High Phthalates and the Road Ahead
Not All Plasticizers Are Created Equal
Not All Created Equal - The European plasticizers market has evolved considerably in the last decade, moving away from classified low phthalates to nonclassified high phthalates and alternative plasticizers belonging to different chemical classes. However, some phthalates continue to be in the spotlight of regulators, environmental nongovernmental organizations and consumer groups. The industry continues to work on making sure that consumers, media, industry and policymakers understand the difference between high and low phthalates.
Phthalates are broadly divided into two groups - high and low - according to their molecular weight. They are different in terms of applications types, their health and environmental effect, and their legal classification. In the case of low phthalates (known under acronyms such as DEHP, DBP, DIBP, BBP), they are classified as substances of very high concern (SVHC). Under the REACH regulation, SVHC substances that will not be granted an authorization for specific applications will be subject to specific phase-out dates; for low phthalates this is Feb. 21, 2015.
However, specific concerns related to phthalates continue to be mistakenly extended to the entire family, mostly because of oversimplification, when high phthalates actually can be safely used in all current applications. Extensive risk assessments performed by independent sources and EU authorities have concluded that high molecular weight phthalates (DINP, DIDP, DPHP) pose no risk to human health in current applications. They do not require any classification or labeling nor are they on the REACH Candidate List for Authorization.
This evolution in the science around phthalates and their legal classification has been closely followed by the global market. In the EU in particular, demand has been steadily shifting away from low molecular weight phthalates (LMW), which were in widespread use until the 2000s, toward high molecular weight phthalates (HMW), which today represent around 85% of all phthalates being produced in the EU.
At the global level, the trend is quite different from what is happening with low phthalates in Europe, with DEHP still representing around 50% of all phthalates used worldwide. It is also important to note that the non-phthalate plasticizer market segment is growing in Europe and elsewhere in the world.
The REACH regulation has been instrumental in further defining the differences between the two main groups of phthalates. In the case of DEHP, BBP, DBP and DIBP, they must follow the authorization process to determine if they can continue to be used in specific applications beyond their sunset date of Feb. 21, 2015. As of Aug. 21, the phthalates authorization application window has closed, and the European Chemicals Agency (ECHA) has announced that several dossiers have been submitted. ECHA said it would disclose details of these applications when the related public consultations start in mid-November.
Three of these low phthalates (DEHP, DBP and BBP) have also been included on the Restriction of Hazardous Substances (RoHS) Directive list of potential substances to be restricted in electrical and electronic equipment.
Finally, in August, the ECHA concluded in its re-evaluation of the restrictions on DINP and DIDP in toys and child-care articles that no further risks have been identified from the use of these substances by adults or children. While the existing restrictions are maintained, it can be concluded that DINP and DIDP are safe for use in all current applications. The final decision from the European Commission is expected later this year.
Pressure at the national level in Europe has been coming mainly from Denmark and France, with Denmark working on its own national phthalate strategy and France working on a national endocrine strategy. In Denmark, a national ban on low phthalates - DEHP, DBP, DIBP and BBP - was announced in December 2012, later to be postponed by two years. This ban will be effective as of 2015 instead of December 2013, as initially planned. The main reason for this postponement is that these four low phthalates continue to be used widely outside the European Union in the manufacture of electrical and electronic equipment and other articles that are subsequently imported into the EU. Thus retailers in Denmark who are importing these articles asked the Danish government to delay the ban.
In addition to the work on an upcoming national endocrine strategy, France has already passed a ban on DEHP in medical tubing used in pediatrics and maternity wards, effective in July 2015. The debate around these substances, often linked to the issue of endocrine disruptors, has been high on the media and political agendas in France, influenced in part by the strong pressure exerted by NGOs, campaigning scientists and consumer groups.
Public Debate And Misconceptions
In public and media debates, participants often mistakenly use the general term "phthalates" when talking about some of them, thus implying that they all have negative health effects, such as being endocrine disruptors. However, there is ample research on the safety of high molecular weight phthalates, which should not be ignored, whether the debate is scientific or political. In fact, most studies claiming to prove that phthalates are endocrine disruptors have studied only DBP or DEHP, both classified as toxic to reproduction.
It is therefore important to avoid making unjustified, undifferentiated and generic claims when referring to the effects of single substances that are not relevant to the entire family.
Another common misconception is that phthalates can readily "leach out" from articles and migrate into the surrounding environment. However, it is actually quite difficult for phthalates to separate from the plastic in which they are physically bound following high-temperature processing. This process can be likened to baking a cake from which the individual components cannot normally be recovered after the baking process, but rather crumbs (in this case abraded PVC particles) may be found. Reports of these plasticizers causing asthma and allergies have since been shown to be unfounded and scientific studies have concluded that household dust does not correlate to human exposure levels for phthalates, and neither is it an indicator of indoor air quality.
It has taken more than 20 years and cost billions of euros to develop large enough volumes of high phthalates to satisfy the needs of tens of thousands of companies throughout the supply chain. High phthalate producers, who are strongly committed to product safety and the use of science and risk assessments, have constantly supported their customers to enable this transition. In addition, plasticizer producers are working on improving the sustainable use of additives as part of the work accomplished by VinylPlus, the European PVC industry sustainability program.
Ensuring that the differences between high and low phthalates are effectively communicated and understood remains a key challenge for the plasticizers sector, although progress has been made in recent years. The industry will continue working hard to provide the information needed by policymakers, regulators, users and other stakeholders to help ensure that society has the benefits of flexible PVC articles and that they are safe and environmentally sustainable.
ECPI European Council for Plasticizers and Intermediates
Av. E Van Nieuwenhuyse 4