EN EN
EUROPEAN
COMMISSION
Brussels, XXX
[…](2013) XXX draft
ANNEX
Detailed explanation of the reasons for the differences accompanying the Draft 
COMMISSION REGULATION EU No .../.. of XXX amending Annex XVII to 
Regulation (EC) No 1907/2006 of the European Parl iament and of the Council on the 
Registration, Evaluation, Authorisation and Restriction of Chemicals ("REACH") as 
regards chromium VI compounds, in accordance with its Article 73(1)Detailed explanation of the reasons for the differences 
accompanying the 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 , in accordance with its 
Article 73(1)
1.Article 73(1) second subparagraph of the REACH Regulation stipulates that where 
the draft amendment diverges from the original propo sal or if it does not take the 
opinions from the European Chemicals Agency  (“ECHA”) into account, the 
Commission shall annex a detailed explanation of the reasons for the differences.
2.The present detailed explanation therefore addresses the reasons for th e differences 
between the original proposal of the Kingdom of Denmark (“Denmark”) , as presented 
in the dossier conforming to the requirements of Annex XV to REACH (“ Annex XV 
dossier ”), and this draft Regulation .  Although the Commission did take the opinio ns 
from the Agency into account, this detailed explanation also addresses the 
divergences between the restriction proposal as amended b y ECHA Committees for 
Risk Assessment ( “RAC”)and for Socio -economic Assessment ( “SEAC ”)and this 
draft Regulation.
3.The restriction proposed by  Denmark on chromium (VI) compounds in leather articles 
was:
“Articles of leather , coming into direct and prolonged or repetitive contact with 
the skin, shall not be placed on the market if the leather contains chromium (VI) 
inconc entrations equal to or higher than 3 mg/kg. ”
4.During the restriction process, both ECHA Committees, RAC and SEAC, agreed with 
Denmark in that there is a need to restrict placing on the market of leather articles 
containing chromium (VI). However, the wordi ng of the suggested restriction was
modified during the opinion forming of the Committees . RAC , in agreement with 
SEAC, extended the scope of the restriction, to cover all leather articles that come into 
contact with the skin. Therefore , the reference to “direct and prolonged or repetitive 
contact” with the skin , used in the original proposal, was removed . 
5.RAC and SEAC suggested a modification of the initial proposal , as follow s:
“Leather articles, or leather parts of articles, coming into contact with t he skin, 
shall not be placed on the market if they contain chromium (VI) in concentrations 
equal to or higher than 3 mg/kg (0,0003%) chromium VI of the total dry weight of 
the leather.”
6.The change suggested by RAC , and supported by  SEAC , was justified by  the 
Committees by :
a)considerations on enforceability of the restriction, based on the advice of the 
Forum on exchange of information on enforcement (“Forum”) about enforceability and practicality of this restriction proposal (Forum 1stadvice, 
May2012) , and the results of the public consultation ;and
b)considerations on better cover age of the exposure conditions by which 
chromium (VI) in leather articles can produce allergic contact dermatitis and 
thus to better reflect the nature of the risks p osed.
As a result of this modification , this restriction would cover also some leather articles 
that would not have been covered b y the initial proposal of Denmark , such as those 
for which an indirect , rather than direct, contact with the skin is forese eable.
7.In addition, SEAC also suggested to include the transitional period of 12 months 
(alread y proposed b y Denmark in the Annex XV dossier ) into the entry , and to 
derogate from the restriction articles placed on the market for the first time before 12 
months after the entry into force of this Regulation . For th elatter , SEAC suggested a 
modification of the initial proposal, as follows:
“By way of derogation, the restriction shall not apply to leather articles placed on 
the market for the first time before [12 month s after the amendment of the REACH 
Annex XVII enters into force ]”
8.The draft Commission Regulation , after having taken into account the RAC and 
SEAC opinions, reads as follows:
"4. Leather articles coming into contact with the skin shall not be placed on t he 
market where they contain chromium VI in concentrations equal to or greater 
than 3 mg/kg (0,0003% by weight) 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 marke t where any of  those leather parts contains chromium VI in 
concentrations equal to or greater than 3 mg/kg (0,0003 % by weight) of the total 
dry weight of that leather part.
6. Paragraphs 4 and 5 shall not apply to the placing on the market of second -
hand articles which were in  end-use in the Union before [ first day of the 13th 
month after the date of the entry into force ].”
9.In addition, the Commission is proposing that the Regulation will start to apply 12
month safter its entry into force.  
10.As far as deleting of the reference to the “direct and prolonged or repetitive contact” 
with the skin is concerned, the Commission concurs with the RAC and SEAC 
opinions and the Forum advice, based on the grounds referred to in paragraph 6 
above. 
11.Paragraphs 4 and 5 of the proposed restriction fullycorrespond to the RAC and SEAC 
opinions on the suggested restriction. The division to two separate paragraphs was 
done for purely formal reasons, as it is articles that are being placed on the market 
under REACH, and not parts of articles. 12.Paragraph 6 introduces the derogation for the placing on the market of second -hand 
articles which were in end -use in the EU before the application date. The 
Commission, taking into account the SEAC opinion, considers that t he rest riction on 
the placing on the market of second -hand articles would impose a disproportionate 
burden on the consumers re -selling these articles. Furthermore, due to the nature of 
those transactions, such restriction would be difficult to enforce, as stated in recital 
(12)of the draft Regulation .The Commission did not consider appropriate to 
derogate also other articles which were alread y placed on the market ,but still in the 
supply chain (including stocks) ,and not having reached the EU end -user y et at the 
time of entry into application of the measure. The Commission considers that the
deferral of application of the Regulation of 12 months after its entry into force is 
sufficient to address SEAC concerns with regard to articles in the supply chain, as 
referred to in paragraph 7 above.
13.In conclusion , the draft Commission Regulation contains the following main change s
compared to the restriction proposed in the Annex XV dossier submitted by Denmark :
•The scope of the restriction was extended. I t is not lim ited to articles (and 
parts of articles) that have strictly  direct and prolonged or repetitive contact 
with the skin. It would further cover any leather articles and articles containing 
leather parts that, under normal or reasonably foreseeable conditions of use, 
come into contact with the skin, as explained in recital ( 5).
•A derogation for placing on the market of second -hand articles which were in 
the end -use in the EU before this Regulation applies was introduced.
The draft Commission Regulation also slightly  diverges from the opinion of 
ECHA Committees in limiting this derogation to second -hand articles which 
were in the end -use in the EU before this Regulation applies only, and not 
derogating all articles placed on the market for the first time befor e this 
Regulation applies .