Opinion of the Scientific Committee on health, environmental and emerging risks on the safety of titanium dioxide in toys.

The Opinion of the Scientific Committee on Health, Environmental and Emerging Risks advises the European Commission on whether the uses of titanium dioxide in toys and toy materials can be considered to be safe in light of the identified exposure, and the classification of titanium dioxide as carcinogenic category 2 after inhalation. Four toy products including casting kits, chalk, powder paints and white colour pencils containing various amounts of TiO2 as colouring agent were evaluated for inhalation risks. For the oral route, childrens' lip gloss/lipstick, finger paint and white colour pencils were evaluated. When it can be demonstrated with high certainty that no ultrafine fraction is present in pigmentary TiO2 preparations used in toys and toy materials, safe use with no or negligible risk for all products considered is indicated based on the exposure estimations of this Opinion. However, if an ultrafine fraction is assumed to be present, safe use is not indicated, except for white colour pencils.

Analysis of different preferences for the EU's regulatory options for endocrine disruptor identification criteria using argumentation theory.

What criteria are most suitable to identify endocrine disrupting substances (EDSs) for regulatory purposes in the EU? The results of the European Commission's public consultation, as part of the process to establish identification criteria for EDSs, show that different regulatory options are supported. Some respondents prefer an option including hazard characterization considerations, whereas others prefer an option that avoids these considerations and introduces several hazard-identification based weight-of-evidence categories. In this study, the argumentation underlying the different preferences for identification criteria are analyzed and compared using pragma-dialectical argumentation theory (PDAT). All responses of non-anonymous, national governments that submitted a response in English (n = 17) were included. Responses of other stakeholder organizations were included if a Google News search returned an opinionated presence in the media on the subject (n = 9). Five topical themes and 21 underlying issues were identified. The themes are 1) mechanistic understanding of EDSs, 2) regulatory considerations related to the identification of EDSs, 3) consistency with existing regulatory frameworks, and 4) evaluations of specific issues related to a category approach and 5) related to including potency. We argue that two overarching (implicit) 'advocacy coalitions' can be discerned, that adopted contrasting positions towards the identified themes and issues. Among these 'coalitions', there appears to be consensus about the necessity of having 'science-based' criteria, though different perspectives exist as to what the most accurate mechanistic understanding of EDSs entails. To move the discussion forward, we argue that a societal dialogue would be beneficial, where EDS science and regulation are discussed as interrelated themes.

Why Do Countries Regulate Environmental Health Risks Differently? A Theoretical Perspective.

Why do countries regulate, or prefer to regulate, environmental health risks such as radiofrequency electromagnetic fields and endocrine disruptors differently? A wide variety of theories, models, and frameworks can be used to help answer this question, though the resulting answer will strongly depend on the theoretical perspective that is applied. In this theoretical review, we will explore eight conceptual frameworks, from different areas of science, which will offer eight different potential explanations as to why international differences occur in environmental health risk management. We are particularly interested in frameworks that could shed light on the role of scientific expertise within risk management processes. The frameworks included in this review are the Risk Assessment Paradigm, research into the roles of experts as policy advisors, the Psychometric Paradigm, the Cultural Theory of Risk, participatory approaches to risk assessment and risk management, the Advocacy Coalition Framework, the Social Amplification of Risk Framework, and Hofstede's Model of National Cultures. We drew from our knowledge and experiences regarding a diverse set of academic disciplines to pragmatically assemble a multidisciplinary set of frameworks. From the ideas and concepts offered by the eight frameworks, we derive pertinent questions to be used in further empirical work and we present an overarching framework to depict the various links that could be drawn between the frameworks.

Reproductive toxicants have a threshold of adversity.

This paper surveys the scientific basis for the current threshold approach for reproductive hazard and risk assessment. In some regulatory areas it was recently suggested to consider reproductive toxicants under the stringent linear extrapolation risk assessment paradigm that was developed for genotoxic carcinogens. First, the current risk assessment paradigm for genotoxic carcinogens is addressed, followed by an overview of reproductive toxicology and its threshold dose approach for hazard and risk assessment, the testing procedures for assessing the reproductive toxicity of chemicals, and the derivation of conclusions on their risk assessment and Classification, Labelling and Packaging (CLP). Relevant details of testing methodologies are discussed, such as exposure time windows, parameters determined, and the coverage of the entire reproductive cycle. In addition, the dose-response relationship is considered, illustrated with several examples. It is concluded that the current risk assessment methodology for genotoxic carcinogens is a debatable worst-case scenario and that for risk assessment of reproductive toxicants the threshold dose approach remains valid.

Scientific governance and the process for exposure scenario development in REACH.

The primary process established by the European Commission to address the science needed to define key REACH concepts and to help rationally implement REACH's ambitions is enshrined in a series of activities known as the REACH Implementation Projects (RIPs). These are projects that aim to define the methodology that could be used, and present the basis for guidance on the actual principles and procedures that may be (are proposed to be) followed in the development of the required documentation that ensures the safe use of chemicals. In order to develop soundly based and equitable regulation, it is necessary that science governance using established and accepted scientific principles must take a leading role. The extent to which such governance is embraced will be determined by many factors, but notably the process adopted to enable scientific discussion to take place. This article addresses the issues of science as they have impacted on the exemplification of the Exposure Scenario concept under REACH. The current RIP activities have created a non-adversarial process in which the key stakeholders are able to discuss the key REACH challenges. But the RIP activities will be finalised before REACH comes into force. A suitable mechanism should perhaps now be identified to ensure that this positive spirit of scientific discussion and collaboration can continue to benefit REACH and those that it serves well into the future.

Probabilistic risk characterization: an example with di(2-ethylhexyl) phthalate.

While probabilistic methods gain attention in hazard characterization and are increasingly used in exposure assessment, full use of the available probabilistic information in risk characterization is still uncommon. Usually, after probabilistic hazard characterization and/or exposure assessment, percentiles from the obtained distributions are used as point estimates in risk characterization. In this way, all information on variability and uncertainty is lost, while these aspects are crucial in any risk assessment. In this paper, we present a method to integrate the entire distributions from probabilistic hazard characterization and exposure assessment into one risk characterization plot. This method is illustrated using di(2-ethylhexyl) phthalate as an example. The final result of this probabilistic risk assessment is summarized in a single plot, containing two pieces of information: the confidence we may have in concluding there is no risk, and the fraction of the population this conclusion applies to. This information leads to a better informed conclusion on the risk of a substance, and may be very useful to define the necessary measures for risk reduction.