EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2014) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending, for the purpose of adopting specific  limit values for chemicals used in toys,  
Appendix C to Annex II to Directive 2009/48/E C of the European Pa rliament and of the 
Council on the safety of toys 
(Text with EEA relevance) 
 EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending, for the purpose of adopting specifi c limit values for chem icals used in toys, 
Appendix C to Annex II to Direc tive 2009/48/EC of the European Parliament and of the 
Council on the safety of 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 toys
1, and in particular Article 46(2) thereof, 
Whereas: (1) In order to ensure a high level of prot ection of children against risks caused by 
chemical substances in toys, Directive 2009/48/EC establishes certain requirements 
with regard to chemical substances such as  those classified as carcinogenic, mutagenic 
or toxic for reproducti on (CMR) under Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council
2, allergenic fragrances and certain metals. In 
addition, Directive 2009/48/EC empowers the Commission to adopt specific limit 
values for chemicals used in toys which are intended for children under 36 months and 
in other toys intended to be placed in the m outh in order to ensure adequate protection 
in the case of toys involvi ng a high degree of exposure.  The adoption of such limit 
values takes the form of an inclusion in Appendix C to Annex II to Directive 
2009/48/EC. 
(2) For a number of chemicals, cu rrently applicable limit values  are either too high in the 
light of available scientific evidence or  do not exist. Specific limit values should 
therefore be adopted for them, taking into account the packaging requirements for food 
as well as the differences between toys and food contact materials. 
(3) In order to advise the European Commission in the preparation of legislative proposals 
and policy initiatives in the area of toy safety, the Comm ission established the Expert 
Group on Toys Safety.  The mission of its su bgroup "Chemicals" is to provide such 
advice with regard to chemical subs tances which may be used in toys. 
(4) Phenol (CAS number 108-95-2) is used as a monomer for phenolic resins in the 
manufacture of plywood3 for toys. The degradation of phenolic antioxidants in 
polymers can be a further source of phenol in toys4. Phenol was identified in emissions 
                                                 
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 E. Edmonds (2013) Occurrence of Phenol and Formaldehyde in Toys. Report commissioned by Toy 
Industries of Europe, p. 4. 
4 See footnote 3, pp. 5 and 8. EN 3   EN from game consoles5, in one of six analysed tents or tunnels for children6 and in 
packaging film7, it was tested in bath toys and other inflatable toys8, and it was 
considered to be present in  polyvinyl chloride (PVC)9. Phenol could further be used as 
a preservative in water-based liquid toys  such as bubble-blowing products, water-
based liquid inks (e.g. fe lt-tipped marker pens)10 or finger paints11. 
(5) In its deliberations on phenol the subgroup "C hemicals" took European standards EN 
71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11: 2005 as the basis. Those standards 
refer to the presence of phenol in toy materials (EN 71-9) and provide specific 
methods of sample preparation (EN 71-10)  and measurement (EN 71-11). EN 71-11 
further sets limit values for phenol in toy materials, namely 15 mg/l (migration limit) 
for phenol as a monomer and 10 mg/kg (content limit) for phenol as a preservative in 
liquid toy materials. 
(6) The subgroup "Chemicals" also took account of  the recommendation of the Scientific 
Committee on Health and Environmental Ri sks (SCHER) that th e migration limit 
value of 15 mg/l for phenol set out in the existing European standard be lowered at 
least by a factor of 2 in order to reach a Margin of Exposure of 100 that could be 
considered sufficiently large12. 
(7) Phenol is classified under  Regulation (EC) No 1272/2008 as mutagenic category 2. 
According to point 5 of Part III of A nnex II to Directive 2009/48/EC, mutagenic 
substances of category 2 such as phenol may be  present in toys in concentrations equal 
to or smaller than the relevant concentr ation established for the classification of 
mixtures containing it, namely 1%, wh ich equals 10 000 mg/kg (content limit). 
Directive 2009/48/EC does not currently provide for a migration limit for phenol. 
(8) In the light of the above, th e subgroup "Chemicals" recomme nded at its meeting of 26 
March 2014 that phenol be limited in toys to 5 mg/l (migration limit) when analysed 
as a monomer, and to a maximum concen tration of 10 mg/kg (content limit) when 
analysed as a preservative. Analyses should be carried out in accordance with 
European standards EN 71-9:2005+A1:2007, EN 71-10:2005 and EN 71-11:2005. 
