Date of

Health hazards

Information • Public Risk Characterization • NICNAS Recommendation • References B14.5. Quality of the Underlying EHS Information NICNAS has published a document that outlines how it conducts its IMAP Assessments. It can be downloaded from the following website https://www.nicnas.gov.au/chemical-information/imap- assessments. In brief, IMAP Assessments have the following characteristics: Scientifically robust risk-based approach — the framework uses simple and transparent criteria to determine the potential exposure and risks from chemicals to human health and the environment. The framework also allows for expert judgement, such as peer review to be applied where appropriate. Achieving assessment outcomes early in the framework — this approach considers advice and requests from stakeholders, including industry and the community, to produce assessment outcomes early in the program and for each tier. The effort and resources being used should match the potential risk of the chemical. At each successive tier, the comprehensiveness (and hence resource intensiveness) of the assessments increases, while the number of chemicals requiring assessment decreases. Using overseas data — a number of other countries and international agencies are generating or gathering information about the human health and environmental effects of a broad range of chemicals. To ensure efficiency and reduce duplication of effort, NICNAS is using this information (where appropriate) in the Australian context. To maximize this information, the framework's human health and environmental scientific criteria are aligned with existing hazard classification frameworks already in use across industry and internationally. Advancements in assessment methodologies — to ensure best practice in assessing chemicals in Australia, internationally recognized assessment tools are used to fill gaps in data on a number of 182 human health and environmental hazard indicators. Tools and approaches being used are QSAR models or computational models for predicting toxicity and data from suitable analogue (similar) chemicals. A flexible approach to exposure information (actual, surrogate or default). The greatest challenge when assessing the risks of chemicals on AICS is limited information on identity, volume and usage on chemicals currently being imported and/or manufactured in Australia. The framework uses surrogate information to estimate exposure, such as from overseas sources, or conservative default values (where actual or surrogate information is not available) in the early stages (Tier I and Tier II assessments). B14.6. Procedures for Updating the Database with New Information Companies that manufacture or import chemicals in Australia have an obligation to notify new chemicals, and to make a secondary notification if the circumstances under which it was originally assessed has changed including where: a significant change of use or new use occurs; a significant increase in production occurs; or if new information arises on the hazardous properties of a chemical. NICNAS conducts secondary notification assessments of chemicals previously assessed and targeted assessments (focused on hazard, exposure or use) of existing chemicals for which there were potential health or environmental concerns or relevant new data. B15. New Zealand Government EHS Databases The information presented below represents a summary of key information about the environmental, health and safety information on industrial chemicals that is available from the New Zealand government. For more detailed information about how New Zealand manages hazardous chemicals visit their website. B15.1. Overview/Description New Zealand’s Environmental Protection Authority (NZEPA) and WorkSafe New Zealand have complementary roles to play to manage risks from exposures to hazardous substances. Hazardous substances are any chemical, or mixture of chemicals, that meets New Zealand’s hazardous classification criteria. These criteria include: explosiveness, flammability, toxicity to people, ability to cause cancer, toxicity to the environment and their ability to generate a different hazardous substance on contact with air or water. Hazardous substances–including petrol, solvents, explosives, industrial chemicals, fireworks, agri- chemicals, household cleaners and cosmetics—need to be approved before they can be used in New Zealand. The role of the NZEPA is to regulate pesticides, household chemicals and other dangerous goods and substances under the Hazardous Substances and New Organisms Act (HSNO). NZEPA makes decisions on whether to approve new hazardous substances. They put rules in place called controls to manage the risks of hazardous substances and to safeguard people and the environment. 183 NZEPA also reassess substances and makes new decisions about whether the controls need to be Reviewed On and even if they needs to be banned. NZEPA also administer hazardous waste and ozone- depleting substances. Under HSNO, a hazardous substance is any substance that has one or more of the following properties above specified levels: • an explosive nature (including fireworks) • flammability • ability to oxidize (i.e. accelerate a fire) • corrosiveness • acute or chronic toxicity (toxic to humans) • ecotoxicity, with or without bioaccumulation (i.e. can kill living things either directly or by building up in the environment) • can generate a hazardous substance on contact with air or water. Rating Based on a count of ingredients of health concern. Other Negative Aspect Rating: Products that contain an ingredient that is banned from a category by regulatory agencies in the U.S., Canada, Japan or the European Union rate 0. Products that contain an ingredient that is being targeted for elimination by regulatory agencies also rate 0. Ratings for products that contain an ingredient that is subject to regulatory restrictions in a category are capped at 8 unless the product label or its manufacturer provides data documenting that the product is in compliance with the applicable restriction. Product Management Rating: Products that are certified as safe or healthy by a credible third-party (e.g., USEPA Design for the Environment) rate 10. If the relevant certification involves a comprehensive evaluation and approval of a product's formulation, those ingredients' contribution to a product's Health Hazard Rating will also be suppressed. GoodGuide adjusts a product's health rating if information is missing that is required to evaluate its potential impact. Their health hazard evaluation requires a complete list of a product's ingredients (with sufficient detail about chemical identity to allow ingredients to be checked against hazard lists) and information about the percent composition of a product (to characterize potential exposures and evaluate compliance with regulatory restrictions). Unfortunately, manufacturers are generally not required to provide both of these types of information for most consumer products. For household chemical products, there is no current regulatory requirement that companies disclose full ingredient lists. For personal care products, ingredient disclosure is required, although it may include generic ingredient names that are not specific enough to support hazard evaluation. To create an incentive for full ingredient disclosure, GoodGuide caps a product's score if it lacks complete ingredient 204 data or lists generic names that do not support chemical-specific evaluations. The caps applied are described as follows: Caps applied by GoodGuide Rating Cap Amount of Ingredient Information Available 0 No information available 4 Some ingredient information available, but list includes generic categories potentially containing high or medium health concern ingredients 6 List includes generic fragrance, without further information 8 Some ingredient information available, but list includes generic categories potentially containing low health concern ingredients All ingredients disclosed, including the constituents of generics like fragrance; or all ingredients reviewed and approved as part of a third-party certification For household chemical products and most personal care products (with the exception of sunscreens), there is no current regulatory requirement that companies disclose percent composition data. This precludes evaluating whether a product is a potentially significant source of exposure to a chemical (e.g., presence of an ingredient at less than 0.1% of a formulation is unlikely to pose a risk, while presence of that ingredient at 10% of a formulation could be a significant source of human exposure). The absence of percent composition data also complicates the evaluation of whether a product is in compliance with applicable regulatory restrictions. Both regulatory agencies and trade associations manage the potential health risks of products by defining thresholds below which an ingredient is deemed safe as used (e.g., use of an ingredient is acceptable provided that it does not exceed 5% of a product's formulation). Unless a product label discloses the percent composition data required to evaluate compliance, GoodGuide caps a product's rating at 8 if it contains ingredients that have been restricted by regulatory agencies or trade associations. GoodGuide increases a product's health rating if information indicates that an ingredient does not pose a health or regulatory concern as it is used in a product. This adjustment has the effect of minimizing the contribution of that ingredient to the product's health rating. Such adjustments are indicated in the “Product Ingredient List” section of GoodGuide product pages with a “Safe Use Exception” icon and an explanation of the basis for suppressing an ingredient. Ratings may be adjusted for the following reasons: • An authoritative third-party (such as USEPA's Safer Choice program) reviewed a product and approved its formulation. 