Law on the protection of dangerous substances

Original Language Title: Gesetz zum Schutz vor gefährlichen Stoffen

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Law on the protection of dangerous substances (Chemicals Act-ChemG)

Unofficial table of contents

ChemG

Date of completion: 16.09.1980

Full quote:

" Chemicals Act in the version of the announcement dated 28 August 2013 (BGBl. 3498, 3991), which is provided by Article 431 of the Regulation of 31 August 2015 (BGBl. I p. 1474).

Status:	New by Bek. v. 28.8.2013 I 3498, 3991;
	Last amended by Art. 1 V v. 20.6.2014 I 824
Note:	Amendment by Art. 431 V v. 31.8.2015 I 1474 (No 35) not yet taken into account

For more details, please refer to the menu under Notes

1

The law is designed to implement the following guidelines:

-: Council 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 L 378, 27.9.1967, p. EC No 196 p. 1), as last amended by Directive 2013 /21/EU (OJ L 197, 21.7.2013, p. OJ L 158, 10.6.2013, p.240),
-: Council 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 the Directive) 89 /391/EEC) EC No 11), as last amended by Directive 2009 /148/EC (OJ L 327, 22.11.2009, p. OJ L 330, 16.12.2009, p.28),
-: 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 the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 346, 31.12.1999, p. EC No L 200 p. 1, 2002 No 71), as last amended by Directive 2013 /21/EU (OJ L 378, 27.4.2013, p. OJ L 158, 10.6.2013, p.240),
-: Directive 2004 /9/EC of the European Parliament and of the Council of 11 February 2004 concerning the inspection and verification of good laboratory practice (GLP) (codified version) (OJ L 327, 30.11.2004, p. EU No 28), as last amended by Regulation (EC) No 219/2009 (OJ L 327, 31.12.2009, p. OJ L 87, 31.3.2009, p.
-: 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 relating to the application of the principles of good laboratory practice and the control of their application in the case of experiments with Chemical substances (codified version) (OJ C 327, 28. EU No 44), as last amended by Regulation (EC) No 219/2009 (OJ L 327, 22.1.2009, p. 1 OJ L 87, 31.3.2009, p.

Footnote

(+ + + Text proof: 26.9.1980 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 EWGRL 548/67 (CELEX Nr: 31967L0548)   
 ERL 24/98 (CELEX Nr: 31998L0024) 
 EGRL 45/99 (CELEX Nr: 31999L0045) 
 ERL 9/2004 (CELEX Nr: 32004L0009) 
 ERL 10/2004 (CELEX Nr: 32004L0010)  Bek v. 28.8.2013 I 3498 + + +) 
  
(+ + + measures on the basis of the EinigVtr cf.  ChemG Annex EV; 
 No more to be used in accordance with the provisions.  Art. 1 No. 9 
 G v. 21.1.2013 I 91 mWv 29.1.2013 + + +)

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Content Summary

First section purpose, scope and definitions

§ 1	Purpose of the law
§ 2	Scope
§ 3	Definitions
§ 3a	Dangerous Substances and Dangerous Mixtures
Section 3b	(dropped)

Second implementation of the
Regulation (EC) No 1907/2006
and Regulation (EC) No 1272/2008

§ 4	Federal authorities involved
§ 5	Tasks of the Federal Agency for Chemicals
§ 6	Tasks of the assessment bodies
§ 7	Cooperation between the Federal Agency for Chemicals and the other Federal Supreme Authorities
§ 8	Free of charge of the national information centre
§ 9	Exchange of information between federal and state authorities
§ 10	Provisional measures
§ 11	(dropped)
§ 12	(dropped)

Section IIaImplementation of the
Regulation (EU) No 528/2012

§ 12a	Federal authorities involved
§ 12b	Tasks of the Federal Agency for Chemicals
§ 12c	Tasks of the assessment bodies
§ 12d	Cooperation between the Federal Agency for Chemicals and the other Federal Supreme Authorities
§ 12e	Information centre, information to the public
§ 12f	Exchange of information between federal and state authorities
§ 12g	Powers of the Federal Office for Chemicals, provisional measures
§ 12h	Regulation

Third classification,
Labelling and packaging

§ 13	Classification, labelling and packaging obligations
§ 14	Authorisation to adopt classification, labelling and packaging requirements
§ 15	(dropped)
Section 15a	(dropped)

Fourth section reporting obligations

§ § 16 to 16c	(dropped)
§ 16d	Participation obligations for mixtures
§ 16e	Communications for the information and treatment centres for poisoning
§ 16f	(dropped)

Fifth section empowerment to ban
and restrictions and
Measures to protect employees

§ 17	Prohibitions and restrictions
§ 18	Toxic animals and plants
§ 19	Measures to protect employees

Sixth Good Laboratory Practice

§ 19a	Good laboratory practice (GLP)
§ 19b	GLP certificate
§ 19c	Reporting
§ 19d	Supplementary provisions

Seventh section General provisions

§ 20	Application and notification documents, Regulation appropriations
§ 20a	(dropped)
§ 20b	Committees
Section 21	Monitoring
Section 21a	Participation of customs offices
Section 22	Information requirements
Section 23	Government orders
§ 24	Enforcement in the area of the Bundeswehr
Section 25	Approximation of Community law or Union law
Section 25a	Fees and expenses ²
Section 26	Fines
§ 27	Criminal provisions
§ 27a	Untrue GLP declarations, Erschleichen of the GLP certificate
§ 27b	Infringements of Regulation (EC) No 1907/2006
§ 27c	Infringements of discharge rules
§ 27d	Recovery

Eighth Section Final Provisions

§ 28	Transitional arrangements
§ 29	(external force)
§ 30	Berlin clause
Section 31	(Entry into force)

Annex 1	Principles of Good Laboratory Practice (GLP)
Annex 2	GLP certificate

2: In accordance with Article 4 (101) (1) in conjunction with Article 5 (3) of the Law of 7 August 2013 (BGBl. 3154) on 14 August 2018, in the table of contents, the statement on § 25a shall be taken as follows: "§ 25a expenses of the party responsible for providing information".

First section
Purpose, scope and definitions

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§ 1 Purpose of the Law

The purpose of the law is to protect people and the environment from the harmful effects of hazardous substances and mixtures, in particular to identify them, to prevent them and to prevent them from being developed. Unofficial table of contents

§ 2 Scope

(1) The provisions of the third section, § § 16e, 17 (1) No. 2 (a) and (b) and § 23 (2) do not apply to

1.: cosmetic products within the meaning of the Food and Feed Code and tobacco products within the meaning of the Provisional Tobacco Act,
2.: Medicinal products subject to an authorisation or registration procedure under the Medicines Act or under the Animal Health Act, as well as other medicinal products, in so far as they do not require approval pursuant to Section 21 (2) of the Medicines Act or in a packaging intended for distribution to the consumer,
2a.: Medical devices within the meaning of § 3 of the Medical Devices Act and their accessories. In the case of medical devices, the preparations as defined in 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 the Member States relating to the classification, Packaging and labelling of dangerous preparations (OJ EC No 1), the provisions of the third section shall apply, unless they are medical devices which are applied in an invasive way or subject to body contact,
3.: wastes for disposal within the meaning of § 3 (1) sentence 2, second half-sentence of the German Circular Economy Act,
4.: radioactive waste within the meaning of the Atomic Energy Act,
5.: Waste water as defined in the Waste Water Management Act, as far as it is discharged into water bodies or wastewater treatment plants.

(2) The provisions of the third and fourth sections, section 17 (1) (2) (a) and (b) and section 23 (2) do not apply to foods, individual feedingstuffs, compound feedingstuffs and feed additives in the sense of the food and food industry. Animal feed code. However, the provisions of the third section and § 16e shall apply to:

1.: foods not intended for direct human consumption by the consumer or the consumer within the meaning of Article 3 (4) of the Food and Feed Code, on the basis of their material properties, in unaltered form,
2.: Individual feedingstuffs and compound feedingstuffs intended to be fed in the prepared, processed or processed state, and for feed additives as defined in the Food and Feed Code.

(3) § § 16d and 23 (2) do not apply to substances and mixtures,

1.: which are intended exclusively for use as active substances in medicinal products subject to authorisation or registration in accordance with the Medicinal Products Act or the Animal Health Act or as active substances in medical devices according to § 3 (2) and (8) is to be used with No. 2 of the Medical Devices Act, or
2.: as far as they are subject to an authorisation procedure in accordance with plant-protection legislation.

Article 17 (1) no. 1 and 3 shall not apply to substances and mixtures as defined in the first sentence of sentence 1, point 2, in so far as appropriate regulations can be made pursuant to the Plant Protection Act. (4) The provisions of the Third Section and § § 16d, 17 and 23 shall apply to the Manufacture, placing on the market or use of substances or mixtures according to § 3a (1) (2) to (5) and (15), and products which may or may contain such substances or mixtures, only in so far as it is commercially available, within the limits of other economic activities or the employment of workers. This restriction shall not apply to:

1.

Arrangements and arrangements

a): on the transport of consumer goods,
b): on waste disposal and air pollution control,

2.

environmentally hazardous substances or mixtures when measures are taken to protect human health, and

3.

Biocidal active substances and biocidal products.

(5) The provisions of the First, Third and Fourth Section, Articles 17 and 18, and the provisions of the Seventh and Eighth Sections do not apply to the transport of dangerous goods by rail, road, inland waterway, sea and air transport, with the exception of intra-company transport. Unofficial table of contents

§ 3 Definitions

Within the meaning of this Act,

1.: Substance: chemical element and its compounds in natural form or obtained by a production process, including the additives necessary to maintain its stability and the impurities resulting from the process used, but with the exception of solvents, which can be separated from the substance without affecting its stability and without changing its composition;
2.: (dropped)
3.: (dropped)
3a.: (dropped)
4.: mixtures: mixtures or solutions consisting of two or more substances;
5.: ' product ' means a specific shape, surface or shape obtained during manufacture, which determines its function to a greater extent than the chemical composition;
6.: Classification: an association with a hazard characteristic;
7.: Manufacturer: a natural or legal person or an unlawfully association of persons who produces or obtains a substance, a mixture or a product;
8.: Importer: a natural or legal person or an unlawfully association of persons who spends a substance, a mixture or a product within the scope of that law; no importer is, who merely has a transit traffic shall be carried out under customs supervision, in so far as no working or processing is carried out;
9.: Placing on the market: the supply to third parties or the provision to third parties; the transfer to the scope of this Act shall be considered as placing on the market, in so far as it is not merely a transit traffic referred to in point 8, second half-sentence;
10.: Use: Used, consuming, storing, storing, working and processing, filling, refilling, mixing, removing, destroying and intra-company promotion;
11.: Biocidal product: a biocidal product within the meaning of Article 3 (1) (a) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and use of biocidal products (OJ L 136, 31.5.2012, p. 1). 1), as amended;
12.: Biocidal active substance: active substance within the meaning of Article 3 (1) (c) of Regulation (EU) No 528/2012.

Provisions of the terms set out in the first sentence shall remain unaffected in regulations of the European Community or of the European Union (EC or EU Regulations). Unofficial table of contents

§ 3a Hazardous substances and dangerous mixtures

(1) Hazardous substances or dangerous mixtures are substances or mixtures which:

1.: explosive,
2.: fire-promoting,
3.: highly flammable,
4.: highly flammable,
5.: flammable,
6.: very toxic,
7.: toxic,
8.: harmful,
9.: corrosive,
10.: irritant,
11.: sensitising,
12.: carcinogenic,
13.: toxic to reproduction,
14.: mutagenic or
15.: are dangerous for the environment;

(2) Environmental hazards are substances or mixtures which are themselves or whose transformation products are suitable, the nature of the natural balance, water, soil or air, climate, animals, (3) Dangerous for the purposes of this Act are also those substances and mixtures which are referred to in Article 3 of Regulation (EC) No 1291/11. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67 /548/EEC and 1999 /45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 327, 30.12.2006, p. 1), as last amended by Regulation (EU) No 286/2011 (OJ L 353, 31.12.2011, p. 1), as amended in each case, is dangerous without being able to be associated with any of the hazards referred to in paragraph 1. (4) The Federal Government is authorized to use the provisions of this Regulation by means of a legal regulation. Consent of the Bundesrat to enact detailed rules on the determination of the hazard characteristics referred to in paragraph 1. Unofficial table of contents

§ 3b (omitted)

Second section
Implementation of Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008

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§ 4 Parties to the Federal Authorities

(1) In the implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European the Chemicals Agency, amending Directive 1999 /45/EC and repealing Council Regulation (EEC) No 793/93, Commission Regulation (EC) No 1488/94, Council Directive 76 /769/EEC, and Directives 91 /155/EEC, 93 /67/EEC, 93 /105/EC and 2000 /21/EC (OJ L 136, 31.5.2000, p. EU No L 396 p. 1, 2007 No 3), as amended, and in the implementation of Regulation (EC) No 1272/2008, shall act in accordance with the provisions of this Section:

1.: The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin), which is subject to the supervision of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as the Federal Office for Chemicals,
2.: the Federal Environment Agency as the environmental assessment body,
3.: the Federal Institute for Risk Assessment, which is subject to the technical supervision of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as an assessment body for health and consumer protection, and
4.: The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin), which is subject to the supervision of the Federal Ministry of Labour and Social Affairs, as an assessment body for safety and health protection of employees.

