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FDA holds reservations regarding phthalates in food contact materials

Time：

2023-08-15

The US Food and Drug Administration (FDA) rejected a citizen's petition for the second time, which required the prohibition of the addition of 8 phthalates to food contact materials and the revocation of 5 phthalate plasticizers previously approved under 21CFR 181.27.

On July 21, 2023, the US Food and Drug Administration (FDA) rejected a citizen's petition for the second time, which required the prohibition of the addition of 8 phthalates to food contact materials and the revocation of 5 phthalate plasticizers previously approved under 21CFR 181.27.

美国食品药品监督管理局 (FDA)请愿书

来源：regulations.gov

Petition Content

Petition prohibiting the addition of 8 phthalates to food contact materials

The petition requests the removal of five previously approved phthalates

Diisobutyl phthalate;

Di-n-butyl phthalate;

Butyl benzyl phthalate;

Dicyclohexylphthalate;

Di-n-hexyl phthalate [also known as dihexyl phthalate];

Diisooctyl phthalate;

Di(2-ethylhexyl) phthalate [also known as DEHP]; and

Diisononyl phthalate.

Butylphthalyl butyl glycolate;

Diethyl phthalate;

Ethylphthalyl ethyl glycolate;

Di-(2-ethylhexyl) phthalate (use on foods of high water content only);

Diisooctylphthalate (use on foods of high water content only)

Background of petition

In 2016, due to concerns about the impact on human health of phthalates transferred from packaging and processing equipment to food, American civil society organizations submitted a petition to the FDA.

Until May 2022, the FDA responded for the first time to this petition and rejected it, stating that "there is no scientific data or information in the petition to prove that these actions are correct.
After the FDA rejected the initial petition, Earthjustice presented new evidence and resubmitted it in June 2022, requesting authorities to review the petition.
In the evaluation announcement of the submitted petition, the FDA stated: "We have evaluated the reconsideration petition and believe that it is not sufficient for the FDA to modify its response to the initial petition

Regulatory direction

Phthalate esters have been regarded as a class of risk substances, and many phthalate ester substances have been included in the scope of risk assessment.

However, the risk assessment of a large class of substances such as phthalates is not overnight and will become more objective with the improvement of relevant data.

Reminder: For enterprises related to the production and use of phthalates, they can pay real-time attention to regulatory trends in various countries and regions, fully understand policy requirements and guidance, and thus produce and manufacture products that meet regulatory requirements.