EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) 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, Ev aluation, Authorisatio n and Restriction of 
Chemicals (REACH)  as regards polycyclic  aromatic hydrocarbons and phthalates 
(Text with EEA relevance) 
  
EN 2   EN 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, Eval uation, Authorisation and Restriction of 
Chemicals (REACH)  as regards polycyclic  aromatic hydrocarbons and phthalates 
(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 
131 thereof,  
Whereas:  (1) Annex XVII to Regulation (EC) No 1907/2006 contains, amongst others, the 
restrictions previously laid down in Council Di rective 76/769/EEC
2.  
(2) Directive 2005/69/EC of the Europe an Parliament and of the Council3 prohibited the 
placing on the market and use of extender oils  for the production of tyres or parts of 
tyres if they contain more than 1 mg/kg of  Benzo (a) pyrene (BaP), or more than 10 
mg/kg of the sum of the eight listed polyc yclic aromatic hydrocarbons (PAHs). That 
restriction is currently laid  down in paragraph 1 of colu mn 2 of entry 50 of Annex 
XVII to Regulation (EC) No 1907/2006.   
(3) At the time of adoption of th at restriction, ther e were no harmonised test methods 
available to determine the specific concentr ation of the eight listed PAHs in extender 
                                                 
1 OJ L 396, 30.12.2006, p. 1. 
2 Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and 
administrative provisions of the Member States relating to restrictions on the marketing and use of 
certain dangerous substances and preparations (OJ L 262, 27.9.1976, p. 201). 
3 Directive 2005/69/EC of the European Parliament and of the Council of 16 November 2005 amending 
for the 27th time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of 
certain dangerous substances and preparations (polycyclic aromatic hydrocarbons in extender oils and 
tyres) (OJ L 323,9.12.2005, p.51).  
EN 3   EN oils. Therefore, the analytical method IP 346:19984, used by the petroleum industry to 
determine the concentration of  polycyclic aromatic compounds (PCA), is referred to in 
that restriction as an indirect method to determine compliance with the limit values specified for BaP and the sum of all listed PAHs.  
(4) The analytical method IP 346:1998 is not specific to the eight listed PAHs. 
Furthermore, it is well established that th is method is limited in its scope to unused 
lubricating base oils, free of  asphaltene fractions and ha ving not more than 5 % of 
their components with a boiling point belo w 300°C. For samples not meeting those 
requirements, that method may be unsuitable. 
(5) As called for in Directive 2005/69/EC, on 3 July 2007 the Commission issued a 
mandate to the European Committee for St andardisation (CEN) for the development 
of a more specific method.  
(6) The new standard method has been adopt ed and published by CEN as EN 16143:2013 
(Petroleum products - Determination of cont ent of Benzo(a)pyrene (BaP) and selected 
polycyclic aromatic hydrocarbons (PAH) in extender oils - Procedure using double LC 
cleaning and GC/MS analysis).  
(7) The Commission considers that, given that this new standard pr ovides a specific 
analytical method to analyse the relevant PAHs in extender oils and overcomes the 
shortcomings of the previous method, it is appropriate to re place the citation of 
method IP 346:1998 by the new standard EN  16143:2013 as the reference method to 
determine compliance of extender oils with th e restriction in para graph 1 of column 2 
of entry 50 of Annex XVII to Regulation (EC) No 1907/2006.     
(8) An informal consultation carried out with Member States and representatives of 
relevant stakeholder associati ons indicated that, for extender  oils, there is in general a 
good correlation between the results of me thod IP 346:1998 and gas-chromatographic 
analytical methods, which follow the same  principle as the new CEN method, to 
measure individual carcinogenic PAHs. Economi c operators have indicated that the 
replacement of IP 346:1998 by the new CEN me thod is not expected to have impacts 
on the compliance of extender oils. However, the new analytical method is reported to 
be more complex and costly to perform than IP 346:1998.  
(9) A transitional period of one year should be  granted whereby both the old and the new 
analytical methods could be used alterna tively for determining compliance with that 
restriction. This transitiona l period should allow laboratories to set up and obtain the 
necessary experience in th e operation of the new analyt ical method. It should also 
facilitate determining compliance of extender oils placed on the market already before 
the entry into force of this Regulation.   
(10) The Commission has completed its re-evaluatio n of the measures of entry 51 of Annex 
XVII to Regulation (EC) No 1907/2006 regard ing the substances bis (2-ethylhexyl) 
phthalate (DEHP), dibutyl ph thalate (DBP) and benzyl but yl phthalate (BBP), in 
accordance with paragraph 3 of that en try. This re-evaluation was launched on 4 
September 2009 by the Commission’s request to the European Chemicals Agency 
                                                
