Act For Protection Against Dangerous Substances

Original Language Title: Gesetz zum Schutz vor gefährlichen Stoffen

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Read the untranslated law here: http://www.gesetze-im-internet.de/chemg/BJNR017180980.html

Law for protection against dangerous substances (chemicals Act - ChemG) ChemG Ausfertigung date: 16.09.1980 full quotation: "chemicals act as amended by the notice of August 28, 2013 (Gazette I p. 3498, 3991), by article 431 of the Decree of 31 August 2015 (BGBl. I p. 1474) has been changed" stand: Neugefasst by BEK. v. 28.8.2013 I 3498, 3991;
 
as last amended by article 1 V v. 20.6.2014 I 824 Note: change article 431 V v. 31.8.2015 I 1474 (No. 35) still not taken into account by learn more about the stand number in the menu under notes 1 the law serves the following directives:-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. 196 p. 1), the last by Directive 2013/21/EC (OJ L 158 of the 10.6.2013, p. 240) has been changed, - Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of article 16 1 of Directive 89/391/EEC) (OJ EC No. L 131, p. 11), the last by Directive 2009/148/EC (OJ L 330 of December 16, 2009, p. 28) has been changed, - Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 on the approximation of the laws, regulations and administrative provisions of relating to the classification, packaging and labelling of dangerous preparations (OJ EC No. L 200 p. 1, 2002 No. L 6 p. 71), most recently by the Directive 2013/21/EC (OJ L 158 of the 10.6.2013, p. 240) has been changed, - Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (codified version) (OJ EU no. L 50, p. 28), most recently by Regulation (EC) No 219 / 2009 (OJ L 87 of the 31.3.2009, p. 109) is has been modified and - Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the approximation of the laws, regulations and administrative provisions for the application of the principles of good laboratory practice and to control of their use in experiments with chemical substances (codified version) (OJ EU no. L 50, p. 44), most recently by Regulation (EC) No 219 / 2009 (OJ L 87 of the 31.3.2009, p. 109) has been changed.
Footnote (+++ text detection from: 26.9.1980 +++) (+++ official note of the standard authority on EC law: implementation of EWGRL 548/67 (CELEX Nr: 31967 L 0548) EGRL 24/98 (CELEX Nr: 31998 L 0024) EGRL 45/99 (CELEX Nr: 31999 L 0045) EGRL 9/2004 (CELEX No.: 32004 L 0009) EGRL 10/2004 (CELEX Nr: 32004 L 0010) cf. Bah v. 28.8.2013 I 3498 +++) (+++ requirements due to the EinigVtr see ChemG annex EV;)
Requirements no longer to apply pursuant Article 1 No. 9 G v. 21.1.2013 I 91 mWv 29.1.2013 +++) first section table of contents purpose, scope and definitions article 1 purpose of the Act section 2 scope article 3 definitions § 3a of dangerous substances and dangerous mixtures § 3 of section b (dropped out) implementing Regulation (EC) No. 1907/2006 and Regulation (EC) No. 1272/2008 § 4 involved federal authorities § 5 tasks of the Federal Office for chemicals § 6 tasks of the assessment bodies article 7 cooperation of the Federal Office for chemicals and the other involved federal upper section 8
Exemption the national information centre article 9 exchange of information between federal and State authorities article 10 provisional measures article 11 (dropped out) § 12 (dropped out) section IIa implementing Regulation (EU) No. 528 / 2012 section 12a of the involved federal authorities § 12 b tasks of the Federal Office for chemicals § 12 c tasks of the assessment bodies Section 12d collaboration of the Federal Office for chemicals and other top authorities involved article 12e helpdesk, information of the public § 12f exchange of information between federal and State authorities § 12 g order powers of the Federal Office for chemicals , provisional measures article 12 h regulation appropriations third section classification, labelling and packaging section 13 classification, labelling and packaging requirements section 14 authorization to classification, labelling and packaging regulations § 15 (dropped out) section 15a (dropped out) fourth section notification requirements sections 16 to 16 c (dropped out) section 16B notification requirements for mixtures § 16e releases for information and treatment centers for poisoning section 16f (dropped out) fifth section empowerment to prohibitions and restrictions, as well as to measures for the protection of workers article 17 prohibitions and restrictions article 18 poisonous animals and plants article 19 measures for the protection of workers sixth section good Laboratory practice § 19a good laboratory practice (GLP) § 19 b GLP certificate § 19 c reporting § 19d supplementary provisions seventh section General provisions article 20 application and communication documents and regulation appropriations section 20a (dropped out) § 20B committees article 21 monitoring § 21a participation of Customs offices article 22 information obligations Article 23 government orders section 24 enforcement in the area of the Bundeswehr § 25 alignment with Community law or Union law § 25a fees and Auslagen2 § 26 penalty provisions of § 27 penal provisions § 27a untrue explanation of GLP, gaining the GLP certificate § 27 b infringements of Regulation (EC) No. 1907/2006 section 27 c infringements of tax legislation section 27 d confiscation eighth section final provisions § 28 transitional provisions article 29 (except entry into force) article 30 Berlin clause Article 31 (force) Annex 1 principles of good laboratory practice (GLP) Annex 2 GLP certificate 2 in accordance with article 4 paragraph 101 number 1 in conjunction with article 5 paragraph 3 of the Act of August 7, 2013 (Gazette I p. 3154) on August 14, 2018, in the table of contents, providing to § 25a shall read as follows: "§ 25a expenses of the party".
First section purpose, scope and definitions article 1 purpose of Act purpose of the law is to protect human beings and the environment against the harmful effects of hazardous substances and mixtures, make it discoverable by in particular, to avert them and to prevent its occurrence.

§ 2 scope of application (1) the provisions of the third section, the sections 16e, 17 paragraph 2(a) and (b) and section 23 para 2 1 No. 2 do not apply to 1 cosmetic products within the meaning of the food and feed law and tobacco products within the meaning of the preliminary tobacco law, 2. as far as according to § 21 para 2 of the medicines Act of approval need no medicinal products which are subject to a licensing or registration procedures under the medicines Act or under the animal health Act, as well as other medicines, or for sale to the consumer specific packaging be delivered, 2a.
Medical devices within the meaning of section 3 of the medical devices act and their accessories. Insofar as medical products, the preparations within the meaning of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 on the approximation of the laws, regulations and administrative provisions of relating to the classification, packaging and labelling of dangerous preparations (OJ EC No. L 200, p. 1) are, or contain, except apply the provisions of the third section, it's medical devices, which invasively or body contact are applied, 3. wastes for disposal within the meaning of § 3 paragraph 1 sentence 2 second half-sentence of the circulatory economic law, 4. radioactive waste within the meaning of the Atomic Energy Act, 5 waste water in accordance with the waste water levy Act, as far as it discharged into waters or sewage plants.
(2) the provisions of the third and fourth section, § 17 para 1 letter a and b and § 23 paragraph 2 do not apply no. 2 for food, feed, feed and feed additives within the meaning of the food and feed law. The provisions of the third section and § 16e apply however for 1 food, which due to their material properties in unmodified form not to direct human consumption by the consumer or the consumer within the meaning of § 3 No. 4 of the food and feed law are determined, 2nd in prepared, treated or processed state fed feed materials and feedingstuffs which are intended to be, and for feed additives within the meaning of the food and feed law.
(3) that section 2 article 16 d and 23 do not apply to substances and mixtures, 1 are determined exclusively intended to be used no 2 and 8 in conjunction with no. 2 of the medical devices act as active ingredient in approval - or requiring registration drugs under the medicines Act or under the animal health Act, or as active substances in medical devices in accordance with article 3 or 2 as far as they are subject to a licensing procedure according to phytosanitary regulations.
Article 17, paragraph 1 does not apply no. 1 and 3 for substances and mixtures pursuant to sentence 1 No. 2, corresponding regulations under the plant protection act may be taken.
(4) the provisions of the third section and the sections 16B, 17 and 23 shall apply to the manufacture, placing on the market or use of substances or mixtures according to § 3a paragraph 1 No. 2 to 5 and 15, as well as products which can unlock such substances or mixtures or contain only in so far as a professional, is in the context of other economic activities or employment. This limitation applies not to 1 regulations and orders a) on the marketing of materials and articles, b) over the waste disposal and air pollution control, 2.
environmentally hazardous substances or mixtures, if measures for the protection of human health and 3. biocidal active substances and biocidal products.
(5) the provisions of the first, third and fourth section, §§ 17 and 18, as well as the provisions of the seventh and eighth section do not apply to the transport of dangerous goods in the rail, road, inland waterway, sea and air transport, excluding the internal transport.

Definitions for the purposes of this Act are section 3 1. substance: chemical element and its compounds in the natural form or obtained by a process, including the additives necessary to preserve its stability and contaminants related to the applied procedures, but with the exception of solvents, which can be separated from the fabric without affecting its stability and without changing its composition
2. (disappeared) 3 (dropped out) 3a.
(lapsed)
4. mixtures: Mixtures or solutions composed of two or more substances;
5. product: Object that receives a specific shape, surface or shape in the production, which determines its function to a greater extent than the chemical composition;
6 classification: an assignment to a hazard characteristic;
7 manufacturer: a natural or legal person or a not incorporated association of persons which produces a substance, a mixture or a product or WINS;
8 importers: a natural or legal person or a not incorporated association of persons that spends a substance, a mixture or a product within the territorial scope of this Act; not a single leader is who performs only a transit transport under customs control, as far as no working or processing is carried out;
9 placing on the market: the sale to third parties or providing to third parties; Spending in the area of application of this Act is regarded as placing on the market, as far as not only a transit traffic by number 8 second half-sentence is it;
10. using: Using, consuming, camps, storage, loading and processing, bottling, decanting, mixing, remove, destroy and in-house transport;
11. biocidal product: a biocidal product within the meaning of article 3 (1) of Regulation (EU) No. 528 / 2012 of the European Parliament and of the Council of May 22, 2012, through the making available on the market and use of biocidal products (OJ OJ L 167 of the 27.6.2012, p. 1) in the currently valid version.
12 biocidal active substance: active ingredient within the meaning of article 3 paragraph 1 (c) of Regulation (EU) No. 528/2012. provisions of the terms listed in sentence 1 in regulations of the European Community or the European Union (EC or EU regulations) shall remain unaffected.

§ 3a dangerous substances and dangerous mixtures (1) dangerous substances or dangerous mixtures are substances or mixtures, the 1st explosive, 2. oxidizing, 3. extremely flammable 4. highly flammable, 5. inflammatory, 6 highly toxic, 7 toxic, irritant 8 harmful, corrosive 9, 10, 11-sensitizing, 12 carcinogenic, 13 reproductive hazard, 14 mutagenic or 15 environment are dangerous;
hazardous properties of ionising radiation are excluded.
(2) dangerous for the environment are substances or mixtures, which itself or its transformation products are the nature of the ecosystem, by water, soil or air, climate, animals, plants or micro-organisms to change that immediately or later risks for the environment can be achieved.
(3) also such substances and mixtures dangerous within the meaning of this Act No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) that are referred to in article 3 of Regulation (EC) No. 1907/2006 (OJ L 353 of 31.12.2008, p. 1), most recently by Regulation (EU) no 286 / 2011 (OJ L 83 of the our, page 1) is changed, are dangerous in its currently valid version, without to can be mapped to one of the danger referred to in paragraph 1.
(4) the Federal Government is authorized to enact further rules on determination of hazard characteristics referred to in paragraph 1 by decree with the consent of the Federal Council.

§ 3 of section b (dropped out) implementing Regulation (EC) No 1907/2006 and Regulation (EC) No. 1272/2008 § 4 involved federal authorities (1) for the implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 for 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 the 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 (OJ EU no. L 396 p. 1, 2007 No. L 136 S. 3) in the currently valid version and in the implementation of Regulation (EC) No. 1272/2008 participate in accordance with this section: 1 the Federal Institute for occupational safety and health, that insofar as is subject to the supervision of the Federal Ministry for environment, nature conservation and nuclear safety, Federal Office for chemicals, 2. the Umweltbundesamt as assessment body environment , 3. the Federal Institute for risk assessment, that as far as the technical supervision of the Federal Ministry for environment, nature conservation and nuclear safety, is as subject to assessment body health and consumer protection, and 4. the Federal Institute for occupational safety and health, which in that regard is subject to the technical supervision of the Federal Ministry of labour and Social Affairs, as a rating for safety and health protection of workers.
(2) the Federal Office for chemicals involved more upper federal authorities in individual cases, if in this particular expertise on individual aspects of assessment of substances, mixtures or products for purposes of Regulation (EC) No 1907/2006 and Regulation (EC) no 1272/2008 are present and the relevant question can be judged not by the authorities referred to in paragraph 1.

