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CEN-CENELEC Management Centre:  Rue de la Science 23,  B-1040 Brussels 
̹ʹͲͳͻ  
ǤǤǤ͹ͳǦ͵ǣʹͲͳͻEN 71-3:2019 (E) 
2 Contents Page 
European foreword ............................................................................................................. .......................................... 5  
Introduction .................................................................................................................. .................................................. 7  
1 Scope ......................................................................................................................... ........................................... 8  
2 Normative references .......................................................................................................... .......................... 8  
3 Terms and de finitions ......................................................................................................... .......................... 8  
4 Requirem ents .................................................................................................................. ................................. 9  
5 Principle ..................................................................................................................... ..................................... 11  
6 Reagents and appara tus ........................................................................................................ .................... 12  
7 Sampling and sampl e preparation ............................................................................................... .......... 12  
8 Migration me thodology ......................................................................................................... .................... 16  
9 Stabilization and analysis of migration solutions ............................................................................ 19 
10 Calculation of  results ........................................................................................................ .......................... 20  
11 Method performance ............................................................................................................ ...................... 21  
12 Test report ................................................................................................................... ................................... 24  
Annex A (informative)   Significant technical changes between this document and the 
previous ver sion .............................................................................................................. ............................. 25  
Annex B (informative)   Information on meth od validation .......................................................................... 26  
B.1 General ....................................................................................................................... ...................................... 26  
B.2 Samples of interlaboratory comparison ......................................................................................... ..... 26  
B.3 Selection of material category/element combinations .................................................................. 27  
Annex C (informative)   Estimation of reproducibility .................................................................................... 28  
Annex D (informative)   Toy material visual particle  size comparison materials ................................. 30  
Annex E (normative)   Method of analysis for general elements ................................................................. 32  
E.1 Principle ..................................................................................................................... ..................................... 32  
E.2 Working solutions ............................................................................................................. ........................... 32  
E.2.1  Stock solution ( M1) ............................................................................................................................. ........ 32  
E.2.2  Diluted stock solution ( M2) ...................................................................................................................... 33  
E.2.3  Working solutions ............................................................................................................. ........................... 33  
E.2.4  Internal standard stock solution .............................................................................................. .............. 33  
E.3 Procedure...................................................................................................................... .................................. 33  
E.4 Analysis ...................................................................................................................... ...................................... 33  
E.5 Calculation ................................................................................................................... ................................... 34  
E.5.1  Calibration curve ............................................................................................................. ............................. 34  EN 71-3:2019 (E) 
3 E.5.2  Calculation of  migrat ion ...................................................................................................... ....................... 34  
Annex F (normative)  Method of analysis for Chromium (V I) ...................................................................... 35  
F.1 Principle ..................................................................................................................... ...................................... 35  
F.2 Reagents ...................................................................................................................... ..................................... 35  
F.3 Apparatus ..................................................................................................................... ................................... 36  
F.4 Procedure ..................................................................................................................... ................................... 37  
F.5 Analysis ...................................................................................................................... ...................................... 37  
F.5.1  General ....................................................................................................................... ...................................... 37  
F.5.2  Chromatographic conditions .................................................................................................... ................ 37  
F.5.3  Limit of detection an d quantifi cation ......................................................................................... ........... 38  
F.5.3.1  General ....................................................................................................................... ...................................... 38  
F.5.3.2  Example of ch romatogram ....................................................................................................... ................. 38  
F.6 Calculation.................................................................................................................... ................................... 38  
F.6.1  Calibration curve ............................................................................................................. ............................. 38  
F.6.2  Calculation of migration ...................................................................................................... ....................... 39  
Annex G (normative)   Method of analysis for organic tin (see H.9) ........................................................... 40  
G.1 Principle ..................................................................................................................... ...................................... 40  
G.2 Reagents ...................................................................................................................... ..................................... 41  
G.3 Apparatus ..................................................................................................................... ................................... 44  
G.4 Procedure ..................................................................................................................... ........... ........................ 44  
G.4.1  Sample deriva tisation ......................................................................................................... ........................ 44  
G.4.1.1  Derivati sation ................................................................................................................ ................................ 44  
G.4.1.2  Category I and III materials .................................................................................................. ..................... 45  
G.4.1.3  Category II materials ......................................................................................................... .......................... 45  
G.4.1.4  Standard additi on method ...................................................................................................... .................. 45  
G.4.2  Calibration standards ......................................................................................................... ........................ 46  
G.5 Analys is ...................................................................................................................... ...................................... 46  
G.5.1  General ....................................................................................................................... ...................................... 46  
G.5.2  Example of GC conditions ...................................................................................................... .................... 48  
G.5.3  Example of MS conditions ...................................................................................................... .................... 48  
G.5.4  Limit of detection an d quantifi cation ......................................................................................... ........... 48  
G.5.5  Example of a GC-M S chromatogram ............................................................................................... ........ 49  
G.6 Calculation.................................................................................................................... ................................... 50  
G.6.1  Calibration curve ............................................................................................................. ............................. 50  
G.6.2  Standard ad dition ............................................................................................................. ............................ 50  
G.6.3  Calculation of migrat ion of organic tin ....................................................................................... .......... 50  EN 71-3:2019 (E) 
4 Annex H (informative)   Rationale ................................................................................................................... ........ 52  
H.1 General ....................................................................................................................... ...................................... 52  
H.2 Mouthing behaviour of c hildren (see Clause 1) ................................................................................ 52 
H.3 Skin contact (see Clause 1) ................................................................................................... .................... 53  
H.4 Toy categories (see 4.1) ...................................................................................................... ....................... 53  
H.5 Test portions (see Clause 7) .................................................................................................. ................... 53  
H.6 Size of test pieces (see 7.2) ................................................................................................. ...................... 53  
H.7 Stability of Chromium (VI) in the migration solution  (see 9.3) ................................................... 54  
H.8 Filtration of migration solutions (see 8.3.2) ................................................................................. ..... 54  
H.9 Organic tin (see Annex G) ..................................................................................................... ..................... 54  
H.10  pH value (see 8.2 and 8.3.1.2) ................................................................................................ .................. 56  
H.11  De-waxing (see 7.2.3) ......................................................................................................... ........................ 56  
Annex ZA (informative)   Relationship between this European Standard and the essential 
requirements of EU Directive 2009/48/EC aimed to be covered ............................................... 57  
Bibliogra phy .................................................................................................................. ............................................... 58  
 EN 71-3:2019 (E) 
5 European foreword 
This document (EN 71-3:2019) has been prepared by Technical Committee CEN/TC 52 “Safety of toys”, 
the secretariat of which is held by DS. 
This European Standard shall be given the status of  a national standard, either by publication of an 
identical text or by endorsement, at the latest by October 2019, and conflicting national standards shall 
be withdrawn at the latest by October 2019. 
Attention is drawn to the possibility that some of th e elements of this document may be the subject of 
patent rights. CEN shall not be held responsible for identifying any or all such patent rights. 
This document supersedes EN 71-3:2013+A3:2018. 
This document has been prepared under a mandate given to CEN by the European Commission and the 
European Free Trade Association, and supports esse ntial requirements of EU Directive 2009/48/EC. 
For relationship with EU Directive 2009/48/EC, see informative Annex ZA, which is an integral part of 
this document. 
The significant changes from the previous edition of this standard are detailed in Annex A. 
EN 71, S afety of toys , consists of the following parts: 
— Part 1: Mechanical and physical properties;  
— Part 2: Flammability;  
— Part 3: Migration of certain elements (this document ); 
— Part 4: Experimental sets for chemistry and related activities;  
— Part 5: Chemical toys (sets) other than experimental sets;  
— Part 7: Finger paints — Requirements and test methods;  
— Part 8: Activity toys for domestic use;  
— Part 9: Organic chemical compounds — Requirements;  
— Part 10: Organic chemical compounds — Sample preparation and extraction;  
— Part 11: Organic chemical compounds — Methods of analysis;  
— Part 12: N-Nitrosamines and N-nitrosatable substances;  
— Part 13: Olfactory board games, cosmetic kits and gustative games;  
— Part 14: Trampolines for domestic use.  
NOTE 1 In addition to the above parts of EN 71, th e following guidance documents have been published: 
CEN/TR 15071, Safety of toys — National translations of warnings and instructions for use in  EN 71 , and 
CEN/TR 15371 (all parts), Safety of toys — Interpretations . EN 71-3:2019 (E) 
6 NOTE 2 Words in italics  are defined in Clause 3 (Terms and definitions). 
According to the CEN-CENELEC Internal Regulation s, the national standards organisations of the 
following countries are bound to implement this Europe an Standard: Austria, Belgium, Bulgaria, Croatia, 
Cyprus, Czech Republic, Denmark, Estonia, Finland, Fo rmer Yugoslav Republic of Macedonia, France, 
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, 
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and 
the United Kingdom. EN 71-3:2019 (E) 
7 Introduction 
The Toy Safety Directive (2009/48/EC) [1] specifies maximum migration limits for three categories of 
toy materials . Certain limit values have been amended (see [4, 5, 6, 7]). The limits for the migration of 
certain elements are expressed in milligram per kilogram toy material  and are detailed in Table 2. The 
purpose of the limits is to minimize children’s exposure to certain potentially toxic elements. EN 71-3:2019 (E) 
8 1 Scope 
This document specifies requirements and test methods for the migration of aluminium, antimony, 
arsenic, barium, boron, cadmium, Chromium (III), Chromium (VI), cobalt, copper, lead, manganese, 
mercury, nickel, selenium, strontium, tin, organic tin and zinc from toy materials  and from parts of toys. 
Packaging materials are not considered to be part of  the toy unless they have  intended play value. 
NOTE 1 See the European Commission guidance document no. 12 on the application of the Directive on the safety 
of toys – packaging [2]. 
The standard contains requirements for the migration of certain elements from the following categories 
of toy materials : 
— Category I: Dry, brittle, powder like or pliable materials; 
— Category II: Liquid or sticky materials; 
— Category III: Scraped-off materials. 
The requirements of this document do not apply to toys or parts of toys which, due to their accessibility, 
function, volume or mass, clearly exclude any hazard due to sucking, licking or swallowing or prolonged 
skin contact when the toy or part of toy is used as intended or in a foreseeable way, bearing in mind the 
behaviour of children. 
NOTE 2 For the purposes of this docu ment, for the following toys and parts of toys the likelihood of sucking, 
licking or swallowing toys is cons idered significant (see H.2 and H.3): 
— All toys intended to be put in the mouth or to the mouth, cosmetics toys and writing instruments categorized 
as toys can be considered to be sucked, licked or swallowed; 
— All the accessible parts and components of toys intended  for children up to 6 years of age can be considered 
to come into contact with the mouth. The likelihood of mouth contact with parts of toys intended for older 
children is not considered sign ificant in most cases (see H.2). 
2 Normative references 
The following documents are referred to in the text in such a way that some or all of their content 
constitutes requirements of this document. For date d references, only the edition cited applies. For 
undated references, the latest edition of the refere nced document (including any amendments) applies. 
EN 71-1:2014+A1:2018, Safety of toys — Part 1: Mechanical and physical properties  
3 Terms and definitions 
For the purposes of this document, the following terms and definitions apply. 
ISO and IEC maintain terminological databases for use in standardization at the following addresses: 
Ȉ IEC Electropedia: available at http://www.electropedia.org/  
Ȉ ISO Online browsing platform: available at http://www.iso.org/obp  
3.1 
base material 
material upon which coatings  can be formed or deposited EN 71-3:2019 (E) 
9 3.2 
coating 
layer of material formed or deposited on a base material  which can be removed by scraping  
Note 1 to entry: Coatings  can include paints, varnishes, lacquers, inks, polymeric coatings  or other substances of 
a similar nature, whether they contain metallic particles or not, and irrespective of the manner of application. 
3.3 
paper 
sheet formed by irregularly intervened fibr es with a mass per unit area of 400 g/m 2 or less 
3.4 
paper board 
sheet formed by irregularly intervened fibr es with a mass per unit area over 400 g/m 2 
Note 1 to entry: The term paper board  also includes materials commonly referred to as card or cardboard with a 
mass per unit area over 400 g/m2. 
3.5 
scraping 
mechanical removal of coatings  down to but not including the base material  
3.6 
toy material 
material present in toys and accessible as determined in accordance with EN 71-1:2014+A1:2018, 8.10 
3.7 
sample 
toy or material subject to testing 
3.8 
laboratory sample 
material taken from a sample  
4 Requirements 
4.1 Toy material categories (see H.4) 
Table 1 contains a list of common toy materials  and their respective categories. Toy materials  not 
specifically listed in Table 1 shall be  assigned to one of the categories. EN 71-3:2019 (E) 
10 Table 1 — Cross-reference table for determining category 
Toy Material  Category I  Category II  Category III  
Coatings  of paints, varnishes, lacquers, printing inks, 
polymers, foams and similar coatings      X 
Polymeric and similar materials, including laminates, 
whether textile reinforced or not, but excluding other textiles      X 
Paper  and paper board      X 
Textiles, whether natural or synthetic      X 
Glass, ceramic, metallic materials      X 
Wood, fibre board, hard board, bone, leather and other solid 
materials      X 
Compressed paint tablets, materials intended to leave a trace or similar materials in solid form appearing as such in the toy (e.g. the cores of colouring pencils, chalk, crayons)
 X     
Pliable modelling materials, including modelling clays and plaster
 X     
Liquid paints, including finger paints, varnishes, lacquers, liquid ink in pens and similar materials in liquid form appearing as such in the toy (e.g. slimes, bubble solution)
   X   
Glue sticks    X   
4.2 Specific requirements 
The migration of elements from toy materials  categorized in accordance with 4.1 shall not exceed the 
migration limits given in Table 2 when tested in  accordance with Clause 7 (sampling and sample 
preparation), Clause 8 (migration procedure) and Clause 9 (stabilization and analysis of migration 
solutions). EN 71-3:2019 (E) 
11 Table 2 — Migration limits from toy materials 
Element  Migration limit  
Category I  
mg/kg  Category II  
mg/kg  Category III  
mg/kg  
Aluminium  5 625  1 406  70 000  
Antimony  45 11,3  560 
Arsenic  3,8 0,9 47 
Barium  1 500  375 18 750  
Boron  1 200  300 15 000  
Cadmium  1,3 0,3 17 
Chromium (III)  37,5  9,4 460 
Chromium (VI)  0,02  0,005  0,2 / 0,053 a 
Cobalt  10,5  2,6 130 
Copper  622,5  156 7 700  
Lead  2,0 0,5 23 
Manganese  1 200  300 15 000  
Mercury  7,5 1,9 94 
Nickel  75 18,8  930 
Selenium  37,5  9,4 460 
Strontium  4 500  1 125  56 000  
Tin 15 000  3 750  180 000  
Organic tin  0,9 0,2 12 
Zinc 3 750  938 46 000  
a The migration limit for Chromium (VI) for Category III toy material (scraped-off toy material) has been 
amended by Commission Directive (EU) 2018/725 [7]. The new limit value (0,053 mg/kg) applies from 2019-
11-18. Before this date the limit value 0,2 mg/kg applies. 
5 Principle 
Soluble elements are extracted from toy materials  using conditions which simulate the material 
remaining in contact with gastric juices for a period of time after swallowing. The concentrations of the 
soluble elements are determined quanti tatively by three different methods: 
— method for determining general elements: Aluminiu m, Antimony, Arsenic, Barium, Boron, Cadmium, 
Chromium, Cobalt, Copper, Lead, Manganese, Mercury, Nickel, Selenium, Strontium, Tin and Zinc; 
— method for determining Chromium (VI); 
— method for determining organic tin. EN 71-3:2019 (E) 
12 6 Reagents and apparatus 
6.1 Reagents 
All reagents, including water, used  for analysis shall be of analytical grade or, if unavailable, technical 
grade reagents which have been determined to ha ve acceptably low levels of impurity to allow the 
analysis to be performed. 
6.1.1 Hydrochloric acid solution , c(HCl) = (0,07 ± 0,005) mol/l. 
6.1.2 Hydrochloric acid solution , c(HCl) = (0,14 ± 0,010) mol/l. 
6.1.3 Hydrochloric acid solution,  c(HCl) = approximately 1 mol/l. 
6.1.4 Hydrochloric acid solution,  c(HCl) = approximately 2 mol/l. 
6.1.5 Hydrochloric acid solution,  c(HCl) = approximately 6 mol/l. 
6.1.6 Isooctane, (C 8H18), 99 %.  
6.2 Apparatus 
Standard laboratory equipment and the following shall be used. 
6.2.1 Equipment for measuring pH,  calibrated and sufficiently accurate for the purposes of this 
European Standard. 
NOTE H.10 contains additional information on equipment for measuring pH. 
6.2.2 Centrifuge,  capable of centrifuging at high spee d to separate the solids (see H.8). 
6.2.3 A means to agitate the mixture , at a temperature of (37 ± 2) °C. 
An orbital or linear shaker or shaking water bath capable of maintaining the migration solution in 
constant motion relative to the sample . 
6.2.4 Plastic containers  of gross volume, between 1,6 times and 5,0 times the volume of hydrochloric 
acid extract. 
6.2.5 High retention filter-paper , ashless filter paper, particle retention in liquids 2,5 μm. 
6.2.6 Membrane filters  with pore sizes of 0,45 μm and 0,02 μm. 
Syringe filters made with a cellulose acetate me mbrane are recommended for the 0,45 μm filter. 
7 Sampling and sample preparation 
7.1 Selection of test portions 
A sample  for testing shall consist of one toy in the form in which it will be marketed. Test portions shall 
be taken from toy materials  of the single toy sample . Identical materials in th e toy may be combined and 
treated as a single test portion but additional toy samples  shall not be used to prepare larger test portions. 
Test portions are taken from each colour of each toy material . Test portions may be composed of more 
than one toy material  or colour only when discrete specimen s cannot be separated physically, e.g. dot 
printing, patterned textiles, multi-coloured printe d surfaces etc. Such test portions shall be 
representative of the whole material. EN 71-3:2019 (E) 
13 NOTE This requirement does not preclude the preparatio n of test portions which represent the material and 
any base material  upon which it is deposited. 
Analysis of toy materials  present in amounts less than 0,010 g is not required (see H.5). 
The above does not preclude the testing of toy materials  before they are used to manufacture a toy (raw 
materials). In these cases, the manufa cturing process shall be assessed in order to ensure that it does not 
influence the migration of elements from the toy materials . 
7.2 Sample preparation 
7.2.1  General 
Appropriate blank solution s shall be analysed so that appropriate corrections can be made when 
necessary (e.g. contamination of reagents and material s). If the blank result exceeds half of the lowest 
value the laboratory intends to report (laboratory’s re porting limit) at least two blank solutions shall be 
analysed and the analytical result shall be corrected by the average value of the blank solutions. 
7.2.2  Sampling 
Whenever possible obtain a test portio n of not less than 0,100 g of each toy material  of the laboratory 
sample  using the appropriate sampling method specified in Table 3. 
Table 3 — Sampling methods 
Toy material  Category 
(Table 1)  Sampling method  
Liquid paints, including finger paints, 
varnishes, lacquers, liquid ink in pens 
and similar materials in liquid form 
appearing as such in the toy (e.g. slimes, 
bubble solutions)  II Mix the laboratory sample . Ink in pens should 
be removed from the pen’s refill before 
mixing.  
Coatings  of paints, varnishes, lacquers, 
printing ink, polymers, foams and similar 
coatings  III NOTE 1 Paper or paper board  samples  with 
paint, varnish, lacquer, printing ink, adhesive or 
similar material applied to their surfaces are not 
subjected to this sampling method but are treated according to the sampling method for paper or 
paper board . 
Remove the coating  from the laboratory 
sample  by scraping  at room temperature, 
taking care to avoid the inclusion of the base 
material . Obtain particles of approximately 
0,5 mm. The use of pre-prepared materials for 
visual size comparison is recommended (see 
Annex D). 
In case of a thick layer or one which is difficult 
to remove (e.g. pliable or plasticised layers), 
the coating  can be cut off and tested as 
polymeric material. 
For coatings  deposited on a non-polymeric 
base material , it is permissible to add a few 
drops of solvent, such as acetone/ethanol 
(1:1) mixture, methylene chloride or 
tetrahydrofuran to soften the coating  and 
assist in its removal from the base material . If EN 71-3:2019 (E) 
14 Toy material  Category 
(Table 1)  Sampling method  
a solvent is used, remove the traces of solvent 
only by evaporation prior to migration. This 
procedure shall not be used if there are 
indications that the use of solvents can affect the migration of an element from the coating . 
NOTE 2 The use of scraping  tools made of plastic 
materials helps to prevent the removal of base 
material  after applying the solvent. 
This solvent assisted procedure may be used 
for verifying previous high results which 
might have been caused by the release of 
elements from scraped off base materials  
underlying the coating , e.g. high release of zinc 
from a coating  scraped off from a base 
material  containing zinc. 
Paper  and paper board  III Prepare a test portion by cutting the 
laboratory sample  using suitable tools. Take 
care to produce clean cut edges. Each 
dimension of the test pieces shall be as near to 
6 mm as possible (see H.6). The use of pre-
prepared materials for visual size comparison 
is recommended (see Annex D). 
If a paper or paper board  sample  has paint, 
varnish, lacquer, printing ink, adhesive or 
similar material applied to its surface, test 
portions of the coating  shall not be taken 
separately. In such cases test portions shall be 
taken from the toy material  so that they also 
include representative parts of the coated 
area. 
Toys and removable components which fit entirely within the small parts cylinder 
(see EN 71-1:2014+A1:2018, 8.2) 
containing accessible glass, ceramic, metallic materials III Apply the migration procedure to the whole 
component including any coatings . 
Components, the coatings  of which have been 
removed for analysis, shall not be used. A separate unchanged component shall be used. 
Compressed paint tablets, materials 
intended to leave a trace or similar 
materials in solid form appearing as such 
in the toy (e.g. the cores of colouring 
pencils, chalk, crayons) I 
Prepare a test portion by cutting the 
laboratory sample  using suitable tools. Take 
care to produce clean cut edges. Each dimension of the test pieces shall be as near to 
6 mm as possible (see H.6). The use of pre-
prepared materials for visual size comparison 
is recommended (see Annex D). Pliable modelling materials, including 
modelling clays and plaster I 
Glue sticks II  
Polymeric and similar materials, 
including laminates, whether textile 
reinforced or not, but excluding other 
textiles III EN 71-3:2019 (E) 
15 Toy material  Category 
(Table 1)  Sampling method  
Textiles, whether natural or synthetic, 
including textile threads III 
Wood, fibre board, hard board, bone, 
leather and other solid materials III 
NOTE No sampling procedure for inaccessible toy materials  or glass, ceramic and metallic toy components 
which do not fit within the small parts cylinder is specif ied as they are not within the scope of this European 
Standard. The exposure to certain elements from inaccessible materials and larger hard components, which cannot 
be swallowed, is not considered significant. 
If a test portion of 0,1 g or more cannot be ob tained, a test portion shall be obtained from each toy material  
present in the sample  in a mass greater than 0,010 g. If the weig ht of the test portion obtained is between 
0,010 g and 0,100 g, this shall be indicated in the repo rt (see Clause 12 h)). In this case the analytical 
results shall be calculated as though 0,100 g of the te st portion had been used (Wtp = 0,100 g, see H.5). 
7.2.3  Dewaxing (see H.11) 
7.2.3.1  General  
If there are indications that the test portion contains grease, oil, wax or similar material dewax the test 
portion according to 7.2.3.2. 
Category II test portions which can be disper sed in 0,07 mol/l HCL shall not be dewaxed. 
De-waxing shall not be carried out on test portions prepared for organic tin analysis. 
NOTE There are certain sample  types known to contain grease, oil, wax or similar material. See H.11 for more 
information on which samples  contain wax and, consequently, would need to be dewaxed. 
7.2.3.2  Dewaxing procedure 
Use a high-retention filter paper (see 6.2.5) which shou ld be as small as possible without risking loss of 
the test portion during the de-waxing procedure. Weigh the test portion, to the nearest 0,001 g, onto the 
filter paper (Wtp). Use this mass of the test portio n for the calculation of the results of the test. For 
category II samples  containing grease, oil, wax or similar materi al, dry the test portion at (37 ± 2) °C for 
approximately 4 h. Fold the filter paper carefully to enclose the test portion without loss. Put the filter 
paper into the thimble of a Soxhlet extractor. Add an  amount of isooctane appropriate for the equipment 
into the boiling flask of the extractor and extract for at  least 60 min with no less than 10 reflux cycles per 
hour. If after 60 min there are indications of residual grease, oil, wax or similar material continue the 
extraction as necessary. 
After extraction, dry the folded filter paper contai n i n g  t h e  d e w a x e d  t e s t  p o r t i o n  a t  ( 8 0  ±  2 )  ° C  f o r  
approximately 1 h to remove the residual solvent. Weigh the dried filter paper parcel, to the nearest 
0,001 g (Wfp). Use Wfp to calculate the volume of water and 0,14 mol/l HCl used in the migration 
procedure (see 8.1.2.1, samples containing grease, oil, wax or similar material). 
The use of a dewaxing step shall be reported (see Clause 12 h)). EN 71-3:2019 (E) 
16 8 Migration methodology 
8.1 Preparation of test portions before migration testing 
8.1.1  General 
For the purposes of the following subclauses the dens ity of the water and hydrochloric acid solution can 
be assumed to be 1,0 g/ml and the solutions can be added volumetrically using suitable dispensers 
accurate to the nearest 0,05 ml.  
The volume of simulant ( V) added shall be recorded for the purpose of calculation of results. 
8.1.2  Category I: Dry, brittle, powd er like or pliable materials an d Category II: Liquid or sticky 
materials 
8.1.2.1  Samples containing grease, oil, wax or similar material 
After dewaxing (see 7.2.3), weigh to the nearest 0,05 g Wfp × 25 of water at (22 ± 3) °C into the 
appropriate sized container (see 6.2.4) containing the filter paper parcel. 
Using a suitable mechanical means (e.g. a glass rod, a pestle or similar implement) homogenize the filter 
paper containing the dewaxed test portion in the water. 
Add to the nearest 0,05 g Wfp x 25 of 0,14 mol/l hydroc hloric acid solution (see 6.1.2) at (22 ± 3) °C and 
mix. 
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH 
adjustment). 
8.1.2.2  Samples not containing grease, oil, wax or similar material 
Weigh the test portion to the nearest 0,001 g (Wtp) into the appropriate sized container (see 6.2.4). Add 
to the nearest 0,05 g Wtp x 50 of an aqueous soluti on of 0,07 mol/l HCl (see 6.1.1) at (22 ± 3) °C. 
For test portions of mass between 0,010 g and 0,100 g, add 5,0 ml of 0,07 mol/l HCl (see 6.1.1) at 
(22 ± 3) °C. 
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH 
adjustment). 
8.1.3  Category III: Scraped-off materials 
8.1.3.1  Glass, ceramic and metallic materials 
Weigh the toy or component to the nearest 0,001 g (W tp) into a 50 ml container with nominal height 
60 mm and nominal diameter 40 mm. 
Add sufficient amount of an aqueous solution of 0,07 mol/l HCl (see 6.1.1) at (22 ± 3) °C to just cover the 
toy or component. 
NOTE This size of container can contain componen ts/toys that fit inside the small parts cylinder. 
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH 
adjustment). 
8.1.3.2  Paper and paper board 
Weigh the test portion to the nearest 0,001 g (Wtp) into the appropriate sized container (see 6.2.4). 
Add to the nearest 0,05 g Wtp × 25 g of water at (22 ± 3) °C. EN 71-3:2019 (E) 
17 Using a suitable mechanical means (e.g. a glass rod, a pestle or si milar implement) homogenize the test 
portion in the water. 
Add to the nearest 0,05 g Wtp × 25 g of 0,14 mol/l hydr ochloric acid solution (see 6.1.2) at (22 ± 3) °C 
and mix. 
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH 
adjustment). 
8.1.3.3  Other materials 
Weigh the test portion to the nearest 0,001 g (Wtp) into the appropriate sized container (see 6.2.4). 
Add to the nearest 0,05 g Wtp x 50 g of an aqueous so lution of 0,07 mol/l HCl (see 6.1.1) at (22 ± 3) °C. 
For test portions of mass between 0,010 g and 0,100 g, add 5,0 ml of 0,07 mol/l HCl (see 6.1.1) at 
(22 ± 3) °C. 
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH 
adjustment). 
8.2 pH adjustment (see H.10) 
8.2.1  General 
Before starting the migration procedure adjust pH as specified in: 
—  8 . 2 . 2  ( p H  a d j u s t m e n t  –  n o  b u f f e r i n g  e f f e c t  b y  t o y  material) if the test portion is not expected to 
contain a significant quantity of alkaline/buffering materials; or 
—  8.2.3 (pH adjustment – buffering effect by toy mate rial) if the test portion is expected to contain a 
significant quantity of alkaline/buffering materials. 
Sample  types for which close pH control is most important include chalk, finger paints, crayons, pigments, 
paints, solid paint tablet s and, in particular, paper  and paper board . 
For each batch of test portions (i.e. test portions taken through the migration procedure at the same time), 
the pH control check measurement shall be performed on  at least one solution from each material type 
within the batch. If the pH measured  is less than 1,10 or more than 1,30 the remaining solutions in the 
batch for test portions of that type shall also be checked. 
8.2.2  pH adjustment – no buffering effect by toy material  
8.2.2.1  Following the addition of diluted of hydrochloric acid as specified in the relevant subclause 
of 8.1 (preparation of test portions before migration testing), shake the mixture gently for approximately 
1 min to mix the contents. 
8.2.2.2  Measure the pH of the mixture at (22 ± 3) °C. 
8.2.2.3  If the pH is greater than 1,30 add 2 mol/l HCl (see 6.1.4) dropwise whilst mixing until the pH 
is within the range 1,10 to 1,30. Proceed to the migration steps (see 8.3, migration procedure). 
8.2.3  pH adjustment – buffering effect by toy material  
8.2.3.1  Shake the mixture gently to mix the contents. 
8.2.3.2  Allow the mixture to stand at (22 ± 3) °C for 2
05 min. 
8.2.3.3  Measure the pH of the mixture at (22 ± 3) °C (pH a). EN 71-3:2019 (E) 
18 If pH a is within the range 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure). 
If pH a is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the 
range 1,10 – 1,20. 
8.2.3.4  Allow the mixture to stand at (22 ± 3) °C for 2
05 min. 
8.2.3.5  Measure the pH of the mixture at (22 ± 3) °C (pH b). 
If pH b is within the range 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure). 
If pH b is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the 
range 1,10 – 1,20. 
8.2.3.6  Allow the mixture to stand at (22 ± 3) °C for 2
010 min. 
8.2.3.7  Measure the pH of the mixture at (22 ± 3) °C (pH c). 
If pH c is within the range of 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure). 
If pH c is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the 
range 1,10 – 1,20. 
8.2.3.8  Allow the mixture to stand at (22 ± 3) °C for 2
010 min. 
8.2.3.9  Measure the pH of the mixture at (22 ± 3) °C (pH d). 
If pH d is within the range of 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure). 
If pH d is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the 
range 1,10 – 1,20. Then proceed with the migr ation procedure (8.3, migration procedure).  
8.3 Migration procedure 
8.3.1  Migration 
8.3.1.1  Migration conditions 
For glass, ceramic and metallic materials, cover the container and allow the contents to stand for 
10
0120 min at (37 ± 2) °C. 
For all other materials, close the container (see 6.2.4) and agitate the mixture at (37 ± 2) °C for 5
060 min 
with a speed of (150 ± 10) min-1. Stop the agitation and leave the co ntainers to stand for a further 
5
060 min at (37 ± 2) °C. 
8.3.1.2  pH control after migration (see H.10) 
After completing migration the pH shall be checked in  order to ensure that the correct pH has been 
maintained throughout the migration procedure. If it is  possible to demonstrate that there is no variation 
of the pH for certain materials (e.g. plastic) it is not necessary to control the pH for that material after 
migration.  
Migration solutions with a pH less than 1,10 or greate r than 1,30 which have been adjusted according to 
8.2.2 (pH adjustment – no buffering effect by toy material) shall be discarded and a new test portion shall 
be analysed using the migration procedure for toy materials  with high buffering capacity (see 8.2.3, pH 
adjustment – buffering effect by toy material). EN 71-3:2019 (E) 
19 For migration solutions with a pH less than 1,10 or greater than 1,30 which have  been adjusted according 
to 8.2.3 (pH adjustment – buffering effect by toy material) the pH measured after migration shall be 
indicated in the test report. 
It is sufficient to carry out the pH control check for one solution from each material type within a batch. 
I f  t h e  p H  m e a s u r e d  i s  l e s s  t h a n  1 , 1 0  o r  m o r e  t h a n  1,30 the remaining solutions in the batch for test 
portions of that type shall also be checked. 
8.3.2  Filtration (see H.8) 
8.3.2.1  General 
Without delay separate the solid matter from the soluti on by filtration through a membrane filter with a 
pore size of 0,45 μm (see 6.2.6). In case filtration is very slow, centrifugation (see H.8) may be used to 
remove particles before filtration. 
For special concerns regarding high copper results see 8.3.2.2 (samples exceeding the copper limit value). 
8.3.2.2  Samples exceeding the copper limit value 
In some rare cases high copper results can be obtained due to minute particles of copper containing 
insoluble matter (normally indicated by e.g. a Tyndall beam or a blue or green coloured filtrate). When 
the migration limits for copper are exceeded repeat the migration and filtration steps using a membrane 
filter (see 6.2.6) with a pore size of 0,02 μm. It is recommended to centrifuge the migration mixture (see 
H.8) and filter it with a 0,45 μm fi lter before the final filtration with a 0,02 μm filter in order to remove 
insoluble copper containing particles. 
9 Stabilization and analysis of migration solutions 
9.1 General 
The methods specified in 9.2 to 9.4 each require a cert ain volume of the prepared migration solution (see 
8.3, migration procedure). Approximately 4 ml are requ ired for the analysis for general elements, at least 
2 ml for Chromium (VI) analysis and approximately 5 ml for organic Tin analysis. 
Whilst it is acceptable to dilute migration solutions in order to provide sufficient volumes for the analyses, 
care should be taken to do this accurately and wi thout compromising the laboratory’s limit of detection 
and other analytical quality parameters. 
9.2 General elements 
If the migration solutions (see 8.3, migration procedur e) are to be retained for more than 24 h prior to 
analysis, they shall be stabilized by the addition of a suitable amount of hydrochloric acid such that the 
concentration HCl of the stored solution is approximately 1 mol/l. 
Analyse the migration soluti on according to Annex E. 
Alternative methods of analysis or mo difications to the methods of this European Standard are acceptable 
only if they are capable of achieving at least the accuracy and precision of the methods specified in 
Annex E. The sensitivity of any alternative methods or modifications shall be adequate and they shall 
have been validated to show that the results achiev ed are equivalent to those of the methods in this 
document. In particular, the limits of quantification (LOQ) shall not be greater than 50 % of the respective 
limit values specified in Table 2. 
NOTE Experience has shown that the detectio n using ICP-OES is suitable for category III toy materials . 
9.3 Chromium (VI) 
Neutralize the migration solution (see 8.3, migratio n procedure) according to F.4 without delay. After 
neutralization the solution is stable for at least 4 h. EN 71-3:2019 (E) 
20 Alternative methods of analysis or mo difications to the methods in this European Standard are acceptable 
only if they are capable of achiev ing at least the accuracy and prec ision of the methods specified in 
Annex F. The sensitivity of any alternative methods or  modifications shall be adequate and they shall have 
been validated to show that the results achieved are equivalent to those of the methods in this European 
Standard. In particular, the limits of  quantification (LOQ) shall not be greater than 50 % of the respective 
limit values specified in Table 2. 
NOTE Experience has shown that the detection using IC  with post-column derivatisation and UV/VIS detection 
is suitable for category III toy materials . 
9.4 Organic tin 
The migration solution (see 8.3, migration procedure) shall be analysed as quickly as possible, preferably 
within 24 h, according to Annex G. 
Alternative methods of analysis or mo difications to the methods in this European Standard are acceptable 
only if they are capable of achiev ing at least the accuracy and prec ision of the methods described in 
Annex G. The sensitivity of any alternative methods or modifications shall be adequate and they shall 
have been validated to show that the results achiev ed are equivalent to those of the methods in this 
Standard. In particular, the limits of quantification  (LOQ) of individual organic tin compounds shall not 
be greater than approximately 15 % of the organic tin limit values specified in Table 2. 
10 Calculation of results 
10.1 Calculation of migration 
10.1.1  General 
Calculate the migration of elements from the toy material  according to: 
— E.5 for general elements (Aluminium, Antimony, Arsenic, Barium, Boron, Cadmium, Chromium, 
Cobalt, Copper, Lead, Manganese, Mercury, Ni ckel, Selenium, Strontium, Tin and Zinc); 
— F.6 for Chromium (VI); 
— G.6 for organic tin. 
10.1.2  Calculation of Chromium (III) 
Chromium (III) is calculated by the following formula: 
   Cr III Cr total Cr VICC C   (1) 
where 
CCr(III)  is the concentration of Chromium (III), in mg/kg; 
CCr(total)  is the concentration of Chromium (all forms), in mg/kg; 
CCr(VI)  is the concentration of Chromium (VI), in mg/kg. 
NOTE The concentration of Chromium (VI) in many ca ses is below 2 % of the total concentration and can 
usually be neglected in Formula (1). EN 71-3:2019 (E) 
21 10.2 Interpretation of results 
When assessing whether or not samples  comply with the migration limit requirements analytical results 
should be interpreted using the data in Clause 11 (method performance). 
In accordance with normal analyti cal quality assurance measures, laboratories are required to determine 
their own method performance data, including me asurement uncertainty (see Clause 11, method 
performance and Annex C). 
NOTE Eurachem Guides [8, 9] give guidance on how to evaluate measurement uncertainty and how to use 
measurement uncertainty for interpretation of analy tical results in relation to compliance assessment. 
11 Method performance 
11.1 Repeatability and reproducibility 
Table 4, Table 5 and Table 6 show the results from  an interlaboratory comp arison performed during 
September 2017.  
Table 4 — Results from interlaboratory comparison for general elements 
Element  Material 
category  Material 
number a lb nc xd 
mg/kg CV Re 
% CV rf 
% CV ig 
% 
Al I 1 18 17 7 122 7,6 2,7 5,7 
Al II 5 18 16 133,8 6,2 3,6 5,6 
B II 4 18 15 303,7 10,3 3,0 5,8 
As I 1 18 17 3,74 12,6 5,8 9,5 
As II 6 17 16 0,958 13,5 7,9 5,8 
Cd III 12 18 17 26,2 12,1 2,0 5,9 
Ba II 5 18 16 363,4 6,4 2,5 4,7 
Ba III 13 15 13 5 021 18,7 6,4 8,2 
Co III 12 18 17 223,4 10,8 2,9 5,0 
Cr(III) I 1 18 16 37,3 7,4 2,7 6,1 
Cr(III) II 9 18 17 7,25 8,0 2,4 5,8 
Cr(III) III 12 18 16 1 110 17,6 3,5 8,0 
Cu I 1 18 17 767,3 11,5 3,6 7,4 
Cu II 4 18 16 156,5 5,8 2,5 4,8 
Hg II 6 17 16 1,23 23,4 7,5 13,1 
Mn I 2 18 15 1 676 10,2 2,5 6,4 
Mn II 4 18 16 301 6,2 3,4 4,2 
Ni III 11 15 12 1 688 19,8 2,3 7,1 
Pb III 11 15 12 35,8 20,6 3,2 8,5 
Pb I 2 18 16 2,11 15,7 6,4 9,2 
Pb II 6 18 15 0,613 19,8 5,4 8,7 
Sb III 12 18 16 712,7 33,9 3,3 19,8 EN 71-3:2019 (E) 
22 Element  Material 
category  Material 
number a lb nc xd 
mg/kg CV Re 
% CV rf 
% CV ig 
% 
Se II 6 18 16 9,53 8,5 4,1 7,7 
Sn III 13 15 14 2 864 47,7 9,9 13,5 
Sr III 12 18 16 10 017 10,3 2,2 6,7 
Sr I 2 18 16 5 310 14,8 2,3 5,6 
Zn III 12 18 15 9 236 12,4 1,9 9,4 
Zn II 4 18 16 108,6 16,1 10,0 11,1 
a See B.2 for more information about materials used in the interlaboratory comparison. 
b l is the number of laboratories reporting result for this parameter. 
c n is the number of results used in the statistical calculations after removal of outliers. 
d x is the mean of the accepted results. 
e CVR is the coefficient of variation of the reproducibility. 
f CVr is the coefficient of variation of the repeatability (indicating the relative spread between duplicate measurements 
from the same migration). 
g CVi is the relative intermediate standard deviation (indicating  the relative spread between two migrations on different 
days in the same laboratory). 
 