(2) In individual cases, the Federal Agency for Chemicals shall take part in additional federal authorities, provided that these special expertise on individual aspects of the evaluation of substances, mixtures or products for the purposes of Regulation (EC) No 1907/2006 and of Regulation (EC) No 1272/2008, and the question in question cannot be finally assessed by the authorities referred to in paragraph 1. Unofficial table of contents

§ 5 Tasks of the Federal Office for Chemicals

(1) In the case of the implementation of Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008, the following tasks shall in particular apply as a joint action in accordance with Article 21 (2) sentence 2, for which the Federal Office of Chemicals is responsible:

1.: Opinions on the draft decisions of the European Chemicals Agency pursuant to the second sentence of Article 9 (8) of Regulation (EC) No 1907/2006,
2.: the tasks of the competent authority of the Member State in the evaluation referred to in Title VI of Regulation (EC) No 1907/2006,
3.: the participation in the identification of the substances referred to in Article 57 in accordance with Article 59 (3) and (5) of Regulation (EC) No 1907/2006,
4.: participation in the harmonised classification and labelling referred to in Article 37 (1), including in conjunction with paragraph 6, of Regulation (EC) No 1272/2008.

(2) In addition to the tasks otherwise assigned to it by this Act, the Federal Office of Chemicals shall also carry out the following tasks in the implementation of Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008:

1.: Preparation of dossiers for the initiation of restriction procedures pursuant to Article 69 (4) of Regulation (EC) No 1907/2006,
2.: preparation of proposals to review existing restrictions under the third sentence of Article 69 (5) 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 the questions to be assessed in the committees and in 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 Regulation (EC) No 1907/2006, and cooperation with the competent authorities of others Member States referred to in Article 43 of Regulation (EC) No 1272/2008,
5.: information to the public under Article 123 of Regulation (EC) No 1907/2006 on risks related to substances,
6.: Transmission, in accordance with Article 124 (1) of Regulation (EC) No 1907/2006, of all information available to it on registered substances whose registration dossiers do not contain all the information referred to in Annex VII to Regulation (EC) No 1907/2006, to the European Chemicals Agency,
7.: the functioning of the national information office referred to in Article 124 (2) of Regulation (EC) No 1907/2006 and the national information office referred to in Article 44 of Regulation (EC) No 1272/2008;
8.: Advice to the Federal Government in all of the matters relating to Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 and matters concerning its development.

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§ 6 Tasks of the evaluation bodies

(1) The assessment bodies shall support the Federal Agency for Chemicals in their tasks pursuant to Article 5 (1) (2) to (4) and (2) (2) (1) to (3) by the responsible and final implementation of their respective duties. Responsibility for evaluation tasks. In the case of the tasks of the Federal Agency for Chemicals in accordance with Article 5 (1) (1) (1) and (2) (4) to (8), they shall act on matters relating to their respective fields of competence The evaluation bodies shall support each other through expert opinions, provided that this is necessary for the performance of their tasks. (2) Environmental risk assessment shall be the responsibility of the assessment body for the environment. including the assessment of risk mitigation actions. (3) The health and consumer protection assessment body's expertise is health-related risk assessment, including the assessment of Risk reduction measures. (4) Specialresponsibility of the assessment body Occupational safety and health protection is the risk assessment, including the assessment of risk mitigation measures. Unofficial table of contents

Section 7 Cooperation of the Federal Agency for Chemicals and the other Federal Supreme Authorities involved

(1) The Federal Agency for Chemicals coordinates the interaction of the federal authorities referred to in § 4 and has an effect on the consistency and freedom of appeal of the overall position. It decides on the overall position, provided that, in the individual case, its conclusiveness and freedom of appeal cannot be achieved in a different way and the delivery of an opinion does not tolerate a postponing. Decisions in accordance with the second sentence in which the Federal Office for Chemicals deviates from the evaluation of an assessment body in accordance with the first sentence of Article 6 (1) requires an in-depth justification to make the assessment bodies active and to forward the assessment bodies to the evaluation bodies. (2) The Federal Agency for Chemicals represents the overall position to the outside world. In doing so, it shall add representatives of the other federal authorities involved in support, provided that they consider it necessary or require them. Unofficial table of contents

§ 8 Freedom of charge of the national information centre

The Federal Agency for Chemicals shall not charge any fees for its activities as a national information point pursuant to Article 124 (2) of Regulation (EC) No 1907/2006 and in Article 44 of Regulation (EC) No 1272/2008. Unofficial table of contents

§ 9 Exchange of information between federal and state authorities

(1) The Federal Chemicals Agency shall inform the competent authorities of the competent authorities, in particular by means of communications from the European Chemicals Agency.

1.: process-oriented research and development as referred to in the third sentence of Article 9 (3) and draft decisions pursuant to the first sentence of Article 9 (8) of Regulation (EC) No 1907/2006,
2.: substances registered as registered in accordance with the second sentence of Article 16 (1) of Regulation (EC) No 1907/2006,
3.: registration dossiers referred to in Article 20 (4), first, fourth and fifth sentences, and in accordance with the second sentence of Article 22 (1) and the second sentence of Article 22 (2) of Regulation (EC) No 1907/2006,
4.: the dose assessment referred to in Article 41 (2), the first sentence of Article 42 (2) and Article 43 (3) and the follow-up to the substance assessment referred to in the third sentence of Article 48 of Regulation (EC) No 1907/2006,
5.: the examination of intermediate products in other Member States in accordance with the fourth sentence of Article 49 of Regulation (EC) No 1907/2006,
6.: the cessation of production, importation or production in accordance with the second sentence of Article 50 (2) and the third sentence of paragraph 3 of Regulation (EC) No 1907/2006,
7.: the determination of the substances referred to in Article 57 in accordance with the third sentence of Article 59 (2) and the first sentence of Article 59 (3) and the authorisation procedure referred to in Articles 64 (5), 4 and 7 of Regulation (EC) No 1907/2006,
8.: the result of requests for the use of an alternative chemical name in accordance with Article 24 (5) of Regulation (EC) No 1272/2008.

(2) The competent national authorities shall inform the Federal Agency for Chemicals, in particular:

1.: knowledge of the use of isolated intermediates from which a risk to human health or the environment may arise in accordance with Article 49 of Regulation (EC) No 1907/2006,
2.: findings obtained in the context of enforcement and surveillance activities within the meaning of the first sentence of Article 124 (1) of Regulation (EC) No 1907/2006, which result in a suspicion of risk,
3.: the provisional measures referred to in Article 23 (2) shall be arranged on presentation of the documents required pursuant to Article 129 (1) of Regulation (EC) No 1907/2006 or Article 52 (1) of Regulation (EC) No 1272/2008.

(3) § 22 shall remain unaffected. Unofficial table of contents

Section 10 Preliminary measures

(1) Where a provisional measure within the meaning of Article 129 of Regulation (EC) No 1907/2006 or in the meaning of Article 52 of Regulation (EC) No 1272/2008 has been adopted on the basis of this Act, the Federal Office for Chemicals shall inform the without delay, the European Commission and the other Member States of the European Union, stating the reasons for the decision taken, and shall provide the scientific or technical information on which this provisional measure is taken (2) The Federal Office of Chemicals shall inform the competent authorities of the National authorities concerning the decision of the European Commission pursuant to Article 129 (2) of Regulation (EC) No 1907/2006 or in Article 52 (2) of Regulation (EC) No 1272/2008. Unofficial table of contents

§ 11 (omitted)

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§ 12 (omitted)

Section IIa
Implementation of Regulation (EU) No 528/2012

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Section 12a Federal authorities

(1) In the implementation of Regulation (EU) No 528/2012, the bodies referred to in Article 4 (1) shall act in accordance with this section. The Federal Institute for Risk Assessment as the Evaluation Centre for Health and Consumer Protection is subject to the supervision of the Federal Ministry of Food, Agriculture and Consumer Protection. (2) Insofar as in § 4 (1) (2) to (4) of the German Federal Ministry of Food and Consumer Protection ( authorities, the Julius Kühn Institute, the Federal Institute for Materials Research and Testing, or the Robert Koch Institute, have special expertise to assess the efficacy and the unacceptable effects on target organisms, The Federal Office of Chemicals may decide on the If the conditions for admission are met in accordance with Article 19 (1) (b) (i) and (ii) of Regulation (EU) No 528/2012, these authorities shall be required to submit an opinion. In addition, the Federal Agency for Chemicals shall participate in the evaluation of the dangerous properties within the meaning of Article 3a (1) (1) (1) to (5) and the resistance of containers and packaging materials to the Federal Agency for Materials Research and Testing, provided that the Federal Institute for Materials Research and Testing has special expertise in the case in question on the basis of further legal competence and the question in question is not available from the Federal Office for Chemicals (3) By way of derogation from paragraph 1, the following shall be taken into account: The granting, renewal, review and waiver of exceptional authorisations referred to in Article 55 (1) of Regulation (EU) No 528/2012, including the instigation of the Commission procedures referred to it, shall be responsible for the following authorities:

1.

the Robert Koch Institute in relation to biocidal products, which must be used in the case of decontamination according to § 18 of the Infection Protection Act,

2.

the Federal Office of Consumer Protection and Food Safety in relation to biocidal products, which

a): In accordance with § 18 of the Infection Protection Act in the event of deforestation and in the case of measures for the control of vertebrate animals, which can be used to spread pathogens, the use of such animals must be used or
b): According to § 17f of the Animal Health Act, disinfection and deforestation prescribed by animal health law may be used.

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Section 12b Tasks of the Federal Office for Chemicals

(1) In the implementation of Regulation (EU) No 528/2012, the following tasks shall in particular apply as co-acts in accordance with Article 21 (2) sentence 2:

1.

the tasks of the evaluating competent authority

a): in the case of the approval of an active substance and the renewal and review of the approval of an active substance in accordance with Chapters II, III and XI of Regulation (EU) No 528/2012,
b): in the case of the granting and renewal and the repeal, review and amendment of Union authorisations in accordance with Chapters VIII and IX of Regulation (EU) No 528/2012,

2.

the participation in the work programme for the systematic examination of all existing active substances in accordance with Article 89 (1) of Regulation (EU) No 528/2012,

3.

the participation in the coordination group referred to in Article 35 and in the Committee on Biocidal Products in accordance with Article 75 of Regulation (EU) No 528/2012.

(2) In addition to the tasks otherwise assigned to it by this Act, the Federal Agency for Chemicals shall also carry out the following tasks in the implementation of Regulation (EU) No 528/2012:

1.: the submission of applications to the Commission in accordance with Article 3 (3) and the first subparagraph of Article 15 (1) of Regulation (EU) No 528/2012;
2.: the tasks of the evaluating competent authority under the simplified authorisation procedure referred to in Article 26, including in conjunction with Chapter IX, of Regulation (EU) No 528/2012,
3.: the receipt of information to the marketing authorisation holder in accordance with the second sentence of Article 27 (1) and the exercise of the powers of the Member State in accordance with Article 27 (2) and the first subparagraph of Article 28 (4) of Regulation (EU) No 528/2012,
4.: the tasks of the competent authority concerned in the granting, renewal and review of national authorisations under Chapter VI, including in conjunction with Chapter IX, 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 referred to in Chapter VII, including in conjunction with Chapter IX, and the exercise of the powers of the Member State in accordance with Article 37 of Regulation (EU) No 528/2012,
6.: the submission of applications to the Commission in accordance with the second subparagraph of Article 44 (5) of Regulation (EU) No 528/2012;
7.: the tasks of the competent authority of the importing Member State with regard to parallel trade in Chapter X of Regulation (EU) No 528/2012,
8.: the granting, renewal, review and waiver of exceptional authorisations referred to in Article 55 of Regulation (EU) No 528/2012, including the application of the Commission procedures referred to in Article 12a (3) of this Regulation, authorities are responsible,
9.: the tasks of the competent authority of the Member State in accordance with Article 56 of Regulation (EU) No 528/2012;
10.: the advice of the Federal Government in all matters relating to Regulation (EU) No 528/2012 and its development.

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Section 12c Tasks of the evaluation bodies

(1) The assessment bodies shall assist the Federal Agency for Chemicals in carrying out their tasks in accordance with Articles 12b (1) and 2 (1) to (9) by the self-responsible and final implementation of their respective areas of competence. Evaluation tasks. They shall also have an effect on matters relating to their respective fields of competence. The evaluation bodies shall support each other through expert opinions, provided that this is necessary for the performance of their tasks. (2) Environmental risk assessment shall be the responsibility of the assessment body for the environment. including the assessment of risk mitigation measures. (3) The assessment body's expertise is health and consumer protection.

1.: the risk assessment in relation to human and home and farm animal health, including the assessment of risk mitigation measures, and
2.: the drawing up of proposals for the setting of maximum residue limits in accordance with Article 19 (1) (e) of Regulation (EU) No 528/2012.

(4) The competence of the Evaluation Centre for Safety and Health of Employees is the risk assessment in relation to occupational safety and health, including the assessment of risk mitigation measures. Unofficial table of contents

§ 12d Cooperation of the Federal Agency for Chemicals and the other Federal Supreme Authorities involved

(1) The Federal Agency for Chemicals coordinates the interaction of the federal authorities referred to in § 12a and acts on the consistency and the freedom of appeal of the decisions and opinions as a whole. (2) Insofar as the Federal Office for In the context of its activities in accordance with § 12b, chemicals must be assessed in accordance with the requirements of Article 19 (1) of Regulation (EU) No 528/2012, it shall decide on the conditions

1.: in accordance with Article 19 (1) (b) (iv) of Regulation (EU) No 528/2012, in agreement with the Environment Evaluation Centre,
2.: in accordance with Article 19 (1) (b) (iii) of Regulation (EU) No 528/2012 as regards the effects on the health of employees, in agreement with the assessment body for the safety and health of workers; and
3.: in accordance with Article 19 (1) (b) (iii) of Regulation (EU) No 528/2012, also in conjunction with Article 19 (1) (e) of Regulation (EU) No 528/2012 as regards a proposal for the establishment of maximum residue levels for food or feed, in agreement with the health and consumer protection assessment body.