(9) While there is a generic migration limit for phenol as a monomer for use in certain 
food contact materials, the basic assumptions for deriving that migration limit are 
                                                 
5 Danish Environmental Protection Agency (EPA) (2003) Survey of chemical substances in consumer 
products Survey no. 32 – 2003. Emission and evaluatio n of chemical substances from selected electrical 
and electronic products, p. 47. http://eng.mst.dk/media/mst/69115/32.pdf   
6 Danish EPA (2004) Mapping of Chemical Substances in Consumer Products nr. 46, 2004. Release of 
chemical substances from te nts and tunnels for children. http://eng.mst.dk/media/mst/69127/46.pdf   
7 Bundesinstitut für Risikobewertung (2009) Limit valu es for phenol in food-contact articles and toys are 
to be updated. Opinion No 038/2009, 18 August 2009. http://www.bfr. bund.de/cm/349/limit_values_f or_phenol_in_food_contact_ articles_and_toys_are_to_be
_updated.pdf   
8 Voedsel en Waren Autoriteit (2004) Market Surveillances on Toy Safety. Report nr. ND04o063/01. 
www.vwa.nl/txmpub/files/?p_file_id=10468   
9 Suortti T (1990) Determination of phenol in poly(vinyl chloride). J Chromatogr. 1990 May 16; 
507:417-20.  http://www.ncbi.nlm.nih.gov/pubmed/2380304   
10 CEN TC 52 (2002) Final report of the work of CEN/TC 52/WG 9 – Risk assessment. Contract 
BC/CEN/97/29.1.1. August 2002, p. 85. 
11 Activity report 1989 – 91 of the Scientific Advisory Committee to examine the toxicity and ecotoxicity 
of chemical compounds (EUR 13976).  In Annex A to: CEN TC 52 (2002)  Final report of the work of 
CEN/TC 52/WG 9 – Risk assessment. Contract BC/CEN/97/29.1.1. August 2002. 
12 Scientific Committee on Health and Environmental Risks (SCHER), Opinion on "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 May 2007, pp. 8 and 9. EN 4   EN different from those for the migration limit for phenol as a monomer in toys. The use 
of phenol as a preservative is not re gulated for food contact materials. 
(10) Formamide (CAS number 75-12-7) is used, am ong others, in the plastics and polymers 
industry, particularly as a so lvent, plasticiser or as a substance associated with a 
blowing agent used in the creation of foam13. In 2010 several Memb er States identified 
formamide in a range of foam toys, such as  puzzle mats, which gave rise to concerns 
for the health of children through inhala tion. Some Member States took or were 
considering taking regulatory action. 
(11) In its deliberations about formamide the subgroup "Chemicals" took the opinion of the 
French Agency for Food, Environmental a nd Occupational Health & Safety (ANSES) 
as a basis. The opinion recommended that emission into the air of formamide from puzzle mats be limited, so that it does not exceed 20 μg/m
3 measured 28 days after 
unpacking and confinement in an outgassing ch amber of new mats before their sale, 
following a test method14 in accordance w ith the ISO 16000-6 a nd 16000-9 standards 
and under suitable conditions for sampling w ithin products and batches of products. 
(12) Formamide is classified under Regulation (EC) No 1272/2008 as toxic to reproduction 
category 1B. According to point 4 of Part  III of Annex II to Directive 2009/48/EC, 
substances toxic to reproduction of category 1B such as formamide may be present in 
toys in concentrations equal to or smaller than the relevant concentration established for the classification of mi xtures containing it, namely 0,5%, which equals 5 000 
mg/kg (content limit), before 1 June 2015, and 0,3%, which equals 3 000 mg/kg 
(content limit) thereaf ter. Directive 2009/48/EC does not  currently provide for an 
emission limit for formamide. 
(13) In the light of the above, the subgroup "C hemicals" recommended, at its meeting of 28 
November 2013, that emissions of formamid e from foam toy materials be limited in 
Appendix C to Annex II of the Directive to 20 μg/m
3 after a maximum of 28 days 
from commencement of the emission test ing. There are no known uses of formamide 
in food contact materials to be considered. 
(14) 1,2-Benzisothiazol-3(2H)-one (1,2-benziso thiazolin-3-one, BIT, CAS number 2634-
33-5) is used as a preservative in toys15 including hobby paints and finger paints16, as 
shown by the results of a market survey i nvolving economic operato rs and their trade 
associations, consumer representatives and al lergy centres as well as through internet 
searches and shop visits17. 
