Biocidal Product Act - Biozidprodukteg

Original Language Title: Biozidproduktegesetz – BiozidprodukteG

Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2013_I_105/BGBLA_2013_I_105.html

105. Federal Act on implementing the biocidal product regulation (biocidal product Act - BiozidprodukteG)

The National Council has decided:

Table of contents


1 section: General provisions § 1.
Scope article 2.
Deployment of biocidal products and treated goods on the market 2 section: duties, authorities, procedures, information and fees § 3.
Competent authority and tasks section 4.
Attaching article 5.
Special procedural provisions in section 6.
Biocidal products directory section 7.
Data sharing section 8.
Testing and assessment bodies article 9.
Poison information § 10.
Notification and reporting requirements of section 11.
Fees section 3: classification, labelling, packaging, safety data sheet, and regulation appropriations § 12.
Classification, labelling and packaging as well as safety data sheets section 13.
Labelling of treated products § 14.
Regulation authorizations, prohibitions and restrictions 4th section: monitoring § 15.
Monitoring § 16.
Monitoring powers article 17.
Provisional seizure § 18.
Seizure section 19.
Foreclosure article 20.
Preliminary restraint and safeguards 5. section: penal provisions article 21.
Penal provisions of section 22.
6 responsibility section: transitional and final provisions article 23.
Applicability of the provisions of other legislation section 24.
Linguistic equality § 25.
Entry into force, suspension of legislation and transitional provisions article 26.
Enforcement 1 section

General terms and conditions

Scope of application

1. (1) this federal law serves the enforcement of Regulation (EU) No. 528/2012 on the making available on the market and use of biocidal products (hereinafter: biocidal product regulation), OJ No. L 167 of the 27.06.2012 governing S. 1, and all other, the area of the placing on the market of biocidal products implementing acts of the European Union, in particular Regulation (EC) no 1451/2007 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 of the Council on the placing on the market of biocidal products, OJ No. L 325 of December 11, 2007 page 3.

(2) the terms used in this federal law, such as in particular 'biocidal product', 'Biocidal product family', 'Active substance' and "treated goods", can be understood in accordance with the definitions laid down in the biocidal product regulation.

(3) on biocidal products is section of the chemicals Act III 1996 - ChemG 1996, Federal Law Gazette I no. 53/1997, not to apply, as far as in paragraph 4 and 5 do not otherwise is intended.

(4) section 38 as well as §§ 41 and 42 with the proviso that authorized consumers not to purchase of biocidal products, which fall under this provision and that no approval to purchase of such biocidal products be granted to consumers, § 43, § 44, article 45, paragraph 1 1996 are first rate, § 46 and section 48 of the chemicals Act apply mutatis mutandis to biocidal products, which exhibit any of the hazardous properties or, if in accordance with Regulation (EC) no 1272 / 2008 on the classification , Labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006, OJ No. L 353 of 31.12.2008 p. 1 (hereinafter: CLP Regulation) are classified, one of the risk categories are allocated to that in article 19, paragraph 4 lit. a first coat of paint and article 19 paragraph 4 lit. b first to fourth painting of the biocidal product regulation listed are.

(5), second sentence, and paragraph 3 and 4 and § 46 para 3 of the chemicals Act 1996 are § 45 para 1 to apply mutatis mutandis to biocidal products, the according to



1 the criteria laid down in the legislation in 1996 the hazardous property of a) 'harmful' (article 3, paragraph 1 Z 8 ChemG 1996, BGBl. I no. 53/1997, amended in accordance with the amendment to the ChemG 2011, BGBl. I no. 7/2012) or b) "sensitizing" (article 3, paragraph 1 Z 11 ChemG 1996, BGBl. I no. 53/1997, amended in accordance with the amendment to the ChemG 2011, Federal Law Gazette I no. 7/2012) exhibit 42 ("sensitisation by inhalation is possible") by inhalation with the phrase or 2.
the criteria laid down in the CLP regulation one of the hazard classes or risk categories a) "acute oral toxicity" category 4, b) "acute dermal toxicity" category 4, c) "acute inhalation toxicity" (gas and dust/mist) category 4, d) "acute inhalation toxicity" (steam) category 3 or 4, e) "Specific target organ systemic toxicity, single exposure" category 1 or 2 f) "Specific target organ systemic toxicity, repeated exposure" , category 1 or 2, g) "Aspiration hazard" category 1 or h) "sensitizer for the respiratory system" category 1, category 1A or 1B to associate are, if they are classified according to the CLP regulation.

(6) if in the biocidal product regulation to Directive 90/167/EEC laying down the conditions for the manufacture, placing on the market and use of medicated feedingstuffs in the community, OJ No. L 92 of the 07.04.1990 p. 42, the Directive 2001/82/EC on the Community code relating to veterinary medicinal products, OJ No. L 311 of 28.11.2001, p. 1, or the Directive 2001/83/EC on the Community code relating to medicinal products, OJ No. L 311 of 28.11.2001, p.67, referred so this is concerning the application of the biocidal product regulation in the Federal territory and the execution of this Federal Act, as a reference to the German medicines Act, Federal Law Gazette No. 185/1983, to understand.

(7) if in the biocidal product regulation to Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, OJ No. L 189 of the 20.07.1990 S. 17, Directive 93/42/EEC concerning medical devices, OJ No. L 169 of the 12.07.1993, p. 1, or the Directive 98/79/EC on in vitro diagnostic medical devices, OJ No. L 331 of the 07.12.1998 S. 1, referred this is so concerning the application of the biocidal product regulation in the Federal territory and the execution of this Federal Act, as a reference to the medical devices act, Federal Law Gazette No. 657/1996, to understand.

(8) if present in the biocidal product regulation to Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ No. 196 of the 16.08.1967 S. 1, or to the Directive 1999/45/EC on the approximation of the laws, regulations and administrative provisions of relating to the classification, packaging and labelling of dangerous preparations OJ No. L 200 of the 30.07.1999 p. 1, reference is made, is to understand this in 1996 concerning the application of the biocidal product regulation in the Federal territory and the execution of this Federal Act as a reference to the legislation.

