Ordinance on the costs of official acts of the federal authorities in accordance with the Chemicals Act (Chemicals-Costing of costs-ChemKostV)

Unofficial table of contents

ChemKostV

Date of completion: 16.08.1994

Full quote:

" Chemical cost regulation as amended by the announcement of 23 May 2014 (BGBl. I p. 591) "

V up. by Article 4 (102) iVm Art. 5 Abs. 3 G v. 7.8.2013 I 3154 mWv 14.8.2018
Status:	New by Bek. v. 23.5.2014 I 591

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 25.8.1994 + + +) 
(+ + + expressed by the legislator on EC law: 
 Implementation of the 
 ERL 8/98 (CELEX Nr: 31998L0008)  V v. 1.7.2002 I 2440   
 Implementation of the   
 EGV 1907/2006 (CELEX Nr: 32006R1907)  G v. 20.5.2008 I 922 
 Implementation of the 
 ERL 121/2006 (CELEX Nr: 32006L0121)  G v. 20.5.2008 I 922 
 ERL 24/98 (CELEX Nr: 31998L0024) see  G v. 20.5.2008 I 922 + + +) 
  

  

Unofficial table of contents

§ 1 Fees

(1) The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) charges for individually attributable public services, which it provides as a federal agency for chemicals under the Chemicals Act, subject to the rates 2 and 3 fees according to the the applicable fee list. The Robert Koch Institute and the Federal Office for Consumer Protection and Food Safety raise the issue within the limits of their respective responsibilities under Article 12a (3) (3) (1) and (2) of the Chemicals Act for exceptional authorisations under Article 55 (1) of the Chemicals Act. The first subparagraph 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 the use of biocidal products (OJ L 327, 30.4.2012, p. 1). Fees as referred to in point 1.8.5 of the applicable fee list. According to § 19b (2) (3) of the Chemicals Act, the Federal Institute for Risk Assessment collects fees in accordance with point 2.1 of the applicable fee list for the issuing of confirmations for good laboratory practice. The charges are included in the fee rates in accordance with § 23 (6) sentence 2 of the Federal Law on Fees in conjunction with § 10 (1) (1), (2), (4), (7) and (8) of the Administrative Costing Act, unless something else from the charge list is different. (2) Requges an individually attributable public service, for which a fixed rate of charge is provided in the charging list, in individual cases an exceptionally high cost, the fee may be increased to twice the rate of this rate (3) Calls for an individually attributable public service, for which the If a charge record is provided for a fee, less work is required than the processing of a form, because the approval or notification documents are transmitted electronically or on a magnetic medium, it may be necessary to: the fee will be reduced by up to 500 euros. Unofficial table of contents

§ 2 (omitted)

Unofficial table of contents

§ 3 Fee reduction

At the request of the fee debtor, a fee reduction or a waiver of fees may be granted where there is a particular public interest in the placing on the market of the substance or of the biocidal product and the applicant is entitled to: It is not possible to expect adequate economic benefits for fees and development costs. Unofficial table of contents

Section 4 Revocation and withdrawal

In the cases of withdrawal or withdrawal of an administrative act, as well as the rejection or withdrawal of an application for the acceptance of an individually attributable public service, fees shall be charged in accordance with the provisions of section 23 (5), first sentence, and 2 of the Federal Law on Fees. Unofficial table of contents

§ 5 Opposition procedure

Fees and charges shall not be levied for the opposition proceedings against a administrative act issued by the competent federal authority pursuant to this Act. Unofficial table of contents

§ 6 Transitional Regulation

This Regulation shall also apply to individually attributable public services, which have already been applied for or started from 1 September 2013 but have not yet been fully provided until 30 April 2014. For the collection of fees and expenses for an individually attributable public service, which is requested or started before 1 September 2013, but has not yet been fully provided, the Chemicals Cost Regulation is in the up to 31. The amended version will continue to be applied in August 2013 In the case of the second sentence, where the authorisation of a biocidal product pursuant to Article 91 of Regulation (EU) No 528/2012 already takes place in accordance with the provisions of Regulation (EU) No 528/2012, the fee stocks shall be found in accordance with point 4 of the Regulation Toll list of the Chemicals-Cost Regulation in the version valid until 31 August 2013 applicable. Unofficial table of contents

