Phthalates/Plasticisers
Phthalates are esters of phthalic acid used as plasticisers in PVC. Without plasticisers, PVC is hard and brittle; phthalates make it flexible and processable.
Relevant phthalates in vinyl gloves:
- DEHP (di-2-ethylhexyl phthalate): formerly the most common PVC plasticiser, now heavily restricted
- DBP (dibutyl phthalate)
- BBP (benzyl butyl phthalate)
- DIBP (diisobutyl phthalate)
Health classification:
DEHP, DBP, BBP, and DIBP are classified as reprotoxic Category 1B and are SVHCs under REACH. They appear on the ECHA candidate list and are subject to use restrictions.
Regulatory situation:
- REACH Annex XVII: restriction of these phthalates in articles to <0.1 % per substance
- EU Toy Directive and RoHS: further restrictions in other product categories
- For medical devices: MDR requires risk assessment for products containing SVHCs
Alternatives: phthalate-free plasticisers (e.g. DINCH, citrates) or alternative materials (nitrile, TPE) are increasingly used.
Frequently asked questions
Do all vinyl gloves contain phthalates?
Not necessarily. Traditional vinyl gloves typically contain DEHP or related phthalates as plasticisers. Newer phthalate-free formulations replace these with alternative plasticisers such as DINCH or citrates. Phthalate-free status must be explicitly declared by the manufacturer.
Why are phthalates particularly relevant for medical devices?
In medical devices, phthalates come into direct body contact and can migrate. The MDR requires a risk assessment for CMR substances and SVHCs in medical devices. Special precautions apply for neonates and pregnant women.
What phthalate-free alternatives exist for vinyl gloves?
Alternative plasticisers such as DINCH (di-isononyl cyclohexane-1,2-dicarboxylate) or trimellitates are used. Switching to nitrile or TPE is the safest option but more costly.