Common use of Bioaccumulation Clause in Contracts

Bioaccumulation. The numeric criterion as suggested in REACH Annex XIII for a bioaccumulative substance is not fulfilled for PFOA. Due to its notable water solubility, PFOA might quickly be excreted via ▇▇▇▇ permeation. Furthermore, PFOA occurs mainly in protein rich tissues like blood and liver (OECD, 2006; ▇▇▇▇▇ et al. 2009). Hence, bioconcentration in ▇▇▇▇ breathing organisms and the accumulation in lipids may not be the most relevant endpoint to consider. Field studies show, that air-breathing organisms are more likely to biomagnify PFOA compared to water breathing organisms. Therefore, the numerical bioaccumulation (B) criterion defined in the REACH regulation Annex XIII (sections 1.1.2 and 3.2.2(a)) is not suitable for PFOA to assess its bioaccumulation potential. Annex XIII (section 3.2.2) defines information which should be taken into account when the numerical criterion is not applicable, for example data on the bioaccumulation potential in terrestrial species or in endangered species (Annex XIII, 3.2.2 (b)). PFOA was found in terrestrial species as well as in endangered species as shown for the polar bear and in animals which are likely to become endangered in the near future (narwhale and beluga whale). These findings are of high concern and indicate a bioaccumulation potential. Furthermore Annex XIII (section 3.2.2 (b)) allows taking data from human body fluids or tissues and the toxicokinetic behavior of a substance into account. For PFOA a gestational and lactational exposure in humans was shown, which are of special concern as the foetus and newborn babies are highly vulnerable to exposure to toxic substances. On top of that data from human body fluids clearly provide quantitative proof of the bioaccumulation of PFOA: Half-lives in humans are around 2-4 years. In addition, recent studies, taking into account relevant confounding factors, show that PFOA blood concentrations in humans increase with increasing age. Finally ▇▇▇▇▇ ▇▇▇▇ (section 3.2.2 (c)) foresees that the ability for biomagnifications in food chains of a substance is assessed. For PFOA field studies provide trophic magnification factors (TMFs) or biomagnification factors (BMFs) for PFOA for aquatic and terrestrial food chains. When air breathing organisms are top predators in these food chains biomagnification was quantitatively demonstrated by TMFs and BMFs > 1 for several food chains, for example TMFs 1.1 – 2.4 in the food chain on wolfs 6.3 – 13 in the food chain of dolphins and 1.4 – 2.6 (protein corrected) in the food chain of beluga whale.

Bioaccumulation. The numeric criterion as suggested in REACH Annex XIII for a bioaccumulative substance is not fulfilled for PFOAAPFO. Due to its notable water solubility, PFOA APFO might quickly be excreted via ▇▇▇▇ permeation. Furthermore, PFOA APFO occurs mainly in protein rich tissues like blood and liver (OECD, 2006; ▇▇▇▇▇ et al. 2009). Hence, bioconcentration in ▇▇▇▇ breathing organisms and the accumulation in lipids may not be the most relevant endpoint to consider. Field studies show, that air-air- breathing organisms are more likely to biomagnify PFOA compared to water breathing organisms. Therefore, the numerical bioaccumulation (B) criterion defined in the REACH regulation Annex XIII (sections 1.1.2 and 3.2.2(a)) is not suitable for PFOA APFO to assess its bioaccumulation potential. Annex XIII (section 3.2.2) defines information which should be taken into account when the numerical criterion is not applicable, for example data on the bioaccumulation potential in terrestrial species or in endangered species (Annex XIII, 3.2.2 (b)). PFOA .. APFO was found in terrestrial species as well as in endangered species as shown for the polar bear and in animals which are likely to become endangered in the near future (narwhale and beluga whale). These findings are of high concern and indicate on a bioaccumulation potential. Furthermore Annex XIII (section 3.2.2 (b)) allows taking data from human body fluids or tissues and the toxicokinetic behavior of a substance into account. For PFOA APFO a gestational and lactational exposure in humans was shown, which are of special concern as the foetus and newborn babies are highly vulnerable to exposure to toxic substances. On top of that data from human body fluids clearly provide quantitative proof of the bioaccumulation of PFOAAPFO: Half-lives in humans are around 2-4 years. In addition, recent studies, taking into account relevant confounding factors, show that PFOA APFO blood concentrations in humans increase with increasing age. Finally ▇▇▇▇▇ ▇▇▇▇ (section 3.2.2 (c)) foresees that the ability for biomagnifications in food chains of a substance is assessed. For PFOA APFO field studies provide trophic magnification factors (TMFs) or biomagnification factors (BMFs) for PFOA APFO for aquatic and terrestrial food chains. When air breathing organisms are top predators in these food chains biomagnification was quantitatively demonstrated by TMFs and BMFs > 1 for several food chains, for example TMFs 1.1 – 2.4 in the food chain on wolfs 6.3 – 13 in the food chain of dolphins and 1.4 – 2.6 (protein corrected) in the food chain of beluga whale.TMFs