§ 5 tasks of the Federal Office for chemicals (1) for the implementation of Regulation (EC) No 1907/2006 and Regulation (EC) no 1272/2008 in particular the following tasks apply as participation acts according to article 21, paragraph 2, sentence 2, the Federal Office for chemicals is responsible for: 1. opinions on draft decisions of the European Chemicals Agency referred to in article 9 paragraph 8 sentence 2 of Regulation (EC) No. 1907/2006 , 2. the tasks of the competent authority of the Member State when assessing under Title VI of Regulation (EC) No 1907/2006, 3. the participation in the identification of substances referred to in article 57 Article 59 paragraph 3 and 5 of Regulation (EC) No 1907 / 2006, 4. the participation in the classification and labelling harmonised under article 37 paragraph 1, also in conjunction with paragraph 6 , Regulation (EC) No. 1272/2008 (2) in addition to her otherwise by this law the Federal Office for chemicals in the implementation of Regulation (EC) takes tasks no. 1907/2006 and Regulation (EC) No. 1272/2008 also the following true: 1. preparation of dossiers to the initiation of limitation proceedings under article 69 (4) of Regulation (EC) No 1907/2006 , 2. preparation of proposals for the review of existing restrictions pursuant to article 69 paragraph 5 sentence 3 of Regulation (EC) No 1907/2006, 3. support of the German members in the committees and the Forum of the European Chemicals Agency in all of these issues to be assessed in the committees and the Forum, 4. cooperation with the European Commission, the European Chemicals Agency and the competent authorities of other Member States pursuant to articles 121 and 122 of the Regulation (EC) No 1907 / 2006 as well as cooperation with the competent Authorities of other Member States referred to in article 43 of Regulation (EC) no 1272/2008, 5 information to the public pursuant to article 123 of Regulation (EC) No 1907/2006 on risks associated with substances, 6 transmission referred to in article 124 (1) of Regulation (EC) No 1907/2006 of all present information about registered substances, their registration dossier No. 1907/2006 contain all the information referred to in annex VII to Regulation (EC) , to the European Chemicals Agency, 7 exercising of the function of the national information centre referred to in article 124 (2) of Regulation (EC) No 1907/2006 and the national information centre referred to in article 44 of Regulation (EC) no 1272/2008, 8 advice to the Federal Government in all regulation (EC) No 1907/2006 and Regulation (EC) no 1272/2008 and their evolution matters.

Article 6 tasks of the assessment bodies (1) the evaluation functions support the Federal Bureau for chemicals at their tasks according to § 5 paragraph 1 number 2 through 4 and paragraph 2 number 1 to 3 by the autonomous and final implementation of the assessment tasks relating to their respective spheres of competence. Number 1 and 2 number 4 to 8 they contribute to the tasks of the Federal Office for chemicals according § 5 paragraph 1 on issues relating to their respective spheres of competence. The evaluation functions support each other through technical opinions, unless this is necessary for the performance of their duties.
(2) technical competence of the assessment body environment is the environmental risk assessment including the evaluation of risk reduction measures.
(3) technical competence of the assessment body is the health risk assessment including the assessment of mitigation measures health and consumer protection.
(4) technical competence of evaluation function for safety and health of workers is the occupational safety and health-related risk assessment including the evaluation of risk reduction measures.

§ 7 collaboration of the Federal Office for chemicals and the other involved federal upper authorities (1) the Federal Office for chemicals coordinates the interaction of the federal upper authorities referred to in article 4 and works towards the consistency and the consistency of the overall position. You decide the overall position, unless in individual cases whose consistency and consistency differently cannot be reached and an opinion will tolerate no delay. Decisions pursuant to sentence 2, in which the Federal Bureau of chemicals by assessing a valuator differs according to § 6, paragraph 1, sentence 1, require a detailed justification, which is to make public record and to submit to the review bodies.
(2) the Federal Office for chemicals represents the overall position after outside. It involves representatives of other participating federal upper authorities to support this, if it deems it necessary, or they can demand it.

Article 8 exemption the national information centre the Federal Bureau for chemicals rises for its activities as a national information centre referred to in article 124 (2) of Regulation (EC) No. 1907 / 2006 and article 44 of Regulation (EC) no 1272 / 2008 no fees.

Article 9 exchange of information between federal and State authorities (1) the Federal Office for chemicals informed the competent authorities of the country in particular about releases of the European Chemicals Agency on 1 process-orientated research and development pursuant to article 9 paragraph 3 sentence 3, as well as draft decisions referred to in article 9 paragraph 8 sentence 1 of Regulation (EC) No 1907/2006, 2nd as register applicable substances referred to in article 16 paragraph 1 sentence 2 of the Regulation (EC) No. 1907/2006 , 3. registration dossiers referred to in article 20 paragraph 4 set 1, 4 and 5 and article 22 paragraph 1 sentence 2 and paragraph 2 sentence 2 of Regulation (EC) No 1907/2006, 4. the dossier evaluation under article 41 paragraph 2, article 42 paragraph 2 sentence 1 and article 43 paragraph 3 and follow-up for substance evaluation referred to in article 48 set 3 of Regulation (EC) No. 1907/2006 , 5. the examination of intermediate goods in other Member States pursuant to article 49 set 4 of Regulation (EC) No 1907/2006, 6 setting the manufacture, importation or production referred to in article 50 paragraph 2 sentence 2 and paragraph 3 sentence 3 of Regulation (EC) No 1907/2006, 7 the identification of substances referred to in article 57 Article 59 of paragraph 2 sentence 3 and article 59 paragraph 3 sentences 1 and 3 and the authorisation procedure pursuant to article 64 paragraph 5 set 4 and 7 of Regulation (EC) No 1907 / 2006, 8 the result of applications for use of an alternative chemical name according to article 24 (5) of Regulation (EC) No. 1272/2008 (2) informing competent authorities of the country the Federal Bureau for chemicals in particular over 1 insights into the use of intra-site isolated intermediates, which a risk to human health or the environment can yield referred to in article 49 of Regulation (EC) No. 1907/2006 , 2. in the context of enforcement and surveillance activities lessons learned within the meaning of article 124 paragraph 1 sentence 1 of the Regulation (EC) No 1907/2006, from which results a suspicion of risk, 3. the ordering of provisional measures pursuant to article 23 paragraph 2 under template after article 129 (1) of Regulation (EC) No 1907 / 2006 or pursuant to article 52 (1) of Regulation (EC) no 1272 / 2008 documents.
(3) section 22 shall remain unaffected.

Section 10 provisional measures (1) if based on this Act is a provisional measure within the meaning of article 129 of Regulation (EC) No 1907 / 2006 or within the meaning of article 52 of Regulation (EC) No. 1272/2008 was enacted, the Federal Office for chemicals the European Commission and the other Member States of the European Union, stating the reasons on the decision taken shall immediately inform and presents the scientific or technical information , on which the provisional measure is based.
(2) the Federal Office for chemicals informed the competent land authorities via the European Commission's decision under article 129 (2) of Regulation (EC) No 1907 / 2006 or pursuant to article 52 (2) of Regulation (EC) no 1272/2008.

§ 11 (dropped out) § 12 (dropped out) section IIa implementing Regulation (EU) No. 528 / 2012 Article 12a involved federal authorities (1) when implementing Regulation (EU) No. 528 / 2012 involved the authorities referred to in article 4, paragraph 1 in accordance with this section. The Federal Institute for risk assessment as a valuator is subject to health and consumer protection to the extent the technical supervision of the Federal Ministry of food, agriculture and consumer protection.
(2) in article 4 paragraph 1 number 2 to 4 are referred to authorities at the Julius Kühn Institut, at the Federal Institute for materials research and testing, or at the Robert Koch Institute special expertise for assessing the effectiveness, as well as the unacceptable effects on the target organisms, the Federal Bureau of chemicals to the decision on the existence of the approval conditions laid down in article 19 may paragraph 1 letter b section i and ii of to Regulation (EU) No. 528 / 2012 get an opinion from such authorities. In addition, the Federal Office for chemicals involved in the Federal Institute for materials research and testing in assessing the hazards within the meaning of § 3a paragraph 1 number 1 to 5 and the resistance of containers and packaging materials unless the Federal Institute for materials research and testing at the relevant question under another legal powers has particular expertise and the relevant question can be assessed by the Federal Office for chemicals not finally.
(3) by way of derogation from paragraph 1 the following authorities are responsible for the issuance, extension, review and repeal of exception approvals referred to in article 55 (1) of Regulation (EU) No. 528 / 2012 including the initiative of the Commission procedures related: 1 the Robert Koch-Institut on biocidal products that must be used according to § 18 of the infection Protection Act at Tuberkulosegesetz, 2. the Federal Office for consumer protection and food safety in relation to biocidal products , the a) according to section 18 of the infection Protection Act pest and measures combating of vertebrates, the pathogens can be spread, must be used or b) must be used according to section 17f of the animal diseases Act animal disease legally prescribed disinfection and pest.

§ 12 b tasks of the Federal Office for chemicals (1) of the implementing Regulation (EU) No. 528 / 2012 shall apply in particular the following tasks as acts of participation according to § 21 paragraph 2 sentence 2: 1 the tasks of the graders competent authority a) with the approval of an active substance and the extension and review of the approval of an active substance according to chapters II, III and XI of to Regulation (EU) No. 528 / 2012 , b) at the granting and extension, the termination, review and change of Union approvals according to chapters VIII and IX of Regulation (EU) No. 528 / 2012, 2. the participation in the work programme for the systematic examination of all old active substances referred to in article 89 (1) of Regulation (EU) No. 528 / 2012, 3. participation in the coordination group referred to in article 35 and the Committee for biocidal products referred to in article 75 of Regulation (EU) No. 528/2012 (2) in addition to you otherwise by this Law tasks takes the place of the Federal true for chemicals in the implementation of the Regulation (EU) No. 528 / 2012 also the following tasks: 1. the submission to the Commission in accordance with article 3 paragraph 3 and article 15 paragraph 1 subparagraph 1 of Regulation (EU) No. 528 / 2012, 2. the tasks of the graders competent authority within the framework of the simplified approval procedure referred to in article 26 , also in connection with chapter IX, of Regulation (EU) No. 528 / 2012, 3. receipt of the notification of the holder of the approval referred to in article 27 paragraph 1 sentence 2 and exercise the powers of the Member State referred to in article 27 paragraph 2 and article 28 paragraph 4 subparagraph 1 of Regulation (EU) No. 528 / 2012, 4. the tasks of the responsible authority in the granting, extension and review national approvals according to chapter VI , also in connection with chapter IX, of Regulation (EU) No. 528 / 2012, 5. the tasks of the competent authority of the Member State concerned or of the reference Member State in the mutual recognition procedure under Chapter VII, also in connection with chapter IX, as well as the exercise of the powers of the Member State referred to in article 37 of Regulation (EU) No. 528 / 2012, 6 the submission to the Commission in accordance with article 44 paragraph 5, indent 2, of the Regulation (EU) No. 528 / 2012 , 7. the tasks of the competent authority of the Member State of importation on the parallel trade by chapter X of Regulation (EU) No. 528 / 2012, 8.
the granting, extension, review and repeal of exception approvals referred to in article 55 of Regulation (EU) No. 528 / 2012 including the instigation of the Commission procedures related, as far as the authorities referred to in Article 12a paragraph 3 are responsible, 9 the tasks of the competent authority of the Member State referred to in article 56 of Regulation (EU) No. 528 / 2012, 10 to advise the Federal Government in all the Regulation (EU) No. 528 / 2012 and their evolution matters.

§ 12c tasks of the assessment bodies (1) the evaluation functions support the Federal Bureau for chemicals at their tasks according to § 12 (b) of paragraph 1 and 2 number 1 to 9 by the independent and final implementation of the assessment tasks relating to their respective spheres of competence. In addition they participate in the questions concerning their respective spheres of competence. The evaluation functions support each other through technical opinions, unless this is necessary for the performance of their duties.
(2) technical competence of the assessment body environment is the environmental risk assessment including the evaluation of risk reduction measures.
(3) technical competence of the assessment body health and consumer protection is 1 the risk assessment in relation to the health of people and of domestic and farm animals, including the assessment of mitigation measures, and 2. the elaboration of proposals for the establishment of residue limits referred to in article 19 paragraph 1 point (e) of Regulation (EU) No. 528/2012 (4) technical competence of evaluation function for safety and health of workers is the risk assessment in relation to occupational safety and health , including the evaluation of risk reduction measures.

