Health concerns about phthalate plasticisers
Phthalates are some of the most researched materials
Plasticised PVC has been used for over 50 years without proof of them causing ill-health, and the environmental effects of phthalates are known to be minimal. Academia and industry have continually worked together to address concerns and to conduct necessary research, making phthalates some of the most researched and best understood chemicals today.
Some concerns have been expressed concerning carcinogenicity. In the 1980s, a test conducts on rats reported liver tumours after an extremely high dosing of DEHP, but subsequent studies clarified that such effects are unique to rodents such as rats and mice and would not occur in primates such as monkeys. In 2000, the International Agency for Research on Cancer (IARC: an affiliate organisation of World Health Organisation - WHO) re-classified DEHP from Group 2B to Group 3 in their carcinogenicity evaluation. Tea and tap water (drinking water sterilised with chlorine) are also included in Group 3, while coffee is included in Group 2.
In past years concerns have been raised about possible risks of PVC products related to endocrine modulation and alleged disruption of certain phthalates.
Phthalates are a large and diverse family of chemical substances with different hazard classifications regarding human health.
- High molecular weight phthalates DINP, DIDP and DPHP, which are the most widely used in Europe, are not endocrine disruptors.
- Low molecular weight phthalates DEHP, DBP, BBP and DIBP have all been classified as toxic to reproduction of category 1B.with hazard phrase H360 (“May damage fertility or the unborn child”)
Brief history of concerns
During the early 1990s, size reduction in reproductive organs of male alligators and their decreased headcount at Lake Apopka in Florida was reported, and the correlation between organic chlorine compounds and endocrine disruptive effects became the centre of concern.Lake Apopka: There are many lakes in Florida, but this was the only lake that suffered pollution by water discharge from a nearby agricultural chemical plant. No such abnormalities were observed in alligators in other lakes of the region. In July, 1991, the Wingspread Statement was announced, stating that “The release and use of toxic substances have had substantial unintended consequences affecting human health and the environment”, at a natural science expert meeting held in Wingspread, Wisconsin, U.S. In 1996, Theo Colborn, Director of the Wildlife and Contaminants project at the World Wildlife Fund, published a book titled Our Stolen Future. The subtitle of the book reads “A scientific detective story”, suggesting, on the basis of already existing scientific information, that endocrine disruption is a serious current issue. In October 1998 the European Parliament adopted a Resolution calling upon the European Commission to take action. The Commission published in December 1999 a “Community Strategy for Endocrine Disrupters” COM (1999) 706. Its main objectives were to identify the problem, its causes and consequences and appropriate policy actions. A first progress report was published in 2001 (COM (2001) 262), a second one in 2004 (SEC (2004) 1372) and a third one in 2007 (SEC(2007) 1635).
What are “endocrine disrupters”?
Information and references are available from this website.
The EU risk assessments for three of the mostly commonly used phthalates – diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) and dibutyl phthalate (DBP) – were published in 2005. The assessments showed no concerns for any current uses of DINP and DIDP. The third risk assessment, for dibutyl phthalate (DBP), shows some risk to plants in the vicinity of processing sites and to workers through inhalation. But in both cases, these risks can be reduced by simple air treatment measures and personal protective equipment. The risk assessments are available on the European Chemicals Bureau web site (http://ecb.jrc.it) as well as on https://www.plasticisers.org.
The risk assessment for di-2-ethylhexyl phthalate (DEHP) was finalised in 2007 and published early 2008. Risk assessment for butylbenzyl phthalate (BBP) was published in 2008.
The EU has an extensive regulatory framework governing chemical safety: this covers potential Endocrine disrupting substances (EDS). Article 57(f) of REACH expressly refers to EDS. Where there is “scientific evidence” of “probable serious effects to human health or the environment” giving rise to concerns, a substance will be added to the list of substances requiring authorisation (Annex XIV) and will be prohibited unless an authorisation is granted (Article 58).