205 • An authoritative third-party (such as a regulatory agency) reviewed the ingredient and determined that its use in a certain type of product (e.g., rinse-off hair products) does not result in significant exposure or health risk. • Percent composition data indicate the level of the ingredient is below the most stringent regulatory or trade association threshold level that defines safe use; the applicable threshold is not the subject of substantial critique in regard to its health protectiveness; and the ingredient is not authoritatively linked to a health endpoint expected to pose low dose risk. GoodGuide scientists collect data on consumer products and chemical ingredients from a variety of sources. Product ingredient lists are obtained from manufacturers, either by referencing company websites or from the manufacturer directly. Health effect information is obtained from authoritative scientific and regulatory sources. GoodGuide assesses the quality and credibility of each contributing data source. They use industry-standard identification and cross-referencing systems to facilitate matching data from external sources (e.g., chemical CAS numbers are used to connect information about product ingredients with chemical health effects). GoodGuide states that it strives to be the most reliable source of information about the potential health effects of consumer products. They focus on ensuring they have correct and complete ingredient lists for a product, which may not always be available on manufacturer websites. They claim to have systems that allow product manufacturers to provide ingredient information directly to GoodGuide, because they are in the best position to know exactly what is in their products. Each GoodGuide product page notes the source of the ingredient data — Provided by the brand. Rated by GoodGuide. B19.2. Scope of Chemicals Addressed GoodGuide focuses on rating everyday household consumer products bought either from offline or online retail outlets like supermarkets or e-commerce sites. Their core product categories are personal care, household chemical and food products. GoodGuide’s goal is to rate the products that comprise the top 80% of current sales in a category, plus innovative products that are marketed as being healthy. GoodGuide use a variety of sources to define their catalogue of available products, identify relevant brands and companies and collect information about product attributes required for their ratings system. To identify, track and organize relationships between products, brands, companies, and product categories, GoodGuide follows informatics standards used to organize consumer product and corporate information. For example, they use standard UPC codes to identify unique products. They can then link their product records to retailer-specific product identifiers as well as respond to bar code scans from mobile users. GoodGuide supplements this with a custom classification system to organize products into categories, because there is no standardized method for grouping products into consumer-relevant product categories. B19.3. Ease of Access and Use of Chemical Information GoodGuide may be searched in any number of ways: • By product category (i.e., Personal Care, Household, Food, Babies and Kids) • By subcategory (e.g., after shave, body washes and cleansers) 206 • By keywords, including chemical name and CAS# Indexes are also available to facilitate searches by Category, Company, Brand, Product and Ingredients. There is no search guide available from their website. GoodGuide also provides mobile apps that make it easy for consumers to search from their phones or other electronic devices. The GoodGuide iOS App and Android Product Scanner are free. Users may download the GoodGuide App from the iTunes App Store or the GoodGuide Product Scanner from the Google Play store. B19.4. Breadth and Depth of EHS Information Available GoodGuide’s product pages provide consumers with key data used to rate products (e.g., a product’s ingredient list or its available certifications). However, their ratings reflect a complex assessment algorithm that uses an extensive amount of data (e.g., health effects and regulatory lists) that is difficult to republish or even consistently cite via URL in a usable and easy to maintain fashion. Thus, GoodGuide typically does not provide access to the entire set of data used to determine health concern levels assigned to ingredients, or to rate the nutritional value of a food product. A search of information on chemical ingredients will yield GoodGuide’s rating of health concerns (high, medium, low or none); a listing of health hazard statements, the product category in which it is found as an ingredient and specific brand name of products that contain it. B19.5. Quality of the Underlying EHS Information GoodGuide currently acquires data from over 1,000 different sources, including scientific institutions, governmental agencies, commercial data aggregators, non-governmental organizations, media outlets and corporations. Product-level information is typically obtained from the manufacturer's website or from product labels. GoodGuide states that they strive to be the most reliable source of information on consumer products. They employ quality assurance and quality control (QA/QC) processes to ensure that the highest standards of data integrity are met and maintained. GoodGuide assesses the quality and credibility of each contributing data source based on the source’s data collection process, public reputation and reviews received by experts in relevant fields. Additionally, their information architecture uses industry- standard identification and cross-referencing systems (e.g., using chemical CAS numbers to connect information about ingredients) to facilitate matching data from external sources. Their QA/QC protocols include procedures to proactively minimize data errors, resolve potential data issues, and ensure timely updates of sources. Anyone who believes that a GoodGuide rating is incorrect or based on inaccurate data is encouraged to report the issue to them for investigation. GoodGuide does not charge any fees for investigating or correcting errors. Upon written request, they can treat submissions as confidential information. To report an error, an email can be sent to their team at GoodGuideHelp@ul.com. 207 GoodGuide’s science team will review complaints and any provided documentation and inform complainants about our determination in a timely manner. Error reports are classified into one of the following: • Raw Data Error: If a user provides evidence indicating that GoodGuide contains incorrect information about a product's identity or attributes (e.g., incorrect product-brand relationship, missing product ingredients, etc.), GoodGuide will attempt to confirm the accuracy of proposed corrections using publicly available sources. If a user proposes alternate, more up-to-date information for consideration in rating a product on any given indicator, GoodGuide will review whether their current data is misleading in the light of the new information provided. In the event that GoodGuide determines a correction or update is warranted, they will proceed to integrate the resulting rating change into their services during their next scheduled database push. If incorrect or out-of-date data materially impacts the rating assigned to a product, GoodGuide will temporarily suspend publishing that entity's record until its score can be publicly updated. • Scoring Methodology Dispute: If a user raises concerns regarding GoodGuide’s rating methodology (e.g., maintaining that an ingredient should have a different level of health concern or takes issue with the scoring rules we use), they will consider a user’s feedback in the context of overall stakeholder feedback on the GoodGuide rating system. GoodGuide do not implement custom modifications specific to a product to their rating methodologies.. They regularly review and enhance our methodologies in response to user feedback and new scientific or regulatory developments. • In many cases, data that would be relevant for a thorough assessment of an important attribute is unavailable for a product. This may be because GoodGuide has not yet identified a credible data source for a given issue or topic. Or it may be that the data are not publicly available because companies have not disclosed critical information. GoodGuide is working collaboratively with key stakeholders around the world, including government agencies, non-profit organizations, private research agencies, and companies to promote the quantity and quality of disclosure of important data to the public. If users are aware of data sources that have not yet included in GoodGuide that would improve their product coverage, contact GoodGuide to nominate these sources for evaluation. B19.6. Procedures for Updating the Database with New Information The age of data used by GoodGuide varies by source. Their stated goal is to refresh product-level information at least once every 18 months. _____________

