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
Restrictions Canada 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
NSN Fees Canada 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 include: Certification Statement Corporate HQ Proposed Site of Manufacture/Import Technical Contact (Canadian Agent) Amount of Substance Date of Exceedance Schedule Identification Confidentiality Claims
Canada Technical Information depends on the Schedule Requirements for chemicals and polymers may include: Physical-Chemical Characteristics Toxicological Data Eco-toxicity Data Analytical Test Method Information Exposure Related Information Any other information in possession / or accessible
Canada Criteria for acceptable data Full Study Reports Methods Results Appropriate Test Methods OECD, EC BTM, HPB, EPA Appropriate Quality Assurance Conditions GLP or equivalent
Canada Low Concern Polymers Changed to Reduced Regulatory Requirement (RRR) polymers Not a Polymer Exemption!! A RRR polymer requires less information in the notification package than a non-rrr polymer. However, the requirements for a RRR polymer are very similar to those for the Polymers Exemption under TSCA. NAMW, Oligomer content 500/1000 daltons, Stability
RRR Polymers Canada Notification required for an unlisted polymer >1,000 kg/year Schedule 9 If meets RRR criteria and is on the NDSL or reactants and monomers are on DSL or NDSL Basic molecular weight use information, etc.
Canada DSL Listing Scheme #1 Notice of Excess Quantity (NOEQ) When the highest level of testing is reached Notice of import or manufacturing exceeding specified trigger volume Scheme #2 Notice of first manufacture or import (NOMI) Highest level of required testing submitted Assessed by CEPA to be non-toxic Notice of first manufacture or import, after assessment, sent to CEPA specified trigger volume not attained Published in Canadian Gazette Only notifiers can import or manufacture their substances until DSL listed
Canada New Website for New Substances Program http://www.ec.gc.ca/substances/nsb/eng /home_e.shtml NSN Information line 800-567-1999 (toll free Canada) 819-953-7156 (outside Canada)
Europe Law 67/548/EEC Government Agency specific country agency Trade Association - CEFIC
Europe REACH!!!!
Europe Inventory EINECS ELINCS NLP Some European countries may require registration and inventory listing for industrial chemicals and products Notification required on pre-market basis Transfer from one company to another Import into the EU include from parent company to a subsidiary or vice-versa Mandatory testing required Volume dependent
Europe European Inventory of Existing Chemical Substances (EINECS) Fixed list (Static Inventory) - About 100,000 listings European List of New Chemical Substances (ELINCS) New chemicals list Notification process to get on list Register chemical in one EU country, then it gets put on ELINCS for all of EU to use New substance can be registered by chemical name or by trade name Trade name gives some protection Others who make chemical would have to register as well
R EA Europe C H!!!!
Notification to ELINCS Europe Based on amounts of chemical in commerce 1000kg, 10,000kg, 100,000kg No Notification for process R & D (PORD) up to 1000kg Before going over an amount, a dossier of information must be submitted prescribed information for each level includes Toxicology testing includes Chemistry testing as well When importing substance (that is ELINCS) from outside EU, notify in each country where import will take place
EU Reduced Notification Typical Testing Requirements (for up to 1,000 kg/yr; 5,000 kg accumulated) Melting/Freezing Temperature Boiling Temperature Water Solubility Partition Coefficient Flammability/Pyrophoric Properties Acute Oral Toxicity Skin Irritation Eye Irritation Skin Sensitization Ames Test Ready Biodegradation Purity/Impurities Structure confirmation UV/IR/NMR spectra
EU Base Set Typical Requirements For over 1,000 kg/yr or 5,000 kg accumulated (in addition to "Reduced" Notification tests) Relative Density Vapor Pressure Surface Tension Auto-flammability Properties Oxidizing Properties Particle Size Analysis Particle Size Analysis Acute Dermal Toxicity or Acute Inhalation Toxicity 28-day Oral Toxicity 28-day Oral Toxicity In-vitro Chromosome Aberration Test or Mouse Lymphoma Assay Acute Toxicity to Trout Acute Toxicity to Daphnia Algal Inhibition Analytical Support for Trout, Daphnia and Algal Studies Abiotic Degradation Soil Adsorption Activated Sludge Respiration Inhibition
Europe REACH!!!!
Europe Exclusions Intermediates for pharmaceuticals must be notified as a new chemical if not on EINECS Cosmetic components placed on market not as final cosmetic product are subject inventory listing and/or notification requirements.
