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Phthalates are phthalic acids esters that are used as plasticizers especially for polyvinyl chloride (PVC). Phthalates are used in many different products, such as cachets, adhesives, building materials, car bodies, toys, childcare articles, food packaging, cosmetics and textiles.
In the EU and the United States the use of phthalates has been limited, because they cause serious health problems. The biggest health risk is linked to heredity and some phthalates are dangerous to the fetus and may weaken fertility. Moving through the mother to the fetus or a phthalate dose received by a small child can seriously damage a child's hormone balance. Phthalates may dissolve in the child’s body with for example saliva, if phthalates are in products which child can put in its mouth. Damages caused by phthalates are not immediately noticeable, they appear later in life.
Phthalates have a wide variety of compounds. Six phthalate compounds which are harmful to health and prohibited in products aimed for children are; di(2-ethylhexyl) phthalate (DEHP), di-n-butyl phthalate (DBP), benzyl butyl phthalate (BBP), diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) and di(n-octyl) phthalate (DNOP). In addition, in cosmetics and medical supplies the use of some other phthalates is limited or prohibited.
Phthalates and Legislation The REACH Regulation 1907/2006/EC concerning the Registration, Evaluation, Authorization and Restriction of Chemicals and its Amendments
Directives 2007/19/EC and 2002/72/EC about Food Contact with Plastic Materials
The Phthalate Directive 2005/84/EC
The Cosmetics Directive 76/768/EEC
Medical Device Directive 2007/47/EC Phthalates and Reach DBP, DEHP and BBP are on SVHC's (Substance of Very High Concern) bachelor list, which was published on October 28th 2008
REACH Annex XVII also limits the use of following phthalates: DINP, DIDP and DNOP
On September 1st 2009 a new list of candidate materials has been published that includes also Diisobutyl phthalate (DIBP), which is mainly used in paints and varnishes as a plasticizer and a bonding agent
REACH requires companies to inform their customers of these compounds and respond to consumers within 45 days after receiving a request if the sold consumer goods contain more than 0.1 percent of DPB, DEPH or BBP. Information should ensure the safe use of the product and at least the name of the substance should be included in it
From 2011 manufacturers and importers must notify The European Chemicals Agency (ECHA) when the objects are containing more than 0.1% by weight DPB, DEHP or BBP and if a total quantity of the produced or the imported substance is more than a thousand kilos per year Phalates and Risk AssessmentMany of the coated products and plastic articles contain phthalates. In 2008 many products were withdrawn from the EU internal market as they contained harmful phthalates. The Finnish authorities have published guidance for manufacturers and importers of toys and other consumer products to prevent the problems caused by phthalates. The webpage of the EU Commission for RAPEX notification systems (Rapid Alert System for Dangerous products) is listed dangerous products which have been recalled from the market. By August 2009 in RAPEX it was announced 80 products, which exceeded the legal limit of phthalates. The majority of these products were toys, but there were also childcare articles and cosmetics. In Finland, the Consumer Agency and the Customs supervises toy and childcare article safety.
This newsletter does not provide all the details of the legislation. Of this reason, the reader should look for the necessary legislation in its entirety.
SGS Services We can analyze phthalates in toys and other plastic materials and products in our laboratory located in Kotka.
We offer a wide range of analyses of harmful substance in consumer goods.
Our experts are happy to answer your questions regarding consumer demands, as well as product quality and safety. We support you in the processes to define requirements, as well as product development and quality testing.
For more information, please contact:
Anja Merenkivi
t: +358 9 6963 667
Asta Tissari
t: +358 9 6963 665
Merja Portaankorva
t: +358 9 6963 662
EmailSGS Inspection Services LtdP.O. Box 128, FI-00211 Helsinki, Finland
t: +358 9 696 3701
f: +358 9 692 4673
Email SGS FinlandSGS Finland The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 56,000 employees, SGS operates a network of over 1,000 offices and laboratories around the world.