Phthalates form a family of synthetic chemicals with a wide variety of uses, ranging from consumer to industrial products. There are different kinds of phthalates and they are commonly used as softeners to make plastics, such as PVC, more flexible and durable.
Although phthalates are mostly used as plasticisers, they can also be found in, for example, adhesives, sealants, paints, rubber materials, wires and cables, flooring, packaging, food contact materials, medical devices and sports equipment.
Due to their wide use, phthalates can be found almost everywhere in our environment. We are exposed to phthalates through food, skin, and air. As phthalates are not chemically bound in the materials they are added to, they can easily leach out or evaporate. All phthalates have not been thoroughly studied, but there is evidence that some of them are harmful to our health as they can, for example, interfere with our hormonal systems and cause allergies. As a result, the use of certain phthalates is already regulated both in Europe and globally.
The use of these chemicals in articles is restricted in the EU/EEA from July 2020, per their endocrine disrupting properties.
EFSA published a scientific opinion last 12th May 2022, on five phthalates authorised for use in plastic food contact materials (FCM) and previously assessed by EFSA in 2005. The five substances are known as DBP, BBP, DEHP, DINP and DIDP:
- di-butylphthalate (DBP) – FCM No 157
- butyl-benzyl-phthalate (BBP) – FCM No 159
- bis(2-ethylhexyl)phthalate (DEHP) – FCM No 283
- di-isononylphthalate (DINP) – FCM No 728
- di-isodecylphthalate (DIDP) – FCM No 729
EFSA’s experts set a new safe level – a group Tolerable Daily Intake (TDI) – for four of the five phthalates (DBP, BBP, DEHP and DINP) of 50 micrograms per kilogram of body weight (µg/kg bw).The fifth phthalate in the assessment, DIDP, does not affect testosterone levels in foetuses, therefore EFSA set a separate TDI of 150 µg/kg bw per day based on its effects on the liver (as in our 2005 evaluation).
EFSA, concluded that Current exposure to these five phthalates from food is not a concern for public health. Dietary exposure to the group of DBP, BBP, DEHP and DINP for average consumers is 7 µg/kg bw or seven times below the safe level, while for high consumers it is 12 µg/kg bw, which is four times lower. For DIDP, the dietary exposure for high consumers is 1,500 times below the safe level.
Despite the conclusions EFSA started to conduct preparatory work for the re-evaluation of phthalates, structurally similar substances and replacement substances that are potentially used as plasticisers in food contact materials (FCMs). This mandate includes a request to consider migration data in the context of the dietary exposure assessment. To this end, EFSA aims to collect results generated in experimental studies on FCMs before their actual use, e.g. tests on migration of plasticisers from FCMs using food/food simulants, or tests on concentration of plasticisers in FCMs.
National food authorities, research institutions, academia, food business operators and other stakeholders are invited to submit data on migration or occurrence of plasticisers (phthalates, structurally similar substances and replacement substances) in FCMs. A draft list of substances identified as potential plasticisers (EFSA CEP Panel, 2022 – under publication), and therefore considered within this call for data, is available at https://doi.org/10.5281/zenodo.6519824. (Ex: Phthalates, Terephthalates, Citrates, Benzoates).
EFSA open a public consultation until the 7th July 2022- Draft protocol for the hazard assessment as part of the risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food
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References
- Identification and prioritisation for risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food
- Call for collection of data on phthalates, structurally similar substances and replacement substances migrating from or occurring in food contact materials (Plasticisers_FCM_2022)
- Draft protocol for the hazard assessment as part of the risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food
- Phthalates. ECHA (European Chemicals Agency)
- Phthalates and other plasticisers: priorities for reassessment
- FAQ: phthalates in plastic food contact materials