Annex (to § 1 (1))
Charge directory

(Fundstelle: BGBl. I 2014, 593-597)


Fees-Nr.Fee charge fee in Euro

1	Procedure of Regulation (EU) No 528/2012 pursuant to § 12a (3) and § 12b ChemG
1.1	EU Drug Approvals
1.1.1	Evaluation of an application for the approval of an active substance as referred to in Article 8 or on the basis of an application for an EU Regulation pursuant to Article 28 (5) of Regulation (EU) No 528/2012, where applicable plus additional fee according to item 1.1.2		189 800
1.1.2	Additional fee for each additional product type in the approval of an active substance according to point 1.1.1		47 500
1.1.3	Evaluation of an application for the renewal of the approval of an active substance in accordance with Article 14 of Regulation (EU) No 528/2012, where a comprehensive assessment is required, where applicable Plus additional fee as per 1.1.4		94 900
1.1.4	Additional fee for each additional product type in the extension of the approval of an active substance according to point 1.1.3		15 800
1.1.5	Evaluation of an application for the renewal of the approval of an active substance in accordance with Article 14 of Regulation (EU) No 528/2012, where no comprehensive assessment is required, if necessary Plus additional fee according to 1.1.6		47 500
1.1.6	Additional fee for each additional product type in the extension of the approval of an active substance according to point 1.1.5		15 800
1.2	National product approvals
1.2.1	National authorisation pursuant to Article 29 of Regulation (EU) No 528/2012
	a)	of a biocidal product, if appropriate plus additional fees as set out in point 1.9	50 000
	b)	a biocidal product family, if necessary plus additional fees as set out in point 1.9	75 000
1.2.2	National authorisation pursuant to Article 29 of Regulation (EU) No 528/2012
	a)	a biocidal product which is identical to the reference product which has been evaluated for EU-active substance approval	14 300
	b)	a biocidal product family which is identical to the reference product family which has been evaluated for EU-active substance approval	19 600
1.2.3	Provisional authorisation referred to in Article 55 (2) of Regulation (EU) No 528/2012
	a)	of a biocidal product, if appropriate plus additional fees as set out in point 1.9	55 000
	b)	a biocidal product family, if necessary plus additional fees as set out in point 1.9	82 500
1.2.4	Provisional authorisation referred to in Article 55 (2) of Regulation (EU) No 528/2012
	a)	a biocidal product which is identical to the reference product which has been evaluated for EU-active substance approval	19 300
	b)	a biocidal product family which is identical to the reference product family which has been evaluated for EU-active substance approval	27 100
1.2.5	National authorisation in accordance with Article 29 of Regulation (EU) No 528/2012 in conjunction with Article 34 (1) of Regulation (EU) No 528/2012
	a)	of a biocidal product, if appropriate plus additional fees as set out in point 1.9	50 500
	b)	a biocidal product family, if necessary plus additional fees as set out in point 1.9	75 750
1.2.6	National authorisation in accordance with Article 29 of Regulation (EU) No 528/2012 in conjunction with Article 34 (1) of Regulation (EU) No 528/2012
	a)	a biocidal product which is identical to the reference product which has been evaluated for EU-active substance approval	14 800
	b)	a biocidal product family which is identical to the reference product family which has been evaluated for EU-active substance approval	20 300
1.2.7	Extension of a national authorisation in accordance with Article 31 of Regulation (EU) No 528/2012, which requires a comprehensive assessment. In case of
	a)	of a biocidal product	50 000
	b)	of a biocidal product family	75 000
1.2.8	Extension of a national authorisation in accordance with Article 31 of Regulation (EU) No 528/2012, where no comprehensive assessment is required. In case of
	a)	of a biocidal product	25 000
	b)	of a biocidal product family	37 500