Hazardous Ingredients

can have more than one hazardous property. For example, methylated spirits and petrol are flammable and toxic. New Zealand groups substances into physical, health and environmental hazards, and assigns a classification number to each type of hazard. If the substance has any hazardous properties, then it is a hazardous substance under the law. If it doesn't have any hazardous properties, then the substance can be considered non-hazardous and companies seeking to manufacture, import or use it don't need to worry about approval. Companies wishing to import or manufacture a substance must determine whether it is hazardous. When a hazardous substance is approved (either under a group standard or individually), controls (or rules) are put in place for their use, so that the risks are managed. Examples of controls include: • Hazardous substances must be appropriately packaged. • Hazardous substances must be used in such a way to minimize environmental effects. • Sites storing large quantities of liquid hazardous substances not in a workplace must have signage and secondary containment (bunding) in place. • Labelling and other information must clearly indicate the hazards of the substances. Each substance has a basic set of controls, known as default controls, depending on the hazard classification of the substance. Similar controls can also be found in group standards to manage the risk of the particular type of group standards. When a substance is approved, these default controls are often modified to make sure they are appropriate for the particular substance being approved. Additional controls may be assigned to them or deleted. Any site containing large quantities of eco-toxic (class 9) hazardous substances needs appropriate emergency management. Emergency management involves preventing accidents and incidents as well as limiting the adverse effects of incidents, should they occur. Requirements for emergency management are split between WorkSafe New Zealand (if a toxic substance - class 6 - and in workplaces) and the NZEPA (if exotoxic - class 9 - and not in workplaces). Emergency management requirements include: • Emergency information on labels, such as first instructions • Emergency information on safety data sheets, such as spill response procedures 184 • Equipment, such as fire-extinguishers • Signage • Secondary containment (bunding) • Emergency response plans. The level of emergency management required depends on the quantity and type of hazardous substances at the location. Where a substance has more than one hazard classification, the lowest threshold quantity is used. Threshold quantities are based on the aggregated quantity of all hazardous substances held at that location for: • Fire extinguishers • Emergency response plans • Secondary containment • Signage requirements The supplier of the hazardous substance is responsible for providing labelling and safety data sheets and ensuring they meet the required performance standards. The person in charge is responsible for ensuring emergency management procedures are in place, wherever threshold quantities are exceeded, including: • Labelling requirements continue to be met • Safety data sheets are available • The right number and type of fire extinguishers are present and correctly located • Emergency response plan has been prepared, tested and is available to staff • The site has appropriate signage • The site has appropriate secondary containment. An emergency response plan is needed for sites where large quantities of hazardous substances are present. The plan describes the emergency procedures for the site and must cover all hazardous substances held, or likely to be held, at the site. The plan must be tested at least every 12 months or within three months of a change to the plan. The plan can be part of emergency planning documentation required under other legislation WorkSafe New Zealand administer the rules for the use of hazardous substances in the workplace. During the application process, NZEPA works collaboratively with WorkSafe NZ and advizes them about the risk assessment for the hazardous substance. From the risk assessment, WorkSafe checks to see if the requirements in the regulations will manage the risks to people in workplaces sufficiently. In some situations, WorkSafe New Zealand may decide that additional requirements are needed to protect workers and other people from the potential harm from a substance. In this case, they may advise the NZEPA that a Safe Work Instrument (SWI) should be developed to address the work-related human health risks identified. An SWI may modify or set some additional requirements to those provided in the regulations. If an SWI is required, WorkSafe will need time to develop one and to obtain the Minister’s agreement before the substance can be approved. Tracking of hazardous substances in workplaces is now administrated by WorkSafe New Zealand, however if a person supplies a substance that triggers a certain threshold, they are required to retain a written record. 185 Polychlorinated Biphenyls (PCBs) are one of a number of persistent organic pollutants (POPs) which are serious environmental pollutants and are banned in New Zealand. However, it is likely that small amounts of PCBs, as with other POPs, will continue to be found and there is a framework to manage their storage and disposal. Companies wishing to manufacture or import substances into New Zealand must: 1. Provide the NZEPA with their business contact information 2. Know the ingredients of their product and if they are hazardous 3. Get a current safety data sheet 4. Label their hazardous substances correctly 5. Package their product properly NZEPA maintains several on-line, searchable databases. Among the databases are the following: The HSNO Application Register — Search for every hazardous substance and new organism application decided under Part 5 of the HSNO Act. Chemical Classification and Information Database (CCID) — Search the CCID to find detailed hazard and physical information about single chemicals for use in hazard classifications and safety information. New Zealand Inventory of Chemicals (NZIoC)— Search for single chemicals here to see if they can be used in products assigned to Group Standards. Group standards are approvals for a group of hazardous substances of a similar nature, type or use. Manufacturers and importers carry out their own assessment and assign their product to certain group standards based on the hazards and intended uses of the products. Once a group standard has been found, they need to keep a record why a particular group standard has been assigned. There are a range of offenses and penalties under HSNO and various other New Zealand regulations. Penalties are dependent on the nature of the offense, and the duty holder of the offender, but can include infringement notices, infringement fees and/or court-imposed orders. Furthermore, court imposed orders may include orders for restoration (put right the offense), adverse publicity (publicly acknowledge the offense), injunctions (stop the offense) and training orders. Maximum penalties range between NZD 5000 (for an individual) and NZD 500 000 (for a company). Prison sentences are reserved for very serious offenses, including reckless conduct without ‘reasonable’ excuse. B15.2. Scope of Chemicals Addressed In Scope The NZIoC is a database of all the hazardous chemical components of products, including pesticides, polymers, and non-infectious organisms that have been approved under group standards. Note that non-hazardous chemicals are not required to be listed, although not all substances listed in the NZIoC are classified as hazardous. There are approximately 28,000 chemicals listed in the NZIoC database. 186 Note that the term "hazardous substances" under HSNO is unique in the world. It covers both single- component chemical substances and formulated products. New Zealand's chemical approval system is also quite different from other countries. A new single-component chemical substance that is not hazardous does not require approval. Out of Scope Some hazardous substances are exempt or excluded from the HSNO. An approval is not needed to import or manufacture these substances. Exempt substances include: • Hazardous substances for use in an exempt laboratory • Radioactive material • Medicine intended for people • Food • Infectious substances • Manufactured articles • Non-hazardous substances B15.3. Ease of Access and Use of Chemical Information Each of the three New Zealand databases — HSNO Application Register, CCID, and NZIoC can be searched by CAS# or chemical name. No guidance document could be located to assist with searches. B15.4. Breadth and Depth of EHS Information Available The amount of EHS information available varies among the three databases as follows: HSNO Application Register — presents the results of the determination of whether the substance meets the definition of hazardous and a very brief basis for that determination. CCID — presents the results of the determination of whether the substances meets the definition of a hazardous substance and includes a more substantial discussion of the scientific evidence available that supports that determination, including references to specific research studies and findings. NZIoC —presents no EHS information, simply the CAS#, Name, Synonyms, Approval Status, Restrictions and Date of Approval. B15.5. Quality of the Underlying EHS Information NZEPA draws on world-class expertise and information on chemicals from local and international science communities and similar government environmental agencies around the world. NZEPA also contributes to the world- wide body of shared knowledge through many international connections. They are committed to science and risk based decision making that is transparent and offers the public the opportunity to participate. 