PBT assessment using the revised annex XIII of REACH: a comparison with other regulatory frameworks.

There is no uniform Persistent, Bioaccumulative, Toxic (PBT) or very Persistent, very Bioaccumulative (vPvB) assessment of chemicals in Europe, as the various regulatory frameworks use only limited or dissimilar PBT assessments, or none at all. The European REACH Regulation requires a PBT/vPvB assessment for all chemical substances that are produced within or imported into the EU in amounts exceeding 10 tonnes per year, using the criteria as described in REACH Annex XIII. However, not all substances on the EU market need to be screened according to these criteria under REACH.

European medicines and feed additives regulation are not in compliance with environmental legislation and policy.

Environmental legislations for water and soil aim at the protection of quality of these compartments. This legislation has major consequences for product registration, amongst others the setting of environmental quality standards. A thorough risk assessment at registration of all products is crucial for the proper operationalisation of the environmental policy.

Pyrene metabolites in the hepatopancreas and gut of the isopod porcellio scaber, a new biomarker for polycyclic aromatic hydrocarbon exposure in terrestrial ecosystems.

The object of this study was to investigate the formation of pyrene metabolites by the isopod Porcellio scaber as a possible tool in the environmental risk assessment of polycyclic aromatic hydrocarbon (PAH) exposure in terrestrial ecosystems. The formation of pyrene metabolites was studied after either pulse exposure to a single high dose, or prolonged exposure (14 d) to a lower dosage. Exposure studies were carried out with unlabeled or radiolabeled pyrene, ion pair chromatography was used for analysis, and reference conjugates were synthesized.