On February 10, 2009, a new regulation which limits the use of phthalates in children’s products goes into effect.  Phthalates are plasticizers (softening agents) used in plastics to make the product flexible and more durable.  They are thought to cause adverse health effects in young children.  Young children have been found to be more susceptible to the negative effects of this group of chemicals because their bodies are still growing and developing.  Reproductive and hormone problems, learning disabilities and an increased risk of developing cancer later in life are among the conditions claimed to be caused by these chemicals. The Consumer Product Safety Commission (CPSC) is responsible for enforcement of the regulation.

The new regulation falls under Section 108 of the Consumer Product Safety Improvement Act. The regulation permanently bans diethyhexyl phthalate (DEHP), dibutyl phthalate (DBP) and butyl benzyl phthalate (BBP) in concentrations greater than 0.1% in children’s toys and childcare items. The U.S. District Court for the Southern District of New York has made it clear that the phthalate regulation applies not only to products manufactured after the effective date, but also to inventory products manufactured earlier. The regulation also temporarily prohibits the use of di-isodecyl phthalate (DIDP), di-isononyl phthalate (DINP) and di-noctyl phthalate (DNOP) in childcare items and toys that can be placed in a child’s mouth, in concentrations greater than 0.1%, until further study of these phthalates can be conducted by a Chronic Hazard Advisory Panel.

The regulation defines children’s toys to be products intended for use during play by children 12 years of age or younger.  Childcare items are defined to be products intended for children three years of age or younger, used to assist in sleeping, feeding, sucking or teething.  The 0.1% limit applies to each phthalate individually and pertains to all parts of children’s toys and childcare items, including inaccessible parts.  It also applies to some apparel, namely bibs and sleepwear intended for children under three years of age.

Packing is not included under the regulation unless it is intended to be used for storing the product.  Sporting goods are also exempt under the regulation unless the product is commonly recognized by consumers as being intended for use by children 12-and-under or it contains a label, packaging or advertising that states appropriate use by the age specified in the regulation.

As of February 10, 2010, manufacturers, importers and private labelers must certify that each shipment of newly-manufactured inventory is in compliance with the new regulation.  Each shipment must be accompanied by a certificate that can be furnished to distributors and retailers that is based on testing performed by an accredited third party laboratory.

There currently are no rapid screening methods for phthalates.  Instead, a chemical method in which plasticizers are extracted from the plastic material using a soxhlet solvent extraction followed with an analysis by gas chromatography, is used.

Microbac Laboratories Hauser Division has extensive experience with consumer product testing.  The laboratory professionals can help you understand the new regulations and perform the compliance testing that you need.

For more information, please contact: microbac_info@microbac.com.