Exemptions Europe R&D defines scientific R&D Volume limit = 100 kg/year Low volume exemptions Reduced notifications Annual and cumulative amounts important Polymers considered notified if All monomers and reactants >2% wt are on EINECS Meets OECD definition of a polymer
Europe REACH!
Europe REACH Regulation 1907/2006 12/18/2006 Pre-registration June, 2008 - December, 2008 Registration Covers: manufacture, import, placing on the market and use of chemical substances. Some exemptions: e.g. radioactive substances, wastes, defense interests, non-isolated intermediates, transport of goods by road, air and water Phase in based on volume Information - the supply chain Evaluation - dossiers by the Agency and Member States Authorization - substances of very high concern Restrictions The new Environmental Agency (Helsinki) will manage
Europe REACH timeline (partial) Pre-registration: by December 1, 2008 SIEF (Substance Info Exchange Forum) Consortia Registration: December 1, 2010 1000 t/yr Carcinogens, mutagens, reproductive toxins (CMR) Risk phrases R50-53 >100 t/yr Registration: by December 1, 2013 100 1000 t/yr Registration: by June 1, 2018 1 100 t/yr
Europe What should you be doing NOW for REACH? Learn personal training Organize to manage Don t underestimate resource needs Train organization Including Senior Management Lists of substances Volumes produced and/or imported Get suppliers commitments Understand customer use and exposures Make Product Stewardship decisions
Europe Resources EU website http://ec.europa.eu/enterprise/reach/links_en.htm REACHcentrum CEFIC http://www.reachcentrum.org/ RIPs (REACH Implementation Projects Seven to date, with guidance documents to supplement http://ecb.jrc.it/reach/ Training courses ACC Keller & Heckman Consultants
Europe REACH!!!!
Japan Laws CSCL - Chemical Substances Control Law ISHL Industrial Safety and Health Law Government Agency MHLW (Ministry of Health, Labor and Welfare) METI (Ministry of Economic Trade and Industry) MOE (Ministry of the Environment) Trade Association - JCIA
Japan Law concerning the Examination and Regulation of Manufacture, etc. of Chemical Substances (1987) Handbook of Existing and New Chemical Substances (ENCS) ENCS Inventory (formerly MITI Inventory) Prevent exposure to chemicals ISHL list Prevent exposure to carcinogens in the workplace
Japan Notification required to the ENCS Mandatory testing Stepwise approach Will depend on biodegradation and bioaccumulation potential Substance gets on list when appears in the Gazette Upon full notification approval Until listed in gazette, no other party can manufacture or import substance Time from notification to listing 1.5 3 years or longer
Japan Restrictions Designated chemicals Exclusions Intermediates for Pharmaceuticals Industrial notification not required Have to declare use to authorities to import
Exemptions Japan R&D [No stated limit; Purpose important Impurities at less than 1% Sited Limited intermediates Medical Devices Cosmetics Radioactive materials Others
Japan ENCS Notifications Low volume notifications Specified times of the year Option of 1,000 kg/year but not listed on inventory Ames test and notice to MOL Annual amount; Annual renewal 1000 to 10,000 kg/yr (next slide) more data needed Full notification Polymers notification 1% rule on impurities monomers below 1% are not required to be listed Low concern criteria
Japan: 1-10te 1 10te Low Volume Requirements Chemical Type Ready Biodegradation Fish Accumulation Other Data Non-ionic, non-polymeric substance MW <800. Test required: If not-ready biodegradable, consider the need for fish accumulation study. Likely to be required. Possible to negotiate exemption based on LogP, and read-across data from substances of similar structure. Could be requested based on structural concerns but unlikely Non-ionic, non-polymeric substance MW >800. Test required: If not-ready biodegradable, consider the need for fish accumulation study. Unlikely to be required, unless structural concerns exist (eg presence of halogens). Could be requested based on structural concerns but unlikely Ionic, non-polymeric substance in which either the anion or cation, or both the anion or cation have MW <800. Test required: If not-ready biodegradable, consider the need for fish accumulation study. Likely to be required. Possible to negotiate exemption based on LogP, and read-across data from substances of similar structure. Likely to be required. Possible to negotiate an exemption based on LogP, and read-across data from substances of similar structure. Ionic, non-polymeric substance in which both the anion or cation have MW >800. Test required: If not-ready biodegradable, consider the need for fish accumulation study Unlikely to be required, unless structural concerns exist (eg presence of halogens). Could be requested based on structural concerns but unlikely Polymer: (Substance meeting polymer definition) and also meeting PLC criteria. Not formally required, but likely to have been concluded as nonbiodegradable, prior to initiating polymer flow scheme tests. Not required for a polymer of low concern. The data from the polymer flow scheme will suffice Polymer: (Substance meeting polymer definition) but not meeting PLC criteria Required Not required, if it can be demonstrated that there is a low presence of MW species at <800 Could be requested based on structural concerns but unlikely especially if species of MW<800 are present at <1% JMRR719
ISHL notifications Japan Low volume <100 kg/yr 30 days prior to marketing Postcard notice Annual renewal Full >100 kg/yr No approval process Substance listed when published in Gazette Some 2006 amendments to ISHL
Law - ICA (1989) Government Agencies NICNAS Australia www.worksafe.gov.au Trade Association - PACIA
Australia Industrial Chemicals Notification and Assessment Act of 1989 (NICNAS) Australian Inventory of Chemical Substances (AICS) About 40,000 substances Industrial Chemicals Notification and Assessment Regulations (July 5, 1990) NICNAS administered by National Occupational Health and Safety Commission
Australia NICNAS scheme consists of: Scientific Assessment Company Registration Total value of substance is 500,000 ($Aus) or greater Compliance Client Support and Education Chemical Assessment Categories permits, limited, polymers of low concern, commercial evaluation, low volume chemical
Inventory AICS Notification required Mandatory testing Australia Similar to EU Base-Set or Canadian Schedule 3 Volume dependent May be some waivers for new chemicals notified under approved foreign schemes Need the actual assessment report from other country
Australia Time from notification until listing: Completion of full notification including testing Goes on AICS 5 years after approval Only notifier can import or manufacture to that point unless repeat notifications are filed However, notifier has option for immediate listing on the public inventory only Listing on confidential inventory is always 5 years after approval
Australia Notification to NICNAS Application for assessment certificate or permit Technical information dossier Handbook for Notifiers Available from NICNAS http://www.nicnas.gov.au/publications/nicnas_handbook.asp
Exclusions Australia Industrial notification NOT required for intermediates for pharmaceutical Notification is required for cosmetics http://www.nicnas.gov.au/publications/chemical_g azette/chemical_gazette_february_2006.asp
Australia Exemptions R&D Volume limit = 100 kg/year Limited notification and approvals Low Volume Exemptions <1,000 kg/year (primarily identity, phys/chem properities and uses) Polymers Reduced requirements for polymers of low concern (PLC) Same criteria as USEPA polymers exemption and Mn must be greater than 1,000 Daltons Molecular weight data, phys/chem properties, use, handling information
New Zealand Agency: ERMA Environmental Risk Management Authority Law Hazardous Substances and New Organisms (HSNO) Act Websites: http://www.hsno.govt.nz
HSNO list The Register New Zealand List of approved hazardous substances with HSNO classifications and controls
Law TCCL Government Agency South Korea MOE (Ministry of the Environment MOL (Ministry of Labor) KCMA (Korean Chemicals Management Assoc.) http://eng.me.go.kr Trade Association - AmCham
South Korea Toxic Chemical Control Law (TCCL) Existing Chemicals List (ECL) Inventory of chemicals initial inventory - chemicals in commerce up to Feb. 8, 1991 About 36,000 Notification Scheme Forms, toxicology testing 45 day review Reduced requirements for chemicals on other inventories (classified as existing ) Fee < $100(US) Only Korean National can notify
South Korea Inventory ECL Requires registration and inventory listing for industrial chemicals and products Notification required If marketed in Korea prior to 1991 (and can be proved), substance exempt from listing If listed on two other national inventories prior to 1991, testing can be reduced Testing required Time from notification to listing: dynamic substances added as approved
South Korea Typical Test Requirements Purity/structure, etc. Physical-chemical; melting point, boiling point, vapor pressure, water solubility, partition coefficient, etc. Acute toxicity Genetic toxicity; Ames, Chromosome Aberration, plus more if either is positive. Biodegradation
South Korea Exemptions R&D No stated limit Purpose important quantities <100kg/yr Not listed on inventory articles Substances controlled by other legislation food additives Pharmaceuticals Radioactive materials
Polymers South Korea Reduced requirements Water solubility is a key measure Stability data not needed if this is below a threshhold Some solvent solubility data needed as well Provide information on stability, molecular weight data, use, handling, information