1.2.9	Registration of a biocidal product belonging to a biocidal product family in accordance with Article 17 (6) of Regulation (EU) No 528/2012		1 200
1.3	Simplified product approvals
1.3.1	Simplified authorisation in accordance with Article 26 of Regulation (EU) No 528/2012
	a)	of a biocidal product	13 400
	b)	of a biocidal product family	20 100
1.3.2	Registration in accordance with Article 27 (1) of Regulation (EU) No 528/2012 of the provision on the market
	a)	of a biocidal product authorised in accordance with the simplified authorisation procedure	1 200
	b)	a biocidal product family authorised in accordance with the simplified authorisation procedure	1 800
1.3.3	Extension of a simplified authorisation
	a)	of a biocidal product	6 700
	b)	of a biocidal product family	10 100
1.4	Authorisation of the same biocidal product
1.4.1	Authorisation pursuant to a Regulation referred to in Article 17 (7) of Regulation (EU) No 528/2012
	a)	of an identical biocidal product	1 200
	b)	of the same biocidal product family	1 800
1.5	Mutual recognitions
1.5.1	Authorisation by mutual recognition in accordance with Article 33 (1), Article 34 (2) or Article 39 of Regulation (EU) No 528/2012
	a)	of a biocidal product	15 500
	b)	of a biocidal product family	23 300
1.5.2	Extension of mutual recognition referred to in Article 33 (1) or Article 34 (2) of Regulation (EU) No 528/2012
	a)	of a biocidal product	3 500
	b)	of a biocidal product family	5 300
1.6	Union authorisations
1.6.1	Evaluation of an application for Union authorisation in accordance with Article 44 of Regulation (EU) No 528/2012
	a)	of a biocidal product, if appropriate plus additional fees as set out in point 1.9	60 000
	b)	a biocidal product family, if necessary plus additional fees as set out in point 1.9	90 000
1.6.2	Evaluation of an application for Union authorisation in accordance with Article 44 of Regulation (EU) No 528/2012
	a)	a biocidal product which is identical to the reference product which has been evaluated for EU-active substance approval	28 500
	b)	a biocidal product family which is identical to the reference product family which has been evaluated for EU-active substance approval	42 700
1.6.3	Evaluation of an application for a provisional Union authorisation pursuant to Article 44 of Regulation (EU) No 528/2012
	a)	of a biocidal product, if appropriate plus additional fees as set out in point 1.9	65 000
	b)	a biocidal product family, if necessary plus additional fees as set out in point 1.9	97 500
1.6.4	Assessment of an application for provisional Union authorisation pursuant to Article 44 in conjunction with Article 55 (2) of Regulation (EU) No 528/2012
	a)	a biocidal product which is identical to the reference product which has been evaluated for EU-active substance approval	33 500
	b)	a biocidal product family which is identical to the reference product family which has been evaluated for EU-active substance approval	50 200
1.6.5	Evaluation of an application for an extension of the Union authorisation in accordance with Article 45 of Regulation (EU) No 528/2012, which requires a comprehensive assessment. In case of
	a)	of a biocidal product	60 000
	b)	of a biocidal product family	90 000
1.6.6	Evaluation of an application for an extension of the Union authorisation in accordance with Article 45 of Regulation (EU) No 528/2012, where no comprehensive assessment is required. In case of
	a)	of a biocidal product	30 000
	b)	of a biocidal product family	45 000
1.7	Changes in national product approvals, Union authorisations and mutual recognition
1.7.1	Amendment of an authorisation in accordance with Article 50 of Regulation (EU) No 528/2012, where administrative changes are necessary. In case of
	a)	of a biocidal product	350
	b)	of a biocidal product family	530
1.7.2	Amendment of an authorisation in accordance with Article 50 of Regulation (EU) No 528/2012, where minor changes are necessary, provided that the Federal Agency for Chemicals (Bundesstelle für Chemicals) is subject to change in accordance with the implementing act referred to in Article 51 of Regulation (EC) No 528/2012. (EU) No 528/2012. In case of
