Six Chemicals in Soft Plastic Toys Banned Across Europe

BRUSSELS, Belgium, July 6, 2005 (ENS) - The European Parliament voted Tuesday to impose a permanent ban on six chemicals used in plastic toys and childcare articles to soften the plastics. Young children can ingest the toxic chemicals when they suck or chew on the soft plastic items.

Known as phthalates, since 1999 the six chemicals have been temporarily banned across the EU in the manufacture of toys and other items intended for children under the age of three because of their carcinogenic, mutagenic and reprotoxic effects.

From now on, three phthalates - DEHP, DBP and BBP - are totally banned for use in any toys or childcare articles where their concentration exceeds 0.1 percent by mass of the plasticized material. Before 1999, concentrations of up to 30 percent sometimes occurred.

The three other phthalates - DINP, DIDP and DNOP - are banned, for the same concentrations, in toys and childcare articles which children could put in their mouths whether or not they are intended for this use.

Besides toys and childcare articles, Parliament also calls on the European Commission to look at other types of material containing these phthalates, especially in the field of healthcare.

In the debate before the vote, Rapporteur Antonios Trakatellis of Greece, a medical doctor, called for the application of the precautionary principle in this case, given that "the risk assessment is not yet complete."


Parliamentary Rapporteur Antonios Trakatellis piloted the phthalates legislation through the European Parliament. (Photo courtesy Office of the MEP)
Trakatellis expressed satisfaction with the concessions Parliament was able to get from the Council of Ministers, which had favored authorizing the second category of phthalates for children above the age of three. However, the ban now applies to all age categories.

On behalf of the European Commission, Vice-President Guenter Verheugen said, “This decision will put an end to several years of uncertainty during which this issue was debated at length and different national policies emerged."

Since 1999, the temporary ban has been prolonged by the Commission on a regular basis. Member states have implemented national measures banning the use of phthalates in toys.

Said Verheugen, who is responsible for enterprise and industry policy, "There is now a more stable legal situation which will enable industry to plan in conditions of certainty."

Verheugen said that the Commission will now examine the question of fragrances, which Parliament had raised in first reading, as part of the next revision of the directive, or law, on toys.

Members of the European Parliament fear that manufacturers' use of aromatic products to mask the naturally unpleasant odour of phthalates encourages children to put the articles into their mouths, where the toxic substances can leach into their saliva and be swallowed.

Commissioner for Health and Consumer Protection Markos Kyprianou of Cyprus, said, “Europe’s citizens expect all products sold on the EU’s internal market to be safe, but this is particularly the case for toys and childcare products."

"Toxic chemicals have no place in children’s toys," said Kyprianou. "Our action on phthalates shows that when a risk is identified, the EU can act effectively to protect the health of its children.”

Greenpeace, which first called attention to the toxic effects of phthalates in 1997, said it has taken too long for these toxics to be removed from children's immediate environment.

"The case of the toxic toys shows how slow the current process for regulating chemicals is, and the urgent need for a much stronger law," Greenpeace said in a statement Tuesday.


Plastics used in toys are softened with toxic chemicals that can cause cancer, mutations, and reproductive damage if they leach out of the plastic when chewed or sucked. (Photo credit unknown)
"Back in 1997 we tested a wide range of popular PVC [polyvinyl chloride] plastic toys, such as rubber ducks, dolls and baby's teethers and showed that they contained dangerous chemicals," Greenpeace said. "We tested more toys in spring 2005, and found that Spiderman Flip 'n Zip and Mattel's Barbie "Fashion Fever" contained high levels of harmful phthalates."

"The chemical and toy industries fought hard to prevent today's decision - but the forces of good have finally won out," Greenpeace said.

Mattel said in 1998 that the company was committed to begin a phase out of phthalates in plastic teething toys for children under the age of three. "The company plans to begin shipment of phthalate-free teethers and other toys intended for the mouth in the first quarter of 1999 on a worldwide basis," Mattel said in a statement.

In December 1999 Mattel announced that it was bringing together "a consortium of the world's most innovative materials developers and consultants to identify materials that are derived from organic and renewable sources while maintaining the safety and structural integrity of the company's products." But the company has made no further announcement about this effort.

Following the vote in Parliament, the industry association European Council of Vinyl Manufacturers (ECVM), expressed its "serious concern" that "political decisions are taken which are totally opposite to the outcome of the EU risk assessments."

“We would like to stress on this occasion that the PVC industry has always put on the market safe products, which have been used for more than 50 years, without any measurable impact on health or the environment," said ECVM Executive Director Jean-Pierre De Grève.

"There is absolutely no reason to limit the use of PVC in any application," said De Grève.

DINP is by far the most common phthalate used in toys, the industry group said. "DINP has undergone an EU Scientific Risk Assessment and the outcome was clearly that children are not at risk from the use of DINP in any toys. DINP has also been investigated by the Consumer Product Safety Commission in the United States and it also confirmed that there is no health risk from its use in toys."

The European Union is currently preparing a new chemicals law called REACH, which aims to ban or control a wide range of dangerous chemicals used in all EU products.

For different reasons, both Greenpeace and the vinyl manufacturers view the new ban as a demonstration that the REACH process, still in the draft stage, is flawed.

The PVC industry group says, "Not applying the outcome of the risk assessments in such a process also puts under consideration the credibility of the REACH approach, which is based on risk assessments."

Greenpeace says the REACH process will be too slow, and "the chemical industry has already succeeded in getting most of the 100,000 chemicals currently in use excluded from the rules."

"Europe is the world's largest chemical producer and yet the majority of chemicals manufactured and used every day have never been properly tested," Greenpeace said Tuesday. "For those that have been tested and found to be toxic, it can take years for them to be controlled; and even then they can still sometimes be used in consumer products."


Infant in intensive care (Photo credit unknown)
Phthlates in health care products are becoming a concern in the United States. On June 8, a study was released by Harvard University scientists that found that babies in Neonatal Intensive Care Units receiving intensive therapy with PVC medical devices were exposed to a toxic phthalate at very high levels - an average of 25 times higher than the general population and up to 50 times higher for the most exposed.

As their medical treatments intensified, the sick infants were exposed to progressively higher exposures of di(2-ethylhexyl) phthalate, or DEHP.

DEHP is a reproductive toxicant that alters development of the male reproductive system in laboratory animal studies. The phthalate is used to soften vinyl plastic medical devices such as IV bags and tubing, and it leaches out of the plastic and into patients' bodies.

The peer-reviewed study, published in the National Institute of Environmental Health journal "Environmental Health Perspectives," also found significantly lower phthalate levels in the babies who received care at the hospital that had switched to DEHP-free medical devices for some applications.