International journal of hygiene and environmental health · 2025
Regulatory framework of phthalates and two common alternatives: A review of the European Union legislation.
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Palandri Lucia, Monti Marco, Scasserra Maria Rosaria, Lugli Camilla, Fasano Marco, Lucaccioni Laura, Righi Elena
Аннотация
BACKGROUND: Globalized supply chains make it harder to regulate hazardous chemicals in products. These include some phthalates with reproductive and developmental toxicity that maybe found in a variety of products. The European Union (EU) was among the first economies to implement policies to limit their use, yet vulnerable populations (children, pregnant women) are exposed to restricted phthalates. Phthalates' regulation varies significantly by product or chemical compound, but literature lacks systematization of current EU legislation.
METHODS: We examined EU regulatory framework for 19 major phthalates (DMP, DEP, DPrP, DiPrP, DMOEP, DBP, DiBP, DPeP, DiPeP, BBP, DHxP, DCHP, DHpP, DEHP, DHNUP, DPHP, DnOP, DiNP, DiDP) and 2 substitutes (DINCH, DEHTP). We reviewed official institutional websites and regulatory agencies to assess uses and bans in food contact materials (FCMs), toys and childcare articles, cosmetics, and medical devices.
RESULTS: The European Chemical Agency (ECHA) is the main authority supervising chemical use in the EU and regulates phthalates mainly through the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Most reviewed phthalates are severely restricted in FCMs. Phthalates classified as toxic for reproduction are limited in toys and childcare articles above 0.1% by weight; they are banned in cosmetics and restricted in medical devices.
CONCLUSIONS: The EU has reduced exposure to phthalates through stringent regulations, effectively protecting newborns and infants. However, gaps remain, as many everyday items may still represent sources of exposure. Ongoing regulatory revisions and international cooperation are essential to ensure safer cross-border commerce and international compliance, to further reduce phthalate exposure and protect public health.
METHODS: We examined EU regulatory framework for 19 major phthalates (DMP, DEP, DPrP, DiPrP, DMOEP, DBP, DiBP, DPeP, DiPeP, BBP, DHxP, DCHP, DHpP, DEHP, DHNUP, DPHP, DnOP, DiNP, DiDP) and 2 substitutes (DINCH, DEHTP). We reviewed official institutional websites and regulatory agencies to assess uses and bans in food contact materials (FCMs), toys and childcare articles, cosmetics, and medical devices.
RESULTS: The European Chemical Agency (ECHA) is the main authority supervising chemical use in the EU and regulates phthalates mainly through the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Most reviewed phthalates are severely restricted in FCMs. Phthalates classified as toxic for reproduction are limited in toys and childcare articles above 0.1% by weight; they are banned in cosmetics and restricted in medical devices.
CONCLUSIONS: The EU has reduced exposure to phthalates through stringent regulations, effectively protecting newborns and infants. However, gaps remain, as many everyday items may still represent sources of exposure. Ongoing regulatory revisions and international cooperation are essential to ensure safer cross-border commerce and international compliance, to further reduce phthalate exposure and protect public health.