Section 12d collaboration of the Federal Office for chemicals and the other involved federal upper authorities (1) the Federal Office for chemicals coordinates the interaction of the federal upper authorities referred to in Article 12a and works towards the rigour and consistency of decisions and opinions as a whole.
(2) as far as the Federal Office for chemicals in the course of their activities according to § 12 b that approval requirements referred to in article 19 (1) of Regulation (EU) to judge no. 528 / 2012 who decides them as regards the conditions 1 to article 19 paragraph 1 letter b point iv of Regulation (EU) No. 528 / 2012 in consultation with the evaluation function environment, 2. under article 19 paragraph 1 letter b digit iii of the Regulation (EU) No. 528 / 2012 with regard to the effects on health of Employed in agreement with the assessment centre for health and safety of employees and 3. pursuant to article 19 paragraph 1 letter b iii of the Regulation (EU) No. 528 / 2012 in addition, also in conjunction with article 19 paragraph 1 point (e) of Regulation (EU) No. 528 / 2012 with regard to a proposal for the setting of MRLs for food or animal feed, in consultation with the assessment body health and consumer protection.
The Federal Office for chemicals decides Furthermore, in consultation with the assessment bodies insofar as their jurisdiction paragraph 2 to 4 is concerned according to § 12 c, about 1 the necessity of risk mitigation, 2. the existence of the approval conditions laid down in article 19 (5) of Regulation (EU) No. 528 / 2012, 3. the results of a comparative assessment pursuant to article 23 of the Regulation (EU) No. 528 / 2012, 4. the authorisation referred to in article 26 (3) of Regulation (EU) No. 528 / 2012 , 5. exception approvals referred to in article 55 of Regulation (EU) No. 528 / 2012, unless not in section 12a paragraph 3 are responsible authorities, as well as 6 opinions and decisions referred to in article 56 paragraph 2 subparagraph 2 and paragraph 3 of the Regulation (EU) No. 528/2012 (3) with the exception of the cases referred to in paragraph 4 represents the Federal Bureau for chemicals the overall position after outside. It involves representatives of other participating federal upper authorities to support that if it deems it necessary, or they can demand it.
(4) decisions of the federal upper authorities referred to in Article 12a paragraph 3 approvals referred to in article 55 (1) of Regulation (EU) No. 528 / 2012 are represented by the authority to the outside that is responsible for the decision. This authority must inform the Federal Office for chemicals immediately about the beginning of the relevant decision-making procedures and about the measures taken by her.

§ 12e helpdesk, informing the public of (1) the Federal Office for chemicals is an information centre for the fulfilment of the tasks referred to in article 81 (2) of Regulation (EU) No. 528 / 2012 a. The information Office is to lead No. 7 according to § 5 paragraph 2 in conjunction with the information centre. § 8 shall apply accordingly.
(2) the Federal Office for chemicals notified pursuant to article 17 paragraph 5 subparagraph 3 of Regulation (EU) No. 528 / 2012 the public about 1. benefits and risks of the use of biocidal products, 2 physical, biological, chemical and other measures as an alternative to the use of biocidal products or as a way to minimize the use of biocidal products, as well as 3 knowledgeable, proper and sustainable use of biocidal products.
(3) the remaining Federal upper authorities referred to in Article 12a support the Federal Office for chemicals in carrying out the tasks according to paragraphs 1 and 2.

§ 12f exchange of information between federal and State authorities (1) the Federal Office for chemicals informed the competent authorities of the country in particular about 1 the following decisions made by you or received messages: a) reports pursuant to article 17 paragraph 6 sentence 1 and article 27 paragraph 1 sentence 2 of the Regulation (EU) No. 528 / 2012, b) measures referred to in article 27 paragraph 2 subparagraph 2 of Regulation (EU) No. 528 / 2012 , c) the granting, extension or revocation of a national authorisation pursuant to chapter VI of Regulation (EU) No. 528 / 2012, d) the recognition of an authorisation pursuant to Chapter VII of Regulation (EU) No. 528 / 2012, e) the granting or revocation of a parallel trade permit pursuant to chapter X of Regulation (EU) No. 528 / 2012, f) the granting of exception approvals referred to in article 55 of Regulation (EU) No. 528 / 2012 , g) the prohibition of experiments or tests or the issuance of regulations referred to in article 56 (3) of Regulation (EU) No. 528 / 2012, h) orders under section 12 g of paragraph 1 sentence 1 and paragraph 3, 2 releases of the European Chemicals Agency on the following decisions made by this or the European Commission or received messages: a) the acceptance or rejection of the application for authorisation or for renewal of the authorisation of a substance, as well as the outcome of the approval procedure for the chapters II and III Regulation (EU) No. 528 / 2012, b) the acceptance or rejection of the application for granting, extension or lifting a Union authorisation of a biocidal product as well as the result of the authorisation procedure, as well as c) reports pursuant to article 17 paragraph 6 sentence 3 of the Regulation (EU) which in section 12a paragraph 3 teach No. 528/2012 (2) designated federal upper authorities the competent land authorities about their decisions and renewal decisions, the Commission referred to in article 55 No. 528/2012 (3) the competent land authorities inform (1) of Regulation (EU) the Federal Office for chemicals in particular about 1 insights gained in the context of enforcement and surveillance activities, for decisions pursuant to article 27 paragraph 2, article 48 paragraph 1 or article 56 (3) of Regulation (EU) No. 528 / 2012 or according to § 12 g of paragraph 1 sentence 1 of importance can, 2. monitoring measures according to § 12 g of paragraph 1 sentence 3, 3. the order of provisional measures pursuant to article 23 paragraph 2 upon presentation of documents , the are required pursuant to article 88 paragraph 1 sentence 2 of the Regulation (EU) No. 528 / 2012.
(4) the information to whether appeals were filed and to what result they did include the paragraphs 1 to 3 also informing about it.
(5) section 22 shall remain unaffected.

§ There are legitimate reasons to believe that a biocidal product, although it according to the Regulation (EU) No. 528 / 2012 was approved, nevertheless represents an immediate or long term serious risk for the health of humans or animals, in particular for vulnerable groups, or the environment 12 g order powers of the Federal Office for chemicals, provisional measures (1) on the basis of new facts, so the Federal Bureau for chemicals in consultation with the assessment bodies may take appropriate provisional measures , in particular the deployment of the biocidal product on the market within the meaning of article 3 No. 528 / 2012 provisionally prohibit paragraph 1(i) of Regulation (EU) or make subject to compliance with certain conditions. Appeals against orders pursuant to sentence 1 have no suspensive effect. The orders of the Federal Office for chemicals pursuant to sentence 1 are enforced by the appropriate authority of the country according to the respective national regulations on the administrative enforcement procedures. § 23 paragraph 2 shall remain unaffected.
(2) for the Union legal decision-making procedures referred to in article 88 of Regulation (EU), no. 528 / 2012 through provisional measures, which were adopted on the basis of paragraph 1 or any other provisions of this Act, shall apply article 10 according to.
(3) the Federal Agency for chemicals can allow a biocidal product in agreement with the rating agencies for essential use in accordance with article 5 (1) of Regulation (EC) no 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in article 16 (2) of Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products (OJ L 325 of December 11, 2007, p. 3), by Regulation (EC) no 298 / 2010 of the Commission by April 9, 2010 (OJ L 90 of the 10.4.2010, p. 4) is has been modified, if the European Commission for the biocidal active substance concerned a decision referred to in article 5 (3) of Regulation (EC) no 1451/2007, also in connection with article 89 (1) of Regulation (EU) No. 528 / 2012, met and complied with the conditions there laid down.

§ 12 h regulation appropriations (1) the Federal Government is empowered, as far as EU law allowed by decree with the consent of the Federal Council requirements to regulate practice and procedure the decisions or acts of participation the federal upper authorities referred to in Article 12a in the framework of the implementation of the Regulation (EU), in particular to determine No. 528 / 2012, 1 that a certain biocidal products) are not eligible or b) only for certain uses, uses or locations , for delivery to certain user groups or under certain other restrictions permitted, 2. that certain substantive or procedural requirements to be observed when a) of applying for and granting of exception approvals referred to in article 55 of Regulation (EU) No. 528 / 2012 and b) according to article 56 of Regulation (EU) No. 528/2012 (2) is the message and official testing of experiments and tests the Federal Government also authorized , by decree with consent to set Federal Council measures on the sustainable use of biocidal products, in particular to determine 1 2 like nature and extent of the use of biocidal products effectively detect devices that are used to the use of biocidal products, are subject to specific control procedures, can be. This may include the introduction of reporting obligations placed and used volumes of biocidal products and the establishment of a framework for a nationwide monitoring program, 3. that and in what form people who have been consulted by biocidal products in the treatment or evaluation of acute and chronic poisoning cases of non-target organisms, have to report such cases of the Federal Office for chemicals or an other appropriate federal authority.
Third section classification, labelling and packaging section 13 classification, labelling and packaging requirements (1) which set classification, labelling and packaging of substances and mixtures after the provisions of Regulation (EC) No. 1272/2008 (2) who as manufacturer or importer substances or mixtures on the market brings, to classify these according to the legal regulation in accordance with § 14, as far as 1 he was after the transition provisions of article 61 of Regulation (EC) no 1272 / 2008 on Directive 67/548/EEC or Directive 1999/45 /. EC has to apply-based provisions or 2. regulations containing the legal regulation according to § 14 No. 1272/2008 go beyond the requirements of Regulation (EC).
(3) a person who has to mark them according to the legal regulation in accordance with § 14 and Pack, as supplier within the meaning of article 2 brings number 26 of Regulation (EC) no 1272 / 2008 substances or mixtures on the market, as far as 1 he was after the transition provisions of article 61 of Regulation (EC) no 1272 / 2008 has to apply the provisions of Directive 67/548/EEC or Directive 1999/45/EC-based or applies or 2. Regulations contains the legal regulation according to § 14 , which go beyond the requirements of Regulation (EC) No. 1272/2008.
In fulfilling the obligations pursuant to sentence 1 suppliers who are committed itself under paragraph 2 to the classification of the substance or mixture can begin the classification of by the manufacturer or importer, provided that they do not have knowledge of their falsity.
(4) further requirements on labelling and packaging under other legislation remain unaffected.

§ 14 authorization to classification, labelling and packaging requirements (1) is the Federal Government authorized by decree with the consent of the Bundesrat 1 substances or mixtures dangerous to classify, 2. calculation procedure to prescribe that certain mixtures due to the classification of substances contained in the mixture, to classify, to determine 3. a) as dangerous substances and mixtures and that and how certain products which contain or can release certain hazardous substances or mixtures , Pack or mark are so foreseeable use will prevent dangers to life and health of people and the environment, b) that and how certain information about dangerous substances and mixtures or products which can release hazardous substances and mixtures, or contain, including recommendations on precautions to be taken when using or about emergency measures in accidents of one of the substances , Mixtures or products on the market brings, in particular in the form of a safety data sheet or a statement of use, supplied and kept up to date are must, c) what aspects the manufacturer or importer at least to note for the classification of substances pursuant to article 13, paragraph 2, d) to pack the hazardous substances, mixtures, or products, and to identify who, if they already have been brought before entry into force of the Legislative Decree constituting the labelling or packaging requirement in the transport , s) that how certain mixtures and products which do not contain certain closer to dangerous substances, to be labelled or can be identified, and f) that and who the labelling of certain substances, mixtures, or products to obtain or to install again is after the placing on the market.
(2) in the Legislative Decree referred to in paragraph 1 also exceptions can be provided from the obligation on the packaging and labelling, as far as the purpose of protection paragraph 3 letter a not degrades referred to in paragraph 1. Under the Ordinance, it can be also determined that the respective figures in other appropriate way to provide are instead a marking.
(3) regulations may be made under paragraphs 1 and 2 for biocidal active substances and biocidal products that are not dangerous substances or mixtures within the meaning of section 3a, as well as for substances, mixtures and products pursuant to article 19, paragraph 2.

§ 15 (dropped out) section 15a (dropped out) fourth section reporting obligations section 16 (dropped out) section 16a (dropped out) § 16 b (dropped out) § 16 c (dropped out) section 16B notification requirements for mixtures (1) which is a Federal Government empowered to require the manufacturer, importer or user of certain mixtures by decree with the consent of the Federal Council for the purpose of determining risks which can arise from mixtures, as well as nature and extent of the use of hazardous substances in mixtures , 1. the designation of these mixtures and their trade names, 2. labelled 3. information about the composition of these mixtures, 4. the year manufactured, imported or used amount of these mixtures, 5 whose application areas, 6 present or reasonably find audit evidence no 440 / 2008, insofar as they are necessary for the determination of dangerous properties of these mixtures, is not using the calculation procedures prescribed pursuant to this Act or on the basis of this Act determine that make him under Regulation (EC) , as well as 7 the content of safety data sheets of the Federal Office for chemicals within a reasonable period of time in writing, if there is evidence, in particular a suspicion justified according to the current state of scientific knowledge that that harmful effects on humans or the environment posed by these mixtures.
(2) the notification obligation can be limited to certain indications as to the composition, depend on the quantity that is manufactured, imported or used, and covered by subsequent changes to the composition. In the Ordinance are provisions about to meet, that and how the confidentiality of the information provided to make sure is at the request of the notification.

