ABSTRACT
This paper presents a comprehensive review of European Union (EU) legislation addressing the safety of chemical substances, and possibilities within each piece of legislation for applying grouping and read-across approaches for the assessment of nanomaterials (NMs). Hence, this review considers both the overarching regulation of chemical substances under REACH (Regulation (EC) No 1907/2006 on registration, evaluation, authorization, and restriction of chemicals) and CLP (Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures) and the sector-specific pieces of legislation for cosmetic, plant protection and biocidal products, and legislation addressing food, novel food, and food contact materials. The relevant supporting documents (e.g. guidance documents) regarding each piece of legislation were identified and reviewed, considering the relevant technical and scientific literature. Prospective regulatory needs for implementing grouping in the assessment of NMs were identified, and the question whether each particular piece of legislation permits the use of grouping and read-across to address information gaps was answered.
Subject(s)
Nanostructures/classification , Nanostructures/toxicity , Nanotechnology/legislation & jurisprudence , Nanotechnology/methods , Endpoint Determination , European Union , Government Regulation , Humans , Prospective Studies , Risk AssessmentABSTRACT
A child with congenital cutaneous form of Histiocytosis X - the Letterer-Siwe disease - is reported. Since birth there is a papulo-nodular and necrotic eruption, involving the entire skin. No changes in internal organs were discovered. The histologic investigation of skin lesions revealed infiltrates of histiocytes with considerable polymorphism. In spite of the treatment with antibiotics, the skin lesions deteriorated with an enlargement of the necrosis. On the 19th day after delivery a corticosteroid treatment was started, which continued for 60 days. The skin lesions improved considerably and gradually disappeared completely. The child was followed up for 7 1/2 years. No relapses or new skin lesions were observed.