187 B15.6. Procedures for Updating the Database with New Information All hazardous substances must be notified to NZEPA prior to their manufacture or import. Over time, new information about a hazardous substance may emerge which suggests that the risks to human health and/or the environment may not be appropriately managed by the existing controls for the substance. Similarly, new information may become available on the benefits of a substance. When this happens, the EPA may reassess the approval for the substance. An amendment makes a change to a hazardous substance approval that is ‘minor in effect’ or corrects a minor or technical error in the approval. A reassessment is an assessment of the effects of an approved hazardous substance and the controls that have been imposed on it. This includes reconsideration of the risks, costs and benefits of the substance. If anyone believes the approval for a hazardous substance should be reassessed, the first step is to outline the reasons. This is called ‘applying for grounds’. Anyone can apply to have a substance reassessed or an approval amended. Some applications are initiated by the NZEPA Chief Executive. B16. People’s Republic of China Government EHS Databases The information presented below represents a summary of key information about the environmental, health and safety information on industrial chemicals that is available from the Chinese government. Unfortunately, as of this writing, the Chinese government has made only a relatively small amount of information available in the English language. Two independent contractor sources relied upon for compiling the information are ChemSafetyPro and CIRS. B16.1. Overview/Description In March of 2011, the State Council of China published its Regulations on Safe Management of Hazardous Chemicals (China Decree 591) and it entered into force on 1 Dec 2011. Decree 591 is the highest chemical control law in China and it regulates hazardous chemicals through the entire supply chain, from manufacture, importation, distribution, storage to transportation and use. Decree 591 is not a single law. It is supported by dozens of ministerial regulations (including China MEP order 7, i.e., China REACH) and numerous guidance documents. Three main ministries involved are the Ministry of Ecology and Environment (MEE), the State Administration of Work Safety (SAWS) and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). Decree 591 requires businesses which handle hazardous chemicals to apply for licenses to operate ("license system") and submit HazChem registrations separately to two ministries (MEE and SAWS). Decree 591 also implements GHS in China requiring companies to provide SDSs and labels prepared in accordance with relevant national standards. 188 In Decree 591, hazardous chemicals are defined as highly toxic chemicals and other chemicals which are toxic, corrosive, explosive, flammable and do harm to human body, facilities and environment. All chemicals meeting GHS hazard classification criteria may fall within its scope. In Jan 2013, China MEE published the updated version of the Inventory of Existing Chemical Substances in China (IECSC). It is only available from them in Chinese, but may be downloaded from this website Some consultants will make an English language version of IECSC available if contacted directly. As of the beginning of 2013, there were 45,612 substances in IECSC. No CAS# were available for 8,486 of them. Any substance that is not listed on IECSC is regarded as a new substance in China and requires notification in accordance with China MEP Order 7 (China REACH). Among all hazardous chemicals placed on the Chinese market, more than 2800 chemicals have been added to the Catalogue of Hazardous Chemicals. This Catalogue is for administrative licensing purposes. Businesses who handle hazardous chemicals listed in the Catalogue are subject to various license requirements. Some hazardous chemicals in the Catalogue belong to highly toxic chemicals, explosives precursors and priority hazardous chemicals for environmental management and are subject to more stringent requirements. • Catalogue of Hazardous Chemicals (2015); • Highly Toxic Chemicals Management; • Explosives Precursors Management; • Priority Hazardous Chemicals for Environmental Management; Any legal entity producing, importing, distributing or using hazardous chemicals in the Catalogue of Hazardous Chemicals in China must obtain a license from local Administration of Work Safety. There are three main types of licenses: • Production license for producers; • Operation license for importers, distributors, sellers, etc.; • Safe use license for certain downstream users(*) *A safe use license is only required if the volume of certain hazardous chemicals used exceeds certain amounts and the industry sector of the user is on the list of applicable industry sectors. Articles 66 and 67 of Decree 591 require domestic manufacturers and importers of hazardous chemicals to register hazardous chemicals with the National Registration Center of Chemicals (NRCC) of SAWS prior to manufacturing or importation. Detailed registration requirements and procedures are outlined in SAWS's order 53 - The Measures for the Administration of Registration of Hazardous Chemicals. This HazChem registration is required for both hazardous substances and mixtures regardless of whether they are included in the Catalogue or not. There is no small volume exemption either. China MEE order 22 was revoked on 15 July 2016. Companies no longer need to register hazardous chemicals with environmental protection authorities. 189 Decree 591 is the most important law implementing GHS in China. Article 15 requires chemical manufacturers to provide Safety Data Sheets and labels prepared in accordance with the relevant national standards. Article 37 prohibits distributors from selling hazardous chemicals without SDSs or labels. Companies who fail to classify, label and package hazardous chemicals in accordance with those standards would face a maximum penalty of 50,000 Yuan or a ban. In addition, Decree 591 gives power to AQSIQ to conduct inspections on imported and exported hazardous chemicals and their packages at ports. SDSs and labels are the main things they inspect. Non- compliant SDSs and labels may result in a delay of customs clearance or returned goods. SAWS issued its revised Catalogue of Hazardous Chemicals in March of 2015. This Catalogue includes 2,828 entries covering more than 2,800 hazardous substances and some mixtures. The Catalogue came into force on 1 May 2015. In Sept 2015, SAWS issued a guidance document containing official GHS classifications for chemicals in the Catalogue. At present, only a Chinese language version of the Catalogue is available from SAWS, although some consulting organizations offer an English language version if contacted directly. The Catalogue is for administrative licensing purposes and does not represent a complete list of hazardous chemicals in China. For example, chemicals classified with acute toxicity GHS category 4 do not meet criteria for inclusion in the Catalogue. However, they are still hazardous and subject to mandatory SDSs and labelling requirements under Decree 591. The Catalogue includes mostly substances. Only a few mixtures are included. A substance refers to an industrial product as it is produced. There is no minimum concentration set for a product to meet the definition of a substance. The Catalogue is also a compulsory GHS classification list in China. For chemicals listed in the Catalogue, industry must use the published classifications or more severe ones to classify their chemicals and prepare safety data sheets. HazChem registration is not limited to those hazardous chemicals listed in the Catalogue. Under SAWS’s order 53, manufacturers and importers of hazardous chemicals must register such chemicals with the NRCC of SAWS prior to production and importation. Not every hazardous chemical in the Catalogue is treated the same. Hazardous chemicals which are indicated as “Highly Toxic” in the Catalogue and explosives precursors are subject to additional license and reporting requirements on storage, sales and purchase under the State Council Decree 591. The Catalogue also includes some chemical weapons precursors and drug precursor chemicals which are subject to additional control by other regulations. Highly toxic chemicals are defined as chemicals with high acute toxicity (usually GHS Acute Toxicity Category 1). Those chemicals can be lethal even in very small quantities. In China, highly toxic chemicals are mainly regulated by the following administrative regulations: • Regulations on Safe Management of Hazardous Chemicals (2011) – State Council Decree 591; • Catalogue of Hazardous Chemicals (2015); • The Measures for the Administration of Licenses for the Purchase and Road Transportation of Highly Toxic Chemicals in China (2005) – Order 77 of the Ministry of Public Security (MPS). 