The Federal Agency for Chemicals shall also decide, in agreement with the evaluation bodies, in so far as their area of responsibility is concerned in accordance with Section 12c (2) to (4) above, on:

1.: the need for risk reduction measures;
2.: the existence of the admission requirements referred to in Article 19 (5) of Regulation (EU) No 528/2012,
3.: the result of a comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012,
4.: the granting of an authorisation in accordance with Article 26 (3) of Regulation (EU) No 528/2012,
5.: Derogations provided for in Article 55 of Regulation (EU) No 528/2012, except where the authorities referred to in Article 12a (3) are competent, and
6.: Opinions and decisions referred to in the second subparagraph of Article 56 (2) and (3) of Regulation (EU) No 528/2012.

(3) With the exception of the cases referred to in paragraph 4, the Federal Office of Chemicals shall represent the total position to the outside. It shall add to the assistance of the other federal authorities involved, if it considers it necessary or require them. (4) Decisions of the federal supervisors referred to in Article 12a (3) on authorisations under Article 55 Paragraph 1 of Regulation (EU) No 528/2012 shall be represented by the external authority, each of which shall be responsible for the decision. That authority shall immediately inform the Federal Agency for Chemicals of the start of the relevant decision-making procedures and of the measures taken by it. Unofficial table of contents

§ 12e Information centre, information to the public

(1) The Federal Agency for Chemicals shall establish an information point for the performance of the tasks referred to in Article 81 (2) of Regulation (EU) No 528/2012. The information centre shall be connected to the information centre in accordance with Section 5 (2) (7). § 8 shall apply accordingly. (2) The Federal Agency for Chemicals shall inform the public, in accordance with the third subparagraph of Article 17 (5) of Regulation (EU) No 528/2012, of:

1.: Use and risk 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 means of minimising the use of biocidal products; and
3.: the competent, orderly and sustainable use of biocidal products.

(3) The other federal authorities referred to in § 12a shall support the Federal Agency for Chemicals in the performance of the tasks referred to in paragraphs 1 and 2. Unofficial table of contents

§ 12f Exchange of information between federal and state authorities

(1) The Federal Agency for Chemicals shall inform the competent national authorities, in particular, of:

1.

the following decisions taken or received by the Commission:

a): Notifications pursuant to the first sentence of Article 17 (6) and the second sentence of Article 27 (1) of Regulation (EU) No 528/2012,
b): Measures referred to in the second subparagraph of Article 27 (2) of Regulation (EU) No 528/2012,
c): the granting, renewal or annulment of a national authorisation under Chapter VI of Regulation (EU) No 528/2012,
d): the recognition of an authorisation under Chapter VII of Regulation (EU) No 528/2012,
e): the granting or termination of a parallel trade permit referred to in Chapter X of Regulation (EU) No 528/2012;
f): the granting of exceptional authorisations under Article 55 of Regulation (EU) No 528/2012;
g): the submission of experiments or experiments or the issue of conditions laid down in Article 56 (3) of Regulation (EU) No 528/2012,
h): Arrangements in accordance with Article 12g (1), first sentence, and (3),

2.

Communications from the European Chemicals Agency on the following decisions taken by the European Commission or the European Commission or received notifications:

a): the adoption or rejection of an application for approval or renewal of the approval of an active substance and the outcome of the authorisation procedure under Chapters II and III of Regulation (EU) No 528/2012,
b): the adoption or rejection of an application for the granting, renewal or annulment of a Union authorisation for a biocidal product and the outcome of the authorisation procedure, and
c): Notifications pursuant to the third sentence of Article 17 (6) of Regulation (EU) No 528/2012.

(2) The federal authorities referred to in Article 12a (3) shall inform the competent national authorities of their decisions and of the Commission's renewal decisions in accordance with Article 55 (1) of Regulation (EU) No 528 /2012. (3) competent authorities shall inform the Federal Agency for Chemicals, in particular:

1.: findings obtained in the context of enforcement and surveillance activities which are relevant to decisions taken pursuant to Article 27 (2), Article 48 (1) or Article 56 (3) of Regulation (EU) No 528/2012 or Article 12g (1) sentence 1 can be
2.: Surveillance measures in accordance with Article 12g (1) sentence 3,
3.: the arrangement of provisional measures in accordance with Article 23 (2) on presentation of the documents required under the second sentence of Article 88 (1) of Regulation (EU) No 528/2012.

(4) The information referred to in paragraphs 1 to 3 shall also include information as to whether the appeal has been filed and the outcome to which it has resulted. (5) § 22 shall remain unaffected. Unofficial table of contents

§ 12g Regulatory Powers of the Federal Agency for Chemicals, provisional measures

(1) There are justifiable reasons on the basis of new facts on the assumption that a biocidal product, although authorised in accordance with Regulation (EU) No 528/2012, nevertheless poses a direct or long-term serious risk to the Health of humans or animals, in particular for vulnerable groups, or for the environment, the Federal Office of Chemicals may, in agreement with the evaluation bodies, take appropriate provisional measures, in particular: Provision of the biocidal product on the market within the meaning of Article 3 (1) (i) of the Regulation (EU) No 528/2012 provisionally prohibit or subject to compliance with certain conditions. Appeals against orders in accordance with the first sentence do not have suspensive effect. The orders of the Federal Office for Chemicals in accordance with the first sentence shall be enforced by the competent authority in each case in accordance with the relevant national law on the administrative enforcement procedure. Article 23 (2) remains unaffected. (2) For the decision-making procedure under Article 88 of Regulation (EU) No 528/2012, provisional measures adopted on the basis of paragraph 1 or other provisions of this Act shall be without prejudice to the decision-making procedure in accordance with Article 88 of Regulation (EU) No 528/ (3) The Federal Office for Chemicals may, in agreement with the assessment bodies, authorise a biocidal product for essential uses as referred to in Article 5 (1) of Regulation (EC) No 1451/2007 of Commission of 4 December 2007 on the second phase of the Ten-Year Work Programme pursuant to Article 16 (2) of Directive 98 /8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 327, 30.4.1998, 3), as amended by Commission Regulation (EU) No 298/2010 of 9 April 2010 (OJ L 327, 22.12.2010, p. 4), provided that the European Commission for the biocidal active substance concerned a decision pursuant to Article 5 (3) of Regulation (EC) No 1451/2007, including in conjunction with Article 89 (1) of Regulation (EC) No 1451/2007. (EU) No 528/2012, and the conditions laid down therein are met. Unofficial table of contents

§ 12h Regulation authorisations

(1) The Federal Government is authorized to the extent permitted by law, with the consent of the Federal Council, to the conditions, content and procedures of the decisions or acts of participation of the federal authorities referred to in § 12a in the case of the Federal Supreme Authorities. to lay down, in particular, the rules for the implementation of Regulation (EU) No 528/2012,

1.

that certain biocidal products

a): are not eligible for authorisation, or
b): may be authorised only for specific uses, uses or places of use, for the submission to specific user groups or under certain other restrictions,

2.

that certain substantive or procedural requirements must be complied with in the case of:

a): the application for and the granting of exceptional authorisations under Article 55 of Regulation (EU) No 528/2012; and
b): The notification and regulatory examination of experiments and trials pursuant to Article 56 of Regulation (EU) No 528/2012.

(2) The Federal Government is also empowered to define, in particular to determine measures for the sustainable use of biocidal products by means of a regulation with the consent of the Federal Council,

1.: that equipment used for the use of biocidal products is subject to certain control procedures;
2.: how the nature and extent of the use of biocidal products can be effectively identified; this may also include the introduction of notification obligations on the quantities of biocidal products placed on the market and used, and the establishment of framework conditions for a nationwide monitoring programme,
3.: that, and in what form, persons who have been involved in the treatment or evaluation of acute and chronic cases of poisoning of non-target organisms by biocidal products, the Federal Agency for Chemicals or any other appropriate Federal authority to report such cases.

Third Section
Classification, labelling and packaging

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Section 13 Classification, labelling and packaging obligations

(1) The classification, labelling and packaging of substances and mixtures shall be governed by the provisions of Regulation (EC) No 1272 /2008. (2) Anyone who places substances or mixtures on the market as a manufacturer or importer shall have them in accordance with the provisions of Regulation (EC) No 1272 /2007/EC. To be classified in accordance with § 14, to the extent that:

1.: in accordance with the transitional provisions of Article 61 of Regulation (EC) No 1272/2008, it shall apply the provisions laid down by Directive 67 /548/EEC or Directive 1999 /45/EC, or
2.: contains the legal regulation in accordance with § 14 regulations, which go beyond the requirements of Regulation (EC) No 1272/2008.

(3) Anyone who places substances or mixtures on the market as a supplier within the meaning of Article 2 (26) of Regulation (EC) No 1272/2008 has to label and package these substances in accordance with the legal regulation according to § 14, to the extent that:

1.: in accordance with the transitional provisions of Article 61 of Regulation (EC) No 1272/2008, it shall apply or apply the provisions laid down by Directive 67 /548/EEC or Directive 1999 /45/EC, or
2.: contains the legal regulation in accordance with § 14 regulations, which go beyond the requirements of Regulation (EC) No 1272/2008.

In the performance of the obligations set out in the first sentence, suppliers who are not themselves obliged to classify the substance or mixture as referred to in paragraph 2 may be based on the classification of the manufacturer or importer, provided that they are not classified by the suppliers of the supplier. (4) Further requirements relating to labelling and packaging in accordance with other legislation remain unaffected. Unofficial table of contents

Section 14 authorizing classification, labelling and packaging requirements

(1) The Federal Government is empowered to do so by means of a regulation with the consent of the Federal Council

1.

to classify substances or mixtures as dangerous,

2.

to prescribe the calculation methods according to which certain mixtures are to be classified on the basis of the classification of those substances contained in the mixture,

3.

to determine

a): , such as dangerous substances and mixtures, and that, and how certain products which may release or contain certain dangerous substances or mixtures are to be packaged or labelled in order to avoid risks to life in the foreseeable use and the health of humans and the environment,
b): and how certain information on dangerous substances and mixtures or products which may release or contain dangerous substances and mixtures, including recommendations on precautionary measures in use or on emergency measures, shall be accidents from the person who places the substances, mixtures or products on the market, in particular in the form of a safety data sheet or instructions for use, must be supplied and kept up-to-date,
c): the minimum requirements to be taken into account by the manufacturer or importer in the classification of the substances in accordance with Article 13 (2),
d): the packaging and labelling of dangerous substances, mixtures or products, if they have been placed on the market before the entry into force of the Regulation on the labelling or packaging requirements,
e): that, and how certain mixtures and products which do not contain certain dangerous substances to be identified are to be labelled or labelled, and
f): that and by whom the labelling of certain substances, mixtures or products shall be preserved or re-affixed after they have been placed on the market.

(2) The legal regulation referred to in paragraph 1 may also provide for exemptions from the obligation of packaging and labelling, insofar as this does not affect the protection for protection referred to in paragraph 1 (3) (a). The Regulation may also specify that, instead of labelling, the relevant information must be supplied in a different appropriate manner. (3) Rules referred to in paragraphs 1 and 2 may also be used for biocidal active substances and biocidal products, which are not dangerous substances or mixtures within the meaning of § 3a, as well as for substances, mixtures and products according to § 19 (2). Unofficial table of contents

§ 15 (omitted)

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§ 15a (omitted)

Fourth Section
Participation obligations

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Section 16d Obligations to participate in mixtures

(1) The Federal Government shall be authorized, by means of a regulation with the consent of the Federal Council, for the purpose of identifying hazards which may arise from mixtures, as well as the nature and extent of the use of dangerous substances in mixtures. to require manufacturers, importer or users of certain mixtures to:

1.: the description of these mixtures and their trade names;
2.: the labelling thereof,
3.: information on the composition of these mixtures,
4.: the quantity of these mixtures produced, imported or used annually;
5.: whose areas of use,
6.: Verifiable verifications under Regulation (EC) No 440/2008 which are available to it or at a reasonable cost, in so far as they are necessary for the identification of dangerous properties of these mixtures which are not obtained by means of the provisions of this Act, or shall determine the calculation procedures prescribed by this law, and
7.: the contents of security data sheets

inform the Federal Office of Chemicals in writing within a reasonable period of time if there is evidence, in particular a suspicion based on the state of the scientific findings, that harmful substances are harmful to these mixtures. (2) The obligation to provide information may be limited to certain information on the composition, made subject to the quantity produced, imported or used, and may be subject to subsequent changes in the The composition is extended. In the regulation, provisions must be made to ensure that the confidentiality of the information provided is to be ensured and, as requested by the person responsible for the notification, the information provided. Unofficial table of contents

Section 16e Communications for the information and treatment centres for poisoning

(1) Anyone who places a dangerous mixture or a biocidal product on the market as a manufacturer or importer or by using a trade name of its own has the Federal Institute for Risk Assessment

1.: the trade name,
2.: information on the composition,
3.: the marking,
4.: Instructions for use,
5.: Recommendations on precautions for use and emergency measures in the event of accidents

, as well as any subsequent change to this information, which may be of importance for the treatment of diseases which may result from the effects of its mixture or of its biocidal product. The notification shall not be required to the extent that the information provided for in the first sentence has already been submitted to the Federal Institute for Risk Assessment. The notification shall be made prior to the initial placing on the market or the entry of the change. (2) Any person who is involved as a doctor for treatment or for assessing the consequences of a condition at least suspected of being on the market Effects of dangerous substances, dangerous mixtures, of products which release or contain dangerous substances or mixtures, or of biocidal products, the Federal Institute for Risk Assessment shall have the substance or mixture, age and sex of the patient, the route of exposure, the quantity received and the to be informed. The notification shall be made in anonymized form with regard to the person of the patient. § 8 Paragraph 1, point 1, second half-sentence of the Infection Protection Act of 20 July 2000 (BGBl. 1045) shall apply accordingly. Sentence 1 shall not apply in so far as these data are to be transmitted to a institution of the statutory accident insurance; the latter shall forward the information in accordance with sentence 1 to the Federal Institute for Risk Assessment. (3) The Federal Institute for Risk Assessment , the information referred to in paragraph 1, including those provided for by other legislation, shall transmit to it the medical facilities to be recorded by the countries, the findings on the health effects collect and evaluate dangerous substances or mixtures of dangerous substances and (information and treatment centres for poisoning) by providing advice and treatment. The bodies designated in accordance with the first sentence shall report to the Federal Institute for Risk Assessment on the findings of their activities, which are of general importance for the consultation and treatment of substances-related diseases. (4) The information provided for in Paragraphs 1 and 2 shall be treated as confidential. The information referred to in paragraph 1 may only be used to:

1.: Respond to requests for medical content with the indication of preventive and curative measures, in particular in emergencies, or
2.: identify the need for improved risk management measures on the basis of a statistical analysis, at the request of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety.

