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Phthalate plasticisers in PVC
A consideration of legislation affecting the use of plasticised polyvinyl chloride.
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In its natural state, polyvinyl chloride (PVC) is a hard, rigid material which has found extensive use in the construction sector – in such applications as window frames, facia cladding, guttering, pipes and electrical insulation. This is usually referred to as ‘uPVC’ or ‘PVCu’ (unplasticised polyvinyl chloride). However, with the addition of plasticisers (oil-like substances) to the polymer, flexibility is introduced. This makes it suitable for a variety of additional applications, including flooring, children’s products, packaging and footwear.
Once plasticised, it is easy to understand why PVC has found such wide use in our modern society – it is comparatively cheap to manufacture consistently, it can be moulded into almost any shape, and can be produced in a wide range of colours. Plasticised PVC is strong, durable and extremely easy to clean, due to having resistance to moisture. The total quantity and composition of the added plasticisers determines the degree of flexibility in the final product. For example, the total plasticiser content of flexible PVC tubing could be as high as 50 per cent by weight of the final material.
Concerns have been raised about one specific group of plasticisers – phthalates – which could be included in PVC compounds. While phthalates are most associated with PVC, they can also be present in other flexible synthetic polymers (such as polyurethane), although typically at much lower concentrations. Some phthalates have been linked with concerns regarding hormonal effects on people exposed to them over a period of time. This is particularly relevant to products used by children, such as toys or teething rings. During use, these may be sucked or chewed, with the possible consequence that the plasticisers could leech or be extracted out of the PVC compound into the child’s digestive system. Once in the body, some phthalates can behave as endocrine disruptors, meaning they can have an effect on the balance of hormones in the body.
It should be noted that while there are many phthalate compounds, only a few are currently considered to pose a significant risk to health. The concerns that were raised led to a European directive (2005/84/EC), which restricted the use of six specific phthalates in toys and childcare articles. The directive defined childcare articles as ‘any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children’. Three of the phthalates (BBP, DEHP and DBP) are restricted in all toys or childcare articles, whereas the other three phthalates (DNOP, DIOP and DINP) are only restricted in toys or childcare articles which can be placed in the mouth. The European Directive was incorporated into the REACH legislation (Regulation (EU) 1907/2006) in Annex XVII. However, the restrictions for BBP, DEHP and DBP will widen to include all articles – not just toys and childcare articles – and a fourth phthalate (DIBP) will be added to this group. This change comes into effect from 7th July 2020 and the full phthalate restrictions in Annex XVII are summarised in table 1.
|Table 1: Phthalate restrictions listed in REACH Regulation (EC) 1907/2006 Annex XVII entry numbers 51 and 52 (applicable from 7th July 2020)|
|Bis (2-ethylhexyl) phthalate||DEHP||117-81-7||No greater than 0.1 per cent by mass of plasticised material in articles|
|Benzyl butyl phthalate||BBP||85-68-7|
|Di-isononyl phthalate||DINP||28553-12-0 or 68515-48-0||No greater than 0.1 per cent by mass of plasticised material in toys and childcare articles which can be placed in the mouth.|
|Di-isodecyl phthalate||DIDP||26761-40-0 or 68515-49-1|
Phthalate REACH SVHCs
In October 2008, the European Chemicals Agency (ECHA) published the first list of Substances of Very High Concern (SVHC). This list contained three of the phthalates in Annex XVII – DEHP, DBP and BBP. Since then, a further eleven phthalates – (see table 2) – have been added, and sunset dates have been set for some of these phthalates. The sunset date is the date from which the placing on the market or the use of the substance within the EU will be prohibited, unless a specific exemption is granted.
|Table 2: Substances of Very High Concern|
|Phthalate||Acronym||CAS number||Current Obligations|
|Bis (2-ethylhexyl) phthalate||DEHP||117-81-7||Suppliers of articles which contain substances on the candidate list above 0.1 per cent (w/w) must provide sufficient information to enable safe use by their customers and respond to any request for information from customers within 45 days of receipt of the request.|
|Benzyl butyl phthalate||BBP||85-68-7|
|Di-isopentyl phthalate||DIPP||605-50-5||In addition to this, ECHA are to be notified if product contains more than 0.1 per cent of any SVHC and more than 1 tonne per annum of the chemical is imported into the EU/EEA|
|1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters*||DHNUP||68515-42-4|
|1,2-Benzenedicarboxylic acid, dipentylester, branched and linear*||84777-06-0|
|1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear*||68515-50-4|
Since February 2015, only EU-based organisations that have successfully applied for an exemption to use BBP, DBP or DEHP can use those phthalates in manufacturing. This does not apply to organisations based outside the EU. It should be noted, however, that this situation might change in the future depending on local legislation.
SVHC legal obligations
Suppliers of articles containing any SVHCs at a concentration greater than 0.1 per cent by weight of the entire article must identify them to their customers and give sufficient information to ensure the product is used safely. Notification to ECHA is also required if, in addition to the 0.1 per cent limit being exceeded, the total amount of the SVHC being imported into the EU is greater than one tonne per annum.
There is also phthalate legislation specific to the USA. This is contained within Section 108 of the Consumer Product Safety Improvement Act of 2008, which is commonly referred to as the ‘CPSIA’. The CPSIA is enforced by the Consumer Product Safety Commission (CPSC) and requires importers and manufacturers to comply with Federal legislation, which includes specific limits for the amount of phthalates that children’s toys and childcare articles can contain.
CPSIA section 108 (as updated by 82 FR 49938), requires less than 0.1 per cent of the phthalates DEHP, DBP, BBP, DINP, DnPP, DnHP, DCHP and DIBP to be present. Under this legislation, a child’s toy is considered to be ‘a consumer product designed or intended by the manufacturer for a child 12 years of age or younger, for use by the child when the child plays’. A childcare article is defined as ‘a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age three and younger, or to help such children with sucking or teething’.
Alternative plasticiser systems
There are many alternatives to the phthalate plasticisers that are included in REACH Annex XVII and the SVHC list. These could include other phthalates, although such a move may potentially only postpone what could be an inevitable move away from phthalate-based plasticisers. Other solutions include adipate-, sebacate- or maleate-based plasticisers. There is also research being performed to develop the use of natural plasticisers, such as epoxidised vegetable oils.
How can we help?
Several phthalate plasticisers are considered to pose a risk to health and have therefore had restrictions or legal obligations placed upon them. There are restrictions in REACH Annex XVII and Federal legislation in the USA through the CPSIA 2008. Laboratory testing can be a key tool in demonstrating compliance to legal requirements. SATRA is an ISO 17025 UKAS-accredited laboratory able to quantify the amount of phthalates present in all articles, in accordance with current European and CPCS standards.
How can we help?
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A number of phthalate plasticisers are considered to pose a risk to health. Some of these are covered by REACH Annex XVII (currently only applicable to children’s toys or childcare articles), whereas others are included by REACH Annex XIV. SATRA is an ISO 17025 UKAS-accredited laboratory able to quantify the amount of phthalates present in all articles, in accordance with current European standards. Please email email@example.com for further information on phthalates or analysis for other restricted substances.