EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2018) XXX  draft  
 
COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament 
and of the Council for the purpose of adopting specific limit values for chemicals used in 
certain toys, as regards formaldehyde  
 (Text with EEA relevance)   EN 1  EN COMMISSION DIRECTIVE (EU) .../…  
of XXX  
amending  Appendix C to Annex II to Directive 2009/48/EC of the European Parliament 
and of the Council for the purpose of adopting specific limit values for chemicals used in 
certain toys, as regards formaldehyde  
 (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 20 09/48/EC establishes certain requirements for chemical substances that are 
classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) 
No 1272/2008 of the European Parliament and of the Council2. Appendix C to 
Annex  II to the Directive 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) Formaldehyde ( CAS number 50 -00-0) is currently not listed in Appendix C to 
Annex  II to Di rective 2009/48/EC. It  is classified as carcinogenic category 1B under 
Regulation (EC) No 1272/2008 . Pursuant to point 4 (a) of Part III of Annex II to 
Directive 2009/48/EC, formaldehyde may be u sed up to a concentration of 0,1  %, 
which corresponds to 1000  mg/kg (content limit).  
(3) 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 Safety3. The mission of its subgroup Working grou p 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.  
(4) Forma ldehyde  is used  as a monomer in the manufacture of polymeric materials . 
Polymeric materials are often used in toys . Children may therefore ingest 
formaldehyde when mouthing toys containing polymeric materials . The tolerable daily 
intake (TDI) for formaldehyde was set by the World Health Organisation ( WHO )4 and 
has been confi rmed by the Scientific  Panel on Food Additives, Flavourings, 
                                                 
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 Register of Commission Expert Groups, Expert Group on Toys Safety  (E01360).  
 http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360   
4 WHO  (1993)  Guidelines  for  drinking -water  quality.  Second  Edition.  World  Heal th  Organisation. 
Geneva. p. 98.  EN 2  EN Processing Aids and Materials in Contact with Food (AFC) of the European Food 
Safety Authority5. The TDI is 0,15 mg/kg bodyweight per day. With an allocation of 
10 % of the TDI to the intake of fo rmaldehyde from toys6,, a child with a bodyweight 
of 10  kg should therefore not take in more than 0,15 mg formaldehyde per day. 
Assuming a daily ingestion of 100  ml of mouthing saliva, the subgroup Chemicals 
recommended, at its meeting on 26 September 20177, a formaldehyde migration limit 
of 1,5  mg/l in polymeric materials when the migration of formaldehyde  is determined 
in accordance w ith the test method in standards  EN 71 -10:20058 and EN 71 -11:20059. 
(5) Formaldehyd e is also used in the manufacture of r esin-bonded wood products such as 
particle board, oriented -strand board (OSB), high -density fibre board (HDF), medium 
density fibre board (MDF) and plywood. Formaldehyde resins include phenol -
formaldehyde (PF), urea -formaldehyde (UF), melamine -formaldehyde (MF) and 
polyacetal ( polyoxymethylene - POM)  resins.  POM tends to be used only for small 
internal components and not in whole toys.  The subgroup Chemicals recommended, at 
its meeting on 26 September 2017, a formaldehyde emission limit of 0,1  ml/m3 when 
the emission of formaldehyde is determined in su ch materials in accordance with the 
test chamber method in standard EN 717 -1:200410. That limit corresponds to the 
indoor air limit value that the WHO  has established to prevent sensory irritation in the 
general p opulation and to prevent cancer11. 
(6) Formaldehyde may also be present in textile toy material due to its use during the 
manufacture of textiles.  According to a  report from the Organisation for Economic 
Cooperation and Development (OECD ) published in 2002, the  lowest threshold 
concentration for allergic contact dermatitis from formaldehyd e is 30 mg/kg12. On th at 
basis  and in order to protect also the most sensitised individuals , the subgroup 
Chemicals recommended, at its meeting on 26  September 2017, a formaldehyde 
content limit of 30 mg/kg when the content of formaldehyde is determined in 
accordance with the water extraction method in standard  EN ISO 14184 -1:201113. 
(7) Formaldehyde ma y be present in leather toy material due to its use during the 
manufacture of leather. Since leather toy material may lead to an exposure similar to 
textile toy material t he subgroup Chemicals  recommended, at its meeting on 
                                                 