(5) The Federal Government is empowered to do so by means of a regulation with the consent of the Federal Council

1.

to extend the obligations referred to in paragraph 3 also to other bodies whose task is to respond to requests for medical content with the indication of preventive and curative measures;

2.

a): extend the obligation to provide information, in accordance with paragraph 1, also to substances and to other mixtures which may cause adverse effects on human beings,
b): extend the notification requirement referred to in paragraph 1 to products which can reasonably release dangerous substances or mixtures which may cause adverse effects on human beings where the knowledge of the substances, mixtures or mixtures thereof is likely to be products intended for the information and treatment centres for poisoning or for the bodies designated in accordance with point 1 in order to carry out the tasks assigned to them,
c): , if it is compatible with the protective purpose of this provision and is permitted under European Union law, certain mixtures should be exempted from the obligation to provide a notification in accordance with paragraph 1; and

3.

detailed rules on the nature and extent of the information referred to in paragraph 1 and the information requirements referred to in paragraphs 2 and 3, as well as the confidential treatment and the earmarking referred to in paragraph 4, shall be taken.

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§ 16f (omitted)

Fifth Section
Authorizing prohibitions and restrictions as well as measures to protect employees

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Section 17 Bans and Restrictions

(1) The Federal Government is authorized, after consulting the parties concerned, by means of a legal regulation with the consent of the Bundesrat, insofar as it is necessary for the purpose specified in § 1 and permissible under European Union law.

1.

to require certain dangerous substances, certain dangerous mixtures or products which may or may contain such a substance or mixture,

a): not to be produced, placed on the market or used for certain purposes only, or only for a particular purpose,
b): can only be used in a specific way or
c): may only be submitted under certain conditions or only to certain persons,

2.

require the placing on the market or use of certain dangerous substances, certain dangerous mixtures or products which may or may contain or contain such a substance or mixture,

a): to indicate this,
b): requires permission to do so,
c): needs to meet certain requirements for its reliability and health, or
d): to prove its expertise in a procedure to be defined in more detail,

3.

prohibit the production or use procedures for which certain dangerous substances are produced.

(2) The Regulation referred to in paragraph 1 may also include prohibitions and restrictions, taking into account the development of substances, mixtures, products or processes, their production, use, disposal or use with a lower risk to (3) paragraph 1 shall also apply to biocidal active substances and biocidal products which are non-hazardous substances or mixtures within the meaning of § 3a, for substances, mixtures and products in accordance with Article 19 (2) and for Substances, mixtures or products whose transformation products are dangerous in the sense of § § 3a (1) (1) to (14). The Regulation referred to in paragraph 1, in conjunction with the first sentence, may also lay down rules for good professional practice in the use of biocidal products. (4) Paragraph 1 (1) (1) and (2) shall also apply to such substances, mixtures or products, (5) The Federal Government may, in accordance with the provisions of the law of the Federal Republic of Germany, be responsible for the substance, mixture or product being dangerous. 1 also rules on procedures and methods for verifying their compliance . In particular, it is also possible to regulate the removal of samples and the methods to be used for this and the analytical methods required for the determination of individual substances or groups of substances. (6) In the case of danger in the case of danger, the The Federal Government shall issue a regulation pursuant to paragraph 1 (1) (1) and (3) without the consent of the Federal Council and without consulting the parties concerned. It shall not enter into force no later than 12 months after its entry into force. Its duration can only be extended with the approval of the Federal Council. (7) The parties concerned shall consist of representatives of the scientific community, consumer protection associations, trade unions and professional cooperatives, to be selected in each case, the the economy, health care and environmental, animal welfare and nature conservation organisations involved. Unofficial table of contents

§ 18 Gifty animals and plants

(1) The Federal Government shall be authorized, in so far as it is necessary for the protection of human life or health, taking into account the interests of nature and animal protection, to prescribe, with the consent of the Federal Council, by means of a decree-law, that instances

1.

of certain toxic animal species

a): should not be introduced or held,
b): may only be introduced or held if appropriate remedies and recommendations for treatment are provided by the importer or keeper of the animal, or
c): may only be imported or held if this is indicated previously by the competent authority,

2.

of certain toxic plant species

a): not planted on certain areas, or
b): in catalogues and lists of goods may only be offered with a reference to their toxicity.

The permit referred to in point 1 (b) and (c) of the first sentence of the first sentence may be subject to conditions. (2) Paragraph 1 (1) shall apply mutatily to dead specimens of toxic species or to parts thereof. Paragraph 1 (2) (b) shall apply mutas to poisonous seeds, toxic plant and propagating material and dead specimens or parts of toxic plant species. (3) § 17 (1) (1) and (2) (c) and (d) shall apply mutas to the provisions of paragraph 2 In the case of animal bodies or parts thereof referred to in paragraph 1 as well as for certain types of toxic semen and dead specimens or parts of toxic plant species. Unofficial table of contents

Section 19 Measures for the protection of employees

(1) The Federal Government is empowered to do so by means of a regulation with the consent of the Federal Council, insofar as it is to protect the life and health of the human being, including the protection of the labour force and the humane design of the work. in the case of the production and use of substances, mixtures and products, and in the case of activities in the field of danger, the measures referred to in paragraph 3 shall be required. Sentence 1 shall not apply to measures pursuant to paragraph 3, to the extent that the relevant provisions are in accordance with the Atomic Energy Act, the Federal Immission Control Act, the Plant Protection Act or the Explosives Act. (2) Dangerous substances within the meaning of this provision are

1.: dangerous substances and mixtures according to Article 3a (1),
2.: substances, mixtures and products which are explosive,
3.: substances, mixtures and products from which substances as referred to in point 1 or 2 are produced or are released during the manufacture or use of the substances,
4.: Substances and mixtures which do not meet the criteria set out in points 1 to 3, but because of their physical-chemical, chemical or toxic properties and the manner in which they exist or are used in the workplace, the the health and safety of workers,
5.: all substances to which a workplace limit value is assigned within the meaning of the regulation referred to in paragraph 1.

(3) The regulation referred to in paragraph 1 may in particular be used to determine:

1.

the person concerned with the manufacture or use of substances, mixtures or products has to determine whether the intended manufacture or use is a hazardous substance, unless it is already in the classification has been carried out in accordance with the provisions of the third section,

2.

that the person concerned with the production or use of dangerous substances shall be required to consider whether substances, mixtures or products or methods of production or use are at a lower risk for human consumption; health is available and is intended to use or has to be used, as far as it is reasonable to do so,

2a.

the manufacturer or importer shall, at the request of the employer, provide the employer with the dangerous substances of the dangerous substances and the valid limit values and, if they do not already exist, recommendations for the substance concentrations to be observed and those of the substances which are to be observed by the the risk posed by hazardous substances or the measures to be taken,

3.

how the workplace, including the technical equipment, the technical equipment and the working methods, must be designed, set up or operated in order to enable them to take account of the state of the art, occupational health and hygiene, and the comply with safety, occupational health, hygiene and other scientific knowledge, which must be taken into account in order to protect employees;

4.

how the operation must be regulated, in particular:

a): that substances and mixtures are designated and that they must be packaged, labelled and recorded in an intra-company manner in order to ensure that workers are not put at risk by unsuitable packaging and that they are identified by means of labelling be informed of the risks,
b): how the manufacturing or use procedure must be designed to ensure that employees are not at risk and that the limit values or guidelines on the concentration of dangerous substances or mixtures in the workplace are in accordance with the state of the art below,
c): what arrangements need to be made to ensure that hazardous substances do not reach the hands of unauthorised persons or are otherwise affected,
d): which personal protective equipment must be made available and used by the employees in accordance with the intended purpose,
e): how the number of workers exposed to hazardous substances must be restricted and how the duration of such employment must be limited,
f): how employees must behave so that they do not endanger themselves and others, and what conditions are to be met, in particular which knowledge and skills must be employed, and what evidence should be given to them in this regard. are to be provided
g): the conditions under which access and employment restrictions must be provided for the protection of workers,
h): that a project manager should be ordered for specific production or use procedures, which responsibilities are to be assigned to the project, and what kind of evidence he has to prove,

5.

how the employees are to be permanently informed of the applicable rules in an activity-related instruction manual and at what intervals on the basis of the operating instructions on the hazards and the necessary the protection of protective measures;

6.

what arrangements should be made to prevent operational disruptions and limit their impact on workers, and what measures should be taken to organise the first aid;

7.

that, and which supervisors responsible for areas in which employees are exposed to particular risks, and which powers must be delegated to enable them to carry out their occupational safety and health tasks,

8.

that, with regard to the protection of employees, a risk assessment must be carried out, which documents must be drawn up for this purpose and that these documents for the assessment of the risk assessment shall be carried out by the competent State authority of the Federal Agency for occupational health and safety and occupational medicine,

9.

which documents are to be made available for inspection by the competent authority of the competent State authority and to be submitted on request, in order to prevent risks for employees;

10.

that a method of production or use, in which special risks exist or are to be obtained for the employees, must be indicated to the competent State authority or may be permitted by the competent State authority,

11.

works where certain dangerous substances or mixtures can be released may only be carried out by establishments recognised by the public authorities;

12.

the health of the workers is to be monitored and records are to be kept and for this purpose,

a): the person concerned with the production or use of hazardous substances, in particular the obligation to have the employees examined in a medical examination,
b): the physician responsible for carrying out a preventive examination has to comply with certain obligations in connection with the findings of the investigation, in particular with regard to the contents of a certificate and the information to be issued by him, and Advice on the outcome of the investigation,
c): the competent authority shall decide if findings of the doctor are deemed to be inaccurate,
d): the data to be recorded shall be transmitted to the competent institution of the statutory accident insurance or to a body designated by it for the purpose of determining work-related health hazards or occupational diseases,

13.

that the employer has to inform the operational or staff council of operations which he/she must experience in order to be able to carry out his/her duties,

14.

the competent national authorities are empowered to issue orders in individual cases for the implementation of legal orders, in particular in the event of danger in arrests against supervisory staff and other employees,

15.

that the operating facilities and working methods in which certain hazardous substances are manufactured or used must be examined by a competent expert or an expert.

(4) Due to the requirements referred to in paragraph 3, notices of expert opinion may be made available to all; where:

1.: indicate in the regulation the date of the contract notice and identify the reference source,
2.: The notice of publication at the Federal Institute for Occupational Safety and Health shall be established in the form of an archive and shall be referred to in the regulation.

Sixth Section
Good laboratory practice

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§ 19a Good Laboratory Practice (GLP)

(1) Non-clinical health and environmental safety tests of substances or mixtures, the results of which shall assess their potential hazards to humans and the environment in an authorisation, permit, registration, registration or registration procedure; or Notification procedures shall be carried out in accordance with the principles of good laboratory practice as set out in Annex 1 to this Act, unless otherwise provided for by Community law or Union law. (2) The applicant or the notifying party or the party liable to participate in a procedure referred to in paragraph 1 Test results shall demonstrate that the tests on which the test results are based meet the requirements of Annex 1. Proof shall be provided by:

1.: the certificate according to § 19b and
2.: the written declaration of the investigator to the extent that the examination has been carried out in accordance with the principles of good laboratory practice.

If proof is not provided, the test results shall be deemed not to have been submitted. (3) Federal authorities carrying out the tests referred to in paragraph 1 shall be responsible for ensuring that the principles of good laboratory practice are complied with in their areas of responsibility. (4) The storage obligation referred to in point 10.2 of Annex 1 may be transferred by the transfer of the documents and written agreement with the adjudicating entity or a third party to be communicated to the competent authority. (5) The provisions of paragraph 1 and 2 shall not be applied to date commenced before 1 August 1990 and until 1 January 1995 completed tests if the competent authority has determined, on a case-by-case basis, that the test can also be used in the light of the principles of good laboratory practice. Unofficial table of contents

§ 19b GLP-Certificate

The competent authority shall, upon request for the conduct of an inspection procedure, issue a certificate of compliance with the principles of good laboratory practice to the person carrying out the tests in accordance with Article 19a (1), if his The test facility or its test site and the tests or phases of tests carried out by it shall comply with the principles of good laboratory practice in accordance with Annex 1. The application in accordance with the first sentence may also establish who, without being obliged to carry out exams in accordance with Section 19a (1), has a legitimate interest in crediting. In the case of Article 19a (3), the Federal Authority shall be issued the certificate by its supervisory authority or by a body designated by that authority. The certificate referred to in sentences 1 and 3 shall be issued in accordance with the model laid down in Annex 2. A request for a certificate in accordance with the first sentence must be decided within a period of three months; Section 42a (2) sentences 2 to 4 of the Administrative Procedure Act shall apply with the proviso that the time limit shall not be completed before the end of the period. of the prescribed inspection procedure as set out in the first sentence. The application procedure for issuing the certificate can be carried out via a single body. The examination of the application for a certificate as referred to in the first sentence shall be accompanied by evidence from another Member State of the European Union or of another State Party to the Agreement on the European Economic Area (EEA) (2) The certificate referred to in the first sentence of paragraph 1 shall be the same as the applicant satisfies the relevant requirements of the first sentence or the requirements of the issuing State which are essentially comparable on the basis of its objectives. (2) 1 shall be equal to:

1.: GLP certificates of other Member States of the European Union or States 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 L 196, 27.7.2005, p EU No L 50 p. 28),
2.: GLP certificates issued by States not members of the European Union if the mutual recognition of GLP certificates is guaranteed,
3.: a confirmation from the Federal Institute for Risk Assessment that a test facility located in a State which is not a Member State of the European Union and which does not guarantee the mutual recognition of GLP certificates shall be confirmed by the Federal Institute for Risk Assessment the findings of the Federal Institute for Risk Assessment shall be carried out in accordance with the principles of good laboratory practice.