(9) if present in the biocidal product regulation to Directive 2009/48/EC on the safety of toys, OJ No. L 170 of June 30, 2009 p. 1, referred this is so concerning the biocidal product regulation in the Federal territory and the execution of this Federal Act, as a reference to the toy labelling regulation, Federal Law Gazette No. 1029/1994, as amended the regulation Federal Law Gazette II No. 139/2012, to understand.

Deployment of biocidal products and treated goods on the market

2. (1) as far as biocidal products may be provided not only with the General principles stated in particular in article 17 of the biocidal product regulation for the authorisation of biocidal products in accordance with an authorisation of the biocidal product regulation or after approval for parallel trade in accordance with article 53 of the biocidal product regulation or within the framework of research and development in accordance with article 56 of the biocidal product regulation on the market and used, is their offering and making available on the market and are used in the Federal territory only permissible , as far as this in the articles 89, article 91, articles 92, 93 and 95 of the biocidal product regulation and in accordance with this Federal Act



1. for biocidal products containing old active substances no. 1451/2007 are listed in annex II of to Regulation (EC), and 2. for biocidal products, which in the Federal territory under the biocidal products Act (BP Act), Federal Law Gazette I no. 105/2000, approved or registered has been, is, and as far as the no pursuant to Directive 98/8/EC concerning the placing of biocidal products (hereinafter: biocidal products directive), OJ No L 123 of the 24.04.1998 p. 1, as last amended by Directive 2013/5/EC, OJ No. L 44 of the 15.02.2013 p. 14, or implementing Act adopted in accordance with the biocidal product regulation and insofar as any measure which was taken on the basis of this Federal Act or on the basis of the biocidal products act is contrary to the.


(2) the European Commission adopts, an implementing regulation in accordance with article 9 paragraph 1 lit. the biocidal product regulation on the approval of an old active substance or decides in accordance with article 9 par. 1 lit. (b) the biocidal product regulation, that an old active substance is not approved, so has the Federal Minister for agriculture and forestry, environment and water management, if not direct the responsible come to these implementing acts legal effects compared to for the provision of biocidal products on the market, with regulation from complying with the requirements specified in the mentioned implementing Act and conditions depending on to make the further deployment of biocidal products, which are affected by a such an implementing Act, or according to the implementing Act to prohibit. In one such regulation is to specify whether and, where appropriate, within which period as a precondition for providing more of the affected biocidal products on the market an application for authorisation of biocidal product regulation and in accordance with this federal law must be made or whether and, where appropriate, at what point the making available on the market or the use of affected biocidal products to certain product types, uses, or user categories is limited or entirely prohibited.

(3) pursuant to section 58 and 94 of the biocidal product regulation has the requirements a person who intends to bring handled goods traffic in Germany. The offering and the making available on the market of treated products, pursuant to section 58 and 94 of the biocidal product regulation does not meet the requirements, are not allowed.

2. section

Tasks, authorities, procedures, information and fees

Competent authority and tasks

§ 3 (1) the Federal Minister for agriculture and forestry, environment and water management is the authority in the Federal territory for the enforcement of the biocidal product regulation, which is responsible in accordance with article 81 of the biocidal product regulation for their application. The Federal Minister for agriculture and forestry, environment and water management has the responsibilities according to the biocidal product regulation and the thereon implementing acts of the European Union Administration, which are directed at the Member States or the competent authorities, to perceive, as far as this federal law not otherwise is intended. These tasks is in addition to the implementation of procedures or the participation in the proceedings in accordance with the biocidal product regulation, including notification procedures, to include also the reimbursement of statements relating to authorisation of biocidal product regulation, as in particular in accordance with article 27 envisaged par. 2, article 35, articles 37 and 44 of the biocidal product regulation.

(2) are the biocidal product regulation information and communications of the Member States or the competent authorities of the European Chemicals Agency (hereinafter: Agency), or the Agency requested such information or communications in a manner, which is explicitly grounded in the biocidal product regulation, so are the corresponding information and communications from the Federal Ministry of agriculture and forestry, in accordance with existing legal obligations to provide environmental and water management. Article 10 mutatis mutandis also applies to information and communications pursuant to this provision.

Install

§ 4 (1) which is the biocidal product regulation application for authorisation of a biocidal product or a biocidal product family within the meaning of article 17 to 38 by the person who intends to bring this in electronic form via the register for biocidal products in accordance with article 71 of the biocidal product regulation at the Federal Ministry of agriculture and forestry, to introduce environmental and water management in the Federal territory in traffic. Only official and academic bodies within the meaning of that provision of the biocidal product regulation are entitled to the transfer of applications in accordance with article 39 of the biocidal product regulation.

(2) applications for permits for parallel trade within the meaning of article 53 of the biocidal product regulation are in electronic form via the register for biocidal products in accordance with article 71 of the biocidal product regulation at the Federal Ministry of agriculture and forestry, to introduce environmental and water management.

(3) reports of experiments or tests for research or development purposes in the sense of article 56 of the biocidal product regulation are writing to the Federal Minister of agriculture and forestry, to set environmental and water management that, if necessary, to decide has in accordance with the criteria set out in the biocidal product regulation by administrative decision about prohibiting or the approval of an experiment or trial or the notices of payment due by the terms and conditions.

(4) for proceedings in accordance with the biocidal product regulation or not otherwise in accordance with this Federal Act the biocidal product regulation or in this Federal Act unless otherwise provided, the General Administrative Procedure Act is AVG 1991 - to apply Federal Law Gazette No. 51/1991.

Special procedural provisions

§ 5 (1) the Federal Minister for agriculture and forestry, environment and water management has one of the parties, to request the intended, then para 1 of the biocidal product regulation, that the Federal Minister of agriculture and forestry, environment and water management will conduct the evaluation of the active substance, to issue a written confirmation within the meaning of article 7, if the not important public interests are opposed, and this makes credible the approval of an active substance , that the application is expected to meet the data requirements and the application fee to be paid on time. A rejection of the certificate within the meaning of article 7 para 1 of the biocidal product regulation has notice of the Federal Minister for agriculture and forestry, to be environmental and water management.

(2) in proceedings for approval of active substances referred to in article 7 to 16 of the biocidal product regulation is the Federal Minister for agriculture and forestry, to be obliged, then as a responsible authority for the assessment of an active substance according to the mentioned provisions of the biocidal product regulation environment and water management, with a written confirmation referred to in paragraph 1 is given such consent, and if adopted the Agency an application for approval of an active substance and the Federal Ministry of agriculture and forestry , Environment and water management in accordance with article 7 paragraph 2 second subparagraph of the biocidal product regulation announced. The applicant who has tabled an amendment to the approval of an active substance to the Agency applies in proceedings before the Federal Minister for agriculture and forestry, environment and water management as a party.