Table 5 — Results from interlaboratory comparison for Chromium (VI) 
Element  Material 
category  Material 
number a lb nc xd 
mg/kg CV Re 
% CV rf 
% CV ig 
% 
Cr(VI) I 3 9 7 0,022 62,4 4,0 25,8 
Cr(VI) II 8 9 9 0,012 56,3 7,8 30,2 
Cr(VI) III 14 8 8 2,97 36,5 6,2 12,6 
a See B.2 for more information about materials used in the interlaboratory comparison. 
b l is the number of laboratories reporting result for this parameter. 
c n is the number of results used in the statistical calculations after removal of outliers. 
d x is the mean of the accepted results. 
e CVR is the coefficient of variation of the reproducibility. 
f CVr is the coefficient of variation of the repeatability (indicating the relative spread between duplicate measurements 
from the same migration). 
g CVi is the relative intermediate standard deviation (indicating  the relative spread between two migrations on different 
days in the same laboratory). 
 EN 71-3:2019 (E) 
23 Table 6 — Results from interlaboratory comparison for organic tin compounds 
Element  Material 
category  Material 
number a lb nc xd 
mg/kg CV Re 
% CV rf 
% CV ig 
% 
Butyl Tin II 7 11 7 0,137 40,5 7,5 15,2 
Butyl Tin III 15 11 10 27,6 37,7 7,8 10,9 
DiButyl Tin II 7 11 8 0,072 55,5 7,9 10,8 
DiButyl Tin III 15 11 10 20,4 37,1 5,0 8,5 
TriButyl Tin III 15 11 10 7,64 71,7 4,3 14,0 
Sum Butyl 
Tin+DiButyl 
Tin II 7 11 8 0,205 41,0 8,1 9,5 
Sum Butyl 
Tin+DiButyl 
Tin+TriButyl 
Tin III 15 11 10 55,7 34,8 5,6 8,5 
a See B.2 for more information about materials used in the interlaboratory comparison. 
b l is the number of laboratories reporting result for this parameter. 
c n is the number of results used in the statistical calculations after removal of outliers. 
d x is the mean of the accepted results. 
e CVR is the coefficient of variation of the reproducibility. 
f CVr is the coefficient of variation of the repeatability (indicating the relative spread between duplicate measurements 
from the same migration). 
g CVi is the relative intermediate standard deviation (indicat ing the relative spread between two migrations on different 
days in the same laboratory). 
More information on the interlaborator y comparison is available in Annex B. 
11.2 Estimation of bias 
In order to estimate the method bias, spiking expe riments were performed during the interlaboratory 
comparison. Unknown to participant laboratories and for each analyte/matrix combination used the 
concentration of the migration solution was increased by a factor of approximately 3. The result of these 
spiking experiments showed recoveries close to 100 % for each analyte. The method bias was therefore 
minimal. 
11.3 Limit of detection (LOD) and limit of quantification (LOQ) 
The limits of detection (LOD) and the limits of quan tification (LOQ) for Cr(VI) and organic tin are given 
in Annex F and Annex G, respectively. For the gener al elements the LOQ obtained with ICP-MS following 
the procedures specified in this standard are more than 50 times better than required for assessing 
compliance of the limit values for any of  the material categories (see Table 2). 
In the interlaboratory comparis on a blank sample from material category II was tested for 
Chromium (VI). 5 out of 8 laboratories did not detect Chromium (VI) reporting LOQs below the limit 
value. 1 laboratory result exceeded the maximum migrat ion limit. The method specified in this standard 
is therefore capable of achieving sufficiently low LOQ for toy material  category II samples . EN 71-3:2019 (E) 
24 The results from the interlaboratory comparison also confirm that special care need to be taken to avoid 
any false positive findings of Chromium (VI) originating from reagents, solutions or materials used. 
12 Test report 
In accordance with normal la boratory practice, the test report shall contain at least: 
a) a title, e.g. Test report, Test Certificate; 
b) the name and address of the laboratory and the name and address of the client; 
c) a serial number or similar uniq ue identification for the report which should appear on each page 
together with pagination in  the form Page .. of ..; 
d) the client’s identification details for the samples  and the identifiers used  by the laboratory, for 
example sample  numbers; 
e) the date of receipt of the items and the date(s) of testing; 
f) identification of the analytical technique used; 
g) a reference to this document (i.e. EN 71-3:2019); 
h) a note of any deviations from the standard and any environmental conditions which can bear upon 
the results; 
i) a note to state that a sample  was dewaxed; 
j) the pH after the migration if it was outside the range of 1,1 to 1,3; k) the test results themselves with units and the measurement uncertainty (if required to assist in the 
interpretation of the results); 
l) the name, position and signature or other identifica tion of the person accepting responsibility for the 
report and the report’s date of issue; 
m) a statement that the results only apply to the items tested. EN 71-3:2019 (E) 
25 Annex A 
(informative)  
 