	a)	of a biocidal product	3 800
	b)	of a biocidal product family	5 700
1.7.3	Amendment of an authorisation in accordance with Article 50 of Regulation (EU) No 528/2012, which requires substantial changes, provided that the Federal Chemicals Agency (Bundesstelle für Chemicals) is subject to the amendment in accordance with the implementing act referred to in Article 51 of the Regulation (EU) No 528/2012. In case of
	a)	of a biocidal product	37 100
	b)	of a biocidal product family	55 700
1.7.4	Amendment of a Union authorisation in accordance with Article 50 of Regulation (EU) No 528/2012, which requires substantial changes, provided that the Federal Agency for Chemicals (Bundesstelle für Chemicals) is subject to the amendment in accordance with the implementing act referred to in Article 51 of the Regulation (EC) No 528/2012 Regulation (EU) No 528/2012. In case of
	a)	of a biocidal product	37 100
	b)	of a biocidal product family	55 700
1.7.5	Amendment of an authorisation referred to in Article 50 of Regulation (EU) No 528/2012 requiring minor modifications, provided that the implementing act referred to in Article 51 of Regulation (EU) No 528/2012 does not include an evaluation of its own by the Federal Agency for Chemicals is carried out. In case of
	a)	of a biocidal product	350
	b)	of a biocidal product family	530
1.7.6	Amendment of an authorisation referred to in Article 50 of Regulation (EU) No 528/2012, which requires substantial changes, provided that the implementing act referred to in Article 51 of Regulation (EU) No 528/2012 does not include an evaluation of its own by the Federal Agency for Chemicals is carried out. In case of
	a)	of a biocidal product	3 800
	b)	of a biocidal product family	5 700
1.8	Other applications and notifications
1.8.1	Examination of the admissibility of an experiment or trial to be reported in accordance with Article 56 (2) of Regulation (EU) No 528/2012		2 900
1.8.2	Authorisation for parallel trade in accordance with Article 53 (1) of Regulation (EU) No 528/2012		230
1.8.3	Authorisation of a request for confidential treatment of data pursuant to Article 66 (4) of Regulation (EU) No 528/2012, per information		120
1.8.4	Issue of a certificate of transport capability		120
1.8.5	Derogation provided for in the first subparagraph of Article 55 (1) of Regulation (EU) No 528/2012 or § 12g (3) ChemG		2 500
1.9	Additional fees for product approvals according to Nos. 1.2.1 or 1.6.1
1.9.1	The further active substance contained
	a)	in a biocidal product	4 000
	b)	in a biocidal product family	6 000
1.9.2	The further product type
	a)	of a biocidal product	4 000
	b)	of a biocidal product family	6 000
1.9.3	Per more user category
	a)	of a biocidal product	4 000
	b)	of a biocidal product family	6 000
1.9.4	Comparative assessment of the active substance contained
	a)	in a biocidal product	10 000
	b)	in a biocidal product family	15 000
1.9.5	Cooperation in the setting of maximum residue limits in accordance with Article 19 (7) of Regulation (EU) No 528/2012
	a)	of a biocidal product	5 000
	b)	of a biocidal product family	7 500
2	Other individually attributable public services
2.1	Exhibition of confirmation of good laboratory practice in accordance with § 19b (2) (3) ChemG		78 per hour of the working hour of a GLP inspector; maximum 25 000
2.2	Procedure laid down in Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 on the export and import of dangerous chemicals (OJ L 327, 30.4.2012, p. OJ L 201, 27.7.2012, p. 60) pursuant to Article 21 (2), second sentence, ChemG
2.2.1	Examination and forwarding to the European Commission of an export message as referred to in Article 8 (2) or (4) of Regulation (EU) No 649/2012, provided that the substance is listed in Annex I, Part 1, of this Regulation		100
2.2.2	Examination and forwarding of an export message to the European Commission pursuant to Article 8 (2) or (4) of Regulation (EU) No 649/2012, provided that the substance is listed in addition to part 2 or 3 of Annex I to this Regulation.		250