Status for phthalater

Status for phthalater

2 Summary and conclusions

This summary gives a short review of the consumption and spread of phthalates in Denmark, present day regulations, the risk assessments at EU level and information activities.

The consumption of phthalates is estimated to have fallen by 15% since 1995. This is due in no small part to the efforts of Danish firms and retailers to find alternatives to phthalates in a number of products.

The dissemination of phthalates in Denmark is monitored in waste water, sludge, earth, food and indoor climate. Measurements are not yet sufficient to assess whether concentrations are increasing or decreasing. Monitoring abroad have shown that background contamination of phthalates in cosmetic products can be detected. It is therefore very difficult to determine the overall exposure of the population to phthalates based on the information available.

Five phthalates are being assessed at EU level for possible risks: diethylhexyl phthalate (DEHP), diisononyl phathalate (DINP), diisodecyl phthalate (DIDP), butylbenzyl phthalate (BBP) and dibutyl phthalate (DBP). Based on provisional conclusions from the risk assessments, the phthalates DEHP and DBP are now entered on the list of dangerous substances, classified as toxic to reproduction. This means that after July 1, 2002, DEHP and DBP in concentrations above 0.5 percent can no longer be sold in chemical products such as paint, varnish and glue sold to private persons.

Provisional conclusions from the EU risk assessments indicate that the impacts on environment and health caused by the various phthalates are different. When completed, the risk assessments may therefore justify a distinction between the different phthalates. Investigations are still required before the risks of phthalates are sufficiently clarified.

Based on the classification of DEHP as toxic to reproduction the use of DEHP has fallen all over EU while the consumption of DINP on the other hand has increased.

The Danish Ministry of the Environment has taken a number of initiatives to inform about and find alternatives to phthalates inter alia by the gathering of information concerning the effect on the environment and health of the use of alternatives. This has been done by integrating this knowledge in ecological guidelines for public purchasers and eco-labelling. Under the Cleaner Products Programme a number of projects have been launched and completed in co-operation with the Industry relating to alternatives to phthalates. Reports on alternatives to phthalates in medical devices, water beds, rainwear and tents were published recently.

In relation to medical devices an assessment has recently come from EU‘s Scientific Committee on Medicinal Products and Medical devices. The Committee found that there may be a risk from the use of DEHP in medical devices for vulnerable groups of patients but in the light of the lack of knowledge of the risks connected with the use of alternative substances, no recommendation can be given at present as to restricting the use of DEHP.

2.1 Future action

Based on this summary future action by the Ministry of the Environment will be to take the initiative and contribute to ensuring the achievement of a joint regulation of phthalates in the EU in order to strenghten Danish Companies competitiveness. If it is not possible to achieve common ground based on the completed risk assessments in EU before 2004, the Ministry of the Environment must consider whether there is a need for national initiatives, for example amendment of the current rules in this field.

Future action will therefore include the following:

Prioritising Danish participation in the completion and follow-up of the risk assessments in the EU.
On completion of the risk assessments and the thereon following initiatives in EU, the present Danish initiatives are to be assessed to ensure that these efforts are carried out in the most proper and suitable manner as regards health.
If the risk assessments are not completed in 2004, a Danish ban will be considered based on a review of use patterns, danger and exposure relations.
Danish Commerce and Service have drawn up a plan to phase out the use of phthalates in toys for children between the ages of 3 and 6 years of age.
The Ministry of the Environment will continue to support the development of and information about alternatives to phthalates to assist Danish companies.
The Ministry of the Environment will continue to carry out information activities aimed at purchasers in the public sector and the retail trade.