EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending Directive 2009/48/EC of the European Parliament and of the Council as 
regards specific limit values for aniline in certain toys  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending Directive 2009/48/EC of the European Parliament and of the Council as 
regards specific limit values for aniline in certain toys  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
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 toys1, and in particular Article 46(2) thereof,  
Whereas:  
(1) Directive 2009/48/EC establishes certain requirements for chemical substances that are 
classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) 
No 1272/2 008 of the European Parliament and of the Council2. Appendix C to Annex 
II to Directive 2009/48/EC lays down specific limit values for chemicals used in toys 
intended for use by children under 36 months or in other toys intended to be placed in 
the mouth.  
(2) Aniline (CAS number 62 -53-3) is classified as carcinogenic category 2 and mutagenic 
category 2 under Regulation (EC) No 1272/20083. According to point 5(a) of Part III 
of Annex II to Directive 2009/48/EC, carcinogenic substances of cate gory 2, such as 
aniline, may be used in toys in individual concentrations equal to or smaller than the 
relevant concentration established in Regulation (EC) No 1272/2008 for the 
classification of mixtures containing those substances, namely 1  %4, which 
corresponds to 10  000 mg/kg ('content limit'). The same content limit applies to 
mutagenic substances of category 25. 
(3) The Scientific Committee on Health and Environmental Risks (SCHER) considered, 
in its opinion of 29 May 2007, that compounds that are carcinogenic, mutagenic  or 
toxic for reproduction (CMR) should not be present in toys6. The European Union 
Risk Assessment Report on aniline7 concluded that for consumers there is a need for 
                                                 
1 OJ L 170, 30.6.2009 , p. 1.  
2 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, amending 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). 
3 Table 3 in Annex VI to Regulatio n (EC) No 1272/2008.  
4 Table 3.6.2 in Annex I to Regulation (EC) No 1272/2008.  
5 Table 3.5.2 in Annex I to Regulation (EC) No 1272/2008.  
6 Scientific Committee on  Health and Environmental Risks  (SCHER). CEN's response to the opinion of 
the CSTEE on the as sessment of CEN report on the risk assessment of organic chemicals in toys . 
Adopted on 29.5.2007.  
 http://ec.europa.eu/health/archive/ph_risk/committees/04_ scher/docs/scher_o_056.pdf  
7 European Chemicals Bureau, Institute for Health and Consumer Protection, 2004. EUR 21092 EN. 
Section 5.2.1.2, p. 180.    
EN 2  EN limiting the health risks associated with the use of products containing aniline. That 
conclusion is based on concerns with regard to mutagenic and carcinogenic effects for 
consumers as a conse quence of exposure to aniline, since aniline is identified as a non -
threshold carcinogen , as confirmed by t he Committee for Risk Assessment of the 
Euro pean Chemicals Agency (RAC) who indicated, in its opinion on restriction of 
substances in tattoo inks and permanent make -up8, that aniline is considered a non -
threshold carcinogen. Aniline may therefore cause cancer at even the slightest level of 
exposure.  
(4) In order to advise the Commission in the preparation of legislative proposals and 
policy initiatives in the area of toy safety, the Commission has established the Expert 
Group on Toys Safety. The mission of its subgroup Working group on Chemicals in 
Toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety 
with regard to chemical substances which may be used in toys.  
(5) During the meeting of the subgroup Chemicals on 18 February 20159, several of its 
members indicated  that aniline coul d be found in coloured toy material such as textiles 
or leather when that material is subjected to the reductive cleavage test provided for in 
Appendix 10 to Regulation 1907/2006 of the European Parliament and of the 
Council10. The occurrence of anilin e in textiles a fter reductive cleavage testing was 
confirmed in a study carried out in  Sweden11 as a follow -up to the meeting of the 
Expert Group on Toys Safety on 8 June 2015. Out of 23 textile samples, aniline was 
identified in one red textile (4  % of all samples) at 91  mg/kg. The occurrence of 
aniline in clothing after reductive cleavage testing  was confirmed in a study with 153 
samples12. Aniline was identified in 9 samples (6 % of all samples) at up to 588 
mg/kg. Moreover, aniline has been found in a fing er paint after reductive cle avage  
according to a German consumer magazine13. The subgroup Chemicals  also noted, by 
written correspondence to the Commission in May 2020, that free aniline could be 
present in finger paints as an impurity of the colorants in such paints.  
(6) At the meeting of the Expe rt Group on Toys Safety  on 8 June 2015 , Germany 
presented a position paper providing a scientific a ssessment of the toxicological 
properties of aniline14. According to that assessment, the existing content limit for 
                                                                                                                                                         
