Plasticisers: Regulation
Why some phthalates were banned from toys and blood bags
What this tab covers How it is regulated and what could disrupt supply: hazard classification, rules in the EU, US and India, anti-dumping duties and other trade measures, and supply-risk notes.Hazards
| Classification | UN number | Key risks |
|---|---|---|
| DEHP, DBP, BBP, DIBP: reproductive toxicity cat 1B (EU CLP); DINP, DOTP, DINCH not classified | not regulated for most grades | Low-molecular-weight phthalates are endocrine disruptors and migrate from products. |
Main rules
| Where | Rule | Effect |
|---|---|---|
| EU | REACH Annex XIV (DEHP, BBP, DBP, DIBP) and Annex XVII entry 51 (0.1% limit in articles from July 2020); entry 52 for DINP, DIDP, DNOP in mouthable toys | low phthalates largely displaced |
| US | CPSC rule (2017) banning eight phthalates above 0.1% in children's toys and childcare articles | DOTP and DINCH in toys |
| EU | Medical Device Regulation limits on CMR phthalates | DEHP substitution in tubing and blood bags |
India
| Rule | Effect |
|---|---|
| Toys (Quality Control) Order 2020 with BIS standards | phthalate limits in toys (indicative) |
| Customs Notification 20/2026-Customs (ADD), 5 Aug 2026 | $40.08/t on Chinese and $140.17/t on Korean phthalic anhydride for five years |
Trade measures
- India ADD on phthalic anhydride (China, Korea), 2026
- US anti-dumping duties on DOTP from Turkey, Malaysia, Taiwan and Poland (ResourceWise)
- US 15% tariff on EU exports (2025)
Supply risk
Low; many producers. Risk is regulatory: further restrictions could cut demand for specific esters.