EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards certain substances classified as 
carcinogenic, mutageni c or toxic for reproduction (CMR), category 1A or 1B  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 2  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards certain substances classified as 
carcinogenic, mutagenic or tox ic for reproduction (CMR), category 1A or 1B  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
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 Registration, 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(2) thereof,  
Whereas:  
(1) Annex I to Regulation (EC) No 1272/2008 of the European Parlia ment and of the 
Council2 lays down criteria for the classification of chemical substances in hazard 
classes , including the hazard classes carcinogenicity, germ cell mutagenicity and 
reproductive toxicity, category 1A or 1B . Substances classified in any of those three 
hazard classes are referred to collectively in this Regulation as 'CMR substances' .  
(2) Annex XVII to Regulation (EC) No 1907/2006 lays down restrictions on the 
manufacture, placing on the market and use of certain dangerous substances, mixtures 
and articles. The Commission has developed criteria for the identification of articles 
that contain  CMR substances and could be used by consumers , in relation to which it 
would be appropriate to add a new restriction to Annex XVII using the simplified 
proce dure referred to in Article 68(2) of that Regulation . According to the criteria  
developed by the Commission , clothing , other textiles  and footwear are considered a 
priority case3. 
(3) Certain CMR  substances are present in clothing  and related accessories, other textiles 
and footwear , either as impurities from the production process  or because they have 
been  added intentionally  to give them specific properties . 
(4) Information from public authorities and stakeholders ' reports indicate the potential for 
consumers to be exposed to CMR  substances present in clothing  and related 
accessories, other textile s or footwear  through  contact with the skin  or through 
                                                 
1 OJ L 396, 30.12.2006, p  1. 
2 Regulation (EC) No 1272/2008 of the European Parliament and Council  of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1).  
3 http://ec.europa.eu/DocsRoom/documents/10045/attachments/1/translations    
EN 3  EN inhalation . These products are widely available for use by consumers, including in a 
private capacity  or when using a product within a public service (for example bed 
linen in a hospital or upholstery in a public library). Therefore , in order to minimise 
such consumer exposure , the placing on the market of CMR substances in clothing  and 
related accessorie s (including sportswear  and bags), or footwear for use by consumers  
should be prohibited where the CMR substances are present in  concentrations above a 
certain level . For the same reason, this restriction should also cover the situation where 
CMR substances  are present in those concentrations in other textiles that come into 
contact  with human skin to an extent that is similar to clothing  (for example , bed linen, 
blankets, upholstery or reusable nappies) . 
(5) The Commission has consulted stakeholders o n the substances and articles that should 
fall within the scope of the new restriction under Article 68(2) of Regulation (EC) No 
1907/20064 and discuss ed specific aspects of the restriction (including the 
concentration limits and availability of testing methods) with them in a technical 
workshop5.  
(6) The substances to be restricted each have  different properties and are used in different 
processes in the clothing  and related accessories , textile and footwear  industr ies. 
Therefore , maximum concentration limits should be specified, either for individual 
substances or for groups of substances, taking into account the technical feasibility of 
achieving those  limits and the availability  of appropriate analytical methods. 
Formaldehyde is used in jackets and coats , and in upholstery , to confer structural and 
flame retardant properties respectively . Due to  the lack of information on suitable 
alternatives , a less strin gent concentration should apply , for a limited period , to 
formaldehyde in jackets,  coats or upholstery  in order to allow operators to adapt to the 
restriction .   
(7) Clothing , related accessories  and footwear , or parts of clothing , related accessories  and 
footwear, that  are made entirely out of natural leather, fur or hide sh ould not be 
covered by the new restriction  to be adopted by this Regulation  because different 
chemical substances and processes are used in their production . For the same reason, 
non-textile fasteners and decorative attachments should not be covered by the new 
restriction.  
(8) Personal protective equipment within the scope of  Regulation (EU) 2016/425 of the 
European Parliament and of the Council6 and medical devices within the scope of 
Regulation (EU) 2017/745  of the European Parliament and of the Council7 should be 
exempted from the new restriction  because of the need for such equipment and devices 
to fulfil specific requirements in terms of safety and functionality.  
(9) The European Chemic al Agency’s Forum for Exchange of Information on 
Enforcement , referred to in Article  76(1)(f)  of Regulation (EC) No  1907/2006 , was 
consulted during the process for developing the restriction and its recommendations 
have been  taken into account.  
                                                 
4 http://ec.europa.eu/growth/tools -databases/newsroom/cf/itemdetail.cfm?item_id=8299  
5 http:/ /ec.europa.eu/growth/tools -databases/newsroom/cf/itemdetail.cfm?item_id=9088  
6 Regulation (EU) 2016/425 of the European Parliament and of the Coun cil of 9 March 2016 on personal 
 protective equipment  and repealing Council Directive 89/686/EEC  (OJ L 81, 31.3.2016, p. 51 –98) 
7 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
 devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 
 1223/2009 and repealing Council Directives  90/385/EEC and 93/42/EEC  (OJ L 117, 5.5.2017, p. 1 –
 175)  
EN 4  EN (10) Operators  should be allowed sufficient time to take appropriate measures to comply  
with the restriction  adopted by virtue of this Regulation . The new restriction should 
therefore only apply from a specified date that is later than the date on which this 
Regulation enters into force .  
(11) Regulation (EC) No  1907/2006 should therefore be amended accordingly.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Comm ittee established under Article  133 of Re gulation (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 day following that o f its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker