The Challenge of Distributing Regulatory Responsibilities for Unknown Risks: Â‘NanoÂ’-Cosmetics and the EU Cosmetics Regulation as a Case Study

Clare Shelley Egan Diana Megan Bowman

doi:10.4172/2155-9627.1000212

Abstract

The adoption of the European Union’s (EU) Cosmetics Regulation–which came into effect as of July 2013–is significant because it was the first piece of legislation at the national or supranational level to include provisions relating specifically to the use of nanomaterials in any products. While the regulation does not change the fundamental aspects of the regulatory regime, which includes putting full responsibility for ensuring the safety of the cosmetic product on the manufacturer/importer, the provision of consumer labelling of nanomaterials suggests a shifting of responsibilities that is new for cosmetics within the EU market. Although this additional shifting of responsibilities is subtle, we argue that it is nonetheless problematic, given current uncertainties about what a ‘nano label’ actually means, in addition to doubts around the capacity to furnish the consumer with sufficient information to enable them to make a fully informed consumer choice. The aim of this article is to understand the challenge of distributing regulatory responsibilities for unknown or unquantified risks through the lens of the Cosmetics Regulation. We present and discuss data gathered in interviews with a small number of cosmetics stakeholdersincluding industry, representatives of government/regulatory agencies, NGOs/civil society and experts (in industry and dialogue)-as a means of illustrating various elements viewed by stakeholders as necessary to be able to take up responsibilities and identifying the constraining factors to doing so, i.e. regulatory challenges. The overarching aim of the article is to understand the implications of the distribution of responsibilities, as set out by the regulation, for enabling consumers to meaningfully differentiate between conventional cosmetic products and those containing nanomaterials.

Highlights

Entry into force of the European Union’s (EU) new regulatory regime for cosmetic products–which are broadly defined with reference to their area of application on the body and the purpose for which they are applied1–occurred in July 2013
The Cosmetics Regulation (Regulation (EC) No 1223/2009) replaces the Cosmetics Directive, and in doing so, among other things, streamlines human safety requirements, increases transparency and harmonisation within the market and reduces the regulatory burden in relation to cosmetic products. This shall be achieved under the regulation by ensuring that consumers’ health is protected and that consumers are well informed by monitoring the composition and labelling of products
We offer an overview of the state-of-the-art regarding the use of nanomaterials in cosmetics within the EU market, differentiating between different types of nanomaterials being utilised within these products, and the potential benefits and/or risks associated with the different families of nanomaterials

Summary

Introduction

In outlining the preparations that industry needs to undertake, Res. C (national industry association representative) focused in on the notification requirements, which would involve significant cost and time, in addition to an active role for his organisation in informing the public that the label indicates the presence of a nano ingredient in the product and “has no meaning at all” as to the safety or use of the product. These respondents felt that, given that the consumer takes part in risk assessment and management through their purchasing decisions, the distribution of regulatory responsibilities across the value chain does not suffice to allow the consumer to enact their responsibility to choose between products that do or do not contain nanomaterials This can be contrasted with industry views, with Res. G (European industry association representative) suggesting that the shifting of some responsibility to the consumer is fair within the purposes of the label, i.e. to provide information regarding the presence of nanomaterials in the product. E and K–had doubts regarding the visibility of the publically available catalogue of nanomaterials, and whether consumers would even use it

Moving Forward

Can they think of alternatives?

What does this understanding mean for the distribution of responsibilities?