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§ 19c Reporting

(1) The Federal Government shall report annually until 31 March for the last calendar year of the European Commission Report on the application of the principles of good laboratory practice within the scope of this Act. The report shall include a list of the inspected test facilities and test sites, an indication of the time points at which inspections were carried out and a summary of the results of the inspections. The Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (Federal Ministry for the Environment, Nature Conservation and Nuclear Safety) is responsible for producing the report by 15 February for the past calendar year. (2) Environment, nature conservation and reactor safety may be published in the Federal Gazette (Bundesanzeiger) a list of test facilities and test sites which carry out tests or phases of tests in compliance with the principles of good laboratory practice. Unofficial table of contents

§ 19d Supplementary provisions

(1) The Federal Institute for Risk Assessment has, in addition to the tasks assigned to it by law, legal regulations or other legislation, the following tasks in the area of good laboratory practice:

1.

the creation, management and updating of the list in accordance with § 19c (2);

2.

Expert advice from the Federal Government and the Länder, in particular in the implementation of the requirements

a): the expertise and the reliability of the persons responsible for carrying out the tests;
b): the nature and equipment of the testing facilities and test sites;
c): laboratory practice, e.g. B. the nature of the test samples, the implementation and quality control of the tests and phases of tests,
d): the collection and documentation of data,
e): monitoring of compliance with the principles of good laboratory practice,

3.

technical advice to the Federal Government through consultation procedures with the European Commission and other Member States of the European Union,

4.

Participation in the implementation of agreements on good laboratory practice with non-EU Member States.

(2) The Federal Government is empowered to amend Annexes 1 and 2 by means of a legal regulation with the consent of the Federal Council for the development of good laboratory practice. (3) The Federal Government shall, with the consent of the Federal Council, adopt general provisions Administrative provisions relating to the procedure of administrative supervision. The general administrative provision can also be used to regulate the transfer of the power of publication to the Federal Institute for Risk Assessment.

Seventh Section
General provisions

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Section 20 Application and notification documents, Regulation authorisations

(1) The Federal Government is empowered to do so by means of a regulation with the consent of the Federal Council

1.: The content and form of application or notification documents submitted to the Federal Office for Chemicals or any other federal authority pursuant to this Act, a legal regulation based on this Act, or any of the EC Treaty provisions referred to in Article 21 (2), first sentence, of the EC Treaty or EU regulation,
2.: ensure that, and for what period, the person who submits such application or notification documents to the Federal Office for Chemicals or any other federal authority has to keep a duplicate of these documents for inspection.

(2) The Federal Agency for Chemicals may apply for applications or documents submitted to it;

1.: require the use of certain forms or formats of other data carriers,
2.: authorise the transmission of data on another data medium;
3.: require the transmission of further copies of the submitted documents, in so far as this is necessary in view of the participation of the other federal authorities referred to in § § 4 and 12a.

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§ 20a (omitted)

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Section 20b Committees

The Federal Government is empowered to form committees with the consent of the Bundesrat, to which the task can be delegated, by means of a legal regulation,

1.

advise the Federal Government or the relevant Federal Ministries, in particular:

a): in the development of methods of audit evidence in accordance with this law,
b): in the preparation of regulations for classification, labelling and packaging in accordance with § § 14 and 19,
c): the designation of substances and mixtures for which a notification obligation pursuant to Section 16d should be justified,
d): for the adoption of prohibition, restriction or protective measures in accordance with § 17, § 18 or § 19 and
e): in the further development of good laboratory practice and

2.

a): identify safety, occupational health and hygiene rules, as well as other scientific findings,
b): for the protection of human beings and the environment, and
c): to propose, for man and the environment, substances, mixtures, products and processes which are not dangerous or less dangerous,

that the competent federal ministry can officially make known. Unofficial table of contents

Section 21 Monitoring

(1) The competent national authorities shall monitor the implementation of this law and the legal regulations based on this law, in so far as this law does not apply any other arrangement. (2) Paragraph 1 shall also apply to EC or EU regulations which: The subject matter of this Act shall be subject to the supervision of its implementation by the Member States. Where the application of EC or EU regulations within the meaning of the first sentence requires the receiving and forwarding of information or other acts of participation of the Member States, the Bundesstelle für Chemicals (Bundesstelle für Chemicals) is responsible for this. (2a) The Federal Government is empowered to implement this Act, the legal regulations based on this Act and the EC or EU regulations referred to in the first sentence of paragraph 2 with the consent of the Federal Council for the implementation of this Act.

1.: to transfer jurisdiction for certain authorisations and declarations of acceptance by way of derogation from the first sentence of paragraphs 1 and 2 of a federal authority, where such authorisations or declarations of consent have to be carried out in a uniform manner on a national basis, or Presuppose the assessment of facts, which as a rule exceed the competence of a country, and
2.: to determine, in the cases referred to in the second sentence of paragraph 2, a different federal authority.

(3) The competent authority of the Land shall be empowered by natural and legal persons and non-legal persons ' associations all to implement this law, the legal regulations based on this law and the provisions of the first sentence of paragraph 2 , and require the necessary information to be provided. In the cases referred to in the second sentence of paragraph 2, those powers shall be those referred to therein, in the cases referred to in paragraph 2a of the federal authority referred to in the Regulation. (4) The persons responsible for monitoring shall be entitled to:

1.: to enter and visit land, business premises, operating rooms, samples of substances, mixtures and products according to their selection, and to be included in the business documents of the to provide information to the person who is responsible for information,
2.: the submission of documents relating to applications, notifications, notifications, registrations and authorisations and other documents in accordance with this Act, the legal regulations based on this Act and the EC or EC Treaty referred to in the first sentence of paragraph 2; or to require EU regulations,
3.: to examine work equipment and work-protection products;
4.: To investigate the presence and concentration of dangerous substances and mixtures, and in particular to identify and measure the presence and concentration of dangerous substances and mixtures.

In order to prevent urgent risks to public safety and public order, the measures referred to in the first sentence of 1, 3 and 4 may also be taken in residential areas and at any time of day and night. The person responsible for providing the information shall accept the measures referred to in the first, third and fourth sentences of the first sentence and the second sentence, and shall support the persons responsible for monitoring, in so far as this is necessary for the performance of their duties, in particular on request to open spaces, containers and containers and to allow samples to be taken. The fundamental right of Article 13 of the Basic Law to inviolability of the dwelling shall be restricted to this extent. (5) The Party of Information may refuse to provide information on such questions, the answers of which shall be answered by him or by one of his answers in § 383 (1) (6) Can the competent national authority be able to use the type and extent of the offence in the manufacture or use of the persons referred to in § 19 of the Code of Civil Procedure. , substances, mixtures and products referred to in paragraph 2 The manufacturer or the user may require the manufacturer or the user to do so by an expert to be determined by the competent authority on his or her own The costs of an expert opinion shall be reimbursed and a copy of the opinion shall be submitted. The provisions of the first sentence shall not apply to the extent provided for in this Act, or to the conditions laid down for the arrangement of tests. (6a) Materials, mixtures and products used in the territory of the country for the purposes of this Act shall be subject to the provisions of this Act. If the law or the legal regulations adopted pursuant to this Act are objected to, they may be brought back to the foreign supplier from the scope of this Act, unless the competent authority of the State concerned has something to do with the law. other than that. This is without prejudice to any intergovernmental agreements to which the legislative bodies have consented in the form of a federal law, as well as legal acts of the European Community or the European Union. (7) The Federal Office for Chemicals and the bodies referred to in § 12a are obliged to collect the data collected by them under this Act, the regulations issued pursuant to this Act and the EC or EU regulations referred to in the first sentence of paragraph 2, and , the authorities of occupational health and safety, general health protection, environmental and nature protection, the general security and the fire and civil protection of the countries, as well as the institutions of the statutory accident insurance, by means of mutual assistance. § 16e paragraph 4 shall remain unaffected. Unofficial table of contents

Section 21a Participation of customs offices

(1) The Federal Ministry of Finance and the customs offices designated by it shall cooperate in the supervision of the import and export of those substances, mixtures and products which are subject to this Act or to a law adopted pursuant to this Act. or any of the EC or EU regulations referred to in Article 21 (2), first sentence, of the EC Treaty. To the extent necessary for the monitoring of the implementation of this Act, of the regulations adopted pursuant to this Act and of the EC or EU Regulations referred to in the first sentence, they may provide information which they may obtain in the framework of their customs duties. (2) where there is evidence of a breach of the rules referred to in paragraph 1, the customs authorities shall inform the competent authorities. They may reject the substances, mixtures and products, as well as their means of transport and packaging, at the expense and risk of the right of disposal, or until such time as the deficiencies found or until the decision of the competent authorities have been completed. Ensure authority. Unofficial table of contents

Section 22 Information requirements

The Federal Agency for Chemicals and the competent national authorities shall inform each other of all the findings which are necessary for the performance of their duties under this Act, the legal regulations issued pursuant to this Act or the provisions of § Article 21 (2), first sentence, of the EC or EU regulations, including the fulfilment of the reporting obligations contained therein, as compared with the European Commission. The Federal Agency for Chemicals has to advise the competent national authorities on request. To the extent that, pursuant to Article 21 (2a) (2), a different federal authority is determined, the duties referred to in sentences 1 and 2 shall be between that authority and the competent national authorities. Unofficial table of contents

§ 23 Government orders

(1) The competent State authority may, in individual cases, take the orders which are intended for the disposal of established or to prevent future violations of this law or against the legal regulations issued pursuant to this Act or against any one in § § (1a) Where an order referred to in paragraph 1 is not carried out immediately within the time limit set or such an arrangement declared to be immediately enforceable, the competent authority may: the work affected by the order, in whole or in part, until the performance of the (2) The competent authority may arrange for a period of not more than three months to have a dangerous substance, a dangerous substance, a dangerous substance, a dangerous substance, a dangerous substance, a dangerous substance, a dangerous substance, a dangerous substance, a dangerous substance. A mixture or a product which may or may contain a dangerous substance or a dangerous mixture shall not be placed on the market only under certain conditions, only in a certain condition or for certain purposes only may be brought or used, in so far as there is evidence, in particular a post- In the light of the scientific evidence, there are reasonable grounds for suspecting that the substance, mixture or product poses a significant risk to human life or health or to the environment. The competent State authority may extend this order by up to one year for important reasons. Sentences 1 and 2 shall apply even if there is evidence, in particular a suspicion based on the state of scientific evidence, of the assumption that a substance or a mixture is dangerous. Orders in accordance with the first and second sentences can only be provided insofar as this is legally permissible. (3) Legal remedies against orders under paragraphs 1a and 2 do not have suspensive effect. Unofficial table of contents

Section 24 enforcement in the area of the Bundeswehr

(1) In the Division of the Federal Ministry of Defence, the law, the legal regulations based on this law and the EC or EU regulations referred to in Article 21 (2), first sentence, are the responsibility of the Federal Ministry of Justice. (2) The Federal Ministry of Defence may, for its division in individual cases and for certain substances, mixtures and products, derogations from the legislation referred to in paragraph 1. if necessary in the interest of national defence and in accordance with European Union law is admissible. Unofficial table of contents

Section 25 Approximation of Community law or Union law

Legal orders under this Act may also be adopted for the purpose of approximation of the laws, regulations and administrative provisions of the Member States of the European Union as far as this is required for the implementation of acts of the European Communities , or the European Union, which relate to the substantive areas of this law. Unofficial table of contents

Section 25a Fees and levies

(1) Fees and levies shall be charged for individually attributable public services in accordance with this Act and the legislation adopted pursuant to this Act, as well as under EC or EU regulations within the meaning of Article 21 (2) sentence 1. § 8 shall remain unaffected. (2) The Federal Government shall be authorized by means of a decree law which does not require the consent of the Federal Council, the chargeable facts and the rates of charges for individually attributable public services of the following (3) He himself has to bear the expenses incurred by the person responsible for providing the information by taking samples of substances, mixtures and products or by taking measurements of his own expenses.

4

Section 25a shall apply in accordance with Article 4 (101) (2) in conjunction with Article 5 (3) of the Law of 7 August 2013 (BGBl. 3154) as from 14 August 2018, as amended:

" § 25a
Expenses of the party responsible for providing information

The person responsible for providing information by taking samples of substances, mixtures and products or by measuring his own expenses shall be borne by him himself. "

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Section 26 Penal rules

(1) Contrary to the law, those who intentionally or negligently act

1.

(dropped)

1a.

(dropped)

1b.

(dropped)

2.

(dropped)

3.