§ 16e releases for information and treatment centers for poisoning (1) manufacturer or importer or using an own trade name who brings a dangerous mixture or a biocidal product on the market, has the Federal Institute for risk assessment 1 the trade name, 2. information on the composition, 3. labelling, 4. Notes on use, 5 recommendations about precautions for use and emergency measures in accidents, as well as any subsequent changes to this information to be communicated , for the treatment of diseases, can go back to influence its composition or its biocidal product which can be of importance. The communication need not, unless the information already have been submitted to the German Federal Institute for risk assessment pursuant to sentence 1. The communication has to be carried out before the first placing on the market or the occurrence of the change.
(2) the Federal Institute for risk assessment a person who as doctor for the treatment or to the assessment of the consequences of a disease will be consulted, at least suspected of that goes back to the effects of hazardous substances, dangerous mixtures of products that contain or release dangerous substances or mixtures or of biocidal products, has the substance or the mixture, age and sex of the patient, the route of exposure, to communicate the intakes and the observed symptoms. The notification has to be made with regard to the person of the patient in an anonymous form. § 8 paragraph 1 number 1 second half-sentence of the infection Protection Act of 20 July 2000 (Federal Law Gazette I p. 1045) shall apply mutatis mutandis. Sentence 1 shall not apply insofar as this information is to transmit a carrier of statutory accident insurance; It has to pass the information pursuant to sentence 1 of the German Federal Institute for risk assessment.
(3) the Federal Institute for risk assessment shall the information pursuant to paragraph 1, even if it this information due to other legal provisions have been submitted, to label the countries medical facilities, which collect evidence on the health effects of hazardous substances or dangerous mixtures and evaluate and substance-related disorders through counseling and treatment help (information and treatment centers for poisoning). The agencies designated pursuant to sentence 1 the Federal Institute for risk assessment report findings due to their activities, which are for the advice and treatment of substance-related disorders of general importance.
(4) the information is confidential under paragraphs 1 and 2. The information may only be used pursuant to paragraph 1, 1 requests of medical content specifying the preventive and curative measures, in particular in cases of emergency, to answer or 2. on request of the Federal Ministry for the environment, performs a statistical analysis to determine the need for improved risk management measures, nature conservation and nuclear safety.
(5) the Federal Government is authorized to extend the duties, which are responsible, on medical content specifying the preventive and curative measures to answer questions, 2. a decree with the consent of the Federal Council 1 pursuant to paragraph 3 also on other sites) the notification obligation pursuant to paragraph 1 to substances and other mixtures to extend that adverse impacts on the people can go out , b) the notification obligation referred to in paragraph 1 on products to extend that predictable can release dangerous substances or mixtures, that adverse impacts on the people can go if the knowledge of the substances, mixtures, or products for the information and treatment centers for poisoning or the authorities designated according to number 1 for the fulfilment of the tasks entrusted to them, c) to exclude certain mixtures from the notification obligation referred to in paragraph 1 , provided with the objective of protection pursued by that provision compatible and is EU law allowed, and 3 qualifiers about the nature and extent of the information according to paragraph 1 and the information requirements to paragraphs 2 and 3 as well as the confidentiality and the purpose limitation according to paragraph 4 to meet.

section 16f (dropped out) fifth section authorization to prohibitions and restrictions as well as to the protection of workers article 17 measures, the Federal Government is prohibitions and restrictions (1) authorized, after consultation of interested parties by decree with the consent of the Federal Council, provided it for the purpose referred to in section 1 is required and EU law allowed 1 to require that certain dangerous substances, certain dangerous mixtures or products, which can release such a substance or a mixture of such or containing , a) not produced only in certain conditions or only for specific purposes, put into circulation or used must, b) may be used only in a certain way or c) only under certain conditions or only to certain people be delivered may, 2. to stipulate that one, certain specific dangerous substances, dangerous mixtures or products which contain or can release such a substance or a mixture of such , manufactures, puts on the market or used a) this display has b) to require a permit, c) must meet specific requirements on its reliability and health or d) has to prove his competence in a closer-to-be-determined process to ban 3. manufacturing or use practices, for which certain dangerous substances apply.
(2) by Regulation pursuant to paragraph 1 also bans and restrictions, taking into account the development of materials, mixtures, products, or procedures, whose manufacture, use, disposal or application with a lower risk for humans or the environment is connected to, can be fixed.
(3) paragraph 1 shall apply also for biocidal active substances and biocidal products that are not dangerous substances or mixtures within the meaning of § 3a of substances, mixtures and products pursuant to article 19, paragraph 2, as well as for substances, mixtures, or products, whose transformation products are dangerous in the sense of § 3a paragraph 1 number 1 to 14. Also rules on good professional practice in the use of biocidal products may be adopted by Regulation pursuant to paragraph 1 in conjunction with sentence 1.
(4) paragraph 1 Nos. 1 and 2 also applies to such substances, mixtures, or products, in which clues, in particular a suspicion justified according to the current state of scientific knowledge for this, that the substance, the mixture or the product is dangerous.
(5) the Federal Government can set also rules on the procedures and methods for the verification of their compliance with the legal regulations referred to in paragraph 1. Including the collection of samples and the procedures to be applied for this purpose and the analysis procedures for the determination of individual substances or groups of substances can be controlled.
(6) in the case of danger in arrears, the Federal Government may adopt a decree number 1 and 3 without the consent of the Federal Council, without consulting the stakeholders referred to in paragraph 1. It occurs no later than twelve months after its entry into force override. Its validity may be extended only with the consent of the Federal Council.
(7) the stakeholders consist of each to select representatives of science, of consumer protection associations, trade unions and professional associations, involved economic, health care and the environmental, animal welfare and nature conservation associations.

§ 18 of poisonous animals and plants (1) the Federal Government shall be authorised insofar as it is necessary for the protection of life or health of the people, taking into account the interests of nature and animal welfare to impose by decree with the consent of the Bundesrat, that copies 1 certain toxic species a) not implemented or not held may, b) only introduced or maintained may when appropriate antidotes and treatment recommendations from the importer or owner will be made available , or c) only introduced or maintained 2. certain toxic species a may be, if this the competent authority previously,) not planted on certain surfaces or b) in catalogues and lists of goods with an indication of their toxicity may be offered.
Permission to hold pursuant to sentence 1 number 1 letters b and c can conditions be connected.
(2) paragraph 1 point 1 applies accordingly for dead specimens of toxic species or parts of these. Paragraph 1 paragraph 2 point (b) applies to toxic seeds, poisonous plant and propagation as well as dead specimens or parts toxic plant species.
(3) article 17 paragraph 1 No. 1 and 2 letter c and d shall apply mutatis mutandis for the referred to in paragraph 2 sentence 1 animal body or its parts as well as for certain types of toxic seeds and dead specimens or parts of toxic species.

Section 19 authorized measures for the protection of employees (1) which is a Federal Government by decree with the consent of the Federal Council, insofar as it is necessary for the protection of life and health of the people including the protection of the labour force and the humane design of work to prescribe for the manufacture and use of substances, mixtures and products, as well as in activities in their danger area measures of the kind described in paragraph 3. Sentence 1 does not apply to measures pursuant to paragraph 3, where equivalent provisions exist according to the Atomic Energy Act, Federal Immission Control Act, plant protection act or law on explosives.
(2) hazardous substances within the meaning of this provision are 1. dangerous substances and mixtures according to § 3a paragraph 1, 2. fabrics, mixtures and products which are explosive, 3. substances, mixtures and products, which in the manufacture or use of substances arising from number 1 or number 2 or be released, 4 fabrics and mixtures not meeting the criteria for the numbers 1 to 3 , but due to its physico chemical, chemical or toxic properties and the way, as they exist at the workplace or used, the health and safety of workers can endanger, 5 all materials where an occupational exposure limit value in accordance with legal regulation is assigned pursuant to paragraph 1.
(3) by Regulation pursuant to paragraph 1 may in particular be determined 1.
as one of the others with the manufacture or use of substances, mixtures or products, has to determine whether it is in regard to the proposed manufacture or use a hazardous material, as far as not already a classification is according to the provisions of the third section, 2nd one that others engaged in the manufacture or use of dangerous substances, is obliged to consider , whether substances, mixtures or products or manufacturing or use practices with a lower risk for human health are available and that he should use them or has to use, as far as it is reasonable to him, 2a.
that the manufacturer or importer the employer requested the dangerous ingredients of dangerous substances as well as the valid limits and, if they still do not exist, notify has 3 such as the workplace including technical equipment, recommendations to be observed concentrations of substances and the dangers posed by the hazardous substances or the measures to be taken, the technical equipment and the working procedures designed to be or must be operated , to the State of technology, occupational health and hygiene, as well as the secured safety, occupational health, hygiene and meet other ergonomic findings, which are to be observed for the protection of workers, 4 as the operation laid down must be, in particular: a) that substances and mixtures are known and intra-corporate packaged as hazardous substances, must be marked and recorded, so that does not endanger workers by an inappropriate packing and taught by a marking on the dangers posed by them , b) as the manufacturing or procedures of use of must be designed, so that workers are not endangered and below the limit values or guide values of the concentration of hazardous substances or mixtures in the workplace after the State of the art, c) what precautions must be taken so that hazardous materials falling into the hands of unauthorized access or lost coming, d) which personal protective equipment must be made available and used as intended by the employees , e) as the number of workers who are exposed to dangerous substances, restricts and limits the duration of such employment must be, f) how employees must behave, so that they do not compromise themselves and others, and what are the conditions for this are, in particular, what knowledge and skills must have employees and which evidence thereof is to provide, g) access and employment restrictions for the protection of workers must be considered under what circumstances , h) that order is a project manager for certain manufacturing or use practices, what responsibilities to assign this are and what knowledge of this to prove has 5 as the workers who are to bring rules to be applied in an activity-based instruction permanently to the knowledge and at what time intervals on the basis of operating instructions about the occurring hazards and protection measures is to instruct, 6 What precautions to prevent operating errors and to limit their consequences for workers and what measures the Organization of the first Help to meet are 7 that and what invigilators for areas where workers are exposed to particular hazards, ordered and what powers them must be transferred, so that the occupational safety and health tasks can be fulfilled, 8 that in regard to the protection of employees a risk assessment to make is which documents for this purpose to create are and that these documents to verify the risk assessment by the competent authority of the country can be forwarded to the Federal Institute for occupational safety and health , 9. what documents to stave off threats to the workers for inspection by the competent authority of the country are ready and present upon request, 10 that a manufacturing or use practices, where special hazards for workers exist or are to obtain, must be indicated or permitted by the competent authority of the country of the competent authority of the country, 11 that work involving specific dangerous substances or mixtures can be released , only establishments officially recognised for it be completed by may, 12 that workers are health to monitor, to keep a record of this and for this purpose a) one, the other deals with the manufacture or use of hazardous substances, can be particularly obliged, workers to let b medically examine) the doctor who is charged with a screening, has to fulfil certain duties in connection with the examination , in particular with regard to the content of a certificate to be issued by him and the information and advice about the outcome of the investigation, c) the competent authority decides, if findings of the doctor are kept for NA, d) to be included in the record statistics shall be transmitted to the competent institution for statutory accident insurance or an agency appointed by him for the purpose of determining work-related health hazards or diseases , 13 that employers notify operations the operational or personnel Council has, he must learn to be able to carry out its tasks, 14 that the competent land authorities are authorised to carry out regulations to adopt, especially in danger in delay against supervisors and other employees, 15 that the equipment and work procedures, in which certain specific orders in individual cases dangerous substances are manufactured or used , must be checked by a specialist or an expert.
(4) due to the requirements under paragraph 3 accessible notices can be referenced anyone expert bodies; This is 1 in the Ordinance to specify the date of the notice to refer to the source, the announcement at the Federal Institute for occupational safety and occupational medicine archive terms secured to lay down 2. and pointed out in the Ordinance.
Sixth section good laboratory practice § 19a good laboratory practice (GLP) (1) non-clinical health and environmental safety testing of substances or mixtures, the results of which should provide an assessment of their potential threats to people and the environment in a licensing, permit -, registration, registration or notification procedure, must be carried in compliance with the principles of good laboratory practices pursuant to annex 1 to this Act, as far as community or Union law nothing is determined.
(2) the applicant or the registration duty, which presents test results in a process referred to in paragraph 1, has to prove that the tests underlying the test results meet the requirements referred to in annex 1. The proof is to provide by 1 the certificate according to § 19b, and 2. the written declaration of the Test Manager, extent to which the test is conducted according to the principles of good laboratory practice.
Is the proof is not provided, the test results are regarded as not submitted.
(3) Federal agencies, which carry out checks referred to in paragraph 1, are responsible for ensuring that the principles of good laboratory practice are complied within their remit.
(4) the retention period can be transferred by passing documents and written agreement with the customer or a third party, to inform the competent authority referred to in point 10.2 of annex 1.
(5) paragraphs 1 and 2 are not to apply for examinations started before 1 August 1990 and completed by January 1, 1995, when the competent authority has determined in the individual case that the testing also taking into account the principles of good laboratory practice is still usable.

