RESUMEN
This paper charts the almost ten years of history of OECD's work on nanosafety, during which the programme of the OECD on the Testing and Assessment of Manufactured Nanomaterials covered the testing of eleven nanomaterials for about 59 end-points addressing physical-chemical properties, mammalian and environmental toxicity, environmental fate and material safety. An overview of the materials tested, the test methods applied and the discussions regarding the applicability of the OECD test guidelines, which are recognised methods for regulatory testing of chemicals, are given. The results indicate that many existing OECD test guidelines are suitable for nanomaterials and consequently, hazard data collected using such guidelines will fall under OECD's system of Mutual Acceptance of Data (MAD) which is a legally binding instrument to facilitate the international acceptance of information for the regulatory safety assessment of chemicals. At the same time, some OECD test guidelines and guidance documents need to be adapted to address nanomaterials while new test guidelines and guidance documents may be needed to address endpoints that are more relevant to nanomaterials. This paper presents examples of areas where test guidelines or guidance for nanomaterials are under development.
Asunto(s)
Guías como Asunto , Nanoestructuras/efectos adversos , Nanotecnología , Pruebas de Toxicidad , Animales , Consenso , Guías como Asunto/normas , Historia del Siglo XXI , Humanos , Nanoestructuras/historia , Nanoestructuras/normas , Nanotecnología/historia , Nanotecnología/normas , Formulación de Políticas , Desarrollo de Programa , Medición de Riesgo , Pruebas de Toxicidad/historia , Pruebas de Toxicidad/normasRESUMEN
The European Union (EU) adopted the first legislation on chemicals management in 1967 with the Dangerous Substances Directive (DSD). Over time the underlying concepts evolved: from hazard identification over risk assessment to safety assessment. In 1981 a premarketing notification scheme was introduced. Approximately 10 years later a risk assessment program started for existing substances following a data collection and prioritization exercise. Integration of science into EU chemicals legislation occurred via several technical committees managed by the European Chemicals Bureau (ECB) and resulted in the Technical Guidance Document on Risk Assessment (TGD), which harmonized the risk assessment methodology. The TGD was revised several times to adapt to scientific developments. The revision process, and the risk assessments for new and existing substances, led to scientific research on chemical risk assessment and thus increased in complexity. The new EU chemicals policy REACH (Registration, Evaluation, Authorization and Restriction of CHemicals) builds on previous experiences and aims to further enhance health and safety. REACH places the burden of proof for chemical safety on industry focusing on managing risks. REACH formalizes the precautionary principle. Furthermore, it underlines a continued scientific underpinning in its implementation, also via stakeholder involvement, and a focus on aligning with international fora.