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Health Risk Assessment,Comparative Analysis of Health Risk Assessment. Frameworks and Recommendations for Best Practices,Executive Summary. UL conducted this research to identify best practices for health risk based product. safety assessment and to facilitate a path forward for personal care product. development This research includes an assessment of views expressed by non. governmental organizations NGOs and activists as well as views from safety. stewardship and sustainability experts from the retail brand and chemical. supplier communities It explores various elements of a full safety assessment. including hazard characterization exposure assessment dose response and risk. characterization, The personal care products landscape discussed in this paper includes five areas. ingredients disclosure priority ingredients and alternatives aggregate exposure. regulatory science and availability of data This report will touch on elements of each. area particularly as related to human safety assessment best practices Best practices. were identified through a detailed expert review of the five primary product safety. risk assessment frameworks available for consumer products Cosmetic Ingredient. Review CIR Scientific Committee on Consumer Safety SCCS International Fragrance. Association IFRA Research Institute for Fragrance Materials RIFM and Flavor. and Extract Manufacturers Association FEMA as well as other safety frameworks. outside of personal care International Council of Chemical Associations ICCA. These frameworks were assessed against the following criteria. Assessment of individual ingredients vs finished formulations. Considerations for ingredients with specific properties or function. Data quality and requirements,Toxicity evaluation hazard and risk. Exposure assessment,Quantitative safety assessment and.
Alternatives assessment guidance,Health Risk Assessment. The criteria were selected based on UL s Introduction developed several online resources to fill. expert knowledge of what constitutes the information demands of consumers. The market for personal care products is, a robust risk based approach and the EWG s Skin Deep database has been. expanding rapidly According to market, elements most central to addressing searched over 232 million times since. researcher Lucintel the global personal, the identified stakeholder issues 2004 GoodGuide launched in 2007 and. care products industry is poised to reach, Based on these criteria UL found many now offers science backed sustainability.
630 487 billion by 2017 with a CAGR of, commonalities between frameworks ratings on the health environmental and. 3 4 per cent over the next five years1, including the health endpoints evaluated social impacts of nearly 240 000 everyday. and the data types used to form With the rapid increase in global access consumer products Over 500 000. conclusions However the frameworks to information more consumers are consumers visit GoodGuide com each. varied considerably in terms of the actively seeking information on the health month looking for data. assessment and determination of the impacts of the products they consume. In light of this growing market and, endpoints to undergo quantitative risk This is especially true for the personal care. the corresponding demand for safety,assessment sector where consumers are becoming. information by consumers there is a,increasingly interested in the products.
Of the 26 individual safety elements need to understand and develop a best. they and their families use every day, assessments assessed SCCS was practice for evaluating personal care. identified as the leading or co leading Non governmental organizations product safety. practice in 15 elements CIR in 13 elements NGOs are active in this area and have. ICCA in nine elements RIFM in six,elements and FEMA in three elements. Despite all the regulations and safety,systems in place for cosmetics today. questions remain about the safety of,cosmetic ingredients and the standards. associated with them The key message,coming from consumers is confusion.
around ingredient safety While some of,these questions and issues are addressed. in this paper in the context of their,relevance to best practices this paper. is not intended to provide a detailed Photo or graphic. analysis of stakeholder issues or their,As a means of moving the debate forward. UL proposes a consensus based set of,voluntary risk based standards designed. to go beyond what is required by the,existing regulations The best practices.
identified in this paper would form the,basis of such risk based standards. Health Risk Assessment, In this study UL Environment reviewed current perceptions of product safety. assessment amongst non governmental organizations NGOs and advocates through The study also examined. a review of secondary sources interviews with individuals from key stakeholder approaches to alternatives. groups retailers brands NGOs and industry associations and a comparative review assessment Although. of some of the primary product safety risk assessment frameworks available with the alternatives assessment. intent of identifying best practices of those frameworks as a means of moving both. is not solely linked to,the debate and industry practice forward. risk assessment many, A total of five primary frameworks were selected for review These include stakeholders identified it as. Cosmetic Ingredient Review CIR an emerging area in need of. Scientific Committee on Consumer Safety SCCS attention. International Council of Chemistry Associations ICCA. International Fragrance Association IFRA RIFM Process and. Flavor and Extract Manufacturers Association FEMA, Four of these frameworks were selected because they are relied upon by a wide.