(dropped)

4.

an enforceable arrangement in accordance with Article 12g (1) sentence 1,

5.

a): contrary to Section 13 (2) in conjunction with a legal regulation pursuant to Section 14 (1) (1), (2) or (3) (c), also in conjunction with Section 14 (3), a substance or a mixture not, not correct, not complete, not in the , or does not classify it in time,
b): contrary to § 13 (3) sentence 1 in conjunction with a regulation pursuant to Article 14 (1) (3) (a), (d) or (e), also in conjunction with Section 14 (3), a substance or a mixture not, not correct, not complete, not in the prescribed manner or not in a timely manner, or not properly, not in full, not in the prescribed manner or not in time, or
c): a legal regulation in accordance with Article 14 (1) (3) (a), (b), (d), (e) or (f) or (2), second sentence, as far as it refers to that fine for a certain amount of the offence;

5a.

(dropped)

6.

a legal regulation in accordance with § 16d, insofar as it refers to this fine for a certain amount of the facts;

6a.

contrary to Article 16e (1), first sentence or sentence 3, in connection with a legal regulation referred to in paragraph 5 (2) or (3), does not make a notification, not correct, not complete or not in good time,

6b.

(dropped)

7.

a legal regulation in accordance with

a): Section 17 (1) (1) (b) or (2) (a), (c) or (d), also in conjunction with the first sentence of paragraph 3,
b): Section 17 (1) (1) (c), also in conjunction with the first sentence of paragraph 3, or
c): Section 17 (5)

to the extent that it refers to this fine for a specific case,

8.

a legal regulation in accordance with

a): Section 18 (1) on toxic animals and plants,
b): Section 19 (1) in conjunction with paragraph 3 on measures for the protection of employees

to the extent that it refers to this fine for a specific case,

8a.

(dropped)

9.

Contrary to § 21 (3), information is not issued despite the admonition, contrary to § 21 (4) sentence 1, point 2, documents are not submitted or an obligation in accordance with § 21 (4) sentence 3 is not complied with,

10.

a fully-retractable arrangement

a): in accordance with Article 23 (1) or
b): in accordance with Article 23 (2), third sentence, in conjunction with the first sentence of sentence 1 on the production, placing on the market or use of substances, mixtures or products

shall be contrary to

10a.

in accordance with Article 28 (11) of a regulation on admission or reporting obligations for certain biocidal products, to the extent that it refers to this fine for a certain amount of the facts; or

11.

of a directly applicable provision in legal acts of the European Communities or of the European Union relating to the subject-matter of this Act, to the extent that a Regulation in accordance with the provisions of the second sentence of the second subparagraph shall apply to a specific case Fines and the infringement cannot be punished as a criminal offence in accordance with Article 27 (1) (3) or (2). The Federal Government is empowered to designate, with the consent of the Federal Council, the individual facts of the acts which may be punishable as administrative offences in accordance with the first sentence, to the extent that this is necessary for the implementation of the provisions of the Federal Council. of the acts.

(2) In the cases referred to in paragraph 1 (7) (b), the administrative offence may be subject to a fine of up to two hundred thousand euros, in the cases referred to in points 4, 5, 6, 7 (a), 8 (b), 10 and 11 of paragraph 1, with a fine, up to a maximum of EUR 1 million. (3) The administrative authority within the meaning of Section 36 (1) (1) of the Code of Administrative Offences shall be punishable by a fine of up to EUR 50 000 and in the other cases with a fine of up to ten thousand euros.

1.

in the cases referred to in point 9 of paragraph 1, in conjunction with Article 21 (3), second sentence

a): the Federal Agency for Chemicals for its business unit pursuant to Article 21 (2), second sentence, or
b): the federal authority referred to in Article 21 (2a) of the Regulation, in so far as it has the powers referred to in Article 21 (3) sentence 1,

2.

(dropped)

3.

is, moreover, the competent authority in accordance with national law.

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Section 27 Criminal law

(1) With a custodial sentence of up to two years or a fine, he shall be punished.

1.: a legal regulation in accordance with Article 17 (1) (1) (a), (2) (b) or (3), also in conjunction with paragraphs 2, 3, first sentence, (4) or (6), on the production, placing on the market or use of the substances referred to therein, mixtures, products, biocidal active substances or biocidal products, to the extent that it refers to this penal code for a specific case;
2.: a fully-enforceable arrangement in accordance with the first sentence of Article 23 (2) concerning the production, placing on the market or use of dangerous substances, mixtures or products; or
3.: of a directly applicable provision in legal acts of the European Communities or of the European Union which is in accordance with the content of a system to which the provisions referred to in paragraph 1 authorize, to the extent that: Regulation of the law referred to in the second sentence refers to this penal code for a certain amount of the offence. The Federal Government is authorized, in so far as it is necessary to enforce the acts of the European Communities or the European Union, to designate, by means of a legal regulation with the consent of the Federal Council, the facts which are deemed to be The offence referred to in sentence 1 shall be punished.

(1a) A custodial sentence of up to three years or a fine shall be punishable by the person concerned by the act referred to in paragraph 1 (3) of the sentence before the second sentence by the fact that he or she is subject to an item of goods within the meaning of Article 2 (6) of the Food and Agriculture Committee. (2) A term of imprisonment of up to five years or a fine shall be punishable by one or more of those referred to in paragraph 1 or paragraph 1a or one in Article 26 (1) (4), (5), (7) (b), (8) (b), Point 10 or 11, the deliberate act referred to in point 10 or 11, or the health of another, or (3) The attempt is punishable. (4) If the perpetrator is negligent, then the sentence shall be punishable by law.

1.: in the cases referred to in paragraph 1 or in paragraph 1, a custodial sentence of up to one year or a fine,
2.: in the cases referred to in paragraph 2, a term of imprisonment of up to two years or a fine.

(5) The court may depart from the penalty referred to in paragraph 2 if the offender voluntarily averts the risk before a significant damage occurs. Under the same conditions, the offender shall not be punished under paragraph 4 (2). If the danger is averted without the intervention of the offender, his voluntary and serious endeavor to achieve this goal is sufficient. (6) Paragraphs 1 to 5 shall not apply if the act is carried out in accordance with § § 328, 330 or 330a of the Criminal Code with the same or more serious punishment is threatened. Unofficial table of contents

§ 27a Untrue GLP declarations, Erschleichen of the GLP certificate

(1) Anyone who, in order to deception in legal transactions, surrenders the declaration pursuant to § 19a, paragraph 2, second sentence 2 of the Truth, or uses an untrue declaration, shall be punished with imprisonment of up to five years or a fine. (2) An office-holder who shall: within its jurisdiction, an untrue attestation pursuant to § 19b (1) or an untrue confirmation pursuant to § 19b (2) number 3 is granted, shall be punished with imprisonment of up to five years or a fine. (3) Anyone who causes an untrue certified or confirmed in accordance with § 19b, or who has received such a certificate or The attempt is punishable by imprisonment for up to one year or a fine. (4) The trial is punishable by punishment. Unofficial table of contents

Section 27b of infringements of Regulation (EC) No 1907/2006

(1) Imprisonment of up to two years or a fine shall be punished for who is against Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, evaluation, authorisation and restriction of chemical substances. Substances (REACH), to create a European Chemicals Agency, amending Directive 1999 /45/EC and repealing Council Regulation (EEC) No 793/93, Commission Regulation (EC) No 1488/94, Council Directive 76 /769/EEC , and Directives 91 /155/EEC, 93 /67/EEC, 93 /105/EC and 2000 /21/EC of the Commission 1. EU No L 396 p. 1, 2007 No OJ L 136, p. 3), by

1.: manufactures or places on the market a substance as such, in a mixture or in a product, contrary to Article 5,
2.: in a registration dossier referred to in Article 6 (1) or (3) or in the first sentence of Article 7 (1) or in the first sentence of Article 7 (5), or in an application for authorisation in accordance with Article 62 (1), in conjunction with paragraph 4, an indication not correct or not complete ,
3.: , contrary to Article 37 (4), in conjunction with Article 39 (1), a chemical safety report shall not be drawn up, not correct, in full or in good time, or
4.: , contrary to Article 56 (1), a substance referred to therein is placed on the market or used for its own use.

(2) The trial shall be punishable. (3) Imprisonment of up to five years or a fine shall be punishable by the person who, by means of an act referred to in paragraph 1, endangers the life or health of another or other property of significant value. (4) If the offender is negligent in the cases referred to in paragraph 1 (4), the penalty shall be a custodial sentence of up to one year or a fine. (5) The offence shall be subject to the negligence of the act referred to in paragraph 1 (1), (2) or (3). The administrative offence can be punished with a fine of up to hundreds of thousands of euros. Unofficial table of contents

Section 27c infringements of the provisions of the discharge

(1) With a custodial sentence of up to two years or a fine, he shall be punished who shall commit an intentional act referred to in Article 26 (1) (7) (b), even though he knows that the dangerous substance, the dangerous mixture or the product (2) In the cases referred to in paragraph 1, the perpetrator shall not lightly recognise that the dangerous substance, the dangerous mixture or the product is intended for use in the case of a criminal law. Illegal action, which is the result of a criminal act, is used The sentence shall be punishable by a sentence of up to one year or a fine. Unofficial table of contents

§ 27d confiscation

Items to which an offence is referred in accordance with § § 27, 27b (1) to (4) or § 27c or an administrative offence pursuant to Article 26 (1) (4), (5), (7) (a) or (b), (10) or (11) or § 27b (5) sentence 1, may be be drafted. Section 74a of the Criminal Code and Section 23 of the Law on Administrative Offences shall apply.

Eighth section
Final provisions

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Section 28 Transitional regime

(1) (omitted) (2) (omitted) (3) (omitted) (4) (omitted) (5) (omitted) (6) (omitted) (7) (omitted) (8) Within the scope of this law, biocidal products containing only biocidal active substances, which are subject to the Regulation By way of derogation from Article 17 (1) of Regulation (EU) No 528/2012 until the following dates on the market, the evaluation or evaluation procedure under this Regulation shall be subject to the assessment procedure laid down in this Regulation; are used:

1.: one year after the publication of the decision referred to in the third subparagraph of Article 89 (1) of Regulation (EU) No 528/2012 in the Official Journal of the European Union, a biocidal active substance for the product type in question not included in the biocidal product , unless otherwise specified in the Commission's decision,
2.: for the provision on the market 180 days as well as for disposal or use 365 days after the date of approval of the active substance or active substances as specified in the decision, pursuant to the third subparagraph of Article 89 (3) of the Regulation (EU) No 528/2012, where an application for admission or parallel recognition has not been made or has not been made in due time in accordance with the second subparagraph of Article 89 (3) of Regulation (EU) No 528/2012,
3.: during an ongoing decision-making procedure on a request for authorisation or mutual recognition of the biocidal product in parallel with the date of Article 89 (3), second subparagraph, of Regulation (EU) No 528/2012, up to the date of -making approval or recognition more effective, or
4.: for the provision on the market 180 days as well as for disposal or use 365 days in accordance with Article 89 (4) of Regulation (EU) No 528/2012, after the application referred to in the second subparagraph of Article 89 (3) of Regulation (EU) No 528/2012 approval or time-parallel mutual recognition has been rejected.

(9) In the case referred to in paragraph 8 (3), the Bundesstelle für Chemicals (Bundesstelle für Chemicals) may, within the framework of the permissible Union law for stocks of the biocidal product, which have already been made available on the market before the granting of the authorisation or parallel recognition, and the measures of the authorisation or recognition decision, or the labelling requirements relating to the authorisation or recognition, do not or are not fully in accordance with the requirements, periods of application for the further provision on the market and the (10) Insofar as Article 91 of Regulation (EU) No No 528/2012 is intended for applications for authorisation or mutual recognition of biocidal products which have been fully received by the Admissions Office before 1 September 2013, the provisions of this Act in the up to Entry into force of the Law implementing Regulation (EU) No 528/2012 of 23 July 2013 (BGBl. (11) The Federal Government is authorized, after consultation of the parties concerned, by means of a regulation with the consent of the Bundesrat, to the purpose specified in § 1, up to the date of the delegated act of the to require the European Commission, in accordance with the second subparagraph of Article 89 (1) of Regulation (EU) No 528/2012, to prescribe the date of the end of the work programme for the systematic examination of all existing active substances, and at least until 14 May 2014, that certain biocidal products within the meaning of paragraph 8 are first placed on the market and may be used after being approved by the Federal Agency for Chemicals. The legal regulation may deviate from the requirements of Regulation (EU) No 528/2012 within the framework of the permissible Union law. A notification procedure may also be provided instead of an authorisation. (12) A communication pursuant to § 16e (1) sentence 1 shall not be required until 1 July 2016 for mixtures which do not have any of the hazard characteristics in accordance with Section 3a (1) (6), (7), (9) or (9). 11 to 14, or are not intended for the consumer, and are not biocidal products, provided that the mixture concerned is not

1.: in the case of detergents and cleaning products as defined in the Laundry and Cleaning Products Act, the Federal Institute for Risk Assessment, a respective current data sheet in accordance with Annex VII, Section C of Regulation (EC) No 648/2004 of the European Parliament, and of 31 March 2004 on detergents (OJ L 327, 30.4.2004, p. 1), as last amended by Regulation (EC) No 551/2009 (OJ L 145, 30.4.2009, p. OJ L 164, 26.6.2009, p. 3),
2.: in the case of other mixtures, the Institute for Occupational Safety and Health of the German Social Accident Insurance in each case an up-to-date safety data sheet in accordance with Article 31 of Regulation (EC) No 1907/2006

in a form predetermined by the respective institution, has been transmitted electronically and is available for the purposes specified in § 16e (4). For mixtures as defined in the first sentence, which were already on the market before 9 November 2011, the transmission of the documents in accordance with the first sentence or the communication pursuant to § 16e (1) sentence 1 shall take place by 1 May 2012. The Federal Government is empowered to extend or to extend the period referred to in the first sentence in the light of the results of the review referred to in Article 45 (4) of Regulation (EC) No 1272/2008 by means of a legal regulation with the consent of the Federal Council. . Unofficial table of contents

Section 29 (external force)