190 The above regulations establish a much tighter regulatory regime for highly toxic chemicals than regular hazardous chemicals in China and set additional requirements on the storage, purchase and sales of highly toxic chemicals. At one time MPS maintained a separate List of Highly Toxic Chemicals. This list has recently been incorporated into the Catalogue of Hazardous Chemicals (2015). There are currently 148 highly toxic chemicals in the Catalogue of Hazardous Chemicals (2015). The Catalogue may be searched by Chinese name or CAS#. Unlike China MEP order 7 which focuses on the registration of new substances, SAWS’s order 53 focuses on chemical products which include both substances and mixtures. A product requires registration if: • It is listed in the Catalogue of Hazardous Chemicals; or; • It is not listed but identified as hazardous based on available data. For a chemical product with unknown hazards (a chemical outside of the Catalogue), hazard identification needs to be conducted by qualified institutes as required by SAWS’s order 60 for physic- chemical identification and classification. If the product is identified as hazardous, registration will be required. All chemicals meeting GHS hazard classification (excluding certain hazard categories such as acute toxicity 5) will require registrations regardless of the volume produced or imported. The following information for each hazardous product needs to be submitted online to the local HazChem registration office which conducts preliminary review and passes complete registration materials to the NRCC of SAWS based in Qingdao City of Shandong Province. • Legal entity information; • Classification and labeling(China GHS); • Physical-chemical properties; • Main uses; • Hazard properties; • Safety requirement for storage, use and transport; • Emergency responses (24h emergency contact number required); • Chinese GHS SDS and labels required. The registration certificate is valid for 3 years and can be renewed 3 months prior to certificate’s expiry date. China REACH was issued in Jan 2010 and came into force on 15 Oct 2010. This regulation is similar in many respects to EU REACH. China REACH requires that manufacturers and importers submit new substance notifications and obtain approvals from the Solid Waste and Chemical Management Center (SCC) prior to production or importation. A foreign exporter may appoint a local Chinese agent (Only Representative) to submit new substance notifications. The notification requirement not only applies to the new substance on its own, in preparation or articles intended to be released, but also applies to new substances used as ingredients or intermediates for pharmaceuticals, pesticides, cosmetics, food additives and feed additives, etc. 191 There are four types of notifications under China REACH which depend on the use and volume of a new substance. In general, with the exception of polymers of low concern which require only a simplified notification; substances produced or imported at or above 1 ton/year require regular notification. For lower volume substances the following applies: (1) scientific research or testing purposes only, scientific research record, simplified notification; (2) isolated intermediate, special conditions, simplified notification; (3) polymer of low concern, general conditions; and (4) regular new substance, regular notification. For simplified notification under general conditions and regular notification, some eco-toxicology studies must be done locally in MEP-approved labs. IECSC is not a static inventory. Generally, new substances will be added into IECSC only after 5 years since the date of the first commencement of manufacturing or importation. Whether hazardous new chemicals substances will be added onto IECSC depends on the review of a technical committee. New substances that have gone through simplified notification or scientific research record are not added into IECSC. Upon obtaining a China REACH registration certificate, companies must fulfill post-notification obligations based on the category of management stated on the certificate. New substances are categorized as general new chemical substances or hazardous new chemical substances based on their hazard properties. Hazardous new chemical substances that are classified as persistent and bioaccumulative or are classified as harmful to ecological environment and human health will be further designated as priority hazardous new chemical substances for environmental management and are then subject to additional post-notification requirements. 192 There are some substantial differences between China REACH and EU REACH as follows: China and EU REACH Characteristic China REACH EU REACH All new substances regardless of volume New and existing substances Scope produced or imported produced or imported >= 1/tonne/year Polymers Notification of polymers Polymers are largely exempt Must be performed by local Chinese No restriction on where testing is Ecotoxicology Studies laboratories performed Must be done on all substances >= 1 Must be done on all substances>= Risk Assessments ton/year 10 tonne/year QSAR Supporting information only Accepted in lieu of some testing Joint Submission Optional Mandatory SVHC List Not applicable yet Yes Articles Out of scope In scope There is no China SVHC list yet. However, there is a Chinese version of REACH restricted substances list. B16.2. Scope of Chemicals Addressed IECSC and China REACH capture all chemicals on the Chinese market, including polymers, regardless of the volume they are produced or imported. The following substances are exempt from China REACH. • Chemical substances subject to other existing laws and regulations (pharmaceuticals, pesticides, cosmetics, food additives, etc.); • Naturally occurring substances; • Impurities (content of a single impurity <10%w/w, total content of all impurities<20%w/w), waste or by-products; • Special categories such as glass, cement, alloys, non-isolated intermediates (*), articles. *On-site isolated intermediate is regarded as non-isolated intermediate in China and thus exempt. B16.3. Ease of Access and Use of Chemical Information A major impediment to using IECSC and the Catalogue of Hazardous Chemicals is that they are not generally available in English. Both may be downloaded and searched by Chinese chemical name or CAS#. No English language help is available for conducting the searches. 193 B16.4. Breadth and Depth of EHS Information Available There is no English language EHS information available from either IECSC or the Catalogue of Hazardous Chemicals. B16.5. Quality of the Underlying EHS Information Not applicable. B16.6. Procedures for Updating the Database with New Information IECSC is updated with new chemicals only 5 years after the commencement of manufacture or import. Moreover, the availability of publicly accessible updated IECSC or Catalogue of Hazardous Chemicals is at the discretion of MEE and SAWS, respectively. B17. Asean-Japan Chemical Safety Database (AJCSD) The information presented below represents a summary of key information available from the Asean- Japan Chemical Safety Database (AJCSD). More detailed information about AJCSD may be found at their website. B17.1. Overview/Description The AJCSD is a free, public online database that provides users with regulatory information on a hundred thousand chemicals in ASEAN and Japan. Participating member countries include: Brunei, Cambodia, Indonesia, Japan, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. The AJCSD contains regulatory information on chemical substances provided directly by the governments of ASEAN countries, hazard and risk information from Japan, GHS Classification results from Japan, Malaysia and Myanmar, and sample SDSs in local language(s). Japan’s NITE is the operator of the AJCSD which began operations in April of 2016. NITE sees the database as a way of promoting gradual harmonization in the region. They emphasize that the database is for reference only, and should not be used as a substitute for regulatory requirements. B17.2. Scope of Chemicals Addressed The focus is on industrial chemicals; however, this is not further described and users should examine the scope of chemicals addressed by each of the countries that is participating in the AJCSD for clarification. B17.3. Ease of Access and Use of Chemical Information AJCSD is publicly accessible and is free of charge to use. There is an English language user’s manual available to assist with searches. There are three ways to search at the AJCSD, Search (Multilingual*), Advanced Search (English only), and Substance Lists (English only). Users can search by CAS# or chemical name in English. Advanced 194 searches may be conducted with multiple keywords, each separated by a space. They may also be conducted by molecular formula. *Burmese, English, Indonesian, Japanese, Khmer, Lao, Malay, Standard Thai or Vietnamese. B17.4. Breadth and Depth of EHS Information Available Searches of AJCSD can yield the following information: ▪ Names, CAS#, and structural formulae for chemical substances; ▪ Sample safety data