FDA to review phthalates safety following NGO petition

By Joseph James Whitworth

- Last updated on GMT

Phthalate petition review is a ‘process requirement’ - ACC

Related tags Food Food and drug administration

The US Food and Drug Administration (FDA) is to review the regulatory clearances for 30 ortho-phthalates used in food packaging.

The move follows a food additive petition filed by 10 non-governmental organisations.

FDA will publish a notice in the Federal Register announcing the petition is under review within the next two weeks and has up to 180 days from this date to consider it and make a formal decision.  

Ortho-phthalates are used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents in cellophane, paper and paperboard, and plastics in contact with food.

The American Chemistry Council (ACC) said the move is not an indication that the petition has merit, or that the agency will revise the regulations - it is an administrative step required by federal regulations.

“FDA’s Center for Food Safety and Applied Nutrition (CFSAN) evaluates food contact materials for safety before they are approved for use. The most widely used commercial phthalates belong to one of the most extensively studied families of chemicals in commerce.

“They have been reviewed and studied by numerous government scientific agencies and regulatory bodies worldwide. Their conclusions have been essentially the same each time: that the phthalates in the marketplace today do not pose a risk to human health at typical real-life exposure levels.”

‘A serious threat’

Tom Neltner, chemicals policy director at the Environmental Defense Fund (EDF), one of the organisations behind the petition​, described the chemicals as a ‘serious threat’ to pregnant woman, their developing fetuses and children.

“But, manufacturers continue to use ortho-phthalates – from farm to fork – even though there are alternatives.”

EDF, Natural Resources Defense Council, Center for Science in the Public Interest, Center for Environmental Health, Center for Food Safety, Clean Water Action, Consumer Federation of America, Earthjustice, Improving Kids’ Environment, and Learning Disabilities Association of America are the organisations behind the petition.

They said there is no longer a reasonable certainty of no harm for the food contact use of the 30 ortho-phthalates and gave reasons for this statement, including: “Absence of data specific to 57% of ortho-phthalates in the class to address reproductive, developmental and endocrine toxicity.

“Absence of adequate migration data to determine dietary exposure to the great majority of chemicals in the class from their food-contact use [and] available data indicating current exposures are above the estimated tolerance for the class.”

Lisa Lefferts, CSPI senior scientist, said although not directly added to foods, ortho-phthalates are found in many, including meat, dairy products, infant foods, oils, and spices.   

“It doesn’t make sense to ban some ortho-phthalates from children’s toys, and phase them out of vinyl flooring, but still approve them for contacting food,” ​she said

“Many ortho-phthalates lack adequate safety studies, but all that have been tested for developmental and reproductive effects show a risk. None should be permitted for contact with food.”  

Filing of citizens petition

The petition also requested the removal of five ortho-phthalates as prior-sanctioned substances in Title 21 Code of Federal Regulations (CFR) Part 181.27 and the banning of eight ortho-phthalates by issuing a new regulation in 21 CFR Part 189.

5 substances concerned: diethyl phthalate, ethyl phthalyl ethyl glycolate, butyl phthalyl butyl glycolate, diisooctyl phthalate, and di(2-ethylhexy1) phthalate

8 chemicals involved: Diisobutyl phthalate; Di-n-butyl phthalate; Butyl benzyl phthalate; Dicyclohexyl phthalate; Di-n-hexyl phthalate; Diisooctyl phthalate; Di(2-ethylhexyl) phthalate (DEHP); and Diisononyl phthalate

FDA said these requests fall outside the scope of a food additive petition and would not be considered.

The groups said they would use another regulatory process – a citizens petition​ – to request action on these.

“We’ve known these food packaging chemicals are dangerous for a while, but the food processing industry has not acted. They are not protecting the public from these toxins, so now it’s time for FDA to do so,”​ said Peter Lehner, Senior Attorney for the Sustainable Food and Agriculture Program at Earthjustice.

The news follows six public health and environmental organizations filing a lawsuit in March against the FDA concerning the restriction of perchlorate in food packaging.

A petition was submitted to FDA in December 2014 but the agency missed the June 2015 deadline.

Earlier this year, the FDA banned three perfluoroalkyl ethyl containing food-contact substances (FCSs) that industry says are no longer manufactured anyway.

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