South Korea Import chemicals under TCCL (new) January 1, 2006 KCMA Confirmation Certificate no longer needed Korean Customs does not need the certificate or approval number, except for 44 chemicals labeled prohibitive or restrictive Approval Certificates for the 44 chemicals are issued from the competent local environmental authority These are given to Korean Customs Importers must submit Confirmation Document on Chemical Substances to KCMA once per year for all chemical products LVE chemicals every shipment Go to KCMA website, www.kcma.or.kr, for more info on importing into Korea
The Philippines Law Republic Act 6969 Toxic Substances and Hazardous and Nuclear Wastes Control Act fo 1990 Government Agency DENR-EMB Department of Environment and Natural Resources Environmental Management Bureau www.emb.gov.ph Trade Association - PCIG
Inventory PICCS The Philippines Philippine Inventory of Chemicals and Chemical Substances Established 2000 by RA 6969 About 24,000 chemicals and chemical substances Updated every 5 years PMPIN (Pre-Manufacture Pre-Import Notification) Process
The Philippines Notification required 90 to 180 days prior to manufacture or import Submit proper form with notification Substance on other national inventories eligible for reduced notification requirements abbreviated PMPIN Detailed PMPIN form Testing required May ask for additional testing
The Philippines DENR-EMB assesses new chemical Hazard Exposure Dose response Risk characterization Risk Management DENR-EMB completes assessment/review Issue PMPIN Compliance Certificate Or, include new chemical on PICCS or Priority Chemical List Return submission to submitter with no action insufficient information DENR-EMB gives clearance File Notice of Commencement to Import or Manufacture Form Then new chemical substance added to PICCS Time from notification to listing: dynamic; substances approved are or will be added
The Philippines Typical Test or Associated Information Requirements Test results or information of the following areas should be submitted; Physical-chemical; melting point, boiling point, vapor pressure, water solubility, partition coefficient, etc. Toxicity (acute or chronic), genetic toxicity, irritation, sensitization, etc. Environmental fate, degradation, etc. The administering agency reserves the right to require additional testing to supplement that provided.
The Philippines Exclusions Non-chemical substances Naturally occurring substances Mixtures Radioactive substances Pesticides Drugs Foodstuffs and cosmetics (RA 3720)
Exemptions R&D Low volume The Philippines 1,000 kg/year, but not listed on the inventory Polymers Broad automatic Polymers exemption Although many polymers are still listed on the PICCS May be exempt from notification Monomers in PICCS Two or more of the top (by weight) are included in definition of another polymer already in PICCS Otherwise these would be like chemical notification Non-isolated intermediates Articles
China Law Provisions on the Environmental Administration of New Chemical Substances Government Agency SEPA CRC Chemical Registration Center www.crc-sepa.org.cn sepa.org.cn Trade Association - AICM
SEPA Website: China Inventory - http://www.crc-sepa.org.cn/cgi sepa.org.cn/cgi- bin/inven/bin/index.htm Procedures and forms SETC State Economic and Trade Commission Responsible for MSDS and Labeling Regulations Occupational Safety and Health Institute of Ministry of Chemical Industry ISO11014-1 1 Format
China Inventory IECSC Inventory of Existing Chemical Substances Manufactured or Imported in China Inventory has been developing for 5+ years Became effective 2003 Reopened again for missed substances clarification needed Notification required Listing on four other national inventories may reduce testing and notification requirements Testing or toxicity information is required Chinese Labs to test 120 day review period
China Polymer Exemption 30 day review R&D Exemption Non-listed substances 30 day review No volume limits Developing Low Volume Exemption Still many questions
China GB6944-2005 - Classification and Code of Dangerous Goods GB1226B List of Dangerous Goods July, 2005 - Technical Criteria for Assessment of Toxicity of Chemicals October, 2005 - Environmental Pollution Preventive Methods on Wasted Dangerous Chemicals
China Circular 65 (December 27, 2005) Effective January 1, 2006 Supposed to implement chemical trade restrictions of the PICs and POPs conventions Revises and expands China s Toxic Chemicals List Exporters of these chemicals must comply with Registration of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals Exporters to China must pay a $10,000 fee for each registered chemical
Thank You & Good Luck!