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Directorate-General for Health and Food Safety
Position formulated
during the CSTEE Plenary
meeting in Brussels, 9 February
1998
Background
The CSTEE has been invited by the EU Commission to give its opinion on the following points:
- The impact on children's health of the use of soft PVC containing phthalates in child-care articles and toys, which children of a young age could put into their mouths
- The limits which ought to be respected in relation to the migration of phthalates from these products
- The test method to be followed and the standards or parameters that should be taken into consideration to measure the phthalate migration level
The CSTEE established a Working Group in order to address these points. The Working Group agreed to the following process by which the health risks to children exposed to phthalates in toys being put in the mouth should be assessed. An exposure dose is calculated from the maximal amounts, which are emitted when a phthalate-containing PVC-toy of 10 square cm is extracted for 12 hrs by a model saliva solution under dynamic conditions, using a body weight of 5 kg. This may be a worst-case approach. Critical effects for the phthalates were assessed from documentation made available to the Working Group, as well as by literature and data base searches. NOAEL (No-Observed-Adverse-Effect-Level) values were identified for 5 phthalates (DINP, DNOP, DEHP, DIDP, BBP), for DBP only a L(lowest)OAEL value was found. A margin of safety was estimated by dividing the NOAEL values by the exposure dose. The Working Group noted that a margin of safety of at least 100 has been used in other exposure situations in order to identify a level of little concern.
Evaluation
For the 3 phthalates DINP, DNOP and DEHP, the estimated margins of safety were below 100, namely 2.7, 62 and 21, respectively. For DIDP, DBP and BBP, the margins of safety were substantially higher (223, 4000 and 25167, respectively). It is recognised that there are uncertainties with respect to assessing the actual exposures applying the current model values, both because these models differ considerably and have not been standardised and validated, and because the measured amounts show large variation throughout the various reported studies. On the other hand, the present assessment process has not taken into account that more than one phthalate may occur in children's toys or that there may be additional exposures through food, air and by dermal contact to these phthalates. Given these considerations and the possible enhanced sensitivity of young children to the effects of phthalates, the CSTEE concluded that the low margins of safety for DINP, DNOP and DEHP give reasons for concern.
The Committee is aware of a planned Dutch study in adult human volunteers, which will in a more comprehensive fashion assess human exposure to phthalates from toys. Results of this study will be compared with in vitro extraction methods in order to arrive at a standardised method. The CSTEE recommends that consideration should be given to applying more physiological extraction methods than have been used previously. The present evaluation of the CSTEE may be modified when the results of the Dutch study become available. It should also be recognised that more extensive testing and evaluation of long-term effects of some of the phthalates may lead to a revision of the NOAEL values.
The CSTEE recommends that guideline values for extractable amounts of individual phthalates in toys be produced promptly, incorporating a margin of safety of at least 100 from their respective NOAEL values. For BBP an additional factor of 5 should be incorporated due to uncertainty about where the NOAEL is. According to the available information, the following values for maximum extracted amounts per 10 square cm and 12 hours would apply: DINP, 750 microgram; DNOP, 1850 microgram; DEHP, 250 microgram, DIDP, 1250 microgram, BBP, 1500 microgram; and DBP, 500 microgram. These values do not take into consideration that children may have additional phthalate exposures. The guideline values must be based on a standardised, validated extraction method. The Committee recommends that before introducing other plasticizers into toys which children can put into their mouths, the risk of their use should be assessed by the same process, which has been applied to the phthalates discussed above.
Explanatory note
During its deliberations the CSTEE expressed the wish to revisit the issue under discussion given the uncertainties mentioned under 'Evaluation' in the opinion above.
The Commission acknowledged this wish and agreed to a new meeting of the 'Phthalates in toys' working group. The date of 20 March 1998 was provisionally scheduled for this purpose.
This fact notwithstanding the Commission also believes that the information contained in the present opinion is enough for it to be published as such and eventually to warrant action.
