EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) 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 bis(pentabromophenyl)ether  
(Text with EEA relevance)   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 bis(pentabromo phenyl)ether  
(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(1) thereof,  
Whereas:  
(1) Bis(pentabromophenyl)ether ('decaBDE') is widely used as an additive flame retardant  
with applicati ons in many different sectors , in particular in plastic and textile articles  
but also  in adhesives, sealants, coatings and inks.  
(2) On 29  November 2012 , the Member State Committee , referred to in Article  76(1)(e) 
of Regulation (EC) No  1907/2006 , identified d ecaBDE as a persistent, 
bioaccumulative and toxic substance ('PBT') and a very persistent and very 
bioaccumulative ('vPvB') substance  in accordance with  points (d) and (e) respectively 
of Article 57 of Regulation (EC) No 1907/2006 . On 19  December 2012 the  substance 
was included in the Candidate List of Substances of Very High Concern ('SVHC') for 
possible inclusion in Annex XIV to REACH.  
(3) On 2  May 2013 , Norway proposed that decaBDE should be listed in Annex A 
(Elimination) to the Stockholm Convention on Per sistent Organic Pollutants (POPs).  
(4) Following Norway’s proposal, the Commission considered that making decaBDE 
subject to the authorisation requirement under Regulation (EC) No 1907/2006  was no 
longer the most appropriate regulatory measure . On 21 June 2013 , the Commission  
requested the European Chemicals Agency ('the Agency' ) to prepare a dossier 
conforming to the requirements of Annex XV to  Regulation  (EC) No  1907/2006  (an 
'Annex XV dossier') , with a view to initiating a restriction process under Articles 69 to 
73 of that Regulation . 
(5) On 4  August 2014 , the Agency , in collaboration with Norway, submitted an Annex 
XV dossier2 to its Committee for Risk Assessment ('RAC') and its Committee for 
                                                 
1 OJ L 396, 30.12.2006, p  1. 
2 http://echa.europa.eu/documents/10162/a3f810b8 -511d -4fd0-8d78 -8a8a7ea363bc  EN 3   EN Socio -Economic Analysis ('SEAC'). The dossier demonstrated that actio n on a Union -
wide basis is necessary to address the risks to human health and the environment 
posed by the manufacture, placing on the market or use of decaBDE, on its own, as a 
constituent of other substances, in mixtures or in articles.  
(6) On 2  June 2015, R AC adopted its opinion, which confirmed that the persistent and 
bioaccumulative properties of decaBDE give rise to specific concerns about its 
widespread distribution and potential to cause irreversible long -term harm to the 
environment, even after emissio ns have ceased. In addition, exposure to decaBDE in 
its lower brominated transformation products may result in neurotoxicity in mammals, 
including humans.  
(7) RAC agreed w ith the conclusion of the Annex  XV dossier that a general restriction on 
all uses of deca BDE, with some specific exceptions, would reduce emissions of 
decaBDE as much as possib le in the medium - to long -term.  
(8) On 10  September 2015, SEAC adopted its opinion, indicating that the proposed 
restriction, as modified by SEAC, is the most appropriate Un ion-wide measure to 
reduce emis sion of decaBDE in terms of  its socio -economic benefits and its socio -
economic costs. SEAC based its opinion on the cost -effectiveness of the proposed 
restriction , as modified , and on a number of addi tional qualitative argume nts. 
(9) SEAC agreed with the eighteen -month deferral of application of the restriction 
proposed in the Annex XV dossier to allow stakeholders to take the necessary 
compliance measures.  
(10) RAC and SEAC agreed with the exemption from  the re striction proposed in th e 
Annex  XV dossier for the civil aviation sector. Following comments received during 
the public consultation , SEAC also suggested that it should cover  military aircraft.  
(11) The proposed  restriction should not apply to electrical and electronic equipment with in 
the scope of Directive 2011/65/EU  of the European Parliament and of the Council3, as 
the placing on the market of such equipment containing polybrominated diphenyl 
ethers ( ‘PBDE ’) in a concentration above 0,1  % by weight is already regulated by th at 
Directive.  
(12) RAC and SEAC also agreed to exempt from the proposed restriction articles already 
placed on the market before the date of application of that restriction . 
(13) Based on information from the public consultation, SEAC suggested exemptions for 
spare parts for motor vehicles covered by Directive 2007/46/EC  of the European 
Parliament and of the Council4, for agricultural and forestry vehicles covered by 
Regulation (EU) No  167/2013  of the European Parliament and of the Council5 and for 
machinery covered by Directive 2006/42/EC6 of the European Parliament and of the 
Council , provided such vehicles and machines  are produced before 1  July 2018. SEAC 
justified th ose exemptions  on the basis of the disproportionate burden that the 
                                                 
3 Directive 2011/65/EU of the European Par liament and of the Council of 8  June 2011 on the restriction 
of the use of certain hazardous substances in electrical and electronic equipme nt (OJ L  174 1.7.2011, 
p. 88). 
4 Directive 2007/46/EC of the European Parliament and of the Council of 5  September 2007 establishing 
a framework for the approval of motor vehicles and their trailers, and of systems, components and 
separate technical units intended for such vehicles ( OJ L  263, 9.10.2007, p.  1). 
5 Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5  February 2013 on the 
approval and market surveillance of agricultural and forestry vehicles ( OL L  60, 2.3.2013, p.  1). 
6 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, 
and amending Directive 95/16/EC  (OJ L 157, 9.6.2006, p.  24). EN 4   EN proposed restriction would impose in  relation to such spare parts, given the low 
volumes involved, the progressive reduction in the quantity of decaBDE required (as 
vehicles and machinery reached the end -of-life stage) and the cost of testing 
alternative materials for the production of such spare parts. SEAC saw no basis for 
treating the spare parts of those vehicles and machines differently , although the ir life 
cycles vary . 
(14) The 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 
restriction process and its recommendations have been  taken into account.  
(15) On 28  September 2015 , the Agency submitted to the Commission the opinions of 
RAC and SEAC7. 
(16) Based on those opinions, the Commission is of the opinio n that an unacceptable risk to 
human health and the environment arises from  the manufacture, use or placing on the 
market of decaBDE, on its own, as a constituent of other substances, in mixtures and 
in articles . The Commission considers that those risks n eed to be addressed on a Union 
wide basis.  
(17) The possibility  to ensure the continued availability of decaBDE for the production of 
aircraft, whether civil or military, should be limited to ten years from the entry into 
force of this Regulation , since this sh ould give  the industry sufficient time to adapt. 
Exemptions should also be granted in relation to the production and the placing on the 
market of spare parts for all aircraft, civil or military, produced before the expiry of 
that period.  
(18) There should be an  exemption for the production and placing on the market of spare 
parts for vehicles and machinery , referred to in recital (13) , that are produced before 
[date  - 18 months after the date of entry into force ]. 
(19) Regulation (EC) No  1907/2006 should therefore b e amended accordingly.  
(20) The measures provided for in this Regulation are in accordance with the opinion of the 
Comm ittee established under Article  133 of Regulation (EC) No  1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1 907/2006 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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
7 http://echa.europa.eu/documents/10162/b5ac0c91 -e110 -4afb-a68d -08a923b53275  EN 5   EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker