Phthalates, their uses, restrictions and ways we help protect your brand
Plasticizers are used in many industries across the globe to increase a polymer’s workability and flexibility in mainly PVC materials. Low and high molecular weight phthalates are used in printing inks, film coatings, and cosmetics as a perfume solvent or chip resistance properties in nail polish, food packaging, in aerosols as a suspension agent, enteric-coatings in pharmaceuticals, medical device equipment, in the formulations of adhesives and sealants, and many more applications. According to the FDA, Phthalates are all around us in our daily lives and their high volume uses in consumer products with their high toxicity exposure levels have caused advocacy groups, regulatory agencies and health organization to take notice. The U.S. Congress established prohibitions and oversight to be administered by the Consumer Product Safety Commission (CPSC) on children’s toy and childcare article in 2008 with inclusion of such limitation in the Consumer Product Safety Act of 2008. The CPSC put forth 16 CFR 1307 in the federal code of regulations to prohibit the use of di-(2-ethyhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexly phthalate (DCHP) at levels not to exceed 0.1% by weight of the materials in children’s toys and childcare articles. Since 2008, phthalates have found themselves either prohibited or limited in use in regulations and legislation around the globe including;
- California Proposition 65
- Health Canada’s Phthalates Regulation SOR/2016-188
- EU: ECHA REACH Annex XVII Restricted Substances
- Washington State Children’s Safe Products Act (CSPA)
- Maine’s Safer Chemicals in Children’s Products Rules
- EU: RoHS Directive 2015/863 amending Annex II to Directive 2011/65/EU
- Australia’s Consumer Protection Notice No. 11 of 2011
- EU Cosmetics Regulation No. 1223/2009
With the increasing restrictions applied to consumer products on phthalates, it can be a burden to manufactures and retailers to keep up with the growing list of these harmful substances and to the overall cost of selling goods applicable to these requirements. There are useful and less costly techniques capable of demonstrating compliance. These techniques include chemical risk management databases, supply chain management software, and screening tools such as onsite FTIR analysis.
We here at Eurofins Product Testing understand the growing need to show compliance to all stakeholders involved. We take pride in understanding the manufacturing processes, the supply chain upstream and down and the ability to provide consultancy at all levels. Please contact us today at USCPTSupport@eurofinsus.com to see how we can help.