EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council as regards polycyclic -aromatic hydrocarbons (PAHs) in granules or 
mulches used as infill material in synthetic turf pitches or in loose form on  playgrounds 
or in sport applications  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council as regards polycyclic -aromatic hydrocarbons (PAHs) in granules or 
mulches used as infill material in synthetic turf pitches or in loose form on  playgrounds 
or in sport applications  
(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) Entry 50 of Annex  XVII to Regulation (EC) No 1907/2006  contains restrictions with 
respect to eight polycyclic -aromatic hydrocarbons (PAHs)2.  
(2) Rubber g ranules are used as infill material in synthetic  turf pitches . Rubber g ranules 
and mulches are also used in loose form on playgrounds  or in sport applications , such 
as golf courses, athletic arenas, horse arena footings, nature trails , or shooting ranges.  
Those granules and mulches originate predominantly from End of Life Tyres (ELT). 
One of the main concern s over the use of ELT granules and mulches is the presence of 
the eight PAH s in the rubber matrix. Granules and mulches are mixtures within the 
meaning of  Article 3(2) of Regulation (EC) No 1907/2006 and hence are not covered 
by the existing entry 50  of Annex XVII to that Regulation . However , the eight PAHs 
are listed as carcinogenic category 1B in Annex VI to Regulation (EC) No 
1272/20083.  Therefore , entry  28 of Annex XVII to Regulation (EC) No 1907/2006  
restricts  the supply o f granules and mulches  to the general public , if those  mixtures 
contain PAHs at concentrations equal to or above 100 mg/kg for BaP or DBAhA , or 
1000 mg/kg for the other six PAHs.   
                                                 
1 OJ L 396, 30.12.2006, p 1.  
2 Benzo[a]pyrene (BaP), Benzo[e]pyrene (BeP), Benzo[a]anthracene (BaA), C hrysene (CHR), 
Benzo[b]fluoranthene (BbFA), Ben zo[j]fluoranthene (BjFA), Benzo[k]fluoranthene [BkFA), 
Dibenzo[a,h]anthracene (DBAhA) . 
3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, am ending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006  (OJ L  353, 31.12.2008, 
p.1). EN 2  EN (3) To perform the risk characterisation of the granules or mulche s containing the eight 
PAHs, t he concentration limits of the individual PAHs in entry 28 of Annex XVII to 
Regulation (EC) No  1907/2006  cannot simply be summed up. By applying an  
additivity approach  in accordance with the Guidance  on the application of Regulation 
(EC) No 1272/20084 and taking into account the relative contribution of the different 
PAHs to the PAH content in rubber granul es and mulches , the maximum 
concentration limit for the sum of t he eight listed PAH s can be calculated and is 
approximately 387 mg/kg5. The Rijksinstituut voor Volksgezondheid en Milieu 
(RIVM)6 and the European Chemicals Agency (hereinafter ‘the Agency’)7 concluded 
in 2017 that this calculated  concentration limit  for mixtures of the eight PAHs  is too 
high to guarantee safe supply and use of these granules in synthetic turf pitches. In its 
evaluation, the Agency recommended lowering the concentration limit of the eight 
PAHs in granules used in synthetic turf pitche s through a restriction under Regulation 
(EC) No 1907/2006  because the current concentration limits we re considered too high 
to provide adequate  protection for  human health .    
(4) Based  on those conclusions and evaluation s, on 17 September 2018 the Netherlan ds 
(hereinafter ‘ the Dossier Submitter’ ) submitted to the Agency  an Annex XV dossier8, 
proposing a restriction on eight PAHs in granules for use as infill material in synthetic 
turf pitches and of granules or mulches  in loose form on playgrounds or in sport 
applications . 
(5) The human health endpoint of utmost concern for these eight PAHs is carcinogenicity 
and the ability to induce genotoxic effects. For non -threshold carcinogens , a dose 
without a theoretical cancer risk cannot be derived. Therefore, the concentrations of 
the eight PAHs in granules used as infill material in synthetic turf pitches and in 
granules or mulches in loose form on playgrounds or in sport applications should be as 
low as possible.  
(6) The Dossier Submitter took into consideration vari ous exposure scenarios related to 
the use of granules in synthetic turf pitches , by workers install ing and maint aining  the 
pitches  and by individuals playing sports  on them  (professional and amateur outfield 
players and goalkeepers ), and related  to granules or mulches used in loose applications 
on playgrounds and in sport applications , where  people and especially children may be 
exposed.  Based on the sampling results by RIVM, excess cancer risks were estimated 
on the basis of the total concentration of the sum of the  eight PAHs currently found in 
ELT infills . The concentration range found for those mixtures was from 6 ,7 mg/ kg to 
21 mg/ kg.  
(7) The Dossier Submitter showed that there is an excess cancer risk for workers and 
general public  exposed to  rubber granules contain ing the calculated mixture 
concentration limit of 387  mg/kg  of the sum of the eight PAHs, whereas at a much 
lower level of concentration the probability that an individual’s exposure to the listed 
PAHs could result in cancer  was estimated considerably lower . The Dossier Submitter 
concluded that for a large part of producers,  concentrations of 15 to 21 mg/kg of the 
sum of the eight PAHs in ELT landfill are technically and economically feasible , and 
                                                 