variety of stakeholders including those in regulatory and industrial sectors While. UL s primary focus was on these frameworks in some cases we also evaluated risk. assessment frameworks that are not specific to the personal care products industry. such as ICCA Consideration of supplementary materials most commonly occurred. when one of the primary frameworks referred readers to additional guidance. We established a set of fundamental review criteria so that a systematic comparison. could be performed across all of the frameworks Several key categories were. evaluated with regard to the following, Assessment of individual ingredients vs finished formulations. Considerations for ingredients with specific properties or function. Data quality and requirements,Toxicity evaluation hazard and risk. Exposure assessment and,Quantitative safety assessment. The study also examined approaches to alternatives assessment Although. alternatives assessment is not solely linked to risk assessment many stakeholders. identified it as an emerging area in need of attention. After an initial review of the key frameworks it became apparent that comprehensive. evaluation of CIR SCCS and ICCA with selected supplemental materials provided the. most robust basis to assess best practices and it would not be necessary to include. the IFRA and FEMA frameworks in a comprehensive criterion by criterion evaluation. Health Risk Assessment, The review indicated that while there were many commonalities such as the health endpoints evaluated and the data types used to. form conclusions other aspects of the frameworks were variable particularly with respect to the endpoints that undergo quantitative. risk assessment Several deficiencies among the frameworks were also noted including. Lack of hazard determinations or classifications that are clearly delineated from the risk assessment process. Lack of considerations of additivity in mixtures for special cases and. Lack of guidance on filling data gaps, Based on a review of the ingredient assessment approaches described in the five primary frameworks UL has developed a series of.
best practice recommendations for assessing ingredient safety in personal care products While the SCCS framework serves as the. basis for many of the best practices recommendations attributes of the CIR RIFM and ICCA assessment approaches are also included. as are more general risk assessment practices identified in supplemental materials i e United States Environmental Protection. Agency U S EPA Organization for Economic Co operation and Development OECD guidance. It is important to note that although UL has identified a framework of best practices in this paper several significant challenges. remain including best practices for alternatives assessment and managing hazard data gaps Finally UL acknowledges that further. work needs to be done to more clearly articulate public concerns as well as the communications necessary to alleviate those concerns. Some of these public and stakeholder concerns are outlined in the next section. Stakeholder Perceptions of Product Safety, UL reviewed on line sources of information related to stakeholder perceptions of product safety and conducted six telephone. interviews This section summarizes some of the major issues identified by stakeholders but is not intended to be a comprehensive. analysis of stakeholder views on the issue of product safety in personal care products. Some stakeholders are critical of the proliferation. of chemicals of concern lists generated by,legislators regulators brands and NGOs Their. criticisms are aimed at lists based primarily on,hazard based assessments rather than at those. that also include risk based assessments which,take exposure into account A list based approach. to product formulation could they argue result,in unintended consequences of selecting an.
untested but preferred alternative to chemicals,known and tested as safe when used in a. particular context and lead to the de selection,of chemicals which pose little or no risk to. consumers in final products,In contrast other stakeholders express skepticism. that safety information is not easily accessible,or fully disclosed As result they are demanding. more information and are creating various red,lists of chemicals of concern.
Health Risk Assessment, It is important that stakeholders along the value chain understand market perceptions. and drivers of market demand when developing best practice approaches to product. safety and when communicating about those approaches. In this section UL summarizes the secondary and primary research it completed on. stakeholder perceptions of product safety and personal care products Section 2 1. summarizes the key issues of concern cited in the public discourse and specifically by. NGOs that actively track health concerns related to personal care products Section 2 2. covers information collected through interviews with stakeholder representatives from. industry associations retailers and specific NGOs working on these issues. 2 1 Background Research, UL reviewed positions on product safety available on the Internet A number of NGOs. are actively campaigning on health issues connected with personal care products and. as a result there has been regular media attention on the questions being raised by. these organizations The most frequent topics being raised include. Ingredient disclosure and product labelling, Use of chemicals of concern and or red listed ingredients. Aggregate chemical exposure2, Belief that regulations are inadequate or inadequately enforced or that. manufacturers are not conducting adequate safety assessments. 2 1 1 Ingredient Disclosure and Product Labelling, As part of the Fair Packaging and Labeling Act FPLA U S federal law requires that.
all ingredients contained in personal care products appear on the label However. U S regulations also permit fragrance and flavor ingredients to be listed simply as. Fragrance or Flavor The FPLA cannot be used to force a company to disclose trade. secrets Fragrance and flavor formulas are complex mixtures of many different natural. and synthetic chemical ingredients and they are the kinds of cosmetic components. most likely to be considered trade secrets, This lack of disclosure of the details of fragrance and flavor product ingredients coupled. with incomplete public information or understanding of the existing safety assessment. of these products has resulted in increasing distrust of both the use of fragrances and. of the companies that manufacture them, For example the Environmental Working Group EWG and the Campaign for Safe. Cosmetics CSC cite studies that found products containing fragrance in the. ingredient list had an average of 14 hidden compounds per formulation including. ingredients linked to hormone disruption3 Furthermore the CSC website states that. if personal care products contain harmful chemicals consumers have a right to know. what ingredients in fragrance may pose a risk to their health While IFRA does publish. fragrance ingredients and makes safety information available to the public NGOs. clearly do not see this as adequate in terms of disclosure since it is not associated with. specific products,Health Risk Assessment, A study by Globescan found that 82 of consumers feel that ingredient transparency is a very important or important factor in. purchase decisions relating to beauty and personal care products4 It also found that while there is increased use of databases like Skin. Deep only 57 of consumers regularly check the list of ingredients in a product before purchasing What is unknown is how many of. the consumers who do check the ingredients list know how to interpret the information presented This suggests that what consumers. really want is the assurance that the product is safe not necessarily an ingredient list. In terms of general product claims a recent UL research report examining the impact of green claims on purchase intent and brand. perception shows that in the category of personal care products claims that positively impacted purchase intent were primarily those. that explicitly related to natural organic bio based content In the study claims in this category were chosen by 44 of respondents. Claims relating to chemicals and toxins were also highly ranked and were chosen by 42 of respondents Interestingly a significant. subset of respondents also reported confusion around natural and organic designations This could indicate that the market is in a. transitional state as consumers are becoming more educated and therefore more skeptical5. This demand is translating to a shift in spending as consumers demonstrate their concern about the ingredients in their personal care. products by purchasing more products they feel are inherently safer In the U S sales of natural and organic personal care products. reached 12 6 billion in 2013 an increase of 11 2 over 2012 and representing 17 9 of the entire personal care industry6. Despite these increases in the US there is a growing consumer distrust of natural and organic personal care products because the U S. Federal Drug Administration FDA currently does not have specific requirements for products bearing the label hypoallergenic or. 2 1 2 Chemicals of Concern and Alternatives, Red Lists of chemicals to be avoided as ingredients are integral to the regulations supporting cosmetic products Red lists are. becoming a common tool employed by the value chain including retailers chemical manufacturers and brands NGOs are also. increasingly using red lists to identify priority ingredients For example the Environmental Defense Fund produced a pocket product. guide list of 10 ingredients to avoid the Campaign for Safe Cosmetics profiles nearly 20 chemicals of concern Women s Voices for the. Earth lists 20 chemicals of concern found in feminine care products the Frank Lipman website lists just over a dozen chemicals to avoid. the Environmental Law Centre in the UK lists nine chemicals to avoid in its Toxic Tour of Toiletries and the David Suzuki Foundation in. Canada developed a cosmetics shoppers guide titled the Dirty Dozen7. Based on a review of these lists the most commonly noted priority ingredients or impurities include. 1 4 dioxane Hydroquinone Petrolatum,Coal Tar Lead and heavy metals Phthalates.
BHA BHT Microbeads Silicones, Formaldehyde and Formaldehyde Nanoparticles Triclosan. Releasing Preservatives,Nitrosamines,Ethanolamine Compounds e g MEA. Many of these ingredients including parabens phthalates and triclosan are now being voluntarily phased out by major manufacturers. The State of California also adopted a red list type approach with the passage of the California Safe Cosmetics Act the Act in 2005. This Act requires manufacturers of cosmetics to report any products that contain ingredients known or suspected to cause cancer birth. defects or other reproductive harm The California Safe Cosmetics Program CSCP collects this data and makes it available to the public. via an online database which currently contains nearly 900 chemicals8. Health Risk Assessment, The key challenge with the list based Samuel Epstein M D from the University NGOs have shared concerns that. approaches is that some are only working of Illinois School of Public Health suggests manufacturers or marketers of cosmetics. lists which have not been fully assessed that the hazardous ingredients present are not required to share their safety. while others take into account mitigating in cosmetics pose high risks of cancer information with the FDA nor are they. factors such as chemical potency or dose genetic damage and reproductive toxicity required to register their establishments. as well as hazard information However Epstein states that this is due to the or file product formulations with the. in general these lists do not reflect virtual lifelong use of many cosmetic FDA and importers of cosmetics are not. our understanding of risk In some products such as shampoos and lotions required to obtain a registration number1. cases chemical hazards do not present their routine daily application to large. In a similar vein the Cancer Prevention, significant risks when they are used in areas of skin the ready skin absorption. Coalition CPC highlights what in its, products with low exposure potential of some ingredients facilitated by.