(3) for proceedings where the Federal Minister for agriculture and forestry, the authorisation of a biocidal product that is suitable for the simplified authorisation procedure to decide environmental and water management as evaluative authority in the course of the simplified registration procedure has, para 1 is to apply by analogy.

(4) an application for authorisation of a biocidal product in the simplified approval procedure within the meaning of article 25 and 26 of the biocidal product regulation is considered installed at the Federal Ministry of agriculture and forestry, environment and water management, if



1. the applicant has a written confirmation within the meaning of paragraph 3 in has the Federal Minister for agriculture and forestry, environment and water management to carry out the assessment of the application for admission in the course of the simplified approval procedure is, 2 which is a request for the Agency has been filed and recorded in the register for biocidal products in accordance with article 71 of the biocidal product regulation and 3 the fees to be paid in accordance with § 11 at the Federal Ministry of agriculture and forestry , Environment and water management have arrived.

(5) for procedures, in which the Federal Minister for agriculture and forestry, environment and water management as evaluative authority in the course of Union approval in accordance with article has to decide 41 to 44 of the biocidal product regulation the Union registration of a biocidal product, paragraphs 1 and 2 are apply accordingly.

(6) information and documents which the biocidal product regulation or which are in accordance with in accordance with this federal law at the Federal Ministry of agriculture and forestry to introduce environmental and water management, shall be provided in German. Derogation submitted summaries of product characteristics within the meaning of article 20 may para 1 lit in procedures to the Union of authorisation, in accordance with article 43 of the biocidal product regulation. a-Z ii of the biocidal product regulation in English are presented. Access certificates are within the meaning of article 61 of the biocidal product regulation in proceedings before the Federal Ministry of agriculture and forestry, to take into account environmental and water management only in accordance of article 61 of the biocidal product regulation if and only if they are intended for submission to the Federal Minister of agriculture and forestry, environment and water management.


(7) approvals of biocidal products are with terms and conditions - in particular with respect to the specifications, the identification and the details of the permitted types of deployment on the market and use - to grant, as far as this is necessary for the compliance with the admission requirements set out in the biocidal product regulation or of this federal law. Legislation, where requirements as regards the conditions for the admission or use of biocidal products are included, in particular as regards the protection of health or the protection of the environment, are taken into account in the procedure significantly.

(8) administrative procedures for the extension of an authorisation of a biocidal product which has been granted by the Federal Ministry of agriculture and forestry, is to proceed in particular in accordance with article 31 of the biocidal product regulation.

(9) administrative procedures to repeal or amend an authorisation of a biocidal product which has been granted by the Federal Ministry of agriculture and forestry, environment and water management, is to proceed in particular in accordance with article 48 to 52 of the biocidal product regulation.

Biocidal products directory

Section 6 (1) the Federal Minister for agriculture and forestry, environment and water management can cause a biocidal products directory, which can include all biocidal products authorised for deployment on the market in the Federal territory.

(2) to these biocidal products, you can deploy each the following information:



1. trade name and registration number of the biocidal product, 2. admission requirements and 3. Summary of the properties of the biocidal product within the meaning of article 22 paragraph 2 of the biocidal product regulation.

(3) where appropriate, can the directory of the biocidal products in accordance with paragraph 1 any person inspect during office hours, in place and place make copies itself or make in accordance with the existing technical facilities at their own expense.

Sharing of data

7. (1) who intends, in accordance with article 64 of the biocidal product regulation after the expiry of the relevant data protection period for a procedure to refer this Federal Act on data of a previous applicant, to the biocidal product regulation or in accordance with in article 64 has this under template para. 2 of the biocidal product regulation to apply for a permit of the Federal Minister for agriculture and forestry, environment and water management-led data relevant for the specific procedure.

(2) to making claims, arise from efforts to share data within the meaning of article 62 and 63 of the biocidal product regulation of, the ordinary courts is to follow.

Testing and assessment bodies

8. (1) for bodies that create information and documents for applications and do it in accordance with the test methods laid down in the biocidal product regulation or this federal law and requirements, the sections 50 to 52 ChemG 1996 and the administrative acts based on it, apply if the methods and requirements must meet the requirements set out in annex II point 6, and annex III point 6 of the biocidal product regulation (principles of good laboratory practice). Foreign test certificates are to be judged ChemG 1996 according to § 53.

(2) as far as testing laboratories, the particulars and documents for applications pursuant to the biocidal product regulation or this federal law create, due to the nature of the information and documents that need to create them, comply with the requirements of paragraph 1, these bodies must meet requirements of article 8 paragraph 5 of the CLP regulation.

(3) the Federal Minister for agriculture and forestry, environment and water management can to check on completeness and the assessment of particulars and documents or parts thereof concerning applications for biocidal product regulation the environmental agency GmbH in the context of it in accordance with § 6 par. 2 Z 33 of the environmental control Act, Federal Law Gazette I no. 152/1998, tasks, attract. As far as this is necessary for the timely and full implementation of attaching, the Federal Minister for agriculture and forestry, environment and water management can attract other knowledgeable persons and suitable facilities to the performance of the above tasks. Such knowledgeable people must at least have successfully completed a university degree in the fields of biology, chemistry, food and biotechnology, medicine, pharmacy, engineering or veterinary medicine or a special University education in the field of Toxicology and have a relevant work experience. Prerequisite for recourse to an appropriate facility is the continuous employment at least someone so knowledgeable in this facility.

(4) if the Federal Minister for agriculture and forestry, environment and water management a information centre within the meaning of article 81 paragraph 2 second subparagraph of the biocidal product regulation establishes that he has, taking into consideration principles of expediency and economy priority provide for the entrustment of creation, the tasks of the national information centre in accordance with article 124 of Regulation (EC) No. 1907/2006 concerning the registration, evaluation , Authorisation and restriction of chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 of Council Regulation (EC) No 1488/94 of the Commission, Directive 76/769/EEC of the Council and directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC of the Commission , OJ No. L of 396 of 30.12.2006 p. 1 (hereinafter: REACH regulation or REACH-V), perceives.