(15) In its deliberations about BIT the subgroup "Chemicals" took as a basis the related 
opinion of the Scientific Committee on Consum er Safety (SCCS) noting that BIT is a 
well-documented contact allergen18. Although the opinion considers BIT as only a 
moderate sensitiser with a lo wer potency than other marketed cosmetic preservatives19, 
                                                 
13 French Agency for Food, Environmental and Occupa tional Health & Safety (ANSES), Opinion on the 
uses of formamide in consumer g oods and health risks related to formamide in children’s foam puzzle 
mats. ANSES Opinion, Request No. 2010-SA-0302, 4 July 2011, p. 4. 
14 Emission test protocol with relative humidity of 50%, a temperature of 23°C, an air renewal rate of  
0.5 volume.h-1, a normal room size of 30 m³ and an emissive surface for the mat of 1.2 m2. 
15 Danish EPA (2014) Survey and health assessment of preservatives in toys. Survey of chemical 
substances in consumer products no. 124, 2014; table 24 on p. 56. 
16 See footnote 15, pp. 38 – 39. 
17 See footnote 15, p. 19 and following. 
18 Scientific Committee on Consumer Safety (SCCS), Opinion on benzisothiazolinone (BIT). Opinion 
adopted on 26 – 27 June 2012, pp. 16 and 26. 
19 See footnote 18, p. 16. EN 5   EN it concludes that isothiazolinones are importa nt contact allergens for the consumer in 
Europe20. 
(16) BIT is classified under Regul ation (EC) No 1272/2008 as a sk in sensitiser. Directive 
2009/48/EC has currently no specific limit value for BIT, nor a general limit value for sensitisers. 
(17) In the light of the above, th e subgroup "Chemicals" consider ed that BIT should not be 
used in toys. In accordance with European Standard EN 71-9, substances not to be used should be limited to the limit of quan tification (LOQ) of an appropriate test 
method
21. Accordingly the subgroup "Chemicals"  recommended, at its meeting of 
26 March 2014, that BIT in toys be limited to its LOQ, namely to a maximum concentration of 5 mg/kg. The use of BIT is  not regulated for food contact materials. 
(18) 5-Chloro-2-methylisothiazolin-3(2H)-one (C MI) and 2-methyl-isothiazolin-3(2H)-one 
(MI) in a ratio of 3:1 (CAS number 55965-84-9)
22 as well as its individual components 
CMI (CAS number 26172-55-4) and MI (C AS number 2682-20-4) are used as 
preservatives in toys23 including hobby paints, finger paints, window/glass paints, 
glues and soap bubbles24. 
(19) In its deliberations about CMI and MI in a ratio of 3:1 as we ll as the individual 
components CMI and MI the subgroup "Chemi cals" took as a basis the related SCHER 
opinion noting that neither CMI and MI in a ratio of 3:1 nor the individual components 
CMI and MI are recommended for use in t oys, due to contact allergic reactions 
observed with these substances in cosmetics25. The subgroup "Chemicals" also took 
account of the related SCCS opinion which cons iders CMI and MI in a ratio of 3:1 an 
extreme contact allergen in humans as demonstrated by available data26. 
(20) CMI and MI in a ratio of 3:1 is classi fied under Regulation (EC) No 1272/2008 as a 
skin sensitiser; CMI and MI individually are not cl assified under the Regulation. 
Directive 2009/48/EC has currently no speci fic limit value for CMI/MI 3:1, nor for 
CMI or MI individually, nor a gene ral limit value for sensitisers. 
(21) In the light of the above the subgroup "Che micals" recommended at its meeting of 
15 February 2012 that CMI and MI in a rati o of 3:1 should not be used in toys. 
(22) According to the German Fede ral Institute for Risk Asse ssment (BfR, Bundesinstitut 
für Risikobewertung)27 limit values for CMI and MI, which are strongly allergenic, 
should be set at a concentration considered  protective for indivi duals who are already 
sensitised. This is the strictest way to limit allergens, since already sensitised 
individuals suffer from an al lergy outbreak at even lowest  allergen concentrations. 
                                                 
20 See footnote 18, p. 26. 
21 EN 71-9:2005+A1:2007, Annex A, section A.10. 
22 Trade names are KathonTM CG, Microcare IT, Microcare ITL, Acticide 14, Acticide LG, according to 
the opinion of the Scie ntific Committee on Consumer Safety (SCCS) of 8 December 2009, p. 6. 