§ 19b GLP certification
(1) the competent authority has one who performs checks according to article 19a, paragraph 1, to grant a certificate of compliance with the principles of good laboratory practice, if its test facility or his Prüfstandort and the tests carried out by him or phases of tests comply with the principles of good laboratory practice pursuant to annex 1 application for inspection procedure. The request pursuant to sentence 1 may also make, who makes credible checks according to article 19a, paragraph 1 to be obliged, without a legitimate interest. In the case of section 19a, paragraph 3, the certificate is granted the federal authority by their authority or one of this particular point. The certificate is pursuant to sentences 1 and 3 to be issued according to the model of annex 2. Pursuant to sentence 1 is an application to issue a certificate within a period of three months to decide; section 42a paragraph 2 sentence 2 to 4 of the administrative procedure act shall apply with the proviso that the period before completion of the prescribed inspection procedure begins pursuant to sentence 1. The application procedure for the issuing of the certificate can be handled via a single point. When the examination of the application for a certificate referred to in sentence 1 evidence from another Member State of the European Union or another Contracting State to the agreement on the European economic area are equal domestic evidence from them indicating that the applicant fulfils the relevant requirements of sentence 1 or essentially comparable due to their objective requirements of the issuing State.
(2) the certificate referred to in paragraph 1 sentence 1 are of the same: 1 GLP certificates of other Member States of the European Union or parties to the agreement on the European economic area pursuant to Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ EU no. L 50, p. 28), 2. GLP certificates from States which are not members of the European Union, if the mutual recognition of certificates of GLP is guaranteed, 3. a confirmation of the Federal Institute for risk assessment, that a test facility, located in a State which is not member of the European Union and the mutual recognition of certificates of GLP not guaranteed, according to the present knowledge tests carries out the Federal Institute for risk assessment according to the principles of good laboratory practice.

§ 19c reporting (1) the Federal Government shall annually by March 31 for the previous calendar year of the European Commission report on the application of the principles of good laboratory practice in the area of application of this Act. The report contains a directory of inspected test facilities and test sites, an indication of the dates for which inspections were conducted and a summary of the results of the inspections. The Supreme Land authorities contribute to the preparation of the report and send their contributions the Federal Ministry for environment, nature conservation and nuclear safety until February 15 for the previous calendar year.
(2) the Federal Ministry for environment, nature conservation and nuclear safety can publish a directory of test equipment and test stand places that carry out tests or phases of tests in accordance with the principles of good laboratory practice, in the Federal Gazette.

§ 19d supplementary provisions (1) the Federal Institute for risk assessment has, in addition to the tasks that are transmitted him through laws, regulations or other laws, in the range of good laboratory practice following tasks: 1. creation, management and updating of the directory according to § 19 c paragraph 2, 2. expert advice to the Federal Government and the countries, in particular for the specification of requirements for a) the competence and reliability of the persons entrusted with the performance of the tests , b) the nature and the equipment test equipment and test bench places, c) the laboratory practices, such as the nature of the test samples, the implementation and quality control of checks and phases of testing, d) the collection and documentation of data, e) the monitoring of compliance with the principles of good laboratory practice, 3. expert advice the Federal Government within the framework of consultation with the European Commission and other Member States of the European Union , 4. participation in the execution of agreements on good laboratory practice with States that are not members of the European Union.
(2) the Federal Government is authorized to amend Annexes 1 and 2 by decree with the consent of the Federal Council for the further development of good laboratory practice.
(3) the Federal Government shall adopt general administrative provisions on the procedure of regulatory monitoring with the consent of the Federal Council. Also a delegation of the publishing power on the Federal Institute for risk assessment can be regulated in the General administrative provision.
Seventh section General provisions article 20 application and communication documents, regulation appropriations (1) which is the Federal Government authorized by decree with consent Federal Council 1 content and form of application or communication documents, which in article 21 paragraph 2 sentence 1 of EC referred to or regulation to submit which are at the Federal Office for chemicals or other federal authority according to this Act, a regulation based on the law or a , to specify to rules 2, that and for what period of time who submit such application or release documents at the Federal Office for chemicals or other federal authority, to retain a double of these documents for reference.
(2) the Federal Office for chemicals can 3 which require notification of further copies of submitted documents for applications or documents that are submitted, the use of their specific forms or any other disk formats require 1, communicate of the information on another disk allow 2. with her, as far as this with regard to the participation of which §4 and other federal authorities referred 12a is required in the section.

Article 20a (dropped out) § 20B committees the Federal Government is authorized to form committees, which can be entrusted with the task by decree with the consent of the Federal Council, the Federal Government or the competent federal ministries to advise 1, in particular: a) in the development of methods for test certificates according to this law, b) in the preparation of regulations for the classification, labelling and packaging according to the sections 14 and 19 , c) in the case of the naming of substances and mixtures, for which a notification obligation should be founded according to § 16 d, d) for the adoption of prohibition, restriction or protection requirements according to article 17, article 18 or article 19 and e) in the further development of good laboratory practice, as well as 2 a) safety to identify occupational health and hygiene rules, as well as other ergonomic knowledge, b) for the protection of man and the environment to draw up recommendations and c) for human and environment not or less dangerous substances , Mixtures, products and processes to propose, that can make the competent Federal Ministry officially known.

Article 21 monitoring (1) the competent authorities of the country have to monitor the implementation of this Act and the regulations based on this law, as far as this law is true no other provision.
(2) paragraph 1 shall apply also for EC or EU regulations concerning matters this Act shall, so far as the Member States are monitoring their implementation. The receipt and forwarding of information or other assistance acts of the Member States are required, for the implementation of EC or EU regulations within the meaning of sentence 1 the Federal Bureau for chemicals is responsible for this.
(2a) which is Government authorized by decree with the consent of the Federal Council for the implementation of this Act, the regulations based on this law, as well as in paragraph 2 sentence of 1 above EC or EU regulations on transfer 1. jurisdiction for certain approvals and declarations of understanding by way of derogation, if these approvals or understanding explanations have to be taken further by paragraphs 1 and 2 sentence 1 of a federal authority or the assessment of facts require the , which usually spatially the jurisdiction of a country go beyond, as well as 2 in the cases of paragraph 2 sentence 2 to determine other federal authority.
(3) the competent authority of the country is authorised to charge rate 1 of EC referred to or EU regulations by natural and legal persons and not legal associations of persons in paragraph 2 all to the implementation of this Act, the regulations based on the law and the necessary information. In the cases of paragraph 2 sentence 2 are there referred to these powers, in the cases of paragraph 2a of the federal authority referred to in the regulation.
(4) which are responsible for monitoring authorized 1 to the operating and business hours, land, business premises, premises to enter and to visit, after their selection to request samples of substances, mixtures and products and to remove and to inspect the business documents of the party, 2.
the submission of documents about applications, notifications, notifications, registrations and approvals as well as other documents under this Act to determine on this law-based legal regulations and in paragraph 2 sentence 1 of above EC or EU regulations to require to check 3. protective equipment and work equipment, to investigate 4. manufacturing and use procedures and in particular the presence and the concentration of hazardous substances and mixtures and to measure.
To prevent urgent threats to public safety and order, the measures may be taken pursuant to sentence 1 Nos. 1, 3 and 4 in residential premises and to any time of day or night. The party has the measures pursuant to sentence 1 Nos. 1, 3 and 4 and set 2 to tolerate, as well as to support the persons entrusted with the monitoring, as far as is required this for the fulfilment of their tasks, open spaces, containers and containers in particular them upon request and to allow the collection of samples. The fundamental rights of laid down in article 13 of the Basic Law on inviolability of the home is limited in this respect.
(5) the party may refuse the information on such questions, whose answer himself or one of his number 1 to 3 of the code of civil procedure referred to members of the risk of prosecution for a crime or misdemeanor would expose in § 383 paragraph 1.
(6) can the competent authority of the country judge the in the manufacture or use of the adverse impacts in article 19 paragraph 2 threatening substances, mixtures and products or that occurred or the measures necessary to avert or prevent nature and scope so it for that purpose by the manufacturer or user may request by the authority for determining experts at his own expense submit an opinion can be and you shall submit a copy of the opinion. Sentence 1 does not apply, as far as this Act tests prescribed or the conditions for the arrangement of tests are set.
(6a) spent substances, mixtures and products within the meaning of this Act on the basis of this Act or the regulations adopted pursuant to this Act shall be reported inland, so they may be spent to return to the foreign supplier of the territorial scope of this Act, unless the competent authority of the country has otherwise. Intergovernmental agreements, where the legislatures have approved in the form of a federal law, as well as legal acts of the European Community or the European Union remain unaffected.
(7) the Federal Office for chemicals and the bodies referred to in Article 12a the data by them on the basis of this Act, the regulations issued based on that Act and which in paragraph 2 sentence 1 of above EC or EU regulations and collected are stored are obliged, to make the authority of the occupational safety and health, general health, environmental and nature protection, General Security and the fire and civil protection of the countries, as well as the winners of the statutory accident insurance in the way of official assistance. Section 16e, paragraph 4 shall remain unaffected.

§ 21a participation of Customs offices (1) the Federal Ministry of finance and the Customs offices designated by him in monitoring the import and export of those substances, mixtures and products serve, which which are subject to this Act or a regulation adopted pursuant to this Act or one in § 21 paragraph 2 sentence 1 of above EC or EU regulations. As far as this is necessary for the monitoring of the implementation of this Act, the regulations issued under this law and the EC referred to in sentence 1 or EU regulations, they can share information gained in their customs operations, with the competent authorities.
(2) are evidence of a violation of the provisions referred to in paragraph 1, the Customs authorities inform the competent authorities. You can reject substances, mixtures and products as well as their transport and packing of goods at the expense and risk of the designated or ensure the identified deficiencies or until the decision of the competent authority.

Section 22 information requirements that inform Federal Office for chemicals and the competent authorities of the country to each other about all findings, the EC called for the exercise of their functions under this Act, the regulations adopted pursuant to this Act or in article 21, paragraph 2, sentence 1 or EU regulations including meeting that included reporting to the European Commission are required. The Federal Bureau of chemicals has to advise the competent land authorities upon request. Accordance with § 21 paragraph 2a paragraph 2 an other federal authority unless otherwise provided, are the obligations referred to in sentences 1 and 2 between that authority and the competent authorities of the country.

Government orders (1) that competent Land Authority may in individual cases the arrangements meet article 23, which are necessary for the Elimination of identified or for the prevention of future offences against this Act or the regulations adopted pursuant to this Act or against a in article 21, paragraph 2, sentence 1 called EC or regulation.
(1a) an order pursuant to paragraph 1 within the deadline will or executed such an arrangement declared immediately enforceable immediately, the competent authority may the work affected by the arrangement wholly or partly up to the fulfilment of the arrangement prohibit, if the prohibition for the protection of life or health of workers is required.
(2) the competent authority of the country may arrange for a period of not more than three months that a hazardous substance, a dangerous mixture or a product that can unlock a hazardous substance or a dangerous mixture or not, contains, may be made only under certain conditions, only in certain conditions, or only for specific purposes, put into circulation or used, if there are indications, in particular a suspicion justified according to the current state of scientific knowledge for , that emanates from the substance, the mixture or the product pose a significant risk to life or human health or the environment. The competent authorities may extend this arrangement for an important reason to up to one year. Sentences 1 and 2 shall also apply if, in particular a suspicion justified according to the current state of scientific knowledge, for the adoption of evidence that a substance or a mixture is dangerous. Orders can be made only pursuant to sentence 1 and 2, Union law permitted.
(3) appeals against orders under paragraphs 1a and 2 have no suspensive effect.

§ 24 law enforcement in the area of the German armed forces (1) In the Division of the Ministry of defence of the enforcement of the Act, the regulations based on the law and the incumbent in § 21 paragraph 2 sentence 1 of above EC or EU regulations, the Ministry of Defense and of him specific points.
(2) the Ministry of defence can allow exceptions to the legislation referred to in paragraph 1 for its Division in some cases and for certain substances, mixtures and products, if this is required and Union legally permissible in the interests of national defence.

Alignment with Community law or Union law § 25 regulations under this Act can also for the purpose of approximation of the laws, regulations and administrative provisions of the Member States of the European Union are adopted, insofar as this is necessary for the implementation of legal acts of the European communities or European Union affecting matters shall of this Act.

§ 25a fees and expenses (1) for individually attributable public services are to raise fees and expenses according to this Act and the legislation adopted for the implementation of this law, as well as to the EC or EU regulations within the meaning of § 21 paragraph 2 sentence 1. § 8 shall remain unaffected.
(2) the Federal Government is authorized by law Ordinance which shall not require the consent of the Federal Council, closer to determine the chargeable offences and the rates for individually attributable public services the federal authorities under this Act.
(3) that the respondents by the taking of samples of substances, mixtures and products or by measurements resulting own expenses he has to wear.
4 § 25a paragraph 101 shall apply in accordance with article 4 paragraph 2 in conjunction with article 5 paragraph 3 of the law of 7 August 2013 (Federal Law Gazette I p. 3154) from 14 August 2018 in the following version: "§ 25a expenses of the respondents the respondents by taking samples of substances, mixtures and products or by measuring emerging own expenses he has to wear."

