The use of phthalates in a growing number of applications is coming under scrutiny because of concern about their potential health effects.
A temporary ban on their use in PVC toys and childcare products intended to be sucked or chewed by infants under three years old was agreed in 2000 and has been renewed every three months since. The proposed EU Directive on phthalates, currently awaiting a second reading in the European Parliament, could make the ban permanent (ENDS Report 357, p 50 ).
A study last year by Dutch research body TNO found that alternatives to phthalates exist for a number of applications, although their use is currently limited to specialist applications because of their greater cost. These include citrates which early last year the EU's scientific toxicity committee declared safe to use in toys.
TNO said that a shift to alternatives could reduce the environmental and human health risks of phthalates. However, it warned that the plasticiser industry was "inflexible" to change because it was "locked in" to the production of phthalates.
In January, Danisco - one of the world's largest producers of food ingredients and additives such as emulsifiers, flavours and sweeteners - announced that it has received EU regulatory approval to use its vegetable-based Grindsted Soft-n-Safe plasticiser in food contact materials such as PVC screw cap liners and cling film. The plasticiser is made from acetic acid and hardened castor oil - a substance already used in chocolate, margarine and cosmetics.
Danisco claims that its plasticiser will also be used in toys and medical equipment "at a later stage", and that US approval will come this year, with several other markets, including Japan, following suit.
In a surprising move, PVC industry lobby group the Danish PVC Information Council "welcomed" Danisco's plasticiser as an alternative to phthalates for use in applications such as toys and medical devices where EU risk assessments had indicated that phthalates could be "problematic". Until now, the PVC industry has staunchly defended phthalates and has no targets to reduce use of the substances.
Greenpeace also welcomed the development but campaigner Jacob Hartmann warned that the proposal under the forthcoming REACH regime to allow the authorisation of hazardous chemicals if manufacturers can demonstrate the risks can be "adequately controlled" could be too lenient to encourage the development of alternatives to phthalates.
Danisco is ready to go into production at its plant in Grindsted in Denmark and expects sales of some €15 million within three to five years.
A significant barrier to the product's use by PVC manufacturers is that it is three or four times more expensive than phthalates. Danisco chief operating officer Torben Svejgård said that Soft-n-Safe was likely to remain more expensive even in full-scale production because of the higher cost of the raw materials.
However, Mr Svejgård predicted that retailers, for whom the greater cost was insignificant compared with the overall cost of a finished product such as a toy, would put increasing pressure on plastics firms to switch to alternatives.
A growing number of retailers and product manufacturers have already decided to phase out or minimise the use of phthalates and PVC, among other substances, in their supply chains (ENDS Report 353, pp 31-32 ).
Although Soft-n-Safe has yet to be used commercially, some companies are testing the product. Danish medical tubing manufacturer Totax Plastics already uses polyadipate plasticisers in medical tubes because of concern about DEHP, and could replace them with Soft-n-Safe without any process changes or significant problems.