Poison information

§ 9 (1) the poisoning information center of Gesundheit Österreich GmbH determines 73 of the biocidal product regulation as that place in accordance with article that takes the appropriate information about biocidal products and answers questions on medical content with regard to preventive and curative measures, in particular in case of emergency, giving.

(2) the poisoning information center has reported her poisoning cases involving at least reasonable suspicion exists that they are caused by a biocidal product, the Federal Minister of agriculture and forestry, environment and water management in writing.

(3) § 54 ChemG 1996 shall apply accordingly.

Notification and reporting requirements

§ 10 (1) of the Federal Ministry of agriculture and forestry, environment and water management has to ensure, that the details of which are to transmit paragraph 3 of the biocidal product regulation at the European Commission, in accordance with article 65 be collected and processed and transmitted in the appropriate manner to the European Commission. In particular information to monitoring measures, information on poisonings and diseases as well as adverse environmental effects are covered by this obligation of submission to the European Commission. Such data shall be even, when 2000, Federal Law Gazette I no. 165/1999, to be regarded as personal data in accordance with the data protection act. The data protection act is 2000 to apply to the collection, processing and transmission of data to the European Commission.

(2) the Federal Minister for agriculture and forestry, environment and water management can to capture in this provision and in § 3 para 2, § 6 and § 15 paragraph 7 addressed data as well as to the exchange of data in the framework of the register for biocidal products (art. 71 of the biocidal product regulation) of the automation-supported data processing and data transmission operate. The processing and transmission of personal data, including the identity of the applicant and paid is allowed in this context only insofar as the data to the enforcement of the biocidal product regulation or Federal Act are necessary or their processing or delivery in the biocidal product regulation is expressly arranged. On the collection, processing, and communication of such data is the data protection Act 2000 to apply.

Fees

11. (1) in particular, if the Federal Minister for agriculture and forestry, environment and water management



1 in the procedures relating to the authorisation of a biocidal product or a biocidal product family, 2. the procedure for approval of an active substance according to the biocidal product regulation, 3. in the procedures for the decision on the implementation of experiments or tests for research or development purposes within the meaning of article 56 of the biocidal product regulation, 4 in the procedure for approving for parallel trade within the meaning of article 53 the biocidal product regulation or 5th in the proceedings in accordance with article 39 of the biocidal product regulation on the mutual recognition of authorisation operates is , so has the applicant or one who takes these regulatory activities in claim, in accordance with a fee tariff regulation, which is to adopt environmental and water management of the Federal Ministry of agriculture and forestry, to pay fees.

(2) the Federal Minister for agriculture and forestry, environment and water management can also for all acts which are done in the interest of those involved, raise fees in accordance with the regulation to be adopted in accordance with paragraph 4. Such fees may be increased in the form of fees to be paid annually.


(3) provided for the amount of the fees to be paid the property of a company as small and medium-sized enterprises in the meaning of article 3 par. 1 lit. æ of the biocidal product regulation is crucial, has the fee to prove that there are the conditions for the application of fees laid down for small or medium-sized businesses.

(4) the fees tariff regulation has the amount of fees referred to in paragraph 1 to 3, taking account of article 80 of the biocidal product regulation and in accordance with the current experience shows that in average costs, particularly for the investigations, tests, reviews and ratings, authorisations and any entries in the biocidal products directory, set in compensatory tariffs.

(5) for official activities, which can be done in the context of the approval of active substances or an authorisation of a biocidal product or a biocidal product family or within the framework of the authorisation of a biocidal product for parallel trade in accordance with the procedure provided for in the biocidal product regulation, the fees anyway, to be paid in advance.

(6) If fees cannot be paid, they're decision to prescribe.

(7) the fees are earmarked for the completion of the biocidal product regulation and this Federal Act for the Federal Minister of agriculture and forestry, to co-opt environmental and water management.

(8) the Federal Minister for agriculture and forestry, environment and water management has for the first time until September 1, 2016 and again to each perform an evaluation of the conduct of the fees until September 1 each third-year. In this evaluation are to examine the socio-economic impact of fees and it is in particular to judge whether the tariffs laid down in a regulation pursuant to paragraph 4 of height, are the type and basically after appropriate and necessary. The Federal Minister for agriculture and forestry, environment and water management has in evaluating each case on any suggestions of the Federal Minister for Economics, to be taken into account, family and youth.

3. section

Classification, labelling, packaging, safety data sheet, and regulation appropriations

Classification, packaging, labelling and safety data sheets

12. (1) contain the labelling of biocidal products that are intended to be provided must be provided information, including the information that may have been written in the approval procedure in accordance with article 69 of the biocidal product regulation in the Federal territory on the market, and this, where is it written instructions, in German language.

(2) as far as the classification, labelling and packaging of biocidal products, in particular with regard to the article 69 para. 1 of the biocidal product regulation addressed marking components (risk identification) not in accordance with the CLP regulation to be made or is carried out in accordance with the CLP regulation, classification, labelling and packaging in particular with regard to the is ChemG 1996 in § 3 1996 on hazardous characteristics according to the ChemG.

(3) for biocidal products that are I no. 105/2000, approved or registered in accordance with the biocidal products Act, Federal Law Gazette, as well as for biocidal products that are approved in accordance with the biocidal product regulation and this federal law, the authorisation or registration holder is responsible for classification required according to the biocidal product regulation and this federal law, labelling and packaging. If the admissions or registration holder has no Office or any branch in the Federal territory, so the person with seat is or establishment in Austria for the required labelling and packaging, the biocidal product concerned to the making available on the market spends to Austria according to the biocidal product regulation and this federal law or shipments has led.

(4) for biocidal products that may be provided para. 2 of the biocidal product regulation and preceding according to § 2 and the 6th section of this Federal Act without approval in the Federal territory on the market pursuant to article 89, the person who brings the biocidal product on the market, for the classification required according to the biocidal product regulation and this federal law, labelling and packaging is responsible. If the person who brings the biocidal product on the market, has no Office or any branch in the Federal territory, anyone who provides the biocidal product on the market, according to the biocidal product regulation and this federal law required labelling and packaging is responsible.

