EN EN
EUROPEAN
COMMISSION
Brussels, XXX
[…](2012) XXX draft
COMMISSION DIRECTIVE ../…/EU
of XXX
amending, for the purpose of adaptation to technical progress, Appendix C of Annex II 
to Directive 2009/48/EC of the European Parliament and of the Council on the safety of 
toys
(Text with EEA relevance)EN 2 ENCOMMISSION DIRECTIVE ../…/EU
of XXX
amending, for the purpose of adaptation to technical progress, Appendix C of Annex II 
to Directive 2009/48/EC of the European Parliament and of the Council on the safety of 
toys
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 
June 2009 on the safety of toy s1,and in particular Article 46(2) thereof ,
Whereas:
(1) Directive 2009/48/EC establishes general requirements for substances which are 
classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December 2008 on cl assification, labelling and packaging of substances and mixtures, 
amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/20062. Such substances may not be used in toy s, in 
components of to ysor in micro -structural lydistinct parts of toys, except if 
inaccessible to children, permitted bya Commission decision or contained in 
individual concentrations equal to or smaller than the relevant concentrations 
established for the classification of mixtures containing them as CMR s. To further 
protect children's health, specific limit value s for such substances can be set out, when 
appropriate, for toys intended for use by  children under three years old or other toys 
intended to be placed in the mouth.
(2) The substance tris(2 -chloroethy l)phosphate (TCEP) is a phosphate ester used as a
flame -retardant plasticiser inpolymers. The main industrial branches in which TCEP 
has been used are the building industry , the furnitur e and the textile industry . TCEP is 
classified under Re gulati on (EC) No 1272/2008 as carcinogen iccategory 2 and toxic 
forreproduction category 1B. In the absence of any specific requirements, TCEP can 
be contained in toy s in concentrations equal to or smaller than the relevant 
concentration established for theclassification of mixtures containing it asCMR s, 
namely 0.5% as from 20 July  2013 and 0.3% as from 1 June 2015 respectively.
  
1OJ L 170, 30.6.2009 , p. 1. 
2OJ L 353, 31.12.2008, p. 1.EN 3 EN(3) TCEP w as comprehensively evaluated in 2009 under Council Regulation (EEC) No 
793/93 of 23 March 1993 on the evaluation and control of the risks of existing 
substances3. The risk assessment report, e ntitled "European Union Risk assessment on 
TCEP ",shows that TCEP easily migrates , and, when ingested, results in toxicity in the 
kidney , liver and brain, causing health d amages and potential lycancer.
(4) The r isk assessment report also shows that since 2001 there is no EU TCEP 
production . Its use in the EU had also declined, TCEP being replaced progressively b y 
other flame retardants. Nevertheless, t he presence of TCEP in toy s can not be excluded , 
as most of the toy s available on the EU market are imported, thus m anufactured 
outside the EU.
(5) Information on TCEP concentration sfound in toy s is available in the Danish 
Environmental Protection Agency (Danish EPA) report from 2004 and 2006 , entitled 
"Survey and risk assessment of perfume and flavours in toy s and childcare articles. 
Survey of chemical substances in consumer products" . The Danish EPA conducted 
two different studies on toys. First, TCEP was not detected above the detection limit in 
anyof the eight sampled toy s. The second study reported that TCEP was found in one 
of the five sampled to ys. Thetoy, a cube made of textile, plastic and foam rubber ,was 
intended for babies. The Danish EPA considered that children, when exposed to toy s 
containi ng TCEP, will ingest, due to their mouthing behaviour, 50% of the amount of 
TCEP present in the toy s.
(6) To asses the health effects of TCEP in toy sand the appropriateness of D irective
2009/48/EC 's generic limits for TCEP as a CMR substance , the Commission s enta 
request for an opinion to the Scientific Committee on Health and Env ironmental Risks 
(SCHER) . In its opinion , adopted on 22 M arch 2012 and entitled "Opinion on tris(2 -
chloroeth yl)phosphate (TCEP) in toy s", SCHER notes that health effects (in particul ar 
kidney effects) have been observed after repeated exposure to 12 mg of TCEP /kg bod y 
weight per day . SCHER also notes that the TCEP content found by the Danish EPA in 
toys(0.5-0.6%) correspond sto a risk for children, even without considering other 
expo sures. When considering TCEP exposure from other sources than toys (e.g. air, 
dust), SCHER concludes that no additional exposure from toys can be considered as 
safe, and recommends setting the limit for TCEP in toy s at the detection limit of a 
sufficient lysensitive analy tical method.
(7) Taking the above considerations into account, the gene ric limit values of 0.5 and 0.3 % 
referred to b y Directive 2009/48/EC appear as inappropriate for children's health. 
SCHER recommends setting the limit for TCEP in toy s at t he detection limit of a 
sufficiently sensitive analy tical method. Following astakeholders' consultation, the 
recommended detection limit for TCEP is 5 mg/kg. As this limit refers to a detection 
level, it is not based on a toxicological approach.
(8) In addition to TCEP, SCHER also assessed TCEP's halogenated substitutes, namely 
tris(2-chloro -1-methy lethy l) phosphate (TCPP) ,CAS No 13674 -84-5, and t ris[2-
chloro -1-(chloromethy l)ethy l] phosphate (TDCP) , CAS No 13674 -87-8, in the same 
opinion of 22 March 2012 . These substitutes were assessed in 2008 under Regulation 
(EEC) No 793/93.
  
3OJ L 84, 5.4.1993, p. 1.EN 4 EN(9) The risk assessments conclude that there is sufficient information from the structures, 
physical-chemical properties, toxico kinetics and mutagenic profiles of TCEP, TDCP 
and TCPP to sup port a read -across. Based on this conclusion, SCHER considers that 
considerations given for TCEP could be applied to its halogenated alternatives as well , 
if used in toy manufacturing.
(10) Directive 2009/48/EC should therefore be amended accordingl y.
(11) The measu res provided for in this Directive are in accordance with the opinion of the 
Committee,
HAS ADOPTED THIS DI RECTIVE:
Article 1
Appendix C of Annex II to Directive 2009/48/EC is amended in accordance with the Annex 
to this Directive.
Article 2
1. Member Stat es shall adopt and publish, by  […(Fill in date falling 18 months after 
publication in the OJ) ]at the latest, the laws, regulations and administrative 
provisions necessary to comply with this Directive. They shall forthwith 
communicate to the Commission t he text of those provisions.
They shall apply those provisions from [… (Fill in same date as in previous 
subparagraph) ].
When Member States adopt those provisions, they shall contain a reference to this 
Directive or be accompanied b y such a reference on th e occasion of their official 
publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Dir ective.
Article 3
This Directive shall enter into force on the twentieth dayfollowing that of its publication in 
the Official Journal of the European Union .
Article 4
This Directive is addressed to the Member States.EN 5 ENDone at Brussels, 
For the Commission
The President
José Manuel BARROSO
ANNEX
Appendix C of Annex II to Directive 2009/48/EC is amended as follows:
The following entry is introduced:
"Substance CAS No Limit value 
TCEP 115-96-8 5 mg/kg (content limit)
TCPP 13674 -84-5 5 mg/kg (content lim it)
TDCP 13674 -87-8 5mg/kg (content limit) "