The nature of such action will be decided, if and when such decision is taken, after due consideration is given to the implications of the opinion and to the options available.
Background
The CSTEE has been invited by the EU Commission to give its opinion on the following points:
- The impact on children's health of the use of soft PVC containing phthalates in child-care articles and toys, which children of a young age could put into their mouths
- The limits which ought to be respected in relation to the migration of phthalates from these products
- The test method to be followed and the standards or parameters that should be taken into consideration to measure the phthalate migration level
The CSTEE established a Working Group in order to address these points. The Working Group agreed to the following process by which the health risks to children exposed to phthalates in toys being put in the mouth should be assessed. An exposure dose is calculated from the maximal amounts, which are emitted when a phthalate-containing PVC-toy of 10 square cm is extracted for 12 hrs by a model saliva solution under dynamic conditions, using a body weight of 5 kg. This may be a worst-case approach. Critical effects for the phthalates were assessed from documentation made available to the Working Group, as well as by literature and data base searches. NOAEL (No-Observed-Adverse-Effect-Level) values were identified for 5 phthalates (DINP, DNOP, DEHP, DIDP, BBP), for DBP only a L(lowest)OAEL value was found. A margin of safety was estimated by dividing the NOAEL values by the exposure dose. The Working Group noted that a margin of safety of at least 100 has been used in other exposure situations in order to identify a level of little concern.
Evaluation
For the 3 phthalates DINP, DNOP and DEHP, the estimated margins of safety were below 100, namely 2.7, 62 and 21, respectively. For DIDP, DBP and BBP, the margins of safety were substantially higher (223, 4000 and 25167, respectively). It is recognised that there are uncertainties with respect to assessing the actual exposures applying the current model values, both because these models differ considerably and have not been standardised and validated, and because the measured amounts show large variation throughout the various reported studies. On the other hand, the present assessment process has not taken into account that more than one phthalate may occur in children's toys or that there may be additional exposures through food, air and by dermal contact to these phthalates. Given these considerations and the possible enhanced sensitivity of young children to the effects of phthalates, the CSTEE concluded that the low margins of safety for DINP, DNOP and DEHP give reasons for concern.
The Committee is aware of a planned Dutch study in adult human volunteers, which will in a more comprehensive fashion assess human exposure to phthalates from toys. Results of this study will be compared with in vitro extraction methods in order to arrive at a standardised method. The CSTEE recommends that consideration should be given to applying more physiological extraction methods than have been used previously. The present evaluation of the CSTEE may be modified when the results of the Dutch study become available. It should also be recognised that more extensive testing and evaluation of long-term effects of some of the phthalates may lead to a revision of the NOAEL values.
The CSTEE recommends that guideline values for extractable amounts of individual phthalates in toys be produced promptly, incorporating a margin of safety of at least 100 from their respective NOAEL values. For BBP an additional factor of 5 should be incorporated due to uncertainty about where the NOAEL is. According to the available information, the following values for maximum extracted amounts per 10 square cm and 12 hours would apply: DINP, 750 microgram; DNOP, 1850 microgram; DEHP, 250 microgram, DIDP, 1250 microgram, BBP, 1500 microgram; and DBP, 500 microgram. These values do not take into consideration that children may have additional phthalate exposures. The guideline values must be based on a standardised, validated extraction method. The Committee recommends that before introducing other plasticizers into toys which children can put into their mouths, the risk of their use should be assessed by the same process, which has been applied to the phthalates discussed above.
Explanatory note
During its deliberations the CSTEE expressed the wish to revisit the issue under discussion given the uncertainties mentioned under 'Evaluation' in the opinion above.
The Commission acknowledged this wish and agreed to a new meeting of the 'Phthalates in toys' working group. The date of 20 March 1998 was provisionally scheduled for this purpose.
This fact notwithstanding the Commission also believes that the information contained in the present opinion is enough for it to be published as such and eventually to warrant action.
The nature of such action will be decided, if and when such decision is taken, after due consideration is given to the implications of the opinion and to the options available.