(5) safety data sheets for biocidal products that are intended to be provided, in the Federal territory on the market must be performed in the German language and article 31 and annex II of the REACH regulation and § 1996 meet 25 ChemG.

(6) in the labelling of biocidal products, whose Wirkstoff is a micro-organism, are providing the risk group in the German language, which the active ingredient according to the § 40 paragraph 4 and 48 is para 1 of the employee - after, to associate BGBl. No. 450/1994, and the it-based administrative acts, and if necessary, the symbol (warning) for biohazard labelling regulation - KennV, Federal Law Gazette II No. 101 / 1997 , Attach Appendix 1.2.,.

Labelling of treated products

§ 13. The labelling of treated goods that are intended to be, must, if necessary, contain information including, where appropriate, to refer to are from the decision on the approval of the active substance, in accordance with article 58 of the biocidal product regulation, brought in the Federal territory on the market and this, as far as it to written notes is, in German language. According to the biocidal product regulation and this federal law required labelling of treated goods marketed in the Federal territory in transport, who is responsible for, which brings the treated goods on the market or to the placing on the market has.

Regulation authorizations, prohibitions and restrictions

Section 14 (1) the Federal Minister for agriculture and forestry, environment and water management has in consultation with the Federal Minister of economy, family and youth, when this is necessary according to the criteria laid down in article 88 of the biocidal product regulation, with regulation, substances that may be contained in biocidal products not or only subject to certain conditions or restrictions, or prohibitions or restrictions for biocidal products containing certain substances or under certain types of products falling , or set for biocidal products with certain hazardous properties or belonging to certain classes of risk. In one such regulation can also be seen above, at what point the active substances covered by the prohibitions or restrictions and other components may be biocidal products or such measures collected biocidal products will no longer be manufactured, placed on the market, made available on the market or used.

(2) the Federal Minister for agriculture and forestry, environment and water management shall notify the European Commission and the other Member States by issuing a regulation referred to in paragraph 1.

(3) if it is to be on the basis of proven interests of defence in special cases as required, the Federal Minister of agriculture and forestry has, after referral to the Federal Minister of national defence and sports regulation to set environmental and water management exceptions to the requirements of the biocidal product regulation and this federal law for certain biocidal products. Care should be take, that the exceptions be set only to the extent, as it is absolutely necessary to safeguard the interests of national defence relevant comparable provisions in other Member States as well as on.

(4) the authorisation of a biocidal product of the product type 15 (Avicides), 17 (Piscicides) or 20 (products against other vertebrate animals) of annex V of biocidal product regulation is inadmissible. The application for admission of such biocidal product is rejected in the procedure for the mutual recognition of a licence, so this decision the European Commission together with a justification of the decision in accordance with article 37 is paragraph 4 to inform the biocidal product regulation.

(5) biocidal products which that article 19 paragraph 4 lit. a or b of the biocidal product regulation meet stated eligibility criteria, may be made to the general public (consumers).

4 section:

Monitoring

Monitoring

Section 15 (1) as far as this Act does not otherwise determined, is responsible to the Governor for official monitoring of the compliance with the regulations of the biocidal product regulation and this federal law, as well as the based acts, such as in particular implementing acts adopted on the basis of the biocidal product regulation,.

(2) the monitoring of the inspection bodies in the sense of § 8 para 1, which is a message in accordance with § 1996 have provided 50 Z 3 ChemG, incumbent on the Federal Minister of agriculture and forestry, environment and water management. § 52 ChemG 1996 shall apply.


(3) the Governor has to operate professionally empowered people as bodies monitoring and appropriate expert can consult or hire. The Federal Minister for agriculture and forestry, environment and water management may adopt detailed rules on the technical competence of these organs by regulation, insofar as this is appropriate with regard to ensuring a necessary for the surveillance level of qualification.

(4) If this is located in the interest of simplicity, quickness, or appropriateness of enforcement, the Federal Minister for agriculture and forestry, environment and water management can determine by regulation that for certain areas of the monitoring within its sphere powers come to individual, specially trained bodies of the Customs authorities that are authorized in accordance with paragraph 1 to the monitoring bodies by this federal law.

(5) the Governor has an audit and sampling schedule for monitoring the compliance with the provisions of the biocidal product regulation and this Federal Act, in particular on the conditions for admission as well as on the classification, establishing labelling and packaging of biocidal products and the Federal Ministry of agriculture and forestry under the point of view of proper and effective control each for the following calendar year, in writing to deliver environmental and water management.

(6) results in the monitoring measures the justified suspicion that elements of the biocidal product regulation or this federal law are not met and further measures of the Federal Ministry of agriculture and forestry, environment and water management are needed, so is immediately in writing to make announcement about this.

(7) the Governor has the Federal Ministry of agriculture and forestry, to report environmental and water management in writing until March 31 of the following year on the monitoring measures carried out in the previous calendar year.

(8) in the case of the monitoring is also the Regulation (EC) No. 765/2008 on the requirements for accreditation and market surveillance relating to the marketing of products, OJ No. L 218 of August 13, 2008 p. 30, to take into account and it may be the information necessary for the implementation of Regulation (EC) to exchange with the No. 765 / authorities responsible for 2008 in Germany. § 64a para 1 ChemG 1996 shall apply mutatis mutandis.

(9) on military property, the measures provided for in this section only in the agreement may be made with the local military commander.

Monitoring powers

Section 16 (1) for agriculture and forestry, environment and water management as well as you are of those consulted experts entitled, everywhere where the biocidal product regulation or this Act collected biocidal products, active substances, or treated goods are manufactured, offered, ready made on the market or used, review to keep the bodies of the Governor and the Federal Minister, as well as to obtain verbal or written information.

(2) the review is, except for the imminent danger, during the usual business or operating hours and attendance of informed employees to perform.

(3) the review affects biocidal products, active substances, or treated goods that are under customs supervision, the review only when a Customs office or at a Customs Act concerning the biocidal product, the active ingredient or the treated goods must be performed; in customs warehouses, free zones or free warehouses, it is permissible at any time while they are open for customs official act, the review.

(4) in the case of the review to take to avoid any non-essential disturbance or obstruction of the operation is carefully.

(5) the bodies authorized to monitor and experts may review manufacturing methods and equipment as well as samples of biocidal products, ingredients, or treated goods to the extent necessary.