Significant technical changes between this document and the previous 
version 
Table A.1 — Significant technical changes betw een this European Standard and the previous 
version 
Clause/Paragraph/Table/Figure  Change  
3 New terms and definitions for sample and laboratory sample added and 
terms and definitions on limit of detection, limit of quantification and other material (whether mass coloured or not) removed. 
4 In Table 2 the limit value for Chromium (VI) for material category III adapted 
to new legal limit values. 
6 The list of reagents and apparatus has been revised 
7 Sampling and sample preparation have been revised and restructured to 
improve the user-friendliness of the standard. In particular sieving is no 
longer required and the corresponding annex with sieve requirements 
(former Annex C) has been deleted. Furthermore, the dewaxing procedure has been revised. 
8 The migration procedure has been revised and more detailed procedures for 
checking the pH before and after migration has been introduced. 
9 The stabilization of the migration solution has been revised. The status of test 
methods (included in Annex E, Annex F and Annex G) has been changed to 
normative. Performance requirements concerning the use of modifications 
to the annexes and alternatives to the specified test methods have been introduced. 
10 The calculation has been revised, in particular Chromium (III) is now 
calculated by subtracting the Chromium (VI) concentration from the total 
chromium concentration. 
11 Data on method performance have been introduced based on the results of 
test method validation and in particular the results of an interlaboratory 
comparison. 
Annex B A new informative annex containing information on the method 
development has been introduced. 
Annex C A new informative annex with estimations of reproducibility has been added. 
Annex D A new annex concerning the use of visual particle size comparison materials 
has been added. 
Annex E Minor revisions of the test method for general elements have been made. 
Annex F The test method for Chromium (III) and Chromium (VI) has been replaced 
by a test method for Chromium (VI) which is capable of determining 
Chromium (VI) at the limit values for all material categories. 
Annex G The test method for organic tin has been revised. 
Annex H Various rationales have been revised and new rationales concerning 
sampling and dewaxing have been added. 
NOTE The technical changes referred to above are the significant changes to the previous version. The list is 
not an exhaustive list of all modifications to the previous version. EN 71-3:2019 (E) 
26 Annex B 
(informative)  
 
