VERY PERSISTANT SUBSTANCES

Environment Environmentally hazardous substance. Very persistent substance. Will bioaccumulate and biomagnify in the food chain. 

PBTs (in addition to those listed by governmental organizations) vPvBs (very persistent, very bioaccumulating) substances... 

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. 

Persistent, Bioaccumulative and Toxic and Very Persistent and Very Bioaccumulative Substances... 

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... 

Article 54 a-f. Criteria for chemicals to be added to Annex XI11 and thus require authorisation category 1 or 2 carcinogens, category 1 or 2 mutagens, category 1 or 2 reproductive toxins, substances which are persistent, bloaccumulative and toxic, very persistent and very bloaccumulative, endocrine disrupting or of equal concern. 

This is also accounted for in the planned EU chemicals regulation. Substances that are very persistent and very bioaccumulative can be introduced subject to authorisation, even when there are no scientifically based indications of (eco)toxicological effects. 

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. 

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. 

A persistent substance undergoes very slow rates of degradation in environmental media and/or metabolism in biological systems. The term therefore refers to the ability of a substance to remain unchanged in the wider environment. 

The PCBs are very efficiently bioaccumulated and biomagnified in food webs in particular, congeners with more than five chlorines are very persistent, with slow or practically absent metabolism. The substances are stored in adipose and fatty tissues and the only effective way for organisms to get rid of the heavier PCBs is through lipid-rich secretions such as mammalian milk, egg yolk, etc. (Skaare et al., 2002). This will, of course, result in serious exposure of embryos and offspring of the following generation. 

Substances being very persistent and very bioaccumulative. 

In an individual concentration of >0.1 % by weight for non-gaseous preparations at least one substance that is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex Xni or has been included in the authorization list for other reasons or... 

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. 

---