Phthalate restrictions update
From July 2020, Regulation (EU) 2018/2005 will restrict four phthalate plasticisers in all articles. Previously, the restriction only applied to three phthalates and was specific to only toys and childcare articles.
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Phthalates are chemical plasticisers added to plastics during manufacturing to change the flexibility and durability of the final material. These plasticisers alter the physical properties of the plastics by weakening the bonds between the polymer chains, so they are not as tightly bonded to each other. This results in increased flexibility. Phthalates are commonly used to soften polyvinyl chloride (PVC), combatting the naturally very rigid and hard properties of unplasticised PVC that is used in window frames in order to create a much softer and malleable final material. Their use is not only confined to PVC, but polyurethane (PU), paint, inks and adhesives can also contain phthalate plasticisers.
The use of phthalates is applicable to many products, including plastic packaging, inflatable toys and other children’s toys and soothers. Although most phthalates are not harmful, their presence in these products raises concern, as there are four that have been identified under REACH as posing an unacceptable risk to human health. These particular substances have been linked to infertility due to their endocrine damaging properties – in which they can cause a change in hormone levels and possibly harm unborn children.
Humans can be exposed to these phthalates through various routes, the most concerning being ingestion. Infants are therefore more at risk of being exposed due to their hand-to-mouth behaviour. This is why the previous version of REACH (Regulation (EC) No 1907/2006) Annex XVII entry 51 only outlined restrictions on toys and childcare items. However, as a result of further studies, an additional route of exposure to phthalates through skin contact has been identified. Hence, children are no longer the only section of the population considered to be at risk.
Changes to entry 51
In December 2018, the EU published an amendment to the restriction of three phthalates (DEHP, BBP and DBP – see table 1) under entry 51 of REACH Annex XVII in the Official Journal of the European Union. This was as a result of new information that had been gathered by the Committee for Risk Assessment and the Committee for Socio-Economic Analysis in support of an amendment. The research revealed that not only does exposure occur through ingestion, but also via prolonged contact with skin and inhalation of air in indoor environments. The study highlighted that there was a risk for not only the consumer, but also the worker. The European Chemical Agency decided to widen the scope of the REACH restriction from plasticised toys or childcare article to any article containing plasticised materials.
|Table 1: Phthalate restrictions listed in REACH Regulation (EC) 1907/2006 Annex XVII entry number 51 (applicable from 7th July 2020 in all articles)|
|Bis (2-ethylhexyl) phthalate||DEHP||117-81-7||Individually or in any combination, no greater than 0.1 per cent by mass of plasticised material in articles.|
|Benzyl butyl phthalate||BBP||85-68-7|
Another key change was to add an additional phthalate to the list – DIBP. The Committee for Risk Assessment stated that this phthalate has a similar hazard profile to that of DEHP, BBP and DBP, and therefore might have been used as a possible alternative to DBP in toys, so it should be subject to the same restrictions. The amendment to REACH Annex XVII did not come into force immediately when the regulation was published. Rather, articles should not contain DIBP, DEHP, BBP or DBP at 0.1 per cent or above by mass after the 7th July 2020. The article should not be placed on the market if either the individual concentration of each phthalate, or the sum of the four phthalates in the plasticised material is greater than 0.1 per cent.
A significant update in Regulation (EU) 2018/2005 provided more thorough definitions of the terms ‘plasticised materials’, ‘prolonged contact with human skin’ and ‘childcare article’, and these are summarised in table 2. From the list of plasticised materials, PVC and PU are most applicable to footwear, as these polymers are often used in coated fabrics and soling materials.
Table 2: Key definitions in Regulation (EU) 2018/2005
|‘Plasticised materials’||Polyvinyl chloride (PVC), polyvinylidene chloride (PDVC), polyvinyl acetate (PVA), polyurethanes (PU) and any other polymer (including polymer foams and rubber materials), with the exception of natural latex and silicone rubber.|
|‘Prolonged contact with human skin’||More than ten minutes continuously or intermittent contact for over 30 minutes per day.|
|‘Childcare article’||Any product that is intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.|
Although the scope of products has been widened to restrict more plasticised materials, there are a few exemptions from these restrictions. These include articles for agricultural use and industrial use in the open air (unless they will come into prolonged contact with skin), materials intended to come into contact with food that are covered under Regulation 10/2011, medical devices and electronic equipment. If a product cannot be identified under these exemptions and it is defined as a ‘plasticised material’, the testing of these materials can be used to demonstrate conformity.
How can we help?
SATRA offers a range of services that include the testing of products to ensure that they comply with REACH. We have an ISO 17025-accredited laboratory with state-of-the-art instruments, and a knowledgeable and experienced team able to assist on any testing or queries you many have regarding these changes. Please contact email@example.com for further information.
This article was originally published on page 6 of the July/August 2019 issue of SATRA Bulletin.