EN    EN EN 
 EN 1   EN  EUROPEAN COMMISSION 
Brussels, xxx 
C(20..) yyy final 
  
Draft 
COMMISSION REGULATION (EU) No …/…  
 
of […] 
amending Annex XVII to Regulation (EC)  No 1907/2006 of the European Parliament 
and of the Council on the Registration, Eval uation, Authorisation and Restriction of 
Chemicals (REACH) as regards Poly cyclic aromatic hydrocarbons  
(Text with EEA relevance) 
 EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending Annex XVII to Regulation (EC)  No 1907/2006 of the European Parliament 
and of the Council on the Registration, Eval uation, Authorisation and Restriction of 
Chemicals (REACH) as regards Poly cyclic aromatic hydrocarbons  
(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 Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), 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/EC
1, and in particular Article 
68(2) thereof, 
Whereas: (1) Benzo[a]pyrene, Benzo[e]pyrene,   Benzo[a]anthracene, Chrysen, 
Benzo[b]fluoranthene, Benzo[j]fluoran thene,  Benzo[k]fluoranthene  and 
Dibenzo[a,h]anthracene, hereinafter referre d to as polycyclic aromatic hydrocarbons 
(PAHs), are classified as carcinogens of cat egory 1B in accordance with Annex VI to 
Regulation (EC) No 1272/2008 of the Europe an Parliament and the Council of 16 
December 2008 on classification, labelling and packaging of substances and mixtures, 
amending and repealing Directives 67/ 548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006
2.  
(2) These PAHs can be found in the plastic and r ubber parts of a wide range of consumer 
articles. They are present as impurities in  some of the raw materials used in the 
production of such articles, in particular in  extender oils and in carbon black. They are 
not added intentionally to the articles a nd do not perform any sp ecific function as 
constituents of the plastic or rubber parts.  
(3) These PAHs are banned for the sale to the ge neral public as substances on their own or 
in mixtures by entry 28 of Annex XVII to Regulation (EC) No 1907/2006. Moreover, 
                                                 
1 OJ L 396, 30.12.2006, p. 1. 
2   OJ L 353, 31.12.2008, p. 1 EN 3   EN entry 50 of Annex XVII to that Regulation re stricts the presence of PAHs in extender 
oils used for the manufacture of tyres.  
(4) Information submitted by Germany to the Commission indicates that articles 
containing PAHs may pose a risk to consumer s' health by ingestion, dermal adsorption 
and, in some cases, by inhalation.  
(5) The conclusion regarding the risk to consumers was based on the estimated dermal 
exposure to PAHs arising from the use of certain consumer arti cles, under realistic 
worst-case conditions of use.  That exposure was found to exceed the Derived Minimal 
Effect Levels (DMEL)3 determined for benzo[a]pyrene, which was used as surrogate 
for the toxicity of the other PAHs.  
(6) The Commission evaluated the informati on provided by Germany and concluded on 
the existence of a risk to consumers posed by articles containing PAHs, indicating that 
a restriction would limit the risk. The Comm ission also consulted industry and other 
stakeholders on the impact of restricting the presence of PAHs  in articles that could be 
used by consumers.   
(7) In order to protect the health of consumers from the risk ar ising from PAHs in articles, 
limits on the PAH content in the accessible plas tic or rubber parts of articles should be 
set, and the placing on the market of articles containing any of the PAHs in 
concentrations greater than 1 mg/kg in those parts should be prohibited.  
(8) This restriction should only apply to those pa rts of articles that come into direct and 
prolonged contact with the human  skin or the oral cavity u nder normal or  reasonably 
foreseeable conditions of use. Articles or parts thereof which are only in short or 
infrequent contact with the sk in or oral cavity should not be included within the scope 
of the restriction as the resulting expo sure to PAHs would be insignificant.  
(9) Alternative raw materials containing low leve ls of PAHs have been identified in the 
Union market. Those include carbon black and oils meeting the requirements of 
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and 
articles intended to come into contact with food4. There is uncertainty as to whether 
suitable low-PAH alternative raw materials ar e available for the accessible parts of the 
consumer articles within the scope of this  restriction, in part icular in technical 
applications including those demanding a hi gh thermal or mechanical performance of 
the plastic or rubber materials.  
(10) The Commission should review the existing li mit value adopted in this restriction in 
particular in the light of new scientific  information, including information on the 
migration of PAHs from plastic and rubber ma terials of the articles covered, as well as 
the availability of alternatives.   
(11) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 
                                                 
3  http://www.echa.europa.eu/do cuments/10162/13643/in formation_requirement s_part_b_en.pdf  
4  OJ L12, 15.01.2011, p. 1.  
 EN 4   EN (12) It is appropriate to provide for a reas onable period of time for the stakeholders 
concerned to take the measures that may be  required to comply with the measures set 
out in this Regulation. 
(13) The measures provided for in this Regulati on 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 day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from [24 months after the entry into force] 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 The President  […] EN 5   EN ANNEX  
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows: 
In Column 2 of entry 50, the following paragraphs 5, 6 and 7 are added:  
 
  
5. Articles shall not be placed on the market for supply to the general 
public, if any of their rubber or plastic components that come into direct and prolonged contact with the human skin or the oral cavity, under normal or reasonably foreseeable conditi ons of use, contain more than 1 
mg/kg (0,0001 % by weight of this component) of any of the listed PAHs.  
Such articles include: 
- toys including activity toys such  as swings and childcare articles  
- sport equipment such as bicycles, golf clubs, racquets 
- house-hold utensils, trolleys, walking frames  
- tools for domestic use  
- clothing, footwear, gloves and sportswear  - watch-straps, wrist-bands, masks, head-bands 
 6. Paragraph 5 shall not apply to ar ticles placed on the market before [ 2 
years after date of entry into force ]. 
  
7. By [ insert date - 6 years after the date of entry into force of this 
Regulation ], the Commission shall review the limit value in paragraph 5 in 
the light of new scientific information, including migration of PAHs from 
the articles referred to therein, and th e availability of alternatives and, if 
appropriate, modify that paragraph accordingly.