Information on method validation 
B.1 General 
The test methods specified in this standard have b een validated by the technical project leader of the 
revision of EN 71-3:2013+A1:2014 and by a peer review laboratory as well as in a interlaboratory 
comparison. The results of the interlaboratory comparison are given in 11.1 (repeatability and 
reproducibility). The results of the technical project leader and peer review laboratory are in line with 
the results from the interlaborator y comparison and have been considered in the estimations provided 
in Annex C. 
B.2 Samples of interlaboratory comparison 
Table B.1 contains an overview of the samples  tested in the interlab oratory comparison. The samples  
were specifically produced for the purpose of method validation. Although the samples  covered the three 
material categories it was not possible to cover the whole variety of possible toy materials  (which could 
cause various matrix effects). It was also not possible to produce samples  covering all specific sample 
preparation steps specified in th is standard such as dewaxing, scraping -off and pH adjustment of 
materials with buffering capacity. 
Table B.1 — Samples of interlaboratory comparison 
Material category  Material number  Elements  Base material  
I 1 Al, As, Cr, Cu  Mixture of calcium sulfate 
and magnesium oxide  
2 Mn, Pb, Sr  Quarts powder  
3 Cr(VI)  Mixture of calcium sulfate and magnesium oxide
 
II 4 B, Cu, Mn, Zn  Water based paint  
5 Al, Ba  Water based paint  
6 As, Hg, Pb, Se  Water based paint  
7 Organic tin compounds  Finger paint  
8 Cr(VI)  Finger paint  
9 Cr Finger paint  
10 None  Finger paint  
III 11 Ni, Pb  Polymer material  
12 Co, Cd, Cr, Sb, Sr, Zn  Polymer material  
13 Ba, Sn  Polymer material  
14 Cr(VI)  Sol Gel, SiO 2-based  
15 Organic tin compounds  Polymer material  EN 71-3:2019 (E) 
27 B.3 Selection of material category/element combinations 
In accordance with Directive 2009/48/EC this European  Standard specifies limit values for the migration 
of 19 elements for three different material categories, i.e. 57 limit values in total (see Table 2). Due to 
limited resources it was not possible to produce an d test reference materials for all 57 element/material 
category combinations. Therefore, a prioritization  of element/material category combinations was 
carried out when planning the revision of EN 71-3:2013+A1:2014. This prioritization was mainly based 
on the reported migration of elements in practice and on the relevance for the method development and 
validation. 
The decision whether an element/material category co mbination was included in the reference materials 
for the revision of EN 71-3:2013+A1:2014 was based on the following: 
— the priority of the element/material category combinations, i.e. combinations with high priority 
(reported migration of elements in the material category) were preferred; 
— the representation of each element in at least on e material category is considered as crucial for the 
purpose of method development/validation because th is allows to have reference material(s) for all 
the elements in question; 
— given the limitations in budget and time frame for the revision of EN 71-3 it was not possible to cover 
all element/material category combinations. 
As the project focused on method development/valida tion the aspect of covering all elements in at least 
one material category had been co nsidered as more important th an to cover all element/material 
combinations with high/medium priority. Consequently, in order to limit the number of 
element/material category combinations  only very few elements were in cluded in all material categories. 
In order to compensate for the missing data fo r certain element/material category combinations 
estimations for the reproducibility have been included in Annex C. EN 71-3:2019 (E) 
28 Annex C 
(informative)  
 
Estimation of reproducibility 
During the revision of EN 71-3:201 3+A1:2014 a lot of data, e.g. from the technical project leader and the 
peer review laboratory as well as from the interlab oratory comparison, had b een produced. Only a few 
data could be given in the standard. Based on the da ta and on the expertise of the experts involved, the 
responsible working group tried to summarize the resu lts and knowledge obtained from the revision of 
this project (SA/CEN/2013-03 Migration of certain elemen ts) in order to help the user of this standard 
in fulfilling the requirements of Directive 2009/48/EC. 
In this process in particular the following aspects had been considered: 
— the limited experience of laboratories participatin g in the interlaboratory comparison in particular 
with regard to the modified methods for organic tin and Chromium (VI) as these methods had been 
provided only shortly before the interlaboratory comparison; 
— in order to facilitate the application of the standa rd, four balanced levels fo r relative reproducibility 
have been introduced which were derived from the data of the interlaborat ory comparison and the 
data from the technical project lead er and peer review laboratory; 
— standard deviations especially on reproduc ibility are usually increasing when element 
concentrations get lower which had also been shown in the interlaboratory co mparison. As a general 
rule this had been treated by a hi gher level of reproducibility generally below 10 mg/kg in Table C.1; 
— bearing in mind the prioritization of element/material category combinations and the need to fill the 
gaps for combinations for which no reference materi als had been available duri ng the revision of the 
standard (see Annex B); 
— applying the standard to a broad spectrum of toys with various compositions within the material 
categories but recognizing that the estimated reproducibility data does not intend to represent the 
worst case (e.g. higher reproducibilities than estimated in Table C.1 could result for certain toy 
materials ); 
— developing a guideline for principal equivalence of  other methods in relation to the results with the 
given methods in this standard; 
— recognizing that the estimated reproducibility data are not intended to replace the standard 
deviation (and measurement uncertainty) data which shall be prepared by each laboratory. 
Table C.1 contains estimations of relative reproducib ility for the elements for each material category at 
concentration at levels approximately at the limit value. EN 71-3:2019 (E) 
29 Table C.1 — Estimations of relative reproduc ibility at concentrations corresponding 
approximately to the li mit values in Table 2 
Element  Estimated coefficient of variation of the reproducibility ( CVR) 
% 
  Material Category I Material Category II Material Category III 
Aluminium 15 15 15 
Antimony 30 30 30 
Arsenic 20 20 20 
Barium 20 15 30 
Boron 15 15 15 
Cadmium 20 20 15 
Chromium (III) 15 20 15 
Chromium (VI) 50 50 50 
Cobalt 15 20 15 
Copper 15 15 15 
Lead 20 20 30 
Manganese 15 15 15 
Mercury 30 30 20 
Nickel 20 20 20 
Selenium 15 20 15 
Strontium 15 15 15 
Tin 20 20 30 
Organic tin 50 50 50 
Zinc 15 15 15 EN 71-3:2019 (E) 
30 Annex D 
(informative)  
 
Toy material visual particle size comparison materials 
When preparing test portions of toy materials  for analysis it is important to control the particle size. Trials 
have shown that the benefits of sieving test portio ns to control the particle size are outweighed by the 
inconvenience and the loss of the test portions in some cases. For that reason, it is recommended that 
comparison materials are used against which test portions can be compared visually. 
Visual comparison materials can conveniently be prepared from typical toys materials such as: 
— Polymeric materials; 
— Paper  and paper board ; 
— Textile materials; 
— Paints and coatings ; 
— Natural materials such as wood, fibre board, bone, leather etc. 
This standard recommends that visual comparison materials be prepared in accordance with 7.2 
(Table 3). Visual comparison materials can be prepar ed which fulfil the size criteria (see below) and 
which have been measured or sieved  to ensure that they do. The comparison materials can be stored in 
transparent containers for ease of use and handled carefully so that the particle sizes do not alter 
significantly with time. They should be checked periodically. 
Table D.1 — Toy material visual pa rticle size comparison materials 
Toy material  Category 
(Table 1)  Comparison material particle size  
Coatings  of paints, varnishes, 
lacquers, printing ink, polymers, 
foams and similar coatings  III approximately 0,5 mm 
prepared by scraping  materials and passing 
through a metal sieve of nominal aperture 
0,500 mm 
Polymeric and similar materials, including laminates, whether 
textile reinforced or not, but 
excluding other textiles III Approximately 6 mm in at least one dimension. 
The visual comparison materials shall show the 
analyst acceptable sized pieces from a variety of 
materials with different thicknesses, some with 3 
d i m e n s i o n s  o f  6  m m  a n d  s o m e  w i t h  o n l y  2  
dimension of 6 mm (when th ey are thinner pieces). 
Paper  and paper board  III Approximately 6 mm in at least one dimension. 
Prepare a variety of particles from materials of 
different thicknesses which demonstrate 
acceptable sizes of materials typically used in toys. EN 71-3:2019 (E) 
31 Toy material  Category 
(Table 1)  Comparison material particle size  
Textiles, whether natural or 
synthetic III Approximately 6 mm in at least one dimension. 
Prepare a variety of particles from materials of 
different thicknesses which demonstrate 
acceptable sizes of materials typically used in toys. 
Toys and removable components which fit entirely within the small 
parts cylinder (see 
EN 71-1:2014+A1:2018, 8.2) containing accessible glass, 
ceramic, metallic materials III Comparison material not required 
Wood, fibre board, hard board, 
bone, leather and other solid 
materials III Approximately 6 mm in at least one dimension. 
The visual comparison materials shall show the 
analyst acceptable sized pieces from a variety of 
materials with different thicknesses, some with 3 d i m e n s i o n s  o f  6  m m  a n d  s o m e  w i t h  o n l y  2  
dimension of 6 mm (when th ey are thinner pieces). 
Compressed paint tablets, 
materials intended to leave a trace or similar materials in solid form 
appearing as such in the toy (e.g. 
the cores of colouring pencils, 
chalk, crayons) I Approximately 6 mm in at least one dimension. 
The visual comparison materials shall show the 
analyst acceptable sized pieces from a variety of 
materials with different thicknesses, some with 3 
d i m e n s i o n s  o f  6  m m  a n d  s o m e  w i t h  o n l y  2  
dimension of 6 mm (when th ey are thinner pieces). 
Pliable modelling materials, 
including modelling clays and plaster I Approximately 6 mm in at least one dimension. 
The visual comparison materials shall show the 
analyst acceptable sized pieces from a variety of 
materials with different thicknesses, some with 3 
d i m e n s i o n s  o f  6  m m  a n d  s o m e  w i t h  o n l y  2  
dimension of 6 mm (when th ey are thinner pieces). 
Liquid paints, including finger 
paints, varnishes, lacquers, liquid 
ink in pens and similar materials in 
liquid form appearing as such in 
the toy (e.g. slimes, bubble 
solutions) II Comparison material not required. 
Glue sticks II Approximately 6 mm in at least one dimension. 
The visual comparison materials shall show the 
analyst acceptable sized pieces from a variety of 
materials with different thicknesses, some with 3 
d i m e n s i o n s  o f  6  m m  a n d  s o m e  w i t h  o n l y  2  
dimension of 6mm (when they are thinner pieces). EN 71-3:2019 (E) 
32 Annex E 
(normative)  
 