(6) the extracted sample is as far as this not their proper assessment is thwarted and it is their nature to divide in two equal parts, which are to be officially closed. One part is to examine the other party for evidentiary purposes to leave.

(7) a division of the extracted sample is inherently not possible the sample shall without to investigate previous Division. Same units of the biocidal product, of the active substance or of the treated goods are still evident, a unit is to take and to be officially closed.

(8) the extracted sample is to examine whether the rules of the biocidal product regulation and this federal law in relation to biocidal products, active substances, or treated goods have been respected. Insofar as this is necessary to carry out a proper investigation, knowledgeable persons or suitable facilities, as the experts are for the examination of the sample to be used.

(9) at the request of the business or owner of the business, the Federal Government for the extracted sample has to make a compensation in the amount of the cost price. The compensation is not applicable if a certain person has been punished or detected on the forfeiture of the goods concerned on the basis of this test. For samples or units, the party as evidence have been left back, is to pay no compensation. The request for compensation can be introduced at the earliest after a communication from the authority, that is no reason for a complaint, after final adjustment of administrative criminal proceedings or after the occurrence of the limitation period in proceedings when the Governor of that State, in which the sample is taken. It decides, is whether and, where appropriate, to what extent to compensate.

(10) the business or business owner as well as their agents, undertakes to grant the institutions authorized in accordance with § 15 of the monitoring and expert insight into the record to leading to the biocidal product regulation or in accordance with this federal law. You have to tolerate the monitoring measures, to provide the necessary assistance and to provide all information necessary for the monitoring.

(11) refuses the business or business owner or his authorised representative to put up the surveillance measures provided for in this federal law, so it can be enforced. The organs of public security have the authorities according to this federal law and bodies about their request to ensure the exercise of the powers in which of the Security Police Act - SPG, Federal Law Gazette No. 566/1991, predefined framework assistance to.

(12) the costs of the monitoring measures are to impose the obligation of the Governor with notice, if legally binding has been determined in a criminal case, that he has not adhered elements of the biocidal product regulation or this federal law. The current personnel expenses is not count in the costs of monitoring measures.

Provisional seizure

Section 17 (1) the supervisory bodies can, taking into consideration the objectives of the biocidal product regulation biocidal products, active ingredients and treated goods which are subject to the regulations of the biocidal product regulation or this Federal Act, where appropriate, including their components and packaging (hereafter referred to as "Objects"), temporarily seize, if there is reasonable suspicion, that they



1 counter in article 2, paragraph 1 laid down conditions offered on the market provided or used be, offered 2. contrary to a prohibition or a restriction in accordance with § 14, made available on the market or used, 3. contrary to a letter of admission in a composition with a classification, labelling or packaging are offered or made available on the market, which can have a significant threat to the health of humans or animals or for the environment , 4. unless an approval is not required, contrary to the provisions relating to the classification, labelling and packaging in a presentation or manner be offered or made available on the market, which may have a significant threat to the health of humans or animals or for the environment, or 5 contrary to requirements, restrictions or conditions that have been set in connection with a proceeding , in a manner be offered or made available on the market, which can have a significant threat to the health of humans or animals or for the environment.

(2) there is the reasonable suspicion that items which are subject to the biocidal product regulation or this federal law, contradict regulations of the biocidal product regulation or Federal Act apart from the cases referred to in paragraph 1, the Board has to seize the affected objects, then if this is due to an apparent threat to the life or health of people, animals or the environment, which could be connected with the delivery or use of the items , appears essential.


(3) If, apart from the cases referred to in paragraphs 1 and 2 according to the circumstances of the individual case of reasonable suspicion is that objects which are subject to the biocidal product regulation or this federal law, contradict regulations of the biocidal product regulation or this Federal Act and is not a provisional seizure, so the Board has to inform the designated the suspicions and to urge him, if necessary by granting a reasonable grace period , to establish the rightful State. If the lawful state contrary to a prompt is not produced by the monitoring body, a reticle of the reimbursement of a display is not allowed.

(4) the supervisory bodies have the Governor of that State in which the provisional seizure is made the provisional seizure immediately. The provisional seizure is override, unless the Governor within two weeks upon receipt of this indicator directs the confiscation decision in accordance with article 18.

(5) on the provisional seizure, the Board has handed over a certificate of the previously designated, in which the place of storage and the nature and the quantity of the seized items to be. This certificate is also draw attention to the criminal consequences of movement or change of the seized items, as well as the violation of the official seal.

(6) the right of disposal over the items seized in accordance with paragraph 1 or 2 for the time being entitled to the Governor. The provisionally seized goods are to leave the operation. This does not apply if the proper storage is not guaranteed or if fear is leaving the items an abuse. Left items are if at all possible to close or to identify that their change without damaging the packaging or the marking is not possible.

(7) the preservation of objects from damage left in the operating responsibility of the previously designated. Special measures are needed to do this, so the previously designated has to notify the competent authority if there is no danger in delay. The measures are carried out in the presence of a monitoring body. The organ has to record a transcript of the process to hold are the measures taken, the possible removal of an official seal and its renewed application.

(8) if the provisionally seized items not in operation can be left, the date designated shall bear the authority incurred transport and storage costs. The Governor with notice decides about the liability of the costs actually and the height.

(9) during the provisional seizure, samples of the items only on order of the competent authority may be removed.

(10) for the compulsory enforcement of a provisional seizure, § 16 para 11 shall apply.

(11) when reference is made in this provision to the biocidal product regulation, Regulation (EC) is no. 528/2012 on the making available on the market and use of biocidal products, OJ No. L 167 of the 27.06.2012 p. 1, as amended to the date of entry into force of this federal law as addressed.

Seizure

The Governor has 18 (1) in accordance with the protection goals of the biocidal product regulation for items that are subject to the biocidal product regulation or this federal law, by decision the seizure



1. If the conditions in accordance with article 17, paragraph 1 Z 1 to 5 or paragraph 2 within two weeks after receipt of the indication of a provisional seizure referred to in paragraph 1 by the supervisory bodies, and 2. If the requirements pursuant to § 17 para 1 are Z 1 to 5 or paragraph 2 within two weeks of receipt indicating a provisional seizure pursuant to § 29 3 Customs law implementation law , Federal Law Gazette No. 659/1994, by the Customs authorities to have.

