ICCA s Contribution to SAICM: The Global Product Strategy The Global Product Strategy (GPS)
About ICCA The International Council of Chemical Associations (ICCA) is the world-wide voice of the chemical industry, representing chemical manufacturers and producers all over the world. ICCA enables and encourages its members to: exchange knowledge and share best practices promote the spirit, principles and practice of Responsible Care present a united chemical industry view to - and interact with - key international organisations support international free trade and the World Trade Organization (WTO). 4 December 2008 2
About ICCA 4 December 2008 3
ICCA Commitment ICCA is committed to SAICM and to achieve the goal set forth by the World Summit on Sustainable Development, that by 2020 chemicals are used and produced in ways that lead to the minimization of significant adverse affects on human health and the environment. The commitment is built upon several voluntary initiatives 4 December 2008 4
ICCA Initiatives www.icca-chem.org 4 December 2008 5
Global Product Strategy (GPS) Product stewardship is the industry s management of the health, safety and environmental aspects of a product throughout its total life cycle working in cooperation with upstream and downstream users. The Global Product Strategy (GPS) is an important pillar of the Responsible Care program builds a foundation for continuous improvement of product stewardship within the industry and with downstream users and customers fosters greater transparency 4 December 2008 6
Global Product Strategy (GPS) Main components Global product stewardship guidelines to share and widely communicate best practices within the chemical industry and with costumer industries A management system approach for implementation product stewardship to continuously improve performance 4 December 2008 7
Global Product Strategy (GPS) Main components A systematic, tiered process for completing risk characterisation and establishing risk management measures for chemicals in commerce until the year 2018 A special focus on working directly with downstream users across the product chain to enhance product stewardship Improve transparency of chemicals management, including the identification of ways to make product stewardship information publicly available A closer cooperation with governments and other stakeholder in a partnership approach to promote product stewardship globally 4 December 2008 8
Global Product Strategy (GPS) Chemical industry s global contribution to SAICM Global Product Strategy (GPS) Regulatory initiatives EU REACH US TSCA US ChAMP Canadian DSL Japan METI GHS etc. Voluntary initiatives Responsible Care ICCA HPV Base set of information OECD / SIDS LRI etc. Globally consistent approach that accommodates national, historical, cultural and regulatory differences 4 December 2008 9
Global Product Strategy (GPS) FAQ: Global Perspektive Does the Global Product Strategy contemplate a uniform international industry approach? The Global Product Strategy provides implementation flexibility and recognizes that there are distinct national, historical, and cultural ways of doing business, distinct regulatory and legal requirements across the globe. By working together to implement the strategy, however, the global industry will improve safe management of chemicals and product stewardship within the many countries and cultures in which its products find beneficial uses. 4 December 2008 10
Global Product Strategy (GPS) FAQ: ICCA Voluntary Programms How does the Global Product Strategy work with other industry initiatives? Concrete measures adopted through GPS are an important part of the global chemical industry s implementation of Responsible Care and the new Responsible Care Global Charter. The Global Product Strategy incorporates important related initiatives, including: ICCA Global Chemicals Management Policy, Long-Range Research Initiative (LRI), High Production Volume chemical testing program (HPV), regional initiatives and activities. 4 December 2008 11
Status of GPS Status of GPS Development / Implementation
ICCA Challenge Global Product Strategy (GPS) GPS as an essential element of Product Stewardship performance is critical to the reputation of the chemical industry GPS was launched at the Dubai conference in Feb. 2006 to increase public confidence All major chemical companies accepted the obligation to put GPS into practice ICCA committed GPS as contribution to the UN SAICM process First positive feedback by UN External review process through ICCM-Conference May 2009 4 December 2008 13
Chemical Policy & Health (CP&H) New organization CP&H Leadership Group ICCM2 Planning Team Task Forces Information Gathering / Sharing Capacity Building Advocacy Performance Monitoring / Reporting 4 December 2008 14
CP&H Priority Objective Improve industry performance 1. Improve intelligent risk assessment processes and information gathering Define a riskassessment-driven base set of information for chemicals in commerce Develop a process for sharing of relevant information Develop an inventory for chemicals in commerce 2. Continuous performance monitoring and reporting (e.g. metrics, milestones, auditing process, etc.) 3. Ongoing capacity building to support developing regions/industries 4. Advocacy of results not intentions to governments and stakeholders 4 December 2008 15
Final Goal - Intelligent risk-based strategy for all chemicals in commerce WSSD 2020 Advocacy Results (e.g. Inventory) Implement Risk management Intelligent Risk assessment Information gathering Capacity building Data sharing Performance monitoring 4 December 2008 16
Base Set of Information
