Danish Environment Minister Ida Auken has decided to ban four industrial chemicals linked to disrupting the human endocrine system, pushing Denmark ahead of the European Union which has already started a process of phasing out phthalates.
Auken said she would introduce a ban this autumn on DEHP, DBP, DIBP and BBP phthalates.
Phthalates are chemical substances which are used to make plastic soft and more flexible. They can be found in everyday products such as rubber boots, oilcloths and vinyl flooring and some of them have already been banned in Europe for use in children's toys.
In deciding the ban, Auken is defying EU regulation in the area. In Spring 2013, the European Commission is due to look into further action in the area of endocrine disrupters that could lead to tougher regulation of phthalates.
Some phthalates with low molecular weight - namely DEHP, DBP, DIBP and BBP - have been linked to reduced sperm count, causing male sterility. They are also being accused of pushing young girls into puberty too early and causing liver cancer in rats.
"The Danish Environment Ministry has enough documentation so we feel now is time for action," Auken told EurActiv.
"The EU will look at this in spring, and we know how long it will take before everyone agrees on what to do. It has to go through all the institutions, and then it has to come into force. It can take a really long time so I don't think that Denmark should wait for that when there are such clear [risk] indications in this area."
"Therefore I take these phthalates off the market," the Danish environment minister said in a telephone interview.
Risking EU court case
Auken also said she considered the EU regulation concerning phthalates "completely inadequate".
"This is an area in the EU which is unregulated, so therefore I think it's correct to do this and let Denmark move ahead," the environment minister said.
The EU’s 2006 REACH regulation requires chemical manufacturers to register the 100,000 or so substances currently on the market and submit them for safety screening and subsequent authorisation. Those that are considered to pose an unacceptable threat to human health or the environment may be phased out and eventually replaced.
Auken said the European Commission on 4 June sent a detailed statement about the Danish Environment Ministry's decree, which showed that there is a disagreement between Denmark and the EU about how REACH should be interpreted.
This means Denmark could risk going to court with the EU over the ban of the four phthalates.
"Of course I don't hope there'll be a case, but if there will be one then I'm ready for it," Auken said, adding that she has academic material as evidence, and that she has consulted the Danish government's specialised Legal Committee which has ensured her she would win an EU court challenge.
Auken said she sees two barriers in the EU regarding chemicals regulation. First, she thinks there has been a lack of willingness to look into the "very complicated" area of endocrine disrupters. Secondly, it's not a secret that "there is strong lobbying in the EU from the chemicals industry, and we will probably hear more from them regarding this area."
Annoyed industry sees a ‘political stunt'
Industry groups have voiced surprise at the move. PVC Information Council Denmark, an organisation under the umbrella of the European polyvinyl chloride industry, said the ban is unnecessary as the most dangerous phthalates were being phased out anyway.
"It has been said by EU experts in Denmark that this is a political stunt and we don't disagree with that," director of PVC Information Council Denmark Ole Grøndahl Hansen told EurActiv.
"The consumption of the phthalates, which she [Auken] attacks, has been markedly on the decrease and they are on their way out in the EU. So why make this noise? It's annoying," Hansen said.
Hansen said that while some phthalates have been classified as dangerous, others have not. Within the last 10 years there has been a marked decrease in using dangerous phthalates in products, he said. And there are many alternative agents so it's possible to completely avoid phthalates in soft plastics such as PVC.
"We have all agreed that we [should] follow what REACH has planned, how the phasing-out should be done, but she [Auken] can't even wait six months," Hansen said.
The industry director highlighted that the decisions about phthalates in the EU are based on scientific risk evaluations which the member states' top scientists have discussed for years. Therefore, in a potential court case, the Danish environment minister would have to argue scientifically against all the member states' researchers' conclusions, Hansen said.
"It will be very difficult for Ida Auken to go through with this in the EU. She would have to prove that phthalates are more dangerous for Danes than for other EU citizens," Hansen said.
[UPDATE]: Maggie Saykali, from the European Council for Plasticisers and Intermediates (ECPI), a trade association representing phthalate manufacturers, reacted to EurActiv's story on the planned Danish ban.
She indicated that phthalates were mainly used in durable applications such as electric cables, floor covering, roof membranes, pool liners and coated fabrics.
"I am not aware of their use in detergents and I don’t see what benefits they will bring to this application," Saykali said. "As for cosmetics (shampoo, nail polish, hair spray and others), only two non-regulated phthalates (DEP and DMP) are used in Europe nowadays. DBP and DIBP are not allowed in Europe as the EU Cosmetics Directive restricts the use of CMR substances in cosmetics." CMR stands for carcinogenic, mutagenic or toxic for reproduction.
Regarding toxicity, she insisted on the distinction between low phtalates – "which were indeed found to be reprotoxic in animal testing" – and high phtalates. The latter, she said, have been "extensively risk assessed by the EU and were found to be safe in all of their current uses."
Saykali acknowledged however that some low phtalates represented a health risk for animals, but that no causal link with humans had been established.
“Four low molecular weight phthalates, namely DEHP, DBP, DIBP and BBP, do cause reduced sperm counts, testicular atrophy and structural abnormalities in the reproductive systems of male test animals and some studies also link these four phthalates to liver cancer in rats," she said. "With respect to the reproductive effects, no effect levels have been identified and no causal relationship between these effects and humans have been reported."
"DEHP has been safely used in medical applications for over 50 years and has contributed to saving millions of lives. With respect to liver cancer in animals, extensive research has shown this to have no relevance for humans”.
- Fall 2012: Denmark to announce ban on four phtalates - DEHP, DBP, DIBP and BBP.
- Spring 2013: European Commission to review endocrine disruptors.
- End 2013: Danish ban on DEHP, DBP, DIBP and BBP enters into force.