https://echa.europa.eu/documents/10162/6434698/orats_final_rar_aniline_en.pdf/0abd36ad -53de -4b0f-
b258 -10cf90f90493   
8 Committee  for Risk Assessment (RAC) , Opinion on an Annex XV dossier proposing restriction on 
substances used in tattoo inks and permanent make -up. Adopted on 20 November 2018. 
https://echa.europa.eu/documents/10162/2b4533af -f717-4bff-939b -2320fb43b462   
9 See Register of Commission Expert Groups, Expert Group on Toys Safety  (E01360).    
https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetailDoc&id=20916&no
=1 
10 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluatio n, 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/EE C and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC  (OJ L 396, 30.12.2006, p. 1 ).  
11 Meeting document of the subgroup Chemicals: EXP /WG/2015 /027/Ann1 , Aniline  from  azodye  
cleavage , Results  from  Sweden.  
12 Brüschweiler et al., Identification of non -regulated aromatic amines of toxicological concern which can 
be cleaved from azo dyes used in clothing textiles, Regulatory Toxicology and Pharmacology 69 (2014) 
263–272. Cited in: ANEC – Position paper on aniline. April 2016. Present ed to the subgroup 
"Chemicals" meeting on 1 June 2016 (EXP/WG/2016/027).  
13 Ökotest 2/2015, p. 69.  
14 Discussion paper EXP/2015/029/rev1.   
EN 3  EN aniline presents a risk for both the systemic and the cancer effects of that substance. 
The subgroup Chemicals concluded, at its meeting on 26  September 201715, that a 
restriction for aniline in toys should target toys and toy components of textile and 
leathe r, and finger paints, since too little information was available so far on the need  
for  an  aniline  restriction in toys or toy materials other than textile, leather and finger 
paints. The subgroup also indicated that the limit value should be 30  mg/kg a fter 
reductive cleavage . That value is the lowest concentration that the reductive cleavage 
test can identify . As regards finger paints, the subgroup indicated that a limit of 
10 mg/kg for free aniline should be set since that is the lowest concentration t hat can 
reliably be checked in routine tests of finger paints.  
(7) The Expert Group on Toys Safety, at its meeting on 19 December 201716, examined 
the setting of limit values of 30  mg/kg for aniline after reductive cleavage in toy 
materials of textile and leath er; of 30  mg/kg for aniline after reductive cleavage in 
finger paints; and of 10  mg/kg for free aniline in finger paints, as indicated earlier by 
the subgroup  Chemicals.  
(8) Pursuant to Article 46(2) of Directive 2009/48/EC, the packaging requirements for 
food laid down in Regulation (EC) No 1935/2004 of the European Parliament and of 
the Council17 are to be taken into account when adopting specific limit values for 
chemicals i n Appendix C to that Directive. The basic assumptions behind the 
migration test methods referred to in Article 11 (4) of Commission Regulation (EU) No 
10/201118, which is a specific measure within the meaning of Article 5 of Regulation 
(EC) No 1935/2004  and which establishes specific requirements for the manufacture 
and marketing of plastic materials and articles intended to come into contact with 
food, are however different from the basic assumptions behind the content limits for 
aniline in certain toys in D irective  2009/48/EC . In addition , it is impossible to 
compare migration limits with content limits. Therefore, further to these conclusions 
there is no way to take account of the packaging requirements for food when setting 
content limits for aniline in ce rtain toys . 
(9) In light of the classification of aniline as a CMR substance, the European Un ion Risk 
Assessment Report on aniline, the opinion of RAC and SCHER and the opinions of 
the Expert Group in Toys Safety and its subgroup Chemicals as well as the studi es on 
the presence of aniline in textiles, it is necessary to set a limit for aniline in textile toy 
material and leather toy material of 30 mg/kg after reductive cleavage and a limit for 
aniline in finger paints of 10 mg/kg as free aniline and 30 mg/kg af ter reductive 
cleavage . 
(10) Directive 2009/48/EC  should therefore be amended accordingly.  
(11) The measures provided for in this Directive are in accordance with the opinion of the 
Toy Safety Committee,  
                                                 
15 Register of Commission Expert Groups, Expert Group on Toys Safety  (E01360). 
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=4151 .  
16 Register of Commission Expert Groups, Expert G roup on Toys Safety  (E01360), tab ‘Meetings’. 
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=1485 .  
17 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338 13.11.2004, p. 4 ). 
18 Commission R egulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to come into contact with food (OJ L 012 15.1.2011, p. 1 ).  
EN 4  EN HAS ADOPTED THIS DIRECTIVE:  
Article 1  
In Appendix C to Annex I I to Directive 2009/48/EC , the following entry is added:  
Substance  CAS No  Limit value  
'Aniline  62-53-3 30 mg/kg  after reductive cleavage in textile 
toy material and leather toy 
material  
10 mg/kg  as free aniline in finger paints  
30 mg/kg  after reductive cleavage in finger 
paints'  
Article  2 
1. Member States shall adopt and publish, by  [Insert here the date 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 the text of those provisions.  
They shall apply those provisions from [Insert here the date 18 months  + 1  day after 
publication in the OJ .]. 
When Member States adopt those provisions, they shall contain a reference to this 
Directive or be accompanied by such a reference on the 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 provi sions 
of national law which they adopt in the field covered by this Directive.  
Article  3 
This Directive shall enter into force on the  twentieth  day following that of its publication in 
the Official Journal of the European Union . 
Article  4 
This Directive is  addressed to the Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen