Potential Future Restricted Materials

Transcription

1 Potential Future Restricted Materials Crystal Ball - Aluminum Presented by: Bruce Calder VP of Consulting Services

2 Crystal Ball - Future Restrictions Projection / risk assessment of a substance - That could face restrictions in the next 5 to 10 years Focus - future restrictions for a substance that - Does not currently have restrictions - May be restricted in the future - Has an applicability to physical products (articles)

3 Agenda Introduction Risk assessment - Process and path to regulation Aluminum - Risks Acute Chronic - Solubility of aluminum / tap water issue Potential regulation - At risk products - Timeline and scope Summary and recommendations Q&A Webinar is 50 minutes with 10 minutes of Q&A (hopefully)

4 Claigan - Restricted Materials Services Services - Monthly (or quarterly) update program Webmeeting and written updates on changes in global restricted materials requirements - Consulting - Laboratory testing - Data gathering - Technical files and declaration - Auditing Restricted Materials Services - RoHS (EU and China) - REACH SVHC and Article 67 - California Proposition 65 - Conflict Minerals - Global requirements - EMC Testing Website Updated

5 Claigan - Monthly Update Program Monthly update program - Monthly web-meeting and Q&A Discussing and explaining recent changes in global restricted materials requirements Focused on your particular products and jurisdictions Interactive - Written report expanding upon topics in the webmeeting - On-call support On-call support for any regulatory or customer related questions

6 Risk Assessment Concept of risk of assessment - (From a national authority perspective) Major step towards regulation - Does the substance pose a risk to human health or the environment? To fail a risk assessment a substance needs to - Be nominated for a risk assessment - Have sufficient peer reviewed data that shows a risk - Potentially affect human health or the environment - Be used in the national authority s jurisdiction

7 Al 3+ - Acute Exposure - Dementia Al 3+ - One of the main soluble forms of aluminum Dementia and acute Al 3+ poisoning - Al 3+ is a recognized neurotoxin Causing acute encephalopathy - Dialysis dementia Al 3+ into the dialysis serum of a dialysis machine From errors in water filtration or aluminum leakage in the medical device Significant number of deaths attributed to the issue Many peer reviewed papers, lawsuits, and confirmed in the CDC toxicology profile Manifests as dialysis dementia

8 Research - Chronic Exposure and Alzheimer s In late 2013, the chronic exposure to the Al 3+ ion was identified as a cause of Alzheimer s - Main literature review Chronic Aluminum Intake Causes Alzheimer s Disease: Applying Sir Austin Bradford Hill s Causality Criteria (2014) - If you are interested in further readings Google scholar. Search Alzheimer s aluminum and restrict the date to 2013 or more recent The question is - Is there sufficient peer reviewed data that a national authority could identify a risk?

9 Comparison of Amount of Peer Reviewed Literature in Risk Assessments 1000 Number of Papers DEHP (EU Risk Assessment) Al3+ Causation Review BPA (NTP Risk Assessment)

10 Proposed Mechanism Al 3+ and Fe 3+ ions are virtually identical - Same valence - Same size - Interpreted by the human body as identical molecules Al 3+ Fe 3+

11 Proposed transport of Al 3+ to the Brain Al 3+ mimics Fe 3+ allowing it to gain entry to the brain - Proven using radioactive Al 3+ to show rapid progress of Al 3+ to the brain after a single glass of Al 3+ in water. Zafar TA, Weaver CM, Martin BR, Flarend R, Elmore D (1997) Aluminum 26Al metabolism in rats. Proc Soc Exp Biol Med 216, Anane R, Bonini M, Grafeille JM, Creppy EE (1995) Bioaccumulation of water soluble aluminium chloride in the hippocampus after transdermal uptake in mice. Arch Toxicol 69, Mechanism - Aluminum utilizes endothelial Tf receptors, evolved for iron uptake, to cross the blood-brain barrier Yokel RA (2006) Blood-brain barrier flux of aluminum, manganese, iron and other metals suspected to contribute to metal-induced neurodegeneration. J Alzheimers Dis 10,

12 Proposed Mechanism Al 3+ takes the bonding site for Fe 3+ Interferes with - Mitochondrial respiration (cells breathing) - Does not release bond quickly - Morris CM, Candy JM, Bloxham CA, Edwardson JA (1982) Distribution of transferrin receptors in relation to cytochrome oxidase activity in the human spinal cord, lower brainstem and cerebellum. J Neurol Sci 111, Crichton RR (2008) Biological Inorganic Chemistry: An Introduction. Elsevier, Amsterdam. Damages - Produces oxidative damage - Leads to NFT (Neurofibrillary tangle) formation Watson JR (2013) Aluminum s Involvement in the Progression of Alzheimer s Disease Journal of Alzheimer s Disease 35 (2013) 7 43.

13 NFT Formation and Aluminum NFT (Neurofibrillary tangle) formation in AD-affected hippocampus of human brain. - Al is blue. NFT is brown - C / D are same cell (early NFT) - E / F are same cell (mid stage NFT) - G / H are same cell (late stage NFT) Al deposits and NFTs - Same locations Not necessarily conclusive - But likely to affect risk assessment

14 How do products fit in? Aluminum is soluble into Al 3+ in ph 8, or above, water Due to legacy issues with Pb in pipes, many drinking water facilities raise the ph of their water over ph 8. Pb3(CO3)2(OH)2 Solubility by ph Aluminum Solubility by ph ph 7 ph 8 WHO safe level 100 µg / L ph 9

15 Solubility of Aluminum by ph Aluminum is amphoteric Can dissolve in both acids and bases Soluble Insoluble Soluble -log(conc.)

16 Aluminum Products and Tap Water Solubility in practice Claigan tested a range of products with aluminum components exposed to tap water - Affected products showed aluminum concentration in the water between 0.86 mg/l and 1.5 mg/l (ICP) mg/l is 15x the WHO safe level of 0.1 mg/l Key notes - Agrees with published levels - Only for products exposed to tap water - Solubility (measured Al) was minimal if water under ph 8 Brita filtered tap water, DI water, and well water

17 Potential Regulation How would aluminum potentially be regulated in the future? High risk products for potential future regulation - Medical devices with aluminum components contacting fluids entering the body - Consumer or professional products with aluminum components that contact tap water and the resulting water is ingested by humans Potential regulation should not include aluminum components and products that only have dermal or no human contact - However, panic / misunderstanding by the public is very possible - Dermal exposure regulation unlikely but overreaction is not uncommon for Children s products California Proposition 65

18 Summary - Risk Assessment Aluminum versus a potential risk assessment - Is there sufficient peer reviewed data that shows a risk Significant amount of peer reviewed data (in quantity and quality) is available. - Is the risk severe enough to potentially affect human health or the environment Risks to human health potentially related to neurotoxicity and Alzheimer s - Is the substance used in the national authority s jurisdiction Aluminum is present in all major jurisdictions - Has the substance been nominated for a risk assessment No visible timeline at this point in major jurisdictions There is potential for aluminum to be restricted in the future, but no clear timeline, jurisdiction, or scope.

19 Overall Summary Potential future regulations - There is a reasonable chance that a risk assessment by a national authority, in the future, could lead to regulation of aluminum in certain applications - No concrete timeline, jurisdictions, or scope Risk related to soluble form of aluminum (Al 3+ ), not aluminum in general - And, not necessarily due to the product itself, but due to drinking water ph levels maintained by many cities Potential regulation should be limited to - Aluminum in medical devices in fluid contacting situations - Aluminum in products contacting drinking water

20 Recommendations Principal recommendations - Monitor emerging requirements - Aluminum components should be avoided (in new designs) for Notes medical devices component contacting fluids entering the human body components that come into contact with tap water that is ingested by humans - There is no requirement to avoid aluminum in these applications, but there is peer reviewed published data that indicates a risk potential risk of regulation in the future

21 Claigan - Restricted Materials Services Services - Monthly (or quarterly) update program Webmeeting and written updates on changes in global restricted materials requirements - Consulting - Laboratory testing - Data gathering - Technical files and declaration - Auditing Restricted Materials Services - RoHS (EU and China) - REACH SVHC and Article 67 - California Proposition 65 - Conflict Minerals - Global requirements - EMC Testing Q&A Website Updated