Regulation On Expenses For Official Acts Of The Federal Authorities Under The Chemicals Act

Original Language Title: Verordnung über Kosten für Amtshandlungen der Bundesbehörden nach dem Chemikaliengesetz

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Regulation on the costs of official acts of the federal authorities according to the Chemicals Act (Chemicals Costs Regulation-ChemKostV)

Non-official table of contents

ChemKostV

Date of expend: 16.08.1994

Full quote:

" Chemical cost regulation in the version of the announcement of the 23. May 2014 (BGBl. I p. 591) "

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

For details, see Notes

Footnote

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



Non-official table of contents

§ 1 Fees

(1) The Federal Institute for Occupational Safety and Health Charges for individually attributable public services, which it provides as a federal agency for chemicals under the Chemicals Act, subject to rates 2 and 3 fees in accordance with 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 in accordance with Article 55 (1). The first subparagraph of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 June 2012 May 2012 on the making available on the market and use of biocidal products (OJ L 327, 28.5.2012, p. 1). Fees as referred to in point 1.8.5 of the applicable fee list. The Federal Institute for Risk Assessment (Bundesinstitut für Risk Assessment) charges fees according to point 2.1 of the applicable fee list for the issuing of confirmations for good laboratory practice in accordance with § 19b (2) (3) of the Chemicals Act. 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. results.(2) Requges an individually attributable public service, for which a fixed charge rate is provided in the charging list, an exceptionally high cost in individual cases, the fee may be increased to twice this rate.(3) Requges an individually attributable public service, for which a rate of charge is provided for in the list of fees, less work than the processing of a form requires, because the approval or notification documents electronically or on a magnetic medium, the fee may be reduced by up to 500 Euro. 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 if a special charge is given to the placing on the market of the substance or the biocidal product. the public interest and the applicant cannot expect an economic benefit commensurate with the charges and development costs. Unofficial table of contents

§ 4 Revocation and withdrawal

In the cases of revocation or withdrawal of an administrative act and the rejection or withdrawal of an administrative act, or the withdrawal of an application for the acceptance of an individually attributable public service 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 appeals procedure

For the appeal proceedings against a federal authority responsible for the appeal proceedings Law adopted does not apply to charges and deposits. Non-official table of contents

§ 6 Transitional rules

This regulation also applies to individually attributable public services, which already from the 1. September 2013 has been requested or started, but up to 30 years. It was not fully completed in April 2014. For the collection of fees and charges for an individually attributable public service, which is prior to the 1. The chemicals-cost regulation in the up to 31 September 2013 has been requested or started, but has not yet been fully completed. 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 Ordinance in the up to 31. August 2013 shall apply. Non-official table of contents