(2) the seizure is by the Governor immediately to repeal, as soon as the conditions referred to in article 17, paragraph 1 no longer exist Z 1 to 5 or 2.

(3) § 17 para 5 to 9 and paragraph 11 is to apply mutatis mutandis to the seizure.

Foreclosure

Section 19 (1) which has Governor to explain the items seized from him in accordance with § 18 as a precautionary measure revoked if the person concerned by verifiable measures ensures that after release of the goods carried the biocidal product regulation and this Federal Act Bill.

(2) the expiration may not be pronounced if the value of the items out of proportion to the importance of the Act or to the accusation that the offender and any danger to the health of humans or animals or for the environment associated with the release of the goods.

(3) the derelict objects are best to use or, if this is not possible, by the previous owner as waste environment recycle or eliminate. A themselves resulting from the exploitation of the proceeds after deduction of transport is storage and recovery costs follow from the previous owner of the items.

Preliminary restraint and safety measures

Section 20 (1) in cases of a threat to the health of humans or animals or for the environment, which has been caused by biocidal products, active substances, or treated goods has the authority responsible for monitoring according to the extent of the threat with notice to have the necessary measures to reduce or eliminate the risk. Such measures, in particular the obligation to take back in traffic brought biocidal products, ingredients, or treated goods or the publication of product recalls, can also be arranged if the classification, labelling and packaging of biocidal products, active substances, or treated goods are contrary to the provisions of the biocidal product regulation or Federal Act in such a way, that is likely to cause a significant underestimation of the hazard, or if the proposed labelling is missing.

(2) in cases of immediate threat, the supervisory bodies or the district administrative authority prior to issuing a notice and without a previous procedure can meet such measures in place; the district administrative authority has taken measures notified to the Governor by her. A written opinion of the Governor is within two weeks of the measures adopted, otherwise the measures repealed considered.

(3) rulings referred to in paragraph 1 are immediately enforceable. If they are not shorter term, they appear upon the expiry of six months from the date of their legal force except for effectiveness.

(4) if the conditions for the issue of a notice referred to in paragraph 1 are no longer available and is to be expected, that which the biocidal product regulation and this Federal Act will comply with regulations affected in the future by the decision, the Governor has on its request to revoke the measures adopted by decision.

5. section

Penal provisions

Section 21 (1) who



1. a biocidal product that is subject to an authorisation requirement, contrary to article 17 offers para 1 of the biocidal product regulation or violates article 2 par. 1 without appropriate approval, brings in traffic or otherwise on the market provides, 2.
it as a holder of an authorisation for a biocidal product family, contrary to article 17 fails para. 6 of the biocidal product regulation, every product of the biocidal product family, for a reporting obligation is to report, within the time limit prescribed and including the required information a biocidal product that is subject to article 53 of the biocidal product regulation of the permit requirements for parallel trade, offers 3. contrary to article 53 of the biocidal product regulation or violates article 2 par. 1 without permission or in contravention of the conditions set out in the permit , brings in traffic or otherwise on the market provides, 4. offers an approved biocidal product contrary to the letter of admission with a marking differ from other than the officially established composition, with one of the established labelling or packaging or packaging or in contrast with a circulation laid down in the notice of admission, brings in traffic or provides otherwise in the market, 5. a biocidal product contrary to a prohibition or a restriction in accordance with § 14, or against a measure , that regulation in accordance with article 14, paragraph 1 has been issued, offers, brings in traffic or otherwise on the market provides or uses, 6 contravenes the obligations of article 16, paragraph 10, 7 an experiment or an attempt to research and development purposes, where an unauthorised biocidal product or a not approved active ingredient certain solely for the use in a biocidal product used, contrary to article 56 of the biocidal product regulation or contrary to section 4 paragraph 3 without the article 56 para 2 of the biocidal product regulation set Period to wait, without the keeping of appropriate records, without reimbursement of the corresponding message, without authorization, contrary to a prohibition or contrary to the conditions laid down in the approval and conditions performs, 8.

a biocidal product contrary to article 2, paragraph 1 or 3 offers, puts on the market or otherwise provides on the market that contains an old substance, not or no longer allowed is in accordance with article 89 of the biocidal product regulation in the concerned active substance/product type combination, 9.
              as a holder of an authorisation for a biocidal product which defined obligation violated para. 1 of the biocidal product regulation in article 47, 10 a treated goods contrary to article 58 paragraph 3 to 4 and para. 6 of the biocidal product regulation or contrary to § 2 paragraph 3 or article 13 without the required identification or a label that meets the requirements of the regulations stated in the biocidal product regulation or Federal Act does not , offers, brings in traffic or otherwise on the market provides, 11 a treated goods contrary to art. 58 para. 2 of the biocidal product regulation or violates article 2 par. 3 without fulfilling the requirements laid down in the biocidal product regulation for the active substances in biocidal products, with which the treated commodity is treated, or that in the treated fabric, offers, brings in traffic, or otherwise on the market provides , 12 a consumer contrary to article 58 para 5 of the biocidal product regulation expressly requested information about biocidal treatment of the treated goods not, not timely or not free provides, 13.
              as a manufacturer of a biocidal product against the article 65 (2) of the biocidal product regulation set forth documentation obligations or breach of the obligation to the storage of samples of production batches, 14.
as a marketing authorisation holder against the in article 68, para. 1 of the biocidal product regulation violates laid down obligations relating to the storage and the provision of records, 15 offered a biocidal product contrary to article 69 of the biocidal product regulation or contrary to § 12 without the required labelling or packaging or labelling or packaging which does not comply with the requirements of the said provisions, brings in traffic or otherwise provides on the market , 16. a biocidal product contrary to article 70 of the biocidal product regulation or violates article 12 paragraph 5 without the required submission of a safety data sheet or safety data sheet, which does not comply with the requirements of these regulations, is down or does not fulfil the other obligations laid down to the safety data sheet, operates 17 advertisement for a biocidal product, which conforms to not article 72 of the biocidal product regulation, by which in art. 72 wording shown in paragraph 1 and 2 of the biocidal product regulation does not , not, not in German, not clear, not legible or not audibly reproduced in full is, 18 operates advertisement for a biocidal product that is contrary to article 72 paragraph 3 misleading the biocidal product regulation with regard to the risks of the biocidal product or contains expressions that para 3 of the biocidal product regulation are inadmissible in accordance with article 72, 19 (3) of the biocidal product regulation offers a biocidal product contrary to article 95 that will bring in traffic or otherwise provides on the market, or 20.
a biocidal product containing an old active substance No. 1451/2007 on the second not in annex II of to Regulation (EC) phase of the 10-year work programme referred to in article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products, OJ No. L 325 of December 11, 2007 page 3, is included, offers, brings in traffic or otherwise on the market provides, commits an administrative offence if the Act constitutes not a criminal offence falling within the jurisdiction of the ordinary courts and is with fine of at least Euro 500 up to 20 180,-euro, to punish up to 40 360,-euro in case of recurrence. The attempt is punishable.