Scope of data gathering and generation GPS activities are focused on chemicals in commerce exceeding a threshold of 1 t/y per company or having a highly toxic / eco-toxic profile generating a major threat to employees or the public even in very small amounts Risk characterisation and risk management measures for chemicals in commerce until the year 2018 4 December 2008 18
Standard requirements - Base set of Information Substance Identity Phys / Chem Tox / Ecotox CAS Number(s) Name(s) Structural Formula Composition being assessed Use Pattern (categories types) Sources of Exposure Physical state Melting Point Boiling Point Relative Density Vapour Pressure Partition Co-efficient Water Solubility Ignition temperature Explosiveness Acute toxicity data (relevant route of exposure e.g. oral, dermal, inhalation) Acute Toxicity (most sensitive species: fish, daphnia or algae) Biodegradability 4 December 2008 19
Base Set of Information - Final toxicological data requirements (Additional technical guidance currently developed on TF IGS level) Standard Parameters 1. Identity 2. Phys-Chem 3. Tox / Ecotoxicity (accidental exposure) 4. Biodegradability Tier 1 (e.g minimal exposure or no hazard potential) Tier 2 (e.g low exposure or low hazard potential) Irritation (Eye / Skin) in case of accidental exposure Irritation (Eye / Skin) Mutagenicity (Ames) Sensitization (Structure) Tier 1-4 Tier 3 (e.g medium exposure or hazard potential) Tier 4 (e.g high exposure or high hazard potential) Irritation (Eye / Skin) Sub acute (28-days) Mutagenicity (Ames) Sensitization Irritation (Eye / Skin) Sub acute (28-days) Mutagenicity Sensitization Repro / Develop toxicity 4 December 2008 20
Base Set of Information - Final ecotoxicological data requirements (Additional technical guidance currently developed on TF IGS level) Standard Parameters 1. Identity 2. Phys-Chem 3. Tox / Ecotoxicity (accidental exposure) 4. Biodegradability Tier 1-4 Tier 1 (e.g minimal exposure or no hazard potential) Tier 2 (e.g low exposure or low hazard potential) Tier 3 (e.g medium exposure or hazard potential) Tier 4 (e.g high exposure or high hazard potential) Relevant information in case of accidental exposure Acute Toxicity (most sensitive species) Acute Toxicity (Fish) Acute Toxicity (Daphnia) Acute Toxicity (Algae) Acute Toxicity (Fish) Acute Toxicity (Daphnia) Acute Toxicity (Algae) Chronic toxicity 4 December 2008 21
Alternative source of information to fulfill the Base set of Information (Quantitative) Structure Activity Relationships Read-across Category approaches Waiving criteria In vitro methods Expert judgment Historical human data available Available Literature and databases 4 December 2008 22
Information / Data Exchange Information / Data Exchange under GPS
How to share information and / or data? Information used for risk assessment under GPS: Information on a substance used solely for risk assessment / management purposes (e.g. under GPS) will be shared among coproducers with no cost compensation Data / Information used for regulatory purposes: Data on a substance used to obtain e. g. a valid government registration would qualify for a simplified cost compensation scheme based on fixed prices for several types of tests and studies Fixed cost categories are a best practice recommendation for companies under GPS. Existing cost sharing agreements (e.g. HPV or REACH consortia) should be maintained as such 4 December 2008 24
Central Global Source of Information - Access via web based portal e.g Company, Association, Public Server Web-Portal 4 December 2008 25
Exchange Forum Levels - Information vs. Data (Additional process guidance currently developed on TF IGS level) e.g. Safety summary for products OECD SIDS dossiers ICCA HPV Dossiers EU-Risk Assessment Public Exchange Forum (Open access via web-link to source) Level 0 e.g. Robust Study Summaries (being made available e.g. via ECHA), Safety data sheet (SDS) Guidance on risk assessment Default exposure scenarios Risk management procedures Information Exchange Forum (Access for chemical industry) No cost compensation Level 1 e.g. Overview of study data within companies Statement of data ownership (yes / no) Additional data exists (yes / no) Judgment of validity Point of contact etc. Data Exchange Forum (Access for chemical industry) Cost compensation Level 2 4 December 2008 26
TF Information gathering / sharing Progress up to now Data requirements of Base Set of Information in tiered approach finalized Sorting criteria for allocation of substances to categories have been established Definition of information (no compensation) versus data (compensation) has been finalized and agreed on Fixed cost categories have been defined and legally checked Future Focus Develop detailed technical guidance on attribution to hazard / exposure categories, additional data requirements, process of information / data exchange, Develop proposal for information to be made publicly available 4 December 2008 27
Timeline
Milestones towards ICCM-2 Timeline 17.-20. Aug 2008 27. Aug 2008 3. Sept 3. Oct Dec Jan March 2008 2008 2008 2009 2009 April 2009 May 2009 CP&H Leadership Group Meeting (Tokyo) Budget 2008 / 2009 for Board Meeting CP&H Briefing Documents (Items for approval) ICCA Steering Committee (Athens) ICCA Board Meeting (Athens) CP&H Leadership Group Meeting (Houston) WEF Davos Regional Press briefings Press ICCM-2 conference (London) 4 December 2008 29
Information
ICCA Global Product Strategy Webpage 4 December 2008 31
ICCA Information on GPS FAQ 4 December 2008 32
Summary The chemical industry is highly committed to product stewardship We are doing everything in our power to make GPS and SAICM a success - this is a top priority for our industry Thank you for your attention 4 December 2008 33