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§ 30 Berlin-clause

(unopposed) Unofficial table of contents

Section 31 (Entry into force)

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Annex 1 (to § 19a, paragraph 1)
Principles of Good Laboratory Practice (GLP)

(Fundstelle: BGBl. I 2013, 3521-3531)

Content oversight section I

1	Scope
2	Definitions
2.1	Good laboratory practice (Good Laboratory Practice, GLP)
2.2	Terms relating to the organisation of a test facility
2.3	Terms relating to non-clinical health and environmental safety tests
2.4	Terms relating to the subject of the test

Section IIprinciples of good laboratory practice

1	Organisation and personnel of the testing facility
1.1	Tasks of the management of the test facility
1.2	Tasks of the investigator
1.3	Tasks of the local test manager
1.4	Tasks of the staff in question

2	Quality assurance program
2.1	General
2.2	Duties of the quality assurance staff

3	Premises and facilities
3.1	General
3.2	Premises and facilities for test systems
3.3	Premises and facilities for dealing with test and reference objects
3.4	Premises and facilities for archives
3.5	Waste disposal

4	Equipment, materials and reagents
5	Test systems
5.1	Physical and chemical testing systems
5.2	Biological test systems

6	Check and reference objects
6.1	Entrance, handling, removal and storage
6.2	Characterization

7	Default Work Instructions (Standard Operating Procedures, SOPs)

8	Audit Flow
8.1	Audit Plan
8.2	Contents of the audit plan
8.3	Conduct of the audit

9	Report on test results
9.1	General
9.2	Contents of the final report

10	Archiving and storage of records and materials

Section I1 Application areas These principles of good laboratory practice shall apply to non-clinical safety tests of test items used in medicinal products, plant protection products and biocides, cosmetic products and veterinary medicinal products as well as in food additives, feed additives and industrial chemicals. These test objects are often synthetic chemical products, but they may also be of natural or biological origin; they may be living organisms. The purpose of the examination of these test objects is to gain data on their properties and their safety for human health and the environment. To the non-clinical health and environmental safety tests, which are carried out by the principles of good laboratory practice are covered, include laboratory tests as well as tests in greenhouses or in the open country. These principles of good laboratory practice are applied to all non-clinical health and safety standards. environmental safety checks carried out by evaluation authorities for registration or authorisation of medicinal products, plant protection products, food and feed additives, cosmetic products, veterinary medicinal products and similar products, and for the notification of industrial chemicals. These principles are Laboratory practice is also applied to phases of tests carried out at a test site. Test sites with their own management can be included in the national GLP monitoring procedure on request.

2 Definitions

2.1

Good Laboratory Practice (GLP) Good laboratory practice is a quality assurance system that deals with the organizational process and the framework conditions under which non-clinical health and environmental relevance Security checks are planned, carried out and monitored, as well as with the recording, archiving and reporting of the tests.

2.2

Terms relating to the organisation of a test facility

1): The test facility comprises the persons, premises and work units necessary for carrying out non-clinical health and environmental safety tests. For tests carried out in phases on more than one site, so-called multi-site tests, the term testing facility includes both the location where the test manager is located and all the other individual Test sites. The test sites can be defined both in their entirety and in each case individually as test equipment.
2): The test site is the place where one or more phases of an audit are performed. Phases of tests are to be understood here as individual parts, sections, steps or steps of tests.
3): The management of the test facility shall mean the person or group of persons who has the responsibility and formal responsibility for the organisation and functioning of the test facility in accordance with these principles of good laboratory practice.
4): The management of a test site shall mean the person or group of persons who shall ensure that those phases of the test for which it has claimed responsibility are carried out in accordance with these principles of good laboratory practice.
5): Client is a natural or legal person who has commissioned, supported or submits a non-clinical health and environmental safety examination.
6): The investigator is the person responsible for the overall management of the non-clinical health and environmental safety assessment.
7): The Principal Investigator (Principal Investigator) shall designate the person who, in the case of a multi-site examination, shall, on behalf of the auditor, assume certain responsibilities for the phases of the test carried out to it. The responsibility of the test manager for the overall management of the test cannot be transferred to the local test manager; this includes the approval of the audit plan and its amendments, the approval of the final report, and the approval of the audit plan. Responsibility for the observance of all applicable principles of good laboratory practice.
8): Quality assurance programme is a defined system, the staff of which is independent of the examination procedure, and which gives assurance to the management of the test facility that the principles of good laboratory practice are complied with.
9): Standard operating procedures (SOPs) are documented procedural instructions on the conduct of those investigations or activities that are usually not included in the test plans or test guidelines. The details are described in detail.
10): A list of the status of all the checks (Master Schedule) is a compilation of information that is used to estimate the workload and track the flow of tests in a test facility.

2.3

Terms relating to non-clinical health and environmental safety tests

1): Non-clinical health and environmental safety assessment, hereinafter referred to as "test", is an investigation or a series of tests carried out with a test subject under laboratory or environmental conditions, in order to: to obtain data on its characteristics and on its safety, with the intention of submitting it to the competent evaluation authorities.
2): Short-term examination is an examination of short duration, which is carried out according to widely used routine methods.
3): The audit plan is a document that describes the objectives and the overall experimental planning for performing the test; it includes all the test plan changes.
4): Test plan change is a planned change of the test plan after the start of the test in the form of a supplement.
5): Test plan deviation is an unintended deviation from the test plan after the start of the test.
6): The test system is any biological, chemical or physical system-or a combination thereof-that is used in a test.
7): Raw data are all the original records and records of the test facility or its verified copies, which are obtained as a result of the original observations or activities during an examination. Raw data include, for example, photographs, microfilm or microfichopia, computer-readable media, dictated observations, recorded data from automated devices, or any other data on storage media, which are recognized to be able to safely store information on a period of time, as described in Section 10.
8): Samples are materials which are taken from the test system for examination, evaluation or storage.
9): The beginning of the experimental phase is the day on which the first test-specific raw data are collected.
10): The end of the experimental phase is the last day on which test-specific raw data are still collected.
11): The start of a test shall be the day on which the investigator underwrites the test plan.
12): Completion of an examination is the day on which the investigator underwrites the final report.

2.4

Terms relating to the subject of the test

1): The object of the test is an object which is subject to the examination.
2): Reference object (comparative object) is an object used for comparison with the test object.
3): Batch is a certain quantity or lot of a test or reference object, which has been manufactured in a particular manufacturing process in such a way that uniform properties are to be expected; it is marked as such.
4): Carrier material is a substance with which the test or reference object is mixed, dispersed or dissolved in order to facilitate the application of the test system.

Section III-Principles of Good Laboratory Practice (GLP) 1 Organisation and staff of the testing facility

1.1

Tasks of the management of the test facility

1)

The management of each test facility shall ensure that these principles of good laboratory practice are complied with in their testing facility.

2)

The line shall at least

a): ensure that a declaration is made with an indication of the person or group of persons who carries out the tasks of the management of the test 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 correct conduct of the audit;
c): to ensure that records of education, training, and practical experience, as well as the description of the tasks, are conducted for all scientific and technical staff;
d): ensure that staff are familiar with the tasks to be carried out and, if necessary, an introduction to these tasks is provided for;
e): ensure that appropriate standard operating procedures are drawn up and followed in accordance with the state of the art, and shall approve all the original standard operating instructions and their revised versions;
f): ensure that a quality assurance programme and the staff required for its implementation are available, as well as to ensure that the performance of the quality assurance tasks is consistent with these principles of good laboratory practice;
g): ensure that, prior to the commencement of each examination, a Head of Audit, with appropriate training, further training and practical experience, is appointed by the management. The replacement of a test manager shall be carried out in accordance with established procedures and must be recorded in writing;
h): ensure that, in the case of multi-site exams, an Official investigator is appointed, where appropriate, who has the appropriate training, further education and practical experience, in order to identify the phases of the examination that are carried out to him. conduct or can be monitored. The replacement of a local test manager shall be carried out in accordance with established procedures and must be recorded in writing;
i): to ensure that each audit plan is approved in writing by the investigator;
j): ensure that the investigator shall forward the approved test plan in good time to the quality assurance staff;
k): to ensure that a chronological filing of all standard operating procedures is carried out;
l): to ensure that a responsible person is designated for the management of archives;
m): ensure that a list of the status of all audits is conducted (Master Schedule);
n): ensure that all supplies in the test facility meet the requirements for their use in the test;
o): to ensure that, in the case of multi-site audits, there are clearly defined channels of communication between the investigator, the local investigator, the quality assurance staff, and the staff who are testing;
p): to ensure that test and reference objects are characterised in a suitable manner;
q): to establish procedures to ensure that computerised systems are suitable for their intended use and are validated, operated and maintained in accordance with these principles of good laboratory practice.

3)

Where certain phases of a test are carried out at a test site for which a management is designated, the management of that test site shall carry out all the tasks referred to in paragraph 2, with the exception of the tasks referred to in paragraph 2 (g), (i), (j) and (o) taking over.

1.2

Tasks of the investigator

1)

The investigator shall be entrusted with the sole supervision of the audit and shall be responsible for the overall performance of the audit and for the final report.

2)

This responsibility shall include at least the following tasks. The investigator has

a): approve the audit plan and any changes made by the date of signature;
b): ensure that the quality assurance staff has a copy of the audit plan and any changes in good time, and that it has become as effective as necessary during the conduct of the audit with the to communicate quality assurance personnel;
c): ensure that audit plans and any changes, as well as standard operating instructions, are available to the audit staff;
d): ensure that the audit plan and the final report of a multi-site audit describe, in particular, the local test managers involved in the conduct of the audit, and the testing facilities and test sites, as well as the delegated tasks;
e): ensure that the procedures described in the test plan are followed; it shall assess and document any possible impact on the quality and reliability of the test, if any, as well as, where appropriate, (b) to arrange for corrective measures to be taken; any deviations from standard operating instructions when carrying out the test shall be confirmed;
f): to ensure that all raw data obtained are recorded and recorded without any gaps;
g): to ensure that computerised systems are validated in the course of an audit;
h): to sign the final report, in order to take responsibility for the reliability of the data and to indicate to what extent the audit is in accordance with these principles of good laboratory practice;
i): to ensure that after completion of the audit, the audit plan, final report, raw data and other related material will be archived. A report must also be drawn up in the event of an abort of an examination and shall be followed accordingly with regard to archiving.

1.3

Tasks of the Local Experimental Ladder The local investigator shall ensure that the stages of the test carried out to him are carried out in accordance with the principles of good laboratory practice to be applied.

1.4

Tasks of the staff in question

1): The staff involved in the conduct of a test must have in-depth knowledge of those sections of the principles of good laboratory practice which affect its participation in the examination.
2): The audit staff shall have direct access to the test plan and to the standard operating instructions relating to its participation in the test. The responsibility for following the instructions contained in these documents is the responsibility of the staff. Any deviation from the instructions must be documented and reported immediately to the investigator and, if necessary, to the local test manager.
3): The testing staff is responsible for the immediate and accurate collection of raw data in accordance with these principles of good laboratory practice as well as for the quality of these data.
4): The testing staff shall have to comply with health measures in order to minimise the risk to themselves and to ensure the reliability of the test. It shall inform the competent person of any health or medical problems which are known to him or her, in order to be able to exclude any possible work which may be detrimental to the examination.

2 Quality assurance programme

2.1

General

1): The test facility shall have a documented quality assurance programme to ensure that the tests are carried out in accordance with these principles of good laboratory practice.
2): The quality assurance programme shall be carried out by one or more persons who are appointed by the management and who are directly responsible for it. These persons must be familiar with the test procedures.
3): These persons may not be involved in the performance of the audit, the quality of which is to be secured.

2.2

Duties of the quality assurance staff Quality assurance personnel shall at least

a)

Keep copies of all approved test plans and standard operating instructions used in the test facility, and have access to the current directory with the status of all the checks (Master Schedule);

b)

to verify that the test plan contains the information required in accordance with the principles of good laboratory practice. This review shall be documented;

c)

carry out inspections in order to determine whether all tests are carried out in compliance with these principles of good laboratory practice. During the inspections, it is also intended to establish whether test plans and standard operating procedures are available and followed directly to the staff under review. There are three types of inspections, which are in the appropriate The standard operating instructions for the quality assurance program are to be described in more detail:

-: audit-related inspections,
-: direction-related inspections;
-: process-related inspections.

keep records of these inspections;

d)

inspect final reports and, where applicable, confirm that methods, procedures and observations have been correctly and comprehensively described, and that the reported results are correct and comprehensive for the raw data of the tests ;

e)

immediately report to the management and the investigator, and, where appropriate, to the local investigator and the appropriate management of inspection results in writing;

f)

to draw up and sign a declaration to be annexed to the final report, the nature and timing of the inspections, the phases of the examination inspected and the dates on which the management and the investigator, and, where appropriate, a Local investigator inspection results have been reported. Furthermore, this declaration serves as confirmation that the final report reflects the raw data.

3 premises and facilities

3.1

General

1): The test equipment shall be of a suitable size, design and position to meet the requirements of the test and to minimise any disturbances which may affect the reliability of the test.
2): The test facility shall be designed in such a way that the individual operations can be sufficiently separated in order to ensure the proper implementation of each individual test.

3.2

Premises and facilities for test systems

1): The test facility shall have a sufficient number of rooms or areas to separate the accommodation of test systems and individual tests for substances or organisms whose biological hazards are known or adopted can be made possible.
2): Appropriate spaces or areas must be available for the diagnosis, treatment and control of diseases, in order to ensure that no unacceptable impairment of the test systems occurs.
3): Storage spaces or areas must be available for supplies and equipment. These storage spaces or areas shall be separate from the accommodation spaces or areas for test systems and shall ensure adequate protection against verials, impurities and spoivers.

