United States: Council Reaches Agreement on Permanent Ban of Six Phthalates, Against Positive Results of Scientific Risk Assessments

The phthalates DBP, BBP, DEHP, DINP, DNOP and DIDP will be permanently banned for use in toys and childcare articles above 0.1%, despite the positive conclusions reached by extensive risk assessments conducted in the framework of the EU Existing Substances Regulation 793/93. Once adopted, the measure will replace the current temporary ban adopted in the framework of the General Product Safety Directive 2001/95.

The ban, in the form of the 22nd amendment to the Marketing and Use Directive 76/769, was first proposed by the European Commission in November 1999 and went through the first reading in the European Parliament shortly after. The Council of the European Union took more than four years to finally adopt a Political Agreement on the proposed text, which will now constitute the Common Position to be submitted to the Parliament for a second reading.

The text agreed upon distinguishes between the phthalates DBP (dibutyl phthalate), BBP (butyl benzyl phthalate) and DEHP (di(2-ethylhexyl) phthalate), which are banned in toys and childcare articles in concentrations of more than 0.1%, and the phthalates DINP (di-isodecyl phthalate), DNOP (di-n-octyl phthalate) and DIDP (di-isodecyl phthalate), which cannot be used in concentration of more than 0.1% in toys and childcare articles intended for children under three years of age and which can be placed in the mouth by them.

Once adopted, the final measure will replace the current temporary ban adopted within the framework of the General Product Safety Directive 92/59, as replaced from 1 January 2004 by Directive 2001/95. The temporary ban was imposed through Decision 1999/815, prolonged by subsequent amending Decisions. It prohibits the marketing of toys intended to be placed in the mouth by children of less than three years of age and which contain one or more of the six phthalates (DBP, BBP, DEHP, DINP, DNOP and DIDP) in concentrations of more than 0.1%.

All six phthalates subject to the ban were assessed in the framework of the Existing Substances Regulation 73/793, with the risk assessment reports issued by the European Chemicals Bureau. For the phthalates DBP, BBP and DINP the risk assessments concluded that there was no need for further risk reduction measures beyond those which were being applied already. For DEHP and DIDP, the risk assessments concluded that there was a need for limiting risks taking into account the risk reduction measures which were already being applied.

The permanent ban agreed upon by the Council is inconsistent with the results of the risk assessments, first, because it imposes more restrictive measures for the phthalates DBP, BBP and DINP than the temporary measures already in place, although the risk assessments concluded that there was no need for further risk reduction measures.

Specifically, under the temporary ban, DBP and BBP were prohibited in concentrations of more than 0.1% if used in toys intended to be placed in the mouth by children of less than 3 years of age. The permanent ban prohibits the use of DBP and BBP in the same concentration limits in any toy, irrespective of whether it is intended to be placed in the mouth by children.

Similarly, the temporary ban for DINP applied to toys intended to be placed in the mouth by children of less than three years of age, while the permanent ban, more restrictively, applies to toys intended for children under three years and which can be placed in the mouth by them.

Second, the current text does not differentiate between different phthalates (such as BBP, DBP and DEHP), for which different conclusions as to their potential risks to consumers were reached by the risk assessments.

Affected companies still have a possibility to present these and other arguments during the second reading of the European Parliament. If, however, the text is adopted and enters into force as currently drafted, these arguments may and will most likely be presented before European Courts in legal actions.

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