Regulation On The Authorisation Of Biocidal Products And Other Chemicals Legal Procedures For 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

Read the untranslated law here: http://www.gesetze-im-internet.de/chembiozidzulv/BJNR251410002.html

Regulation on the authorisation of biocidal products and other chemicals-legal procedure for biocidal products and biocidal active substances (biocides approval regulation ChemBiozidZulV) ChemBiozidZulV Ausfertigung date: 04.07.2002 full quotation: "biocide authorization regulation of 4 July 2002 (BGBl. I S. 2514), by article 15 of the law of August 22, 2006 (BGBl. I S. 1970) has been changed" stand: amended by art. 15 G v. 22.8.2006 I in 1970 about the stand number you see in the menu see remarks footnote (+++ text detection from) : 9.7.2002 +++) the V 1 d was adopted as article G v. 4.7.2002 I 2514 by the Federal Government after consultation with the interested parties with the consent of the Federal Council. She entered into force article 4 of this V on the 9.7.2002 according.

§ 1 scope of application, purpose this Regulation applies to 1 the authorisation of biocidal products according to section 12a, sentence 1 and § 12 c of the chemicals Act, 2. the finding to the Elimination of the approval means according to section 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 certificates and registrations pursuant to § 12 g of the chemicals Act, 5 the examination of biocidal active substances according to § 12 h of the chemicals Act , 6. the submission of documents, including records and communication of changes in cases of scientific or process-orientated research and development pursuant to section 12i para 2 of the chemicals Act, 7 the approval tests, which may cause a release into the environment, article 12i par. 3 of the chemicals Act, 8 the communication of changes and new findings after section 16f para 1 sentence 1 Nos. 1 and 2 of the chemicals Act.
You used to regulate the details of these procedures, which specify the regulations in certain areas.

§ 2 to submit general rules for the submission of documents (1) documents on which the admissions in which are to be submitted procedure referred in article 1, the DMV in four same sets. The admission Board can use a form designated by her or a certain format of other disk require 1, allow the communication of the information on another suitable medium 2., providing additional copies of submitted documents require 3. insofar as this is required information requirements referred to in 22, section 1a No. 4 of this Act in respect to the involvement of the authorities referred to in section 12j para 2 sentence 2 of the chemicals Act, or to meet in §.
(2) applications and documents that introduce one of the procedures referred to in paragraph 1, shall include information on name and address of the applicant or notification, the location of the production plant as well as the identity of the biocidal product including all biocidal active substances contained in it or of biocidal active substance and a summary of the main content of the submitted documents. Is not the manufacturer of the biocidal active substance, are the subject of in addition to information about the manufacturing plant of the biocidal active substance. Biocidal agents are named in annex I of to Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ EC No. C 196 p. 1) name specified in the most recent version published in the official journal of the European communities or, if the name is not listed there, with the name specified in the European existing substances list EINECS or, if the name is also not listed there, General named common at the international standards organization (ISO common name) or, if a such does not exist , to denote at least with the chemical name according to the system of the International Union of pure and applied chemistry (IUPAC nomenclature). Documents already submitted by the applicant or notification of admissions over the same biocidal product or same biocidal active substance, reference is to take. In the case of imports, including name and address of the manufacturer are appointed. In the event of the application is filed by a representative, authorization by a written declaration of the manufacturer or importer is to prove.