Section 26 penalty provisions (1) any person who intentionally or negligently 1 is (lapsed) 1a.
(lapsed) 1 b (dropped out) 2 (dropped out) 3 (dropped out) 4. an enforceable order to contravenes section 12 g of paragraph 1 sentence 1, 5. b) violates article 13 paragraph 2 in connection with a legal regulation according to § 14 paragraph 1 number 1, 2 or number 3 letter c, also in connection with article 14 paragraph 3, one substance or a mixture does not incorrectly, incompletely, classifies in the prescribed manner or in a timely manner (b).
contrary to § 13 paragraph 3 sentence 1 in conjunction with a legal regulation according to § 14 para 1 No. 3 letter a, d or letter e, each also in combination with article 14 paragraph 3, has a substance or a mixture does not incorrectly, incompletely, features not in the prescribed manner or in a timely manner or not, not, not fully packed in the prescribed manner or in a timely manner or c) a legal regulation according to § 14 paragraph 1 number 3 letter a , b, d, e, or letter f or paragraph 2 sentence 2 is contrary to, insofar as it refers to this penalty provision for a specific offence, 5a.
(lapsed)
6. a legal regulation to section 16B is, insofar as it refers to this penalty provision for a specific offence, 6a.
contrary to § 16e, paragraph 1, sentence 1 or set of 3, each also in combination with a regulation under paragraph 5 number 2 or number 3, a communication not, incorrectly, incompletely or not in time makes, 6B. (disappeared) 7 a decree after a) § 17 paragraph 1 number 1 point (b) or paragraph 2 letter a, c, or d, each also in combination with paragraph 3 sentence 1 , b) § 17 paragraph 1 number 1(c), in connection with paragraph 3 sentence 1, or c) contravenes article 17, paragraph 5, as far as it references for a particular offense on this fine provision 8 a decree after a) § 18 paragraph 1 of poisonous animals and plants, b) contravenes article 19 paragraph 1 in connection with paragraph 3 on measures for the protection of workers , as far as on this fine provision point for a particular offense, 8a.
(lapsed)
9 contrary to section 21 paragraph 3 not given information despite reminder, not presents number 2 documents contrary to article 21, paragraph 4, sentence 1 or an obligation according to article 21, paragraph 4, sentence 3 does not fulfil an enforceable order of a 10) according to § 23 paragraph 1 or b) according to § 23 paragraph 2 sentence 3 in connection with sentence 1 of the manufacture, placing on the market or use of substances , Mixtures or products contravenes, 10a.
a legislative decree is pursuant to section 28 paragraph 11 on registration or reporting requirements for certain biocidal products, insofar as it references this penalty provision for a specific offence, or 11 a directly applicable provision in legislation of the European communities or the European Union is contrary to, the matters shall of this Act is concerned, as far as a legal regulation to set references for this penalty provision 2 for a specific offence and the offence not number 3 or paragraph 2 as a criminal offence can be punished according to article 27, paragraph 1. The Federal Government is entitled to refer to the individual facts of acts that can be punishable pursuant to sentence 1 as offences with fine, as far as this is necessary for the carrying out of acts by decree with the consent of the Federal Council.
(2) the offence can number 7 in the cases of paragraph 1 letter b with a fine up to two hundred thousand euros, in cases of paragraph 1 number 4, 5, 6, 7 letter a, point 8 point (b), number 10 and 11 with a fine of up to fifty thousand euro and in other cases a fine punishable up to ten thousand euros.
(3) managing authority within the meaning of article 36, paragraph 1, number 1 of the code of administrative offences is 1 in the cases of paragraph 1 No. 9 in connection with article 21, paragraph 3, sentence 2 a) the Federal Bureau of chemicals for their business area in accordance with article 21, paragraph 2, sentence 2 or b) which in the legal regulation according to § 21 paragraph 2a described federal authority, as far as the designated powers are available to you in article 21, paragraph 3, sentence 1 , 2 (lapsed) 3 in addition the authority competent under national law.

Section 27 (1) sanctions with imprisonment up to two years or with fine is who 1 punished, a legal regulation according to § 17 para 1 No. 1 letter a, number 2 letter b or number 3, also in connection with paragraph 2, 3 sentence 1, paragraph 4 or 6 of the manufacture, placing on the market or use there known substances, mixtures, products, biocidal active substances or biocidal products contravenes , as far as reference for a particular offense on this regulation, 2. an enforceable order according to § 23 paragraph 2 sentence 1 on the manufacture, placing on the market or the use of hazardous substances, contravenes mixtures or products or 3. a directly applicable provision in legislation of the European communities or the European Union is contrary to that content corresponds to a regulation, which empower the provisions referred to in paragraph 1 , as far as a legal regulation pursuant to sentence 2 for a certain offence refers to this regulation. The Federal Government is authorized, as far as this is necessary for the enforcement of the legal acts of the European communities or the European Union to refer to facts which are punishable as a criminal offence pursuant to sentence 1 by decree with the consent of the Federal Council.
(1a) with imprisonment up to three years or will be punished with fines, who a in paragraph 1 number 3 part of the sentence before sentence 2 designated action this commits, that he establishes a requirement object within the meaning of article 2 paragraph 6 of the food and feed law or brings in traffic.
(2) with imprisonment up to five years or with fine punished who a in paragraph 1, paragraph 1a, or one in § 26 paragraph 1 number 4, 5, 7 point (b), point 8 point (b), number 10 or number the life or health of another or strange things of significant value at risk 11 deliberate act referred to.
(3) the attempt is punishable.
(4) the perpetrators are acting with negligence, so the sentence 1 in the cases of paragraph 1 or paragraph 1a sentence is imprisonment up to one year or fined, 2. in the cases of paragraph 2 up to two years or a fine.
(5) the Court can refrain from punishment referred to in paragraph 2 If the perpetrator voluntarily averts the danger before substantial damage. Under the same conditions, the offender is not punished no. 2 pursuant to paragraph 4. The danger is averted without the help of the offender, be voluntary and serious effort to achieve this goal is sufficient.
(6) paragraphs 1 to 5 do not apply if the Act is under threat after the sections 328, 330 and 330a of the Penal Code with same or heavier punishment.

§ 27a untrue declarations of GLP, gaining the GLP certificate who of deception in legal relations number 2 gives the explanation to article 19a, paragraph 2, sentence 2 the truth contrary to (1) or an untrue statement used, is punishable by up to five years or punished with fines.
(2) a public officials, the within its jurisdiction a false certificate according to § 19 b paragraph 1 or false confirmation according to § 19 b paragraph 2 No. 3 issued, is punishable by up to five years or punished with fines.
(3) a person who causes a false certificate or confirmation is granted b according to § 19, or who used such certificate or confirmation to the deception in legal relations, is punishable by up to one year or fined punished.
(4) the attempt is punishable.

§ 27B infringements of Regulation (EC) No. 1907/2006 (1) with imprisonment up to two years or with fine is who against regulation (EC) punished, No 1907/2006 of the European Parliament and of the Council of 18 December 2006 for 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 the 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 (OJ EU no. L 396 p. 1, 2007 No. L 136 S. 3) violates, by it 1 violates article 5 establishes a substance as such, in a mixture or in a product or in traffic 2 in a registration dossier referred to in article 6, paragraph 1 or paragraph 3 or article brings, 7 paragraph 1 sentence 1 or paragraph 5 sentence 1 or in an application for authorisation according to article 62 paragraph 1 in connection with paragraph 4 a specified incorrectly or not fully makes 3. contrary to article 37 paragraph 4 in conjunction with article 39 paragraph 1 not, incorrectly, incompletely or not in time creates a chemical safety report or 4. contrary to article 56, paragraph 1 for use in traffic brings a listed substance or even used.
(2) an attempt is punishable.
(3) with imprisonment up to five years or with fine will be punished who endangers the life or health of another or strange things of significant value through an act referred to in paragraph 1.
(4) the perpetrators in the cases of paragraph 1 is number 4 due to negligence, the penalty is up to one year or a fine of imprisonment.
(5) any person, who is a designated Act negligently commits number 1, 2 or 3 number in paragraph 1. The offence can be punished with a fine up to one hundred thousand euro.

section 27c infringements of tax legislation (1) imprisonment up to two years or with fine will be punished, who a in article 26 paragraph 1 number 7 letter of b, deliberate act commits, even though he knows that the dangerous substance, the dangerous mixture or the product should be used for an unlawful act which carries out the facts of a criminal code,.
(2) the perpetrators in the cases of paragraph 1 does not recognize lightly that the dangerous substance, the dangerous mixture or the product should be used for an unlawful act which carries out the facts of a criminal code, so the penalty is imprisonment up to one year or a fine.

section 27 d recovery items, the one offence under §§ 27, 27 b paragraph 1 to 4 or § 27 c or an offence pursuant to section 26 paragraph 1 number 4, 5, 7 2(a) or 2(b), number 10 and number 11 or § 27 (b) paragraph 5 sentence 1 applies, can be withdrawn. section 74a of the Penal Code and article 23 of the code of administrative offences are to be applied.
Eighth section final provisions § 28 transitional provisions (1) (dropped out) (2) (dropped out) (3) (dropped out) (4) (dropped out) (5) (dropped out) (6) (dropped out) (7) (lapsed) (8) In the territorial scope of this Act biocidal products that contain, in accordance with Regulation (EC) No. 1451 only biocidal agents may / 2007 have been evaluated or are still in the local assessment procedures under this Regulation (1) of Regulation (EU) No. 528, by way of derogation from article 17 / 2012 up to be deployed and used the following dates on the market : 1 year after publication of the decision in accordance with article 89 paragraph 1 subparagraph 3 of the Regulation (EU) not to permit no. 528 / 2012 in the official journal of the European Union, for the particular product-type of a biocidal active substance contained in the biocidal product, provided that in the decision of the Commission otherwise determines is, 2. deploy on the market for 180 days, as well as to the disposal or use 365 days after the date set in the decision of approval of the active substance and the substances referred to in Article 89 paragraph 3 subparagraph 3 of the Regulation (EU) No. 528 / 2012, unless an application for registration or temporary parallel recognition in accordance with article 89 paragraph 3 subparagraph 2 of Regulation (EU) No. 528 / 2012 not or not timely is, 3. during an ongoing process of decision on an application for registration or temporary parallel mutual recognition of biocidal product pursuant to article 89 paragraph 3 subparagraph 2 of Regulation (EU) No. 528 / 2012 up to the date of effect of the approval or recognition , or 4 for providing on the market for 180 days, as well as to the disposal or use 365 days in accordance with article 89 (4) of Regulation (EU) No. 528 / 2012, after the request pursuant to article 89 paragraph 3 subparagraph 2 of Regulation (EU) No. 528 / 2012 for approval or temporally parallel mutual recognition has been rejected.
(9) in the case of paragraph 8 number 3 can set the Federal Bureau for chemicals within the framework of the EU law allowed for stocks of the biocidal product, which already have been deployed before granting the approval or parallel recognition on the market and not or not fully comply with the requirements of the accreditation or recognition decision or the labelling requirements related to the registration or recognition, use deadlines for further deployment in the market and further use.
(10) in article 91 of Regulation (EU) No. 528 / 2012 nothing else unless otherwise provided, are for applications for approval or recognition of biocidal products which are received prior to September 1, 2013 in full at the admissions, the provisions of this Act in which, until the entry into force of the Act on the implementation of the Regulation (EU) No. 528 / 2012 from July 23, 2013 (Federal Law Gazette I p. 2565) amended further to apply.
(11) the Federal Government is authorized, after consultation of interested parties by decree with the consent of the Federal Council for the purpose referred to in paragraph 1 to the delegated Act the European Commission in accordance with article 89 paragraph 1 subparagraph 2 of Regulation (EU) No 528 / 2012 certain date of the end of the work programme for the systematic examination of all old active substances, up to but at least 14 may 2014 , to prescribe that certain biocidal products within the meaning of paragraph 8 only may be placed on the market and used, after they are approved by the Federal Office for chemicals. Requirements of the Regulation (EU) No. 528 / 2012 within the framework of the Union legally permissible may be waived under the Ordinance. Also a registration procedure can be provided instead of an authorisation.
(12) an is announcement according to § 16e, paragraph 1, sentence 1 to July 1, 2016, not required for mixtures that meet none of the danger characteristics according to § 3a paragraph 1 number 6, 7, 9 or 11 to 14 or are not designed for the consumer and which not to biocidal products are, unless for the specific mixture 1 in the case of detergents and cleaning agents in the sense of the washing and cleaning agent Act the Federal Institute for risk assessment a each current data sheet annex VII section C of Regulation (EC) No 648 / 2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104 of the 8.4.2004, p. 1), most recently by Regulation (EC) No 551 / 2009 (OJ L 164 of 26.6.2009, p. 3) has been amended is 2nd in the case of other mixtures an each current safety data sheet No. 1907/2006 in a form prescribed by the respective Institute has been sent electronically the Institute for occupational safety and the German statutory accident insurance according to article 31 of Regulation (EC) and for the purposes referred to in Section 16e, paragraph 4. For mixtures pursuant to sentence 1, which were already before the 9th November 2011 in traffic, the transmission of documents pursuant to sentence after section 16e, paragraph 1, sentence 1 to 1 may 2012 must be made 1 or the communication. The Federal Government will be authorized by decree with the consent of the Federal Council the period referred to in sentence 1, taking into account the results of the review referred to in article 45 (4) of Regulation (EC) No. 1272/2008 to extend or shorten.

