 and 2 of the Chemicals Act.
purpose of the regulation is to provide details of these procedures, which specify the legal regulations in partial areas. Non-official table of contents
§ 2 General rules on the submission of documents
(1) documents that the admissions office in one of the documents referred to in § 1 shall be submitted to the Admissions Office in four equal sentences. The admissions office may
- use a pre-print or a specific one of the Require Formates of Other Volume,
- Allow the submission of information on another suitable volume,
- The transmission of further copies of submitted documents, insofar as this is related to the participation of the authorities referred to in § 12j (2) sentence 2 of the Chemicals Act, or
() Applications and documents which initiate one of the procedures referred to in § 1 must provide information on the name and address of the applicant. or to be notified, 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 shall contain the documents submitted. If the applicant is not a manufacturer of the biocidal active substance, additional information on the production operation of the biocidal active substance shall be made. Biocidal active substances shall be included in Annex I to Council Directive 67 /548/EEC of 27 June 1991. June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ No L 327, p. EC No C 196 p. 1) in its latest version, published in the Official Journal of the European Communities, or, if the name is not listed there, with the name given in the European Altstoffverzeichnis EINECS or, if the name is not listed there, with the common name (ISO Common Name) commonly used by the International Organisation for Standardisation, or, where such a name is not available, at least the chemical name after to the International Union of Pure and Applied Chemistry (IUPAC nomenclature) system. 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 proved by a written declaration by the manufacturer or importer. Non-official table of contents
§ 3 Presentation of proof of proof, test methods
(1) On presentation of proof of proof in one of the procedures referred to in § 1 , the applicant or the party to the notification shall declare in writing that the nature of the biocidal product, the biocidal active substance or, where appropriate, the other ingredient to which the information contained in the application or notification is concerned, shall be , which corresponds to the biocidal product tested, biocide active substance or ingredient. The determination of physical and chemical properties of a biocidal 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 referred to in Article 1 (1), (3) and (5) shall be carried out in accordance with the methods described in Annex V to Directive 67 /548/EEC, in its latest version published in the Official Journal of the European Communities, and subject to compliance with to 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
- Directive 67 /548/EEC does not contain any rules for certain checks,
- which is included in the policy 67 /548/EEC are not suitable for the examination of a particular property, or
- the other methods with a lower number of Test animals or with a lower load on the animals shall result in equivalent results compared to the test methods set out in Annex V to Directive 67 /548/EEC.
In the case of equivalent test methods, the same test methods shall be used in each case; which permits the renunciation of animal testing or, if this is not possible, requires the least possible number of experimental animals, or where the least load is applied to the test animals. § 20a of the Chemicals Act remains unaffected. It's before the 9. The tests carried out on the basis of test methods other than those referred to in sentences 1 to 4 have been carried out in July 2002 and shall be submitted to the relevant test evidence. The admissions office shall accept these verifications if they are sufficient for the purpose of the examination and in this way further tests on vertebrate animals can be avoided.(3) If a test with regard to a particular substance property is not appropriate, because the substance is to be converted under 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 reflect the complete results of the tests carried out. The test methods used shall provide complete information. 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. Non-official table of contents
§ 4 Restrictions on the eligibility of 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 June 1998 on the February 1998 concerning the placing on the market of biocidal products (OJ L 327, 28.11.1998 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 to discontinue the need for admission according to § 12a sentence 2 no. 4 of the Chemicals Act
(1) Biocidal product may not be obtained from another Member State of the European Communities or State Party to the Agreement on the European Economic Area, subject to the derogation provided for in Article 12a sentence 2 (4) of the Chemicals Act. where it has been established by the admissions office that the relevant conditions are met. The determination shall be made in writing at the admissions office.(2) Applications referred to in paragraph 1 shall include
- the information referred to in Annex IIB Sections I and II of the Directive 98 /8/EC,
- proving the authorisation or registration of the biocidal product in the Member State of the European Communities or Contracting State of the Agreement on the European Economic Area, from which the biocidal product is to be introduced,
- the name of the registered or registered product in Germany Reference product,
- a written confirmation from the manufacturer of the biocidal product that both the biocidal product to be introduced and the reference product of the biocidal product, the biocidal active substances used have been manufactured in accordance with 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 Section 12a of the Chemicals law is not required if
- for the biocidal product to be introduced in the Member State of the European Communities or State Party to the Agreement on the European Economic Area, from which it is introduced, a valid authorisation or registration,
- for the reference product a valid registration or registration in Germany exists and the requirements specified in this approval or registration also with regard to the biocidal product to be introduced,
- both biocidal products are manufactured by the same company or affiliated company or under licence according to the same formula ,
- the biocidal active substances are the same and
- no evidence of this the two biocidal products are present in different ways or that there are other differences which may be relevant for the protection of human and animal health or the environment.
determine that they are only subject to the condition that the conditions in question introduced or to be imported do not change retroactively and that the authorisation or registration of the imported or imported product must be: Biocidal product in the country of origin and of the reference product in Germany is not changed or expires. Non-official table of contents
§ 6 Samples
From the applicants and the notification of the procedures referred to in § 1, the admissions office can at the time of failure or expiry of the authorisation or registration, the failure to determine the determination in accordance with § 5, the inclusion 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 safety data sheet require.