Chemicals Regulation – Global Challenges Helsinki Chemicals Forum 2010 Lena Perenius Executive Director

Chemical Regulation- Global Challenges The Global Challenge: To ensure that, by the year 2020, chemicals are produced and used in ways that minimize significant adverse impacts on the environment and human health. 2002 Johannesburg World Summit on Sustainable Development SAICM is the strategy and process to achieve that goal

Opportunities and Challenges To improve global regulatory systems Many regulatory developments around the world To increase Regulatory Convergence facilitating trade and a level playing field To introduce Smart Regulations Delivering desired results in the least burdensome way Allowing industry to innovate and to compete fairly and effectively

Trends in Regulatory Developments Implement Global Harmonised System for classification and labelling, Modernise and improve existing chemicals legislation Introduce a regulatory system for chemicals EU: REACH is Europe's contribution to SAICM under implementation – gaining experience review in 2010

What’s new in REACH? Burden of proof/responsibility No difference new/existing substances Obligation to work together and share data New obligations on downstream users

Is REACH impacting the global regulatory developments?  Inventory  Prioritisation for assessment for risk management   From hazard to risk  Burden of proof/responsibility on industry  Convergence of rules for new/existing substances  Obligation to work together and share data in supply chain  Authorisation/substitution

Possible barriers for REACH elements Burden of proof/responsibility Societal values and capacity Convergence new/existing substances Existing approach (if any) Data sharing Confidentiality, workability Authorisation Bureaucracy, cost REACH is comprehensive and ambitious – Is it the “smartest”? Complex and costly with workability issues still to be solved

Cooperation contributing to regulatory convergence Making it happen UN, OECD, Governments, Industry Global Chemicals Industry: Responsible Care Global Charter Product Stewardship objective to “Enhance the management of chemical products worldwide” Global Product Strategy Industry’s contribution to SAICM and convergence Risk characterization and risk management measures for chemicals in commerce until the year 2018

ICCA vision Global Product Strategy (GPS) By 2020, through a combination of voluntary and regulatory initiatives, we will have: Established a base-set of hazard and exposure information adequate to conduct safety assessments for chemicals in commerce Provided global capacity to implement best assessment practices and management procedures, especially in developing countries Shared relevant product information with co-producers, governments and the public Worked across the value chain so suppliers and customers can effectively evaluate the risks and enhance their performance Made information on chemicals publicly available (GPS IT-portal via http://www.icca-chem.org/.) 3/28/20173/28/20173/28/2017

Global Product Strategy (GPS) – Industry’s global contribution to SAICM Globally consistent approach that accommodates national, historical, cultural and regulatory differences  Voluntary initiatives Responsible Care ICCA HPV Base Set of Information OECD / SIDS LRI etc. Regulatory initiatives EU REACH US TSCA US ChAMP Canadian CMP Japan CSRs GHS Cooperation UNEP UNIDO OECD NGOs ICCA internal etc.. 3/28/20173/28/20173/28/2017 10 4 December 2008 10

Back-up slides

Benefits of GPS implementation Even level playing field of the global conditions of competition (through harmonization of global product safety standards) Improvement of global chemicals management Open access to relevant product safety information for co-producers, governments and the public Joint information base for chemicals supports classification and labeling under GHS Achieving a balance between regulation and voluntary industry commitments. The goal is a single global standard in Product Safety Global harmonization of chemicals management systems will eventually help to reduce trade barriers. 3/28/20173/28/20173/28/2017 12

Chemical Regulation- Global Challenges Agenda Johannesburg declaration – SAICM Opportunities and Challenges for Regulatory Convergence Trends in Regulation considering the main elements of REACH Regulatory cooperation Governments, OECD, industry Industry’s contribution to SAICM and convergence: GPS