Section 29 (other than entry into force) § 30 Berlin clause (void) article 31 (force) Annex 1 (to article 19a paragraph 1) principles of good laboratory practice (GLP) (site: BGBl. I 2013, 3521-3531) table of contents section I 1 scope 2 definitions 2.1 good laboratory practice (GLP good laboratory practice) 2.2 terms relating to the organisation of a test facility 2.3 terms concerning the non-clinical health and environmental safety testing 2.4 terms concerning the test object, section II principles of good laboratory practice 1 Organization and personnel of the test facility 1.1 tasks of led the testing device 1.2 tasks of Test Manager 1.3 tasks of the local investigator in charge 1.4 tasks of the examiner staff 2 quality assurance programme 2.1 General 2.2 tasks of the quality assurance personnel 3 premises and facilities 3.1 General 3.2 premises and facilities for test systems 3.3 premises and facilities for handling test and reference items 3.4 premises and facilities for archives 3.5 waste disposal 4 devices, reagents and materials 5 test systems 5.1 physical and chemical test systems 5.2 biological test systems 6 test and reference items 6.1 input , Handling, sampling and storage 6.2 characterisation 7 SOPs (standard operating procedures, SOPs) 8 test procedure 8.1 inspection plan 8.2 content of the test plan 8.3 test 9 report on the test results of 9.1 General 9.2 content of the final report 10 archiving and retention of records and materials section I 1 scope these principles of good laboratory practice apply to the non-clinical safety testing of test items, in medicinal , Plant protection products and biocides, cosmetic products, veterinary medicinal products, as well as food additives, feed additives, and industrial chemicals are included. Often, these inspection items are synthetic chemical products; You can but be also natural or biological origin; under certain circumstances it can be living organisms. Purpose of checking these test items is to obtain data on its properties and their safety for human health and the environment.
To the non-clinical health and environmental safety testing, are covered by the principles of good laboratory practice include laboratory tests as well as tests in greenhouses or outdoors.
These principles of good laboratory practice apply to all non-clinical health and environmental safety testing, required by evaluation authorities regarding the registration or approval of pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary medicinal products and similar products, as well as to the application of industrial chemicals.
These principles of good laboratory practice are also used on stages of inspections that are carried out on a Prüfstandort. Test bench places can be recorded with its own line on request in the national GLP monitoring procedures.
2 definitions 2.1 good laboratory practice (GLP good laboratory practice) good laboratory practice is a quality assurance system that are concerned with the organisational process and the conditions, under which non-clinical health and environmental safety tests planned, carried out and monitored as well as the recording, archiving and reporting of tests.
2.2. terms concerning the organisation of a test facility 1)
Test facility includes the people, facilities and units of work that are necessary for the conduct of non-clinical health and environmental safety testing. Tests performed in phases to more than one location, so called multi-site audits, the term test facility includes the location where the test head is located, as well as all other individual test locations. The test bench places can be defined collectively as well as individually as a testing facility.
(2) Prüfstandort is the place where one or more stages of an examination carried out. See phases of testing individual parts, sections, are steps or levels of tests.
(3) management of the testing facility may refer to the person or group of persons which has the authority and formal responsibility for the organisation and functioning of the test facility according to these principles of good laboratory practice.
(4) management of a test place identifies the person or group of persons which has to ensure, that those phases of the test, for which it has responsibility, be carried out according to these principles of good laboratory practice.
(5) the contracting authority is a natural or legal person who is a non-clinical health and environmental safety testing in order, supported, or submit.
(6) Test Manager is the person who is responsible for the overall management of the non-clinical health and environmental safety testing.
(7) local investigator (principal investigator) means the person who accepts certain responsibilities for the conferred phases of trials in the case of a multi-site test, on behalf of the test conductor. The responsibility of the test conductor for the overall management of the examination cannot be transferred to the local investigator; This includes the approval of the Protocol and its amendments, the approval of the final report, as well as the responsibility for compliance with all applicable principles of good laboratory practice.
(8) quality assurance program is a defined system, whose staffing of the audit process is independent, and that gives certainty to the direction of the test facility, compliance with the principles of good laboratory practice.
(9) SOPs (standard operating procedures, SOPs) are documented operating procedures on the implementation of those investigations or activities are not described in test plans or test guidelines in appropriate detail.
(10) directory with the status of all checks (master schedule) is a compilation of information that is used to estimate the workload and tracking the progress of tests in a testing facility.
2.3 terms concerning the non-clinical health and environmental safety checks 1) non-clinical health and environmental safety testing, hereinafter referred to "Test", is a study or set of studies performed with a test object under laboratory - or environmental conditions to obtain data about its properties and its safety with the intention to submit these to the assessment authorities.
(2) short time test is a test of short duration, which is carried out according to widely used routine methods.
(3) test plan is a document that describes the objectives and experimental total planning to carry out the check; It includes all inspection plan changes.
(4) inspection plan change is a planned change of the inspection plan after the start of the examination in the form of a supplement.
(5) test schedule variance is a unintentional departure from the inspection plan after commencement of the trial.
(6) test system is any biological, chemical or physical system - or a combination thereof - that is used during a test.
(7) raw data are all original records and documentation of the test facility, or verified copies, incurred as a result of the original observations or activities during a test. Raw data includes, for example, photographs, microfilm or microfiche copies, computer-readable media, dictated observations, recorded data from automated devices or any other data on storage media, which are recognized as suitable, described details of one, as in section 10 to save period.
Materials that are removed for the investigation, evaluation or retention of the test system are 8) samples.
(9) the beginning of the experimental phase is the day on which the first exam-specific raw data collected.
(10) the end of the experimental period is the last day when testing specific raw data collected.
(11) the beginning of a test is the day on which the test manager signs the inspection plan.
(12) the conclusion of an audit is the day where the test Director signs the final report.
2.4 terms concerning the test item 1) test object is an object that is subject to the audit.
(2) reference object (object of comparison) is an object that is used for comparison with the test item.
(3) batch is a quantity or lot of test or reference item, so created in a particular production run, certain that uniform properties are to be expected; It is marked as such.
(4) the carrier material is a substance with which the test or reference item mixed, dispersed or resolves to facilitate the application of the test system.
Section II principles of good laboratory practice (GLP) 1 Organization and personnel of the checking device 1.1 tasks of led the testing device 1) has the line of each test facility to ensure compliance with these principles of good laboratory practice in their testing facility.
2) the line has at least a) to ensure that exists in a declaration stating the person or group of persons, which shall exercise the responsibilities of the leadership of the testing facility within the meaning of these principles of good laboratory practice;
b) to ensure that a sufficient number of qualified personnel, suitable premises, equipment and materials are available to ensure the timely and proper conduct of the examination.
c) to ensure that records of training, Fort - and training as well as practical experience and the task description for all scientific and technical staff;
d) to ensure that staff with the tasks that you want to run it, are familiar and, if necessary, an introduction to these tasks is provided.
e) to ensure that adequate and the State of the art creates appropriate standard operating procedures and to be followed, and has to approve all original standard operating procedures, as well as their revised versions;
f) to ensure that there is a quality assurance program and the manpower required for its implementation, as well as to ensure that the perception of the quality assurance tasks in accordance with these principles of good laboratory practice is carried out;
to make sure g) named a test lead with appropriate education, continuing and training and practical experience from the line before the start of each test. Replacing a test conductor must be done according to established procedures and it should be noted in writing;
h) to ensure that in case of multi site checks, where appropriate, a local investigator is named, has a corresponding education, training and training and practical experience that the stages of assessing conferred on him to manage or monitor. Replacing a local investigator in charge must be done according to established procedures and it should be noted in writing;
i) to ensure that each inspection plan; approved in writing by the head of the inspection
j) to ensure that the test lead in time leads to the approved audit plan the quality assurance personnel;
k) to ensure that a chronological file of all standard operating procedures;
l) to make sure that a person responsible for the management of archives is determined;
m) to ensure that a directory with the status of all checks (master schedule);
n) to ensure that all supplies in the testing device meet the requirements with respect to their use in the examination;
o) to ensure that there exist well-defined communication paths between test lead, local investigator, quality assurance personnel, and be tested personnel at multi-site audits;
p) ensure that test and reference items in an appropriate manner are characterized;
(q) to establish procedures, make sure that computer-based systems for their intended application are appropriate and validated in accordance with these principles of good laboratory practice, operated and maintained.
(3) certain phases of a test on a Prüfstandort carried out, for which a line was named, the line of this test bench place has to take over all tasks with the exception of the tasks referred to in paragraph 2 letter g, i, j and o in paragraph 2.
1.2 duties of the test head 1) test lead is entrusted with the sole supervision of the audit and is responsible for the overall conduct of the examination and for the final report.
2. this responsibility includes at least the following tasks. The test head has) the audit plan, as well as any changes made by dated signature to approve;
b)
to ensure that the quality assurance personnel each time has a copy of the inspection plan, as well as any changes, and he has to communicate; as effectively as required with the quality assurance personnel during the conduct of the examination
c) to ensure that the examiner staff test plans and amendments and standard operating procedures are available.
d) to ensure, describe that the inspection plan and the final report of a multi-site test notably involved local investigator and the test facilities and test sites testing the implementation as well as the delegated tasks;
e) to ensure that the procedure described in the inspection plan; followed He has to evaluate possible effects of any variations in test plan on the quality and reliability of the examination, to document and to take corrective measures if necessary; He has any deviations from standard operating procedures in the conduct of the examination to confirm;
f) to ensure that all raw data; seamlessly captured and recorded
g) to ensure that used computer-aided systems are validated in the course of an examination;
h) the final report dated to subscribe in order to take over the responsibility for the reliability of the data and to indicate to what extent the test matches with these principles of good laboratory practice;
i) to ensure that after completion of examination test plan, final report, raw data and other related material are archived. Also cancel of an exam is a report and according to procedures with regard to the archiving.
1.3 tasks of the local investigator in charge, the local investigator ensures that the phases transmitted to him the examination in accordance with the applicable principles of good laboratory practice are carried out.
1.4 tasks of the examiner staff 1) personnel involved in the conduct of a trial must have sound knowledge of those sections of the principles of good laboratory practice which affect his participation in the examination.
(2) the inspection staff must have direct access to the audit plan and on the standard procedures relating to his participation in the examination. The responsibility to follow the instructions in this document is the examiner staff. Any deviation from the instructions is to document and immediately notify the head of the inspection and, if necessary, the local investigator.
(3) the examiner staff is responsible for the prompt and accurate capture of raw data in accordance with these principles of good laboratory practice, as well as for the quality of this data.
(4) the examiner staff has to keep health precautions to limit harm to itself even to a minimum and to ensure the reliability of the test. It has relevant to share with known health or medical issues of the competent person him to any works to be excluded from, where impairment testing seems to be possible.
2 quality assurance programme 2.1 General information 1) the test apparatus must have a documented quality assurance programme to ensure that you have performed the tests in accordance with these principles of good laboratory practice.
(2) the quality assurance program is carried out by one or more persons, are determined by the Board and which are directly responsible for it. Such persons must be familiar with the test procedures.
(3) these persons must not involved in the conduct of the examination, the quality of which is to secure.
The quality assurance personnel at least has 2.2 tasks of the quality assurance staff) to provide copies of all approved test plans and standard operating procedures, which are used in the testing device, and access to the directory of the current status of all tests (master schedule) to have;
(b)) to check, whether the test plan contains the information required according to the principles of good laboratory practice. This review shall be documented;
(c) carry out inspections to determine if all checks in accordance with these principles of good laboratory practice. During the inspections should be whether inspection plans and standard operating procedures are available directly to the testing personnel and be followed also found.
There are three types of inspections, which are closer to describe in appropriate standard operating procedures for the quality assurance program: - test-related inspections, facility-based inspections, - process-related inspections.
Records of these inspections are to be kept;
(d) the final reports to inspect and, where applicable, to confirm that methods, procedures, and observations have been described correctly and comprehensively and that the reported results correctly and comprehensively reflect the raw data of the tests;
(e) immediately the Committee and the head of the inspection and, if necessary, the local investigator and its corresponding line inspection results in writing to report;
(f) a draft declaration for incorporation in the final report and to sign out of the way and time of the inspections the inspected phases of the exam as well as the dates on which the leadership and the test lead and, if necessary, a local investigator inspection results were reported to emerge. Still, this statement serves as a confirmation that the final report reflects the raw data.
3 rooms and facilities 3.1 General 1) the test apparatus has a suitable size, exhibit construction and location to meet the requirements and to restrict interference, which could affect the reliability of the test, a minimum.
(2) the test apparatus must be laid out so that the individual work processes sufficiently cannot be separated, to ensure the proper implementation of each individual test.
3.2 premises and facilities for test systems 1) the test apparatus must have a sufficient number of rooms or areas, to allow the separate placement of test systems and individual tests for substances or organisms, whose biological risk posed is known or can be assumed.
(2) suitable rooms or areas must be for the diagnosis, treatment and control of diseases available, to ensure that no unacceptable degradation of the test systems occurs.
(3) for supplies and equipment, storage rooms or areas must be present. These storage rooms or areas must be separated from the accommodation spaces or areas for inspection systems and ensure adequate protection against vermin, contamination and spoilage.
3.3 premises and facilities for handling test and reference items 1) to avoid contamination and mix-ups, separate rooms or areas for receipt and storage of test and reference items and mixing of the test objects with materials must be present.
(2) the storage rooms or areas for the test items must be separated from the rooms or areas in which the systems are housed. You need suitable, identity, concentration, to maintain purity and stability of the test objects and to ensure the safe storage of dangerous substances.
3.4 premises and facilities for archives premises for archives must be return point patterns for secure storage and retrieval of inspection plans, raw data, final reports, test and reference items and specimens available. Facilities and conditions in the archives are designed to prevent a premature deterioration of the archival material.
3.5 waste disposal waste are to manage and eliminate that the tests will not be compromised. These include provisions for appropriate collection, storage, disposal, decontamination and transport procedures.
4 devices, reagents and materials 1) apparatus, including validated computerised systems, used to the acquisition, recording and playback of data and control of environmental conditions important for examining, are appropriate to accommodate and must have an appropriate design and adequate performance.
(2) the equipment used during a test is to check at regular intervals in accordance with the standard operating procedures, to clean, maintain and calibrate. Records are to be kept. Calibrations, can be attributed where necessary, to national or international measurement standards.
(3) equipment and materials used in a test should not affect inspection systems.
(4) chemicals, reagents and solutions are to be marked that identity (with concentration, if necessary), expiry date and specific storage instructions are shown so. Information on origin, date of manufacture and durability must be available. The expiry date can be extended on the basis of documented evaluation or analysis.
5 test systems 5.1 physical and chemical test systems 1) are appropriate to accommodate devices involving physical and chemical data obtained, and must have an appropriate design and adequate performance.
(2) ensuring the function of physical and chemical inspection systems must be ensured.
5.2
Biological test systems 1) for the storage, housing, handling and care of biological test systems are suitable conditions to create in order to ensure the quality of the data.
(2) newly arrived animal and plant test systems are separated to accommodate until their health status has been determined. If an unusual mortality or morbidity occurs, this delivery fails tests must be used. Plant inspection systems are to destroy, if necessary, suitably, animal inspection systems must be treated according to the standards of the animal welfare act. At the beginning of the experimental phase of the examination, inspection systems must be free from all diseases or impairments, which could affect the purpose or the conduct of the examination. Test systems that fall ill or are injured, in the course of the examination are, if necessary, to isolate and treat, to ensure the integrity of the examination. There are records to lead on diagnosis and treatment of any diseases before or in the course of scrutiny.
(3) origin, arrival date and State of arrival of the inspection records must be executed.
(4) biological test systems are during a sufficient period of time to the environmental conditions of the examination to acclimatise prior to the first administration of the test or reference item.
(5) all information necessary for the identification of the test systems are to attach to their cages or containers. Test system individuals who will be taken in the course of the test from their cages or containers must as far as possible, apply suitable identification.
(6) during use, any cages or containers for test systems at appropriate intervals must be cleaned and made germ-free. Materials that come with the test systems into contact, must be free of impurities in concentrations that could affect the test. Litter for animals is so often to change how it requires good animal care practices. The use of pesticides shall be documented.
(7) test systems for field tests are to apply, that influence the examination by spray mist drift or previously used pesticides is avoided.
6 test and reference items 6.1 receipt, handling, sampling and storage 1) records are to lead, showing that the characterization of the test and reference items, the date of receipt, the expiration date, the received and the quantities used in the tests.
(2) handling, removal and storage procedures are set so that the homogeneity and stability guarantees as far as possible and contamination or mix-ups are excluded.
(3) the storage containers are identification data, to attach expiration date and specific storage instructions.
6.2 characterization 1) each test and reference item is in an appropriate way to mark (for example, by code, Chemical Abstracts registry number (CAS number), name, biological parameters).
(2) for each test must identity, including batch number, purity, composition, concentrations, or other properties to the characterization of each batch of the test or reference items be known.
(3) for the delivery of the test item by a contracting authority a procedure to determine how clearly confirms the identity of the subject of the test, which is used in the test, is in collaboration between client and test facility.
(4) the stability of test and reference items under storage and test conditions must be known for all tests.
(5) if the test subject in a carrier substance is administered, are the homogeneity, concentration and stability of the test item in this carrier to determine. Test items for field tests (such as spraying fluids), these parameters can be determined through separate laboratory tests.
(6) for a possible analytical hedge is from each batch of test items, used in a test, with the exception of short time trials, kept a samples.
7 SOPs (standard operating procedures, SOPs) 1) a test facility with written standard operating procedures have, approved by their management and are intended to ensure the quality and reliability of the data obtained in the course of the examination in the testing device. The revised versions of the standard operating procedures shall be approved by the management of the testing device.
Standard operating procedures relevant to the work carried out there in the current version must be immediately available 2) each single unit of work and each individual workspace of the testing device. Analytical methods, published books, manuals and articles can be used as a supplement to these standard instructions.
(3) Prüfungsbedingte are deviations from standard operating procedures to document and confirm by the head of the inspection and, if necessary, by the local investigator.
(4) standard operating procedures must be available at least for the following areas, using the details given under the respective headings as illustrative examples are: 1. test and reference items receipt, identification, labelling, handling, collection and storage.
2. equipment, materials and reagent a) equipment operation, maintenance, cleaning, calibration;
b) computerized systems validation, operation, maintenance, security, controlled system change (change control) and data backup (back-up);
c) materials, reagents and solutions preparation and labelling.
3. lead records, reporting, storage, and retrieval coding tests, data collection, reporting, indexing systems, handling of data, including use of computer-based systems.
4. test systems, as far as for the examination of relevant a) preparation of rooms and space environmental conditions for test systems;
b) procedure for entrance, implementation, proper accommodation, characterisation, identification and care of test systems;
c) preparation, observation and study of the test systems before, during and at the end of the test;
(d) handling of animals, that moribund or dead will be found in the course of the audit;
e) collection, identification and handling of specimens including section and histopathology;
(f) plant and location of test systems in test areas.
5. quality assurance procedures activity of quality assurance personnel at the organisational and time planning, implementation, documentation and reporting of inspections.
8 test procedure 8.1 inspection plan 1) before starting each test must be a written test plan. The inspection plan must be approved by dated signature of the head of the inspection and verified by the quality assurance staff for GLP compliance in accordance with section II, point 2.2 letter b.
(2a) test schedule changes must be justified and approved by dated signature of the test conductor and must be kept together with the inspection plan.
(2B) test plan deviations must be described by the head of the inspection and of the responsible local investigator immediately, explains, confirmed and dated and stored along with the raw data.
(3) in the case of short term testing, a standard inspection plan with test-specific additions can be used.
8.2 content of the Protocol of the inspection plan must contain at least the following information: 1) name of the test, the test and reference items a) descriptive title;
b) Declaration on the type and purpose of the test;
(c) designation of the test item by code or name (IUPAC, CAS number, biological parameters, etc.);
(d) to use reference object.
2) data about the customer and the test facility a) name and address of the contracting authority;
b) name and address of the test facility, as well as of any other exam involved test facilities and test sites;
c) name and address of the test conductor;
d) name and address of the local investigator in charge and the designation of the phases of the test provided by the test head under his responsibility.
3) dates a) the date of approval of the Protocol by the signature of the test conductor.
b) estimated dates for beginning and end of the experimental phase of the examination.
(4) test methods refer to the applicable OECD test guidelines or other applicable test guidelines or methods.
5) particulars, as far as for the examination of relevant a) justification for selection of the test system;
b) characterisation of the test system, such as species, root, under root, origin, number, body weight range, sex, age and other relevant information;
c) application and justification for their choice;
d) doses and concentrations, frequency and duration of application;
(e) detailed information on the experimental overall planning, including the chronological description of the testing procedure, all methods, materials and conditions, type and frequency of to analysis, measurements, observations and examinations and, if necessary, to apply statistical procedures.
(6) records list to retain records.
8.3 conduct of tests 1)
Each test must be given a unique name. All documents relating to this inspection and materials must have this designation. Samples from the test are said to indicate that their origin is clearly understandable. Such labelling serves the traceability of the sample on a particular test.
(2) the test shall be performed according to the test plan.
(3) all data collected during the test are immediately, without delay by the uplifting person to record accurately and legibly. These records are dated to sign or sign off.
(4) any change is in the raw data to perform, that the original recording remains clear; It is provided with a statement of reasons, as well as with date and signature or symbol of the person taking out the change.
(5) data generated as a direct computer input, are to be marked at the time of data entry by the responsible persons. Computer-aided systems must be designed so that at any time the recording of a full audit trails is available, which displays all data changes without mislead the original data. All data modifications can be linked to the person changing it for example by using date and time-dated (electronic) signatures. Changes shall be reasoned.
9 report on the test results 9.1 General 1) a final report must be created for each test. A standard final report with test-specific additions can be created in short time trials.
(2) every report of a local investigator in charge involved in assessing or participating specialist is dated to sign this.
(3) the final report must be signed dated from the Test Manager to document the assumption of responsibility for the reliability of the data. Furthermore, it is to indicate to what extent the audit complies with these principles of good laboratory practice.
(4) corrections and additions to a final report are to perform in the form of supplements. In these addenda are clearly setting out the reasons for the corrections or additions and be signed by the head of inspection dated.
(5) a reformatting of the final report to comply with registration requirements of a national evaluation Agency represents no correction, addition or change of the final report in the above sense.
9.2 content of the final report the final report shall contain at least the following information: 1) name of the test, the test and reference items a) descriptive title;
b) description of the test item by code or name (IUPAC, CAS number, biological parameters, etc.);
(c) designation of the reference item by name;
(d) characterisation of the test item including purity, stability and homogeneity.
2) data about the customer and the test facility a) name and address of the contracting authority;
b) name and address of all involved in test facilities and test sites;
c) name and address of the test conductor;
d) name and address of the local investigator in charge, as well as the delegated phases of the examination, if applicable;
(e) the name and address of the scientists who have contributed reports to the final report).
(3) dates date of beginning and end of the experimental phase of the examination.
(4) Declaration of quality assurance, the nature and time of the inspection, the inspected phases of testing, as well as the times emerge from, have been reported where the line and the test lead, as well as, if necessary, a local investigator inspection results. This statement also serves as confirmation that the final report reflects the raw data.
5) description of materials and test methods a) description of the used methods and materials;
b) reference to OECD test guidelines or other test guidelines /-methods.
6) results a) summary of results;
(b) all information required in the inspection plan and data;
(c) presentation of the results, including calculations and the measures of statistical significance;
d) assessment and discussion of the results and, where appropriate, conclusions.
(7) storage repositories of the inspection plan, the samples of test and reference items, specimens, raw data and the final report.
10 archiving and retention of records and materials 10.1 to the archives may have access only from the line to authorised persons. There are records to lead on removal and return.
10.2 is the following 15 years in the archives to save: a) inspection plan, raw data, samples of test and reference items, samples and final report of each audit.
b) records of all inspections performed according to the quality assurance program, as well as the directory that contains the status of all checks (master schedule);
(c) records of the education, training and training and practical experience of the staff, as well as the job descriptions;
d) records and reports of the maintenance and calibration of equipment;
e) validation documentation for computerised systems;
f) chronological file of all standard operating procedures;
(g) records to the control of the environmental conditions.
If for certain audit-related materials, no archiving period was set in set 1, their disposal must be documented. If samples of test and reference items be disposed of before the end of the defined archiving period, is to justify this and document. Samples of test and reference items and specimens must be stored only as long, as their quality allows for an assessment.
10.3 archived material is to index to facilitate an orderly storage and retrieval.
10.4 If a test facility or an archive of the contract adjusts the activity and has no legal successor is the archives to the archives of the principal of the trials to convict.

