In view of the demonstrated poor performance of the new EN 71 part 3 test method and the greatly-enlarged range of analytes included with wide ranges of limits, it is virtually impossible for any pigment supplier to provide assurances as to whether a particular product may be suitable for use in toys.
Legally, the onus has always been on the toy manufacturer or importer into the EU to demonstrate compliance by testing of the finished toy.
Our position is that according to EN71/3, cadmium pigments should not be intentionally used in those parts of toys that are accessible to children.
New Directive
New Directive
The original EU Directive covering toy safety (1988/378/EEC) has been updated. The new requirements are laid down in Directive 2009/48/EC (37 pages, approx. 1MB).
Application
The Directive defines toys as "products designed or intended, whether or not exclusively, for use in play by children under 14 years of age".
The polymer used for the toy must not be one of those restricted under the former Directive 91/338/EEC (now replaced by a word-identical entry in Annex XVII of REACH).
As regards chemicals, the new Directive bans the use of substances in toys which are classified as "CMR" under Regulation 1272/2008 ("CPL"). There are certain derogations from this requirement : please see the Directive itself for further details.
The use of materials containing arsenic, cadmium, lead or mercury is not permitted in those parts of toys which are accessible to children.
Limits
Limits
New limits have been calculated for toys, based on the estimated safe exposure to children - while of course building in a large margin of safety. In all cases the limits are lower than those which were present in the previous version of EN 71 part 3.
The new Directive lays down limits for extractable levels of 19 analytes from the finished toy, compared with the seven in the previous regime. It also lays down three types of toy matrix sample : A) dry / brittle / powder-like or pliable, B) liquid or sticky and C) scraped-off.
The new limits are as follows:
| Analytes | A | B | C |
| Aluminium (Al) | 2250 | 560 | 28130 |
| Antimony (Sb) | 45 | 11.3 | 560 |
| Arsenic (As) | 3.8 | 0.9 | 47 |
| Barium (Ba) | 1500 * | 375 * | 18750 * |
| Boron (B) | 1200 | 300 | 15000 |
| Cadmium (Cd) | 1.3 | 0.3 | 17 |
| Chromium (III) | 37.5 | 9.4 | 460 |
| Chromium (VI) | 0.02 | 0.005 | 0.053 |
| Cobalt (Co) | 10.5 | 2.6 | 130 |
| Copper (Cu) | 622.5 | 156 | 7700 |
| Lead (Pb) | 2 | 0.5 | 23 |
| Manganese (Mn) | 1200 | 300 | 15000 |
| Mercury (Hg) | 7.5 | 1.9 | 94 |
| Nickel (Ni) | 75 | 18.8 | 930 |
| Selenium (Se) | 37.5 | 9.4 | 460 |
| Strontium (Sr) | 4500 | 1125 | 56000 |
| Tin (Sn) | 15000 | 3750 | 180000 |
| Organic tin | 0.9 | 0.2 | 12 |
| Zinc (Zn) | 3750 | 938 | 46000 |
All of the limits above are in mg extracted / kg of sample
* The original limits for barium set in Directive 2009/48/EC were 4500, 1125 and 56000 mg/kg respectively. These were reviewed in the light of new information from the USA and revised downwards to those in the above table. This was done by Regulation 681/2013 and a copy of this document can be downloaded here.
Testing
Testing
Following introduction of the new Directive covering toys, updating of the controlling 'EN 71' standards covering test methods was necessary.
The most critical standards were those covering extractable metals : we were able to folloow the development of these and we - and other pigment producers - raised several concerns :-
a) The limits for each substance differ by about a factor of 50 from highest to lowest. In practice, if a company is asked whether a particular product is likely to be suitable for toy use, it is autoatically necessary to consider the lowest limits in each case.
b) The ratio of the limits for chromium (III) and chromium (VI) for each matrix type is about 2000 : industry was not aware of any test method which could reliably cope with the different limit ranges while being simulataneously capable of distinguishing the two forms of chromium. This particular concern has been confirmed in the final test method.
Reliability
Reliability
Once development of the new test methods was complete, three standard samples were prepared - representing each of the toy matrix types - and these were circulated to round-robin testing by 24 reputable laboratories which carry out toy testing. From the results returned, statistical methods were used to judge the reliability of the results.
The resulting performance data is summarised in the table below; ideally every cell would contain 'OK':
| Analyte | Al | Sb | As | Ba | B | Cd | Cr (tot) | Cr (III) | Cr (VI) |
| PF | X | X | X | X | ? | X | ? | ||
| DP | X | OK | X | ? | ? | X | ? | ? | |
| Plaster | X | X | ? | X | X | X | X |
| Analyte | Co | Cu | Pb | Mn | Ni | Se | Sr | Sn | Zn |
| PF | OK | OK | X | ? | X | ? | OK | ? | ? |
| DP | X | X | X | ? | X | X | ? | X | |
| Plaster | ? | X | X | ? | ? | ? | ? | X | X |
PF: paint film
DP: dried paint film
In the table, 'OK' indicates satisfactory performance, 'X' in a red cell indicates unacceptable performance and '?' in a yellow cell indicates questionable performance.
Insufficient results for mercury were available to allow any statistical analysis to be carried out. As organic tin compounds should never be present in a colourant, the standard test samples were lot loaded with these.
In some cases the method proved incapable of distringuishing between chrioum (III) and chromium (VI) : in these cases, performace was reported for total chromium and the other two cells in the table are black. Where testing for chromium (III) and chromium (VI) was possible results for both are reported and the cell for total chromium is black.
Because of the generally poor performace of the test method, it has not been possible to include the analytical tolerance percantages which were present in the earlier version of EN 71 part 3. Instead, each laboratory offering toy testing has to calculate, and use, its own analytical tolerance data.
Conclusion
Conclusion
In view of the demonstrated poor performance of the new EN 71 part 3 test method and the greatly-enlarged range of analytes included with wide ranges of limits, it is virtually impossible for any pigment supplier to provide assurances as to whether a particular product may be suitable for us in toys.
Legally, the onus has always been on the toy manufacturer or importer into the EU to demonstrate compliance by testing of the finished toy.
Of course, should the testing regime be revisited in the light of any compliance problems raised with the autorities by the toy industry, this position may change.