Method of analysis for general elements 
E.1 Principle 
This method quantifies Aluminium, Antimony, Arsenic, Barium, Boron, Cadmium, Chromium, Cobalt, 
Copper, Lead, Manganese, Mercury, Nickel, Selenium, Strontium, Tin and Zinc in the migration solution 
(see 8.3, migration procedure). The migration solution  and its dilutions are an alysed directly by ICP-MS. 
E.2 Working solutions 
E.2.1  Stock solution ( M1) 
Prepare a stock solution ( M1) diluting the commercial available stock solutions of the individual elements 
(concentration = 1 000 mg/l) in hydrochloric acid soluti on (see 6.1.1) to a volume of 50 ml, according to 
the scheme in Table E.1. 
Table E.1 — Preparation scheme stock solution M1 
Element  Volume stock  
ml Volume  
ml Concentration  
mg/l  
Aluminium  0,5 50,0  10,0  
Antimony  0,5 50,0  10,0  
Arsenic  0,5 50,0  10,0  
Barium  0,5 50,0  10,0  
Boron  0,5 50,0  10,0  
Cadmium  0,5 50,0  10,0  
Chromium  0,5 50,0  10,0  
Cobalt  0,5 50,0  10,0  
Copper  0,5 50,0  10,0  
Lead  0,5 50,0  10,0  
Manganese  0,5 50,0  10,0  
Mercury  0,05  50,0  1,0 
Nickel  0,5 50,0  10,0  
Selenium  0,5 50,0  10,0  
Strontium  0,5 50,0  10,0  
Tin 0,5 50,0  10,0  
Zinc 0,5 50,0  10,0  EN 71-3:2019 (E) 
33 E.2.2  Diluted stock solution ( M2) 
Dilute 0,5 ml of stock solution M1 in hydrochloric acid (see 6.1.1) to 50 ml. 
E.2.3  Working solutions 
Sequentially dilute diluted stock solutions ( M1) and ( M2) with hydrochloric acid solution (see 6.1.1), in 
order to obtain standards to be used for cali bration according to the scheme in Table E.2. 
Table E.2 — Preparation scheme working solutions 
Working solutions  Volume M1 Volume M2 Volume HCl 
(6.1.1)  Volume total  Concentration of 
each element  
 ml ml ml ml μg/la 
Working solution W1   1,25  48,75  50,0  2,5 
Working solution W2   2,5 47,50  50,0  5,0 
Working solution W3   5,0 45,0  50,0  10,0  
Working solution W4 0,125    49,875  50,0  25,0  
Working solution W5 0,250    49,75  50,0  50,0  
Working solution W6 0,50    49,50  50,0  100,0  
a The concentration of mercury is respectively 0,25 μg/l, 0,50 μg/l, 1,00 μg/l, 2,5 μg/l, 5,0 μg/l and 10,0 μg/l. 
E.2.4  Internal standard stock solution 
Prepare an Internal Standard stoc k solution diluting 250 μl of a commercial available stock solution 
containing at least one element, e.g. Bismuth, In dium, Lithium or Yttrium, (100 μg/ml in 7 % HNO 3 
(volume fraction)) to a volume of 500 ml. This soluti on can either be used to prepare the standard and 
sample solutions, or by mixing with these solutions using continuous flow before entering the spray chamber. 
E.3 Procedure 
Use the migration solution (see 8.3, migration proced ure). The elements shall be within the range of the 
calibration curve and therefore dilutions of the mi gration solutions can be necessary. For example, a 
dilution range of 2, 20, 200 and 2 000 can be used. 
E.4 Analysis 
The migration solution can be analysed directly respectively after dilution using Inductively Coupled 
Plasma-Mass Spectrometry (ICP-MS) to determin e the content of general elements (Aluminium, 
Antimony, Arsenic, Barium, Boron, Cadmium, Cob alt, Chromium, Copper, Lead, Manganese, Mercury, 
Nickel, Selenium, Strontium, Tin and Zinc). 
Optimize the instrument according to the manufacturer’s instructions. The quantification limit for each 
element should be well below the limits set in Tab le 2 divided by the dilution caused by the migration 
test (50). Dilution is often required when determinin g elements close to or above the migration limit (see 
Table 2). EN 71-3:2019 (E) 
34 Table E.3 contains recommended isotopes (m/z) fo r the determination of elements in the migration 
solution using ICP-MS. 
Table E.3 — Recommended isotopes (m/z) for the determination of elements in the migration 
solution using ICP-MS 
Element  Recommended Isotope  Element  Recommended Isotope  
Aluminium  27Al Lead  208Pb 
Antimony  121Sb Manganese  55Mn 
Arsenic  75As Mercury  202Hg 
Barium  137Ba Nickel  60Ni 
Boron  11B Selenium  82Se 
Cadmium  111Cd Strontium  87Sr 
Chromium 52Cr Tin 118Sn 
Cobalt  59Co Zinc 66Zn 
Copper  65Cu     
Care shall be taken to avoid the polyatomic and isobaric interference (e.g. from ArC + when determining 
Chromium), meaning that the instrument should be equipped with either a collision/reaction system or 
a high resolution mass spectrometer. 
E.5 Calculation 
E.5.1  Calibration curve 
Prepare calibration curves of each element of intere st by plotting the concentration of the standards of 
the element of interest against the measuring signal. 
Calibration curves used to calculate analytical result s shall have a correlation coefficient no less than 
0,990. 
E.5.2  Calculation of migration 
Calculate the migration of the element from the test portion as follows (E.1): 
1000CV fMWtp  (E.1) 
where 
M is the migration of an element from the toy material, in mg/kg; 
C is the concentration of the element in the migration solution, in μg/l; 
V is the volume of simulant added, in ml; 
Wtp is the weight of the test portion, in g; 
f is the dilution factor, appropriate for an y dilutions made during the analysis. 
Report the results to the number of significant figu res appropriate for the precision of the analysis. EN 71-3:2019 (E) 
35 Annex F 
(normative)  
 
Method of analysis for Chromium (VI) 
F.1 Principle 
This method quantifies Chromium (VI) in the migration solution (see 8.3, migration procedure). 
To prevent interconversion of Chromium (III) and Chromium (VI), the migration solution is neutralized 
directly after the migration step. Experiments have show n that at a pH of 7 to 8 both species are stable. 
Chromium (VI) is separated from other Chromium species using an ion exchange column and detected 
by inductively coupled plasma – mass spectrometry (ICP-MS). 
Other chromatographic systems (instrument, separation column, eluent, chromatographic conditions) as 
the one described here can be used as long as the method: 
— uses an ion exchange separation mechanism, 
— is able to achieve sufficient separation of Chromiu m (VI) from Chromium (III) (baseline separation; 
also when there is much more Chromium (III) than Chromium (VI) in the migration solution), 
NOTE Peak tailing of Chromium (III) can significantly affect the LOQ and reproducibility of the Chromium (VI) 
determination if the Cr(VI) elutes after Cr(III), the Cr(III) concentrations is ve ry high and the peaks are not baseline 
separated. 
— ensures that there is no interconversion between Chromium (VI) and Chromium (III) during analysis, 
— achieves a sufficient LOQ for the limit values specified in this standard. 
Due to the very low concentrations which have to be measured special care should be taken to avoid any 
false positive findings of Chromium (VI) originat ing from reagents, solutions or materials used. 
F.2 Reagents 
All reagents, including wate r, used for analysis shall be of analyti cal grade or, if unavailable, technical 
grade reagents which have been determined to have  acceptably low levels of  impurity to allow the 
analysis to be performed. 
F.2.1 Nitric acid , (65 % to 69 %) trace metal grade 
F.2.2 Ammonia , NH 3 (25 % in water) 
F.2.3 Ammonia solution , 0,7 mol/l 
Add 5,3 ml of ammonia (see F.2.2) to a 100 ml volume tric flask. Make up to the mark with water and mix 
carefully. 
F.2.4 Hydrochloric acid solution , 0,07 mol/l 
F.2.5 Mobile phase , 75 mM HNO 3 (see F.2.1) adjusted to pH = 7,0 with ammonia (see F.2.2) and/or 
ammonia solution (see F.2.3) 
F.2.6 Potassium dichromate  (K2Cr2O7), dried for (16 ± 2) h at (102 ± 2) °C EN 71-3:2019 (E) 
36 F.2.7 Chromium (VI) stock solution  
Dissolve 2,829 g potassium dichromate (K 2Cr2O7) (see F.2.6) in water in a 1 000 ml volumetric flask and 
make up to the mark with water. Alternatively, a commercially available solution at 1 000 mg/l of 
hexavalent Chromium can be used. This solution will be stable for at least three months. 
NOTE Information on the stability of commercial  solution is usually provided by the supplier. 
F.2.8 Chromium (VI) solution ( M1), 1 mg/l 
Prepare a Chromium (VI) solution ( M1) by diluting 0,1 ml of the stock standard solution (see F.2.7) in 
mobile phase (see F.2.5) to a volume of 100 ml. Make up to the mark with mobile phase (see F.2.5) and 
mix. This solution will be stable for at least one week. 
NOTE Information on the stability of commercial solutions is usually provided by the supplier. 
F.2.9 Diluted Chromium (VI) solution ( M2), 1 μg/l, freshly prepared 
Dilute 0,05 ml of Chromium (VI) solution M1 (see F.2.8) in mobile phase (see F.2.5) in a 50 ml volumetric 
flask. Make up to the mark with mobile phase (see F.2.5) and mix carefully. 
F.2.10 Working solutions  (Calibrating Standards), freshly prepared 
Prepare 6 working solutions according to Table F.1. 
After the addition of ammonia solution (see F.2.3) to  the hydrochloric acid (see F.2.4) check pH and, if 
necessary, adjust the pH to 7,5 ± 0,5 using ammonia s olution (see F.2.3) or hydrochloric acid (see F.2.4). 
Table F.1 — Preparation scheme for working solutions 
Working 
solutions  Volume  
M2 (F.2.9)  Volume 
hydrochloric 
acid solution  
(F.2.4)  Volume ammonia 
solution  
(F.2.3)
 Volume mobile 
phase  
(F.2.5)
 Volume total
 Concentration of Chromium 
(VI)
 
  ml ml ml   ml μg/l  
W1 0 4,0 0,4 
amount 
needed in 
order to 
achieve a 
total 
volume of 
10,0 ml  10,0  0 
W2 0,2 4,0 0,4 10,0  0,020  
W3 0,4 4,0 0,4 10,0  0,040  
W4 0,8 4,0 0,4 10,0  0,080  
W5 1,2 4,0 0,4 10,0  0,120  
W6 1,6 4,0 0,4 10,0  0,160  
F.3 Apparatus 
F.3.1 Variable pipettes  with disposable tips, variable range 
The tip ejector shall not be made of stainless steel. 
F.3.2 Volumetric flasks Class A , plastic 
F.3.3 Column  packed with polymeric, non-porous, weak ion exchange phase EN 71-3:2019 (E) 
37 F.3.4 Chromatographic system  suitable for trace metal analysis ( e.g. Bio inert Liquid chromatograph, 
Ion Chromatograph) 
F.3.5 Inductively coupled plasma  mass spectrometer (ICP-MS)  equipped with chromatographic 
system (see F.3.4). The instrument shall be able to determine 52Cr with high sensitivity. This normally 
requires an ICP-MS with a collision/reaction system or a high resolution mass spectrometer. 
F.3.6 Equipment for measuring pH  in small volumes, calibrated and sufficiently accurate for the 
purposes of this European Standard. 
F.4 Procedure 
For the category I and II sample , pipette 2 ml ( V1) of migration solution (see 8.3, migration procedure) 
and 0,2 ml of ammonia solution (see F.2.3). Add 2, 8 ml of mobile phase (see F.2.5) and mix thoroughly. 
Check the pH of the solution obtained and, if necessa ry, adjust the pH to 7,5 ± 0,5 using ammonia solution 
of suitable concentration or hydrochloric acid of suitable concentration. Record the final volume of the 
solution obtained after th e pH adjustment, in ml ( V2). 
NOTE For the adjustment of pH the following concentrations of ammonia solution have been found suitable: 
— pH < 2: 2 mol/l ammonia solution; 
— pH between 2 and 3: 0,4 mol/l ammonia solution; 
— pH > 3: 0,1 mol/l ammonia solution. 
For the category III sample , pipette 0,2 ml ( V1) of migration solution (see 8.3, migration procedure) and 
0,02 ml of ammonia solution (see F.2.3). Add 4,78 ml of mobile phase (see F.2.5) and mix thoroughly. 
Check the pH of the solution obtained and, if necessa ry, adjust the pH to 7,5 ± 0,5 using ammonia solution 
(see F.2.3) or hydrochloric acid (see F.2.4). Record the final volume of the solution obtained after the pH 
adjustment, in ml ( V2). 
F.5 Analysis 
F.5.1  General 
Optimize the ICP-MS for optimal detection of Ch romium, normally at mass 52 according to the 
manufacturer’s recommendations. The instrument settings shall give a sufficient reduction of the 
40Ar12C signal to eliminate false-positive results. A suitable integration time for the MS is 1 s. 
F.5.2  Chromatographi c conditions 
Table F.2 — Example of ch romatographic settings 
Parameter  Setting  
Mobile phase  75 mM HNO 3 adjusted to pH = 7,0  
Flow rate  0,8 ml/min  
Column  Polymeric, non-porous, weak  ion exchange phase 5 μm, 
4,6 mm x 50 mm  
Column temperature  Ambient  
Injection volume  100 Ɋ 
Total analysis time  3 min  EN 71-3:2019 (E) 
38 F.5.3  Limit of detection and quantification 
F.5.3.1  General 
Table F.3 contains typical limits of detection (LOD) and quantification (LOQ) expressed in mg/kg toy 
material . 
Table F.3 — Typical detection limit (L OD) and quantification limit (LOQ) 
Element  LOD  
mg/kg LOQ  
mg/kg 
Chromium (VI) 0,000 75 0,002 5 
F.5.3.2  Example of chromatogram 
 
