In a commentary published on October 22, 2016 in the Regulatory Toxicology and Pharmacology, Alan Boobis and several representatives of academia, industry and regulation criticized the scheme for the classification of cancerogens used by the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO). They deemed the IARC’s approach “outmoded” and accused it of causing “unintended consequences” such as “health scares, costs, and diversion of public funds.” Consequently, the authors advocated for “modern approaches based on hazard and risk characterization” to be used not only for carcinogens, but also for endocrine disrupting chemicals (EDC). This article was hailed in several media outlets, including the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), FoodDive, and Chemistry World.

Other stakeholders, however, dispute the conclusions of Boobis’ commentary, as Philip Lightowlers summarized in his article published on November 10, 2016 by the regulatory news provider Chemical Watch. Jack de Bruijn, head of risk management unit at the European Chemicals Agency (ECHA), commented that “the use of hazard classification [within the Regulation (EC) No 1272/2008 on the classification, labelling and packaging (CLP) of substances and mixtures] . . . has been working well and has contributed to a lot of protection for people and workers over many years.” Michael Warhurst, head of ChemTrust, said that “threats to public health are best addressed by eliminating exposure to substances with undesirable properties whenever possible, rather than setting allowable levels of exposure.”

The recurrent industry-ignited attacks on hazard-based approaches to chemicals management coincide with the ongoing debate on the criteria for the identification of EDC, which are currently being prepared by the European Commission (EC) for integration in the European legislation (FPF reported). In an article published on November 29, 2016, the non-profit organization International Chemical Secretariat (ChemSec) discusses the recent developments demonstrating that “lobbyists [are] pushing the EU to abandon the hazard approach,” and contemplates on the possible consequences for public health.

ChemSec recapitulates that risk assessment heavily relies on exposure data to ensure that certain chemicals will not cause harm. However, “it is simply impossible to have full knowledge of how the substance is used, how it is spread, how people and the environment may be exposed and where the waste will end up, and so forth.” Therefore, a risk assessment process relies on a lot of assumptions, and, although this is an established scientific methodology, “it cannot be any better than the information we put into it, and it will always include uncertainties.” Furthermore, the way the risk assessment is used depends on a policy decision defining the risk levels that are deemed “acceptable.”

The uncertainty component of risk assessment is the main reason of why “parts of industry” lobby against the hazard approach and in favor of a more risk-based paradigms, ChemSec explains. The “need for more data” claim can be used to postpone regulatory decisions on certain chemicals, and, furthermore, “the outcome of the risk assessment can be altered depending on the data you put in.” Therefore, calling “a risk-based approach more scientific than a hazard-based approach is . . . simply nonsense,” ChemSec concludes.

ChemSec recommends keeping the hazard-based approach, “especially for . . . the worst chemicals and the most vulnerable groups.” Substances of Very High Concern (SVHCs) are such chemicals, and they should be substituted wherever possible.

Read more

Boobis, A., et al. (2016). “Classification schemes for carcinogenicity based on hazard-identification have become outmoded and serve neither science nor society.Regulatory Toxicology and Pharmacology (published October 22, 2016).

ECETOC (October 25, 2016). “Academics, former regulators and other scientists challenge WHO cancer agency classification schemes as outmoded.

FoodDive (November 1, 2016). “Why experts are challenging WHO’s ‘outmoded’ cancer research methods.

Rebecca Trager (November 2, 2016). “WHO cancer agency criticized for outdated chemical risk methods.Chemistry World

Philip Lightowlers (November 10, 2016). “Scientists challenge IARC hazard-only identification of carcinogens.Chemical Watch

ChemSec (November 29, 2016). “Why are lobbyists pushing the EU to abandon the hazard approach and what would it mean if we did?