Annex 2 (to § 19 b paragraph 1) country seal/coloured logo good laboratory practice/good laboratory practice GLP certificate/statement of GLP compliance (according to/according to § 19 b paragraph 1 legislation) (site: BGBl. I 2013, 3532) a GLP inspection for monitoring compliance with GLP principles according to the chemicals Act or Directive 2004/9/EC has been carried out in: assessment of conformity with GLP according to legislation and Directive 2004/9/EC at : □ test/test facility □ Prüfstandort/test site (unique name and address/unequivocal name and address) tests according to categories/areas of expertise (according to/according ChemVwV-GLP No. 5.3 / OECD guidance) date of inspection/date of inspection (Tag.Monat.Jahr/day.month.year) who called test equipment/Prüfstandort is located in the national GLP monitoring process and will be monitored for compliance with the GLP principles.
 
The above mentioned test facility/test site is included in the national GLP compliance programmes and is inspected on a regular basis.
On the basis of the inspection report is hereby declares that the above mentioned tests in compliance with the GLP principles can be performed in this test facility / this Prüfstandort.
 
Based on the inspection report it can be confirmed, that this test facility/test site is able to conduct the aforementioned studies in compliance with the principles of GLP.
Signature, date/signature, date (name and function of the responsible person / name and function of responsible person) (name and address of the GLP monitoring authority / name and address of the GLP monitoring authority)