Key 
Y intensity, in cps 
X retention time, in min 
Figure F.1 — Example of chromatogram of 0,08  μg/l Chromium (VI) using the conditions in 
Table F.2 
F.6 Calculation 
F.6.1  Calibration curve 
Prepare calibration curves by plotting the concentr ation of the standards against the measuring signal. 
For quantification, the calibration curve shall have a correlation coefficient better or equal to 0,990. EN 71-3:2019 (E) 
39 F.6.2  Calculation of migration 
Calculate the amount of migrated Chromium (VI) by Formula (F.1). 
1000CV FMWtp  (F.1) 
where 
Migration is the migration of Chromium (VI) from the toy material, in mg/kg; 
C is the concentration of Chromium (VI) obtain ed from the regression curve, in μg/l; 
V is the volume of simulant added for the migration procedure (see 8.3, migration 
procedure), in ml; 
Wtp is the weight of the test portion, in g; 
F is a correction factor calculated with Formula (F.2). 
1
2VFV  (F.2) 
where 
V1 is the volume after neutralization an d final dilution with eluent, in ml. 
V2 is the volume of the solution from the migr ation procedure (see 8.3, migration procedure) 
used for Chromium (VI) determination, normally 0,2 or 2, in ml; 
Report the results to the number of significant figures justified by the precision of the measurement. EN 71-3:2019 (E) 
40 Annex G 
(normative)  
 
Method of analysis for organic tin (see H.9) 
G.1 Principle 
This method quantifies organic tin compounds and/or cations as mentioned in Table G.1 in the migration 
solution (see 8.3, migration procedure), and cove rs the main organic tin cation/compound additives 
which can be present in toys. The anionic part bound to the organic tin cation is mainly dependent on the 
chemical environment and is not determined using this method. 
Table G.1 — Organic tin compounds and cations 
RnSn(4-n)+ R n Name  Acronym  
MeSn3+ Methyl  1 Methyltin cation  MeT  
Me2Sn2+ Methyl  2 Dimethyltin cation  DMT  
BuSn3+ Butyl  1 Butyltin cation  BuT 
Bu2Sn2+ Butyl  2 Dibutyltin cation  DBT  
Bu3Sn+ Butyl  3 Tributyltin cation  TBT 
Bu4Sn Butyl  4 Tetrabutyltin  TeBT  
OcSn3+ Octyl  1 Monooctyltin cation  MOT  
Oc2Sn2+ Octyl  2 Dioctyltin cation  DOT  
Pro2Sn2+ Propyl  2 Dipropyltin cation  DProT  
Ph2Sn2+ Phenyl  2 Diphenyltin cation  DPhT  
Ph3Sn+ Phenyl  3 Triphenyltin cation  TPhT  
Most organic tin compounds are too polar to be analysed directly by gas-chromatography and shall be 
derivatised to form non-polar alkyltin compounds prior to analysis. 
The per-alkylated organic tin compounds behave in  a completely different way from their parent 
compounds. Tetra-alkylated organic tin compou nds which are already per-alkylated, such as 
tetrabutyltin, are determined in th e same analysis even if they are no t affected by the derivatisation. 
This standard method utilizes in situ  derivatisation using tetraethylbor ate to produce ethyl organic tin 
derivatives. The ethylated derivatives are extracted with hexane and analysed by GC-MS. For 
quantification single ion mode should be used to ac hieve sufficiently low LOQ for quantification at the 
migration limits (see Table 2). 
The concentration is determined by calibration of the total procedure using an internal standard mixture. 
The internal standards shall have chemical properties as similar as possible to the organic tin compound 
of interest. Table G.2 contains recommended internal standards. EN 71-3:2019 (E) 
41 Table G.2 — Recommended internal st andards for organic tin compounds 
Organic tin compound  Internal standard  
Methyltin cation  Butyl tin (d9)  
Dimethyltin cation  Butyl tin (d9)  
Butyltin cation  Butyl tin (d9)  
Dibutyltin cation  Butyl tin (d9)  
Tributyltin cation  Tributyl tin (d27)  
Tetrabutyltin  Tetrabutyl tin (d36)  
Monooctyltin cation  Butyl tin (d9)  
Dioctyltin cation  Butyl tin (d9)  
Dipropyltin cation  Butyl tin (d9)  
Diphenyltin cation  Triphenyl tin (d15)  
Triphenyltin cation  Triphenyl tin (d15)  
For matrices which cause a low recovery of the intern al standard even after the procedure used in G.4.1.3 
is applied, standard addition (see G.4.1. 4) should be used for quantification. 
G.2 Reagents 
Use reagents of highest purity. 
G.2.1  Hydrochloric acid,  HCl (37 %). 
G.2.2  Acetic acid,  CH3COOH, glacial. 
G.2.3  Sodium acetate,  CH3COONa. 
G.2.4  Methanol,  CH3OH. 
G.2.5  Hexane,  C6H14. 
G.2.6  Sodium tetraethylborate,  NaB(C 2H5)4, CAS# 15523-24-7. 
G.2.7 Methyltin trichloride,  MeTCl, CH 3SnCl 3, CAS# 993-16-8. 
G.2.8 Dimethyltin dichloride , DMTCl, (CH 3)2SnCl 2, CAS# 753-73-1. 
G.2.9 Butyltin trichloride,  BuTCl, C 4H9SnCl 3, CAS# 1118-46-3. 
G.2.10 Dibutyltin dichloride,  DBTCl, (C 4H9)2SnCl 2, CAS# 683-18-1. 
G.2.11 Tributyltin chloride,  TBTCl, (C 4H9)3SnCl, CAS# 1461-22-9. 
G.2.12 Tetrabutyltin,  TeBT, (C 4H9)4Sn, CAS# 1461-25-2. EN 71-3:2019 (E) 
42 G.2.13 Monooctyltin trichloride,  MOTCl, C 8H17SnCl 3, CAS# 3091-25-6. 
G.2.14 Dioctyltin dichloride,  DOTCl, (C 8H17)2SnCl 2, CAS# 3542-36-7. 
G.2.15 Dipropyltin dichloride,  DProTCl, (C 3H6)2SnCl 2, CAS# 867-36-7. 
G.2.16 Diphenyltin dichloride,  DPhTCl, (C 6H5)2SnCl 2, CAS# 1135-99-5. 
G.2.17 Triphenyltin chloride,  TPhTCl, (C 6H5)3SnCl, CAS# 639-58-7. 
G.2.18 Tributyl-d27-tin chloride,  TBTCl (d27), (C 4D9)3SnCl, CAS# 1257647-76-9. 
G.2.19 Tetrabutyl-d36-tin,  TeBT (d36), (C 4D9)4Sn, CAS# 358731-92-7. 
G.2.20  Monobutyl-d9-tin trichloride,  BuTCl (d9), C 4D9SnCl 3. 
G.2.21 Triphenyl-d15-tin chloride , TPhTCl (d15), (C 6D5)3SnCl, CAS# 358731-94-9. 
G.2.22  Tetrahydrofuran (THF),  C4H8O, CAS# 109-99-9. 
G.2.23  Sodium chloride,  NaCl, CAS# 7647-14-5. 
G.2.24  Dichloromethane (DCM),  CH2Cl2, CAS# 75-09-2. 
G.2.25  Multi-component solutions and prepared reagents  
G.2.25.1  Multi-component-standard solution in methanol, Stock solution A  
For the preparation of 1 000 mg/l of organic tin cation stock solution, in TBT equivalents, weigh, to the 
nearest 0,1 mg, the amounts of organic tin compounds specified in Table G.3 into a 100 ml volumetric 
flask. Dissolve these compounds in a small amount of methanol (see G.2.4). Then make up to the mark 
with methanol (see G.2.4) and mix carefully. 
If stored at 4 °C in the dark, the so lution is stable for at least two months. 
NOTE If using a commercial organic tin standard solution, information on the stability is usually provided by 
the supplier. EN 71-3:2019 (E) 
43 Table G.3 — Required portions of organic tin compounds, and their weighing factors, 
corresponding to 100 mg of organic ti n cations (expressed as TBT cation) 
Substance  Weighed 
portion  
mg MW of 
substance  
g/mol  MW of 
organic tin 
cation  
g/mol  Weighing 
factor  a Organic tin 
cation  Relative 
molecular 
weight  b 
Methyl tin trichloride  82,8  240,1  133,7  0,557  MeT  2,169  
Dimethyl tin dichloride  75,7  219,7  148,8  0,677  DMT  1,949  
Di-n-propyl tin dichloride  95,1  275,8  204,9  0,743  DProT  1,416  
Butyl tin trichloride  97,3  282,2  175,8  0,623  BuT 1,650  
Dibutyl tin dichloride  104,8  303,8  232,9  0,767  DBT  1,245  
Tributyl tin chloride  112,2  325,5  290,0  0,891  TBT 1,000  
n-Octyl tin trichloride  116,6  338,3  231,9  0,686  MOT  1,251  
Di-n-octyl tin dichloride  143,4  416,0  345,1  0,830  DOT  0,840  
Tetrabutyl tin  119,7  347,2  347,1  1,000  TeBT  0,835  
Diphenyl tin dichloride  118,5  343,8  272,9  0,794  DPhT  1,063  
Triphenyl tin chloride  132,9  385,5  350,0  0,908  TPhT  0,829  
a Weighing factor = molar mass (organic tin cation)/molar mass (organic tin chloride). 
b Compared to tributyltin. Relative molecular weight = molar mass (tributyl tin cation) / molar mass (organic tin cation). 
G.2.25.2  Calibration solution of organic tin cati ons, working solutions BI, BII and BIII  
For working solution BIII (suitable for category III materials), dilute from the stock solution A (see 
G.2.25.1) to a concentration of 10 mg of each organic tin cation (expressed as TBT cation) per litre in 
methanol (see G.2.4, dilution factor 100, relative to stock solution A). 
For working solution BII (suitable for category II materials), dilute from working solution BIII to a 
concentration of 0,25 mg (dilution factor 40, relative to working solution BIII) of each organic tin cation 
(expressed as TBT cation) per litre in methanol (see G.2.4.). 
For working solution BI (suitable for category I ma terials), dilute from working solution BIII to a 
concentration of 1 mg (dilution factor 10, relative to working solution BIII) of each organic tin cation 
(expressed as TBT cation) per litre in methanol (see G.2.4.). 
NOTE Working solution BI is only needed when applying standard addition to category I samples . 
G.2.25.3 Mix solution of the internal standard s in methanol, internal standard stock solution  C 
Weigh, to the nearest 0,1 mg, into a 100 ml volume tric flask, approximately 100 mg of tributyl-d27-tin 
chloride (see G.2.18), 100 mg of te trabutyl-d36-tin (see G.2.19), 100 mg of triphenyl-d15-tin chloride (see 
G.2.21) and 100 mg of monobutyl-d9-tin trichloride (see G.2.20) and dissolve in a small amount of 
methanol (see G.2.4). Make up to the mark with methanol (see G.2.4) and mix carefully. 
The solution is stable for up to one y ear when stored in the dark at 4 °C. 
NOTE If using a commercial organic tin internal standard solution, information on the stability is usually 
provided by the supplier. EN 71-3:2019 (E) 
44 G.2.25.4 Working solution of the internal stan dards in methanol, inte rnal standard working 
solution D (2 mg deuterated organic tin compound per litre in methanol)  
Pipette 0,200 ml of the internal standard stock solution  C into a 100 ml volumetric flask. Make up to the 
mark with methanol (see G.2.4) and mix carefully. 
G.2.26 Hydrochloric acid solution,  c(HCl) = (0,070 ± 0,005) mol/l. 
G.2.27 Acetate buffer solution  
Dissolve about 10,0 g sodium acetate (see G.2.3) in 250 ml of water into a 500 ml volumetric flask. Add 
1,2 ml glacial acetic acid (see G.2.2). Make up to the mark with water and mix carefully. 
G.2.28 Derivatisation agent  
Under inert atmosphere, e.g. nitrogen , for preparation of 10 ml of derivatization reagent solution, weigh 
about 2 g of sodium tetraethylborate (see G.2.6) into  a 10 ml volumetric flask and make up to volume 
with tetrahydrofuran (THF, G.2.22). This solution is stable for at least a week. 
NOTE If using a commercial organic tin internal stan dard solution, information on the stability is usually 
provided by the supplier. 
CAUTION — Derivatisation reagent is flammable an d catches fire spontaneously if exposed to air.  
G.3 Apparatus 
NOTE 1 It is important to exercise care to avoid contamin ation. Therefore, it is essential that flasks, equipment 
and anything making contact with samples  and extracts thereof, are dedicated. It is essential to avoid cleaning by 
dishwashers. Instead rinsing with ethanol and hexane (see G.2.5) is preferred. 
NOTE 2 To minimize recovery losses by adsorption, the use of plastic vessels before derivatization, and glass 
vessels during and after derivatization is preferred. 
NOTE 3 It is important to verify blank values. 
G.3.1 Volumetric flasks.  
G.3.2 Variable pipettes  for organic fluids with disposable tips, with a volume range from 10 μl to 
100 μl, 100 μl to 1 000 μl and 1 ml to 5 ml. 
G.3.3 20 ml glass vials with gas-tight caps  (e.g. headspace vials). 
G.3.4 Shaker capable of vigorously agitating the mixture.  
G.3.5 Gas chromatograph,  equipped with split/splitless injector and mass spectrometer using 
electron impact (EI) mode. 
G.4 Procedure 
G.4.1  Sample derivatisation 
G.4.1.1  Derivatisation 
In a glass vial (see G.3.3), add 5,00 ml of migration solution (see 8.3, migration procedure). Add 0,100 ml 
internal standard solution D (see G.2.25.4). 5 ml of acetate buffer (see G.2.27) is added to the migration 
solution. Then 0,050 ml of 20 % sodium tetra ethyl bo rate (see G.2.28) and 2 ml of hexane (see G.2.5) are EN 71-3:2019 (E) 
45 added, and the vial is immediately closed to avoid ev aporation of the most volatile derivatized organic tin 
compounds. The mixture is shaken for approximately 60 min with a shaker (see G.3.4) and subsequently 
left to stand until the phase separation is complet e. The two phases should be completely clear. 
Depending on the material category of the sample  proceed with G.4.1.2 or G.4.1.3. 
NOTE Signs like cloudiness, gel formation, foam, precipita tion or liquid droplets on the reaction vessel walls 
have been found to potentially severely decrease the ex traction efficiency. Different organic tin compounds are in 
such case typically affected to highly different degree, mo re than can be corrected for by normalizing to the different 
internal standards. In case of doubt it is also possible to directly proceed with G.4.1.3 also for category I and III 
material samples . 
G.4.1.2  Category I and III materials 
For category I and III materials phases are usually well separated. In this case, the hexane fraction can be 
used for GC-MS analysis and the analytes can be quan tified (after normalization to internal standard) 
from the external standard calibration (see G.4.2). If phase separation is poor proceed as specified in 
G.4.1.3. 
After GC-analysis verify that inte rnal standard recoveries are > 60 % (internal standard peak areas 
compared to internal standard peak areas in the calibration solutions), otherwise the derivatisation (see 
G.4.1.1) is performed again followed by  the separation process in G.4.1.3. 
G.4.1.3  Category II materials 
NOTE 1 For category II samples , phases are often not well separated and it is essential to improve extraction 
efficiency, which is why special treatment is needed. 
Add 3 g NaCl (s), 0,9 ml HCl (37 %) and 0,5 ml DCM (dichloromethane, G.2.24) to the solution after 
derivatization (see G.4.1.1) and mix, e.g. by vortexing, until the dissolution of the NaCl is complete or 
almost complete. 
Leave to stand until the two phases have completely se parated. If problems with  phase separation occur 
ultrasonicate for 30 min and leave to stand until the two phases have completely separated. Analyse the 
organic fraction with GC-MS. If the responses of th e internal standards are more  than 50 % compared to 
the average responses in the calibration solutions, quantify according to G.4.2. If the recoveries of internal 
standards are lower than that, proceed according to G.4.1.4. 
NOTE 2 50 % recovery corresponds to about 60 % recovery in G.4.1.2 since the organic phase is diluted. 
G.4.1.4  Standard addition method 
Repeat the procedure with another test portion (see G. 4.1.1) but before acetate buffer is added, spike the 
migration solution with a concentration corresponding to 5 to 10 times the migration limit of the sample  
category (Table 2) of each organic tin cation (use 0,200 ml of the calibration standard, working solution 
BI, BII or BIII (see G.2.25.2) depending on the sample  category). 
After shaking for 60 min add 3 g NaCl (s), 0,9 mL HCl (37 %) and 0,5 ml DCM (dichloromethane, G.2.24) 
to the solution after derivatization and mix, e.g. by vort exing, until the dissolution of the NaCl is complete 
or almost complete. 
Quantify by the standard addition according to G.6.2, using the spiked solution and the unspiked solution 
from G.4.1.3. 
NOTE 1 If the response of tetrabutyltin-d36 is good, but the response of butyltin-d9, tributyltin-d27 or 
triphenyltin-d15 is low, and especially if  it is also lower in the spiked solution than in the unspiked solution, this can 
be an indication of insufficient derivatization reagent. It is essential to repeat the procedure with another test 
portion with a higher amount of tetraethylborate. EN 71-3:2019 (E) 
46 NOTE 2 If the peak area of an analyte in the spiked solution is much less than 5 times the peak area in the 
unspiked solution, i.e. the concentration is much higher than the migration limit, higher spiking concentrations are 
necessary for reliable calculations. 
G.4.2  Calibration standards 
Take 6 20 ml glass vials (see G.3.3), add to each vial 5 ml hydrochloric acid solution (see G.2.26) and add 
to each vial with a pipette  (see G.3.2), respectively 0,020 ml, 0,10 0 ml and 0,400 ml of working solution 
BII (see G.2.25.2) and 0,020 ml, 0,100 ml and 0,400 ml of working solution BIII (see G.2.25.2). Add 
0,100 ml internal standard solution D (see G.2.25.4) an d 5 ml of acetate buffer (see G.2.27). Then 0,050 ml 
of 20 % sodium tetra ethyl borate (see G.2.28) and 2 ml of hexane (see G.2.5) are added. The mixture is 
shaken for 60 min with a shaker (see G.3.4) and left to stand until the phase separation is complete. The 
hexane fraction is then analysed by GC-MS. 
Table G.4 — Preparation scheme for calibrations standards 
Calibrations 
standards  Working solution  
 
