Eighteenth Regulation 
 
on the Amendment of the Germ an Ordinance on Commodities ∗ 
 
of ……. 
 The Federal Ministry of Food, Agriculture a nd Consumer Protection decrees the following on 
the basis of  - Section 32 (1) Number 1 and 3 of the Food and Feed Code as amended on 26 April 2006 
(Federal Law Gazette I p. 945) in agreement w ith the Federal Ministry of Economics and 
Technology and  
- Section 46 (1), first sentence, number 2 of  the Food and Feed C ode as amended on 26 
April 2006 (Federal Law Gazette I p. 945): 
  
Article 1 
 The German Ordinance on Commodities, as  amended on 23 December 1997 (Federal Law 
Gazette 1998 I p. 5), last amended by the Ordina nce of .... (Federal Law Gazette I p. ...) shall 
be amended as follows:  1. The following Number 2 shall be added to Annex 4:  
 
1 2 3 
„2. 
 Commodities made of leather which are intended to 
come into prolonged contact with the human body, in particular clothing items, watchstraps, bags and rucksacks, chair covers, neck pouches and leather toys Procedures which ensure that 
chromium(VI) is detectable in the commodity using the method described in Annex 10 No 8.”  
 
2. The following Number 8 shall be added to Annex 10: 
                                                 
∗ The obligations under Directive 98/34/EC of the European Parlia ment and of the Council of 22 June 1998 laying down a procedure  for the 
provision of information in the field of technical standards and regul ations and under the rules on Information Society service s (OJ EC No. L 
204, p. 37), last amended by Council Directive 98/48/EC of 20. 07.98 (OJ EC No. L 217, p. 18), have been complied with.   
  
1 2 3 
„8. Determining the chromium(VI) 
content Method of analysis which has been 
published in the Official List of test methods pursuant to Section 64 (1) of the Food and Feed Code under the classification code B 82.02-11 as of 2008-10.”  
 
 
Article 2 
Entry into force 
 
This Ordinance shall take eff ect on the day after promulgation. 
___________________ 
 The Bundesrat has given its consent.    Bonn,  
  
Federal Minister of Food, 
Agriculture and Consumer Protection   
 Rationale 
 
A. General Part  
 About 80 % of leather produced throughout the world is tanned using chromium salts. 
Contamination of commodities with chromium(VI) is techni cally avoidable by conducting 
appropriate processes and by using conventional auxiliary agents.  
 When in contact with skin, chromium(VI) may provoke irritable/toxic or  allergic eczema. The 
allergenic effects of chromium(VI) may cause life-long sensitization wi th manifest contact 
dermatitis. Chromium(VI) is among the most importa nt allergenic substances in terms of the 
frequency of occurrences of sensitization. The aim should be to minimise both the 
sensitization rate among the population and th e frequency of the occurrence of allergic 
reactions regarding co ntact allergies.  
 Clinical data on protective gloves indicate that concentrations of more that 5 milligrams of 
chromium(VI) per kg of leather may cause painful and therapy-resistant dermatitides. To avoid allergies, chromium(VI) must not be  detectable in personal protective equipment 
(PPE) such as work gloves. The analytical detection limit stated in ISO 17075:2007 “Leather 
– Chemical tests – Determination of ch romium(VI) content” or in DIN EN 420:2003 
“Protective gloves – Genera l requirements and test me thods” is 3 milligrams of 
chromium(VI) per kg of leather.  In order to avoid an allergic disorder cau sed by chromium(VI) from commodities made of 
leather which are intended to come into pr olonged contact with the human body or from 
leather toys, it should be prescribed from now on that these products – similarly to the rules 
on PPE – should also be produced in such a wa y that the residual c ontent of allergenic 
chromium(VI) is undetectable.    The implementation of the Ordinance shall not re sult in any costs for the Federal Government. 
 The Länder have mentioned the following costs:  
One-off costs: Approx.     - 
Annual personnel costs: Approx. EUR 5,000 Annual material costs: Approx. EUR 500 
  
 This revision may cause additional costs for the affected economic sectors, particularly small 
and medium-sized enterprises. The chance that minor cost-induced cha nges to the unit price 
may occur cannot be excluded. However, no effects on the price level, in particular the consumer price level, are to be expected.  
  B. Specific part
 
 re Article 1  
 For commodities made of leather which are inte nded to come into prolonged contact with the 
human body, and for  leather toys, it is prescrib ed that chromium(VI) must not be detectable 
in these products when Method B 82.02-11, as of 2008-10 and as described in the official list 
in Section 64 of the Food and Feed Code, is conducted.   re Article 2  Regulates the coming into force of the Ordinance.   
Footnotes: 
The obligations under Directive 98/34/EC of the European Parlia ment and of the Council of 22 June 1998 laying down a procedure for the 
provision of information in the field of technical standards and regul ations and under the rules on Information Society service s (OJ EC No. L 
204, p. 37), last amended by Council Directive 98/48/EC of 20. 07.98 (OJ EC No. L 217, p. 18), have been complied with.  
 
The obligations under Directive 98/34/EC of the European Parlia ment and of the Council of 22 June 1998 laying down a procedure for the 
provision of information in the field of technical standards and regul ations and under the rules on Information Society service s (OJ EC No. L 
204, p. 37), last amended by Council Directive 98/48/EC of 20 July 1998 (OJ EC No. L 217, p. 18), have been complied with.