Asset (to § 1 paragraph 1)
Fees Directory

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

Charge Nr.Fee Fee in
Euro
1 Procedure of Regulation (EU) No 528/2012 pursuant to § 12a (3) and § 12b ChemG
1.1 EU Ingredient Approvals
1.1.1 Evaluation of an application for 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, if applicable plus Additional fee according to no. 1.1.2 189 800
1.1.2 Additional fee for each additional product type when approving an active substance according to no. 1.1.1 47 500
1.1.3 Evaluation of an application for renewal of the approval of an active substance in accordance with Article 14 of Regulation (EU) No 528/2012, in which a comprehensive assessment is required, if necessary plus additional fee according to no. 1.1.4 94 900
1.1.4 Additional fee for each additional product type in the renewal of the approval of an active substance according to no. 1.1.3 15 800
1.1.5 Evaluation of an application for an extension of the approval of an active substance in accordance with Article 14 of Regulation (EU) No 528/2012, in which: no comprehensive assessment is required, if necessary plus additional fee according to No. 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 no. 1.1.5 15 800
1.2 National Product Leases
1.2.1 National approval pursuant to Article 29 of the Regulation (EU) No 528/2012
a) of a biocidal product, if applicable plus additional fees according to No. 1.950 000
b) of a biocidal product family, if applicable plus additional fees according to No. 1.9 75 000
1.2.2 National approval pursuant to Article 29 of Regulation (EU) No 528/2012 
a) of a biocidal product, which is identical to the reference product that has been evaluated for EU drug approval14 300
b) one 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 Preliminary approval pursuant to Article 55 (2) of Regulation (EU) No 528/2012
a) of a biocidal product, if applicable plus additional fees according to No. 1.955 000
b) one Biocidal product family, if necessary plus additional fees according to No. 1.9 82 500
1.2.4 Preliminary approval pursuant to Article 55 (2) of Regulation (EU) No 528/2012 
a) of a biocidal product, which is identical to the reference product that has been evaluated for EU active substance approval19 300
b) one 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 approval 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 applicable plus additional fees according to No. 1.950 500
b) of a biocidal product family, if applicable plus additional fees according to No. 1.9 75 750
1.2.6 National approval in accordance with Article 29 of Regulation (EU) No 528/2012 in conjunction with Article 34 (1) of the Regulation (EU) No 528/2012
a) of a biocidal product which is identical to the reference product evaluated for EU active substance approval14 800
b) of a biocidal product family that is identical to the reference product family that has been evaluated for EU drug approval 20 300
1.2.7 Extension of a national authorisation in accordance with Article 31 of Regulation (EU) No 528/2012, where a comprehensive assessment is required. In case
a) of a biocidal product50 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, in which no comprehensive assessment is required. In case
a) of a biocidal product25,000
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 authorisations
1.3.1 Simplified approval pursuant to 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 referred to in Article 27 (1) of the Regulation (EU) No 528/2012 of the provision on the market
a) a biocidal product approved according to the simplified approval procedure1 200
b) a biocidal product family approved in accordance with the simplified authorisation procedure 1 800
1.3.3 Extension of a simplified admission
a) of a biocidal product6 700
b) of a biocidal product family 10 100
1.4 Admission of an identical biocidal product
1.4.1 Admission pursuant to a regulation pursuant to Article 17 (7) of Regulation (EU) No. 528/2012
a) of a same biocidal product1 200
b) of a same biocidal product family 1 800
1.5 Mutual recognitions
1.5.1 Admission 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 product15 500
b) of a biocidal product family 23 300
1.5.2 Extension of a mutual recognition pursuant to Article 33 (1) or Article 34 (2) of Regulation (EU) No 528/2012
a) of a biocidal product3 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 applicable plus additional fees according to no. 1.9 60 000
b) of a biocidal product family, if applicable plus additional fees according to No. 1.9 90 000
1.6.2 Evaluation of an application for Union authorisation after Article 44 of Regulation (EU) No 528/2012
a) of a biocidal product, which is identical to the reference product evaluated for EU active substance approval28 500
b) of a biocidal product family that is identical to the reference product family that has been evaluated for EU drug approval 42 700
1.6.3 Evaluation of an application for provisional EU authorisation under Article 44 of Regulation (EU) No 528/2012
a) of a biocidal product, if applicable plus additional fees according to No. 1.9 65 000
b) of a biocidal product family, if applicable plus additional fees according to No. 1.9 97 500
1.6.4 Evaluation of an application provisional authorisation of the Union, pursuant to Article 44, in conjunction with Article 55 (2) of Regulation (EU) No 528/2012
a) of a biocidal product which is identical to the reference product for the EU-active substance approval rated33 500
b) of a biocidal product family, which is identical to the reference product family, which is EU active substance approval rating was assessed 50 200
1.6.5 Evaluation of an application for renewal of the Union authorisation in accordance with Article 45 of Regulation (EU) No 528/2012, where a comprehensive assessment is required. In case
a) of a biocidal product60 000
b) of a biocidal product family 90 000
1.6.6 Evaluation of an application for renewal of the Union authorisation in accordance with Article 45 of Regulation (EU) No 528/2012, in which no comprehensive assessment is required. In case
a) of a biocidal product30 000
b) of a biocidal product family 45 000
1.7 Changes in national product approvals, union approvals and mutual recognitions 
1.7.1 Change of approval pursuant to Article 50 of the Regulation (EU) No 528/2012, where administrative changes are required. In case
a) of a biocidal product350
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 required, provided that the Federal Agency for Chemicals (Bundesstelle für Chemicals) is to modify the amendment in accordance with the implementing act referred to in Article 51 of the Regulation (EU) No 528/2012. In case
a) of a biocidal product3 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 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 (EU) No 528/2012. In case
a) of a biocidal product37 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 Regulation (EU) No 528/2012. In case
a) of a biocidal product37 100
b) of a biocidal product family 55 700
1.7.5 Amendment of an authorisation in accordance with Article 50 of Regulation (EU) No 528/2012, where minor changes are required, provided that the implementing act does not include a separate assessment pursuant to Article 51 of Regulation (EU) No 528/2012 is carried out by the Federal Office of Chemicals. In case
a) of a biocidal product350
b) of a biocidal product family 530
1.7.6 Amendment of an authorisation in accordance with Article 50 of Regulation (EU) No 528/2012, which requires substantial changes, provided that the implementing act in accordance with Article 51 of Regulation (EU) No 528/2012 does not make its own assessment by: the Federal Agency for Chemicals is taking place. In case
a) of a biocidal product3 800
b) of a biocidal product family 5 700
1.8 Other Applications and Messages
1.8.1 Examination of the admissibility of a Regulation pursuant to Article 56 (2) of the Regulation (EU) No 528/2012 for the experiment or experiment to be reported 2 900
1.8.2 Approval for parallel trade in accordance with Article 53 (1) of Regulation (EU) No. 528/2012 230
1.8.3 Approval of a request for confidential treatment of data pursuant to Article 66 (4) of Regulation (EU) No 528/2012, Information 120
1.8.4 Exhibition of a traffic capability certificate    120
1.8.5 Exception authorisation pursuant to the first subparagraph of Article 55 (1) of Regulation (EU) No 528/2012 or § 12g (3) ChemG 2 500
1.9 Additional charges for Product approvals according to point 1.2.1 or no. 1.6.1
1.9.1 The more active ingredient it contains
a) in a biocidal product4 000
b) in a biocidal product family 6 000
1.9.2 Per additional product type
a) of a biocidal product4 000
b) of a biocidal product family 6 000
1.9.3 Per additional user category
a) of a biocidal product 4 000
b) of a biocidal product family 6 000
1.9.4 Comparative evaluation of each containing Active ingredient
a) in a biocidal product10 000
b) in a biocidal product family 15 000
1.9.5 Cooperation in setting 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 working hour of a GLP inspector;
at most 25 000
2.2 Method of 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 196, 27.7.2012, p. 60) in accordance with Article 21 (2), second sentence, ChemG
2.2.1 Examination and forwarding of an export message pursuant to Article 8 (2) or (4) of the Regulation (EU) No 649/2012 to the European Commission, provided that the substance is listed exclusively in Annex I, Part 1 of this Regulation    100
2.2.2 Examination and forwarding of an export message pursuant to Article 8 (2) or (4) of Regulation (EU) No 649/2012 to the European Commission, provided that the substance is listed in addition to part 2 or 3 of Annex I to this Regulation      250