opinion is a lack of oversight and states,detergents in most products the. Over reliance on red list approaches that cosmetics are the least regulated. inhalation absorption of volatile, may lead manufacturers to substitute products under the Federal Food Drug. ingredients or their contaminants and, alternatives that have not yet made it and Cosmetic Act FFDCA CPC notes that. the additive or synergistic interactions, onto red lists or have data gaps In short the National Institute of Occupational. between multiple carcinogenic or, the unintended consequence of a red list Safety and Health found that 884 of the.
otherwise toxic ingredients 9 Other, approach is that it may encourage use of chemicals available for use in cosmetics. authors making similar points include Drs, chemicals for which potential health and have been reported to the government as. Anne Steinemann and Lance Wallace10, safety impacts are poorly understood toxic substances12. The emerging science of alternative These claims are being investigated. U S federal law states that cosmetics, assessments may offer a solution to help through research at academic institutions. do not need to be approved by the, limit unintended consequences For example a study conducted in.
FDA However the law specifies that, 2 1 3 Aggregate and Cumulative Exposure Reading UK concluded that exposure to. manufacturers have a legal responsibility, to Chemicals low doses of many different chemicals. to ensure the safety of their products,resulting from application of cosmetics. Risks associated with specific ingredients before being placed on the market and. and other environmental exposures, may be increased due to a typical person s that safety can be substantiated through. combine to create the conditions to, use of multiple products daily and over a trained toxicologists Further the FDA.
produce cancer In particular the study, lifetime cumulative exposure or through authorizes the cosmetics industry to. indicated a higher incidence of cancer, exposure to similar chemicals in a number provide a second safety opinion through. in areas of the breast where multiple, of different products aggregate For the Cosmetics Ingredient Review panel. products are typically applied11, example a study by the Campaign for The FDA does have a seat on the CIR panel. Safe Cosmetics indicates that women use Aggregate exposure is explored further and therefore is privy to all information. an average of nine personal care products in UL s analysis of the product safety submitted EWG notes on its website that. each day exposing themselves to a assessment frameworks in 36 years this industry panel has only. mixture of over 100 individual chemicals 2 1 4 Inadequate or Poorly Enforced rejected 11 ingredients as unsafe for use. It is also not clear whether other sources Regulations in cosmetics The European Union on the. of exposure to the same chemicals e g in other hand banned more than a thousand. NGOs and the public have indicated low, food has been considered by these groups ingredients from use in cosmetics in.
levels of trust in regulatory oversight, in terms of overall risk However it should 200313 It should be noted that virtually all. of the personal care products industry, be noted ingredients are generally specific of the banned EU ingredients have never. due in part to a perception that current, to product types and that consumers been used in cosmetics. regulations of personal care products are,rarely use the same products over their. weak or that they are poorly enforced,Health Risk Assessment.
