Editorial
Concerns around chemicals in everyday products, especially those used by children, have been growing steadily in recent years. Among them, phthalates have become one of the most discussed.
These substances are commonly used to make plastics softer and more flexible, meaning they can be found in a wide range of items, from toys and clothing to flooring and packaging. But some types have raised health concerns, particularly for their potential effects on hormones and development.
A study led by the Tegengif Foundation in the Netherlands, together with several European NGOs, found that certain plastic drinking bottles for children released diisobutyl phthalate (DIBP) — a substance that is banned in plastics due to its links to reproductive harm and developmental risks.
Research also suggests that exposure is widespread. According to the Human Biomonitoring for Europe (HBM4EU) initiative, traces of phthalates are commonly detected in children’s urine across Europe, with around 17% potentially exposed to levels that may pose health risks when multiple substances are combined.
To better understand how these risks are being addressed, Healthy.mt asked the European Chemicals Agency (ECHA) to clarify how children’s exposure to phthalates is currently being managed.
- The main (potential) human health hazard for ortho-phthalates is related to reproductive toxicity.
- Phthalates were also frequently found in breach of conditions of the restriction in soft plastic materials such as PVC bath accessories or plastic elements of shoes.
- They affect the sexual development of boys which can lead to infertility in adults.
- Toys were checked most frequently and detected non-compliance ranged from 2% to 19%.
- Enforcement of EU’s chemicals regulation falls within the remit of the Member States.
- Nearly 4000 controls focused specifically on restrictions on phthalates.
Many regulatory risk management measures in place
ECHA representative Mikko Väänänen comments that ECHA has assessed data on four groups of phthalates and phthalate-like substances (ortho-phthalates; isophthalates; terephthalates; and trimellitates). The most known phthalates are ortho-phthalates. Ortho-phthalates have also been the focus of regulators in the EU due to the hazard properties of many of them.
The main (potential) human health hazard for ortho-phthalates is related to reproductive toxicity. Many of these substances therefore already have a harmonised classification (CLH) in the EU for reproductive toxicity.
Mikko Väänänen
He emphasizes that they may damage fertility or the unborn baby and interfere with our hormonal system.
In particular, they affect the sexual development of boys which can lead to infertility in adults.
Apart from boys, pregnant women and young children in general have been found to be the most vulnerable groups to the effects of phthalates. Some of them are also identified as endocrine disruptors (ED), says ECHA representative.
A wide range of regulatory risk management measures are already in place.Many phthalates are classified as toxic to reproduction and they are restricted on their own and in mixtures that are intended for consumer use. They are also restricted in consumer clothing or related accessories as well as in other textiles that come into contact with the skin.
Phthalates covered by this restriction include: DEHP, DBP, DIBP, BBP, diisopentylphthalate 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich, bis(2-methoxyethyl) phthalate, dipentyl phthalate, and dihexyl phthalate. In addition, the use of DEHP, DBP, DIBP and BBP has been separately restricted under the EU’s REACH Regulation since July 2020.
This restriction covers, for example, uses in children’s swimming aids, flooring, coated fabrics and paper, recreational gear, mattresses, footwear and office supplies.
ECHA has also assessed the regulatory needs for ortho-phthalates as a group, concluding that further restrictions on ortho-phthalates may be justified.
There is also an ongoing process to propose a harmonised classification of C4–C6 ortho-phthalates as toxic to reproduction and as endocrine disruptors for both humans and the environment; this proposal was submitted by France, according to the ECHA representative.
The proposal from the French authorities to harmonise classification of C4-C6 ortho-phthalates reflects the latest scientific evidence.
A restriction of several ortho-phthalates is also included in the European Commission’s Restrictions Roadmap, but work on this initiative has not started yet.
Control mechanisms
Member States are responsible for concrete enforcement activities as described in response to your previous question above. National controls in EU Member States are the primary enforcement mechanism.
Mikko Väänänen comments that in addition to national enforcement, ECHA coordinates enforcement projects in its Enforcement Forum, which coordinates and harmonises the actions of national enforcement on the EU level. The Forum runs and reports the results of the EU wide harmonised enforcement projects. These enforcement projects regularly focus on restrictions on hazardous substances, including phthalates in consumer articles, especially toys and childcare materials.
Controls in the projects are always carefully targeted towards goods likely to be non-compliant, so results are not representative for the EU market as a whole.
Across these enforcement projects, nearly 4000 controls focused specifically on restrictions on phthalates.
The level of detected non-compliance varied depending on the product type checked. Toys were checked most frequently and detected non-compliance ranged from 2% to 19%.
Phthalates were also frequently found in breach of conditions of the restriction in soft plastic materials such as PVC bath accessories or plastic elements of shoes.
When non-compliant products are detected, inspectors take enforcement measures and companies withdraw the products from the market or online platforms.
SOURCE
ECHA answers to Healthy.mt
