Persistent and very bioaccumulative vPvB

Authorisation will also be required for persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances. The PBT and vPvB criteria are defined in Annex XII of the Regulation (Table 7). There are subtle differences in the... 

These relationships allow for screening and ranking of toxicity so that the least toxic option may be used if deemed appropriate. They are applied in many jurisdictions for regulatory use in the prediction of ecological effects (and fate) of chemicals when there are no actual toxicity data and decisions need to be made about their use [99]. QSARs have been developed, for example, to predict which chemicals may exhibit persistence, bioaccumulation, and toxicity (PBT) properties, or be very persistent and very bioaccumulative (vPvB) [99]. These methods have been applied to the prediction of chemicals that fall under the European REACH initiative and also high production volume (HPV) chemicals [99]. Currently available QSARs for predicting a compound s fall into two general classes those that have been developed for a nonspecific mode of action, and those that have been developed for specific types or classes of chemicals [99]. 

Predictions for very persistent and very bioaccumulative (VPVB) substances using physico-chemical parameters and the EUSES model often result in false-positive values [136]. 

A Chemical Safety Report that documents chemical risk assessments must be prepared for substances that a company manufactures or imports at >10 tonnes per year. If a substance is identified as dangerous or very persistent and very bioaccumulative (VPVB), a set of exposure scenarios detailing the relevant risk management measures necessary to reduce exposures must be attached as an Annex to existing Safety Data Sheets. 

NOEC No-observed effect concentration vPvB Very persistent and very bioaccumulative... 

If the pharmaceutical fulfills the criteria for PBT (Persistent, Bioaccumulative and Toxic) and/or vPvB (very Persistent and very Bioaccumulative), the following phrase is added The substance fulfills the EU criteria for PBT/vPvB classification. 

Criteria for the Identification of Persistent, Bioaccumulative, and Toxic Substances (PBT substances) and Very Persistent and Very Bioaccumulative Substances (vPvB substances)... 

In other words, the substance under consideration must be evaluated using the formal rules for classifying hazards (i.e.. Directive 67/548/EEC) to determine if it is "dangerous." In addition, values for DNELs, DMELs, and PNECs must be derived and the substance assessed to determine whether it would be considered a PBT or very persistent/very bioaccumulative (vPvB) substance based on the data assembled in the first step of the CSA. 

The Danish List of Undesirable Substances is a list of chemicals of concern that the government believes should be avoided to the extent feasible in commerce. Using a systematic analysis, substances are selected automatically if they meet some clear and defined criteria, for example, problematic classifications, because they are imder suspicion for being PBT/vPvB (Persistent, Bioaccumulative, Toxic/very Persistent, very Bio accumulative) or endocrine-disrupting. 

EC5jj=median effective concentration fw=freshwater LC5 j=median lethal concentration m=marine mw=marine water na=not applicable OSPAR=Oslo and Paris Convention for the Protection of the Marine Environment of the Northeast Atlantic PBT=persistent, bioaccumulative, and toxic POPs=persistent organic pollutants RfD=referencedose sed.=sediment USEPA=US Environmental Protection Agency vPvB=very persistent, very bioacumulative. 

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