• Document: INTERNATIONAL FUNDAMENTALS Country by Country Comparison Of Chemical Control Laws & Regulations. March 7, 2007 Rich LeNoir Basell USA Inc
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INTERNATIONAL FUNDAMENTALS Country by Country Comparison Of Chemical Control Laws & Regulations March 7, 2007 Rich LeNoir Basell USA Inc Country Chemical Registration Requirements • DO NOT ASSUME IF CHEMICAL CAN BE USED IN THE US (appears on TSCA inventory), THAT IT CAN BE USED everywhere else in the world Canada • Law - CEPA (Canadian Environmental Protection Act) • Government Agencies – Health Canada – Environment Canada • www.ec.gc.ca • Trade Association – CCPA (Canadian Chemical Producers Association) Canada • New Substances Notification Regulations (NSNR) • General Overview: – Original regulations in force in July 1, 1994. • Updated in 2005 – Pre-manufacturing / pre-importation notification scheme. – “Up-front” safety testing prescribed by law. – Regulations apply to discrete chemical substances, polymers, and others. Canada • New Substances Notification Regulations (NSNR) – Requires Canadian importers and manufacturers of “new substances” to notify the government before introducing substances to Canada. – Penalties for non-compliance (Fines, jail). Canada • What is a ‘New Substance’? – Substances not present on the Domestic Substances List (DSL) are considered to be “new” to Canada and are subject to notification. Canada • Domestic Substances List (DSL) – A national inventory of ~ 24,000 substances considered to be “existing” in Canadian commerce. – The “original list” consisted of substances: • that were in Canadian commerce 1984 - 1986. • that were manufactured or imported in quantities over 100 kg in any one year between 1984 - 1986. – Substances “on the DSL” are exempt from notification under NSNR. Canada • Non-Domestic Substances List (NDSL) – A national inventory of more than 44,000 substances considered to be “existing” in international commerce. – “TSCA minus DSL” • Started as a 5 year lag. – NDSL (2002) = TSCA Inventory (1996) – DSL – With new regulations last year, now 1 year lag • November, 2005 – added 4 years worth of chemicals Canada • So, are there any advantages to having a substance listed on the NDSL? – May be imported or manufactured in greater quantities before notification is required. – May require less information in the notification package. Canada • Exemptions from Notification – Substances not subject to notification under the NSN Regulations include the following: • Substances on the DSL • Articles, blends, and mixtures • Impurities • Transient reaction intermediates • Substances carried through Canada • Polymer subject to the “Two-Percent Rule” Canada • Restrictions – SNAc (Significant New Activity) – SNAN (SNAc Notice) • Exclusions – NOT for intermediate for pharmaceutical, cosmetics • Recent change that requires “industrial” clearance – R&D • Limited notification for “product development” • Volume limit = 1,000 kg/year – Limited notification and approvals – Low Volume Exemptions • Annual amounts important Canada • New Substance Notification System – Notification system is a tiered system requiring notifiers to submit a series of notifications as greater quantities of materials are manufactured or imported into Canada. Canada • New Substances Notification Schedules – October, 2005 – New schedules • Roman numerals replaced by Arabic • Accumulation triggers are now eliminated • Triggers are now only annual quantities • Revised Form • No pause in review process • Submit 2 copies (either in English or French) • Keep information for 5 years – Schedules list the required information to be submitted to Canadian EPA Canada • New Substance Notification Schedules – Schedule 12 – Overview of Information Requirements • Three guidance charts – provide pathway of schedules and applicable provisions • Chart 1 – R&D, Contained Site-Limited Intermediate or Contained Export-Only substances • Chart 2 – Chemicals/Biochemicals • Chart 3 – Polymers/Biopolymers Canada • NSN Fees – For each Schedule submission – Dependant on submitters sales Canada • Within each schedule, there are two types of information requirements: – Administrative information – Technical information Canada Administration Information Requirements i

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