23 See footnote 15, table 24 on p. 56. 
24 See footnote 15, pp. 38 – 39. 
25 See footnote 12, p. 8 and table 1 on p. 9. 
26 Scientific Committee on Consumer Safety (SCCS), Opinion on the mixture of 5-chloro-2-
methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3 (2H)-one. Opinion adopted on 8 December 
2009, p. 35. 
27 Position paper of the German Federal Institute for Risk Assessment (Bundesinstitut für 
Risikobewertung, BfR) of 24.9.2012, p. 4. EN 6   EN According to the abovementioned SCCS opinion such concentration is below 2 
mg/kg28. 
(23) According to the BfR, market surveillance is able to routinel y quantify CMI down to 
0,75 mg/kg and MI down to 0,25 mg/kg29 (limits of quantification, LOQs). 
(24) In the light of the above, the Expert Group on Toys Safety recommended at its 
meeting of 23 May 2014 to also limit the us es of CMI and MI individually to their 
LOQs. 
(25) While there is a specific migration limit for MI individually as an additive for use in 
certain food contact materials, the basic a ssumptions for deriving that migration limit 
are different from those for the content lim it for MI in toys. The uses of CMI and MI 
in a ratio of 3:1 and of CMI individually are not regulated for food contact materials. 
(26) A variety of preservatives other than BIT, CM I and MI in a ratio of 3:1 as well as CMI 
and MI individually are available, which c ould be used in toys instead. They most 
likely do not present any health risk30 to children playing with  toys, when such toys 
are preserved at concentrations  usually applied in practice31. 
(27) In view of the above, Appendix C of Annex II to Directive 2009/48/EC  should be 
amended to include a migration limit as well as a content limit for phenol, an emission limit for formamide, and content limits for BIT, for CMI and MI in a ratio of 3:1, as well as for CMI and MI individually, in toys
. 
(28) The measures provided for in this Directiv e are in accordance with the opinion of the 
Toy Safety Committee, 
 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Appendix C of Annex II to Directive 2009/ 48/EC is replaced by the following: 
"Appendix C 
Specific limit values for chemicals used in t oys intended for use by children under 36 months 
or in other toys intended to be placed in the mouth adopted in accordance with  Article 46(2) 
Substance CAS No Limit value  
TCEP 115-96-8 5 mg/kg (content limit) 
TCPP 13674-84-5  5 mg/kg (content limit) 
TDCP 13674-87-8 5 mg/kg (content limit) 
Bisphenol A 80-05-7 0,1 mg/l (migration limit) in accordance with the 
methods laid down in EN 71-10:2005 and EN 71-11:2005. 
                                                 
28 See footnote 27, p. 33. 
29 See footnote 28, p. 4. 
30 Parabens, 2-phenoxyethanol, formaldehyde, bronopol. See footnote 15, p. 80 and following, p. 120 and 
following. 
31 See footnote 15, p. 8. EN 7   EN Phenol 108-95-2 5 mg/l (migration limit) as a monomer 
10 mg/kg (content limit) as a preservative Compliance with both limits is to be determined 
in accordance with the methods laid down in EN 
71-10:2005 and EN 71-11:2005. 
Formamide 75-12-7 20 μg/m3 (emission limit) after a maximum of 
28 days from commencement of the emission testing of foam toy materials. 
1,2-benzisothiazol-3(2H)-one 2634-33-5 5 mg/kg (content limit) 
reaction mass of: 5-
chloro-2- methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-
methyl-2H -isothiazol-
3-one [EC no. 220-239-6] (3:1) 55965-84-9 1 mg/kg (content limit) 
5-Chloro-2-methyl-
isothiazol-3(2H)-one  26172-55-4 0,75 mg/kg (content limit) 
2-methylisothiazol-
3(2H)-one 2682-20-4 0,25 mg/kg (content limit) 
" 
Article 2 
1. Member States shall adopt and publish, by [ Fill in date falling 18 months after 
publication in the OJ) ] at the latest, the laws, re gulations 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 [ 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 by such a reference on the occasion of their official publication. Member States shall determin e 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. 
Article 3 
This Directive shall enter into force on the tw entieth 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 8   EN Done at Brussels, 
 For the Commission 
 The President