EN EN
EUROPEAN
COMMISSION
Brussels, XXX
[…](2013) XXX draft
COMMISSION REGULATION (EU) No …/..
of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council on the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH) as regards chromium VI compounds
(Text with EEA relevance)EN 2 ENCOMMISSION REGULATION (EU) No …/..
of XXX
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council on the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH) as regards chromium VI compou nds
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 ,as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1,and in particular Article 68 
(1) thereof,
Whereas:
(1) On 19 January 2012 ,the Kingdom of Denmark submitted to the European Chemicals 
Agency (hereinafter ‘Agency ’)a dossier pursuant to Article 69(4) of Regulation (EC) 
No 1907/2006, in order to initiate the restriction sprocess in accordance with Articles 
69 to 73 of that Regulation (hereinafter ‘ Annex XV dossier’ ). In that dossier ,it was 
demonstrated that exposu re to chromium VI contained in leather articles or leather 
parts of articles , coming into contact with the skin, posesa risk to human health . 
Chromium VI compounds can induce new cases of sensiti sation and elicit allergic 
response . The dossier demonstrate s that action on a Union -wide basis is necessary .
(2) Chromium VI  compounds are formed in leather through the oxidation of chromium III
compounds , which are added in some tanning processes to cross -link the collagen 
subunits in order to increase leather's dime nsional stability ,as well as its resistance to 
mechanical action and heat . According to the Annex XV dossier ,the mechanisms of 
and conditions under which chromium VI isformed are known and most tanneries in 
the Union have alread y developed and widel y implemented measures in order to 
control and minimise its formation. 
(3) On 28 November 2012 the Committee for Risk Assessment (hereinafter ‘RAC’)
adopted byconsensus the opinion on the restriction proposed in the Annex XV 
dossier . According to the RAC opinion , the restriction isthe most appropriate Union -
wide measure to address theidentified risks posed by chromium VI comp ounds in 
leather, both in terms of effectiveness and practicability .However, in its opinion RAC 
proposed to modify the restriction by deleting the notion of direct and prolonged 
contact with the skin , originall y included in the Annex XV dossier.
  
1OJ L 396, 30.12.2006, p 1.EN 3 EN(4) The proposed restriction focuses onthe risk of induction of skin sensitisation related to 
direct or indirect skin contact with leather articles or leather parts of articles contain ing
chromium VI . In already sensitised people ,such contacts may also elicit allergic 
response at lower concentrations than those needed for the induction of sensitisation . 
(5) The proposed restriction should cover leather ar ticles and articles containing leather 
parts that ,under normal or reasonabl y foreseeable conditions of use, come into contact 
with the skin. This restriction should not be limited to consumers but should also cover 
workers, who are exposed to chromium VI  compounds in their activities undertaken at 
the workplace , through leather articles or leather parts of articles ,coming into contact 
with the skin ,such as gloves or shoes. 
(6) The EN ISO 17075 standard method is the onl y internationally recognised analytical 
method currently available to detect chromium VI in leather . The determination limit 
of the EN ISO 17075 standard method is 3 mg/kg (0 ,0003 % by weight) of chromium 
VIcontent in the total dry weight of the leather . Fixing s uch threshold for the 
restrict ion o fthe placing on the market of leather articles or articles containing leather 
parts is therefore justified for monitorability and enforceability purposes . 
(7) According to the RAC opin ion, t he threshold of 3 mg/kg (0 ,0003 % by weight) of 
chromium VI  content in the total dry weight of the leather corresponds to exposures 
higher than the Lowest-Observed Adverse Effect L evel for elicitation . According to 
the opinion of RAC, thatthreshold is expected to be 80% effective in reducing the 
occurrence of new chromium VI -related allergic dermatitis cases due to chromium VI 
in leather articles. 
(8) The effect iveness of the restriction on the number of cases of chromium allergy can be 
determined b y monitoring cases of chromium VI-related allergic dermatitis . Should 
the prevalence of the allergy  not decrease ,or should an analytical method to detect 
lower content of chromium VI become available and berecognised as reliable , this 
restriction should be reviewed . 
(9) On 6March 2013 the Committee for Socio -Economic Analy sis(hereinafter 'SEAC')
adopted by consensus the opinion on the restriction proposed in the Annex XV 
dossier. According to the SEAC opinion ,the restriction, as modified by RAC, is the 
most appropriate Union -wide measure to address the identified risks in te rms of the 
proportionality of its socio -economic benefits to its socio -economic costs .
(10) The Forum for Exchange of Information on Enforcement was consulted during the 
restrictions process.
(11) On 8 April 2013 the Agency submitted to the Commission the opinion sof RAC and 
SEAC based on which the Commission concluded thatan unacceptable risk to human 
health ar osefrom the presence of chromium VI compounds in leather articles and 
articles containing leather parts, coming into contact with the skin, which needs to b e 
addressed on a Union -wide basis. The socio -economic impacts of this restriction, 
including the availability of alternatives, have been taken into account. 
(12) The restriction onthe placing on the market of second -hand articles would impose a 
disproportiona te burden on the consumers re-selling these articles . Furthermore , due to 
the nature of those transactions, such restriction would be difficult to enforce.
Therefore, this restriction sh ould not appl y to leather articles or articles containing 
leather part swhich were in end-use before this Regulation applies . 
(13) It is appropriate to provide for a period of 12 month safter the entry into force of this 
Regulation for the stakeholders concerned to take measures to comply with th is EN 4 ENRegulation , including addressi ng articles that are alread y in the supply chain ,
including in stocks .
(14) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006 ,
HAS ADOPTED THIS REGULATION:
Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation. 
Article 2
This Regulation shall enter into force on the twentieth d ayfollowing that of its publication in 
the Official Journal of the European Union . 
It shall appl y from (firstdayof the 13thmonth after the date of the entry into force) .
This Regulation shall be binding in its entirety and directly applicable in all M ember States.
Done at Brussels, 
For the Commission
The PresidentEN 5 ENANNEX 
In Annex XVII to Regulation (EC) No 1907/2006, the following paragraphs 4, 5 and 6 are 
added to column 2 of entry 47:
4. Leather articles coming into contact with 
the skin shall not be placed on the market 
where theycontain chromium VI in 
concentrations equal to or greater than 3 
mg/kg (0 ,0003% by wei ght) of the total dry 
weight of the leather .
5. Articles containing leather parts coming 
into contact with the skin shall not be placed 
on the market where anyof those leather 
parts contain s chromium VI in 
concentrations equal to or greater than 3 
mg/kg (0 ,0003% by wei ght) of the total dry 
weight of thatleather part.
6. Paragraph s4 and 5 shall not appl y to the 
placing on the market of second -hand 
articles which were in end-usein the Union
before [ first day of the 13th month after the 
date of the entry into force ].