Cosmetics and personal care products in the United States are affected by number of different regulations see text box for overview. Cosmetics Regulation, The FDA regulates cosmetics under the authority of two laws the Federal Food Drug and Cosmetic Act FD C Act. and the Fair Packaging and Labeling Act FPLA According to these laws cosmetic products and ingredients with the. exception of color additives do not need FDA premarket approval The law does state that manufacturers or marketers of. cosmetics have a legal responsibility to ensure the safety of their products. Over the past few years a number of legislative proposals have been put forward to increase the FDA s authority over. regulating cosmetics The latest proposal is the Safe Cosmetics and Personal Care Products Act which was introduced in. March 2013 and would amend the FD C Act This Act would require1. Cosmetics brand owners that market in the US to register annually and submit safety data for the ingredients in their. The Secretary of Health and Human Services HHS to establish labeling requirements establish a safety standard issue. guidance for good manufacturing practices and issue recalls on products in violation of the FFDCA. The Secretary of HHS to evaluate the safety of cosmetics and ingredients to create three lists for ingredients 1 a. prohibited and restricted list 2 a safe without limits list and 3 a priority assessment list. This Act was referred to the Subcommittee on Workforce Protections in August 2013 and no further action has been. Washington State and the State of California have enacted their own legislation focused on personal care products. Washington State s Children s Safe Products Act adopted in 2008 includes a ban of phthalates from personal care. products marketed to or used by children1 The California Safe Cosmetics Act was passed in 2005 which requires. manufacturers of cosmetics to report any products that contain ingredients known or suspected to cause cancer birth. defects or other reproductive harm The California Safe Cosmetics Program CSCP collects this data and makes it. available to the public via an online database which currently lists nearly 900 chemicals. 2 2 Stakeholder Interviews, To supplement the research UL conducted a small number of structured telephone interviews with individual stakeholders from four. distinct groups brands industry associations retailers and NGOs These interviews were not intended to be fully representative or. quantitative but rather were designed to expand on our research findings Key findings are outlined below. 2 2 1 Research into Viable Alternatives, All stakeholders agreed that alternatives assessment is an emerging area which requires more attention The retailer representative. felt that the safety standards actually do a good job in addressing risk but that hazards have been insufficiently addressed In. particular in terms of ingredient transparency and development of safer formulations this individual felt that many unwanted. chemicals remain on the market At the same time this retailer questioned whether natural products are actually performing better. than other products, Similarly the NGO representative felt that product development should start with identifying the least hazardous possible alternative. ingredients followed by risk assessment This interviewee also felt that there is inadequate consideration of product end of life or. of the impacts of complex mixtures14 Industry association members felt that while hazard is important consideration of exposure. Health Risk Assessment, and resultant risk is critical to the safety assessment by authorities and agreed that more work needs to be done on ingredient.
alternatives assessment Both risk and hazard based approaches will be supported by an agreed upon alternatives assessment. 2 2 2 Inadequate Consumer Information, Both the retailer and NGO interviewees felt that consumers were demanding ingredient disclosure and that in the absence of. disclosure they do not have adequate information to make informed purchasing decisions Although neither interviewee specified. fragrances in their comments at present these are the only ingredients which are not disclosed The retailer representative said that. the products they buy and sell are safe and that regulations are being sufficiently followed and enforced but that consumers have. changing expectations about safety and that industry safety authorities need to do more to meet these expectations. 2 2 3 Data Availability, Data availability regarding key ingredients and alternatives and the integration of such data into safety authority assessments was. cited as a key concern by both industry association and NGO representatives. 2 2 4 Patchwork of Regulations, All stakeholders commented on the fragmented regulatory and quasi regulatory landscape facing personal care product. manufacturers The industry association representative commented that the regulatory framework i e the Federal Food Drug and. Cosmetic Act needs to be modernized and that a stronger federal statute would be better than patchworks from different state. level regulations 15 The retailer representative also commented on the patchwork of regulations. The next sections provide a brief overview of the regulatory framework currently in place followed by a detailed review those. frameworks in section 4 leading to identification of best practices in section 5 The conclusion identifies the best practices. recommendations and how they address the concerns identified. Health Risk Assessment, Assessment of Product Safety industry CIR meetings are open to involved in all aspects of the chemical. Risk Assessment Frameworks the public and that public comment is industry for example the American. accommodated for each of the substance Chemistry Council ACC ICCA was created. As noted in the introduction a total of product review The U S FDA which in 1989 to coordinate the work of chemical. five primary frameworks were selected for serves as a non voting member of the companies and associations on issues. review CIR Expert Panel often relies on or and programs of international interest. Cosmetic Ingredient Review CIR considers CIR assessments when a safety ICCA operates by coordinating the work of. determination is needed but it is not member associations and their member. Scientific Committee on Consumer, bound by CIR safety conclusions17 companies through the exchange of.
Safety SCCS,information and the development of,It should be noted that UL was not able. International Council of Chemical common positions on policy issues of. to identify an assessment guideline,Associations ICCA international significance. document from CIR In the absence of such, International Fragrance Association a document UL s research team relied on Three main areas on which ICCA focuses. IFRA RIFM and individual ingredient assessments and include Chemicals Policy Health. personal communication in some cases to Climate Change Energy and Responsible. Flavor and Extract Manufacturers, inform the evaluation of this framework Care ICCA often partners with the. Association FEMA, 3 1 2 Scientific Committee on Consumer United Nations Environment Programme.