(G.2.25.2) Volume Working 
solution Volume 
hydrochloric 
acid solution   
(G.2.26) Concentration of 
each organo tin 
compound (TBT 
equivalents) 
   μl ml mg/l a 
Standard 1 BII 20 5,0 0,001 
Standard 2 BII 100 5,0 0,005 
Standard 3 BII 400 5,0 0,02 
Standard 4 BIII 20 5,0 0,04 
Standard 5 BIII 100 5,0 0,2 
Standard 6 BIII 400 5,0 0,8 
a mg/l refers to the equivalent concentration in the migration solution. 
G.5 Analysis 
G.5.1  General 
Optimize the instrument (see G.3.5) according to the manufacturer’s instructions. 
Analyse the analytes in the Selective Ion Monitoring (SIM) mode (see Table G.5) or Multiple Reaction 
Monitoring (MRM) mode (see Table G.6). Generally, hi gh mass fragment ions are preferable to minimize 
interference, but depend on the system used (column etc.). One quantifier and two qualifier ions should 
be used, whenever possible. EN 71-3:2019 (E) 
47 Table G.5 — Selected ion monitoring for organic tin cations 
Organic tin  
Ethyl derivative  Abbreviation  m/z  
Dimethyl tin Methyl tin Butyl tin 
Di-n-propyl tin 
Dibutyl tin 
Tributyl tin n-Octyl tin 
Tetrabutyl tin 
Diphenyl tin 
Di-n-octyl tin 
Triphenyl tin
 DMT MeT BuT 
DProT 
DBT 
TBT MOT TeBT DPhT 
DOT 
TPhT
 135, 151, 179 163, 165, 191, 193 121, 149, 179, 235 
191, 193, 233, 235 
205, 207, 261, 263 
205, 207, 289, 291 177, 179, 289, 291 177, 179, 289, 291 195, 301, 305 
261, 263, 375 
347, 349, 351
 
Internal Standards      
Butyl tin (d9) Tributyl tin (d27) Tetrabutyl tin (d36) Triphenyl tin (d15)
 BuT (d9) TBT (d27) TeBT (d36) TPhT (d15)
 180, 242, 244 217, 281, 318 190, 254, 318 364, 366
 
Table G.6 — Example of MRM data 
Analyte  Precursor ion  Quantification ion  Qualification ion 1  
MeT  193 165 137 
DProT  235 151 193 
MBT-d9  244  152  180  
MBT 
(BuT)  235 151 179 
DBT  263 151  
TBT-d27  318 190 254 
TBT  291 179 235 
MOT  291 179   
  179   151 
TeBT-d36  318 190 254 
TeBT  291 179  235  
DPhT  303 197 275 
DOT  263 151  
TPhT-d15  366 201  
TPhT  351 197  
NOTE The interlaboratory comparison has shown that the qualification ion 
123 might not be suitable for certain matric es. For this reason this ion has been 
deleted from the table. In case more qualifier ions are needed the precursor ion 
can be changed to another molecule based on a different tin isotope. 
Quantify the gas chromatographic signals. The ev aluation using peak ar eas is recommended. EN 71-3:2019 (E) 
48 A typical injection sequence is as follows: 
— hexane; 
— calibration solutions; 
— blank extract; 
— sample solutions (in replicate runs); 
— quality control sample. 
Examples of GC and MS conditions are given in G.5.2 and G.5.3 respectively. 
G.5.2  Example of GC conditions 
Injection conditions:  Pulsed splitless, pulse pressure = 30 kPa, pulse time = 0,5 min 
Purge flow = 50 ml/min, purge time = 2,00 min 
Injection temperature: 275 °C 
Carrier: Helium; Constant flow: 1,7 ml/min 
Column: 5 %-diphenyl-95 %-dimethyl polysiloxane copolymer, 
30 m × 0,32 mm ID × 0,25 μm film thickness 
Oven temperature program: 50 °C (1 min) – 20 °C/min – 325 °C (4 min) 
Injection volume: 2 μl 
G.5.3  Example of MS conditions 
Transfer line:  280 °C  
Electron impact:  70 eV  
Electron multiplier:  source dependent  
Selected ion monitoring 
mode:  choose at least three of the most intensive non-interfered fragment ions  
NOTE The concentration of the organic tin compound is already expressed as TBT as this is how the working 
solutions are prepared (see Table G.3). 
G.5.4  Limit of detection and quantification 
In Table G.7 typical limits of detection (LOD) and quantification (LOQ) for organic tin compounds are 
given. In a sample , several organic tin compounds can be present, and the LOQ of a single compound 
should be under 1/3 of the migration limit (see Table 2). EN 71-3:2019 (E) 
49 Table G.7 — Typical detection limits (LOD) and qu antification limits (LOQ) expressed in mg/kg 
toy material (as TBT equivalents) 
Element  LOD  
mg/kg  LOQ  
mg/kg  
Methyltin  0,02  0,06  
Dimethyltin  0,02  0,05  
Butyltin  0,02  0,06  
Tributyltin  0,02  0,06  
Monooctyltin  0,01  0,03  
Dioctyltin  0,01  0,04  
Dibutyltin  0,02  0,06  
Dipropyltin  0,02  0,06  
Tetrabutyltin  0,02  0,05  
Diphenyltin  0,02  0,06  
Triphenyltin  0,01  0,04  
G.5.5  Example of a GC-MS chromatogram 
 
Key 
Y abundance 
t time, in min 
Figure G.1 — Example of a GC-MS chromato gram of ethylated organic tin compounds EN 71-3:2019 (E) 
50 G.6 Calculation 
G.6.1  Calibration curve 
The procedure shall be calibrated using internal standards that are comparable to the organic tin 
compound of interest. In the calibration curves the peak areas for the different organotin compounds 
divided by the peak area for the relevant internal standard (see Table G.2) is plotted against the 
concentration of the organotin substa nce. For quantification the calibration curve shall have a correlation 
coefficient better or equal to 0,990. 
Using the calibration curve, the concentration of a compound in a migration solution (see C in G.6.3) is 
calculated from the peak area of the compound di vided by the peak area fr om the relevant internal 
standard in the migration solution. 
G.6.2  Standard addition 
When using standard addition, the concentration of each detected organic tin cation in the migration 
solution, C, is calculated according to the following formula: 
 ,
, ,  sample spike
spiked sample sample IS sample
IS spiked sample IS sampleACCAA A
AA§·
¨¸
¨¸ ¨¸ ¨¸
©¹ (G.1) 
where 
C is the concentration of the substance in the migration solution, in mg/l as 
TBT equivalents; 
Cspike  is the concentration added to the migration solution by the spike, in mg/l 
as TBT equivalents; 
sampleA  is the peak area for the substance in  the chromatogram of the unspiked 
solution; 
,IS sampleA  is the peak area for the relevant in ternal standard (see Table G.2) in the 
chromatogram of the unspiked solution;  
 spiked sampleA  is the peak area for the substance in the chromatogram of the spiked 
solution;  
, IS spiked sampleA   is the peak area for the relevant in ternal standard (see Table G.2) in the 
chromatogram of the spiked solution; 
G.6.3  Calculation of migrati on of organic tin  
For each detected organic tin cation the migration shall be calculated according to the following formula: 
CVMWtp  (G.2) EN 71-3:2019 (E) 
51 where 
M is the migration of an organic tin compound from the toy material, in mg/kg as TBT 
equivalents; 
C is the concentration of the substance in the migration solution (from G.6.1 or G.6.2), in 
mg/l as TBT equivalents; 
V is the volume of simulant added, in ml; 
Wtp is the weight of the test portion, in g. 
Organic tin compounds other than th ose specified in Table G.3 can also be present in toys and shall be 
included when calculating the organic tin concentration. 
The migration of organic tin shall be calculated by adding the migration values expressed as tributyltin 
for all the single organic tin compounds (see also H.9).  EN 71-3:2019 (E) 
52 Annex H 
(informative)  
 
