Botex Products are Phthalate Free, opening up the multi-billion dollar toy market for Botex.
May 17, 1999
To Whom It May Concern: Please note the following:
Published by Merchandise Testing Laboratories, Inc.
Vol. VI . No 1298
September 1998
EUROPEAN RECOMMENDATION REGARDING THE USE OF PHTHALATES IN THE MANUFACTURE OF PVC TOYS
In July, the European Commission adopted a recommendation concerning the use of phthalate plasticizers in PVC products intended for children under three and designed to be chewed, bitten or sucked.
BACKGROUND
A phthalate (pronounced "thalate") is a plasticizer that is added to
polyvinyl chloride (PVC) in order to make the end product malleable and soft. Phthalates do not bond to PVC polymers themselves, so they leach easily through saliva. A danger is thought to exist when children play with teething toys and rings that include phthalates because the act of biting can cause phthalates to enter a child's system through the child's saliva.
Studies indicate that when phthalates enter the body, a number of health risks present themselves. Test cases have shown ingestion to cause liver and kidney damage, as well as present reproductive concerns. In addition, several organizations, including the U.S. Environmental Protection Agency have designated one common phthalate used in the manufacture of toys, DEHP, as a probable carcinogen.
THE EUROPEAN RECOMMENDATION
In light of health concerns, authorities in several European nations,
including Austria, Belgium, Denmark, Germany and the Netherlands
recommended regulatory guidance on soft PVC toys intended or likely to be used in the mouth, such as teething rings and bath toys. In response, the European Commission has decided to adopt the recommendation of these countries and issued an invitation to Member States to check the level of migration of phthalates to ensure that they do not exceed levels suggested by the Scientific Committee of Toxicity, Ecotoxicity and the Environment (CSTEE). The committee set guidance levels for 6 common phthalates as follows:
DINP 1.2 mg
DNOP 3.0 mg
DEHP 0.4 mg
DIDP 2.0 mg
BBP 6.8 mg
DBP 0.8 mg
These guideline values are at this point more or less arbitrary. The
values represent levels of migration of phthalate (per sample) into saliva solution based on a 6cm2 sample, a test time of 6 hours and a child weighing 8 kg. Until there is an agreed upon test method (see next paragraph), however, these values can only be viewed as an abstract guideline.
CURRENT STATE OF AFFAIRS
There is currently no universally accepted test method to determine levels of phthalate migration. Until one is developed, the CSTEE has indicated that no final regulation can be set. A study by the Dutch health authorities seeks to determine this method. It should be available by early fall.
While the European Commission's recommendation seeks to regulate phthalate use, the nation of Austria has opted to place a ban on phthalate plasticizers for children under 3 and intended to be put in the mouth. The ban is slated to go into effect January 1, 1999.
It should be pointed out that the U.S. has not taken the same approach as its European counterparts. This is because up until now, the U.S. Consumer Product Safety Commission (CPSC) has not taken a position against the use of phthalates, instead allowing manufacturers the option of employing a voluntary standard for DEHP. The CPSC has reached the preliminary conclusion that there is not enough data to justify banning or setting out mandatory regulations for soft PVC toys containing phthalates for children under 3. Research is ongoing, however.
CONCLUSION
While there is still a great deal of ongoing research surrounding the use of phthalate plasticizers in PVC toys, it is clear that nations are placing a great deal of scrutiny on soft PVC toys. Toy manufacturers and retailers, in addition to monitoring the use of all phthalates, should focus their attention on two in particular: DINP, and DEHP. These two are the most commonly used phthalates in the manufacture of toys., The European Commission has singled them out and currently requires Member States to inform the commission about testing methods used, levels of migration found and the conclusions drawn from these findings.
In reference specifically to Botex, we are pleased to confirm that all
products manufactured by Botex do not contain the phthalates: DINP, DNOP, DEHP, DIDP, BBP and DBP.
Yours truly,
Don Greer
President & CEO
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