A more detailed description of each of UNEP United Nations Institute for. these frameworks is provided below Training and Research UNITAR and the. Europe s SCCS is a group of independent, 3 1 Frameworks Evaluated Organization for Economic Co operation. scientists that provides opinions to, 3 1 1 Cosmetic Ingredient Review and Development OECD. the European Commission or EC the, CIR established by the Personal Care executive body of the European Union ICCA published a detailed guidance. Product Council PCPC is an Expert Panel EU SCCS provides guidance for testing document titled International Council. comprising industry representatives and evaluating the safety of cosmetic of Chemical Associations ICCA Guidance. and expert toxicologists chemists and based upon a risk assessment process on Chemical Risk Assessment 19 which. dermatologists The charge of the CIR, defined by the World Health Organization provides a comprehensive approach. Expert Panel is to review published and WHO 18 The charge of SCCS is to to assessing risks in chemicals on an. unpublished industry provided literature evaluate select cosmetics ingredients ingredient basis The guidance was. and data for all cosmetic ingredients or on the positive list or by mandate from produced for developing regions and. group of chemically similar ingredients EU commission SCCS often works in small and medium sized companies and. as determined by internal chemists early partnership and harmonizes assessment is part of a series of guidance documents. in the process to determine whether the approaches with other European Union to help ICCA member companies. ingredients are safe under their current EU agencies such as the Scientific fulfill their commitment to perform. use Committee on Health and Environmental risk assessment under global product. Following its review the CIR Expert Panel Risks SCHER and the Scientific strategy define safe use conditions and. votes on a final safety evaluation and Committee on Emerging and Newly if necessary implement risk management. summarizes its findings in a final safety Identified Health Risks measures so that safe use conditions. evaluation report which is published in a 3 1 3 International Council of Chemical are met Although the ICCA framework. peer reviewed journal the International Associations is not followed within the personal care. Journal of Toxicology Toxicity evaluation industry it is widely recognized as a best. The ICCA is comprised of numerous trade, and guidance documents are then risk assessment practice.
associations representing companies,developed for the personal care products. Health Risk Assessment,3 1 4 International Fragrance Association. IFRA was founded in 1973 to develop and publish standards for the safe use of fragrance ingredients and materials in a wide variety of. consumer products20 Together with its scientific arm the Research Institute for Fragrance Materials RIFM IFRA develops standards. for individual fragrance ingredients based on a risk assessment approach that incorporates current use levels product type and the. potential for exposure when products are used as intended21 22 RIFM s analyses and conclusions are vetted by an independent Expert. Advisory Panel of dermatologists pathologists toxicologists and environmental scientists with no ties to the fragrance industry The. scientific analyses produced by RIFM are published in peer reviewed journals and IFRA s standards for fragrance ingredients are posted. to its website IFRA represents an 8 billion global industry and its members supply 90 of the global market for fragrance materials. 3 1 5 Flavor and Extract Manufacturers Association. FEMA in conjunction with its Expert Panel of scientists has developed and published safety data to support the self affirmed. Generally Recognized as Safe GRAS status of over 2 700 individual flavoring ingredients since 197023 The FEMA Expert Panel relies. on groups of structurally related chemicals as a key component of its risk assessment approach for food flavoring ingredients This. is much like the safety evaluation approaches used for these ingredients by the WHO s Joint Expert Committee on Food Additives. JECFA and the European Food Safety Authority24 25 26 The primary stakeholders include flavoring and food manufacturers who rely. on the self affirmed GRAS status of individual flavoring ingredients the U S FDA and the general public who can review the FEMA. Expert Panel s GRAS lists and the scientific analysis supporting ingredients GRAS status The Expert Panel is recognized by the U S. FDA and by the domestic and international food industry. 3 2 Key Attributes Reviewed, Although the information reviewed during this analysis is qualitative it was critical to establish a set of fundamental review criteria. so that a systematic comparison could be performed across all of the frameworks Several key categories were evaluated and are. presented in Table 3 1,Health Risk Assessment,Table 3 1 Key Framework Evaluation Criteria. Category Criteria Questions Addressed, Individual Ingredients How are ingredients identified.
