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Entry 51 and 52 of Annex XVII to REACH - Phthalates in toys and childcare articles

In Entries 51 and 52 of Annex XVII respectively it is stated that the substances DEHP, DBP and BBP on the one side and the substances DINP, DIDP and DNOP on the other side "shall not be used as substances or or in mixtures, in concentrations of greater than 0.1% by weight of the plasticised material…". Does the 0.1% limit apply to each phthalate listed individually, or whether it applies to the 3 or 6 phthalates combined? How should this limit of 0.1% be applied when a product contains traces of more than one these substances?

The threshold of 0.1% is the standard threshold used in Annex XVII. The value of 0.1% has been chosen because it represents a measurable quantity. It is being used to take into account impurities, not to allow the use of certain substances, e.g. phthalates in toys and childcare articles. One should be aware that in order to plasticise a toy or childcare article concentrations of phthalates of more than 10 per cent are needed. Different restrictions are applied to each of the two groups of phthalates. The limit value of 0.1% should therefore be applied for each group of phthalates combined, i.e. the concentration of DEHP, DBP and BBP combined should not be higher than 0.1% and the concentration of DINP, DIDP and DNOP combined should also not be higher than 0.1%. Conclusion: A toy or childcare article would not comply with the Entry 51 or Entry 52 respectively if it contained either more than 0.1% of DEHP, DBP and BBP combined or more than 0.1% of DINP, DIDP and DNOP combined. However, it would be considered compliant if it contained only 0.09% of DEHP, DBP and BBP combined and 0.09% of DINP, DIDP and DNOP combined.

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