sheets (SDSs); ▪ GHS classification results from Japan, Malaysia and Myanmar; and ▪ hazardous and risk assessment results from Japan. How each participating country regulates a particular substance or group of substances can also be searched for comparison purposes. B17.5. Quality of Underlying EHS Information The AJCSD provides reliable data published by international authorities. However, NITE notes that Information or data is provided on an “as is” and “as available” basis. The operator and the participating countries make every effort to ensure, but do not guarantee, the accuracy or completeness of the information or data. Since the hazard and risk information derives from the Japan CHRIP database, users have assurance that this information has been compiled by experts and has undergone peer- review. B17.6. Procedures for Updating the Database with New Information The AJCSD contains information for a lot of substances. The quality of the database is ensured by regular updates performed once every two months, and by a continual verification process. B18. US National Library of Medicine TOXNET Database Presented below is a summary of EHS information on industrial chemicals that is available from US National Library of Medicine TOXNET Database. For more detailed information, the reader should consult directly with their website. The reader should also be aware that several of the most important data sources contributing information to the TOXNET database (e.g., USEPA IRIS, etc.) are reviewed in greater detail in other sections of this report. B18.1. Overview/Description TOXNET® (TOXicology Data NETwork) is a group of databases covering chemicals and drugs, diseases and the environment, environmental health, occupational safety and health, poisoning, risk assessment and regulations, and toxicology. It is managed by the Toxicology and Environmental Health Information Program in the Division of Specialized Information Services of the National Library of Medicine. 195 TOXNET may be used to find: • Specific chemicals, mixtures, and products • Chemical nomenclature • Chemicals that may be associated with a disease, condition or symptom • Chemicals associated with consumer products, occupations, hobbies, and more • Special toxic effects of chemicals in humans and/or animals • Citations from the scientific literature TOXNET provides links to PubMed®, NLM's free web interface to the world's biomedical literature, and to additional sources of toxicological information. Specific databases that can be searched through TOXNET include: B18.1.1. Chemical Nomenclature and Structure ChemIDplus® ChemIDplus contains over 400,000 chemical records. More than 300,000 of those records include chemical structures. ChemIDplus is searchable by Name, Synonym, CAS Registry Number, Molecular Formula, Classification Code, Locator Code, Structure, and/or Physical properties. Enhanced structure display is available in ChemIDplus Advanced. B18.1.2. Toxicology Data Toxicological information may be found in the following databases: CCRIS (Chemical Carcinogenesis Research Information System) CCRIS is developed and maintained by the National Cancer Institute (NCI). It contains over 9,000 chemical records with carcinogenicity, mutagenicity, tumor promotion, and tumor inhibition test results. Data are derived from studies cited in primary journals, current awareness tools, NCI reports, and other special sources. Test results have been reviewed by experts in carcinogenesis and mutagenesis. CCRIS provides historical information from the years 1985 - 2011. It is no longer updated. CPDB (Carcinogenic Potency Database) CPDB provides standardized analyses of the results of 6540 chronic, long-term animal cancer tests conducted since the 1950s and reported in the general published literature or by the National Cancer Institute and the National Toxicology Program. This database was developed at the University of California, Berkeley, and Lawrence Berkeley Laboratory. CPDB provides historical information from the years 1980 - 2011. It is no longer updated. CTD (Comparative Toxicogenomics Database) CTD contains manually curated data describing cross-species chemical-gene/protein interactions and chemical- and gene-disease relationships. The results provide insight into the molecular mechanisms underlying variable susceptibility and environmentally influenced diseases. These data will also provide insights into complex chemical-gene and protein interaction networks. CTD is developed with funding from the National Institutes of Environmental Health Sciences (NIEHS) at North Carolina State University (NCSU). The database is updated several times a year. 196 GENE-TOX (Genetic Toxicology) GENE-TOX was created by the U.S. Environmental Protection Agency (EPA) and has genetic toxicology test results on over 3,200 chemicals. Selected literature was reviewed by scientific experts for each of the test systems under evaluation. GENE-TOX provides historical information from the years 1991-1998. It is no longer updated. HSDB® (Hazardous Substances Data Bank) HSDB provides toxicity data for over 5,800 potentially hazardous chemicals. It also has information on emergency handling procedures, industrial hygiene, environmental fate, human exposure, detection methods, and regulatory requirements. The data are fully referenced and reviewed by a Scientific Review Panel. Haz-Map® Haz-Map is an occupational health database designed for health and safety professionals and for consumers seeking information about the health effects of exposure to chemicals and biological agents. The database is a "map" of workplace hazards to help you prevent occupational diseases. Haz-Map links jobs, hazardous tasks with occupational diseases and their symptoms, and other non-occupational diseases such as hobbies. Household Products Database The Household Products Database has information on the potential health effects of chemicals contained in common products used inside and around the home. Information is also available for some industrial grade products. Products can be searched by brand name, product type, manufacturer, ingredient/chemical name, and by health effects. The record for each product shows the ingredients as reported by the manufacturer. For many products, a link to the manufacturer’s Safety Data Sheet (formerly Material Safety Data Sheet) is provided which includes more information such as handling, disposal, and health effects. IRIS (Integrated Risk Information System) IRIS, developed by the U.S. Environmental Protection Agency (EPA), is a human health assessment program that evaluates information on health effects (cancer and non-cancer) that may result from exposure to environmental contaminants, and which is subsequently compiled into a database. Reviewed by EPA scientists and representing EPA consensus, IRIS covers over 550 chemicals. ITER (International Toxicity Estimates for Risk) ITER provides health risk values and cancer classifications from authoritative groups worldwide for chemicals of environmental concern. It presents risk data in a tabular format for easy comparison between organizations, and includes synopses explaining data variations where they exist. ITER also has links to source documentation and more details. It is compiled by Toxicology Excellence for Risk Assessment (TERA). LactMed® (Drugs and Lactation) LactMed is a database of over 1,000 drugs and other chemicals to which breastfeeding mothers may be exposed. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. Suggested therapeutic alternatives to those drugs are provided, where appropriate. All data are derived from the scientific literature and fully referenced. 197 Data are organized into substance-specific records, which provide a summary of the pertinent reported information and include links to other NLM databases. Supplemental links to breastfeeding resources from credible organizations are also provided. LactMed is updated monthly. TRI (Toxics Release Inventory) TRI is a set of publicly available databases containing information on releases of specific toxic chemicals and their management as waste, as reported annually to the EPA by U.S. industrial and federal facilities. This inventory was established under the Emergency Planning and Community Right to Know Act of 1986 (EPCRA). TRI's data, beginning with the 1987 reporting year, covers air, water, land, and underground injection releases, as well as transfers to waste sites. In agreement with the Pollution

Prevention