vs Finished Formulations Is formulation level analysis preferred and if so for what endpoints. Is a method provided for roll up of individual ingredient assessments into a product assessment. Does the framework address chemical loading additivity or synergistic reactions within a. formulation, Considerations for Does the framework distinguish between intentionally added ingredients and impurities If so does. Ingredients with Specific the evaluation methodology for intentionally added ingredients and impurities differ. Properties or Functions Do compounds with certain hazardous properties undergo a distinct assessment process i e are. suspected carcinogenic mutagens and reproductive toxins treated differently than irritants. Does the framework have any chemical specific recommendations i e are certain chemicals. prohibited outright or required to undergo a more rigorous assessment process. Do the frameworks have special considerations for flavorings fragrances and nanomaterials. Data Quality Does the framework specify minimum health data requirements for evaluating product safety. Requirement Does the framework specifically address data quality What studies should and should not be used. and is there a specific scoring system e g the Klimisch system utilized to evaluate product safety. Are there recommended data sources, If no ingredient specific data are available what are the recommendations for filling data gaps. Toxicity Evaluation What toxicity endpoints are evaluated. Does the framework have separate evaluation of hazard versus risk. Does the framework recommend the use of regulatory lists to establish hazard. What endpoints are subject to quantitative risk assessment. Toxicity Assessment by Endpoint, Repeated Dose Toxicology Is this endpoint required assessed. What are the data recommendations requirements for the framework. What is the general methodology for the evaluation of this endpoint. Is there a discussion of what constitutes an adverse vs adaptive effect chronic toxicity. Are there specific endpoints the LOAEL should not be based on e g changes in body weight chronic. Is how is the issue of human relevance addressed,Mutagenicity Is this endpoint required assessed. What are the data recommendations requirements for the framework. What is the general methodology for the evaluation of this endpoint. How is positive negative in vitro mutagenicity data interpreted. Carcinogenicity Is this endpoint required assessed. What are the data recommendations requirements for the framework. What is the general methodology for the evaluation of this endpoint. How is carcinogenic MOA considered in the analysis by the frameworks and how do the framework. approaches compare, How does the framework handle linear vs nonlinear extrapolation conceptually and what specific.
extrapolation methods are used,Health Risk Assessment. Category Criteria Questions Addressed, Skin and Eye Irritation Is this endpoint required assessed. What are the data recommendations requirements for the framework. What is the general methodology for the evaluation of this endpoint. Developmental and Is this endpoint required assessed. Reproductive Toxicity What are the data recommendations requirements for the framework. What is the general methodology for the evaluation of this endpoint. How is the issue of maternal toxicity addressed,Sensitization Is this endpoint required assessed. What are the data recommendations requirements for the framework. What is the general methodology for the evaluation of this endpoint. Neurotoxicity Is this endpoint required assessed, What are the data recommendations requirements for the framework. What is the general methodology for the evaluation of this endpoint. Phototoxicity Is this endpoint required assessed, What are the data recommendations requirements for the framework.
What is the general methodology for the evaluation of this endpoint. Endocrine Activity Is this activity required assessed. What is the general methodology for the evaluation of this activity. Exposure Assessment Does the framework address assessment of aggregate exposures i e exposure to same ingredient. across multiple products exposures, What are the sources of exposure equations and exposure assumptions. Safety Determination How is overall safety determined for each endpoint. Comparisons Does the framework address approaches for characterizing uncertainty in evaluation. Uncertainty Assessment How do the different SFs compare across assessments. How does each endpoint assessment factor into overall safety assessment. Alternatives Assessment Does the framework provide any approaches for evaluating alternatives. Notes LOAEL Lowest Observed No Affect Level MOA Mode of Action SF Safety Factor. Summary of Framework Comparison, Based on the criteria detailed in table 3 1 UL found many commonalities among frameworks such as the health endpoints evaluated. and the data types used to form conclusions However the frameworks varied considerably both in terms of the assessment to be. conducted and in the determination of the endpoints to undergo quantitative risk assessment. UL s analysis also identified the following potential development areas. Lack of consistent hazard classifications and processes that are clearly delineated from the risk assessment process. Lack of generally agreed upon or consistent approaches to alternative assessment. Lack of consistency in terms of consideration of additivity in mixtures. Lack of a clear process in event of data deficiency. This analysis derived several leading practices from across the frameworks to inform development of an overarching best practice. framework for evaluating personal care product safety in a way that is transparent and can be consistently applied. A detailed summary of the framework comparison results is presented in Appendix A. Health Risk Assessment,Best Practices Recommendations. The Table below summarizes best practices for all of the criteria reviewed. Table 5 1 Best Practices,Category Question Best Practice. Ingredient vs Ingredient All Ingredients should be identified using the INCI system and CAS numbers where. Full Formulation Identification available, Product Level Evaluation of the toxicity of whole product formulation Recognizing that it is not feasible.