5 https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2007.415 . Referred to in the position paper 
of the German Federal Institu te for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) for the 
subgroup Chemicals EXP/WG/2016/041.  
6 Scientific Committee on Toxicity, Ecotoxicity and the Environment  (CSTEE). Opinion on "Assessment 
of the bioavailability of certain elements in t oys". Adopted on 22 June 2004.  
 http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out235_en.pdf   
 Scientific Committee on  Health and Environ mental Risks  (SCHER). Opinion on " Risk from organic 
CMR substances in toys ". Adopted on 18 May 2010.  
 Scientific Committee on  Health and Environmental Risks  (SCHER). Opinion on "Evaluation of the 
migration limits for chemical elements in Toys". A dopted on 1 July 2010.  
7 Register of Commission Expert Groups, Expert Group on Toys Safety  (E01360), tab ‘Meetings’. 
http://ec.europa.eu/transpa rency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=4151 . 
The limit value was included in meeting document EXP/WG/2017/023 . 
8 Safety of toys - Part 10: Organic chemical compounds – Sample  preparation and extraction . 
9 Safety of toys - Part 11: Organic chemical compounds – Methods  of analysis . 
10 Wood -based panels - Determination of formaldehyde release - Part 1: Formaldehyde emission by the 
chamber method . 
11 World Health Organisation (WHO) 2010, WHO guidelines for indoor air quality: selected pol lutants. P. 
140-142. http://www.euro.who.int/__data/assets/pdf_file/0009/128169/e94535.pdf  
12 EXP/WG/2016/ 058. 
13 Textiles - Determination of formaldehyde - Part 1: Free and hydrolysed  formaldehyde (water extraction 
method)  (ISO 14184 -1:2011) . EN 3  EN 26 September 2017, a formaldehyd e content limit of 30 mg/kg when the content of 
formaldehyde is determined in accordance with  standard  EN ISO 17226 -1:200814. 
(8) Formaldehyde in paper toy material should have a content limit of 30 mg/kg according 
to the recommendation of the subgroup Chemical s at its meeting on 26  September 
2017, when determined in accordance with the water extraction method in  standard  
EN 645:199315 and with  standard  EN 1541:200116. That conclusion was based on the 
consideration that paper toy material may lead to an exposure s imilar to textile and 
leather toy material.  
(9) Formaldehyde may be present in water -based toy material due to its function as a 
preservative. It could be used in water -based toy materials such as soap bubbles or 
inks in felt -tip pens , and also in dry material s intended to be mixed with water prior to 
use. In light of the opinion of the Scientific Committee on Health and Environmental 
Risks (SCHER) that CMR compounds should not be present in toys17, the subgroup 
Chemicals recommended, at its meeting on 3  May 201818, a formaldehyde limit of 
10 mg/kg in water -based toy material when the content of formaldehyde is determined 
according to the test method published by the European Directorate for the Quality of 
Medicines & HealthCare of the Council of Europe ( the EDQM method ) on the 
Determination of free formaldehyde in cosmetic products19. The recommended limit is 
close to the lowest value that can be reliably determined by the EDQM method and 
takes account of traces of formaldehyde that certain other preservatives m ay release.  
(10) The Expert Group on Toys Safety took note , at is meeting on 19 December 201720, of 
the recommendations of its subgroup Chemicals regarding the limits for formaldehyd e 
in different toy materials. It expressed support and suggested a number of 
improvements for the Commission to consider.  
(11) Pursuant to Article 46(2) of Directive 2009/48/EC , the packaging requirements for 
food as laid down in Regulation (EC) No 1935/2004 are to be taken into account when 
adopting specific limit values for chemicals in Appendix C to th at Directive  The basic 
assumptions behind the specific migration limit for formaldehyde as a monomer in 
plastic food contact material21 are, however,  different from the basic assumptions 
behind the recommended migration limit for formaldehyde as a monomer in toys.  
Therefore,  it is not possible to take account of the packaging requirements for food 
when setting a limit for formaldehyde as a monomer in toys. . 
(12) In light of the available scientific evidence and  the recommendations of the Expert 
Group on Toys Safety and its subgroup Chemicals , it is necessary to set the 
recommended  limits for formaldehyde in different toy materials.  
                                                 
14 Leather - Chemical determination of formaldehyde content – Part 1: Method using high performance 
liquid chromatography  (ISO 17226 -1:2008) . 
15 Paper and board intended to come into c ontact with foodstuffs - Preparation of a cold water extract . 
16 Paper and board intended to come into contact with foodstuffs - Determination of formaldehyde in an 
aqueous extract . 
17 Scientific Committee on  Health and Environmental Risks  (SCHER). CEN's response to the opinion of 
the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys . 
Adopted on 29.5.2007.  
 http://ec.e uropa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_056.pdf   
18 Register of Commission Expert Groups, Expert Group on Toys Safety  (E01360), tab ‘Meetings’. 
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=6870 . 
19 https://www.edqm.eu/en/cosmetics -testing   
20 Register of Commission Expert Gr oups, Expert Group on Toys Safety  (E01360), tab ‘Meetings’.  
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=1485  
21 Entry 15 in Table 2 of Annex I of Regulation (EU) No 10/2011. OJ L12, 15.1.2011, p. 1.  EN 4  EN (13) Appendix C to Annex II to Directive 2009/48/EC should therefore be amended 
accordingly.  
(14) The measures provid ed for in this Directive are in accordance with the opinion of the 
Toy Safety Committee  established under  Article 47 of Directive 2009/48/EC,  
HAS ADOPTED THIS DIRECTIVE:  
Article 1  
In Appendix C to Annex II to Directive 2009/48/EC , the following entry is added: 
 
Substance  CAS No  Limit value  
‘Formaldehyde  50-00-0 1,5 mg/l (migration limit) in polymeric toy 
material  
0,1 ml/m3 (emission limit) in resin -bonded wood 
toy material  
30 mg/kg (content limit) in textile toy material  
30 mg/kg (content limit) in leather toy material  
30 mg/kg (content limit) in paper toy material  
10 mg/kg (content limit) in water -based toy 
material. ’ 
Article 2  
1. Member States shall adopt and publish, by [Insert here the date that is 18 months 
after the 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 that is 18 months + 
1 day after the 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 provisions 
of national law which they adopt in the field covered by this Directive.  
Artic le 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.  EN 5  EN Done at Brussels,  
 For the Commission  
 The Presiden t 
 Jean-Claude Juncker