 
4 IP 346:1998 - Determination of PCA in unused lubrica ting base oils and asphaltene free petroleum fractions -  
Dimethyl sulphoxide extraction refractive index method.   
EN 4   EN (ECHA) to review the available new scien tific information and to evaluate whether 
there is evidence that would justify a re-examination of the existing restriction. In 
providing the information to the Commission in March 2010, ECHA pointed out that 
an assessment of the relevant REACH re gistration dossiers should be considered. 
Therefore, the Commission asked ECHA to proceed as suggested. However, in April 2011, the Kingdom of Denmark initiated the restrictions pro cess regarding the 
presence of those phthalates in articles for i ndoor use and articles that may come into 
direct contact with the skin or mucous membranes, in which, amongst other things, the 
registration dossiers were consid ered. As communicated in [xx.xx.2014]5, at the end of 
the restriction process, the Commission did not consider that  there is unacceptable risk 
and did not propose an amendment to A nnex XVII to Regulation (EC) No 1907/2006. 
Furthermore, by means of Comm ission Regulation (EU) No 143/20116, the 
Commission included those phthalates into  Annex XIV to Regulation (EC) No 
1907/2006. Consequently, pursuant to Article 69 (2) of that Regulation, ECHA has the 
obligation to consider after the “sunset da te” whether the use of  those phthalates in 
articles poses a risk to human health or  the environment that is not adequately 
controlled. Therefore, no further review of  those phthalates was considered necessary 
and it is therefore appropriate to delete  that paragraph from that entry.   
(11) In January 2014, the Commission completed its re-evaluation of the measures of entry 
52 of Annex XVII to Regulation (EC) No  1907/2006 regarding the substances Di-
‘isonyl’ phthalate (DINP), Di- ‘isodecyl’ ph thalate (DIDP) and Di -n-octyl phthalate 
(DNOP), in accordance with paragraph 3 of  that entry. This re-evaluation was 
launched on 4 September 2009 by the Commi ssion’s request to ECHA to review the 
available new scientific information and to  evaluate whether there is evidence that 
would justify a re-examination of the exis ting restriction. The available information 
was subsequently complemented by the info rmation from the registration dossiers 
received by the 2010 registration deadline.  ECHA then submitted its draft review 
report to its Committee for Risk Assessm ent (RAC) for a detailed evaluation. RAC 
adopted its opinion in March 2013 and the final ECHA review report was provided to 
the Commission in August 2013. Based on the ECHA report the Commission decided not to propose any amendment to the provisi ons of entry 52 of Annex XVII, and to 
consider the re-evaluation in accordance with paragraph 3 of that entry as completed. 
The Commission's conclusions on the re -evaluation have been made publicly 
available
7. It is therefore appropriate  to delete paragraph 3 from that entry.        
(12) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 
(13) The measures provided for in this Regula tion are in accordance with the opinion of 
the Committee established under Article 133 of Regulation (EC) No 1907/2006, 
                                                 
5 [the OJ reference to the communication] 
6 Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation 
(EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, 
Authorisation and Restriction of Chemicals ( REACH ) (OJ L 044, 18.2.2011, p.2) 
7 http://ec.europa.eu/enterprise/sectors/ chemicals/files/reach /entry-52_en.pdf  
EN 5   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Annex XVII to Regulation (EC) No 1907/2006 is am ended 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 . 
 This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President