4 https:// www. echa.europa.eu/documents/10162/23036412/clp_en.pdf  
5 This value should not be seen as an absolute value, as it may change depending on the concentrations 
and relative contribution of the individual PAHs in ELT infill . 
6 https://www.rivm.nl/bibliotheek/rapporten/2017 -0017.pdf  
7 https://echa.europa.eu/documents/10162/13563/annex -xv_report_rubber_granules_en.pdf/dbcb4 ee6-
1c65 -af35-7a18 -f6ac1ac29fe4  
8 https://www.echa.europa.eu/documents/10162/9777e99a -56fb-92da -7f0e-56fcf848cf18  EN 3  EN proposed to apply a concentration li mit of 1 7 mg/kg . The Dossier Submitter estimated 
that 95  % of the ELT -derived infill material would comply with this concentration 
limit.  
(8) In order to ensure safe use of any granules or mulches and avoid substitution towards 
alternatives that may cause the same or even greater concern for human health than 
recycled rubber , the Dossier Submitter suggested that the restriction should cover 
mixtures made of recycled rubber and of other materials, may they be virgin or 
recycled, synthetic or natural materials . 
(9) As the limit value of 17 mg/kg proposed by the Dossier Submitter is significantly 
lower than the 100 -1000 mg/kg limit values that are currently applicable to the 
granules, the restriction would mean that some ELT -derived granule producers  would 
have to incr ease the rate of compliance testing and switch to cleaner production input 
or cease the production of infill material. The restriction would render 5 % of the 
currently produc ed granules  incompliant if the application  of the restriction were to 
become effective immediately. Therefore , the Dossier Submitter suggested a 
transitional period of twelve months to  allow a limited but reasonable period for 
downstream users (turf producers , distribut ors and companies installing  the turf) to 
continue using granules  that have already been supplied to them  but do not comply 
with the proposed limit value  of 17mg/kg ). 
(10) On 7 June 2019, the Agency’s Committee for Risk Assessment (RAC) adopted an 
opinion9 concluding that a PAH s content i n rubber granules corresponding to the  
calculated  concentration limit for mixtures in accordance with entry 28 of Annex XVII 
to Regulation (EC) No 1907/2006 is unacceptable and such levels for non -threshold 
substances should not be permitted  and they do no t provide  an adequate level of 
protection to workers and the general p ublic . RAC agreed that the PAH content should 
be lowered and , recommended  a concentration limit of 20 mg/kg of the sum of the 
eight  PAHs in rubber granules.  RAC reiterated that the proposed 20 mg/kg limit is not 
based upon the estimated  risk but it is a measure aimed solely at avoiding very high 
PAH concentrations. RAC furthermore indicated that with respect to  risk reduction 
there is no significant difference between  choosing 17 mg /kg over 20 mg/kg , 
recognising that , except for smokers, the greatest exposure to the general public is not 
from granules and mulches but from food sources and inhaled air.    
(11) RAC agreed wit h the Dossier Submitter that, while no supporting information on th e 
content of the eight  PAHs in cork, thermoplastic elastomers (TPE) and ethylene 
propylene diene rubber (EPDM) has been provided, the proposed PAH limit should 
apply to any other type of synthetic pitch infill material in order to avoid similar or 
greater risk through regrettab le substitution.  
(12) For enforcement reasons, RAC recommended that the restriction with respect to 
granules or mulch es placed on the market for use as infill material in synthetic turf 
pitches and in loose form on playgrounds or in sport applications  require a specific 
marking referring to a unique batch number . This batch number  allow s the traceability 
of the material to a tested batch placed on the market . Furthermore, RAC 
recommended including  definition s for granules, mulch es, infill material in synthetic 
turf pitches  and use in loose form  on playgrounds and in sport applications . 
                                                 
9 https://echa.europa.eu/documents/10162/0a91bee3 -3e2d -ea2d -3e33 -9c9e7b9e4ec5  EN 4  EN (13) On 20 September 2019, the Agency’s Committee for Socio -economic analysis 
(SEAC) adopted its opinion10, indicating that the proposed restriction, as modified by 
RAC, is the most app ropriate Union -wide measure to address the  identified  risks , 
taking into account its socio -economic benefits and its socio -economic costs . SEAC 
noted  as well the preventive nature of the restriction.  
(14) SEAC agreed that the twelve -month deferral of application of the restriction initially 
proposed in the Annex XV dossier  for a concentration level of 17 mg/kg , would also 
be appropriate for a concentration level of 20 mg/kg, in order  to allow all concerned 
stakeholders to t ake the necessary compliance measures.   
(15) The Forum for Exchange of Information on Enforcement was consulted during the 
opinion making process and its recommendations were taken into account .  
(16) On 12 November 2019, the Agency submitted the opinions of RAC and  SEAC to the 
Commission. Taking into account the Annex XV dossier and the RAC and SEAC 
opinions , the Commission considers  that there is an unacceptable risk to human health 
from the placing on the market or use of  granules  or mulches containing  PAH as infi ll 
material in synthetic turf pitches or in loose form on playgrounds or in sport 
applications  that needs to be addressed on a Union wide basis . The Commission 
concludes  that the restriction  proposed in the Annex XV dossier, with the 
modifications proposed by RAC and SEAC , is the most  appropriate Union -wide 
measure  to address the risk  identified to human health  and that its socio -economic 
impact is limited .  
(17) Stakeholders should be allowed sufficient time to take appropriate measures to comply 
with t he proposed restriction. The application of the restriction should therefore be 
deferred by twelve  months.   
(18) Regulation  (EC) No 1907/2006 should therefore be amended accordingly.  
(19) The measures provided for in this Regulation are in accordance with the opinio n 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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen  
                                                 
10 https://echa.europa.eu/documents/10162/53688823 -bf28-7db7 -b9eb -9807773b2109