Rationale 
H.1 General 
Migration limits for certain elements in toy materials  or parts of toys are given in Annex II, III.13 of the 
Toy Safety Directive 2009/48/EC [1]. The limits in th e Toy Safety Directive have  been influenced by an 
RIVM report according to the criteria of the relevant Sc ientific Committee, in order to ensure that these 
elements, if present, are at safe levels  for children and in accordance with good manufacturing practice. 
The assessment includes a differentiation of toys into three toy categories, based on different assumed 
consumption. The migration limits do not apply to toys or components of toys which, due to their 
accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or 
prolonged contact with skin, bear ing in mind the normal and fore seeable behaviour of children. 
This standard specifies the sampling, sample preparation, migration procedure (Clause 6 to Clause 8) and 
three methods for quantifying the elements in the migration soluti on based on ICP-MS and GC-MS, 
respectively (Annex E, Annex F and Annex G). The migration procedure simulates contact of the toy 
material  with gastric juices for a period of time after swallowing. 
In Clause 11 performance criteria are given for the analytical techniques to determine the amount of a 
certain element in the resulting migration solution . These methods have been developed and validated 
in a project, funded by the Euro pean Commission (SA/CEN/2013-03 Mi gration of certain elements), by 
the technical project leader. They were confirmed by the peer review laborator y and finally validated by 
the results of an interlaboratory comparison. The results and background are given in Clause 11 and 
Annex B. The method performance is available for the prioritized elements for which reference materials 
were prepared during the revision work. In order to include all elements in all 3 material categories an 
estimation of the reproducibility data is given in the informative Annex C. Other standards preparation 
and analytical techniques may also be used, as long as they meet th e requirements specified in Clause 11 
and are in line with the expectations of Annex C. 
This standard contains requirements and test methods for the migration of certain elements in a wide 
range of toys and toy materials . The compliance of toys with th e element migration requirements of 
Directive 2009/48/EC [1] can be demonstra ted by compliance with this standard. 
H.2 Mouthing behaviour of children (see Clause 1) 
Most studies on mouthing behaviour look at children under three years old. Only 3 studies are known 
that observe children over three years of age [11, 12, 13], of which only one presents mouthing duration 
data [11]. The mean mouthing time on toys for 4 ye ars and 5 years old children was very low (3 min and 
1 min per day, respectively) with a maximum observed mouthing time on toys of 20 min and 11 min per 
day. 
By the age of 6 years, children do not mo uth their toys to any significant degree. EN 71-3:2019 (E) 
53 H.3 Skin contact (see Clause 1) 
The RIVM has conducted a study on the assessment methodology of chemical safety of toys with a focus 
on elements and identified the oral exposure to element s as the relevant route [10]. Most if not all toys 
or accessible parts of toys will come in contact with the skin, which can result in dermal exposure and via 
hand to mouth contact in additional oral exposur e. For systemic exposure to elements, the dermal 
exposure route is less relevant than the oral exposure  route, as the dermal absorption of elements is 
distinctly lower as their oral absorption. Therefore, as a worst case simulant hydrochloric acid was 
chosen as gastric simulant for migration, also covering other exposure routes. 
H.4 Toy categories (see 4.1) 
Directive 2009/48/EC [1] sets migration limits for certain elements in three different toy categories, 
based on the assumed ingestion of the materials. The assumed ingestion of the materials is based on an 
RIVM report [10] and a SCHER opinion [15]. Further explanation of the categories is given in the 
Explanatory Guidance Document [3]. 
Category I: Dry, brittle, powder like or pliable  
Category I includes solid toy material  from which powder-like material is released during play. The 
material can be ingested. Contamination of the hands with powder contributes to enhanced oral 
exposure. The assumed ingestion is 100 mg per day. 
Category II: Liquid or sticky  
Category II includes fluid or viscous toy material  which can be ingested and/or to which dermal exposure 
occurs during playing. The assumed ingestion is 400 mg per day. 
Category III: Scraped-off  
Category III includes solid toy material  with or without a coating  which can be ingested as a result of 
biting, tooth scraping, sucking or licking. This category includes those materials which are not covered 
by category I and II. The assumed ingestion is 8 mg per day. 
H.5 Test portions (see Clause 7) 
It is not always possible, especially for category III toys (scraped off), to obtain 0,100 g of toy material . 
If less than 0,010 g of toy material  can be obtained, it is not required to analyse. From such a small amount 
of toy material  the exposure to certain elements is considered to be negligible. 
If 0,010 g to 0,100 g of toy material  is available, the test is performed as if it were 100 mg of material. The 
migration is calculated as though 100 mg of the test  portion had been used. This compensates for the low 
exposure to certain elements by mi gration from such low amounts of toy material . 
H.6 Size of test pieces (see 7.2) 
The results of the interlaboratory comparison (polymeric disk with high element content) showed that 
the particle size has a significant impact on the test results. It is therefore important to closely follow the 
instructions on particle size in 7. 2 taking into account the Annex D. 
The test pieces should have at least one dimension of approximately 6 mm, bu t preferably two or three 
dimensions. As an example, a paper  sheet shall be cut in pieces of approximately 6 mm by 6 mm. A cord 
shall be cut in pieces of approximat ely 6 mm in length. The aim is to  achieve comparable procedures for 
sample preparation and similar surface areas of the te st portions prepared in different laboratories. EN 71-3:2019 (E) 
54 H.7 Stability of Chromium (VI) in th e migration solution (see 9.3) 
Interconversion of Chromium (III) and Chromium (VI)  can occur. This equilibrium is influenced by the 
pH. Therefore, immediately after the migration proced ure (including filtration) the migration solution 
shall be stabilized by performing a neutralization st ep. Experiments have shown that at a pH of 7 to 8 
Chromium (VI) is sufficiently stable for 4 h,  the approximate time it takes for analysis. 
H.8 Filtration of migration solutions (see 8.3.2) 
Experiments have shown that centrifuges which are capable of achieving at least 7 000 g are capable of 
separating insoluble material within a convenient tim e. Centrifugation at high speed for about 45 min at 
about 7 000 g (6.2.2) provides a migration solution that is significantly easier to filter. The time and 
acceleration may be adapted when us ing a more efficient centrifuge. 
It is possible for small pigment particles to pass through a 0,45 μm membrane filter (6.2.6). This could 
lead, in certain cases, to falsely high results possibly due to elements chemically bound to the suspended 
particles. 
Currently this phenomenon is known for copper ph thalocyanines (e.g. Pigment blue 15, which can be 
used in finger paints and is permitted by EN 71-7). When not removed by a 0,02 μm pore size membrane 
filter (6.2.6) these pigments lead to an exaggerated copper result. These pigments give a green or blue 
coloured solution and the part icles can cause a Tyndall beam. 
For this reason, the standard requires an additional fi ltration step with a 0,02 μm filter for migration 
solutions which: 
— exceed the copper limit value and 
— show the described characteristics (i.e. coloured solution, mostly blue or green; Tyndall beam) 
in order to avoid too high results. 
If the high copper concentration was caused by such pigments the solution should be colourless or the 
colour should have changed after filtration with a 0, 02 μm pore size membrane filter (6.2.6) due to the 
removal of the green or blue colour portion of the total colour. The copper result should also be 
considerably lower after the filtration. The filtra tion may be conducted with the original 0,07 M 
hydrochloric acid solution or after dilution with 0, 07 M hydrochloric acid or water (sometimes necessary 
to speed the filtration). 
H.9 Organic tin (see Annex G) 
The requirement in the Toy Safety Directive is for total migratable organic tin. The method in Annex G 
determines the migration of individual organic tin compounds. The method was validated using a list of 
organic tin compounds that was selected for this purpose by the working group responsible for this 
project (CEN/TC 52/WG 5 “Safety of toys – Chemical pr operties”). Selection was based on the toxicity and 
exposure (presence in toys). Other organic tin compou nds can also be present in toys and have then also 
to be analysed and reported. 
EFSA has published an opinion on oral exposure of consumers to organic tin compounds [14]. The group 
TDI for organic tin compounds is expressed either as Sn content or as TBT chloride. For this European 
Standard it was chosen to express the migration of individual organic tin compounds as TBT, as the 
chloride is removed during the derivatisation step. 
Recently it has been shown that inorganic tin substances can react under certain conditions with the 
derivatisation reagent sodium tetr aethylborate (G.2.6) producing triethy lmonomethyl tin, in addition to 
the expected product tetraethyl tin. This can lead to a false-positive result for methyl tin for example for EN 71-3:2019 (E) 
55 coated tin toys where test portions of the coating  have been obtained by scraping  off or for samples  of wet 
oil paints that were stored in tinplate containers. 
Experiments have shown that: 
— with increasing concentration of inorganic tin, the detected methyl tin concentration increases as 
well (Figure H.1), 
— the amount of the generated MeT is dependent on the quality of the derivatisation reagent. 
These experimental results indicate that the meth ylation can be caused by an impurity in the 
derivatisation reagent which means that the impact of this effect on the methyl tin results shall be 
evaluated for each new batch of derivatisation reagent. 
 
Key 
X concentration of inorganic tin in migration solution, in mg/l 
Y detected as MeSn3+ in migration solution, in mg TBT/l 
Figure H.1 — False positive methyl tin relati onship with concentration of inorganic tin 
When methyl tin results are suspected to be false positive the following actions can be taken to check if 
the results are false positive and to get more correct results: 
— repeat the scrape off process and avoid to scrape off metallic material from the base material ; 
— use a further organic tin method (e.g. ISO 22744); 
— use another derivatization reagent, e.g. tetrapropylborate; 
— prepare a blank sample with the same concentration of inorganic tin as in th e test portion (normally 
known from analysis of general elements) and conduct the determination of organic tin according to 
Annex G. Estimate from this result  the amount of false positive methyl tin and therefore its impact on 
the result. Possibly the methyl tin result of the sample  can be corrected by the methyl tin result from 
the tin containing blank sample. 
The method in Annex G has been optimized to ensu re the correct pH value during derivatization. EN 71-3:2019 (E) 
56 H.10  pH value (see 8.2 and 8.3.1.2) 
After sample preparation, a migration procedure under acidic conditions is performed. The concentration 
of the hydrochloric acid and the pH control are impo rtant parameters during this migration procedure. 
Therefore, it is important that the hydrochloric acid  solutions used in the extraction step are carefully 
prepared and standardized before us e. The hydrochloric acid solution ha s been shown to be stable for at 
least 3 months. 
Experience has shown that deviations in the pH value during the migration procedure can have a 
significant impact on the results of the analysis. Therefore, it is important to follow the specified 
procedure precisely. 
After adding the hydrochloric acid, it can take sever al minutes until a stable pH value is reached. In most 
cases the pH value will be stable.  In some special cases (e.g. paper  samples ) the pH value can change 
throughout the migration and the effects of this have been investigated and addressed in this European 
Standard. 
It is important that the equipment specified in 6.2.1 is capable of measuring pH with accuracy required 
by this European Standard. In practice, a pH meter with an accuracy of ± 0,02 is sufficient. To accurately 
deter mine th e pH at about 1,2 it i s nec es sary  to use pH buff ers clo se to t hi s pH when cal ibrating  t he  electrode. Calibration buffers with pH 1,00 and 2,00 are recommended. It has been found that pH 
measurements without stirring improves the stability of the measurement. 
H.11  De-waxing (see 7.2.3) 
Every sample  needs to be assessed to determine whether or not the de-waxing procedure specified in 
7.2.3.2 is required. Indications that a sample  contains grease, oil, wax or similar material could be: 
— the declaration of the composition of the toy material , 
— that the sample  is hydrophobic, 
— the smoothness of material. 
Furthermore, the following sample  types usually contain wax: 
— Category 1: wax crayons, certain modelling clays, leads of coloured pencils, certain toy cosmetics (e.g. 
lipstick, eyeshadow); 
— Category 2: certain toy cosmetics (e.g. lipgloss). 
Different temperatures are used to dry the test portions before and after dewaxing. The lower 
temperature applied before dewaxing avoids melting of the wax and the higher temperature applied after 
reduces the drying time. EN 71-3:2019 (E) 
57 Annex ZA 
(informative)  
 
Relationship between this European Standard and the essential 
requirements of EU Directive 2009/48/EC aimed to be covered 
This European Standard has been  prepared under a Commission’s standardization request Mandate 
M/445 to provide one voluntary means of confor ming to essential requirements of Directive 
2009/48/EC. 
Once this standard is cited in the Official Journal of the European Union under that Directive, compliance 
with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of 
this standard, a presumption of conformity with the corresponding essential requirements of that 
Directive, and associated EFTA regulations. 
Table ZA.1 — Correspondence between this European Standard and Directive 2009/48/EC 
Essential Requirements of 
Directive 2009/48/EC  Clause(s)/subclause(s) of this EN
 Remarks/Notes  
Annex II, III point 13 4.2 Specific requirements Limit values have been 
amended by Commission 
Directive 2012/7/EU [4] 
(cadmium), Commission 
Regulation (EU) No 681/2013 [5] (barium), Council Directive 
(EU) 2017/738 [6] (lead) and 
Commission Directive (EU) 
2018/725 [7] (Chromium 
(VI)). 
WARNING 1 —  Presumption of conformity stays valid only as long as a reference to this European 
Standard is maintained in the list published in the Official Journal of the European Union. Users of this 
standard should consult frequently the latest list published in the Official Journal of the European Union. 
WARNING 2 —  Other Union legislation may be applicable to  the product(s) falling within the scope of 
this standard. EN 71-3:2019 (E) 
58 Bibliography 
[1] Directive 2009/48/EC of the European Parliame nt and of the Council of 18 June 2009 on the 
safety of toys 
[2] European Commission Guidance document No. 12 on the application of the Directive on the 
safety of toys – packaging 
[3] The European Commission, An explanatory guidance document (to Directive 2009/48/EC)  
[4] Commission Directive 2012/7/EU of 2 March 20 12 amending, for the purpose of adaptation to 
technical progress, part III of Annex II to Direct ive 2009/48/EC of the European Parliament and 
of the Council relating to toy safety 
[5] Commission Regulation (EU) No 681/2013 of 17 July 2013 amending part III of Annex II to 
Directive 2009/48/EC of the European Parliame nt and of the Council on the safety of toys 
[6] Council Directive (EU) 2017/738 of 27 March 2017 amending, for the purpose of adapting to 
technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the 
Council on the safety of toys, as regards lead 
[7] Commission Directive (EU) 2018/725 of 16 May 2018 amending, for the purpose of adaptation 
to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC 
of the European Parliament and of the Council on the safety of toys, as regards chromium VI 
[8] E LLISON  S.L.R., W ILLIAMS  A., eds. Eurachem/CITAC guide: Quantifying Uncertainty in Analytical 
Measurement, Third edition, (2012), available from www.eurachem.org  
[9] E LLISON  S.L.R., W ILLIAMS  A., eds. Eurachem/CITAC guide: Use of uncertainty information in 
compliance assessment. (First Edition (2007), available from www.eurachem.org  
[10] Chemicals in toys. A general Methodology for assessment of safety of toys with a focus on 
elements. RIVM report 320003001/2008 
[11] S MITH  S.A., N ORRIS  B.J. Research into the mouthing behaviour of children up to 5 years old. Report 
URN 02/748, Consumer and Competition Policy Directorate . Dept. of Trade and Industry, UK, 2002 
[12] T ULVE  N.S., S UGGS  J.C., M CCURDY  T., C OHEN  HUBAL  E.A., M OYA J. Frequency of mouthing behavior in 
young children. J. Expo. Anal. Environ. Epidemiol.  2002, 12 pp. 259–264 
[13] B LACK  K., S HALAT  S.L., F REEMAN  N.C.G., J IMENEZ  M., D ONNELLY  K.C., C ALVIN  J.A. Children’s mouthing 
and food-handling behavior in an agricultural community on the US/Mexico border. J. Expo. Anal. 
Environ. Epidemiol.  2005, 15 pp. 244–251 
[14] Opinion of the Scientific panel on Contaminants in the Food Chain on a request from the 
Commission to assess the health risks to consumers associated with exposure to organotins in 
foodstuffs, 2004, The EFSA Journal 102 , 1-119 
[15] Scientific Committee on Health and Environmen tal Risks (SCHER), Final Opinion on Estimates of 
the amount of toy materials ingested by children, adopted on 8 April 2016 EN 71-3:2019 (E) 
59 [16] Measurement of pH Definition, Standard s and procedure IUPAC Recommendations 2002. Pure 
Appl. Chem.  2002, 74 (11) pp. 2169–2200 
[17] ISO 8124-3, Safety of toys — Part 3: Migration of certain elements  
[18] ISO 22744 (all parts), Textiles and textile product — Critical substances potentially present in 
components of textile product materials — Determination of organotin compounds  
 