Act of 1990, source reduction and recycling data is also included in TRI TOXMAP® TOXMAP is a Geographic Information System (GIS) using maps of the United States to show the amount and location of toxic chemicals released into the environment. Data is derived from the EPA's Toxics Release Inventory (TRI), which provides information on the releases of toxic chemicals into the environment as reported annually by industrial facilities around the United States. TOXMAP also contains information from the EPA's Superfund Program. B18.1.3. Toxicology Literature TOXLINE® TOXLINE provides bibliographic information (1840s to present) covering the biochemical, pharmacological, physiological, and toxicological effects of drugs and other chemicals. It contains over 5 million references, most with abstracts, indexing terms, and Chemical Abstracts Service (CAS) Registry Numbers. The toxicology subset of MEDLINE®/PubMed is part of TOXLINE. TOXLINE also contains references from specialized journals, government reports, meeting abstracts, and other relevant collections of toxicology literature. DART® (Developmental and Reproductive Toxicology Database) DART contains references to reproductive and developmental toxicology literature. DART is created from a search profile run against PubMed. DART previously contained additional citations from various sources that no longer exist, and from journals which are now indexed by Medline. B18.2. Scope of Chemicals Addressed The scope of TOXNET is very broad and includes chemicals in commerce, chemical contaminants found in the environment, biological agents, drugs, pesticides, biocides, diseases, genes and proteins. B18.3. Ease of Access and Use of Chemical Information TOXNET is easily accessed and searched. Individual databases may be searched one at a time or multiple databases may be searched simultaneously using single or multiple keywords, chemical name or CAS#. There is an abundance of help with search strategies available. TOXNET may even be searched from mobile devices. Detailed training and guidance are available for those wishing to search TOXNET by visiting TOXNET and Beyond Training Class Schedule and Workbook for a class schedule and to download the TOXNET manual. 198 B18.4. Breadth and Depth of EHS Information Available The breadth and depth of EHS information available from TOXNET varies considerably based on the contributing data source and substance being queried. Generalizing somewhat, extensive EHS data are available for pesticides, biocides, high volume chemicals and those chemicals that have been produced and used for longer durations and have been subject to more intensive government agency scrutiny based on their uses/exposures and suspected hazard properties. Raw data measuring the properties of chemicals (physical chemical properties, environmental fate and behavior, eco-toxicity, and mammalian toxicology) from a full range of tests and models (e.g., Quantitative Structure Activity Relationships (QSAR), computational toxicology methods, etc.) are available, as well as robust summaries of those data, hazard and exposure characterizations and risk assessments. A clear advantage of TOXNET is that it can provide the user with rapid access to the full gamut of EHS information that is available on a particular substance from multiple sources. B18.5. Quality of the Underlying EHS Information The data and information stored in each participating data source are the responsibility of the data owner. The National Library of Medicine cannot guarantee the correctness of the data, and provides explicit warnings that it cannot be held responsible or liable for errors. TOXNET does provide brief descriptions of the sources and the peer review the data has undergone for each data source. Most sources have some procedures in place to assure the quality and reliability of the information they rely upon for making chemical safety assessments; however, users of the information should confirm the robustness of those procedures by checking with the relevant sources. B18.6. Procedures for Updating the Database with New Information TOXNET databases are updated when new information becomes available. New data is checked for at least once a week. Users can refer to the TOXNET Databases Size Report to see if a specific database has been updated. Users should note that some databases are no longer updated and are maintained as historical resources. B19. GoodGuide Presented below is a summary of EHS information on industrial chemicals that is available from GoodGuide. For more detailed information, the reader should consult directly with their website. B19.1. Overview/Description GoodGuide was launched approximately 10 years ago. Its stated mission is to provide consumers with the information they need to make better shopping decisions. GoodGuide believes that as more 199 consumers choose products that contain ingredients with fewer health concerns, retailers and manufacturers face compelling incentives to make and sell better products. To fulfill their mission, GoodGuide combines manufacturer-provided information about product ingredients with authoritative information on the health effects of chemicals. They rate products so that consumers can have instant access to credible information about products that would be very difficult for anyone to develop on their own. GoodGuide employs a team of scientific experts in product and chemical information and have been engaged in this project for ten years. According to GoodGuide they have grown to become the web's most comprehensive and credible resource for information about the impact of consumer products on human health. More than 1 million consumers use GoodGuide's website and mobile apps every month to help decode product labels, research ingredients, and make more informed decisions about the products they purchase. With GoodGuide, users can: • Use their ratings to quickly identify the highest rated products on the market. • Find out whether a product contains ingredients with health concerns. • Rely on their science expertise to interpret complex information about the potential health effects of different chemicals. • Get advice while shopping by using the GoodGuide iOS App, Product Scanner for Android, or the mobile website. International Users Though GoodGuide’s product ratings currently cover U.S. based products, similar versions of the same product are available in many countries. Persons who live outside of the U.S. can still use the website as thousands of consumers currently do, but will need make sure to compare the ingredient lists for differences. GoodGuide Ratings The GoodGuide Rating was developed using methodologies that are grounded in the sciences of informatics and health risk assessment. Products are scored from a low of 0 to a high of 10. The higher the rating, the better the product from a health perspective. Note that GoodGuide maintains complete control over its rating system — brands do not have any influence over the ratings they assign to their products. GoodGuide uses “ontologies,” or structural frameworks for organizing information, to define “what matters” when assessing the health performance of a product or company. The major issues covered are summarized in their ratings overview. GoodGuide’s issue framework is derived from current standards of practice in the scientific domains relevant to assessing health impacts. For example, they track issues that mirror the standard output of chemical risk assessments or nutritional evaluations. Their reliance on the informatics systems that have been developed by scientific, regulatory or other authorities to address specific issues ensures that their system provides science-based ratings and can take advantage of standardized information generation. For each issue, GoodGuide identify a set of “indicators” that provide evidence about how a product performs on that issue. Product-level indicators are based on attributes of a product related to its potential health impacts (e.g., the level of health concern about the ingredients of a personal care product). 200 Data availability is one of the most important criteria for selecting indicators. In order to ensure they have comparable information available for rating products, they require that indicator information is publicly available for the majority of rated products. Data availability influences GoodGuide's rating system in two important ways: o In many cases, data availability considerations require GoodGuide to rely on “screening-level” indicators rather than “data-intensive” indicators. In a world of perfect information, for example, product health ratings would be based on detailed health risk assessments that combine information about the health hazards of ingredients with data characterizing consumer exposure to those chemicals. Unfortunately, these data are almost never made available by manufacturers, so GoodGuide utilizes more readily ascertainable hazard indicators (e.g., the number of ingredients of health concern in a product). o Because the pervasive lack of transparency about product attributes undermines the public's ability to evaluate performance, GoodGuide has created a number of indicators that track data availability and product impact ratings. At the product level, Data Adequacy indicators track whether the specific data elements that are needed to assess a product's health impact are public. GoodGuide penalize personal care or household chemical products missing complete ingredient lists in their scoring system because these products lack the data needed to assess chemical safety. At the product-level, the GoodGuide ratings system is designed to support comparisons of products within a product category (e.g., after shave, body wash and cleansers, candy, etc.). The evaluative framework used to assess personal care products contains a different set of issues and indicators than the framework used to assess food products - the former focuses on characterizing the health impacts of ingredients, while the latter focuses on characterizing the nutritional value of products. GoodGuide rolls-up indicator scores into issue-specific groups (e.g., human health impacts, ingredient disclosure) to assign ratings. All issues and indicators are not equal. In order to generate a rating that accurately reflects the relative importance of different issues or indicators, they apply weights to issues and utilize different aggregation algorithms. GoodGuide’s rating frameworks define what is known as a “value tree” in multi-attribute utility theory. Each specific set of indicators, sub-issues or major issues are hierarchically organized into “nodes.” For each node, they specify the weights or aggregation algorithm used to compile scores from the constituents of that node. Aggregation algorithms are used throughout their ratings system to combine sets of scores. Available methods include: • Maximum (select the highest score in a set). This is generally used in positive nodes that include certification indicators because this value promotes the most positive signal about an issue, without dilution due to inaction or no data on other indicators relevant to the same issue. • Minimum (select the lowest score in a set). This is generally used in negative nodes that include Hazard or Restriction indicators because this value promotes the most negative signal about an issue, without dilution by positive values on other indicators relevant to the same issue. 