(2) if the biocidal product regulation or this federal law, the regulations adopted on the basis of this Federal Act, notices, or other arrangements contravenes, commits, if the fact is not the offence of a criminal offence falling within the jurisdiction of the ordinary courts, and not after paragraph 1 an administrative offence is a criminal offence, and up to 5 090 EUR in case of recurrence with fine is up to 10 180 , - Euro to punish. The attempt is punishable.

(3) committed action in accordance with paragraph 1 or 2 by spending a biocidal product, substance or a covered commodity to Austria, so the seat or the establishment of domestic leaders, which has led this movement or has obtained the biocidal product, the active ingredient or the treated commodity is considered crime scene.

(4) insofar as reference is made in paragraphs 1 and 2 to the biocidal product regulation, Regulation (EC) is no. 528/2012 on the making available on the market and use of biocidal products, OJ No. L 167 of the 27.06.2012 p. 1, as amended to the date of entry into force of this federal law as addressed. With the reference to Regulation (EC) no 1451/2007 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 of the Council on the placing on the market of biocidal products, OJ No. L 325 of December 11, 2007 page 3, Z is 20 in paragraph 1 addressed the current version of the regulation at the time of entry into force of this federal law.

Accountability

§ 22 (1) as far as in this federal law not else is intended is the responsibility for compliance with the provisions of this Federal Act and the administrative acts based on it, as well as the relevant regulations of the European Union after the administrative penal code 1991 - VStG, Federal Law Gazette No. 52/1991.

(2) a person in charge is representative within the meaning of § 9 para 2 or 3 VStG ordered, whose order is thus to give the Prime Minister of the country in which the contracting person or registered person community has its headquarters and its branch, in writing. This is to document the approval of the responsible officer and to specify its main residence. The order becomes effective upon receipt of this notice by the Governor. Their input is to be confirmed by the Governor at the request in writing.

6 article

Transitional and final provisions

Applicability of the provisions of other legislation

The references to other federal laws in this Federal Act are section 23 (1) to be understood as references to the applicable version, insofar as not expressly referred to a certain version.

(2) when referenced in this Federal Act on other rules than federal laws, these references to reference the version are so understanding that stood at the entry into force of this federal law in force, as far as not expressly referred to a specific version.

(3) where reference is made to regulations of the European Union directly for biocidal products, active substances, or treated goods each EU law in force-standing version is decisive, unless it has been referred to a certain version.

Linguistic equal treatment

§ 24. As far as the designations employed in this federal law relating to natural persons, the selected form applies to both sexes. In the application of these terms to certain natural persons the respective gender-specific form is to use.

Entry into force, suspension of legislation and transitional provisions

Section 25 (1) with the exception of § 1 5 subpara 1 lit. b and Z 2 lit. h enter into force this September 1, 2013 federal law. At the same time experience the biocidal products Act, Federal Law Gazette I pursuant to § 46 para 6 of the biocidal products act as federal law applicable No. 105/2000, and the Ordinance banning the use of substances for stock protection and pesticides, Federal Law Gazette No. 652/1993, override. Article 1 par. 5 subpara 1 lit. b and Z 2 lit. h shall enter into force 1 June 2015.              

(2) the fees tariff regulations adopted on the basis of article 41 of the biocidal products Act are considered to apply regulations in accordance with section 11 of the Federal Act for the notices of payment due of the fees in approval procedures in accordance with this federal law and procedure for the approval of active substances according to the biocidal product regulation and this federal law with the proviso, in approval procedures for biocidal products and approval for active ingredients of the respective substantive activities of the authority to attract appropriate tariff items being.

(3) the biocidal products act old active ingredient regulation, Federal Law Gazette II No. 353/2008, is to apply Regulation in accordance with § 2 para 2 of the Federal Act.

(4) pending at the time of entry into force of this federal law at the Federal Ministry of agriculture and forestry, environment and water management in accordance with articles 21 and 22 of the biocidal products Act are to continue para. 2 of the biocidal product regulation according to the biocidal product regulation and this Federal Act pursuant to article 90.


(5) authorisation and registration procedures under the biocidal products Act, which are pending at the time of entry into force of this federal law at the Federal Ministry of agriculture and forestry, environment and water management, are under the provisions of the biocidal products Act and taking account of article 91 of the biocidal product regulation to continue.

(6) according to the biocidal products act issued approvals and registrations remain even after the entry into force of this federal law in force. The provisions of the biocidal product regulation and this Federal Act on such approvals and registrations shall apply from 1 September 2013.

(7) packs of biocidal products, in respect of the labelling particulars, in article 69 para. 1 of the biocidal product regulation (risk identification) are addressed, must be marked in accordance with the CLP regulation, but taking into account the hazards referred to in § 3 ChemG are 1996 marked, may, if it is contrary not the respective registration or registration permit, until 1 June 2015 in the Federal territory on the market are provided. Packs located to 1 June 2015 in the Federal territory on the market of biocidal products with a such hazard labelling may be sold until June 1, 2017.

Enforcement

Section 26 (1) if in the following not other surely is, with the completion of the biocidal product regulation and this federal law, the Federal Minister for agriculture and forestry, environment and water management.

(2) the Federal Minister for agriculture and forestry, environment and water management has in the issuing of regulations made pursuant to article 14, paragraph 1, to establish family and youth the agreement with the Federal Minister for economic.

(3) the Federal Minister for agriculture and forestry, environment and water management has to make the agreement with the Federal Minister of finance at the enactment of regulations in accordance with § 15 para 4.

Fischer

Faymann