§ 3 submission of inspection certificates, inspection methods (1) submission of test certificates in one of the procedures referred to in article 1 has to explain that the nature of the biocidal product, the biocidal active substance or, where appropriate, of the other ingredient to which relate the information contained in the application or the communication, corresponds to that of the tested biocidal product, biocidal active substance or ingredient in writing the applicant or duty. The determination of physical and chemical properties of a biocidal active substance is, if necessary, to make changes to the pure active ingredient of the biocides. The composition of the sample is to specify. The names of the bodies responsible for the tests shall be accompanied by the Declaration.
(2) checks in the context of proceedings under article 1 are according to the methods described in annex V of to Directive 67/548/EEC in their most recent version published in the official journal of the European communities and in accordance with the principles of good laboratory practice, making no. 1, 3 and 5. Started tests can be completed under the laws at the beginning. The tests must be carried out according to other internationally recognized scientific methods if 1 contains no provisions the Directive 67/548/EEC for certain checks, 2. the test methods referred to in Directive 67/548/EEC for the examination of a particular property are not suitable or the other methods with a smaller number of animals or with a lower burden of animals lead 3 equivalent results compared to the test methods listed in annex V of Directive 67/548/EEC.
At equivalent test methods the one is each to apply, which allows the abandonment of animal testing or, if this is not possible, the minimum number of animals required or occurs at the slightest stress for the animals. section 20a of the chemicals Act remain unaffected. Are prior to 9 July 2002 tests other than in sentences 1 to 4 designated test methods has been carried out, are the appropriate audit evidence to present. The Admissions Office will accept this proof of testing when it suffice for the purpose of testing and further testing on vertebrate animals can be avoided in this way.
(3) is an assessment with regard to a specific material property are carried out doesn't make sense, because the substance converts among the expected testing and exposure conditions, the examination may be held on the fabric to the transformation product.
(4) test certificates must reflect the full results of the tests. Full information can be disclosed about the used test methods. In the cases of paragraph 2 sentence 3 No. 2 and 3 is to use the methods chosen to establish.

§ 4 limitations the approval ability at V of 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 certain biocidal products biocidal products of the product types 15 (Avicides), 17 (Piscicides) and 23 (products against other vertebrate animals) of the annex EC No. L 123, p. 1) may 1, not pursuant to section 12a set 1, also in conjunction with § 12 c are allowed or registered according to § 12f of the chemicals Act. A recognition of foreign certificates or registrations such biocidal products according to § 12 g of the chemicals Act may not be granted. § 12c para 2 of the chemicals Act remain unaffected.

§ 5 (1) a biocidal product may statement about the Elimination of the approval means according to section 12a, sentence 2 No. 4 of the chemicals Act, claiming the exemption of 12a sentence 2 No. 4 of the chemicals Act from another Member State of the European communities or Contracting State of the agreement on the European economic area would only be introduced if by the admission Board it has been determined that this relevant conditions are fulfilled. The finding is to apply for the admission Board in writing.
(2) applications referred to in paragraph 1 must include the 1 referred to in Annex IIB of sections I and II of Directive 98/8/EC, 2 proof of 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, 3. the designation of the reference product approved in Germany or registered , 4. a written confirmation of the biocidal product manufacturer that the biocidal product to be introduced as well as the reference product was manufactured by him, a company associated with or licensed to same formula and that the used biocidal active ingredients are the same.
(3) the Admissions Office determines that approval need not be under section 12a of the chemicals Act, if 1.
for the biocidal product to be introduced in the Member State of the European communities or Contracting State of the agreement on the European economic area, which is introduced, is a valid authorisation or registration, 2 for the reference product is a valid authorisation or registration in Germany and the requirements laid down in the authorisation or registration in terms of the biocidal product to be imported are met, 3. both biocidal products by the same company or affiliated companies or under licence according to the same formula produced , 4. the biocidal active ingredients are the same and 5 no evidence available, that both biocidal products work differently, or there are other differences, which may be for the protection of the health of humans and animals or the environment are of importance.
The assessment decision is to determine that this applies only with the proviso that the conditions relating to the biocidal product that is imported or to be imported are not change and that the authorisation or registration of the introduced or to be introduced biocidal product in the country of origin and the reference product is not changed in Germany or expires.

§ 6 samples of the applicants and notification of the procedures referred to in article 1 may the body of approval up to the point of refusal or of expiry of the authorisation or registration, the refusal of the determination under section 5, the inclusion of biocidal active substance in annex I of Directive 98/8/EC or the termination of the tests according to section 12i of the chemicals Act at any time the submission of samples of the biocidal product, the biocidal active substance or of the reference product, including the respective packaging , Require labelling, instructions for use and, where appropriate, the safety data sheet.