201 • Mean (calculate the average of all scores in a set). This is generally used when aggregating scores from a set of positive and negative sub-nodes in order to allow real world signals (from either quantitative metrics or compliance counts) to influence a score in either a positive or negative direction. • Preferred (select score from top available indicator in a rank ordered set of indicators). This is used in nodes where data sources or indicators have been rank ordered based on quality or relevance to an issue. It promotes the score from the best available source or indicator. • Matrix (apply a custom calculation to a set of indicators). This is used in product-level ratings when a set of indicators have to be combined using domain-specific rules to correctly characterize an issue. Prominent examples include the scoring rules applied to rate food products on their nutritional value; personal care products on their potential human health impact; and attribution of extra credit for product performance. Value judgments are unavoidable in rating systems, and GoodGuide's is no exception. Even the most scientifically grounded assessment requires value judgments about the relative importance of various issues and types of evidence, as well as the treatment of data gaps. GoodGuide acknowledge that users can disagree over the relative weight given to different health hazards as there is no objective, correct solution to the problem of how to aggregate such disparate concerns. More detail is provided below for the methodology GoodGuide uses to score Personal Care and Household Chemical Products. GoodGuide counts the number of ingredients in each product that are categorized as low, medium or high health concern. They then factor in other negative information (such as regulatory restrictions) and any available positive information (such as third-party certifications) to assign product ratings. To rate a personal care or household chemical product, GoodGuide considers the following attributes: • A health hazard rating based on the number of product ingredients categorized as low, medium or high health concern; • Indicators that the product exhibits other negative aspects (e.g., does the product contain ingredients that have been banned or subjected to regulatory restrictions); • Indicators that the product is among the best on the market in its category (e.g., has the product been certified as safe or healthy by a credible third-party); • Indicators of data gaps that preclude evaluation of the product (e.g., no or inadequate disclosure of product ingredients). In order to identify ingredients of health concern, GoodGuide utilize the science of health hazard assessment and rely on lists of chemicals labeled hazardous by various authoritative organizations. GoodGuide tracks whether chemicals are recognized or suspected of causing any of twelve major types of human health problems, ranging from cancer to endocrine toxicity to skin or eye toxicity. They combine this hazard data with chemical potency, human detection frequency and toxicity testing information, in order to assign ingredients to four levels of health concern: none, low, medium and high. An ingredient raises no health concern if: • It is not on any of GoodGuide's lists of toxic chemicals which cause suspected or recognized health effects; 202 • It has not been detected in human tissue or urine; It is not a high production volume chemical that lacks safety data. • An ingredient raises a low level of health concern if: • It exhibits two or less suspected health effects; and/or • It has a relatively low toxic potency for inhalation and ingestion exposures; and/or • It is only occasionally detected in human tissue or urine; and/or • It lacks at least half of the six basic toxicity tests required to assess chemical safety. An ingredient raises a medium level of health concern if: • It exhibits three or more suspected health effects; and/or • It has a relatively moderate toxic potency for inhalation and ingestion exposures; and/or • It is regularly detected in human tissue or urine. An ingredient raises a high level of health concern if: • It exhibits one or more recognized health effects; and/or • It has a relatively high toxic potency for inhalation and ingestion exposures; and/or • It is frequently detected in human tissue or urine. Chemicals are identified as recognized toxicants based on hazard identification efforts of authoritative national and international scientific and regulatory agencies. To date, such efforts have been focused on only a few types of toxicity. GoodGuide utilizes California's Proposition 65 lists of chemicals in order to identify recognized carcinogens, reproductive toxicants, and developmental toxicants. Chemicals are listed on Proposition 65 following a scientific peer review process and regulatory rule-making, which incorporates the hazard identification efforts of a variety of other authoritative bodies, including the International Agency for Research on Cancer and the National Toxicology Program. Hence, a substantial weight of toxicological or epidemiological evidence supports the decision to list a chemical as a recognized health hazard under Proposition 65. Stakeholders that believe a chemical does not cause a recognized health effect have the opportunity to argue that the evidence does not support identifying the chemical as a hazard. If a chemical is listed under Proposition 65, such arguments failed to convince neutral scientific and regulatory experts. GoodGuide also relies on a peer-reviewed article in the medical journal Lancet to identify recognized neurotoxicants. Chemicals are identified as suspected toxicants based on reports in the scientific or regulatory literature, or on information abstracted from major toxicological databases. Lists of suspected toxicants are linked to twelve health effects. Suspected toxicants possess evidence that they can cause specific adverse health effects. However, no authoritative hazard identification process is currently conducted by regulatory agencies or scientific organizations for these health effects. It is important to consider a chemical on a “suspected” list as a preliminary indication that the chemical may cause this effect, rather than a definitive finding that it does. In order to identify suspected toxicants, information is abstracted from the principal toxicology text books (such as Casarett and Doull's Toxicology), medical journal articles, regulatory actions, and international chemical hazard resources (such as the European Union). The weight of toxicological or epidemiological evidence supporting suspect hazard identification can vary significantly between chemicals. For example, evidence from two different laboratory species indicates that acetonitrile can cause cardiovascular toxicity. In contrast, overwhelming evidence indicates that carbon monoxide causes cardiovascular toxicity in humans. These disparate data lead to designation as a “suspected” toxicant as an 203 authoritative agency has yet to compile lists of cardiovascular toxicants. Identifications developed by regulatory agencies or scientific references often undergo peer review, but an administrative process that allows for debate over and conclusive resolution to the toxicity designation of a chemical has yet to be put in place. GoodGuide separates ingredients into two categories — “ingredients of health concern” and “controversial ingredients.” Only the former contribute to a product’s rating. A chemical must be identified as a potential health hazard by a GoodGuide-approved authoritative source (e.g., a regulatory agency like USEPA or a scientific group like the National Toxicology Program) in order to be labeled an ingredient of concern. This system ensures that our ratings are based on the best available scientific evidence. GoodGuide labels chemicals as “controversial” ingredients if they have not been identified as hazardous by authoritative sources, but are the subject of current debate regarding potential adverse effects. “Controversial” chemical designations do not contribute to the product rating because the evidence of hazard is inconclusive, however they are flagged in the event a consumer wants to avoid such chemicals.