Testing to test animals and or conduct long term toxicity testing in humans whole product. testing for skin irritation eye irritation and sensitization in humans is recommended If a. company opts out of product level testing e g because a new formulation is very similar. to a product that has already been tested a scientific justification should be presented. Product Level Risk Specific consideration should always be given to possible chemical interactions that could. Assessment increase the toxicity of the individual ingredients Recognizing that information on specific. chemical interactions is sparse best practices for the safety evaluation of personal care. products should consider dose additivity for ingredients that have a similar mode of action. or affect chronic toxicity to the same target organ via a common mechanism. Considerations Impurities Best practices require reliably identifying and quantifying ingredient impurities and by. for Ingredients Byproducts products Priority impurities should be evaluated as intentionally added ingredients. with Specific,Properties or, CMR and Other Excluding hazardous CMRs without a risk assessment based on other agency industry. High Hazard determinations e g Proposition 65 reflects a conservative best practice From a purely. Ingredients as scientific perspective excluding chemicals below a risk threshold derived used best risk. Determined by assessment practices will not improve product safety. Authoritative, Fragrances Reliance on IFRA and bans and restrictions established by SCCS over levels established. by IFRA for overlapping ingredients If a compound with a sensitizing hazard is present. in a final product at a level greater than 100 ppm the manufacturer should perform an. independent assessment of the sensitization potential to determine if a safe level can. be derived based on the data as well as investigate any clinical epidemiological evidence. With respect to respiratory sensitization the only best practice is to prohibit the use of. ingredients that are classified as respiratory sensitizers. Flavorings Reliance on FEMA assessments However if a flavoring has been evaluated by EFSA or JECFA. and a lower acceptable limit has been derived that level should be used preferentially. Nanomaterials Best practices for safety evaluation of nanomaterials should consider both U S FDA s. recommended approach and SCCS s mandatory requirements risk assessment needs to be. carried out on a case by case basis, Use of CIR and Ingredient safety assessments are conducted by authoritative agencies e g CIR SCCS and. SCCS Assessments U S FDA Where safety determinations vary the most restrictive levels should be used. preferentially The manufacturer should perform an independent MOS assessment.

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Phenological Analysis of Brown Rot Blossom Blight of Sweet ...

Phenological Analysis of Brown Rot Blossom Blight of Sweet

Phenological Analysis of Brown Rot Blossom Blight of Sweet Cherry Caused by Monilinia laxa L. Tamm, Chr. E. Minder, and W. Fliickiger First and third authors ...

Beam lightning network position paper

Beam lightning network position paper

Furthermore, the team plans to evaluate current Lightning Network implementations for the possibility of a fork. Several implementations are at an impressive condition and the team would be happy to gain a speed boost from taking over the work that has already been done. That goes especially for the parts that require minimal adaption for Mimblewimble, like the transportation layer and onion ...



React.js (Fundamentals, Hooks, Context) Redux Node.js Overview APIs (REST, GraphQL) Databases (SQL, NoSQL) Console Git and GitHub Mobile Development (React Native) Desktop Applications (Electron) UX/UI Fundamentals SEO for developers DevOps (Monitoring, CI/CD, Deployment) Software Testing Agile Methodologies (Scrum) Project Management Interview ...

The Safeguarding of the Audiovisual Heritage: Ethics ...

The Safeguarding of the Audiovisual Heritage Ethics

The Safeguarding of the Audiovisual Heritage: Ethics, Principles and Preservation Strategy (IASA-TC 03) Co-Edited by Will Prentice and Lars Gaustad 4th Edition 2017 This publication provides guidance to audiovisual archivists on a professional approach to the safeguarding of physical and digital audio and video objects ISBN 91-976192-0-5n

TS 103 224 - V1.1.1 - Speech and multimedia Transmission ...

TS 103 224 V1 1 1 Speech and multimedia Transmission

The present document describes a sound field recording and reproduction technique which can be applied for all types of terminals but is especially suitable for modern multi-microphone terminals including array techniques. The present document provides an additional simulation technique which can be used instead of the part 1 of ETSI multi-part



The manuscript for this volume was prepared entirely by Simo Parpola. He has also done almost all of the editing and typesetting work on the volume. The format of this volume differs somewhat from that of other SAA volume in that there is an extensive Introduction to the corpus of texts edited here.