3.3

Premises and facilities for dealing with test and reference objects

1): In order to avoid contamination and confusion, separate spaces or areas must be present for the entry and storage of the test and reference objects and for mixing the test objects with carrier substances.
2): The storage spaces or areas for the test objects shall be separated from the spaces or areas in which the test systems are housed. They must be appropriate to maintain the identity, concentration, purity and stability of the test objects and to ensure the safe storage of dangerous substances.

3.4

Premises and facilities for archive premises for archives must be available for the safe storage and retrieval of test plans, raw data, final reports, back-up patterns of test and reference objects and samples . The equipment and conditions in the archives must be designed in such a way as to prevent premature spoiding of the archive material.

3.5

Waste disposal waste is to be handled and disposed of in such a way as to ensure that the tests are not endangered. This includes arrangements for the appropriate collection, storage, disposal, decontamination and transport procedures.

4 devices, materials and reagents

1): Equipment, including validated computer-aided systems used for the collection, recording and reproduction of data and for the control of environmental conditions relevant to the test, shall be appropriately accommodated and shall be subject to the following conditions: have a suitable design and sufficient performance.
2): The equipment used in a test shall be checked, cleaned, waiting and calibrated at regular intervals in accordance with the standard operating instructions. Records of this shall be kept. Calibrations must be able to be attributed to national or international measurement standards where necessary.
3): Equipment and materials used in a test shall not interfere with the test systems.
4): Chemicals, reagents and solutions are to be labelled in such a way that identity (with concentration, if necessary), expiry date and special storage instructions can be seen. Information on origin, date of manufacture and durability must be made available. The expiration date can be extended on the basis of a documented assessment or analysis.

5 test systems

5.1

Physical and chemical testing systems

1): Devices with which physical and chemical data are obtained are expediently accommodated and must have a suitable design and sufficient capacity.
2): Ensuring the functioning of physical and chemical testing systems must be ensured.

5.2

Biological test systems

1): For the storage, accommodation, handling and care of biological test systems, appropriate conditions must be created to ensure the quality of the data.
2): Newly arrived animal and plant test systems shall be separately accommodated until their state of health has been established. If an unusual mortality or morbidity occurs, this delivery must not be used for exams. Plant testing systems shall, where appropriate, be destroyed in a suitable manner, animal testing systems shall be treated in accordance with the provisions of the Animal Welds Act. At the beginning of the experimental phase of the test, the test systems shall be free from any disease or impairment which may affect the purpose or the performance of the test. Testing systems that are ill or injured in the course of the test shall, if necessary, be isolated and treated in order to ensure the integrity of the test. Records shall be kept on the diagnosis and treatment of any disease before or during the course of an examination.
3): Records must be kept of origin, date of arrival and condition upon arrival of the test systems.
4): Prior to the first application of the test or reference object, biological test systems shall be acclimatized to the environmental conditions of the test during a sufficient period of time.
5): All information required for identification of the test systems shall be affixed to their cages or containers. Test system individuals taken from their cages or containers during the course of the test shall, as far as possible, bear the appropriate identification characteristics.
6): During use, all cages or containers for test systems must be cleaned at appropriate intervals and germarm must be made. Materials with which the test systems come into contact must be free from impurities in concentrations that may have an impact on the test. Litter for animals is to be changed as often as it requires good animal care practice. The use of pesticides must be documented.
7): Test systems for open-air tests shall be designed in such a way as to avoid any influence on the test by spray mist drift or plant protection products used in the past.

6 Test and Reference Items

6.1

Entrance, handling, removal and storage

1): Records shall be kept, showing the characterisation of the test and reference objects, the date of receipt, the expiry date, the quantities received and the quantities used in the tests.
2): Handling, removal and storage procedures shall be determined in such a way as to ensure that homogeneity and stability are as far as possible and that impurities or confusion are excluded.
3): Labelling particulars, expiry date and special storage instructions shall be affixed to the storage containers.

6.2

Characterization

1): Each test and reference object shall be identified in a suitable manner (e.g. B. by Code, Chemical-Abstracts-Register-Number (CAS number), designation, biological parameters).
2): For each test, identity, including batch number, purity, composition, concentration or other characteristics, shall be known for the characterisation of each batch of test or reference objects.
3): In the case of the supply of the test subject by a contracting entity, a procedure shall be established in cooperation between the contracting authority and the auditor, in which way the identity of the test object used in the test shall be unambiguous is confirmed.
4): The stability of the test and reference objects under storage and test conditions must be known for all tests.
5): If the test object is to be administered in a carrier, the homogeneity, concentration and stability of the test object in this carrier material must be determined. For test items for open-air tests (e.g. B. Injection liquids) these parameters may be determined by separate laboratory tests.
6): For possible analytical hedging, a reset pattern shall be kept from each batch of a test subject used in a test, with the exception of short-term tests.

7 standard operating procedures (Standard Operating Procedures, SOPs)

1)

A test facility must have written standard operating instructions approved by its management and intended to ensure the quality and reliability of the data obtained in the course of the examination in the test facility. . Also, the revised versions of the standard operating instructions must be approved by the management of the test facility.

2)

Each individual unit of work and each individual work area of the test facility must be available directly to the standard operating instructions that are relevant to the work carried out there. Published textbooks, analytical methods and specialist articles as well as operating instructions can be used as a supplement to these standard instructions.

3)

Test-related deviations from standard operating instructions must be documented and confirmed by the investigator and, where appropriate, by the local test manager.

4)

Default work instructions must be at least for the following areas, where the details given under the headings are to be considered as illustrative examples:

1.

Testing and reference counter-input, identification, marking, handling, removal and storage.

2.

Equipment, materials and reagents

a): Equipment operation, maintenance, cleaning, calibration;
b): Computer-aided system validation, operation, maintenance, security, controlled system change (change control) and data backup (back-up);
c): Materials, reagents and solutionsPreparation and labelling.

3.

Record, report, retain and re-encode the audits, collect data, report, index systems, deal with data, including the use of computer-based systems.

4.

Test systems as far as relevant for the test

a): Preparation of rooms and room environmental conditions for test systems;
b): Procedures for the receipt, implementation, proper accommodation, characterisation, identification and supply of the test systems;
c): Preparation, observation and examination of the test systems before, during and at the end of the test;
d): the handling of animals which are found in the course of the moribund or dead test;
e): Collection, marking and handling of samples, including section and histopathology;
f): Installation and site selection of test systems on test surfaces.

5.

Quality assurance process of quality assurance personnel in the organizational and scheduling planning, implementation, documentation and reporting of inspections.

8 Examination procedure

8.1

Audit Plan

1): A written test plan must be available prior to the start of each examination. The test plan shall be approved by the investigator by the date of signature and shall be verified by the quality assurance staff on GLP conformity in accordance with point 2.2 (b) of Section II.
(2a): Changes in the test plan must be justified and approved by the certified signature of the test manager and must be kept together with the test plan.
(2b): Test plan deviations must be immediately described, explained, confirmed and dated and kept together with the raw data by the test manager and the responsible local test manager.
(3): In the case of short-term examinations, a standard test plan can be used with examination-specific supplements.

8.2

Contents of the test plan The test plan shall contain at least the following information:

1)

Name of the test, the test and reference objects

a): descriptive title;
b): Declaration on the nature and purpose of the audit;
c): Name of the test subject by code or name (IUPAC, CAS number, biological parameters, etc.);
d): the reference object to be used.

2)

Information on the adjudicating entity and the verifier

a): the name and address of the contracting authority;
b): the name and address of the test facility and any other test facilities and test sites involved in the test;
c): the name and address of the investigator;
d): Name and address of the local test manager and the name of the stages of the test, which have been placed under his responsibility by the investigator.

3)

Dates

a): The date of approval of the audit plan by the signature of the investigator.
b): Expected dates for the beginning and end of the experimental phase of the test.

4)

Test method reference to the OECD test guidelines to be applied or other test guidelines or methods to be applied.

5)

Individual details, if relevant for the examination

a): Justification for the selection of the test system;
b): Characterisation of the test system, such as animal species, strain, sub-strain, origin, number, body weight range, gender, age and other relevant information;
c): the method of application and the justification for their choice;
d): Doses and concentrations, frequency and duration of the application;
e): Detailed information on the overall experimental planning, including the chronological description of the test run, all methods, materials and conditions, as well as the nature and frequency of the analyses, measurements, observations and observations to be carried out. Studies and the statistical procedures which may be used.

6)

Record list of records to be kept.

8.3

Conduct of the audit

1): Each test must be given an unmistakable name. All documents and materials relating to this test shall have this name. Samples taken from the test shall be labelled in such a way that their origin is clearly comprehensible. Such a marking serves for the traceability of the sample to a certain test.
2): The test shall be carried out in accordance with the test plan.
3): All data collected during the examination shall be recorded immediately, immediately, accurately and legibly by the person in charge. These records are to be signed or signed.
4): Any change in the raw data shall be carried out in such a way as to show the original record; it shall be accompanied by a justification and by the date and signature or the abbreviation or abbreviation of the person making the change.
5): Data that are generated as a direct computer input are to be marked at the time of data entry by the persons responsible for this. Computer-assisted systems must be designed to ensure that, at all times, the recording of a full audit trail is available, indicating all data changes, without making the original data unrecognizable. All data changes must be able to be associated with the person changing them, for example: B. by using date and time (electronic) signatures. Changes must be justified.

9 Report on test results

9.1

General

1): A final report must be created for each check. In the case of short-term examinations, a standard final report can be prepared with examination-specific additions.
2): Each report of a local investigator or specialists involved in the examination shall be required to be signed by the said report.
3): The final report must be signed by the investigator in order to document the assumption of responsibility for the reliability of the data. It should also be stated to what extent the audit is in accordance with these principles of good laboratory practice.
4): Corrections and additions to a final report shall be carried out in the form of supplementary reports. In these supplements, the reasons for the corrections or additions are to be clearly stated and signed by the investigator.
5): A reformatting of the final report for the fulfilment of the admission requirements of a national evaluation authority does not constitute a correction, addition or amendment of the final report in the above sense.

9.2

Contents of the final report The final report must contain at least the following information:

1)

Name of the test, the test and reference objects

a): descriptive title;
b): Name of the test subject by code or name (IUPAC, CAS number, biological parameters, etc.);
c): the name of the reference object by the name;
d): Characterization of the test object including purity, stability and homogeneity.

2)

Information on the adjudicating entity and the verifier

a): the name and address of the contracting authority;
b): the name and address of all the testing facilities and test sites involved;
c): the name and address of the investigator;
d): the name and address of the local test manager and the delegated phases of the test, where applicable;
e): Name and address of scientists who have contributed to reports on the final report.

3)

Time at the beginning and end of the experimental phase of the test.

4)

the declaration of quality assurance, the nature and timing of the inspections, the phases of the inspection inspected and the dates on which the management and the investigator, and, where appropriate, a local test manager, shall be responsible for: Inspection results have been reported. 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 methods and materials used;
b): Reference to OECD audit guidelines or other audit policies/methods.

6)

Results

a): Summary of results;
b): all information and data required in the test plan;
c): the presentation of the results, including the calculations and the statistical significance;
d): Evaluation and discussion of the results and, where appropriate, conclusions.

7)

Storage locations of the audit plan, the samples, raw data and the final report of the test and reference objects.

10 Archiving and storage of recordings and materials

10.1

Only persons authorized to do so may have access to the archives. Records shall be kept for collection and return.

10.2

The following is to be kept in the archives for 15 years:

a): the test plan, the raw data, the recovery pattern of test and reference objects, samples and final report of each test;
b): records of all inspections carried out in accordance with the Quality Assurance Programme and the list of the status of all examinations (Master Schedule);
c): records of initial, continuing and continuing training and practical experience of staff, as well as the descriptions of tasks;
d): records and reports on the maintenance and calibration of the equipment;
e): Validation documents for computerised systems;
f): chronological filing of all standard operating instructions;
g): Records for monitoring environmental conditions.

If no archiving period has been set in sentence 1 for certain test-relevant materials, the disposal of such materials must be documented. If return samples of test and reference objects are disposed of before the end of the specified archiving period, this is to be justified and documented. Samples of test and reference objects as well as samples shall only be kept for as long as their quality allows an assessment.

10.3

Archived material is to be indexed in order to make it easier to store and retrieve properly.

10.4

If a test facility or a contract archive cees the activity and has no legal successor, the archive shall be transferred to the archives of the clients of the exams.

Unofficial table of contents

Annex 2 (to § 19b (1))
Country Seal/Coloured Logo Good Laboratory Practice/Good Laboratory Practice GLP Certification/Statement of GLP Compliance
(according to § 19b (1) of the Chemicals Act)

(Fundstelle: BGBl. I 2013, 3532)

A GLP inspection to monitor compliance with GLP principles in accordance with the Chemicals Act and/or Directive 2004 /9/EC has been carried out in:

Assessment of conformity with GLP according to chemicals law and Directive 2004 /9/EC at:

□ Test facility/test facility □ Test site/test site (unmistakable name and address/unequivocal name and address) Tests by category/areas of expertise (moderate/according to ChemVwV-GLP No. 5.3/OECD guidance) Date of inspection/date of Inspection (day.month.year/day.month.year)

The test facility/test site is located in the national GLP monitoring procedure and is regularly monitored for compliance with GLP principles.		The above mentioned test facility/test site is included in the national GLP Compliance Programme and is inspected on a regular basis.
On the basis of the inspection report, it is hereby confirmed that the above-mentioned tests can be carried out in compliance with GLP principles in this test facility/test site.		Based on the inspection report it can be confirmed, that this test facility/test site is able to conduct the studies in compliance with the Principles of GLP.

Signature, Date/Signature, Date (name and function of responsible person/
Name and function of responsible person) (name and address of the GLP monitoring authority/
Name and address of the GLP Monitoring Authority)